Lancet needle cartridge, cartridge lancet device, and method of using and making the same

• US 9,392,968 B2
• Filed: 01/23/2008
• Issued: 07/19/2016
• Est. Priority Date: 01/23/2008
• Status: Active Grant

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): SIMPSON, SARAH A
• Application Number:
  US12/018,648
• Publication Number:
  US 20090187204A1
• Time in Patent Office: 3,100 Days
• Field of Search: 606/181, 606/182, 606/183, 606/186
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150473 Double-ended needles, e.g. used with pre-evacuated sampling tubes 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 5/150503 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15182 Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance

Abstract

Assembly for use on a device includes a member comprising a plurality of lancet needles arranged generally parallel to each other and one of a cap comprising a single lancet opening structured and arranged to receive therein an end portion of a finger tip and a cap comprising a plurality of openings which are each sized to allow one of the lancet needles to pass therethrough. 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. An assembly for use on a device, the assembly comprising:

a member comprising a plurality of lancet needles arranged generally parallel to each other; and

one of;

a cap comprising a single lancet opening structured and arranged to receive therein an end portion of a finger tip; and

a cap comprising a plurality of openings which are each sized to allow one of the lancet needles to pass therethrough,

wherein the assembly is structured and arranged to assume a first position and a second position, and, in the second position, a distance between an outer surface of the cap and ends of the plurality of lancet needles is less than in the first position.

2. The assembly of claim 1, wherein the device comprises at least one of a lancet device, a testing device, and a skin allergy test.

3. The assembly of claim 1, wherein the assembly comprises the cap comprising a single lancet opening structured and arranged to receive therein an end portion of a finger tip device, and wherein the lancet opening is arranged in a peripheral area of the cap.

4. The assembly of claim 1, wherein the assembly comprises the cap comprising a plurality of openings which are each sized to allow one of the lancet needles to pass therethrough, and wherein the member is movable at least from one position wherein each lancet needle does not extend out past an outer surface of the cap and another position wherein each lancet needle extends out past the outer surface of the cap.

5. The assembly of claim 1, wherein the assembly comprises the cap comprising a single lancet opening structured and arranged to receive therein an end portion of a finger tip device, and wherein the lancet opening movable from one position which coincides with one of the lancet needles to another position which coincides with another of the lancet needles.

6. The assembly of claim 1, wherein the assembly comprises the cap comprising a single lancet opening structured and arranged to receive therein an end portion of a finger tip device, and wherein the member is movable from one position wherein the lancet opening coincides with one of the lancet needles to another position wherein the lancet opening coincides with another of the lancet needles.

7. The assembly of claim 1, wherein the cap and member are generally circular shaped.

8. The assembly of claim 1, wherein the cap is generally cylindrically shaped.

9. The assembly of claim 1, wherein the cap comprises a generally circular end surface and a generally cylindrical sidewall and wherein the lancet opening is located at a corner area between the end surface and the sidewall.

10. The assembly of claim 1, wherein the lancet opening is located at a corner area of the cap.

11. The assembly of claim 1, further comprising at least one spring structured and arranged to bias the member towards the cap.

12. The assembly of claim 1, further comprising at least one spring structured and arranged to bias the member away from the cap.

13. The assembly of claim 1, wherein the member and the cap are movable relative to each other from a retracted position to a puncturing position and one of:

the cap is rotatable relative to the member; and

the member is rotatable relative to the cap.

14. The assembly of claim 1, wherein the member and the cap are axially movable relative to each other and the cap is rotatable relative to the member.

15. The assembly of claim 1, wherein the member and the cap are axially movable relative to each other and the member is rotatable relative to the cap.

16. The assembly of claim 1, wherein the member and the cap are movable relative to each other and at least one of:

the cap is a one-piece member; and

the member is a one-piece member.

17. The assembly of claim 1, wherein the member and the cap are movable relative to each other and at least one of:

the cap is a generally cylindrical member; and

the member is a generally cylindrical member.

18. The assembly of claim 1, wherein the member and the cap are movable relative to each other and at least one of:

the cap is a generally cylindrical member; and

the member is a generally disk-shaped member.

19. The assembly of claim 1, wherein the member and the cap are movable relative to each other and at least one of:

the cap is a rotatable between distinct angular positions which correspond to angular positions of the lancet needles; and

the member is a rotatable between distinct angular positions which correspond to angular positions of the lancet needles.

20. The assembly of claim 1, wherein the member and the cap are movable relative to each other and at least one of:

the cap is rotatable between distinct angular positions which correspond to angular positions of the lancet needles and axially movably only at the distinct angular positions; and

the member is rotatable between distinct angular positions which correspond to angular positions of the lancet needles and axially movably only at the distinct angular positions.

21. The assembly of claim 1, wherein the member and the cap are movable relative to each other and at least one of:

the cap is a one-piece member; and

the member is a one-piece member that is capable of being mounted to a portion of the device.

22. The assembly of claim 1, wherein the device is structured and arranged to be disposed of after all of the lancet needles are used to puncture a user'"'"'s skin.

23. The assembly of claim 1, wherein the member is non-removably mounted to a portion of the device, whereby the device is structured and arranged to be disposed of after all of the lancet needles are used to puncture a user'"'"'s skin.

24. The assembly of claim 1, wherein the member and the cap are movable relative to each other and at least one of:

the cap comprises a member for limiting axial movement of the relative movement of the cap and the member; and

the member comprises a member for limiting axial movement of the relative movement of the cap and the member.

