Body fluid sampling device and methods of use

• US 5,879,311 A
• Filed: 05/16/1997
• Issued: 03/09/1999
• Est. Priority Date: 05/17/1996
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Mercury Diagnostics, Inc.
• Inventors: Roe, Jeffrey N., Radwanski, Ryszard, Duchon, Brent G., Douglas, Joel S., Drexler, Andrew M.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US08/857,680
• Time in Patent Office: 662 Days
• Field of Search: 600/573, 600/576, 600/578, 600/583, 606/181, 606/182
• 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 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• 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 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• 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 lancer. 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 carrying disposable lancet member, the disposable lancet member includes a body holding a skin lancing member, a capillary tube, and a pusher member for pushing the capillary tube forward relative to the carrier for drawing-in fluid from the lanced skin, 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-containing 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 safety device is moved to its non-safety position by an upper end of the capillary tube within the lancet carrier.

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 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.

7. The lancet 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 supported.

8. 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.

9. The lancing device according to claim 8 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.

10. The lancing device according to claim 9, 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.

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

a housing;

a lancet carrier carrying a disposable lancet member, the disposable lancet member includes a body holding a skin lancing member, a capillary tube, and a pusher member for pushing the capillary tube forward relative to the carrier for drawing-in fluid from the lanced skin, the carrier 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 a 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.

12. The lancing device according to claim 11, 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.

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

a housing;

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

a spring-biased hammer for pushing the carrier 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.

14. The lancing device according to claim 13, 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.

15. A lancet carrier adapted to carry a disposable lancet, the lancet carrier comprising a sleeve 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 including an upwardly facing seat adapted to support a disposable lancet, the seat includes a plurality of upwardly facing shoulders having a pair of downwardly inclined ramps and a slot disposed below the ramps, the lancet including vertically spaced projections extending outwardly therefrom and bearing against respective ones of the upwardly facing shoulders.

16. 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;

a capillary tube; and

a pusher member for moving the capillary tube forwardly within the housing for drawing-in the body fluid.

17. The lancing device according to claim 16 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.

18. The lancing device according to claim 17, 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.

19. 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 a plurality of times 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.

20. The method according to claim 19 wherein step A comprises abutting the housing against a surface of the user'"'"'s body other than a finger tip thereof.

21. The method according to claim 19 wherein step A comprises abutting the housing against the user'"'"'s forearm.