Single-use device for stabilizing the eyeball, indicating the intravitreal injection site and sampling vitreous reflux

Abstract

The invention concerns a disposable auxiliary device for stabilizing the eyeball of a patient, indicating the optimal site for intravitreal injection and sampling of vitreous reflux, and the related kit. The device consists of an elongated main body (1), with an intermediate portion (4) as a handle and a distal portion (2) ending with a ring element (5), lying on a plane inclined from about 30° to about 45° with respect to the plane on which the patient must be positioned. The distal portion (2) also comprises a longitudinal guide element (8), for the insertion and retention of a strip or membrane of absorbent and reactive material, the length of which exceeds the terminal part of the longitudinal guide element (8), so as to be able to absorb the vitreous reflux generated by the retraction of the needle with which the intravitreal injection is performed and react with the vitreous reflux, as well as being able to indicate the optimal point in which the intravitreal injection must be performed.

Description

[0001] SINGLE-USE DEVICE FOR STABILIZING THE EYEBALL, INDICATING THE INTRAVITREAL INJECTION SITE AND SAMPLING VITREOUS REFLUX

[0002] DESCRIPTION

[0003] Field of the invention

[0004] The present invention relates to a disposable device that stabilizes the eyeball for intravitreal injection, indicates the injection site, and simultaneously samples vitreous reflux. More specifically, the invention concerns an auxiliary device that the surgeon, when performing an intraocular injection, can hold with the hand not performing the injection, for the purpose of immobilizing the eyeball in the primary position (i.e., looking straight up when the patient is supine) and indicating the optimal point for needle insertion. At the same time, the device allows the drop of vitreous reflux generated by the needle withdrawal to be collected and its content of one or more molecules of interest to be immediately determined.

[0005] Background of the invention

[0006] Intraocular injection of drugs and molecules of various nature into the eyeball has become common practice in the treatment of a number of widespread diseases, such as age-related macular degeneration, macular edema, some infectious retinitis, and some tumors, to name just the most common.

[0007] Drug administration sites within the eyeball are primarily the anterior chamber and the vitreous cavity, although suprachoroidal injection routes are also used, albeit less frequently. The advantage of intraocular injections is twofold: the ability to deliver therapeutic doses to a very confined site and thus achieve effective concentrations with small amounts of drug, and the ability to cross the blood-retinal barrier, which effectively limits the access of molecules from the bloodstream to the anterior and vitreous chambers. The vitreous chamber represents the largest volume of the eye, approximately 4 cc, filled with vitreous humor and bounded by the retina posteriorly and the crystalline lens and pars plana anteriorly. Many retinal and choroidal diseases, such as age-related macular degeneration or macular edema, benefit from direct drug injection into the vitreous chamber due to the resulting high bioavailability of the drug. At the same time, the abundance of proteins present in the vitreous chamber can provide important information on the health and progression of many diseases, as well as on the effectiveness of applied pharmacological treatments.

[0008] Intravitreal injection is performed with small-gauge needles (typically 30G) and must be administered in a very specific region of the eye, represented by an annular band called the pars plana, extending approximately 1 .5-3.0 mm from the corneoscleral limbus, the junction between the cornea and the sclera. The injection is administered under topical anesthesia only, with anesthetic drops instilled a few minutes beforehand and the patient positioned supine.

[0009] Currently, millions of intravitreal injections are performed annually worldwide, and it is very important that the eye be stabilized in the primary position during this procedure to ensure precise, safe, and repeatable injections. Various devices exist to stabilize the eye in the primary position, allowing for the injection, some even allowing the eyelids to be held open at the same time.

[0010] Examples of such auxiliary devices are disclosed, in particular, in the publication by Andrew Beers “Help for Intravitreal Injections” in Review of Ophthalmology, of September 10, 2023 (https: / / www.reviewofophthalmology.com / article / help-for-intravitreal-injections) and, more specifically, for instance, in the published patent application US 2014 / 0371723 A1 (Dennis P. Han e Ravi Shankar Singh) and in the article by Ahmed, I. et al. in European Journal of Ophthalmology (1 -6, 2021 , DOI: 10.1 177 / 1 120672121 1060947). The first publication describes the device referred to in Beers' article as the Rapid Access Vitreal Injection (RAVI) Guide, a guiding device for stabilizing an intraocular injection site. The device comprises, on the distal portion of a handle element, a substantially quadrangular perforated plate of appropriate size, designed to rest on the corneal surface. The flanges are configured to secure the ocular structure and maintain a distance between the lower palpebral fissure, while the hole indicates the position where the needle should be inserted for intravitreal injection.

