Medicinal product delivery device
The drug delivery device integrates anti-rotation features and injection end indicators into its design, addressing rotation prevention and visibility issues while reducing production complexity and cost.
Patent Information
- Authority / Receiving Office
- RU · RU
- Patent Type
- Patents
- Current Assignee / Owner
- REGENERON PHARMACEUTICALS INC
- Filing Date
- 2018-06-29
- Publication Date
- 2026-07-09
AI Technical Summary
Existing drug delivery devices face issues with rotation prevention and needle end indication, particularly for visually impaired users, complicating production and increasing costs when separate anti-rotation devices and injection end indicators are used.
A drug delivery device with a tubular body featuring anti-rotation devices and a cap that includes geometric configurations, such as arrows or projections, to prevent rotation and indicate the injection end, while allowing for easy assembly and reduced production complexity.
The solution effectively prevents device rotation and clearly indicates the injection end, enhancing user safety and simplifying production without excessive cost, making it suitable for both sighted and visually impaired users.
Smart Images
Figure 00000001 
Figure 00000002 
Figure 00000003
Abstract
Description
RELATED APPLICATION
[0001] This application claims priority to U.S. Provisional Application No. 62 / 527,408, filed June 30, 2017, the entire disclosure of which is incorporated herein by reference. INTRODUCTION
[0002] Various embodiments of the present invention relate to a drug delivery device (e.g., an automatic medical injector or other injection device) having one or more anti-rotation devices configured to reduce and / or prevent the delivery device from rotating. The anti-rotation devices may be provided on the body of the delivery device, only on a cap configured to be removably engaged with the delivery device, or on both the body and the cap of the delivery device.
[0003] As illustrated in U.S. Patent No. 8,529,510 B2, for example, an injection device may include a tubular body that is prone to rolling over a surface when the device is placed on its side (e.g., when the longitudinal axis of the device is parallel or, alternatively, substantially parallel to the surface). Thus, there is a need for one or more anti-roll devices designed to resist the rolling of such a device.
[0004] Furthermore, the injection device has an injection end from which a needle extends to penetrate the user's body. To prevent unintentional needlestick injury and / or damage to the needle, there is a need to clearly notify and / or otherwise indicate the location of the injection end to the user. The injection device described in U.S. Design Patent No. D677,380 is provided with an arrow pointing to the injection end of the illustrated injection device. However, the arrow is flush with the outer surface of the injection device, making it difficult or impossible to perceive, for example, for visually impaired individuals. Furthermore, the injection device described in Patent No. D677,380 is prevented from rotating by its generally rectangular cross-section.However, equipping the injection device with separate anti-rotation devices (e.g., a rectangular cross-sectional shape) and an injection end indicator (e.g., a printed arrow) excessively complicates production and increases costs.
[0005] There is therefore a need for an injection device with anti-twist devices that are also configured to indicate the injection end to the user, regardless of whether the user is sighted or has a visual impairment. DETAILED DESCRIPTION OF THE ESSENCE OF THE INVENTION
[0006] According to one aspect of the present invention, a drug delivery device may comprise a tubular body comprising a first end region, a second end region, and a cavity extending between the first end region and the second end region. The outer surface of the tubular body comprises a first opening communicating with the cavity. The outer surface of the tubular body may further comprise a step extending along the boundary of the first opening, and a portion of the step closest to the second end region of the tubular body may be made in the shape of an arrow. The drug delivery device may also comprise a cap configured to engage with the second end region of the tubular body, wherein the cap may comprise 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 comprise a side wall extending radially outward from the first end to the second end, and the side wall may comprise a projection.
[0007] Various embodiments of the drug delivery device may include one or more of the following aspects: the drug delivery device may be an automatic medical syringe; the cavity of the drug delivery device may be configured to accommodate a syringe therein, wherein the syringe may contain a certain volume of the drug, and wherein the first opening is configured to visualize the volume of the drug; when the cap of the drug delivery device does not engage with the tubular body, the ledge may be configured to limit the rotation of the tubular body; when the cap of the drug delivery device does engage with the tubular body, only the protrusion may be configured to limit the rotation of the drug delivery device;the cap projection may comprise a plurality of projections, wherein each projection of the plurality of projections may be located on the same circumference as an adjacent projection; the cap of the drug delivery device may comprise a groove located between adjacent projections, wherein the projection comprises a first end and a second end, wherein the first end of the projection is spaced from the central longitudinal axis of the cap by a first distance, the second end of the projection is spaced 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 drug delivery device may further comprise a second opening located diametrically opposite to the first opening.
[0008] In another aspect, the present invention comprises a drug delivery device having a tubular body comprising a first end region, a second end region and a central longitudinal axis, wherein the outer surface of the tubular body comprises a geometric configuration extending from the central longitudinal axis, a portion of the geometric configuration is made in the form of an arrow, and the geometric configuration is configured to limit the rotation of the tubular body.The drug delivery device may further comprise a cap configured to engage with a region of the second end of the tubular body, wherein the cap may comprise a first end comprising an opening communicating with the inner region of the cap, a second end having an end wall, and a side wall extending radially outward from the first end to the second end, and wherein the side wall comprises a protrusion configured to limit the rotation of the cap.
