Cover assembly with coagulant compartment and use thereof in blood monitoring / management systems

Abstract

The present invention relates to a cover / cap assembly having a first compartment, a second compartment, or both. Each compartment will include a top side and a bottom side, the bottom side of the compartment including a frangible material. The first or second compartment can include a first material or a second material. The first or second material can include a flocculating red blood cell coagulability and / or gelling agent, such as a high absorbency cellulose and / or polymer formulation, or a red blood cell flocculating agent. The material within the compartment can be selectively released upon compression of a recess and / or button, the recess and / or button being positioned directly above the first and / or second compartment. A collection and / or biohazard waste management and disposal system is introduced, the collection and / or biohazard waste management and disposal system including the cap / cover assembly described above and a collection container. The cap can include a perimeter having a tapped and / or snap-fit assembly adapted to positively attach the cap to a collection canister. The collection canister can include a red blood cell flocculating agent coating.

Description

Technical Field

[0001] This application claims the benefit of U.S. Application No. 17 / 026.106, filed September 18, 2020, which claims priority to U.S. Provisional Application No. 63 / 055.577, filed June 23, 2020, both of which are incorporated herein by reference.

[0002] This invention relates to the field of lids and / or covers for containers. Background Technology

[0003] Containment and management of waste and other materials containing potential biohazards (such as blood) require careful handling. The presence of blood in fluids and other materials, such as those generated during the processing of animal and / or human bodies and / or carcasses and / or throughout the process (e.g., surgery, specimen handling, carcass disposal, processing, and / or management facilities (morgues, morgues, hospitals, veterinary offices, taxidermy, tissue banks)), necessitates the use of processes and equipment to minimize contact with and / or spillage of said fluids and / or waste.

[0004] Fluid / waste spills and contact issues pose a significant risk of exposing patients, attending clinicians, and the surrounding surgical environment to blood contaminants. Existing collection dishes / containers used in material collection and disposal do not effectively control exposure to liquid / waste contaminants, at least in part, due to the presence of any blood in a fluid state in the existing collected materials.

[0005] Containers used for collecting biohazardous materials, particularly those collected from surgical procedures, may contain a cap with a port that must be manually opened and emptied by the user for disposal of the liquid waste contents. This process poses a risk of contamination to the user performing the disposal activity, to others within the immediate vicinity where the contents are being disposed of, and to the overall area where the process is being performed. Especially in the medical field, there is a need for safer methods for handling and disposing of liquid or semi-liquid waste materials to prevent these potential and significant health and safety risks and / or other hazards.

[0006] The liquidity of collected materials is at least partially related to a liquid state in which any blood in the material remains for several hours under standard room temperature and collection conditions. Any blood present can remain in a liquid state for a much longer period, depending on the other materials present. Techniques for rapidly and easily reducing the liquidity of collected materials (especially biohazardous materials) are largely undeveloped and do not meet current needs.

[0007] Blister packaging assemblies, or "blister packs," have been used for convenient packaging of various consumer goods, such as chewing gum, throat lozenges, and certain medications. In this sense, "blister pack" should be understood as relating to pre-formed plastic and / or foil packaging used for small consumer goods, food, and pharmaceuticals (chewing gum, etc.). The blister pack typically provides a cavity or pocket made of formable mesh, aluminum foil, or plastic on one side, and cardboard or other less conventional back wall or seal on the other side. The product can be easily retrieved by the user by applying force against the back wall, allowing the product to pass through the foil or plastic compartments, and, for example, into the user's hand. In a typical blister pack, the contents of the blister pack's "cavity" compartment are released when the user applies direct force against the back wall of the "pack," while the back wall remains intact.

[0008] Typically, when direct pressure is applied to the rear wall of the blister pack, the weakest part of the front wall or outer shell layer of the blister pack assembly will be thrust out of the compartment because the front wall material is perforated by the product contained within the compartment. When pressure is applied to the blister pack, the backing seal breaks, and the contents of the blister pack are ejected through a tear in the backing seal.

[0009] The blister packaging unit is described in German patent application DE10343668A1, which relates to a hermetically sealed blister packaging for pharmaceuticals. In another example, German patent application DE202007003050U1 relates to a blister packaging for a liquid substance that is released into the external environment via diffusion.

[0010] The medical field still requires improved equipment, materials, and methods to handle and securely manage the disposal of liquid or semi-liquid materials containing blood or blood components, and to avoid and / or minimize user contact. Summary of the Invention

[0011] This invention provides a solution to these and other problems existing in the art.

[0012] In a general and holistic sense, the present invention provides materials, devices, and systems for the secure management and disposal of potentially hazardous materials that may contain fluid components, such as those collected during or after laboratory, medical, or other processes.

[0013] Specifically, there are devices and methods for processing and disposing of materials that may contain blood or blood products and are collected during a surgical procedure. The devices and methods of the present invention accommodate covering assemblies, such as covers, caps, and / or caps, and provide a tool that allows for a safer, non-contact disposal solution for potentially biohazardous materials. In this sense, a waste collection and biohazard single-use system is provided.

