Autoinjector with anti-roll feature

Abstract

The present disclosure relates to a therapeutic agent delivery device with an anti-roll feature. In one embodiment, a therapeutic agent delivery device includes a housing, a first opening, and a flange. The housing includes a first end, a second end, and a lumen extending between the first end and the second end. And the first opening is communicated with the pipe cavity. The flange extends around a portion of a periphery of the first opening. The first opening in communication with the lumen has a first shape and the flange extending around a portion of the periphery of the first opening has a second shape. The first shape is different from the second shape.

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 527,408, filed on June 30, 2017, the entire disclosure of which is hereby incorporated by reference herein.

[0003] introduction

[0004] Various embodiments of the present disclosure are directed to a therapeutic agent delivery device (e.g., an autoinjector or other injection device) having one or more anti-roll features configured to reduce and / or prevent rolling of the delivery device. The anti-roll feature may be provided only on the body of the delivery device, only on a cap configured to detachably engage the delivery device, or on both the body and the cap of the delivery device.

[0005] As shown in U.S. Pat. No. 8,529,510 B2, for example, an injection device may include a tubular housing that tends to roll across a surface when the device is placed on its side (e.g., when the longitudinal axis of the device is parallel or otherwise substantially parallel to the surface). Thus, one or more anti-roll features designed to prevent the device from rolling are desired.

[0006] In addition, the injection device has an injection end from which the needle can extend to penetrate the user. In order to prevent accidental needle injuries and / or damage to the needle, it is necessary to easily communicate to the user and / or otherwise indicate the injection end. The injection device described in U.S. Design Patent No. D677,380 is provided with an arrow pointing to the injection end of the depicted injection device. However, the arrow is provided flush with the outer surface of the injection device and is therefore difficult or impossible to detect, for example, by a visually impaired person. In addition, the injection device described in the '380 patent can be prevented from rolling by providing the injection device with a generally rectangular cross-sectional configuration. However, providing the injection device with separate features for preventing rolling (e.g., a rectangular cross-sectional configuration) and indicating the injection end (e.g., a printed arrow) would unduly complicate manufacturing and increase costs.

[0007] Therefore, there is a need for an injection device anti-roll feature that is also configured to indicate the injection end to the user, regardless of whether the user has normal or impaired vision. Summary of the invention

[0008] According to one aspect of the present disclosure, a therapeutic agent delivery device may include a tubular body, the tubular body including a first end portion, a second end portion, and a lumen extending between the first end portion and the second portion. The outer surface of the tubular body includes a first opening connected to the lumen. The outer surface of the tubular body may also include a flange extending around the periphery of the first opening, and the portion of the flange closest to the second end portion of the tubular body may be shaped as an arrow. The therapeutic agent delivery device may also include a cap configured to engage the second end portion of the tubular body, wherein the cap may include a central longitudinal axis, a first end having a first cross-sectional size, and a second end having a second cross-sectional size greater than the first cross-sectional size. The cap may also include a sidewall extending radially outward from the first end to the second end, and the sidewall may include 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 automatic injector; the lumen of the therapeutic agent delivery device may be configured to receive a syringe therein, wherein the syringe may include a volume of the therapeutic agent, and wherein the first opening is configured to allow visualization of the volume of the therapeutic agent; when the cap of the therapeutic agent delivery device is not engaged with the tubular body, the flange may be configured to restrict rolling of the tubular body; when the cap of the therapeutic agent delivery device is engaged with the tubular body, only the protrusion may be configured to restrict the therapeutic agent delivery device rolling; the protrusion of the cap may include a plurality of protrusions, wherein each of the plurality of protrusions may be circumferentially spaced apart from an adjacent protrusion; the cap of the therapeutic agent delivery device may include a recess disposed between adjacent protrusions, wherein the protrusion includes a first end and a second end, wherein the first end of the protrusion is spaced apart from the central longitudinal axis of the cap by a first distance, and wherein the second end of the protrusion is spaced apart from the central longitudinal axis of the cap by a second distance greater than the first distance; and the outer surface of the tubular body of the therapeutic agent delivery device may also 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 portion, a second end portion, and a central longitudinal axis, wherein an outer surface of the tubular body includes a geometric structure extending away from the central longitudinal axis, a portion of the geometric structure is shaped as an arrow, and the geometric structure is configured to restrict rolling of the tubular body. The therapeutic agent delivery device also includes a cap configured to engage the second end portion of the tubular body, wherein the cap may include: a first end, the first end including an opening communicating with an interior of the cap; a second end, the second end having an end wall; and a sidewall, the sidewall extending radially outward from the first end to the second end, and wherein the sidewall includes a protrusion configured to restrict rolling 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 structures, wherein each geometric structure may include a portion shaped as an arrow; the geometric structures may be circumferentially spaced apart from each other on the outer surface of the tubular body, the outer surface of the tubular body including a window, and wherein the geometric structure surrounds a portion of the window; the window allows visualization of the interior of the tubular body; and the side wall of the cap may include a plurality of protrusions spaced apart from each other along the circumferential direction. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0013] Many inventions are described and illustrated herein. The described inventions are not limited to any single aspect or embodiment thereof, nor to any combination and / or arrangement of these aspects and / or embodiments. In addition, each aspect of the described invention and / or its embodiments may be used alone or in combination with one or more other aspects of the described invention and / or its embodiments. For the sake of brevity, certain arrangements and combinations are not discussed and / or illustrated separately herein. It is noteworthy that embodiments or implementations described herein as "exemplary" should not be interpreted as being preferred or advantageous, for example, relative to other embodiments or implementations; on the contrary, it is intended to reflect or indicate that the embodiment is an "example" embodiment.