[0009] Various embodiments of the drug delivery device may comprise one or more of the following aspects: the outer surface of the tubular body of the drug delivery device may comprise a plurality of geometric configurations, wherein each geometric configuration may comprise a portion formed in the form of an arrow; the geometric configurations may be arranged at a certain distance from each other along the circumference on the outer surface of the tubular body, the outer surface of the tubular body comprises a window, and wherein the geometric configuration surrounds a portion of the window; the window provides visualization of the interior of the tubular body; and the side wall of the cap may comprise a plurality of projections arranged at a certain distance from each other along the circumference.DETAILED DESCRIPTION OF THE DRAWINGS
[0010] The accompanying drawings, incorporated into and forming a part of this description, illustrate various examples of embodiments of the present invention and, together with this description, serve to explain the principles of the described embodiments of the present invention. The drawings illustrate various aspects of the present invention and, where appropriate, reference numerals illustrating the same structures, components, materials and / or elements in different figures have the same designations. It should be understood that, in addition to those clearly illustrated, various combinations of structures, components and / or elements are contemplated and included within the scope of the present invention.
[0011] Numerous inventions are described and illustrated herein. The described inventions are not limited to any single aspect or embodiment, nor to any combination or combination of such aspects or embodiments. Furthermore, each aspect of the described inventions or embodiments may be used alone or in combination with one or more other aspects of the described inventions or embodiments. For clarity, specific combinations or combinations are not specifically described or illustrated herein.In particular, an embodiment or implementation described herein as "presented as an example" is not to be construed as preferred or advantageous, for example, over other embodiments or implementations; rather, it is intended to reflect or indicate that the embodiment(s) is an "example" of the embodiment(s) of the invention.
[0012] Fig. 1A is a side view of an exemplary embodiment of a drug delivery device according to one embodiment of the present invention.
[0013] Fig. 1B is an exploded view of the drug delivery device illustrated in Fig. 1A.
[0014] Fig. 1C is a side sectional view of the drug delivery device illustrated in Fig. 1A taken along the X-X axis, in which the device comprises a syringe assembly and a power assembly in accordance with one embodiment of the present invention.
[0015] Fig. 2A is a perspective view of the body of the drug delivery device illustrated in Fig. 1A.
[0016] Fig. 2B is a side view of the housing illustrated in Fig. 2A, wherein the housing is rotated 90° with respect to the position illustrated in Fig. 1A.
[0017] Fig. 2C is another side view of the housing illustrated in Fig. 2A, with the housing rotated 90° relative to the position illustrated in Fig. 2B.
[0018] Fig. 3A is a perspective view of an exemplary embodiment of a cap of a drug delivery device according to the present invention, such as illustrated in Fig. 1A.
[0019] Fig. 3B is a side view of the cap illustrated in Fig. 3A.
[0020] Fig. 3C is a cross-sectional view of the cap illustrated in Fig. 3A.
[0021] Fig. 3D is an enlarged view of the cutout illustrated in Fig. 3C.
[0022] Fig. 3E is a top view of the cap illustrated in Fig. 3A.
[0023] Fig. 4A is a perspective view of an alternative exemplary cap of a drug delivery device according to the present invention, such as that illustrated in Fig. 1A.
[0024] Fig. 4B is a cross-sectional view of the cap illustrated in Fig. 4A.
[0025] Fig. 4C is an enlarged view of the cutout illustrated in Fig. 4B.
[0026] Fig. 5A is a perspective view of another alternative exemplary cap of a drug delivery device according to the present invention, such as that illustrated in Fig. 1A.
[0027] Fig. 5B is a side view of the cap illustrated in Fig. 5A.
[0028] Fig. 5C is a bottom view of the cap illustrated in Fig. 5A.
[0029] Fig. 5D is an enlarged view of the cutout illustrated in Fig. 5A, as well as various sizes of the cutout.
[0030] As used herein, the terms "comprises," "comprising," "includes," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or device that contains a list of elements including more than just those elements may also include other elements not explicitly listed or not inherent in such process, method, article, or device. The term "exemplified" is used in the meaning of "example," as opposed to "ideal." Additionally, the terms "first," "second," and the like as used herein do not denote order, quantity, or importance, but rather are used to distinguish one element or structure from another. Furthermore, as used herein, the singular does not imply a limitation in quantity, but rather denotes the presence of one or more referenced elements.
[0031] The term "distal end" or any variants thereof means the portion of the device that is furthest from the injection site or the delivery site of the drug to the patient during the injection. Conversely, the term "proximal end" or any variants thereof means the portion of the device that is closest to the injection site or the delivery site of the drug to the patient during the injection. Additionally, as used herein, the terms "about," "essentially," and "approximately" generally mean + / - 10% of the stated value. DETAILED DESCRIPTION OF THE INVENTION
[0032] Embodiments of the present invention relate to a drug delivery device (e.g., an automatic injector or other injection device) with an anti-rotation device on its housing and / or cap. Such devices facilitate the use of the automatic injector by providing a predictable position of the device. For example, anti-rotation devices on the disclosed automatic injector reduce the likelihood of the automatic injector rolling off a table, counter, or away from the user. In one embodiment of the present invention, the outer surface of the automatic injector housing may comprise one or more protruding portions or geometric configurations that reduce or prevent rotation of the housing.Protruding parts or geometric configurations may also be configured to alert the user to the injection end of the automatic medical syringe (from which the needle extends into the user's body). In another embodiment of the present invention, the automatic medical syringe may comprise a cap configured to cover the injection end of the automatic medical syringe. In such embodiments, the cap may also be equipped with anti-twist devices.One skilled in the art will appreciate that, while this document describes various useful characteristics and features of automatic medical injectors, and describes several embodiments of these characteristics and features, these characteristics and features can be represented in a variety of aesthetic ways on, in, or as part of the device according to the present invention. While illustrating one or more visual embodiments of characteristics or features, the present description is not limited to the illustrated embodiments. Aspects of the present invention are described in more detail below.
