Ampoule crushing tool

Abstract

Disclosed herein is a tool for crushing ampoules contained within an applicator for a therapeutic agent. The ampoule crushing tool may be configured to be placed at an angle relative to a flat surface. Furthermore, the ampoule crushing tool may include an overflow reservoir for collecting a volume of therapeutic agent released during the ampoule crushing operation. Furthermore, the ampoule crushing tool may form a fully enclosed cavity so that the ampoule crushing tool can contain the therapeutic agent even if the therapeutic agent is released from the ampoule along an unpredictable trajectory. The ampoule crushing tool may also be shaped to properly orient an applicator containing the ampoule within the ampoule crushing tool.

Description

TECHNICAL FIELD

[0001] Cross-reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 094,231, filed on October 20, 2020, the entire contents of which are incorporated herein by reference.

[0002] The disclosed embodiments relate to an ampule breaking tool, for example, an ampule breaking tool for preparing a drug applicator to be used.

BACKGROUND ART

[0003] The body surface of a human body can be affected by various disorders. For example, many skin diseases produce lesions on the skin. Some of these lesions take the form of epidermal proliferation on the skin. For example, warts are small epidermal growths caused by viral infection, which are commonly found on hands and feet. The most common type of wart is called verruca vulgaris, which can be caused by multiple different strains of human papillomavirus (HPV).

[0004] These warts located on most parts of the body may sometimes be referred to as verruca vulgaris, but those on the feet may be referred to as plantar warts; those on the genitals may be referred to as genital warts or condylomata. Other epidermal viral diseases such as molluscum contagiosum resemble warts but are caused by distinct viruses. These virus-mediated skin proliferations are unsightly and may pose a significant risk of canceration and metastasis, so it is considered desirable to remove them. Other superficial hyperproliferative disorders include seborrheic keratosis, actinic keratosis, and porokeratosis, which resemble warts but are caused by non-viral mechanisms.

[0005] Various methods are used to remove warts, molluscum contagiosum, and other skin conditions, including cryotherapy; surgical curettage; laser treatment; irritants such as salicylic acid and zinc oxide; acids such as nitric acid and squalic acid; 2,4-dinitrochlorobenzene and Candida antigens; and chemotherapeutic agents such as bleomyosin, podophyllotoxin, and 5-fluorouracil. Many of these treatments can be painful, while others may leave unsightly scars or require daily application. Many of these skin disorders remain refractory even after multiple follow-up treatments. Therefore, improved treatment methods are needed to treat these conditions. [Overview of the project] [Problems that the invention aims to solve]

[0006] In some embodiments, the ampoule breaking device includes a body having a first end and a second end; and a support configured to incline the first end of the body to a first height vertically above a second height of the second end of the body when the ampoule breaking device is placed on a flat surface and while the device is operating to break an ampoule.

[0007] In some embodiments, a method for destroying an ampoule includes (1) placing a tool on a flat surface, (2) placing a drug applicator with an ampoule into the cavity of the tool, and (3) operating the tool to destroy the ampoule while the tool holds the drug applicator at an angle inclined with respect to the flat surface.

[0008] In some embodiments, the ampoule disruption device includes a body having a first end and a second end, and a cavity located at the first end of the body, the cavity configured to receive at least the distal end of a drug applicator, the distal end comprising a dispenser tip, and the cavity comprising a sidewall and a recessed reservoir, the reservoir configured to collect the drug released from the ampoule during the ampoule disruption operation.

[0009] In some embodiments, the method for destroying an ampoule involves (1) placing a drug applicator with an ampoule inside a cavity of a tool, (2) destroying the ampoule with the tool to release the drug inside the ampoule out of the drug applicator, and (3) collecting the released drug inside the cavity.

[0010] In some embodiments, the ampoule breaking device includes a base portion having a first cavity and a cover portion having a second cavity, wherein the cover portion and the base portion are movable relative to each other to form an open configuration and a closed configuration, in which the cover portion covers the base portion and the first cavity and the second cavity form a closed housing.

[0011] In some embodiments, the ampoule breaking device includes a cavity configured to receive a drug applicator having an ampoule, the cavity comprising a first portion and a second portion, the first portion being shaped and positioned to receive the dispensing end of the drug applicator, and the second portion being shaped and positioned to receive the tube end of the drug applicator, the first portion having a tapered shape, and the second portion having a cylindrical shape.

[0012] This disclosure is not limited to this extent, and it should be understood that the concepts described above, and any additional concepts described below, can be arranged in any suitable combination. Furthermore, other advantages and novel mechanisms of this disclosure will become apparent from the following detailed description of various non-limiting embodiments, in conjunction with the accompanying drawings. [Brief explanation of the drawing]

[0013] Non-limiting embodiments of the present invention will be described by reference to the accompanying drawings, which are schematic and not intended to be drawn to any particular scale. In the drawings, each identical or substantially identical element shown is usually represented by a single number. For clarity, not all elements are labeled in all figures, nor are all elements of each embodiment of the present invention shown, and illustrations are not necessary for those skilled in the art to understand the invention. In the figures:

[0014] [Figure 1A-B] Figure 1A is a perspective view of an ampoule crushing tool holding an applicator, according to an exemplary embodiment, in an open configuration. Figure 1B is a perspective view of the ampoule crushing tool of Figure 1A in a closed configuration, with the cover portion of the ampoule crushing tool indicated by dashed lines. [Figure 2] This is a side cross-sectional view of an ampoule crushing tool holding an applicator, according to one exemplary embodiment. [Figure 3] This is a perspective view of the base of an ampoule crushing tool according to an exemplary embodiment.