[0014] In one embodiment, the device includes a cover and / or cover assembly comprising a first compartment containing a coagulant material capable of coagulating blood components (red blood cells). The first compartment has a top side and a bottom side, wherein the top side includes a compressible button or recess. In this embodiment, the compressible button or recess is preferably located above a fragile layer positioned on the bottom side of the first compartment, wherein the fragile layer, upon breakage, releases the coagulant material and functions to coagulate and / or gel blood components (e.g., red blood cells) within the material.

[0015] In some embodiments, the coagulant material is selectively released from the compartment and into a container or other receiver upon breakage of the fragile layer / cover. Thus, in operation, when the compressible button or recess is compressed, the coagulant, particularly a blood coagulant, is selectively released. Subsequently, any blood components in the container and / or compartment will rapidly form a coagulated semi-solid, gel-like state, thus allowing for substantially spill-free, more easily disposed clumps of solid and / or semi-solid material.

[0016] In other embodiments, the cover and / or cap assembly includes a second compartment containing a erythrocyte flocculant material capable of flocculating blood components (erythrocytes). The second compartment has a top side and a bottom side, wherein the top side includes a compressible button or recess. In this embodiment, the compressible button or recess is preferably located above a fragile layer positioned on the bottom side of the compartment, wherein the fragile layer, upon breakage, releases the erythrocyte flocculant material and functions to flocculate erythrocytes by interacting with their surface, thereby inhibiting blood clotting.

[0017] Almost any coagulant capable of clotting blood (or more precisely, red blood cells (and even more precisely, flocculating red blood cells)) is a material that can be used in this device / cover / cap.

[0018] Table 1 shows examples of flocculants for human red blood cells (RBCs). RBCs are flocculated (uncoagulated) by these flocculants and may also be coagulated upon exposure and / or in combination with a coagulant such as that provided by this apparatus and method to provide solid or semi-solid clumps.

[0019] Table I

[0020]

[0021] In the presence of an RBC flocculant in a fluid containing blood, RBCs bind together and form heavier particles that settle within a container / bottle / tube / collapsible bag or other vessel in which the sample / material is collected. Once the flocculent RBCs in the collected biological material have settled, they are readily redispersible and do not coagulate and / or form solid clumps that are then easily and firmly disposed of. Therefore, these RBCs can be coagulated by providing one or more suitable coagulants to the flocculent or dispersed red blood cells.

[0022] In some embodiments, the flocculant comprises polydiallyldimethylammonium chloride (PDMC). Almost any type of flocculant can be used to achieve the sedimentation of red blood cells in a liquid. Examples of RBC flocculants include both polymeric and non-polymeric RBC flocculants. Non-polymeric RBC flocculants may contain acids, such as HCl or other acid molecules.

[0023] The selection of an appropriate coagulant (or blood clotting agent) requires that the reagent be able to form solid, gel-like, or semi-solid clumps from fluid containing flocculated red blood cells.

[0024] Kits are provided in which blood clotting / gelling agents are packaged as part of a cap / lid assembly and configured to securely attach (screws, clips, etc.) to an opening in a collection vessel, such as to the top opening of a collection vessel or device. In some embodiments, the cap / lid / lid assembly is configured to receive a blister pack as described above, and the blood clotting / gelling agent is contained within the blister pack as part of the cap assembly. In some embodiments, the cap assembly is configured to securely attach to the opening of a collection vessel.

[0025] In some embodiments, the blister pack may include two films, which may be composed of multiple layers of different or identical materials. The films may be made of plastic and / or metal, such as aluminum, but other materials such as paper or the like may theoretically be used or added to. The two films, in particular, are a base layer or base film (support) and a cover layer or cover film (cover).

[0026] One or more pores or recesses for holding the liquid, particularly a pharmaceutical formulation, may be present in the base film or support, into which the liquid is introduced. The covering film or the cover is then placed on the base film or support and fixed or attached thereto, and this is preferably carried out, for example by adhesive, heat sealing, welding, etc., at the edges or in connecting areas, particularly in areas of flat, mating surfaces.

[0027] The blister pack can be sealed with an inert compound that minimizes interference with the analysis of blood, blood components, or other chemicals to be introduced into the collection container. To enable the blister to break under pressure, a fragile seal is typically provided around at least a portion of the periphery of the blister cavity. This fragile seal technology allows for relatively simple and controlled reagent release while eliminating the need for complex fluid handling systems or external puncture devices.

[0028] The sealing material used for the blister pack can be a plastic film made of materials such as polyethylene, polypropylene, polybutene, polyvinyl chloride, or combinations thereof. The sealing material used for the blister pack can also be aluminum foil.

[0029] The blister cavity or pocket can be made of formable mesh, typically a thermoformable plastic such as PVC, PVDC, polyvinyl chloride trifluoroethylene (PCTFE), or cyclic olefin copolymer (COC) or polymer (COP). These materials can be combined with polypropylene (PP), polyethylene (PE), or ethylene glycol-modified polyethylene terephthalate (PETg) for added protection.

