Analysis system and method for determining an analyte in a body fluid

• US 9,439,591 B2
• Filed: 12/07/2010
• Issued: 09/13/2016
• Est. Priority Date: 06/07/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Frey, Stephan-Michael, List, Hans, Rittinghaus, Andrea, Zimmer, Volker, Ihle, Guenter, Roedel, Wolfgang
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/962,000
• Publication Number:
  US 20110137205A1
• Time in Patent Office: 2,107 Days
• Field of Search: 606/181, 606/183, 600/583, 600/575, 600/584, 422/69
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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 5/150419 comprising means for capillary action
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• 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 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A system for determining an analyte in a body fluid includes a magazine comprising two partial magazines, one including chambers containing analysis elements having a sample contact zone and a reagent system containing a reagent, whose reaction with the body fluid results in a change of a variable, and another including chambers containing puncturing elements having a tip having a capillary channel, which forms a fluid connection between the tip and a sample transfer zone of the puncturing element. The system may also include an analysis instrument having a puncturing drive for driving a puncturing element on a movement path, a mounting for receiving the magazine such that one chamber of the magazine at a time is located in a functional position, in which a puncturing element in the chamber can be moved by the puncturing drive, and a measuring and evaluation apparatus for measuring the change of the variable.

Claims

1. An analysis system for determining an analyte in a body fluid sample acquired through a prick in the skin, including:

a multi-part magazine comprising at least a puncturing element magazine and an analysis element magazine, each having a plurality of chambers, wherein

in the analysis element magazine, the plurality of chambers are analysis element chambers, which each contain one analysis element, each analysis element having a sample contact zone and a reagent system containing at least one reagent, whose reaction with the sample results in a measurable change of a measuring variable, and

in the puncturing element magazine, the plurality of chambers are puncturing element chambers, which each contain one puncturing element, each puncturing element having a tip for piercing into the skin, the tip having a capillary channel which forms a fluid connection between the tip and a sample transfer zone of the puncturing element,

a reusable analysis instrument having

a puncturing drive for driving a puncture movement of a puncturing element on a movement path, which comprises a propulsion phase in the puncturing direction and, after reaching a reversal point of the puncture movement, a retraction phase opposite to the puncturing direction,

a mounting for receiving the multi-part magazine in such a manner that one puncturing element chamber of the puncturing element magazine at a time is located in a functional position, in which a puncturing element in the puncturing element chamber can be moved by the puncturing drive, and

a measuring and evaluation apparatus for measuring the measurable change of the measuring variable and for determining a desired analysis result,

wherein

in the functional position of the multi-part magazine, both the puncturing element magazine and the analysis element magazine can be brought into a relative position, in which a puncturing element exit opening of a puncturing element chamber and a puncturing element entry opening of an analysis element chamber are adjacent to one another aligned in such a manner that a puncturing element can be moved from the puncturing element chamber through the puncturing element exit opening of the puncturing element chamber and through the puncturing element entry opening of the adjacent analysis element chamber into the analysis element chamber,

the puncturing element entry opening of the analysis element chamber is sealed by means of a sealing film which is opened before or during the puncture movement of the puncturing element from the puncturing element chamber into the analysis element chamber, and

the movement path of the puncturing element includes a transfer position in which the sample transfer zone of the puncturing element is positioned adjacent to the sample contact zone of the analysis element, to thereby produce a fluid connection by a relative movement, transverse to the puncturing direction, between the puncturing element and the analysis element to transfer the sample from the puncturing element to the analysis element.

2. A system according to claim 1, wherein the analysis element chamber has a magazine outlet opening, which is sealed by means of a sealing film and which is aligned with the puncturing element entry opening of the analysis element chamber such that the puncturing element can pass through the analysis element chamber and through both the puncturing element entry opening and the magazine outlet opening on the movement path of the puncture movement.

3. A system according to claim 1, wherein each puncturing element chamber has a connection element entry opening and wherein the puncturing element exit opening and the connection element entry opening are both sealed by means of a sealing film.

4. A system according to claim 1, wherein each puncturing element has a coupling structure and the puncturing drive has a coupling element corresponding thereto for bidirectionally coupling puncturing elements with the puncturing drive.

5. A system according to claim 1, wherein each analysis element is positioned in a corresponding analysis element chamber in a fluid transfer position which is fixed in the puncturing direction.

6. A system according to claim 1, wherein at least a part of the propulsion phase of the puncture movement is linear.

7. A system according to claim 1, wherein the sample contact zone of the analysis element includes a surface oriented in the puncturing direction, and the fluid connection is produced by contacting the surface of the sample contact zone of the analysis element with the sample transfer zone of the puncturing element.

