ES2806177B2 - Lancet device for allergy testing - Google Patents

Description

DESCRIPTION

Lancet device for allergy testing

Scope and state of the art

The present invention relates to a lancet device for allergy tests specially designed to perform punctures according to the prick-test method, that is, to puncture for the intraepidermal application of allergens.

The prevalence of allergic diseases has increased considerably in recent years (Bibliography 1-3). Today it is estimated that around 20% of the world population suffers from some degree of type I hypersensitivity and that these conditions are the cause of morbidity and mortality in all countries (Bibliography 4, 5). These pathologies include asthma and allergic rhinitis, atopic dermatitis and food allergy.

The use of paraclinical tests in the diagnosis of allergy dates back to 1873, when Charles Blackley (Bibliography 6) designed an immediate skin test, which later became known as the scarification method: the substance is deposited on the skin previously excised with a scarifier. In 1926, Lewis and Grant (Bibliography 7) first introduced skin prick tests or prick tests, which consist of placing solutions on the patient's skin and making a small puncture through the drop. Later, in the 70s, the intraepidermal technique was definitely introduced as a diagnostic method after the modifications made by Pepys, who used hypodermic needles for its execution (Bibligrafía 8).

Despite the multiple in vitro tests that have been developed over the years for the study of allergic pathologies, intraepidermal tests offer greater diagnostic yield and, as a general rule, tend to have greater sensitivity than laboratory tests (Bibliography 9). For this reason, they continue to be the initial diagnostic approach to allergic patients when the specialist doctor suspects an IgE-mediated reaction or type I hypersensitivity. There are numerous factors that can condition the result of the aforementioned skin tests: allergenic extracts, age, concomitant treatments , place on the body surface where they are performed, accessories (lancets or needles), method used for the test (Bibliography 10), etc.

Variability in skin test results depends on the way the instruments are used. The answer varies according to the angle at which the instrument is applied in relation to the skin, the force exerted, and the personal experience of the person performing the test (bibliography 10); variations that may be imperceptible when the tests are carried out by expert personnel.

The most diverse epicutaneous instruments (Bibliography 7) are used in skin tests, such as the standardized Morrow-Brown needle (Dome Hollister-Stier, West Haven) and the ALK lancet (Milles Allergy Products). Others have been derived from them, such as the Osterballe precision needle and the Allerprick (bibliography 10). The coefficient of variation to measure the precision of the standardized Morrow-Brown needle is estimated at 10% and that of the ALK lancet at 21% (bibliography 11-12).

The pnck-test technique is performed by placing the antigenic extract on the skin for the subsequent introduction into the epidermis of the patient of a quantity of the product through a puncture. It is usually done for comfort on the volar surface of the forearms, although if it is not possible to use this area (pediatric patients, skin lesions, excessive hair ...), it could be done in other areas of the body (for example, on the back ). Before performing it, it must be verified that the skin area is adequate, does not present tissue damage or alterations, and that the patient does not suffer from any disease or is receiving medication that interferes with the results of the test. The area of the forearm to be punctured is the one between about 5 cm above the wrist and about 3 cm below the elbow (bibliography 13). After properly marking with a marker, several drops of allergenic extract are deposited, separated from each other at least 2 cm. Through the drop, at a 90 ° angle to the skin, it is punctured with a lancet for approximately one second while maintaining stable pressure. The lancets to be used are sterile stainless steel instruments with a 1 mm tip, single use, disposable and nickel free. Puncture through the drop of the extract allows a small amount of it to penetrate the superficial layers of the skin (about 3.3 x 10 "6 mL). Bleeding should not occur, because it can be the cause of a false positive, but the lancet must penetrate far enough into the skin for the extract to penetrate the epidermis. If the placement of the extracts is too close to each other, the reactions will overlap or cause a false positive by axon reflex of a strongly positive proximal reaction (Bibliography 7) The reading of the immediate reaction is made after 15-20 minutes, coinciding with the point of maximum skin reaction.

