WO2017031434A1

WO2017031434A1 - Cartridge for recycling medical waste, container and method for sterilizing waste

Info

Publication number: WO2017031434A1
Application number: PCT/US2016/047793
Authority: WO
Inventors: Jean Louis GUIRETTE; Robert GUIRETTE
Original assignee: Galia Textil
Priority date: 2015-08-20
Filing date: 2016-08-19
Publication date: 2017-02-23

Abstract

A method for sterilizing medical waste includes placing the medical waste in an elastic compression bag; dispensing fluid into the elastic compression bag; sealing the elastic compression bag; placing the sealed elastic compression bag into a container; placing the container inside a sterilization autoclave chamber; and sterilizing the medical waste by vaporizing the fluid using the sterilization autoclave chamber. A cartridge system for holding medical waste includes a cartridge including an outer holder, an inner holder disposed in the outer holder, a protective padding disposed in the inner holder for receiving a sharp object, and a cap that is affixed to the outer holder. The cap is configured to rotate clockwise or counterclockwise about a longitudinal axis of the outer holder to provide at most partial access to the protective padding for the sharp object through one of a plurality of through-holes on the cap. The cartridge system also includes a capsule for housing the cartridge; and a red cap affixed to the capsule that closes the plurality of through-holes.

Description

CARTRIDGE FOR RECYCLING MEDICAL WASTE, CONTAINER AND

METHOD FOR STERILIZING WASTE

RESERVATION OF COPYRIGHTS

[0001] A portion of the disclosure of this patent document contains material, which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.

FIELD OF INVENTION

[0002] Embodiments of the invention generally relate to a system for sterilizing medical waste. Embodiments of the invention generally relate to a method for sterilizing medical waste. Embodiments of the invention generally relate to a cartridge for holding medical waste.

BACKGROUND

[0003] Public and private health institutions, including clinics, hospitals, research facilities, etc., produce large amount of medical waste as a result their daily activities. According to industry practice, the medical waste can be categorized as anatomical waste {e.g., body parts and organs) or non- anatomical waste {e.g., sharps that have been in contact with animal or human blood, biological fluids, tissues, cultures, live vaccines, containers or materials saturated with blood products). According still to industry practice, the medical waste can also be categorized as either risk waste or non-risk waste. The risk waste is further divided into 7 groups: (1) infectious waste, (2)

l pathological waste, (3) sharps, (4) pharmaceutical waste, (5) genotoxic waste, (6) chemical waste, and (7) radioactive waste.

[0004] Infectious waste is any waste that is contaminated by any type of bacterium, virus, parasites, or fungi. Examples of infectious waste include cultures, waste from surgery and autopsies, waste from infected patients, waste from infected hemodialysis patients, infected animals from laboratories, and any material having been in contact with infected patients.

[0005] Pathological waste includes, for example, tissues, organs, body parts, fetuses, blood and body fluids, etc.

[0006] Sharps includes, for example, needles, syringes, scalpels, infusion sets, saws and knives, surgical blades, broken glass, any other items that can cut and puncture.

SUMMARY

[0007] Medical waste can fall under one or more categories. Although the specification describes treatment of certain waste in a particular manner, one of ordinary skill in the art would recognize that, based on the disclosure of the present specification, the inventor's system and method may be applied to any and all medical waste.

[0008] According to one aspect of the invention, one or more embodiments disclosed herein relate to a method for sterilizing medical waste comprising placing the medical waste in an elastic compression bag; dispensing fluid into the elastic compression bag; sealing the elastic compression bag; placing the sealed elastic compression bag into a container; placing the container inside a sterilization autoclave chamber; and sterilizing the medical waste by vaporizing the fluid using the sterilization autoclave chamber.

[0009] In another aspect, one or more embodiments disclosed herein relate to a system for sterilizing medical waste, comprising: a sterilization autoclave chamber that receives a container holding a sealed elastic compression bag, the sealed elastic compression bag holds medical waste; a reservoir holding fluid; a controller for controlling sterilization parameters of the sterilization autoclave chamber, wherein the sterilization autoclave chamber sterilizes the medical waste by vaporizing the fluid inside the sealed elastic compression bag at a predetermined temperature over a predetermined amount of time set by the controller.

[0010] In yet another aspect, one or more embodiments disclosed herein relate to a cartridge system for holding medical waste, comprising: a cartridge comprising: an outer holder, an inner holder disposed in the outer holder, a protective padding disposed in the inner holder for receiving a sharp object, and a cap that is affixed to the outer holder, wherein the cap is configured to rotate clockwise or counterclockwise about a longitudinal axis of the outer holder to provide at most partial access to the protective padding for the sharp object through one of a plurality of through-holes on the cap; a capsule for housing the cartridge; and a red cap affixed to the capsule that closes the plurality of through-holes.

[0011] Other aspects and advantages of the invention will be apparent from the following description and the appended claims.

BRIEF DESCRIPTION OF DRAWINGS

[0012] FIG. 1 shows a compression bag.

[0013] FIG. 2 shows a compression bag.

[0014] FIG. 3 shows a hospital red bag to be disposed in a compression bag.

[0015] FIG. 4 shows a compression bag placed inside a container and in a position to be filled.

