Lancing device and method of sample collection

• US 6,749,618 B2
• Filed: 08/14/2001
• Issued: 06/15/2004
• Est. Priority Date: 10/19/1999
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kennedy, Gwenn E., Flynn, Stephen J., Lipoma, Michael V., Levaughn, Richard W.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US09/929,649
• Publication Number:
  US 20020029058A1
• Time in Patent Office: 1,036 Days
• Field of Search: 606/182, 606/172, 606/183, 604/136, 604/137, 604/156, 604/157, 600/583
• US Class Current: 606/182
• 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 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.

2. The lancing device according to claim 1, wherein the forward facing annular land comprises a raised lip around at least a portion of the opening.

3. The lancing device according to claim 2, wherein the raised lip is an annular ring.

4. The lancing device according to claim 2, wherein the raised lip is adjacent the opening.

5. The lancing device according to claim 2, wherein the raised lip projects 1 mm to 3 mm.

6. The lancing device according to claim 1, wherein the forward-facing annular land is about 2 mm across.

7. The lancing device according to claim 1, wherein the opening has a diameter of 4 mm to 8 mm.

8. The lancing device according to claim 7, wherein the opening has a diameter of 4 mm to 6 mm.

9. The lancing device according to claim 1, the end cap further comprising:

(a) a forward panel, the forward panel having the opening therethrough.

10. The lancing device according to claim 1, wherein the transparent end cap comprises clear plastic.

11. 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.

12. The method according to claim 11, wherein the step of pressing the forward-facing annular land against the sample site comprises:

(a) applying compressive pressure to the sample site.

13. The method according to claim 12, wherein the step of applying compressive pressure to the sample site comprises:

(a) applying steady compressive pressure to the sample site.

14. The method according to claim 12, wherein the step of applying compressive pressure to the sample site comprises:

(a) applying varying compressive pressure to the sample site.

15. The method according to claim 12, wherein the method further comprises:

(a) removing the lancing device from the sample site when the body fluid sample is a size indicated by the sample size indicator.