[0011] The article by Ibrar Ahmed et al. cited above discloses the device referred to in Beers' publication as Precivia. It is a disposable device made of transparent plastic, consisting of a tubular body essentially shaped like a truncated cone, tapered downwards, with a circular lower flange designed to rest on the corneal surface at the limbus, from which a guide tube for the syringe branches off. This tubular body is angled at 28°with respect to the main tubular body, allowing the syringe to be inserted at the correct distance from the limbus at the correct angle, and penetrating the needle to the correct depth to inject the drug into the vitreous chamber.

[0012] Another device to be used as an aid to facilitate the performance of an intraocular injection is described in US patent 9693893 B2 (Coroneo). The document concerns a device to be used during the intraocular injection procedure, comprising an elongated main body, with a handle portion and a portion in contact with the surface of the eye at the distal end, in which the portion in contact with the surface of the eye has the shape of a ring lying on a plane inclined with respect to the handle (at an angle between 105° and 150°), interrupted by the part diametrically opposite to the part connecting to the handle. Inside the arc of the ring there is a straight portion bearing a graduated scale, such that when the device is placed on the sclera at the edge of the corneoscleral limbus, and tangent to it, the graduation indicates the distance in mm from the limbus, thus indicating to the surgeon the right position to perform the injection.

[0013] It is known that when a needle penetrates the eye to inject a drug, the increase in intraocular pressure due to the volume of the drug and the presence of a small breach in the scleral wall cause the prolapse (reflux) of a very small amount of fluid, which consists essentially of vitreous humor (Brodie FL, Ruggiero J, Ghodasra DH, Eftekhari K, Hui JZ, Brucker AJ, VanderBeek BL, A novel method for the measurement of reflux from intravitreal injections: data from 20 porcine eyes, Curr Eye Res. 2014 Jul; 39(7):752-7). The droplet of vitreous hu- mor emerging on the scleral surface during intravitreal injection could be collected and analyzed, for example, using proteomic methods to determine the presence and quantities of many molecules in the vitreous, including biochemical and / or molecular markers, drugs, metabolites, and proteins.

[0014] The idea of analyzing the reflux droplet caused by intravitreal injection was explored further by the research group led by the authors of this invention, who published a first article on the topic in 2016. (Cacciamani A, Parravano M, Scarinci F, Esposito G, Varano M, Micera A, A Simple Spontaneous Vitreal Reflux Collecting Procedure During Intravitreal Injection: Set-Up and Validation Studies, Curr Eye Res. 2016 Jul; 41 (7):971 -6).

[0015] Several subsequent publications have analyzed the reflux droplet that escapes from the sclera following intravitreal injection, using different collection media such as absorbent paper, micropipettes, or glass capillaries, and then transferring the collected material using various techniques. In each case, the analysis is then carried out in a laboratory, and the result is obtained at a later time, and not at the same operating site (see, for example, Cacciamani A, Esposito G, Scarinci F, Parravano M, Dinice L, Di Nicola M, Micera A, Inflammatory mediators in the vitreal reflux of patients with diabetic macular edema, Graefes Arch Clin Exp Ophthalmol. 2019 Jan; 257(1 ):187-197).

[0016] A device specifically designed to combine intravitreal injection with vitreous humor sampling is disclosed in US Patent 1 1806277 B2 (Tumlinson et al., assignee: Twenty Twenty Therapeutics LLC). However, this device is not an auxiliary device to be used in conjunction with the syringe used for intravitreal injection, but rather a true injection device equipped with a needle that performs both the actions of injecting the drug into the vitreous and withdrawing from it, through actual aspiration, a significant amount of vitreous humor, which must then be analyzed separately. The device comprises a first chamber for the liquid to be injected using a primary needle and a second chamber, separate and adjacent to the first one, designed to receive the vitreous sample aspirated through a hypodermic needle. In this case, too, the vitreous sample collected is intended to be analyzed separately. Furthermore, in this case, the proposed device has no auxiliary function in immobilizing the eyeball, nor in facilitating the surgeon's maneuver by indicating the ideal point for administering the injection.

