Adjustable lancet device and method

• US 8,888,804 B2
• Filed: 01/07/2011
• Issued: 11/18/2014
• Est. Priority Date: 08/15/2003
• Status: Active Grant

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US12/986,613
• Publication Number:
  US 20110098736A1
• Time in Patent Office: 1,411 Days
• Field of Search: 606/181, 606/182, 600/573, 600/583
• US Class Current: 606/181
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/15029 for driving devices, i.e. means for driving the piercing element
• 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 5/150824 by visual feedback
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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

Lancet device that includes a body. A front cover includes a skin engaging end that includes a lancet opening through which a lancet needle extends. A holding member is movably mounted within the body. The holding member includes a front end and a rear end. The front end is configured to receive a lancet. A main spring is disposed between the front and rear ends of the holding member. A first stop surface is arranged on a front portion of the holding member. A second stop surface is axially retained to a front portion of the body. At least partial rotation of the front cover causes the skin engaging end to move axially relative to the second stop surface.

Claims

1. A lancet device, comprising:

a removable front cover comprising a skin engaging end that includes a lancet opening through which a lancet needle may extend;

a body having an axial length that is greater than an axial length of the front cover;

the front cover having an internal surface that movably engages with an external surface of the body;

a trigger arranged on a side of the body at a location that is closer to a front end of the body than to a rear end of the body;

an axially movable holding member comprising a front end and a rear end;

the front end of the holding member being configured to receive a lancet;

a first spring disposed between the front and rear ends of the holding member;

a first stop surface arranged on a front portion of the holding member;

a fixed second stop surface;

a back cap configured to move between a retracted position and an original position; and

the back cap having a portion that extends within the body and a portion that extends outside the body,

wherein at least partial rotation of the front cover causes the skin engaging end to move axially relative to the second stop surface, and

wherein contact between the first and second stop surfaces defines a puncturing position of the lancet needle.

2. The lancet device of claim 1, wherein the back cap is configured to move the holding member to the retracted position.

3. The lancet device of claim 1, wherein the back cap is coupled to a surface that engages the rear end of the holding member.

4. The lancet device of claim 1, wherein the back cap includes a surface that engages the rear end of the holding member.

5. The lancet device of claim 4, wherein the back cap comprises an opening that receives the rear end of the holding member.

6. The lancet device of claim 1, wherein the back cap includes a surface that engages projections disposed on the rear end of the holding member.

7. The lancet device of claim 1, further comprising a second spring for biasing the back cap towards the original position.

8. The lancet device of claim 1, wherein the first spring biases the holding member towards an extended position, and further comprising a second spring for biasing the holding member in an opposite direction.

9. The lancet device of claim 8, wherein said first spring and said second spring are arranged to surround portions of the holding member.

10. The lancet device of claim 8, wherein the first spring is coupled one side of the holding member and to a surface of the body.

11. The lancet device of claim 1, further comprising a locking member mounted to the rear end of the holding member.

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

13. The lancet device of claim 1, further comprising a mechanism for at least temporarily maintaining a depth setting position of the front cover.

14. The lancet device of claim 1, wherein the holding member comprises an integrally formed deflecting member that engages a surface of the body.

15. The lancet device of claim 1, further comprising a deflecting member configured to be deflected by the trigger.

16. The lancet device of claim 1, further comprising indicia arranged on at least one of the front cover and the body.

17. The lancet device of claim 1, wherein the first spring is disposed between the trigger and the back cap.

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

adjusting a set depth of penetration of the needle by rotating the front cover to a desired set position;

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

triggering the lancet needle to penetrate the user'"'"'s skin,

wherein the puncture allows a blood sample to be taken.

