Disclosed embodiments relate to an ampule crush tool, for example, an ampule crush tool for preparing a medicament applicator for use.
The body surfaces of the body can be affected by various disorders. For example, many cutaneous disorders produce lesions on the skin. Some of these lesions take the form of epidermal growths on the skin. For instance, warts are small epidermal skin growths caused by viral infections, often found on the hands or feet. The most common type of wart is called Verruca vulgaris, which can be caused by multiple different strains of the human papilloma virus (HPV). On most parts of the body these warts may be referred to as common warts; on the feet, however, they may be referred to as plantar warts; when on the genitals they may be referred to as genital warts or condoloma. Other epidermal viral conditions such as Molluscum contagiosum resemble warts but are caused by distinct viruses. These viral mediated skin growths may be unsightly and may pose a significant risk for cancerous transformation and for spreading, making their removal desirable. Other superficial hyper-proliferative disorders resemble warts but are caused by non-viral mechanisms and include seborrheic keratosis, actinic keratosis, and porokeratosis.
Multiple modalities have been used to remove warts, Molluscum contagiosum, and other cutaneous diseases, including cryotherapy; surgical curettage; laser treatment; irritants such as salicylic acid and zinc oxide; acids such as nitric acid and squaric acid, immunotherapeutics such as imiquimod, 2,4-dinitrochlorobenzene and Candida antigen, and chemotherapeutics such as bleomyocin, podophyllotoxin and 5-fluorouracil. Many of these therapies can be painful, while others can leave disfiguring scars and/or require daily application. Many of these cutaneous disorders remain recalcitrant even after multiple follow-up treatments. Accordingly, improved therapies are needed for treating these conditions.
In some embodiments, an ampule fracture device includes a body having a first end and a second end, and a support configured to incline the first end of the body at a first height vertically above a second height of the second end of the body when the ampule fracture device is rested on a flat surface and while the device is actuated to fracture an ampule.
In some embodiments, a method of fracturing an ampule includes (1) placing a tool on a flat surface, (2) placing a medicament applicator having an ampule within a cavity of the tool, and (3) actuating the tool to fracture the ampule while the tool holds the medicament applicator at an inclined angle relative to the flat surface.
In some embodiments, an ampule fracture device includes a body having a first end and a second end, and a cavity disposed on the first end of the body, the cavity configured to receive at least a distal end of a medicament applicator, the distal end including a dispenser tip, wherein the cavity includes a sidewall and a reservoir that is recessed relative to the sidewall, the reservoir being configured to collect a medicament expelled from an ampule during an ampule fracturing operation.
In some embodiments, a method of fracturing an ampule includes (1) placing a medicament applicator having an ampule within a cavity of a tool, (2) fracturing the ampule with the tool, causing medicament from the ampule to be expelled out of the medicament applicator, and (3) collecting the expelled medicament within the cavity.
In some embodiments, an ampule fracture 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 moveable relative to one another to form an open configuration and a closed configuration, wherein, in the closed configuration, the cover portion covers the base portion, and the first cavity and the second cavity form a closed enclosure.
In some embodiments, an ampule fracture device includes a cavity configured to receive a medicament applicator having an ampule, wherein the cavity includes a first portion and a second portion, the first portion shaped and positioned to receive a dispensing end of the medicament applicator, and the second portion shaped and positioned to receive a tube end of the medicament applicator, the first portion having a tapered shape, and the second portion having a cylindrical shape.
It should be appreciated that the foregoing concepts, and additional concepts discussed below, may be arranged in any suitable combination, as the present disclosure is not limited in this respect. Further, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying figures.
Non-limiting embodiments of the present invention will be described by way of example with reference to the accompanying figures, which are schematic and are not intended to be drawn to scale. In the figures, each identical or nearly identical component illustrated is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention. In the figures:
To treat various body surface disorders, a clinician may employ one or more of a number of suitable therapeutics. Therapeutics for treating such disorders may include ointments, creams, or other suitable therapeutics, which may be applied to the skin of a patient. In some instances, the clinician may apply a therapeutic to a patient using a wooden stick, for example, when the therapeutic is contained within a jar.
In other instances, the clinician may apply the therapeutic using an applicator which may contain the therapeutic in a breakable ampule made from glass, plastic, or any other suitable material. One example of such an applicator is discussed in U.S. application Ser. No. 16/621,854, published as U.S. Patent Application Publication No. US 2021/0138214, also published as WO 2018/232277, each of which is incorporated by reference herein.
