Multi-lancet unit, method and lancet device using the multi-lancet unit, and method of assembling and/or making the multi-lancet unit

• US 9,017,356 B2
• Filed: 02/08/2008
• Issued: 04/28/2015
• Est. Priority Date: 02/09/2007
• Status: Expired due to Fees

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven, Schwartz, Brian, Carhart, David A., Fuller, Paul R.
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US12/525,982
• Publication Number:
  US 20110160759A1
• Time in Patent Office: 2,636 Days
• Field of Search: 606181-183, 600/583
• US Class Current: 606/181
• 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 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150534 Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
• 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 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15155 Piercing elements which are specially shaped or are provided with fittings or attachments to facilitate nesting, stacking or joining together end-to-end or side-by-side
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/1518 Security or safety mechanism to be deactivated for forwarding next piercing element
• CPC Class Codes: A61B 5/15182 Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display

Abstract

A lancet device includes a housing, a trigger, a system for placing the lancet device in a trigger-set or armed position, and a multi-lancet unit comprising a plurality of lancets arranged one in front of the other and positioned in the housing. Each lancet includes a front end, a needle which extends from the front end, and a rear end. The front end of at least one of the plurality lancets is removably connected to the rear end of another of the plurality of lancets. A method of puncturing a surface of skin using the lancet device includes arranging the lancet device adjacent against a user'"'"'s skin and triggering the lancet device so that one of the plurality of lancet is caused to penetrate the user'"'"'s skin.

Claims

1. A lancet device comprising:

a housing;

a trigger having a portion extending outside the housing so as to be contacted by a user;

a front cover having a skin engaging surface and an opening allowing a needle of a lancet to pass therethrough during skin puncturing;

a cocking system configured to place the lancet device in a trigger-set or armed position;

the cocking system comprising a cocking member arranged in an area of a rear end of the housing;

a multi-lancet unit comprising a plurality of lancets arranged one in front of the other and positioned in the housing;

each lancet comprising a front end, a needle which extends from the front end, and a rear end;

a lancet holding member receiving therein the multi-lancet unit and being movable within the housing; and

a lock member that is movable to a locking position that prevents axial movement of the lancet holding member,

wherein, when the lock member is not in the locking position, the holding member is capable of moving between an initial position, a trigger-set position, and a puncturing position,

wherein the front end of at least one of the plurality lancets is removably connected to the rear end of another of the plurality of lancets.

2. The lancet device of claim 1, wherein the plurality of lancets comprises two lancets.

3. The lancet device of claim 1, wherein the plurality of lancets comprises at least three lancets.

4. The lancet device of claim 1, wherein the plurality of lancets is between five lancets and twenty lancets.

5. The lancet device of claim 1, wherein the plurality of lancets is between eight lancets and twelve lancets.

6. The lancet device of claim 1, wherein each of the plurality of lancets comprises a generally cylindrical portion.

7. The lancet device of claim 1, wherein each of the plurality of lancets comprises a generally circular cross-section when viewed perpendicular to a center axis of the plurality of lancets.

8. The lancet device of claim 1, wherein at least one of the plurality of lancets comprises a locking mechanism.

9. The lancet device of claim 8, wherein the locking mechanism comprises at least one of a circumferential locking recess and a tapered recess.

10. The lancet device of claim 1, wherein each of the plurality of lancets comprises a locking recess.

11. The lancet device of claim 1, further comprising a depth adjustment system.

12. A method of puncturing a surface of skin using the lancet device of claim 11, the method comprising:

arranging the lancet device adjacent against a user'"'"'s skin; and

triggering the lancet device so that one of the plurality of lancets is caused to penetrate the user'"'"'s skin.

13. The lancet device of claim 1, further comprising:

a depth adjustment system; and

the lancet holding member comprising;

an opening arranged behind a front end of the lancet holding member;

an integrally formed deflecting member; and

a longitudinal length that is greater than a longitudinal length of the housing.

14. The lancet device of claim 1, further comprising:

a rotatably mounted depth adjustment element.

15. The lancet device of claim 1, further comprising at least one of:

a system for removing or ejecting a lancet of the plurality of lancets; and

a system for advancing or positioning an unused lancet into a position previously held by a used lancet that has been removed.

16. The lancet device of claim 1, further comprising a manually activated system for removing or ejecting a used lancet of the multi-lancet unit.

