Patent Description:
Medication delivery pens have been developed to facilitate the self-administration of medication. A conventional medication delivery pen is identified generally by the numeral <NUM> in <FIG>. Pen <NUM> contains a cartridge with sufficient medication for several doses. The conventional cartridge has opposed proximal and distal ends. The distal end is closed by a pierceable and resealable rubber septum identified by the numeral <NUM> in <FIG>. The proximal end receives a stopper in sliding fluid-tight engagement. The conventional cartridge is disposed in an elongate pen-like body <NUM> with a proximal end (not shown) and an opposed distal end <NUM>. The proximal end of the pen body includes a plunger for selectively driving the stopper of the cartridge in the distal direction and a dose setting mechanism for determining the distance through which the plunger and stopper can move. Distal end <NUM> of pen body <NUM> includes an array of threads <NUM> for threaded engagement with a pen needle assembly <NUM>. Pen needle assembly <NUM> includes a needle cannula <NUM> with opposed proximal and distal points <NUM> and <NUM> and a threaded mounting skirt <NUM> which surrounds the proximal tip <NUM>. Mounting skirt <NUM> is threadably engageable with threads <NUM> on distal end <NUM> of pen body <NUM>. A safety shield <NUM> is releasably engaged over distal point <NUM> and portions of mounting skirt <NUM> to prevent accidental needle sticks. Existing medication delivery pens are further disclosed in <CIT>.

A person who must periodically inject doses of medication will carry a medication delivery pen <NUM> and a supply of pen needle assemblies <NUM>. Each pen needle assembly <NUM> has its needle cannula <NUM> safely and sterility sealed in its own shield <NUM>, and is accessed immediately prior to administering a dose of medication. Pen needle assembly <NUM> is then mounted to distal end <NUM> of the pen <NUM>. This mounting causes proximal point <NUM> of needle cannula <NUM> to pierce rubber septum <NUM> of the cartridge, to place needle cannula <NUM> in communication with the medication in pen <NUM>. Pen <NUM> is then used to inject the selected dose of medication. After completing the injection, needle assembly <NUM> is separated from pen <NUM> and is discarded. Pen <NUM> may be used repeatedly in this manner until the medication is exhausted. Such pens <NUM> offer many conveniences and efficiencies. However, the storage of unused needles and the final disposal of used needles has presented problems. In particular, supplies of new needles often are loosely scattered in the bottom of purses or briefcases, and used needles are often disposed of unsafely.

With reference to <FIG> and <FIG>, a pen needle magazine dispenser is configured to store sterile, unused needles and provides means to store used needles until final disposal. As shown in <FIG>, an example pen needle magazine dispenser includes a container <NUM> which can have a cover (not shown). Container <NUM> includes a top surface covered by a sterility barrier <NUM>. Container <NUM> includes a plurality of cavities <NUM>, with each cavity <NUM> dimensioned to receive a sleeve <NUM> containing a pen needle assembly <NUM>, described further below. Each pen needle assembly <NUM> is originally sealed in its respective sleeve <NUM> and cavity <NUM> by the sterility barrier <NUM> that is attached to the top surface of container <NUM>. The sterility barrier <NUM> can comprise, for example, a substrate with apertures aligned with the cavities <NUM> and a clear or opaque plastic or foil film adhered to the substrate. The sterility barrier <NUM> can also be adhered directly to the top surface of the container <NUM>. Thus, the sterility barrier <NUM> provides sterility for unused pen needle assemblies <NUM> contained in each sleeve <NUM> in a cavity <NUM>, and a simple means for the user to identify whether the pen needle assembly <NUM> in a particular sleeve <NUM> has been used. For example, the sterility barrier <NUM> can have indicia printed thereon such as indicia printed over the aperture for each cavity <NUM> that corresponds to a location of a pen needle assembly <NUM>.

<FIG> also depicts an exploded perspective view of a pen needle assembly <NUM>, an adapter <NUM> and a medication delivery pen <NUM> exploded therefrom. Adapter <NUM> includes a hub <NUM> with an open proximal end <NUM> having a set of threads <NUM> dimensioned to mate with threads <NUM> on distal end <NUM> of conventional medication delivery pen <NUM>. Adapter <NUM> also includes a post <NUM> with an opening <NUM> in its distal end <NUM>. The hub <NUM> and post <NUM> share a channel for receiving a needle assembly <NUM>. For example, the hub <NUM> and post <NUM> can be defined by a tubular wall and are integral to the adapter. After adapter <NUM> has been threaded onto distal end <NUM> of pen <NUM>, distal end <NUM> of adapter <NUM> is used to remove pen needle assembly <NUM> from sleeve <NUM> by inserting key <NUM> on proximal end <NUM> of needle assembly <NUM> into a corresponding key way within the adapter <NUM>.

