Therapeutic drug delivery device

Abstract

To provide a therapeutic drug delivery device.SOLUTION: A therapeutic drug delivery device comprises: a housing including a first end, a second end, and a lumen extending between the ends, an outer surface of the housing having a first opening in communication with the lumen; and a cap configured to engage the second end of the housing, the cap having a central longitudinal axis, the first end having a first cross-sectional dimension, the second end having a second cross-sectional dimension greater than the first cross-sectional dimension, and a sidewall extending from the first end to the second end, the sidewall including an exterior surface. The cap includes a first surface that is radially outermost and a second surface that is radially offset from the first surface. The second surface defines a surface of a recess that extends partially into a thickness of the cap. The recess is surrounded by a continuous boundary that surrounds the second surface, and the continuous boundary defines a shape of the recess. The recess includes a distal width that is greater than a proximal width, the continuous boundary forms an acute angle at the proximal width, and a portion of the recess is arrow-shaped.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] The present invention relates to medical devices, and more particularly to therapeutic drug delivery devices. (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 62 / 527,408 (filed June 30, 2017), the entire disclosure of which is hereby incorporated by reference herein. [Background technology]

[0002] Various embodiments of the present disclosure relate to therapeutic agent delivery devices (e.g., autoinjectors or other injection devices) having one or more anti-roll features configured to reduce and / or prevent rotation of the delivery device. The anti-roll features may be provided only on the body of the delivery device, only on a cap configured to removably engage the delivery device, or on both the body and cap of the delivery device.

[0003] As shown in U.S. Patent No. 5,929,999, for example, an injection device may include a tubular housing that is susceptible to rotation across a surface when the device is placed on the surface (e.g., when the longitudinal axis of the device is parallel or otherwise substantially parallel to the surface). Thus, there is a need for one or more anti-roll features designed to prevent rotation of the device.

[0004] Furthermore, the injection device has an injection end that can extend so that the needle penetrates the user's body. To prevent inadvertent needle injury and / or damage to the needle, there is a need to easily communicate and / or otherwise indicate the injection end to the user. The injection device described in Patent Document 2 is provided with an arrow pointing to the indicated injection end of the injection device. However, the provided arrow is flush with the outer surface of the injection device and is therefore difficult or impossible to grasp, for example, due to visual impairment. Furthermore, rotation of the injection device described in Patent Document 2 is prevented by providing the injection device with a generally rectangular cross-sectional configuration. However, providing an injection device with another feature to prevent rotation (e.g., a rectangular cross-sectional configuration) and excessively indicating the injection end (e.g., a printed arrow) complicates manufacturing and increases costs.

[0005] Therefore, there is also a need for an anti-roll feature in an injection device that is configured to present the injection tip to a user, whether the user is sighted or visually impaired. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 8,529,510 [Patent Document 2] U.S. Design Patent No. 677380 Summary of the Invention [Problem to be solved by the invention]

[0007] The present invention has been made in view of the above-mentioned problems. [Means for solving the problem]

[0008] According to one aspect of the present disclosure, a therapeutic agent delivery device may include a tubular body including a first end, a second end, and a lumen extending between the first end and the second portion. The outer surface of the tubular body may include a first opening communicating with the lumen. The outer surface of the tubular body may further include a ledge extending around the periphery of the first opening, and a portion of the ledge closest to the second end of the tubular body may be shaped like an arrowhead. The therapeutic agent delivery device may also include a cap configured to engage the second end of the tubular body, the cap including a central longitudinal axis, a first end having a first cross-sectional dimension, and a second end having a second cross-sectional dimension larger than the first cross-sectional dimension. The cap may further include a sidewall extending radially outward from the first end to the second end, the sidewall including a protrusion.

[0009] Various embodiments of the therapeutic agent delivery device may include one or more of the following aspects. The therapeutic agent delivery device may be an autoinjector. The lumen of the therapeutic agent delivery device may be configured to receive a syringe therein, the syringe may contain a volume of therapeutic agent, and the first opening may be configured to allow visualization of the volume of therapeutic agent. The ledge may be configured to limit rotation of the tubular body when the cap of the therapeutic agent delivery device is not engaged with the tubular body. The protrusion may be configured to limit rotation of the therapeutic agent delivery device only when the cap of the therapeutic agent delivery device is engaged with the tubular body. The protrusion of the cap may include a plurality of protrusions, each of which may be circumferentially spaced from an adjacent protrusion. The cap of the therapeutic agent delivery device may include recesses disposed between adjacent protrusions, the protrusions including a first end and a second end, the first end of the protrusions being spaced from a central longitudinal axis of the cap by a first distance and the second end of the protrusions being spaced from a central longitudinal axis of the cap by a second distance greater than the first distance. The outer surface of the tubular body of the therapeutic agent delivery device may further include a second opening disposed diametrically opposite to the first opening.

[0010] In another aspect, the present disclosure includes a therapeutic agent delivery device having a tubular body including a first end, a second end, and a central longitudinal axis, wherein an outer surface of the tubular body includes a geometric configuration extending away from the central longitudinal axis, a portion of the geometric configuration shaped like an arrowhead, the geometric configuration configured to limit rotation of the tubular body. The therapeutic agent delivery device may further include a cap configured to engage the second end of the tubular body, the cap including a first end including an opening communicating with an interior of the cap, a second end having an end wall, and a sidewall extending radially outward from the first end to the second end, the sidewall including a protrusion configured to limit rotation of the cap.

