Lancing Device and Method of Sample Collection

• US 20080021493A1
• Filed: 07/31/2007
• Published: 01/24/2008
• Est. Priority Date: 10/19/1999
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kennedy, Gwenn, Lipoma, Michael, Levaughn, Richard, Flynn, Stephen
• Granted Patent: US 8,366,729 B2
• Time in Patent Office: Days
• 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;

a lancet driver within the housing for mounting a lancet and driving said lancet through body tissue as a sampling site;

adjustable stroke controller to vary the depth of penetration of the lancet into the body tissue;

a pressure applicator 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 5, 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.

7. The device of claim 1, wherein the adjustable stroke controller is adjustable to any one of multiple discreet positions each corresponding to a particular depth of penetration.

8. The device of claim 7, wherein the adjustable stroke controller is adjustable to any one of at least five positions.

9. A lancing device, comprising:

a housing;

a lancet driver within the housing for mounting a lancet and driving said lancet through body tissue as a sampling site;

adjustable stroke controller to vary the depth of penetration of the lancet into the body tissue;

a pressure applicator to stimulate the generation of a sample of body fluid of a desired quantity.

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

11. The device of claim 10, 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.

12. The device of claim 9, wherein the adjustable stroke controller is adjustable to any one of multiple discreet positions each corresponding to a particular depth of penetration.

13. The device of claim 12, wherein the adjustable stroke controller is adjustable to any one of at least five positions.

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

mounting a lancet to a lancet driver within a housing;

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

adjustably controlling a lancing stroke to vary the depth of penetration of the lancet into the body tissue; and

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

15. The method of claim 14, further comprising stimulating the sampling site to generate a sample of body fluid of a desired quantity.

16. The method of claim 15, further comprising viewing through a transparent window of the housing from outside the housing.

17. The method of claim 16, wherein the viewing comprises observing a size of a fluid sample being collected after the lancet has pierced the skin at the sampling site.

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

mounting a lancet to a lancet driver within a housing;

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

adjustably controlling a lancing stroke to vary the depth of penetration of the lancet into the body tissue; and

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

19. The method of claim 18, further comprising viewing through a transparent window of the housing from outside the housing.

20. The method of claim 19, wherein the viewing comprises observing a size of a fluid sample being collected after the lancet has pierced the skin at the sampling site.