Disposable lancet device cap with integral lancet and/or test strip and testing device utilizing the cap

• US 8,211,036 B2
• Filed: 05/27/2005
• Issued: 07/03/2012
• Est. Priority Date: 05/27/2005
• Status: Active Grant

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven
• Primary Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US11/138,277
• Publication Number:
  US 20060271084A1
• Time in Patent Office: 2,594 Days
• Field of Search: 600/300, 600/306, 600/372, 600/382, 600/384, 600/573, 600/583, 600/584, 606/167, 606/170, 606/172, 606/181, 606/182, 606/184, 606/185
• US Class Current: 600/583
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150908 by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod
• 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 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Abstract

Cap for a testing device. The cap includes a lancet movably mounted within the cap and a skin-engaging end having an opening that allows a portion of a needle of the lancet to pass therethrough. A test strip may be arranged on the cap. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

Claims

1. A cap for a testing device, the cap comprising:

a body having a skin-engaging end and a connecting end;

a housing arranged within the body of the cap and being disposed axially between the skin-engaging end and the connecting end;

a space arranged between the housing and the body and being disposed axially between the skin-engaging end and the connecting end;

the connecting end being configured to connect the body to the testing device;

a lancet movably mounted within the cap and comprising a proximal end, a needle projecting from the proximal end, and a distal end;

the proximal end of the lancet being disposed axially between the skin-engaging end and a distal end of the housing; and

a skin-engaging end having an opening that allows a portion of the needle of the lancet to pass therethrough.

2. The cap of claim 1, wherein the cap is structured and arranged to be removably mounted to the testing device.

3. The cap of claim 1, wherein the opening is less than approximately 10 times a diameter of the needle.

4. The cap of claim 1, further comprising an open end adapted to be removably connected to the testing device.

5. The cap of claim 1, further comprising a mechanism for ensuring that the cap is mounted to the testing device in a single rotational position.

6. The cap of claim 1, wherein the cap is structured and arranged to be non-rotationally removably mounted to the testing device.

7. The cap of claim 1, further comprising an arrangement for adjusting a depth of penetration of the needle of the lancet.

8. The cap of claim 1, further comprising a test strip having one end extending to the opening.

9. The cap of claim 1, further comprising a test strip having one end extending to the opening and another end extending along a side wall of the cap.

10. The cap of claim 1, further comprising a test strip at least partially arranged on an outer surface of the cap.

11. The cap of claim 1, further comprising a test strip having contacts arranged on a side wall of the cap.

12. The cap of claim 1, further comprising a test strip having contacts arranged in an area of the opening.

13. The cap of claim 1, wherein the cap is disposable.

14. The cap of claim 1, further comprising a mechanism for retaining the cap on the testing device.

15. The cap of claim 14, wherein the mechanism comprises a projection.

16. The cap of claim 14, wherein the mechanism comprises an inwardly facing circumferential projection.

17. The cap of claim 1, further comprising an arrangement for biasing the lancet towards a retracted position.

18. The cap of claim 17, wherein the arrangement comprises a spring.

19. The cap of claim 17, wherein the arrangement comprises at least one member connected to a portion of the cap via a living hinge.

20. The cap of claim 1, further comprising an arrangement for retaining the lancet in a retracted position.

21. The cap of claim 20, wherein the arrangement for retaining the lancet in a retracted position comprises at least one projection arranged on the lancet and at least one projection non-movably connected to the cap.

22. The cap of claim 20, wherein the arrangement for retaining the lancet in a retracted position comprises at least one projection arranged on the lancet and at least one projection integrally formed with the cap.

23. The cap of claim 20, wherein the arrangement for retaining the lancet in a retracted position comprises at least one projection arranged on the lancet and at least one projection arranged on an inner side wall of the cap.

24. The cap of claim 20, wherein the arrangement for retaining the lancet in a retracted position comprises at least one circumferential projection arranged on the lancet and at least one circumferential projection arranged on an inner cylindrical side wall of the cap.

25. A testing device comprising the cap of claim 1, the testing device comprising a body and a display.

26. A testing device comprising the cap of claim 1, the testing device comprising a body, a display, and a triggering system.

27. A testing device comprising the cap of claim 1, the testing device comprising a body, a display, and a mechanism for making electrical contact with a portion of the cap.