[0011] Various embodiments of the therapeutic agent delivery device may include one or more of the following aspects: The outer surface of the tubular body of the therapeutic agent delivery device may include a plurality of geometric configurations, each of which may include a portion shaped like an arrowhead; The geometric configurations may be circumferentially spaced from one another on the outer surface of the tubular body, the outer surface of the tubular body including a window, the geometric configuration surrounding a portion of the window; The window permits visualization of the interior of the tubular body; The sidewall of the cap may include a plurality of protrusions circumferentially spaced from one another.

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. The drawings illustrate different aspects of the disclosure, and where appropriate, reference numerals indicating like structures, components, materials, and / or elements in different figures are similarly labeled. It is understood that various combinations of structures, components, and / or elements other than those specifically shown are contemplated and are within the scope of the present disclosure.

[0013] There are many inventions described and illustrated herein. The described inventions are not limited to any single aspect or embodiment thereof, nor to any combinations and / or permutations of such aspects and / or embodiments. Moreover, each of the described aspects of the invention and / or embodiments thereof may be employed alone or in combination with one or more of the other aspects and / or embodiments of the described invention. For the sake of brevity, certain permutations and combinations are not separately described and / or illustrated herein. Notably, an embodiment or implementation described herein as "exemplary" is not to be construed as preferred or advantageous over other embodiments or implementations, for example. Rather, it is intended to reflect or indicate that the embodiment(s) are "exemplary" embodiment(s). [Brief explanation of the drawings]

[0014] [Figure 1A] 1 provides a side view of an exemplary therapeutic agent delivery device according to one embodiment of the present disclosure. [Figure 1B] 1B provides an exploded view of the therapeutic agent delivery device of FIG. 1A. [Figure 1C] 1B provides a cross-sectional view of the therapeutic agent delivery device of FIG. 1A along line XX, where the device contains a syringe assembly and a power supply box, according to one embodiment. [Figure 2A] 1B provides a perspective view of the housing of the therapeutic agent delivery device of FIG. 1A. [Figure 2B] 2B provides a side view of the housing shown in FIG. 2A, with the housing rotated 90 degrees relative to the perspective shown in FIG. 1A. [Figure 2C] 2B provides another side view of the housing shown in FIG. 2A, with the housing rotated 90 degrees relative to the perspective shown in FIG. 2B. [Figure 3A] 1A provides a perspective view of an exemplary cap of a therapeutic agent delivery device of the present disclosure, such as that shown in FIG. 1A. [Figure 3B] 3B provides a side view of the cap shown in FIG. 3A. [Figure 3C]3B provides a cross-sectional view of the cap shown in FIG. 3A. [Figure 3D] 3D provides a close-up view of the recess shown in FIG. 3C. [Figure 3E] 3B provides a top view of the cap shown in FIG. 3A. [Figure 4A] 1B provides a perspective view of an alternative exemplary cap of a therapeutic agent delivery device of the present disclosure, such as that shown in FIG. 1A. [Figure 4B] 4B provides a cross-sectional view of the cap shown in FIG. 4A. [Figure 4C] 4C provides a close-up view of the recess shown in FIG. 4B. [Figure 5A] 1B provides a perspective view of another alternative exemplary cap of a therapeutic agent delivery device of the present disclosure, such as that shown in FIG. 1A. [Figure 5B] 5B provides a side view of the cap shown in FIG. 5A. [Figure 5C] 5B provides a bottom view of the cap shown in FIG. 5A. [Figure 5D] 5A provides a close-up view of the recess shown in FIG. 5A and some dimensions of the recess. DETAILED DESCRIPTION OF THE INVENTION

[0015] As used herein, the terms "comprises," "comprising," "includes," "including," or any other variation thereof, are intended to cover a non-exclusive inclusion, whereby a process, method, article, or apparatus that includes a list of elements does not include only those elements, but may include other elements not expressly listed or other elements not inherent in such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." Additionally, the terms "first," "second," and the like, are used herein not to denote any order, quantity, or importance, but rather to distinguish one element, structure from another. Furthermore, the terms "a" and "an," as used herein, do not denote a limitation of quantity, but rather indicate the presence of one or more of the referenced item.

[0016] The term "distal end" or any variation thereof refers to the portion of the device that is furthest from the patient's injection or therapeutic agent delivery site during an injection procedure. Conversely, the term "proximal end" or any variation thereof refers to the portion of the device that is closest to the patient's injection or therapeutic agent delivery site during an injection procedure. Furthermore, as used herein, the terms "about," "substantially," and "approximately" generally mean + / - 10% of the stated value.