17. The lancet device of claim 1, further comprising a system for removing or ejecting a used lancet of the multi-lancet unit and for causing removal of the front cover.

18. A method of puncturing a surface of skin using the lancet device of claim 17, the method comprising:

arranging the lancet device adjacent against a user'"'"'s skin; and

triggering the lancet device so that one of the plurality of lancets is caused to penetrate the user'"'"'s skin.

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

arranging the lancet device adjacent against a user'"'"'s skin; and

triggering the lancet device so that one of the plurality of lancets is caused to penetrate the user'"'"'s skin.

20. A lancet device comprising:

a housing;

a front cap having a skin engaging surface and a lancet opening allowing for passage therethrough of a lancet needle during skin puncturing;

a trigger;

a depth adjustment system arranged in an area of a rear end of the housing;

a plurality of lancets arranged one in front of the other and positioned in the housing;

each lancet comprising a front end, a needle which extends from the front end, and a rear end;

an advance button movable between a first position and a position causing each of;

ejection of one of the lancets; and

removal of the front cap,

wherein the front end of at least one of the plurality lancets is removably connected to the rear end of another of the plurality of lancets.

21. The lancet device of claim 20, wherein the plurality of lancets comprise at least three lancets.

22. The lancet device of claim 20, wherein the plurality of lancets is between eight lancets and twelve lancets.

23. The lancet device of claim 20, wherein each of the plurality of lancets comprises a generally cylindrical portion.

24. The lancet device of claim 20, further comprising a cocking system for placing the lancet device in a trigger-set or armed position.

25. The lancet device of claim 20, further comprising a holding member which houses the plurality of lancets.

26. The lancet device of claim 20, wherein the plurality of lancets comprises a multi-lancet unit and further comprising a system, including the advance button, for removing or ejecting a lancet of the multi-lancet unit which is activated by the advance button.

27. The lancet device of claim 20, wherein the plurality of lancets comprises a multi-lancet unit and further comprising a manually activated system, including the advance button, for removing or ejecting a used lancet of the multi-lancet unit which is manually activated by the advance button.

28. The lancet device of claim 20, wherein the plurality of lancets comprises a multi-lancet unit and further comprising a lancet holding member locking system.

29. A method of puncturing a surface of skin using the lancet device of claim 20, the method comprising:

arranging the lancet device adjacent against a user'"'"'s skin; and

triggering the lancet device so that one of the plurality of lancets is caused to penetrate the user'"'"'s skin.

30. A lancet device comprising:

a trigger arranged on a sidewall and having a portion that can be contacted by a user;

a front cap mountable to a front portion of the sidewall and having a skin engaging surface with an opening allowing a lancet needle to pass therethrough;

a lock member movable to a position locking a holding member;

a releasable retaining member retaining the holding member in a trigger-set position;

a depth adjustment system;

a cocking system configured to place the lancet device is in a trigger-set position;

a multi-lancet unit comprising a plurality of lancets arranged one in front of the other and being insertable into the holding member as a unit; and

an advancing system for axially moving or advancing the multi-lancet unit when the holding member is in a locked position.

31. A lancet device comprising:

a housing;

a trigger;

a cocking system configured to place the lancet device in a trigger-set or armed position;

the cocking system comprising a cocking member arranged in an area of a rear end of the housing;

a multi-lancet unit comprising a plurality of lancets arranged one in front of the other and positioned in the housing;

each lancet comprising a front end, a needle which extends from the front end, and a rear end;

a lancet holding member receiving therein the multi-lancet unit and being movable within the housing;

a retaining member holding the holding member in a trigger-set position;

the retaining member releasing the holding member when a user activates the trigger;

a lock member that is movable to a locking position and is so caused to move upon activation of a lancet ejection system and that prevents axial movement of the lancet holding member,

wherein the front end of at least one of the plurality lancets is removably connected to the rear end of another of the plurality of lancets.