19. A lancet device with depth of penetration adjustment, comprising:

a body;

a trigger arranged on a side of the body at a location that is closer to a front end of the body than to a rear end of the body;

a front cover comprising a skin engaging end that includes a lancet opening through which a lancet needle may extend;

the front cover having an internal surface that rotatably engages with an external surface of the body;

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

the front end of the holding member being configured to receive a lancet comprising a lancet needle;

a first spring disposed inside the body between the front end of the holding member and a surface of the body;

a back cap configured to move the holding member to a retracted position and having a portion which extends within a rear portion of the body;

a second spring disposed between the rear end of the holding member and a surface of the back cap;

a moveable stop surface coupled to a front portion of the holding member and being disposed inside the body; and

a fixed stop surface disposed inside the body,

wherein at least partial rotation of the front cover causes the skin engaging end to move axially relative to the fixed stop surface, and

wherein contact between the movable and fixed stop surfaces defines one of a plurality of puncturing positions of the lancet needle.

20. A lancet device having depth of penetration adjustment and comprising:

a first housing comprising a proximal end and a distal end;

a rotatably mounted cap having a skin engaging surface and a lancet opening;

the cap having a portion rotatably disposed over an external surface of the proximal end of the first housing when installed on the lancet device;

a member having a proximal end portion structured and arranged to hold a lancet, the member being at least partially contained within the first housing;

a first spring for biasing the member towards an extended position;

the first spring surrounding a portion of the member and having a distal end which contacts a portion of the first housing and a proximal end which contacts a portion of the member;

a trigger arranged on a side of the first housing and being positioned closer to the proximal end of the first housing than to the distal end of the first housing;

the trigger being structured and arranged to move between a first position and a second position and to cause a triggering of the lancet device whereby the member is caused to move towards the extended position by the first spring;

a second housing comprising a distal end, a guide wall arranged at a proximal end, and an opening arranged on the guide wall;

the proximal end of the second housing being disposed within the first housing and the distal end of the second housing being disposed outside of the first housing;

at least a portion of the member being able to move within the opening of the guide wall;

the second housing being configured to move the member to a retracted position when the second housing is moved away from the proximal end of the first housing;

a second spring for biasing the second housing towards the first housing;

the second spring surrounding a portion of the member, being arranged within a space disposed within the second housing, and being disposed between the guide wall and a projecting portion arranged at a distal end portion of the member;

a surface having an opening arranged in the first housing between the guide wall and the first spring, the opening allowing a portion of the member to pass there through,

wherein at least a portion of the member is always retained within the first housing.

21. A lancet device having depth of penetration adjustment arranged at a front end of the lancet device, comprising:

a housing having a front end and a rear end;

a cover having an opening and a surface for positioning the lancet device relative to a skin surface;

the cover being removably mountable to the front end of the housing;

the cover having a portion rotatably disposed over an external surface of the front end of the housing when installed on the lancet device;

a lancet holding member movable within the housing, the lancet holding member being capable of holding a lancet;

a deflectable element arranged within the housing and having a portion that contacts a retaining surface when the lancet device is in a cocked position;

a movable stop surface arranged within the housing and that moves with the lancet holding member;

a fixed stop surface,

a first biasing element arranged in the housing;

the lancet holding member being configured to move toward the front end of the housing when the first biasing element expands axially;

a trigger arranged on a side of the housing, wherein, during triggering of the lancet device, movement of the trigger relative to the side of the housing results in the lancet holding member moving to a puncturing position;

the trigger having a portion that contacts the deflectable element;

a cocking member arranged at the rear end of the housing and being structured and arranged to place the lancet device in a cocked position when the cocking member is moved away from the front end of the housing;

a second biasing element structured and arranged to bias the cocking member toward the front end of the housing;

the second biasing element being axially compressed during cocking of the lancet device; and

rotation of the cover relative to the housing providing depth of penetration adjustment,

wherein, during triggering of the lancet device, the trigger causes inward deflection of the deflectable element, and

wherein the lancet device is placed in the cocked position by movement of the cocking member relative to the housing until the portion of the deflecting element engages with the retaining surface of the housing.

22. The device of claim 21, wherein a change in depth of penetration adjustment changes an overall length of the lancet device, and wherein an axis of the first biasing element is axially aligned with an axis of the second biasing element.

23. The device of claim 21, wherein the first biasing element is axially arranged in front of the second biasing element and the trigger is arranged closer to the front end of the housing than to the rear end.

