Bag for collecting and separating blood components

Abstract

The present invention pertains to the field of medicine and relates to a bag used for the collection, storage and separation of blood derivatives. The present patent is designed to enable the collection and separation of blood components in a single bag, suitable for generating fractionated bags and blood sample aliquots. This practice eliminates the risk of contamination due to the transfer and / or exposure of the blood products. The invention relates to a bag (1) composed of two superimposed polymeric films (2) and (3) sealed along their perimeter, and provided at its two ends with connectors (4), (5), (6), and (7), and handles (8) and (9), respectively; the bag (1) comprises an hourglass-shaped narrowing (10), formed by two trapezoidal seams (11) and (12) arranged opposite each other; the narrowing (10) has a length of between 6 mm and 15 mm (preferably 10 cm), a width of between 2 cm and 6 cm (preferably 4 cm), and angles (α), (β), (γ), and (δ) of between 10° and 60° (preferably 20°), while two or more demarcation lines (13) and (14) are placed transversely on both faces, on the narrowed region (11).

Description

[0001] "Blood component collection and separation bag"

[0002]

[0001] The present invention, belonging to the field of medicine, refers to a bag applied to the collection, storage and separation of blood products. The present patent is designed to enable the collection and separation of blood components in a single bag, capable of generating fractionated bags and aliquots of blood samples. This practice eliminates the risk of contamination due to the transfer and / or exposure of blood products.

[0003]

[0002] The object of this patent application is a device that functions uniquely, from blood collection, separation into two main byproducts – plasma and red blood cell concentrate – in physically separate volumes, and volume(s) for counter-testing, to the use of the byproducts in medical procedures or in other processes for the production of other blood products from these main byproducts. This device was specially designed and developed to achieve great practicality and offers significant advantages, both in its use and in its manufacture.

[0004]

[0003] It is also the objective of this application to present a blood component collection, storage and separation bag with low manufacturing costs, which meets the desired medical, safety and hermeticity requirements, in addition to offering practical utility, thus offering the medical community a differentiated option in relation to existing blood collection bags on the market of similar products, by offering benefits to its users.

[0005]

[0004] Currently, there are several models of blood bags, which adequately perform the function of collection and storage. Whole blood, which is collected in the blood bank for a closed and anticoagulated collection system, does not require any additional processing after it is obtained. This blood is used for transfusion only in patients with massive or active bleeding, polytrauma or hemorrhagic shock, or when a patient needs to simultaneously increase their oxygen-carrying capacity and expand their blood volume.

[0006]

[0005] Despite this practical use, almost all whole blood collected in blood banks is broken down into various blood components through mechanical transfer and separation steps (centrifugation). These components are then transfused in the form of packed red blood cells, red blood cells with few white blood cells, or plasma. This practice is widely publicized, adopted, and applied, and has proven effective in clinical treatment by healthcare professionals.

[0007]

[0006] Despite the practice of separating blood components, it is understood that the fact that it depends on the step of transferring the collection bag to a separation bag, along with satellite bags, can bring inconveniences regarding the possibility of contamination, loss of volume during transit, and cost due to the use of sterilized materials.

[0008]

[0007] In an attempt to eliminate the transfer step, some models have been developed. Document WO1993021892A1 describes a system, method, and bag for the centrifugal separation of two or more fractions of a compound liquid, for example, blood, consisting of a centrifuge with one or more chambers adapted to receive an elongated bag containing the liquid to be separated, and comprising one or more narrow and long constrictions of the inner chamber, arranged transversely to the direction of separation, and means arranged to these constrictions for fixing the bag after separation. Said system provides means for laterally stretching the bag immediately adjacent to these protrusions. The bag can be arranged to be sealed with the aid of one or more pairs of bars on the boundary layers for the various fractions. These pairs of bars can be arranged inside and / or outside the chamber. Such an arrangement aims to separate liquids and their fractions; however, it does not function as a blood collector.

[0008] US20020138066A1 refers to a multi-compartment bag intended to inactivate and store pathogens in blood or blood components, which includes multiple subcompartments interconnected by a locking assembly that can be opened. Each subcompartment may contain a component necessary for pathogen inactivation or blood storage. By opening the locking assembly, the subcompartments become a single compartment, and the components contained within each subcompartment can be mixed to form a combined solution for pathogen inactivation and / or storage of blood or blood components.