The list of allergens that are applied varies according to the geographic area; Batteries are used with those with the highest prevalence in each area, and in general they are mites, epithelia of domestic animals, fungi and pollens, being able to modify these batteries depending on the allergenic prevalence of the area in which we are.

There are numerous background documents regarding allergy testing lancing devices, including the following:

- ES 20092019 A1 of 09.16.1989, referring to a device to perform allergy tests.

US 6,095,988 A1 of 08/01/2000, which discloses a self-loading apparatus and a skin test system for rapidly loading a multi-head applicator used for epicutaneous application of biological agents.

- EP 1695666 A1 of 08.30.206, refers to a unit of equipment with containers to receive allergens and also a disposable mark on the skin to assign a certain allergen to a position of the skin test.

- WO 2006/030201 A1 of 23.03.2006, describes a housing with a hole and a lancet that slidably fits in the hole. The lancet functions as a positive displacement piston.

- US 2011/0118624 A1 of 09.05.011, discloses a device that includes a handle assembly connected to a cylinder assembly having a first and second cylinder housing.

- WO 2014/070103 A1 of 08.05.2014, describes a surgically invasive pointed article for penetration of the skin and capillary extraction of whole blood and whose penetration capacity can be deactivated after use by deforming the tips.

- WO2017182530 DE 26.10.2017, discloses an apparatus for administering liquid to the skin of a patient.

Additionally, through document US 2017/0027494, it describes a puncture test kit comprising a lower tray with wells arranged in a matrix, each of which wells contains a vial with a small amount of an antigen and a rubber cap. that can be pricked with a needle to remove a small amount of antigen. A penetration plate is arranged above the wells and has on its lower surface a plurality of piercing needles, each associated with one of the wells. A sterile cover is provided to contain the entire assembly.

Furthermore, from EP 2119469 A1 an inexpensive micro-needle device is known, which allows to perform a skin test with a simple operation during a short period of time for the diagnosis of allergies. The micro-needle device comprises: a plate-shaped micro-needle substrate, micro-needles extending perpendicularly from the substrate a with a density of 100 to 10,000 needles per 1 cm2, a synthetic or natural resin material , non-metallic, capable of piercing the skin from 50 ^ m to 500 ^ m deep, and allergen retention means (4) formed in the micro-needles containing at least one allergen.

Despite the advances established over the years, the intraepidermal testing technique ( prick-test) as it is carried out today differs little from that carried out by Lewis and Grant almost 100 years ago (bibliography 7), existing the need to develop a device that optimizes such tests, saving time, money and antigenic extracts.

Object of the invention

Starting from the state of the art described above, the object of the invention is the development of a lancet device that makes it possible to solve the aforementioned drawbacks of complexity, precision of handling and high requirement of storage space.

According to the invention, these objectives are achieved through the characteristics corresponding to claim 1. Further further objectives are achieved through the characteristics indicated in the dependent claims.

According to the invention, there is provided a lancet device for intraepidermal tests in the study of allergies. It is shaped like a rectangular plate with a length and a height that is characterized in that it consists of at least two laterally contiguous pentagonal lobes, consisting of a handle portion that occupies approximately two-thirds of the height of the plate and portions triangular tips extending the remaining third of their height, the upper ends of which are laterally spaced by a preset distance, and each tip portion being configured with a pointed end to form a puncture needle of predetermined length, and with respective lateral extensions on both sides of said pointed termination intended to abut the penetration of the needle-shaped termination into the epidermis of a patient subjected to an allergy test.

In order to provide adequate support on the patient's skin and to stop the penetration of said pointed end in the form of a puncture needle, the lancet device is designed so that the magnitude of the lateral extensions on either side of the pointed termination is twice the vertical extent of the pointed termination, that is, in a 2: 1: 2 ratio.

In order to comply with the clinical-health recommendations, the lancet device is configured so that the distance / separation between the triangular portions of contiguous lobes is 20 mm or greater, while the length of the pointed end in the form of a needle is at most 1mm, and the magnitude of each lateral extension on either side of the tip is 2mm, all in accordance with international clinical-health standards and regulations.

