Magazine for annulary capillary lancets

• US 7,740,599 B2
• Filed: 07/11/2005
• Issued: 06/22/2010
• Est. Priority Date: 01/23/2003
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Scherer, Jörg, Mönch, Ronald, Schabbach, Michael, Sacherer, Klaus-Dieter
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Stout; Michael C
• Application Number:
  US11/178,810
• Publication Number:
  US 20060008389A1
• Time in Patent Office: 1,807 Days
• Field of Search: 600/583, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking

Abstract

A device for receiving a body fluid for analysis, comprising a container and at least one sample-receiving unit which can be impinged upon by the body fluid at a receiving point and which can be extracted from a guide chamber of the container by means of a drive unit. According to the invention, a coupling device is provided in order to couple the sample receiving unit to the drive unit to ensure back and forth movement between the guide chamber and the receiving point.

Claims

1. Device for receiving a body fluid for analytical purposes comprising:

a container;

at least one sample receiving unit for a single-use test that can be pushed out of a guide chamber of the container by means of a drive unit and to which the body fluid can be applied at a receiving site;

wherein the container is designed as a magazine for storing a plurality of sample receiving units;

a lancing unit constructed as a lancet is integrated in the sample receiving unit to carry out a lancing movement towards a body part of a test person;

means for separately retracting the sample receiving unit and the lancing unit into the guide chamber;

wherein the means for separately retracting the sample receiving unit and the lancing unit includes a double plunger incorporated into the drive unit;

the double plunger having an inner plunger received inside an outer plunger in a telescoping manner;

the sample receiving unit and the lancing unit each having holding claws configured to move in a clamping manner to couple the sample receiving unit to the drive unit for a forwards and backwards movement between the guide chamber and the receiving site;

the guide channel having outer guide blocks positioned to clamp the holding claws of the sampling unit to the outer plunger when the outer plunger is extended; and

the sample receiving unit having inner guide blocks positioned to clamp the holding claws of the lancing unit to the inner plunger when the inner plunger is extended.

2. Device according to claim 1, wherein the drive unit and the sample receiving unit are separated from one another in an initial position.

3. Device according to claim 1, wherein the drive unit and sample receiving unit couple in a form fitting manner.

4. Device according to claim 3, wherein the holding claws are movable in a distance-dependent manner between a release position and an engaging position during the forwards and backwards movement.

5. Device according to claim 3, wherein the outer and inner guide blocks are each formed by an inclined bevel that can be tracked by the engaging means.

6. Device according to claim 3, wherein the holding claws are located at a proximal end of the sample receiving unit.

7. Device according to claim 3, wherein at least one of the holding claws is shifted into an engaging position under its own tension.

8. Device according to claim 3, wherein the double plunger has a head member and that the holding claws automatically engages the head member of the double plunger when the double plunger is advanced axially.

15. Device according to claim 1, wherein the sample receiving unit can be moved in a sliding guide of the guide chamber.

16. Device according to claim 1, wherein the sample receiving unit has an analytical test element to examine the body fluid.

17. Device according to claim 1, wherein the sample receiving unit has a capillary active transport channel for the body fluid.

18. Device according to claim 17, wherein the transport channel is formed by a ring gap between a lancet and a wall area of the sample receiving unit surrounding the lancet.

19. Device according to claim 17, wherein the transport channel ends on an analytical test field via a lateral outlet in the transport area.

20. Device according to claim 1, wherein the guide chamber is closed by a sealing foil at least in the area of an ejection opening and that the sample receiving unit has a free end area facing the direction of advance to pierce the sealing foil.

21. Device according to claim 1, wherein the sample receiving unit is constructed as a test strip or as an injection molded test body in particular for examining blood.

22. Device according to claim 1, wherein the container as a drum magazine has a plurality of guide chambers running axially each for one sample receiving unit that are distributed in the circumferential direction.

23. Analytical instrument and in particular transportable hand device for medical diagnostics, comprising a device for receiving a body fluid according to claim 1.

24. Sample receiving unit for a body fluid in particular a test strip or tube having coupling means for a form-fitting drive coupling in order to push it out of and return it into a guide chamber for use in a device according to claim 1.

9. Device for receiving a body fluid for analytical purposes comprising a container and at least one sample receiving unit for a single-use test that can be pushed out of a guide chamber of the container by means of a drive unit and to which the body fluid can be applied at a receiving site, wherein a lancing unit is integrated into the sample receiving unit to carry out a lancing movement towards a body part containing the body fluid;

wherein the drive unit has a double plunger that can be longitudinally moved therein to separately extend and retract the sample receiving unit and lancing unit;

the double plunger having an inner plunger received inside an outer plunger in a telescoping manner;

the sample receiving unit and the lancing unit each having holding claws configured to move in a clamping manner;

the guide channel having guide blocks positioned to clamp the holding claws of the sampling unit to the outer plunger when the outer plunger is extended; and

the sample receiving unit having guide blocks positioned to clamp the holding claws of the lancing unit to the inner plunger when the inner plunger is extended.