[0014] Figure 1A A side view of an exemplary therapeutic agent delivery device according to one embodiment of the present disclosure is provided.

[0015] Figure 1B supply Figure 1A An exploded view of a therapeutic agent delivery device.

[0016] Figure 1C Provided according to one embodiment, taken along line XX Figure 1A A cross-sectional view of a therapeutic agent delivery device, wherein the device includes a syringe assembly and a power pack.

[0017] Figure 2A supply Figure 1A A perspective view of a housing of a therapeutic agent delivery device.

[0018] Figure 2B supply Figure 2A A side view of the housing is depicted, wherein the housing is Figure 1A The viewing angle shown is rotated 90°.

[0019] Figure 2C supply Figure 2A Another side view of the housing depicted, wherein the housing is Figure 2B The viewing angle shown is rotated 90°.

[0020] Figure 3A The therapeutic agent delivery device of the present disclosure is provided, for example Figure 1A A perspective view of an exemplary cap for a therapeutic agent delivery device is depicted.

[0021] Figure 3B supply Figure 3A A side view of the cap depicted.

[0022] Figure 3C supply Figure 3A A cross-sectional view of the cap depicted.

[0023] Figure 3D supply Figure 3C A close-up view of the depicted notch.

[0024] Figure 3E supply Figure 3A A top view of the cap depicted.

[0025] Figure 4A The therapeutic agent delivery device of the present disclosure is provided, for example Figure 1A A perspective view of an alternative exemplary cap for a therapeutic agent delivery device is depicted.

[0026] Figure 4B supply Figure 4AA cross-sectional view of the cap depicted.

[0027] Figure 4C supply Figure 4B A close-up view of the depicted notch.

[0028] Figure 5A The therapeutic agent delivery device of the present disclosure is provided, for example Figure 1A A perspective view of another alternative exemplary cap for a therapeutic agent delivery device is depicted.

[0029] Figure 5B supply Figure 5A A side view of the cap depicted.

[0030] Figure 5C supply Figure 5A Bottom view of the cap depicted.

[0031] Figure 5D supply Figure 5A A close-up view of the notch depicted along with several dimensions of the notch.

[0032] As used herein, the term "comprising" or any other variation thereof is intended to cover non-exclusive inclusions, so that the process, method, article or equipment comprising a series of elements not only includes those elements, but may include other elements that are not explicitly listed or inherent to such processes, methods, articles or equipment. The term "exemplary" is used in the sense of "example" rather than "ideal". In addition, the terms "first", "second", etc. do not represent any order, quantity or importance in this article, but are used to distinguish elements, structures. In addition, the terms "a" and "an" herein do not represent quantitative restrictions, but represent the existence of one or more quoted items.

[0033] The term "distal end" or any variation thereof refers to the portion of the device that is farthest from the site of injection or therapeutic agent delivery to the patient 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 site of injection or therapeutic agent delivery to the patient during an injection procedure. Furthermore, as used herein, the terms "about," "substantially," and "approximately" generally mean + / - 10% of the indicated value. DETAILED DESCRIPTION

[0034] Embodiments of the present disclosure relate to a therapeutic agent delivery device (e.g., an automatic syringe or other injection device) having an anti-roll feature on its tubular body and / or cap. These features promote the use of the automatic syringe by providing predictability of the device position. For example, the anti-roll feature on the described automatic syringe can reduce the possibility that the automatic syringe accidentally rolls off from the surface of, for example, a table or counter or rolls off from the user. In one embodiment, the outer surface of the housing of the automatic syringe may include one or more raised portions or geometric structures that reduce or otherwise prevent the housing from rolling. The raised portion or geometric structure may also be configured to indicate the injection end of the automatic syringe to the user (the needle may extend from the injection end to the user). In other embodiments, the automatic syringe may include a cap configured to cover the injection end of the automatic syringe. In such embodiments, the cap may also be provided with an anti-roll feature. It will be understood by those of ordinary skill in the art that although various practical properties and features of the automatic syringe are described herein, and several variations of these properties and features are described, these properties and features may be presented in a variety of aesthetic ways on, in, or as part of the device according to the present disclosure. In depicting one or several visual variations in a property or feature herein, the disclosure is not intended to be limited by the depicted variations. Various aspects of the disclosure are described in more detail below.