[0017] Embodiments of the present disclosure relate to therapeutic agent delivery devices (e.g., autoinjectors or other injection devices) with anti-roll features on the tubular body and / or cap. Such features facilitate use of the autoinjector by providing predictability to the device's position. For example, anti-roll features on the described autoinjectors may reduce the likelihood that the autoinjector will inadvertently roll off a surface, such as a table or counter, or roll away from the user. In one embodiment, the exterior surface of the autoinjector's housing may include one or more raised portions or geometric configurations that reduce or otherwise prevent rotation of the housing. The raised portions or geometric configurations may also be configured to present to the user the injection end of the autoinjector (wherein the needle may extend into the user's body). In other embodiments, the autoinjector may include a cap configured to cover the injection end of the autoinjector. In such embodiments, the cap may also be provided with an anti-roll feature. Various practical properties and features of autoinjectors have been described herein, and while several variations of those properties and features have been described, it will be understood by those skilled in the art that those properties and features may be presented in several aesthetic ways in or as part of a device according to the present disclosure. In showing one or a few visible variations on a property or feature herein, the present disclosure is not intended to be limited by the variations shown. Aspects of the present disclosure are described in more detail below.

[0018] As shown in FIG. 1A, an exemplary therapeutic agent delivery device 100 may include an injection device, including, but not limited to, an autoinjector. The delivery device 100 may include a distal end 101a and a proximal end 101b. The delivery device 100 may include an elongated housing 104 and a cap 102 configured to removably engage the proximal end of the housing 104. The distal end 101a may include an opening in the housing 104. As shown in FIG. 2A, such opening may be closed by a cap. The cap may have any suitable size or configuration. In some embodiments, the cap may be flush or substantially flush with the distal end 101a of the housing 104 to clearly communicate to a user that the distal end 101a is not the injection end of the delivery device 100. The housing 104 may include a generally circular cross-sectional configuration. In some embodiments, however, the housing 104 may include any suitable cross-sectional configuration, including, but not limited to, a rectangular, triangular, or oval shape. Housing 104 may comprise any suitable material, including, but not limited to, glass, resin, metal, rubber, silicone, or a combination thereof. In some embodiments, housing 104 may be generally opaque. In other embodiments, however, housing 104 may include one or more transparent or translucent portions to allow visualization within housing 104. For example, as described in further detail below, housing 104 may include one or more openings or windows to allow such visualization. In some embodiments, the windows may be covered by a transparent or translucent material, such as glass or resin.

[0019] The housing 104 may include a lumen 105 and an outer surface 108. The outer surface 108 may include an opening or window (e.g., the opening 112 shown in FIG. 1B) configured to allow visualization within the housing 104 or to allow visualization of the contents within the lumen 105 (FIG. 2B) of the housing 104. While a single opening 112 is shown in FIG. 1A, the housing 104 may be provided with a greater number of openings 112, including, for example, two openings, three openings, or four or more openings. In some embodiments, however, the housing 104 may be provided without any openings. In embodiments with multiple openings 112, the openings 112 may be circumferentially spaced apart around the outer surface 108. For example, two openings 112 may be positioned diametrically opposite one another. Additionally or alternatively, the openings 112 may be longitudinally spaced apart from one another on the outer surface 108. For example, the first opening 112 and the second opening 112 may be positioned at approximately the same radial position on the outer surface 108 (but spaced longitudinally along the axis XX). Furthermore, the opening 112 may include any suitable configuration. For example, the opening 112 may be shaped as a circle, a rectangle, a triangle, a pentagon, an octagon, or an ellipse. As shown in FIG. 1A , for example, the opening 112 may include an elongated configuration. For example, the width of the opening 112 may be approximately 7.5 mm, and the length of the opening may be approximately 31.9 mm. In some embodiments, for example, when the housing 104 is configured to receive a syringe 106 configured to hold less than 1 mL, the length of the opening 112 may be significantly shorter than approximately 31.9 mm. The width of the opening 112 may be constant or may vary along its length. For example, the width of a proximal portion of the opening 112 may be greater than the width of a distal portion of the opening 112, thereby providing the opening 112 with a generally spear-shaped configuration. In some embodiments, the sidewalls of the opening 112 may taper away from each other.

[0020] In some embodiments, the proximal end of opening 112 can be configured to present the injection end to the user. For example, the proximal-most side of opening 112 can be configured to terminate in an apex that "points" toward cap 102. Alternatively, the proximal-most side of opening 112 can be configured as an arrowhead that points toward cap 102.

[0021] As indicated above, the outer surface 108 may include one or more anti-roll features configured to prevent or otherwise inhibit rotation of the housing 104. For example, the housing 104 may include one or more protrusions disposed about the opening 112. As described in further detail below, the anti-roll feature(s) may include a raised ledge 114 that surrounds part or all of the periphery of the opening 112, as shown in FIGS. 1A-1C and 2A-2C and as described in further detail below. Specifically, the present disclosure contemplates that the ledge 114 may extend 100% around the circumference of the opening 112, less than 100% around the circumference of the opening 112, less than 75% around the circumference of the opening 112, less than 40% around the circumference of the opening 112, less than 30% around the circumference of the opening 112, or less than 20% around the circumference of the opening 112. Those skilled in the art will readily recognize that the described anti-roll features may be provided on the outer surface 108 even if the outer surface 108 does not include any openings 112. Furthermore, in embodiments in which multiple openings 112 are provided on the outer surface 108, one or more of the openings 112 may not include an associated ledge 114, or all of the openings 112 may include an associated ledge 114. Nevertheless, the present disclosure contemplates multiple ledges on the outer surface 108. Furthermore, the outer surface 108 may include one or more geometric features configured to facilitate gripping by a user during handling. Such geometric features may include texture, protrusions, concave scallops, and / or a low-intensity heat-activated adhesive material (e.g., a material configured to provide a temporary adhesive surface when activated by the heat of a user's hand).