8. A system according to claim 1, wherein the relative movement between the puncturing element and the analysis element is caused by a contact pressure element, which when moved transverse to the puncturing direction, presses against the puncturing element located in the transfer position.

9. A system according to claim 8, wherein the contact pressure element is positioned between the puncturing element magazine and the analysis element magazine.

10. A system according to claim 9, wherein the contact pressure element includes guide structures on one of an upper side and a lower side which contact one of the puncturing element magazine and the analysis element magazine.

11. The system according to claim 8, wherein the contact pressure element includes a lower side with a recess facing toward the puncturing element magazine to thereby form a peripheral receptacle chamber around a through opening of the contact pressure element, into which any film parts protruding after opening of the sealing film of the puncturing element exit opening may extend.

12. A system according to claim 1, wherein the relative movement between the analysis element and the puncturing element is caused by a pivot movement of a connection element, which extends through the puncturing element chamber and produces a connection between the puncturing element and the puncturing drive.

13. A system according to claim 1, wherein the analysis element magazine and the puncturing element magazine are movable relative to one another transverse to the puncturing direction.

14. A system according to claim 1, wherein each analysis element chamber is adjacent to a desiccant chamber including a desiccant, the desiccant chamber and the analysis element chamber being connected to one another so that an air exchange takes place between the two chambers.

15. A system according to claim 1, wherein the multi-part magazine is a drum magazine.

16. A system according to claim 1, wherein the measuring and evaluation apparatus comprises a photoelectric measuring unit, and

the analysis element magazine has at least one transparent area located such that a change of the measuring variable in an analysis element can be photometrically measured using the photoelectric measuring unit.

17. A system according to claim 1, wherein the capillary channel of each puncturing element extends beyond its sample transfer zone into a sample excess zone and a transfer of the sample only occurs when a first partial quantity of the sample, which is first received after the piercing into the skin in the capillary channel of the puncturing element, has passed the sample transfer zone and is located in the sample excess zone, a second partial quantity of the sample being located in the sample transfer zone.

18. A system according to claim 1, wherein the capillary channel of the puncturing element extends beyond the sample transfer zone into a sample excess zone.

19. The system according to claim 1, wherein the sealing film is glued on the analysis element magazine using hot-melt adhesive in a hot-melt adhesive method, and

each opening of the chambers has at a border of the opening a hot-melt adhesive receptacle recess for receiving excess hot-melt adhesive.

20. A multi-part magazine for an analysis instrument, including:

a puncturing element magazine having a plurality of puncturing element chambers, each containing a puncturing element,

an analysis element magazine having a plurality of analysis element chambers, each containing an analysis element,

wherein

each analysis element has a sample contact zone and a reagent system containing at least one reagent, whose reaction with a body fluid results in a measurable change of a measuring variable, and

each puncturing element has a tip for piercing into the skin having a capillary channel which forms a fluid connection between the tip and a sample transfer zone of the puncturing element,

wherein

the multi-part magazine is configured to be received in a mounting of an analysis instrument such that one puncturing element at a time in one of the puncturing element chambers of the multi-part magazine can be moved by a puncturing drive of the analysis instrument on a movement path, which comprises a propulsion phase in the puncturing direction, in order to execute a puncture movement and which comprises a transfer position in which the sample transfer zone of the puncturing element is positioned adjacent to the sample contact zone of the analysis element, to thereby produce a fluid connection by a relative movement, transverse to the puncturing direction, between the puncturing element and the analysis element to transfer the sample from the puncturing element to the analysis element, and

wherein

the puncturing element magazine and the analysis element magazine are movable relative to one another so that a puncturing element exit opening of a puncturing element chamber and a puncturing element entry opening of an analysis element chamber are adjacent and aligned,

the analysis element magazine further including a transparent area,

the analysis element being positioned in the analysis element magazine relative to the transparent area in such a manner that a change of a measuring variable in the analysis element can be measured by means of a photoelectric measuring unit, which is positioned outside the multi-part magazine.

21. The multi-part magazine according to claim 20, wherein the multi-part magazine is configured to be moved into a functional position, in which a puncturing element in one of the puncturing element chambers can be moved by the puncturing drive of the analysis instrument in order to execute the puncture movement, and

the transparent area of the analysis element magazine is located in front of an optic of the photoelectric measuring unit.

22. The multi-part magazine according to claim 20, wherein the analysis element magazine further includes a positioning element, and

the photoelectric measuring unit has a positioning contour, which cooperates with the positioning element to position the transparent area of the analysis element magazine relative to the measuring unit.

