Body fluid sampling device and methods of use

• US 20040162506A1
• Filed: 01/08/2004
• Published: 08/19/2004
• Est. Priority Date: 05/17/1996
• Status: Active Grant

• 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., Douglas, Joel S., Drexler, Andrew M.
• Granted Patent: US 7,901,363 B2
• Time in Patent Office: Days
• 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 lancing device for lancing the skin to sample blood or interstitial fluid, comprising:

a housing;

a lancet carrier adapted to hold a disposable lancet, the carrier mounted adjacent a front end of the housing for movement relative thereto;

a cockable spring-biased hammer mechanism for displacing the lancet carrier forwardly to lance the skin;

a latch for releasably retaining the hammer mechanism in a cocked position; and

a latch-releasing mechanism including a skin-contacting portion for being rearwardly displaced in response to being pressed against the skin, and a latch-releasing portion for releasing the latch in response to the rearward displacement of the skin-contacting portion.

2. The lancing device according to claim 1 wherein the skin-contacting portion comprises a sleeve mounted at the front end of the housing, the sleeve being spring-biased forwardly and being displaceable rearwardly in response to being pressed against the skin, to cause the latch-releasing portion to release the latch.

3. The lancing device according to claim 1, further comprising a safety device normally disposed in a safety position for preventing the hammer mechanism from being cocked, and being movable to a non-safety position in response to installation of the lancet carrier into the housing for enabling the hammer mechanism to be cocked.

4. The lancing device according to claim 3, wherein the lancet carrier carries a disposable lancet which includes a body having a skin-lancing member and a capillary tube, and further including a manually actuable pusher member for pushing the capillary tube forwardly relative to the carrier for drawing-in fluid from the lanced skin, the safety device being moved to its non-safety position by an upper end of the capillary tube.

5. The lancing device according to claim 4;

wherein the lancet carrier comprises a sleeve mounted in the housing;

the sleeve including an internal surface forming a through-passage extending from an upper end to a lower end of the sleeve;

a disposable lancet seated in the through-passage;

the internal surface configured to permit insertion and removal of the disposable lancet solely through the upper end;

the internal surface including at least one upwardly facing seat on which the disposable lancet is supported.

6. The lancing device according to claim 1, wherein the lancet carrier carries a disposable lancet which included a body having a skin-lancing member and a capillary tube, and further including a pusher member for pushing the capillary tube forwardly relative to the carrier for drawing-in fluid from lanced skin.

7. The lancing device according to claim 1, wherein the lancet carrier comprises a sleeve mounted in the housing;

the sleeve including an internal surface forming a through-passage extending from an upper end to a lower end of the sleeve;

a disposable lancet seated in the through-passage;

the internal surface configured to permit insertion and removal of the disposable lancet solely through the upper end;

the internal surface including at least one upwardly facing seat on which the disposable lancet is supported.

8. The lancing device according to claim 3, wherein the lancet carrier comprises a sleeve mounted in the housing;

the sleeve including an internal surface forming a through-passage extending from an upper end to a lower end of the sleeve;

a disposable lancet seated in the through-passage;

the internal surface configured to permit insertion and removal of the disposable lancet solely through the upper end;

the internal surface including at least one upwardly facing seat on which the disposable lancet is supported.

9. The lancing device according to claim 6, wherein the lancet carrier comprises a sleeve mounted in the housing;

the sleeve including an internal surface forming a through-passage extending from an upper end to a lower end of the sleeve;

a disposable lancet member seated in the through-passage;

the internal surface configured to permit insertion and removal of the disposable lancet member solely through the upper end;

the internal surface including at least one upwardly facing seat on which the disposable lancet member is supported.

10. The lancing device according to claim 1 wherein the skin contacting portion includes a sleeve structure mounted for repeated rearward displacements to urge body fluid from lanced skin.

11. The lancing device according to claim 10 wherein the skin contacting portion is shaped to form a depressed ring of body tissue in surrounding relationship to an incision formed in the skin.

12. The lancing device according to claim 11 wherein the lancet carrier carries a disposable element having a skin-lancing member, and a capillary tube for drawing-in body fluid from an incision.

13. The lancing device according to claim 12, further including a pusher for pushing the capillary tube downwardly relative to the carrier.

14. The lancing device according to claim 13, further including a safety device normally disposed in a safety position for preventing the hammer mechanism from being cocked, and being movable to a non-safety position by a rear-end of the capillary tube.

15. The lancing device according to claim 11, further including a safety device normally disposed in a safety position for preventing the hammer mechanism from being cocked, and being movable to a non-safety position in response to installation of the lancet carrier into the housing for enabling the hammer mechanism to be cocked.

16. A lancing device for lancing skin to sample blood or interstitial fluid, comprising;

a housing;

a lancet carrier adapted to carry a disposable lancet and installable into a front end of the housing and being movable relative thereto;

a cockable spring-biased hammer mechanism for displacing the lancet carrier forwardly to lance the skin;

a latch-releasing mechanism for releasing the latch; and

a safety device normally disposed in a safety position for preventing the hammer mechanism from being cocked, and being movable to a non-safety position in response to installation of the lancet carrier into the housing for enabling the hammer mechanism to be cocked.

