STICKPACK-TYPE PACKAGING FOR A TEST STRIP

Abstract

The application concerns a stickpack-type packaging comprising an elongate foil tube having two transverse sealing joints, such that a tightly closed fill space is provided in the foil tube for storing a product. It is proposed that a single disposable test strip is arranged in the fill space, wherein the test strip has a chemistry pad for detecting an analyte in a sample, and the chemistry pad is arranged at a distance at least from one of the transverse sealing joints.

Claims

1. A method for producing a stickpack-type packaging containing a test strip, comprising: a) forming an elongate foil tube having a first longitudinal end and a second longitudinal end; b) sealing the first longitudinal end of the foil tube by a first heat-sealed transverse joint, thereby providing an open fill space for receiving a test strip; c) after step b), introducing the test strip into the open fill space; and d) after step c), sealing the second longitudinal end of the elongate foil tube by a second heat-sealed transverse joint, thereby closing the open fill space containing the test strip.

2. The method of claim 1 wherein the test strip has a dosing end and a meter end, the test strip having a heat sensitive chemistry pad for detecting an analyte in a sample, the chemistry pad being located closer to the dosing end than to the meter end, and wherein step (c) comprises introducing the test strip with the dosing end being positioned adjacent to the first longitudinal end of the foil tube.

3. The method according to claim 2 wherein the chemistry pad is arranged closer to the first transverse sealing joint than to the second transverse sealing joint.

4. The method of claim 2, and further comprising purging the open fill space with dry gas before introducing the test strip into the open fill space.

5. The method of claim 2, and further comprising drying the test strip before introducing it into the open fill space.

6. The method of claim 5, and further comprising purging the open fill space with dry gas before introducing the test strip into the open fill space.

7. The method according to claim 2, wherein step a) comprises forming the elongate foil tube by a method selected from the group consisting of: i) joining mutually opposite longitudinal edges of a flexible flat web; ii) providing two congruent pieces of a flexible flat web on top of each other and joining their paired longitudinal edges by respective longitudinal sealing joints, and iii) cutting a section from an extruded tube material.

8. The method of claim 7 wherein forming the elongate foil tube comprises joining mutually opposite longitudinal edges of a flexible flat web.

9. The method of claim 8 in which joining mutually opposite longitudinal edges comprises joining the edges by a heat-sealed longitudinal joint.

10. The method according to claim 2, wherein the foil tube is provided with an adhesive area or a rubber lining on its outer surface for placing a used test strip thereon.

11. The method of claim 2 wherein step (b) comprises tearing the foil tube at a pre-weakened or tooth-shaped tear section.

12. A method for using a stickpack-type packaging comprising: a) providing a stickpack-type packaging obtained by the method according to claim 1; b) withdrawing the test strip from the packaging by tearing the foil tube; c) applying a sample to the chemistry pad; and d) comparing a color of the chemistry pad resulting from a reaction with the analyte to one or more reference colors in order to evaluate a test result.

13. The method of claim 12 comprising the elongate foil tube having an outer surface comprising an imprint of the one or more reference colors, wherein the comparison of the color is made optically by a mobile device including a digital camera.

14. The method of claim 13 wherein step c) comprises applying a body fluid to the chemistry pad.

Description

[0039] In the following, the invention is further elucidated on the basis of an embodiment example shown schematically in the drawings, where

[0040] FIG. 1 shows a front view of stickpack packaging including a single disposable test strip;

[0041] FIG. 2 is a back view of the stickpack of FIG. 1;

[0042] FIG. 3 shows the opened stickpack of FIG. 1 and the test strip attached to the outside;

[0043] FIG. 4 is a schematic view of a machine for manufacturing of a stickpack including a test strip.

[0044] As depicted in FIGS. 1 to 3, an exemplary embodiment of a stickpack packaging 10 comprises an elongate foil tube 12 closed by a longitudinal sealing joint 14 and two transverse sealing joints 16, 18 at the longitudinal ends of the foil tube 12, such that a fill space 20 is closed on all sides, wherein a single disposable test strip 22 is arranged.

[0045] FIG. 1 shows the test strip 22 in phantom lines enclosed in the fill space 20. The test strip 22 has a rectangular carrier foil 24 and a chemistry pad 26 in a section of the carrier foil 24. The chemistry pad 26 contains enzymes and auxiliary substances like mediators for detecting an analyte in a liquid sample, specifically for glucose in a blood sample. Such test strips 22 are known per se and are available e.g. under the trade name ACCU-Chek. It is also conceivable that the test strips are intended for other purposes, e.g. for measuring lactate or cholesterol level.

[0046] The chemistry pad 26 is susceptible to heat, moisture and other influences. While the foil tube 12 is essentially air and moisture tightly closed to shield against environmental influences during storage, measures should be taken to avoid thermal damage of the chemistry pad 26 during manufacturing of the package 10, as explained in more detail below.

