COVERING ASSEMBLY WITH COAGULANT COMPARTMENT AND USES THEREOF IN A BLOOD MONITORING/MANAGEMENT SYSTEM

Abstract

Disclosed is a covering/lid assembly having a first compartment, a second compartment, or both. Each compartment will comprise a top side and a bottom side, the bottom side of the compartment comprising a frangible material. The first or second compartment may comprise a first material or a second material. The first or second material may comprise a flocculated red blood cell coagulant, or a red blood cell flocculent. The material within a compartment may be selectively released upon compressing a dimple and/or button located directly above the first and/or second compartment. A collection and/or biological waste management and disposal system is presented, comprising a lid/covering assembly as described and a collection container. The lid may include a perimeter having a threaded and/or snap-on assembly suitable for securely attaching the lid to a collection canister. The collection canister may comprise a red blood cell flocculent coating.

Claims

1. A covering and/or lid assembly for a container, said covering and/or lid assembly comprising a first compartment comprising: a first chamber, a compressible button or dimple, said compressible button or dimple being situated above the first chamber, and a frangible covering being situated below the first chamber; a blood coagulant material is contained in the first chamber, and wherein the blood coagulant material is selectively released from the first chamber into the container upon compression of the button or dimple, and the blood coagulant material is configured to form a coagulated mass of blood in the container to provide spill-free disposal of blood.

2-3. (canceled)

4. The covering and/or lid assembly of claim 1 wherein the blood coagulant material comprises styptic powder.

5. The covering and/or lid assembly of claim 1 comprising a coupling adapter along a perimeter of the lid, said coupling adaptor comprising a threaded configuration suitable for attaching the covering assembly onto a top opening of the container.

6. The covering and/or lid assembly of claim 1 wherein the coagulated mass is a solid mass.

7. The covering and/or lid assembly of claim 1, wherein the frangible covering comprises a foil or plastic film.

8. The covering and/or lid assembly of claim 1, further comprising: a second compartment, said second compartment comprising a second chamber, a second compressible button or dimple, said second compressible button or dimple being situated above the second chamber, and a second frangible covering being situated below the second chamber, wherein the second chamber, contains a red blood cell flocculent, wherein said red blood cell flocculent is configured to form flocculated red blood cells in the container, wherein said red blood cell flocculent does not form a coagulated mass upon contact with blood in the container, and wherein the second material is released into the container upon compression of the second compressible button or dimple.

9. (canceled)

10. The covering and/or lid assembly of claim 8, wherein the red blood cell flocculent is polyDADMAC.

11. (canceled)

12. The covering and/or lid assembly of claim 8, wherein the blood coagulant material is styptic powder.

13. A collection and disposal system comprising a collection container and a covering and/or lid assembly, wherein: the collection container has a canister configuration and a volume capacity of 100 ml, 250 ml, 500 ml, 1,200 ml or 5000 ml; and wherein the covering and/or lid assembly is as defined in claim 1, wherein the covering and/or lid assembly comprises a coupling adapter suitable for securely attaching to an opening of the collection container.

14. The collection and disposal system of claim 13, wherein the collection container has a volume of about 1200 ml. or 5000 ml.

15. (canceled)

16. The collection and disposal system of claim 13 wherein the collection container comprises a surface coating of a red blood cell flocculent, and wherein the red blood cell flocculent is configured to form flocculated red blood cells within the collection container.

17. The collection and disposal system of claim 16 wherein the red blood cell flocculent comprises polyDADMAC.

18-19. (canceled)

20. A lid assembly for a container, comprising: a first compartment, a first compressible button, and a frangible covering, wherein the first compressible button and the frangible covering define the first compartment, wherein the frangible covering is situated below the first compartment; and a blood coagulant material within the first compartment, wherein the blood coagulant material is configured to be selectively released from the first compartment into the container upon compression of the first compressible button, and wherein the blood coagulant material is configured to form a mass of coagulated blood within the container.

21. The lid assembly of claim 20, wherein the blood coagulant material comprises aluminum chloride, styptic powder, copper sulfate, aluminum sulfate, potassium aluminum, potassium ferrate, ferric sulfate, ferrous sulfate, ferric chloride, or zinc sulfate.

