Cover assemblies with coagulant compartments and their use in blood monitoring / management systems

Abstract

Disclosed is a cover / lid assembly having a first compartment, a second compartment, or both. Each compartment comprises an upper portion and a lower portion, with the lower portion of the compartment being comprised of a flexible material. The first or second compartment may be comprised of a first material or a second material. The first or second material may comprise a superabsorbent cellulose and / or polymer formulation, or an agglutinated red blood cell solidifying and / or jellifying agent, such as a red blood cell agglutinating agent. The material within the compartment may be selectively released upon compression of a recess and / or button located directly above the first and / or second compartment. A collection and / or biological waste management and disposal system is presented, including the lid / covering assembly as described and a collection container. The lid may include a periphery having threads and / or a snap-on mechanism suitable for securely attaching the lid to a collection canister. The collection canister may include a red blood cell agglutinating agent coating.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of U.S. Application No. 17 / 026,106, filed on September 18, 2020, which claims the priority of U.S. Provisional Application No. 63 / 055,577, filed on June 23, 2020, both of which are hereby incorporated by reference.

[0002] The present invention relates to the field of lids and / or covers for containers.

Background Art

[0003] The containment and management of waste having potentially biohazardous substances such as blood requires careful handling. The presence of blood in liquids and other materials, for example, materials generated during the processing and / or treatment of animals and / or human bodies and / or cadavers (e.g., surgery, dissection, handling, processing and / or management of cadavers (morgue, funeral home, hospital, veterinary hospital, dissection, tissue bank)) generally requires the use of procedures and devices that minimize the contact and / or outflow of liquids and / or waste. The problem of liquid / waste outflow and contact creates a significant risk of exposing patients, healthcare providers, and the surrounding surgical environment to blood contaminants. Existing collection containers / vessels used for the collection and disposal of materials cannot effectively control the exposure to liquid / waste contaminants because at least in part, the blood present in the collected materials is in a fluid state.

[0004] Containers for collecting biologically hazardous materials, particularly those collected from surgical procedures, may include lids with ports that must be manually opened and emptied by the user to dispose of the contents, which are liquid waste. This procedure poses risks of contamination to the user performing the disposal activity, to others near the area where the contents are disposed of, and to the entire area where the procedure is being performed. Particularly in the medical field, safer disposal methods are needed for handling and disposing of liquid or semi-liquid waste to protect against these potential and significant health and / or other hazards.

[0005] The fluidity of collected materials is, at least in part, related to the liquid state in which any blood in the material remains for several hours under standard room temperature and collection conditions. Depending on what other substances are present, the blood may remain liquid for much longer. Technologies for rapidly and easily reducing the fluidity of collected materials, especially biohazardous materials, remain largely undeveloped to meet current needs.

[0006] Blister packaging subassemblies, or "blister packs," have been used as convenient packaging for a variety of consumer products, such as chewing gum, cough drops, and certain medications. When used in this sense, "blister pack" is understood to refer to pre-molded plastic and / or foil packaging used for small consumer products, food, and pharmaceuticals (such as chewing gum). A blister pack typically provides a cavity or pocket made of moldable web, aluminum foil, or plastic on one side, and a cardboard or other less suitable back wall or seal on the other side. The product can be easily dispensed and retrieved by the user, for example, by applying force to the back wall to eject the product through the aluminum foil or plastic compartment, into the user's hand. In a typical blister pack, the contents of the blister pack "chamber" compartment are ejected when the user applies direct force against the back wall of the "pack," leaving the back wall intact.

[0007] Generally, applying direct pressure to the back wall of a blister pack causes the front wall material to be perforated by the product contained within the "pack" compartment, thus pushing out the weakest part of the front wall or surrounding layer of the blister "pack" assembly. When pressure is applied to the blister, the back seal ruptures, and the contents of the blister are discharged through the tear in the back seal.

[0008] The blister pack unit is described in German Patent Application Publication No. 10343668, which relates to a leak-proof blister pack for pharmaceuticals. As another example, German Patent Application Publication No. 202007003050 relates to a blister pack for liquid substances released into the external environment by diffusion.

