PEN AND PEN NEEDLE ADAPTER WITH FEATURE TO IMPROVE ACCESS TO PACKAGED NEEDLE ASSEMBLY

Abstract

An injection pen, or an adapter for an injector pen, configured to connect at its distal end with a needle assembly, and having a tubular wall comprising a through cut from the distal end to pierce and capture barrier material covering needle assembly packaging containing a needle assembly in a cavity therein. The though cut has an opening with an edge that scythes the barrier material when the hub is pressed against the needle assembly packaging to access the needle assembly. The edge can have a tooth for piercing the barrier material. The opening can be dimensioned and shaped and angled relative to the longitudinal axis of the pen or adapter to facilitate capturing scythed barrier material and guiding it away from the needle assembly to ensure the pierced barrier material does not hinder connection of the needle assembly to the pen or adapter.

Claims

1. An injection pen, comprising: a pen body comprising a tubular wall having a proximal end, and an opposite distal end configured to be connected to a needle assembly; wherein the distal end of the tubular wall comprises a through cut, the through cut defining an opening in the tubular wall, the through cut having an edge configured to pierce barrier material provided on needle assembly packaging when the distal end is depressed against the needle assembly packaging to access a needle assembly stored therein, and the opening of the through cut being configured to receive barrier material after it has been pierced to guide it away from the needle assembly.

2. The injection pen of claim 1, wherein the edge of the through cut comprises a tooth that extends from the distal end.

3. The injection pen of claim 1, wherein the tooth extends from the distal end by a distance corresponding to at least the thickness of the barrier material.

4. The injection pen of claim 1, wherein the tooth comprises a pointed tip.

5. The injection pen of claim 1, wherein the tooth comprises a rounded tip.

6. The injection pen of claim 1, wherein the edge of the through cut comprises a scything edge along at least one side of the opening.

7. The injection pen of claim 1, wherein the opening of the through cut has an arcuate shape.

8. The injection pen of claim 1, wherein the opening of the through cut has a straight shape.

9. The injection pen of claim 1, wherein the through cut is disposed in the tubular wall at a designated angle between a longitudinal axis of the pen body and a perpendicular axis at the distal end.

10. The injection pen of claim 9, wherein the designated angle is selected to capture the barrier material after being pierced by the edge of the through cut and guide the barrier material away from the needle assembly.

11. The injection pen of claim 1, wherein the through cut has a distal end adjacent the distal end of the pen body and a proximal end that is opposite the distal end of the through cut, and the opening extends between the distal end of the through cut and the proximal end of the through cut; and wherein the through cut is arranged in a selected one of a first direction and a second direction, the first direction allowing the distal end of the through cut to precede the proximal end of the through cut when the pen is rotated in a clockwise direction about its longitudinal axis, and the second direction allowing the distal end of the through cut to precede the proximal end of the through cut when the pen is rotated in a counterclockwise direction about its longitudinal axis.

12. The injection pen of claim 1, wherein the distal end is dimensioned to fit in a cavity of the needle assembly packaging in which a needle assembly is stored and to receive at least part of the needle assembly.

13. An adapter for an injection pen, the adapter comprising: a hub comprising a tubular wall having a proximal end configured to be connected to an injection pen and a distal end configured to be connected to a needle assembly, the tubular wall defining a channel therein that extends between the proximal end and the distal end and along a longitudinal axis of the hub, the channel being configured to receive at least part of a needle assembly therein; wherein the distal end of the tubular wall comprises a through cut, the through cut defining an opening in the tubular wall, the through cut having an edge configured to pierce barrier material provided on needle assembly packaging when the huh is depressed against the needle assembly packaging to access a needle assembly stored therein, and the opening of the through cut being configured to receive barrier material after it has been pierced to guide it away from the needle assembly.

14. The adapter of claim 13, wherein the edge of the through cut comprises a tooth that extends from the distal end of the hub.

15. The adapter of claim 13, wherein the tooth extends from the distal end of the hub by a distance corresponding to at least the thickness of the barrier material.

