Patent Description:
Insulin and other injectable medications are commonly given with drug delivery devices, such as a drug delivery pen, whereby a disposable pen needle is attached to facilitate drug container access and allow fluid egress from the container through the needle into the patient.

Drug delivery devices, such as the exemplary drug delivery pen <NUM> shown in <FIG> and <FIG>, typically comprise a dose knob/button <NUM>, an outer sleeve <NUM>, and a cap <NUM>. The dose knob/button <NUM> allows a user to set the dosage of medication to be injected. The outer sleeve <NUM> is gripped by the user when injecting medication. The cap <NUM> is used by the user to securely hold the drug delivery pen <NUM> in a shirt pocket, purse or other suitable location and provide cover/protection from accidental needle injury.

<FIG> is an exploded view of the drug delivery pen <NUM> of <FIG>. The dose knob/button <NUM> has a dual purpose and is used both to set the dosage of the medication to be injected and to inject the dosed medicament via the leadscrew <NUM> and stopper <NUM> through the medicament cartridge <NUM>, which is attached to the drug delivery pen through a lower housing <NUM>. In standard drug delivery pens, the dosing and delivery mechanisms are all found within the outer sleeve <NUM> and are not described in greater detail here as they are understood by those knowledgeable of the prior art. The distal movement of the plunger or stopper <NUM> within the medicament cartridge <NUM> causes medication to be forced into the needle <NUM> of the hub <NUM>. The medicament cartridge <NUM> is sealed by septum <NUM>, which is punctured by a septum penetrating needle cannula <NUM> located within the hub <NUM>. The hub <NUM> is preferably screwed onto the lower housing <NUM>, although other attachment means can be used, such as attaching to the cartridge <NUM>. To protect a user, or anyone who handles the pen injection device <NUM>, an outer cover <NUM>, which attaches to the hub <NUM>, covers the hub. An inner shield <NUM> covers the patient needle <NUM> within the outer cover <NUM>. The inner shield <NUM> can be secured to the hub <NUM> to cover the patient needle by any suitable means, such as an interference fit or a snap fit. The outer cover <NUM> and the inner shield <NUM> are removed prior to use. The cap <NUM> fits snugly against outer sleeve <NUM> to allow a user to securely carry the drug delivery pen <NUM>.

The medicament cartridge <NUM> is typically a glass tube sealed at one end with the septum <NUM> and sealed at the other end with the stopper <NUM>. The septum <NUM> is pierceable by a septum penetrating cannula <NUM> in the hub <NUM>, but does not move with respect to the medicament cartridge <NUM>. The stopper <NUM> is axially displaceable within the medicament cartridge <NUM> while maintaining a fluid tight seal.

An exploded perspective view of a pen needle <NUM> of an exemplary drug delivery pen is shown in <FIG>. The pen needle <NUM> includes the cover (outer shield) <NUM>, an inner shield <NUM>, a needle cannula <NUM>, and a hub <NUM>. A proximal end <NUM> of the needle cannula <NUM> is inserted into a center opening in the distal (patient) end <NUM> of the hub <NUM> until a predetermined length of the distal (patient) end <NUM> of the needle cannula <NUM> remains extended. The needle cannula <NUM> is secured by epoxy or adhesive in the distal end <NUM> of the hub <NUM> within the hub protrusion <NUM>.

To protect users from injury and the needle cannula <NUM> from being damaged, the inner shield <NUM> covers the exposed portion of the needle cannula <NUM>. The open proximal end <NUM> of the inner shield <NUM> is placed over the exposed portion of the needle cannula <NUM>. The open proximal end <NUM> of the cover <NUM> envelops the inner shield <NUM>, needle cannula <NUM>, and hub <NUM>.

