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

Abstract

Disclosed is a covering/lid assembly having a separate first compartment, a second compartment, or both a first and a second compartment, and a button and/or dimple situated on the top side of each compartment. Each compartment will comprise a top side and a bottom side, the bottom side of at least one of the compartments comprising a frangible material. The first or second compartment may comprise a first or a second material. The first material may comprise a red blood cell or blood coagulant or a red blood cell flocculant. Where the first compartment comprises a red blood cell or blood coagulant material, the second compartment will comprise a red blood cell flocculant material. The material from each compartment may be selectively released upon compressing the dimple and/or button of the top side of the respective compartment. A collection and/or biological waste management and disposal system is presented, comprising a covering/lid assembly as described, and a collection container. The covering/lid may include a perimeter having a threaded and/or snap-on assembly suitable for securely attaching the covering/lid assembly to a collection canister. The collection and/or biological waste management and disposal system may include a container comprising a red blood cell flocculant and saline solution. This container may be detachably secured to the canister or provided as a separate accessory to the system.

Claims

1. A covering and/or lid assembly comprising a first compartment having a top and a bottom side, said first compartment comprising: a top side comprising a button or dimple; a bottom side comprising a frangible covering; and an interior chamber comprising a first material, wherein the interior chamber of the first compartment is situated between the top side and the bottom side of the first compartment, and wherein the first material is selectively released from the interior chamber of the first compartment upon compression of the button or dimple.

2. The covering and/or lid assembly of claim 1, wherein the first material comprises a blood coagulant material suitable for coagulating red blood cells.

3. The covering and/or lid assembly of claim 2, wherein the blood coagulant material is suitable for coagulating red blood cells in a fluid comprising urine, saline, blood, an anti-coagulant, or any combination thereof.

4. The covering and/or lid assembly of claim 2, wherein the red blood cells are flocculated red blood cells.

5. The covering and/or lid assembly of claim 1 having a perimeter comprising a coupling adapter having a threaded configuration.

6. The covering and/or lid assembly of claim 1, wherein the first material is released from the interior chamber through the bottom side of the first compartment upon compression of the button or dimple.

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 top side comprising a button or dimple; a bottom side comprising a frangible covering; and an interior chamber comprising a second material, wherein the interior chamber of the second compartment is situated between the top side and the bottom side of the second compartment, and wherein the second material is selectively released from the interior chamber of the second compartment upon compression of the button or dimple.

9. The covering and/or lid assembly of claim 8, wherein the second material comprises a red blood cell flocculant.

10. The covering and/or lid assembly of claim 9, wherein the red blood cell flocculant comprises polyDADMAC.

11. The covering and/or lid assembly of claim 9, wherein the first material comprises a blood coagulant.

12. The covering and/or lid assembly of claim 9, wherein the red blood cell flocculant is suitable for flocculating red blood cells in a fluid.

13. The covering and/or lid assembly of claim 12, wherein fluid comprises urine, saline, blood, an anti-coagulant material, disinfectant material, or any combination thereof.

14. A collection and disposal system comprising: a collection container comprising a top end; and a covering and/or lid assembly of claim 1, wherein the covering and/or lid assembly comprises a coupling adapter suitable for securely attaching the covering and/or lid assembly to the top end of the collection container.

15. The collection and disposal system of claim 14, wherein the collection container has a volume of about 1200 ml., about 1,500 ml, about 2,000 ml or about 5000 ml.

16. The collection and disposal system of claim 14, wherein the covering and/or lid assembly comprises: a second compartment, said second compartment comprising: a top side comprising a second button or dimple, a bottom side comprising a frangible covering; and an interior chamber comprising a second material, wherein the interior chamber of the second compartment is situated between the top side and the bottom side of the second compartment, and wherein the second material is selectively released from the interior chamber of the second compartment upon compression of the button or dimple.

17. The collection and disposal system of claim 14 wherein the second material comprises a red blood cell flocculant.

18. The collection and disposal system of claim 15 wherein the red blood cell flocculant comprises polyDADMAC.

19. The collection and disposal system of claim 17 wherein the first material of the first compartment comprises a red blood cell coagulant.

20. The collection and disposal system of claim 19 wherein the red blood cell flocculant is in an amount suitable for sedimenting red blood cells within a volume of fluid.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0033] FIG. 1 illustrates an embodiment of the covering and/or lid assembly disclosed herein.

[0034] FIG. 2 illustrates an embodiment of the collection system disclosed herein.

[0035] FIG. 3 illustrates a plan view of one embodiment of the covering assembly and/or lid top portion disclosed herein.

[0036] FIG. 4 illustrates a plan view of one embodiment of the covering assembly and/or lid bottom portion disclosed herein.

[0037] FIG. 5 illustrates another embodiment of the covering assembly disclosed herein.

[0038] FIG. 6 illustrates a plan view of another embodiment of the covering assembly top portion disclosed herein.

[0039] FIG. 7 illustrates a plan view of another embodiment of the covering assembly bottom portion disclosed herein.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0040] 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.

[0041] As used here, the term “flocculant” 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.

[0042] 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.”

[0043] 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.

[0044] 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.

[0045] As used herein, “blood coagulant enhancing substance” means any of the variously named compounds that may be used as a blood coagulant.

[0046] 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.

[0047] The following examples are presented to demonstrate preferred embodiments of the invention.

Example 1—Covering/Lid Assembly

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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

[0054] 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.

[0055] 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.

[0056] 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 flocculant 35.

[0057] 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.

[0058] 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 flocculant 35. Examples of flocculated containers are described in U.S. Patent Publication Nos. 2019/0302906A1, 2019/02154659A1, 2019/0154658A1, and U.S. Pat. No. 10,401,347, which are hereby incorporated by reference.

[0059] 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

[0060] 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.

[0061] 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.

[0062] The covering assembly and/or lid 201 may comprise a plastic material, such as a polyethylene or a polypropylene.

[0063] The frangible material layer 205 will be positioned at a bottom side of a first compartment 207. The first compartment may contain a red blood cell flocculant 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 be released into the container. This release is provided by a breach of the frangible material, such as by applying 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, such as from the application of the force, the material is released into the container where it will mix and contact with a fluid or mixture of fluids, in a container.

[0064] A second compartment 209 may also be provided, this compartment comprising a preferred material, such as a red blood cell flocculant or blood coagulant (capable of transforming flocculated red blood cells in a fluid 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.

[0065] 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 flocculant or a flocculated red blood cell coagulant material) will be forced through the frangible layer of the compartment and into a collection device interior.

[0066] 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.

[0067] 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 flocculant, 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 flocculant 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.

[0068] 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.

[0069] Covering assembly 201 may be interchangeably used with the collection system 100 previously described herein.

[0070] 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.

[0071] 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.

[0072] 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.

BIBLIOGRAPHY

[0073] The following references are incorporated herein in their entirety. [0074] 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 March, 17(3). [0075] 2. Ratermann, A., et al., (1980), Journal of Agricultural Food Chemistry. 1980, 28, 2, 438-44. [0076] 3. U.S. patent application Ser. No. 12/924,547. [0077] 4. U.S. patent application Ser. No. 15/868,983. [0078] 5. U.S. patent application Ser. No. 16/363,674. [0079] 6. U.S. patent application Ser. No. 16/257,876. [0080] 7. U.S. patent application Ser. No. 16/257,673. [0081] 8. U.S. Pat. No. 10,401,347. [0082] 9. German patent application DE10343668A1. [0083] 10. German patent application DE202007003050U1.