Adjustable tip for a lancet device and method

• US 6,530,937 B1
• Filed: 01/28/2000
• Issued: 03/11/2003
• Est. Priority Date: 01/28/2000
• Status: Expired due to Term

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US09/493,675
• Time in Patent Office: 1,138 Days
• Field of Search: 606/1, 606/181-185, 600/461, 600/583, 604/192, 604/198, 604/263
• US Class Current: 606/182
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• 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: A61M 3/00 Medical syringes, e.g. enemata; Irrigators A61M5/00 takes precedence; pistons A61M5/315

Abstract

A lancet device, a tip for a lancet device and method of using the lancet device. The lancet device has a body portion for firing the lancet and a tip portion. The tip for a lancet device includes a front assembly which includes a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element, a slot is disposed in one of the sidewall portion and the lancet stop element, and at least one following element extending into the slot, wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element. The method includes adjusting a set depth of penetration of the needle by moving the at least one following element, disposing the distal end of the lancet device against a surface of skin, and triggering the firing mechanism to cause the needle to penetrate the surface of the skin to the set depth, wherein the puncture allows a blood sample to be taken.

Claims

1. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

an actuator comprising a generally annular rotatable member that engages the at least one following element;

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the at least one following element is fixed to the lancet stop element.

2. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

an actuator comprising a generally annular rotatable member that engages the at least one following element;

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the at least one following element is fixed to the annular member.

3. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

an actuator comprising a generally annular rotatable member that engages the at least one following element;

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the slot is disposed on the lancet stop element.

4. The tip of claim 3, wherein the slot comprises a camming slot.

5. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot;

an actuator comprising a generally annular rotatable member that engages the at least one following element; and

an outer generally annular rotatable member,

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the at least one following element is fixed to the generally annular rotatable member.

6. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot;

an actuator comprising a generally annular rotatable member that engages the at least one following element; and

an outer generally annular rotatable member,

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the generally annular rotatable member comprises a slot.

7. The tip of claim 6, wherein the slot on the generally annular rotatable member comprises a camming slot.

8. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

an actuator comprising a generally annular rotatable member that engages the at least one following element;

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the at least one following element is fixed to the lancet stop element.

9. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

an actuator comprising a generally annular rotatable member that engages the at least one following element;

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

further comprising at least one tooth disposed on one of the lancet stop element and the front assembly.

10. The tip of claim 9, wherein the lancet stop element comprises a first section which includes at least one ratchet tooth and a second section which includes a camming lug, the first section being partially separated from the second section by at least one separating slot.

11. The tip of claim 10, wherein the first section and the second section are partially separated by at least two separating slots such that the separating slots define at least two connecting walls.

12. The tip of claim 11, wherein the second section further comprises a circumferential separating slot for separating a portion of the deflecting wall from the cylindrical wall of the lancet stop element such that the deflecting wall is connected to the cylindrical wall by a connecting wall.

13. The tip of claim 12, wherein the connecting wall allows the deflecting wall to deflect inward towards a center axis of the lancet stop element.

14. The tip of claim 11, wherein the second section further comprises a deflecting wall for connecting the camming lug to a cylindrical wall of the lancet stop element.

15. The tip of claim 9, wherein the front assembly comprises an internal spline having a plurality of teeth for engaging the at least one tooth disposed on the lancet stop element.

16. The tip of claim 9, further comprising at least two ratchet teeth being disposed on the lancet stop element approximately 180 degrees apart from one another.

17. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

an actuator comprising a generally annular rotatable member that engages the at least one following element;

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the lancet stop element is moveably retained within the front assembly such that it can rotate and move axially with respect to the front assembly.

18. The tip of claim 17, wherein the lancet stop element is moveable towards and away from the plane such that at least one ratchet tooth maintains engagement with an internal spline disposed on an internal surface of the front assembly throughout this movement.

19. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

an actuator comprising a generally annular rotatable member that engages the at least one following element;

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the front assembly further comprises a bearing surface disposed between at least two shoulders, and wherein an annular member is rotatably disposed on the bearing surface and is retained from axial movement by at least one shoulder.

20. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

an actuator comprising a generally annular rotatable member that engages the at least one following element;

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the front assembly further comprises engaging lugs which cooperate with engaging grooves on a lancet body and a manual lancet release button for separating the lancet from the lancet body.