16. The adapter of claim 13, wherein the tooth comprises a pointed tip.

17. The adapter of claim 13, wherein the tooth comprises a rounded tip.

18. The adapter of claim 13, wherein the edge of the through cut comprises a scything edge along at least one side of the opening.

19. The adapter of claim 13, wherein the opening of the through cut has an arcuate shape.

20. The adapter of claim 13, wherein the opening of the through cut has a straight shape.

21. The adapter of claim 13, wherein the through cut is disposed in the tubular wall at a designated angle between the longitudinal axis of the hub and a perpendicular axis at the distal end of the hub.

22. The adapter of claim 21, wherein the designated angle is selected to capture the barrier material after being pierced by the edge of the through cut and guide the barrier material away from the needle assembly.

23. The adapter of claim 13, wherein the through cut has a distal end adjacent the distal end of the hub and a proximal end that is opposite the distal end of the through cut, and the opening extends between the distal end of the through cut and the proximal end of the through cut; and wherein the through cut is arranged in a selected one of a first direction and a second direction, the first direction allowing the distal end of the through cut to precede the proximal end of the through cut when the hub is rotated in a clockwise direction about the longitudinal axis, and the second direction allowing the distal end of the through cut to precede the proximal end of the through cut when the hub is rotated in a counterclockwise direction about the longitudinal axis.

24. The adapter of claim 13, wherein the hub is dimensioned at its proximal end to mate with a pen.

25. The adapter of claim 13, wherein the hub has a post section at its distal end that is dimensioned to fit in a cavity of the needle assembly packaging in which a needle assembly is stored and to receive at least part of the needle assembly; and wherein the through cut is disposed in the post section of the hub.

Description

BRIEF DESCRIPTION OF TI-IE DRAWINGS

[0022] The above and/or other aspects and advantages of embodiments of the invention will be more readily appreciated from the following detailed description, taken in conjunction with the accompanying drawings, of which:

[0023] FIG. 1 is an exploded perspective view of a conventional pen needle and the distal end of a conventional medication delivery pen;

[0024] FIG. 2 is an exploded perspective view of a conventional pen, a conventional pen needle and a conventional partially assembled pen needle magazine dispenser;

[0025] FIG. 3 is a perspective view of the medication delivery pen and pen needle magazine dispenser of FIG. 2, when attaching or removing the pen needle from the adapter;

[0026] FIG. 4A is a perspective view of an adapter constructed in accordance with an illustrative embodiment for use with a medication delivery pen to load a pen needle assembly;

[0027] FIGS. 4B and 4C are, respectively, partial perspective and cross-section views of the adapter in FIG. 4A;

[0028] FIGS. 5A, 5B and 5C are a sequence of views showing an adapter constructed in accordance with an illustrative embodiment piercing and scything a barrier material covering a cavity containing a pen needle assembly, and capturing and moving the material away from the cavity opening;

[0029] FIG. 6A is a perspective view of an adapter constructed in accordance with another illustrative embodiment for use with a medication delivery pen to load a pen needle assembly;

[0030] FIGS. 6B and 6C are, respectively, partial perspective and cross-section views of the adapter in FIG. 6A;

[0031] FIG. 7A is a perspective view of an adapter constructed in accordance with another illustrative embodiment for use with a medication delivery pen to load a pen needle assembly; and

[0032] FIGS. 7A and 7B are, respectively, partial perspective and cross-section views of an adapter constructed in accordance with yet another illustrative embodiment for use with a medication delivery pen to load a pen needle assembly;

[0033] FIGS. 8A and 8B are, respectively, partial perspective and cross-section views of an adapter constructed in accordance with still yet another illustrative embodiment for use with a medication delivery pen to load a pen needle assembly;

[0034] FIG. 9A is a perspective view of an example pen needle magazine dispenser having an individual sterility barrier for a corresponding cavity containing a pen needle assembly; and

[0035] FIGS. 9A and 9B are perspective views, respectively, of an example needle assembly container, and an example package having a pen needle assembly and an individual sterility barrier.