[0022] The ledge 114 may include any suitable configuration. For example, the ledge 114 may include a generally rectangular cross-sectional configuration. In some embodiments, the radially outermost surface of the ledge 114 (e.g., the surface of the ledge 114 that is parallel to the outer surface 108) may be curved, for example, to promote comfort during handling. The sidewall of the ledge 114 (e.g., the sidewall 114b shown in FIG. 1C) may define a 90-degree angle with respect to the outer surface 108. In some embodiments, the angle defined by the sidewall 114b may be greater or less than 90 degrees. In still further embodiments, the sidewall 114b may gradually taper away from the outer surface 108. In embodiments in which the ledge 114 surrounds substantially the entire opening 112, the ledge 114 may include a substantially uniform configuration (e.g., cross-sectional shape). Alternatively, one or more portions of the ledge 114 may include a different configuration than the remainder of the ledge 114. For example, as shown in FIGS. 1A-1C, the proximal end 114a of the ledge 114 can be configured to convey direction to the user. More specifically, the proximal end 114a can include a proximal tapering configuration. For example, the proximal end 114a can be shaped as an arrowhead, spear, arrow, or halberd that points toward the proximal end 114b. In alternative embodiments, the proximal end 114a can be shaped as a hook, bolt, or wedge. In still further embodiments, the proximal end 114a can include an elongated portion having a length dimension that is greater than a width dimension for some or all of the elongated portion. Although not shown, one or more corners of the distal end (e.g., the arrowhead corner 114c shown in FIG. 1A) can be rounded.

[0023] The ledge 114 and the housing 104 may be fabricated in one piece. For example, the ledge 114 may be integrally formed with the outer surface 108 during a casting process. Alternatively, the ledge 114 may be affixed or otherwise secured to the outer surface 108 during a process subsequent to the formation of the housing 104. For example, the ledge 114 may be assembled separately from the manufacture of the housing 104 and attached around the opening 112 by a suitable adhesive or welding process. In such an embodiment, it is contemplated that the ledge 114 may be "mounted" to the outer surface of an already-manufactured housing of the injection device. Those skilled in the art will understand that the ledge 114 may be manufactured by any suitable process, including, but not limited to, casting, 3D printing, and / or cutting.

[0024] In some embodiments, the ledge 114 may include a constant height and / or width, or may include a varying height and / or width. For example, the ledge 114 may include a sawtooth or wavy profile. Specifically, adjacent portions of the ledge 114 may be separated by the outer surface 108.

[0025] 1B, an exploded view of delivery device 100 is shown, including cap 102, housing 104, and syringe 106 configured to be received within lumen 105 of housing 104. Syringe 106 may be configured to contain, for example, a therapeutic agent (e.g., a biologic or other dosage form, etc.) intended to be delivered to (and / or by) a user of device 100 (e.g., via needle 107 shown in FIG. 1C). In some embodiments, syringe 106 may be configured to hold at least 1 mL of therapeutic agent. In other embodiments, syringe 106 may be configured to hold a nominal volume of at least 1 mL, 1.5 mL, 2 mL, 2.25 mL, 3 mL, or 5 mL of therapeutic agent. In other embodiments, syringe 106 may be configured to hold a nominal volume of less than 1 mL. Additionally, housing 104 may include any suitable injection activation and / or propulsion mechanism, such as, for example, a power supply for actuating needle 107 and / or for delivering therapeutic agent. Such injection activation and / or propulsion mechanisms may be located in any suitable location within device 100.

[0026] As indicated above, opening 112 may be configured to allow a user of device 100 to view the contents of syringe 106. For example, a user may be able to recognize that device 100 is being used by determining that syringe 106 is empty or otherwise partially empty. Similarly, a user may be able to recognize that device 100 is not being used by determining that syringe 106 is filled (or substantially filled) with a therapeutic agent. Additionally, housing 104 may include a needle cover 118 configured to cover all or a portion of needle 107 of syringe 106, for example, when syringe 106 is received within housing 104. In one embodiment, needle cover 118 may retract into housing 104 when force is applied distally against the proximal end of needle cover 118, for example.

[0027] 1A, 1B, 3A-3E, 4A-4C, and 5A-5C, a cap 102 is shown. As indicated above, the cap 102 can be configured to engage the proximal end of the housing 104. With specific reference to FIGS. 3A-3E, 4A-4C, and 5A-5C, the cap 102 can include a central longitudinal axis CC. The cap 102 can include a distal end 130 and a proximal end 132. The distal end 130 can include a diameter smaller than the diameter of the proximal end 132. Alternatively, although not shown, the distal end 130 can include a diameter larger than the diameter of the proximal end 132. Still further, the distal end 130 and the proximal end 132 can include substantially similar diameters. In some embodiments, the distal end 130 can include an outer diameter substantially equal to the outer diameter of the housing 104. In embodiments in which the proximal end 132 includes a diameter larger than the diameter of the distal end 130 , the outer diameter of the proximal end 132 may also be larger than the outer diameter of the housing 104 .

