Lancing device and method of sample collection

• US 8,366,729 B2
• Filed: 07/31/2007
• Issued: 02/05/2013
• Est. Priority Date: 10/19/1999
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Levaughn, Richard W., Flynn, Stephen J., Kennedy, Gwenn E., Lipoma, Michael V.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): Dang, Anh
• Application Number:
  US11/831,706
• Publication Number:
  US 20080021493A1
• Time in Patent Office: 2,016 Days
• Field of Search: 606/181, 606/182, 606/183, 606/172, 600573-584
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/150259 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 5/150816 by tactile feedback, e.g. vibration
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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

A lancing device and method for self-collecting a sample of body fluid by penetrating a body tissue at a sampling site. The invention includes a housing geometry configured for ease of use at different sampling sites on the body, even by persons having reduced dexterity and/or poor vision. Depth of penetration is selectively controlled by adjusting the stroke range of a spring-driven lancet carrier. A pressure applicator is included for stimulating flow of the body fluid. A transparent portion permits observation of the sampling site.

Claims

1. A lancing device, comprising:

a housing having a forward end including a cap, a rearward end and a longitudinal axis and defining a cavity;

a lancet carrier within the cavity of the housing for mounting a lancet, the lancet carrier comprising a limit member directly attached thereto;

a contact surface located within the cavity of the housing that directly contacts the limit member to selectively stop the lancet carrier at a plurality of locations along the longitudinal axis; and

an user accessible member having a portion extending outside of the housing for selectively moving the contact surface, the user accessible member having a central axis about which the user accessible member rotates that is perpendicular to the longitudinal axis of the housing, wherein the contact surface is carried by the user accessible member and provides a plurality of stopping positions each at a different distance from the central axis; and

a pressure applicator at the forward end of the cap of the housing to tension skin at the sampling site through application of compressive pressure at the sampling site.

2. The device of claim 1, wherein the pressure applicator is further to stimulate the generation of a sample of body fluid of a desired quantity.

3. The device of claim 2, further comprising a transparent window to permit internal visualization of the housing from outside the housing.

4. The device of claim 3, wherein the transparent window is configured to permit observation of a size of a fluid sample being collected after the lancet has pierced the tissue at the sampling site.

5. The device of claim 1, further comprising a transparent window to permit internal visualization of the housing from outside the housing.

6. The device of claim 1, wherein the contact surface has at least five surfaces.

7. The lancing device of claim 1, wherein the limit member is positioned between the rear end of the housing and the user accessible member.

8. A lancing device, comprising:

a housing having a skin engaging end and a rear end opposite the skin engaging end;

a lancet carrier within the housing for mounting a lancet, the lancet carrier comprising a limit member directly attached to the lancet carrier; and

an adjustable stroke controller to vary a depth of penetration of the lancet into the body tissue, wherein the adjustable stroke controller extends outside of the housing and carries an adjustable contact surface for directly contacting the limit member to selectively stop the lancet carrier at different locations along a longitudinal axis of the housing, wherein the adjustable stroke controller is positioned between the adjustable stroke controller and the rear end of the housing, wherein the adjustable stroke controller further has a central axis about which the user accessible member rotates that is perpendicular to a longitudinal axis of the housing.

9. The device of claim 8, further comprising a transparent window to permit internal visualization of the housing from outside the housing.

10. The device of claim 9, wherein the transparent window is configured to permit observation of a size of a fluid sample being collected after the lancet has pierced the tissue at the sampling site.

11. The device of claim 8, wherein the adjustable stroke controller is adjustable to any one of at least five positions.

12. A method of lancing a region of skin with a lancing device, comprising:

mounting a lancet to a lancet carrier within a housing comprising a cap, the lancet carrier comprising a limit member directly attached to it;

adjustably controlling a lancing stroke to vary a depth of penetration of the lancet into the body tissue using an adjustable stroke controller, wherein the adjustable stroke controller extends outside of the housing and carries and adjustable contact surface for directly contacting the limit member to selectively stop the lancet driver at a plurality of positions along a longitudinal axis of the housing, wherein the adjustable stroke controller has a central axis of rotation perpendicular to the longitudinal axis of the housing;

driving said lancet through the region of skin as a sampling site; and

applying pressure to tension skin at the sampling site through application of compressive pressure at the sampling site.

13. The method of claim 12, further comprising stimulating the sampling site to generate a sample of body fluid of a desired quantity.

14. The method of claim 13, further comprising a viewing through a transparent window of the housing from outside the housing.

15. The method of claim 14, wherein the viewing comprises observing a size of a fluid sample being collected after the lancet has pierced the skin at the sampling site.

16. A method of lancing a region of skin with a lancing device, comprising:

mounting a lancet to a lancet carrier within a housing comprising a body and a cap;

adjustably controlling a lancing stroke to vary a depth of penetration of the lancet into the body tissue by rotation of a thumbwheel having a central axis of rotation perpendicular to a longitudinal axis of the housing on which a variable contact surface is carried, a portion of the thumbwheel extending outside of the housing;

driving said lancet through the region of skin as a sampling site to the depth of penetration selected, wherein the thumbwheel is positioned midway in the housing and the a limit member is positioned on a side of the thumbwheel opposite a skin-engaging end of the housing such that the limit member contacts the variable contact surface during forward motion of the lancet carrier; and

stimulating the sampling site to generate a sample of body fluid of a desired quantity.

17. The method of claim 16, further comprising a viewing through a transparent window of the housing from outside the housing.

18. The method of claim 17, wherein the viewing comprises observing a size of a fluid sample being collected after the lancet has pierced the skin at the sampling site.