Abstract
An allergy test device for applying a liquid medium onto or into the skin, having a film with a flat part for placing on the skin and with at least one part which is spaced apart from the skin during use and has a container for receiving the liquid medium, wherein each container of each spaced-apart part has at least one closable opening. Each spaced-apart part is designed to be deformable in the direction of the flat part of the film, and a valve is arranged movably in the at least one opening of each container, wherein the opening of the container is sealed off in a closure position of the valve, and, upon deformation of the spaced-apart part, the valve is at least partially opened in a position deviating from the closure position.
Claims
1-20. (canceled)
21. An allergy test device for applying a liquid medium onto or into skin, comprising: a film with a flat part for laying on the skin and at least one spaced part spaced apart from the skin during use; and a container for receiving the liquid medium associated with the at least one spaced part; wherein the container of the at least one part has at least one closable opening; wherein the at least one spaced part is deformable in a direction of a flat part of the film and a valve is slidably arranged in the at least one closable opening; and wherein the at least one closable opening is sealed in a closed position of the valve and the valve is at least partly opened in a position deviating from the closed position when the at least one spaced part is deformed.
22. The allergy test device according to claim 21, wherein the container is integral with the at least one spaced part of the film.
23. The allergy test device according to claim 22, further comprising a filling opening for filling the container with the liquid medium arranged in the at least one spaced part.
24. The allergy test device according to claim 23, wherein the filling opening is configured to be closed with a lid.
25. The allergy test device according to claim 21, wherein the container is formed by a cup connected to the at least one spaced part of the film.
26. The allergy test device according to claim 21, wherein the at least one spaced part of the film or the entire film is elastically deformable.
27. The allergy test device according to claim 26, wherein the film is made of one of thermoplastic synthetic material and silicone.
28. The allergy test device according to claim 21, wherein the at least one spaced part is formed by a protuberance of the film, so that during use a cavity is formed between the film and the skin.
29. The allergy test device according to claim 28, wherein the cavity formed during use is a closed cavity.
30. The allergy test device according to claim 28, wherein a vent hole is arranged in the protuberance.
31. The allergy test device according to claim 21, further comprising at least one pointed or sharp element for local and superficial injury to the skin on at least one of a side of the container and the valve facing the skin during use.
32. The allergy test device according to claim 31, where the at least one pointed or sharp element is made in one piece with at least one of the container and the valve.
33. The allergy test device according to claim 21, wherein: the valve comprises a substantially cylindrical body with at least one channel; the cylindrical body in the closed position of the valve sealing the at least one closable opening of the container; and the cylindrical body in a position deviating from the closed position opening at least one channel to the container.
34. The allergy test device according to claim 33, wherein the at least one channel runs inside the cylindrical body with a connection to the at least one closable opening on a lateral surface of the cylindrical body.
35. The allergy test device according to claim 33, wherein the at least one channel runs on a surface of the cylindrical body.
36. The allergy test device according to claim 33, wherein a sealing lip for sealing the at least one closable opening of the container in the closed position is integrated on the cylindrical body.
37. The allergy test device according to claim 21, further comprising an adhesive film with a peel-off film on a side of the flat part of the film facing the skin during use.
38. The allergy test device according to claim 21, wherein several spaced parts of a film are arranged in at least two rows.
39. The allergy test device according to claim 38, wherein a number of the spaced parts of the film in each row is different.
40. The allergy test device according to claim 21, wherein an identification is arranged on an outside of at least one of the at least one spaced part.
41. The allergy test device according to claim 21, wherein the film is formed at least partly from transparent material.
42. The allergy test device according to claim 21, further comprising a transport lock having substantially cylindrical elements, the transport lock being arranged on an underside of the film for enclosing the container and the valves in the at least one spaced part.
43. The allergy test device according to claim 37, wherein a ruler is arranged on the transport lock for measuring allergic reactions on the skin.
44. The allergy test device according to claim 43, wherein the ruler comprises semi-circular recesses.
45. The allergy test device according to claim 21, wherein sterile packaging is provided.
46. The allergy test device according to claim 28, wherein at least one of the film, the container, the valve and the at least one pointed or sharp element is one of at least partly formed from a biocompatible material and at least partly coated with a biocompatible coating.