[0035] like Figure 1A As shown, an exemplary therapeutic agent delivery device 100 may include an injection device, including but not limited to an automatic injector. The delivery device 100 may include a distal portion 101a and a proximal portion 101b. The delivery device 100 may include an elongated housing 104 and a cap 102, the cap being configured to removably engage the proximal portion of the housing 104. The distal portion 101a may include an opening into the housing 104. As shown in FIG. Figure 2AAs shown, such openings can be closed by caps. The caps can have any suitable size or configuration. In some embodiments, the caps can be flush or substantially flush with the distal portion 101a of the housing 104, so as to clearly convey to the user that the distal portion 101a is not the injection end of the delivery device 100. The housing 104 can include a generally circular cross-sectional configuration. However, in some embodiments, the housing 104 can include any suitable cross-sectional configuration, including but not limited to a rectangular, triangular or oval shape. The housing 104 can include any suitable material, including but not limited to glass, plastic, metal, rubber, silicone or a combination thereof. In some embodiments, the housing 104 can be substantially opaque. However, in other embodiments, the housing 104 can include one or more transparent or translucent parts to allow visualization into the housing 104. For example, as discussed in more detail below, the housing 104 can include one or more openings or windows to allow this visualization. In some embodiments, the window can be covered by a transparent or translucent material such as glass or plastic.

[0036] 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., Figure 1B 104 ), the opening or window being configured to allow visualization into the housing 104 or to allow the lumen 105 ( Figure 2B ) to visualize the contents. Figure 1A A single opening 112 is depicted in the figure, but the shell 104 may be provided with a greater number of openings 112, including, for example, two openings, three openings, or four or more openings. However, in some embodiments, the shell 104 may not be provided with any openings. In an embodiment having a plurality of openings 112, the openings 112 may be spaced circumferentially around the outer surface 108. For example, two openings 112 may be positioned diametrically relative to each other. Additionally or alternatively, the openings 112 may be spaced longitudinally from each other on the outer surface 108. For example, the first opening 112 and the second opening 112 may be located at approximately the same radial position on the outer surface 108, but spaced longitudinally along the axis XX. Furthermore, the openings 112 may include any suitable configuration. For example, the openings 112 may be shaped as a circle, a rectangle, a triangle, a pentagon, an octagon, or an ellipse. As Figure 1AAs shown, for example, the opening 112 can include an elongated configuration. For example, the width of the opening 112 can be about 7.5 mm, and the length of the opening can be about 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 can be much shorter than about 31.9 mm. The width of the opening 112 can be constant or vary along its length. For example, the width of the proximal portion of the opening 112 can be greater than the width of the distal portion of the opening 112, thereby providing a generally halberd-shaped configuration for the opening 112. In some embodiments, the sidewalls of the opening 112 can taper away from each other.

[0037] In some embodiments, the proximal end of the opening 112 can be configured to indicate the injection end to the user. For example, the most proximal side of the opening 112 can be configured to end at a vertex "pointing" toward the cap 102. Alternatively, the most proximal side of the opening 112 can be configured as an arrow pointing toward the cap 102.

[0038] As described above, the outer surface 108 may include one or more anti-roll features configured to prevent or otherwise inhibit rolling of the housing 104. For example, the housing 104 may include one or more protrusions disposed around the opening 112. As described in more detail below, the anti-roll feature may include a raised lip 114 around a portion or the entire periphery of the opening 112, such as Figures 1A to 1C and FIG. 2A to FIG. 2C As shown and described in more detail below. Specifically, the present disclosure contemplates that the flange 114 may extend 100% around the opening 112, extend less than 100% around the opening 112, extend less than 75% around the opening 112, extend less than 40% around the opening 112, extend less than 30% around the opening 112, or extend less than 20% around the opening 112. One of ordinary skill 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 an opening 112. Even in embodiments where multiple openings 112 are provided on the outer surface 108, one or more openings 112 may not include an associated flange 114, or all openings 112 may include an associated flange 114. Regardless, the present disclosure contemplates multiple flanges on the outer surface 108. In addition, the outer surface 108 may include one or more geometric features that are configured to facilitate a user's grip during manipulation. Such geometric features may include textures, protrusions, recessed scallops, and / or low-strength heat-activated adhesive materials (eg, materials configured to provide a temporary adhesive surface when activated by heat from a user's hands).

