Lancing device and method of sample collection

• US 6,283,982 B1
• Filed: 10/19/1999
• Issued: 09/04/2001
• Est. Priority Date: 10/19/1999
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Facet Technologies LLC
• Inventors: Kennedy, Gwenn E., Flynn, Stephen J., Lipoma, Michael V., Levaughn, Richard W.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US09/420,649
• Time in Patent Office: 686 Days
• Field of Search: 606/182, 606/172, 606/183, 604/136, 604/137, 604/156, 604/157, 600/583
• US Class Current: 606/172
• 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 for use with a lancet to penetrate tissue and facilitate collection of a sample of a body fluid, said lancing device comprising:

(a) a housing;

(b) a lancet carrier translationally mounted to said housing for carrying a lancet along a stroke traversing to an extended position wherein a tissue penetrating portion of the lancet extends a distance outwardly of said housing, said lancet carrier comprising a limit member; and

(c) a thumb wheel rotationally mounted to said housing about an axis of rotation generally perpendicular to a central axis of said housing, and comprising an eccentric contact surface forming a selectively movable stop for contacting said limit member to limit the stroke of the lancet carrier in the direction of the extended position.

2. The lancing device of claim 1, further comprising indicia on said thumbwheel for indicating the distance the tissue penetrating portion of the lancet extends outwardly of said housing in said extended position.

3. The lancing device of claim 1, further comprising indexing means for incrementing rotation of said thumbwheel relative to said housing through a plurality of discrete positions.

4. The lancing device of claim 3, wherein said indexing means comprises an arcuate series of detents formed in said housing and at least one cooperating projection formed on said thumbwheel.

5. The lancing device of claim 1, further comprising a pressure applicator, said pressure applicator comprising a forward panel of said housing defining an opening therethrough, and a raised lip surrounding at least a portion of said opening.

6. The lancing device of claim 1, wherein said housing comprises a releasable endcap, and wherein at least a portion of said endcap is transparent.

7. A lancing device for use with a lancet to penetrate tissue and facilitate collection of a sample of a body fluid, said lancing device comprising:

(a) a housing;

(b) a lancet carrier translationally mounted to said housing for carrying a lancet along a stroke traversing an extended position wherein a tissue penetrating portion of the lancet extends a distance outwardly of said housing, said lancet carrier comprising a limit member; and

(c) a thumb wheel rotationally mounted to said housing, and comprising an eccentric contact surface forming a selectively movable stop for contacting said limit member to limit the stroke of the lancet carrier in the direction of the extended position,

wherein said lancet carrier comprises a first gripping jaw, a second gripping jaw positioned in opposition to said first gripping jaw, biasing means for biasing said first and second gripping jaws from an open position for receiving and releasing a lancet towards a closed position for gripping a lancet, a first release arm extending from said first gripping jaw, and a second release arm extending from said second gripping jaw.

8. A lancing device for use with a lancet to penetrate tissue and facilitate collection of a sample of a body fluid, said lancing device comprising:

(a) a housing;

(b) a lancet carrier translationally mounted to said housing for carrying a lancet along a stroke traversing an extended position wherein a tissue penetrating portion of the lancet extends a distance outwardly of said housing, said lancet carrier comprising a limit member, and

(c) a thumb wheel rotationally mounted to said housing, and comprising an eccentric contact surface forming a selectively movable stop for contacting said limit member to limit the stroke of the lancet carrier in the direction of the extended position,

wherein said housing is generally symmetric about perpendicular first and second planes of symmetry, has an aspect ratio of no more than 4;

1, and has a transverse ratio of at least 3;

2.

9. A lancing device for use with a lancet to penetrate tissue and facilitate collection of a sample of a body fluid, said lancing device comprising:

(a) a housing;

(b) a lancet carrier mounted to said housing for releasably engaging a lancet, said lancet carrier comprising;

(i) a first gripping jaw;

(ii) a second gripping jaw positioned in opposition to said first gripping jaw to define a lancet-receiving channel between said first and second gripping jaws, said first and second gripping jaws being movable between a closed position for gripping a lancet and an open position for receiving and releasing a lancet;

(iii) biasing means for biasing said first and second gripping jaws toward said closed position; and

(iv) a first release arm connected to said first gripping jaw and a second release arm connected to said second gripping jaw, whereby application of force to said first and second release arms moves said first and second gripping jaws toward said open position.

10. The lancing device of claim 9, wherein said first and second gripping jaws comprise opposed portions of an integrally-formed split cylinder joined about a common hinge point.