24. A lancet device having depth of penetration adjustment, comprising:

a housing having a front end and a rear end;

an intermediate member disposed at the front end of the housing;

a front cover having an opening and a surface for positioning the lancet device relative to a skin surface;

the front cover having a portion rotatably disposed over an external surface arranged in an area of a front end of the intermediate member;

a lancet holding member movably arranged within the housing, the lancet holding member comprising a projecting portion and being capable of holding a lancet;

the projecting portion having a surface that contacts a retaining surface when the lancet device is in a cocked position;

a first biasing element surrounding a portion of the lancet holding member;

the first biasing element having a first end contacting a portion of the lancet holding member and a second end contacting a portion of the housing;

the lancet holding member being configured to move toward the front end of the housing when the first biasing element expands axially;

a trigger arranged on a side of the housing and being located closer to the front end of the housing than to the rear end, wherein, during triggering of the lancet device, movement of the trigger relative to the side of the housing results in the lancet holding member moving to a puncturing position;

a cocking member arranged at the rear end of the housing and being structured and arranged to place the lancet device in a cocked position when the cocking member is moved away from the front end of the housing;

the cocking member having a portion disposed within the housing and a portion arranged outside the housing;

a second biasing element surrounding another portion of the holding member and being structured and arranged to bias the cocking member toward the front end of the housing;

the second biasing element being axially compressed during cocking of the lancet device and being axially spaced from the first biasing element;

wherein, during triggering of the lancet device, the projecting portion moves out of contact with the retaining surface;

wherein a change in depth of penetration adjustment changes an overall length of the lancet device,

wherein the depth of penetration adjustment occurs via rotation of the front cover about an axis of the lancet holding member, and

wherein the lancet device is placed in the cocked position by movement of the cocking member relative to the housing until the projecting portion engages with the retaining surface.

25. The device of claim 24, wherein an axis of the first biasing element is axially aligned with an axis of the second biasing element.

26. The device of claim 24, wherein the first biasing element is axially arranged in front of the second biasing element.

27. The device of claim 24, wherein the front cover comprises a front cover assembly having a front portion and a rear portion, the rear portion being removably mountable to the housing and the front portion being rotatable relative to the rear portion, and further comprising an indicator and indicia indicating different depth of penetration positions arranged on the front and rear portions.

28. The device of claim 24, wherein the intermediate member has an internal surface connected via a connecting interface to an external surface of the housing.

29. The device of claim 24, wherein the intermediate member is removably connectable to the housing.

30. The device of claim 24, wherein the intermediate member is threadably connected to the housing.

31. The device of claim 24, wherein the intermediate member comprises a stop surface adapted to limit movement of the lancet holding member toward the puncturing position.

32. A lancet device, comprising:

a body comprising a front end and a rear end;

a trigger arranged on the body at a location that is closer to the front end than to the rear end;

a removable front cover assembly comprising;

a skin engaging surface;

a lancet opening; and

a depth adjustment mechanism;

a holding member movably mounted within the body and comprising a rear end and a front end configured to receive a lancet;

the holding member comprising a deflecting portion;

the trigger being configured to cause the deflecting portion to disengage from a retaining surface during triggering of the lancet device;

a wall arranged within the body;

the front end of the holding member being arranged on one side of the wall and the rear end of the holding member being arranged on another side of the wall;

a first spring surrounding a portion of the holding member, being structured and arranged to move the holding member to an extended position, and being axially disposed in front of the wall;

the first spring having a front end axially retained between surfaces arranged on the holding member;

a second spring surrounding another portion of the holding member and being structured and arranged to move the holding member from the extended position to an intermediate position;

a cocking mechanism structured and arranged to move the holding member to a retracted position when the cocking mechanism is moved away from the front end of the body;

the cocking mechanism comprising a first portion arranged within the body and a second portion extending outside the body;

the second spring being arranged within an inner space of the cocking mechanism and being structured and arranged to bias the cocking mechanism toward the front end of the body; and

a movable surface arranged on the holding member and being capable of contacting a fixed surface when the holding member is moved toward the front end of the body,

wherein the movable and fixed surfaces are arranged closer to the front end of the body than to the rear end of the body when the holding member is in the intermediate position.

33. The lancet device of claim 32, wherein the second spring has one end contacting a wall of the cocking mechanism and another end contacting a locking member arranged at the rear end of the holding member.