The distal end <NUM> of the cover <NUM> is closed to prevent contamination and damage to the inner components of the pen needle <NUM>, and to prevent injury to anyone who may handle it prior to use. The proximal end <NUM> of the hub <NUM> is typically covered by a sanitary paper or foil cover or label (not shown) glued on an end <NUM> of the cover <NUM>. The pen needle is then ready for shipment to a user. When the user is ready to use the pen needle, the sanitary cover (not shown) is removed from the cover <NUM>, the hub <NUM> is screwed onto a lower housing <NUM> of a standard pen <NUM> (<FIG> and <FIG>), and the cover <NUM> and shield <NUM> are separately removed from the hub <NUM>/cannula <NUM> subassembly by a pulling action. The distal end <NUM> of the inner shield <NUM> is closed to cover the distal end <NUM> of the needle cannula <NUM> after the cover <NUM> is removed to protect the user from an accidental needle stick. The inner shield <NUM> is then removed to access the needle cannula <NUM>.

Following an injection with a drug delivery pen <NUM>, as shown in <FIG> and <FIG>, the used pen needle, which includes the hub <NUM> and needle <NUM>, or "sharps", are unthreaded from the lower housing <NUM> and properly disposed of, such as in a sharps container. Used sharps may become contaminated by body fluids and the like creating a hazard for anyone that may handle them following their use. Sharps disposal containers store the disposed sharps and prevent unintentional contact with any object disposed therein.

As noted above, removing a used pen needle from the drug delivery pen <NUM> for proper disposal presents a safety risk because the used needle <NUM> is exposed. Accordingly, a need exists for removing a used pen needle from a drug delivery pen that substantially reduces or eliminates accidental needle sticks.

Existing drug delivery pens are disclosed in <CIT>, and <CIT>.

<CIT> discloses a removal device for removing and disposing of a pen needle. A cam within a rotatable ejector assembly is moved axially during ejector assembly rotation so that a second end of the cam provides a pen needle ejecting motion. Summary of the Invention.

In accordance with the present invention, a removal device removes a used pen needle from a drug delivery device without exposing the needle.

In accordance with the present invention, a removal device is disposed in a cap of a drug delivery device for removing a used pen needle from a drug delivery device without exposing the needle.

The foregoing objects are basically attained by providing a removal device as defined by the appended claims for removing and disposing of a pen needle connectable to a drug delivery device. The removal device includes a body having a cavity for receiving the pen needle of the drug delivery device. A patient end of a needle of the pen needle is covered by the body of the removal device. An ejector is movably connected to the body for engaging the received pen needle and selectively ejecting the engaged pen needle from the body. The ejected pen needle can be properly disposed of in a sharps container without exposing a needle of the pen needle, thereby substantially preventing an accidental needle stick.

The foregoing objects are also attained by providing a method as defined by the appended claims of removing a pen needle from a drug delivery device without exposing a needle thereof. The pen needle of the drug delivery device is inserted in a cavity of a body of a removal device. A patient end of a needle of the pen needle is covered by the body of the removal device. The received pen needle is engaged with an ejector movably connected to the body. The drug delivery pen is removed from the body of the removal device such that the engaged pen needle is retained by the body. The engaged pen needle is selectively ejected from the body with the ejector. The ejected pen needle can be properly disposed of in a sharps container without exposing a needle of the pen needle, thereby substantially preventing an accidental needle stick.

Objects, advantages, and salient features of the invention will become apparent from the following detailed description, which, taken in conjunction with the annexed drawings, discloses exemplary embodiments of the invention.

The above benefits and other advantages of the various embodiments of the present invention will be more apparent from the following detailed description of exemplary embodiments of the present invention and from the accompanying drawing figures, in which:.

Throughout the drawings, like reference numbers will be understood to refer to like parts, components and structures.