[0033] As illustrated in Fig. 1A, the exemplary drug delivery device 100 may comprise an injection device, including, but not limited to, an automatic medical injector. The delivery device 100 may comprise a distal end 101a and a proximal end 101b. The delivery device 100 may comprise an elongated body 104 and a cap 102 configured to be removably engaged with the proximal end of the body 104. A portion of the distal end 101a may comprise an opening in the body 104. Such an opening may be closed by a cap, as illustrated in Fig. 2A. The cap may have any suitable size or configuration. In some embodiments of the present invention, the cap may be flush or substantially flush with the distal end 101a of the housing 104, thereby indicating to the user that the portion of the distal end 101a is not the injection end of the delivery device 100.The housing 104 may generally have a circular cross-sectional configuration. In some embodiments of the present invention, the housing 104 may comprise any suitable cross-sectional configuration, including, but not limited to, a rectangular, triangular, or oval shape. The housing 104 may comprise any suitable material, including, but not limited to, glass, plastic, metal, rubber, silicone, or a combination thereof. In some embodiments of the present invention, the housing 104 may be generally opaque. However, in other embodiments of the present invention, the housing 104 may comprise one or more transparent or translucent portions for visualizing the interior of the housing 104. For example, as described in more detail below, the housing 104 may comprise one or more openings or windows that provide such visualization.In some embodiments of the present invention, the windows may be covered with a transparent or translucent material, such as glass or plastic.
[0034] The housing 104 may comprise a cavity 105 and an outer surface 108. The outer surface 108 may comprise an opening or window (for example, an opening 112 illustrated in Fig. 1B) configured to visualize the interior of the housing 104 or to provide visualization of the contents inside the cavity 105 (Fig. 2B) of the housing 104. Although one opening 112 is illustrated in Fig. 1A, the housing 104 may be equipped with a greater number of openings 112, including, for example, two openings, three openings, or four or more openings. In some embodiments of the present invention, the housing 104 may be provided without any openings. In some embodiments having a plurality of openings 112, the openings 112 may be located at a certain distance around the circumference on the outer surface 108. For example, two openings 112 may be located diametrically opposite to each other.Additionally or alternatively, the openings 112 may be spaced apart in the longitudinal direction from one another on the outer surface 108. For example, the first opening 112 and the second opening 112 may be located at essentially the same radial position on the outer surface 108, but spaced apart in the longitudinal direction along the X-X axis. Furthermore, the opening 112 may have any suitable configuration. For example, the openings 112 may be formed in the shape of a circle, rectangle, triangle, pentagon, octagon, or oval. For example, as illustrated in Fig. 1A, the opening 112 may have 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 of the present invention, the length of the opening 112 may be less than approximately 31.9 mm, for example, when the housing 104 is configured to accommodate a syringe 106 that is configured to contain less than 1 ml. The width of the opening 112 may be constant or vary along its length. For example, the width of the proximal portion of the opening 112 may be greater than the width of the distal portion of the opening 112, thus providing a generally arrow-shaped configuration of the opening 112. In some embodiments of the present invention, the side walls of the opening 112 may converge from each other in a cone.
[0035] In some embodiments of the present invention, the proximal portion of the opening 112 may be configured to point the user toward the injection end. For example, the proximal portion of the opening 112 may be configured as a closure at the top, "pointing" toward the cap 102. Alternatively, the near side of the opening 112 may be configured as an arrow pointing toward the cap 102.
[0036] As mentioned above, the outer surface 108 may comprise one or more anti-rotation devices for preventing or, in other words, slowing down the rotation of the housing 104. For example, the housing 104 may comprise one or more projections located near the opening 112. As described in more detail below, the anti-rotation device(s) may comprise a step 114 surrounding a part or the entire boundary of the opening 112, as illustrated in Figs. 1A-1C and 2A-2C, and described in more detail below. In particular, the present invention contemplates that the step 114 may extend 100% around the opening 112, less than 100% around the opening 112, less than 75% around the opening 112, less than 40% around the opening 112, less than 30% around the opening 112, or less than 20% around the opening 112.It will be readily understood by those skilled in the art that the described anti-rotation devices may be provided on the outer surface 108, even if the outer surface 108 does not comprise an opening 112. Even in embodiments of the present invention in which a plurality of openings 112 are provided on the outer surface 108, one or more openings 112 may not comprise an associated step 114, or all openings 112 may comprise steps 114 associated with them. Despite this, the present invention contemplates a plurality of steps on the outer surface 108. Additionally, the outer surface 108 may comprise one or more geometric elements configured to facilitate a user's grip during manipulation.Such geometric features may include texture, protrusions, recessed cutouts, and / or a heat-activated adhesive (e.g., a material configured to provide a temporary adhesive surface that is activated by heating by the user's hand).
