Apparatus and method for crushing tablets

Abstract

A tablet crushing device is described for crushing one or more tablets. The device includes a male crushing section and a female crushing section that forms a closed chamber with the male crushing section. The male crushing section is rotatable relative to the female crushing section, allowing a set of serrated edges to move relative to one another to crush the one or more tablets into powder. A spring, valve, and adapter system selectively injects liquid and filters air through, allowing for repeated injection and withdrawal of the liquid / powder mixture.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application relies for priority on U.S. Provisional Patent Application No. 63 / 364,100, entitled “Devices and Methods for Crushing Pills,” filed May 3, 2022. The above-mentioned application is incorporated herein by reference in its entirety. [Technical field]

[0002] This disclosure relates to an apparatus and system for crushing solid pharmaceuticals (tablets) into powder and mixing the powder with liquid / water. In particular, this disclosure relates to a sealed, closed-loop pharmaceutical crushing and dispensing system for solid tablets that need to be mixed with a liquid to create a suspension before being administered to a patient. [Background technology]

[0003] In some cases, patients in various medical facilities require enteral or oral drug administration with a liquid drug obtained by crushing a solid drug, such as a tablet, and mixing it with a liquid. Currently, medical personnel crush tablets in an open container, mix the crushed powder with a liquid in the open container to produce a suspension, insert a syringe into the open container, draw the liquid suspension drug into the syringe, and then use the syringe to administer the drug to the patient.

[0004] Unfortunately, crushing tablets in an open environment can cause tablet dust to spread and be inhaled by patients, caregivers, medical professionals, or other clinicians who may be crushing tablets. This can be harmful to the clinician's health. Continuous inhalation of tablet dust from various tablets can even result in serious illness, allergic reactions, or other adverse health conditions. In some cases, crushed tablet powder or dust that spreads into the air can even be genotoxic, carcinogenic, or teratogenic and impair fertility. Therefore, clinicians engaged in tablet crushing are typically required to wear protective gear such as personal protective equipment (PPE) and / or face shields. This can be cumbersome to wear, reduce efficiency, and delay the administration of medication to patients. Commonly available tablet crushing equipment is not completely sealed from the environment, and using the tablet crushing equipment can pose significant health risks to users. Furthermore, commonly available tablet crushing equipment typically has multiple compartments that often result in unnecessary thinning or failure points.

[0005] US Pat. No. 5,399,433 discloses a closed system tablet crushing device. Patent Document 1 describes a device including a closed-system grinding injector for liquefying and delivering a solid dosage form, the closed-system grinding injector comprising: (a) a sidewall shaped to define a cylindrical inner surface; (b) an upper barrel opening; and (c) a bottom barrel wall; (c) a fluid port disposed on the bottom barrel wall; (a) a plunger shaft; and (b) a plunger head shaped to define a bottom plunger wall shaped to define a lower surface; and (c) a plunger head annular seal, the plunger head being insertable into the barrel such that (a) the plunger head defines a closed-system syringe chamber between the bottom barrel wall and the lower surface of the bottom plunger wall, and (b) the plunger head annular seal is insertable into and movable within the barrel such that (a) the plunger head defines a closed-system syringe chamber between the bottom barrel wall and the lower surface of the bottom plunger wall, and (b) the plunger head annular seal forms a plunger head annular seal between (a) the top barrel opening and the cylindrical inner surface of the plunger head; and (b) a barrel cap configured to be attachable to the top barrel opening and the cylindrical inner surface of the plunger head; and (c) a barrel cap forming a fluid-tight seal with the top barrel opening. (b) a plunger shaft shaped to define a cap opening through the barrel cap, the plunger shaft slidably disposed through the cap opening such that the plunger head forms a fluid-tight seal between the plunger shaft and a periphery of the cap opening; (a) a solid dosage form support disk disposed below the bottom plunger wall such that a grinding compartment is defined between the lower surface of the bottom plunger wall and the upper surface of the solid dosage form support disk, and (b) a knob configured such that (a) the solid dosage form is formed when (b) the plunger head is inserted into the barrel and (c) the closed system grinding syringe is oriented upright and the knob is actuated, the grinding compartment grinds the solid dosage form into a powder and at least 75% of the powder passes through the plurality of holes and enters a portion of the closed system syringe chamber below the solid dosage form support disk.The '1996 patent further discloses that "it is noted that the air in the closed syringe chamber 46 prior to the introduction of the liquid 73 is sufficiently compressible such that the force required to introduce the liquid 73 can be easily manually applied by a medical professional." Additionally, the '1996 patent uses a "dual-needle closed pressure equalizing syringe" for pressure management within the device--[t]he use of the dual-needle closed pressure equalizing syringe allows for the ejection of liquid 73 from the liquid compartment of the dual-needle closed pressure equalizing syringe into the liquid channel 74 and the simultaneous return of gas from the gas flow 78 into a separate gas compartment within the dual-needle closed pressure equalizing syringe.

[0006] Although US Patent No. 5,933,636 provides a system for crushing tablets, it does not describe a simple, compact, easy-to-use device with a single chamber for crushing tablets and mixing the crushed tablet powder with water / liquid, thereby minimizing / eliminating drug loss. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] International Publication No. 2020240554A1 Summary of the Invention [Problem to be solved by the invention]

[0008] Therefore, there is a need for a sealed closed-loop pill crusher device that allows a user to crush a tablet and mix the crushed tablet with a liquid to create a suspension without exposing the crushed tablet to the atmosphere, thereby eliminating the need for a caregiver or medical professional to wear protective gear while crushing the tablet. There is also a need for a small, easy-to-handle sealed closed-loop tablet crushing device with a single chamber that crushes tablets and mixes the crushed tablet powder with a liquid, thereby preventing loss of medication associated with the transfer of the crushed tablet to a second chamber, typically for mixing with the liquid. There is also a need for a tablet crushing device that is compatible with and can be connected to any syringe, which in some embodiments is used to administer a medication to a patient. [Means for solving the problem]

[0009] The following embodiments and aspects thereof are described and illustrated in connection with systems, apparatus, and methods that are merely exemplary and not limiting in scope. This application discloses multiple embodiments.

[0010] Disclosed herein is a device for crushing or grinding one or more solid pharmaceutical objects, the device comprising: a male grinding portion having a proximal end, a distal end, and a first plurality of serrated edges on an outer surface thereof, a female grinding portion defining a chamber for receiving the one or more solid pharmaceutical objects, a spring, a valve coupled to the spring and having a stop member, an adapter coupled to the valve and the distal end of the female grinding portion and configured to selectively seal the closed chamber, and a filter disposed between the distal end of the female grinding portion and the adapter and configured to prevent liquid, pharmaceutical powder, or a mixture of the liquid and pharmaceutical powder from passing through the device, and further configured to allow air to flow in and out of the closed chamber. The distal end of the male grinding part is configured to be at least partially received within the chamber of the female grinding part to form a closed chamber, an outer surface of the chamber of the female grinding part has a second plurality of serrated edges, and the male grinding part is configured to rotate relative to the female grinding part such that the first plurality of serrated edges move relative to the second plurality of serrated edges to break the one or more solid pharmaceutical agents into powder, and the distal end of the female grinding part is configured to receive the spring.

[0011] Optionally, the apparatus includes a syringe, the adapter being a syringe adapter configured to receive the syringe, the syringe configured to inject a liquid into the enclosed chamber.

[0012] Optionally, each of the first plurality of serrated edges has a first end and a second end, wherein a spacing between the first ends of each of the first plurality of serrated edges is less than a spacing between the second ends of each of the first plurality of serrated edges.

[0013] Optionally, the proximal end of the male grinding portion comprises a groove that allows for manual gripping of the male grinding portion and rotation of the male grinding portion relative to the female grinding portion. Optionally, a length of the male grinding portion ranging from 0.05 inches to 5 inches remains protruding above the female grinding portion during grinding of the one or more solid pharmaceutical agents.

[0014] Optionally, the device further comprises a retaining ring, the proximal end of the female grinding portion comprising a plurality of slots to receive the retaining ring, the retaining ring comprising a plurality of members configured to couple to the male grinding portion and prevent the male grinding portion from disengaging from the female grinding portion during operation.

[0015] Optionally, the stop member is configured to be pressed into the spring when the syringe is connected to the syringe adapter. Optionally, when the stop member is pressed against the spring, at least one opening is provided in the closed chamber and configured to allow the liquid and the powder to mix to produce a liquid and powder mixture. Optionally, the device further comprises at least one seal that mates with the female grinding portion to prevent the liquid and powder mixture from leaking out of the closed chamber.

[0016] Optionally, the spring is characterized by a spring constant having a value in the range of 0.09 to 0.27 lbs / mm.

[0017] Optionally, at least a portion of the female grinding portion is transparent to allow a user to visualize the grinding of the solid pharmaceutical agent.

[0018] Optionally, the filter is a hydrophobic filter.

[0019] Optionally, the valve is a hollow member having at least one opening, and the filter is positioned to surround the at least one opening to prevent the liquid, the pharmaceutical powder, or a mixture of the liquid and the pharmaceutical powder from passing through the at least one opening.

[0020] The present application also discloses a method of crushing a tablet and mixing the crushed tablet with a liquid to form a suspension. The method includes the steps of: placing one or more tablets in a female grinding section having a chamber configured to receive the one or more solid pharmaceutical agents and having a first plurality of serrated edges; inserting a male grinding section into the female grinding section to form a closed chamber with the female grinding section, the male grinding section having a proximal end, a distal end, and a second plurality of serrated edges, the female grinding section configured to receive the spring, a valve having at least one opening coupled to the spring, a filter disposed near the at least one opening and configured to allow only air to flow into and out of the closed chamber; rotating the male grinding section relative to the female grinding section to move the first plurality of serrated edges relative to the second plurality of serrated edges to crush the tablets into powder; attaching a syringe to an adapter coupled to the valve; injecting a liquid into the closed chamber through the valve using the syringe; and withdrawing a mixture of liquid and powder from the closed chamber using the syringe.

[0021] Optionally, the filter is a hydrophobic filter.

[0022] Optionally, the method further comprises repeating the steps of aspirating the liquid and powder mixture, injecting the liquid and powder mixture back into the closed chamber, and aspirating the liquid and powder mixture. Optionally, the method further comprises, after repeating the step of aspirating the liquid and powder mixture, removing the syringe from the adapter and administering the liquid and powder mixture to a patient using the syringe.

[0023] Optionally, the powder comprises particles having a size adapted to pass through holes located within the valve, the holes having a diameter between 1.25 mm and 5 mm.

[0024] Optionally, sound is generated by rotating the male grinding element relative to the female grinding element, the pitch of the sound changing as the tablet is crushed into the powder.

[0025] Optionally, at least a portion of said closed chamber is visible from outside said female grinding portion.

[0026] The present specification also discloses an apparatus for crushing or grinding one or more solid pharmaceuticals, the apparatus comprising: a male grinding part having a first proximal end, a second distal end, a proximal end, and a distal end, the distal end of the male grinding part being adapted to be inserted at least partially into the proximal end to form a closed chamber and contain the one or more solid pharmaceuticals; a female grinding part having a first inner surface or chamber and a second outer surface for receiving the one or more solid pharmaceuticals; a spring coupled to the distal end of the female grinding part; a hollow valve having at least two openings, coupled to the spring at the proximal end and having a stop member at the proximal end; a filter surrounding the at least two openings; and an adaptor coupled to the distal end of the valve and the distal end of the female grinding part to seal the closed chamber from the atmosphere. The male grinding part rotates relative to the female grinding part to crush or grind the one or more solid pharmaceuticals into powder. A portion of the inner surface of the female grinding part adjacent the distal end of the female grinding part is configured to receive the spring. The filter is configured to prevent liquid, medicinal powder, or a mixture of the liquid and medicinal powder from passing through the opening and allows air to pass through the closed chamber to break up the one or more solid medicinal objects.