[0030] Blood coagulation / gelling agents: Various types of blood coagulation / gelling agents may be used in conjunction with embodiments of the present invention. These (agents) may contain cellulose materials, their salts, and inorganic compound salts (e.g., Cu(II), Ag(I), Fe(II), Fe(III), Ti(IV), and Ni(II)). The coagulation / gelling agents may be applied by atomization and / or as a powder of a cellulose-rich compound. As an example, the following can be used... PolySorb TMCalcium and sodium salts of micro-dispersed oxidized cellulose Or similar reagents may be used to coagulate the components (complexes) for disposal. Effective coagulants / gelling agents may include solutions containing any of the following compounds: methanol; polyaluminum chloride; silver nitrate; copper(II) sulfate, copper(II) bromide; sulfuric acid; ferrous sulfate subsulfate; ferric chloride; aluminum sulfate; or zinc sulfate. The flocculating erythrocyte coagulant and / or gelling agent may be provided in powder, tablet, or liquid form as part of this device and the method of using this device. Table II provides examples of the flocculating erythrocyte coagulant and / or gelling agents. As a component of the cap / lid assembly, the cellulose material in powder form may be provided in the compartment of the cap assembly and readily released into the container / tank without exposing the container contents to the risk of operator / technician exposure.

[0031] Table 2

[0032]

[0033]

[0034] Cover / lid assembly for tanks, collection bags and containers: Collection equipment that houses tanks, collection bags and containers, suitable for performing collection and visually estimating blood loss and can be used with the cover and / or lid assembly provided herein.

[0035] In some embodiments, the cover / cover assembly may contain one or more fragile compartments. The fragile compartments will include a coagulant that will effectively coagulate flocculated red blood cells in the fluid.

[0036] In another embodiment, the cap / cover assembly will include a first fragile compartment comprising a cellulose coagulant / gelling agent that will effectively coagulate and / or remove the liquid component of the preparation agent containing suspended flocculated red blood cells in the fluid, and a second fragile compartment comprising a red blood cell flocculant. This embodiment of the cap / cover assembly is envisioned for use with a collection tank or other container having an interior that has not been treated to contain a coating of red blood cell flocculant, such as a red blood cell flocculant (e.g., polydiallyldimethylammonium chloride). As part of a blood loss assessment device, the cap having these two fragile compartments will be used with a collection device whose interior surface has not been previously treated to contain a coating comprising red blood cell flocculant. Before or during the collection of fluid into the container, the red blood cell flocculant in the second fragile compartment will be released into the interior of the collection container. The presence of the erythrocyte flocculant will allow any erythrocytes in the collected material / fluid to settle in the container and form a discernible level of settled erythrocytes. However, if the contents of the container are disturbed, the settled flocculent erythrocytes can be easily dispersed and no solidification will occur. To convert the flocculent erythrocytes into more easily disposable solid and / or semi-solid clumps, the flocculent erythrocyte coagulant and / or gelling material contained in the second fragile compartment of the cover assembly can be reliably and simply released into the interior of the container without opening the container or removing the cover / cover assembly. Safe, reliable, non-contact assemblies and devices are provided for simultaneously assessing the level of settled erythrocytes in the material (and calculating its blood volume) and disposing of collected material containing or suspected of containing blood and / or erythrocytes in a single assembly without exposing the contents to the environment or the user.

[0037] In any embodiment, the cap assembly may be configured to have a circumference that allows the cap assembly to be reliably and tightly fitted over the top or opening of a collection device, such as a biofluid collection device. The biofluid collection device may take the form of devices described in U.S. Patent 10,401,347 and U.S. Patent Applications Nos. 16 / 363,674, 16 / 257,876, and 16 / 257,673, as well as corresponding patents and patent applications outside the United States, which contain erythrocyte flocculant as a component, provided as a surface coating of erythrocyte flocculant on the surface of the collection container, such as on the inner surface of the container. The container may have a canister, envelope, or bag shape, or other configuration, on which the coating of erythrocyte flocculant material may be provided. These patents and patent applications are specifically incorporated herein by reference in their entirety.

[0038] In summary, this cover and / or cap assembly can be used with a collection device, such as a tank, collection bag, or sleeve, which is preferably sufficiently transparent or at least translucent to enable visual inspection of the material level (e.g., sedimentation level) of flocculated red blood cells (RBCs, not coagulated blood) within the collection device. The collection device may be made of solid or flexible materials, such as rigid plastic or glass, or of flexible materials, such as plastic or other non-rigid materials, and is suitable for containing liquid and / or semi-liquid materials that include or are suspected of including blood. This liquid and / or semi-liquid material containing or suspected of including blood is used to contain liquid medical waste materials containing blood.

[0039] These descriptions are provided as examples and are not intended to provide any limitations on potential embodiments contemplated for use and practice of this device. Attached Figure Description

[0040] Other objects, features, and advantages of the invention will become more apparent upon reading the following non-limiting description and with reference to the accompanying drawings, in which:

[0041] - Figure 1 Examples of the coverings and / or cover assemblies disclosed herein are shown.

[0042] - Figure 2 An embodiment of the collection system disclosed herein is shown.

[0043] - Figure 3 A plan view of an embodiment of the cover assembly and / or top section of the cover disclosed herein is shown.

[0044] - Figure 4 A plan view of an embodiment of the cover assembly and / or the bottom section of the cover disclosed herein is shown.