10. Device according to claim 9, wherein the lancing unit can be displaced in a guide of the sample receiving unit in its direction of movement.

11. Device according to claim 9, wherein the lancing unit can puncture the body part at a predetermined distance to a free front area of the sample receiving unit.

12. Device according to claim 9, wherein the lancing unit can be coupled in a form-fitting manner to the drive unit by means of the holding claws for a reciprocating lancing movement.

13. Device according to claim 9, wherein the drive unit has a control device to control the sequence of movements of the sample receiving unit and/or lancing unit.

14. Device according to claim 9, wherein the sample receiving unit has limit stops for the lancing unit formed by projecting edges of the body.

25. Device according to claim 9, further comprising:

the double plunger having an inner plunger received inside an outer plunger in a telescoping manner;

the sample receiving unit and the lancing unit each having holding claws configured to move in a clamping manner;

the guide channel having guide blocks positioned to clamp the holding claws of the sampling unit to the outer plunger when the outer plunger is extended; and

the sample receiving unit having guide blocks positioned to clamp the holding claws of the lancing unit to the inner plunger when the inner plunger is extended.

26. A device for receiving a body fluid for analytical purposes, comprising:

a container defining one or more guide chambers;

a unitary disposable received in each of the guide chambers, the disposable including a sample receiving unit integrated with a lancing unit, the lancing unit being moveable relative to the sample receiving unit;

a drive unit configured to extend and retract the sample receiving unit and the lancing unit in a separate manner relative to the guide chamber;

a coupling device configured to couple the drive unit and the disposable in a form fitting manner to facilitate the extension and retraction of the sample receiving unit and the lancing unit in the separate manner; and

wherein the coupling device includes holding claws on both the sample receiving unit and the lancing unit configured to move in a clamping manner.

27. The device of claim 26, further comprising:

the drive unit including a double plunger;

the double plunger including an inner plunger received inside an outer plunger in a telescoping manner;

the inner plunger and the outer plunger both having a head piece; and

the holding claws being configured to grip the head pieces of the inner plunger and the outer plunger in an form fitting manner to facilitate separate retraction.

28. The device of claim 26, wherein the drive unit includes angled push rods.

29. The device of claim 26, wherein the sample receiving unit has a test field to analyze the body fluid.

30. The device of claim 26, wherein the container is a drum.

31. The device of claim 26, wherein the container is a disc.

32. A method, comprising:

coupling a drive unit to a sample receiving unit that includes an integrated lancing unit by coupling the drive unit in a form fitting manner to at least the lancing unit, wherein the sample receiving unit and the lancing unit are integrated together to form a unitary disposable;

extending the sample receiving unit out of a guide chamber of a container with a drive unit;

cutting an incision in skin with the lancing unit by extending the lancing unit from the sample receiving unit with the drive unit;

retracting the lancet from the incision with the drive unit;

collecting body fluid from the incision with the sample receiving element after said retracting the lancet;

retracting the sample receiving unit into the guide chamber with the drive unit after said collecting the body fluid;

wherein said coupling the drive unit to the sample receiving unit further includes coupling the drive unit in a form fitting manner to the sample receiving unit;

wherein the drive unit includes a double plunger that has an inner plunger received inside an outer plunger in a telescoping manner;

wherein the sample receiving unit and the lancing unit each have holding claws configured to move in a clamping manner;

wherein the guide channel and the sample receiving unit each have guide blocks; and

wherein said coupling the drive unit to the sample receiving unit includes

clamping the holding clamps of the lancing unit to the inner plunger with the guide blocks in the sample receiving unit by extending the inner plunger, and

clamping the holding clamps of the sampling unit to the outer plunger with the guide blocks in the guide channel by extending the outer plunger.

33. The method of claim 32, further comprising:

disengaging the drive unit from the sample receiving unit after said retracting the sample receiving unit into the guide chamber.

34. The method of claim 33, wherein said disengaging the drive unit includes:

unclamping the holding clamps of the lancing unit from the inner plunger by retracting the inner plunger; and

unclamping the holding clamps of the sampling unit from the outer plunger by retracting the outer plunger.

35. The method of claim 32, further comprising:

positioning the drive unit to engage a second sampling unit by indexing the container.