Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
  • A61B10/0035—Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches

Definitions

• the present invention relates to a method for the production of a diagnostic test device for the skin, more particularly the test plaster, provided with compartments, in accordance with the preamble of Claim 1, as disclosed in European Patent 0 ⁇ 0577.
• test plasters are used to test the allergic reaction of the skin of a test person towards various test substances and test liquids, which to this end are introduced into the compartments in the test plaster, after which the test plaster is applied to the skin.
• a test plaster of this type in accordance with EP 05 ⁇ 0577 generally comprises at least one compartment for taking up a diagnostic medium, an adhesive strip on which the compartment is accommodated as well as a removable protective strip attached to the adhesive strip on the same side as the compartment(s) , the protective strip being provided with an opening at the location of each compartment, wherein one or more rows of compartments is/are accommodated on the adhesive strip and the protective strip has a corresponding number of rows of openings.
• the compartments are usually, and preferably, provided with a base and a raised edge surrounding the base, the shape of the openings corresponding to the periphery of the edge.
• compartments of the test plaster are in practice usually provided with an absorbent material for taking up liquid, usually filter paper.
• test plasters of this type have been produced by producing the compartment(s) individually by injection moulding and then mounting said compartment(s) in the corresponding opening(s) in a separate machine operation.
• So-called mats with a multiplicity of branches are formed in an injection mould. Said mats are removed from the mould, after moulding, by means of ejector pins, after which the branches bearing the compartments are broken from the central trunk and then stored. For storage, the branches are piled in a tube to form a stack.
• the branches bearing the compartments are removed from the tube one by one and laid in a slide, after which the branches are removed in such a way that the compartments remain behind in the slide.
• the slide is then further transported and positioned under a punching unit such that a cutting tool is positioned above each compartment.
• a sheet of filter paper is laid beneath the punches, after which the punches cut squares from the filter paper, after which the punches continue to push these squares until the latter rest on the base of the compartments.
• the slide is then further transported to a handling device provided with suction elements or suction cups. With the aid of the suction elements or suction cups, each compartment is removed from the slide and placed on an adhesive strip.
• Said heavy wear has an adverse effect on the dimensional accuracy, as a result of which the punched-out squares of filter paper are not able reliably to remain held tightly in the compartments; the compartments on a tree are not all exactly identical, which means that the cutting tools in the punching installation would each individually have to be adjusted to these differences in order to obtain squares of filter paper which are held tightly in the compartments. In practice, this adjustment of the cutting tools to the moulds is not readily possible, at least not at reasonable cost.
• the separate fitting of the filter paper in the compartments can, as a consequence of, inter alia, dimensional inaccuracies, lead to inadequate adhesion between the filter paper and the compartments, with the result that the filter paper is held inadequately in place and/or in the compartments.
• a further disadvantage of compartments produced by injection moulding is the consequence of the fact that very smooth and accurate surfaces of the compartments are required for good separation from the injection mould.
• the aim of the invention is, inter alia, to overcome these disadvantages by providing a method with which test plasters of the type described in said European Patent can be produced in an efficient and simple manner, preferably continuously and/or by machine.
• the aim of the invention is to provide a method for the production of a diagnostic test device for the skin, with which method shaping of the compartments, the base and raised edge thereof, as well as mounting of the compartments thus formed on the adhesive strip in the openings intended for said compartments can be carried out continuously and in conjunction, preferably in a single machine operation.
• the invention also relates to the test plasters obtained in accordance with the method.
• test plasters are produced by carrying out the various steps of the production process, as described above, continuously and in conjunction.
• the wording continuously and in conjunction is used to denote that shaping of the compartments, production of the base and raised edge and mounting of the compartments on adhesive strip are carried out not in individual production operations but in production steps which are achievable in one installation or in one production operation.
• the method according to the invention is preferably carried out in a single machine operation.
• an installation of this type constitutes a further aspect of the present invention.
• the strip of plastic material, the strip of plastic film, the strip of filter paper, the strip of laminate containing filter paper or the strip of filter paper provided with a liquid-impermeable or water-repellent coating is preferably a continuous strip.