[0016] FIG. 5 shows a sealed compression bag holding a hospital red

[0017] FIGS. 6 A and 6B show two mechanisms for sealing the compression bag. [0018] FIG. 7 shows a storage that contains a plurality of sealed compression bags awaiting processing.

[0019] FIG. 8 shows a metallic container that serves as a protection mechanism to prevent the compression bag from contacting components of the sterilization autoclave.

[0020] FIG. 9 shows a metallic container having a protective case.

[0021] FIG. 10 shows a sealed compression bag being placed inside a metallic container.

[0022] FIG. 11 shows a sealed compression bag being placed inside a metallic container.

[0023] FIGS. 12 A and 12B each show a metallic container disposed in a sterilization autoclave chamber.

[0024] FIG. 13 a unidirectional flow device that may be used in conjunction with a sealed compression bag.

[0025] FIG. 14 shows a unidirectional flow device inserted into a sealed compression bag.

[0026] FIG. 15 shows a unidirectional flow device inserted into a sealed compression bag.

[0027] FIG. 16A shows a metallic container.

[0028] FIG. 16B shows a top-down view of a through-hole of a cap of a metallic container.

[0029] FIG. 16C shows a compression bag placed inside a metallic container.

[0030] FIG. 16D shows a unidirectional flow device being introduced into the compression bag via an opening of the bag.

[0031] FIG. 16E shows force being applied to a disk of a unidirectional flow device such that a passage between an interior and an exterior of a metallic container is open. [0032] FIG. 16F shows the absence of force being applied to a disk of a unidirectional flow device or when the pressure inside a sealed compression bag is greater than that outside a metallic container.

[0033] FIG. 16G shows the entire structure of FIG. 16E being placed inside a sterilization autoclave chamber.

[0034] FIG. 16H shows a cap of a metallic container.

[0035] FIG. 161 shows a unidirectional flow device.

[0036] FIG. 16J shows a unidirectional flow device working in conjunction with a compression bag.

[0037] FIG. 17 shows protective padding that is configured to receive sharps.

[0038] FIG. 18 shows an inner holder.

[0039] FIG. 19A shows an outer holder that is configured to hold the inner holder shown in FIG. 18.

[0040] FIG. 19B shows a group of circular through-holes aligned over a diametrical axis of a cap.

[0041] FIG. 19C shows a cap having non-circular through-holes.

[0042] FIG. 20 shows a protective padding being disposed at a bottom of an inner holder within the outer holder.

[0043] FIG. 21 shows a sharp, pointed object being inserted into the structure of

FIG. 20 via one of the structure's through-holes.

[0044] FIG. 22 shows sharps inside a cartridge.

[0045] FIG. 23 shows a capsule holding a cartridge.

[0046] FIG. 24 shows an encapsulation mechanism.

[0047] FIG. 25 shows a process of removing a cartridge from a capsule and placing the cartridge into a sterilization autoclave chamber. [0048] FIG. 26 A shows a deformed inner holder after having been subjected to sterilization treatment within a cartridge.

[0049] FIG. 26B shows a deformed inner holder after having been subjected to sterilization treatment.

DETAILED DESCRIPTION

[0050] In the following detailed description, numerous specific details are set forth in order to provide a more thorough understanding of one or more embodiments of the invention. However, it will be apparent to one of ordinary skill in the art that the invention may be practiced without these specific details. In other instances, well-known features have not been described in detail to avoid unnecessarily complicating the description.

[0051] Throughout the application, ordinal numbers (e.g., first, second, third, etc.) may be used as an adjective for an element (i.e. , any noun in the application). The use of ordinal numbers is not to imply or create a particular ordering of the elements nor to limit any element to being only a single element unless expressly disclosed, such as by the use of the terms "before," "after," "single," and other such terminology. Rather, the use of ordinal numbers is to distinguish between the elements. By way of an example, a first element is distinct from a second element, and the first element may encompass more than one element and succeed (or precede) the second element in an ordering of elements.

[0052] It is to be understood that the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a syringe" includes reference to one or more of such syringes. Further, it is to be understood that "or," as used throughout this application, is an inclusive or, unless the context clearly dictates otherwise.

[0053] Terms like "approximately," "substantially," etc., mean that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.

[0054] Inventors disclose a novel system and method for treating (i.e. , sterilizing) infectious medical waste, non-anatomical medical waste, and sharps.

[0055] Specific embodiments will now be described in detail with reference to the accompanying figures. Like elements in the various figures are denoted by like reference numerals for consistency. Like elements may not be labeled in all figures for the sake of simplicity.

