Surgery – Truss – Pad
Patent
1986-04-11
1989-06-06
Howell, Kyle L.
Surgery
Truss
Pad
424449, A61B 1500
Patent
active
048362174
DESCRIPTION:
BRIEF SUMMARY
This invention relates to a novel means for carrying out occlusive epicutaneous tests (patch tests). This type of test is employed for detecting contact allergies (contact sensitization) to some specific substance (allergen) or for testing allergic and/or irritant properties of a substance. For the sake of simplicity, the method of this invention is called "My Test".
The term "patch test" derives from the fact that initially patches of fabric or paper were used for carrying out the tests, these patches being soaked with the substance to be tested. During the years many different types of patches have been employed. In connection with the invention the term patch primarily denotes the area carrying the test substance.
In the epicutaneous testing procedure, the substance suspected to have allergenic or irritant properties is applied to normal skin under occlusion for a certain period of time, this application being effected in a controlled manner and with a suitable formulation and concentration of the test substance. This will then, in contact allergy cases, produce an allergic eczema in the test area. Irritant substances give rise to irritative eczema reactions of a similar character (Manual of Contact Dermatitis; Fregert S, 2nd ed. Munksgaard, Copenhagen /1981/ p. 71-76). Usually the test substance is applied in a suitable vehicle, as a rule petrolatum or water. The "patches" in the patch test method are nowadays usually small cup of alumnium foil which when the test is to be carried out are filled with a suitably formulated preparation of the test substance and applied in a manner such that the test will be performed under occlusion. Often a plurality of patches are affixed to an adhesive tape covered with a detachable protective foil.
The methods and materials commonly employed for patch tests are unsatisfactory in respect of safety requirements; this applied especially to methods and materials used for metal salts. Improvements are therefore desirable. Cp. Kalimo, K. et al., Concact Dermatitis 10 (1984), p. 25-29: Schmidt H. et al., Contact Dermatitis 6 (1980), p. 91-94. In allergy testing procedures irritative reactions are common, in particular if the test substances are employed in concentrations close to their thresholds of irritancy. At least in part this is due to the fact that the test substances are not evenly distributed over the skin contact area. Microscopic examinations of standard patch test material have shown that most of the allergens when incorporated in the recommended petrolatum vehicles are dispersed unevenly therein, either in the form of particles or as droplets of varying size (Vannestre D. et al., Contact Dermatitis 6 (1980), p. 197-203; Fossereau J. et al., Occupational Contact Dermatitis. Munksgaards, Copenhagen /1982/, p. 45). The largest of these inclusions measure more than 0.5 mm in diameter. Such particles when dissolving in sweat produce a high local concentration of the allergen and cause pore inflammations ("poritis") around hair follicles. Another disadvantage is that the amount of test substance applied in a standard patch test may vary within a sixth-power range (Fisher T. et al., Contact Dermatitis 1 /1984/, p. 285-87). All this shows that it is highly desirable to achieve improvements in the pharmacological properties of materials to be employed in patch test procedures.
My test solves many of the aforesaid problems, in that it gives an accurate dosage, uniform surface distribution and high bioavailability of the test substance. My test thus offers a solution to such problems of low bioavailability, uncertain dosage and uneven surface distribution as may easily arise when petrolatum is employed as the vehicle.
The present invention provides methods applicable to occlusive patch test techniques, said methods (a) minimizing the required amount and increasing the dosage precision of the test substance (does per unit area), (b) permitting the manufacture of test preparations which are stable in storage, and (c) permitting prefabricated test strips to be made each cont
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Howell Kyle L.
Philpitt Fred
Sykes Angela D.
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