Blood removal system

• US 7,223,276 B2
• Filed: 05/27/2003
• Issued: 05/29/2007
• Est. Priority Date: 05/28/2002
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Schabbach, Michael, Kintzig, Hans, Thoes, Bruno Robert, Ruschke, Peter
• Primary Examiner(s): Nguyen; Anhtuan T.
• Assistant Examiner(s): Nguyen; Tuan Van
• Application Number:
  US10/445,606
• Publication Number:
  US 20040092996A1
• Time in Patent Office: 1,463 Days
• Field of Search: 606/1, 606/181, 606/182, 600/583, 504/207
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/15113 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 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15157 Geometry of stocking means or arrangement of piercing elements therein
• 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

Blood removal system for removing blood for diagnostic purposes including a housing, a lancet guide, and a lancet drive with a drive spring. The lancet drive comprises a cocking device, in order to tension the drive spring, a drive rotor that is driven by the drive spring, and an output-side coupling mechanism, by means of which the rotational movement of the drive rotor is converted into the puncturing movement.

Claims

1. A blood removal system for removing blood for diagnostic purposes, comprising:

a housing;

a lancet drive connected to the housing and including;

a drive spring;

a cocking element connected to the drive spring;

a drive rotor connected to the drive spring; and

a coupling mechanism coupled to the drive rotor;

wherein;

during a cocking phase of the lancet drive the cocking element rotates in a first direction to tension the drive spring while the drive rotor is inhibited from rotating in the first direction;

during a driving phase of the lancet drive the drive rotor is rotatably driven in the first direction while the cocking element is arrested against a backward rotation, the coupling mechanism converting rotational movement of the drive rotor to movement of the lancet along a puncture path; and

a 360°

rotation of the drive rotor causes a single puncture and return movement of the lancet.

2. The blood removal system of claim 1, wherein the cocking element rotates about a first axis, and the drive rotor rotates about a second axis substantially parallel to the first axis.

3. The blood removal system of claim 2, wherein the first axis is coaxial to the second axis.

4. The blood removal system of claim 1, further including a rotatable actuation element coupled to the cocking element.

5. The blood removal system of claim 1, further including a transmission coupled to the cocking element, the transmission having a translatory movable actuation element.

6. The blood removal system of claim 1, wherein the cocking element rotates about a first axis.

7. The blood removal system of claim 6, further including a translatory movable actuation element that is movable in an actuation direction, the first axis being transverse to the actuation direction.

8. The blood removal system of claim 7, wherein the actuation element includes a gear rod and a pinion gear that is coupled to the cocking element during the cocking movement.

9. The blood removal system of claim 8, wherein the pinion gear, the cocking element, and the drive rotor are components of a drive module.

10. The blood removal system of claim 9, wherein the drive rotor includes a recess and the drive module further includes a control pin that travels along the recess as the drive rotor rotates during the drive phase, thereby determining at least a part of the puncture and return movement of the lancet, the recess being formed on a side of the drive rotor facing the cocking element.

11. The blood removal system of claim 9, wherein the pinion gear, the cocking element, and the drive rotor rotate about a common axis.

12. The blood removal system of claim 1, wherein the drive rotor moves through an angle of rotation range including a preparation range during which the drive rotor rotates at a first speed and a puncture range during which the drive rotor rotates at a second speed that is faster than the first speed.

13. The blood removal system of claim 12, wherein drive rotor rotation is inhibited at a transition in the angle of rotation range between the preparation range and the puncture range such that upon further rotation of the cocking element, the drive spring is tensioned.

14. The blood removal system of claim 1, further including a pawl configured to inhibit drive rotor rotation, and a release coupled to the pawl configured to permit drive rotor rotation.

15. The blood removal system of claim 1, wherein the drive rotor is automatically released to permit drive rotor rotation when the drive spring is tensioned to a tensioned state.

16. The blood removal system of claim 1, wherein the coupling mechanism includes a recess and a control pin engaging the recess.

17. The blood removal system of claim 16, wherein the control pin travels along the recess as the drive rotor rotates during the drive phase, thereby determining at least a part of the puncture and return movement of the lancet.

18. The blood removal system of claim 16, wherein a maximum displacement of the lancet in the puncturing direction is determined by a lower reversal point of a control curve defined by the recess.

19. The blood removal system of claim 16, wherein the recess is formed in the drive rotor.

20. The blood removal system of claim 1, wherein the lancet moves in the housing along a predetermined puncture path.

22. The blood removal system of claim 1, wherein the coupling mechanism includes a pushrod having a holding element configured to couple with the lancet.