[0045] - Figure 5 Another embodiment of the cover assembly disclosed herein is shown.

[0046] - Figure 6 A plan view of another embodiment of the top segment of the cover assembly disclosed herein is shown.

[0047] - Figure 7 A plan view of another embodiment of the bottom segment of the cover assembly disclosed herein is shown. Detailed Implementation

[0048] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Although any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this technique, preferred methods and materials are described herein.

[0049] As used herein, the term "flocculator" is intended to refer to a molecule with a cationic charge that is capable of promoting the aggregation of red blood cells (RBCs) in a fluid at room temperature and forming sedimented RBC clumps in less than 30 minutes at room temperature without centrifugation. The flocculants defined herein do not provide for the coagulation, solidification, or gelation of liquids containing blood or blood components (e.g., red blood cells).

[0050] Referring to an element with the indefinite article "a" or "an" does not preclude the possibility of multiple elements, unless the context explicitly requires the presence of only one element. Therefore, the indefinite article "a" or "an" usually means "at least one".

[0051] As used herein, "patient" or "subject" refers to an individual who has symptoms of cancer or other malignant tumors or is at risk. A patient may be human or non-human and may include animals such as horses, dogs, cattle, pigs, or other animals. Similarly, a patient or subject may include a human patient who is an adult or adolescent (e.g., a child). Furthermore, a patient or subject may refer to any living organism, preferably a mammal (e.g., human or non-human), from which blood volume (blood volume) is desired to be determined and / or monitored based on the administration of the composition contemplated herein.

[0052] As used in this article, “waste” refers to a mixture containing blood or blood components (such as red blood cells). Biowaste from hospital / clinical sources is an example.

[0053] As used herein, “blood clotting and / or gelling-enhancing substance” or “blood clotting material” refers to a substance that can provide solid or semi-solid gel-like clumps from a liquid or semi-liquid material comprising blood or blood components (e.g., red blood cells).

[0054] As used herein, “approximately” means one or more values ​​within a statistically meaningful range, such as a specified concentration, length, molecular weight, pH, sequence characteristics, time frame, temperature, or volume. Such a value or range can be on the order of magnitude, typically within 20%, more typically within 10%, and even more typically within 5% of a given value or range. The permissible variation covered by “approximately” will depend on the specific system studied and will be readily understood by those skilled in the art.

[0055] Examples are given below to illustrate some embodiments of the present invention.

[0056] Example 1 - Tank Cover / Lid Assembly

[0057] This example illustrates a description of an embodiment of a cover assembly / cover 1. The cover assembly / cover is as follows: Figure 1 , Figure 3 and Figure 4 As shown.

[0058] The cover assembly / lid 1 accommodates a top segment 10 and a bottom segment 20, and also accommodates a fragile compartment 5 located on a first surface 25 of the bottom segment 20. The cover assembly / lid 1 may comprise a transparent plastic material, such as polyethylene or polypropylene. The fragile compartment 5 accommodates a blood clotting enhancer 50, which can be selectively released from the fragile compartment 5.

[0059] In this embodiment, the blood clotting-enhancing substance 50 may be a powder, such as... Figure 4 As shown. However, the blood coagulation and / or gelling enhancer and / or biological waste coagulant 50 may be in powder, tablet, or liquid form, and may be selected from any of the blood coagulation and / or gelling compounds listed above. The blood coagulation and / or gelling enhancer and / or biological waste coagulant 50 may be enclosed in a fragile compartment 5. The fragile compartment may be provided as a blister pack, the blister pack including a release side comprising a fragile material, such as aluminum, tin, or other foil, plastic, or other fragile material. The blood coagulation and / or gelling enhancer 50 may be contained within the blister pack. Alternatively, the blood coagulation and / or gelling enhancer and / or coagulant may be packaged in a box, bottle, tray, cartridge, or card.

[0060] The cover assembly / lid 1 may also accommodate a coupling adapter 8 along its periphery 12. The coupling adapter 8 has a threaded connection adapted to attach the cover assembly 1 to the tank 30 to provide a fluid-tight seal. The coupling adapter 8 may include, for example, a threaded connection, a screw connection, or a locking connection. Figure 1 As shown, the cover assembly / cover 1 may accommodate a compressible button or recess 11 on a first surface 15 of the top segment 10 of the cover assembly, which is made of a non-fragile material. In some embodiments, the compressible button or recess 11 is located above the fragile compartment 5, and when a compressive force is applied by the user (e.g., "pushing" the recess / button in), the blood clotting-enhancing substance 50 is released from the delivery compartment 55 because the fragile layer of the compartment (e.g., by the force applied against the fragile layer by the substance contained within the fragile compartment and / or by the pressure applied when the button or recess 11 is pressed) opens / breaks.