• the raised edge is most preferentially impermeable, so that after the test plaster has been applied to the skin said plaster does not produce any leakage of the aqueous or alcoholic test solutions.
• impermeable as used in the present application, with regard to the raised edge and the coating applied to the filter paper, is used to denote that the raised edge or, respectively, the coating is not permeable to or does not absorb, transport or release the test substance, in general a water or alcohol-based solution or a vaseline jelly-based preparation.
• the filter paper loses its permeable characteristics as a result of pressing. This is a very important aspect of the present invention.
• the at least one compartment is preferably provided with a base and raised edge by means of pressing, optionally in combination with heating to a temperature in order to facilitate the shaping of the compartment, the base and the raised edge, for example a temperature above the softening point of the plastic used.
• the punching and/or cutting out of one or more compartments from the continuous strip is carried out using a pressing tool and/or blanking punch which is provided with a shape such that the desired periphery of the compartments is obtained on cutting out or punching, and which can also be provided with a shape such that the punch can likewise be used for pressing the compartments, with the formation of the base and raised edge.
• the invention also relates to a method for the production of compartments for a diagnostic test plaster, as well as compartments of this type, comprising the following steps: shaping one or more compartments by means of pressing and cutting or punching the one or more compartments from a strip of material.
• Compartments of this type produced from a strip of material by pressing and cutting have the great advantage that the surface thereof can be rough. This is because, in particular, a rough underside of the compartments makes good adhesion to the adhesive strip possible. In this context rough must be understood to mean a less smooth surface than would be obtained by injection moulding. Furthermore, compartments of this type have the great advantage that the filter paper, often required for the tests, cannot become detached from the compartments since the filter paper was already part of the strip. Further advantageous embodiments according to the invention can be seen from the subsidiary claims.
• Fig. 1 shows a perspective view, with an exposed section of a compartment according to the invention
• Fig. 2 shows a diagrammatic cross-section in which shaping of a compartment according to the invention is shown
• Fig. 3 shows a diagrammatic cross-sectional view which shows a further step in shaping a test plaster
• Fig. shows a diagrammatic perspective view of part of an installation for shaping diagnostic test plasters
• Fig. shows a diagrammatic perspective view of another installation for shaping diagnostic test plasters
• Fig. 6 shows a diagrammatic perspective view of a diagnostic test plaster.
• Fig. 1 shows a compartment 13 according to the invention for a diagnostic test device.
• Said compartment 13 comprises a base 15 and a raised edge 16 abutting said base 15 on all sides.
• Said compartment 13 has been produced in accordance with the invention by pressing and punching from a band of material.
• Said band of material can be made of a plastic, such as polypropene, from filter paper, etc.
• Said material can also have been produced from a laminate of, for example, one or more of the abovementioned materials.
• the band of filter paper is provided on the underside 20, that is to say the underside of the compartment 13 to be shaped, is provided with a film or coating, for example of polypropene. Said film is not shown individually in Figs. 1, 2 and 3. but in practice will preferably be present as a very thin layer.
• Fig. 2 shows a band of filter paper 21 which extends over a die 22 provided with openings, which die is provided with cutting edges 23 around the openings.
• a pressing tool/blanking punch 2k and a pressure pad 25 are also shown.
• the shape of the top of the compartment 13 to be produced has been made in the bottom of the pressing tool/blanking punch 24.
• which recess is surrounded by a rib 27.
• the peripheral rib 27 provides the compartment 13 with a channel 29 which runs all round the base
• the thick base 15 is not or is only slightly compressed during pressing and consequently has approximately the same thickness as the strip of filter paper 21. As a result of said non-compression or only slight compression, the absorbent properties of the thick base section remain virtually unchanged. If the all-round rib 27 is sufficiently wide, the channel 29 will also be sufficiently wide, such that said channel forms a liquid lock and renders transport of the diagnostic test material applied to the base 15 to the surrounding raised edge 16 more difficult. As a result of the local compression of material at the location of region 30. said transport is rendered even more difficult when filter paper is used as the material for the band 21.
• a channel width of 0.05 to 0.4 mm. preferably of 0.1 to 0.25 mm, is found to provide a good water lock in practice.
• a 0.5 to 1.25 mm, preferably 0.75 mm to 1 mm, for example 0.85 mm, thick base of filter paper has very good properties for the intended test purposes.
• the mould block 25 is provided with so-called blind holes with a raised edge 31 °n the base to shape the raised edge 16 of the compartment 13. which raised edge is hollow viewed from the underside.