[0015] [Figure 4A-B] Figure 4A is a perspective view of an open-configured ampoule crushing tool according to an exemplary embodiment. Figure 4B is a perspective view of the closed-configured ampoule crushing tool of Figure 4A according to an exemplary embodiment. [Figure 5] This is a cross-sectional view of the ampoule crushing tool of Figure 4B along line 5-5, according to one exemplary embodiment. [Figure 6A-B] Figure 6A is a bottom view of the cover portion of an ampoule crushing tool according to an exemplary embodiment. Figure 6B is a top view of the base portion of the ampoule crushing tool of Figure 6A according to an exemplary embodiment. [Figure 7] Figure 7 is a perspective view of the cover portion of an ampoule crushing tool according to an exemplary embodiment. [Modes for carrying out the invention]

[0016] To treat various surface skin disorders, clinicians may use one or more of several appropriate treatments. These treatments may include ointments, creams, or other suitable medications that can be applied to the patient's skin. In some cases, for example, if the medication is in a bottle, the clinician may apply it to the patient using a wooden stick.

[0017] In other examples, clinicians may apply therapeutic drugs using applicators that contain the therapeutic drug in a fragile ampoule made of glass, plastic, or any other suitable material. An example of such an applicator is discussed in U.S. Patent Application No. 16 / 621,854, published as U.S. Patent Application Publication No. 2021 / 0138214, also published as WO2018 / 232277, which are incorporated herein by reference, respectively.

[0018] An exemplary embodiment of the applicator 102 is shown in Figure 1A, and a cross-section of the applicator 102 is shown in Figure 2. The applicator 102 may include an ampoule 146 and an outer tube 148, the ampoule being positioned within the outer tube. The applicator 102 may also include a dispenser tip 152 with an outlet 150. The applicator may also include a cap 154 ​​that can cover the outlet 150 of the dispenser tip 152.

[0019] When clinicians use such applicators, the ampoules contained within the applicator may need to be crushed before use to release the therapeutic agent contained within the ampoule for administration to the patient. In some cases, it may be difficult to break the ampoule by hand. Therefore, the inventors recognized the need for a tool to assist in crushing the ampoules contained within the applicator. Considering the above, the inventors recognized the advantages of an ampoule crushing tool for preparing an applicator for use by crushing the ampoule contained within the applicator.

[0020] The applicator may include a dispenser tip and a cap covering the dispenser tip. In some embodiments, the cap does not have to form an airtight seal. In some embodiments, the cap may be intentionally designed not to form an airtight seal depending on the application. For example, in some cases, the cap may be designed to allow ventilation through the cap so that the dispenser tip of the applicator can self-seal. Specifically, after being exposed to air for a certain period of time, at least a portion of the therapeutic agent (e.g., the portion of the therapeutic agent disposed toward the outlet of the dispenser tip) may cure over time.

[0021] The cured therapeutic agent may block the outlet of the dispenser tip to enable a self-sealing effect, preventing the therapeutic agent from flowing out of the dispenser tip. The self-sealing effect may be caused by evaporation of a solvent (such as water or alcohol) from the therapeutic agent, leaving a solid that enables the self-sealing effect. The self-sealing effect can function as a tamper-evident seal, or the self-sealing mechanism may help prevent degradation or oxidation of the therapeutic agent.

[0022] In some cases, a clinician may remove the cap of the applicator before crushing the ampoule, and initiate crushing of the ampoule while the cap is removed. Accordingly, in some cases (e.g., when the cap of the applicator does not form an airtight seal, and / or when the clinician removes the cap of the applicator before crushing and begins crushing the ampoule with the cap removed), the act of using the ampoule crushing tool to crush the ampoule contained within the applicator may cause a volume of the therapeutic agent contained within the applicator to move toward the outlet of the applicator (such as the dispenser tip) and thus be released from the applicator.

[0023] Accordingly, the inventors have further recognized the advantages of an ampule breaking tool that can minimize the volume of therapeutic agent released when the ampule is broken. In some cases, a clinician may wish to prevent undesired exposure to the therapeutic agent. Accordingly, the inventors have also recognized the advantages of an ampule breaking tool that can contain the volume of therapeutic agent released from the applicator when the ampule is broken.

[0024] Embodiments disclosed herein relate to an ampule breaking tool configured to receive an applicator for applying a therapeutic agent to a patient. In some embodiments, the ampule breaking tool includes a mechanism for preventing a volume of therapeutic agent from being released from the applicator during an ampule breaking operation, and a mechanism for containing the volume of therapeutic agent released from the applicator during the breaking operation.

[0025] An ampule breaking tool according to the present disclosure may include two mutually movable parts, such as a cover portion and a base portion. The cover and base portions may be movable relative to each other via a hinge (e.g., a living hinge, a pivot hinge, a pin hinge, a case hinge, a concealed hinge, or other suitable type of hinge). In some embodiments, the cover portion and the base portion are formed as a single continuous part with a living hinge, while in other embodiments, the cover portion and the base portion are formed as two separate parts (e.g., where the two separate parts are connected by a hinge).

[0026] The combination of the cover portion and the base portion may be constructed to receive an applicator that includes an ampule, and the ampule holds a therapeutic agent. The cover and / or base portion may include one or more ribs for crushing the ampule. For example, the cover portion may include one or more ribs, and when the applicator is placed in the ampule breaking tool and the cover portion is pressed against the base portion, or when the cover portion and the base portion are moved toward each other, the ribs serve to break the ampule contained within the applicator.

[0027] Conversely, the base portion may include one or more ribs, which function to break the ampoule contained within the applicator when the applicator is placed inside the ampoule crushing tool and the cover portion is pressed onto the base portion, or when the cover portion and the base portion move toward each other. Needless to say, one or more ribs do not have to be located on either the base portion or the cover portion.

[0028] For example, both the base and cover portions may include one or more ribs. Alternatively, multiple ribs may be scattered between the cover and base portions, for example, in an alternating pattern. Any suitable arrangement of ribs can be used, as will be understood by those skilled in the art.