[0017] The Chinese patent publication CN 1 13749850 B discloses a disposable auxiliary device for use in stabilizing a patient’s eyeball, configured to indicate the optimal point for needle insertion in an intravitreal injection. The device consists of an elongated main body, held like a pen, with an intermediate grip portion and a distal portion terminating in a ring element, with a diameter of approximately 12 mm and lying on a plane inclined from approximately 30° to approximately 45° with respect to the plane on which the patient is to be positioned. This device is not designed to collect vitreous humor samples.

[0018] Finally, patent documents CN 1 10801343 A, CN 217566538 U, US 10667944 B2, and CN 1 13952109 A disclose further devices for stabilizing the eye during an ophthalmic surgery procedure that are not designed to collect vitreous humor samples. Considering the prior art described, it is evident that it would be extremely advantageous to have an auxiliary device that not only stabilizes the eyeball and indicates the optimal site for intravitreal injection but also performs an in-situ determination of molecules present in the vitreous reflux.

[0019] Summary of the invention

[0020] The object of this invention is, therefore, to provide a device that the surgeon can hold with the non-dominant hand, which allows, during the operation, not only to stabilize the eye in the primary position and indicate the point at which the injection is to be performed, like already known devices of this type, but also, at the same time, allows to collect the vitreous reflux by directly indicating, and without transferring material, its content of one or more target molecules (markers).

[0021] To this end, it is proposed, according to the present invention, to provide a device consisting of an elongated main body, similar in shape and size to a pen, with an intermediate portion shaped or variously provided with elements in relief designed to provide a non-slip and / or ergonomic grip, and configured to be held similarly to a pen, at an angle of approximately 30°-45°with respect to the horizontal plane on which the patient lies, supine and with the eye in the primary position, and a distal portion ending with a ring element fixed at an angle such as to be horizontal when positioned on the eye of the supine patient. The ring element has a diameter corresponding to the size of the corneoscleral limbus, i.e., approximately 12 mm, and is fixed to the main body via one or more connecting rods, so as to be able to perform the function of stabilizing the eyeball in the primary position when resting on the patient’s eye at the limbus. According to the present invention, the terminal portion of the device is also equipped with a guide for the insertion and retention of a strip or membrane of absorbent and reactive material, such as blotting paper or similar material. In use, the terminal portion of the absorbent and reactive strip housed in the guide exceeds the terminal edge of the device by approximately 4 mm, and in addition to indicating, preferably at approximately 3 mm, the point at which the surgeon should perform the injection (with the other hand), it is designed in such a way as to be able to absorb the vitreous reflux occurring after the needle is withdrawn, and react with it to indicate analytical results.

[0022] Specifically, the absorbent strip is suitably treated to react, indicating the presence of one or more desired molecules in the vitreous reflux, for example by turning toward predetermined colors using colorimetric materials. The strip, soaked in vitreous reflux, can thus indicate the presence and concentration of one or more target molecules or markers.

[0023] The use of the auxiliary device according to the invention, therefore, requires the surgeon to hold it in a manner similar to a pen, with the hand opposite the one holding the syringe containing the drug to be injected. The patient is positioned supine, and the device is placed on the corneoscleral limbus, with the 12 mm diameter circular element precisely sized for the limbus. In this way, the eye is stabilized, and the patient’s gaze movements are neutralized. The strip of absorbent material extending 4 mm beyond the device at the distal end also marks a point 3 mm from the edge of the limbus, which is the ideal injection site. This corresponds to the pars plana ciliaris, the band of tissue between the anterior portion of the retina (ora serrata) and the ciliary body. This band represents the ideal site for minimizing the risks of intraocular injection.

[0024] As soon as the desired drug is injected, the needle is withdrawn and the vitreous reflux that spontaneously escapes is absorbed by the strip of absorbent material. The capillary action transports the fluid along the strip until it comes into contact with the antibody-colorimetric system (or similar) contained therein. Said system, changing color, shows the presence of the target molecule through a reaction, and by changing in color intensity, using appropriate support scales and additional software, the concentration of the target molecule can be detected.