47. The allergy test device according to claim 46, wherein at least one of the film, the container, the valve, and the at least one pointed or sharp element is one of: at least partly formed from polyether ether ketone (PEEK), and at least partly coated with a parylene coating.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0037] The invention is explained in more detail with reference to the attached drawings. These show:
[0038] FIG. 1Aa schematic representation of the principle of the allergy test device according to the invention in a sectional side view in the closed position of the valve, in which the opening of the container is sealed;
[0039] FIG. 1Bthe allergy test device according to FIG. 1A in a position that deviates from the closed position of the valve, in which the opening of the container for releasing the liquid medium is at least partly opened;
[0040] FIG. 2a sectional view through an embodiment of the allergy test device according to the invention with a container integrated with the film;
[0041] FIG. 3Aa sectional view through a further embodiment of the allergy test device according to the invention in the closed position of the valve;
[0042] FIG. 3Bthe allergy test device according to FIG. 3A in a position for releasing the liquid medium that deviates from the closed position of the valve;
[0043] FIG. 4Aa sectional view through a further embodiment of the allergy test device according to the invention in the closed position of the valve;
[0044] FIG. 4Bthe allergy test device according to FIG. 4A in a position for releasing the liquid medium that deviates from the closed position of the valve;
[0045] FIG. 5a perspective view of a transport lock with an integrated ruler for measuring the allergic reaction;
[0046] FIG. 6a sectional view through a variant of the allergy test device with a transport safety device arranged thereon;
[0047] FIG. 7a detail VII from FIG. 6 in magnification;
[0048] FIG. 8a perspective plan view of an embodiment of an allergy test device according to the invention from above; and
[0049] FIG. 9a perspective view of an allergy test device arranged in packaging.
DETAILED DESCRIPTION
[0050] FIG. 1A shows a schematic representation of the principle of the allergy test device 1 according to the invention for applying a liquid medium M onto or into the skin H of a patient or subject. The allergy test device 1 has a film 2 with a flat part 3 for resting on the skin H and a part 4 spaced apart from the skin H during use. The film 2 can be formed at least partly from transparent material, for example from transparent thermoplastic synthetic material or transparent silicone. Each spaced part 4 of the film 2 has a container 5 for receiving the liquid medium M, the allergic reaction to which is to be tested. The medium M can also be viscous or in the form of a paste or gel. Each container 5 in the spaced part 4 has at least one closable opening 6 through which the liquid medium M can be applied to the skin H or introduced into the skin H. The flat part 3 of the film 2 can be fixed on the surface of the skin H with an adhesive or an adhesive film (not shown). According to the invention, each spaced part 4 is designed to be deformable in the direction of the flat part 3 of the film 2. A valve 7 is slidably arranged in the at least one opening 6 of each container 5. In FIG. 1A, the valve 7 is in its closed position, in which the opening 6 of the container 5 is sealed and the liquid medium M is prevented from escaping from the container 5.
[0051] If, according to FIG. 1B, a deformation of the spaced part 4 and of the container 5 is caused by the application of a force F to the spaced part 4 of the film 2, the valve 7 is brought into a position deviating from the closed position according to FIG. 1A as soon as it is present on the surface of the skin H and is thereby displaced into the interior of the container 5. The displacement of the valve 7 opens the opening 6 of the container 5 at least partly, whereby the liquid medium can escape from the container 5 onto the surface of the skin H. In the illustrated schematic example, the valve 7 is formed by a frustum-shaped plug, which opens an annular gap between the valve 7 and the opening 6 when it is moved out of the closed position, through which the liquid medium M can escape from the container 5. When the force F is removed, the spaced part 4 of the film 2 preferably returns to the original shape shown in FIG. 1A. For this purpose, at least the spaced part 4 of the film 2, preferably the entire film 2, is made of elastically deformable material. This prevents components of the allergy test device 1, such as the valve 7, from resting on the surface of the skin H and preventing or influencing the allergic reaction to the liquid medium M.