According to an especially preferred embodiment the lancet device is provided with at least five lobes with their respective five pointed endings as a puncture needle.

Still in accordance with a further feature of the invention, each laterally contiguous lobe of the lancet device is provided with a tear line for separation of the device from a respective lobe.

Still according to a further feature of the invention, the lancet device is manufactured from a metallic material, such as stainless steel for example. In this way, the device can be endowed with characteristics of corrosion resistance and sterilization capacity, as well as mechanical resistance and stability.

Also in accordance with yet another feature to enhance the mechanical strength and stability of the lancet device, each lobe consists of a portion of increased thickness.

Brief description of the drawings

The attached drawings show, by way of non-limiting example, a possible embodiment of the lancet device for allergy tests according to the design of the invention where:

Figure 1 illustrates a perspective view of the lancet device according to the invention.

Figures 2 and 3 respectively show plan and cross-section views through line AA.

Figure 4 illustrates an enlarged detail of the circularly framed area of Figure 2.

Detailed description of an embodiment of the invention

As shown in Figures 1 to 3, the lancet device for intraepidermal tests in the study of allergies according to the invention has a plate-shaped (1), generally rectangular, with a length (L) and a height (H ) and a reduced thickness (E) in relation to its aforementioned length and height dimensions, as will be explained in greater detail later.

It can be seen that said plate consists of lobes (2), preferably five, generally configured with a pentagonal shape that are arranged laterally contiguous, so that on said plate (1) a handle portion (20) is determined which occupies in a approximately two-thirds of the height of the plate, as well as respective tip portions (21), approximately triangular, which extend for the remaining third of their height (H) in each lobe (2).

Additionally, it can be seen that the upper ends (210) of said tip portions (21) are laterally spaced by a preset distance (D) and that said portions form an angle α of 70 ° from each other.

As can be seen in greater detail through Figure 4, each tip portion (201) has a pointed end (2100) forming a puncture needle with a predetermined length (P), this end being preferably triangular and subtending an angle p 50 °.

Additionally, as shown in said figure 4, on either side of said pointed end there are lateral extensions (2101) destined to stop the penetration of the needle-shaped end into the epidermis of a patient subjected to a intraepidermal allergy test.

It should be mentioned that the magnitude of the lateral extensions (2101) on either side of the pointed end (2100) like a needle are chosen according to a 2: 1: 2 ratio; that is, the magnitude of each lateral extension being twice the pointed end / puncture needle, in order to provide adequate support on the patient's skin and stop the penetration into the epidermis of said pointed end as a puncture needle.

Furthermore, it should be mentioned that preferably the distance / separation (D) between the triangular portions (21) of contiguous lobes (2) is 20 mm or greater, while the length (P) of the pointed needle-shaped termination ( 2100) is at most 1 mm, the magnitude of each of the lateral extensions (2101) to either side of said pointed end / puncture needle being approximately 2 mm.

Referring again to Figures 1 and 2, it can be seen that between each laterally contiguous lobe (2) there is a break line (S) to be able to separate each of said lobes (2) from each other.

This lancet device is preferably made of a nickel-free metallic material, for example stainless steel.

The use of a suitable metallic material provides properties of mechanical strength and resistance to corrosion, and even provides sterilization capacity.

As clearly shown in Figure 3, each lobe (2) consists centrally of a raised (201) that can provide strength and mechanical stability to the constituent plate of the lancet device.

A device in accordance with the above disclosed that has, among others, the following technical advantages:

- Low manufacturing costs;

- It takes up much less space (up to 50 times less space than other existing products);

- Does not contain plastic waste;

- It is 100% recyclable;

- It is sterilizable / reusable;

- A larger pre-tip surface than conventional lancets, which acts as a stop to ensure that the tip does not pass beyond the epidermis;

- Thermally resistant, both at high temperatures and at cryogenic temperatures;

- Resistant to corrosion and food acids used in certain tests with this type of lancets;

- Greater mechanical resistance (shock resistant);

- Maximum hygiene, less adherence of dirt and external agents.