28. A testing device comprising the cap of claim 1, the testing device comprising a body, a display, a triggering system, and contacts for making electrical contact electrical contacts of the cap.

29. A method of puncturing a surface of skin using a testing device comprising the cap of claim 1, the method comprising:

arranging the skin-engaging end adjacent against a user'"'"'s skin;

triggering the testing device so that the needle is caused to puncture the user'"'"'s skin;

testing fluid from the puncture; and

removing the cap and installing a new cap on the testing device.

30. A disposable cap for a testing device, the cap comprising:

a body having a skin-engaging end and a connecting end;

the connecting end being configured to connect the cap to the testing device;

the connecting end comprising an internal member configured to releasably engage with an external member of the testing device;

a lancet movably mounted within the body and comprising a proximal end, a needle projecting from the proximal end, and a distal end;

the proximal end of the lancet being disposed axially between the skin-engaging end and the connecting end;

the distal end of the lancet being disposed axially closer to the connecting end of the body than to the skin-engaging end of the body;

an outer surface of the lancet being spaced from an inner surface of a side wall of the body;

the skin-engaging end having an opening that allows a portion of the needle of the lancet to pass therethrough; and

a test strip for testing a fluid in an area of the opening and being arranged on the body.

31. The cap of claim 30, wherein the cap is structured and arranged to be removably mounted to the testing device.

32. The cap of claim 30, wherein the opening is less than approximately 5 times a diameter of the needle.

33. The cap of claim 30, wherein the connecting end comprises an open end adapted to be removably connected to the testing device.

34. The cap of claim 30, further comprising a mechanism for ensuring that the cap is mounted to the testing device in a single rotational position.

35. The cap of claim 30, wherein the cap is structured and arranged to be non-rotationally removably mounted to the testing device.

36. The cap of claim 30, wherein the test strip is at least partially arranged on an outer surface of the cap.

37. The cap of claim 30, wherein the internal and external members are the only mechanism for retaining the cap on the testing device.

38. The cap of claim 30, further comprising an arrangement for biasing the lancet towards a retracted position.

39. The cap of claim 30, further comprising an arrangement for retaining the lancet needle in a retracted position.

40. A testing device comprising the cap of claim 30, the testing device comprising a body and a display.

41. A testing device comprising the cap of claim 30, the testing device comprising a body, a display, and a triggering system.

42. A testing device comprising the cap of claim 30, the testing device comprising a body, a display, and a mechanism for making electrical contact with the test strip.

43. A testing device comprising the cap of claim 30, the testing device comprising a body, a display, a triggering system, and contacts for making electrical contact electrical contacts of the test strip.

44. A method of puncturing a surface of skin using a testing device comprising the cap of claim 30, the method comprising:

arranging the skin-engaging end adjacent against a user'"'"'s skin;

triggering the testing device so that the needle is caused to puncture the user'"'"'s skin;

testing fluid from the puncture; and

removing the cap and installing a new cap on the testing device.

45. A disposable cap for a testing device, the cap comprising:

a body comprising;

an annular housing arranged within the body and being disposed axially between a skin-engaging end and a distal end of the body; and

an annular space arranged between the annular housing and the body and being disposed axially between the skin-engaging end and the distal end of the body;

a lancet having a needle projecting from a proximal end of the lancet and being movably mounted within the annular housing;

the proximal end of the lancet being disposed axially between the skin-engaging end and a distal end of the annular housing;

an arrangement for biasing the lancet towards a retracted position;

the skin-engaging end having an opening that allows a portion of the needle of the lancet to pass therethrough; and

a test strip arranged on the body for testing a fluid in an area of the opening.

46. The disposable cap of claim 45, further comprising an arrangement for changing a length of movement of the lancet.

47. The disposable cap of claim 45, further comprising an arrangement for adjusting a penetration depth of the needle of the lancet.

48. A glucose meter comprising the disposable cap of claim 45.

49. A method of testing a fluid sample using the glucose meter of claim 48, the method comprising:

arranging the skin-engaging end adjacent against a user'"'"'s skin;

triggering the glucose meter so that the needle is caused to puncture the user'"'"'s skin;

testing fluid from the puncture; and

removing the cap and installing a new cap on the glucose meter.