[0039] The flange 114 can include any suitable configuration. For example, the flange 114 can include a generally rectangular cross-sectional configuration. In some embodiments, the radially outermost surface of the flange 114 (e.g., the surface of the flange 114 that is parallel to the outer surface 108) can be curved, for example, to improve comfort during manipulation. The sidewalls of the flange 114 (e.g., Figure 1C The sidewall 114b shown in the figure can define a 90 degree angle with the outer surface 108. In some embodiments, the angle defined by the sidewall 114b can be greater than or less than 90 degrees. In other embodiments, the sidewall 114b can gradually taper away from the outer surface 108. In embodiments where the flange 114 surrounds substantially the entire opening 112, the flange 114 can include a substantially uniform configuration (e.g., a cross-sectional configuration). Alternatively, one or more portions of the flange 114 can include a different configuration than the rest of the flange 114. For example, as shown in FIG. Figures 1A to 1C As shown, the proximal portion 114a of the flange 114 can be configured to convey direction to the user. More specifically, the proximal portion 114a can include a proximal tapered configuration. For example, the proximal portion 114a can be shaped as an arrow, a spear, an arrowhead, or a halberd pointing to the proximal end 101b. In alternative embodiments, the proximal portion 114a can be shaped as a barb, a bolt, or a wedge. In other embodiments, the proximal portion 114a can include an elongated portion having a length dimension greater than some or all of the width dimensions of the elongated portion. Although not depicted, one or more corners of the distal portion (e.g., Figure 1A The corners 114c) of the arrows shown may be rounded.

[0040] The flange 114 and the housing 104 can be made into a one-piece construction. For example, the flange 114 can be formed integrally with the outer surface 108 during the molding process. Alternatively, the flange 114 can be attached or otherwise fixed to the outer surface 108 in a process after the housing 104 is formed. For example, the flange 114 can be manufactured separately from the manufacture of the housing 104 and adhered around the opening 112 by a suitable adhesive compound or welding process. In such embodiments, it is envisioned that the flange 114 can be "reassembled" onto the outer surface of the manufactured housing of the injection device. Those of ordinary skill in the art will understand that the flange 114 can be manufactured by any suitable process, including but not limited to molding, 3D printing and / or cutting.

[0041] In some embodiments, flange 114 may include a constant height and / or width, or may include a variable height and / or width. For example, flange 114 may include a sawtooth or corrugated profile. Specifically, adjacent portions of flange 114 may be separated by outer surface 108.

[0042] Now turn to Figure 1B, which depicts an exploded view of a delivery device 100, which includes a cap 102, a housing 104, and a syringe 106 configured to be received within a lumen 105 of the housing 104. The syringe 106 can be configured to include a therapeutic agent, such as a biologic or other agent, which is intended to be delivered (e.g., via Figure 1C The syringe 106 may be configured to hold at least 1 mL of a therapeutic agent. In other embodiments, the syringe 106 may be configured to hold at least 1 mL, 1.5 mL, 2 mL, 2.25 mL, 3 mL, or 5 mL of a nominal volume of a therapeutic agent. In other embodiments, the syringe 106 may be configured to hold a nominal volume of less than 1 mL. The housing 104 may also include any suitable injection actuation and / or propulsion mechanism, such as a power pack for actuating the needle 107 and / or delivering the therapeutic agent. Such an injection actuation and / or propulsion mechanism may be placed in any suitable position in the device 100.

[0043] As described above, the opening 112 can be configured to allow a user of the device 100 to visualize the contents of the syringe 106. For example, the user can identify that the device 100 has been used by determining that the syringe 106 is empty or otherwise partially empty. Similarly, the user can identify that the device 100 has not been used by determining that the syringe 106 is full (or substantially full) of therapeutic agent. The housing 104 can also include a needle cover 118, which is configured to cover all or a portion of the needle 107 of the syringe 106, for example, when the syringe 106 is received in the housing 104. In one embodiment, the needle cover 118 can be retracted into the housing 104, for example, if a force is applied to the proximal end of the needle cover 118 in the distal direction.

[0044] Now turn to Figure 1A , Figure 1B , FIG. 3A to FIG. 3E , FIG. 4A to FIG. 4C as well as FIG. 5A to FIG. 5C , depicting the cap 102. As described above, the cap 102 can be configured to engage the proximal end of the housing 104. FIG. 3A to FIG. 3E , FIG. 4A to FIG. 4C and FIG. 5A to FIG. 5C, the cap 102 may include a central longitudinal axis CC. The cap 102 may include a distal portion 130 and a proximal portion 132. The diameter of the distal portion 130 may be smaller than the diameter of the proximal portion 132. Alternatively, although not shown, the diameter of the distal portion 130 may be greater than the diameter of the proximal portion 132. In addition, the distal portion 130 and the proximal portion 132 may have substantially similar diameters. In some embodiments, the outer diameter of the distal portion 130 may be substantially equal to the outer diameter of the housing 104. In embodiments where the diameter of the proximal portion 132 is greater than the diameter of the distal portion 130, the outer diameter of the proximal portion 132 may also be greater than the outer diameter of the housing 104.

[0045] The proximal portion 132 can be defined by a proximal face 132a. The proximal face 132a can include a substantially flat configuration. The proximal face 132a can be a substantially continuous wall configured to close the proximal end of the cap 102. In this way, the envisioned disclosure can prevent the disclosed device from being used without removing the cap 102. The cap 102 can also include a generally cylindrical skirt 134 that droops from the proximal face 132a. In some embodiments, a circular groove 133 can be disposed between the skirt 134 and the proximal face 132a. The skirt 134 can define an opening 135 to the interior of the cap 102 at the distal end 130. The opening 135 can be configured to receive the needle cover 118 so that the cap 102 can releasably engage the housing 104.