[0029] To perform an ampoule crushing operation (e.g., crushing an ampoule contained in an applicator using an ampoule crushing tool), the clinician begins by opening the cover so that the clinician can insert the applicator into the ampoule crushing tool. The clinician can then place the applicator inside the ampoule crushing tool, for example, so that the applicator fits into the base.

[0030] After placing the applicator in the base portion, the clinician can close the cover portion and break the ampoule contained within the applicator (for example, via the ribs mentioned above). After breaking the ampoule, the clinician can open the cover portion again and remove the applicator prepared for use on the patient. Thus, the clinician can apply the therapeutic agent contained within the applicator to the patient.

[0031] In some embodiments, the ampoule crushing tool includes a mechanism to prevent the therapeutic agent from being released from the applicator while the ampoule crushing tool is being used to crush the therapeutic agent-containing ampoule housed in the applicator. For example, the ampoule crushing tool may include one or more supports configured to position the ampoule crushing tool, and by extension the applicator contained within the ampoule crushing tool, at an inclination during the crushing operation. In some embodiments, the ampoule crushing tool includes one or more supports attached to a body (e.g., a base).

[0032] The support may be positioned at the first end of the ampoule crushing tool's body (i.e., the end opposite the first end) such that when the ampoule crushing tool is placed on a flat surface, the first end of the ampoule crushing tool's body is positioned vertically higher than the second end of the ampoule crushing tool's body. Thus, the support can serve to tilt the ampoule crushing tool relative to the surface.

[0033] As can be understood from the above, the applicator can fit onto the ampoule crushing tool in an orientation substantially parallel to the ampoule crushing tool, but it can also be inclined along the body of the ampoule crushing tool. In some cases, the exit of the applicator may be positioned toward the first end of the ampoule crushing tool.

[0034] Therefore, the applicator's outlet may be positioned vertically higher than the portion of the applicator containing the therapeutic agent (e.g., an ampoule). Thus, when the ampoule contained within the applicator is crushed, the inclined orientation acts to allow gravity to pull the therapeutic agent away from the applicator's outlet, allowing it to settle towards the end of the applicator opposite the outlet. In some cases, the inclined support of the ampoule crushing tool may help prevent the release of therapeutic agent during the ampoule crushing operation or reduce the amount of therapeutic agent released from the applicator.

[0035] Nevertheless, in some cases, a certain volume of therapeutic agent may be released from the applicator during the ampoule crushing operation. Therefore, the ampoule crushing tool may include a mechanism that allows the tool to collect the volume of therapeutic agent released from the applicator during the ampoule crushing operation. For example, in some embodiments, the ampoule crushing tool includes an outflow reservoir constructed to collect the volume of therapeutic agent released during the ampoule crushing operation. The outflow reservoir may be located at a first end of the ampoule crushing device (i.e., the end configured to accommodate the outlet of the applicator).

[0036] An outflow reservoir may be formed within a cavity in the body of the ampoule crushing tool. The cavity may include side walls, and the outflow reservoir may be recessed relative to the side walls of the cavity. In some embodiments, the ampoule crushing tool may include a splash shield configured to direct the volume of therapeutic agent released during the ampoule crushing operation toward the outflow reservoir. Thus, the outflow reservoir can collect the volume of therapeutic agent released during the ampoule crushing operation and prevent undesirable exposure to the therapeutic agent.

[0037] In some cases, the volume of therapeutic agent released from the applicator during the ampoule crushing operation may exit the applicator along an unpredictable trajectory. Therefore, the ampoule crushing tool may also include a mechanism to contain all of the therapeutic agent released from the applicator during the ampoule crushing operation. For example, the cover and base portions may be constructed such that the cover portion is movable relative to the base portion between an open configuration and a closed configuration.

[0038] In an open configuration, the cover portion may be sufficiently far from the base portion so that the applicator can be placed inside the ampoule crushing tool. Conversely, in a closed configuration, the cover portion may completely cover the base portion so that the combination of the cover portion and the base portion forms a complete enclosure. In some embodiments, the cover portion and the base portion may each include extended sidewalls, such that the extended sidewalls of the cover portion overlap with the extended sidewalls of the case portion.

[0039] In some embodiments, the overlapping portion may form a seal. Thus, the ampoule crushing tool can further prevent undesirable exposure to the therapeutic agent, as the seal may help contain the volume of therapeutic agent released during the ampoule crushing operation within the ampoule crushing tool.

[0040] In some embodiments, the ampoule crushing tool may include a mechanism that allows the ampoule crushing tool to hold the applicator in a predetermined orientation. For example, the ampoule crushing tool may include a cavity constructed to house the applicator. The cavity may include a first portion and a second portion. The first portion may be shaped to receive the dispensing end of the applicator (i.e., the end containing the outlet of the applicator), while the second portion may be shaped to receive the tube end of the applicator (i.e., the end containing the ampoule).

[0041] To this end, the first portion of the cavity may have a tapered shape, and the second portion of the cavity may have a cylindrical shape. Thus, the cavity of the ampoule crushing tool can be shaped to hold the applicator in a manner in which the tube end of the applicator is held by the second end of the ampoule crushing tool, and the dispensing end of the applicator is held by the first end of the ampoule crushing tool.

[0042] Certain non-limiting embodiments are described in further detail with reference to the drawings. Since this disclosure is not limited to the specific embodiments described herein, it should be understood that the various systems, elements, mechanisms, and methods described in relation to these embodiments may be used individually and / or in any desired combination.

[0043] Figure 1A is a perspective view of the ampoule crushing tool 100 in an open configuration, and Figure 1B is a perspective view of the ampoule crushing tool 100 in a closed configuration. As can be seen from Figures 1A and 1B, the ampoule crushing tool 100 may include a cover portion 104 and a base portion 106. In Figure 1B, the cover portion 104 is shown by dashed lines to reveal the applicator 102 held within the base portion 106. In the open configuration, the cover portion 104 may be positioned at a distance from the base portion 106, whereas in the closed configuration, the cover portion 104 may be flush with or overlapping the base portion 106.