Infectious Medical Waste

[0056] One or more embodiments of the invention relate to a system and method for treating infectious medical waste. Infectious medical waste may be treated using physical process, thermal process, chemical process, or a combination thereof to eliminate infectious characteristics and make such waste unrecognizable in shape and form. The system and method according to one or more embodiments of the invention are directed to creating a microclimate in a compression bag, thereby sterilizing all waste, whether liquid, solid, or gas, within the compression bag. According to one or more embodiments of the invention, the microclimate is created inside a hermetically sealed compression bag. Specifically, once the medical waste is hermetically sealed inside a compression bag, a sterilizing agent is introduced into the compression bag to facilitate sterilization of the waste. The system and method advantageously treat medical waste more efficiently and economically compared to existing systems and methods and comply with government regulations and laws governing the disposal of such medical waste around the world. [0057] FIG. 1 shows a compression bag that is configured to hold hospital red bags. In general, a hospital red bag is used for the disposal of non-sharp and infectious medical waste. The compression bag has an opening (100). The compression bag may be made of elastic or elastomeric material including, but not limited to, latex, natural rubber, nitrile, polybutadiene, polyurethane. Advantageously, once hermetically sealed, the bag allows for expansion of its walls due to internal forces generated by water vapor (during the sterilization process). Once internal forces are expelled, the bag's elastic walls return to their initial form and size while retaining their elasticity. Accordingly, because of the excellent mechanical properties of the compression bag, the walls of the compression bag do not break during sterilization processes that involve high temperature, thereby preventing waste from escaping from the interior of the compression bag and contaminating the surrounding environment. The compression bag is able to operate in temperature ranges from 100 to 150 degrees Celsius. The compression bag is also impermeable, thereby prevents wastes from permeating from the interior and contaminating the surrounding environment. One of ordinary skill in the art would appreciate that the dimension, color, and shape of the compression bag can vary depending on the specific needs of the health institution.

[0058] FIG. 2 shows a compression bag that is configured to hold hospital red bags. The compression bag of FIG. 2 is similar to FIG. 1. One difference is that the opening of the compression bag (200) of FIG. 2 is substantially smaller than the diameter of the compression bag. FIG. 1, on the other hand, shows a compression bag whose opening (100) is substantially equal to the diameter of the compression bag. The compression bag of FIG. 2 may allow for an easier closing of the compression bag.

[0059] FIG. 3 shows a hospital red bag to be disposed in the compression bag of FIG. 1 or FIG. 2. The hospital red bag is used for identification, separation, and packing of infectious medical waste. The hospital red bag is configured to handle non-anatomical waste. Packing of infectious medical waste is to be carried out in waterproof translucent red polyethylene bags each having a minimum of 200 gauge. The bags are each marked with the universal biohazard symbol, with the legend "Infectious Biological Hazardous Waste," and comply with the minimum tension resistance standards, elasticity, and torn resistance standards. In addition, such bags are configured to be filled up to 80% of their capacity and be closed before being transported to a temporary storage. The bag shall not be opened or emptied. As shown in FIG. 3, the hospital red bag is sealed and contains infectious medical waste.

[0060] FIG. 4 shows a compression bag (400) placed inside a container (402) and in a position to be filled. Due to the elastic nature of the compression bag (400), a single person can easily place or remove the compression bag (400) from the container (402). FIG. 4 also shows a hospital red bag (404) being disposed in the compression bag (400). The interior wall of the container (402) (i.e., the wall in contact with the compression bag) may be coated with resin or rubber to smoothen the contact. Specifically, the interior of the container (402) may be treated such that the compression bag (400) is protected from tear, pierce, puncture, cut, break, or damage when being filled with hospital red bags (404). Although FIG. 4 only shows the container (402) holding one hospital red bag (404), the number is not limited and can vary depending on the size and shape of the container (402) and the compression bag (400).

[0061] FIG. 5 shows a sealed compression bag (500) holding a hospital red bag

(502). The sealed compression bag sits inside the container (504).

[0062] FIGS. 6 A and 6B show two mechanisms for sealing the compression bag. One of ordinary skill in the art would appreciate that the compression bag may be hermetically sealed in any manner, not limited to those disclosed.

[0063] In FIG. 6A, the opening (600) of the compression bag (602) is closed by a simple knot. In FIG. 6B, the compression bag (602) is sealed by a cable tie (604), which may be made of plastic, elastomeric material of latex, vinyl, nitrile, polyure thane, or other materials that are elastic. The sealing mechanism is to hermetically seal the compression bag (602) so as to prevent medical waste from leaving the compression bag (602) as well as to provide sufficient flexibility to introduce object (e.g., water, catalyst, etc.) into the compression bag (602).

[0064] FIG. 7 shows a storage (700) that contains a plurality of sealed compression bags (702) awaiting processing. As with the interior wall of the container, the interior wall of the storage (700) (i.e. , the wall in contact with the compression bags) may be coated with resin or rubber to smoothen the contact between the storage (700) and the sealed compression bags (702) such that the sealed compression bags (702) are protected from tear, pierce, puncture, cut, break, or damage.

[0065] When the time comes to sterilize the sealed compression bags (702) in a sterilization autoclave, the sealed compression bags (702) may first be placed into a metallic container. FIG. 8 shows a metallic container (800) that serves as a protection mechanism to prevent the compression bag from contacting components of the sterilization autoclave, including temperature sensors that could perforate the compression bag and electrical wires or power source that may scratch, damage, or even burn the compression bag.

[0066] As also shown in FIG. 8, the metallic container (800) is coated with protective coating (802) covering its entire interior surface, including the cap portion (804) on top. Such protective coating (802) eliminates rough edges, sharp ends, burrs, and any other roughness that may pierce, tear, cut, break, or damage the compression bag. Furthermore, the protective coating (802) prevents the sealed compression bag from making any contact with the sterilization autoclave. Various laboratory tests (including temperature tests that mimic the sterilization environment) illustrate damage and breakage to the sealed compression bag when the sealed compression bag directly contacts the metal portions of the sterilization autoclave or the metal portions of the metallic container (800). The protective coating (802) may be vulcanized natural rubber, polyure thane, synthetic rubber, or any other known material having similar properties for providing protection.