[0028] Proximal end 132 may be defined by proximal end surface 132a. Proximal end surface 132a may include a substantially flat configuration. Proximal end surface 132a may be a substantially continuous wall configured to close the proximal end of cap 102. In this manner, the contemplated disclosure prevents use of the disclosed device without removing cap 102. Cap 102 may also include a generally cylindrical skirt 134 extending from proximal end surface 132a. In some embodiments, a circular groove 133 may be disposed between skirt 134 and proximal end surface 132a. Skirt 134 may define an opening 135 at distal end 130 within cap 102. Opening 135 may be configured to receive needle cover 118, in which state cap 102 may releasably engage housing 104.

[0029] The cap 102 may include a second skirt (not shown) disposed within an opening 135 extending from the inner surface of the proximal end face 132a and concentrically arranged with the skirt 134. The second skirt may include a diameter smaller than the diameter of the skirt 134. Further, the second skirt may include a length smaller than the length of the skirt 134. Referring again to FIGS. 3A, 4A, and 5A, the cap 102 may include a cylindrical extension 143 extending distally from the second skirt and beyond the skirt 134 and distal end 130 of the cap 102. The cylindrical extension 143 may be generally disposed in the center of the skirt 134. In one embodiment, the cylindrical extension 143 may define a central lumen (not shown). The lumen may be configured to receive the resilient material 144 therein. In some embodiments, the resilient material 144 may define a lumen 143a, for example, to receive a needle. Cylindrical extension 143 may include one or more selectively activated gripping features configured to retain resilient material 144 within lumen 143. Cylindrical extension 143 may be secured to the interior of second skirt or may be assembled with cap 102 as a one-piece construction. The outer diameter of cylindrical extension 143 may be smaller than the inner diameter of second skirt. Further, second skirt may be configured to be received within the lumen of needle cover 118.

[0030] Cap 102 may be made from any suitable material, including, but not limited to, glass, resin, metal, rubber, silicone, or a combination thereof. In some embodiments, cap 102 may be made from the same material as housing 104. In other embodiments, cap 102 may be made from at least one material that is different from the material of housing 104. Still further, cylindrical extension 143 may be made from a different material than the rest of cap 102. For example, cap 102 may be made from resin and cylindrical extension 143 may be made from metal.

[0031] For example, as shown in FIGS. 3A and 4A , the outer surface of skirt 134 may curve inward as it extends from proximal end 132 to distal end 130. As shown differently, the outer surface of skirt 134 may curve radially outward as it extends from distal end 130 to proximal end 132. In some embodiments, for example, the curve of the outer surface of skirt 134 may include a substantially concave configuration when viewed from a perspective radially outward of cap 102. In other embodiments, the configuration may be substantially convex when viewed from that perspective. The curvature of skirt 134 may be configured to facilitate a grip by a user when handling cap 102. In still further embodiments, some or all of the outer surface of skirt 134 may be substantially linear when viewed from that perspective. In some embodiments, the outer skirt 134 may be corrugated such that a portion of the outer surface of the skirt 134 (e.g., extending to the proximal end 132) may angle outward, as shown in FIG. 5A. Such an outward angle may also be configured to facilitate gripping by a user when handling the cap 102.

[0032] The outer surface of the skirt 134 may also include one or more protrusions 136 (e.g., protrusions 136a-136d). The protrusions 136a-136d may be substantially similar to one another or may include different configurations. For simplicity, the following description is provided for a single protrusion 136 (e.g., protrusion 136a). The protrusion 136a may include a generally rectangular configuration. As shown in FIGS. 3A, 3B, 4A, 5A, and 5B, the length of the protrusion 136a may be generally disposed along the direction of the longitudinal axis CC. Those skilled in the art will appreciate that the protrusions may include any suitable configuration or shape. For example, instead of a rectangular configuration, the protrusion 136a may include a generally rectangular, circular, or triangular configuration. Regardless of the configuration, the protrusion 136a may generally follow the curvature of the outer surface of the skirt 134 described above.

[0033] The skirt 134 may include any suitable number of protrusions 136a. For example, while four protrusions 136a-136d are shown, one skilled in the art will understand that the skirt 134 may be provided with, for example, at least or exactly one, at least or exactly two, at least or exactly three, at least or exactly five, at least or exactly six, at least or exactly seven, at least or exactly eight, or nine or more protrusions. Additionally, some embodiments of the skirt 134 may not include any protrusions. In those embodiments in which the skirt 134 is provided with two or more protrusions 136a, the protrusions may be spaced apart from one another by any suitable distance. For example, the protrusions may be equally spaced around the outer surface of the skirt 134. The protrusions 136a may be positioned at any location along the length of the skirt 134. For example, the protrusions 136a may be positioned centrally between the distal end 130 and the proximal end 132 (not shown), near the proximal end 132, or near the distal end 130 (not shown). The protrusion 136a may include a first end 138 and a second end 140. The first end 138 may be spaced a first distance from the central longitudinal axis CC, and the second end 140 of the protrusion 136a may be spaced a second distance from the central longitudinal axis CC that is greater than the first distance.