[0044] The cover portion 104 and the base portion 106 may be movable relative to each other via the hinge 134. Thus, when the cover portion 104 is moved relative to the base portion 106 so that the ampoule crushing tool 100 is in an open configuration, the applicator 102 (e.g., an applicator containing an ampoule of therapeutic drug) may be placed inside the base portion 106 of the ampoule crushing tool 100. The ampoule crushing tool 100 can then be positioned in a closed configuration by moving the cover portion 104 toward the base portion 106 with the applicator 102 inside the ampoule crushing tool 100.

[0045] The operation of transitioning the ampoule crushing tool 100 from an open configuration to a closed configuration can be useful for crushing ampoules placed in the applicator 102, as will be described in more detail below. In some embodiments, the ampoule crushing tool may move between the open and closed configurations by moving the cover portion closer to or away from the base portion, by moving the base portion closer to or away from the cover portion, or by a combination of both.

[0046] In some embodiments, the ampoule crushing tool may have a tubular portion for receiving the tube portion of the applicator, and a second portion for receiving the dispensing end of the applicator (e.g., the cap end and / or dispenser tip of the applicator). In some embodiments, for example, the second portion may flare out relative to the tubular portion to accommodate the applicator cap and / or dispenser tip. In the exemplary embodiment shown in Figure 1A, the tubular portion is formed from a tubular portion 137 of the base portion 106 and a tubular portion 127 of the cover portion 104. The second portion is formed from a flared portion 139 of the base portion 106 and a flared portion 129 of the cover portion 104.

[0047] In some embodiments, the cover portion 104 and the base portion 106 include a mechanism for crushing ampoules housed in the applicator 102. For example, as described above, when the cover portion 104 moves from an open configuration to a closed configuration, the cover portion 104 may include one or more crushers 126 (shown in Figure 4A) configured to crush ampoules housed in the applicator 102.

[0048] In connection therewith, the base portion 106 may include one or more crushers 124 configured to crush ampoules housed in the applicator 102 when the cover portion 104 moves from an open configuration to a closed configuration. In some embodiments, only the cover portion 104 includes one or more crushers 126, and in other embodiments, only the base portion 106 includes one or more crushers 124. In some embodiments, both the base portion 106 and the cover portion 104 include one or more crushers 124, 126.

[0049] In some embodiments, the crusher 126 may take the form of pins, as shown in Figure 7. In some embodiments, the pins may have different lengths. For example, in some embodiments, the crusher 126 may include one or more long pins 162 and one or more short pins 164, where the one or more long pins 162 extend further from the body of the cover portion 104 than the one or more short pins 164. The crusher 126 may be arranged such that the one or more long pins 162 contact the central portion of the ampoule 146 when the applicator 102 is positioned in the ampoule crushing tool 100, and the one or more short pins 164 contact either end of the ampoule 146 during the ampoule crushing operation.

[0050] Therefore, one or more longer pins 162 can contact the ampoule 146 before one or more shorter pins 164, allowing one or more longer pins 162 to crush the ampoule 146 first. Subsequently, one or more shorter pins 164 may contact the ampoule 146. However, in other embodiments, the pins may have the same length.

[0051] In some embodiments, the crushers may be positioned to align with specific portions of the ampoule. For example, one or more crushers may be positioned to contact the central portion of the ampoule, or one or more crushers may be positioned to contact the ends of the ampoule. For example, in the embodiment of Figure 7, two pins 164 are positioned on either side of pin 162. Pin 162 is positioned to contact the central portion of the ampoule, and pins 164 are positioned to contact the ends of the ampoule. Pin 162 may be positioned in the central region of the tubular portion 127, and pins 164 may be positioned in the end region of the tubular portion 127. Pins positioned to contact the ends of the ampoule may help to break the ends of the ampoule 146.

[0052] In some configurations, an intact end of the ampoule may obstruct the flow of the drug toward the dispenser tip. Including a pin positioned to contact the end of the ampoule may help to break the end and reduce the likelihood of the end remaining intact. However, it should be understood that in other embodiments, the crushing tool does not include a crusher positioned to contact the end of the ampoule. For example, one or more crushers may be positioned to contact the central portion of the ampoule. Alternatively, in some embodiments, the ampoule crushing tool includes only a single crusher positioned to contact one end of the ampoule.

[0053] In some embodiments, the crushers 124 and 126 may take the form of ribs. The ribs may be curved, flat-edged, or have any other suitable shape. In some embodiments, the shape of the ribs on the cover portion may differ from the shape of the ribs on the base portion. For example, crusher 124 may have curved ribs and crusher 126 may have flat-edged ribs, while in some embodiments the opposite may be true. For example, crusher 124 may have flat edges while crusher 126 may be curved. As will be understood by those skilled in the art, in some embodiments both crushers 124 and 126 may have flat edges, and in other embodiments both crushers 124 and 126 may have curved edges.

[0054] The crushers 124 and 126 can be arranged in any number of suitable patterns. For example, in some embodiments, the crushers 124 and 126 may be arranged at equal intervals along the base portion 106 and the cover portion 104, respectively. In other embodiments, the crushers 124 and 126 may be arranged in an alternating pattern such that the crusher 124 on the base portion 106 is offset from the crusher 126 on the cover portion 104. In some embodiments, the crushers 124 and 126 may be positioned at or near the second end 116 of the ampoule crushing tool 100. In such embodiments, the crushers 124 and 126 can be arranged so that they crush the ampoule 146, which can be done when the ampoule crushing tool 100 is placed on a flat surface such as a surface 136, at or near the second end 116.