With reference to <FIG>, a removal device <NUM> for removing and disposing of a pen needle <NUM> connectable to a drug delivery device <NUM>, in accordance with an example not being part of the present invention, includes a body <NUM> having a cavity <NUM> for receiving the pen needle of the drug delivery device such that a patient end <NUM> of a needle <NUM> of the pen needle is covered by the body. An ejector <NUM> is movably connected to the body <NUM> for engaging the received pen needle <NUM> and selectively ejecting the engaged pen needle from the body. The ejected pen needle <NUM> can be properly disposed of in a sharps container without exposing a needle <NUM> of the pen needle, thereby substantially preventing an accidental needle stick. While the following description and details of exemplary embodiments of the present invention are generally disclosed with respect to a typical drug delivery device, such as the drug delivery pen shown in <FIG> and <FIG>, the present invention can more broadly apply to a pen needle for use in conjunction with other injection devices, such as syringes and infusion devices. The assembly and operation of a typical drug delivery pen <NUM>, as shown in <FIG> and <FIG>, is described in <CIT>.

As described above, the drug delivery pen <NUM> includes a lower housing <NUM> to which a hub <NUM> of the pen needle <NUM> is threadably connected, as shown in <FIG>. The pen needle <NUM> includes a needle <NUM> and a hub <NUM>. A proximal end of the needle <NUM> is inserted into a center opening in the distal (patient) end of the hub <NUM> until a predetermined length of the distal (patient) end <NUM> of the needle <NUM> remains extended. The needle <NUM> is secured by epoxy or adhesive in the distal end of the hub <NUM> within the hub protrusion <NUM>. A plurality of recesses <NUM> are formed in the outer surface of the hub <NUM>, as shown in <FIG>.

The pen needle removal device <NUM> includes a body <NUM>, as shown in <FIG>. The body <NUM> includes an outer wall <NUM>, an inwardly tapering wall <NUM>, and an inner wall <NUM>, as shown in <FIG>. The outer wall <NUM> extends upwardly from a free end <NUM> to an upper edge <NUM>. The free end <NUM> of the outer wall <NUM> forms a base, thereby allowing the removal device <NUM> to sit flat on a surface to facilitate removing a pen needle <NUM> from the drug delivery device <NUM>. The inwardly tapering wall <NUM> tapers inwardly from the upper edge <NUM> to an inner edge <NUM>. The inner wall <NUM> extends toward the base from the inner edge <NUM>. The inner wall <NUM> preferably has a first portion <NUM> having a first diameter and a second portion having a second diameter. The first portion <NUM> of the inner wall <NUM> extends from the inner edge <NUM>. Inwardly extending ribs <NUM> can be formed on an inner surface of the first portion <NUM> of the inner wall, as shown in <FIG>. An inwardly extending shoulder <NUM> is formed at the end of the first portion <NUM>, and the second portion <NUM> extends toward the base from the shoulder <NUM>. The first diameter is larger than the second diameter. A first opening <NUM> is formed in an end of the inner wall <NUM> to receive the ejector <NUM>. Preferably, the body <NUM> of the removal device <NUM> is unitarily formed as a single piece. Although the removal device <NUM> is shown having an inwardly tapering wall to form a concave configuration, the removal device may be configured to be convex or planar. Preferably, the removal device <NUM> is made of plastic.

A cavity <NUM> is formed in the body <NUM> and is defined by the inwardly tapering wall <NUM> and the inner wall <NUM>. The cavity <NUM> accommodates a pen needle <NUM>, as shown in <FIG>. The first portion <NUM> of the inner wall <NUM> accommodates the hub <NUM> of the pen needle, as shown in <FIG> and <FIG>. Preferably, an interference fit is formed between the first portion <NUM> of the inner wall <NUM> and the pen needle hub <NUM>. The shoulder <NUM> is a stop to limit insertion of the drug delivery device <NUM> by engaging a surface of the pen needle hub <NUM>. The hub protrusion <NUM> is received within the second portion <NUM> of the inner wall <NUM>.

