Adjustable disposable/single-use blade lancet device and method

• US 8,105,347 B2
• Filed: 11/16/2004
• Issued: 01/31/2012
• Est. Priority Date: 11/16/2004
• Status: Active Grant

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US10/988,636
• Publication Number:
  US 20060106411A1
• Time in Patent Office: 2,632 Days
• Field of Search: 606/181, 606/182, 606/184, 606/185, 600/573, 600/583
• US Class Current: 606/181
• CPC Class Codes: A61B 17/32093 for skin incisions
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• 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 5/150717 manually removed
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

Single-use blade lancet device includes a body having a rear end and a front end that includes a blade tip opening. A trigger is mounted to the body. A blade member is movably mounted within the body and includes a front end and a rear end. The blade member is movable between a first retracted position, an extended position, and a second retracted position. A biasing arrangement biases the blade member from the first retracted position towards the extended position and then towards the second retracted position. A guiding arrangement guides the blade member while the blade member moves from the first retracted position towards the extended position and then towards the second retracted position. During movement of the blade member, the guiding arrangement ensures that blade member maintains substantially the same orientation with respect to the body. 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 single-use blade lancet device, comprising:

a body comprising a rear end and a front end that includes a blade tip opening;

a trigger at least one of associated with the body and mounted to the body;

a blade member movably mounted within the body and comprising a front end and a rear end;

the blade member being movable at least between a first retracted position, an extended position, and a second retracted position;

a biasing arrangement that biases the blade member from the first retracted position towards the extended position and then towards the second retracted position; and

a guiding arrangement which guides the blade member while the blade member moves from the first retracted position towards the extended position and then towards the second retracted position,

wherein, during movement of the blade member, the guiding arrangement ensures that blade member maintains an orientation which is substantially parallel to an axis extending from the blade tip opening to the rear end of the body, and

wherein, during the movement of the blade member, the blade member at least one of;

has a side edge whose distance from the axis changes;

has a side edge whose distance from the axis increases between the first and second retracted positions; and

has a first side edge that moves toward the axis and a second side edge that moves away from the axis.

2. The device of claim 1, wherein the biasing arrangement comprises a spring.

3. The device of claim 1, wherein the biasing arrangement comprises at least one compression spring.

4. The device of claim 1, wherein the biasing arrangement comprises a leaf spring.

5. The device of claim 1, wherein the biasing member comprises two spaced apart compression springs.

6. The device of claim 1, wherein the trigger is movably mounted to the body.

7. The device of claim 1, wherein the body comprises a first housing part connected to a second housing part.

8. The device of claim 1, wherein the blade member comprises a body portion made of one material and a blade tip portion made of a different material.

9. The device of claim 1, wherein the guiding arrangement comprises two projections coupled to the blade member and two generally C-shaped cam recesses arranged within the body.

10. The device of claim 1, wherein the guiding arrangement comprises two projections coupled to the body and two generally C-shaped cam recesses arranged on the blade member.

11. The device of claim 1, wherein the guiding arrangement comprises two projections and two generally C-shaped cam recesses formed in the blade member.

12. The device of claim 1, wherein the guiding arrangement comprises a plurality of projections extending from one side of the blade member and a plurality of generally C-shaped cam recesses.

13. The device of claim 1, wherein the guiding arrangement comprises a plurality of non-movable projections and a corresponding plurality of generally C-shaped cam recesses, each generally C-shaped cam recess receiving therein one of the non-movable projections.

14. The device of claim 1, further comprising a trigger spring biasing the trigger towards an extended position.

15. The device of claim 1, wherein the trigger comprises a slot which receives therein a portion of the blade member when the blade member is in the second retracted position.

16. The device of claim 1, wherein the trigger comprises a slot which receives therein a portion of the blade member when the trigger moves from an extended position to a triggered position.

17. The device of claim 16, wherein the trigger comprises a cam surface which engages with the blade member when the blade member is in the first retracted position.

18. The device of claim 1, further comprising an adjusting system that adjusts a depth of penetration.

19. The device of claim 18, wherein the adjusting system comprises an engaging projection and a plurality of engaging recesses which are each configured to receive the engaging projection.

20. The device of claim 1, further comprising a removable safety device configured to prevent movement of the blade member.

21. The device of claim 1, wherein the body comprises a generally rectangular shape.

22. The device of claim 1, wherein the blade member comprises generally rectangular-shaped metal plate with a pointed blade tip defined by a tapered sharpened edge and a straight blunt edge.

23. The device of claim 1, wherein the guiding arrangement guides a blade tip of the blade member along a curved path.

24. The device of claim 1, wherein the guiding arrangement guides a blade tip of the blade member along a partially circular path.

25. The device of claim 1, wherein the body comprises oppositely arranged projecting ribs which movably guide the blade member.

26. The device of claim 1, wherein the blade member comprises at least one straight edge which remains substantially parallel to the axis throughout movement of the blade member.

27. The device of claim 1, wherein the blade member comprises a width, a thickness and a length, wherein the width is less than the length, and wherein the width is greater than the thickness by a factor of at least five.

