METHOD FOR PRODUCING A STICKPACK TYPE PACKAGING AND METHOD FOR USING A STICKPACK TYPE PACKAGING

Abstract

The application relates to a stickpack-type packaging comprising an elongated foil tube (12) having two transverse sealing gaskets (16,18), such that a hermetically sealed filling space (20) is provided in the foil tube (12) for storing a product. It is proposed that a single disposable test strip (22) is disposed in the filling space (20), wherein the test strip (22) has a chemical pad (26) for detecting an analyte in a sample, and the chemical pad (26) is disposed at a distance of at least one of the transverse sealing gaskets (16,18).

Description

1 / 10 “METHOD FOR PRODUCING A STICKPACK TYPE PACKAGING AND METHOD FOR USING A STICKPACK TYPE PACKAGING” Field of Invention

[0001] The present invention relates to a stickpack-type packaging comprising an elongated foil tube preferably having a longitudinal sealing gasket, wherein two transverse sealing gaskets are provided at the longitudinal ends of said foil tube, so that an essentially airtight and moisture-proof filling space is provided in the foil tube for storing a product. The present invention further relates to a method for producing and a method for using such stickpack-type packaging. Background of the Invention

[0002] Among the various types of packaging for particulate products, one type called "stickpack" is widely used commercially. Such stickpacks provide several advantages, particularly from the point of view of continuous production and dosing of small quantities of product.

[0003] In the field of blood glucose testing, the use of disposable test strips for spot measurements is well known. The user provides a fresh blood sample by pricking a finger and transferring a drop of blood to the test strip. For the test strips to be optically evaluated, a chemical pad is provided in a holder for an enzymatic reaction to allow the detection of glucose concentration through a color change. These test strips are usually sold in large quantities, for example, 50 strips, in a vial or container of test strips. Description of the Invention

[0004] Based on this, an objective of the invention is to further expand the production and application of stickpack type packaging concepts and Petition 870240040525, dated 05 / 14 / 2024, page 12 / 25 2 / 10 provide greater user convenience and special product protection, specifically in challenging environments.

[0005] The combination of the features stated in the independent claims is proposed to achieve this objective. Advantageous embodiments and other developments of the invention are derived from the dependent claims.

[0006] The invention is based on the idea of ​​providing a single disposable test strip in a user-friendly package. Thus, a stickpack packaging is proposed in which a single disposable test strip is disposed in the filling space, wherein the test strip has a chemical pad to detect an analyte in a sample, and the chemical pad is disposed at a distance of at least one of the transverse sealing joints. In this arrangement, it is largely avoided that the reactive components in the chemical pad are damaged by negative impacts, specifically the influence of heat, during the sealing of the package. For this purpose, a full-face chemical coating of the test strip should be avoided, and the chemical pad should be provided in an end section or an intermediate section of the test strip distant from at least one or both of the transverse sealing joints.The stickpack provides a compact receptacle with enhanced protection against environmental influences, specifically humidity and dust in the ambient air. Thus, the reliability of test results can be guaranteed even under adverse conditions. Furthermore, the single-dose test quantity allows the user to purchase and / or keep available only the necessary number of tests for a given period, without the need to transport a large and unnecessary volume of packaging.

[0007] Advantageously, the chemical pad is placed near a first transverse sealing joint and at a greater distance from a second transverse sealing joint, where the first sealing joint Petition 870240040525, dated 05 / 14 / 2024, page 13 / 25 A 3 / 10 crossbar is provided before the test strip in the foil tube, so that the first crossbar sealing joint cannot affect the chemical pad in its vicinity.

[0008] Another improvement in this direction is achieved when the test strip comprises a holder of a generally rectangular shape and the chemical pad is provided in an end section and / or in an intermediate section of the holder.

[0009] In order to account for an optical test assessment, the foil tube has a stamp of one or more, preferably two to six and more preferably three reference colors on its outer surface, wherein the reference colors are adapted to compare a color change of the chemical pad resulting from a reaction with the analyte to assess a test result.

[00010] For optimized color definition, each of the reference colors is provided by a special color that is premixed before printing.

[00011] As an even more advantageous measure, reference colors define a color scale and / or a grayscale scale to compare the color change of the chemical pad.