The ejector <NUM> has a flange <NUM> and a wall <NUM> extending therefrom. Feet <NUM> extend outwardly from the free end of the wall <NUM>. The ejector <NUM> extends through the opening <NUM>, as shown in <FIG>. The feet <NUM> prevent the ejector from being withdrawn past the shoulder <NUM> and the flange <NUM> prevents the ejector from being pushed through the first opening <NUM>. A second opening <NUM> is formed in the free end <NUM> of the outer wall <NUM> to provide access to the ejector <NUM>. The flange <NUM> facilitates selective manipulation of the ejector by the user.

To remove the pen needle <NUM> from the drug delivery device <NUM>, such as after the pen needle has been used to make an injection, the drug delivery device is inserted in the cavity <NUM> of the removal device <NUM> until the base surface <NUM> of the pen needle hub <NUM> abuts the shoulder <NUM> of the removal device, as shown in <FIG>. The base of the removal device <NUM> can be placed on a table to facilitate insertion of the drug delivery device <NUM>, thereby further preventing accidental needle sticks by not requiring the user to hold the removal device. The hub protrusion <NUM> and needle <NUM> are disposed within the wall <NUM> of the ejector <NUM>. An interference fit is created between the pen needle hub <NUM> and the second portion <NUM> of the inner wall <NUM> of the removal device <NUM>, thereby securely retaining the pen needle <NUM> within the removal device while the lower housing <NUM> of the drug delivery device <NUM> is rotated and unthreaded from the pen needle <NUM>, as shown in <FIG>. The friction between the hub <NUM> of the pen needle <NUM> and the second portion <NUM> of the inner wall <NUM> of the removal device <NUM> prevents movement of the pen needle as the drug delivery device <NUM> is unthreaded from the removal device <NUM>. Preferably, the diameter of the second portion <NUM> is less than that of the pen needle hub <NUM> to create the interference fit therebetween. The pen needle <NUM> is securely retained within the removal device <NUM> with the patient end <NUM> of the needle <NUM> shielded within the wall <NUM> of the ejector <NUM> such that the user can carry the removal device <NUM> with the pen needle <NUM> disposed therein until the pen needle can be properly disposed of, such as in a sharps container.

Alternatively, the ribs <NUM> formed on the second portion <NUM> of the inner wall <NUM> of the removal device <NUM> engage the recesses <NUM> formed in the pen needle hub <NUM>. Accordingly, the ribs <NUM> prevent rotation of the pen needle hub <NUM> such that the drug delivery device <NUM> can be unthreaded from the removal device <NUM> while securely retaining the pen needle <NUM> in the removal device.

When the pen needle <NUM> is to be ejected from the removal device <NUM>, the user pushes the ejector flange <NUM> inwardly in a direction substantially opposite to the insertion direction of the drug delivery device, as shown in <FIG>. The ejector <NUM> is moved in a direction substantially parallel to a longitudinal axis of the needle <NUM>. The second portion <NUM> of the inner wall <NUM> guides movement of the ejector wall <NUM> during ejection of the pen needle <NUM>. The feet <NUM> engage the base surface <NUM> of the hub <NUM>, thereby overcoming the interference fit between the hub <NUM> and the second portion <NUM> of the inner wall <NUM> such that the pen needle <NUM> can be properly disposed of.

In an exemplary embodiment of the present invention shown in <FIG>, the removal device comprises a cap <NUM>. As described above, the drug delivery pen <NUM> includes a lower housing <NUM> to which a hub <NUM> of the pen needle <NUM> is threadably connected, as shown in <FIG>. The pen needle <NUM> includes a needle <NUM> and a hub <NUM>. A proximal end of the needle <NUM> is inserted into a center opening in the distal (patient) end of the hub <NUM> until a predetermined length of the distal (patient) end <NUM> of the needle <NUM> remains extended. The needle <NUM> is secured by epoxy or adhesive in the distal end of the hub <NUM> within the hub protrusion <NUM>.