28. The device of claim 1, wherein the blade member comprises a width, a thickness and a length, wherein the width is less than the length, and wherein the width is greater than the thickness by a factor of at least ten.

29. The device of claim 1, wherein the guiding arrangement comprises two spaced apart circular projections extending from an inner surface of the body and two spaced apart C-shaped cam recesses formed in or on the blade member.

30. The device of claim 1, wherein the body comprises at least one side opening through which a portion of the trigger protrudes.

31. The device of claim 1, wherein the body comprises an ergonomic shape to facilitate gripping.

32. The device of claim 1, wherein the front end of the body comprises an outwardly curved skin engaging surface.

33. The device of claim 1, wherein the body comprises a two-piece plastic body.

34. The device of claim 1, wherein the body comprises internal projecting fins which guide the movement of the blade member within the body.

35. The device of claim 1, wherein the blade tip opening is a rectangular-shaped opening.

36. The device of claim 1, wherein the blade tip opening is a rectangular-shaped slot.

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

disposing the front end of the device against a user'"'"'s skin;

triggering the trigger to cause a blade tip of the blade member to penetrate the user'"'"'s skin; and

preventing the user from moving the blade member to the extended position and to the first retracted position.

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

adjusting a set depth of penetration;

disposing the front end of the device against a user'"'"'s skin;

triggering the trigger to cause a blade tip of the blade member to penetrate the user'"'"'s skin; and

preventing the user from moving the blade member to the extended position and to the first retracted position.

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

adjusting a set depth of penetration;

disposing the front end of the device against a user'"'"'s skin;

triggering the trigger to cause a blade tip of the blade member to penetrate the user'"'"'s skin; and

ensuring that the trigger remains in a triggered position.

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

disposing the front end of the device against a user'"'"'s skin;

triggering the trigger to cause a blade tip of the blade member to penetrate the user'"'"'s skin; and

preventing the user from moving the trigger to an original armed or extended position.

41. A method of using the device of claim 1, the method comprising:

removing a removable safety device from the body;

disposing the front end of the device against a user'"'"'s skin; and

triggering the trigger to cause movement of the blade member.

42. A method of using the device of claim 1, the method comprising:

moving an adjusting mechanism to a desired set position;

removing a removable safety device from the body;

disposing the front end of the device against a user'"'"'s skin; and

triggering the trigger to cause movement of the blade member.

43. A method of using the device of claim 1, the method comprising:

removing a removable safety device from engagement with the blade member;

disposing the front end of the device against a user'"'"'s skin; and

triggering the trigger to cause movement of the blade member.

44. A method of using the device of claim 1, the method comprising:

moving an adjusting mechanism to a desired set position;

removing a removable safety device from engagement with the blade member;

disposing the front end of the device against a user'"'"'s skin; and

triggering the trigger to cause movement of the blade member.

45. A single-use blade lancet device, comprising:

a body comprising a rear end, a front end that includes a blade tip opening, and a sidewall arranged between the front end and the rear end;

a trigger;

a blade member movably mounted within the body and comprising a front end and a rear end;

the blade member being movable at least between a first retracted position, an extended position, and a second retracted position;

a biasing arrangement arranged on a side of the blade member and biasing the blade member from the first retracted position towards the extended position and then towards the second retracted position; and

a guiding arrangement which guides the blade member while the blade member moves from the first retracted position towards the extended position and then towards the second retracted position,

wherein, during movement of the blade member, the guiding arrangement ensures that blade member maintains an orientation which is substantially parallel to an axis extending from the blade tip opening to the rear end of the body, and

wherein, during the movement of the blade member, the blade member at least one of;

has a side edge whose distance from the sidewall of the body changes;

has a side edge whose distance relative to the axis is different in each of the first and second retracted positions; and

has a first side edge that moves toward the axis and a second side edge that moves away from the axis.

46. The device of claim 45, wherein the biasing arrangement comprises a spring.

47. The device of claim 45, wherein the biasing arrangement comprises at least one compression spring.

48. The device of claim 45, wherein the biasing arrangement comprises a leaf spring.

49. The device of claim 45, wherein the guiding arrangement comprises projections and generally C-shaped cam recesses.

50. A single-use blade lancet device, comprising:

a body comprising a blade tip opening;

a trigger;

a blade member movably mounted within the body and comprising a front end and a rear end;

the blade member being movable at least between a first retracted position, an extended position, and a second retracted position;

a biasing arrangement arranged on a side of the blade member and biasing the blade member from the first retracted position towards the extended position and then towards the second retracted position; and

a guiding arrangement which guides the blade member while the blade member moves from the first retracted position towards the extended position and then towards the second retracted position,

wherein, during movement of the blade member, the guiding arrangement ensures that blade member maintains an orientation which is substantially parallel to an axis extending through the blade tip opening, and

wherein, a distance between a side of the blade member and the axis is different in each of the first retracted position, the extended position, and the second retracted position.

51. The device of claim 50, wherein the guiding arrangement comprises projections engaging with generally C-shaped cam recesses.