[0061] In the embodiments, and as such Figure 4 As shown, the first fragile compartment 55 includes a non-fragile top layer 57 and a bottom fragile layer 59. Applying pressure to the non-fragile layer 57 causes a force to be applied to the bottom fragile layer 59, resulting in the fragile layer breaking or tearing. The breaking and / or tearing of the fragile layer, in turn, results in the release of a blood clotting-enhancing substance 50 into a sealed collection device. A compressible button and / or recess 11 positioned on the non-fragile top layer 57 may be composed of one or more plastic materials that are foldable and capable of being bent by applied pressure. The bottom fragile layer 59 may include a thin aluminum film or other material that will break and / or tear under pressure applied to the button and / or recess. The applied pressure may originate, for example, from a user pressing inward or downward on the button and / or recess, thus creating air pressure applied against the interior of the fragile compartment and through the bottom fragile layer 59.

[0062] Example 2 - Collection System

[0063] This example illustrates a collection system 100 of the present invention. The system is as follows... Figure 2 As shown. The collection system 100 accommodates a collection vessel that can be connected to a cover and / or lid assembly 1. The cover and / or lid assembly 1 accommodates a top segment 10 and a bottom segment 20, and also accommodates a fragile chamber 5 located on a first surface 25 of the bottom segment 20 of the cover assembly.

[0064] The fragile chamber 5 contains blood-coagulant / gelling agents and / or blood-coagulation-enhancing substances 50, which can be selectively released from the fragile chamber 5. The blood-coagulant and / or gelling-enhancing substances 50 can be sealed in a compartment 55, which may be a blister pack. The blister pack is made of a fragile material on its surface, such as plastic and / or aluminum foil. The cover and / or cap assembly 1 has a coupling adapter 8 along the periphery 12 of the cover assembly 1, and the coupling adapter 8 has a threaded structure adapted to attach the cover assembly 1 to the top opening of the can 30 to provide a reliable, fluid-tight closure.

[0065] Cover assembly 1 may accommodate a compressible button or recess 11 on a first surface 15 of the top segment 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 air into engagement with the fragile compartment 55, causing blood clotting and / or gelling enhancer 50 within the delivery compartment 55 to be released into the adjacent tank 30. Tank 30 contains a fluid sample 60 containing fluids, such as settled RBCs and other media to be disposed of. When the blood clotting and / or gelling enhancer 50 is released from the delivery compartment 55 and mixes with the fluid sample 60 in the tank 30, the waste components of the fluid sample 60 will coagulate and / or gel (or otherwise solidify) to prevent accidental spillage or splashing of biohazardous material onto technicians. The gelation / coagulation of the fluid sample 60, carried out by the blood-coagulant / gelling (or coagulating) substance 50, can then be replaced by flocculant 35 instead of the flocculated RBCs. The coagulant / gelling agent will comprise a composition including a highly absorbent cellulose material as cellulose. Such a cellulose material may include sodium; 2,3,4,5,6-pentahydroxyhexanal; acetate. Powder form of this or other suitable reagent may be contained within the compartment of the cap / cap assembly.

[0066] Waste is collected once in collection system 100 and then the entire system and waste contents are discarded. Collection system 100 is self-contained and does not require cleaning to dispose of its contents, thereby preventing biohazards. No additional solutions or other cleaning agents are required to dispose of the contents in collection system 100.

[0067] Collection system 100 may be implemented as propped or mounted on a support, such as a tower for an IV drip container. Each time a medical procedure is completed and fluid is collected in collection system 100, the closed system and its contents are disposed of. A new collection system is then installed in place of the previously used collection system, and the new system is used to process any additional waste. Tank 30 may be, for example, a flocculation container with flocculant 35. Examples of flocculation containers are described in U.S. Patent Applications Nos. 16 / 363,674, 16 / 257,876, 16 / 257,673, and 15 / 868,983, which are incorporated herein by reference.

[0068] The collection system 100 also provides for estimating the blood volume (blood volume) in the contents within the collection container 30.

[0069] Example 3 - Non-contact biological material collection and disposal system

[0070] This example illustrates a non-contact system for collecting and disposing of biohazardous materials, minimizing user intervention. The system provides for collecting and processing a fluidized bed containing suspected or contained biological material (e.g., blood) in a collection container, for assessing the volume of blood present in the collected material, and for converting the contents of the container into easily disposable solid and / or semi-solid clumps within the container without disassembling the cover / cap assembly.

[0071] Implementation of the covering assembly, for example Figure 5 , Figure 6 and Figure 7 As shown. Cover assembly 201 accommodates a top segment 210 and a bottom segment 220. A first chamber accommodates a fragile material layer 205 located on a first surface 225 of the bottom segment 220 of the cover assembly. The cover assembly and / or cover 201 may comprise a plastic material, such as polyethylene or polypropylene.

[0072] A fragile material layer 205 is positioned at the bottom side of a first compartment 207. This first compartment can hold red blood cell flocculant material or blood clotting agent material 250. A first button / recess 211 is implemented directly above the fragile chamber, and when the button and / or recess is pressed, the material in the compartment applies a force against the surface of the fragile material, causing the surface to break and thus discharging the material into the internal chamber of the collection container. Therefore, by applying the force to break the surface of the first fragile chamber, the material is released into the container, where it mixes with and comes into contact with the fluid contents.

[0073] A second compartment 209 may also be provided, comprising a preferred material, such as a erythrocyte flocculant or blood clotting agent (capable of converting flocculated erythrocytes into solid and / or semi-solid clumps or gels). The solid and / or semi-solid clumps can then be readily disposed of without splashing or spilling into other personnel, technicians, or the surrounding area at risk.