[0025] Brief description of the drawings

[0026] The specific features of the invention, as well as its advantages, will become more evident with reference to some of its preferred embodiments, illustrated in the accompanying figures, in which:

[0027] Figures 1 and 2 show two perspective views from two different angles of a specific embodiment of the disposable auxiliary device according to the present invention;

[0028] Figures 3A, 3B, and 3C show, respectively, orthogonal top view, bottom view, and side view in the operating position of the same device as in Figures 1 and 2;

[0029] Figure 4 shows an enlarged perspective view of the front portion of the same device as in the previous figures;

[0030] Figure 5 shows an enlarged perspective view of the front portion of the same device of Figures 1 -4, complete with a strip of absorbent indicator material which, included in a kit with the device, forms a second embodiment of the device of the present invention;

[0031] Figure 6 shows an enlarged orthogonal view of the anterior portion of the same device as Figures 1 -4, complete with a different strip of absorbent indicator material, which, included in a kit with the device itself, forms a third embodiment of the device of the present invention; and

[0032] Figure 7 shows a schematic partial view of the device according to the invention with a strip of absorbent indicator material inserted, resting on the patient’s eye while the intravitreal injection is performed. Detailed description of the invention

[0033] The specific object of this invention is therefore a disposable auxiliary device for stabilizing a patient’s eyeball, indicating the optimal site for intravitreal injection and sampling vitreous reflux, said device consisting of: an elongated main body (1 ), similar in size to a pen and configured to be held in a pen-like manner, said main body having an intermediate handle portion (4) equipped with one or more peripheral grip elements, and a distal portion ending with a ring element (5), having an internal diameter of approximately 12 mm, corresponding to the corneoscleral limbus and lying on a plane inclined from approximately 30° to approximately 45° with respect to the plane on which said patient must be positioned, wherein said distal portion further comprises a longitudinal guide element (8) with parallel edges, configured to receive and hold in position a strip or membrane (3) of absorbent and reactive material, said strip or membrane exceeding the terminal part of said longitudinal guide element by approximately 4-4.5 mm, so as to be able to absorb a vitreous reflux generated by the retraction of the needle with which said intravitreal injection is performed, as well as to indicate the optimal point at which the intravitreal injection must be performed.

[0034] Preferably, the peripheral grip elements on the intermediate portion of the handle are elements in relief for an ergonomic, non-slip grip, such as a series of transverse grooves around the intermediate portion of the handle, or a series of raised transverse collars around said intermediate portion, possibly made of a different, softer and more resilient material than that used for said elongated main body.

[0035] According to a preferred embodiment of the disposable device of the invention, the ring element of the distal portion is fixed to the main body via one or more connecting rods (6). In a further preferred embodiment, the ring element is fixed to the main body of the device via two connecting rods, provided on the ring in diametrically opposed positions and aligned along the longitudinal axis of the device. These two connecting rods are of different lengths, so as to keep the ring on a plane inclined from approximately 30° to approximately 45° with respect to the plane on which the patient is to be positioned. In particular, the connecting rod located at the distal end of the device can be reduced to a simple welding point.

[0036] Preferably, the elongated main body of the device of the invention has a length of approximately 12-15 cm and a circular or elliptical cross-section. Its cross-section may be, for example, circular or elliptical and preferably have a diameter or axes between approximately 8 and 15 mm.

[0037] According to some preferred embodiments, the ring element may have a quadrangular cross-section with sides between 1 and 3 mm, or a circular or elliptical cross-section, with diameters or axes varying between approximately 1 and 3 mm.

[0038] According to another aspect, the present invention concerns a disposable auxiliary kit for stabilizing a patient’s eyeball, indicating the optimal site for intravitreal injection, and sampling vitreous reflux, the kit consisting of: a) a disposable auxiliary device as defined above, and b) one or more strips or membranes (3) of absorbent and reactive material, each having a width corresponding to the internal width of the parallel- edged guide element and configured to exceed the terminal part of the longitudinal guide element by approximately 4 mm, so as to be able to absorb vitreous reflux. Furthermore, the strip is provided with a marking or a hole approximately 1 -1 .5 mm from the terminal edge of the strip itself, to indicate the optimal point at which the intravitreal injection should be performed, which will be between 3 and 4 mm from the corneoscleral limbus.

[0039] In a preferred embodiment, the one or more strips of absorbent and reactive material have the shape of a rectangle with a circular end whose diameter is greater than the width of the strip itself. The central point of this circular bulbous portion, possibly perforated, will be positioned, when the strip of absorbent and reactive material is inserted into the device, at the optimal point where the intravitreal injection must be performed, i.e., 3-4 mm from the edge of the ring element.