22. The lid assembly of claim 20, wherein the container is a collection canister.

23. The lid assembly of claim 20 wherein the container comprises a second compartment, a second compressible button, and a frangible covering, wherein the frangible covering is situated below the second compartment; and a red blood cell flocculent within the second compartment, wherein the red blood cell flocculent is configured to be selectively released from the second compartment into the container upon compression of the second compressible button, and wherein the red blood cell flocculent is configured to form flocculated red blood cells within the container.

24. The lid assembly of claim 23, wherein the red blood cell flocculent is polyDADMAC.

25. The lid assembly of claim 20, wherein the frangible covering comprises a foil or plastic film.

26. The lid assembly of claim 20, further comprising a coupling adapter along a perimeter of the lid assembly, the coupling adaptor comprising a threaded configuration configured to attach the lid assembly to a top opening of the container.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] FIG. 1 illustrates an embodiment of the covering and/or lid assembly disclosed herein.

[0033] FIG. 2 illustrates an embodiment of the collection system disclosed herein.

[0034] FIG. 3 illustrates a plan view of one embodiment of the covering assembly and/or lid top portion disclosed herein.

[0035] FIG. 4 illustrates a plan view of one embodiment of the covering assembly and/or lid bottom portion disclosed herein.

[0036] FIG. 5 illustrates another embodiment of the covering assembly disclosed herein.

[0037] FIG. 6 illustrates a plan view of another embodiment of the covering assembly top portion disclosed herein.

[0038] FIG. 7 illustrates a plan view of another embodiment of the covering assembly bottom portion disclosed herein.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0039] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of skill in the art to which the disclosure pertains. Although any methods and materials similar to or equivalent to those described herein can be used in the practice or testing of the present technology, the preferred methods and materials are described herein.

[0040] As used here, the term “flocculent” is intended to mean a molecule that has a cationic charge that is capable of facilitating the coalescence of RBCs in a fluid at room temperature, and form a settled RBC mass with less than 30 minutes at room temperature without centrifugation.

[0041] Reference to an element by the indefinite article “a” or “an” does not exclude the possibility that more than one element is present, unless the context clearly requires that there be one and only one element. The indefinite article “a” or “an” thus usually means “at least one.”

[0042] As used herein, “patient” or “subject” means an individual having symptoms of, or at risk for, cancer or other malignancy. A patient may be human or non-human and may include, for example, animal such a horse, dog, cow, pig or other animal. Likewise, a patient or subject may include a human patient including adults or juveniles (e.g., children). Moreover, a patient or subject may mean any living organism, preferably a mammal (e.g., human or non-human) from whom a blood volume is desired to be determined and/or monitored from the administration of compositions contemplated herein.

[0043] As used herein, “waste” means any mixture in any amount comprising blood and/or a coagulant of any type that is enclosed in a receptacle sealed by any embodiment of the covering assembly.

[0044] As used herein, “blood coagulant enhancing substance” means any of the variously named compounds that may be used as a blood coagulant.

[0045] As used herein, “about” means within a statistically meaningful range of a value or values such as a stated concentration, length, molecular weight, pH, sequence identity, timeframe, temperature or volume. Such a value or range can be within an order of magnitude, typically within 20%, more typically within 10%, and even more typically within 5% of a given value or range. The allowable variation encompassed by “about” will depend upon the particular system under study, and can be readily appreciated by one of skill in the art.

[0046] The following examples are presented to demonstrate preferred embodiments of the invention.

EXAMPLE 1

Covering/Lid Assembly

[0047] The present example presents a description of one embodiment of the covering assembly/lid 1. The covering assembly/lid is illustrated in FIGS. 1, 3, and 4.

[0048] The covering assembly/lid 1 includes a top portion 10 and a bottom portion 20, and further includes a frangible compartment 5 situated on a first surface 25 of the covering assembly bottom portion 20. Covering assembly/lid 1 may comprise a transparent plastic material, such as a polyethylene or a polypropylene. The frangible compartment 5 contains a blood coagulation enhancing substance 50 that is selectively releasable from the frangible compartment 5.

[0049] In one embodiment, the blood coagulation enhancing substance 50 may be powder, as illustrated in FIG. 4. However, blood coagulation enhancing substance 50 may be in the form of a powder, a tablet, or a liquid, and may be selected from any of the aforementioned blood coagulant compounds previously listed. The blood coagulation enhancing substance 50 may be enclosed in a frangible compartment 5. The frangible compartment may be provided as a blister pack, the blister pack comprising a release side comprising a frangible material, such as an aluminum, tin, or other foil, aplastic, or other frangible material. The blood coagulation enhancing substance 50 may be contained within the blister pack. Alternatively, the blood coagulation enhancing substance may be packaged in a box, a bottle, a tray, a cartridge, or a card.