[0055] Needless to say, the crushers 124 and 126 do not need to take the form of ribs, as many suitable types of crushers are conceivable. For example, the crushers 124 and 126 may take the form of spikes, hammers, blades, protrusions, or other suitable shapes to crush the ampoules contained in the applicator 102.

[0056] Therefore, the ampoule crushing tool 100 may help to crush the ampoule 146 on the applicator 102 more easily than when a clinician crushes the ampoule 146 by hand (for example, by applying less force). Specifically, in some embodiments, using the ampoule crushing tool 100 can reduce the force required to crush the ampoule 146 to less than about 5 pounds, less than about 6 pounds, less than about 7 pounds, less than about 8 pounds, less than about 9 pounds, less than about 10 pounds, less than about 11 pounds, less than about 12 pounds, less than about 13 pounds, less than about 14 pounds, or less than about 15 pounds.

[0057] Combinations of the ranges referenced above are also possible. For example, in some embodiments, the ampoule crushing tool 100 may be configured to reduce the force required to crush the ampoule 146 from about 5 pounds to about 15 pounds, from about 6 pounds to about 14 pounds, from about 7 pounds to about 13 pounds, from about 8 pounds to about 12 pounds, or from about 9 pounds to about 11 pounds.

[0058] In some embodiments, the ampoule crushing tool 100 includes a support 112 configured to allow the ampoule crushing tool 100 to rest at an inclination when placed on a flat surface 136, as shown in Figure 2. When the ampoule crushing tool 100 is placed at an inclination, the applicator 102 may also be placed at an inclination within the ampoule crushing tool 100. For example, the ampoule crushing tool may have a first end 118 and a second end 116 opposite the first end 118. In some cases, the support 112 may be positioned at the first end 118 to raise the first end 118 to a first height relative to the surface 136.

[0059] Therefore, the support 112 can position its first end 118 at a height higher than the second height of the second end 116 relative to the surface 136. In some cases, the applicator 102 is placed inside the ampoule crushing tool 100 in an orientation parallel to the ampoule crushing tool 100, for example, parallel to the longitudinal axis A of the cavity 160 of the ampoule crushing tool 100. Thus, if the support 112 tilts and orients the ampoule crushing tool 100, the support 112 can similarly tilt and orient the applicator 102.

[0060] Specifically, the applicator 102 may include a first end 108 and a second end 110. The first end 108 of the applicator 102 may be positioned on the first end 118 of the ampoule crushing tool 100. Similarly, the second end 110 of the applicator 102 may be positioned on the second end 116 of the ampoule crushing tool 100. Thus, the applicator 102 can be oriented to a similar incline compared to the ampoule crushing tool 100.

[0061] Such orientation may help prevent the therapeutic agent stored in the applicator 102 from being released during the crushing operation. For example, in some cases, the therapeutic agent may be stored in an ampoule 146 located inside the tube 148 of the applicator 102. Thus, tilting as shown in Figure 2 can help gravity G move the therapeutic agent towards the second end 110 of the applicator 102 after the ampoule 146 of the applicator 102 has been crushed.

[0062] In some embodiments, the support 112 may be configured to tilt the ampoule crushing tool 100 with respect to the surface 136 by at least about 5 degrees, at least about 6 degrees, at least about 7 degrees, at least about 8 degrees, at least about 9 degrees, at least about 10 degrees, at least about 11 degrees, at least about 12 degrees, at least about 13 degrees, at least about 14 degrees, at least about 15 degrees, at least about 16 degrees, at least about 17 degrees, at least about 18 degrees, at least about 19 degrees, or at least about 20 degrees.

[0063] In some embodiments, the support 112 may be configured to tilt the ampoule crushing tool 100 with respect to the surface 136 by an angle of approximately 20 degrees or less, approximately 19 degrees or less, approximately 18 degrees or less, approximately 17 degrees or less, approximately 16 degrees or less, approximately 15 degrees or less, approximately 14 degrees or less, approximately 13 degrees or less, approximately 12 degrees or less, approximately 11 degrees or less, approximately 10 degrees or less, approximately 9 degrees or less, approximately 8 degrees or less, approximately 7 degrees or less, approximately 6 degrees or less, and approximately 5 degrees or less.

[0064] Combinations of the ranges referenced above are also possible. For example, in some embodiments, the support 112 may be configured to tilt the ampoule crushing tool 100 relative to the surface 136 by about 5 to 20 degrees, or about 6 to 18 degrees, or about 7 to 16 degrees, or about 7 to 14 degrees, or about 8 to 12 degrees, or about 9 to 11 degrees, or about 9 to 10 degrees.

[0065] In some cases, the ampoule crushing tool may include a second support 114. The second support 114 may be positioned at the second end 116 of the ampoule crushing tool 100. As seen in Figures 1A, 1B, 4A, and 4B, the second support 114 may include two flanges 158 (e.g., legs) to stabilize the ampoule crushing tool 100 when it is placed on the surface 136. The second support 114 may be configured to have a height lower than the height of the support 112 in order to maintain the slope between the first end 118 and the second end 116.

[0066] In some embodiments, the ampoule crushing tool may be used as follows: The clinician can first place the ampoule crushing tool 100 on the surface 136. The clinician can then open the ampoule crushing tool 100 by moving the cover portion 104 to expose the base portion 106. Subsequently, the clinician can place the applicator 102 into the base portion 106 such that the first end 108 of the applicator 102 is placed inside the first end 118 of the ampoule crushing tool 100 and the second end 110 of the applicator 102 is placed inside the second end 116 of the ampoule crushing tool 100.

[0067] Next, the clinician can close the cover portion 104 over the base portion 106 and break the ampoule contained within the applicator 102 as described above. Without being bound by theory, during the crushing process, the therapeutic agent contained within the ampoule 146 of the applicator 102 may sink toward the second end 110 of the applicator 102 due to gravity acting on the therapeutic agent and the height difference between the first end 108 and the second end 110 of the applicator 102.

