Lancing device and method of sample collection
AssigneeTheraSense, Inc.
InventorsRichard W. Levaughn, Stephen J. Flynn, Gwenn E. Kennedy, Michael V. Lipoma
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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.
Claims15
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 having front and back housing shells;
- (b) a lancet carrier mounted with said housing for releasably carrying a lancet having a tissue penetrating portion;
- (c) a transparent end cap removably and releasably attachable to the housing, the end cap comprising;
- (i) an opening for allowing passage of the tissue penetrating portion of the lancet through the cap, the opening having a diameter less than a diameter of the lancet;
- (ii) a forward-facing annular land surrounding the opening;
- and
- (iii) a sample size indicator;
- (d) a stroke control means comprising an indexing means for controlling the depth of penetration of the tissue penetrating portion of the lancet, the indexing means constructed to provide tactile feedback;
- (e) a cocking actuator operably connected to the lancet carrier;
- and
- (f) a trigger button operably connected to the lancet carrier and the cocking actuator, the trigger button positioned on the lancing device between the cocking actuator and the transparent end cap.
A method of collecting a body fluid sample, the method comprising:
- (a) positioning a lancing device on a desired sample site, the lancing device comprising:
- (i) a housing having front and back housing shells;
- (ii) a lancet carrier mounted with the housing and carrying a lancet having a tissue penetrating portion;
- (iii) a transparent end cap removably and releasably attached to the housing, the end cap comprising:
- (A) an opening for allowing passage of the tissue penetrating portion therethrough, the opening having a diameter less than a diameter of the lancet;
- (B) a forward-facing annular land surrounding the opening;
- and
- (C) a sample size indicator;
- (iv) a stroke control means comprising an indexing means for controlling the depth of penetration of the tissue penetrating portion, the indexing means constructed to provide tactile feedback;
- (v) a cocking actuator operably connected to the lancet carrier;
- (vi) a trigger button operably connected to the lancet carrier and to the cocking actuator, the trigger button positioned on the lancing device between the cocking actuator and the transparent end cap;
- (b) actuating the cocking actuator;
- (c) pressing the forward-facing annular land against the sample site;
- (d) pressing the trigger button to release the lancet so that the tissue penetrating portion penetrates the sample site;
- and
- (e) monitoring the sample site through the transparent end cap;
- and
- (f) comparing the body fluid sample with the sample size indicator.
Dependencies are inferred from the claim text.