[0050] Covering assembly/lid 1 may also include a coupling adapter 8 along a perimeter 12 of the covering assembly 1. The coupling adapter 8 with a threaded connection that is suitable for attaching the covering assembly 1 onto a canister 30 to provide a fluid-tight seal. Coupling adapter 8 may comprise, for example, a threaded connection, or a screw connection, or a locking connection. As shown in FIG. 1, the covering assembly/lid 1 may include a compressible button or dimple 11, that is comprised of a non-frangible material, on a first surface 15 of the covering assembly top portion 10. The compressible button or dimple 11 in some embodiments is situated above the frangible compartment 5, and when a compressive force (such as pushing the dimple/button “in”), is applied by a user to the compressible button or dimple 11, the blood coagulation enhancing substance 50 is released from the delivery compartment 55, as the frangible layer of the compartment opens/breaks, for example, by the force exerted by a substance contained within the frangible compartment against the frangible layer and/or the pressure exerted upon pressing the button or dimple 11.

[0051] In one embodiment, and as shown in FIG. 4, a first frangible compartment 55 comprises a non-frangible top layer 57 and a bottom frangible layer 59. Application of pressure to the non-frangible layer 57 results in force being applied to bottom frangible layer 59, causing the frangible layer to break or tear. The break and/or tear of the frangible layer in turn results in the release of the blood coagulation enhancing substance 50, and into an enclosed collection device.

[0052] The compressible button and/or dimple 11 located on the non-frangible top layer 57 may be comprised of one or more plastic materials that are pliable and able to be bent by an applied pressure. The bottom frangible layer 59 may comprise a layer of aluminum film or other material that will be broken/torn by an applied pressure to the button and/or dimple. The applied pressure may originate from, for example, a user pressing the button and/or dimple in or down, thus creating air pressure to be applied against the interior of the frangible compartment and through the bottom frangible layer 59.

EXAMPLE 2

Collection System

[0053] The present example presents the collection system 100 of the present invention. The system is illustrated in FIG. 2. The collection system 100 includes a collection vessel that may connect to a covering and/or lid assembly 1. The covering and/or lid assembly 1 includes a top portion 10 and a bottom portion 20, and further includes a frangible chamber 5 situated on a first surface 25 of the covering assembly bottom portion 20.

[0054] Frangible chamber 5 contains a blood coagulation enhancing substance 50 that is selectively releasable from the frangible chamber 5. The blood coagulation enhancing substance 50 may be enclosed in a compartment 55, which may be a blister pack. The blister pack is made up on one surface a frangible material, such as a surface comprising plastic and/or an aluminum foil material. The covering and/or lid assembly 1 has a coupling adapter 8 along a perimeter 12 of the covering assembly 1, and the coupling adapter 8 with a threaded configuration that is suitable for attaching the covering assembly 1 onto the top opening of a canister 30 to provide a secure, fluid-tight closing.

[0055] Covering assembly 1 may include a compressible button or dimple 11 on a first surface 15 of the covering assembly top portion 10. The compressible button or dimple 11 may be situated above the detachable chamber 5. When the compressible button or dimple 11 is compressed, the button or dimple 11 pushes air that engages the frangible compartment 55, which causes the blood coagulation enhancing substance 50 within the delivery compartment 55 to be released into the adjacent canister 30. Canister 30 a fluid sample 60 including fluids such as settled RBCs and other media to be disposed. When the blood coagulation enhancing substance 50 released from delivery compartment 55 and is mixed with the fluid sample 60 in canister 30, the waste components of fluid sample 60 coagulate and prevent formation of a biohazard. Coagulation of fluid sample 60 by the blood coagulation enhancing substance 50 may take place, for example, in the presence of a flocculent 35.

[0056] Waste is collected in collection system 100 a single time and then the entire system and waste contents are discarded. Collection system 100 is self-contained, does not require cleanup for disposal of the contents therein, and thereby prevents creation of a biohazard. No additional solution or other cleaning is required for disposal of the contents in collection system 100.