[00012] According to a preferred embodiment, the print comprises two reference color scales of different sizes, wherein a small-sized reference color scale is provided in a first zone of the foil tube and a comparatively larger-sized reference color scale is provided in a second zone of the foil tube, preferably arranged opposite the first zone. Both scales should display the same reference colors. Thus, different methods of test evaluation—e.g., visual or by an instrument—can be employed.

[00013] The sheet tube can be formed from one of the Petition 870240040525, dated 05 / 14 / 2024, p. 14 / 25 4 / 10 of the following alternatives: i) a flexible flat frame having a longitudinal sealing joint joining its mutually opposing longitudinal edges; ii) two pieces of a flexible flat weave supplied one on top of the other and having two longitudinal sealing joints along their paired longitudinal edges; and iii) an extruded tube section that is free of longitudinal sealing joints.

[00014] Advantageously, the sheet tube is formed by a flat composite layer mesh comprising, preferably, an aluminum layer. This allows for providing a very flexible, firm and strong containment with low weight.

[00015] In order to further suppress the influence of moisture, it may be even more advantageous when the foil tube includes a desiccant to dry the filling space. The desiccant may be disposed within the filling space or in a foil material of the foil tube.

[00016] Another improvement in use provides that the foil tube contains an adhesive area or a rubber lining on its outer surface for placing a used test strip on it. It is also conceivable that a protective foil is provided on the adhesive area to which the adhesive may partially adhere when it is detached, so that the foil can be affixed elsewhere as a label, for example, on a clinical report.

[00017] Another embodiment of the invention relates to a method for producing a stickpack-type packaging comprising the steps of: a) to form an elongated sheet tube, preferably by joining mutually opposite longitudinal edges of a flexible flat weave; b) seal the leaf tube at the first and second joints Petition 870240040525, dated 05 / 14 / 2024, page 15 / 25 5 / 10 heat-sealed transverse sections are provided at the longitudinal ends of the foil tube, thus providing a hermetically sealed filling space for storing a product; c) provide a disposable test strip that has a chemical pad to detect an analyte in a sample; d) insert the test strip into the filling space before closing the second transverse sealing joint; and e) Place the test strip in step d) so that the chemical pad is positioned at a distance from the second transverse sealing joint.

[00018] In this way, the advantageous effects are achieved as described above in relation to the product of the process.

[00019] For greater moisture reduction, it is advantageous to purge the packing space with dry gas and / or dry the test strip before introducing it into the packing space.

[00020] As another advantageous measure, a print of one or more reference colors is applied to the initial sheet material so that the print appears on the outer surface of the sheet tube.

[00021] Advantageously, the sheet tube is formed by one of the following steps: i) Joining mutually opposite longitudinal edges of a flexible flat weave, preferably by means of a heat-sealed longitudinal joint; ii) provide two congruent pieces of a flexible flat weave one on top of the other and join their paired longitudinal edges by respective longitudinal sealing gaskets; and iii) cut a section of an extruded tube material.

[00022] Another embodiment of the invention relates to the use of a stickpack type packaging comprising the following steps: a) provide a stickpack type packaging, including a Petition 870240040525, dated 05 / 14 / 2024, page 16 / 25 6 / 10 single disposable test strip; b) remove the test strip from the packaging by tearing the foil tube, preferably along a pre-weakened or serrated tear section; c) Apply a sample, preferably of a body fluid, to the chemical pad; and d) Compare a change in the color of the chemical pad resulting from a reaction with the analyte to the reference color stamp to evaluate a test result.

[00023] Advantageously, color comparison is done optically by an instrument, in particular a mobile device, preferably including a digital camera (specifically a smartphone), or visually by a user. Brief Description of the Drawings

[00024] The invention is further elucidated next based on an embodiment shown schematically in the drawings, in which: Figure 1 shows a front view of the stickpack packaging including a single disposable test strip; Figure 2 is a rear view of the stickpack from Figure 1; Figure 3 shows the open stickpack from Figure 1 and the test strip attached to the outside; and Figure 4 is a schematic view of a machine for manufacturing a stickpack, including a test strip. Description of Embodiments of the Invention

[00025] As described in Figures 1 to 3, an exemplary embodiment of a stickpack packaging 10 comprises an elongated foil tube 12 closed by a longitudinal sealing gasket 14 and two transverse sealing gaskets 16, 18 at the longitudinal ends of the foil tube 12, so that a filling space 20 is closed on all sides, Petition 870240040525, dated 05 / 14 / 2024, page 17 / 25 7 / 10 where a single disposable test strip 22 is disposed of.