[0034] The cap 102 may also include one or more recesses 142 (e.g., recesses 142a and 142b). Although only two recesses 142 are shown, the cap 102 may include a greater or lesser number of recesses 142. For example, the cap 102 may include, for example, at least or exactly one, at least or exactly three, at least or exactly four, at least or exactly five, at least or exactly six, at least or exactly seven, at least or exactly eight, or nine or more recesses 142. In some embodiments, the cap 102 may be provided without any recesses 142. The recesses 142 may extend partially through the thickness of the skirt 134. In some embodiments, one or more recesses 142 may extend completely through the thickness of the skirt 134.

[0035] The recess 142 may include any suitable configuration. For example, the recess 142 may include an inverted triangular shape (as shown in FIGS. 3A-3D, 5A, and 5B). The inverted triangular recess 142 may include one or more straight or curved sides, or a combination of straight and curved sides (e.g., forming an arrowhead shape). For example, FIGS. 3A-3D, 5A, and 5B show an example recess 142 with a curved side on the side of the recess 142 closest to the distal end 130 of the cap 102. Specifically, as shown in FIGS. 3A, 5A, and 5B, for example, the base side of the recess 142b may include a concave curvature. The foot side of the recess 142 may also include a curvature (e.g., a convex curvature). Alternatively, or in addition, the recess 142 may include a teardrop shape (as shown in FIGS. 4A-4C). The teardrop shape may include a wider base disposed closer to the distal end 130 or closer to the proximal end 132. In some aspects, the recess 142 may include a substantially equilateral triangular configuration. In other aspects, as shown, for example, in FIG. 3A , the recess 142 may include a triangular shape with an isosceles configuration, with the legs of the triangular shape including substantially equal lengths greater than the lengths of the base. A single cap 102 may also include recesses 142 of different shapes, for example, having alternating triangular or teardrop shapes. One or more recesses 142 may include a distal width greater than a proximal width. In such embodiments, the narrow proximal width of the recess 142 may be configured to indicate (e.g., point toward) the injection end or direction to a user of the device 100. Alternatively, one or more recesses 142 may include a distal width less than a proximal width. Alternatively, or in addition, recess 142 may include a distinctive feature that indicates a particular therapeutic agent contained within syringe 106, an amount of therapeutic agent disposed within syringe 106, a rate of drug delivery from syringe 106, or a combination thereof. For example, teardrop-shaped recess 142 (e.g., in FIG. 4A ) may indicate a particular dosage of a selected therapeutic agent, while triangular recess 142 (e.g., in FIG. 3A or 5A ) may indicate a second dosage of the same therapeutic agent. Alternatively, teardrop-shaped recess 142 may indicate a particular dosage of a selected therapeutic agent, while triangular recess 142 may indicate a second dosage of a second therapeutic agent that is different from the selected therapeutic agent.The indications may also be provided using color, texture, or any distinctive feature known to those skilled in the art. Additionally, as shown in FIGS. 3C and 4B , the depth to which the recesses 142 may extend into the thickness of the skirt 134 may be constant or may vary across the width and / or length of the recesses 142. In some embodiments, each of the recesses 142 may include a similar configuration. In other embodiments, one or more recesses 142 may differ from the other recesses 142 provided on the skirt 134. Each of the recesses 142 may include a surface 145 that may either follow the above-described curvature of the skirt 134 or deviate from that curvature. The surface 145 of the recesses 142 may be provided with any suitable texture and / or surface treatment that enhances grip when handling the cap 102.

[0036] As shown in Figures 3B-3D, 4B, 4C, 5A, and 5B, each of the recesses 142 may further include a sloping surface 147 that defines the depth of the recess 142. The surface 147 may include a straight surface (such as the surfaces shown in Figures 3C, 3D, 4B, 4C, 5A, and 5B), where the surface 147 represents a linear discontinuity in the surface of the skirt 134. Alternatively, the surface 147 may include a curved discontinuity in the surface of the skirt 134. One or more boundaries of the surface 147 may also be curved or straight, and the shape of the recess 142 may be determined by the boundaries of the surface 147. Furthermore, the surface 147 may define the depth of the recess 142. For example, surface 147 may define the depth of recess 142 as an angled inclination (as shown in FIGS. 3D and 4C ), where surface 147 may include a surface that is inclined with respect to longitudinal axis CC and / or with respect to the surface of skirt 134. The angled inclination may include, for example, a vertical angle, where surface 147 may be perpendicular to the surface of skirt 134, or may define a concave edge within the surface of skirt 134. Recess 142 may include surface 147 in a portion of recess 142, while other portions of recess 142 gradually form or are flush with skirt 134 (as shown in FIGS. 3B-3D and 4B ). In such an embodiment, recess 142 may extend into skirt 134 at varying depths. Alternatively, recess 142 may include surface 147 around the entire periphery of recess 142. In other words, the depth of recess 142 within the surface of skirt 134 may remain constant, such that surface 147 extends within the surface of skirt 134 at all points around the perimeter of recess 142 .

[0037] As shown in at least Figures 3A, 3B, 4A, 4B, and 5A-5C, each of the recesses 142 may be positioned between adjacent protrusions 136. Those skilled in the art will understand that the recesses 142 may be provided only between certain pairs of adjacent protrusions 136. That is, the recesses 142 may be omitted between certain pairs of adjacent protrusions. The number and configuration of the recesses 142 may be configured to facilitate gripping by a user when handling the cap 102.