[0027] Optionally, the adapter is a syringe adapter adapted to receive a syringe for injecting a liquid through the distal end of the valve and into the closed chamber to mix the medicinal powder with the liquid.

[0028] Optionally, the distal end of the male grinding portion has a serrated edge for crushing or crushing the solid pharmaceutical agent.

[0029] Optionally, the proximal end of the male grinding portion comprises a groove that allows for manual gripping of the male grinding portion and rotation of the male grinding portion relative to the female grinding portion. Optionally, a length of the male grinding portion ranging from 0.05 inches to 5 inches remains protruding above the female grinding portion during grinding of the one or more solid pharmaceutical agents.

[0030] Optionally, the proximal end of the female grinding portion includes a number of slots that allow a retaining ring to fit therein, and the retaining ring includes a number of tabs that prevent the male grinding portion from becoming disconnected from the female grinding portion during operation of the device.

[0031] Optionally, the stop member, when the syringe is connected to the syringe adapter, is forced into the interior of the spring such that the pair of openings enter the closed chamber to allow the liquid and the pharmaceutical powder to mix to produce a liquid mixture. Optionally, the device further comprises at least one sealing member coupled to an inner surface adjacent the proximal end of the female grinding portion to prevent the liquid mixture from leaking out of a connection point between the male grinding portion and the female grinding portion. Optionally, the liquid mixture is pushed and pulled from the syringe into the closed chamber one or more times to allow thorough mixing of the pharmaceutical powder and the liquid. The syringe is disconnected and reconnected to the syringe adapter one or more times to allow thorough mixing of the pharmaceutical powder and the liquid, followed by removal of the liquid mixture from the device.

[0032] Optionally, the spring constant of the spring is between 0.09 lbs / mm and 0.27 lbs / mm.

[0033] Optionally, at least a portion of the wall of the female grinding portion is transparent to allow visualization of the solid pharmaceutical agent being ground or crushed.

[0034] Optionally, the filter is a hydrophobic filter.

[0035] A method for crushing and liquefying tablets is also disclosed, which includes the steps of placing one or more tablets in a female grinding section having a first inner surface or chamber for receiving the one or more tablets and a second outer surface, and inserting a cylindrical male grinding section having a first proximal end and a second proximal end into the female grinding section to form a closed chamber within the female grinding section, a portion of the inner surface of the female grinding section proximate a distal end of the female grinding section configured to receive a spring, a proximal end of a hollow cylindrical valve having at least two openings is coupled to the spring, and a cylindrical hollow filter is disposed in the closed chamber surrounding a pair of the openings to prevent tablet particles or water / liquid from passing through the openings and to crush the one or more tablets. rotating the proximal end of the male grinding section relative to the female grinding section to crush the tablets to obtain the tablet powder; forcing water / liquid through the hollow valve and through the pair of openings into the crushing chamber with a syringe connected to a syringe adapter coupled to the distal end of the valve, connecting the syringe to the syringe adapter so that the pair of openings exposes the tablet powder in the crushing chamber, mixing the water / liquid with the crushed tablet powder to produce the liquid tablet powder mixture; and administering the liquid mixture to a patient by drawing it from the female grinding section into the syringe.

[0036] Optionally, the filter is a hydrophobic filter.

[0037] Optionally, the liquid is forced into the crushing chamber and drawn into the syringe multiple times to thoroughly mix the water / fluid with the tablet powder, and the syringe is disconnected and reconnected to the syringe adapter one or more times to allow thorough mixing of the tablet powder and the water / fluid.

[0038] Optionally, the syringe is an Enfit™ syringe.

[0039] Optionally, the syringe is used to administer the liquid-tablet-powder mixture to a patient.

[0040] Optionally, the tablet powder comprises particles capable of passing through holes located within the valve, the holes having a diameter between 1.25mm and 5mm.

[0041] Optionally, rotating the male grinding element relative to the female grinding element to crush the tablets produces a sound of varying pitch indicating completion of the crushing.

[0042] Optionally, a transparent portion of the wall of the female grinding section provides a visual indication of the completion of crushing of the tablets.

[0043] These and other embodiments herein are explained in more depth in the figures and detailed description provided hereinafter. [Brief description of the drawings]

[0044] The accompanying drawings show various embodiments of the systems, methods, and embodiments of various other aspects of the present disclosure. Those skilled in the art will understand that the illustrated member boundaries (e.g., boxes, groups of boxes, or other shapes) in the drawings represent one example of a boundary. In some examples, it may be possible that one member can be designed as multiple members, or multiple elements can be designed as one element. In some examples, an element shown as an internal component of one element may be implemented as an external component of another element, and vice versa. Furthermore, the members may not be drawn to scale. A non-limiting and non-exhaustive description is described with reference to the following drawings. The components in the figures are not necessarily to scale, with emphasis instead being placed on illustrating the principles. [Figure 1A] FIG. 2 is a side cross-sectional view showing various components of a tablet breaking device according to certain embodiments herein. [Figure 1B] FIG. 1B is an exploded perspective view of the tablet crushing device shown in FIG. 1A according to an embodiment herein. [Figure 1C] 1B is a perspective view, a cross-sectional view, and a side plan view of the valve and stop member shown in FIG. 1A according to an embodiment herein. [Figure 1D] 1 shows both a top view and a side view of a sawtooth having a 9-tooth design provided on the surface of a male / female grinding section of a tablet crushing device, according to an embodiment herein, that allows for clockwise rotation of the male grinding section relative to the female grinding section. [Figure 1E] FIG. 1 shows both a top view and a side view of a sawtooth having a 9-tooth design provided on the surface of a male / female grinding section of a tablet crushing device, according to an embodiment herein, that allows for counterclockwise rotation of the male grinding section relative to the female grinding section. [Figure 1F] FIG. 1 shows both a top view and a side view of a sawtooth having a 24-tooth design provided on the surface of a male / female grinding section of a tablet crushing device, according to an embodiment herein, that allows for counterclockwise rotation of the male grinding section relative to the female grinding section. [Figure 1G] FIG. 1 shows both a top view and a side view of a sawtooth having a 12-tooth design provided on the surface of a male / female grinding section of a tablet crushing device, according to an embodiment herein, that allows for clockwise or counterclockwise rotation of the male grinding section relative to the female grinding section. [Figure 1H] 1 shows both a top view and a side view of a sawtooth having multiple teeth disposed on the surface of a male / female grinding section of a tablet crushing device, according to an embodiment herein, that allows for counterclockwise rotation of the male grinding section relative to the female grinding section. [Figure 1I] FIG. 1 shows a perspective view of sawtooth on the surface of a male / female grinding portion of a tablet crushing device having a plurality of teeth that allows for counterclockwise rotation of the male grinding portion relative to the female grinding portion according to one embodiment herein. [Figure 1J] FIG. 13 is a perspective view of male / female sawtooth - inverted teeth shown - provided on the surface of a detail of a tablet crushing device according to certain embodiments herein. [Figure 1K] FIG. 1K is a flow chart illustrating the operation steps of the tablet crushing device shown in FIG. 1A, according to certain embodiments herein. [Figure 2A] FIG. 1 is a perspective view of a tablet crushing device according to certain embodiments herein. [Figure 2B] FIG. 2B is an exploded perspective view of exemplary components of the tablet crushing device shown in FIG. 2A, according to an embodiment herein. [Figure 2C]FIG. 2B is a perspective view showing the male and female crushing sections of the tablet crushing device shown in FIG. 2A. [Figure 2D] FIG. 2B is a perspective view of the male grinding portion of the device shown in FIG. 2A. [Figure 2E] FIG. 2B is a perspective view of the female grinding portion of the device shown in FIG. 2A. [Figure 2F] FIG. 2F is a perspective view of a retainer disposed between the male and female grinding portions of the device shown in FIG. 2A. [Figure 2G] FIG. 2B is a perspective view of a seal disposed between the male and female grinding portions of the device shown in FIG. 2A. [Figure 2H] FIG. 2B is a perspective view of the distal end of the funnel-shaped female grinding portion of the device shown in FIG. 2A. [Figure 2I] FIG. 2B is a perspective view of a spring disposed within the distal end of the female grinding portion of the device shown in FIG. 2A. [Figure 2J] FIG. 2I is a perspective internal view of the valve coupled with the spring shown in FIG. 2I. [Figure 2K] FIG. 2J is a perspective view of a stop member disposed at the proximal end of the valve shown in FIG. 2J so that the valve can be coupled with the spring shown in FIG. 2I. [Figure 2L] FIG. 2J is a perspective view of a filter encasing the side opening of the valve shown in FIG. 2J. [Figure 2M] FIG. 2B is a perspective view of an adapter attached to the bottom of the cap attached to the distal end of the female grinding portion of the device shown in FIG. 2A. [Figure 2N] 2L, according to an embodiment of the present disclosure. [Figure 2O] 1 is a table showing exemplary parameters of a spring that can be used with the devices herein. [Figure 2P] 2C shows a perspective view, a top view, a cross-sectional view, and an exploded cross-sectional view of the adapter shown in FIG. 2M according to an embodiment herein. [Figure 2Q] 2F show a perspective view, a bottom view, and a cross-sectional view of the retainer shown in FIG. 2F, according to an embodiment herein. [Figure 2R]2A, 2B, and 2C according to an embodiment of the present disclosure. [Figure 2S] 2D, according to an embodiment of the present disclosure, a perspective view, a bottom view, and a cross-sectional view of the male grinding part shown in FIG. [Figure 2T] 2E, according to an embodiment of the present disclosure, show a perspective view, a top view, and a cross-sectional view of the female grinding portion shown in FIG. 2E. [Figure 3A] FIG. 3A is a perspective view of a tablet crushing device according to an embodiment herein. [Figure 3B] FIG. 3B is a side view showing a tablet placed inside the tablet crushing device shown in FIG. 3A. [Figure 3C] FIG. 3C is a side view showing a male grinding section connected to a female grinding section forming an enclosed grinding chamber within the device shown in FIG. 3A. [Figure 3D] FIG. 3D is an enlarged cross-sectional view of the area indicated in FIG. 3C, showing the connection of the male grinding portion to the female grinding portion. [Figure 3E] FIG. 13 is a side view showing the male grinding part fully inserted into the female grinding part and the twisting motion to crush the tablets. [Figure 3F] FIG. 3B is a cross-sectional view of the distal end of the female grinding section showing the path of compressed air when the apparatus shown in FIG. 3A is being used to crush tablets. [Figure 3G] FIG. 3F is a side view of the device of FIG. 3E having a syringe adapter attached to the distal end of the female grinding section for mixing the crushed tablets with liquid. [Figure 3H] FIG. 3H is a cross-sectional view of the device of FIG. 3G showing the liquid mixture exiting the female grinding portion and entering into the syringe adapter. [Figure 3I] FIG. 3H shows an empty device as described in FIG. 3H according to an embodiment herein, from which the liquid mixture is aspirated using a syringe and the remaining device is disposed of as medical waste. [Figure 3J] FIG. 2 is a side view of a tablet crushing apparatus according to another embodiment of the present disclosure. [Figure 3K] FIG. 3K is a side view of the device of FIG. 3J with liquid in the internal chamber. [Figure 4] FIG. 4 is a flow chart illustrating exemplary steps of the operation of the tablet crushing device shown in FIGS. 3A-3I, according to certain embodiments herein. [Figure 5A] FIG. 2 is a front view of a tablet crushing device according to another embodiment of the present disclosure. [Figure 5B] 13 illustrates a cap for a male grinding part according to another embodiment of the present disclosure. [Figure 5C] FIG. 5B is a perspective view of the tablet crushing apparatus shown in FIG. 5A according to an embodiment herein. [Figure 5D] FIG. 5B is an exploded perspective view of exemplary components of the tablet crushing device shown in FIG. 5A, according to certain embodiments herein. [Figure 5E] 5D according to an embodiment of the present disclosure. FIG. [Figure 5F] 5D according to an embodiment of the present disclosure. FIG. [Figure 5G] 5F shows a cross-sectional view of the valve stem shown in FIG. 5F according to an embodiment of the present disclosure. [Figure 5H] FIG. 5B is a cross-sectional view of the device 500 shown in FIG. 5A according to an embodiment herein. [Figure 6] FIG. 6 is a flow chart illustrating exemplary steps of the operation of the tablet crushing device shown in FIGS. 5A-5H, according to certain embodiments herein. [Figure 7] Figure 7A illustrates the tablet crusher apparatus shown in Figure 5A in an undeployed state according to certain embodiments herein, Figure 7B illustrates the tablet crusher apparatus shown in Figure 5A in a partially deployed state according to embodiments herein, and Figure 7C shows the tablet crusher apparatus shown in Figure 5A in an assembled, fully deployed state with the female grind section having a minimum internal volume according to embodiments herein. [Figure 8]FIG 8A illustrates a protective cone for preventing harmful pressing of the valve of the tablet crushing device shown in FIG 5D according to an embodiment herein. FIG 8B is a cross-sectional view of the protective cone shown in FIG 8A according to an embodiment herein. FIG 8C shows a perspective view of the protective cone shown in FIG 8A according to an embodiment herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] In one embodiment, the present disclosure provides a sealed closed loop tablet crushing device. The device allows a user to crush tablets and mix the crushed tablets with a liquid to create a suspension without the crushed tablets being exposed to the atmosphere. The tablet crushing device thereby allows a caregiver or medical professional to crush tablets without being exposed to tablet dust, which can be dangerous. Thus, in an embodiment, the tablet crushing device described herein eliminates the need for a user to wear protective clothing / equipment to crush tablets. In an embodiment, the tablet crusher is a small and easy to handle device that includes a single chamber for crushing tablets and mixes the crushed tablet powder with a liquid. Further, in an embodiment, the tablet crushing device crushes the tablets so that they can enter holes located in the valve and then be mixed with the liquid. In one embodiment, the tablet powder can pass through holes having a diameter ranging from 1.25 mm to 5 mm, preferably about 2. 5 mm. Thus, the diameter can be reduced by up to 50% and increased by up to 100%. In one embodiment, the tablet crushing device provides both an audible and visual means for a user to confirm that the solid pharmaceutical agent has been crushed to the required degree.