23. The blood removal system of claim 1, wherein the coupling mechanism includes a rotatable element coupled to the drive rotor and a driving sleeve, the rotatable element having a control curve formed on an outer surface, and the driving sleeve having a control pin configured to travel within the control curve as the rotatable element rotates with rotation of the drive rotor.

24. The blood removal system of claim 23, wherein the drive sleeve moves within the housing along a puncturing axis as the drive rotor rotates in the first direction.

25. The blood removal system of claim 23, wherein the lancet reaches a position of maximum penetration when the control pin reaches a lower reversal point along the control curve.

26. The blood removal system of claim 1, wherein the drive spring encircles a portion of the drive rotor.

27. The blood removal system of claim 1, wherein the cocking element is coupled to a shaft having a control curve formed on an outer surface.

28. The blood removal system of claim 27, further including an actuator element having a control pin, the actuator element being configured to move along a puncturing axis during the cocking movement such that the control pin travels within the shaft control curve, thereby causing the shaft and the cocking element to rotate in the first direction.

29. The blood removal system of claim 28, wherein the actuator clement moves away from the housing exit opening during the cocking movement.

30. The blood removal system of claim 1, further including a locking cam having a first catch and a second catch, the drive rotor including a stop element that engages the first catch during the cocking movement, thereby inhibiting drive rotor rotation.

31. The blood removal system of claim 30, wherein the locking cam is pivotally mounted within the housing for movement between a first position wherein the first catch engages the stop element and a second position wherein the first catch disengages the stop element, thereby permitting drive rotor rotation.

32. The blood removal system of claim 31, wherein the stop element engages the second catch after the drive phase.

33. The blood removal system of claim 31, wherein the locking cam is movable to a third position when the second catch disengages the stop element, thereby permitting a preparation angle of drive rotor rotation after which the stop element engages the first catch.

34. The blood removal system of claim 33, wherein the coupling mechanism couples to the lancet as the drive rotor rotates through the preparation angle of drive rotor rotation.

35. The blood removal system of claim 33, wherein the lancet drive is configured to eject a used lancet as the drive rotor rotates through the preparation angle of drive rotor rotation.

36. The blood removal system of claim 1, wherein the cocking element and drive rotor rotate about a first axis that is substantially perpendicular to a puncturing axis.

37. The blood removal system of claim 36, further including a pinion coupled to the cocking element and an actuator element having a gear rod, wherein the gear rod engages the pinion as the actuator element is moved along the puncturing axis, thereby causing the pinion and the cocking element to rotate about the first axis.

38. The blood removal system of claim 36, wherein the cocking element includes a first recess substantially opposite the drive rotor and a second recess facing the drive rotor.

39. The blood removal system of claim 38, wherein the drive spring is positioned substantially within the second recess.

40. The blood removal system of claim 38, further including a free wheel connected to the pinion and positioned substantially within the first recess.

41. The blood removal system of claim 40, wherein the free wheel includes an elastic tongue that engages a stop of the cocking element to facilitate simultaneous movement of the pinion and the cocking element in the first direction about the first axis during the cocking movement, and disengages the stop to permit movement of the pinion relative to the cocking element in the opposite direction.

42. The blood removal system of claim 36, wherein the drive rotor includes a substantially circular control curve that is eccentrically located relative to the first axis.

43. The blood removal system of claim 42, further including a lancet holder configured to receive the lancet, the lancet holder including a control pin and being movably positioned within the housing such that the control pin travels within the drive rotor control curve as the drive rotor rotates about the first axis.

44. The blood removal system of claim 42, further including a separating disc positioned between the drive rotor and the spring, the separating disc forming a gap for receiving a portion of the lancet holder.

45. The blood removal system of claim 1, wherein the drive rotor moves through an angle of rotation range including a preparation range during which the drive rotor rotates at a first speed and a puncture range during which the drive rotor rotates at a second speed that is different than the first speed.

21. The blood removal system of claim further including a lancet guide connected to the housing, the lancet guide being configured to guide the lancet along the puncture path.

46. A blood removal system for removing blood for diagnostic purposes, comprising:

a housing;

a lancet drive connected to the housing and comprising;

a drive spring;

a cocking element connected to the drive spring;

a drive rotor connected to the drive spring; and

a coupling mechanism coupled to the drive rotor;

wherein;

during a cocking phase of the lancet drive the cocking element rotates in a first direction to tension the drive spring while the drive rotor is inhibited from rotating in the first direction;

during a driving phase of the lancet drive the drive rotor is rotatably driven in the first direction while the cocking element is arrested against a backward rotation, the coupling mechanism converting rotational movement of the drive rotor to movement of the lancet along a puncture path; and

the coupling mechanism comprises a control curve and a control pin which travels along the control curve during the drive phase, thereby determining at least a part of the puncture path.

