Volumetric dry blood collection apparatus

Abstract

The invention relates to a volumetric dry blood collection apparatus (10) which is widely used in many fields such as community screening, inborn metabolism patients, newborn screening, hormone analysis, pharmacokinetic studies, epidemiological studies, clinical chemistry, biomarker discovery studies, drug level studies, toxicology, forensic medicine, infectious diseases (HIV, hepatitis, tuberculosis, malaria) and therapeutic drug monitoring.

Description

[0001] VOLUMETRIC DRY BLOOD COLLECTION APPARATUS

[0002] Technical Field

[0003] The invention relates to a volumetric dry blood collection apparatus which is widely used in many fields such as community screening, inborn metabolism patients, newborn screening, hormone analysis, pharmacokinetic studies, epidemiological studies, clinical chemistry, biomarker discovery studies, drug level studies, toxicology, forensic medicine, infectious diseases (HIV, hepatitis, tuberculosis, malaria) and therapeutic drug monitoring.

[0004] State of the Art

[0005] Nowadays, there are dry blood cards (DBC) that absorb blood when blood is spilt and preserve the blood sample until it can be analysed. DBC are paper-like capillary blood spots made of nitrocellulose. This system is preferred due to it is easy to carry, provides fast results and the blood collection operation is relatively painless.

[0006] DBC is widely used in many areas such as newborn screening for inborn metabolic diseases and therapeutic drug monitoring. Besides, DBC has become increasingly popular in population studies due to its easy of collection and transport. However, the major disadvantage of this method is that the amount of blood drawn on paper is not standardised and is affected by the haematocrit level. This situation is affect the repeatability and accuracy of the results obtained. Volumetric dry blood systems (VDBS) have been developed to eliminate these problems of dry blood cards. By means of these systems minimise the variations caused by the amount of blood sample taken and the haematocrit (the ratio of the volume of red blood cells to the total blood volume) level. In this way, the accuracy of the results obtained is much higher than that of DBC. Due to the high accuracy of VDBS systems, they are increasingly being used for different purposes.

[0007] Volumetric dry blood systems (VDBS) used in the present art are disposable products with a certain shelf life. With their increasing areas of use, they create an intense waste burden in terms of the environment. All existing products are made of materials such as polyethylene and polypropylene, which are not biodegradable in nature. Another disadvantage of existing VDBS systems is that they have a certain shelf life. This is due to contact with air due to the use of open grid structures for drying the end of the kit. The open grid structure also leaves the end of the VDBS systems open to contamination. Although closed systems have been developed to reduce the risk of contamination, these products are very costly for VDBS, which are disposable products.

[0008] Some VDBS systems in the known state of the art use the hybrid blood collection method. In these systems, blood is either impregnated on a nitrocellulose membrane calculated to receive a certain volume of blood or on a nitrocellulose membrane via capillary tubes calculated to receive a certain amount of blood. Impregnation of the blood on the nitrocellulose membrane reduces the possibility of obtaining homogenous and standardised amounts of blood. This situation has a negative effect on the repeatability and accuracy of the analyses. Since the levels of analytes in blood samples taken to VDBS are analysed by highly sensitive methods such as liquid chromatography tandem mass spectrometry, the error that will occur can reach extremely large dimensions.

[0009] This situation reveals the necessity of a volumetric dry blood collection apparatus that is biodegradable, does not come into contact with air while waiting on the shelf and after use, works independently of the nitrocellulose membrane, and thus has a long shelf life.

[0010] As a result of the relevant research on the matter, WO2019227124A1 application was found. The document relates to a blood sampling apparatus for analysis. The sampling apparatus comprises a porous polymer monolith sampling substrate disposed in a substantially impermeable housing. The present technique is a non-biodegradable product and becomes environmentally hazardous waste after use.

[0011] Another application encountered as a result of the research is US2017023446A1. The application relates to an apparatus for taking blood samples for use in research or diagnostic tests. The apparatus mentioned in the present art consists of carbon compounds that do not easily degrade in nature and is a waste product that harms the environment after use.

[0012] As a result, due to the above-mentioned disadvantages and the inadequacy of the existing solutions, a development in the relevant technical field has become necessary.

[0013] Aim of Invention

[0014] The invention is inspired by the present situations and has the purpose of solving the above-mentioned problems. The main aim of the invention is to provide a volumetric dry blood collection apparatus having biodegradable plastic properties except the end which can absorb the blood. Thus, a waste product that does not harm the environment and disappears in nature over time is provided.

[0015] The other aim of the invention is to ensure that the polymeric membrane end is cut off from contact with air and dried by placing hydrophilic superabsorbents in the hollow structure inside the tube and / or in the lid part. In this way, a product with a long shelf life and no risk of contamination is provided.

