阅读说明：本技术 葡萄糖测试装置和方法 (Glucose testing device and method ) 是由 V.许伦 I.凯斯 B.科舍雷克 R.派克 M.塞蒂布迪 M.伯格 D.卡默勒 U.霍 于 2018-07-31 设计创作，主要内容包括：本发明涉及一种在手持式仪表中使用的葡萄糖测试装置,包括：一次性测试垫(16),其响应于体液中的葡萄糖；以及支撑构件(30),其适于在施加部位处支撑测试垫(16),以用于将体液从用户的皮肤施加到测试垫(16)的接收区域(38)上,其中,接收区域(38)背对支撑构件(30)。为了改进用户辅助,提出了一个或多个间隔件元件(20)邻近于测试垫(16)设置在支撑元件(30)上,其中,所述一个或多个间隔件元件(20)具有在接收区域(38)上方突出的皮肤接触端部区段(36)。(The invention relates to a glucose testing device for use in a hand-held meter, comprising: a disposable test pad (16) responsive to glucose in a bodily fluid; and a support member (30) adapted to support the test pad (16) at an application site for applying body fluid from the skin of a user onto a receiving area (38) of the test pad (16), wherein the receiving area (38) faces away from the support member (30). In order to improve the user assistance, it is proposed that one or more spacer elements (20) are arranged on the support element (30) adjacent to the test pad (16), wherein the one or more spacer elements (20) have a skin contact end section (36) protruding above the receiving area (38).)

1. A glucose testing device for use in a hand-held meter, comprising: a disposable test pad (16) responsive to glucose in a bodily fluid; and a support member (30) adapted to support the test pad (16) at an application site for applying body fluid, in particular as a blood drop, from the skin of a user onto a receiving area (38) of the test pad (16), wherein the receiving area (38) faces away from the support member (30), characterized in that one or more spacer elements (20) are arranged on the support member (30) adjacent to the test pad (16), wherein the one or more spacer elements (20) have a skin contacting end section (36) protruding above the receiving area (38).

2. Device according to claim 1, wherein the test pad (16) is movable relative to the support member (30) and the spacer element (20) thereon.

3. Device according to claim 1 or 2, wherein a bottom side of the test pad (16) provided at the application site abuts flat and completely against the support member (30), and the receiving area (38) is arranged on a top side of the test pad (16) opposite to the bottom side of the test pad (16).

4. Device according to any one of claims 1 to 3, wherein the spacer elements (20) are arranged adjacent to the boundary of the receiving area (38) such that they are integrally separated from the test pad (16) at the application site and do not have a solid connection to the test pad (16) at the application site.

5. The device according to any one of claims 1 to 4, wherein the spacer element (20) is selected from the group comprising ridges, bars, pins, spikes, edges, rectangles, triangles and saw tooth structures.

6. Device according to any one of claims 1 to 5, wherein the spacer element (20) has a chamfered, chamfered and/or rounded profile.

7. Device according to any one of claims 1 to 6, wherein the spacer element (20) is made as a rigid shaped part from a non-elastic material.

8. Device according to any one of claims 1 to 7, wherein the spacer elements (20) are arranged on opposite sides of a preferably rectangular test pad (16).

9. The device according to any one of claims 1 to 8, wherein the end section (36) of the spacer element (20) has a linear or pointed contact surface for contacting the skin of a user.

10. The device according to any one of claims 1 to 9, wherein the spacer element (20) is adapted to provide tactile feedback to a user and/or to substantially prevent a finger from coming into direct contact with the test pad (16) during sample application.

11. The device of any one of claims 1 to 10, wherein the test pad (16) is at least partially compressible or becomes at least partially compressible after application of a sample.

12. The device according to any one of claims 1 to 11, wherein the height of the spacer element (20) is in the range from 0.5 mm to 5 mm, in particular in the range from 1 mm to 3 mm.

13. The device according to any one of claims 1 to 12, wherein the support member (30) comprises a window (40) for optically scanning a bottom side of the test pad (16) opposite the receiving area (38).

14. The device according to claim 13, wherein the window (40) comprises an optical element or defines an opening without an optical element.

15. The device according to any one of claims 1 to 14, wherein the support member (30) is formed as a tip (18) for guiding a transport belt (14) carrying a plurality of test pads (16) spaced apart from each other.

16. The device according to any one of claims 1 to 15, wherein the support member (30) is adapted to position a test strip carrying a single test pad (16).

17. A cassette for glucose testing, comprising a device according to any one of claims 1 to 16, wherein the support member (30) is formed as a deflection tip (18) for a transport belt (14) carrying a plurality of test pads (16) spaced apart from each other, and wherein the spacer elements (20) are arranged on both sides of the transport belt (14), preferably as injection-molded parts on both sides of the transport belt (14).

18. A hand-held meter for glucose testing, comprising: a cassette (10) or device according to any of the preceding claims; and preferably a photometric detection unit (28) operable for detecting a measurement value on the test pad (16).