- Lower risk of contamination;

- Greater durability;

- Greater grip surface and greater ergonomics, which allows greater stability and control of the pressure on each and every one of the tips, thus ensuring an identical pressure and greater uniformity of the test;

- Maximum precision. The tips can be viewed at any time from any angle, which allows us to make sure that we have carried out the puncture / punctures exactly where it is desired and avoiding the risk of unwanted punctures;

- Standardized tips, complying with European standards (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3565910/);

- 1 mm lancets that ensure minimal skin trauma (which avoids pain and false positives);

- Distance between all the tips complying with European standards (> 2 cm) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3565910/);

- Optimal use of the skin surface (technical advantage of special relevance in children, where the skin surface we have is smaller);

- Possibility of bending / cutting in the spaced area to modify / adapt the arrangement of the tips;

- Ease of use, which ensures maximum intra- and inter-observer reproducibility;

- It allows a maximum saving of the allergenic extract since the test is carried out by introducing the utensil into a well containing said extract;

- Since the contact surface with the allergenic extract is smaller than that of other existing utensils, the adhesion by surface tension is just and necessary, not wasting extract;

It will be appreciated by those skilled in the art that changes could be made to the embodiment described above without departing from the broad inventive concept thereof. I know therefore, it is understood that this invention is not limited to the particular embodiment described, but that it is intended to cover modifications within the scope of the present invention as defined in the present description.

Even having sufficiently described the object of the invention, it only remains to point out that embodiments derived from changes in shape, dimensions and the like, as well as those resulting from an application of the foregoing, should be considered included in its scope, so that the invention It is only limited by the scope of the following claims.

Related bibliography

1. Davies RJ, Rusznak C, Devalia JL. Why is allergy increasing? Enviromental factors. Clin Exp Allergy 1998; 28 (suppl 6): 8-14

2. Frew A. Ethical aspects of allergen standardization and skin testing. Allergy 1993; 48 (suppl 14): 81-82

3. Blumenthal M, Bousquet J, Burney P. Evidence for an increase in atopic disease and possible causes. Clin Exp Allergy 1993; 23: 484-92

4. Ewan P. Twin to twin atopy. Lancet 1995; 345: 1508-9.

5. Dewear JC, Wheatley AP. The heritability of allergy disease. In: Hall P, ed. Genetics of asthma and atopy. Monographs in allergy. Basel: S. Karger, 1996; 33: 4-34.

6. Blackley CH. Experimental researches on the cause and nature of catarrhus aestivus. London: Bailliere Tindall and Cox, 1873.

7. Adkinson NF Jr. YJW Busse WW, Bochner BS, Holgate ST. Middlenton's Allergy Principles & Practice. 6th edition. Philadelphia: Simons F.E.R .; 2003.

8. Pepys J. Skin testing. Br J Hosp Med 1975: 412-17.

9. Finnerty JP, Summerell S, Holgate ST. Relationship between skin-prick tests, the multiple allergosorbent test and symptoms of allergic disease. Clin Exp Allergy 1989; 19: 51-6.

10. Pastorello EA. Skin tests for diagnosis of IgE-mediated allergy. Position paper: allergen standarization and skin testing. European Academy of Allergology and Clinical Immunology. Allergy 1993; 48 (Suppl 14): 57-62.

11. Kniker W. Multi-test skin testing in allergy: a review of published findings. Ann Allergy 1993; 71: 485-99.

12. Montalvo A, Martín S, Mesa A, et al. Comparative study of three types of lancets to perform the prick test. Allergol Immunopathol 1996; 24: 58-64.

13. Bernstein IL, Storms WW. Practice parameters for allergy diagnostic testing. Joint Task Force on Practice Parameters for the Diagnosis and Treatment of Asthma. The American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology. Ann Allergy Asthma Immunol 1995; 75 (6 Pt 2): 543-625.

14. Morrow Brown. H. Su & Thantrey. N. Prick testing for allergens standardized by using a precision needle. Clin Allergy 11.95-98.1981.