• the way in which the compartments 13 are shaped from a band of material 21 will be clear from Fig. 2.
• the band of material 21 is placed between, on one side, the pressing tool/blanking punch 24 and, on the other side, the die 22 in such a way that said strip completely covers the die openings in the die 22.
• the pressing tool/blanking punch is then moved downward relative to the die 22 and the mould block 25- During this operation a piece, which in the present example is a square piece, will be cut out from the band of material as a result of the interaction of the cutting edges 32 of the pressing tool/blanking punch 24 and the cutting edges 23 of the die 22. Said cut-out piece of material is pushed by the pressing tool/blanking punch 24 into the mould cavity 33 in the mould block 25, the piece from the band of material being pressed into the compartment 13 shown in Fig. 1.
• the base section 15 will not be compressed or will barely be compressed, so that the absorption properties of the filter paper do not change, whilst that section of the cut-out piece of material which has to form the region 30 and the raised edge 16 is compressed to greater density. Said greater density of the filter paper reduces the absorbency and transport capacity of the filter paper.
• the shaped compartment 13 can, as is shown diagrammatically in Fig. 3. be removed from the mould cavity 33 in the mould block 25 by means of a suction cup or suction device 40.
• Fig. 4 shows, diagrammatically, a unit for shaping, in accordance with the invention, compartments for a diagnostic test plaster.
• Said unit consists of a die 22 provided with a multiplicity of die openings 41, and a mould block 25 which is in the form of a slide and is provided with a multiplicity of mould cavities 33. corresponding to the number of die openings 4l, and a multiplicity of suction cup devices 40, likewise in a corresponding number.
• a band 21 of, preferably, filter paper is fed over the die 22 and the slide 25 is positioned with its mould cavities 33 below the die openings 41 of the die 22.
• the punches 24 are moved downward, during which operation they cut pieces of material from the band 21 and then press said pieces to form compartments 13. as has been described.
• the punches 24 are then raised back out of the mould cavities 33 and die openings 4l, after which the slide 25 is removed from beneath the die 22 and positioned with its mould cavities 33 below the suction cup devices 40.
• the suction cup devices 40 then remove the shaped compartments from the mould cavities 33, after which said compartments can be placed immediately on the adhesive strip of a test plaster.
• the pressing tools 51 are arranged upstream of the cutting tools 52, which reciprocate according to the arrow R.
• the pressing tools are pressed against the band of filter paper from below and interact with counter-moulds which are positioned above the band of filter paper 53 and are not shown.
• the counter-moulds are lifted slightly so that the band of filter paper provided with relief, in the form of "pre ⁇ formed” compartments, can be transported further in the direction of arrow T. Further transport takes place in such a way that a section of the band of filter paper which is provided with relief, that is to say a pre-formed compartment, comes to rest over each die opening 55 of the die 56 located downstream.
• the cutting tools 52 which can be provided with oblique cutting faces, the "pre-formed compartments" 54 are cut from the band of filter paper.
• compartments which have been cut out can, if appropriate, be collected in a slide, as is shown in Fig. 4.
• a length of adhesive strip 58 is fed, for example from a roll, beneath the die, as is indicated by arrow S, so that the cut-out compartments can be positioned and, if necessary, pressed down on the adhesive strip immediately by means of the cutting tools 52.
• the length of adhesive strip 58 can already have been provided with a protective strip 60 provided with a number of rows of openings 59- The transport step with suction cups and the like is then superfluous.
• the essential steps for the method using the installation according to Fig. are as follows: feeding a band of plastic material, filter paper, laminate containing filter paper or filter paper provided with an impermeable coating to a press; pre-forming the compartments using the press; further transporting that section of the band which is provided with pre-formed compartments to a cutting or punching installation; cutting out or punching out the pre-formed compartments from the band using the cutting or punching installation.
• the cut-out or punched-out compartments are placed on the adhesive strip by the cutting or punching installation immediately after cutting out or punching out.
• the cutting or punching installation and press preferably operate simultaneously, in order to increase the production speed.
• test plasters formed in this way can be of any arbitrary shape, for example the shape shown in Fig. 6.
• Fig. 6 shows a diagnostic test plaster known per se from EP 05 ⁇ 0577- Said test plaster consists of a compartment 3 for taking up a diagnostic agent, an adhesive strip 1, on which the compartment 3 is accommodated, as well as a removable protective strip 4 attached to the same side of the adhesive strip 1 as the compartment(s) 3.
• the protective strip 4 being provided with an opening 7 at the location of each compartment, one or more rows of compartments 3 being accommodated on the adhesive strip 1 and the protective strip 4 having a corresponding number of rows of openings 7-