[0036] Throughout the drawing figures, like reference numbers will be understood to refer to like elements, features and structures.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0037] Reference will now be made in detail to embodiments of the present invention, which are illustrated in the accompanying drawings. The embodiments described herein exemplify, but do not limit, the present invention by referring to the drawings.

[0038] With reference to FIGS. 4A, 4B and 4C, the tip or distal end of an example pen, or an example detachable adapter 160 for the pen, is constructed in accordance with an illustrative embodiment to overcome the above-described problems of a sterility barrier or other material 150 covering a cavity 35 in the container 30 of a pen needle magazine dispenser or covering a package (e.g. the package 42 in FIG. 9B containing a single needle assembly 100). As described herein, the tip or distal end 164 of an example adapter 160 shall be described in accordance with different example embodiments illustrated in FIGS. 4A through 8B. It is to be understood, however, that the tip or distal end 164 of the adapter 160 can be integrally provided to an example pen. In other words, the adapter 160 is not threaded or snap-fit to the end of a pen, but rather the pen has a distal end or tip thereof that is integrally formed thereon and similar to the distal end or tip 164 of the adapter 160 in accordance with the different example embodiments illustrated in FIGS. 4A through 8B.

[0039] When pierced to remove a needle assembly 100, all or part of the barrier or packaging material 150 can bunch at the opening to the cavity 35 or package 42, which can impede connection between the adapter 160 and the needle assembly 100 and/or impede movement of the connected adapter and needle assembly in and out of the cavity 35 or package 42. It is to be understood that the sterility barrier or other material 150 used to enclose a pen needle assembly 100 (i.e., in a cavity 35 of a container 30 or an individual needle assembly package 42) has a designated thickness Th and can be deployed as a layer across multiple cavities in a container 35 (e.g., FIG. 2), or as a single label or sticker 150 over a package 42 (FIG. 9B) or over respective ones of the cavities 35 in a container 30 (FIG. 9A).

[0040] As shown in FIGS. 4A, 4B and 4C, the example adapter 160 has an interior space or channel 163 extending along its longitudinal axis that is dimensioned and shaped to receive a pen needle assembly 100 at its distal end 164. The adapter 160 has a proximal end 161 configured to be connected to or mounted on the distal end 6 of a pen 1. For example, the adapter 160 can have a hub 166 with threads 162 at its proximal end 161 for cooperating with threads 8 on the distal end 6 of a pen 1. The hub 166 can have an integral section thereof configured as a post 165 that is dimensioned at its distal end 164 to be inserted at least partially into a cavity 35 of a container, or into a package 42, that is dimensioned to store a needle assembly 100 therein. The hub 166 therefore can have a similar diameter to a pen (e.g., about ⅜ inch (in) or 88 millimeters (mm) interior diameter of the interior space or channel 163 plus the thickness of the wall of the hub 166 on each side of the interior diameter). The hub 166 can be removably engaged with the pen 1 (e.g., via threads, or snap or pressure fit) or can be integral to the pen 1. The post 165 can have a diameter similar to that of a needle assembly 100 (e.g., about ⅛ in or less than 0.150 in as illustrated by an example diameter C shown in FIG. 2), for example. The shape of the interior space or channel 163 and the exterior shape of the hub 166 and post 165 are illustrated as tubular or cylindrical. It is to be understood that the interior space or channel 163, and the exterior shape of the hub 166 or post 165 can have different shapes such as triangular in cross-section of the interior space, or triangular perimeter of the hub 166 and/or post 165, and that the dimensions and shape can vary internally or externally along the longitudinal axis of the adapter 160. In addition, the exterior of the hub 160 can be provided with ribs 168 or other texture to improve gripping thereof by a user, or can be smooth.