The pen needle removal device, or cap, <NUM>, as shown in <FIG>, includes a body <NUM> having first and second openings <NUM> and <NUM> disposed at opposite ends thereof. The drug delivery device <NUM> is inserted through the second opening and the ejector <NUM> is inserted through the first opening <NUM>. A flexible clip <NUM> is connected to the body <NUM> of the cap <NUM> to facilitate carrying the drug delivery device <NUM> by the user. An inwardly extending retaining ring <NUM> is disposed on an inner surface <NUM> of the body <NUM>, as shown in <FIG> and <FIG>. The retaining ring <NUM> preferably extends around an entire inner circumference of the cap body <NUM>. A cavity <NUM> within the cap <NUM> is defined by the body <NUM> of the cap.

The ejector <NUM> has a base <NUM> from which a wall <NUM> extends outwardly, as shown in <FIG>. A tab <NUM> extends outwardly from the wall <NUM> proximate the base <NUM>. The tab <NUM>, which preferably extends around the entire circumference of the wall <NUM>, engages an end <NUM> of the cap <NUM>, as shown in <FIG>, to limit movement of the ejector <NUM> into the cap <NUM>.

The ejector <NUM> can have a plurality of flexible fingers <NUM> disposed proximate an end <NUM> of the ejector wall <NUM>, as shown in <FIG>. A tab <NUM> extends outwardly from each of the flexible fingers <NUM>. Each tab <NUM> has a flat surface <NUM> that abuts an end <NUM> of a recess <NUM> formed in an inner surface <NUM> of the cap <NUM>. The flexible fingers <NUM> flex inwardly to allow insertion of the ejector <NUM> into the cap <NUM>. The engagement of the flat surface <NUM> of the flexible finger tab <NUM> with the end <NUM> of the recess <NUM> in the cap body <NUM> prevents complete withdrawal of the ejector <NUM> from the cap <NUM>.

The ejector <NUM> is movable between first and second positions. In a first position, as shown in <FIG> and <FIG>, the ejector <NUM> is pushed into the cap body <NUM> such that the ejector tab <NUM> abuts the end <NUM> of the cap <NUM>. As shown in <FIG>, the cap wall <NUM> is received between the retaining ring <NUM> and the threaded portion of the lower housing <NUM>. The end <NUM> of the ejector <NUM> also abuts the retaining ring <NUM>. When the ejector is in the first position, it is an indication to the user that a pen needle is not connected to the drug delivery device <NUM>.

In the second position, the ejector <NUM> is partially withdrawn from the cap body <NUM>, as shown in <FIG>. The ejector <NUM> being in the second position is an indication to the user that a pen needle <NUM> is connected to the drug delivery device <NUM>. The insertion of the pen needle <NUM> causes the base <NUM> of the hub <NUM> to partially push the ejector <NUM> out of the cap <NUM>. Movement of the ejector <NUM> out of the cap <NUM> is limited by engagement of the flat surface <NUM> of the flexible finger tab <NUM> with the end <NUM> of the recess <NUM> in the cap body <NUM>.

When a drug delivery device <NUM> with a pen needle <NUM> attached thereto is inserted in the cavity <NUM> of the cap <NUM>, a base surface <NUM> of the hub <NUM> engages the end <NUM> of the ejector wall <NUM> and moves the ejector from the first position (<FIG>) to the second position (<FIG>). The drug delivery device <NUM> is further inserted in the cap <NUM> until an interference fit is created between the outer surface of the hub wall <NUM> and the retaining ring <NUM>, as shown in <FIG> and <FIG>, thereby preventing further insertion of the drug delivery device. The drug delivery device <NUM> can then be rotated and unthreaded from the pen needle <NUM> such that the pen needle is securely retained in the cap <NUM>, as shown in <FIG>. Friction between the retaining ring <NUM> and the pen needle hub <NUM> prevents the pen needle from rotating and being removed with the drug delivery device <NUM>. The patient end <NUM> of the needle <NUM> is covered by the ejector <NUM>, thereby preventing accidental needle sticks. The user can carry the cap <NUM> with the pen needle <NUM> securely retained therein until the pen needle can be properly disposed of, such as in a sharps container.