47. The blood removal system of claim 46, wherein the control curve is located in the drive rotor.

48. The blood removal system of claim 46, wherein the cocking element is coupled by a transmission to a translatory movable actuation element.

49. A blood removal system for removing blood for diagnostic purposes, comprising:

a housing;

a lancet drive connected to the housing and comprising;

a drive spring;

a cocking element connected to the drive spring;

a drive rotor connected to the drive spring; and

a coupling mechanism coupled to the drive rotor;

wherein;

during a cocking phase of the lancet drive the cocking element rotates in a first direction to tension the drive spring while the drive rotor is inhibited from rotating in the first direction;

during a driving phase of the lancet drive the drive rotor is rotatably driven in the first direction while the cocking element is arrested against a backward rotation, the coupling mechanism converting rotational movement of the drive rotor to movement of the lancet along a puncture path; and

the cocking element is coupled by a transmission to a translatory movable actuation element.

50. The blood removal system of claim 49, wherein the axis of rotation of the cocking element is transverse to the direction of movement of the actuation element.

51. The blood removal system of claim 50, wherein the actuation element comprises a gear rod on a pinion gear that is coupled with the cocking element during the cocking phase of the lancet drive.

52. The blood removal system of claim 51, wherein the pinion gear, the cocking element and the drive rotor are components of a drive module and are rotatable about a common axis.

53. The blood removal system of claim 49, wherein the axis of rotation of the drive rotor is perpendicular to the direction of the puncture path.

54. A blood removal system for removing blood for diagnostic purposes, comprising:

a housing;

a lancet drive connected to the housing and comprising;

a drive spring;

a cocking element connected to the drive spring;

a drive rotor connected to the drive spring; and

a coupling mechanism coupled to the drive rotor;

wherein;

during a cocking phase of the lancet drive the cocking element rotates in a first direction to tension the drive spring while the drive rotor is inhibited from rotating in the first direction;

during a driving phase of the lancet drive the drive rotor is rotatably driven in the first direction while the cocking element is arrested against a backward rotation, the coupling mechanism converting rotational movement of the drive rotor to movement of the lancet along a puncture path; and

the axis of rotation of the drive rotor is perpendicular to the direction of the puncture path.

55. The blood removal system of claim 54, wherein the axis of rotation of the cocking element is parallel or coaxial to the axis of rotation of the drive rotor.

56. The blood removal system of claim 55, wherein the cocking element and the drive rotor are components of a drive module and are rotatable about a common axis.

57. The blood removal system of claim 56, wherein the drive spring comprises a spiral spring located in the drive module.

58. The blood removal system of claim 54, wherein the drive rotor rotates through a preparation angle of rotation range at a first speed and rotates through a puncture angle of rotation range at a second speed that is faster than the first speed.

59. A blood removal system for removing blood for diagnostic purposes, comprising:

a housing;

a lancet drive connected to the housing and comprising;

a drive spring;

a cocking element connected to the drive spring;

a drive rotor connected to the drive spring; and

a coupling mechanism coupled to the drive rotor;

wherein;

during a cocking phase of the lancet drive the cocking element rotates in a first direction to tension the drive spring while the drive rotor is inhibited from rotating in the first direction;

during a driving phase of the lancet drive the drive rotor is rotatably driven in the first direction while the cocking element is arrested against a backward rotation, the coupling mechanism convening rotational movement of the drive rotor to movement of the lancet along a puncture path; and

the drive rotor rotates through a preparation angle of rotation range at a first speed and rotates through a puncture angle of rotation range at a second speed that is faster than the first speed.

60. The blood removal system of claim 59, wherein in the preparation angle of rotation range torque is transferred from the cocking element to the drive rotor by turning the cocking element.

61. The blood removal system of claim 59, wherein the rotational movement of the drive rotor is inhibited at a transition in the angle of rotation range between the preparation range and the puncture range such that the drive spring, upon further rotation of the cocking element, is tensioned far puncture movement.

62. The blood removal system according to claim 61, wherein the inhibition of the rotational movement of the drive rotor is provided by a pawl coupled with a release.

63. The blood removal system of claim 61, wherein the inhibition is self-releasing, wherein the drive rotor is released when the drive spring reaches a tensioned state required for the puncture movement.

64. The blood removal system of claim 61, comprising a lancet holder with elastic arms and a stop element, the elastic arms and the stop element having a shape corresponding to the shape of a lancet such that the lancet is held in the lancet holder in a reproducible longitudinal position.