21. A lancet device, comprising:

a lancet body comprising a lancet firing mechanism which is at least partially enclosed within a lancet body shell;

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

an actuator comprising a generally annular rotatable member that engages the at least one following element;

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element.

22. A front cap mechanism for a lancet device wherein the front cap mechanism includes a proximal end for attaching to the lancet device and a distal end for allowing a needle to project therefrom, a lancet of the lancet device having a surface from which the needle projects, the mechanism comprising:

a front cap having a distal opening adapted to allow the needle to project therethrough;

a nut rotatably disposed on an outer surface of the front cap;

a stop cap movably disposed within the front cap and adapted to allow the needle to project therethrough;

the stop cap comprising a lancet stop surface and an opening;

wherein the lancet stop surface is adapted to allow the needle to project through the opening and is adapted to prevent further movement of the lancet when the surface of the lancet contacts the lancet stop surface, and

wherein the stop cap further comprises at least one ratchet tooth and wherein the front cap further comprises an internal spline having a plurality of teeth for engaging the at least one ratchet tooth.

23. The mechanism of claim 22, wherein the at least one ratchet tooth comprises at least two ratchet teeth disposed approximately 180 degrees apart from one another.

24. The mechanism of claim 23, wherein the stop cap further comprises a first section which includes at least one ratchet tooth and a second section which includes a camming lug, the first section being partially separated from the section by at least one separating slot.

25. The mechanism of claim 24, wherein the second section further comprises a deflecting wall for connecting the camming lug to a cylindrical wall of the stop cap.

26. The mechanism of claim 25, wherein the second section further comprises a circumferential separating slot for separating a portion of the deflecting wall from the cylindrical wall of the stop cap such that the deflecting wall is connected to the cylindrical wall by a connecting wall.

27. The mechanism of claim 26, wherein rotation of the nut in one direction causes movement of the lancet stop surface towards the distal end and wherein rotation of the nut in the opposite direction causes movement of the lancet stop surface away from the distal end.

28. The mechanism of claim 25, wherein the camming lug is guided within the circumferential camming slot when the stop cap is moved axially or rotated and wherein the camming lug engages a recess formed on the nut.

29. The mechanism of claim 24, wherein the first section and the section are partially separated by at least two separating slots such that the separating slots define at least two connecting walls.

30. A front cap mechanism for a lancet device wherein the front cap mechanism includes a proximal end for attaching to the lancet device and a distal end for allowing a needle to project therefrom, a lancet of the lancet device having a surface from which the needle projects, the mechanism comprising:

a front cap having a distal opening adapted to allow the needle to project therethrough;

a nut rotatably disposed on an outer surface of the front cap;

a stop cap movably disposed within the front cap and adapted to allow the needle to project therethrough;

the stop cap comprising a lancet stop surface and an opening;

wherein the lancet stop surface is adapted to allow the needle to project through the opening and is adapted to prevent further movement of the lancet when the surface of the lancet contacts the lancet stop surface, and

wherein the stop cap is moveably retained within the front cap such that it can rotate and move axially with respect to the front cap.

31. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

an outer generally annular rotatable member,

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the at least one following element is fixed to the generally annular rotatable member.

32. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

an outer generally annular rotatable member,

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the generally annular rotatable member comprises a slot.

33. The tip of claim 32, wherein the slot on the generally annular rotatable member comprises a camming slot.

34. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

the at least one following element being fixed to the lancet stop element,

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element.

35. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

at least one tooth disposed on one of the lancet stop element and the front assembly,

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the front assembly comprises an internal spline having a plurality of teeth for engaging the at least one tooth disposed on the lancet stop element.

36. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

at least one tooth disposed on one of the lancet stop element and the front assembly,

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

further comprising at least two ratchet teeth being disposed on the lancet stop element approximately 180 degrees apart from one another.

37. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

at least one tooth disposed on one of the lancet stop element and the front assembly,

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element, and

wherein the lancet stop element comprises a first section which includes at least one ratchet tooth and a second section which includes a camming lug, the first section being partially separated from the second section by at least one separating slot.

38. The tip of claim 37, wherein the first section and the second section are partially separated by at least two separating slots such that the separating slots define at least two connecting walls.

39. The tip of claim 38, wherein the second section further comprises a circumferential separating slot for separating a portion of the deflecting wall from the cylindrical wall of the lancet stop element such that the deflecting wall is connected to the cylindrical wall by a connecting wall.