19. A glucose testing method for use in a hand-held meter, comprising

-providing a disposable test pad (16) responsive to glucose in a body fluid,

-positioning the test pad (16) on a support member (30) at an application site of a body fluid, wherein one or more spacer elements (20) are arranged on the support member (30) adjacent to the test pad (16),

-applying body fluid, in particular as a drop of blood, from the skin of a user onto a receiving area (38) of the test pad (16), wherein the receiving area (38) faces away from the support member (30),

-contacting the user's skin by means of a skin contacting end section (36) of the one or more spacer elements (20), which skin contacting end section protrudes above the receiving area (38), thereby preventing direct contact of a finger with the test pad (16) during sample application, in order to improve the accuracy of the glucose test.

Technical Field

The invention relates to a glucose testing device for use in a hand-held meter, comprising: a disposable test pad responsive to glucose in a bodily fluid; and a support member adapted to support the test pad at an application site for applying body fluid, in particular body fluid as a blood drop, from the skin of a user and in particular from a finger of the user onto a receiving area of the test pad, wherein the receiving area faces away from the support member such that the sample fluid is applied from the top and the opposite side is supported flat. The invention relates in particular to a test tape cartridge and also to a hand-held meter as a glucose concentration measuring device.

Background

In the field of blood glucose testing, it is known to use disposable test elements in handheld blood glucose meters for on-site measurements. The user provides a fresh blood sample by pricking a finger and transferring a drop of blood onto the test element. In particular, a plurality of test elements may be provided for sequential use on a test tape which may be loaded into the meter in the form of a replaceable tape cartridge. Thus, the user does not need to be aware of the handling of each individual test element. However, the instrument is typically used by patients outside of the laboratory environment, and therefore the measurements may be susceptible to unintended user manipulation. For example, contamination on a user's finger (e.g., contamination from food) may result in additional glucose content in a blood drop produced on the finger. Thus, if the user does not properly wash his finger before performing the test, an erroneously high glucose value may occur. Furthermore, some users may tend to press their fingers relatively hard against the test field or test pad, or the user may rub their fingers against the test pad during the measurement. In the extreme case of user manipulation of the scene, significant measurement bias may occur.

Disclosure of Invention

On this basis, it is an object of the present invention to further improve the known testing devices and apparatuses and methods to ensure an improved accuracy of the blood glucose measurements during the data acquisition phase or the detection phase.

Combinations of features set out in the independent claims are presented to achieve this object. Advantageous embodiments and further developments of the invention result from the dependent claims.

The invention is based on the following idea: measurement distortion is prevented by assisting the user in applying the sample to the test field. Thus, a glucose testing device is proposed in which one or more spacer elements are arranged on a support member adjacent to a test pad, wherein the one or more spacer elements have a skin-contacting end section, in particular a finger-contacting end section, which protrudes above a receiving area of the test pad. In this way, the user receives tactile feedback already before touching the test pad. The skin or finger is prevented from pressing directly onto the test pad and/or even from touching the test pad. Only the drop of blood reaches the receiving area of the test pad. Furthermore, the spacer element reduces the risk of the user wiping contaminated blood from the finger surface. Instead, most uncontaminated blood from the portion of the drop of blood further from the skin or finger surface is applied to the test pad.

In order to provide the test pad at the application site, the test pad may be moved relative to the support member and relative to the spacer element thereon.

For a large-area wetting with body fluid, it is advantageous if the bottom side of the test pad abuts flat and preferably over the whole surface against the support member, while the receiving area is arranged on the top side of the test pad opposite the bottom side of the test pad.

It is further advantageous if the spacer elements are arranged adjacent to the boundary of the receiving area such that they are integrally separated from the test pad at the application site and do not have a strong connection to the test pad at the application site.

Advantageously, the spacer element is selected from the group comprising ridges, bars, pins, spikes, edges, rectangular, triangular and saw tooth structures.

To address the specific sample application process, the spacer elements advantageously have a chamfered, chamfered and/or rounded profile.

In order to achieve a user-assistance effect, it is further advantageous if the spacer element is made of a non-elastic material as a rigid shaped part.

According to a preferred embodiment, the spacer elements are arranged on opposite sides of the test pad, preferably of rectangular profile. This configuration is particularly advantageous for tape cartridges when the spacer elements are arranged on opposite sides of the test tape.

Advantageously, the spacer element is adapted to provide tactile feedback to the user during sample application.

For this purpose, the end section of the spacer element has a linear or pointed contact surface for contacting the skin of the user.

As a further advantageous measure, the spacer element is adapted to substantially prevent direct contact of a finger with the test pad during sample application.

Such a device is particularly important when the test pad is at least partially compressible or becomes at least partially compressible after wetting.

For an optimized functional value, the height of the spacer elements should be in the range from 0.5 to 5 mm, in particular in the range from 1 to 3 mm.

For direct measurement at the application site, it is advantageous if the support member comprises a window for optically scanning the underside of the test pad opposite the receiving area. In this connection, it is also advantageous if the window comprises an optical element or defines an opening without an optical element.