[0038] 3A, 4A, and 5A, for example, each of the recesses 142 can be positioned any suitable distance from the distal end 130 and the proximal end 132 of the cap 102. For example, as shown in FIG. 5B, the recesses 142 can be positioned a distance m from the distal end 130 and a distance n from the proximal end 132. Distance m can be measured, for example, from the end of the recess 142 closest to the distal end 130 to the edge of the cap 102 at the distal end 130, and distance n can similarly be measured, for example, from the end of the recess 142 closest to the proximal end 132 to the edge of the cap 102 at the proximal end 132. Both distance m and distance n can be any distance that allows the recesses 142 to fit on and / or within the cap 102. In some embodiments, each of distances m and n can be about 0.5 mm to about 5 mm, such as about 1 mm to about 4.5 mm, about 1.5 mm to about 4.5 mm, about 2 mm to about 4.5 mm, about 2.5 mm to about 4.5 mm, or about 3 mm to about 4.5 mm. For example, each of distances m and distance n can be about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, or about 5 mm, or any other distance. In some embodiments, distance m can be about 3.1 mm to about 3.9 mm, such as about 3.3 mm, 3.35 mm, 3.4 mm, 3.45 mm, 3.5 mm, 3.55 mm, 3.6 mm, 3.65 mm, 3.7 mm, 3.75 mm, 3.8 mm, 3.85 mm, 3.9 mm, or 3.95 mm. In one embodiment, for example, distance m can be about 3.365 mm. In some embodiments, distance n can be about 3.9 mm to about 4.5 mm, such as about 3.9 mm, about 4 mm, about 4.05 mm, about 4.1 mm, about 4.15 mm, about 4.2 mm, about 4.25 mm, about 4.3 mm, about 4.35 mm, about 4.4 mm, about 4.45 mm, or about 4.5 mm. In one embodiment, for example, distance n can be about 4.262 mm. These dimensions are exemplary and one skilled in the art will appreciate that many other dimensions and ranges of dimensions are possible.

[0039] Each of the recesses 142 may also have any suitable dimensions (e.g., length, width, height, recess depth) for fitting on the cap 102. FIG. 5D shows an exemplary triangular recess 142 having one curved side and multiple dimensions a-f. Table 1 below lists some exemplary measurements for dimensions a-f. It should be understood that these measurements are approximate and merely exemplary, and that many other possible measurements for dimensions a-f (or other dimensions of the recesses 142) may be suitable.

[0040] [Table 1]

[0041] In some embodiments, the color of the cap 102 may be coordinated to the color of the ledge 114. For example, the color of the protrusion 136 may be coordinated to the color of the ledge 114. Similarly, the color of the recess 142 may be coordinated to the color of the ledge 114. While it is contemplated that the described coordination may include color matching, one skilled in the art will understand that other color coordination schemes are within the scope of the present disclosure. Coordination between one or more colors of the cap 102 and the ledge 114 (or housing 104) may assist a user in engaging the cap 102 with its respective housing.

[0042] 1A-1C and 2A-2B, the ledge 114 may be configured to prevent or otherwise inhibit rotation of the housing 104, for example, when the housing 104 is resting on a flat surface. For example, when the housing 104 is resting on a surface such that the axis XX is substantially parallel to the surface, the ledge 114 may frictionally engage the surface to prevent or otherwise inhibit the housing 104 from rolling on the surface. Additionally, the ledge 114 may be configured to stop or otherwise slow the rotational speed of the housing 104 that is already rotating on the surface. To provide improved anti-roll performance, all or a portion of the ledge 114 may include an adhesive, e.g., a rubber coating, to increase friction.

[0043] Similarly, the protrusions 136 may be configured to prevent or otherwise inhibit rotation of the cap 102, for example, when the cap 102 is resting on a flat surface. For example, when the cap 102 is resting on a surface such that the axis CC is substantially parallel to the surface or is not substantially perpendicular to the surface, one or more protrusions 136 may frictionally engage the surface to prevent or otherwise inhibit the cap 102 from rolling on the surface. Additionally, one or more protrusions 136 may be configured to stop or otherwise slow the rotational speed of the cap 102 that is already rolling on the surface. To provide improved anti-roll performance, all or some of the protrusions 136 may include an adhesive, e.g., a rubber coating, to increase friction.

[0044] As noted above, the cap 102 may include a proximal end 132 having a diameter larger than the diameter of the distal end 130. As a result, when the cap 102 engages the housing 104 and the delivery device 100 is on a surface, the proximal end 101b of the housing 104 may be raised off the surface, causing the axis XX to form an angle with the surface. As a result of such raising, all or a portion of the ledge 114 may be prevented from contacting the surface. In such a case, the protrusion 136 serves to frictionally engage the surface to prevent or otherwise inhibit the delivery device 100 from rotating on the surface. Additionally, the protrusion 136 may be configured to stop or otherwise slow the rotational speed of the delivery device 100 already rotating on the surface.

