TUBERCULIN SKIN TEST APPARATUS

Abstract

The invention relates to a disposable tuberculin skin test application apparatus. It aims to assist healthcare professionals in identifying the test area and accurately evaluating the results obtained from that area.

Description

1 TARIFF TUBERCULIN SKIN TEST APPARATUS TECHNICAL FIELD The invention relates to a disposable tuberculin skin test application apparatus. Health 5 The area to be tested is determined by the personnel and the results obtained in that area. It aims to help in the accurate evaluation of the results. PREVIOUS TECHNIQUE Tuberculosis (TB) is a respiratory, preventable and treatable disease. Tuberculosis is a disease. It is a widespread public health problem worldwide. Globally, 1.5 million people lose their lives. Every year on a global scale, 10 million people die. More than a million people contract tuberculosis. The causative agent of the disease... It is the Mycobacterium Tuberculosis bacillus. The bacillus is transmitted from a tuberculosis patient through the air. It is transmitted to a healthy person. The risk of developing tuberculosis following infection is 15. The risk is 5% in the first 2 years (World Health Organzaiton, Global tuberculosis report 2023. https: / / www.who.int / teams / global-tuberculosis-programme / tb-reports / global-tuberculosis (sis-report-2023). There has been an increase in contact tracing in our country over the last 15 years. In 2017, an average of 9.9 contact tracing examinations were conducted per patient (Turkish Ministry of Health). Ministry of Health Diagnosis and Treatment Guide, 2019). 20 Prevention, control, and elimination of tuberculosis are part of public health programs. It is an important component. Among the diagnostic methods preferred and currently valid for this purpose... One of them is the Tuberculin Skin Test (TCD). (CDC, 2023. What You Need to Know About) the TB Skin Test. https: / / www.cdc.gov / tb / communication-resources / skin-test-fact- (sheet.html). The tuberculin skin test is a test that indicates tuberculosis infection. The test is performed on 25 It indicates whether a person is infected with the tuberculosis bacillus. It is an indirect method in diagnosing the disease. It helps in this way. Tuberculin Skin Test; - In TB diagnosis - 30 in the selection of individuals to receive BCG vaccination - In studies related to acquired vaccine allergy after BCG vaccination - Immunotherapy (immunity) achieved through BCG vaccination tuberculin test during supportive treatment 2 - The emergence of non-specific sensitivity to PPD tuberculin solution. It is used in epidemiological studies that enable the extraction of this material (CDC, 2020. Tuberculin Skin Testing. https: / / www.cdc.gov / tb / hcp / mantoux / skin-test-fact-sheet.html; TC (Ministry of Health Diagnosis and Treatment Guide, 2019). 5 Tuberculin Skin Test Application Technique In this technique, a purified protein derivative is used for testing. (PPD) tuberculin solution is used. PPD tuberculin solution, one dose is 5 Tuberculin units (TU) / 0.1 ml is an intradermal test solution. 10 The solution is injected into the person being tested. The injection is given below the elbow, on the left side. The injection is administered intradermally to the inner (volar) surface of the upper 2 / 3 of the forearm. It is recommended that the area be free of skin lesions and away from veins. This is the Mantoux test. It is referred to as the method. Tuberculin skin test, 1 ml, graduated, single-use 27 gauge 15 It is administered with a syringe that has a needle of a certain thickness. Just below the surface of the skin. The injection is performed by holding the needle with the oblique tip pointing upwards. Then a bubble with a diameter of 6-10 mm should form. If this test has not been performed properly, immediately... A second test dose is administered a few centimeters away and the location is recorded (CDC). 2020. Tuberculin Skin Testing. https: / / www.cdc.gov / tb / hcp / mantoux / skin-test-fact-20 sheet.html; Turkish Ministry of Health Diagnosis and Treatment Guide, 2019). Reading the Test: If the person being tested has previously been exposed to the tuberculosis bacillus (natural exposure to the bacillus) (with exposure or BCG vaccine), hyperemia (redness) at the test site within 2-3 days and 25 Induration (prominence) occurs. The diameter of the hyperemia is not important. It manifests as hardness. The diameter of the detected induration is important. The presence of induration is determined by inspection and It is detected by palpation. The onset of induration can also be determined with the tip of a ballpoint pen. The points can be detected more precisely. 