[0009]

[0009] US5632906 refers to an apparatus and method for transferring the separated component in liquid from a flexible bag into a centrifugal container. The apparatus comprises a centrifugal container to accommodate a flexible blood collection bag filled with blood, and a mechanism for pushing the blood collection bag. The pushing mechanism consists of a pair of rollers to push a soft part of the material from the cylindrical portion of the centrifugal container in opposite directions such that the soft part of the material is deformed inward to project into the centrifugal container and increase the internal pressure of the flexible bag to transfer the separated component out of the flexible bag. According to the apparatus and method, the yield for collecting the separated component obtained by centrifugal separation can be increased.However, this arrangement presents disadvantages regarding torsion during bag constriction, which can lead to unsuitable angles (corners that may change during centrifugation). Furthermore, the use of external devices for shaping the bag can cause distortions. Additionally, the transfer of liquids between bags can cause contamination of the contents.

[0010] The present invention aims to provide a bag that has means to collect, store and separate blood components by centrifugation (or natural decantation), allowing the generation of secondary bags and samples for examination, without the need for a transfer step.

[0010]

[0011] Unlike the patents mentioned above, the present "BLOOD COMPONENT COLLECTION AND SEPARATION BAG" refers to a device with a differentiated shape and markings, which allows the separation of plasma and red blood cell concentrate through centrifugation (or natural decantation), and subsequent cutting with welding in a specific and demarcated separation region between the volumes containing the byproducts. This process produces two bags ready for use due to its configuration, adequately defined for this purpose. The entire process occurs without contact with the external environment (air), and also allows for the obtaining of small counter-sample volumes, available for subsequent processes and procedures, in pre-defined volume(s).

[0011]

[0012] This feature of being a blood collector that already serves to separate the fractions after centrifugation, without contact with the external environment, is an improvement over document WO1993021892A1.

[0012]

[0013] This bag is made of appropriate materials and contains the necessary elements for its use, following standard connections for equipment at both ends, as well as support elements to be displayed on suitable supports before and after separation into two bags. The initial bag has a total capacity of 500ml, following the standard for donation, or other volumes for other situations or circumstances. The bag has two halves, one with a capacity between 55% and 60% and the other between 40% and 45% of the total volume, respectively, which can be adjusted if necessary for proper functioning of the process, and to accommodate the volume of the connection between the two main parts and the volume(s) of the counter-sample(s), as described in more detail below.

[0014] In its middle section, it has a "neck," or constriction, that allows for more precise separation of byproducts into two phases (each in a specific volume) and connects the two main chambers into a single continuous volume at the time of collection for homogeneity, although predisposed to separation in the subsequent process. The bag's design and production predispose it to the formation of two main drop-shaped volumes, which, linked by the most acute angle, create an hourglass-like shape with obtuse angles that are joined by this narrowing in the central part. The function of this narrowing is to prevent the sequestration of non-homogeneous material or edges incompatible with centrifugation or decantation, and consequently, to separate plasma and red blood cell concentrate in the most perfect way possible. It also facilitates and makes the gluing and cutting of the separated volumes more precise.

[0013]

[0015] The bag's design allows for the use of a centrifuge for separation, and after separation, each bag contains all the necessary elements for connections to equipment in both bags at the end of the process, following current standards, including for fixation and support. It also provides for one or more volumes attached to the bags, or not, for counter-testing when required in healthcare procedures or subsequent processes for the production of other blood products.

[0014]

[0016] One portion or volume is designed for plasma and the other for red blood cell concentrate, and the neck volume must be compatible with the possible variations in the volumes of these byproducts in the initial collection volume, as well as the natural variations in the proportion of these same byproducts in each collection.

[0015]

[0017] For the separation process, a volume limiter is applied to prevent excessive deformation of the bag shape and to ensure a consistent volume shape that guarantees the safety of the separation process. This limiter is externally positioned and may or may not be defined according to the bag configuration, without interfering with the quality of the contents of the bags. Furthermore, said limiter must be compatible with the equipment or separation method and procedures, and the design of the initial bag.

[0016]

[0018] The neck or narrowing that joins the two main volumes is important for the separation cut, and is already planned to accommodate variations in the percentage of volumes during the process and procedures.

[0017]

[0019] After centrifugation, the initial bag goes to the gluing and cutting process, which reserves, in addition to the two main volumes, one or smaller volumes of samples for counter-testing. The collection bag is then transformed into two bags ready for storage, immediate use, or later processing to obtain other blood products.

[0018]

[0020] The stock exchange operates as follows:

[0019]

[0021] The bag is compatible with all equipment and procedures, and is commonly used for collection;

[0020]

[0022] - After collection, the bag can be stored before sorting or proceed to the sorting and production process of the individual volumes;

[0021]

[0023] - For the separation process, the bag is inserted into a centrifuge or other means available for this purpose, where two byproducts are obtained, namely plasma and red blood cell concentrate. The method prescribed to limit the volume and shape during the separation of the phases must be used to avoid undesirable phenomena during the separation, gluing, and cutting processes;

[0022]

[0024] - After separation, the bag undergoes a welding and cutting process, forming the main volumes and the counter-sample volume(s). This results in two bags containing the by-products and equipped with standard connections for equipment used in healthcare application procedures, or for new processes to obtain other blood products. The counter-sample volume(s) may or may not be attached to the bags containing the final by-products.