[0009] In medical technology, there is still a need for improved equipment, materials, and methods for handling blood or liquid or semi-liquid substances containing blood components, managing their safe disposal, and avoiding and / or minimizing user contact. [Overview of the project] [Problems that the invention aims to solve]

[0010] This disclosure provides solutions to these and other problems present in the art. [Means for solving the problem]

[0011] In a general and overall sense, the present invention provides materials, apparatus, and systems for the safe management and disposal of potentially health-hazardous materials, such as materials collected during or after laboratory, medical, or other procedures, which may contain liquid components. In particular, apparatus and methods are presented for the handling and disposal of hazardous materials collected during surgical procedures, including blood or blood products. The disclosed apparatus and methods include cover assemblies such as lids, covers, and / or caps, providing tools that enable a higher level of safety, contactless disposal solutions for potentially biohazardous materials. In this sense, waste collection and biohazard disposable systems are provided.

[0012] In one embodiment, the apparatus comprises a cover and / or lid assembly including a first compartment containing a coagulant material capable of coagulating blood components (red blood cells), the first compartment having a top surface and a bottom surface, the top surface including a compressible button or recess. In this embodiment, the compressible button or recess is preferably located on a flexible layer situated below the first compartment, the flexible layer functioning to release the coagulant material upon rupture, causing the blood components within the material, such as red blood cells, to coagulate and / or gel.

[0013] In some embodiments, the coagulation material is selectively released from the compartment into a container or other receiver upon rupture of the flexible layer / cover. Thus, in operation, when a compressible button or indentation is compressed, the coagulant, particularly a blood coagulant, is selectively released. Any blood components in the container and / or compartment then rapidly form a coagulated semi-solid, gel-like state, thus allowing for the acquisition of a solid and / or semi-solid mass of material that is essentially spill-free and more readily disposable.

[0014] In other embodiments, the cover and / or lid assembly comprises a second compartment containing a hemagglutinating material capable of agglutinating blood components (red blood cells), the second compartment having an upper and lower surface, the upper surface including a compressible button or recess. In this embodiment, the compressible button or recess is preferably located above a flexible layer situated below the compartment, the flexible layer, upon rupture, releases the hemagglutinating material, which then associates with the surface of red blood cells to agglutinate them, thereby inhibiting blood coagulation.

[0015] In effect, virtually any coagulant capable of coagulating blood, more specifically red blood cells, and even more specifically agglutinated red blood cells, is a material that can be used within the apparatus / lid / cap of the present invention.

[0016] Table 1 shows examples of human erythrocyte (RBC) agglutinants. When red blood cells agglutinated (not coagulated) with these agglutinants are exposed to and / or bound to coagulants provided by the apparatus and methods of the present invention, they can further coagulate to provide a solid or semi-solid mass. JPEG0007911723000001.jpg37170

[0017] Red blood cells present in a liquid containing blood, in the presence of a hemagglutinant, bind to each other, thus forming heavy particles that settle in the container / bottle / tube / foldable bag or other container into which the sample / material is collected. Even after settling, the agglutinated RBCs in the collected biomaterial can be easily redispersed, do not solidify, and / or form solid masses that can be easily and safely disposed of. However, agglutinated or dispersed red blood cells can be solidified by supplying them with one or more suitable solidifying agents.

[0018] In some embodiments, the coagulant consists of polydiallyldimethylammonium chloride (polyDADMAC). In fact, virtually any type of coagulant can be used to achieve the precipitation of red blood cells in a liquid. Examples of RBC coagulants include high molecular weight RBC coagulants and non-high molecular weight RBC coagulants. Non-high molecular weight RBC coagulants include acids such as HCl or other acid molecules.

[0019] The selection of an appropriate solidifying gelling agent (or blood coagulant) requires that the agent be capable of forming a solid, gel-like, or semi-solid mass from a liquid containing agglutinated red blood cells.

[0020] A kit is provided in which a blood coagulation / gelling agent is packaged as part of a lid / cap / cover assembly and configured to be securely attached (by screws, snaps, etc.) to a collection container opening, such as the top opening of a collection container or device. In some embodiments, the lid assembly of the cap / lid / cover is configured to include a blister pack as described above, with the blood coagulation / gelling agent contained within the blister pack as part of the lid assembly. In some embodiments, the lid assembly is configured to be securely attached to the opening of a collection container.

[0021] In some embodiments, a blister pack may consist of two films, which may be composed of several layers of different or identical materials in turn. The films may be made of plastic and / or metal, such as aluminum, but other materials such as paper may also be used, or additionally used. In particular, the two films may be a base layer or base film (support) and a cover layer or cover film (cover).

[0022] The base film or support may have one or more grooves or depressions for holding liquid, into which liquid, particularly a pharmaceutical formulation, is introduced. The cover film or cover is then placed on the base film or support and fixed or attached thereto, for example, at the edges or connecting areas, particularly flat contact surface areas, preferably by bonding, heat sealing, welding, etc.