[0037] The step 114 may have any suitable configuration. For example, the step 114 may have a substantially rectangular configuration in cross-section. In some embodiments of the present invention, the radially outermost surface of the step 114 (for example, the surface of the step 114 parallel to the outer surface 108) may be curved, for example, to ensure convenience during manipulation. The side wall (for example, the side wall 114b illustrated in Fig. 1C) of the step 114 may form an angle of 90 degrees with the outer surface 108. In some embodiments of the present invention, the angle formed by the side wall 114b may be greater than or less than 90 degrees. In yet another embodiment of the present invention, the side wall 114b gradually tapers in a direction away from the outer surface 108.In embodiments of the present invention in which the steps 114 surround substantially the entire opening 112, the step 114 may have substantially the same configuration (e.g., cross-sectional configuration). Alternatively, one or more portions of the step 114 may have a configuration that differs from the rest of the step 114. For example, as illustrated in Figs. 1A-1C, the proximal portion 114a of the step 114 may be configured to indicate a direction to the user. In particular, a portion of the proximal end 114a may have a configuration that is approximately conical. For example, a portion of the proximal end 114a may be configured as an arrowhead, a spear, an arrow, or an arrow-shaped shape pointing in the direction of the proximal end 101b. In alternative embodiments of the present invention, the proximal end 114a may be configured as an arrow, a lightning bolt, or a wedge.In other additional embodiments of the present invention, the proximal end portion 114a may comprise an elongated portion having a length dimension greater than the width dimension for some or all of the elongated portions. Although not illustrated, one or more corners of the distal end region (e.g., corner 114c of the arrow illustrated in Fig. 1A) may be rounded.
[0038] The shoulder 114 and the body 104 can be formed as a single configuration. For example, the shoulder 114 can be integrated with the outer surface 108 during casting. Alternatively, the shoulder 114 can be secured or otherwise fixed to the outer surface 108 during a process subsequent to the casting of the body 104. For example, the shoulder 114 can be manufactured separately from the production process of the body 104 and glued near the opening 112 using a suitable adhesive or a welding process. In such embodiments of the present invention, it is contemplated that the shoulder 114 can be "old-fashionedly secured" to the outer surface of the already manufactured body of the injection device. Those skilled in the art will understand that the shoulder 114 can be produced using any suitable process, including, but not limited to, casting, 3D printing and / or cutting.
[0039] In some embodiments of the present invention, the step 114 may have a constant height and / or width, or have a variable height and / or width. For example, the step 114 may have a serrated or corrugated profile. In particular, the adjacent portions of the step 114 may be separated from the outer surface 108.
[0040] Referring now to Fig. 1B, a delivery device 100 is illustrated in disassembled form, including a cap 102, a housing 104, and a syringe 106 configured to be installed in a lumen 105 of the housing 104. The syringe 106 may be configured to accommodate a drug, such as a biological or other dosage form, intended for delivery (for example, via a needle 107 illustrated in Fig. 1C) to (and / or by) a user of the device 100. In some embodiments of the present invention, the syringe 106 may be configured to contain at least 1 ml of the drug. In other embodiments of the present invention, the syringe 106 may be configured to contain at least 1 ml, 1.5 ml, 2 ml, 2.25 ml, 3 ml, or 5 ml of the drug.In other embodiments of the present invention, syringe 106 may be configured to contain a nominal volume of less than 1 ml. Housing 104 may also contain any suitable injection activation and / or actuation mechanism, such as a power unit for actuating needle 107 and / or delivering a drug. Such an injection activation and / or actuation mechanism may be located at any suitable location in device 100.
[0041] As mentioned above, the opening 112 can be configured to allow the user of the device 100 to visualize the contents of the syringe 106. For example, the user may be able to determine that the device 100 has been used by determining that the syringe 106 is empty or, in other words, partially empty. Similarly, the user may be able to determine that the device 100 has not been used by determining that the syringe 106 is filled (or almost filled) with a medicinal preparation. The housing 104 can further comprise a needle cap 118 configured to, for example, cover all or part of the needle 107 of the syringe 106 when the syringe 106 is placed inside the housing 104. In one embodiment of the present invention, the needle cap 118 can be retracted into the housing 104, for example, if a force is applied against the proximal end of the needle cap 118 in the distal direction.
[0042] Referring now to Fig. 1A, 1B, 3A-3E, 4A-4C and 5A-5C, in which the cap 102 is illustrated. As mentioned above, the cap 102 can be configured to engage with the proximal end of the body 104. With reference to Fig. 3A-3E, 4A-4C and 5A-5C, the cap 102 can comprise a central longitudinal axis CC. The cap 102 may comprise a portion of the distal end 130 and a portion of the proximal end 132. The region of the distal end 130 may have a diameter smaller than the diameter of the region of the proximal end 132. Alternatively, although not illustrated, the region of the distal end 130 may comprise a diameter larger than the diameter of the region of the proximal end 132. Furthermore, the region of the distal end 130 and the region of the proximal end 132 may have substantially the same diameters. In other embodiments of the present invention, the region of the distal end 130 may have an outer diameter substantially equal to the outer diameter of the housing 104.In embodiments of the present invention in which the region of the proximal end 132 has a diameter larger than the region of the distal end 130, the outer diameter of the region of the proximal end 132 may also be larger than the outer diameter of the housing 104.