[0023]

[0025] It is noted that the present patent does not present this problem, since it does not twist the bag to create a strangulation, as the bag itself has a configuration and shape that allows for post-centrifugation separation without the use of mechanical bag-shaping devices. Furthermore, in the present invention there is no need to apply a separation cylinder after collection and centrifugation, milking, and use of secondary bags. Additionally, after centrifugation and closure with a cut, the bag produces smaller secondary bags containing separated fractions without the risk of contamination by transfer, as occurs in document US5632906.

[0024]

[0026] Furthermore, the present patent focuses primarily on the separation of plasma and red blood cell concentrate, which already meets a large part of hospital needs, quickly and efficiently.

[0025]

[0027] Blood is a living emulsion, a product of the human body, and therefore exhibits enormous variations in content and physical characteristics, making theoretical fluid mechanics analysis for its processing quite imprecise.

[0026]

[0028] To better understand the functional dimensions of the present bag, empirical tests were carried out with prototypes in various dimensions and with variations in centrifuge speed to determine parameters that would allow the manufacture of a collection bag capable of undergoing the separation process without drastically altering the current procedures for collecting and using the separated bags, that is, that would allow, as far as possible, the use of current equipment, supports, transport, storage and reprocessing systems for obtaining blood products.

[0027]

[0029] Where possible, standard measurements were used to reduce the cost of molds and tooling for bag production. Measurements were determined to strike a balance between the need for precision in separation and less turbulence during welding and cutting, which would lead to the formation of a very narrow neck, and the need for bag dimensions that would allow for a smaller centrifuge, so as not to interfere with current laboratory layouts and procedures.

[0028]

[0030] Experiments were conducted, including considerations for storage time and other factors that lead to changes in the physical characteristics of blood after collection, such as ambient temperature. Percentages of plasma and red blood cell concentrate were determined among the races to choose the range in which the vast majority of blood types in humanity would be found, based on the literature.

[0029]

[0031] The neck's volume dimensions accommodate the percentage variations of the two byproducts, and its width (diameter) and length allow for free flow during collection to maintain homogeneity. This facilitates centrifugation and separation of the byproducts, forming a precise boundary between them and reducing turbulence during welding and cutting, thus preventing mixing. Regarding the transition zone between mixtures, this bag is designed to occur in the region of the counter-sample(s), as the purpose of the counter-sample is to detect pathogens, thus avoiding problems with the effectiveness of phase separation.

[0030]

[0032] Similarly, and with the same objectives, the angle connecting the main volumes and the neck was studied. Experimentally, it was observed that a very acute angle facilitates separation but greatly increases the larger fraction of the pocket, causing problems with the centrifuge size and pocket handling for welding and cutting. An angle tending towards a right angle increases the possibility of turbulence and hinders separation. In the tests, we found a satisfactory relationship in both aspects.

[0033] In view of the above, the following are the fixed dimensions (those currently used), the proposed dimensions, and the ranges in which the desired characteristics of precise separation and cutting are still maintained; in the outer dimensions, either precision in cutting or ease of handling of the bag is lost.

[0031]

[0034] - Taper length: between 6mm and 15mm, preferably 10cm;

[0032]

[0035] - Taper width: between 2cm and 6cm, preferably 4cm;

[0033]

[0036] - Angles of the vertices, located at the ends of the tapering: between 10 e and 60 e , preferably 20 e ;

[0034]

[0037] - Total internal length between the edges of the two halves, including the tapering: between 25cm and 35cm, preferably 28cm;

[0038] - Capacity of the larger half-part: between 55% and 60% of the total volume, with internal widths of the half-parts between 10cm and 15cm, preferably 12cm;

[0039] - Capacity of the smaller half-part: between 40% and 45% of the total volume, with internal widths of the half-parts between 10cm and 15cm, preferably 12cm.

[0035]

[0040] For example, in a bag containing a total volume of 600mL, the capacity of the larger half will be between 330mL and 360mL, while the capacity of the smaller half will be between 240mL and 270mL.

[0036]

[0041] Thus, the present patent was designed with the aim of obtaining a utensil with the fewest possible number of parts, conveniently configured and arranged to perform its functions with unparalleled efficiency and versatility, without the aforementioned drawbacks.

