Lancing device and method of sample collection

• US 20040225311A1
• Filed: 06/09/2004
• Published: 11/11/2004
• Est. Priority Date: 10/19/1999
• Status: Abandoned Application

• 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.
• Application Number:
  US10/864,933
• Publication Number:
  US 20040225311A1
• 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

1-30. -30. (Canceled)

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

(a) a housing having front and back housing shells;

(b) a lancet carrier mounted with the housing for releasably carrying a lancet having a tissue penetrating portion from a retracted to position to an extended position;

(c) a transparent plastic 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 yet greater than a diameter of the tissue penetrating portion; and

(ii) a pressure applicator surrounding the opening;

(d) a cocking actuator operably connected to the lancet carrier; and

(e) 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.

32. The lancing device according to claim 31 further comprising stroke control means for controlling the distance the tissue penetrating portion of the lancet extends beyond the opening in the end cap when the lancet carrier is moved to the extended position, the stroke control means comprising indexing means to provide tactile feedback.

33. The lancing device according to claim 32, wherein the stroke control means has at least five positions.

34. The lancing device according to claim 31, wherein the pressure applicator comprises a raised lip around at least a portion of the opening.

35. The lancing device according to claim 34, wherein the raised lip is an annular ring.

36. The lancing device according to claim 34, wherein the raised lip is adjacent the opening.

37. The lancing device according to claim 34, wherein the raised lip projects 1 mm to 3 mm.

38. The lancing device according to claim 31, wherein the pressure applicator comprises a forward-facing annular land surrounding the opening.

39. The lancing device according to claim 38, wherein the forward-facing annular land is about 2 mm across.

40. The lancing device according to claim 31, wherein the opening has a diameter of 4 mm to 8 mm.

41. 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 for releasably carrying a lancet having a tissue penetrating portion from a retracted to position to an extended position;

(iii) a transparent plastic end cap removably and releasably attachable to the housing, the end cap comprising;

(A) 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 yet greater than a diameter of the tissue penetrating portion; and

(B) a pressure applicator surrounding the opening;

(iv) a cocking actuator operably connected to the lancet carrier; and

(v) 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 pressure applicator 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.

43. The method according to claim 41, wherein the step of pressing the pressure applicator against the sample site comprises:

(a) applying compressive pressure to the sample site.

44. The method according to claim 43, wherein the step of applying compressive pressure to the sample site comprises:

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

45. The method according to claim 43, wherein the step of applying compressive pressure to the sample site comprises:

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

42. (Canceled)