[0067] FIG. 9 shows a metallic container (900) having a protective case (902).

The protective case (902) is used to isolate its contents from any rough edges, sharp ends, burrs, and any other roughness. As with the protective coating, the protective case (902) in FIG. 9 prevents the compression bag from contacting components of the sterilization autoclave, including temperature sensors that could perforate the compression bag and electrical wires or power source that may scratch, damage, or even burn the compression bag. Furthermore, the protective case (902) prevents the sealed compression bag from making any contact with the sterilization autoclave. Various laboratory tests (including temperature tests that mimic the sterilization environment) illustrate damage and breakage to the sealed compression bag when the sealed compression bag directly contacts the metal portions of the sterilization autoclave. The protective case (902) may be made from cotton, rayon, cotton-rayon polyester mix woven fabric, non-woven polypropylene fabric, cellulosic fibers fabric, or any other known material having similar properties for providing protection.

[0068] FIG. 10 shows a sealed compression bag (1000) being placed inside a metallic container (1002). The metallic container is closed with a cap (1004). The metallic container (1002) is coated with protective coating (1006). The entire structure is now ready to be placed into a sterilization autoclave for treating.

[0069] FIG. 11 shows a sealed compression bag (1100) being placed inside a metallic container (1102). The metallic container (1102) is closed with a cap (1104). Also shown in FIG. 11 is the sealed compression bag (1100) being enclosed inside a closed protective case (1106). The entire structure is now ready to be placed into a sterilization autoclave for treating. Note that the dimension of the protective case (1106) is not limited and can exceed that of the metallic container (1102) such that there are folds (1108) in the opening of the protective case (1106). Note that, different from FIG. 10, the metallic container (1102) in FIG. 11 does not have protective coating on its interior wall. However, one of ordinary skill in the art would appreciate that the protective coating and the protective case may be used in combination.

[0070] FIGS. 12A and 12B each show a metallic container (1200) disposed in a sterilization autoclave (1202). FIG. 12A shows the structure of FIG. 10 placed in a sterilization autoclave (1202). FIG. 12B shows the structure of FIG. 11 placed in a sterilization autoclave (1202).

[0071] One or more embodiments of the invention relate to placing medical waste in a sealed environment and sterilizing the content at high temperature to neutralize any infectious characteristics of the medical waste. The sterilization process is carried out in a sterilization autoclave chamber that is configured to withstand pressure created by water vapor at temperatures ranging from 100 to 200 degrees Celsius. In general, sterilization temperatures by water vapor are between 121 and 134 degrees Celsius. To achieve sterility, medical waste is heated in a chamber by injected steam until the waste reaches a time and temperature setpoint. The medical waste is then maintained at the setpoint for a period of time depending on the bioburden present and its resistance to steam sterilization. Sterilization is aimed at reducing the amount of microorganism or other potential pathogens that may be present in the waste. The degree of sterilization may be expressed by multiples of the decimal reduction time, or D-value, denoting the time needed to reduce the initial number N₀ of microorganism and pathogen to one tenth of its original amount. The sterility assurance level (i.e., the maximum allowable amount of microorganism and pathogen present that qualifies the treated waste as non-infectious) for each jurisdiction and waste category can vary. Upon cooling, the sterilized compression bag can be removed for disposal or further processing. [0072] Dimension of the sterilization chamber can vary depending on the need of the health institution. The sterilization capacity of the sterilization autoclave chamber (i.e., the amount of sterilizing agent the sterilization system holds) may be between 20 and 40 liters, for example, and can vary depending on the need of the health institution. The sterilizing agent may be stored in a container separate from the sterilization autoclave chamber or may be a portion of the sterilization autoclave chamber. The container storing the sterilizing agent may be a vessel, a reservoir, etc., and can vary depending on the nature of the agent (e.g., chemical additive, water, etc.). In one or more embodiments the agent is water condensed from water vapor used in a previous sterilization cycle. Accordingly, there may be a pipe, device, or mechanism that captures the condensation and reintroduces the same into a new batch of medical waste to be treated.

[0073] The sterilization autoclave chamber functions may require manual control or may be automated. The sterilization autoclave chamber functions may allow for customization. Specifically, the autoclave chamber may enable a user to select a temperature range of between 100 and 150 degrees Celsius for sterilizing infectious medical waste or enable a user to select a temperature range of between 100 and 200 degrees Celsius for sterilizing sharps. Furthermore, in addition to adjusting temperature, a user may set the amount of time for sterilizing medical waste, adjust the amount of water to be dispensed and introduced into the sealed compression bag, select the types, and the amount of chemical additives to be added, etc. One of ordinary skill in the art would recognize that the parameters disclosed above are merely illustrative purposes and can vary depending on the nature of the medical waste being treated, the thoroughness of the treatment, the needs of the health institution, etc.