[0041] In accordance with an advantageous aspect of illustrative embodiments, the tip or distal end 164 of the adapter 160 is provided with a through cut 200 in the tubular wall of the post 165. As will be described below in connection with various illustrative embodiments, the through cut 200 can have different lengths, widths, shapes and angles between a scything edge 208 of the through cut 200 and the distal end surface 204 of the adapter (hereinafter referred to as the scything angle 210), and each of these characteristics can impact the ability of the adapter to pierce and guide the barrier material 150 away from the cavity 35 or package 42 containing the needle assembly 100. In addition and accordance with another advantageous aspect of illustrative embodiments, the tip of the scything edge 208 can be configured as a tooth 202 with a shape (e.g. point) that facilitates piercing the material 150. Further, the tooth 202 can extend a selected distance from the distal end surface 204 to improve effectiveness of piercing the material 150, as well as catching the material 150 and guiding it away from the interior or opening of the cavity 35 or package 42.

[0042] In accordance with an illustrative embodiment depicted in FIGS. 4A, 4B and 4C, the through cut 200 has an arcuate shape. The length of the through cut 200, the width of the through cut 200, the degree of curve of the through cut 200's arcuate shape, and the direction of the through cut 200 (e.g., extending from the distal end surface 204 to the right or left direction such as to the right as depicted in the elevation view of the adapter 160 in FIG. 4C), and the scything angle 210 can be selected and can vary, depending on the flexibility and thickness of the material 150. For example, a larger width and/or length of the through cut 200 can allow capture of more material 150 than a smaller width and/or length. This larger width and/or length of the through cut 200 can be helpful when piercing a material 150 layer (e.g., a layer covering an area on top of the container 30 in FIG. 2 that includes plural cavity 35 openings) versus a material 150 label (e.g, a label covering only an individual cavity opening as shown in FIG. 9A). Further, the scything angle 210 and the degree of curve of the through cut 200's arcuate shape impacts the scything edge 208's ability to cut through the material and therefore both can be selected to optimize guidance of pierced and/or cut portion(s) 152 of the material 150 away from the interior or opening of the cavity 35 or package 42.

[0043] In accordance with another aspect of illustrated embodiments, the adapter 160 through cut 200 can be configured to form a tooth 202 that extends a selected distance from the distal end surface 204 to improve effectiveness of piercing the material 150. For example, the tooth 202 can extend beyond the distal end surface 204 by a distance d that is greater than or equal to the thickness of the material 150 (d≥Th) to aid piercing and scything. In addition, the tooth 202 can have different shapes such as having a pointed end, a rounded end, or a blunt end.

[0044] Reference is now made to FIGS. 5A, 5B and 5C, which depict a sequence of operations of the adapter 160 depicted in FIGS. 4A-4C piercing and scything a material 150 in accordance with an illustrative embodiment. For illustrative purposes, FIGS. 5A, 5B and 5C depict a partial, cross-sectional view of a layer of a material 150 covering a cavity 35 in a container 40 having a needle assembly disposed therein, as evidenced by the showing of the end of the needle assembly catheter 105 that is inserted into the space 163 in the adapter 160 when the adapter 160 successfully connects with the needle assembly 100. FIGS. 5A, 5B and 5C also depict a partial, cross-sectional of an adapter 160's post 165 having a through cut 200. Also shown are the scything edge 208 and tooth 202 of the adapter 160. In the illustrated embodiment of FIG. 5A, the tooth 202 of the adapter 160 is in contact with the material 150 but has not yet pierced it. When the adapter 160 is pressed by a user into the container cavity 35, which could also be another type of needle assembly package 42 with barrier material 150, the tooth 202 precedes the distal end surface 204 of the adapter 160 and pierces the material 150 to create a punctured opening in the material, as depicted in FIG. 5B. With reference to FIG. 5C, further movement of the post 165 down into the cavity 35 causes trimmed or cut material piece(s) 152 to be guided along the scything edge 208. Further, the adapter 160 can be rotated clockwise to encourage scything or cutting of the material 150 in a circular motion such that additional trimmed or cutaway material 152 can be guided away from the opening of the cavity by the guiding edge 208 of the through cut 200. Accordingly, the adapter 160 realizes the advantages of conveniently piercing the material 150 to access a stored, unused needle assembly 100 from a package (i.e., cavity 35 in a container 40 or interior space of a package 42), and ensuring that material pieces 152 are guided away from the storage cavity or space and therefore do not become lodged therein. The material 150 is therefore less likely to impede the connection of the adapter 160 (i.e., or pen with integrally formed with a tip or distal end that is similar to the distal end 164 of the adapter 160) to the stored needle assembly 100. Further, the material 152 is less likely to hinder movement of the connected needle assembly 100 from the cavity or space for use, and then back into the cavity or space for final storage and disposal after use.