[0074] The second button / recess 213, which defines the side of the second compartment (the top side), will be positioned directly above the second fragile layer, and when the second button and / or recess is pressed, material within the second compartment (e.g., red blood cell flocculant or flocculating red blood cell coagulant material) will be forced through the fragile layer of the compartment and into the internal collection device.

[0075] The first button / recess 211 and the second button / recess 213 may each be substantially level with the first surface 215 of the top segment 210 of the cover assembly to improve the compactness of the cover assembly 201 and allow for stackable storage of more than the cover assembly 201. This also ensures that the first button / recess 211 and the second button / recess 213 are not exposed to forces that may be pressed on them during packaging and shipping of the cover assembly 201.

[0076] The flocculating erythrocyte coagulant / gelling and / or coagulant substance may be a powder or other form, such as tablets or liquid. The flocculating erythrocyte coagulant / gelling (reagent) and / or blood coagulant, erythrocyte flocculant, or both, may be contained in a blister pack enclosed within the first or second compartment, for example, within a pack made of plastic and / or aluminum foil. Alternatively, the flocculating erythrocyte coagulant / gelling (reagent) and / or erythrocyte coagulant, or erythrocyte flocculant, may be packaged in another material, such as a box, bottle, tray, cartridge, or card, within the first or second compartment or both compartments.

[0077] The cover assembly 201 also accommodates a coupling adapter 208 along its periphery 212, and the coupling adapter 208 has a threaded connection adapted to attach the cover assembly 201 to the tank 230 to provide a fluid-tight seal. The coupling adapter 208 may include a threaded connection, a screw connection, or a locking connection.

[0078] The cover assembly 201 is interchangeable with the collection system 100.

[0079] Example 4 - Blood volume in liquid calculated blood (excluding anticoagulants), high molecular weight (MW) flocculant

[0080] The high molecular weight flocculant, established in this study for effectively flocculating human erythrocytes in human blood, is poly(diallyldimethylammonium chloride). The high molecular weight form of poly(diallyldimethylammonium chloride) material has an average molecular weight of 400,000 to 500,000. Lower molecular weight forms of poly(diallyldimethylammonium chloride) may also be used. The flocculant, in powder, tablet, liquid, or other forms, may be contained in the compartment of the cover and / or cap of this device and selectively released into a canister on which the cover / cap is fitted.

[0081] As part of the blood management system claimed, the amount of blood in the collected material within the tank can be calculated using the following formula:

[0082]

[0083] Where Vb equals the calculated blood volume in the material, and Vm equals the observed erythrocyte sedimentation level in a container with flocculant. It is equal to the packaging ratio determined for the container / container, and Hct is equal to the hematocrit of the animal / human from which the liquid material was collected.

[0084] Example 5 - Aggregative coagulation of flocculated red blood cells precipitated from human blood (without anticoagulant). Material

[0085] This example illustrates the use of this tank cover assembly, which contains a blood coagulant / blood component coagulation and / or gelling agent within a compartment to perform flocculation of red blood cells from a volume of human blood (without anticoagulant). The human blood used in the following studies did not (and never) contain an anticoagulant. The coagulant / clotting agent examined is a highly absorbent cellulose-containing material with a high molecular weight (e.g., Liqui-LocPlus). TM A cellulose material (coagulant). At the end of the 30-minute settling period, 1 ounce (approximately 100 ml) of cellulose coagulant (Liqui-LocPlus) is added. TMThe coagulant / gelling agent was added to test tank 4. During a 30-minute period prior to the addition of the coagulant / gelling agent, the settled RBCs and other materials (saline, other blood components) in the container were not in a solid and / or gelling state. To determine whether the settled flocculent RBCs and other materials in the tank had been effectively coagulated in the coagulant, the coagulant and / or gelling agent was released into the tank. The material in the tank, which contained the flocculent RBCs, began to coagulate / gel within approximately 1 minute, and the entire contents of the tank formed a solid, gelling mass (“plug”). This was ready to be firmly disposed of as biohazardous material to address any exposure. Therefore, after 2 minutes, the coagulated, gelling material in the tank was suitable for safe and effective disposal without the risk of spillage or contact with personnel handling the container. Therefore, as part of the tank cover / lid, coagulants and / or coagulant / gelling agents can be released from a compartment on the cover into the tank by compression through a recess positioned above the compartment, to easily and quickly coagulate / gel the contents for simple and secure disposal of biohazardous waste, thereby complying with routine hazardous waste treatment practices at hospitals / facilities and / or medical waste collection facilities.

[0086]

[0087]

[0088]

[0089] In Test 4, at the end of the 30-minute settling period, the settled RBCs in the tank were stirred to disrupt them, thus suspending them in the liquid. Cellulose coagulants (e.g., Liqui-LocPlus) were used. TM Carboxycellulose (1 oz Liqui-Loc, carboxycellulose) is added to the suspension. Within approximately 1 minute, the mixture begins to solidify, and after 2 minutes, the entire contents of the container are in a solidified, gelled state. This gelled / solidified material is in a form that is definitively and reliably suitable for the safe disposal of biohazardous waste, eliminating any contact between the container contents and personnel.