[0046] The cap 102 may include a second skirt (not shown) disposed within the opening 135, depending from the inner surface of the proximal end face 132a and arranged concentrically with the skirt 134. The diameter of the second skirt may be smaller than the diameter of the skirt 134. In addition, the length of the second skirt may be smaller than the length of the skirt 134. Figure 3A , Figure 4A and Figure 5A, the cap 102 may include a cylindrical extension 143 extending from the second skirt and extending distally beyond the skirt 134 and the distal portion 130 of the cap 102. The cylindrical extension 143 may be disposed substantially 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 an elastic material 144 therein. In some embodiments, the elastic material 144 may define a lumen 143a for receiving, for example, a needle. The cylindrical extension 143 may include one or more selectively actuated gripping features configured to hold the elastic material 144 in the lumen 143. The cylindrical extension 143 may be fixed in the second skirt, or may be made into a one-piece structure with the cap 102. The outer diameter of the cylindrical extension 143 may be smaller than the inner diameter of the second skirt. In addition, the second skirt may be configured to be received in the lumen of the needle cover 118.

[0047] Cap 102 can be made of any suitable material, including but not limited to glass, plastic, metal, rubber, silicone, or a combination thereof. In some embodiments, cap 102 can be made of the same material as housing 104. In other embodiments, cap 102 can be made of at least one material different from the material of housing 104. In addition, cylindrical extension 143 can be made of a different material from the rest of cap 102. For example, cap 102 can be made of plastic, and cylindrical extension 143 can be made of metal.

[0048] For example Figure 3A and Figure 4A As shown, the outer surface of the skirt 134 can bend inward as it extends from the proximal portion 132 to the distal portion 130. In other words, the outer surface of the skirt 134 can bend radially outward as it extends from the distal portion 130 to the proximal portion 132. For example, in some embodiments, the curvature of the outer surface of the skirt 134 can include a substantially concave configuration when viewed from a radially outward angle of the cap 102. In other embodiments, the configuration can be substantially convex when viewed from said angle. The curvature of the skirt 134 can be configured to facilitate grasping by a user during manipulation of the cap 102. In other embodiments, some or all of the outer surface of the skirt 134 can be substantially linear when viewed from said angle. In some embodiments, such as, for example Figure 5A As shown, the outer skirt 134 can have a fold so that a portion of the outer surface of the skirt 134 (e.g., extending to the proximal portion 132) can be angled outward. This outward angle can also be configured to facilitate gripping by a user during manipulation of the cap 102.

[0049] The outer surface of the skirt 134 may also include one or more protrusions 136, such as protrusions 136a-136d. The protrusions 136a-136d may be substantially similar to each other or may include different configurations. For the sake of brevity, the following description is provided with respect to a single protrusion 136 (e.g., protrusion 136a). The protrusion 136a may include a generally rectangular configuration. Figure 3A , Figure 3B , Figure 4A , Figure 5A and Figure 5B As shown, the length of the protrusion 136a can generally be arranged along the direction of the longitudinal axis CC. It will be understood by those of ordinary skill in the art that the protrusion can include any suitable configuration or shape. For example, instead of a rectangular configuration, the protrusion 136a can include a generally elliptical, circular or triangular configuration. Regardless of the configuration, the protrusion 136a can generally follow the above-mentioned curvature of the outer surface of the skirt 134.

[0050] The skirt 134 may include any suitable number of projections 136a. For example, even though four projections 136a-136d are depicted, it will be understood by those skilled in the art 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 more projections. In addition, some embodiments of the skirt 134 may not include any projections. In those embodiments in which the skirt 134 is provided with more than one projection 136a, the projections may be spaced apart from each other by any suitable distance. For example, the projections may be equally spaced around the outer surface of the skirt 134. The projections 136a may be placed at any position along the length of the skirt 134. For example, the projections 136a may be placed centrally between the distal portion 130 and the proximal portion 132 (not shown), closer to the proximal portion 132 or closer to the distal portion 130 (not shown). The projections 136a may include a first end 138 and a second end 140. The first end 138 may be spaced apart a first distance from the central longitudinal axis CC, and the second end 140 of the protrusion 136 may be spaced apart a second distance from the central longitudinal axis CC that is greater than the first distance.

[0051] The cap 102 may also include one or more notches 142, such as notches 142a and 142b. Although only two notches 142 are depicted, the cap 102 may include a greater or lesser number of notches 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 more notches 142. In some embodiments, the cap 102 may not be provided with any notches 142. The notches 142 may partially extend through the thickness of the skirt 134. In some embodiments, one or more notches 142 may extend completely through the thickness of the skirt 134.