[0068] In some embodiments, the support 112 may be constructed as a tower support, while the support 114 may be constructed as a flanged support. In other words, the support 112 may be configured to lift the first end 118 of the ampoule crushing tool 100 above the surface 136, and the support 114 may be constructed to stabilize the ampoule crushing tool 100 on the surface 136. In some embodiments, only the support 112 is included, and the support 114 is not included, resulting in the second end 110 contacting the surface 136 without any additional support other than the support 112 that contacts the surface 136.

[0069] Alternatively, the ampoule crushing tool 100 may include any suitable type of support. For example, the ampoule crushing tool does not need to include separate, isolated supports 112, 114. Instead, the ampoule crushing tool 100 may include a single continuous support extending along the length of the base portion 106. Such a support can be constructed to have a suitable slope, as described above. For example, a single continuous support may be wedge-shaped to provide a slope. Needless to say, the ampoule crushing tool 100 does not need to include exactly one or two supports, and embodiments with three or more supports are also conceivable.

[0070] In some embodiments, the ampoule crushing tool 100 includes a mechanism configured to collect the drug released from the applicator 102 during the ampoule crushing operation. For example, the ampoule crushing tool 100 may include an outflow reservoir 122 located within a cavity 132 of the base portion 106, as shown in Figure 3. The cavity 132 may be located at the first end 118 of the ampoule crushing tool 100. The cavity 132 may include a side wall 156, and the outflow reservoir 122 may be recessed relative to the side wall 156 of the cavity 132. Based on the orientation of the applicator 102 as described above, the therapeutic drug released from the applicator 102 during the ampoule crushing operation may tend to follow a trajectory toward the first end 118 of the ampoule crushing tool 100.

[0071] In some cases, the ampoule crushing tool 100 may include a splash shield 120 (as shown in Figure 7). The splash shield 120 is positioned on the cover portion 104 and can be shaped to complement the spill reservoir 122. Thus, the splash shield 120 can be shaped to guide the drug released from the applicator 102 during the ampoule crushing operation toward the spill reservoir 122. For example, the splash shield 120 can take the form of a U-shape (as in the embodiment of Figure 7), a V-shape, or any other suitable shape. In some embodiments, as in the embodiment of Figure 7, the U-shaped splash shield 120 may have a base 123 that interconnects two inclined side walls 121.

[0072] The slanted walls can form a taper that narrows toward the base 123. Alternatively, the splash shield 120 may consist of an overlapping portion of the cover portion 104 and the base portion 106. Thus, the therapeutic agent released toward the first end 118 of the ampoule crushing tool 100 during the ampoule crushing operation may tend to be collected in the outflow reservoir 122 recessed against the sidewall of the cavity 132, rather than settling randomly within the cavity 132.

[0073] In some embodiments, the volume of the spill reservoir 122 and the cavity 132 is sufficient to accommodate the entire volume of the therapeutic agent in the applicator while the applicator is held in the cavity 132. If leakage occurs in the applicator, the ampoule crushing tool 100 can serve to capture and retain the leaked therapeutic agent.

[0074] In some embodiments, the ampoule crushing tool may help contain the released therapeutic agent by forming a completely enclosed cavity when in a closed configuration. As shown in Figures 4A–5, the ampoule crushing tool 100 can form a completely enclosed cavity when in a closed configuration. The completely enclosed cavity can form a complete seal to the external environment so that the therapeutic agent can be contained even if it is released from the applicator 102 along an unpredictable trajectory. In some embodiments, the cover portion 104 may include a first extended sidewall portion 128, and the base portion 106 may include a second extended sidewall portion 130.

[0075] To completely enclose the applicator 102 within the ampoule crushing tool 100, the first extended sidewall portion 128 and the second extended sidewall portion 130 can be shaped to overlap each other when the ampoule crushing tool 100 is in a closed configuration. Thus, when the applicator 102 is placed inside the ampoule crushing tool 100 in a closed configuration, the base portion 106 and the cover portion 104 form a completely enclosed cavity, reducing undesirable exposure to the therapeutic agent by collecting the therapeutic agent released from the applicator 102 during the ampoule crushing operation.

[0076] In some embodiments, the ampoule crushing tool 100 can be shaped to hold the applicator 102 in a specific orientation, as shown in Figures 6A-6B. For example, the cover portion 104 may include a first cavity portion 138 and a second cavity portion 140. The first cavity portion 138 may be shaped to accommodate the tube end of the applicator 102 (e.g., the second end 110), while the second cavity portion 140 may be shaped to accommodate the dispensing end of the applicator 102 (e.g., the first end 108). Similarly, the base portion 106 may include a first cavity portion 142 and a second cavity portion 144.

[0077] The first cavity portion 142 may be shaped to accommodate the tube end (e.g., the second end 110) of the applicator 102, while the second cavity portion 144 may be shaped to accommodate the dispensing end (e.g., the first end 108) of the applicator 102. The first cavity portion 138 of the cover portion 104 may be shaped to fit onto the first cavity portion 142 of the base portion 106. Similarly, the second cavity portion 140 of the cover portion 104 may be shaped to fit onto the second cavity portion 144 of the base portion 106.

[0078] Therefore, the ampoule crushing tool can be shaped such that the applicator 102 is oriented so that its dispensing end (e.g., first end 108) is positioned at the first end 118 of the ampoule crushing tool 100, and the tube end (e.g., second end 110) is positioned at the second end 116 of the ampoule crushing tool 100.

[0079] Various embodiments of this disclosure can be used individually, in combination, or in various arrangements not specifically described in the embodiments described above, and therefore their application is not limited to the details and arrangements of elements shown in the description or drawings above. For example, an embodiment described in one embodiment can be combined in any way with an embodiment described in another embodiment.