25. The assembly of claim 1, wherein the member is removably mounted to a movable portion of the device.

26. The assembly of claim 1, wherein at least one of:

the member is removably mounted to an axially movable portion of the device; and

the member is removably mounted to an axially and rotatably movable portion of the device.

27. The assembly of claim 1, wherein the member is mounted to an axially and rotatably movable portion of the device.

28. The assembly of claim 27, further comprising a device for rotating the movable portion of the device between discrete rotational positions, wherein each position results in the lancet needle opening being substantially aligned with one of the lancet needles.

29. The assembly of claim 27, further comprising a device for rotating the movable portion of the device between discrete rotational positions, wherein each position results in one of the lancet needles being substantially aligned with the lancet needle opening.

30. The assembly of claim 29, further comprising a back cap structured and arranged to move the movable portion from an initial position to a puncturing position.

31. The assembly of claim 30, further comprising a spring structured and arranged to bias the movable portion towards the initial position.

32. The assembly of claim 30, further comprising a spring structured and arranged to bias the movable portion towards the puncturing position.

33. The assembly of claim 1, further comprising a back cap structured and arranged to move the member from an initial position to a puncturing position.

34. The assembly of claim 1, wherein the cap is non-removably mounted.

35. The assembly of claim 1, wherein the cap is non-movably mounted.

36. The assembly of claim 1, wherein the member comprises a disk-shaped portion having a surface from which the lancet needles project and rod-shaped portion extending from a side opposite the surface.

37. The assembly of claim 1, further comprising at least one retractable protection member arranged to cover at least one of the lancet needles.

38. The assembly of claim 1, further comprising an arrangement for ensuring that the cap rotates in only one direction.

39. The assembly of claim 1, further comprising an arrangement for ensuring that the member rotates in only one direction.

40. The assembly of claim 1, further comprising an arrangement for ensuring that the cap rotates in only one direction relative to a body of the device.

41. The assembly of claim 1, further comprising an arrangement for ensuring that the lancet opening rotates in only one direction relative to a body of the device and between a number of discrete positions corresponding to a number of the lancet needles.

42. The assembly of claim 1, further comprising an arrangement for ensuring that the lancet opening moves in only one direction relative to a body of the device and between a number of discrete positions corresponding to a number of the lancet needles.

43. The assembly of claim 1, further comprising a system for guiding a linear movement of the member relative to a body of the device at each of a number of discrete positions corresponding to a number of the lancet needles.

44. The assembly of claim 1, further comprising a system for preventing rotational movement of the cap when the cap is arranged on a body of the device.

45. The assembly of claim 1, wherein the member comprises a device for allowing a user to safely install the member on a portion of the device.

46. The assembly of claim 1, wherein the member comprises a removable and/or breakable device for allowing a user to safely install the member on a portion of the device.

47. The assembly of claim 1, further comprising a system for moving the member to at least one of an initial position and a retracted position.

48. The assembly of claim 1, further comprising a mechanism mounted to the cap for moving the member to at least one of an initial position and a retracted position.

49. The assembly of claim 1, further comprising a trigger for causing the member to move from at least one of an initial position and a retracted position to a puncturing position.

50. The assembly of claim 1, further comprising a system moving the member to at least one of an initial position and a retracted position and for causing the member to move to a puncturing position.

51. The assembly of claim 1, further comprising a mechanism coupled to a portion of the device for at least one of:

moving the member to at least one of an initial position and a retracted position; and

for causing the member to move to a puncturing position.

52. The assembly of claim 1, further comprising a first mechanism coupled to a portion of the device for moving the member to at least one of an initial position and a retracted position and a second mechanism coupled to another portion of the device for causing the member to move to a puncturing position.

53. The assembly of claim 1, wherein the member is movably mounted to the cap.

54. The assembly of claim 1, wherein the member is axially movably mounted to the cap.

55. The assembly of claim 1, wherein the member is rotatably mounted to the cap.

56. The assembly of claim 1, wherein the member is non-removably mounted to the cap.

57. The assembly of claim 1, wherein the member is biased away from the cap by a biasing member arranged between the member and the cap.

58. The assembly of claim 1, wherein at least one of:

the member is coupled to the cap and further comprise a mechanism for rotating the member relative to the cap between discrete positions; and

the member is coupled to the cap and further comprise a mechanism for temporarily retaining and/or locking the member in a plurality of discrete rotational positions relative to the cap.

59. The assembly of claim 1, wherein the member additionally comprises at least one needle arranged generally perpendicular to the lancet needles.

60. A method of puncturing a surface of skin using the assembly of claim 1, the method comprising:

disposing a skin engaging end of the cap against a user'"'"'s skin; and

manually causing the member to move towards a puncturing position.

61. A method of puncturing a surface of skin using the assembly of claim 1, the method comprising:

adjusting a depth of penetration; and

disposing a skin engaging end of the cap against a user'"'"'s skin; and

causing the member to move towards a puncturing position.

62. An assembly for use on a device, the assembly comprising:

a cartridge comprising a plurality of lancet needles arranged generally parallel to each other; and

a cap comprising a single lancet opening structured and arranged to receive therein an end portion of a finger tip,

wherein a distance between an outer surface of the cap and ends of the plurality of lancet needles is changeable between an initial position of the assembly and a puncturing position of the assembly.

63. The assembly of claim 62, further comprising a device for adjusting a depth of penetration into the finger tip.