[0074] Although certain medical waste inherently possesses moisture, and may need not have additional fluids introduced to sterilize the same, the inventors propose adding a predetermined amount of water, for example, into the sealed compression bag via the closed opening to ensure thorough sterilization, i.e., sufficient moisture throughout the sealed compression bag to achieve sterilization.

[0075] Fluids, like water or chemical additive, may be introduced before or after sealing the compression bag. The compression bag may be filled by directly adding fluid into the opening or, if the compression bag has already been sealed, may be introduced using a unidirectional flow device. The unidirectional flow device enables water, water vapor, chemical additive, and other intended fluids to enter the compression bag, but prevents any medical waste that is already in the sealed compression bag to escape therefrom.

[0076] FIG. 13 shows an example of a unidirectional flow device that may be used in conjunction with a sealed compression bag. The unidirectional flow device comprises a spring (1300), a disk (1302), an opening (1304), a bottom portion (1306), a protrusion (1308), and a ramp (1310). The unidirectional flow device comprises an actuated closing mechanism in which the spring (1300) pushes against the disk (1302) to seal the opening (1304). To enable fluid to flow through the unidirectional flow device in a first direction (1312), force must act upon the disk (1302) such that there is a passage between the opening (1304) and the through portion (1314) of the unidirectional flow device. The actuated closing mechanism advantageously prevents medical waste from flowing in a second direction (1316). The bottom portion (1306) of the unidirectional flow device is configured to be inserted into the sealed compression bag. The external surface of the unidirectional flow device is smooth and free of rough edges, sharp ends, burrs, and any other surface roughness that may damage the compression bag's surface. The bottom portion (1306) may comprise a finishing known in the industry as "mirror finishing," which allows for a smoother and easier introduction of the unidirectional flow device into the sealed compression bag. The protrusion (1308) is configured to pass through the cable tie and secure the unidirectional flow device against the sealed compression bag. Properly placed, the protrusion (1308) should be adjacent to the cable tie. The protrusion (1308) may be coated with adhesive. The ramp (1310) serves as a guide that prevents the user from inserting the unidirectional flow device too deeply into the sealed compression bag.

[0077] FIG. 14 shows a unidirectional flow device (1400) inserted into a sealed compression bag (1402). The sealed compression bag is sealed by a cable tie whose characteristics have been described. FIG. 14 also shows that the disk of the unidirectional flow device has been acted on and, accordingly, fluid can be added into the sealed compression bag in a first direction.

[0078] FIG. 15 shows a unidirectional flow device (1500) inserted into a sealed compression bag (1502). The sealed compression bag (1502) is sealed by a cable tie (1504) whose characteristics have been described. FIG. 15 also shows that the disk (1506) of the unidirectional flow device prevents any medical waste from attempting to flow in a second direction (1508). Thus, the medical waste cannot escape the sealed compression bag.

[0079] Although FIGS. 13-15 show a specific type of unidirectional flow device being used to introduce fluid into a sealed compression bag, other types of devices can be used. For example, a valve can be affixed to the opening of the sealed compression bag. For example, rather than using a unidirectional flow device, a bi-directional flow device may be used. For example, a tube can be affixed to the opening of the sealed compression bag and used to transport fluid into the sealed compression bag.

[0080] Once fluids have been introduced into the compression bag, the compression bag is ready to be treated. The sealed compression bag is placed into a metallic container, which is, in turn, placed into a sterilization autoclave shown in FIGS. 12A and 12B. [0081] An example sequence for sterilizing infectious medical waste is described below in reference to FIGS. 16A-16J. FIG. 16A shows a metallic container. The metallic container (1600) shown in FIG. 16A is similar to those shown in FIGS. 12A and 12B. However, unlike FIGS. 12A and 12B (which feature a closed metallic cap), FIG. 16A shows the metallic container (1600) having a cap (1602) comprising a through-hole (1604). The metallic container (1600) may be made from rust-proof metallic material like stainless steel, for example. As discussed above, the metallic container (1600) may be coated with protective coating (1606) covering its entire interior. As also discussed above, the thickness, shape, and size of the metallic container (1600) can vary depending on the needs of the individual health institution. The metallic container (1600) is designed such that straight angles in the joints of body of the metallic container (1600) and cap (1602) are prevented. Advantageously, this prevents sharp corners from injuring personnel handling the metallic container (1600).

[0082] FIG. 16B shows a top-down view of the through-hole of the cap of the metallic container. The through-hole serves as the only passage between the interior and the exterior of the metallic container.

[0083] FIG. 16C shows a compression bag (1608) placed inside a metallic container (1600). The opening (1610) of the compression bag (1608) sits outside of the metallic container (1600), whereas the body of the compression bag (1608) is inside the metallic container. The neck (1612) of the compression bag (1608) is secured and located in the through-hole (1604). At this stage, the neck (1612) of the compression bag (1608) is held tightly enough by the through-hole (1604) such that no medical waste from within the compression bag (1608) can escape the same.

[0084] FIG. 16D shows a unidirectional flow device (1614) being introduced into the compression bag (1608) via the bag's opening (1610). [0085] FIG. 16E shows force being applied to disk (1616) of the unidirectional flow (1614) device such that the passage between the interior and the exterior of the metallic container (1600) is open. As a result, water, water vapor, chemical additive, etc., may be introduced into the compression bag (1608) in the first direction (1618) (i.e. , into the compression bag (1608)). FIG. 16E shows the compression bag completely inflated due to the fluid pressure that enters the bag through the unidirectional flow device (1616).

