WO1997032523A1 - New laminar support applicable to epicutaneous testing - Google Patents

Abstract

New laminar support intented to carry out epicutaneaous tests, the support comprising a lamina or film of transparent and pressure-adhesive material (10) framed by a rigid support (5) provided with marking points (6) where the allergens will be applied, the film (10) being characterized in that it provides for the scarification by means of the lancet (20), it is transpirable (12), porous (4), and also provides for the production of reaction patterns (3), resulting in the new laminar support (10').

Description

 NEW APPLICABLE LAMINAR SUPPORT FOR REALIZATION

OF EPICÜTANEAN TESTS

D E S C R I P C I Ó N

OBJECT OF THE INVENTION

The present specification refers to a patent application for an invention related to a new laminar support, applicable for performing epicutaneous tests, whose obvious purpose is to adequately obtain the diagnosis concerning allergic diseases, using the new support as the element that acts directly on the patient's skin, for the performance of skin tests, against the suspected allergen, substantially facilitating the performance of the tests and also reducing the operations that involve the detection of the allergen that affects the patient proper.

FIELD OF THE INVENTION

This invention has its application within the industry dedicated to the manufacture of auxiliary elements for the diagnosis of allergic diseases, consequently entering the field of medicine.

BACKGROUND OF THE INVENTION

The allergy, in general, affects 10% of the world's population, and it has been found that it increases continuously in developed countries.

HOJADESUSTITUCI _TION (REGLA26) The diagnosis of allergic diseases is based largely on the performance of skin tests, against the suspected allergen.

As is known, the introduction of epicutaneous tests, known as Prick-Test, has greatly facilitated the performance and consequently the obtaining of the relevant results, since it allows to test a large number of allergens in a fast, sensitive way and comfortable for the patient.

The so-called Prick-Tests, are based on scarification, for example with a lancet, through a drop of allergen solution, which is deposited on the skin.

The operation cited above, allows a certain amount of the applied allergen to penetrate the patient's skin, and consequently, cause the allergic reaction.

Currently, the routine performance of the tests cited above, include the following. Namely:

- Skin tightening of the approximate place where each of the allergens to be tested is deposited, normally between 8 and 12 different points are marked for the application of as many different allergens.

- The reading of the reaction corresponding to each of the tested allergens, a reading that is generally done 15 or 20 minutes after scarification, and subsequent deposition of the allergen.

HOJADESUSTITUCI _TION (REGLA26) Both skin tightening, and subsequent reaction reading, mean a waste of time for the technical staff that performs it, and it has been found that in these skin tightening operations, and in the subsequent reading of the reaction, the following disadvantages arise. Namely:

- Skin tightening is dirty and uncomfortable for the patient, since the Be marks are made with a pen or marker, directly on the skin.

- The reading, regardless of being tedious, is inaccurate, since the reaction corresponds to an area and, in the best case, two approximate diameters are taken with a millimeter ruler.

It should be noted that the data of the reading must be subsequently transcribed to a paper, and in no case is there a physical record of the test performed.

The obvious solution to the current problem in this area would be to be able to have a laminar support, which would allow its application to carry out the epicutaneous tests, which was provided with cleanliness and comfort, in order to avoid staining the patient's skin with ink, as well as wasting time during the marking stage.

It would be desirable, in relation to hygiene, to avoid that the tip of the dropper, from which the allergen is applied, preventing it from touching the skin of each patient, making the fact that the dropper could be impossible be contaminated with substances of all kinds, which can

SUBSTITUTE SHEET (RULE 26) be on the skin of patients undergoing the aforementioned test.

It would also be desirable to have an invention that allowed a perfect uniformity in the distribution, when the allergens were deposited in predefined sites, making the tests more uniform for all patients, and consequently there would be a better use of the skin, being able to use this requested uniformity, to be used in order to achieve a design that could be used as a multiple applicator.

It is also required that a facility with respect to the scarification operation be contemplated, since the drop deposited on a sheet of plastic material, with less adhesion capacity for liquids than the skin, adopts a substantially more convex form, which facilitates its location at the time of scarification with the lancet.

Also, the invention should be provided with the possibility of having a specific protection against scratching, since during the waiting time, between scarifying and reading, which, as stated above, ranges between 15 and 20 minutes, It has frequently verified the contamination that is generated between some allergens and others, due to the scratching generated by the pruritus that the allergic realization causes, action that would be totally prevented for its realization, if there were a film or film that together with the greatest efficiency in the elimination of the remaining allergen with blotting paper, given the lower adhesion, it can prevent, or at least lessen this inconvenience.

SUBSTITUTE SHEETS (RULE 26) For the realization of the reading, there is a reaction that is identified as an over-elevation of the skin, in the area of scarification, which would be verified in a comfortable and effective way, by having a film of plastic material that makes said elevation can be identified very well by the greater reflection of light on this material.

As for the graphic record, it should be noted that, when the contours of the reaction area can be drawn on the self-adhesive film, the result of the tests can, once the test has been performed, be fixed in the patient's medical history, being configured accordingly as a graphic and real register.