[0052] The recess 142 may include any suitable configuration. For example, the recess 142 may include an inverted triangular shape (eg, FIG. 3A to FIG. 3D , Figure 5A and Figure 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., to form an arrow-like shape). For example, FIG. 3A to FIG. 3D , Figure 5A and Figure 5B An exemplary notch 142 is shown, wherein the side of the notch 142 closest to the distal portion 130 of the cap 102 has a curved side. Figure 3A as well as Figure 5A and Figure 5B As shown, the bottom side of the recess 142b may include a concave curvature. The leg side of the recess 142 may also include a curvature, such as a convex curvature. Alternatively or in addition, the recess 142 may include a teardrop shape (such as FIG. 4A to FIG. 4C ). The teardrop shape can include a wider base disposed in a direction closer to the distal portion 130 or closer to the proximal portion 132. In some aspects, the notch 142 can include a substantially equilateral triangular configuration. In other aspects, the notch 142 can include a triangle having an isosceles configuration, wherein the legs of the triangle can include substantially equal lengths that are greater than the length of the base, e.g., Figure 3AAs shown. A single cap 102 may also include notches 142 of different shapes, for example, having alternating triangular or teardrop shapes. The distal width of one or more notches 142 may be greater than the proximal width. In such embodiments, the narrow proximal width of notch 142 may be configured to indicate (e.g., point to) an injection end or direction to a user of device 100. Alternatively, the distal width of one or more notches 142 may be less than the proximal width. Alternatively or in addition, notch 142 may include different configurations to indicate a specific therapeutic agent included in syringe 106, an amount of therapeutic agent disposed in syringe 106, a rate at which therapeutic agent is delivered from syringe 106, or a combination thereof. For example, (e.g., Figure 4A The teardrop-shaped notch 142 may indicate a specific dose of a selected therapeutic agent, while (e.g., Figure 3A or Figure 5A The teardrop-shaped notch 142 may indicate a particular dose of a selected therapeutic agent, while the triangular notch 142 may indicate a second dose of a second therapeutic agent that is different from the selected therapeutic agent. Indications may also be provided by color, texture, or any distinguishing feature known to one of ordinary skill in the art. Additionally, as Figure 3C and Figure 4B As shown, the depth that the notch 142 can extend into the thickness of the skirt 134 can be constant, or can vary in the width and / or length of the notch 142. In some embodiments, each notch 142 can include a similar configuration. In other embodiments, one or more notches 142 can be different from other notches 142 disposed on the skirt 134. Each notch 142 can include a surface 145 that can follow or deviate from the above-mentioned curvature of the skirt 134. The surface 145 of the notch 142 can be provided with any suitable texture and / or surface treatment to improve the grip during the manipulation of the cap 102.

[0053] like FIG. 3B to FIG. 3D , Figure 4B , Figure 4C , Figure 5A and Figure 5B As shown, each notch 142 may also include an inclined surface 147 that defines the depth of the notch 142. The surface 147 may include a straight surface (eg, Figure 3C , Figure 3D , Figure 4B , Figure 4C , Figure 5A and Figure 5B), where surface 147 is described as a straight discontinuity of the surface of skirt 134. Alternatively, surface 147 may include a curved discontinuity of the surface of skirt 134. One or more edges of surface 147 may also be curved or straight, wherein the shape of recess 142 may be determined by the edges of surface 147. In addition, surface 147 may define the depth of recess 142. For example, surface 147 may be inclined at an angle (e.g., Figure 3D and Figure 4C 147 may include a surface at an angle relative to the longitudinal axis CC and / or relative to the surface of the skirt 134. The angular inclination may include, for example, a vertical angle, wherein the surface 147 may be perpendicular to the surface of the skirt 134 or define a recessed lip in the surface of the skirt 134. The recess 142 may include a surface 147 at a portion of the recess 142, while other portions of the recess 142 gradually form or become flush with the skirt 134 (e.g., FIG. 3B to FIG. 3D and Figure 4B ). In such embodiments, the recess 142 may extend into the skirt 134 at varying depths. Alternatively, the recess 142 may include a surface 147 around the entire perimeter of the recess 142. In other words, the depth of the recess 142 in the surface of the skirt 134 may remain constant such that the surface 147 extends into the surface of the skirt 134 at every point around the perimeter of the recess 142.

[0054] If at least Figure 3A , Figure 3B , Figure 4A , Figure 4B and FIG. 5A to FIG. 5C As shown, each of the notches 142 can be located between adjacent protrusions 136. Those of ordinary skill in the art will appreciate that the notches 142 can be provided only between certain pairs of adjacent protrusions 136. That is, the notches 142 can be omitted between certain pairs of adjacent protrusions. The number and configuration of the notches 142 can be configured to facilitate gripping by a user during manipulation of the cap 102.