A further refinement relating to a tape cassette provides that the support member is formed as a tip for guiding a transport tape which carries a plurality of test pads spaced apart from one another.

Alternatively, for use with a single disposable, the support member is adapted to position a test strip carrying a test pad.

Another aspect of the invention relates to a cassette for glucose testing, comprising a testing device according to the invention, wherein the support member is formed as a deflection tip for a transport tape carrying a plurality of test pads spaced apart from each other, and wherein the spacer elements are arranged on both longitudinal sides of the transport tape, preferably as injection-molded parts.

The invention also relates to a hand-held meter for glucose testing comprising the above-described cassette or testing device and preferably a photometric detection unit operable to detect a measurement value on a test pad.

Yet another aspect of the invention relates to a glucose testing method for use in a hand-held meter, comprising the steps of:

-providing a disposable test pad responsive to glucose in a body fluid,

-placing and positioning the test pad on a support member at a body fluid application site, wherein one or more spacer elements are arranged on the support member adjacent to the test pad,

applying body fluid, in particular as a drop of blood, from the skin of a user onto a receiving area of the test pad, wherein the receiving area faces away from the support member,

-contacting the skin of the user by means of a skin contacting end section of the one or more spacer elements, the skin contacting end section protruding above the receiving area, thereby preventing direct contact of a finger with the test pad during sample application, in order to improve the accuracy of the glucose test.

In this way, similar effects and advantages are achieved as already mentioned above.

Drawings

The invention will be further elucidated on the basis of an example of embodiment which is schematically shown in the drawing, in which

FIG. 1 shows a test tape cartridge for glucose testing having a deflecting tip and a finger contact spacer element protruding from the tip; the test system comprises;

FIG. 2 is a perspective view of a handheld glucose meter configured to use a test strip cartridge;

FIG. 3 is an enlarged cross-sectional view of FIG. 1; and

figures 4a-d show various forms of spacing elements on the tip.

Detailed Description

As depicted in fig. 1, an exemplary embodiment of a disposable cartridge 10 for blood glucose testing includes: a housing 12; a windable conveyor belt 14 carrying a plurality of test pads 16 spaced apart from one another; and a deflecting tip 18 for successively providing a test pad 16 on tip 18 for application of a sample in contact with a user's finger, wherein protruding spacer elements 20 on tip 18 provide tactile feedback to the user during application of a sample and prevent direct contact of the skin or finger with the test pad. The transfer of the transport belt 14 is accomplished by two reels as in a conventional audio or video cassette (not shown).

As further shown in FIG. 2, the portable glucose meter 12 is adapted to receive a disposable test strip cartridge 10 that may be inserted into a compartment of the meter housing 24. When the tip cap 26 is opened, the tip 18 of the inserted cartridge 10 is accessible and the user then applies a drop of blood by piercing a finger with the piercing aid and contacting the top side of the detection pad 16. During this manipulation step, the tip 18 serves as a support member 30 beneath the detection pad 16.

The hand-held meter 22 is provided with a photometric measuring unit 28 for determining the glucose concentration from the measurement values. For this purpose, the test pad 16 on the transport belt 14 is formed by a layered chemical field that responds to the analyte (i.e., glucose) by a color change. The measurement unit 22, provided as a reflectometer, then allows the analyte concentration to be measured by optically scanning the rear side of the test element 22 in the optical window of the support member 30 and optically scanning the transparent transport belt 14. The measurement results and other information may be displayed to the user on the display 32.

As is evident from fig. 3, the spacer element 20 is arranged laterally to the band 14 as a rigid one-piece construction of the tip 18, preferably as an injection-molded part. These spacer elements are formed as ribs or ridges protruding from the flat or curved support surface 34 of the support member 30. The linear skin contacting end section 36 of spacer element 20 protrudes above the upper fluid (blood) receiving area 38 of the active test pad 16 on tip 18. Since the test pad 18 is or becomes at least partially compressible after application of the sample, the spacer element 20 should have a sufficient height (e.g. in the range from 1 to 3 mm measured from the base) in order to avoid direct finger pressure. Such pressure after wetting can lead to undesired changes of the layered test structure (especially in the case of pressing the cover web provided for sample spreading into the chemical field), thereby impairing the optical measurement.

Spacer elements 20 are arranged on opposite sides of the rectangular profile of test pad 16. Thus, the user receives tactile information before the user's finger contacts the test pad 16, thus avoiding the application of excessive pressure. In addition, spacer element 20 reduces unwanted finger movement during sample application, for example, due to vibration.

Fig. 4 schematically illustrates various embodiments of the spacer element 20 on the cartridge tip 18. In fig. 4a, the spacer element 20 has a chamfered triangular shape terminating in a pointed contact surface 36. Also evident is an optical window 40 in the center of the support surface 34 for reflectometry measurements. Fig. 4b shows a saw tooth structure of the spacer element 20, while fig. 4c and 4d illustrate spikes and rounded pins as spacer element 20.