40. The tip of claim 39, wherein the connecting wall allows the deflecting wall to deflect inward towards a center axis of the lancet stop element.

41. The tip of claim 38, wherein the second section further comprises a deflecting wall for connecting the camming lug to a cylindrical wall of the stop cap.

42. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot;

the lancet stop element being moveable towards and away from the plane in response to movement of the at least one following element;

the lancet stop element being moveably retained within the front assembly such that it can rotate and move axially with respect to the front assembly,

wherein the lancet stop element is moveable towards and away from the plane such that at least one ratchet tooth maintains engagement with an internal spline disposed on an internal surface of the front assembly throughout this movement.

43. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

the lancet stop element being moveable towards and away from the plane in response to movement of the at least one following element,

wherein the front assembly further comprises a bearing surface disposed between at least two shoulders, and wherein an annular member is rotatably disposed on the bearing surface and is retained from axial movement by at least one shoulder.

44. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

the lancet stop element being moveable towards and away from the plane in response to movement of the at least one following element,

wherein the front assembly further comprises engaging lugs which cooperate with engaging grooves on a lancet body and a manual lancet release button for separating the lancet from the lancet body.

45. A tip for a lancet device, comprising:

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a slot disposed in one of the sidewall portion and the lancet stop element;

at least one following element extending into the slot; and

a rotatable nut disposed on the front assembly comprising one of a plurality of projections and grooves disposed on an outer surface,

wherein the lancet stop element is moveable towards and away from the plane in response to movement of the at least one following element.

46. A lancet device comprising:

a housing having an end;

a lancet holding member capable of holding a lancet, the lancet holding member being at least partially contained within the housing;

a biasing element capable of biasing the lancet holding member toward an extended position;

a trigger capable of releasing the lancet holding member from a retracted position; and

a cap capable of covering the end of the housing and capable of positioning the lancet device relative to a skin surface, the cap comprising;

a front assembly comprising a side wall portion, a skin-engaging portion at least partially defining a plane beyond which a lancet needle may extend, and a lancet stop element;

a generally annular rotatable member disposed on the front assembly, the generally annular rotatable member comprising a slot, the generally annular rotatable member comprising one of a plurality of projections and grooves disposed on an outer surface; and

at least one following element extending into the slot;

wherein rotation of the generally annular rotatable member relative to the skin engaging portion causes movement of the at least one following element to move the lancet stop element toward and away from the plane, to allow adjustment of a penetration depth of a lancet.

47. A lancet device comprising:

a housing having an end;

a lancet holding member capable of holding a lancet, the lancet holding member being at least partially contained within the housing;

a lancet held by the lancet holding member;

a biasing element capable of biasing the lancet holding member toward an extended position;

a trigger capable of releasing the lancet holding member from a retracted position;

a cap capable of covering the end of the housing and capable of positioning the lancet device relative to a skin surface, the cap comprising;

a first sleeve; and

a second sleeve at least partially contained within the first sleeve, the second sleeve comprising a stop surface;

wherein rotation of the first sleeve relative to the second sleeve causes the second sleeve to move at least axially without changing an overall length of the lancet device tip.

48. A lancet device tip, comprising:

a first sleeve;

a second sleeve rotatably connected to the first sleeve to allow relative rotation between the second sleeve and the first sleeve; and

a third sleeve contained within the first sleeve, the third sleeve comprising a stop surface; and

wherein rotation of the second sleeve relative to the first sleeve causes the third sleeve to move within the first sleeve.

49. The lancet device tip of claim 48, wherein the second sleeve is rotatably connected between discrete predetermined positions to the first sleeve.

50. The lancet device tip of claim 49, wherein the rotatable connection between discrete predetermined positions comprises at least one projection which engages notches.

51. The lancet device tip of claim 48, wherein an overall length of the cap does not change when the second sleeve is rotated relative to the first sleeve.

52. The lancet device tip of claim 48, wherein the second sleeve comprises a slot, and wherein the third sleeve comprises at least one following element extending into the slot.

53. The lancet device tip of claim 48, wherein the second sleeve comprises indicia that indicates a relative position of the first and third sleeves.

54. The lancet device tip of claim 48, wherein the second sleeve comprises a ridged surface to facilitate rotation of the first and second sleeves relative to each other.