[0023] The blister pack may be sealed with an active compound that minimizes interference with the analysis of blood, blood components, or other chemicals introduced into the collection canister. A flexible seal is often provided around at least a portion of the blister cavity to allow the blister to rupture under pressure. Such flexible sealing techniques enable relatively simple and controlled release of the drug without requiring complex liquid handling systems or external puncture means.

[0024] The blister pack sealing material may be, for example, a plastic film made of a material composed of polyethylene, polypropylene, polybutylene, polyvinyl chloride, or a combination thereof. Further, the blister pack sealing material may be an aluminum foil.

[0025] The blister cavity or pocket can be made from a thermoformable web, typically PVC, PVDC, polychlorotrifluoroethylene (PCTFE), or a cyclic olefin copolymer (COC) or polymer (COP). These above materials can be combined with polypropylene (PP), polyethylene (PE), or glycol-modified polyethylene terephthalate (PETg) etc. to enhance the protection.

[0026] Blood coagulant / gelling agent. Various types of blood coagulant / gelling agents can be used with embodiments of the present invention. These may include salts of inorganic compounds such as cellulose-based materials, their salts, Cu(II), Ag(I), Fe(II), Fe(III), Ti(IV), Ni(II), etc. The coagulant / gelling agent may be applied in the form of an aerosolized cellulose-rich compound and / or in powder form. As examples, Liqui-Loc®, PolySorb™, calcium sodium salt of microdispersed oxidized cellulose (QUICKSTOP!®), etc. can be employed to solidify the waste composition. An effective coagulant / gelling agent may consist of a solution containing any of the following compounds. Methanol, aluminum polychloride, silver nitrate, copper(II) sulfate, copper(II) bromide, ferrous sulfate, ferrous sulfite, ferric chloride, aluminum sulfate, or zinc sulfate, etc. The agglutinated red blood cell coagulant and / or gelling agent can be provided in powder, tablet, or liquid form as part of the device of the present invention and the method using the device. Table 2 shows examples of the agglutinated red blood cell coagulant and / or gelling agent. As a component of the lid / cap assembly, a powder of a cellulose-based material is provided within a compartment of the lid assembly and can be easily released into the container / canister without the risk of exposing the container contents to the operator / technician. JPEG0007911723000002.jpg94153

[0027] Canister, collection bag, and container cover / closure assembly. A collection device including a canister, collection bag, and container suitable for collection and visual estimation of blood loss may be used with the cover and / or closure assembly provided herein.

[0028] In some embodiments, the lid / cover assembly may include one or more flexible compartments. One of the flexible compartments consists of an aggregating agent that effectively aggregates aggregated red blood cells in a liquid.

[0029] In another embodiment, the lid / cover assembly comprises a first flexible compartment containing a cellulose solidifying / gelling agent that effectively solidifies and / or removes the liquid component of a preparation of suspended agglutinating red blood cells in liquid, and a second flexible compartment containing a red blood cell agglutinator. The lid / cover assembly of this embodiment is intended to be used with a collection canister or other container having an interior that has not been treated to contain a red blood cell agglutinator, such as a red blood cell agglutinator coating (e.g., polyDADMAC). As part of a blood loss assessment device, the lid having these two flexible compartments is employed with a collection device that has not been pre-treated to include an interior consisting of a red blood cell agglutinator coating. Before or during the collection of liquid into the container, the red blood cell agglutinator in the second flexible compartment is released into the collection container. The presence of the red blood cell agglutinator allows the red blood cells in the collected material / liquid to settle in the container, forming a separable settling red blood cell plane. However, settled agglutinated red blood cells can easily disperse if the contents of the container are disturbed and solid coagulation is absent. To more easily convert agglutinated red blood cells into a disposable solid and / or semi-solid mass, the agglutinated red blood cell coagulation and / or gelling material contained in the second flexible compartment of the lid assembly can be safely and easily released into the container without opening the container or removing the lid / cover assembly. A safe, reliable, and contactless assembly and apparatus are provided for both evaluating the settled red blood cell plane in the material (and calculating the amount of blood therefrom) and disposing of collected material that has or is suspected of having blood and / or red blood cells, in a single assembly, without exposing the contents to the environment or the user.