[0046] In embodiments, the tablet crushing device completely crushes the entire tablet in a closed environment without exposure to the atmosphere, eliminating significant medication waste and, more importantly, loss of the intended dose. The device also ensures complete mixing of the tablet powder with a liquid, such as water, as the liquid and tablet powder mixture flows back and forth between the syringe and the same closed environment (chamber) in which the tablet is crushed. In various embodiments, a syringe of any size can be used with the tablet crushing device described herein to mix the crushed tablet powder with the liquid. In embodiments, the syringe can also be used to administer the pharmaceutical to the patient. It is noted herein that the syringe is separate from the tablet crushing device described herein.

[0047] Furthermore, in one embodiment, the tablet crushing device of the present invention is designed to avoid undesirable pressure build-up in the closed crushing chamber of the device by providing a filter that allows only air to pass, but not tablet particles, from the chamber when no syringe is attached, and allows liquid to pass in and out of the chamber when a syringe is attached. Thus, in an embodiment, a syringe is used to open a valve.

[0048] In the description and claims of this application, the words "comprise", "comprise", "have", "comprises" and each of their forms are not necessarily limited to the members in the list to which the words may be associated. Thus, they are intended to be equivalent in meaning and do not imply that the item or items following any one of these words is an inclusive list of such items or items or are limited to only the listed items. It should be noted that any feature or element described in connection with a particular embodiment herein can be used and implemented with any other embodiment unless otherwise specified.

[0049] Also, it should be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context dictates otherwise. Although any systems and methods similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, the preferred systems, devices, and methods are described herein.

[0050] In embodiments, the term "serrated" refers to having or exhibiting a jagged edge, while the term "serrated" refers to teeth or points on the edge of a sawtooth surface.

[0051] In embodiments, the term "liquefy" is defined as mixing a crushed solid pharmaceutical with a liquid to create a suspension.

[0052] This specification relates to multiple embodiments. The following disclosure is provided to enable those skilled in the art to practice the invention. The language used in this specification should not be interpreted as a general disclaimer of any one particular embodiment, or used to limit the scope of the claims beyond the meaning of the terms used in this specification. The general principles defined in this specification may be applied to other embodiments and applications without departing from the spirit and scope of the present invention. Furthermore, the terms and expressions used are for the purpose of describing exemplary embodiments, and should not be considered as limiting. Thus, the present invention should be accorded the widest scope encompassing numerous alternatives, modifications, and equivalents consistent with the principles and features disclosed. For clarity, details regarding technical materials known in the technical fields related to the present invention have not been described in detail so as not to unnecessarily obscure the present invention.

[0053] Also, it should be noted that while the various components described herein may be described with reference to specific embodiments, the components are interchangeable and may be used in any combination such that the device achieves the purposes described herein.

[0054] FIG. 1A is a side view showing various components of a tablet crushing device according to one embodiment of the present specification. FIG. 1B is an exploded perspective view of a portion of the tablet crushing device shown in FIG. 1A according to one embodiment of the present specification. With reference to FIG. 1A and FIG. 1B, the device 100 comprises a convex male grinding section 102 having a first smooth inner surface 104 and an opposing second outer surface 105 with a serrated edge having a plurality of notches or teeth as shown in FIG. 1B to assist in crushing tablets. The device 100 further comprises a female grinding section 106 having an inner surface 103 and an opposing outer surface 109. In an embodiment, the female grinding section 106 is hollow and / or funnel-shaped. In an embodiment, the female grinding section 106 also comprises a serrated edge having a plurality of notches or teeth extending outwardly from its inner surface. Although the male portion 102 has been described as being convex and the female portion 106 as being funnel-shaped, the male portion 102 and female portion 106 are configured such that a) the female portion 106 is configured to receive the male portion 102, and b) once received in the female portion 106, at least a portion of the male portion 102 physically contacts the female portion 106 to form opposing mating grinding surfaces. Thus, in an alternative embodiment, the male portion 102 can have a cylindrical outer surface while the female portion 106 can have a slightly larger cylindrical chamber for receiving the male portion 102. In another alternative, the male portion 102 can have a curved outer surface while the female portion 106 has a slightly larger but curved inner chamber to complement and mate with the male portion 102. As a further alternative, the male portion 102 can have a convex outer surface while the slightly larger inner surface / chamber of the female portion 106 is funnel-shaped and configured to receive the male portion 102.

[0055] In an embodiment, the inner surface 103 of the female grinding section 106 forms a chamber for receiving a solid pharmaceutical product, such as a tablet, so that the tablet can be crushed or ground. The inner surface / chamber 103 of the female grinding section 106 is configured to receive the second serrated surface 105 of the male grinding section 102, and the second serrated surface 105 of the male grinding section 102 and the inner surface 103 of the female grinding section 106 form an enclosed grinding or crushing chamber. In an embodiment, the inner surface 103 of the female grinding section 106 also includes a serrated edge having a plurality of notches or teeth. In an embodiment, with respect to the following description, it is noted that the male grinding section is rotated upon insertion into the female grinding section. Thus, the direction of rotation described herein refers to the movement of the male grinding section relative to the female grinding section.

[0056] In embodiments, the term "serrated" refers to having or exhibiting a jagged edge, while the term "serrated" refers to teeth or points on the edge of a sawtooth surface. In embodiments, the outer surface of the male grinding section is provided with a serrated edge that aids in the crushing of tablets when the distal end of the male grinding section is inserted into the female grinding section and rotated relative to the female grinding section. In embodiments, the inner surface / chamber of the female grinding section is provided with a serrated edge that aids in the crushing of tablets when the distal end of the male grinding section is inserted into the female grinding section and rotated relative to the female grinding section. In embodiments, the sawtooth comprises a plurality of teeth having a predetermined depth, shape, number, and orientation that allows or enables clockwise or counterclockwise rotation of the male grinding section relative to the female grinding section. The plurality of teeth helps to reduce the effort required to crush / crush tablets placed within the female grinding section, so that the device is easy and convenient to use. In an embodiment, the number of teeth provided on the outer surface of the male crushing section and the inner surface of the distal end of the female crushing section of the tablet crushing device herein may range from 1 to 100. In an embodiment, the depth of the teeth, measured from tip to base, is measured axially and ranges from 0.5 mm to 10 mm. In an embodiment, the teeth may be designed in multiple shapes. In an embodiment, the sawtooth allows or permits rotation in a clockwise direction, a counterclockwise direction, or both.

[0057] 1D-1J illustrate multiple shapes or designs of serrations that may be provided on the outer surface of the male grinding section or the inner surface / chamber of the female grinding section of a tablet crushing device according to embodiments herein. Although FIG. 1D-1J show both top and side views of the serrations of the male grinding section, it should be understood that the female grinding section may have corresponding serrations with opposing patterns. Thus, the serrations of both the male grinding section and the female grinding section work in combination for the desired clockwise, counterclockwise, or bidirectional motion. In embodiments where the male grinding section includes clockwise serrations, the female grinding section includes clockwise serrations. In embodiments where the male grinding section includes counterclockwise serrations, the female grinding section includes counterclockwise serrations. In embodiments, the male grinding section and the female grinding section include serrations with opposing orientations. In various embodiments, the serrated surfaces of the male and female grinding sections are designed to fit together so that when the male grinding section is inserted into the female grinding section, the serrated surfaces interdigitate with each other, and tablets placed in the female grinding section are completely crushed. This is necessary to minimize the volume of liquid left behind in the device when the crushed tablets are mixed with the liquid to create a suspension and the liquid suspension is drawn through the device via a syringe.

[0058] It should further be appreciated that in one embodiment, the serrated edge of the male grinding portion converges at one end of the outer surface of the male grinding portion, and the serrated edge extends downwardly on the outer surface of the male grinding portion and diverges such that the spacing between the first and second serrated edges (and thus the teeth located on the first and second serrated edges) increases as one moves from the top end of the outer surface of the male grinding portion to the bottom end of the outer surface of the male grinding portion.

[0059] In an embodiment, clockwise or counterclockwise rotation occurs due to the directional interaction of the saw teeth that generate either a shearing or crushing action based on the movement. FIG. 1D illustrates saw teeth provided on the surface of the male / female grinding section of a tablet crushing device having a nine-tooth design that allows for clockwise rotation of the male grinding section relative to the female grinding section, according to an embodiment herein. As seen in cross-sectional view 170 and perspective view 171, nine teeth 172 or serrated edges are provided and positioned to allow for rotation in a clockwise direction. In an embodiment, the teeth that allow for clockwise rotation of the male grinding section relative to the female grinding section are designed to be more aggressive when rotated in a clockwise direction, with a higher chance of catching and shearing the tablet. When the teeth provided on the surfaces of the male and female grinding sections begin to interlock, the inclination of the teeth is locked due to the aggressive design angle. In an embodiment, the back inclination of the teeth allows the teeth to "ratchet" against each other when rotated in a counterclockwise direction, allowing the user to repeat the crushing motion without having to reposition their hands.

[0060] 1E illustrates serrations provided on the surface of a male / female grinding section of a tablet crushing device having a nine-tooth design that allows for counterclockwise rotation of the male grinding section relative to the female grinding section, according to embodiments herein. As seen in cross-sectional view 173 and perspective view 174, nine teeth 175 or serrated edges are provided and positioned to allow for rotation in a counterclockwise direction.