[0090] Example 6 - Suitable for coagulating biowaste products containing flocculated human RBCs and coagulating polymers Compatible materials

[0091] Blood components, such as red blood cells, precipitated from blood that has not yet been processed to contain anticoagulants, will cause the red blood cells to flocculate upon contact with a flocculant, resulting in a uniform and observable sedimentation level. Human red blood cells exposed in containers to a high molecular weight flocculant (e.g., high molecular weight (mw) polydiallyldimethylammonium chloride) will also form an observable sedimentation level. For disposal in accordance with recognized biohazard safety hospital / medical facility protocols, liquid or semi-liquid hazardous biological waste should be treated, for example, to provide a solid, semi-solid, and / or gelled composition that will not splash, spill, or otherwise expose technicians and others to the contents of the container for safe disposal.

[0092] The tank cover assembly can accommodate compartments containing a flocculating red blood cell coagulant. The coagulant (RBC coagulant, gelling agent) may include a highly absorbent cellulose component. A composition used in the healthcare industry (hospitals) for coagulating / gelling biowaste contains multiple components, including cellulose (e.g., Liqui-LocPlus, StatSorb, Isosorb, MediVacSolidPlus), and other highly absorbent formulation ingredients (components), as part of a suitable coagulating / gelling formulation.

[0093] It should be understood that the present invention is not limited to a particular method or system, and variations are certainly possible. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0094] Many embodiments of the invention have been described. However, it will be understood that various modifications can be made without departing from the spirit and scope of the invention. Therefore, other embodiments are within the scope of the following claims.

[0095] bibliography

[0096] The following references are incorporated herein by reference in their entirety.

[0097] 1. Nouri, S., et al., (2015). “Efficacy and Safety of Aluminum Chloridein Controlling External Hemorrhage: An Animal Model Study”. Iran Red Crescent Medical Journal. March 17, 2015 (3).

[0098] 2. Ratermann, et al., (1980), Journal of Agricultural Food Chemistry. 1980, 28, 2, 438-44.

[0099] 3. U.S. Patent Application No. 12 / 924,547.

[0100] 4. U.S. Patent Application No. 15 / 868,983.

[0101] 5. U.S. Patent Application No. 16 / 363,674.

[0102] 6. U.S. Patent Application No. 16 / 257,876.

[0103] 7. U.S. Patent Application No. 16 / 257,673.

[0104] 8. U.S. Patent 10,401,347.

[0105] 9. German patent application DE10343668A1.

[0106] 10. German patent application DE202007003050U1.

Claims

1. A cover and / or lid assembly for a container, said cover and / or lid assembly comprising: A first compartment, comprising a first chamber, a compressible button or recess located above the first chamber, and a fragile cover located below the first chamber, wherein a flocculating erythrocyte coagulant and / or coagulating material is contained within the first chamber, and wherein, upon compression of the button or recess, the flocculating erythrocyte coagulant and / or coagulating material is selectively released from the first chamber into the container, and the material is configured to form a solid and / or semi-solid human blood clot within the container to provide spill-free disposal. The covering and / or cover assembly also includes: The second compartment includes a second chamber, a second compressible button or recess located above the second chamber, and a second fragile cover located below the second chamber. The second chamber contains a human red blood cell flocculant material, wherein the flocculant material is configured to form flocculated human red blood cells in the container, and wherein the flocculant material does not form solid, semi-solid, or gel-like clumps when in contact with human blood in the container.

2. The covering and / or cover assembly according to claim 1, wherein, The flocculating red blood cell coagulation and / or coagulating materials include cellulose or polymer formulations.

3. The covering and / or cover assembly according to claim 2, wherein, The flocculated red blood cell coagulant and / or coagulating material includes a cellulose material that coagulates a liquid containing human flocculated red blood cells.

4. The cover and / or lid assembly of claim 1, comprising a coupling adapter along the periphery of the lid, the coupling adapter including a threaded structure adapted to attach the cover assembly to a top opening of the container.

5. The covering and / or cover assembly according to claim 1, wherein, The fragile covering includes foil or plastic film.

6. The covering and / or cover assembly according to claim 1, wherein, The human red blood cell flocculant material is polydiallyldimethylammonium chloride.

7. The covering and / or cover assembly according to claim 1, wherein, The flocculated red blood cell coagulant and / or coagulating material includes powder.

8. The covering and / or cover assembly according to claim 7, wherein, The flocculated red blood cell coagulation and / or coagulating material is a cellulose material.

9. A collection and disposal system comprising a collection container and a cover and / or a lid assembly, wherein: The collection container has a canister structure and a volume capacity of 100 ml, 250 ml, 500 ml, 1200 ml, or 5000 ml; and wherein the cover and / or lid assembly is as defined in claim 1, wherein the cover and / or lid assembly includes a coupling adapter adapted to be securely attached to the opening of the collection container.

10. The collection and disposal system according to claim 9, wherein, The tank includes a surface coating of human red blood cell flocculant, and wherein the human red blood cell flocculant is configured to form flocculated human red blood cells within the collection container.