[0086] FIG. 16F shows the absence of force being applied to the disk of the unidirectional flow device or when the pressure inside the compression bag is greater than that outside the metallic container. As a result, the passage between the interior and the exterior of the metallic container is closed and no infectious medical waste can escape from the compression bag in the second direction (1620) (i.e., out of the compression bag (1608)).

[0087] FIG. 16G shows the entire structure of FIG. 16E being placed inside a sterilization autoclave chamber (1622).

[0088] FIG. 16H shows the cap (1624) of the metallic container (1600). The through-hole (1626) of the cap (1624) is maintained sealed by the inserted unidirectional flow device (1614).

[0089] FIG. 161 shows an alternative form of the unidirectional flow device.

Specifically, the unidirectional flow device in FIG. 161 comprises an extension cord (1628). The unidirectional flow device is installed in the through-hole (1626) of the cap (1624). In this embodiment, the unidirectional flow device is firmly secured to the through-hole (1626). For example, this may be accomplished by using a thread mechanism in which the unidirectional flow device is threaded to the through-hole (1626). The extension cord (1628) may be a flexible hose fabricated with stainless steel. The flexible hose is free to move about inside the metallic container (1600) and makes it easier to connect the unidirectional flow device to the compression bag (1608). [0090] FIG. 16J shows the unidirectional flow device working in conjunction with the compression bag (1608). The compression bag (1608) is sealed by a cable tie (1630). The unidirectional flow device is of the type shown in FIG. 161.

[0091] Fluid is (e.g., water, water vapor, chemical additive, etc.) introduced from the sterilization autoclave chamber (1622) into the metallic container (1600) due to pressure differentials. Specifically, pressure outside of the metallic container (1600) is greater than that inside the metallic container (1600).

Sharps

[0092] Sharps (pointed objects) are found in almost every health institution. If treated improperly, they can cause harm to persons and the environment. Existing regulations do not specifically dictate the method for treating sharps. The regulations, however, do require that sharps be made unrecognizable and properly labelled before disposal. The Medical Waste Tracking Act of 1989 further requires that medical waste generators segregate waste at their point of origin and package sharps into rigid, puncture-resistant, leak-resistant containers before transporting off- site.

[0093] One or more embodiments of the invention relate to a cartridge for processing sharps (pointed objects) and a method for reducing contaminated sharps into unrecognizable, ordinary waste. The cartridge comprises a protective padding, an inner holder, an outer holder, and a cap.

[0094] FIG. 17 shows protective padding (1700) that is configured to receive sharps (1702). The protective padding (1700) may be a porous material of foamed-type or expanded-type. Such padding (1700) may be made of foamed or expanded polystyrene, foamed polyurethane or any other material that serves the purposes of receiving and securing sharps (pointed objects). The padding (1700) is to allow the sharps (1702) to perforate easily and remain firmly affixed without moving. Upon engaging the protective padding (1700), the sharps (1702) stand firmly lengthwise. Accordingly, the sharp object (1702) remains immobilized and is oriented correctly during all stages of handling. The protective padding (1700) deforms in high temperature and encapsulates the sharps.

[0095] FIG. 18 shows an inner holder (1800) that is a container made from plastic material, such as polyethylene terephthalate (PET), polyvinyl chloride (PVC), polypropylene, polystyrene, polycarbonate, polyethylene, etc. As shown in FIG. 18, the inner holder (1800) is made such that the wall thickness (1802) decreases towards one end. The inner holder (1800) also deforms in high temperature and encapsulates the deformed protective padding.

[0096] FIG. 19A shows an outer holder (1900) that is configured to hold the inner holder shown in FIG. 18. The outer holder is a metallic container made of, for example, aluminum, steel, or stainless steel. The metallic container is configured to withstand the high sterilization temperature used to treat sharps and withstand humidity. The outer holder has perforations (1902) that enable thorough treatment of the inner holder shown in FIG. 18. The perforations enable water vapor and warm air to enter the outer holder and treat the inner holder and the inner holder's medical waste content.

[0097] FIG. 19A also shows a cap (1904) having through-holes (1906). The cap (1904) may be made of the same or different material as the outer holder (1900). The cap (1904) is to serve as a guide for a user inserting sharps into the outer holder and to prevent objects from escaping from the inner holder. The cap (1904) may be turned clockwise or counterclockwise with respect to the outer holder without being detached from the same. The cap (1904) is attached to the outer holder (1900). The cap (1904) can only be removed from the outer holder (1900) when a user applies a predetermined amount of force. Thus, it is not possible for a child to accidentally detach the cap (1904) from the outer holder (1900). Also, the cap (1904) does not detach from the outer holder due to an inadvertently dropping thereof. The cap (1904) advantageously allows for efficient filling of the cartridge with sharps.

[0098] FIG. 19B shows a group of circular through-holes (1906) aligned over a diametrical axis. One of ordinary skill in the art would appreciate that the shape and size of the through-holes can vary depending on the sharps to be inserted.