34. The lancet device of claim 32, wherein a change in depth adjustment changes an overall length of the lancet device.

35. A lancet device, comprising:

a body comprising a front end and a rear end;

a trigger arranged on the body at a location that is closer to the front end than to the rear end;

a front cover assembly comprising;

a front cover comprising a skin engaging surface having a lancet opening; and

an intermediate member having a rear end coupled to the front end of the body;

the front cover having an internal surface rotatably disposed over an external surface of the intermediate member;

a holding member movably mounted within the body and comprising a rear end and a front end configured to receive a lancet;

the holding member comprising a deflecting portion;

the trigger being configured to cause the deflecting portion to disengage from a retaining surface during triggering of the lancet device;

a wall arranged within the body;

the front end of the holding member being arranged on one side of the wall and the rear end of the holding member being arranged on another side of the wall;

a first spring surrounding a portion of the holding member, being structured and arranged to move the holding member to an extended position, and being axially disposed in front of the wall;

a second spring surrounding another portion of the holding member and being structured and arranged to move the holding member from the extended position to an intermediate position;

a cocking mechanism structured and arranged to move the holding member to a retracted position when the cocking mechanism is moved away from the front end of the body;

the cocking mechanism comprising a first portion arranged within the body and a second portion extending outside the body;

the second spring being arranged within an inner space of the cocking mechanism and being structured and arranged to bias the cocking mechanism toward the front end of the body;

a movable surface arranged on the holding member; and

a fixed surface capable of limiting axial forward movement of the holding member when the holding member is moved toward the extended position,

wherein the movable and fixed surfaces are closer to the front end of the body than to the rear end of the body when the holding member is in the intermediate position, and

wherein a position of the fixed surface does not change when the depth adjustment mechanism is moved between different depth adjustment positions.

36. The lancet device of claim 35, wherein the second spring has one contacting a wall of the cocking mechanism and another end contacting a locking member arranged at the rear end of the holding member.

37. The lancet device of claim 35, wherein a change in depth adjustment changes an overall length of the lancet device and the trigger comprises a projection that contacts the deflecting portion.

38. The device of claim 35, wherein the intermediate member is removably connectable to the body.

39. The device of claim 35, wherein the fixed surface is arranged within the intermediate member.

40. A lancet device, comprising:

a body comprising a front end and a rear end;

a trigger arranged on the body at a location that is closer to the front end than to the rear end;

a front cover assembly comprising;

a front cover comprising a skin engaging surface having a lancet opening; and

an intermediate member having a rear end coupled to the front end of the body;

the front cover having an internal surface rotatably and adjustably disposed over an external surface of the intermediate member;

a holding member movably mounted within the body and comprising a rear end and a front end configured to receive a lancet;

the holding member comprising a deflecting portion;

the trigger being configured to cause the deflecting portion to disengage from a retaining surface during triggering of the lancet device;

a wall arranged within the body;

the front end of the holding member being arranged on one side of the wall and the rear end of the holding member being arranged on another side of the wall;

a first spring surrounding a portion of the holding member, being structured and arranged to move the holding member to an extended position, and being axially disposed in front of the wall;

a second spring surrounding another portion of the holding member and being structured and arranged to move the holding member from the extended position to an intermediate position;

a cocking mechanism structured and arranged to move the holding member to a retracted position when the cocking mechanism is moved away from the front end of the body;

the cocking mechanism comprising a first portion arranged within the body and a second portion extending outside the body;

the second portion having a cross-sectional width that is greater than a cross-sectional width of the rear end of the body;

the second spring being arranged within an inner space of the cocking mechanism and being structured and arranged to bias the cocking mechanism toward the front end of the body;

a movable surface arranged on the holding member; and

a fixed surface capable of limiting axial forward movement of the holding member when the holding member is moved toward the extended position,

wherein the movable and fixed surfaces are closer to the front end of the body than to the rear end of the body when the holding member is in the intermediate position, and

wherein a position of the fixed surface does not change when the front cover is moved between different depth adjustment positions, and

wherein, with the front cover assembly removed, an overall length of the holding member is longer than an overall length of the body.

