BLOOD GLUCOSE MEASUREMENT DEVICES AND METHODS OF USING THE SAME

• US 20120029830A1
• Filed: 07/27/2010
• Published: 02/02/2012
• Est. Priority Date: 12/31/2009
• Status: Abandoned Application

• Current Assignee: Julie K. Turner, Richard W. Turner
• Original Assignee: Julie K. Turner, Richard W. Turner
• Inventors: Turner, Richard W., Turner, Julie K.
• Application Number:
  US13/130,929
• Publication Number:
  US 20120029830A1
• Time in Patent Office: Days
• US Class Current: 702/19
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150503 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 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15196 semi-automatically retracted, i.e. in which the retraction of the piercing unit requires a deliberate action by the user such as manual release of spring-biased retraction means
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Blood glucose measurement devices and methods of using the same. In at least one exemplary embodiment of a device of the present disclosure, the device comprises a main housing sized and shaped to receive a lancet assembly and a test strip holder, a circuit board positioned within the main housing, the circuit board capable of producing data indicative of a test strip fluid, and a processor operably coupled to the circuit board, the processor capable of receiving and processing the data from the circuit board and displaying a processed result on a screen.

Claims

1. A device, comprising:

a main housing sized and shaped to receive a lancet assembly and a test strip holder;

a circuit board positioned within the main housing, the circuit board capable of producing data indicative of a test strip fluid; and

a processor operably coupled to the circuit board, the processor capable of receiving and processing the data from the circuit board and displaying a processed result on a screen.

2. The device of claim 1, further comprising:

a lancet assembly positioned at least partially within the main housing, the lancet assembly comprising a lancet and a lancet mechanism.

3. The device of claim 2, wherein the lancet assembly is removable from the main housing.

4. The device of claim 2, wherein the lancet assembly comprises a lancet holder sized and shaped to removably engage a lancet.

5. The device of claim 2, wherein the lancet mechanism is operable to cause the lancet to at least partially protrude from the main housing.

6. The device of claim 2, wherein the lancet mechanism comprises a button, whereby depression of the button causes the lancet to at least partially protrude from the main housing.

7. The device of claim 6, wherein when the button is released, the lancet retracts back into the main housing.

8. The device of claim 2, wherein the lancet assembly further comprises a depth mechanism to adjust a penetration depth of the lancet.

9. The device of claim 8, wherein the depth mechanism comprises a dial so that the penetration depth of the lancet is a variable penetration depth.

10. The device of claim 8, wherein the depth mechanism comprises a body having a defined width, wherein when the body is positioned relative to the lancet assembly, the lancet is capable of protruding only a known distance beyond the body.

11. The device of claim 10, wherein the body comprises a plurality of interchangeable bodies, each of the plurality of interchangeable bodies having various defined widths.

12. The device of claim 2, further comprising:

a removable lancet assembly cap, the removable lancet assembly cap sized and shaped to removably enclose the lancet within the lancet assembly.

13. The device of claim 1, further comprising:

a test strip holder positioned within the main housing, the test strip holder sized and shaped to receive a plurality of test strips.

14. The device of claim 13, wherein the test strip holder is removable from the main housing.

15. The device of claim 13, wherein the main housing further comprises a housing coupling arrangement capable of receiving, retaining, and dispensing the test strip holder.

16. The device of claim 15, wherein the housing coupling arrangement comprises a slot sized and shaped to receive a flange of the test strip holder.

17. The device of claim 15, wherein the housing coupling arrangement comprises a protrusion sized and shaped to engage an indention of the test strip holder.

18. The device of claim 14, further comprising:

a first removable test strip holder cap, the first removable test strip holder cap sized and shaped to removably close a cavity defined within the test strip holder to enclose one or more optional test strips within the test strip holder.

19. The device of claim 18, further comprising a second removable test strip holder cap, the second removable test strip holder cap sized and shaped to removably close a cavity defined within the test strip holder to enclose one or more optional test strips within the test strip holder

20. The device of claim 14, further comprising:

a desiccant positioned within the test strip holder, the desiccant capable of reducing a local humidity level within the test strip holder.

21. The device of claim 1, further comprising:

a used test strip slot defined within the main housing, the used test strip slot sized and shaped to received one or more used test strips for retention within the main housing.

22. The device of claim 1, further comprising:

an absorbent pad removably coupled to the main housing, the absorbent pad capable of absorbing blood from a user.

23. The device of claim 1, wherein the circuit board comprises a test strip acceptance and reading area, the test strip acceptance and reading area capable of receiving at least part of a test strip and producing the data indicative of a test strip fluid from the test strip.

24. The device of claim 1, further comprising:

a display operably coupled to the processor, the display capable of displaying the processed result from the processor.

25. The device of claim 24, wherein the display comprises a liquid crystal display.

26. The device of claim 1, further comprising:

a user controller operably coupled to the processor, the user controller capable of selecting between two or more processor operations.

27. The device of claim 26, wherein the user controller comprises one or more buttons.

28. The device of claim 1, further comprising:

a memory device operably coupled to the processor, the memory device capable of receiving and storing data from the circuit board.