[0057] Collection system 100 may be propped up or set up on a stand, such as a tower for IV drip containers. Each time a medical procedure is completed and fluids are collected in the collection system 100, the enclosed system and the contents therein are disposed. A new collection system is then substituted in place of the used collection system, and the new system is used to process additional waste. The canister 30 may be, for example, a flocculated container, having flocculent 35. Examples of flocculated containers are described in U.S. patent application Ser. Nos. 16/363,674, 16/257,876, 16/257,673, and 15/868,983, which are hereby incorporated by reference.

[0058] Collection system 100 also provides for estimation of blood volume in the contents within collection vessel 30.

EXAMPLE 3

Contact-Free Biological Material Collection and Disposal System

[0059] The present example presents a contact-free system for collecting and disposing of biologically hazardous materials that minimizes user handling. The system provides for collection and processing of a fluid suspected to include or including a biological material, such as blood, into a collection canister, assessing a volume of blood that is present in the collected material, and transforming the content of the container into a readily disposable solid and/or semi-solid mass in the container, without removal of the covering/lid assembly.

[0060] An embodiment of the covering assembly is illustrated in FIGS. 5, 6, and 7. Covering assembly 201 includes a top portion 210 and a bottom portion 220. A first chamber includes a frangible material layer 205 situated on a first surface 225 of the covering assembly bottom portion 220.

[0061] The covering assembly and/or lid 201 may comprise a plastic material, such as a polyethylene or a polypropylene.

[0062] The frangible material layer 205 will be positioned at a bottom side of s first compartment 207. The first compartment may contain a red blood cell flocculent material or a blood coagulant material 250. A first button/dimple 211 will be located directly above the frangible chamber, and upon pressing the button and/or dimple, the material in the compartment will apply a force against the frangible material surface that breaks the surface, thus expelling the material into an interior chamber of a collection container. Thus, as the surface of the first frangible chamber is breached from the application of the force, the material is released into the container where it will mix and contact with the fluid contents.

[0063] A second compartment 209 may also be provided, this compartment comprising a preferred material, such as a red blood cell flocculent or blood coagulant (capable of transforming flocculated red blood cells into a solid and/or semi-solid mass). This solid and/or semi-solid mass may then be easily disposed of, without risk of splashing or spilling onto another person or in the surrounding area.

[0064] A second button/dimple 213 defining one side (the top side) of the second compartment, will be located directly above a second frangible layer, and upon pressing the second button and/or dimple, the material within the second compartment (such as a red blood cell flocculent or a flocculated red blood cell coagulant material) will be forced through the frangible layer of the compartment and into a collection device interior.

[0065] The first button/dimple 211 and the second button/dimple 213 may each be substantially level with first surface 215 of the covering assembly top portion 210 to improve the compactness of covering assembly 201, and allow for stackable storage for more than one covering assembly 201. This may also ensure that the first button/dimple 211 and the second button/dimple 213 do not become exposed to force that would press upon them upon packaging and shipping of the covering assembly 201.

[0066] The flocculated red blood cell coagulant substance may be a powder, or other form, such as a tablet, or a liquid. The flocculated red blood cell coagulant, red blood cell flocculent, or both, may be enclosed in a blister pack within the first compartment or the second compartment, for example, within a pack made of a plastic and/or aluminum foil. The flocculated red blood cell coagulant or red blood cell flocculent may alternatively be packaged in another material such as, for example, a box, a bottle, a tray, a cartridge, or a card, within the first compartment or second compartment, or both compartments.

[0067] Covering assembly 201 also includes a coupling adapter 208 along a perimeter 212 of the covering assembly 201, and the coupling adapter 208 with a threaded connection that is suitable for attaching the covering assembly 201 onto a canister 230 to provide a fluid-tight seal. Coupling adapter 208 may comprise, for example, a threaded connection, or a screw connection, or a locking connection.

[0068] Covering assembly 201 may be interchangeably used with the collection system 100 previously described herein.

[0069] The examples set forth above are provided to give those of ordinary skill in the art a complete disclosure and description of how to make and use the embodiments of the methods for prediction of the selected modifications that may be made to a biomolecule of interest, and are not intended to limit the scope of what the inventors regard as the scope of the disclosure. Modifications of the above-described modes for carrying out the disclosure can be used by persons of skill in the art, and are intended to be within the scope of the following claims.

[0070] It is to be understood that the disclosure is not limited to particular methods or systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0071] A number of embodiments of the disclosure have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the present disclosure. Accordingly, other embodiments are within the scope of the following claims.