[0016] A further aim of the invention is to provide an apparatus which operates independently of the nitrocellulose membrane, and which is free from adverse effects, such as a reduced possibility of obtaining a homogeneous and standardised amount of blood as a result of impregnation of blood into the nitrocellulose membrane.

[0017] In order to fulfil the above-mentioned purposes a volumetric dry blood collection apparatus which comprise a membrane insert capable of absorbing a fixed volume of blood, urine, saliva and similar body fluids, and which is widely used in many fields such as community screening, inborn metabolism patients newborn screening, hormone analyses, pharmacokinetic studies, epidemiological studies, clinical chemistry, biomarker discovery studies, drug level studies, toxicology, forensic medicine, infectious diseases (HIV, hepatitis, tuberculosis, malaria) and therapeutic drug monitoring, characterized in that it includes the following;

[0018] • An outer body forming the structure of said volumetric dry blood, collection apparatus,

[0019] • A retaining element at the head of the membrane end that allows easy insertion and removal from the outer body; and

[0020] • Absorbent carrier compartment structured inside and at the bottom of the outer body, which allows moisture transfer without contact with the membrane end and drying of the membrane end without contact with air, thus increasing the shelf life of the volumetric dry blood collection apparatus.

[0021] The structural and characteristic features and all advantages of the invention will be more clearly understood by means of the figures given below and the detailed description written by making references to these figures, and therefore, the evaluation should be made by taking these figures and detailed description into consideration. Figures to Help Understanding the Invention

[0022] Figure 1 is a general and cross-sectional view of the inventive apparatus.

[0023] Figure 2 is an alternative general and sectional view of the inventive apparatus.

[0024] Figure 3 is a view of alternative geometrical structures of the membrane end portion.

[0025] Description of Part References

[0026] 1 . Retaining element

[0027] 2. Membrane end

[0028] 3. Outer body

[0029] 4. Absorbent carrier chamber

[0030] 5. Bottom cover

[0031] 10. Volumetric dry blood collection apparatus

[0032] Detailed Description of the Invention

[0033] In this detailed description, preferred embodiments of the inventive volumetric dry blood collection apparatus (10) are described only for the purpose of a better understanding of the subject matter.

[0034] The inventive volumetric dry blood collection apparatus (10), as shown in Figures 1 or 2, basically comprises a polymeric membrane end (2) having a controlled cavity structure and a closed system carrying this end, i.e. a retaining element (1 ), an outer body (3) or tube and a bottom cover (5). Said polymeric membrane end (2) is capable of absorbing a constant volume of blood, urine, saliva and similar body fluids. The polymeric membrane end reaches saturation within 2-10 seconds depending on the cavity volume. It has the ability to release metabolomics in blood, urine and other body fluids under appropriate conditions. It releases metabolomics within maximum 30 minutes under appropriate conditions.

[0035] The polymeric membrane end apparatus (2) of the volumetric dry blood collection apparatus (10) of the invention may be manufactured from hydrophobic polymers (poly tetrafluroethylene, polyethylene) according to different sintering methods (press moulding, selective laser sintering, etc.). The volume of the polymeric membrane end part can be 10-100 microlitre capacity. The polymeric membrane end (2) has the capacity to take blood, urine and other body fluids with a sensitivity of at least ± 5%. As shown in Figure 3, the membrane end (2) can be in different geometric structures (cylindrical, polygonal, conical). The membrane end (2) part, which has a controlled gap structure with hydrophobic character, is treated with different surfactants in order to gain affinity against blood and other body fluids such as urine and saliva and to release metabolites in a controlled manner. For this purpose, cationic, anionic and nonionic surfactants can be used.

[0036] The inventive volumetric dry blood collection apparatus (10) comprises an outer body (3) forming a closed system carrying a membrane end portion. In addition, in one embodiment of the invention, the outer body (3) comprises a bottom cover (5) which closes the outer body (3) from the bottom side and prevents contact with air. Said retaining element (1), outer body (3) and bottom cover (5) are made of biodegradable polymers (polyglycolic acid, polylactic acid and polycapralactone). In this way, the inventive volumetric dry blood collection apparatus (10) is 99% biodegradable. The carrier apparatus is produced by injection moulding and / or three-dimensional printer technologies. The carrier apparatus comprises three main parts: the part holding the polymeric membrane (1), the outer body (3) and the hydrofibic superabsorbent carrier chamber (4). Polyvinyl alcohol, polyacrylic acid, sodium polyacrylate, silica gel, metal salts, carboxy methyl cellulose are used as superabsorbent. The superabsorbent can be placed in the bottom cover (5) of the absorbent carrier chamber (4) and / or in the outer body (3) / tube. The superabsorbents allow the polymer membrane to dry without contact with air. In one embodiment of the invention, the outer body (3) or tube portion may be cylindrical, square, rectangular. In addition, the outer body (3) or tube portion may be transparent and / or in different colours depending on the intended use. The outer body (3) part has a screw, gasket or plug-in structure at the bottom and / or top and is produced in such a way as to prevent contact with air. In this way, the shelf life of the inventive volumetric dry blood collection apparatus (10) is at least 1 year. As can be seen in the cross-sectional view in Figure 1 , the super hydraulic polymer absorbent and the polymeric membrane end (2) do not come into contact with each other, but have a grid structure to ensure moisture transfer.

