Assembly for receiving body fluids, and method for the production thereof

• US 8,142,366 B2
• Filed: 02/26/2008
• Issued: 03/27/2012
• Est. Priority Date: 09/01/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Fuerst, Otto, Haar, Hans-Peter, Calasso, Irio Giuseppe
• Primary Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US12/037,197
• Publication Number:
  US 20080200887A1
• Time in Patent Office: 1,491 Days
• Field of Search: 600562-584, 606/167, 606181-183
• US Class Current: 600/583
• 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 5/150022 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150335 by radiation
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• 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
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

For an assembly for receiving body fluids comprising a sampling element (10) that has a collecting area (12) for collecting body fluid obtained by a puncture, it is proposed that the collecting area is formed by a longitudinal slot (12) which is elongated as a capillary that is open on both sides via side openings (28, 30) on the sampling element (10).

Claims

1. Assembly for receiving body fluids comprising a sampling element which is provided with a lancing member for insertion into a body part and has a collecting area for collecting body fluid obtained by a puncture, wherein the collecting area is formed by a longitudinal slot which is elongated as a capillary and is open on both sides via side openings on the sampling element, wherein the lancing member has a distal end that is closed, and comprising a sample receiving element to which body fluid can be applied via the collecting area and provided with a test field for an analyte in the body fluid, wherein the longitudinal slot is separated from the sample receiving element in a collecting position of the sampling element and is in fluidic contact with the sample receiving element in a transfer position of the sampling element, and wherein a distance between the test field and the sampling element varies between the collecting position and the transfer position.

2. Assembly according to claim 1, characterized in that the length of the longitudinal slot is such that the longitudinal slot is partially within and partially outside the body part in the collecting position of the sampling element.

3. Assembly according to claim 1, characterized in that the longitudinal slot has a distal receiving section protruding into the skin of the body part and a proximal venting section located outside the skin when the body fluid is collected.

4. Assembly according to claim 1, characterized in that the longitudinal slot has a length of 0.5 to 4 mm and a width of less than 500 μ

m.

5. Assembly according to claim 1, characterized in that the longitudinal slot is arranged at a distance of about 50 to 200 μ

m from a distal tip of the sampling element which forms the lancing member.

6. Assembly according to claim 1, characterized in that the sampling element has a distal shaft section with a tapered cross-section in the area of the longitudinal slot and a proximal shaft section with a widened cross-section.

7. Assembly according to claim 1, characterized in that a side opening as an outlet of the longitudinal slot can be brought into fluidic contact with the sample receiving element.

8. Assembly according to claim 1, characterized in that a side opening of the longitudinal slot is connected in the transfer position to an actuator in order to transfer body fluid onto the sample receiving element.

9. Assembly according to claim 8, characterized in that the actuator acts on the body fluid in the longitudinal slot by pneumatic displacement.

10. Assembly according to claim 8, characterized in that the actuator is formed by a membrane that can be deformed against the longitudinal slot.

11. Assembly according to claim 8, characterized in that the actuator has a passage for compressed air that can be coupled to a side opening of the longitudinal slot.

12. Assembly according to claim 1, characterized in that the sample receiving element has a larger capillary attraction for the body fluid than the longitudinal slot.

13. Assembly according to claim 1, characterized in that the sampling element is movably mounted in a guide relative to the sample receiving element.

14. Assembly according to claim 1, characterized in that the sample receiving element forms a case which receives the sampling element.

15. Assembly according to claim 1, characterized in that several sampling elements are stored in a first magazine and several sample receiving elements are stored in a second magazine, wherein the magazines as separate units can be connected together in order to couple the sampling elements and sample receiving elements in pairs.

16. Assembly according to claim 1, characterized in that a plurality of sampling elements are arranged in a magazine such that they can be ejected axially and that their associated sample receiving elements preferably arranged in push-through chambers are arranged in front of the magazine in the direction of ejection.

17. Portable blood analyser for receiving at least one assembly according to claim 1 preferably in the form of a single-use article.

22. Assembly according to claim 1, characterized in that the longitudinal slot has a length of 1 to 2 mm and a width of less than 100 μ

m.

23. Assembly according to claim 8, characterized in that the actuator acts on the body fluid in the longitudinal slot by mechanical displacement.

24. Assembly according to claim 16, wherein the magazine is a drum magazine.

18. System for analysing body fluids comprising a sampling element which is provided with a lancing member for insertion into a body part and has a longitudinal slot elongated as a capillary that is open on both sides via side openings as a collecting area for collecting body fluid obtained by a puncture at a collecting position, wherein the lancing member has a distal end that is closed, and a sample receiving element to which body fluid can be applied via the collecting area at a transfer position, wherein the sample receiving element is provided with a test field for an analyte in the body fluid, wherein an actuator is provided for transferring body fluid from the sampling element onto the sample receiving element when the sample receiving element is at the transfer position, and wherein a distance between the test field and the sampling element varies between the collecting position and the transfer position.

19. System according to claim 18, characterized in that the actuator acts from a side opening on the body fluid in the longitudinal slot and that an analyte in the body fluid is measured on the opposing side of the sampling element.

20. System according to claim 19, characterized in that in a transfer position, the sampling element is in fluidic contact with the sample receiving element via the side opening facing away from the actuator.

21. System according to claim 18, characterized in that a preferably optical measuring unit is provided to detect an analyte on the test field to which body fluid has been applied.

25. An assembly, comprising:

a sample receiving element having a test field;

a lancing element guided by the sample receiving element, the lancing element having a slot with opposing side openings for collecting body fluid, wherein the lancing member has a distal end that is closed;

the slot of the lancing element being moveable relative to the sample receiving element from a collecting position to a transfer position;

at the collecting position the slot of the lancing element is extended from the sample receiving element for collecting the body fluid in the slot and the slot is unable to transfer the body fluid to the test field; and

at the transfer position the slot of the lancing element is aligned with the test field and is able to transfer the body fluid from the slot to the test field.

26. The assembly of claim 25, further comprising:

a displacement mechanism configured move the body fluid from the slot to the test field when the slot is at the transfer position.

27. The assembly of claim 26, in which the displacement mechanism includes a membrane located opposite the test field for pushing the body fluid from the slot onto the test field when the slot of the lancing element is located at the transfer position.

28. The assembly of claim 26 in which the displacement mechanism includes an air passage located opposite the test field for directing a blast of air that blows the body fluid from the slot onto the test field when the slot of the lancing element is located at the transfer position.

29. The assembly of claim 26, further comprising:

wherein the lancing element moves in a longitudinal direction when moving from the collecting position to the transfer position; and

wherein the displacement mechanism is configured to move the body fluid from the slot to the test field in a transverse direction relative to the longitudinal direction.

30. The assembly of claim 25, in which the test field has greater capillary affinity than the slot to promote transfer of the body fluid from the slot to the test field.

31. The assembly of claim 25, wherein the sample receiving element has a broad side that faces the opposing side openings when at the transfer position to facilitate transfer of the body fluid.