[0080] The embodiments described herein can be embodied as methods, and an example thereof is provided. The operations performed as part of the method can be ordered in any suitable manner. Thus, embodiments can be constructed in which the operations are performed in a different order than those illustrated, which may include performing several operations simultaneously, although these are shown as sequential operations in the exemplary embodiments.

[0081] Furthermore, some actions are described as being performed by a “user.” It should be understood that a “user” does not necessarily have to be a single individual; in some embodiments, actions attributed to a “user” may be performed by a team of individuals and / or individuals in combination with computer-aided tools or other mechanisms.

[0082] The use of ordinal numbers such as "first," "second," and "third" in a claim to modify claim elements does not imply priority, precedence, or temporal order in which the actions of a method are performed for one claim element relative to other claim elements. Rather, they are used solely as labels to distinguish claim elements, to differentiate one claim element with a particular name from another element with the same name (but due to the use of ordinal numbers).

[0083] Furthermore, the expressions and terms used herein are for illustrative purposes only and should not be considered limiting. The use of “includes,” “contains,” “has,” “contains,” “involves,” and variations thereof herein means that the items listed thereafter and their equivalents, as well as additional items, are included.

[0084] While these teachings have been described in relation to various embodiments and examples, the teachings of the present invention are not intended to be limited to such embodiments or examples. On the contrary, as those skilled in the art will understand, these teachings encompass a variety of alternatives, modifications, and equivalents. Accordingly, the foregoing description and drawings are merely illustrative.

Claims

1. It is an ampoule destroying device: A body having a first end and a second end; and The ampoule breaking device includes a support configured to incline the first end of the main body at a first height vertically above a second height of the second end of the main body when the ampoule breaking device is placed on a flat surface and while the device is operating to break an ampoule, The first end of the main body is inclined at a position greater than the vertical height of the second end and is adjacent to the applicator exit. The aforementioned ampoule destruction device.

2. The ampoule destruction device according to claim 1, wherein the main body is configured to hold a drug applicator having an ampoule in a cavity of the main body at an inclination, at least partially based on the difference between a first height and a second height.

3. The ampoule breaking device according to claim 1, further comprising a cover movable relative to the main body, the cover comprising at least one rib configured to crush the ampoule when the cover moves toward the main body.

4. The ampoule breaking device according to claim 1, wherein the support includes a first tower portion and a second flange portion, the first tower portion being located at a first end of the main body and the second flange portion being located at a second end of the main body.

5. The ampoule breaking device according to claim 4, wherein the first tower portion reaches a third height perpendicular to the surface and above the fourth height of the second flange portion.

6. The ampoule breaking device according to claim 1, wherein the main body includes a plurality of ribs having curved edges configured to crush ampoules.

7. The ampoule breaking device according to claim 6, further comprising a cover, the cover comprising a plurality of ribs having flat edges configured to crush the ampoule.

8. The ampoule breaking device according to claim 6, wherein a plurality of ribs having curved edges are arranged at the second end of the main body.

9. The ampoule breaking device according to claim 1, further comprising a cavity located at a first end of the main body, the cavity configured to receive at least the distal end of a drug applicator, the distal end comprising a dispenser tip, the cavity comprising a side wall and a reservoir recessed to the side wall, the reservoir comprising a reservoir configured to collect the drug released from the ampoule during the ampoule breaking operation.

10. The ampoule destruction device according to claim 1, wherein the main body includes a base portion having a first cavity and a cover portion having a second cavity, the cover portion and the base portion being movable relative to each other to form an open configuration and a closed configuration, in the closed configuration the cover portion covers the base portion and the first cavity and the second cavity form a closed housing.

11. The ampoule breaking device according to claim 1, further comprising a cavity configured to receive a drug applicator having an ampoule, the cavity comprising a first portion and a second portion, the first portion being formed and positioned to receive the dispensing end of the drug applicator, and the second portion being formed and positioned to receive the tube end of the drug applicator, the first portion having a tapered shape, and the second portion having a cylindrical shape.

12. How to destroy an ampoule: Place the tool on a flat surface; Placing a drug applicator containing an ampoule inside the tool's cavity; and This involves activating the tool to destroy the ampoule while holding the drug applicator at an angle to the flat surface with the tool placed on the flat surface, The first end of the tool body is inclined at a position greater than the vertical height of the second end and is adjacent to the exit of the applicator. The aforementioned method.

13. The method according to claim 12, further comprising removing the drug applicator from the tool cavity at an inclined angle in order to retain the drug within the drug applicator.

14. The method according to claim 12, wherein when the tool is activated to break the ampoule, the drug from the ampoule is released out of the drug applicator.

15. The method according to claim 14, further comprising preventing at least a portion of the drug from being released when the tool is activated to break the ampoule.

16. The method according to claim 14, further comprising collecting the drug released in the cavity.

17. The method according to claim 12, wherein destroying the ampoule with a tool includes moving the cover portion of the tool from an open configuration to a closed configuration.

18. It is an ampoule destroying device: A body having a first end and a second end; and A cavity located at the first end of the main body, configured to receive at least the distal end of a drug applicator, the distal end including a dispenser tip, includes the cavity, The ampoule breaking device comprises a cavity including a side wall and a recessed reservoir, the reservoir being configured to collect the drug released from the ampoule during the ampoule breaking operation.

19. The ampoule breaking device according to claim 18, wherein the main body includes a spray shield shaped and positioned to guide the drug released from the ampoule towards a reservoir during the ampoule breaking operation.

20. The ampoule breaking device according to claim 19, wherein the spray shield includes a first portion and a second portion, and when the ampoule breaking device is in a closed configuration, the first portion overlaps with the second portion and the second portion overlaps with the first portion.