Alternatively, the retaining ring <NUM> can be formed as a plurality of ribs around the inner surface of the cap <NUM> that engage the recesses <NUM> (<FIG>) in the pen needle hub <NUM>. When the drug delivery device <NUM> is rotated, the retaining ring ribs <NUM> engage the recesses in the pen needle hub <NUM>, thereby preventing the pen needle <NUM> from rotating with the drug delivery device. Accordingly, the pen needle <NUM> is securely retained in the cap <NUM>.

When the pen needle <NUM> is to be ejected from the cap <NUM>, the user pushes the base <NUM> of the ejector <NUM> inwardly in a direction substantially opposite to the insertion direction of the drug delivery device <NUM>, as shown in <FIG>. The ejector <NUM> is moved in a direction substantially parallel to a longitudinal axis of the needle <NUM>. The end <NUM> of the ejector wall <NUM> engages the base surface <NUM> of the hub <NUM>, thereby overcoming the interference fit between the hub <NUM> and the retaining ring <NUM> of the cap <NUM> such that the pen needle <NUM> can be properly disposed of. The ejector tab <NUM> abuts the end <NUM> of the cap <NUM>, thereby limiting insertion of the ejector <NUM> into the cap.

The ejector cavity <NUM>, which is defined by the base <NUM> and the wall <NUM>, can accommodate an inner shield <NUM> (<FIG>) disposed on the hub protrusion <NUM>. To perform an injection, the user removes the cap <NUM> from the drug delivery device <NUM>, thereby providing access to the pen needle <NUM>. Pulling the cap overcomes the interference fit between the pen needle hub <NUM> and the retaining ring <NUM>, such that the pen needle hub remains connected to the drug delivery device <NUM>. Alternatively, the retaining ring ribs <NUM> do not engage the walls of the pen needle hub <NUM> so that the drug delivery device can be pulled outwardly from the cap <NUM> with the pen needle <NUM> connected to the drug delivery device. The inner shield <NUM> is then removed from the pen needle hub <NUM> so that the injection can be made. The used pen needle is then reinserted into the cap <NUM>, as described above, such that the ejector <NUM> moves to the second position, as shown in <FIG>, thereby indicating the presence of a pen needle. The used pen needle can then be properly disposed of as described above.

Claim 1:
A removal device for removing and disposing of a pen needle (<NUM>) connectable to a drug delivery device (<NUM>), comprising:
a cap (<NUM>) having a body (<NUM>) having a cavity (<NUM>) for receiving the pen needle (<NUM>) of the drug delivery device (<NUM>) such that a patient end (<NUM>) of a needle (<NUM>) of the pen needle (<NUM>) is covered by said body (<NUM>);
a first and a second opening (<NUM>, <NUM>) disposed at opposite ends of said body (<NUM>), and removably connectable to the drug delivery device (<NUM>) inserted through said second opening (<NUM>); and
an ejector (<NUM>) movably connected to said body (<NUM>) via said first opening (<NUM>), said ejector (<NUM>) comprising and ejector cavity (<NUM>) for engaging the received pen needle (<NUM>) and selectively ejecting the engaged pen needle (<NUM>) from said body (<NUM>),
wherein
said ejector (<NUM>) is in a partially withdrawn position from the cap body (<NUM>) when said cap (<NUM>) is connected to the drug delivery device (<NUM>) to which the pen needle (<NUM>) is connected, as an indication that the pen needle (<NUM>) is connected to the drug delivery device (<NUM>), and
said ejector (<NUM>) is in an inserted position when said cap (<NUM>) is connected to the drug delivery device (<NUM>) to which the pen needle (<NUM>) is not connected, as an indication that the pen needle (<NUM>) is not connected to the drug delivery device (<NUM>).