Analytical device with lancet and test element

• US 9,215,993 B2
• Filed: 05/03/2013
• Issued: 12/22/2015
• Est. Priority Date: 08/29/2001
• Status: Expired due to Term

• 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
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US13/886,576
• Publication Number:
  US 20130239390A1
• Time in Patent Office: 963 Days
• Field of Search: 600/583, 606/181, 606/182
• US Class Current: 1/1
• 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 process for manufacturing an analytical device, the analytical device including i) a lancet with a lancet needle which contains a tip for puncturing the skin to generate a wound and a lancet body including an elastic material, 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 color change and the analytical test element being connected to the lancet body, the process comprising the acts of:

a) providing a lancet body including an elastic material and a lancet needle including a puncturing tip embedded in the elastic material, the lancet needle being movable relative to the elastic material from a pre-use position with the puncturing tip embedded within the elastic material to a use position with the puncturing tip extending out of the elastic material;

b) sterilizing both the puncturing tip of the lancet needle and the elastic material of the lancet body in which the puncturing tip of the lancet needle is embedded, the elastic material being adapted to maintain sterility of the puncturing tip while the tip remains embedded in the elastic material; and

c) following step b, connecting the lancet body and test element to form the analytical device.

2. Process for manufacturing an analytical device as claimed in claim 1 wherein the lancet needle is configured to be movable relative to the lancet body.

3. Process for manufacturing an analytical device as claimed in claim 1, whereas said sterilizing is done by means of gamma radiation.

4. The method of claim 1 in which the elastic material is in a fixed position relative to the lancet body.

5. The method of claim 1 in which said providing is providing the lancet needle to be movable relative to the lancet body from the use position to a post-use position in which the puncturing tip is withdrawn into the lancet body and into the elastic material.

6. The method of claim 1 in which said providing is to position the puncturing tip of the lancet needle fully contained within the lancet body.

7. The method of claim 6 in which said providing is providing the lancet needle to be movable relative to the lancet body from the use position to a post-use position in which the puncturing tip is withdrawn into the lancet body and into the elastic material.

8. The method of claim 1 in which the lancet body further comprises a supportive material to which the elastic material is attached.

9. A method for manufacturing an analytical device, comprising the acts of:

embedding at least a tip for puncturing skin of a lancet needle in an elastic material, the elastic material and the lancet needle being carried by a lancet body, the lancet needle being movable relative to the elastic material from a pre-use position with the puncturing tip embedded within the elastic material to a use position with the puncturing tip extending out of the elastic material;

sterilizing both the puncturing tip of the lancet needle embedded in the elastic material and the elastic material; and

attaching to the lancet body an analytical test element including a test field in which a test reagent reacts with a body fluid generating a measurable electrical signal or a color change.

10. The method of claim 9, wherein the attaching the analytical test element includes attaching the lancet needle to be movable relative to the analytical test element.

11. The method of claim 9, wherein the embedding the at least puncturing tip of the lancet needle in the elastic material includes the lancet needle being movable relative to the lancet body.

12. The method of claim 9, further comprising:

positioning a lancet tape belt that includes a plurality of lancet needles having respective puncturing tips of the lancet needles embedded in elastic material over a test element tape belt that includes a plurality of the analytical test elements, wherein a single lancet needle is paired with a single analytical test element; and

said attaching including assembling the lancet tape belt with the test element tape belt.

13. The method of claim 12, further comprising:

separating the assembled lancet tape belt and test element tape belt into individual analytical test devices.

14. The method of claim 9, further comprising:

injection molding the lancet body wherein the lancet body includes the elastic material.

15. A method for manufacturing an analytical device, comprising the acts of:

injection molding a lancet body wherein the lancet body includes a portion made of an elastic material;

embedding at least a tip for puncturing skin of a lancet needle in the elastic material of the lancet body, the lancet needle being movable relative to the elastic material from a pre-use position with the puncturing tip embedded within the elastic material to a use position with the puncturing tip extending out of the elastic material;

sterilizing both the tip of the lancet needle and the elastic material of the lancet body; and

attaching an analytical test element to the lancet body.