Glucose test arrangement and method

Patent metadata

Field	Value
Publication number	US-12350040-B2
Application number	US-202016784319-A
Country	US
Kind code	B2
Filing date	Feb 7, 2020
Priority date	Aug 2, 2017
Publication date	Jul 8, 2025
Grant date	Jul 8, 2025

Abstract

A glucose test arrangement is provided for use in a handheld meter. The arrangement comprises a disposable test pad responsive to glucose in a body fluid, and a supporting member adapted to support the test pad at an application site for applying body fluid from a user's skin onto a receiving area of the test pad. The receiving area faces away from the supporting member. One or more spacer elements are arranged on the supporting member adjacent to the test pad, wherein the one or more spacer elements have a skin-contacting end section which protrudes above the receiving area.

First claim

What is claimed is:

1. A glucose test method for use in a handheld meter, comprising:
providing a disposable test pad which is responsive to glucose in a body fluid, the test pad having a top side and an opposite bottom side and a receiving area arranged on the top side,
positioning the test pad on a supporting member at an application site for body fluid, the supporting member further comprising one or more spacer elements arranged adjacent to the application site, the test pad being movable relative to the supporting member,
applying a drop of blood from a user's skin onto the receiving area of the test pad, where the receiving area faces away from the supporting member,
contacting the user's skin by means of a skin-contacting end section of the one or more spacer elements which protrudes above the receiving area, thereby preventing direct finger contact with the test pad during sample application for enhanced accuracy of the glucose test.

2. A glucose test arrangement for use in a handheld meter, comprising:
a supporting member having an application site and one or more spacer elements arranged adjacent to and on opposed sides of the application site;
a pair of tape spools;
a transport tape stored on and extending between the pair of tape spools; and
a plurality of flat, spaced apart test pads carried by the transport tape, each test pad being responsive to glucose in a body fluid and each having a top side comprising a receiving area and an opposite bottom side, the transport tape being movable relative to the supporting member,
the supporting member supporting the transport tape and one of the test pads at the application site for application of a drop of blood from a user's skin onto the receiving area,
the bottom side of the test pad fully and flatly abutting the supporting member and the receiving area facing away from the supporting member
each of the one or more spacer elements having a skin-contacting end section which protrudes outwardly from the application site in a direction orthogonal to the application site, the skin-contacting end section extending beyond the top side of the test pad, and
the one or more spacer elements providing a haptic feedback to the user and preventing direct finger contact with the test pad during sample application.

3. The arrangement according to claim 2 , wherein the spacer elements are arranged adjacent to a boundary of the receiving area such that they are bodily separate from the test pad at the application site and without solid connection to the test pad at the application site.

4. The arrangement according to claim 2 , wherein each skin-contacting end section is selected from the group comprising ridges, bars, pins, spikes, edges, rectangles, triangles, and saw-tooth structures.

5. The arrangement according to claim 2 , wherein each skin-contacting end section has a beveled, chamfered and/or rounded contour.

6. The arrangement according to claim 2 , wherein the end section of the spacer elements has a linear or pointed contact surface positioned to contact the user's skin.

7. The arrangement according to claim 2 , wherein the spacer elements are made of a non-elastic material as a rigid formed part.

8. The arrangement according to claim 2 , wherein the spacer elements are provided on the supporting member so as to be arranged on opposite sides of the test pad provided at the application site.

9. The arrangement according to claim 2 , wherein the test pad is at least partly compressible or becomes at least partly compressible after sample application.

10. The arrangement according to claim 2 , wherein the spacer elements have a height in the range from 0.5 mm to 5 mm.

11. The arrangement according to claim 10 , wherein the height is in the range from 1 mm to 3 mm.

12. The arrangement according to claim 2 , wherein the supporting member comprises a window in the support surface for optically scanning the bottom side of the test pad opposite to the receiving area.

13. The arrangement according to claim 12 , further comprising a photometric detection unit operable for detecting measuring values on the test pad.

14. The arrangement of claim 12 , wherein the window contains an optical element or delimits an opening free from an optical element.

15. The arrangement according to claim 12 , wherein the supporting member positions a test strip carrying the test pad.

16. The arrangement according to claim 2 , wherein the test pad is carried on a transport tape comprising a plurality of further test pads each spaced apart from each other, and wherein the supporting member is formed as a tip guiding the transport tape.

17. The arrangement according to claim 2 , wherein the arrangement comprises a tape cassette for glucose tests, wherein the supporting member is formed as a deflection tip for a transport tape which carries the test pad and a plurality of further test pads spaced apart from each other, and wherein the spacer elements are provided on the supporting member and arranged on both sides of the transport tape and comprise injection-molded parts.

18. A tape cassette for glucose tests, the tape cassette comprising:
a housing containing a transport tape carrying a plurality of spaced apart test pads, the transport tape being guided between two spools in the housing,
wherein between the spools each test pad is successively provided across a tip of the housing, each said test pad comprising a layered chemistry field responsive to glucose contained in an applied fluid sample by a color change,
the transport tape being transparent at least at the location of each test pad, and each test pad further comprising a receiving area having a planar top surface for application of the fluid sample;
said tip comprising a planar supporting member having an optical window therein, wherein the glucose-responsive color change in said test pad is observable through the optical window when the fluid sample is applied from a user's skin to one of the test pads positioned over the optical window for optical scanning of a rear side of the transport tape at the location of said test pad, said rear side fully and flatly abutting the supporting member and being on an opposite side of the transport tape from the plurality of test pads,
the supporting member having a pair of spacer elements arranged on opposite sides of the transport tape, wherein said transport tape is guided across the supporting member and between the spacer elements,
said spacer elements comprising a skin-contacting end section which protrudes above the supporting member and extends in a direction orthogonal to the plane of the supporting member and the planar top surface of the receiving area of one of the test pads provided at the application site, and
wherein said spacer elements are configured to provide a haptic feedback to a user and prevent direct contact of a user's finger with the receiving area of the test pad when applying the fluid sample.

Assignees

• Roche Diabetes Care Inc

Inventors

• Huellen Volker
• Keth Ingrid
• Koschorreck Beate
• Setiabudi Miguel
• Berg Max
• Kammerer Daniel
• Hohenadel Ulisse
• Sieffert Daniel
• Pachl Rudolf

Classifications

• G01N33/523

  the element being adapted for a specific analyte · CPC title

• G01N2021/7796

  Special mountings, packaging of indicators · CPC title

• G01N2021/7759

  Dipstick; Test strip · CPC title

• G01N21/78

  producing a change of colour · CPC title

• A61B5/157

  {Devices} characterised by integrated means for measuring characteristics of blood · CPC title