[0040] According to preferred embodiments of the kit of the invention, the one or more strips or membranes (3) of absorbent and reactive material, shown in Figures 5 and 6, contain an antibody-colorimetric system, and are selected from strips of blotting paper, nitrocellulose, or hydrophilic PTFE. They preferably have a protein band and two analytical bands for the colorimetric detection of the relevant marker.

[0041] Exemplary embodiments of the auxiliary device according to the invention and the related kit are illustrated in detail in the attached Figures 1 -6. In particular, Figures 1-4 show an embodiment of the device according to the invention, consisting of the main body 1 with the end portion 2 and the intermediate handle portion 4, while Figures 5 and 6 show an enlarged detail of the end portion 2 with two different shapes of strips or membranes 3 of absorbent and reactive material inserted.

[0042] With reference to Figures 1-4, the illustrated embodiment of the device consists of a cylindrical main body 1 having the size of a pen, approximately 13 cm in diameter with a circular cross-section of about 12 mm, intended to be held at the intermediate handle portion 4 like a pen, at an angle of approximately 45° from the horizontal plane on which the patient lies supine with the eye in the primary position (or upwards when the patient is supine). The handle portion 4 is designed to be held by the surgeon’s non-dominant hand, or rather, by the hand not performing the intravitreal injection, i.e., the right hand for the left eye and vice versa.

[0043] A circular ring element 5 with an internal diameter of 12 mm, itself with a circular cross-section of 2 mm in diameter, is attached to the cylindrical main body 1 of the device. This ring element is connected to the main body 1 by means of two connecting rods 6 and 7, forming an angle with it such that a circular ring element 5 is parallel to the horizontal plane when the device is held.

[0044] With reference also to Figures 5 and 6, the end portion 2 of the device is designed with a longitudinal guide element 8 with parallel edges, so as to be able to accommodate a strip or membrane 3 (shown in Figures 5 and 6) of absorbent paper or similar material, 20-25 mm long, preferably graduated, facing upwards, which exceeds the end portion 2 of the device by approximately 4 mm, with a reference point 3 mm from the end of the end portion 2. The strip or membrane 3 can thus indicate to the surgeon the exact injection point, located 3 mm from the corneoscleral limbus. In the embodiment shown in Figure 6, the strip or membrane 3 has the shape of a rectangle with a circular end whose diameter is greater than the width of the strip itself. The central point of the strip or membrane 3, which may be perforated, is positioned, when the strip or membrane 3 of absorbent and reactive material is inserted into the device, at the optimal point where the intravitreal injection must be performed.

[0045] For greater clarity, Figure 7 shows, schematically, the distal portion 2 of the device according to the invention with a strip 3 of absorbent indicator material inserted, resting on the patient’s eye so as to stabilize the eyeball in the primary position while the intravitreal injection is performed. The tip of the needle is inserted by the surgeon at the point indicated on strip 3 itself. Once the injection of any drug has been performed, the retraction of the needle will provide a passive reflux of a very small quantity of vitreous humor that will wet the strip or membrane 3 which is housed in the device, and the capillarity will make the vitreous sample rise along the strip or membrane 3, which will instantly provide a colorimetric measurement of the molecule of interest, for example a protein, against which appropriate antibodies are present in the strip or membrane 3, allowing an extemporaneous reading of the concentration of that molecule in the vitreous humor.

[0046] Suitable materials for manufacturing the components of the disposable device of the invention are rigid synthetic materials, particularly thermoplastic resins, such as acrylonitrile-butadiene-styrene (ABS) resins, which are commonly used thermoplastic polymer blends. Optionally, one or more portions of the intermediate handle portion 4 can be made of a soft plastic material, such as silicone, polycarbonate, or PVC, which ensures the device can be sterilized in an autoclave (170 °C) or by gamma irradiation.

[0047] As stated above, the device and kit according to the present invention first of all correctly position the needle of the syringe used for intravitreal injection and simultaneously stabilize the eye in the primary position by means of the 12 mm diameter ring that rests on the limbus, while the elongated pen-like shape allows the operator to comfortably grip it with the hand that is not performing the injection. Secondly, and unlike the prior art, the device and kit of the invention allow for the immediate analysis of the drop of vitreous humor that comes out after the needle is withdrawn, thanks to the strip or membrane of absorbent material suitably soaked in antibodies for various molecules / proteins, and the colorimetric system contained in the strip. The strip material passively absorbs the vitreous fluid flowing back from the hole resulting from the needle exit and provides an immediate visual result on the content of one or more target molecules in the vitreous.