[0061] IF shows sawtooth on the surface of the male / female grinding section of a tablet crushing device according to one embodiment herein, having a 24 tooth design that allows for counterclockwise rotation of the male grinding section relative to the female grinding section. As seen in cross-sectional view 176 and perspective view 177, 24 teeth 178 or sawtooth edges are provided and positioned to allow for rotation in a counterclockwise direction.

[0062] 1G shows sawtooth provided on the surface of a male / female grinding section on the distal end of a tablet crushing device according to an embodiment herein, having a 12 tooth design that allows for either clockwise or counterclockwise rotation of the male grinding section relative to the female grinding section. As seen in cross-sectional view 179 and perspective view 180, 12 teeth 181 or sawtooth edges are provided and symmetrically arranged such that rotation can be either clockwise or counterclockwise.

[0063] 1H illustrates serrations provided on the surface of a male / female grinding section of a tablet crushing device having a plurality of teeth that allow for counterclockwise rotation of the male grinding section relative to the female grinding section, according to embodiments herein. As seen in cross-sectional view 182 and perspective view 183, a plurality of teeth 184 or serrated edges are provided and arranged in a counterclockwise design.

[0064] FIG. 1I is a perspective view of sawtooth provided on the surface of the male / female grinding section of a tablet crushing device according to one embodiment herein, showing the angle of the teeth. In an embodiment, the arrangement angle 186 of each tooth 185 may range from 0 degrees to 180 degrees. In a preferred embodiment, the arrangement angle 186 ranges from 45 degrees to 60 degrees, and in a particular embodiment, the arrangement angle 186 is 60 degrees. In an embodiment, a smaller arrangement angle of the teeth provides a user with a mechanical advantage to apply pressure to a tablet placed in the female grinding section of the tablet crushing section to crush said tablet, since the arrangement angle is inversely proportional to the downward force transmitted perpendicular to the crushing surface. Thus, in an exemplary embodiment, instead of, for example, 135 degrees, it is advantageous to have the arrangement angle 186 be 60 degrees, with the smaller the arrangement angle, the greater the mechanical advantage obtained. In other embodiments, a larger arrangement angle of the teeth provides a compact design feature. In some embodiments, the surface of the male grinding part including said teeth is conical with some teeth decreasing near the distal tip of the member so that different placement angles can be defined for the same tooth.

[0065] FIG. 1J is a perspective view of a saw tooth provided on the surface of a male or female crushing section of a tablet crushing device according to an embodiment herein, showing the inverted teeth. In one embodiment, the tooth 636 is inverted at a midpoint along its length. The inverted teeth 187 provide a design in which, when the male crushing section inserted into the female crushing section is rotated to crush the tablet, the tablet placed in the female crushing section of the tablet crushing device falls on the side of the tooth, thereby making said crushing easier and more efficient. Furthermore, with a non-inverted teeth design, some tablets may get stuck in the tip portion of the male crushing section, thereby preventing the user from performing the crushing process. Thus, the inverted teeth design eliminates such problems, thereby allowing said crushing to be easily performed.

[0066] In an embodiment, a portion of the inner surface 103 of the female grinding section 106 located at the distal end 107 of the female grinding section 106 is configured to receive or be coupled to the spring 110, which in turn is configured to receive or be coupled to the valve 112. In one embodiment, the portion of the inner surface 103 of the female grinding section 106 located at the distal end 107 of the female grinding section 106 is cylindrical in shape and is sized / designed so that the spring 110 fits snugly therein, as shown in FIG. 1A. In an embodiment, the distal portion of the female grinding section 106 is narrower than the proximal portion / mouth / opening configured to receive the male grinding section 102. The valve 112 is preferably a hollow elongated member having a proximal end 122 and a distal end 117. A stop member 114 is coupled to the proximal end 122, which fits over the spring 110 forming a sealing contact. Thus, when tablets are crushed in the crushing chamber formed in the female grinding section 106 by the insertion of the male grinding section 102, the stop member 114 prevents any material from exiting the distal end 107 of the female grinding section 106. In one embodiment, the stop member 114 and the valve 112 may be formed as a single member, rather than as two separate parts / components.

[0067] The valve 112 further comprises at least two side openings 116. In an embodiment, the side openings 116 of the valve 112 allow for the passage of air in and out of the grinding chamber to generate an up and down movement of the male grinding section 102 relative to the female grinding section 106, thereby allowing the crushing of the tablets, thereby avoiding excessive pressure build-up in the closed grinding chamber of the device 100. Thus, in an embodiment, the air travels through a filter before exiting through the valve 112, allowing the air to travel in and out of the device 100 while the tablets are being crushed in the device. In an embodiment, the valve 112 is enclosed within a filter 118, which in one embodiment is cylindrical. In one embodiment, the filter 118 is a hydrophobic filter that allows only air to pass through, preventing liquids or solid particles from flowing in or out of the side openings 116. In an embodiment, the filter 118 also prevents foreign objects from entering the device 100 from the outside. In one embodiment, the filter 118 is a porous polymer filter, although in other embodiments, various suitable materials can be used for the filter 118. In one embodiment, the filter 118 is a polyethylene filter. In an embodiment, the filter is manufactured using a porous polymer having a porosity in the range of 5 microns to 60 microns.

[0068] FIG. 1C illustrates multiple views of the valve 112 and stop member 114 shown in FIG. 1A, according to embodiments herein. A perspective view 151 shows the valve 112 including at least one opening 116 and a stop member 114 coupled to a proximal end 122 of the valve 112. A top view 152 corresponding to the perspective view 151 shows the valve 112 and stop member 114 to have a circular cross section, and when sliced ​​through a section line 153, a cross section view 154 is obtained. As can be seen from the cross section view 154, the valve 112 forms a hollow tube, which in one embodiment has a length 155 of 17.670 mm and a diameter 156 of 3.800 mm. In one embodiment, the stop member 114 has a first diameter 157 of 3.9 mm, a second diameter 158 of 6 mm, and a length 159 of 5.45 mm, with the first thickness being less than the second thickness. In one embodiment, the overall length 160 of the valve 112 and stop member 114 is 26.77 mm. In embodiments, the dimensions provided herein are any range between a 50% decrease in the stated value to a 100% increase in the stated value, and any increment therein. In other embodiments, the dimensions provided herein are any range between a 10% decrease in the stated value to a 10% increase in the stated value, and any increment therein.

[0069] In an embodiment, the tablet crushing device herein is designed for pediatric use and has smaller dimensions than those described above. In one embodiment, a tablet crushing device designed for pediatric use has dimensions that are 25% to 30% smaller than tablet crushing devices designed for adults. An exemplary design and dimensions of a tablet crushing device for pediatric use are shown in FIG. 5H below.

[0070] It should be noted that the dimensions provided in and throughout this specification are meant to be merely exemplary in nature, and that these dimensions may vary so long as the device meets the objectives of this specification. In addition, where the size of a particular component varies, in embodiments, other components are also adjusted proportionately, if necessary, to achieve the objectives of this specification.

[0071] Additionally, the distal end 107 of the female grinding section 106 may, in some embodiments, include a portion 108 configured to be coupled with a valve housing / syringe adapter 120. In embodiments, the valve housing / syringe adapter 120 may be glued onto the distal end 107, in which case the portion 108 is smooth / not threaded. In embodiments, the portion 108 is threaded to allow for threaded engagement of the valve housing / syringe adapter 120, in which case the device 100 is provided as a reusable device. The threading of the portion 108 allows for removal of the valve housing / syringe adapter so that the filter and adapter can be changed for reuse of the device 100. In one embodiment, the various members of the device 100 may be fabricated from plastic and / or metal and / or silicon cone or a mixture thereof.

[0072] FIG. 1K is a flow chart showing steps pf of the operation of the tablet crushing device shown in FIG. 1A according to one embodiment of the present specification. With reference to FIG. 1A and FIG. 1K, in step 191, one or more tablets to be crushed are placed in the female crushing section 106 to be received by the inner surface / chamber 103. In step 192, the male crushing section 102 is inserted into the female crushing section 106 to form a crushing chamber in the female crushing section 106, where crushing is accomplished by the outer serrated surface 105 of the male crushing section 102 and the inner surface / chamber 103 of the female crushing section 106. In step 193, the tablet is crushed by rotating the male crushing section 102 relative to the female crushing section 106. In one embodiment, the male crushing section 102 is rotated in a clockwise direction relative to the female crushing section 106. In step 194, once one or more tablets have been crushed, a syringe (not shown) containing water / fluid is connected to the syringe adapter 120. In step 195, water / fluid is injected by a syringe through the distal end 117 of the valve 112, through the hollow length of the valve 112 towards the proximal end 122, and into the crushing chamber. In an embodiment, the connection of the syringe to the syringe adapter 120 creates an upward force that pushes the stop member 114 through the spring 110 and into the crushing chamber in the female grinding section 106. In step 196, the water / fluid flows out of the side opening 116 of the valve 112 into the crushing chamber and mixes with the crushed tablet powder to form a liquid mixture. In step 197, the liquid mixture is aspirated by using a syringe assisted by the side opening 116. The device 100 allows the liquid mixture to flow back and forth between the syringe and the crushing chamber as many times as the user requires, allowing the fluid to be thoroughly mixed with the tablet powder. In various embodiments, any size syringe can be used with tablet crushing apparatus 100, and in embodiments, the same syringe that is required to administer to the patient can be used with tablet crushing apparatus 100 to mix the powder with the fluid. In embodiments, the syringe is an Enfit™ syringe.

[0073] FIG. 2A is a perspective view of a tablet crushing device according to an embodiment herein. FIG. 2C is an exploded perspective view of an exemplary member of the tablet crushing device shown in FIG. 2A according to an embodiment herein. FIG. 2C is a perspective view of the male and female crushing sections of the tablet crushing device shown in FIG. 2A. Referring to FIGS. 2A-C, the device 200 comprises a substantially cylindrical male crushing section 202 having a proximal end 201 and a convex distal end 203. The proximal end 201 comprises a plurality of grooves 211 for providing a user with a better grip while using the device 200. The distal end 203 comprises a serrated edge 213 for assisting in crushing the tablets. FIG. 2D is a perspective view of the male crushing section of the device shown in FIG. 2A. In various embodiments, the serrated edge comprises a plurality of teeth having different numbers, depths, shapes, and orientations, as described with reference to FIGS. 1D-1J above. In one embodiment, the serrated edge 213 of the device 200 comprises teeth ranging in number from 1 to 100 with various shapes as described with respect to Figures 1D-1J, the teeth having depths ranging from 0.5 mm to 10 mm as measured from tip to base, allowing clockwise, counterclockwise, or bi-directional rotation of the male grinding section relative to the female grinding section. The multiple teeth help reduce the effort required to crush / crush tablets placed within the female grinding section, making the device easy and convenient to use.

[0074] FIG. 2S shows multiple views of the male grinding portion shown in FIG. 2D according to one embodiment herein. FIG. 2S includes a perspective view 2004 of the male grinding portion 202. The top view 2006 of the male grinding portion 202 shows that the member 202 has an outer diameter 2008 of 55.210 mm and a circular cross section that provides a cross section 2012 when sliced ​​through the section line 2010. The view 2012 shows the portion proximal to the proximal end 201 having a length 2014 of 18.00 mm, a first intermediate portion length 2016 of 50.90 mm, and a second intermediate portion length 2018 proximal to the distal end 203 of 52.40 mm. In an embodiment, the male grinding portion has an overall length 2020 of 97.43 mm and an overall diameter 2022 of the distal end 203 of 44.196 mm. In embodiments, the dimensions provided herein are any range between a 50% decrease in the stated value to a 100% increase in the stated value, and any increment therein. In other embodiments, the dimensions provided herein are any range between a 10% decrease in the stated value to a 10% increase in the stated value, and any increment therein.