[00026] Figure 1 shows test strip 22 in ghost lines enclosed in the fill space 20. Test strip 22 has a rectangular backing sheet 24 and a chemical pad 26 in a section of the backing sheet 24. The chemical pad 26 contains enzymes and auxiliary substances as mediators to detect an analyte in a liquid sample, specifically for glucose in a blood sample. Such test strips 22 are known per se and are available, for example, under the trade name ACCU-Chek. It is also conceivable that the test strips are intended for other purposes, for example, to measure lactate or cholesterol levels.

[00027] Chemical pad 26 is susceptible to heat, humidity and other influences. While foil tube 12 is essentially airtight and moisture-proof to protect against environmental influences during storage, measures must be taken to prevent thermal damage to chemical pad 26 during packaging 10 manufacturing, as explained in more detail below.

[00028] Foil tube 12 has first and second stamps 28, 28' of a series of 30 different reference colors on the front and back sides, respectively. The 30 reference colors define a color scale and / or grayscale scale to compare a color change of the chemical pad 26 resulting from a reaction with the analyte, in order to evaluate a test result on the spot, to ensure color fastness, purposely, exact colors are used which are premixed before the stamps 28, 28' are made on the initial foil tube 12 material.

[00029] As shown in Figure 1, a generally smaller stamp 28 on the front side is intended for an optical comparison performed by an instrument. Such an instrument may be constructed as a mobile device, including a digital camera, specifically a smartphone in conjunction with Petition 870240040525, dated 05 / 14 / 2024, page 18 / 25 8 / 10 a diagnostic software application. Due to the reduced size of the 28 print, an extended area on the front side can be used for manufacturer labels or other information. Figure 2 shows a comparatively larger 28' print on the back side, which can be a device-independent visual color comparison conducted by the user. Each of the 28, 28' prints can contain three reference colors 30, representing low, medium, and high analyte concentration.

[00030] A section of the end of the sheet tube 12 can be provided with a pre-weakening tear line 32 that extends transversely to the longitudinal axis of the tube. Another option for simplified tearing of the open packaging 12 in the longitudinal direction can be provided by serrated transverse edges 34.

[00031] As illustrated in Figure 3, the test strip 22 can be used by tearing along the tear line 32, applying the blood sample to the chemical pad 26 of the removed test strip 22, and comparing the color change, caused by the reaction of the chemical pad 26 with the analyte, to the print 28. The final step can be performed by fixing the upper side of the test strip 22 to an adhesive area 36 on the foil tube 12 so that the arrangement remains fixed during image capture by a camera. In this way, the color of the test field 26 can be evaluated from the back side through a hole 38 in the holder 24 and instrumentally compared with the print 28.

[00032] Before use, the adhesive area 36 can be covered by a peelable label or sheet (not shown), to which the adhesive can partially adhere when it is detached from the sheet tube 12, so that the label can be affixed elsewhere, for example, on a clinical report.

[00033] Figure 4 illustrates the production of packaging 10 in a continuous vertical mode of operation on a stickpack machine 40. As a starting material, a flat weave 42 is unwound from a roll and formed into a Petition 870240040525, dated 05 / 14 / 2024, page 19 / 25 9 / 10 tube in a forming boss 44. The initial material 42 consists of a composite layer material, including an aluminum layer and an inner sealing layer, and is already supplied with stamps 28, 28' before forming the tube 12.

[00034] 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 fused together under the influence of heat and pressure for a given time. Advantageously, these parameters can be adjusted within the sealing temperature range of 110 to 200 °C, sealing pressures of 0.5 to 5 bar, and sealing times of 0.3 to 2 s. In this regard, the influence of temperatures and sealing times on the chemical pad 26 must be taken into account.

[00035] Therefore, mutually opposite longitudinal edges of the tubular sheet body are heat-sealed by a vertical thermal shoe 46 used to form the longitudinal sealing joint 14 before introducing a test strip 22.

[00036] The formation of the transverse sealing joints 16, 18 is achieved in pairs by engaging the horizontal thermal shoes 48, which also include a corrugated knife for cutting the edges 34. In this way, the upper transverse sealing joint 18 of a previous package 10 is provided at the same time as the lower transverse sealing joint 20 of a subsequent sheet tube 12.