[0052] Such an allergy test device 1 can be manufactured relatively easily, preferably from suitable plastics by injection molding. The arrangement of the valve 7 in the opening 6 of the container 5 with the liquid medium M can result in a defined opening of at least part of the opening 6 of the container 5 when pressure is applied to the spaced part 4 of the film 2 in the direction of the surface of the skin H, and thus a safe application of the liquid medium M to the skin surface can be achieved. In the illustrated variant according to FIGS. 1A and 1B, the container 5 is integrated with the film 2 or the spaced part 4 of the film 2 and is manufactured with it in one piece. Here, the spaced part 4 is formed by a protuberance 11 of the film 2, so that when the allergy test device 1 is used, a preferably closed cavity 12 to the skin H is formed. However, the spaced part 4 of the film 2 does not necessarily have to be closed.
[0053] FIG. 2 shows a sectional view through another embodiment of the allergy test device 1 according to the invention with a container 5 integrated with the film 2. The spaced part 4 of the film is also formed here as a protuberance 11, whereby a closed cavity 12 to the skin surface forms. The container 5 is formed as a cup from the spaced part 4 of the film 2 and has a filling opening 8 which can be closed with a lid 9 for filling the container 5 with the liquid medium M. In the spaced part 4 of the film 2 or in the protuberance 11, a vent hole 13, possibly with a ventilation valve (not shown), can also be provided. The valve 7 is formed by an essentially cylindrical body 15 having a channel 16 running in it (see FIGS. 4A and 4B). On the side of the valve 7 that faces the skin H during use, pointed or sharp elements 14 are provided for local and superficial injury to the skin H, which are preferably produced in one piece with the valve 7. An adhesive film 18 with a peel-off film 19 can be arranged on the side of the flat part 3 of the film 2 that faces the skin H during use, as indicated schematically.
[0054] FIG. 3A shows a sectional view through a further embodiment of the allergy test device 1 according to the invention with the valve 7 in the closed position. Here the container 5 is formed by an independent body essentially in the form of a cup 10 and is connected appropriately tightly to the spaced part 4 of the film or the protuberance 11, for example by gluing. In the opening 6 of the container 5, a valve 7 is arranged, which is formed by an essentially cylindrical body 15 with channels 16 on the surface of the cylindrical body 15. These channels on the surface of the cylindrical body 15 forming the valve 7 can be formed by one or several axial grooves. In the closed position of the valve 7, the opening 6 of the container 5 is sealed by an extension of the diameter of the cylindrical body 15. In addition or as an alternative to this, a sealing lip 17 can also be arranged at the upper end of the cylindrical body 15 facing away from the skin H, which sealing lip can be easily produced in particular in an injection molding process.
[0055] If, according to FIG. 3B, the valve 7 is moved out of the closed position according to FIG. 3A by deformation of the spaced part 4 of the film 2, the channels 16 on the outside of the cylindrical body 15 of the valve 7 are opened and the liquid medium can run from the container 5 onto the surface of the skin H. Pointed or sharp elements 14, which serve to puncture or score the skin H, can be arranged on the side of the container 5 facing the skin H. The pointed or sharp elements 14 are preferably integral with the container 5 and manufactured in one piece with it.
[0056] FIG. 4A shows a sectional view through a further embodiment of the allergy test device 1 according to the invention with the valve 7 in the closed position. In contrast to the embodiment according to FIGS. 3A and 3B, the valve 7 is formed by an essentially cylindrical body 15 with a channel 16 inside the cylindrical body 15 with a connection to at least one opening 16 on the lateral surface of the cylindrical body 15. Pointed or sharp elements 14 are arranged on the side of the valve 7 facing the skin H and are preferably made in one piece with the valve 7. In addition, in this exemplary embodiment, a lyophilisate L (for example, a freeze-dried allergen) is arranged in the channel 16 inside the cylindrical body 15, which is mixed with the liquid medium M and thereby activated when the valve 7 is moved out of the closed position (see FIG. 4B). The lyophilisate L can be preformed, pressed, chemically/physically bound or encapsulated. Instead of a preformed plug of the lyophilisate L, coating the inner wall of the channel 16 or other suitable points of the allergy test device 1 with the lyophilisate L is also conceivable (not shown).