[0099] FIG. 19C shows a cap having non-circular (1906) through-holes. The through-holes are jagged and correspond to a similarly- shaped syringe to be inserted.

[00100] FIG. 20 shows the protective padding (2000) being disposed at a bottom of the inner holder (2002), which is held by an outer holder (2004). The outer holder (2004) comprises a cap (2006) having a plurality of through-holes (2008). The entire structure shown in Figure 20 may be referred to as a cartridge.

[00101] FIG. 21 shows a sharp, pointed object being inserted into a cartridge via one of the cartridge's through-holes.

[00102] FIG. 22 shows sharps inserted into a cartridge (2200). The sharps are stabilized in their upright position by the protective padding. The cartridge (2200) shown in FIG. 22 is ready to be treated.

[00103] FIG. 23 shows a capsule (2300) for holding the cartridge. The capsule (2300) may be labelled with appropriate warning labels. The warning labels may be necessary to comply with government regulations, as set forth above. Those skilled in the art will appreciate that the warning labels may differ based on the government regulations in place where the capsule is being used. For example, in one or more embodiments, the capsule (2300) may have a minimum resistance of 12.5 N in all of its components (determined by measuring the strength required to perforate sides and bottom with a 21 x 32 mm-gauge hypodermic needle by means of strength gauge or tensometer). [00104] FIG. 24 shows an encapsulation mechanism that complies with the requirements of "Safe-Ensemble Cap with Permanent Closing" for all containers holding sharps. FIG. 24 shows a red cap (2400) (made of polypropylene, for example) offering a safe ensemble with a permanent closing mechanism. The cap is inserted over the capsule (2300) shown in FIG. 23 and attaches with a closing mechanism so as to contain the cartridge (2200) fully. In one or more embodiments, the closing mechanism may be a coupling lock, as shown in FIG. 24. Alternatively, in one or more embodiments, the closing mechanism may be a threaded cap. The closing mechanism is not limited, so long as the red cap (2400) is able to be fixed to the capsule shown in FIG. 23 and allows for prevention of accidental opening of the capsule. In one or more embodiments, to allow insertion of additional sharps into a capped capsule (2300), the red cap (2400) may be removable so that the additional sharps may be inserted via the through-holes of the cartridge (2200) contained within.

[00105] FIG. 25 shows the process of removing (2500) a cartridge from a capsule and placing (2502) the cartridge into a sterilization autoclave chamber. The cartridge may be directly placed into the sterilization autoclave chamber or may be placed into the compression bag described above. The compression bag may or may not be placed into a metallic container, as also described above. Once the cartridge (2200) is emptied from the capsule (2300), a new cartridge may be inserted into the capsule. Accordingly, in one or more embodiments, the capsule may be reused.

[00106] In one or more embodiments, once placed inside a sterilization autoclave chamber, the cartridge is subjected to a sterilization cycle by saturated vapor in a temperature range between 100 and 150 degrees Celsius. The corresponding pressure for the aforementioned temperature range is between 100 and 150 KPa.

[00107] In one or more embodiments, the sterilization autoclave is equipped with a heating system (e.g. , a radiation/thermal conduction unit, a warm air convection unit, etc.). The heating system is capable of heating the interior of the autoclave to between 100 and 200 degrees Celsius. Sharps subjected to this temperature range deform. In particular, the temperature range exceeds the thaw point of various plastic materials that make up the various sharps. Thus, the proposed treatment method complies with the regulation requiring that sharps be made unrecognizable after treatment. For the purpose of this application, the term "unrecognizable" is defined as "the loss of physical and biological-infectious characteristics of an object to not be reused."

[00108] In one or more embodiments, once placed inside a sterilization autoclave chamber, the cartridge (2200) is first subjected to a sterilization cycle by saturated vapor in a temperature range between 150 and 200 degrees Celsius. Subsequently, the cartridge (2200) is subjected to a dry heating cycle in a temperature range between 100 and 200 degrees Celsius. The treatment time for each portion or the combination (vapor treatment and dry heating) may be between 1 and 120 minutes. As with treating infectious medical waste, the sterilization autoclave can be customized with various settings, including temperature, amount of time for sterilization, etc. Vapor treatment sterilizes the sharps; dry heating deforms the sharps and makes them unrecognizable. After treatment, the deformed cartridge (2200) may be cooled to between 45 and 50 degrees Celsius to enable safe removable from the sterilization autoclave chamber.

[00109] When the vapor sterilization process is complete, the sterilization autoclave chamber's door may automatically open slightly to allow the remaining water to escape and prevent pressure from developing inside before the dry heating process begins. The sterilization autoclave chamber may be any shape and size. The sterilization autoclave chamber may have a capacity that is between 20 and 40 liters.

[00110] In one or more embodiments of the invention, once placed inside a sterilization autoclave chamber, the cartridge (2200) is only subjected to a dry heating cycle in a temperature between 100 and 200 degrees Celsius. Different from the aforementioned procedures, the vapor treatment may not be used. Accordingly, one of ordinary skill in the art would appreciate that, in one or more embodiments, vapor treatment, chemical treatment, and dry heating may be used in various combinations to sterilize medical waste without departing from the spirit of the invention.