[00037] A vertical feed tube 46 extends into the filling space 20 and allows the introduction of a test strip 22 carrying the chemical pad 26. To keep the filling space 20 free of moisture, it is conceivable to purge the filling space with dry gas and / or dry the test strip 22 beforehand. Another option is to provide the starting material 42 with a desiccant. Petition 870240040525, dated 05 / 14 / 2024, p. 20 / 25 10 / 10

[00038] As mentioned above, the chemical pad 26 must not be thermally stressed by the thermal shoes 46, 48. This can be achieved by proper arrangement and feeding of the test strip 22, so that the chemical pad 26 is positioned at a distance of at least one of the transverse sealing joints 16, 18.

[00039] In the configuration shown in Figure 4, the longitudinal sealing joint 14 and the lower transverse sealing joint 16 are formed before the introduction of the test strip 22. After removing the thermal shoes 46, 48, the chemical pad 26 can be placed upside down in the lower end section of the support 24, so that it has the maximum distance for heat impact during the closing of the upper transverse sealing joint 18 in the next step. Certainly, it is also conceivable that the chemical pad 26 be arranged in an intermediate section of the support 24, as shown in Figure 1, while a full-face chemical coating or an arrangement of the chemical pad 26 in the upper end section without the remaining distance to the closing transverse sealing joint 18 should be avoided. Petition 870240040525, dated 05 / 14 / 2024, page 21 / 25

Claims

1 / 3 Claims 1.METHOD FOR PRODUCING A STICKPACK TYPE PACKAGING (10) comprising the steps of: a) forming an elongated foil tube (12), preferably by joining mutually opposite longitudinal edges of a flexible flat mesh (42), b) sealing the foil tube (12) by first and second heat-sealed transverse joints (16,18) provided at the longitudinal ends of the foil tube (12), thus providing a closed filling space (20) for storing a product, c) providing a disposable test strip (22) having a chemical pad (26) for detecting an analyte in a sample, the method characterized by: d) providing the first transverse sealing joint (16) before the test strip (22) in the foil tube (12), e) introducing the test strip (22) into the filling space (20) before closing the second transverse joint (18), f) placing the test strip (22) in step e), so that the chemical pad (26) is positioned at a distance from the second transverse joint (18).

2. METHOD, according to claim 1, characterized by further comprising purging the filling space (20) with dry gas and / or drying the test strip (22) before introducing it into the filling space (20).

3. METHOD, according to any one of claims 1 to 2, characterized by further comprising applying an impression (28) of one or more reference colors (30) to the screen (42), so that the impression (28) appears on the outer surface of the foil tube (12).

4. METHOD, according to any of the claims Petition 870240040525, dated 05 / 14 / 2024, p. 22 / 25 2 / 3 1 to 3, characterized by the sealing of the sheet tube (12), as defined in step b), comprising a heat-sealed longitudinal joint (14) of the edges.

5. METHOD, according to any one of claims 1 to 4, characterized in that the chemical pad (26) is disposed near the first transverse sealing joint (16) and at a greater distance from the second transverse sealing joint (18).

6. METHOD, according to any one of claims 1 to 5, characterized in that the foil tube (12) is provided with an adhesive area (36) or a rubber liner on its outer surface for placing a test strip (22) used on the outer surface.

7. METHOD, according to any one of claims 1 to 6, characterized by further comprising forming the sheet tube (12) by one of the following steps: i) joining the mutually opposite longitudinal edges of a flexible flat weave (42), preferably by a heat-sealed longitudinal joint (14); ii) providing two congruent pieces of a flexible flat weave (42) one on top of the other and joining their paired longitudinal edges by respective longitudinal sealing joints (14); and iii) cutting a section of an extruded tube material.

8. METHOD FOR USING A STICKPACK TYPE PACKAGING (10) characterized by comprising: a) providing a stickpack type packaging (10) obtained by a method as defined in any of claims 1 to 7, b) removing the test strip (22) from the packaging (10) by tearing the foil tube (12), preferably at a pre-weakened or serrated tear section (32), c) applying a sample, preferably of a body fluid to the chemical pad (26), d) comparing a color of the chemical pad (26) resulting from a reaction with the analyte with the reference color stamp (30) to evaluate a test result, wherein the color comparison is made optically by a mobile device including a digital camera. Petition 870240040525, dated 05 / 14 / 2024, page 24 / 25

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