[0030] In any embodiment, the lid assembly may be configured to have a perimeter that allows the lid assembly to fit securely and snugly onto the top or opening of a collection device, such as a biological fluid collection device. The biological fluid collection device may take the form of a device as described in U.S. Patent Publication 10,401,347, U.S. Patent Application Publications 16 / 363,674, 16 / 257,876, and 16 / 257,673, and corresponding patents and patent applications outside the United States, and may include as a component a hemagglutinating agent provided on the inner surface of the collection container, such as a surface coating of the hemagglutinating agent on the inner surface of the collection container. The container may be canister-shaped, envelope-shaped, bag-shaped, or other configurations, as long as it is in a shape that can be coated with the hemagglutinating agent. These patents and patent applications are incorporated herein by reference in their entirety.

[0031] In summary, the cover and / or lid assembly of the present invention may be used with a collection device such as a canister, collection bag, or sleeve that is preferably sufficiently transparent or at least translucent so that the plane of material, such as sediment or agglutinated red blood cells (sedimented red blood cells, not coagulated blood), can be visually detected within the collection device. The collection device may be made of a solid material such as rigid plastic or glass, or a flexible material such as plastic or other non-rigid material, suitable for containing liquid and / or semi-liquid material consisting of or suspected to be blood. Examples of such liquid and / or semi-liquid material consisting of or suspected to be blood include liquid medical waste material consisting of blood.

[0032] These descriptions are provided as examples and are not intended to provide limitations on potential embodiments that may be assumed for the use and practice of this device. [Brief explanation of the drawing]

[0033] Figure 1 shows one embodiment of a cover and / or lid assembly disclosed herein.

[0034] Figure 2 shows one embodiment of the collection system disclosed herein.

[0035] Figure 3 shows a plan view of one embodiment of the cover assembly and / or upper lid portion disclosed herein.

[0036] Figure 4 shows a plan view of one embodiment of the cover assembly and / or the lower side of the lid disclosed herein.

[0037] Figure 5 shows another embodiment of the cover assembly disclosed herein.

[0038] Figure 6 shows a plan view of another embodiment of the upper part of the cover assembly disclosed herein.

[0039] Figure 7 shows a plan view of another embodiment of the lower part of the assembly disclosed herein. [Modes for carrying out the invention]

[0040] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this disclosure relates. Any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of the art, but preferred methods and materials are described herein.

[0041] As used herein, the term “coagulant” is intended to mean a cationically charged molecule that promotes the aggregation of RBCs in a liquid at room temperature and can form a precipitated RBC mass at room temperature in less than 30 minutes without centrifugation. Coagulants as defined herein do not provide coagulation, solidification, or gelation of a liquid containing blood or blood components (e.g., red blood cells).

[0042] The indefinite article "a" or "an" does not rule out the possibility of multiple elements unless the context clearly requires the presence of only one element. Thus, the indefinite article "a" or "an" typically means "at least one."

[0043] As used herein, “patient” or “subject” means an individual having symptoms of or at risk of having cancer or other malignant tumors. Patients may be human or non-human and may include animals such as horses, dogs, cattle, and pigs. Similarly, patient or subject may include human patients, including adults or minors (e.g., children). Furthermore, patient or subject may mean any living organism, preferably a mammal (e.g., human or non-human), for which it is desirable to determine and / or monitor blood volume from administration of the compositions intended herein.

[0044] As used herein, “waste” means blood or mixtures containing blood components such as red blood cells. Examples include biowaste from hospital / clinical sources.

[0045] As used herein, "blood coagulation and / or gelling-promoting substance" or "blood coagulation substance" means a substance that can provide a solid or semi-solid gelatinous mass from a liquid or semi-liquid material containing blood or blood components such as red blood cells.

[0046] As used herein, "approximately" means that the stated value or numerical value, such as concentration, length, molecular weight, pH, sequence identity, time frame, temperature, or volume, is within a statistically meaningful range. Such values ​​or ranges may be within one order of magnitude of a given value or range, typically within 20%, more typically within 10%, and even more typically within 5%. The acceptable variation encompassed by "approximately" depends on the specific system under study and will be readily apparent to those skilled in the art.

[0047] The following examples are presented to illustrate some embodiments of the present invention. [Example 1: Canister cover / lid assembly]

[0048] This embodiment describes one embodiment of the cover assembly / lid 1. The cover assembly / lid 1 is illustrated in Figures 1, 3, and 4.

[0049] The cover assembly / lid 1 includes an upper portion 10 and a lower portion 20, and further includes a flexible compartment 5 located on a first surface 25 of the lower portion 20 of the cover assembly. The cover assembly / lid 1 may be made of a transparent plastic material such as polyethylene or polypropylene. The flexible compartment 5 contains a blood coagulation-promoting substance 50 that can be selectively released from the flexible compartment 5.