17. The lancing device according to claim 16, wherein the lancet carrier carries a disposable lancet which includes a body having a skin-lancing member and a capillary tube, and further including a pusher member for pushing the capillary tube forwardly relative to the carrier for drawing-in fluid from the lanced skin.

18. The lancing device according to claim 17, wherein the lancet carrier comprises a sleeve mounted in the housing;

the sleeve including an internal surface forming a through-passage extending from an upper end to a lower end of the sleeve;

the internal surface configured to permit insertion and removal of the disposable lancet solely through the upper end;

the internal surface including at least one upwardly facing seat on which the disposable lancet is supported.

19. The lancing device according to claim 16, wherein the lancet carrier comprises a sleeve mounted in the housing;

the sleeve including an internal surface forming a through-passage extending from an upper end to a lower end of the sleeve;

a disposable lancet seated in the through-passage;

the internal surface configured to permit insertion and removal of the disposable lancet solely through the upper end;

the internal surface including at least one upwardly facing seat on which the disposable lancet is supported.

20. A lancing device for lancing skin to sample blood or interstitial fluid, comprising:

a housing;

a carrier carrying a disposable lancet, the disposable member including a body having a skin-lancing member and a capillary tube;

a spring-biased hammer for pushing the carrier forwardly so that the lancet lances the skin; and

a pusher member for pushing the capillary tube forwardly relative to the carrier for drawing-in fluid from lanced skin.

21. The lancing device according to claim 20, wherein the carrier comprises a sleeve mounted in the housing;

the sleeve including an internal surface forming a through-passage extending from an upper end to a lower end of the sleeve;

the internal surface configured to permit insertion and removal of the disposable lancet solely through the upper end;

the internal surface including at least one upwardly facing seat on which the disposable lancet is supported.

22. In combination, a disposable lancet and a carrier therefore;

the carrier comprising a sleeve adapted to be mounted in a housing;

the sleeve including an internal surface forming a through-passage extending from an upper end to a lower end of the sleeve;

the disposable lancet seated in the through-passage;

the internal surface configured to permit insertion and removal of the disposable lancet solely through the upper end;

the internal surface including at least one upwardly facing seat on which the disposable lancet is supported.

23. The combination according to claim 22 wherein the seat includes a plurality of the upwardly facing shoulders, the lancet including vertically spaced projections extending outwardly therefrom and bearing against respective ones of the upwardly facing shoulders.

24. The combination according to claim 23 wherein the upwardly facing shoulders comprise a pair of downwardly inclined ramps and a slot disposed below the ramps.

25. A lancet carrier adapted to carry a disposable lancet, the lancet carrier comprising a sleeve adapted to be mounted in a housing, the sleeve including an internal surface forming a through-passage extending from an upper end to a lower end of the sleeve and configured to permit insertion and removal of a disposable lancet solely through the upper end, the internal surface including an upwardly facing seat adapted to support a disposable lancet.

26. A sampling device for sampling body fluid, comprising:

a housing defining a longitudinal axis;

incision-forming means mounted in the housing for forming an incision through a skin surface;

a stimulator member mounted at a forward end of the housing and being depressible against the skin to depress a ring of body tissue in surrounding relationship to the skin for urging body fluid toward and outwardly through the incision to form a drop of body fluid at an open end of the incision; and

a pusher member for moving the capillary tube forwardly relative to the lancet carrier for drawing-in the body fluid.

27. The lancing device according to claim 26 wherein the incision forming means comprises:

a lancet carrier carrying a disposable lancet, the lancet including a skin-lancing member and a capillary tube, the lancet carrier mounted adjacent a front end of the housing for longitudinal movement relative thereto; and

means for driving the lancet carrier forwardly and then rearwardly in a substantially continuous motion to form an incision through the skin surface and retract the lancet from the incision.

28. The lancing device according to claim 27, further including a cockable spring biased hammer mechanism in the housing for displacing the lancet carrier forwardly;

and a safety device disposed in the housing normally in a safety position for preventing the hammer mechanism from being cocked, and being movable to a non-safety position by a rear end of the capillary tube.

29. A method of taking a sample of body fluid, comprising the steps of:

A) abutting a forward end of a housing against a skin surface of a user'"'"'s body;

B) forming an incision through the skin surface;

C) pressing the housing against the skin surface to repeatedly depress a ring of body tissue in surrounding relationship to the incision to urge body fluid toward and outwardly through the

incision to form a drop of body fluid at an open end of the incision;

D) extending the capillary tube forwardly relative to the carrier; and

E) inserting a forward end of the capillary tube into the drop of body fluid to draw-in the body fluid.

30. The method according to claim 29 wherein step A comprises abutting the housing against a surface of the user'"'"'s body other than a finger tip thereof.

31. The method according to claim 29 wherein step A comprises abutting the housing against the user'"'"'s forearm.