• the compartments 3 are usually, and preferably, provided with a base 5 and a raised edge 6 surrounding the base, the shape of the openings 7 corresponding to the periphery of the edge 6.
• the compartments 3 of the test plaster are usually provided with an absorbent material for taking up liquid, usually filter paper.
• an absorbent material for taking up liquid usually filter paper.
• the compartment is produced as in accordance with the invention.
• the test plaster in Fig. 5 is concerned, reference is also made to European Patent 05 0577. which must be considered to be incorporated herein by reference.
• the present invention has three main embodiments, depending on the material from which the compartments are formed. These embodiments will now be discussed individually: A Compartments formed from plastic
• the compartments are formed by cutting out or punching from a continuous strip of plastic material.
• plastic material any material which is suitable per se can be used, polypropene is preferably used.
• filter paper can then be fitted in the compartments formed in this way, which filter paper, according to a further preferred aspect, is also shaped by punching or cutting out using suitable tools and fitted in the compartments.
• the compartments are formed from a laminate of a plastic and filter paper.
• the plastic used can be any suitable plastic known per se, polypropene preferably being used. Polypropene is preferable because it is inert towards a large number of test substances used and because it is environmentally friendly and easily degradable.
• the laminate is preferably applied to the adhesive strip (1) in such a way that the filter paper forms that side which faces away from the adhesive strip, so that said side is available for taking up the test solutions.
• pressing of the compartments with the formation of the base and raised edge is preferably carried out in such a way that the raised edge thus obtained, which preferably consists of filter paper on the upper surface, is rendered impermeable to the test solution.
• the raised edge thus obtained which preferably consists of filter paper on the upper surface, is rendered impermeable to the test solution.
• the compartments are formed from filter paper which has been coated with an impermeable coating.
• an impermeable coating In general a liquid-impermeable, in particular a water- or alcohol-impermeable or water/alcohol-repellent coating will be used for this.
• the coating used must be inert towards the test substances used and must not dissolve in these substances. Suitable coatings will be apparent to the person skilled in the art; thus polypropene can be considered, for example.
• this coating is applied to that side of the filter paper which faces towards the adhesive strip. In this way that side of the filter paper which faces away from the adhesive strip is still available for absorption of the test solutions.
• a further advantage of this embodiment is that the filter paper can be provided with specific coatings for specific reactive test substances - in particular from the so-called oil series - which react with polypropene compartments or polypropene laminates as described under A and B, or dissolve the polypropene.
• compartments shaped from coated filter paper do not have to be provided with a further material for absorption of the test solution and that coating the filter paper with a water-impermeable or water-repellent coating is generally simple and less expensive than the provision of a polypropene/filter paper material.
• test plasters obtained in accordance with the embodiments B and C described above are novel and constitute further aspects of the invention.
• the invention therefore also relates to a diagnostic test device for the skin, comprising at least one compartment 3 for introduction of a diagnostic agent, an adhesive strip 1 on which the compartment 3 is accommodated, and also a removable protective strip 4 attached to the same side of the adhesive strip 1 as the compartment 3.
• the protective strip 4 being provided with an opening 7 at the location of each compartment, one or more rows of compartments 3 being accommodated on or in the adhesive strip 1 and the protective strip 4 having a corresponding number of rows of openings (that is to say at least one row with at least one opening), characterised in that the compartments 3 are formed from a laminate of filter paper and a plastic material, or filter paper which has been coated with an impermeable coating.
• test plasters are the same as described for the above method.
• the compartments 3 preferably comprise a base 5 and an edge 6 surrounding the base.
• the laminate is preferably a polypropene/filter paper laminate, that side of the compartment which faces away from the adhesive strip 1 preferably being formed by the filter paper.
• the coating is preferably applied to that side of the compartment which faces towards the adhesive strip 1.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Medical Informatics (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
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• Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
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• Investigating Or Analysing Biological Materials (AREA)

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Cited By (2)

Citations (3)

• 1996
  • 1996-01-05 NL NL1002033A patent/NL1002033C2/nl not_active IP Right Cessation
• 1997
  • 1997-01-06 WO PCT/NL1997/000003 patent/WO1997024987A1/nl active Application Filing
  • 1997-01-06 AU AU14004/97A patent/AU1400497A/en not_active Abandoned

Patent Citations (3)

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