[0050] In one embodiment, the blood coagulation promoting substance 50 may be a powder, as illustrated in Figure 4. However, the blood solidification and / or gelling promoting substance and / or biowaste solidifying agent 50 may be in the form of a powder, tablet, or liquid, and may be selected from any of the blood solidification and / or gelling compounds listed above. The blood solidification and / or gelling promoting substance and / or biowaste solidifying agent 50 may be enclosed in a flexible compartment 5. The flexible compartment may be provided as a blister pack, which may include a release surface made of a flexible material such as aluminum, tin foil, or plastic. The blood solidification and / or gelling promoting substance 50 may be contained within the blister pack. Alternatively, the blood solidification and / or gelling promoting substance and / or solidifying agent may be packaged in a box, bottle, tray, cartridge, or card.

[0051] The cover assembly / lid 1 may include a coupling adapter 8 along the perimeter 12 of the cover assembly 1. The coupling adapter 8 has a threaded connection suitable for mounting the cover assembly 1 onto the canister 30 to provide a liquid-tight seal. The coupling adapter 8 may consist of, for example, a threaded connection, a screw connection, or a locking connection. As shown in Figure 1, the cover assembly / lid 1 may include a compressible button or recess 11 made of a non-plastic material on the first surface 15 of the upper part 10 of the cover assembly. In some embodiments, a compressible button or dimple 11 is located on a flexible compartment 5, and when a compressive force (such as "pressing" the dimple / button) is applied to the compressible button or dimple 11 by the user, the flexible layer of the compartment opens / breaks due to the force exerted on the flexible layer, for example, by the substance contained within the flexible compartment and / or the pressure applied when pressing the button or dimple 11, and the blood coagulation-promoting substance 50 is released from the delivery compartment 55.

[0052] In one embodiment, and as shown in Figure 4, the first flexible compartment 55 includes an upper inflexible layer 57 and a lower flexible layer 59. When pressure is applied to the inflexible layer 57, a force is applied to the lower flexible layer 59, causing the flexible layer to rupture or tear. The rupture and / or tearing of the flexible layer then results in the release of the blood coagulation-promoting substance 50 and its release into the enclosed collection device. The compressible button and / or recess 11 located in the upper non-flexible layer 57 may consist of one or more flexible plastic materials that can be bent by applied pressure. The lower non-flexible layer 59 may consist of a layer of aluminum film or other material that is broken / torn by the pressure applied to the button and / or recess. The applied pressure may originate, for example, from the user pressing or pushing down on the button and / or recess, which creates air pressure applied to the interior of the flexible compartment and through the lower flexible layer 59. [Example 2: Collection System]

[0053] This embodiment presents a collection system 100 of the present invention, which is shown in Figure 2. The collection system 100 includes a collection container which can be connected to a cover and / or lid assembly 1. The cover and / or lid assembly 1 includes an upper part 10 and a lower part 20, and further includes a flexible chamber 5 positioned on a first surface 25 of the lower part 20 of the cover assembly.

[0054] The flexible chamber 5 contains a blood coagulation / gelling agent and / or blood coagulation promoter 50 that can be selectively released from the flexible chamber 5. The blood coagulation agent and / or blood coagulation promoter 50 may be sealed in a compartment 55, which may be a blister pack. The blister pack has a surface on one side made of a flexible material, such as plastic and / or aluminum foil material. The cover and / or lid assembly 1 has a coupling adapter 8 along the perimeter 12 of the cover assembly 1, and the coupling adapter 8 has a threaded configuration suitable for attaching the cover assembly 1 over the upper opening of the canister 30 to provide a secure, liquid-tight closure.

[0055] The cover assembly 1 may include a compressible button or recess 11 on the first surface 15 of the upper part 10 of the cover assembly. The compressible button or recess 11 may be located above the removable chamber 5. When the compressible button or recess 11 is compressed, it pushes out the air involved in the flexible compartment 55, thereby releasing the blood solidification and / or gelling-promoting substance 50 in the delivery compartment 55 into the adjacent canister 30. The canister 30 contains a liquid sample 60 containing liquid such as settled RBCs and the discharge medium. When the blood solidification and / or gelling-promoting substance 50 released from the delivery compartment 55 is mixed with the liquid sample 60 in the canister 30, the waste components of the liquid sample 60 solidify and / or gel (or coagulate), preventing biohazardous materials from accidentally spilling or scattering to technical personnel. The gelling / solidification of the liquid sample 60 with the blood coagulation / gelling (or coagulation) substance 50 may then be carried out against the agglutinated RBCs in the presence of a coagulant 35. The gelling / gelling substance consists of a composition comprising a highly absorbent cellulosic material such as cellulose. Such a cellulosic material may consist of sodium; 2,3,4,5,6-pentahydroxyhexanal; acetate. This or other suitable agent in powder form may be contained in the compartment of the lid / cap assembly.