[0057] If according to FIG. 4B the valve 7 is moved out of the closed position according to FIG. 4A by deformation of the spaced part 4 of the film 2, the openings 16 on the lateral surface of the cylindrical body 15 of the valve 7 are opened and the liquid medium can run from the container 5 through the openings 16 to enter the channel 16 running inside the cylindrical body 15, where the liquid medium M is mixed with the lyophilisate L. To support the mixing of the liquid medium M with the lyophilisate L, moldings 25 can be arranged on the inner wall of the cylindrical body 15. The mixture of the liquid medium M with the lyophilisate L then reaches the skin H or penetrates the skin H. The pointed or sharp elements 14 for puncturing or scoring the skin H are arranged on the side of the valve 7 facing the skin H.
[0058] FIG. 5 shows a perspective view of a transport lock 20 for the allergy test device 1. The transport lock 20 has essentially cylindrical elements 21 placed according to the number and arrangement of the spaced parts 4 or protuberances 11 of the allergy test device 1, which are designed to be arranged on the underside of the film 2 for enclosing the containers 5 and valves 7 in the spaced parts 4 of the allergy test device 1 (see FIGS. 6 and 7). A ruler 22, preferably with semi-circular recesses 23 of different diameters, can be arranged on the transport lock 20 for measuring allergic reactions on the skin H. The respective diameters of the semi-circular recesses 23 can be printed to facilitate determination of the size of the weals of the allergic reaction.
[0059] FIG. 6 shows a sectional view through a variant of the allergy test device 1 with the transport lock 20 according to FIG. 5 arranged thereon.
[0060] FIG. 7 shows detail VII from FIG. 6 in magnification. The essentially cylindrical elements 21 protrude into the protuberances 11 of the film 2 and surround the underside of the container 5 located therein with the valves 7 slidably arranged in the opening 6. Because the spaced part 4 of the film rests on the free end of the cylindrical element 21, deformation of the spaced part 4 and hence unintentional displacement of the valve 7 from the closed position is prevented. Thus, unintentional outflow of the liquid medium M from the container can be effectively prevented. Before the allergy test is carried out, the transport lock 20 is detached from the allergy test device 1, whereby deformation of the spaced parts 4 of the film 2 for releasing the liquid media M onto the skin H is made possible. The transport lock 20 can simply be plugged onto the allergy test device 1 or it can also be attached to the flat part 3 of the film 2 with adhesive bonds.
[0061] FIG. 8 shows a perspective plan view of an embodiment of an allergy test device 1 according to the invention from above. In this case, several spaced parts 4 of the film 2 or protuberances 11 are arranged in two rows R.sub.1 and R.sub.2. The number n.sub.1 and n.sub.2 of the protuberances 11 in each row R.sub.1 and R.sub.2 is deliberately designed to be different in order to permit easier and unambiguous assignment of the respective liquid media M and to facilitate the diagnosis of the allergy test. In the exemplary embodiment shown, six (n.sub.1=6) spaced parts 4 with six containers 5 for six different liquid media M, i.e. six different allergy tests, are arranged in the first row R.sub.1, while five (n.sub.2=5) spaced parts 4 with five containers 5 for five liquid media M, i.e. five different allergy tests, are arranged in the second row R.sub.2. Overall, the allergic reaction to eleven different substances can be tested simultaneously with this allergy test device 1, or at least to nine different substances if two containers 5 are reserved for a positive control with histamine and a negative control free of active ingredient.
[0062] An identification Id, for example a number or a letter, can be arranged on the upper side of the protuberances 11 for clear assignment, or a labeling field can be placed.
[0063] FIG. 9 shows a perspective view of an allergy test device 1 arranged in packaging 24. In the example shown, the allergy test device 1 with the transport lock 20 arranged on it can be seen from below. The packaging 24 is preferably at least partly transparent to make it possible to view the allergy test device 1. The allergy test device 1 can be sterilized before it is placed in the packaging 24 or afterwards using common sterilization methods.
[0064] The individual components of the allergy test device 1, such as the film 2, the containers 5, the valves 7 and/or the pointed or sharp elements 14 are preferably made of biocompatible material, for example polyether ether ketone (PEEK), or are coated with a biocompatible coating, for example, a parylene coating.