[0075] The device 200 further comprises a cylindrical or syringe-shaped female grinding section 204 having an inner surface 280 and an outer surface 282. During operation, the male grinding section 202 is received by the inner surface / chamber 280 of the female grinding section 204. In one embodiment, the entire length of the male grinding section 202, except for the groove 211 at the proximal end 201, forms an enclosed crushing / crushing chamber within the female grinding section 204 and is inserted into the female grinding section 204 to crush one or more tablets placed within the crushing chamber. In one embodiment, the distal end 207 of the inner surface / chamber 280 of the female grinding section 204 also comprises a serrated edge to aid in crushing the tablets. When a tablet placed inside the female grinding section 204 is fully crushed, the serrated edge 213 of the male grinding section 202 and the serrated edge provided on the inner surface / chamber 280 fully mate. In one embodiment, when the male grinding portion 202 is fully inserted into the female grinding portion 204, a small length of the male grinding portion 202 remains protruding above the female grinding portion 204 to prevent a user's fingers from being injured / pinched while rotating the male grinding portion 202 relative to the female grinding portion 204. In one embodiment, said small length of the male grinding portion 202 that remains protruding above the female grinding portion 204 ranges from 0.05 inches to 0.2 inches, and in one embodiment, is approximately 0.1 inches.

[0076] Figure 2E is a perspective view of the female grinding section of the device shown in Figure 2 A. With reference to Figures 2A-2E, the female grinding section 204 includes a proximal end 205 having a grooved edge 215 to assist a user in gripping while rotating the male grinding section 202 relative to the female grinding section 204 to crush tablets placed within the chamber of the female grinding section 204.

[0077] To aid in the grinding of the solid pharmaceutical, the male grinding section 202 is rotated to be pushed up into the female grinding section 204 until the solid pharmaceutical is completely ground and the serrated edge 213 of the male grinding section 202 and the serrated edge on the inner surface / chamber 280 of the female grinding section 204 are fully engaged. However, to prevent the male grinding section 202 from accidentally falling out of the female grinding section 204 during the grinding / crushing process (which releases pharmaceutical powder into the atmosphere), the device 200 further comprises a retainer or retaining ring 208 and a sealing member disposed between the male grinding section 202 and the female grinding section 204 and configured to both engage the male grinding section 202 into the female grinding section 204 and seal the grinding chamber from the atmosphere, creating a substantially near airtight seal. In an embodiment, the sealing member may be an O-ring, an X-ring, a wing tip, or any other similar structure of any other shape that provides a sealing mechanism for accomplishing the purposes herein.

[0078] FIG. 2F is a perspective view of a retainer 208 disposed between the male and female grinding portions of the device shown in FIG. 2A. FIG. 2G is a perspective view of a sealing member 206 disposed between the male and female grinding portions of the device shown in FIG. 2A. Referring to FIGS. 2A-2G, in an embodiment, the retainer 208 is integrated into the male grinding portion 202 and configured to provide a locking mechanism between the male grinding portion 202 and the female grinding portion 204. In an embodiment, the retainer 208 is a retaining ring. In one embodiment, the mouth / opening at the proximal end 205 of the female grinding portion 204 is configured with a plurality of slots / openings 217 that accommodate the protruding portion 219 of the retainer 208 to allow the retainer 208 to fit snugly around the mouth or proximal end 205 of the female grinding portion 204. In one embodiment, the proximal end 205 includes at least one slot 217 (FIG. 2E), and preferably four slots 217, into which the four protruding portions 219 (FIG. 2F) of the retainer are inserted to attach the retainer 208 around the proximal end 205 (FIGS. 2A, 2F) of the female grinding portion 204. The retainer 208 includes at least one, and up to an equal number of corresponding retaining tabs 209 (shown in FIG. 2F). When the male grinding portion 202 is mated and pressed into the female grinding portion 204, the retainer 208 automatically engages the corresponding retaining tabs with the slots on the female portion, thereby preventing separation of the members during operation of the device 200. The retainer 208 allows rotation and vertical / up-down movement of the male grind 202 relative to the female grind 204, but prevents separation or disengagement of the male grind 202 from the female grind 204 during operation of the device 200, thereby allowing for a sealed closed system in which tablet particles cannot escape to the outside environment. In one embodiment, the device 200 is a disposable / single use device and is not removable once the retainer 208 is fitted around the proximal end 205 of the female component 204. In one embodiment, the device 200 is a disposable / single use device that is provided in a sterile package and does not require sterilization prior to use.

[0079] In another embodiment, the device 200 is provided as a reusable device that may need to be sterilized by the user before each use. In a reusable embodiment of the device 200, the holding portion 208 is not provided and the male grinding portion 202 and the female grinding portion 204 are held together by the user during operation of the device. Additionally, the device 200 includes a filter 218 (described below) that may need to be replaced / cleaned after a predetermined number of uses of the device.

[0080] Figure 2Q shows multiple views of the retainer 208 shown in Figure 2F, according to one embodiment herein. Perspective view 241 shows retainer 208 with at least one and up to an equal number of corresponding retaining tabs 209 and at least four protruding members 219, as described with reference to Figure 2F above. Top view 242 shows retainer 208 has a circular cross-section, which when sliced ​​through section line 243 provides cross-section view 245, and when sliced ​​through section line 244 provides cross-section view 246. Cross-sectional views 245, 246 show an outer diameter 247 of retainer 208 as 49.21 mm, a length 248 of each of the plurality of retainer tabs 209 of 14.90 mm, an inner diameter 2481 of retainer 208 formed by the free ends of retainer tabs 209 of 41.45 mm, a distance 249 that protruding member 219 extends away from retainer 208 of 1.80 mm, a length 2482 of tab 209 minus the length of protruding member 219 of 10.90 mm, and a diameter 2483 of retainer 208 along the distance that protruding member 219 extends away from retainer 208 of 52.62 mm. In embodiments, the dimensions provided herein may range anywhere between a 50% decrease in the stated value to a 100% increase in the stated value, and any increment therein. In other embodiments, the dimensions provided herein are any range between a 10% decrease in the stated value to a 10% increase in the stated value, and any increment therein. In an embodiment, a portion of the inner surface 280 of the female grinding section 204 located at the distal end 207 of the female grinding section 204 is configured to receive or be coupled to the spring 210, which in turn is configured to receive or be coupled to the valve 212. A perspective view of the distal end of the funnel-shaped female grinding section of the device shown in FIG. 2A. FIG. 2I is a perspective view of the spring 210 disposed within the distal end 207 of the female grinding section of the device shown in FIG. 2A. FIG. 2J is a perspective inside view of the valve coupled to the spring shown in FIG. 2I. The valve 212 has a proximal end 284 and a distal end 286. FIG. 2K is a perspective view of a stop member disposed at the proximal end 284 of the valve 212 shown in FIG. 2J, which can be coupled or mated with the spring shown in FIG. 2I. FIG. 2K is a perspective view of a stop member 214 coupled to the proximal end 284 of the valve 212 for coupling with the spring 210 shown in FIG. 2J.

[0081] 2A-2K, a portion 240 of the inner surface 280 of the female grinding section 204 located at the distal end 207 of the female grinding section 204 and configured to receive / couple the spring 210 is cylindrical in shape and sized / designed to allow the spring 210 to fit snugly therein. The valve 212 is a hollow elongated member with a stop member 214 coupled to the proximal end 280, which fits over the spring 210 forming a sealing contact, as shown in FIG. 2J. The valve 212 further comprises a pair of side openings 216 encased in a filter 218 that prevents liquid or solid particles from exiting the side openings 216. FIG. 2L is a perspective view of the filter 218 encasing the side openings 216 of the valve 212 shown in FIG. 2J. In an embodiment, air travels through the filter 218 before exiting through the valve 212, allowing air to travel in and out of the device 200 while tablets are being crushed within the device. In one embodiment, the filter 218 is a hydrophobic filter that allows only air to pass through and prevents liquids or solid particles from flowing in or out of the side opening 216. In an embodiment, the filter 218 also prevents foreign objects from entering the device 200 from the outside. In one embodiment, the filter 218 is a porous polymer filter, although in other embodiments, a variety of suitable materials can be used for the filter 218. In one embodiment, the filter 218 is a polyethylene filter. In an embodiment, the filter is manufactured using a porous polymer having a porosity in the range of 5 microns to 60 microns. FIG 2N shows multiple views of the filter shown in FIG 2L according to one embodiment herein. As seen in perspective view 250 and top view 251, filter 218 is shaped as a ring and configured to surround side opening 216 of valve 212 shown in FIG 2J. Circular top view 251 is sliced ​​along section line 252 to obtain cross-sectional view 253 of filter 218. In one embodiment, filter 218 has an inner diameter 254 of 4.4 mm and an outer diameter 255 of 12 mm. In one embodiment, thickness 256 of annular filter 218 is about 6.35 mm.

[0082] In one embodiment, the spring 210 is a corrosion-resistant compression spring. FIG. 2O is a table showing exemplary parameters of a spring that may be used in the devices herein. As shown in table 270, in an embodiment, the compression spring 210 has a length of 14 mm, an outer diameter of 5.5 mm, an inner diameter of 4.5 mm, and a spring constant of 0.18 lbs / mm. In an embodiment, the spring may be plastic, metal, stainless steel, or silicone, or any other corrosion-resistant material. In one embodiment, the spring 210 is easily compressible since it has a low spring constant of 0.18 lbs / mm, the spring constant being the amount of force required per millimeter of compression. In an embodiment, the dimensions provided herein are any range between a 50% decrease in the stated value to a 100% increase in the stated value, and any increment therein. In other embodiments, the dimensions provided herein are any range between a 10% decrease in the stated value to a 10% increase in the stated value, and any increment therein.

[0083] In one embodiment, an adapter 299 is provided to fit to the bottom of the cap 220. In one embodiment, the adapter 299 may be a syringe tip attached to the distal end 207 of the cap 220. In one embodiment, the adapter 299 may be shaped like a cap that can fit or screw onto the distal end or bottom of the cap 220. FIG. 2M is a perspective view of an adapter 299 that may fit to the bottom of the cap 220 shown in FIG. 2B. In one embodiment, the adapter 299 is a syringe adapter for receiving a syringe (not shown). In an embodiment, any size and type of syringe may be used with the device 200. In an embodiment, when the adapter / cap / tip 299 is attached to the distal end of the cap 220, the valve 212 is opened, thereby allowing water / fluid to flow up the device 200.

[0084] FIG. 2P shows multiple views of the cap 220 shown in FIG. 2B, according to an embodiment herein. A perspective view 271 of the cap 220 shows a distal end 272 for mating with the bottom of the distal end 207 of the female grinding portion 204, and a proximal end 274 with a nozzle 276 for receiving an Enfit syringe (not shown), the distal end 272 being wider than the proximal end 274. A top view 278 of the cap 220 shows that in one embodiment, a section 279 of the cap 220 has a length of 14.2 mm. The top view 278 corresponding to the perspective view 271 shows that the cap 220 has a circular cross section, and when sliced ​​through a section line 280, a cross section 281 is obtained. In one embodiment, a diameter 282 of the distal end 272 is 17.50 mm, a diameter 283 of the proximal end 274 is 13.073 mm, and a length 284 of the cap 220 is 33.20 mm. A portion 285 of the cross section 281 is shown in an exploded cross section 286 which shows the diameter 287 of the nozzle 276 as 5.375 mm. In one embodiment, the nozzle 276 is surrounded by a threaded section having a length 288 of 6.82 mm and a pitch 289 of 2.500 mm for connection with an N-Fit™ syringe (not shown). The threaded section includes smaller threads such that the diameter 290 of the nozzle 276 is 8.65 mm with the smaller threads alternating with larger threads such that the diameter 291 of the nozzle 276 is 10.230 mm with the larger threads.

[0085] In embodiments, the dimensions provided herein are any range between a 50% decrease in the stated value to a 100% increase in the stated value, and any increment therein. In other embodiments, the dimensions provided herein are any range between a 10% decrease in the stated value to a 10% increase in the stated value, and any increment therein.