11. The collection and disposal system according to claim 10, wherein, The human red blood cell flocculant includes polydiallyldimethylammonium chloride.

12. The collection and disposal system according to claim 9, wherein, The second chamber contains a human red blood cell flocculant material, wherein the flocculant material is configured to form flocculated human red blood cells in the collection container, and wherein the flocculant material does not form solid, semi-solid, or gel-like clumps when in contact with human blood in the collection container.

13. The collection and disposal system according to claim 12, wherein, The flocculated red blood cell coagulation and / or coagulating material is a cellulose material.

14. A lid assembly for a container, the lid assembly comprising: The first compartment, the first compressible button, and the fragile cover. The first compressible button and the fragile cover define the first compartment, wherein the fragile cover is located below the first compartment; flocculating red blood cell coagulant and / or coagulant material is located within the first compartment. The flocculating red blood cell coagulant and / or agglutinating material is configured to selectively release from the first compartment into the container upon compression of the first compressible button. The flocculating red blood cell coagulant and / or coagulating material is configured to form solid, gelled, and / or semi-solid blood clots within the container. The covering and / or cover assembly also includes: The second compartment includes a second chamber, a second compressible button or recess located above the second chamber, and a second fragile cover located below the second chamber.

15. The cover assembly according to claim 14, wherein, The container is a collection tank.

16. The cover assembly according to claim 14, wherein, The container includes a surface coating of a human red blood cell flocculant, wherein the human red blood cell flocculant is configured to dissolve within the container and form flocculated human red blood cells.

17. The cover assembly according to claim 14, wherein, The human erythrocyte flocculant is located in a second compartment, wherein the human erythrocyte flocculant is configured to selectively release from the second compartment into the container when the second compressible button is compressed, and wherein the human erythrocyte flocculant is configured to form flocculated human erythrocytes within the container.

18. The cover assembly according to claim 17, wherein, The human red blood cell flocculant is polydiallyldimethylammonium chloride.

19. The cover assembly of claim 17, further comprising a coupling adapter along the periphery of the cover assembly, the coupling adapter including a threaded structure configured to attach the cover assembly to a top opening of the container.

20. A cover and / or lid assembly comprising a first compartment, the first compartment including a top side and a bottom side, the first compartment comprising: Including the top side of the button or recess; Including the bottom side of the fragile covering; as well as Including the internal chamber of the first material, The internal chamber of the first compartment is located between the top and bottom sides of the first compartment. Furthermore, the first material is selectively released from the internal cavity of the first compartment when the button or recess is compressed. The covering and / or cover assembly also includes: The second compartment includes: Including the top side of the button or recess; Including the bottom side of the fragile covering; and Including the internal chamber of the second material, The internal chamber of the second compartment is located between the top and bottom sides of the second compartment. Furthermore, the second material is selectively released from the internal cavity of the second compartment when the button or recess is compressed.

21. The cover and / or cap assembly according to claim 20, wherein, The first material includes a blood clotting agent material suitable for clotting red blood cells.

22. The covering and / or cover assembly according to claim 21, wherein, The blood clotting material is suitable for clotting red blood cells in a fluid, including urine, saline, blood, an anticoagulant, or any combination thereof.

23. The covering and / or cover assembly according to claim 21, wherein, The red blood cells mentioned are flocculent red blood cells.

24. The cover and / or cap assembly of claim 20, comprising a coupling adapter having a threaded structure.

25. The cover and / or cap assembly according to claim 20, wherein, The first material is released from the internal chamber through the bottom side of the first compartment when the button or recess is compressed.

26. The cover and / or cap assembly according to claim 20, wherein, The fragile covering includes foil or plastic film.

27. The cover and / or cap assembly according to claim 20, wherein, The second material includes a red blood cell flocculant.

28. The covering and / or cover assembly according to claim 27, wherein, The red blood cell flocculant includes polydiallyldimethylammonium chloride.

29. The cover and / or cap assembly according to claim 27, wherein, The first material includes a blood clotting agent.

30. The cover and / or cap assembly according to claim 27, wherein, The red blood cell flocculant is suitable for flocculating red blood cells in a fluid.

31. The cover and / or cap assembly according to claim 30, wherein, Fluids include urine, saline, blood, anticoagulants, bactericidal materials, or any combination thereof.

32. A collection and disposal system, comprising: Collection container, the collection container including a top; and The covering and / or cover assembly as described in claim 20, The covering and / or cover assembly includes a coupling adapter adapted to securely attach the covering and / or cover assembly to the top of the collection container.

33. The collection and disposal system according to claim 32, wherein, The collection container has a volume of 1200ml, 1500ml, 2000ml, or 5000ml.

34. The collection and disposal system according to claim 32, wherein, The second material includes a red blood cell flocculant.

35. The collection and disposal system according to claim 34, wherein, The red blood cell flocculant includes polydiallyldimethylammonium chloride.

36. The collection and disposal system according to claim 34, wherein, The first material of the first compartment includes a red blood cell coagulant.

37. The collection and disposal system according to claim 36, wherein, The amount of the erythrocyte flocculant is suitable for precipitating erythrocytes in a large volume of fluid.

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