32. A lancet device having lancet ejection and depth of penetration adjustment, comprising:

a housing;

a wall arranged in the housing and having an opening;

a rotatable depth of penetration adjustment member;

a trigger arranged on a side of the housing and being closer to a front end of the housing than to a rear end of the housing;

the trigger having a portion extending outside the housing so as to be contacted by a user;

a cocking system configured to place the lancet device in a trigger-set or armed position;

the cocking system comprising a cocking member arranged in an area of a rear end of the housing and having a portion extending into the housing and a portion extending outside the housing;

a lancet holding member axially movable within the housing and comprising;

a rear portion arranged on a rear side of the wall;

a front portion arranged on a front side of the wall;

an opening arranged behind a front end of the lancet holding member;

an integrally formed deflecting member; and

a longitudinal length that is greater than a longitudinal length of the housing;

said deflecting member being configured to retain the lancet holding member in the trigger-set or armed position when in contact with a surface;

said deflecting member being movable upon activation of the trigger;

a first spring surrounding a portion of the lancet holding member and having a front end in contact with a portion of the lancet holding member;

a second spring arranged axially behind the first spring and surrounding another portion of the lancet holding member;

the second spring extending into a space disposed inside the cocking member;

a rear end of the lancet holding member being arranged axially in front of a rear end of the cocking member when the lancet device is in the trigger-set or armed position;

a slide arranged on a side of the housing and being closer to the front end of the housing than to the rear end of the housing;

the slide comprising;

a portion disposed inside the housing;

a portion extending outside the housing;

a portion that can extend into the opening of the lancet holding member and contact a lancet; and

a portion that can be slid forward to a position located in front of the front end of the housing,

wherein the lancet holding member is capable of moving between an initial position, the trigger-set or armed position, and a puncturing position.

33. The lancet device of claim 32, further comprising at least one of:

a front cover;

the rotatable depth of penetration adjustment member being arranged in the area of the rear end of the lancet device;

a lock member that is movable to a locking position that prevents axial movement of the lancet holding member, wherein, when the lock member is not in the locking position, the lancet holding member is capable of moving between the initial position, the trigger-set or armed position, and the puncturing position;

the slide comprising plural components;

a multi-lancet unit comprising a plurality of lancets arranged one in front of the other and positioned in the housing and each lancet comprising a front end, a needle which extends from the front end, and a rear end; and

/or

a lock member that is movable to a locking position upon activation of the slide.

34. A lancet device having lancet ejection and depth of penetration adjustment, comprising:

a housing;

a wall arranged in the housing and having an opening;

the wall being arranged closer to a rear end of the housing than to a front end of the housing;

a front cover having a skin engaging surface and an opening allowing a needle of a lancet to pass therethrough during skin puncturing;

a trigger arranged on a side of the housing and being closer to the front end of the housing than to the rear end of the housing;

the trigger having a portion extending outside the housing so as to be contacted by a user;

a cocking system configured to place the lancet device in a trigger-set or armed position;

the cocking system comprising a cocking member arranged in an area of the rear end of the housing and having a portion extending into the housing and a portion extending outside the housing;

a lancet holding member axially movable within the housing and comprising;

a rear portion arranged on a rear side of the wall;

a front portion arranged on a front side of the wall;

an opening arranged behind a front end of the lancet holding member;

an integrally formed deflecting member; and

a longitudinal length that is greater than a longitudinal length of the housing;

said deflecting member being configured to retain the lancet holding member in the trigger-set or armed position when in contact with a surface arranged in or on the housing;

said deflecting member being movable out of retaining engagement with the surface during triggering of the lancet device;

a first spring disposed in front of the wall and surrounding a portion of the lancet holding member;

a second spring disposed behind the wall, surrounding another portion of the lancet holding member, and extending into a space disposed inside the cocking member;

a rear end of the lancet holding member being arranged axially in front of a rear end of the cocking member when the lancet device is in the trigger-set or armed position;

a lancet ejector arranged on a side of the housing and being closer to the front end of the housing than to the rear end of the housing;

the lancet ejector comprising;

a portion disposed inside the housing;

a portion extending outside the housing;

a portion that can extend into the opening of the lancet holding member and contact a lancet; and

a portion that can be slid forward to a position located in front of the front end of the lancet holding member,

wherein the lancet holding member is capable of moving between an initial position and a puncturing position, and

wherein the lancet device is capable of assuming plural different depth of penetration adjustment positions.

35. The lancet device of claim 34, further comprising:

a lock member that is movable to a locking position that prevents axial movement of the lancet holding member; and

a multi-lancet unit comprising a plurality of lancets arranged one in front of the other and positioned in the housing.