TEST UNIT FOR CARRYING OUT A ONE-TIME TESTING OF A BODY FLUID

• US 20080097244A1
• Filed: 07/03/2007
• Published: 04/24/2008
• Est. Priority Date: 01/19/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Arnitz, Theo
• Granted Patent: US 9,039,638 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/247 Hygienic covers, i.e. for covering the sensor or apparatus during use
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• 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 5/150404 Specific design of proximal end
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• 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 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• 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 5/1519 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
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood

Abstract

The invention concerns a test unit for carrying out blood analyses comprising a lancing element that can be pricked into a body part which has a capillary channel for transporting the body fluid that leads from a lancing member to a target site. According to the invention a pretensioned distal sterile cover and a liquid permeable proximal sterile cover are proposed for the lancing element that is advantageously formed as a deep-drawn component.

Claims

1. Test unit for carrying out one-time analyses in a body fluid, in particular blood, comprising a lancing element that can be pricked into a body part which has a capillary channel for transporting the body fluid that leads from a lancing member to a target site, characterized by a sterile cover for the lancing element which is pretensioned and when pierced uncovers a passage opening.

2. Test unit according to claim 1, characterized in that the sterile cover is arranged distally in front of the lancing member.

3. Test unit according to claim 1, characterized in that the sterile cover is formed by a rubber-elastic pretensioned tear-membrane.

4. Test unit according to claim 1, characterized in that the sterile cover is formed by a shrink-membrane that is tensioned by the action of heat.

5. Test unit according to claim 1, characterized in that the clear width of the uncovered passage opening is larger and preferably several times larger than the piercing cross-section of the lancing element.

32. Test unit according to claim 26, further comprising:

a hand-held device with a housing for the insert of at least one test unit according to one of the previous claims.

33. Test unit according to claim 32, characterized in that negative pressure can be applied to an inner space of the housing that is sealed air-tight by the test unit so that transport of body fluid is assisted.

34. Method for producing a test unit according to claim 1, characterized in that the lancing element is incorporated in an unsterile environment into the receiving part and is covered by a sterile cover and then the receiving part with the integrated lancing element is sterilized preferably by X-ray irradiation and subsequently the detection element is inserted in an unsterile manner.

6. Test unit for carrying out one-time analyses in a body fluid, in particular blood, comprising a lancing element that can be pricked into a body part which has a capillary channel for transporting the body fluid that leads from a lancing member to a target site, characterized by a sterile cover for the lancing element which is at least partially permeable to the body fluid.

7. Test unit according to claim 6, characterized in that the sterile cover is arranged proximally after the lancing element.

8. Test unit according to claim 6, characterized in that the sterile cover is surface-connected to a section of the lancing element.

9. Test unit according to claim 6, characterized in that the sterile cover spans a cross-section in particular an orifice cross-section of the capillary channel.

10. Test unit according to claim 6, characterized in that the sterile cover forms a germ filter that seals against the passage of germs.

11. Test unit according to claim 6, characterized in that the sterile cover is formed by a sterile-tight filter fleece.

12. Test unit according to claim 6, characterized in that the sterile cover covers an opening of a receiving part for the lancing element.

13. Test unit according to claim 6, characterized in that the detection element is arranged on a rear side of the liquid permeable lancing cover that faces away from the lancing element.

14. Test unit for carrying out one-time analyses in a body fluid, in particular blood, comprising a lancing element that can be pricked into a body part which has a capillary channel for transporting the body fluid that leads from a lancing member to a target site, characterized in that the lancing element is formed by a one piece deep-drawn component.

15. Test unit according to claim 14, characterized in that the lancing element is deep-drawn from a ductile material, preferably stainless steel sheet metal, which optionally contains anti-bacterial components such as silver or iodine.

16. Test unit according to claim 14, characterized in that the lancing element has a hollow cannula.

17. Test unit according to claim 16, characterized in that the lancing element has a radially projecting flange at the proximal end of the hollow cannula.

18. Test unit according to claim 14, characterized in that the lancing element is arranged in a receiving part preferably designed as an injection-moulded part.

19. Test unit according to claim 18, characterized in that the receiving part has a push guide for the lancing element running in the lancing direction.

20. Test unit according to claim 18, characterized in that a return spring that is pretensioned during the lancing advance movement of the lancing element is arranged between the receiving part and the lancing element.

21. Test unit according to claim 18, characterized in that the receiving part has form-locking means to hold it in a form-locking manner in a housing.

22. Test unit according to claim 14, characterized by a detection element for detecting an analyte in the body fluid to which body fluid can be applied preferably via the capillary channel.

23. Test unit according to claim 22, characterized in that the detection element has a measuring field extending transversely to the lancing direction.

24. Test unit according to claim 22, characterized in that the detection element is coupled with the lancing element by connecting means and in particular latching means.

25. Test unit according to claim 14, characterized in that a plunger is arranged in the lancing element designed as a hollow cannula.

26. Test unit for carrying out one-time analyses in a body fluid, in particular blood, comprising a lancing element that can be pricked into a body part which has a preferably capillary channel for the body fluid which starts from a lancing member, characterized in that a plunger is arranged in the lancing element designed as a hollow cannula.

27. Test unit according to claim 26, characterized in that the hollow cannula can be moved relative to the plunger so that body fluid is sucked into the channel and/or displaced therefrom.

28. Test unit according to claim 26, characterized in that the plunger seals a cross-section of the channel preferably by means of a circumferential seal.

29. Test unit according to claim 26, characterized in that the plunger is connected with a receiving part for the lancing element in a non-displaceable manner wherein the receiving part forms a push guide for the lancing element.

30. Test unit according to claim 26, characterized in that the lancing element is driven by a lancing drive at least in an advance movement for pricking into the body part.

31. Test unit according to claim 26, characterized in that the lancing element has a limited collection volume for body fluid of less than 100 microliters, preferably of less than 10 microliters.