[0056] The waste is collected only once in the collection system 100, after which the entire system and its contents are disposed of. The collection system 100 is self-contained and does not require cleaning for disposal of its contents, thereby preventing the occurrence of biohazards. No additional solutions or other cleaning are required to dispose of the contents within the collection system 100.

[0057] The collection system 100 can be propped up on a stand such as an IV drip container tower, or installed on a surface. Each time a medical procedure is completed and the liquid is collected in the collection system 100, the enclosed system and its contents are discarded. A new collection system is then used in place of the used collection system, and the new system is used to process the next batch of waste. The canister 30 may be, for example, a coagulant container having a coagulant 35. Examples of coagulant containers are described in U.S. Patent Application Publication Nos. 16 / 363,674, 16 / 257,876, 16 / 257,673, and 15 / 868,983, which are incorporated herein by reference.

[0058] The collection system 100 can also be used to estimate the amount of blood in the contents of the collection container 30. [Example 3: Non-contact biological material collection and disposal system]

[0059] This embodiment presents a contactless system for collecting and disposing of biologically hazardous materials, minimizing user handling. The system collects and processes liquids containing or suspected to contain biological materials such as blood into a collection canister, assesses the amount of blood present in the collected material, and converts the contents of the container into a solid and / or semi-solid mass that can be easily disposed of within the container without removing the cover / lid assembly.

[0060] Embodiments of the cover assembly are shown in Figures 5, 6, and 7. The cover assembly 201 includes an upper portion 210 and a lower portion 220. The first chamber includes a flexible material layer 205 located on a first surface 225 of the lower portion 220 of the cover assembly. The cover assembly and / or lid 201 may be made of a plastic material, such as polyethylene or polypropylene.

[0061] The flexible material layer 205 is located below the first compartment 207. The first compartment may contain a hemagglutinating material or a blood coagulation material 250. The first button / recess 211 is located directly above the flexible chamber, and when the button and / or recess is pressed, the material in the compartment applies a surface-breaking force to the surface of the flexible material, resulting in the material being discharged into the internal chamber of the collection container. Thus, once the surface of the first flexible chamber is broken by the application of force, the material is released into the container, where it mixes with and comes into contact with the liquid contents.

[0062] A second compartment 209 may be provided, which consists of a preferred material such as a hemagglutinant or blood coagulant (capable of converting agglutinated red blood cells into a solid and / or semi-solid mass or gel). This solid and / or semi-solid mass can then be easily disposed of without the risk of scattering or spillage to other people, technicians, or the site / surroundings.

[0063] A second button / recess 213 defining one side (upper side) of the second compartment is positioned directly above the second flexible layer. When the second button and / or recess is pressed, the material in the second compartment (such as a hemagglutinating agent or agglutinating red blood cell solidifying agent material) is pushed through the flexible layer of the compartment into the collection device.

[0064] The first button / recess 211 and the second button / recess 213 may be substantially horizontal to the first surface 215 of the upper part 210 of the cover assembly 201, respectively, in order to improve the compactness of the cover assembly 201 and allow multiple cover assemblies 201 to be stacked and stored. This prevents the first button / recess 211 and the second button / recess 213 from being subjected to forces that would press against them during packaging and shipping of the cover assembly 201.

[0065] The agglutinating red blood cell solidifying / gelling and / or agglutinating agent may be in powder or other forms such as tablets or liquids. The agglutinating red blood cell solidifying / gelling and / or blood coagulant, red blood cell agglutinator, or both may be sealed in a blister pack within the first or second compartment, for example, in a pack made of plastic and / or aluminum foil. The agglutinating red blood cell solidifying / gelling agent and / or red blood cell agglutinator, or red blood cell agglutinator, may alternatively be packaged in another material, for example, a box, bottle, tray, cartridge, or card, within the first or second compartment, or both compartments.

[0066] The cover assembly 201 also includes a coupling adapter 208 along its perimeter 212, the coupling adapter 208 including a threaded connection suitable for mounting the cover assembly 201 onto the canister 230 to provide a liquid-tight seal. The coupling adapter 208 may consist of a threaded connection, or a screw connection, or a locking connection.