[00111] FIG. 26A shows a deformed inner holder (2600) after having been subjected to treatment. The integrity of the outer holder (2602) is still in place as it is made of metallic components. The sharps (2604) inside the inner holder, however, are deformed and made unrecognizable.

[00112] FIG. 26B shows a detailed version of FIG. 26A. Notably, the sharp ends of the pointed object (2604) are embedded in the inner holder's thick side (2608), but do not perforate the same. FIG. 26B also shows the deformed sharps being enveloped by the deformed protective padding (2610). Because the deformed sharps (2604) are unrecognizable and, importantly, are impossible to use for their intended purposes, embodiments of the invention comply with regulations requiring "loss of physical and biological-infectious characteristics of the object to not be used again."

[00113] While the invention has been described with respect to a limited number of embodiments, those skilled in the art, having benefit of this disclosure, will appreciate that other embodiments can be devised which do not depart from the scope of the invention as disclosed herein. Accordingly, the scope of the invention should be limited only by the attached claims.

Claims

CLAIMS What is claimed is:

1. A method for sterilizing medical waste, comprising:

placing the medical waste in an elastic compression bag;

dispensing fluid into the elastic compression bag;

sealing the elastic compression bag;

placing the sealed elastic compression bag into a container;

placing the container inside a sterilization autoclave chamber; and

sterilizing the medical waste by vaporizing the fluid using the sterilization autoclave chamber.

2. The method according to Claim 1, wherein the sterilizing comprises subjecting the container to steam and heat for between 1 and 120 minutes and at a temperature range between 100 and 200 degrees Celsius.

3. The method according to Claim 2, wherein:

the sterilizing comprises subjecting the container to steam and heat for between

1 and 20 minutes, and

the temperature range is between 121 and 134 degrees Celsius.

4. The method according to Claim 1, wherein the dispensing comprises introducing the fluid using a unidirectional flow device that prevents the medical waste from escaping the sealed elastic compression bag.

5. The method according to Claim 4, wherein the unidirectional flow device is a spring valve that is coupled to a flexible hose.

6. The method according to Claim 1, wherein the sealed elastic compression bag is sealed using an elastic cable tie.

7. The method according to Claim 1, wherein: the sealed elastic compression bag is sealed by securing a neck of the compression bag to a through-hole of a cap of the container, the container is a metallic container having a protective coating on an interior, and

the protective coating comprises at least one selected from a group consisting of: vulcanized natural rubber, polyurethane, and synthetic rubber.

8. The method according to Claim 1, wherein the fluid is water from a previous sterilization cycle.

9. A system for sterilizing medical waste, comprising:

a sterilization autoclave chamber that receives a container holding a sealed elastic compression bag, the sealed elastic compression bag holds medical waste;

a reservoir holding fluid;

a controller for controlling sterilization parameters of the sterilization autoclave chamber,

wherein the sterilization autoclave chamber sterilizes the medical waste by vaporizing the fluid inside the sealed elastic compression bag at a predetermined temperature over a predetermined amount of time set by the controller.

10. The system according to Claim 9, wherein the reservoir is coupled to the sterilization autoclave chamber using at least one selected from a group consisting of: a flexible hose and pipe.

11. The system according to Claim 9, wherein the sealed elastic compression bag is sealed by securing a neck of the compression bag to a through-hole of a cap of the container.

12. The system according to Claim 9, wherein the predetermined amount of time is between 1 and 120 minutes and the predetermined temperature is between 100 and 200 degrees Celsius.

13. The system according to Claim 9, wherein the fluid is dispensed from the reservoir into the sterilization autoclave chamber using a unidirectional flow device that allows the fluid to enter the sealed elastic compression bag and prevents the hospital waste from escaping the sealed elastic compression bag.

14. The system according to Claim 13, wherein the unidirectional flow device is a spring valve that is coupled to a flexible hose.

15. The system according to Claim 9, wherein:

the sealed elastic compression bag is sealed by securing a neck of the compression bag to a through-hole of a cap of the container, the container is a metallic container having a protective coating on an interior, and

16. The system according to Claim 9, wherein the fluid is water from a previous sterilization cycle.

17. A cartridge system for holding medical waste, comprising:

a cartridge comprising:

an outer holder,

an inner holder disposed in the outer holder,

a protective padding disposed in the inner holder for receiving a sharp object, and

a cap that is affixed to the outer holder, wherein the cap is configured to rotate clockwise or counterclockwise about a longitudinal axis of the outer holder to provide at most partial access to the protective padding for the sharp object through one of a plurality of through-holes on the cap;

a capsule for housing the cartridge; and

a red cap affixed to the capsule that closes the plurality of through-holes.

18. The cartridge system according to Claim 17, wherein:

the inner holder comprises at least one selected from a group consisting of: polyethylene terephthalate (PET), polyvinyl chloride (PVC), polypropylene, polystyrene, polycarbonate, polyethylene, the protective padding comprises at least one selected from a group consisting of: polyethylene and polyurethane, and

the cap and the outer holder each comprise at least one selected from a group consisting of: elemental metal and alloy.

19. The cartridge system according to Claim 17, wherein the cartridge is removable from the capsule.

20. The cartridge system according to Claim 17, wherein the cartridge is sterilized using at least one selected from a group consisting of: dry heating, steam, and chemical treatment.