Detection meter and mode of operation

• US 20100021947A1
• Filed: 06/08/2009
• Published: 01/28/2010
• Est. Priority Date: 06/06/2008
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Hu, Charles, Tomasco, Michael F., Emery, Jeffrey L.
• Granted Patent: US 9,636,051 B2
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/150396 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A method for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid by using a device comprising at least one analyte quantification member and a sensor associated therewith, the method includes: applying a first sample to the analyte quantification member; and detecting the presence or absence of an adequate sample volume; wherein upon detection of the absence of an adequate sample volume, initiating a finite timed period, and signaling the user to introduce a second sample of body fluid to the analyte quantification member. Associated arrangements and devices are also disclosed.

Claims

1. A method of performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid by using a device comprising at least one analyte quantification member and a sensor associated therewith, the method comprising:

applying a first sample to the analyte quantification member; and

detecting the presence or absence of an adequate sample volume;

wherein upon detection of the absence of an adequate sample volume, initiating a finite timed period, and signaling the user to introduce a second sample of body fluid to the analyte quantification member.

2. The method of claim 1, further comprising:

interrogating the analyte quantification member with the sensor during the finite timed period to detect the presence or absence of an adequate sample volume applied to the at least one analyte quantification member.

3. The method of claim 2, wherein upon detection of the absence of an adequate sample volume within the timed period, signaling the user that the assay is being terminated.

4. The method of claim 2, wherein upon detection of an adequate sample volume during the timed period, continuing with the assay.

5. The method of claim 4, further comprising interrogating the analyte quantification member subsequent to the timed period to ascertain the presence or concentration of the analyte.

6. The method of claim 1, where the analyte comprises glucose and the body fluid comprises blood.

7. The method of claim 1, wherein the at least one analyte quantification member comprises an assay pad containing a chemical reagent formulated to produce a color change upon reaction with the analyte.

8. The method of claim 1, wherein the device comprises a plurality of the analyte quantification members.

9. The method of claim 8, wherein the device comprises a removable cartridge containing a plurality of the analyte quantification members.

10. The method of claim 7, wherein the sensor comprises an optical sensor constructed to produce signals indicative of the color change.

11. The method of claim 1, wherein the finite time period is less than 1 minute.

12. The method of claim 11, wherein the finite time period is 45 seconds or less.

13. The method of claim 1, wherein the signaling comprises producing at least one of a visual signal and an audible signal.

14. The method of claim 1, wherein the device further comprises at least one skin-penetration member, the method further comprising:

piercing the skin of a user with the least one skin-penetration member thereby creating a wound opening for expression of body fluid therefrom.

15. The method of claim 14, wherein the skin is pierced prior to introducing the first sample of body fluid to the least one analyte quantification member.

16. The method of claim 1, further comprising, subsequent to signaling the user to introduce a second sample of body fluid to the analyte quantification member, at least one of:

(i) manually milking a wound to express the second sample therefrom, and (ii) applying a catalyst to the skin in the vicinity of a wound.

17. The method of claim 16, wherein the catalyst comprises a vacuum.

18. The method of claim 14, further comprising applying a catalyst to the skin of the user prior to, during, or subsequent to piercing the skin with the at least one skin-penetration member.

19. The method of claim 18, wherein the catalyst comprises a vacuum.

20. The method of claim 1, further comprising providing the device with an anticoagulant material on at least portions thereof that normally contact the body fluid.

21. The method of claim 14, wherein the device further comprises a skin interface member, and at least one of the skin interface member and the skin penetration member comprising a guide element, the method further comprising:

subsequent to signaling the user to introduce a second sample of body fluid, taking at least one additional measure to express additional body fluid from the wound; and

placing the skin, in the vicinity of the wound, into contact with the skin interface member such that the guide element is capable of facilitating transfer of the second sample to the analyte quantification member.

22. The method of claim 21, wherein both the skin interface member and the skin penetration member comprise a guide element.

24. The device of claim 21, wherein the controller and the sensor are configured and arranged such that the at least one analyte quantification member is interrogated by the sensor during the finite timed period to detect the presence or absence of an adequate sample volume.