48-72 hours after the test (2- (3 days) The induration diameter is measured in millimeters with a transparent ruler. 30 of the forearm The diameter perpendicular to the line is read (In special cases, the measurement can be taken up to 96 hours). (can be done). When noting the absence of induration, use "0 mm" instead of "negative". is written (Table 1). 3 Table 1. Evaluation of the Tuberculin Skin Test (CDC, 2020. Tuberculin Skin Test). Testing. https: / / www.cdc.gov / tb / hcp / mantoux / skin-test-fact-sheet.html; TC Health Ministry of Health Diagnosis and Treatment Guide, 2019; Source: Republic of Turkey Ministry of Health Diagnosis and Treatment Guide. Treatment Guidelines, 2019) The system described in document CN101524275 involves a tuberculin skin test on the body. It relates to a pocket-sized ruler with a viewing hole. This system, It does not involve any form of wearable equipment. The main focus of our invention is 10 by defining the boundaries of the test area and measuring the swelling as a result of the test. It has a circular form and incorporates structures that facilitate measurement. In this application... It is designed as a device that healthcare personnel can use continuously. Our invention features a separate application for each patient and indicates the point at which the test is administered to the patient. a guide that indicates and allows the patient to take their own measurements. 15 It contains. Document CN202313344 is circular in form, enabling post-test measurement. It is a device that allows monitoring of swelling. This device is used for tuberculin testing. This is a positioning measurement film. The measurement film is made of transparent plastic and is applied to the skin. It has adhesive properties. The round hole in the center of the film is for skin testing. It is used. The film has a graduated measuring ring on it. The KR20140144952 document can be pasted onto the binding. This allows for testing. It performs the function of marking the area. It also performs post-testing. It also includes a ruler structure that makes measurement possible. 4 THE PURPOSE OF THE INVENTION The invention has implications for all areas where the Tuberculin Skin Test (TST) can be applied (healthcare). (in all private or state institutions / organizations where the service is provided) healthcare personnel The only one that can be used before the Tuberculin Skin Test is administered by It relates to disposable medical equipment. The equipment is also used in training 5 healthcare professionals. as educational material in practical courses of all faculties and colleges It will be available for use. The aim of our invention is to define the boundaries of the tuberculin skin test area and to test As a result, circular structures were created to measure the swelling and to facilitate the measurement. The goal is to ensure the effective evaluation of the test result through its presence. 10 Another aim of the invention is to benefit the medical and healthcare fields, especially healthcare professionals. Its purpose is to serve as an educational guide for students studying in the field of science. Another purpose of the invention is to prevent infection because the device is single-use. It does not pose a risk and is suitable for individual use. LIST OF FIGURES Figure 1. Appearance of the Tuberculin Skin Test Apparatus on the Forearm. Figure 2. Open view of the Tuberculin Skin Test Apparatus. The equivalents of the references given in the figures are: 20 a. Chapter One b. Part Two c. Chapter Three 1. Guide 2. Open area 25 3. Ruler area 4. Lock 5. Table 6. Table DETAILED DESCRIPTION OF THE INVENTION The invention is a disposable Tuberculin Skin Test (TST) application device. The device is designed to be placed on the forearm of the patient undergoing the test. The device is soft. It is made of a plastic material, and the device is fitted at the wrist and elbow. It has locks (4) that will allow it to be fixed. Locks (4); Velcro, button, snap or it has one of the forms that includes interlocking structures. Thus the device must be secured in such a way as to prevent it from moving on the patient's arm They provide. The apparatus described in the invention consists of three parts (a, b, c) that enable the test to be performed. 