[0055] For example, Figure 3A , Figure 4A and Figure 5A As shown, each notch 142 can be positioned at any suitable distance from the distal portion 130 and the proximal portion 132 of the cap 102. For example, Figure 5BAs shown, the notch 142 can be positioned at a distance m from the distal portion 130 and a distance n from the proximal portion 132. The distance m can be measured, for example, from the end of the notch 142 closest to the distal portion 130 to the edge of the cap 102 at the distal portion 130, and the distance n can be similarly measured, for example, from the end of the notch 142 closest to the proximal portion 132 to the edge of the cap 102 at the proximal portion 132. Both the distance m and the distance n can be any distance that allows the notch 142 to fit on and / or within the cap 102. In some embodiments, each of the distances m and n can be between about 0.5 mm and about 5 mm, for example, between about 1 mm and about 4.5 mm, between about 1.5 mm and about 4.5 mm, between about 2 mm and about 4.5 mm, between about 2.5 mm and about 4.5 mm, or between about 3 mm and about 4.5 mm. For example, each of distance m and distance n can be about 0.5mm, about 1mm, about 1.5mm, about 2mm, about 2.5mm, about 3mm, about 3.5mm, about 4mm, about 4.5mm or about 5mm, or any other distance. In some embodiments, distance m can be between about 3.1mm and 3.9mm, for example, about 3.3mm, 3.35mm, 3.4mm, 3.45mm, 3.5mm, 3.55mm, 3.6mm, 3.65mm, 3.7mm, 3.75mm, 3.8mm, 3.85mm, 3.9mm or 3.95mm. In one embodiment, for example, distance m can be about 3.365mm. In some embodiments, the distance n can be between about 3.9 mm and about 4.5 mm, for example, 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, the distance n can be about 4.262 mm. It should be understood that these dimensions are exemplary, and those of ordinary skill in the art will appreciate that many other dimensions and size ranges are possible.

[0056] Each notch 142 may also have any suitable dimensions (eg, length, width, height, notch depth) for fitting onto the cap 102 . Figure 5D An exemplary triangular recess 142 having one curved side and multiple dimensions af is depicted. Table 1 below lists some exemplary measurements of the dimensions af. It should be understood that these measurements are approximate and are merely exemplary, and that many other possible measurements of the dimensions af (or other dimensions of the recess 142) may be suitable.

[0057] Table 1.

[0058]

[0059] In some embodiments, the color of the cap 102 can be coordinated with the color of the flange 114. For example, the color of the protrusion 136 can be coordinated with the color of the flange 114. Similarly, the color of the recess 142 can be coordinated with the color of the flange 114. Although it is expected that the described coordination can include matching colors, it will be understood by those of ordinary skill in the art that other color coordination schemes are also within the scope of the present disclosure. The coordination between one or more colors of the cap 102 and the flange 114 (or the housing 104) can help the user to engage the cap 102 with its corresponding housing.

[0060] Now re-reference Figures 1A to 1C and FIG. 2A to FIG. 2B , the flange 114 can be configured to prevent or otherwise inhibit rolling of the housing 104 when, for example, the housing 104 is on a flat surface. For example, when the housing 104 is on a surface such that the axis XX is substantially parallel to the surface, the flange 114 can frictionally engage the surface to prevent or otherwise inhibit rolling of the housing 104 on the surface. In addition, the flange 114 can be configured to stop or otherwise slow the rotation speed of the housing 104 that has rolled on the surface. In order to provide improved anti-roll performance, all or some portions of the flange 114 can include a tacky, for example, rubber coating to increase friction.

[0061] Similarly, the protrusions 136 can be configured to prevent or otherwise inhibit the rolling of the cap 102 when, for example, the cap 102 is on a flat surface. For example, when the cap 102 is on a surface such that the axis CC is substantially parallel to the surface or substantially not perpendicular to the surface, one or more protrusions 136 can frictionally engage the surface to prevent or otherwise inhibit the rolling of the cap 102 on the surface. In addition, one or more of the protrusions 136 can be configured to stop or otherwise slow down the rotation speed of the cap 102 that has rolled on the surface. In order to provide improved anti-roll performance, all or some portions of the protrusions 136 can include a tacky, for example, rubber coating to increase friction.

[0062] As described above, the cap 102 may include a proximal portion 132 having a diameter greater than the diameter of the distal portion 130, and when the cap 102 is engaged with the housing 104 and the delivery device 100 is on a surface, the proximal end 101b of the housing 104 may be raised away from the surface so that the axis XX forms an angle with the surface. Due to this elevation, all or a portion of the flange 114 may be prevented from contacting the surface. In this case, the protrusion 136 is used to frictionally engage with the surface to prevent or otherwise inhibit the delivery device 100 from rolling on the surface. In addition, the protrusion 136 can be configured to stop or otherwise slow the rotation speed of the delivery device 100 that has been rolling on the surface.

