Body fluid sampling device and methods of use

• US 7,901,363 B2
• Filed: 01/08/2004
• Issued: 03/08/2011
• Est. Priority Date: 05/17/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Jeffrey N., Radwanski, Ryszard, Duchon, Brent G., Drexler, Andrew M., Douglas, Joel S.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Danega; Renee
• Application Number:
  US10/753,973
• Publication Number:
  US 20040162506A1
• Time in Patent Office: 2,616 Days
• Field of Search: 600/583, 606/181
• US Class Current: 600/583
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• 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 device for sampling body fluid includes a housing having a sleeve at a forward end thereof which is displaceable in response to being pressed against a user'"'"'s skin to trigger the firing of a lancet. After the lancet is removed from the incision, the sleeve is repeatedly pressed against the skin to depress a ring of body tissue in surrounding relationship to the incision to express body fluid outwardly through the incision. A pusher member is then actuated to push a capillary tube through a front end of the housing for drawing-in body fluid. The lancet is a disposable lancet which includes a body supporting a skin-lancing member and the capillary tube. The disposable lancet passes through an upper end of a lancet carrier when being installed or removed. The device cannot be armed until the disposable lancet is installed in the housing, because the capillary tube functions to push a safety device to a non-safety position.

Claims

1. A method of sampling comprising:

loading a disposable sampling module having a lancet and a capillary tube into a lancing device that includes a housing, wherein the capillary tube is located inside the housing during said loading the disposable;

initiating a lancing cycle by pressing the housing of the lancing device against skin;

lancing the skin to obtain a blood sample in response to said initiating the lancing cycle;

collecting the blood sample on the surface of the skin with the sampling module by extending the capillary tube relative to the lancet;

wherein the lancing device includes a pusher;

wherein said collecting the sample of blood includes pushing the capillary tube with the pusher to extend the capillary tube relative to the lancet to minimize the amount of direct manual handling of the capillary tube;

wherein during said pushing the capillary tube moves from inside the housing to project outside of the housing; and

wherein the disposable sampling module includes a slot with a plurality of pairs of opposed holding fingers that frictionally grip the capillary tube.

2. The method of claim 1 further comprising transferring the sample module for analysis after the blood sample has been obtained.

3. The method of claim 1, further comprising:

wherein the pusher includes a knob that is biased by a spring; and

wherein said pushing the capillary tube includes applying force to the knob.

4. The method of claim 1, wherein said loading the disposable sampling module includes:

loading the lancet into a carrier; and

attaching the carrier to the lancing device, wherein the carrier is configured to attach to the lancing device in only one circumferential relationship to ensure the capillary tube is aligned with the pusher.

5. The method of claim 1, further comprising:

unloading the disposable sampling module from the lancing device;

discarding the disposable sampling module; and

loading a new disposable sampling module into the lancing device.

6. A method of sampling comprising:

loading a disposable sampling module having a lancet and a capillary tube into a lancing device that includes a housing, wherein the capillary tube is located inside the housing during said loading the disposable;

initiating a lancing cycle by pressing the lancing device against skin;

lancing the skin to obtain a blood sample in response to said initiating the lancing cycle;

collecting the blood sample on the surface of the skin with the sampling module by extending the capillary tube relative to the lancet;

wherein the lancing device includes a pusher;

wherein said collecting the sample of blood includes pushing the capillary tube with the pusher to extend the capillary tube relative to the lancet, wherein during said pushing the capillary tube moves from inside the housing to project outside of the housing;

wherein said loading the disposable sampling module includes loading the lancet into a carrier, and

attaching the carrier to the lancing device, wherein the carrier is configured to attach to the lancing device in only one circumferential relationship to ensure the capillary tube is aligned with the pusher;

wherein the carrier includes guide ramps;

wherein the lancet includes bosses;

wherein said loading the lancet into the carrier includes riding the bosses of the lancet along the guide ramps of the carrier; and

wherein the disposable sampling module includes a slot with a plurality of pairs of opposed holding fingers that frictionally grip the capillary tube.

7. The method of claim 6, further comprising transferring the sampling module for analysis after the blood sample has been obtained.

8. A method of sampling according to claim 6, further comprising analyzing said blood sample.

9. A method of sampling according to claim 6, further comprising informing a user to remove said skin when said lancing cycle is complete.

10. A method of sampling according to claim 9 wherein informing said user comprises giving a visual signal when said lancing cycle is complete.

11. The method of claim 6, further comprising:

unloading the disposable sampling module from the lancing device;

discarding the disposable sampling module; and

loading a new disposable sampling module into the lancing device.

12. A method of sampling comprising:

loading a disposable sampling module having a lancet and a capillary tube into a lancing device that includes a housing, wherein the capillary tube is located inside the housing during said loading the disposable;

initiating a lancing cycle pressing the housing of the lancing device against skin;

lancing the skin to obtain a blood sample in response to said initiating the lancing cycle;

collecting the blood sample on the surface of the skin with the sampling module by extending the capillary tube relative to the lancet;

wherein the lancing device includes a pusher;

wherein said collecting the sample of blood includes pushing the capillary tube with the pusher to extend the capillary tube relative to the lancet to minimize the amount of direct manual handling of the capillary tube;

wherein the disposable sampling module includes a slot with a plurality of pairs of opposed holding fingers that frictionally grip the capillary tube; and

wherein during said pushing the capillary tube moves from inside the housing to project outside of the housing;

wherein said loading the disposable sampling module includes;

loading the lancet into a carrier; and

attaching the carrier to the lancing device, wherein the carrier is configured to attach to the lancing device in only one circumferential relationship to ensure the capillary tube is aligned with the pusher;

wherein the disposable sampling module includes a cylindrical body, a needle projecting from a lower end of the body, a lower boss projecting radially outward from the body, and a pair of upper bosses projecting radially outward from the body;

wherein the lower boss and the upper bosses are circumferentially spaced apart from one another;

wherein the upper bosses are disposed at a same elevation above the lower boss;

wherein the carrier has an inner surface that includes a pair of downwardly inclined, upwardly facing guide ramps;

wherein the guide ramps have lower ends that intersect to form an upwardly open recess; and

wherein said loading the lancet into the carrier includes

engaging the guide ramps with the upper bosses of the disposable sampling module, and

ensuring the lower boss enters the recess in the carrier by guiding the upper bosses with the guide ramps.

13. The method of claim 12, wherein the disposable sampling module includes a slot with a plurality of pairs of opposed holding fingers that frictionally grip the capillary tube.

14. The method of claim 13, wherein the needle and the capillary are offset from one another in a parallel relationship.