[0037]

[0042] This patent offers the following advantages: for example, in disaster situations, blood can be collected on-site, samples can be sent via rapid systems (e.g., drones), and separated by decantation for 6 to 8 hours at the collection site itself.

[0038]

[0043] Lower cost;

[0039]

[0044] Faster assembly;

[0045] - Better installation than the materials currently used.

[0040]

[0046] FIG. 1 illustrates a top view of the blood component collection and separation bag.

[0041]

[0047] FIG. 2 illustrates a top view of the blood component collection and separation bag, after collection and joining of the demarcation lines by heat sealing, forming wide welds.

[0042]

[0048] FIG. 3 illustrates a top view of the blood component collection and separation bag, after cutting the wide welds with cutting knives, producing two counter-samples and half-parts.

[0043]

[0049] FIG. 4 illustrates a top view of the bag containing divided blood.

[0044]

[0050] FIG. 5 illustrates a perspective view of the bag.

[0045]

[0051] According to Figures 1 to 5, the bag (1) consists of two overlapping and welded polymer films (2) and (3), and has connections (4), (5), (6) and (7) at its two ends, and handles (8) and (9), respectively; the bag (1) has a tapering (10) in the shape of an hourglass, formed by two trapezoidal seams (11) and (12), oppositely arranged to each other; the tapering (10) has a length between 6mm and 15mm (preferably 10cm), a width between 2cm and 6cm (preferably 4cm) and angles (a), (|3), (y) and (õ) between 10° and 60° (preferably 20°), while transversely there are two or more demarcation lines (13) and (14), on both faces, over the region of the narrowing (1 1 ).

[0046]

[0052] As one embodiment, the lower region of the polymer films (2) and (3), below the respective demarcation lines (12), are joined by heat welding, forming welds (13) wide enough to be divided by cutting knives, producing one or more counter-proofs (15) and half-parts (16) and (17), with capacities between 55% and 60% and between 40% and 45% of the total volume, respectively.

[0053] As another embodiment, the internal widths of the half-parts (16) and (17) of the bag (1) are between 10cm and 15cm (preferably 12cm), while the total internal length is between 25cm and 35cm (preferably 28cm).

[0047]

[0054] Optionally, the bag may have an external volume limiter during the centrifugation process.

[0048]

[0055] This "BLOOD COMPONENT COLLECTION AND SEPARATION BAG" is intended for the separation of plasma and red blood cell concentrate by centrifugation or decantation, without transfer to satellite bags and without contact with the external environment (air).

[0049]

[0056] The bag measurements (01) are trivalent and similar to a conventional bag, except that both ends have all the accessories for equipment and for connecting accessories such as the collection needle. The transfusion equipment resembles conventional bags and conventional standards. In the central neck constriction area, this bag can vary in length, which can be 8 centimeters or up to 3 or 4 times longer. This variation in measurement depends on the blood type and the volume to be collected. Since the total volume collected is around half a liter, 500 ml at most, the advantage is the variation in length and neck measurements. The central area has a lateral constriction of the bag where the thermal cut is made.It is important to point out that after the cut is made, the two bags are perfectly capable of being separated and hung up due to the design and assembly engineering of the bag itself.

Claims

CLAIMS 1- “BLOOD COMPONENT COLLECTION AND SEPARATION BAG”, characterized by a bag (1) consisting of two overlapping and welded polymer films (2) and (3) around it, and equipped at its two ends with connections (4), (5), (6) and (7), and handles (8) and (9), respectively; the bag (1) has a funnel (10) in the shape of an hourglass, formed by two trapezoidal seams (11) and (12), oppositely arranged to each other; the tapering (10) has a length between 6mm and 15mm (preferably 10cm), a width between 2cm and 6cm (preferably 4cm) and angles (a), (|3), (y) and (õ) between 10° and 60° (preferably 20°), while transversely two or more demarcation lines (13) and (14) are placed on both faces, over the region of the narrowing (11). 2- “BLOOD COMPONENT COLLECTION AND SEPARATION BAG”, according to claim 1 characterized by the lower region of the polymeric films (2) and (3), below the respective demarcation lines (12) being joined by heat welding, forming wide welds (13) sufficient to be divided by cutting knives, producing one or more counter-samples (15) and half-parts (16) and (17), with capacities between 55% and 60% and between 40% and 45% of the total volume, respectively. 3- “BLOOD COMPONENT COLLECTION AND SEPARATION BAG”, according to claims 1 and 2, characterized in that the internal widths of the half-parts (16) and (17) of the bag (1) are between 10cm and 15cm (preferably 12cm), while the total internal length is between 25cm and 35cm (preferably 28cm).

Images