[0045] In accordance with another illustrative embodiment depicted in FIGS. 6A, 6B and 6C, an adapter 160 has a through cut 202 that is straight compared to the arcuate through cut in the adapter 160 depicted in FIGS. 4A, 4B and 4C. The adapter 160 can optionally have multiple through cuts 202 such as the three through cuts 202 disposed about the periphery of the tubular wall, as shown in FIGS. 6A and 6B. Also, the scything angle 210 of the adapter 160 in FIGS. 6A, 6B and 6C is greater than the scything angle 210 of the adapter 160 depicted in FIGS. 4A, 4B and 4C. The straightened scything edge 208 and larger scything angle in FIGS. 6A, 6B and 6C can be more effective at physically moving pierced material 152 away from opening to cavity 35 or package 42 than the scything edge 208 and scything angle 210 of the adapter 160 depicted in FIGS. 4A, 4B and 4C. For example, the through cut 202 in FIGS. 6A, 6B and 6C can be dimensioned to have more space for capturing trimmed material piece(s) 152 that the through cut 202 in the adapter 160 depicted in FIGS. 4A, 4B and 4C. Also, the larger the scything angle 210 of the adapter 160 in FIGS. 6A, 6B and 6C can be useful to draw the material piece(s) 152 farther above and away from the container 40's cavity 35 or the interior space of a package 42 than the through cut 202 in the adapter 160 depicted in FIGS. 4A, 4B and 4C.

[0046] In accordance with another aspect of illustrated embodiments, the through cut 202 of an adapter 160 or distal end of a pen may not be completely through the wall of the post 165, such that distal end surface 204 can have solid perimeter around access orifice 206 as in FIG. 6B. As stated above, the hub 166 and/or port 165, and/or their opening 163 and access orifice 206, can be different cross-sectional shapes such as circular or triangular or other shape.

[0047] As stated above, the direction of the through cut 202 can be selected for operating the scything edge 208 during a clockwise or counterclockwise motion of the adapter 160 by a user. For example, the direction of the through cut 200 shown in FIGS. 4B and 4C is for clockwise rotation of the pen 1 with adapter 160 to pierce and cut barrier material 150 covering a container 40 or package 42. FIGS. 7A and 7B depict the through cut 200 shown in FIGS. 4B and 4C, except in an opposite direction for counterclockwise rotation of the pen 1 with adapter 160 to pierce and cut barrier material 150 covering a container 40 or package 42.

[0048] Similarly, the direction of the through cut 200 shown in FIGS. 6B and 6C is for clockwise rotation of the pen 1 with adapter 160 to pierce and cut barrier material 150 covering a container 40 or package 42. FIGS. 8A and 8B depict the through cut 200 shown in FIGS. 6B and 6C, except in an opposite direction for counterclockwise rotation of the pen 1 with adapter 160 to pierce and cut barrier material 150 covering a container 40 or package 42.

[0049] It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the above description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or carried out in various ways. Also, it will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled” and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting.

[0050] The above-presented description and figures are intended by way of example only and are not intended to limit the present invention in any way except as set forth in the following claims. It is particularly noted that persons skilled in the art can readily combine the various technical aspects of the various elements of the various illustrative embodiments that have been described above in numerous other ways, all of which are considered to be within the scope of the invention.