25. The device of claim 22, wherein the controller is configured and arranged such that upon detection of the absence of an adequate sample volume within the timed period, signaling the user that the assay is being terminated.

26. The device of claim 22, wherein the controller is configured and arranged such that upon detection of an adequate sample volume during the timed period, the device continues with the assay.

27. The device of claim 24, wherein the controller and the sensor are configured and arranged to interrogate the at least one analyte quantification member subsequent to the timed period to ascertain the presence or concentration of the analyte.

28. The device of claim 21, wherein the analyte comprises glucose in the body fluid comprises blood.

29. The device of claim 21, wherein the at least one analyte quantification member comprises an assay pad containing a chemical reagent formulated to produce a color change upon reaction with the analyte.

30. The device of claim 21, wherein the device comprises a plurality of the analyte quantification members.

31. The device of claim 28, wherein the device comprises a removable cartridge containing the plurality of the analyte quantification members.

32. The device of claim 27, wherein the sensor comprises an optical sensor constructed to produce signals indicative of the color change.

33. The device of claim 21, wherein the finite time period is less than 1 minute.

34. The device of claim 31, wherein the finite time period is 45 seconds or less.

35. The device of claim 21, wherein the signal comprises at least one of a visual signal and an audible signal.

36. The device of claim 21, further comprising at least one skin-penetration member.

37. The device of claim 28, further comprising a plurality of skin-penetration members, and each of the plurality of analyte quantification members having a respective skin-penetration member associated therewith.

38. The device of claim 34, wherein the at least one skin-penetration member comprises a needle having an inner lumen, and the at least one passageway comprising the inner lumen of the needle.

39. The device of claim 35, further comprising a removable cartridge containing the plurality of analyte quantification members and the plurality of skin-penetration members.

40. The device of claim 34, further comprising a catalyst producing mechanism configured and arranged to apply a catalyst for the expression of body fluid from the wound prior to, during, or subsequent to piercing the skin with the at least one skin-penetration member.

41. The device of claim 38, wherein the catalyst producing mechanism is configured and arranged to apply a catalyst for the expression of body fluid from the wound subsequent to the signal to the user indicating the absence of an adequate sample volume of body fluid.

42. The device of claim 34, wherein the catalyst producing mechanism comprises a vacuum pump.

43. The device of claim 21, wherein an anticoagulant material is provided on at least a portion of the passageway.

44. The device of claim 36, wherein an anticoagulant material is provided on at least a portion of the inner lumen.

23. A device for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid, the device comprising:

at least one analyte quantification member;

at least one passageway in fluid communication with the at least one analyte quantification member;

a sensor constructed and arranged to interrogate the least one analyte quantification member and to detect the presence or absence of an adequate sample volume applied to the at least one analyte quantification member; and

a controller in signal communication with the sensor, the controller is configured and arranged such that upon detection of the absence of an adequate sample volume, the controller initiates a finite timed period and signals the user to introduce another sample of body fluid into the at least one passageway.

45. The device of claim 23, further comprising a skin interface member and a skin penetration member, wherein at least one of the skin interface member and the skin penetration member comprises a guide element configured to guide a flow of body fluid in a desired direction toward a desired location.

46. The device of claim 45, wherein both the skin interface member and the skin penetration member comprise a guide element.

47. A device for collecting a sample of body fluid, the device comprising:

a skin interface member and a skin penetration member, wherein at least one of the skin interface member and the skin penetration member comprises a guide element configured to direct a flow of body fluid placed thereon.

48. The device of claim 47, wherein the skin penetration member comprises a hollow needle having an inner lumen, the guide element configured to facilitate introduction of the sample of body fluid into the inner lumen.

49. The device of claim 48, wherein the application guide is provided with a funnel-like or concave dome shape.

50. The device of claim 47, wherein the guide element is formed from a polymer, metal, ceramic, or combination thereof.

51. The device of claim 47, wherein the guide element further comprises at least one fluid flow enhancing feature.

52. The device of claim 51, wherein the at least one fluid flow enhancing feature comprises a hydrophobic coating, a hydrophilic coating, or a capillary groove.

53. The device of claim 47, wherein the guide element is configured to limit a depth of penetration of the skin penetration member.