[0045] In some embodiments, devices according to the present disclosure may be used to package and / or deliver therapeutic agents to treat a patient. For example, in some embodiments, devices according to the present disclosure may be used to package and / or deliver therapeutic agents for the treatment, management, or prevention of, for example, arthritis, asthma, chronic pain (e.g., chronic back pain), allergic reactions, illnesses and diseases (e.g., eosinophilic esophagitis), dermatitis, muscle-wasting disorders, hypercholesterolemia, abnormal LDL cholesterol levels, cardiovascular events, bacterial or viral infections, or other diseases, symptoms, or conditions. In some embodiments, therapeutic agents according to the present disclosure may include small molecules (e.g., molecules having a molecular weight of 900 Da or less) or large molecules (e.g., molecules having a molecular weight greater than 900 Da). In some embodiments, therapeutic agents according to the present disclosure may include macromolecules such as proteins, antibodies, or portions of antibodies having a molecular weight greater than 30 kDa. For example, therapeutic agents used with devices of the present disclosure may include, for example, dupilumab, alirocumab, evolocumab, trevoglumab, evinacumab, sarilumab, or fasinumab. In some embodiments, therapeutic agents according to the present disclosure may include a PCSK9 inhibitor, an interleukin-4 receptor inhibitor, an interleukin-5 receptor inhibitor, or an interleukin-13 receptor inhibitor. In some embodiments, devices according to the present disclosure may be used to deliver therapeutic agents to patients in populations that may benefit from anti-inflammatory features, such as elderly patients, patients with rheumatoid arthritis, pediatric patients, and / or patients with physical or psychiatric disabilities.

[0046] The above description and examples are illustrative and not intended to be limiting. Those skilled in the art may make certain modifications and / or variations without departing from the general scope of the invention. For example, as explained, the above-described embodiments (and / or aspects thereof) may be used in combination with each other. In addition, portions of the above-described embodiments may be removed without departing from the scope of the invention. In addition, modifications may be made to adapt a particular situation or aspect to the teachings of the various embodiments without departing from their essential scope. Many other embodiments will also be apparent to those skilled in the art upon reviewing the above description.

[0047] Additionally, although certain objects and advantages of the embodiments (and variations thereof) disclosed herein have been described, not necessarily all such objects or advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the systems and techniques described herein may be embodied or performed in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other objects or advantages as may be taught or suggested herein.

Claims

1. 1. A therapeutic drug delivery device comprising: a housing including a first end, a second end, and a lumen extending between the first end and the second end, an outer surface of the housing having a first opening in communication with the lumen; a cap configured to engage the second end of the housing, the cap having a central longitudinal axis, a first end having a first cross-sectional dimension, a second end having a second cross-sectional dimension larger than the first cross-sectional dimension, and a sidewall extending from the first end to the second end, the sidewall including an exterior surface; The cap further includes a radially outermost first surface and a second surface radially offset from the first surface, the second surface defining a surface of a recess extending partially within a thickness of the cap, the recess being surrounded by a continuous boundary surrounding the second surface, the continuous boundary defining a shape of the recess, the recess including a distal width that is greater than a proximal width, the continuous boundary further forming an acute angle at the proximal width, and a portion of the recess being arrow-shaped.

2. 10. The therapeutic agent delivery device of claim 1, wherein the first opening has a width of about 7.5 mm and a length of about 31.9 mm.

3. 10. The therapeutic agent delivery device of claim 1, wherein the therapeutic agent delivery device comprises dupilumab.

4. The therapeutic agent delivery device of claim 1 , wherein the lumen is configured to receive a drug container therein.

5. 10. The therapeutic drug delivery device of claim 1, wherein the lumen is configured to receive a drug container therein, the drug container comprising a syringe having a volume of therapeutic drug, and the first opening is configured to allow visualization of the volume of therapeutic drug.

6. The therapeutic agent delivery device of claim 1 , wherein the housing further comprises a second opening disposed diametrically opposite the first opening.

7. 2. The therapeutic agent delivery device of claim 1, wherein the housing further comprises a second opening disposed diametrically opposite the first opening, the second opening having a circular, rectangular, triangular, pentagonal, octagonal, or elliptical shape.

8. The therapeutic agent delivery device of claim 1 , wherein the recess includes a plurality of sides, the plurality of sides including straight sides, curved sides, or a combination of both.

9. 10. The therapeutic agent delivery device of claim 1, wherein the second end of the therapeutic agent delivery device is an injection end and the proximal width of the recess is configured to indicate the injection end to a user of the therapeutic agent delivery device.

10. The therapeutic agent delivery device of claim 1 , wherein the second surface of the recess is positioned closer to the central longitudinal axis of the cap than the first surface.

11. The therapeutic agent delivery device of claim 1 , wherein the cap has a proximal end.

12. The therapeutic agent delivery device of claim 1 , wherein the cap has a proximal end, the proximal end including a substantially flat configuration.

13. The therapeutic agent delivery device of claim 1 , wherein the first opening has a surface that defines its depth.

14. 10. The therapeutic agent delivery device of claim 1, wherein the first opening has a surface that defines its depth, the surface of the first opening being flush with an outer surface of the housing.

15. The therapeutic agent delivery device of claim 1 , wherein the recess extends into the thickness of the cap to a varying depth.

16. The therapeutic agent delivery device of claim 1 , wherein a portion of the recess gradually becomes flush with the second surface of the cap.

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