[0048] Quantitative data can be obtained via a dedicated smartphone application, open to Android and iOS systems, capable of interfacing the colorimetric data with a preset curve to produce a clear and intuitive real-time report on the presence / absence of the marker and its possible concentration, to facilitate the ophthalmologist’s decision.

[0049] The present invention has been described with reference to some specific embodiments thereof, but it is understood that variations or modifications may be made thereto by those skilled in the art without departing from the scope of protection as defined in the appended claims.

Claims

CLAIMS1. A disposable auxiliary device for stabilizing a patient’s eyeball, indicating the optimal site for intravitreal injection and sampling vitreous reflux, said device consisting of: an elongated main body (1 ), similar in size to a pen and configured to be held in a pen-like manner, said main body (1 ) having an intermediate handle portion (4) equipped with one or more peripheral grip elements, and a distal portion (2) ending with a ring element (5), having an internal diameter of approximately 12 mm and lying on a plane inclined from approximately 30° to approximately 45° with respect to the plane on which the patient must be positioned, wherein said distal portion (2) further comprises a longitudinal guide element (8) with parallel edges, configured to receive and hold in position a strip or membrane (3) of absorbent and reactive material, said strip or membrane (3) exceeding the terminal part of said longitudinal guide element (8) by approximately 4-4.5 mm, so as to be able to absorb a vitreous reflux generated by the retraction of the needle with which said intravitreal injection is performed, as well as to indicate the optimal point at which the intravitreal injection must be performed.

2. The disposable auxiliary device according to claim 1 , wherein said peripheral grip elements on said intermediate handle portion (4) are elements in relief for an ergonomic non-slip grip.

3. The disposable auxiliary device according to claims 1 or 2, wherein said ring element (5) is fixed to the main body (1 ) via one or more connecting rods (6, 7).

4. The disposable auxiliary device according to claim 3, wherein said ring element (5) is fixed to the main body (1 ) by means of two connecting rods (6, 7), provided on said ring (5) in diametrically opposed positions and aligned along the longitudinal axis of the device, said two connecting rods (6, 7) each being of such length as to maintain said ring (5) on a plane inclined fromapproximately 30° to approximately 45° with respect to the plane on which said patient is to be positioned.

5. The disposable auxiliary device according to any one of the preceding claims, wherein said elongated main body (1 ) has a length of approximately 12- 15 cm and a circular or elliptical cross-section.

6. The disposable auxiliary device according to claim 5, wherein said cross-section has diameters or axes between about 8 and 15 mm.

7. The disposable auxiliary device according to any one of the preceding claims, wherein said ring element (5) in turn has a circular or elliptical crosssection with diameter or axes varying between approximately 1 and 3 mm.

8. A disposable auxiliary kit for stabilizing a patient’s eyeball, indicating the optimal site for intravitreal injection and sampling vitreous reflux, said kit consisting of: a) a disposable auxiliary device as defined in any of claims 1 -7; b) one or more strips or membranes (3) of absorbent and reactive material, each having a width corresponding to the internal width of said guide element (8) with parallel edges and being configured to exceed the terminal part of said longitudinal guide element (8) by approximately 4 mm, so as to be able to absorb said vitreous reflux, said one or more strips or membranes (3) also being provided with a marking or a hole approximately 1 -1.5 mm from the terminal edge of the strip or membrane (3) itself, to indicate the optimal point at which the intravitreal injection must be performed.

9. The disposable auxiliary kit according to claim 8, wherein said one or more strips or membranes (3) of absorbent and reactive material have the shape of a rectangle with a circular end with a diameter greater than the width of the strip (3) itself, the central point of which, possibly perforated, is positioned, when the strip or membrane (3) of absorbent and reactive material is inserted into the device, at the optimal point where the intravitreal injection must be performed, said point being 3-4 mm from the edge of said ring element (5).

10. The disposable auxiliary kit according to claims 8 or 9, wherein said one or more strips or membranes (3) of absorbent and reactive material contain an antibody-colorimetric system, and are chosen from strips of blotting paper,nitrocellulose or hydrophilic PTFE and, furthermore, they preferably present a protein band and two analytical bands for the colorimetric detection of the relevant marker.

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