Blood sampling device

• US 7,655,019 B2
• Filed: 08/19/2004
• Issued: 02/02/2010
• Est. Priority Date: 08/20/2003
• Status: Active Grant

• Current Assignee: Facet Technologies LLC
• Original Assignee: Facet Technologies LLC
• Inventors: Campbell, Stephanie J., Solis, Mitchell A., Griffin, Carl E., Pynes, Mary Kate, LeVaughn, Richard W., Ruf, Christopher J., Kennedy, Gwenn E., Heath, Jason R., Robbins, Avi M., Flynn, Stephen J., Irwin, John C.
• Primary Examiner(s): Manahan; Todd E
• Assistant Examiner(s): Mendoza; Michael G
• Application Number:
  US10/569,025
• Publication Number:
  US 20060235454A1
• Time in Patent Office: 1,993 Days
• Field of Search: 606/167, 606/181, 606/182, 606/183, 604/22, 604/117, 604/110, 604207-211
• US Class Current: 606/183
• 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 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150725 removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
• CPC Class Codes: A61B 5/150885 Preventing re-use
• 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 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking

Abstract

A sampling device (20) having a housing (24) with a lancet cartridge (22) mounted therein. The lancets (26) of the lancet cartridge (22) are interconnected by a flexible web (28). The lancet cartridge (22) is not positively engaged within the housing (24) and can be easily removed. The housing (24) has an opening (42) with an adjacent flexible or compressible fin (60) for dampening the motion of the lancet (26). The lancet cartridge (22) has at least one lancet (26) with an endcap, and the housing has a cap-removal mechanism (74) for separating the endcap from the housing (24). Anti-tampering features prevent opening of the device when the lancet cartridge (22) is oriented with a lancet (26) in a firing position.

Claims

1. A device for sampling a body fluid, said device comprising a housing and a lancet cartridge removably installed within the housing, the lancet cartridge comprising a plurality of lancets arranged in a circular array and each having a sharp lancet tip directed radially outwardly, said lancets being interconnected to one another by a flexible web that allows the lancets to move independently of one another in a radial direction, the device further comprising a drive mechanism within the housing for propelling an active lancet selected from the plurality of lancets from a retracted position fully within the lancet cartridge radially outwardly to an extended position wherein at least a tip portion of the lancet projects outward from the lancet cartridge, said drive mechanism comprising a contact face for imparting motion to the active lancet without positive attachment to the lancet cartridge.

2. The sampling device of claim 1, wherein the contact face of the drive mechanism comprises an angled female recess, and the lancet cartridge has at least one complementary angled male profile for alignment within the angled female recess.

3. The sampling device of claim 1, wherein the housing comprises a resilient portion having a protuberance thereon for engaging at least one recess in the lancet cartridge to index advancement of the lancet cartridge within the housing.

4. A device for sampling a body fluid, said device comprising a housing having an opening therein, a plurality of lancets arranged in a circular array and each having a sharp lancet tip directed radially outwardly, said lancets being interconnected to one another by a flexible web that allows the lancets to move independently of one another in a radial direction, a drive mechanism within the housing for propelling the lancet along a lancing path, from a retracted position fully within the lancet cartridge to an extended position wherein at least a tip portion of the lancet projects through the opening in the housing, and a dampening fin adjacent the opening for dampening the motion of the lancet upon contact of the lancet against the dampening fin in the extended position.

5. The sampling device of claim 4, wherein the housing further comprises a pair of flanges positioned on opposite sides of the opening, said flanges having inwardly inclined faces for guiding the lancet along the lancing path.

6. A device for sampling a body fluid, said device comprising a housing and a plurality of lancets contained within said housing, said plurality of lancets being arranged in a circular array and each having a sharp lancet tip directed radially outwardly, said lancets being interconnected by a flexible web that allows the lancets to move independently of one another in a radial direction.

7. The sampling device of claim 6, further comprising a plurality of alignment tabs, each alignment tab associated with a respective one of the plurality of lancets, and wherein the housing comprises a channel in which the alignment tabs are received.

8. The sampling device of claim 7, wherein the channel comprises a ring-shaped channel portion and an extension channel portion extending radially from the ring-shaped channel portion.

9. A device for sampling a body fluid, said device comprising:

a housing having an arm with a wedge-shaped profile and an inclined ramp;

a plurality of lancets arranged in a co-planar array defining a firing plane, each lancet having a body portion, a sharp tip extending from the body portion, and an endcap covering the sharp tip;

an advancing mechanism for advancing one of the plurality of lancets into contact with the arm of the housing to drive the wedge-shaped profile between the body portion of the lancet and the endcap, and thereby separate the endcap from the body portion of the lancet, and to drive the separated endcap into contact with the inclined ramp to move the separated endcap out of the firing plane; and

the plurality of lancets being interconnected to one another by a flexible web that allows the lancets to move independently of one another in a radial direction.

10. The sampling device of claim 9, wherein the separated endcap is driven into a well for retaining the endcap out of the firing plane.

11. A lancet cassette for removable installation within a sampling device, said lancet cassette comprising a plurality of lancets arranged in a circular array and each having a sharp lancet tip directed radially outwardly, said lancets being interconnected to one another by a flexible web that allows the lancets to move independently of one another in a radial direction.

12. The lancet cassette of claim 11, further comprising a plurality of alignment tabs, each alignment tab attached to an inner end of a respective one of the plurality of lancets.

13. The lancet cassette of claim 12, wherein the plurality of lancets are positioned on an annular carrier disk having a central opening through which the plurality of alignment tabs project.

14. The lancet cassette of claim 11, further comprising at least one hook for engagement with an anti-tamper shelf portion of the sampling device.

15. The lancet cassette of claim 11, wherein each lancet comprises a removable protective endcap, and wherein the lancet cassette further comprises a well beneath the end cap of each lancet for retaining the endcap upon removal from the lancet.

16. The lancet cassette of claim 11, further comprising a lower face having surface features for engaging an advancing mechanism of the sampling device.

17. The lancet cassette of claim 11, further comprising an outer circumferential rim having a plurality of detents formed therein for indexing engagement with a cooperating protuberance of the sampling device.

18. A device for sampling a body fluid, said device comprising:

an outer housing having first and second portions hingedly connected to one another, an opening, and an arm having a wedge-shaped profile projecting inwardly from one of the first and second portions;

a lancet cassette for removable installation within the outer housing, the lancet cassette comprising a plurality of lancets arranged in a circular array within a firing plane, and a flexible web interconnecting the plurality of lancets that allows the lancets to move independently of one another in a radial direction and along the firing plane, each lancet comprising a lancet body, a sharp tip directed radially outwardly, and a protective endcap removably positioned over the sharp tip;

a drive mechanism within the housing for propelling an active lancet along a lancing path in the firing plane, from a retracted position fully within the lancet cartridge radially outwardly to an extended position wherein at least a tip portion of the active lancet projects through the opening in the housing; and

an advancing mechanism for sequentially advancing each of the plurality of lancets into an active position in the housing, wherein the endcap of the active lancet is separated from the body portion thereof as it enters the active position by contact with the wedge-shaped profile and wherein the separated endcap is moved out of the firing plane.

19. The sampling device of claim 18, further comprising a dampening fin adjacent the opening in the housing for contact with the active lancet in its extended position.

20. The sampling device of claim 18, further comprising a guide channel defined between a pair of flanges positioned on opposite sides of the opening through the outer housing.