One illustrative embodiment of an applicator 102 is shown in
In instances where the clinician uses such an applicator, the ampule contained within the applicator may be crushed prior to use in order to release the therapeutic contained within the ampule for administration to a patient. In some instances, the ampule may be difficult to break by hand. Accordingly, the inventors have recognized that need for a tool to assist with breaking the ampule contained within an applicator.
In view of the above, the inventors have recognized the advantages of an ampule crush tool to prepare an applicator for use by breaking the ampule contained within the applicator.
The applicator may include a dispenser tip and a cap that covers the dispenser tip. In some embodiments, the cap may not form an airtight seal. In some embodiments, a cap may be purposefully designed not to form an airtight seal, depending on the application. For example, in some instances, the cap may be designed to permit venting through the cap to allow the dispenser tip of the applicator to self-seal. Specifically, after being exposed to air for a period of time, at least a portion of the therapeutic (e.g., a portion of the therapeutic positioned towards an outlet in the dispenser tip) may harden over time. The hardened therapeutic may block the outlet of the dispenser tip, enabling a self-sealing effect, and may prevent the therapeutic from flowing out of the dispenser tip. The self-sealing effect may be caused by evaporation of solvent (e.g., water or alcohol) from the therapeutic, which may leave behind a solid, enabling the self-sealing effect. The self-sealing effect may serve as a tamper-evident seal, or the self-sealing feature may help to prevent degradation or oxidation of the therapeutic. In some cases, the clinician may remove the cap of the applicator prior to crushing the ampule and may proceed to crush the ampule while the cap is removed. Thus, in some instances (e.g., instances where the cap of the applicator does not form an air tight seal and/or instances where the clinician removes the cap of the applicator prior to crushing and proceeds to crush the ampule with the cap removed), the act of using the ampule crush tool to crush the ampule contained within the applicator may cause a volume of the therapeutic contained within the applicator to be displaced towards an outlet of the applicator (e.g., a dispenser tip) and thus, expelled from the applicator. Accordingly, the inventors have further recognized the advantages of an ampule crush tool capable of minimizing the volume of the therapeutic expelled when the ampule is crushed.
In some instances, the clinician may wish to prevent unwanted exposure to the therapeutic. Thus, the inventors have also recognized the advantages of an ampule crush tool capable of containing the volume of the therapeutic expelled from the applicator when the ampule is crushed.
Embodiments disclosed herein relate to an ampule crush tool constructed to accommodate an applicator for applying a therapeutic to a patient. In some embodiments, the ampule crush tool includes features for preventing a volume of the therapeutic from being expelled from the applicator during an ampule crushing operation and features for containing a volume of the therapeutic expelled from the applicator during the crushing operation.
An ampule crush tool according to the present disclosure may include two portions movable relative to one another, such as a cover portion and a base portion. The cover and base portion may be movable relative to one 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 piece with a living hinge, while in other embodiments, the cover portion and the base portion are formed as two separate pieces (e.g. with a hinge connecting the two separate pieces). The combination of the cover and base portions may be constructed to accommodate an ampule-containing applicator, wherein the ampule holds a therapeutic. The cover and/or base portions may include one or more ribs for crushing the ampule. For example, the cover portion may include one or more ribs such that when the applicator is placed in the ampule crush tool and the cover portion is pressed over the base portion, or the cover portion and base portion are otherwise moved toward one another, the ribs serve to fracture the ampule contained within the applicator. Conversely, the base portion may include one or more ribs such that when the applicator is placed in the ampule crush tool and the cover portion is pressed over the base portion, or the cover portion and the base portion are otherwise moved toward one another, the ribs serve to fracture the ampule contained within the applicator. Of course, the one or more ribs need not be disposed on either the base portion or the cover portion. For example, both the base portion and the cover portion may include one or more ribs. Alternatively, a plurality of ribs may be interspersed between the cover portion and the base portion, for example, in an alternating pattern. As will be appreciated by one of skill in the art, any suitable arrangement of ribs may be employed.
To perform an ampule crushing operation (e.g., use the ampule crush tool to crush the ampule contained within the applicator), the clinician may begin by opening the cover portion, allowing the clinician to insert the applicator into the ampule crush tool. The clinician may then place the applicator within the ampule crush tool, for example, such that the applicator nests within the base portion. After placing the applicator within the base portion, the clinician may then close the cover portion to fracture the ampule contained within the applicator (e.g., via the ribs described above). After fracturing the ampule, the clinician may then reopen the cover portion and remove the applicator, which is prepared for use with a patient. Thus, the clinician may then apply the therapeutic contained within the applicator to the patient.