Finally, it would also be necessary to have an invention that would allow accuracy and automation of the reading, since it would be optimal to be able to quantify the test result, according to its real surface through a simple scanner that would be applied on the graphic record obtained as mentioned above, avoiding the tedious measurement of each test, giving an accurate result, calculated by planimetry.

However, so far, there is no knowledge of the existence of an invention that is endowed with all the characteristics indicated as suitable.

DESCRIPTION OF THE INVENTION

The new laminar support applicable for the realization of epicutaneous tests that the invention proposes, constitutes by itself only an evident novelty within the field of application of the same, gathering in its

SUBSTITUTE SHEETS (RULE 26) general context all the characteristics mentioned above as suitable.

More specifically, the new laminar support applicable for performing epicutaneous tests object of the invention, is constituted from a sheet of plastic material, disposable, constituted as a film, of a substantially reduced thickness, allowing to make the scarification operation by using a lancet, and having the relevant flexibility so that the allergic reaction is not inhibited.

At the same time, the invention is configured from a porous material, in order to allow perspiration, and at the same time, the drawing of the reaction perimeter.

The invention has a body that acts as a frame, whereby the sheet or film is framed in a rigid support that allows BU removal from the skin, without losing its integrity at any time, serving this rigid support to label, at the factory, the points of application of the allergens, an application that would not allow at any time a contact of the storyteller or similar, by means of which the application of the allergens is carried out, with the patient's skin.

DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, a descriptive sheet is attached as an integral part thereof, with an illustrious character in which

SUBSTITUTE SHEETS (RULE 26) tractive and not limiting, the following has been represented:

Figure number 1.- Shows a diagram, in which the different elements and characteristics thereof have been represented, which result in the obtaining and physical configuration of a new laminar support applicable for performing epicutaneous tests.

Figure number 2.- Shows a plan view of the new laminar support itself by the anterior zone.

Figure number 3.- Corresponds to a plan view of the object represented in figure number 2 seen by the rear or back area, coated with adhesive for direct application on the patient.

Figure number 4.- Corresponds to a sectional view of the object represented in figures numbers 2 and 3.

PREFERRED EMBODIMENT OF THE INVENTION

In view of the number 1 and unique figure, it can be seen how the new laminar support applicable for performing epicutaneous tests is constituted from a transparent and self-adhesive sheet or film

(10), qualified to perform on it, the relevant scarification (1), by means of a lancet (20), with the quality that the transparent and self-adhesive film (10) is breathable (2), and at at the same time, allow the realization of drawings (3), as well as being porous (4), provided that the transparent and self-adhesive film (10) endowed with the characteristics (1),

SUBSTITUTE SHEETS (RULE 26) (2), (3) and (4), is incorporated on a rigid support (5), which is capable of allowing the labeling of the allergen application points (6), labeling that would be carried out at the factory, giving as result the union of the characteristics (1), (2), (3) and (4), with the applications of the elements (5) and (6), all located on the transparent and self-adhesive film (10), to achieve the configuration of a test (10 ') that configures the new laminar support object of the invention.

It should be noted that the adhesive coating has been referenced with (11)

It is not considered necessary to make this description more extensive so that any person skilled in the art understands the scope of the invention and the advantages derived therefrom.

The materials, shape, size and arrangement of the elements will be susceptible to variation, as long as this does not imply an alteration to the essentiality of the invention.

The terms in which this report has been described should always be taken broadly and not limitatively.

SUBSTITUTE SHEET (RULE 26)

Claims

1.- New laminar support, applicable for performing epicutaneous tests, of those intended to facilitate the diagnosis of allergic diseases, being used to perform skin tests against the suspected allergen, characterized by being constituted from a sheet or film of transparent and self-adhesive plastic material (10), which is framed in a rigid support (5), which is equipped with the application points (6) of the allergens, configuring all three elements, film trans ¬ parente (10), support (5) and labeling points (6), such as the new laminar support (10 '). 2.- New laminar support, applicable for performing epicutaneous tests, according to the first claim, characterized in that the transparent and self-adhesive film (10), is capable of allowing scarification (1), by means of lancets (20), being breathable (2), flexible and porous (4), allowing drawings to be made (3), on the perimeter of the embodiment. SUBSTITUTE SHEET (RULE 26) AMENDED CLAIMS [receiv _b i _d as by the International Bureau on August 1, 1997 ^{(1/8/97) *} claim 1 as amended; another claim does not change (1 page ⁾ ] 1. -New laminar support, applicable for performing epicutaneous tests, of those intended to facilitate the diagnosis of allergic diseases, which stand between the suspected allergen of those normally used for this type of tests and the skin, in order to prevent the allergen from being in contact with it before and after scarification with standardized lancets, following the procedure normally used called "Prick Test" on bare skin, characterized in that the laminar support is constituted by a thin transparent, flexible self-adhesive membrane and fully integrates (10), which must be perforated, together with the skin, by the lancet in the place where the allergen used in these tests is deposited, preventing that once the puncture is performed it continues its contact with the skin, and by Both its penetration. Said membrane (10), has a slightly adhesive surface on its back (11), and is framed in a rigid charcoal support (5) on its obverse, in order to avoid deformation, facilitate its application to the skin and also the of the different allergens, by delimiting different areas of application within the membrane itself, giving rise to the new laminar support (10 ").