[0086] FIG. 2R is a cross-sectional view of the device 200 shown in FIGS. 2A, 2B, and 2C, according to an embodiment herein. As shown, in one embodiment, the overall length 2001 of the device 200 is 131.3 mm, the internal volume is 53 ml, and the internal diameter 2002 is 44.20 mm. As shown in FIG. 2R, the device 200 has a stroke of 34.8, which represents the maximum distance, or sliding distance, that the male and female grinding sections can separate from each other, which then results in the female grinding section or the internal volume of the device 200. In embodiments, the dimensions provided herein are any range between a 50% decrease in the stated value to a 100% increase in the stated value, and any increment therein. In other embodiments, the dimensions provided herein are any range between a 10% decrease in the stated value to a 10% increase in the stated value, and any increment therein.

[0087] 2E, according to one embodiment herein. FIG. 2T includes a perspective view 2030 of the female grinding section 202 having a proximal end 205 and a distal end 207. The top view 2032 of the female grinding section 202 shows that the member 204 has a circular cross-section that provides a cross-section 2038 when sliced ​​through section line 2034 and a cross-section 2040 when sliced ​​through section line 2036. View 2038 shows the inner surface at the distal end 207 with a serrated edge 2043 to aid in crushing the tablets. Additionally, in one embodiment, the outer diameter 2042 of the proximal end 205 is 55.2 mm. View 2040 shows that the inner diameter 2044 of the female grinding portion 204 near the proximal end 205 (configured to receive the male grinding portion) is 45.044 mm, the length 2046 of the proximal portion of the member 204 is 17.4 mm, the length 2048 of the intermediate portion of the member 204 is 39.4 mm, the length 2050 of the distal portion of the member 204 is 17.9 mm, and the overall length 2052 of the member 204 is 93.4 mm. View 2040 also shows that in one embodiment, the outer diameter 2054 of the distal end 207 is 12.873 mm, and the diameter 2056 of the bulb 212 coupled to the distal end 207 is 2.02 mm. In embodiments, the dimensions provided herein are any range between a 50% decrease in the stated value to a 100% increase in the stated value, and any increment therein. In other embodiments, the dimensions provided herein are any range between a 10% decrease in the stated value to a 10% increase in the stated value, and any increment therein.

[0088] FIG. 3A is a perspective view of a tablet crushing apparatus according to one embodiment herein. The structure and components of tablet crushing apparatus 300 are similar to those described with reference to FIGS. 2A-2M above. Tablet crushing apparatus 300 includes a male crushing section 302 that is at least partially inserted into a female crushing section 304 during operation of apparatus 300. According to one embodiment, male crushing section 302 is fully inserted into female crushing section 304 such that a short length of male crushing section 302 remains protruding above female crushing section 304 to prevent injury or pinching of a user's fingers while rotating male crushing section 302 relative to female crushing section 304. In one embodiment, said short length of male crushing section 302 that remains protruding above female crushing section 304 ranges from 0.05 inches to 0.2 inches, and in one embodiment, is about 0.1 inches. FIG. 3B is a side plan view showing a tablet positioned inside female crushing section 304 of the tablet crushing apparatus shown in FIG. 3A. As shown in Figure 3B, a tablet 330 is placed within the female grinding section 304. In one embodiment, as shown in Figure 3B, the inner surface of the female grinding section 304 includes a serrated edge 306 to aid in crushing the tablet 330.

[0089] In various embodiments, the serrated edge comprises multiple teeth having different numbers, depths, shapes, and orientations as described with reference to Figures 1D-1J above. In one embodiment, the serrated edge 306 of the device 300 comprises teeth ranging in number from 1 to 100 having various shapes as described with reference to Figures 1D-1J, the teeth having depths ranging from 0.5 mm to 10 mm as measured from tip to base, allowing clockwise, counterclockwise, or bidirectional rotation of the male grinding section relative to the female grinding section. The multiple teeth help reduce the effort required to crush / crush tablets placed within the female grinding section, making the device easy and convenient to use.

[0090] FIG. 3C is a side plan view showing a male grinding section mated with a female grinding section forming an enclosed crushing chamber in the device shown in FIG. 3A. FIG. 3C shows a male grinding section 302 connected / mated onto a female grinding section 304 forming an enclosed crushing chamber 308 in the device of FIG. 3A. As described with reference to FIGS. 2A-2M above, the tablet crushing device herein comprises a seal member and a retainer ring. In an embodiment, the seal member may be an O-ring, an X-ring, a wing tip, or any other similar structure of any other shape that provides a sealing action that effectively creates a near airtight seal for purposes herein. In an embodiment, the retainer is integrated into the male grinding section 302 and configured to provide a locking mechanism between the male grinding section 302 and the female grinding section 304. In one embodiment, the mouth / opening at the proximal end 315 of the female grinding portion 304 is configured with multiple slots / openings (in one embodiment, four slots as shown in FIG. 2E) to accommodate the protruding tabs of the retainer (four tabs as shown in FIG. 2F) to allow the retainer to fit snugly around the mouth or proximal end 315 of the female grinding portion 304. FIG. 3A shows the protruding portion 316 of the retainer ring fitted within the proximal end 315 of the female grinding portion.

[0091] FIG. 3D is an exploded cross-sectional view of the area 320 shown in FIG. 3C, illustrating the connection or mating of the male grinding section 302 to the female grinding section 304. A retention slot is disposed over the mouth / proximal end 315 of the female grinding section 304, which causes the retention tab to bend away from the inner wall of the female grinding section 304 when connected or mated. FIGS. 3C and 3D show the protrusion 316 and retention tab 318 bending toward the inner surface of the proximal end 315 of the female grinding section 304 when the distal end 317 of the male grinding section 302 is inserted into the proximal end 315 of the female grinding section 304, thereby allowing the male grinding section 302 to be inserted into the female grinding section 304 and preventing separation of the members during operation of the device 300.

[0092] 3E is a side plan view showing the male grinding section 302 fully inserted within the female grinding section 304, including a schematic diagram showing the twisting or rotating motion to crush the tablet 310. In an embodiment, the male grinding section 302 is considered to be fully inserted within the female grinding section 304 when the proximal grooved end 319 of the male grinding section 302 comes to rest against the proximal grooved end 315 of the female grinding section 304, as shown in FIG. 3A. In one embodiment, to crush the tablet 330, the grooved end 315 of the male grinding section 302 is held by the user while rotating the grooved end 319 of the male grinding section 302, as shown by the arrow 323 shown in FIG. 3E.

[0093] FIG. 3F is a cross-sectional view of the distal end of the female grinding section of the apparatus shown in FIG. 3A, which is being used to grind tablets. In an embodiment, the inner surface of the distal end 321 of the funnel-shaped female grinding section 304 is configured to receive or be coupled to a spring 340, which in turn is configured to receive or be coupled to a valve 342. As described above with reference to FIGS. 2A-2M and as shown in FIG. 3F, the inner surface of the distal end 321 of the female grinding section 304 includes a groove 344 designed for the spring 340 to fit snugly into and mate with the groove 344. The valve 342 is a hollow elongated member with a stop member 346 at a proximal end, which fits over the spring 340 forming a sealing contact, as shown in FIG. 3F. The valve 342 further includes at least two side openings 348 encased within a cylindrical filter 350 that prevents liquid or solid particles from flowing out of the side openings 348. In one embodiment, the filter 350 is a hydrophobic filter that only allows air to pass through and prevents water / liquid or solid particles from flowing in or out of the side opening 348 .

[0094] As shown in Figure 3E, when tablets are being crushed in the crushing chamber 308, the stop member 346 prevents any tablet dust from exiting the distal end 321 of the female crushing section 304. The side opening 348 allows air 352 (shown by the blue dotted arrow in Figure 3F) to flow out through the chamber, while the filter 350 prevents any liquid or solid particles from exiting through the side opening 348, thereby allowing a pressure differential to be maintained within the closed crushing chamber of the apparatus 300.

[0095] FIG. 3G shows the apparatus of FIG. 3E with a syringe adapter attached to the distal end 321 of the female grinding section for mixing the crushed tablets with water / liquid. FIG. 3E shows the apparatus of FIG. 3E with a syringe adapter attached to the distal end 321 of the female grinding section 304 for mixing the crushed tablets with water / liquid to form a liquid mixture 360. During operation of the apparatus 300, once one or more tablets are fully crushed, a syringe is connected to the distal end 321 of the female grinding section 304 via the syringe adapter 362. In an embodiment, the syringe is used to push up through the distal end of the valve 342, through the hollow length of the valve 342, and into a crushing chamber in the female grinding section 304 that is sealed from above by the distal end 317 of the male grinding section 302. In an embodiment, the connection of the syringe to the syringe adapter 362 creates an upward force that pushes the stop member 346 up through the spring 340 and into the crushing chamber in the female grinding section 304. This allows the water / fluid to flow out the side opening 348 into the crushing chamber and mix with the crushed tablet powder forming a liquid mixture 360.

[0096] As shown in FIG. 3G, the connection of the syringe to the syringe adapter 362 creates an upward force, forcing the liquid mixture 360 ​​upwardly out the distal end 317 of the male grinding section 302, shown in FIG. 3G via arrow 365. A plurality of retainer tabs 318 (shown in FIG. 3C) of a retainer ring fitted around the mouth of the female grinding section 304 helps to prevent the male grinding section 302 from separating from the female grinding section 304. Additionally, a sealing member 368 (shown in FIG. 3C) disposed between the male grinding section 302 and the female grinding section 304 seals the grinding chamber from the atmosphere by preventing the liquid mixture 360 ​​from leaking out of the female grinding section 304, thereby creating a substantially near air-tight seal.

[0097] In an embodiment, connection of a syringe to a syringe adapter 362 effectively opens the valve 342, bypassing the filter 350 and allowing the liquid mixture 360 ​​to flow out of the female grind 304 and into an attached syringe (not shown) via the syringe adapter 362. FIG. 3H is a cross-sectional view of the device of FIG. 3G, showing the liquid mixture flowing out of the female grind and into the syringe adapter. FIG. 3H shows the liquid mixture 360 ​​(shown as a solid blue arrow) flowing out of the female grind 304 into the syringe adapter 362 in the device shown in FIG. 3G. In an embodiment, as shown in FIG. 3H, when the valve 342 is opened, at least a portion of the side opening 348 is no longer exposed / covered by the filter 350, thereby allowing the liquid mixture 360 ​​to flow from the exposed portion of the side opening 348 into the valve 342 and then into the syringe adapter 362, as shown by the solid blue arrow.

[0098] The liquid mixture 360 ​​flows out of the female grinding portion 304 as shown by the blue arrow in FIG. 3H due to the opening of the valve 342 when a syringe (not shown) is attached to the syringe adapter 362 and the syringe is used to aspirate the liquid tablet mixture 360. FIG. 3I is a diagram showing an empty device as described in FIG. 3H from which the liquid mixture is aspirated using a syringe, with the remaining device being disposed of as medical waste, according to one embodiment herein. FIG. 3I shows the empty device 300 with the liquid tablet mixture 360 ​​aspirated and disposed of as medical waste in a medical waste container 370.

[0099] FIG. 3J is a side view of a tablet crushing device according to another embodiment of the present specification. The syringe-shaped device 371 includes a male crushing section 372 and a female crushing section 374 that are mated and used to crush tablets, as described with reference to FIGS. 2A-2M. The distal end of the male crushing section 372 is provided with a serrated edge 373 to aid in crushing the tablet placed in the female crushing section 374. The inner surface of the female crushing section 374 is provided with a serrated edge 378 (shown in FIG. 3K). The male crushing section 372 is inserted into the female crushing section and rotated to crush the tablet. When the tablet placed in the female crushing section 374 is fully crushed, the serrated edge 373 of the male crushing section 372 and the serrated edge 378 provided on the inner surface of the female crushing section 374 are fully mated. The device 371 further includes an upper chamber 376 where liquid / water is added prior to the addition of the tablet.