In some embodiments, the ampule crush tool includes features for preventing the therapeutic from being expelled from the applicator while the ampule crush tool is used to crush the therapeutic-containing ampule housed within the applicator. For example, the ampule crush tool may include one or more supports configured to position the ampule crush tool, and by extension the applicator contained within the ampule crush tool, at an incline during the crushing operation. In some embodiments, an ampule crush tool includes one or more supports attached to a body (e.g., a base portion). A support may be positioned on a first end of the body of the ampule crush tool such that the first end sits vertically higher than a second end of the body of the ampule crush tool (i.e., the end opposite from the first end) when the ampule crush tool rests on a flat surface. Thus, the support may serve to incline the ampule crush tool relative to the surface. As will be appreciated from the above, the applicator, which may fit into the ampule crush tool in an orientation substantially parallel to the ampule crush tool, may also be inclined along with the body of the ampule crush tool. In some instances, the outlet of the applicator may be positioned towards the first end of the ampule crush tool. Thus, the outlet of the applicator may be positioned at a height that is vertically higher than the portion of the applicator containing the therapeutic (e.g., the ampule). Accordingly, as the ampule contained within the applicator is crushed, the inclined orientation may serve to allow gravity to pull the therapeutic away from the outlet of the applicator, allowing the therapeutic to settle toward the end of the applicator opposite to the outlet end. In some cases, the inclined support of the ampule crush tool may serve to prevent the therapeutic from being expelled or decrease the amount of therapeutic expelled from the applicator during an ampule crushing operation.
Nevertheless, in some instances, a volume of the therapeutic may be expelled from the applicator during the ampule crushing operation. Thus, the ampule crush tool may include features that allow the ampule crush tool to collect the volume of the therapeutic expelled from the applicator during the ampule crushing operation. For example, in some embodiments, the ampule crush tool includes a spill reservoir constructed to collect the volume of the therapeutic expelled during the ampule crushing operation. The spill reservoir may be disposed on the first end of the ampule crush device (i.e., the end constructed to accommodate the outlet of the applicator). The spill reservoir may be formed within a cavity of the body of the ampule crush tool. The cavity may include a sidewall, and the spill reservoir may be indented relative to the sidewall of the cavity. In some embodiments, the ampule crush tool may include a splash shield constructed to direct the volume of the therapeutic expelled during the ampule crushing operation towards the spill reservoir. Thus, the spill reservoir may collect the volume of the therapeutic expelled during the ampule crushing operation, preventing unwanted exposure to the therapeutic.
In some instances, the volume of the therapeutic expelled from the applicator during the ampule crushing operation may leave the applicator along an unpredictable trajectory. Thus, the ampule crush tool may also include features for containing all of the therapeutic expelled from the applicator during the ampule crushing operation. For example, the cover portion and the base portion may be constructed such that the cover portion is movable relative to the base portion between an open configuration and a closed configuration. In the open configuration, the cover portion may be sufficiently distant from the base portion such that the applicator may be placed into the ampule crush tool. Conversely, in the closed configuration, the cover portion may fully cover the base portion such that the combination of the cover portion and the base portions forms a complete enclosure. In some embodiments, the cover portion and the base portion may each include an extended sidewall such that the extended sidewall of the cover portion overlaps with the extended sidewall of the case portion. In some embodiments, the overlap may form a seal. Thus, the ampule fracture tool may further prevent unwanted exposure to the therapeutic, as the seal may help contain the volume of the therapeutic expelled during the ampule crushing operation within the ampule crush tool.
In some embodiments, the ampule crush tool may include features that allow the ampule crush tool to hold the applicator in a predetermined orientation. For example, the ampule fracture tool may include a cavity constructed to accommodate the applicator. The cavity may include a first portion and a second portion. The first portion may be shaped to receive a dispensing end of the applicator (i.e., the end containing the outlet of the applicator), while the second end may be shaped to receive a tube end of the applicator (i.e., the end containing the ampule). To that end, the first portion of the cavity may have a tapered shape, while the second portion of the cavity may have a cylindrical shape. Thus, the cavity of the ampule crush tool may be shaped to hold the applicator in an orientation where the dispensing end of the applicator is held on the first end of the ampule crush tool and the tube end of the applicator is held on the second end of the ampule crush tool.