41. The lancet device of claim 40, wherein the second spring has one end contacting a wall of the cocking mechanism and another end contacting a locking member arranged at the rear end of the holding member.

42. The lancet device of claim 40, wherein a change in depth adjustment changes an overall length of the lancet device and the trigger comprises a projection that contacts the deflecting portion.

43. The device of claim 40, wherein the intermediate member is removably connectable to the body.

44. The device of claim 40, wherein the fixed surface is arranged within the intermediate member.

45. A lancet device, comprising:

a body comprising a front end and a rear end;

a trigger arranged on the body at a location that is closer to the front end than to the rear end;

a removable front cover comprising a skin engaging surface and a lancet opening;

the front cover having an internal surface disposed over an external surface of the body and being removable from the body via rotation relative thereto;

a holding member movably mounted within the body and comprising a rear end and a front end configured to receive a lancet;

the holding member comprising a projecting portion;

the trigger being configured to cause release of retaining engagement between the projecting portion and a retaining surface during triggering of the lancet device;

a wall arranged within the body;

the front end of the holding member being arranged on one side of the wall and the rear end of the holding member being arranged on another side of the wall;

a first spring surrounding a portion of the holding member, being structured and arranged to move the holding member to an extended position, and being axially disposed in front of the wall;

a second spring surrounding another portion of the holding member and being structured and arranged to move the holding member from the extended position to an intermediate position;

a cocking mechanism structured and arranged to move the holding member to a retracted position when the cocking mechanism is moved away from the front end of the body;

the cocking mechanism comprising a first portion arranged within the body and a second portion extending outside the body;

the second spring being compressed when a wall of the cocking mechanism is moved away from the front end of the body and being structured and arranged to bias the cocking mechanism toward the front end of the body; and

a first stop surface movable with the holding member and being capable of contacting a second stop surface when the holding member is moved toward the front end of the body,

wherein the front cover is removable and installable on the lancet device via rotation in opposite directions, and

wherein depth of penetration is determined by contact between the first stop surface movable with the holding member and the second stop surface and the second stop surface is arranged axially behind a rear end of the front cover.

46. The lancet device of claim 45, wherein the second spring has one end contacting the wall of the cocking mechanism and another end contacting a locking member arranged at the rear end of the holding member.

47. The device of claim 45, wherein the body comprises a main body and an intermediate member and the external surface of the body is arranged on a front end of the intermediate member.

48. The device of claim 45, wherein a position of the second stop surface is user adjustable between discrete depth setting positions.

49. A lancet device, comprising:

a body comprising a front end and a rear end;

a trigger arranged on the body at a location that is closer to the front end than to the rear end;

a removable front cover comprising a skin engaging surface and a lancet opening;

the front cover having an internal surface disposed over an external surface of the body and being removable from the body;

a holding member movably mounted within the body and comprising a rear end and a front end configured to receive a lancet;

the holding member comprising a deflectable projecting portion;

the trigger being configured to cause release of retaining engagement between the deflectable projecting portion and a retaining surface during triggering of the lancet device;

a surface arranged within the body;

the front end of the holding member being arranged on one side of the surface and the rear end of the holding member being arranged on another side of the surface;

a first spring structured and arranged to move the holding member to an extended position and being axially disposed in front of the surface of the body;

a second spring structured and arranged to move the holding member from the extended position to an intermediate position and being axially disposed in back of the surface of the body;

a cocking mechanism structured and arranged to move the holding member to a retracted position when the cocking mechanism is moved away from the front end of the body;

the cocking mechanism comprising a first portion arranged within the body and a second portion extending outside the body;

the second spring being compressed when a surface of the cocking mechanism is moved away from the front end of the body and being structured and arranged to bias the cocking mechanism toward the front end of the body; and

a first stop surface movable with the holding member and being capable of contacting a second stop surface when the holding member is moved toward the front end of the body,

wherein depth of penetration is determined by contact between the first stop surface movable with the holding member and the second stop surface, and,

wherein the second stop surface is arranged axially between a rear end of the front cap and the surface of the body.

50. The device of claim 49, wherein a position of the second stop surface is user adjustable between discrete depth setting positions.