55. The lancet device tip of claim 48, wherein the third sleeve moves axially relative to the first sleeve when the second sleeve is rotated relative to the first sleeve.

56. The lancet device tip of claims 48, further comprising a fourth sleeve.

57. A lancet device comprising:

a housing having an end;

a lancet holding member capable of holding a lancet, the lancet holding member being at least partially contained within the housing;

a lancet held by the lancet holding member;

a biasing element capable of biasing the lancet holding member toward an extended position;

a trigger capable of releasing the lancet holding member from a retracted position;

a cap capable of covering the end of the housing and capable of positioning the lancet device relative to a skin surface, the cap comprising;

a first sleeve;

a second sleeve rotatably connected to the first sleeve to allow relative rotation between the second sleeve and the first sleeve; and

a third sleeve contained within the first sleeve, the third sleeve comprising a stop surface;

wherein rotation of the second sleeve relative to the first sleeve causes the third sleeve to move within the first sleeve, and wherein the lancet strikes the third sleeve when the lancet holding member is released from the retracted position to the extended position, and wherein a penetration depth of the lancet is adjustable by adjusting the position of the third sleeve.

58. The lancet device of claim 57, wherein the second sleeve is rotatably connected between discrete predetermined positions to the first sleeve.

59. The lancet device of claim 58, wherein the rotatable connection between discrete predetermined positions comprises at least one projection which engages notches.

60. The lancet device of claim 57, wherein an overall length of the cap does not change when the second sleeve is rotated relative to the first sleeve.

61. The lancet device of claim 57, wherein the second sleeve comprises a slot, and wherein the third sleeve comprises at least one following element extending into the slot.

62. The lancet device of claim 57, wherein the second sleeve comprises indicia that indicates a relative position of the first and third sleeves.

63. The lancet device of claim 57, wherein the second sleeve comprises a ridged surface to facilitate rotation of the first and second sleeves relative to each other.

64. The lancet device of claim 57, wherein the third sleeve moves axially relative to the first sleeve when the second sleeve is rotated relative to the first sleeve.

65. The lancet device of claim 57, further comprising a fourth sleeve.

66. A lancet device tip, comprising:

a first sleeve;

a second sleeve rotatably connected to the first sleeve;

a third sleeve contained within the first sleeve, the third sleeve comprising a stop surface; and

a fourth sleeve contained within the first and second sleeves;

wherein positions of the first, second, and third sleeves are adjustable relative to each other.

67. The lancet device tip of claim 66, wherein an overall length of the lancet device tip does not change when the positions of the first, second, and third sleeves are adjusted relative to each other.

68. The lancet device tip of claim 66, wherein the second sleeve comprises a slot, and wherein the third sleeve comprises at least one following element extending into the slot.

69. The lancet device tip of claim 66, wherein the third sleeve moves axially relative to the first sleeve when the second sleeve is rotated relative to the first sleeve.

70. The lancet device tip of claim 66, wherein the second sleeve is rotatably connected between discrete predetermined positions to the first sleeve.

71. A lancet device comprising:

a housing having an end;

a lancet holding member capable of holding a lancet, the lancet holding member being at least partially contained within the housing;

a lancet held by the lancet holding member;

a biasing element capable of biasing the lancet holding member toward an extended position;

a trigger capable of releasing the lancet holding member from a retracted position;

a cap capable of covering the end of the housing and capable of positioning the lancet device relative to a skin surface, the cap comprising a first sleeve, a second sleeve, a third sleeve, and a fourth sleeve, wherein positions of the first, second, and third sleeves are adjustable relative to each other; and

wherein the lancet strikes the third sleeve when the lancet holding member is released from the retracted position to the extended position, and wherein a penetration depth of the lancet is adjustable by adjusting the position of the third sleeve.

72. The lancet device of claim 71, wherein an overall length of the cap does not change when the positions of the first, second, and third sleeves are adjusted relative to each other.

73. The lancet device of claim 71, wherein the second sleeve comprises a slot, and wherein the third sleeve comprises at least one following element extending into the slot.

74. The lancet device of claim 71, wherein the third sleeve moves axially relative to the first sleeve when the second sleeve is rotated relative to the first sleeve.

75. The lancet device of claim 71, wherein the second sleeve is rotatably connected between discrete predetermined positions to the first sleeve.