5 It includes three sections, structuring the elbow and forearm of adult individuals. The length between them has been taken as the basis. The average of the elbow-to-forearm measurement in our country. A study conducted on adult individuals showed it to be 23.73±2.22 cm (Study and Ark, 2021. A Study on the Determination of Anthropometric Data of Individuals Aged 18-65 Years. Field Research: Higher Education Institution Application. Ergonomics 2021; 4(3),147-10 161). In the pilot study conducted by the inventors, randomly selected adults The average measurement obtained from the individuals was found to be 24.6 cm. Therefore... Our invention is based on a forearm length of 24 cm. Based on the information above, the first part of the apparatus (a) is from the wrist. It is the closed section extending up to an area of ​​8 cm towards the elbow. The second section (b), 15 The third section (c) is the 7 cm long open area where the injection will be made (2). The other 9 cm of closed space outside the injection site, located below the elbow. is the area. A guide (1) that enables the interpretation of the test on section (c) of the third section. It is available. The tabular information to be included in the Guide (1) is given below. (Table 2). Based on this table, the skin's reaction will be shown in Table 20 in section (a) of the first part. The area (3) can be interpreted with the rulers (5, 6). In BCG patients 0-5 mm Negative 6-14 mm BCG positivity mm and above Positive, infection (+) BCG in you 0-5 mm Negative 6-9 mm Suspicious reaction; 1 week then repeat the test, 6-9 mm Negative >10 mm Booster phenomenon* mm and above Positive 6 In immunocompromised individuals, a reading of 5 mm or higher is considered positive. is done** Table 2. Tuberculin Skin Test Guidelines In the first part of the apparatus (a), the diameter of the induration is determined as described above. two transparent-colored surfaces with circular lines that allow for measurement There are separate rulers (5, 6). In the circular diameter configuration of the rulers (5, 6) 5 The evaluation was based on the Tuberculin Skin Test results specified in Table 1. Tables Circles above (5, 6) indicate skin test assessments with BCG in red, skin without BCG Test evaluations are shown in blue. These colors are not mandatory. Different colors can also be used. On the red ruler with circular lines. (5) the innermost ring is 0-5 millimeters, the middle ring is 6-14 millimeters and the outermost ring is 10 It shows measurements in millimeters and above. The other blue ones contain circular lines. In the ruler (6), the innermost ring is 0-5 millimeters, the middle ring is 6-9 millimeters, and the outermost ring is... The ring size indicates 10 millimeters and above. The guide shows both with and without BCG. The colors used in the separation match the colors on the rulers (5, 6). The test After application, the device is removed from the patient's arm and given back to the patient. 15 To evaluate the results, the patient is brought back with the device to the health center 48 hours after the test. When it comes to its establishment, by means of the rulers (5, 6) on the apparatus The diameter of the induration is being measured. 25

Claims

7 REQUESTS 1. This is a tuberculin skin test device, its characteristic feature is that it can be tested on the wrist and elbow. locks (4) that will allow it to be fixed and the test to be carried out It will include the first part (a), the second part (b) and the third part (c), 5 - Section 1 (a) allows measurement of the diameter of the induration. It should contain a ruler area (3) which includes two separate circular transparent rulers (5, 6), - The second part (b) should include the open area where the injection will be made (2), - A guide (1) that enables the interpretation of the test on section (c) of the third part. It is characterized by its inclusion. 10 2. The locks mentioned in Claim 1 are (4) and their feature is that the device is on the patient's arm. Velcro fasteners to ensure it is secured in place, preventing it from moving. from forms that include button, snap or interlocking structures It is characterized by having someone.

3. The table mentioned in Claim 1 is (5), the characteristic of which is that the diameter of the induration is 15 The interior, which has a transparent background and colored lines, allows for measurement. It is characterized by containing concentric circles.

4. The table mentioned in Claim 1 is (6), the characteristic of which is the diameter of the induration. The interior, which has a transparent background and colored lines, allows for measurement. It is characterized by containing inward circles. 20 30

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