Turning to the figures, specific non-limiting embodiments are described in further detail. It should be understood that the various systems, components, features, and methods described relative to these embodiments may be used either individually and/or in any desired combination as the disclosure is not limited to only the specific embodiments described herein.
In some embodiments, the ampule crush tool may have a tubular portion for receiving a tube portion of an applicator, and may have a second portion for receiving a dispensing end of an applicator (e.g., the cap end of an applicator and/or a dispenser tip of an applicator). In some embodiments, the second portion may flare out relative to the tubular portion, e.g. to accommodate the cap and/or dispenser tip of the applicator. In the illustrative embodiment of
In some embodiments, cover portion 104 and base portion 106 include features for crushing an ampule contained within applicator 102. For example, cover portion 104 may include one or more crushers 126 (as shown in
In some embodiments, crushers 126 may take the form of pins, as shown in
In some embodiments, the crushers may be positioned to align with certain portions of the ampule. For example, one or more crushers may be positioned to contact a central portion of the ampule, and one or more crushers may be positioned to contact the ends of the ampule. For example, in the
In some embodiments, the crushers 124, 126 may take on the form of ribs. The ribs may be curved, flat-edged, or 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, the crushers 124 may be curved ribs, while the crushers 126 may be flat-edged ribs. In some embodiments, the reverse is true. For example, the crushers 124 may be flat edged while the crushers 126 may be curved. As will be appreciated by one of skill in the art, in some embodiments, the crushers 124, 126 may both be flat-edged, and in other embodiments, the crushers 124, 126 may be both curved.
The crushers 124, 126 may be arranged in any number of suitable patterns. For example, in some embodiments, the crushers 124, 126 may be evenly spaced along base portion 106 and cover portion 104 respectively. In other embodiments, the crushers 124, 126 may be arranged in an alternating pattern such that the crushers 124 on base portion 106 are offset from the crushers 126 on cover portion 104. In some embodiments, the crushers 124, 126 may be positioned at or near second end 116 of ampule crush tool 100. In such embodiments, the crushers 124, 126 may be positioned such that the crushers 124, 126 fracture the ampule 146, which may be located at or near second end 116 when ampule crush tool 100 is placed on a flat surface, such as surface 136.
Of course, the crushers 124, 126 need not take on the form of ribs, as many suitable types of crushers are contemplated. For example, the crushers 124, 126 may take the form of spikes, hammers, blades, protrusions, or other suitable forms for crushing the ampule contained within applicator 102.
Accordingly, ampule crush tool 100 may help a clinician more easily break ampule 146 of applicator 102 as compared to breaking ampule 146 by hand (e.g., by exerting less force). Specifically, in some embodiments, using ampule crush tool 100 may reduce a force required to crush ampule 146 to about less than 5 lbf, about less than 6 lbf, about less than 7 lbf, about less than 8 lbf, about less than 9 lbf, about less than 10 lbf, about less than 11 lbf, about less than 12 lbf, about less than 13 lbf, about less than 14 lbf, or about less than 15 lbf. Combinations of the above-referenced ranges are also possible. For example, in some embodiments, ampule crush tool 100 may be configured to reduce the force required to break ampule 146 to about 5 lbf to about 15 lbf, to about 6 lbf to about 14 lbf, to about 7 lbf to about 13 lbf, to about 8 lbf to about 12 lbf, or to about 9 lbf to about 11 lbf.
In some embodiments, the ampule crush tool 100 includes a support 112 configured to allow ampule crush tool 100 to rest at an incline when placed on a flat surface 136, as shown in
Such an orientation may serve to prevent a therapeutic stored in applicator 102 from being expelled during a crushing operation. For example, in some instances, the therapeutic may be stored in an ampule 146 disposed in a tube 148 of applicator 102. Thus, when inclined as shown in
In some embodiments, support 112 may be configured to incline ampule crush tool 100 relative to 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. In some embodiments, support 112 may be configured to incline ampule crush tool 100 relative to surface 136 by less than or equal to about 20 degrees, less than or equal to about 19 degrees, less than or equal to about 18 degrees, less than or equal to about 17 degrees, less than or equal to about 16 degrees, less than or equal to about 15 degrees, less than or equal to about 14 degrees, less than or equal to about 13 degrees, less than or equal to about 12 degrees, less than or equal to about 11 degrees, less than or equal to about 10 degrees, less than or equal to about 9 degrees, less than or equal to about 8 degrees, less than or equal to about 7 degrees, less than or equal to about 6 degrees, or less than or equal to about 5 degrees. Combinations of the above-referenced ranges are also possible. For example, in some embodiments, the support 112 may be configured to incline ampule crush tool 100 relative to surface 136 by about 5 degrees to about 20 degrees, or about 6 degrees to about 18 degrees, or about 7 degrees to about 16 degrees, or about 7 degrees to about 14 degrees, or about 8 degrees to about 12 degrees, or about 9 degrees to about 11 degrees, or about 9 degrees to about 10 degrees.