With reference to <FIG>, pen needle assembly <NUM> includes a hub <NUM> having a plurality of keys <NUM> and a distal end <NUM> having a set of threads <NUM> thereon dimensioned to mate with the set of threads <NUM> within sleeve <NUM>. A needle cannula <NUM> is mounted within hub <NUM> and includes a distal point <NUM> and a proximal point <NUM>. When a key <NUM> of needle assembly <NUM> is inserted into a corresponding key way in the adapter <NUM>, rotation of medication delivery pen <NUM> causes pen needle assembly <NUM> to rotate within sleeve <NUM> and move key <NUM> of needle assembly <NUM> along the key way into a channel in the adapter <NUM>. As key <NUM> moves from the key way into the channel of the adapted <NUM>, edge <NUM> moves over a helical surface in the adapter <NUM> so to lock key <NUM> in the adapter channel and prevent pen needle assembly <NUM> from sliding out of adapter <NUM>. The adapter's helical surface interaction with edge <NUM> also aids in driving pen needle assembly <NUM> into adapter <NUM> to a predetermined position where surface <NUM> is in contact with distal end <NUM> of adapter <NUM> to firmly hold pen needle assembly <NUM> within adapter <NUM>.

To remove an unused needle assembly <NUM> from a cavity <NUM> of the container <NUM>, a pen <NUM> with adapter <NUM> is inserted into a cavity <NUM> in the container <NUM> of the pen needle magazine dispenser, as shown in <FIG>, and rotated (e.g., in the clockwise direction A) to attach a needle assembly <NUM> in the cavity <NUM> to the adapter <NUM> as described above. After use, the used pen needle assembly <NUM> mounted on adapter <NUM> on medication delivery pen <NUM> is reinserted into the sleeve <NUM> in the cavity until detent <NUM> and retention groove <NUM> mate and the set of threads <NUM> on pen needle assembly <NUM> come into contact with the set of threads <NUM> within sleeve <NUM>. Medication delivery pen <NUM> is then rotated in the opposite direction B, shown in <FIG>, to thread pen needle assembly <NUM> back into sleeve <NUM> and pen <NUM> is then pulled out of container <NUM> as pen needle assembly <NUM> is pulled out of adapter <NUM>.

The distal end <NUM> of the post <NUM> of the adapter <NUM> must break through the sterility barrier <NUM> over the cavity <NUM> to access the needle assembly <NUM> inside. A problem occurs when a piece(s) of the broken barrier <NUM> is pushed into the cavity <NUM> or otherwise bunches at the opening to the cavity <NUM>, which can impede connection between the adapter <NUM> and the pen needle assembly <NUM> and/or impede movement of the connected adapter and needle assembly in and out of the cavity <NUM>.

The above and other problems are overcome, and additional advantages are realized, by an injection pen having the features defined within claim <NUM> or by an adapter for an injection pen having the features defined within claim <NUM>.

It is an aspect of illustrative embodiments to provide a pen body, or detachable pen needle adapter, for an injection pen that comprises 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.

In accordance with aspects of illustrative embodiments, the edge of the through cut comprises a tooth that extends from the distal end.

In accordance with aspects of illustrative embodiments, the tooth extends from the distal end by a distance corresponding to at least the thickness of the barrier material.

In accordance with aspects of illustrative embodiments, the tooth comprises a pointed tip or a rounded tip.

In accordance with aspects of illustrative embodiments, the edge of the through cut comprises a scything edge along at least one side of the opening.

In accordance with aspects of illustrative embodiments, the opening of the through cut has an arcuate shape, or a straight shape.

In accordance with aspects of illustrative embodiments, 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. For example, 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.

In accordance with aspects of illustrative embodiments, 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.

In accordance with aspects of illustrative embodiments, 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.

It is an aspect of illustrative embodiments to provide an adapter for an injection pen having a hub comprising a tubular wall having a proximal end configured to be connected to an injection pen and the distal end thereof 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; and wherein the distal end of the tubular wall comprises the through cut.

In accordance with aspects of illustrative embodiments, the hub is dimensioned at its proximal end to mate with a pen. Further, 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 the through cut is disposed in the post section of the hub.

Additional and/or other aspects and advantages of the present invention will be set forth in the description that follows, or will be apparent from the description, or may be learned by practice of the invention. The present invention may comprise pen needle adapters and methods for operating same having one or more of the above aspects, and/or one or more of the features and combinations thereof. The present invention may comprise one or more of the features and/or combinations of the above aspects as recited, for example, in the attached claims.

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:.

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

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.