15. Osterballe O. & Weeke. B. A new Lancet for Skin Prick Testing. Allergy 34.209-212.1979.

16. Haynen. J et al. Prick-test and intracutaneous test. Acta Allergologia 29.225-227.1974.

17. Carr WW, Martin B, Howard RS, Cox L, Borish L: Comparison of test devices for skin prick testing. J Allergy Clin Immunol 2005, 116 (2): 341-346. 57.

18. Nelson HS, Kolehmainen C, Lahr J, Murphy J, Buchmeier A: A comparison of multiheaded devices for allergy skin testing. J Allergy Clin Immunol 2004, 113 (6): 1218-1219.

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19. Demoly P, Bousquet J, Manderscheid JC, Dreborg S, Dhivert H, Michel FB: Precision of skin prick and puncture tests with nine methods. J Allergy Clin Immunol 1991, 88 (5): 758-762.

20. Heinzerling L et al. The skin prick test - European standards. Clin Transl Allergy. 2013 Feb 1; 3 (1): 3. doi: 10.1186 / 2045-7022-3-3

21. Dreborg S. Methods for skin testing. EAACI Position Paper. Allergy 1989; 44 (Suppl. 10): 22-30

22. Bousquet et al. Practical guide to skin prick tests in allergy to aeroallergens. Allergy.

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23. Masse et al. Comparison of five techniques of skin prick tests used routinely in Europe. Allergy. 2011 Nov; 66 (11): 1415-9. doi: 10.1111 / j.1398-9995.2011.02679.x. Epub 2011 Jul 29.

Claims (11)

1. Lancet device for intraepidermal tests in the study of allergies in the shape of a rectangular plate (1), with a length (L) and a height (H) characterized in that it consists of at least two laterally contiguous pentagonal lobes (2) , consisting of a handle portion (20) occupying two-thirds of the height of the plate and triangular tip portions (21) that extend for the remaining third of its height (H), whose upper ends (210) They are laterally separated by a preset distance (D), and each tip portion (201) being configured with a pointed end (2100), forming a puncture needle with a predetermined length (P), and with respective lateral extensions ( 2101) on either side of said pointed termination intended to stop the penetration of the needle-shaped termination into the epidermis of a patient subjected to an intraepidermal allergy test. Lancet device according to the first claim, characterized in that the plate has a thickness (E) of reduced value compared to its height and length (H and L), preferably in a ratio (E: H: L) from 0 , 2: 50: 100 to 0.4: 50: 100. Lancet device according to claim 1, characterized in that the pointed end (2100) constituting the puncture needle has a triangular shape. Lancet device according to claim 3, characterized in that the pointed end (2100) subtends an angle (P) of preferably 50 °. Lancet device according to claim 1, characterized in that the magnitude of the lateral extensions (2101) on either side of the pointed end (2100) like a needle is chosen to be twice the length (P) of said pointed end, so that they keep with said pointed portion a ratio of 2: 1: 2, ideal to provide adequate support on the patient's skin and stop the penetration of said pointed end as a puncture needle. Lancet device according to at least one of the preceding claims, characterized in that the distance / separation (D) between the triangular portions (21) of contiguous lobes (2) is 20 mm or greater, while the length ( P) of the pointed needle-shaped termination is at most 1mm, with the magnitude of the lateral extensions (2101) on either side of it being approximately 2mm. Lancet device according to claim 6, characterized in that the angle (a) formed between the triangular portions (21) of adjoining lobes is preferably 70 °. Lancet device according to claim 1, characterized in that it is preferably provided with at least five lobes (2). Lancet device according to at least one of the preceding claims, characterized in that between each laterally contiguous lobe (2) there is a tear line (S) to be able to separate each of said lobes (2) from each other. Lancet device according to at least one of the preceding claims, characterized in that it is made of a nickel-free metallic material, such as stainless steel. Lancet device according to at least one of the preceding claims, characterized in that each lobe (2) has a central elevation (201) to provide strength and mechanical stability to the constituent plate of the lancet device.