[0037] Since the inventive volumetric dry blood collection apparatus (10) operates independently of the nitrocellulose membrane, it offers a structure free from all negative effects arising from the use of nitrocellulose. Due to it is made of biodegradable material, it becomes a waste that does not harm the environment in nature. Besides, thanks to the membrane end (2) part in the absorbent carrier chamber (4), which dries without contact with the absorbent, a long shelf life apparatus is offered. The inventive volumetric dry blood collection apparatus (10) can be used especially in the health sector for newborn screening, congenital metabolism patients, hormone analysis, urinalysis, therapeutic drug monitoring, screening of viral diseases such as Crimean Congo Haemorrhagic Fever and home diagnosis. Within the scope of R&D studies, it can also be used in genetic analysis, lipid analysis, molecular biology, biomarker discovery studies, drug level studies, toxicology, forensic medicine, pharmacokinetics and epidemiological studies.

[0038] With the use of the inventive volumetric dry blood collection apparatus (10), medical professionals and healthcare providers will benefit greatly from the ease of sample collection, as it reduces patient discomfort and allows for more frequent monitoring. Clinical laboratories can streamline workflows and increase efficiency with this new apparatus. Pharmaceutical companies and research institutions can use the inventive apparatus for drug development, pharmacokinetic studies and therapeutic monitoring. Also, the inventive apparatus holds great promise for remote and point-of-care environments by enabling access to healthcare services in resource-limited regions. With its wide-ranging applications, the volumetric dry blood collection apparatus has the potential to revolutionise the field of blood testing and improve health outcomes for countless individuals worldwide.

Claims

CLAIMS1. A volumetric dry blood collection apparatus (10) which comprise a membrane end (2) capable of absorbing a fixed volume of blood, urine, saliva and similar body fluids, and which is used in many fields such as community screening, inborn metabolism patients newborn screening, hormone analysis, pharmacokinetic studies, epidemiological studies, clinical chemistry, biomarker discovery studies, drug level studies, toxicology, forensic medicine, infectious diseases (HIV, hepatitis, tuberculosis, malaria) and therapeutic drug monitoring, characterized by comprising;• an outer body (3) forming the structure of said volumetric dry blood collection apparatus (10),• a retaining element (1 ) located at the head of the membrane end (2), which allows it to be easily inserted and removed from the outer body (3); and• an absorbent carrier chamber (4) structured inside and at the bottom of the outer body (3), which provides moisture transfer without contact with the membrane end (2) and drying of the membrane end (2) without contact with air, thus increasing the shelf life of the volumetric dry blood collection apparatus (10)2. A volumetric dry blood collection apparatus (10) according to claim 1 , characterized in that; the membrane end (2) is a hydrophobic polymer such as polytetrafluroethylene or polyethylene.

3. A volumetric dry blood collection apparatus (10) according to claim 1 , characterized by comprising; a screw port or gasket located at the bottom of the retaining element (1) which enables the retaining element (1) to be attached to the outer body (3).

4. A volumetric dry blood collection apparatus (10) according to claim 1 , characterized by comprising; the retaining element (1) and the outer body (3) made of biodegradable polymers.

5. A volumetric dry blood collection apparatus (10) according to claim 1 , characterized by comprising a bottom cover (5) made of biodegradable polymers, which closes the outer body (3) from the bottom side and prevents contact with air.

6. A volumetric dry blood collection apparatus (10) according to claim 1 , characterized by comprising; the absorbent carrier chamber (4) comprises polyvinyl alcohol, polyacrylic acid, sodium polyacrylate, silica gel, metal salts or carboxy methyl cellulose as absorbent.

7. A volumetric dry blood collection apparatus (10) according to claim 1 , characterized by comprising; the outer body (3) has a cylindrical, square, rectangular shapes and coloured or transparent.

Images