[0100] FIG. 3K is a side view of the device of FIG. 3J containing liquid within the internal chamber. With reference to FIG. 3J and FIG. 3K, liquid is pumped between the upper chamber 376, the male grinding section 372, and the female grinding section 374 to mix with the crushed tablet. An opening / hole 381 is provided at the distal end of the male grinding section 372 to allow liquid to pass to the female grinding section 374 and mix with the crushed / milled tablet powder. Thus, the device 371 eliminates the need for a syringe attached to the distal end of the female grinding section 374 to push out liquid to be mixed with the crushed tablet powder, as the liquid is provided within the chamber of the device. The device 371 further comprises a cap 380 connected to the distal end of the female grinding section, which is made of a filter material that allows air to flow in and out of the device during the tablet crushing process, but prevents liquid from passing through or leaking out of the device 371. In one embodiment, the filter is a hydrophobic filter. In other embodiments, the filter is a porous polymer filter, while in other embodiments, a variety of suitable materials (such as, but not limited to, polyethylene) can be used to fabricate the filter within the cap 380. In an embodiment, the filter is fabricated using a porous polymer having a porosity ranging from 5 microns to 60 microns. Once the tablet powder is thoroughly mixed with the liquid, the cap 380 is removed and the liquid mixture 382 is aspirated via a syringe (not shown in the figures) for administration of the liquid mixture to the patient. In an alternative embodiment, the liquid tablet mixture may be drawn back into the male grinding portion 372, such that the male grinding portion 372 coupled with the upper chamber 376 operates as a syringe, whereby the mixture may then be injected directly into the patient via the opening 381 or extracted via a syringe for delivery to the patient.

[0101] FIG. 4 is a flow chart illustrating exemplary steps of the operation of the tablet crushing device shown in FIGS. 3A-3I, according to one embodiment herein. With reference to FIGS. 3A-3G and 4, in step 402, one or more tablets are placed in the female crushing section 304, as shown in FIG. 3B. In step 404, the male crusher part 302 is inserted into the female crushing section 304 forming an enclosed crushing chamber 308 therein, as shown in FIG. 3C. In one embodiment, the male crusher part is inserted into the female crushing section until the proximal grooved end 319 of the male crusher part 302 rests on and abuts the proximal grooved end 315 of the female crushing section 304, as shown in FIG. 3A. Upon insertion, the male crusher part 302 is automatically attached to the female crushing section 304 such that it cannot be removed from the female crushing section 304 without breaking a tab structure located on the female crushing section 304.

[0102] In step 406, the proximal grooved end 319 of the male grinding section 302 is rotated relative to the female grinding section 304 to crush the tablet into powder, as shown in FIG. 3E. In an embodiment, one or more of the inner surface of the female grinding section 304 and the distal end of the male grinding section 302 include serrated edges to aid in crushing the tablet. In one embodiment, an audible alarm or sound is emitted by the serrated edges while the tablet is being crushed. As the tablet particles get smaller, at least one of the pitch and frequency of the sound changes, allowing the user to know when the tablet is completely crushed. In one embodiment, a portion of the wall of the female grinding section 304 is designed to be transparent to provide a visual indication to the user that the tablet has been completely crushed into powder form. In an embodiment, the powder form fills no more than 40% to 90% of the crushing chamber formed in the female grinding section 304. In a preferred embodiment, the tablet powder does not fill more than 50% of the crushing chamber formed in the female grinding section 304. In one embodiment, the device 300 is capable of crushing up to 50 tablets at a time, preferably 3 tablets at a time.

[0103] In embodiments, the tablet crushing device 300 eliminates drug loss and increases the intended dose yield as the entire tablet is completely crushed in a closed atmosphere without exposure to the atmosphere. In one embodiment, the device 300 captures at least 76% of the tablet being crushed, and in a preferred embodiment, 90% or more of the tablet being crushed is mixed with the liquid to create a liquid suspension form that can be delivered to the patient.

[0104] As air enters and leaves the chamber through side openings 348 covered by filters 350, a suitable pressure level is maintained within the sealed crushing chamber 308, which allows air to pass while preventing liquid or solid particles from escaping through the side openings 348.

[0105] At step 408, a syringe containing water / liquid is connected to the syringe adapter 362. At step 410, the water / liquid is forced up from the distal end of the valve 342 connected to the syringe adapter, through the hollow length of the valve 342, and into the crushing chamber 308. At step 412, the connection of the syringe to the syringe adapter 362 forces the stop member 346 with the side opening 348 up through the spring 340 and into the crushing chamber 308 in the female grinding section 304. At step 414, the water / liquid flows into the crushing chamber from the side opening 348 and mixes with the crushed tablet powder to form the liquid mixture 360.

[0106] In step 416, the liquid mixture 360 ​​is aspirated from the female grind 304 into a connected syringe (not shown). In an embodiment, the fluid mixture 360 ​​flows out of the female grind 304 through the side opening 348 and the syringe adapter 362, bypassing the filter 350 via the force of the fluid moving through the valve 342, as shown in FIG. 3H, as the valve 342 opens. In an embodiment, steps 410-416 may be repeated to allow the mixture to flow back and forth between the syringe and the crushing chamber as many times as the user requires to thoroughly mix the fluid with the pharmaceutical powder. In various embodiments, any size syringe may be used with the tablet crushing apparatus 300, and in an embodiment, the same syringe that is required to be administered to the patient may be used with the tablet crushing apparatus 300 to mix the tablet powder with the fluid.

[0107] In one embodiment, once the tablets have been crushed and mixed with the water / fluid pushed by the syringe, the syringe can be removed while the syringe is still carrying at least a portion of the liquid tablet powder mix for administration to the patient. The same or a different syringe can then be attached to the device 300 to push in more water / fluid for further mixing with any remaining tablet powder mix in the device 300. In an embodiment, the device 300 is washed / flushed multiple times by pushing water / fluid by attaching a syringe to the device until all residual tablet powder mix is ​​removed from the device 300. In step 418, the empty tablet crushing device 300 is disposed of as medical waste, as shown in FIG. 3I.

[0108] FIG. 5A is a perspective view of a tablet crushing device according to another embodiment of the present disclosure. FIG. 5B illustrates a pentagonal cap of a male crushing part according to another embodiment of the present disclosure. FIG. 5C shows another view of the tablet crushing device shown in FIG. 5A. FIG. 5B is an exploded perspective view of exemplary members of the tablet crushing device shown in FIG. 5A according to one embodiment of the present disclosure.

[0109] The structure and components of the tablet crushing device 500 are similar to those described with reference to Figures 2A-2M above. With simultaneous reference to Figures 5A-5E, the tablet crushing device 500 includes a male crushing section 502 that is at least partially inserted into a female crushing section 504 during operation of the device 500. According to one embodiment, the male crushing section 502 is fully inserted into the female crushing section 504 such that a short length of the male crushing section 502 remains protruding above the female crushing section 504 to prevent injury or pinching of a user's fingers while rotating the male crushing section 502 relative to the female crushing section 504. Both the proximal end of the male crushing section 502 and the proximal end of the female crushing section 504 each include a five-point grip 550 having deep features to aid in a user's grip while rotating the male crushing section 502 relative to the female crushing section 504 to crush tablets disposed within the chamber of the female crushing section 504. In an embodiment, the deep features of the grip 550 are ergonomically designed such that the inscribed circle defining the base of the grip 550 is approximately 10% smaller than the circle surrounding the outside / top of the grip 550. A pentagonal grip cap 520 fits over the male grinding portion 502 such that each of the five grooves 521 of the grip cap 520 aligns with a respective groove 518 of the male grinding portion 502. In an embodiment, the grip 550 may be designed in other shapes such as, but not limited to, a textured cylindrical grip design. As discussed above, the cap 520 provides precise hand grip placement as well as ergonomic comfort when the hand is used to provide rotation.

[0110] To aid in the grinding of the solid pharmaceutical article, the male grinding section 502 is forced into the female grinding section 504 and rotated until the solid pharmaceutical article is completely ground by the action between the male grinding section 502 and the female grinding section 504. In an embodiment, the inner concave surface of the distal end 525 of the female grinding section 504 includes a serrated edge 596 and the outer convex surface of the distal end 526 of the male grinding section 502 includes a serrated edge 597 to aid in the grinding of the tablet when the distal end 526 of the male grinding section 502 is inserted into the female grinding section 504 and rotated relative thereto to grind the tablet into a powder. In various embodiments, the serrated edge includes multiple teeth having different numbers, depths, shapes, and orientations, embodiments of which have already been described with reference to Figures 1D-1J above. In various embodiments, the serrated edge of the device 500 comprises a plurality of teeth ranging in number from 1 to 100 having various shapes as described with respect to Figures 1D-1J, the teeth having a depth ranging from 0.5 mm to 10 mm as measured from tip to base, allowing clockwise, counterclockwise, or bidirectional rotation of the male grinding section relative to the female grinding section. The plurality of teeth helps to reduce the effort required to crush / crush tablets placed within the female grinding section, making the device easy and convenient to use.

[0111] To prevent the male grinding portion 502 from accidentally falling off the female grinding portion 504 during the grinding / disintegration process (which releases the pharmaceutical powder to the atmosphere), the device 500 further comprises a retaining portion or retaining ring 530 and a sealing member 532 disposed between the male grinding portion 502 and the female grinding portion 504 and configured to both allow the male grinding portion 502 to engage the female grinding portion 504 and to seal the grinding chamber from the atmosphere, creating a substantially near airtight seal. In an embodiment, the sealing member may be an O-ring, an X-ring, a wing tip, or any similar structure of any other shape that provides a sealing mechanism for accomplishing the purposes herein.

[0112] In an embodiment, a portion of the inner surface of the female grinding portion 504 located at the distal end 525 of the female grinding portion 504 is configured to receive or be coupled to the spring 510, which in turn is configured to receive or be coupled to the stop member 514 that forms a sealing contact. The distal end 525 of the female grinding portion 504, in an embodiment, is cylindrical in shape and is sized / designed so that the spring 510 fits snugly therein. The stop member 514 further includes a valve stem 592 designed to mate with the valve 512, which in one embodiment is a hollow elongated member having a proximal end 584 and a distal end 586. In other embodiments, the valve may be solid or may provide a single opening that provides a path for liquid to flow out of the female grinding portion 504 via a syringe.

[0113] The filter 519 is positioned between the distal end of the valve stem 592 and an opening located at the proximal end 584 of the valve 512 that engages the valve stem 592, and thus the spring 510, at its proximal end 584. In an embodiment, the filter is positioned within the valve 512 such that the filter covers the sidewall of the opening located at the proximal end 584 of the valve 512. The filter 519 prevents liquids or solid particles from exiting the device. In an embodiment, the filter 519 need not surround the valve stem 592, but may be provided as a separate connection between the female grinding portion 504 and the syringe adapter. In an embodiment, the filter 519 may be designed and appropriately positioned to provide an alternative path for air to travel through the device 500 while preventing liquids or solid particles from exiting the device. In an embodiment, the filter is a hydrophobic filter. In other embodiments, the filter is a porous polymer filter, while in other embodiments, a variety of suitable materials (such as, but not limited to, polyethylene) can be used to make the filter at 519.

[0114] In an embodiment, a cap 580 is coupled to the distal end 586 of the valve 512, which allows air to flow in and out of the device 500 during the tablet crushing process, but prevents liquid from passing through or leaking out of the device 500. Once the tablet powder is thoroughly mixed with the liquid, the cap 580 is removed and the liquid and tablet mixture is aspirated via a syringe (not shown) for administration of the liquid and tablet mixture to a patient. In an embodiment, the cap 580 prevents inadvertent depression of the valve stem 592, which extends beyond the accommodation of the valve 512 to engage the syringe while crushing the tablet. When the valve stem 592 is depressed, the liquid mixed within the device may leak out as it displaces the stop member 514 upward and compromises the sealing contact.