[0067] The cover assembly 201 can be used interchangeably with the collection system 100. [Example 4: Blood volume in liquid - calculation] [(Blood without anticoagulants. High-MW coagulant)]

[0068] The high molecular weight flocculant established in this study for effectively agglutinating human red blood cells in human blood is poly(diallyldimethylammonium chloride). The high molecular weight form of polyDADMAC material has an average molecular weight of 400,000 to 500,000. A low molecular weight form of polyDADMAC may also be used. This flocculant, in powder, tablet, liquid, or other form, may be contained in a compartment of the lid and / or cap of the device and subsequently selectively released into a canister fitted with the lid / cap.

[0069] As part of the claimed blood management system, the amount of blood in the sample within the canister can be calculated according to the following formula: JPEG0007911723000003.jpg1051

[0070] Here, Vb is the calculated volume of blood in the material, Vm is the observational sedimentation plane of red blood cells in the container containing the coagulant, η is the determined filling density for the container, and Hct is the hematocrit of the animal / human from which the liquid material was collected. [Example 5: A polymer solidified material obtained by agglutinating red blood cells precipitated from human blood (without anticoagulant)]

[0071] This embodiment demonstrates the use of a canister cover assembly of the present invention containing a blood coagulant / blood component solidifying agent and / or gelling agent in a compartment for processing agglutinated red blood cells from a volume of human blood (without anticoagulant). The human blood used in the following tests did not contain anticoagulants. The solidification / coagulant considered was a high molecular weight cellulose-containing material, specifically a superabsorbent cellulose-based material (e.g., Liqui-Loc Plus). TM It was a solidifying agent. After a 30-minute settling period, 1 ounce (approximately 100 ml) of cellulose-based solidifying agent (Liqui-Loc Plus TMThe solidifying agent / gelling agent was added to the canister of Test 4. Thirty minutes before adding the solidifying agent / gelling agent, the settled RBCs and other substances in the container (physiological saline, other blood components) were not in a solid and / or gel state. Therefore, to confirm whether the solidifying agent was effective in solidifying the settled and aggregated RBCs in the canister, the solidifying agent and / or gelling agent was released into the canister. The substances in the canister, including the aggregated RBCs, began to solidify and gel, and within one minute, the entire substance in the canister formed a solid, gel-like mass ("plug"). This is a state that can be quickly and safely disposed of as an exposed biohazard. Therefore, after two minutes, the solidified gel-like material in the canister was suitable for safe and efficient disposal without the risk of spillage or contact to container handlers. Thus, as part of the cover / lid of the presented canister, the coagulant and / or solidifying / gelling agent is released from the compartment on the lid into the canister by compressing a recess located above the compartment, allowing for easy and rapid solidification / gelling of the contents in accordance with conventional hazardous waste handling practices in hospitals / facilities and / or medical waste collection facilities for the easy and safe disposal of biohazardous waste. JPEG0007911723000004.jpg143153JPEG0007911723000005.jpg142153JPEG0007911723000006.jpg144153JPEG0007911723000007.jpg144153In Test 4, after a 30-minute sedimentation period in the canister, the settled RBCs were stirred to disperse them and suspend them in the liquid.Cellulose-based solidifying agent (e.g., Liqui-Loc Plus) TM Carboxycelose was added to a suspension (Liqui-Loc 1 ounce, carboxycelose). Within approximately 1 minute, the mixture began to solidify, and after 2 minutes, the entire contents of the canister formed a solidified jelly state. This jelly / solidified material, in this state, was a safe and secure form for the safe disposal of biohazardous waste, eliminating the possibility of human contact with the contents of the canister. [Example 6: Solidifying and / or Coagulating Polymer Material Suitable for Solidifying Biological Waste Containing Aggregated Human RBCs]

[0072] Blood components, such as red blood cells that have settled from blood that has not been treated to contain anticoagulants, will agglutinate upon contact with a coagulant, producing red blood cells that form a uniform, observable settling plane. Human red blood cells that come into contact with a polymer coagulant (e.g., polymer polyDADMAC) in a container will form an observable settling plane. For disposal purposes in accordance with accepted biohazard-responsive hospital / healthcare facility protocols, liquid or semi-liquid hazardous biowaste must be treated to provide a solid, semi-solid, and / or gelling composition that will not splash, spill, or expose technicians and others to the canister contents for safe disposal.

[0073] The canister cover assembly may include a compartment containing an agglutinating red blood cell solidifying agent. The solidifying agent (RBC coagulant, gelling agent) may include a highly absorbent cellulose composition. Compositions used in the healthcare industry (hospitals) to solidify / gelle biological waste include several compositions containing cellulose (e.g., Liqui-Loc Plus, StatSorb, Isosorb, Medi Vac Solid Plus) and other highly absorbent formulation components as part of a suitable solidification / gelling formula.