[0043] The region of the proximal end 132 can be formed by the surface of the proximal end 132a. The surface of the proximal end 132a can have a substantially flat configuration. The surface of the proximal end 132a can be a substantially continuous wall configured to close the proximal end of the cap 102. In this case, the proposed invention prevents the use of the described device without removing the cap 102. The cap 102 can also include a substantially cylindrical skirt 134 extending from the surface of the proximal end 132a. In some embodiments of the present invention, an annular groove 133 can be located between the skirt 134 and the surface of the proximal end 132a. The skirt 134 can form an opening 135 at the distal end 130 in the inner part of the cap 102.The opening 135 may be configured to receive the needle cap 118 in such a way that the cap 102 can be releasably engaged with the housing 104.
[0044] The cover 102 may comprise a second skirt (not illustrated) located inside the opening 135, extending from the inner surface of the proximal end 132a and concentrically aligned with the skirt 134. The second skirt may have a diameter smaller than the diameter of the skirt 134. In addition, the second skirt may have a length shorter than the length of the skirt 134. Referring to Fig. 3A, 4A and 5A, the cap 102 may comprise a cylindrical protruding portion 143 extending from the second skirt and distally extending beyond the skirt 134 and the region of the distal end 130 of the cap 102. The cylindrical protruding portion 143 may be located substantially in the center of the skirt 134. In one embodiment of the present invention, the cylindrical protruding portion 143 may form a central cavity (not illustrated). The cavity may be configured to accommodate an elastic material 144 therein.In some embodiments of the present invention, the elastic material 144 may form a cavity 143a for accommodating, for example, a needle. The cylindrical protruding portion 143 may comprise one or more selectively actuated gripping elements configured to retain the elastic material 144 within the cavity 143. The cylindrical protruding portion 143 may be fixed together with the second skirt or may be manufactured together with the cap 102 as a single structure. The outer diameter of the cylindrical protruding portion 143 may be smaller than the inner diameter of the second skirt. In addition, the second skirt may be configured to be placed within the cavity of the needle cap 118.
[0045] The cap 102 may be made of any suitable material, including, but not limited to, glass, plastic, metal, rubber, silicone, or a combination thereof. In some embodiments of the present invention, the cap 102 may be made of the same material as the housing 104. In other embodiments of the present invention, the cap 102 may be made of at least one material different from the material of the housing 104. In addition, the cylindrical protruding portion 143 may be made of a material different from the rest of the cap 102. For example, the cap 102 may be made of plastic, and the cylindrical protruding portion 143 may be made of metal.
[0046] As illustrated in Fig. 3A and 4A, the outer surface of the skirt 134 may be curved inward as it extends from the region of the proximal end 132 to the region of the distal end 130. In other words, the outer surface of the skirt 134 may curve outward in a radial direction from the region of the distal end 130 to the region of the proximal end 132. In some embodiments of the present invention, for example, the curved outer surface of the skirt 134 may have a substantially concave configuration when viewed in perspective radially outward from the cap 102. In other embodiments of the present invention, the configuration may be substantially concave when viewed in perspective. The curvature of the skirt 134 may be configured to facilitate the grip of the user during manipulation of the cap 102.In still other embodiments of the present invention, some portion or all of the surface of the skirt 134 may be substantially flat when viewed in perspective. In some embodiments of the present invention, as illustrated in Fig. 5A, the outer skirt 134 may be curved such that the outer surface of the skirt 134 (e.g., extending from the region of the proximal end 132) may be inclined outward. Such an outward inclination may also be designed to facilitate the user's grip during manipulation of the cap 102.
[0047] The outer surface of the skirt 134 may also comprise one or more projections 136, for example, projections 136a-136d. The projections 136a-136d may be substantially the same as each other, or may have different configurations. For brevity, the following description is provided with respect to a single projection 136 (for example, projection 136a). The projection 136a may have a substantially rectangular configuration. As illustrated in Figs. 3A, 3B, 4A, 5A and 5B, the length of the projection 136a may be, in general, may be located along the direction of the longitudinal axis C-C. Those skilled in the art will understand that the projection may have any suitable configuration or shape. For example, instead of a rectangular configuration, the projection 136a may have, in general, an elongated, circular, or triangular configuration. Regardless of the configuration, the projection 136a may, in general, repeat the above-mentioned curvature of the outer surface of the skirt 134.
[0048] The skirt 134 may comprise any suitable number of projections 136a. For example, even though four projections 136a-136d are illustrated, those 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 more than 8 projections. Additionally, some embodiments of the skirt 134 may not have any projections. In such embodiments of the present invention, where the skirt 134 is provided with more than one projection 136a, the projections may be spaced from each other by any suitable distance. For example, the projections may be spaced at equal distances along the outer surface of the skirt 134. The projection 136a may be located in any position along the length of the skirt 134.For example, the projection 136a may be located centrally between the region of the distal end 130 and the region of the proximal end 132 (not illustrated) closer to the region of the proximal end 132, or closer to the region of the distal end 130 (not illustrated). The projection 136a may comprise a first end 138 and a second end 140. The first end 138 may be spaced from the central longitudinal axis C-C by a first distance, and the second end 140 of the projection 136 may be spaced from the central longitudinal axis C-C by a second distance greater than the first distance.