[0047] The foil tube 12 has first and second imprints 28, 28 of a number of different reference colors 30 on its front and back side, respectively. The reference colors 30 define a color-scale and/or gray-scale for comparing a color change of the chemistry pad 26 resulting from a reaction with the analyte in order to evaluate a test result on the spot in order to guarantee fastness of colors, purposively spot colors are used which are premixed before the imprints 28, 28 are made on the starting material of the foil tube 12.

[0048] As shown in FIG. 1, a generally smaller imprint 28 on the front side is intended for an optical comparison carried out by an instrument. Such an instrument may be constructed as a mobile device including a digital camera, specifically a smart phone in conjunction with a diagnostic software application. Due to the reduced size of the imprint 28, an extended area of the front side may be used for manufacturer's labels or other information. FIG. 2 shows a comparatively larger imprint 28 on the back side, which can for a device-independent visual color comparison conducted by the user. Each of the imprints 28, 28 may contain three reference colors 30, representing low, medium and high analyte concentration.

[0049] An end section of the foil tube 12 may be provided with a pre-weakening tear line 32 running transverse to the longitudinal tube axis. Another option for simplified tearing the packaging 12 open in longitudinal direction may be provided by tooth-shaped transversal edges 34.

[0050] As illustrated in FIG. 3, the test strip 22 may be used by tearing the tear line 32, applying the blood sample to the chemistry pad 26 of the withdrawn test strip 22 and comparing the color change, caused by reaction of the chemistry pad 26 with the analyte, to the imprint 28. The last step can be carried out by attaching the upper side of the test strip 22 to an adhesive area 36 on the foil tube 12 such that the arrangement remains fixed during capture of an image by a camera. In this way, the color of the test field 26 can be evaluated from the rear side through a hole 38 in the carrier 24 and instrumentally compared to the imprint 28.

[0051] Prior to use, the adhesive area 36 may be covered by a detachable label or sheet (not shown), on which the adhesive may partially adhere when it is detached from the foil tube 12, such that the label can be affixed elsewhere, e.g. on a clinical report.

[0052] FIG. 4 illustrates the production of the packaging 10 in a continuous vertical mode of operation in a stickpack machine 40. As a starting material, a flat web 42 is unwound from a roll and formed into a tube on a forming shoulder 44. The starting material 42 consists of a composite-layer material including an aluminum layer and an inner sealing layer and is already provided with the imprints 28, 28 prior to forming the tube 12.

[0053] The inner sealing layer may consist of a thermoplastic polymer, namely Polyethylene (PE) or Polypropylene (PP) or a copolymer of both or a combination with other plastic materials. Thus, mutually opposed sealing layers can be fusion bonded under the influence of heat and pressure over a given time. Advantageously, these parameters may be adjusted in the range of sealing temperatures from 110 to 200? C., sealing pressures of 0.5 to 5 bar and sealing times of 0.3 to 2 s. In this connection, the influence of the sealing temperatures and times on the chemistry pad 26 should be taken into account.

[0054] Accordingly, mutually opposite longitudinal edges of the tubular foil body are heat-sealed by a vertical heat shoe 46 used to form the longitudinal sealing joint 14 before introducing a test strip 22.

[0055] The forming of the transverse sealing joints 16, 18 is achieved pairwise by engaging horizontal heat shoes 48, which also include a corrugated knife for cutting the edges 34. In this way, the upper transverse sealing joint 18 of a preceding packaging 10 is provided at the same time as the lower transverse sealing joint 20 of a trailing foil tube 12.

[0056] A vertical supply tube 46 extends into the fill space 20 and allows to introduce a test strip 22 carrying the chemistry pad 26. For keeping the fill space 20 free of moisture, it is conceivable to purge the fill space with dry gas and/or drying the test strip 22 in advance. Another option is providing the starting material 42 with a desiccant.

[0057] As mentioned above, the chemistry pad 26 should not be thermally stressed by the heat shoes 46, 48. This can be achieved by suitable arrangement and feeding of the test strip 22, such that the chemistry pad 26 is arranged at a distance from at least one of the transverse sealing joints 16, 18.

[0058] In the configuration shown in FIG. 4, the longitudinal sealing joint 14 and the lower transverse sealing joint 16 are formed prior to introducing the test strip 22. After removing the heat shoes 46, 48, the chemistry pad 26 can be placed headfirst on the lower end section of the carrier 24, such that it has the maximum distance to the impact of heat during closing of the upper transverse sealing joint 18 in the following phase. Of course, it is also conceivable that the chemistry pad 26 is arranged in a middle section of the carrier 24, as shown in FIG. 1, whereas a full faced chemistry coating or an arrangement of the chemistry pad 26 in the upper end section without remaining distance to the closing transverse sealing joint 18 should be avoided.