[0115] In another embodiment, a protective cone is molded into the housing of the valve 512, which extends beyond the exposed valve stem 592, requiring a secondary manual process to actuate the valve. FIG. 8A illustrates a protective cone for preventing inadvertent pressing of the valve of the tablet crusher shown in FIG. 5D, according to an embodiment herein. A cross-sectional view of the protective cone shown in FIG. 8A, according to one embodiment herein. A perspective view of the protective cone shown in FIG. 8A, according to one embodiment herein. With reference to FIGS. 5A-5E and 8A-8C, in one embodiment, a protective cone 802 is molded into the housing of the valve 512 to protect the distal end 594 of the valve stem 592 that extends beyond the valve housing 512. As seen in FIGS. 8B and 8C, the cone 802 extends beyond the tip 594, whereby the cone 802 protects the valve stem 592 that extends beyond the valve housing 512 from being inadvertently pressed.

[0116] In yet another embodiment, FIG. 5E shows a perspective view of an extended stop member and valve stem of the tablet crushing device shown in FIG. 5D according to an embodiment herein. FIG. 5F shows another perspective view of the stop member and valve stem of the tablet crushing device shown in FIG. 5D. With reference simultaneously to FIG. 5D-FIG. 5F, the stop member 514 is fitted to a spring 510 that forms a sealing contact and is coupled to a proximal end 590 of the valve stem 592. In an embodiment, as shown in FIG. 5E, FIG. 5F, and FIG. 5G, the valve stem 592 having both a proximal end 590 and a distal end 594 is designed to have an "X" shaped cross section. A cross section of the valve stem shown in FIG. 5F according to an embodiment herein is shown. The valve stem 592 includes four flanges 593 that extend longitudinally along the length of the valve stem 592, such that the cross section of the stem 592 is in the shape of an "X", the "X" being formed by the flanges 593. The "X" shaped design of the valve stem 592 prevents clogging of the crushed tablet powder when mixed with water. In an embodiment, the drug or tablet particles passing through the X shape have four opportunities to enter and exit the device compared to a cylindrical solid stem, whereby the drug or tablet particles have only one path for entry and exit. In an embodiment, the valve stem 592 may be designed in various shapes to prevent / minimize clogging, such as but not limited to a T-shape or I-shape, increasing the surface area through which the particles pass when entering or exiting the device 500.

[0117] FIG. 5H is a cross-sectional view of the device 500 shown in FIG. 5A according to an embodiment herein. In an embodiment, the design and dimensions of the tablet crushing device shown in FIG. 5H may be implemented for pediatric use. As shown, in one embodiment, the overall length 540 of the device 500 is 190 mm, the internal volume is 30 ml, and the internal diameter 542 is 35 mm. As shown in FIG. 5H, the device 500 has a stroke of 32, which represents the maximum distance, or sliding distance, that the male and female grinding sections can separate from each other, which then results in the internal volume of the female grinding section or device 500. In an embodiment, the dimensions provided herein are any range between a 50% decrease in the stated value to a 100% increase in the stated value, and any increment therein. In other embodiments, the dimensions provided herein are any range between a 10% decrease in the stated value to a 10% increase in the stated value, and any increment therein.

[0118] FIG 6 is a flow chart illustrating exemplary steps of operation of the tablet crushing device shown in FIG 5A-5H, according to one embodiment herein. With reference to FIG 5A-5H and FIG 6, in step 602, one or more tablets are placed into the female crush section 504. In step 604, the male crush section 502 is inserted into the female crush section 504 to form a sealed crushing chamber within the female crush section 504. Upon insertion, the male crush section 502 automatically locks with the female crush section 504 to prevent removal of the parts during operation.

[0119] In step 606, the proximal grooved end of the male grinding section 302 is rotated relative to the female grinding section 304, using a five-point grip 518 to assist in said rotation, to crush the tablet into a powder. In an embodiment, either or both of the inner surface of the female grinding section 504 and the distal end of the male grinding section 502 are provided with serrated edges to aid in crushing the tablet. In an embodiment, as described above, also in step 606, a filter 518 prevents crushed particles from escaping the apparatus.

[0120] In step 608, a syringe containing water / liquid is connected to the distal end 594 of the valve 512 protected by the valve cap 580. In step 610, the water / liquid is forced by the syringe up from the distal end 594 of the valve 512 through the gaps between the four flanges 593 that extend longitudinally along the length of the valve stem 592 of the valve 512 and into the crushing chamber. In step 612, upon connecting the syringe to the valve 512, the stop member 514 is forced up through the spring 510 and into the crushing chamber in the female grinding section 504. In step 614, the water / liquid flows into the crushing chamber, assisted by the gaps between the four flanges 593 that extend longitudinally along the length of the valve stem 592, and mixes with the crushed tablet powder to form a liquid and tablet mixture. The flanges 593 provide the valve 512 with an "X" shaped cross section. The "X" shaped design of the valve stem 592 prevents clogging of the crushed tablet powder when it is mixed with water via a syringe connected to the valve cap 580. In embodiments, the valve stem 592 can be designed in various shapes to prevent / minimize clogging. In step 616, the liquid and tablet mixture is aspirated from the female grind 504 into a connected syringe (not shown).

[0121] FIG. 7A illustrates the tablet crushing device shown in FIG. 5A in an unassembled state according to an embodiment herein. As can be seen, the male crushing section 702 is separate from and not inserted into the corresponding female crushing section 704. In an embodiment, the male crushing section has a serrated edge or surface 709 provided on the convex curved surface portion. In an embodiment, the female crushing section has a serrated edge or surface 708 provided on the inner concave surface portion. FIG. 7B illustrates the tablet crushing device shown in FIG. 5A in a partially assembled state according to an embodiment herein. As seen in FIG. 7B, the male crushing section 702 is at least partially inserted into the female crushing section 704 and locked in place by using a locking mechanism 706, such as a retainer ring, as described above with reference to FIG. 2F. In the locked state, the maximum volume of the female crushing section 704 is obtained. A tablet may be placed within the volume of the female crushing section 704, which has a serrated edge 708 provided on its inner surface. Tablets may be crushed by rotating the male grinding section 702 relative to the female grinding section 704 until the tablet is completely crushed and the distal edge 710 of the male grinding section 702 is aligned with the distal edge 712 of the female grinding section 704. Figure 7C illustrates the tablet crushing apparatus shown in Figure 5A in a fully deployed and used state with the female grinding section having a minimum internal volume, according to embodiments herein.

[0122] The above examples are merely illustrative of the many applications of the system herein. Although only a few embodiments of the invention are described herein, it should be understood that the invention may be embodied in many other specific forms without departing from the spirit or scope of the invention. Thus, the examples and embodiments should be considered as illustrative rather than restrictive, and the invention may be modified within the scope of the appended claims.

Claims

1. 1. An apparatus for crushing or grinding one or more solid pharmaceutical agents, comprising: a male grinding portion having a proximal end, a distal end, and a first plurality of serrated edges on an outer surface; a female grinding portion defining a chamber for receiving the one or more solid pharmaceutical agents, the distal end of the male grinding portion being configured to be at least partially received within the chamber to form a closed chamber; Springs and a valve coupled to the spring and having a stop member; an adapter configured to be coupled to the valve and the distal end of the female grinding portion to selectively seal the closure chamber; a filter disposed between the distal end of the female grinding portion and the adapter and configured to prevent liquid, pharmaceutical powder, or a mixture of the liquid and pharmaceutical powder from passing through the device, and configured to allow air to flow in and out of the closed chamber; an outer surface of the chamber of the female grinding portion having a second plurality of serrated edges, the first plurality of serrated edges being configured to move relative to the second plurality of serrated edges as the male grinding portion rotates relative to the female grinding portion to grind the one or more solid pharmaceutical agents into a powder; The distal end of the female grinding portion is configured to receive the spring. Device.

2. 10. The device of claim 1, further comprising a syringe, the adapter being a syringe adapter configured to receive the syringe; The syringe is configured to inject a liquid into the closed chamber. Device.

3. 2. The apparatus of claim 1, each of the first plurality of serrated edges has a first end and a second end; a spacing between the first ends of each of the first plurality of serrated edges is less than a spacing between the second ends of each of the first plurality of serrated edges. Device.

4. 2. The device of claim 1, wherein the proximal end of the male grinding portion comprises a groove that permits manual gripping of the male grinding portion and rotation of the male grinding portion relative to the female grinding portion.

5. 5. The device of claim 4, wherein a length of the male grinding portion ranging from 0.05 inches to 5 inches remains protruding above the female grinding portion during grinding of the one or more solid pharmaceutical agents.

6. 10. The apparatus of claim 1, further comprising a retaining ring; the proximal end of the female grinding portion includes a plurality of slots for receiving the retaining ring; the retaining ring comprises a plurality of members configured to couple to the male grinding portion and prevent the male grinding portion from disengaging from the female grinding portion during operation; Device.

7. 3. The device of claim 2, wherein the stop member is configured to be forced into the spring when the syringe is connected to the syringe adapter.

8. 8. The device of claim 7, wherein when the stop member is pressed against the spring, at least one opening is provided in the closed chamber and configured to allow the liquid and the powder to mix to produce a liquid and powder mixture.

9. 9. The apparatus of claim 8, further comprising at least one seal mating with said female grinding portion to prevent said liquid and powder mixture from leaking out of said closed chamber.

10. 2. The apparatus of claim 1, wherein the spring has a spring constant in the range of 0.09 to 0.27 lbs / mm.

11. 10. The device of claim 1, wherein at least a portion of the female grinding portion is transparent to allow a user to visualize the grinding of the solid pharmaceutical agent.

12. 10. The apparatus of claim 1, wherein the filter is a hydrophobic filter.

13. 2. The apparatus of claim 1, The valve is a hollow member having at least one opening, the filter is positioned to surround the at least one opening to prevent the liquid, the pharmaceutical powder, or a mixture of the liquid and the pharmaceutical powder from passing through the at least one opening. Device.

14. A method for producing a suspension by crushing a tablet and mixing the crushed tablet with a liquid, comprising the steps of: providing one or more tablets within a female grinding portion having a chamber configured to receive the one or more tablets and having a first plurality of serrated edges; inserting a male grinding section into the female grinding section to form a closed chamber with the female grinding section, the male grinding section having a proximal end, a distal end, and a second plurality of serrated edges, the female grinding section configured to receive the spring, a valve having at least one opening coupled to the spring, a filter disposed adjacent the at least one opening and further configured to allow only air to flow into and out of the closed chamber; rotating the proximal end of the male grinding portion relative to the female grinding portion to move the first plurality of serrated edges against the second plurality of serrated edges to crush the tablet into a powder; attaching a syringe to an adapter coupled to the valve; injecting a liquid into the closed chamber through the valve using the syringe; drawing the liquid and powder mixture from the closed chamber using the syringe; The method according to claim 1,

15. 15. The method of claim 14, wherein the filter is a hydrophobic filter.

16. 15. The method of claim 14, further comprising, after the step of aspirating the liquid and powder mixture, repeating the steps of injecting the liquid and powder mixture back into the closed chamber and aspirating the liquid and powder mixture.

17. 17. The method of claim 16, further comprising, after repeating the step of aspirating the liquid and powder mixture, removing the syringe from the adapter and administering the liquid and powder mixture to a patient using the syringe.

18. 15. The method of claim 14, the powder includes particles having a size adapted to pass through holes located within the valve; The diameter of the hole is 1.25 mm to 5 mm. method.

19. 15. The method of claim 14, Rotating the male crushing part relative to the female crushing part generates sound; The pitch of the sound changes as the tablet is crushed into the powder. method.

20. 15. The method of claim 14, wherein at least a portion of the closed chamber is visible from outside the female grinding portion.

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