[0049] The cap 102 may comprise one or more cutouts 142, for example, cutouts 142a and 142b. Although only two cutouts 142 are illustrated, the cap 102 may comprise a greater or lesser number of cutouts 142. For example, the cap 102 may comprise, 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 than eight cutouts 142. In some embodiments of the present invention, the cap 102 may not be equipped with any cutouts 142. The cutouts 142 may partially extend through the thickness of the skirt 134. In some embodiments of the present invention, one or more cutouts 142 may completely extend through the thickness of the skirt 134.
[0050] The notches 142 may have any suitable configuration. For example, the notches 142 may have an inverted triangular shape (as illustrated in Figs. 3A-3D, 5A and 5B). The inverted triangular shape of the notches 142 may have one or more straight or curved sides, or a combination of straight and curved sides (for example, to form an arrow-shaped shape). For example, Figs. 3A-3D, 5A and 5B illustrate examples of notches 142 with a curved side for the side of the notch 142 closest to the region of the distal end 130 of the cap 102. In particular, as illustrated in Fig. 3A and Fig. 5A and 5B, the base side of the notch 142b may have a concave curvature. The side sides of the notch 142 may also have a curvature, for example, a convex curvature. Alternatively or in addition, the cutouts 142 may be teardrop shaped (as illustrated in Figs. 4A-4C).The teardrop shape may comprise a wide base located in a direction closer to the region of the distal end 130 or closer to the region of the proximal end 132. In some aspects, the notches 142 may have a configuration of a substantially equilateral triangle. In other aspects, the notches 142 may have a triangular shape having an isosceles configuration, where the lateral sides of the triangular shape may have a substantially equal length, greater than the length of the base, as illustrated, for example, in Fig. 3A. The single cap 102 may also comprise notches 142 of various shapes, for example, having an alternative triangular or teardrop shape. One or more notches 142 may have a distal width greater than the proximal width. In such embodiments of the present invention, the narrow proximal portion of the notches 142 may be configured to indicate (for example, a direction) to the injection end or direction to the user of the device 100.Alternatively, one or more notches 142 may have a distal width that is smaller than the proximal width. Alternatively or in addition, the notches 142 may have a distinct configuration to indicate a specific drug contained within the syringe 106, the amount of drug located in the syringe 106, the rate of drug delivery from the syringe 106, or a combination thereof. For example, the teardrop-shaped notches 142 (e.g., according to Fig. 4A) may indicate a specific dosage of the selected drug, while the triangular notches 142 (e.g., according to Fig. 3A or 5A) may indicate a second dosage of the same drug. Alternatively, the teardrop-shaped notches 142 may indicate a specific dosage of the selected drug, while the triangular notches 142 may indicate a second dosage of a second drug that is different from the selected drug.The indications may also be provided in the form of colors, textures, or distinctive features known to those skilled in the art. In addition, as illustrated in Figs. 3C and 4B, the depth to which the cutout 142 may be formed in the thickness of the skirt 134 may be constant or may vary along the width and / or length of the cutout 142. In some embodiments of the present invention, each of the cutouts 142 may have a similar configuration. In other embodiments of the present invention, one or more cutouts 142 may differ from other cutouts 142 provided on the skirt 134. Each cutout 142 may have a surface 145 that may repeat or differ from the above-described curvature of the skirt 134. The surface 145 of the cutout 142 may be provided with any suitable texture and / or surface treatment to improve the grip when manipulating the cap 102.
[0051] As illustrated in Fig. 3B-3D, 4B, 4C, 5A and 5B, each cutout 142 may further have a beveled surface 147 defining the depth of the cutout 142. The surface 147 may comprise a straight surface (as illustrated in Figs. 3C, 3D, 4B, 4C, 5A and 5B), where the surface 147 is illustrated as a straight line interrupting the surface of the skirt 134. Alternatively, the surface 147 may comprise a curve interrupting the surface of the skirt 134. One or more edges of the surface 147 may also be curved or straight, and the shape of the cutout 142 may be defined by the edges of the surface 147. In addition, the surface 147 may define the depth of the cutout 142. For example, the surface 147 may define the depth of the cutout 142 by means of an angular slope (as illustrated in Figs. 3D and 4C), on which surface 147 has a surface that is at an angle to the longitudinal axis C-C and / or to the surface of skirt 134.The angle of inclination may have a perpendicular angle, for example, where the surface 147 may be perpendicular to the surface of the skirt 134, or define a concave edge in the surface of the skirt 134. The cutouts 142 may comprise the surface 147 on one part of the cutout 142, while other parts of the cutouts 142 gradually form or become flush with the skirt 134 (as illustrated in Figs. 3B-3D and 4B). In such embodiments of the present invention, the cutout 142 may extend inside the skirt 134 to different depths. Alternatively, the cutout 142 may comprise the surface 147 around the entire perimeter of the cutout 142. In other words, the depth of the cutout 142 on the surface of the skirt 134 may remain constant such that the surface 147 extends deep into the surface of the skirt 134 at each point of the perimeter of the cutout 142.