21. The ampoule breaking device according to claim 18, further comprising a support configured to incline the first end of the main body at a first height perpendicular to the second height of the second end of the main body when the ampoule breaking device is placed on a flat surface and while the device is operating to break an ampoule.

22. The ampoule breaking device according to claim 18, wherein the cavity comprises a first portion and a second portion, the first portion being formed and positioned to receive the dispensing end of a drug applicator, and the second portion being formed and positioned to receive the tube end of a drug applicator, the first portion having a tapered shape, and the second portion having a cylindrical shape.

23. The ampoule destruction device according to claim 18, wherein the main body includes a base portion having a cavity and a cover portion having a second cavity, the cover portion and the base portion being movable relative to each other to form an open configuration and a closed configuration, in the closed configuration the cover portion covers the base portion and the cavity and the second cavity form a closed housing.

24. A method of destroying an ampoule; Placing a drug applicator within the cavity of the tool, the drug applicator having an ampoule within it; Using a tool to break the ampoule and release the drug from the ampoule outside the drug applicator; and The method comprising collecting the drug released within the cavity.

25. The method according to claim 24, further comprising directing the released drug toward a reservoir.

26. The method according to claim 24, further comprising placing the tool on a flat surface, wherein when the ampoule is destroyed by the tool, the tool holds the drug applicator at an angle inclined with respect to the flat surface.

27. The method according to claim 24, wherein destroying the ampoule with a tool includes moving the cover portion of the tool from an open configuration to a closed configuration.

28. It is an ampoule destroying device: Base portion having a first cavity; and A cover portion having a second cavity, wherein the cover portion and the base portion are movable relative to each other to form an open configuration and a closed configuration, in which the cover portion covers the base portion, the first cavity and the second cavity form a closed housing, and the drug applicator is configured to be housed in the cavity of the ampoule destruction device defined by the closed housing, the drug applicator having an ampoule inside the drug applicator. The ampoule destruction device, including the cover portion.

29. The ampoule breaking device according to claim 28, wherein the base portion includes a first side wall, and the cover portion includes a second side wall, and the first and second side walls are configured to overlap each other in a closed configuration.

30. The ampoule destruction device according to claim 28, wherein the enclosed enclosure is configured to keep the drug released from the ampoule inside the enclosed enclosure during the ampoule destruction operation.

31. The ampoule breaking device according to claim 28, wherein the first cavity includes a side wall and a reservoir recessed to the side wall, the reservoir being configured to collect the drug released from the ampoule during the ampoule breaking operation.

32. The ampoule breaking device according to claim 28, wherein the first cavity comprises a first portion and a second portion, the first portion being formed and positioned to receive the dispensing end of a drug applicator, and the second portion being formed and positioned to receive the tube end of a drug applicator, the first portion having a tapered shape, and the second portion having a cylindrical shape.

33. The ampoule breaking device according to claim 28, further comprising a body having a first end and a second end, and a support configured such that when the ampoule breaking device is placed on a flat surface, the first end of the body is inclined at a first height perpendicular to the second height of the second end of the body.

34. The ampoule crushing device according to claim 28, wherein the cover portion includes a first crusher and a second crusher, the first crusher extending from the cover portion at a distance of a first distance, and the second crusher extending from the cover portion at a distance of a second distance which is longer than the first distance.

35. The ampoule breaking device according to claim 34, wherein the ampoule breaking device is configured to accommodate an ampoule such that when the ampoule breaking device moves from an open configuration to a closed configuration, the second crusher contacts the ampoule before the first crusher.

36. The ampoule breaking device according to claim 35, wherein a first crusher is positioned in the first end region of the tubular portion of the ampoule breaking device, and a second crusher is positioned in the central region of the tubular portion of the ampoule breaking device.

37. The ampoule breaking device according to claim 36, wherein the tubular portion of the ampoule breaking device is configured to receive the tubular portion of an applicator containing an ampoule, and when the applicator is received into the ampoule breaking device, the first crusher is aligned with the first end of the ampoule and the second crusher is aligned with the central region of the ampoule.

38. The ampoule breaking device according to claim 37, further comprising a third crusher positioned in a second end region of the tubular portion of the ampoule breaking device, and the third crusher being aligned with the second end of the ampoule when an applicator is received into the ampoule breaking device.

39. It is an ampoule destroying device: A cavity configured to receive a drug applicator having an ampoule; The ampoule breaking device comprises a cavity including a first portion and a second portion, the first portion being formed and positioned to receive the dispensing end of a drug applicator, and the second portion being formed and positioned to receive the tube end of a drug applicator, the first portion having a tapered shape, and the second portion having a cylindrical shape.

40. The ampoule breaking device according to claim 39, wherein the cavity includes a plurality of ribs having curved edges configured to crush the ampoule.

41. The ampoule breaking device according to claim 40, further comprising a cover, the cover comprising a plurality of ribs having flat edges configured to crush the ampoule.

42. The ampoule breaking device according to claim 39, comprising a body having a first end and a second end, and a support configured such that when the ampoule breaking device is placed on a flat surface, the first end of the body is inclined at a first height perpendicular to the second height of the second end of the body.

43. The ampoule breaking device according to claim 39, wherein the cavity is configured to receive at least the distal end of a drug applicator, the distal end comprising a dispenser tip, the cavity comprising a side wall and a reservoir recessed to the side wall, the reservoir being configured to collect the drug released from the ampoule during the ampoule breaking operation.

44. The ampoule breaking device according to claim 39, wherein the cavity is positioned on a base portion, and the ampoule breaking device further includes a cover portion having a second cavity, the cover portion and the base portion being movable relative to each other to form an open configuration and a closed configuration, in which the cover portion covers the base portion, and the cavity and the second cavity form a closed housing.

45. The ampoule breaking device according to claim 42, wherein the first end of the main body is inclined at a position greater than the vertical height of the second end and is adjacent to the outlet of the applicator.

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