23. A method for producing a multi-part magazine according to claim 20, including the steps of:

a) equipping the puncturing element magazine with puncturing elements;

b) sealing a puncturing element exit opening of each puncturing element chamber with a film;

c) sealing a connection element entry opening of each puncturing element chamber with a film;

d) sterilizing the puncturing elements in the puncturing element magazine;

e) connecting the puncturing element magazine and the analysis element magazine;

f) sealing a puncturing element entry opening of each analysis element chamber of the analysis element magazine with a film;

g) equipping the analysis element magazine with analysis elements; and

h) sealing a magazine outlet opening of each analysis element chamber of the analysis element magazine with a film.

24. The method according to claim 23, further including the step of:

introducing a desiccant into a desiccant chamber in such a manner that the desiccant can absorb moisture from an analysis element chamber.

25. The method according to claim 23, wherein the sterilizing step is performed by irradiation by means of beta radiation.

26. The multi-part magazine according to claim 20, wherein the relative movement being one of (a) relative movement between the puncturing element and the analysis element caused by a contact pressure element positioned in the puncturing direction between the puncturing element magazine and the analysis element magazine, which when moved transverse to the puncturing direction, presses against the puncturing element, (b) relative movement between the puncturing element and the analysis element caused by a pivot movement of a connection element connecting the puncturing element and the puncturing drive, and (c) relative movement between the puncturing element magazine and the analysis element magazine relative to one another traverse to the puncturing direction.

27. A multi-part magazine for an analysis instrument, including:

a puncturing element magazine having a plurality of puncturing element chambers, each containing a puncturing element,

an analysis element magazine having a plurality of analysis element chambers, each containing an analysis element,

wherein

each analysis element has a sample contact zone and a reagent system containing at least one reagent, whose reaction with a body fluid results in a measurable change of a measuring variable, and

each puncturing element has a tip for piercing into the skin having a capillary channel which forms a fluid connection between the tip and a sample transfer zone of the puncturing element,

wherein

the multi-part magazine is implemented for being received in a mounting of an analysis instrument in such a manner that one puncturing element at a time in one of the puncturing element chambers of the multi-part magazine can be moved by a puncturing drive of the analysis instrument on a movement path, which comprises a propulsion phase in the puncturing direction, in order to execute a puncture movement,

wherein

the puncturing element magazine and the analysis element magazine are movable relative to one another so that a puncturing element exit opening of a puncturing element chamber and a puncturing element entry opening of an analysis element chamber are adjacent to one another aligned in such a manner that one puncturing element can be moved from the puncturing element chamber through its puncturing element exit opening and through the puncturing element entry opening of the adjacent analysis element chamber into the analysis element chamber and into a transfer position in which the sample transfer zone of the puncturing element is positioned adjacent to the sample contact zone of the analysis element, to thereby produce a fluid connection by a relative movement, transverse to the puncturing direction, between the puncturing element and the analysis element to transfer the sample from the puncturing element to the analysis element, and

the puncturing element entry opening of the analysis element chamber is sealed by means of a sealing film, which is positioned and implemented to be opened before or during the puncture movement of the puncturing element from the puncturing element chamber into the analysis element chamber.

28. The multi-part magazine according to claim 27, wherein each puncturing element chamber has a connection element entry opening, which is sealed by means of a sealing film.

29. The multi-part magazine according to claim 27, wherein each analysis element is positioned in a corresponding analysis element chamber in a fluid transfer position which is fixed in the puncturing direction.

30. The multi-part magazine according to claim 27, wherein the relative movement between the analysis element and the puncturing element is caused by a pivot movement of a connection element, which extends through the puncturing element chamber and produces a connection between the puncturing element and the puncturing drive.

31. The multi-part magazine according to claim 27, wherein the analysis element magazine and the puncturing element magazine are movable relative to one another transverse to the puncturing direction.

32. The multi-part magazine according to claim 27, wherein the multi-part magazine is a drum magazine.

33. The multi-part magazine according to claim 27, wherein the capillary channel of the puncturing element extends beyond the sample transfer zone into a sample excess zone.

34. The multi-part magazine according to claim 27, wherein the sealing film is glued on the analysis element magazine using hot-melt adhesive in a hot-melt adhesive method, and each opening of the chambers has at a border of the opening a hot-melt adhesive receptacle recess for receiving excess hot-melt adhesive.

35. The multi-part magazine according to claim 27, wherein the relative movement is caused by a relative movement between the puncturing element and the analysis element caused by a contact pressure element positioned in the puncturing direction between the puncturing element magazine and the analysis element magazine, which when moved transverse to the puncturing direction, presses against the puncturing element.