[0052] As illustrated, at least in Figs. 3A, 3B, 4A, 4B and 5A-5C, each notch 142 can be located between adjacent projections 136. Those skilled in the art will understand that the notches 142 can be provided only between certain pairs of adjacent projections 136. Thus, the notches 142 can be omitted between certain pairs of adjacent projections. The number and configuration of the notches 142 can be configured to facilitate the user's grip when manipulating the cap 102.
[0053] As illustrated in Fig. 3A, 4A and 5A, for example, each notch 142 can be located at any suitable distance from the region of the distal end 130 and the region of the proximal end 132 of the cap 102. For example, in Fig. 5B, the notch 142 may be positioned at a distance m from the region of the distal end 130 and at a distance n from the region of the proximal end 132. The distance m may be measured from, for example, the end of the notch 142 closest to the region of the distal end 130 to the edge of the cap 102 on the region of the distal end 130, and the distance n may also be measured from, for example, the end of the notch 142 closest to the region of the proximal end 132 to the edge of the cap 102 on the region of the distal end 132. The distance m and the distance n may both be distances that ensure the placement of the notch 142 on and / or inside the cap 102.In some embodiments of the present invention, each distance m and n may be from about 0.5 mm to about 5 mm, such as from about 1 mm to about 4.5 mm, from about 1.5 mm to about 4.5 mm, from about 2 mm to about 4.5 mm, from about 2.5 mm to about 4.5 mm, from about 3 mm to about 4.5 mm. For example, each distance m and distance n may be from 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 of the present invention, the distance m may be from about 3.1 mm to 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 of the present invention, for example, the distance m may be about 3.365 mm.In some embodiments of the present invention, the distance n may be from 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 of the present invention, for example, the distance n may be about 4.262 mm. It should be understood that these distances are given as an example, and one of skill in the art will understand that any other distances and size ranges are possible.
[0054] Each cutout 142 may also have any suitable dimensions (e.g., length, width, height, cutout depth) for placement on the cap 102. Fig. 5D illustrates an example of a triangular cutout 142 having one curved side and a plurality of dimensions a-f. Table 1 below lists examples of dimensions a-f. It should be understood that these dimensions are approximate and are provided solely as an example, and that other possible dimensions a-f (or other dimensions of the cutout 142) may be used.
[0055] Table 1. Size Range(s) of the measurement provided as an example (mm) The measurement shown as an example (mm) a 1-12, 5-10, 6-10, 7-10, 8-10, 9-10 9,5325 b 1-12, 5-10, 6-10, 7-10, 8-10, 9-10 9,1394 c 1-10, 3-9, 4-8, 5-8, 6-8, 7-8 7,4116 d 1-11, 3-10, 3-9, 4-8, 5-8, 6-8, 7-8 8,1015 e 0,1-5, 0,1-3, 0,1-1, 0,1-0,5 0,3558 f 0,1-1, 0,1-0,5, 0,1-0,4, 0,2-0,4, 0,3-0,4 0,3811
[0056] In some embodiments of the present invention, the color of the cap 102 may correspond to the color of the step 114. For example, the color of the projections 136 may correspond to the color of the step 114. Similarly, the color of the cutouts 142 may correspond to the color of the step 114. Although it is assumed that the described relationship may include a color match, those skilled in the art will understand that other matching schemes can be used within the scope of the present invention. The relationship between one or more colors of the cap 102 and the step 114 (or housing 104) may help the user engage the cap 102 with its corresponding housing.
[0057] With new reference to Figs. 1A-1C and 2A-2B, the step 114 can be configured to prevent or, in other words, hinder the rotation of the housing 104, when, for example, the housing 104 is on a flat surface. For example, when the housing 104 is located on a surface such that the X-X axis is actually parallel to this surface, the step 114 can frictionally engage with the surface to prevent or, in other words, hinder the rotation of the housing 104 on such a surface. In addition, the step 114 can be configured to stop or, in other words, slow down the rotation speed of the housing 104 already rotating on the surface. To provide improved stabilization characteristics, all or some parts of the step 114 can comprise an adhesive coating, for example, a rubber coating, to enhance adhesion.
[0058] Similarly, the projections 136 can be configured to prevent or, in other words, hinder the cap 102 from rotating when, for example, the cap 102 is located on a flat surface. For example, when the cap 102 is located on a surface such that the C-C axis is substantially parallel to this surface, or substantially not perpendicular to this surface, one or more projections 136 can engage with the surface by friction to prevent or, in other words, hinder the cap 102 from rotating on this surface. In addition, one or more projections 136 can be configured to stop or, in other words, slow down the rotation speed of the cap 102 that is already rotating on this surface. To provide improved stabilization characteristics, all or some parts of the projections 136 can comprise an adhesive coating, for example, a rubber coating, to increase friction.
[0059] As mentioned above, the cap 102 may comprise a portion of the proximal end 132 having a diameter larger than the diameter of the portion of the distal end 130. As a result, when the cap 102 is engaged with the housing 104 and the delivery device 100 is on the surface, the proximal end 101b of the housing 104 may be raised above the surface such that the X-X axis forms an angle with this surface. As a result of such an elevation, contact with this surface may be excluded for all or part of the step 114. In such embodiments of the present invention, the projections 136 serve to engage by friction with the surface to prevent or otherwise hinder the rotation of the delivery device 100 on the surface. In addition, the projections 136 may be configured to stop or otherwise slow down the rotation speed of the delivery device 100 that is already rotating on the surface.