[0074] This disclosure is not limited to any particular method or system, and should be understood to be subject to change. Furthermore, the terms used herein are for illustrative purposes only and are not intended to limit any particular embodiment.

[0075] Numerous embodiments of this disclosure have been described. However, it should be understood that various modifications can be made without departing from the spirit and scope of this disclosure. Therefore, other embodiments are also within the scope of the following claims. (Prior art document) The following documents are incorporated in their entirety into this book. 1. Nouri, S., et al., (2015). “Efficacy and Safety of Aluminum Chloride in Controlling External Hemorrhage: An Animal Model Study”. Iran Red Crescent Medical Journal. 2015 Mar., 17(3). 2. Ratermann, A., et al., (1980), Journal of Agricultural Food Chemistry. 1980, 28, 2, 438-44. 3. U.S. Patent Application Publication No. 12 / 924,547 4. U.S. Patent Application Publication No. 15 / 868,983. 5. U.S. Patent Application Publication No. 16 / 363,674 6. U.S. Patent Application Publication No. 16 / 257,876 7. U.S. Patent Application Publication No. 16 / 257,673 8. U.S. Patent Publication No. 10,401,347 9. German Patent Application Publication No. 10343668 10. German Patent Application Publication No. 202007003050

Claims

1. A cover and / or lid assembly for a container, Chamber 1 and A compressible button or recess positioned above the first chamber, The chamber comprises a lower layer located below the first chamber, The red blood cell coagulation and / or coagulation material is contained in a delivery compartment, which is a space within the first chamber. The delivery compartment is located below the button or recess and above the lower layer. The red blood cell coagulation and / or coagulation material is selectively released from the delivery compartment in the first chamber through the lower layer into the container when the button or recess is compressed. The red blood cell coagulation and / or coagulation material is configured to form a solid and / or semi-solid mass of human blood in the container in order to provide waste disposal without blood spillage. The aforementioned cover and / or lid assembly further comprises: The second chamber and A second compressible button or recess positioned above the second chamber, The present invention further comprises a second lower layer located below the second chamber, The second chamber contains a human hemagglutinating agent, The agglutinant is configured to form agglutinated human red blood cells in the container. The aforementioned coagulant does not form solid, semi-solid, or jelly-like clumps even when in contact with human blood in the container, and is used in covers and / or lid assemblies.

2. The cover and / or lid assembly according to claim 1, wherein the red blood cell coagulation and / or coagulation material is made of cellulose or a polymer preparation.

3. The cover and / or lid assembly according to claim 2, wherein the red blood cell coagulation and / or coagulation material is a cellulose-based material that solidifies a liquid containing human agglutinated red blood cells.

4. The lid is further provided with a coupling adapter along its circumference, The cover and / or lid assembly according to claim 1, wherein the coupling adapter includes a threaded configuration suitable for attaching the cover assembly to the upper opening of the container.

5. The lower layer is made of foil or plastic film. The cover and / or lid assembly according to claim 1.

6. The cover and / or lid assembly according to claim 1, wherein the human hemagglutinating agent is polyDADMAC.

7. The cover and / or lid assembly according to claim 1, wherein the flocculant is a powder.

8. The cover and / or lid assembly according to claim 7, wherein the flocculant is a cellulose-based material.

9. Collection containers and Cover and / or lid assembly, Equipped with, The collection container has a canister configuration and a volume capacity of 100 ml, 250 ml, 500 ml, 1,200 ml, or 5,000 ml. The cover and / or lid assembly is as defined in claim 1, The cover and / or lid assembly includes a coupling adapter suitable for securely attaching to the opening of the collection container. The canister includes a surface coating of a human hemagglutinant. A collection and disposal system comprising a human red blood cell agglutinant configured to form agglutinated human red blood cells in the collection container.

10. The collection and disposal system according to claim 9, wherein the human erythrocyte agglutinator is polyDADAMC.

11. The second chamber and A second compressible button or recess positioned above the second chamber, The system comprises a second lower layer located below the second chamber, The second chamber contains a human hemagglutinating agent, The agglutinant is configured to form aggregated human red blood cells in the container. The collection and disposal system according to claim 9, wherein the coagulant does not form solid, semi-solid, or jelly-like clumps even when in contact with human blood in the container.

12. The collection and disposal system according to claim 11, wherein the flocculant is a cellulose-based material.

13. The cover and / or lid assembly according to claim 1, and the lid assembly for a container equipped with a collection canister.

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