29. The device of claim 28, wherein the memory is further capable of receiving and storing software accessible by the processor for operating the device.

30. The device of claim 1, further comprising:

a power source operably coupled to the processor, the power source capable of supplying power to operate the device.

31. The device of claim 30, wherein the power source comprises a battery.

32. The device of claim 31, wherein the battery is rechargeable.

33. The device of claim 31, wherein the battery is removable from the device.

34. The device of claim 1, further comprising:

a data transfer mechanism operably coupled to the processor or a memory coupled thereto, the data transfer mechanism capable of transferring the data from the device to an external computer.

35. The device of claim 34, wherein the data transfer mechanism is further capable of transferring software to or from the device.

36. The device of claim 34, wherein the data transfer mechanism comprises a USB port.

37. The device of claim 34, wherein the data transfer mechanism comprises a wireless communications apparatus.

38. The device of claim 1, wherein the main housing is sized and shaped to fit within a garment pocket.

39. A device, comprising:

a main housing;

a test strip holder removably positioned at least partially within the main housing, the test strip holder capable of receiving at least one test strip;

a lancet assembly removably positioned at least partially within the main housing, the lancet assembly capable of receiving a lancet;

a circuit board positioned within the main housing, the circuit board comprising a test strip acceptance and reading area capable of receiving at least part of a test strip and producing the data indicative of a test strip fluid from the test strip;

a processor operably coupled to the circuit board, the processor capable of receiving and processing the data from the circuit board; and

a display operably coupled to the processor, the display capable of displaying the processed result from the processor.

40. A device, comprising:

a main housing sized and shaped to receive a lancet assembly and a test strip holder;

a lancet assembly positioned at least partially within the main housing, the lancet assembly comprising;

a lancet,

a lancet mechanism, the lancet mechanism operable to cause the lancet to at least partially protrude from the main housing, and

a depth mechanism to adjust a penetration depth of the lancet;

a test strip holder positioned within the main housing, the test strip holder sized and shaped to receive a plurality of test strips;

a used test strip slot defined within the main housing, the used test strip slot sized and shaped to received one or more used test strips for retention within the main housing;

an absorbent pad removably coupled to the main housing, the absorbent pad capable of absorbing blood from a user;

a circuit board positioned within the main housing, the circuit board comprising a test strip acceptance and reading area capable of receiving at least part of a test strip and producing the data indicative of a test strip fluid from the test strip;

a processor operably coupled to the circuit board, the processor capable of receiving and processing the data from the circuit board;

a memory device operably coupled to the processor, the memory device capable of receiving and storing data from the circuit board;

a display operably coupled to the processor, the display capable of displaying the processed result from the processor; and

a power source operably coupled to the processor, the power source capable of supplying power to operate the device.

41. A device for testing blood glucose levels, comprising:

a main housing;

a test strip holder removably positioned at least partially within the main housing, the test strip holder capable of receiving at least one glucose test strip;

a lancet assembly removably positioned at least partially within the main housing, the lancet assembly capable of receiving a lancet;

a circuit board positioned within the main housing, the circuit board capable of producing data indicative of blood from a used test strip;

a processor operably coupled to the circuit board, the processor capable of receiving and processing the data from the circuit board; and

a display operably coupled to the processor, the display capable of displaying a processed blood glucose level result indicative of the data on a screen.

42. A method of testing a blood glucose level, the method comprising the steps of:

removing a test strip from a test strip holder of a glucose testing device;

inserting at least part of the test strip into a test strip acceptance and reading area of the glucose testing device;

positioning the glucose testing device on or near a user'"'"'s skin;

operating a lancet of the glucose testing device to penetrate the user'"'"'s skin so that a quantity of blood exits a skin puncture caused by the lancet;

transferring at least part of the quantity of blood to the test strip; and

operating the glucose testing device to obtain data indicative of a blood glucose level from the quantity of blood.

43. The method of claim 42, further comprising the step of:

wiping excess blood from the quantity of blood onto an absorbent pad coupled to the glucose testing device.

44. The method of claim 42, further comprising the step of:

removing the test strip from the test strip acceptance and reading area; and

inserting the test strip into a used test strip slot defined within the glucose testing device to store the test strip within the glucose testing device.

45. A kit, comprising:

a device for testing a blood glucose level;

a blood glucose test strip assembly sized and shaped to be received within the device; and

a lancet sized and shaped to be received within a lancet assembly within the device.

46. The kit of claim 45, further comprising:

a tablet comprising a sugar, the tablet sized and shaped to fit within the device.

47. A kit, comprising:

a device for testing a blood glucose level;

a blood glucose test strip assembly sized and shaped to be received within the device;

a test strip packet comprising one or more test strips, the one or more test strips sized and shaped to fit within the blood glucose test strip assembly; and

a lancet packet comprising one or more lancets, the one or more lancets sized and shaped to be received within a lancet assembly within the device.

48. The kit of claim 47, wherein the test strip packet comprises a desiccant.

49. The kit of claim 47, further comprising:

a tablet packet comprising one or more tablets comprising a sugar, the one or more tablets sized and shaped to fit within the device.