With reference to <FIG>, the tip or distal end of an example pen, or an example detachable adapter <NUM> for the pen, is constructed in accordance with an illustrative embodiment to overcome the above-described problems of a sterility barrier or other material <NUM> covering a cavity <NUM> in the container <NUM> of a pen needle magazine dispenser or covering a package (e.g. the package <NUM> in <FIG> containing a single needle assembly <NUM>). As described herein, the tip or distal end <NUM> of an example adapter <NUM> shall be described in accordance with different example embodiments illustrated in <FIG>. It is to be understood, however, that the tip or distal end <NUM> of the adapter <NUM> can be integrally provided to an example pen. In other words, the adapter <NUM> 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 <NUM> of the adapter <NUM> in accordance with the different example embodiments illustrated in <FIG>.

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

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

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

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

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

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

In accordance with another illustrative embodiment depicted in <FIG>, an adapter <NUM> has a through cut <NUM> that is straight compared to the arcuate through cut in the adapter <NUM> depicted in <FIG>. The adapter <NUM> can optionally have multiple through cuts <NUM> such as the three through cuts <NUM> disposed about the periphery of the tubular wall, as shown in <FIG>. Also, the scything angle <NUM> of the adapter <NUM> in <FIG> is greater than the scything angle <NUM> of the adapter <NUM> depicted in <FIG>. The straightened scything edge <NUM> and larger scything angle in <FIG> can be more effective at physically moving pierced material <NUM> away from opening to cavity <NUM> or package <NUM> than the scything edge <NUM> and scything angle <NUM> of the adapter <NUM> depicted in <FIG>. For example, the through cut <NUM> in <FIG> can be dimensioned to have more space for capturing trimmed material piece(s) <NUM> that the through cut <NUM> in the adapter <NUM> depicted in <FIG>. Also, the larger the scything angle <NUM> of the adapter <NUM> in <FIG> can be useful to draw the material piece(s) <NUM> farther above and away from the container <NUM>'s cavity <NUM> or the interior space of a package <NUM> than the through cut <NUM> in the adapter <NUM> depicted in <FIG>.

In accordance with another aspect of illustrated embodiments, the through cut <NUM> of an adapter <NUM> or distal end of a pen may not be completely through the wall of the post <NUM>, such that distal end surface <NUM> can have solid perimeter around access orifice <NUM> as in <FIG>. As stated above, the hub <NUM> and/or port <NUM>, and/or their opening <NUM> and access orifice <NUM>, can be different cross-sectional shapes such as circular or triangular or other shape.

As stated above, the direction of the through cut <NUM> can be selected for operating the scything edge <NUM> during a clockwise or counterclockwise motion of the adapter <NUM> by a user. For example, the direction of the through cut <NUM> shown in <FIG> is for clockwise rotation of the pen <NUM> with adapter <NUM> to pierce and cut barrier material <NUM> covering a container <NUM> or package <NUM>. <FIG> depict the through cut <NUM> shown in <FIG>, except in an opposite direction for counterclockwise rotation of the pen <NUM> with adapter <NUM> to pierce and cut barrier material <NUM> covering a container <NUM> or package <NUM>.

Similarly, the direction of the through cut <NUM> shown in <FIG> is for clockwise rotation of the pen <NUM> with adapter <NUM> to pierce and cut barrier material <NUM> covering a container <NUM> or package <NUM>. <FIG> depict the through cut <NUM> shown in <FIG>, except in an opposite direction for counterclockwise rotation of the pen <NUM> with adapter <NUM> to pierce and cut barrier material <NUM> covering a container <NUM> or package <NUM>.

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. 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.

Claim 1:
An injection pen, the injection pen comprising:
a pen body (<NUM>) comprising a tubular wall having a proximal end (<NUM>), and an opposite distal end (<NUM>) configured to be connected to a needle assembly (<NUM>) of the injection pen;
wherein the distal end (<NUM>) of the tubular wall comprises a through cut (<NUM>), the through cut (<NUM>) defining an opening in the tubular wall, the through cut (<NUM>) having an edge configured to pierce a barrier material (<NUM>) provided on a needle assembly packaging (<NUM>) of the needle assembly (<NUM>) when the distal end (<NUM>) is depressed against the needle assembly packaging (<NUM>) to access the needle assembly (<NUM>) stored therein, and the opening of the through cut (<NUM>) being configured to receive the pierced barrier material (<NUM>) to guide the pierced barrier material (<NUM>) away from the needle assembly (<NUM>),
wherein the through cut (<NUM>) is disposed in the tubular wall at a designated angle (<NUM>) between a longitudinal axis of the pen body (<NUM>) and a perpendicular axis at the distal end (<NUM>);
wherein the designated angle (<NUM>) is selected so that the through cut captures the barrier material (<NUM>) after being pierced by the edge of the through cut (<NUM>) and guide the captured barrier material (<NUM>) away from the needle assembly (<NUM>).