[0063] In some embodiments, the device according to the present disclosure can be used for packaging and / or delivering therapeutic agents for treating patients. For example, in some embodiments, the device according to the present disclosure can be used for packaging and / or delivering therapeutic agents for treating, managing or preventing, for example, arthritis, asthma, chronic pain (e.g., chronic lower back pain), allergic reactions, diseases and conditions (e.g., eosinophilic esophagitis), dermatitis, muscular atrophy, hypercholesterolemia, abnormal low-density lipoprotein cholesterol levels, cardiovascular events, bacterial or viral infections or other conditions, symptoms or diseases. In some embodiments, the therapeutic agent according to the present disclosure can include small molecules (e.g., molecules with a molecular weight of 900Da or less) or macromolecules (e.g., molecules with a molecular weight of more than 900Da). In some embodiments, the therapeutic agent according to the present disclosure can include a macromolecule with a molecular weight greater than 30kDa, such as a protein, an antibody, or a portion of an antibody. For example, therapeutic agents used with the devices of the present disclosure may include, for example, dupilumab, alirocumab, evolocumab, trevogrumab, evinacumab, sarilumab, or fasinumab. In some embodiments, therapeutic agents according to the present disclosure may include PCSK9 inhibitors, interleukin 4 receptor inhibitors, interleukin 5 receptor inhibitors, or interleukin 13 receptor inhibitors. In some embodiments, devices according to the present disclosure may be used to deliver therapeutic agents to patients in a population that may benefit from anti-roll features, such as elderly patients, rheumatoid arthritis patients, pediatric patients, and / or physically or mentally disabled patients.

[0064] The above description and examples are illustrative, rather than restrictive. Those of ordinary skill in the art may make many modifications and / or changes without departing from the overall scope of the present invention. For example, and as already described, the above embodiments (and / or aspects thereof) may be used in combination with each other. In addition, without departing from the scope of the present invention, parts of the above embodiments may be deleted. In addition, without departing from the scope thereof, modifications may be made to adapt specific situations or aspects to the teachings of various embodiments. After reviewing the above description, many other embodiments will be apparent to those skilled in the art.

[0065] In addition, although multiple objects and advantages (and variations thereof) of the embodiments disclosed herein are described, not all of these objects or advantages may be achieved according to 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 taught herein without necessarily achieving other objects or advantages that may be taught or suggested herein.

Claims

1. A therapeutic agent delivery device, comprising: a tubular body comprising a first end portion, a second end portion, and a lumen extending between the first end portion and the second portion, wherein an outer surface of the tubular body comprises two openings communicating with the lumen, wherein each opening comprises a generally elliptical shape, and the outer surface of the tubular body further comprises a flange extending around each of the openings, each flange extending away from the respective opening having a first width, wherein a portion of the flange closest to the second end portion of the tubular body is shaped as an arrow having an apex, and wherein a second width of the flange at the apex is greater than the first width of the flange; and A cap configured to engage the second end portion of the tubular body, wherein the cap includes a central longitudinal axis, a first cap end, a second cap end, an outer surface extending between the first cap end and the second cap end, and four notches disposed in the outer surface, wherein each notch extends from the first cap end to the second cap end.

2. The therapeutic agent delivery device of claim 1, wherein: The therapeutic agent delivery device is an autoinjector.

3. The therapeutic agent delivery device of claim 1, wherein: The lumen is configured to receive a syringe therein.

4. The therapeutic agent delivery device of claim 3, wherein: The syringe includes a volume of the therapeutic agent, and wherein the first opening is configured to allow visualization of the volume of the therapeutic agent.

5. The therapeutic agent delivery device of claim 1, wherein: The therapeutic agent delivery device comprises dupilumab, alirocumab, evolocumab, trevogrumab, evinacumab, sarilumab, or fasinumab.

6. A therapeutic agent delivery device comprising: a tubular body comprising a first end portion, a second end portion, and a lumen extending between the first end portion and the second portion, wherein an outer surface of the tubular body comprises a first opening communicating with the lumen, wherein the first opening is surrounded by a first opening periphery, and wherein the first opening periphery has a generally circular or elliptical shape, and the outer surface of the tubular body further comprises a flange extending around the first opening periphery; and A cap configured to engage the second end portion of the tubular body, wherein the cap includes a central longitudinal axis, a first portion, a second portion, and a sidewall extending from an end of the first portion to an end of the second portion, wherein the cap further includes a plurality of protrusions and a plurality of recesses.

7. The therapeutic agent delivery device of claim 6, wherein: Each of the notches comprises a triangular shape.

8. The therapeutic agent delivery device of claim 6, wherein: The therapeutic agent delivery device is an autoinjector.

9. The therapeutic agent delivery device of claim 6, wherein: The lumen is configured to receive a syringe therein.

10. The therapeutic agent delivery device of claim 9, wherein: The syringe includes a volume of the therapeutic agent, and wherein the first opening is configured to allow visualization of the volume of the therapeutic agent.

11. The therapeutic agent delivery device of claim 6, wherein: The flange is configured to restrict rolling of the tubular body when the cap is not engaged with the tubular body.

12. The therapeutic agent delivery device of claim 6, wherein: Each protrusion of the plurality of protrusions is circumferentially spaced apart from an adjacent protrusion.

13. The therapeutic agent delivery device of claim 12, wherein: Each notch of the plurality of notches is disposed between adjacent protrusions.

14. The therapeutic agent delivery device of claim 6, wherein: The therapeutic agent delivery device comprises dupilumab, alirocumab, evolocumab, trevogrumab, evinacumab, sarilumab, or fasinumab.

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