ANALYTICAL DEVICE WITH LANCET AND TEST ELEMENT

• US 20130239390A1
• Filed: 05/03/2013
• Published: 09/19/2013
• Est. Priority Date: 08/29/2001
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Kuhr, Hans-Juergen, Fritz, Michael, Weiss, Thomas, Forster, Richard
• Granted Patent: US 9,215,993 B2
• Time in Patent Office: Days
• US Class Current: 29/428
• 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 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• 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 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150312 Sterilisation of piercing elements, piercing devices or sampling devices piercing element stocking means, e.g. cartridges, A61B5/15176
• 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 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150534 Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15058 Joining techniques used for protective means
• 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 5/15142 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: Y10T 29/49826 Assembling or joining

Abstract

The invention concerns an analytical device containing a lancet comprising a lancet needle and a lancet body, the lancet needle movable relative to the lancet body and the lancet body composed, in the area of the tip of the lancet needle, of an elastic material in which the tip of the lancet needle is embedded, and an analytical test element connected to the lancet body. The invention also concerns an analytical device containing a lancet comprising a lancet needle and a lancet body in the form of a hollow body in the area of the tip of the lancet needle and surrounds the tip of the lancet needle, the lancet needle movable relative to the lancet body and the hollow body composed at least partially of an elastic material, and an analytical test element connected to the lancet body. The invention concerns a process for manufacturing an analytical device.

Claims

1. A manufacturing method comprising:

providing a cartridge having a plurality of cavities for holding penetrating members;

sealing a plurality of cavities with a sterility barrier;

providing said cartridge with a plurality of analyte sensors by coupling a sensor layer to the cartridge.

2. The method of claim 1 wherein said sensor layer comprises said analyte sensors secured to a material selected from the following:

polymer, foil, or paper.

3. The method of claim 1 wherein said sensors are electrochemical sensors.

4. The method of claim 1 wherein sealing creates a sterile environment in said cavities.

5. A manufacturing method comprising:

providing a cartridge having a plurality of cavities for holding penetrating members;

sealing a plurality of cavities with a sterility barrier;

providing said cartridge with a plurality of optical analyte detecting members by coupling a analyte detecting member layer to the cartridge.

6. The method of claim 5 further comprising providing said cartridge with a plurality of optically transparent portions aligned with said optical analyte detecting members.

7. The method of claim 5 wherein said analyte detecting member layer comprises said optical analyte detecting members secured to a material selected from the following:

polymer, foil, or paper.

8. The method of claim 5 wherein sealing creates a sterile environment in said cavities.

9. The method of claim 5 further comprising applying a second sterility barrier to said cartridge.

10. A manufacturing method comprising:

providing a cartridge having a plurality of cavities for holding penetrating members;

sealing a plurality of cavities with a seal layer;

providing a plurality of analyte detecting members by coupling a analyte detecting member layer to the cartridge.

11. A method comprising:

providing a cartridge having a plurality of cavities;

inserting a plurality of penetrating members at least partially contained in said cavities of the cartridge wherein the penetrating members are slidably movable to extend outward from lateral openings on said cartridge to penetrate tissue;

adding a sterility barrier to said cartridge, said sterility barrier covering a plurality of said lateral openings.

12. A manufacturing method comprising:

providing a cartridge having a plurality of cavities for holding penetrating members;

sterilizing said cartridge while each of said cavities is in a sealed condition and the cartridge contains a plurality of penetrating members;

using a planar sheet of sterility barrier material to cover a plurality of said cavities to create a sterile environment inside each of said cavities.

13. A manufacturing method comprising:

providing a cartridge having a plurality of cavities for holding penetrating members;

sealing a plurality of cavities with a sterility barrier;

providing said cartridge with a plurality of analyte detecting members by coupling a analyte detecting member layer to the cartridge.

14. Process for manufacturing an analytical device containing

i) a lancet with

a lancet needle which contains a tip for puncturing the skin generating a wound

and with a lancet body which surrounds the lancet needle at least in the area of the tip, and

ii) an analytical test element, with a test field in which a test reagent reacts with a body fluid generating a measurable electrical signal or a colour change and the analytical test element being connected to the lancet body whereas the process for manufacturing contains the steps of

a) sterilization of the tip of the lancet needle, and afterwards

b) connecting lancet body and test element forming the analytical device.

15. Process for manufacturing an analytical device as claimed in claim 14 whereas the lancet is characterized in that the lancet needle being movable relative to the lancet body.

16. Process for manufacturing an analytical device as claimed in claim 14, whereas the lancet is characterized in that the lancet body being composed at least in the area of the tip of the lancet needle of an elastic material in which the tip of the lancet needle is embedded.

17. Process for manufacturing an analytical device as claimed in claim 14, whereas the sterilization of the tip of the lancet needle is done by means of gamma radiation.

18. A manufacturing method comprising:

providing a cartridge having a plurality of cavities for holding penetrating members;

sealing a plurality of cavities with a seal layer;

providing a plurality of analyte sensors by coupling a sensor layer to the cartridge.