In some instances, ampule crush tool may also include a second support 114. Second support 114 may be disposed at second end 116 of ampule crush tool 100. As seen in
In some embodiments, an ampule crush tool may be used as follows. A clinician may first place ampule crush tool 100 on surface 136. The clinician may then open ampule crush tool 100 by moving cover portion 104 and exposing base portion 106. Subsequently, the clinician may place applicator 102 within base portion 106 such that first end 108 of applicator 102 is placed into first end 118 of ampule crush tool 100, and second end 110 of applicator 102 is placed into second end 116 of ampule crush tool 100. The clinician may then close cover portion 104 over base portion 106, fracturing the ampule contained within applicator 102 as described above. Without wishing to be bound by theory, during the crushing operation, the therapeutic contained within the ampule 146 of applicator 102 may settle towards second end 110 of applicator 102 due to the force of gravity exerted on the therapeutic and the height difference between first end 108 and second and 110 of applicator 102.
In some embodiments, support 112 may be constructed as a tower support, while support 114 may be constructed as a flanged support. In other words, support 112 may be constructed to elevate first end 118 of ampule crush tool 100 above surface 136, and support 114 may be constructed to stabilize ampule crush tool 100 on surface 136. In some embodiments, only support 112 is included, and support 114 is not included, such that the second end 110 contacts the surface 136 without having any additional support besides support 112 contacting the surface 136.
Alternatively, ampule crush tool 100 may include any suitable type of support. For example, ampule crush tool need not include separate and distinct supports 112, 114. Instead, ampule crush tool 100 may include a single continuous support extending along the length of base portion 106. Such a support may be constructed to have a suitable incline, as described above. For example, the single continuous support may be wedge-shaped to provide the incline. Of course, ampule crush tool 100 need not include exactly one or two supports, as embodiments with three or more supports are also contemplated.
In some embodiments, ampule crush tool 100 includes features configured to collect medicament expelled from applicator 102 during an ampule crushing operation. For example, ampule crush tool 100 may include a spill reservoir 122 located within a cavity 132 of base portion 106, as shown in
In some embodiments, the volume of the spill reservoir 122 and cavity 132 is sufficient to contain the entire volume of the therapeutic in the applicator while the applicator is held within the cavity 132. In the event of a leak in the applicator, the ampule crush tool 100 may serve to catch and retain leaked therapeutic.
In some embodiments, the ampule crush tool may form a fully enclosed cavity when in the closed configuration to help contain expelled therapeutic. As shown in
In some embodiments, ampule crush tool 100 may be shaped to hold applicator 102 in a specific orientation, as shown in
Various aspects of the present disclosure may be used alone, in combination, or in a variety of arrangements not specifically discussed in the embodiments described in the foregoing and is therefore not limited in its application to the details and arrangement of components set forth in the foregoing description or illustrated in the drawings. For example, aspects described in one embodiment may be combined in any manner with aspects described in other embodiments.
The embodiments described herein may be embodied as a method, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.
Further, some actions are described as taken by a “user.” It should be appreciated that a “user” need not be a single individual, and that in some embodiments, actions attributable to a “user” may be performed by a team of individuals and/or an individual in combination with computer-assisted tools or other mechanisms.
Use of ordinal terms such as “first,” “second,” “third,” etc., in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another or the temporal order in which acts of a method are performed, but are used merely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term) to distinguish the claim elements.
Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having,” “containing,” “involving,” and variations thereof herein, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.
While the present teachings have been described in conjunction with various embodiments and examples, it is not intended that the present teachings be limited to such embodiments or examples. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents, as will be appreciated by those of skill in the art. Accordingly, the foregoing description and drawings are by way of example only.
This application claims the benefit of U.S. Provisional Application No. 63/094,231, filed Oct. 20, 2020, which is hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/054752 | 10/13/2021 | WO |
Number | Date | Country | |
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63094231 | Oct 2020 | US |