[0060] In some embodiments of the present invention, the devices according to the present invention can be used for packaging and / or delivering a drug for treating a patient. For example, in some embodiments of the present invention, the devices according to the present invention can be used for packaging and / or delivering a drug for treating, treating or preventing, for example, arthritis, asthma, chronic pain (e.g., chronic low back pain), allergic reactions, diseases and disorders (e.g., eosinophilic esophagitis), dermatitis, muscle atrophy, hypercholesterolemia, atypical LDL cholesterol levels, cardiovascular complications, bacterial or viral infections or other disorders, symptoms or diseases.In some embodiments of the present invention, the medicaments of the present invention may comprise micromolecules (e.g., molecules having a molecular weight of 900 Da or less) or macromolecules (e.g., molecules having a molecular weight greater than 900 Da). In some embodiments of the present invention, the medicaments of the present invention may comprise macromolecules, such as proteins, antibodies, or antibody portions, having a molecular weight greater than 30 kDa. For example, medicaments for use with the devices of the present invention may comprise, for example, dupilomab, alirocumab, evolocumab, alarmumab, evinacumab, sarilumab, or fasinumab.In some embodiments of the present invention, the medicaments of the present invention may comprise PCSK9 inhibitors, an interleukin 4 receptor inhibitor, an interleukin 5 receptor inhibitor, or an interleukin 13 receptor inhibitor. In some embodiments of the present invention, the devices of the present invention may be used to deliver drugs to patients in certain populations that would benefit from anti-rolling devices, such as geriatric patients, patients with rheumatic polyarthritis, pediatric patients, and / or patients with physical or mental illnesses.
[0061] The above description and examples are illustrative and not limiting. One skilled in the art will be able to make various modifications and / or changes without departing from the general scope of the present invention. For example, and as described, the above-described embodiments of the present invention (and / or aspects thereof) can be used in combination with each other. Additionally, portions of the above-described embodiments of the present invention can be deleted without departing from the scope of the present invention. Furthermore, modifications can be made to adapt certain situations or aspects to the teachings of various embodiments of the present invention without departing from its scope. Numerous other embodiments of the present invention will also be apparent to those skilled in the art upon consideration of the above description.Additionally, although a number of objectives and advantages of embodiments of the present invention set forth in this document (and variations thereof) are described, not all such objectives or advantages will necessarily be achieved in accordance with any particular embodiment of the present invention. Thus, for example, those skilled in the art will understand that the systems and technologies described in this document can be implemented or executed in such a way as to achieve or optimize one advantage or a group of advantages described in this document, without necessarily achieving other objectives or advantages as explained or suggested in this document.
Claims
1. A drug delivery device comprising: a housing comprising a first end, a second end and a cavity extending between said first and second ends, wherein the outer surface of the housing includes a first opening in communication with said cavity, and wherein said cavity is configured to accommodate a syringe having a volume of a medicinal product; and a cap configured to engage with a second end of said body, wherein said cap includes 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 said first cross-sectional dimension, and wherein the cap includes a side wall extending from said first end to said second end, wherein said side wall includes an outer surface and projections, wherein said cap further includes a cutout, wherein said cutout extends partially into the thickness of said cap and includes a surface defining the depth of said cutout, wherein said cutout has a distal width and a proximal width, wherein the distal width is greater than the proximal width, and wherein a portion of the cutout is made in the shape of an arrow.
2. A drug delivery device according to claim 1, characterized in that the first opening is designed to provide visualization of the volume of the drug.
3. A drug delivery device according to claim 1, characterized in that it contains dupilumab.
4. The drug delivery device of claim 1, wherein the width of the first opening is approximately 7.5 mm and the length of the first opening is approximately 31.9 mm.
5. A drug delivery device according to claim 1, characterized in that the first opening is made in the shape of a circle, rectangle, triangle, pentagon, octagon, or oval.
6. The drug delivery device according to claim 1, characterized in that the housing additionally contains a second opening located diametrically opposite to said first opening.
7. A drug delivery device according to claim 6, characterized in that the second opening is made in the shape of a circle, rectangle, triangle, pentagon, octagon, or oval.
8. The drug delivery device of claim 1, wherein said cutout has sides, wherein said sides include a straight side, a curved side, or a combination thereof.
9. The drug delivery device of claim 1, wherein the second end of the device is an injection end, and the proximal width of the cutout is configured to indicate the injection end to the user of the device.
10. A drug delivery device according to claim 1, characterized in that the surface of said cutout has an edge.
11. A drug delivery device according to claim 10, characterized in that said edge is curved or straight.
12. The drug delivery device according to paragraph 11, characterized in that the surface of said cutout is made flush with said outer surface of said cap.
13. The drug delivery device of claim 1, wherein said cap includes a portion of the proximal end.
14. The drug delivery device of claim 13, wherein said proximal end portion has a substantially flat configuration.
15. The drug delivery device of claim 1, wherein the first opening includes a surface that defines the depth of the first opening.