Patent Description:
In the field of medicament packaging, it is known to store a drug content, in the form for example of a lyophilized drug, a power drug, or an active substance of a drug, in a medical container usually referred to as a "vial". A vial is typically made of glass and is sealed by an elastomeric septum that is crimped by an aluminum cap. A portion of elastomer at the center of the septum is covered by a plastic or aluminum part. This part can be removed by a healthcare professional prior to the reconstitution procedure so that the healthcare professional can have access to a center portion made of rubber, which can be pierced by a needle of an injection device such as a syringe.

To reconstitute the drug, the user usually uses a disposable syringe to transfer the diluent from an ampoule or a vial into the vial containing the lyophilized drug or power drug. When the diluent is already stored in a prefilled syringe, the healthcare professional transfers the diluent directly from the syringe to the vial containing the lyophilized drug. The healthcare professional uses a needle for this transfer in order to pierce the rubber septum of the vial.

However, this process commonly involves a number of steps. First, a standard needle may be attached to a syringe that is pre-filled with diluent. Second, the needle may be used to pierce a stopper of a vial containing the dry vaccine. Finally, the dry vaccine and diluent are mixed, and the solution is aspirated back into the syringe for administration, typically by piercing the vial stopper with the needle. It is an object of this invention to provide an improvement over this technique, which suffers from a number of drawbacks.

Indeed, during the whole process, the needle tip may be damaged due to the removal of the needle shield, piercing of the septum of the vial, and/or misalignment during insertion of the needle. A damaged or bent needle, or a needle which may contain burs, is thus significantly less sharp than it was before piercing the vial stopper during reconstitution, which may cause pain to a patient during the injection of the drug. To this end, various adapters are used, see for example <CIT>, <CIT>, <CIT>, <CIT>, or <CIT>.

Another major drawback of the known processes is that, when the user withdraws the reconstituted drug from the vial through the needle, the user needs to adjust the length of the portion of the needle that is inserted in the vial as the amount of drug in the vial decreases. In a practical way, the user needs to slowly draw the needle back from the container by pulling the syringe away from the vial, so that the opening of the needle constantly remains in contact with the drug, in other terms, below the surface of the drug. Not only is this handling hard to perform, but also such movement of the needle in the vial may lead to a loss of a significant amount of drug that remains in the vial.

In one aspect, a medical device is provided. The medical device is configured to be connectable with a vial. The medical device includes a tubular body and an adapter. The tubular body defines a container for containing a composition, and has a spike located at a distal end thereof. The spike has at least one through hole in fluid communication with the container. The adapter is formed with or coupled to the body, and is located at or about the spike.

In another aspect, a medical device assembly including a plunger and the aforementioned medical device is provided.

In another aspect, a method of reconstitution of a pharmaceutical composition is provided. The method includes providing the aforementioned medical device assembly, connecting the adapter with the vial, the vial containing a solid drug, injecting a quantity of diluent from the medical device assembly into the vial, mixing the diluent and the solid drug in the vial to create a reconstituted pharmaceutical composition, aspirating the reconstituted pharmaceutical composition from the vial into the body, and detaching the adapter from the body.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary aspects of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.

The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the concept. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art.

For purposes of the description hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the concept as it is oriented in the drawing figures. However, it is to be understood that the concept may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the concept.

As employed herein, the term "distal" shall mean a generally patient-contacting end of an object. As employed herein, the term "proximal" shall mean a location farthest from a distal location of an object.

As employed herein, the term "number" shall mean one or an integer greater than one (e.g., a plurality).

<FIG> shows an isometric view of a medical device assembly <NUM> and medical device <NUM> for the same, and shown with a vial <NUM> spaced from the medical device assembly <NUM>, in accordance with one non-limiting embodiment of the disclosed concept. In one example non-limiting embodiment, the medical device assembly <NUM> is a syringe assembly, and the medical device <NUM> is a syringe barrel. However, it will be appreciated that suitable alternative medical devices and assemblies are contemplated herein. The medical device assembly <NUM> can generally be stated as including a plunger <NUM> and the medical device <NUM>. The plunger <NUM> is partially located within the medical device <NUM> and is configured to slide within the medical device <NUM> in order to move a solution into and out of the medical device <NUM>. <FIG> shows the medical device assembly <NUM> connected to the vial <NUM>. Typically, the vial <NUM> will be closed by a pierceable septum. The vial <NUM> may initially contain a solid drug, such as a dry vaccine and the medical device assembly <NUM> may initially contain a pharmaceutical composition such as a diluent. When the medical device assembly <NUM> is connected to the vial <NUM>, as shown in <FIG>, the solid drug and pharmaceutical composition can be mixed by expelling the pharmaceutical composition into the vial <NUM>, and the resultant composition, such as a vaccine, can be aspirated back into the medical device assembly <NUM> for administration to a patient. This process will be further discussed below, along with advantages associated with employing the medical device assembly <NUM> and medical device <NUM> for the same, such as protecting medical practitioners from undesirable injury during reconstitution and/or administration of vaccines.

<FIG> shows an isometric view of the medical device <NUM>, and <FIG> shows an enlarged view of a portion of the medical device <NUM> of <FIG>. As shown in <FIG>, the medical device <NUM> has a tubular body <NUM> having a distal end <NUM> and an opposite and spaced apart, proximal end <NUM>. The body <NUM> further has a spike <NUM> located at the distal end <NUM>, and the spike <NUM> is preferably hollow and has at least one through hole <NUM>, <NUM> (see also <FIG>) in order to allow a solution to exit and enter the body <NUM>. In the exemplary embodiment, it will be appreciated that manufacturing the medical device <NUM> is advantageously simplified by employing more than one through hole <NUM>, <NUM> in the spike <NUM>. However, suitable alternative embodiments, such as those with a spike having only one single through hole, are contemplated herein. The medical device <NUM> also includes a flange <NUM> extending from the proximal end <NUM> of the body <NUM>, and in one example embodiment, being located generally perpendicular with respect to, the body <NUM>. The medical device <NUM> further includes an adapter <NUM> formed with or coupled to the body <NUM>. As such, it will be appreciated that the body <NUM> and the adapter <NUM> may be a unitary component made from one single piece of material, e.g., an injection molded piece wherein the piece of material is formed from one or more polymers. When connecting the medical device <NUM> having the adapter <NUM> to a vial, the spike <NUM> is configured to pierce the septum of the vial to allow the reconstitution of a drug.

Continuing to refer to <FIG>, the example adapter <NUM> is located at or about the spike <NUM>, and has a number of deflector members (eight example deflector members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are shown in <FIG>) each configured to be connectable with the vial <NUM> (<FIG> and <FIG>). The deflector members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be a plurality of deflector members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> surrounding the spike <NUM>, and configured to deflect radially inwardly and outwardly with respect to the spike <NUM>. Advantageously, the adapter <NUM> includes from two to ten deflector members, preferably from four to eight deflector members. Typically, an adapter member will include four, five, six, seven or eight deflector members. Preferably, each of the deflector members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> includes an elongated member <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and a tooth <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> extending inwardly from the elongated member toward a longitudinal axis (see, for example, longitudinal axis <NUM> shown in <FIG>) of the body <NUM>. Advantageously, each of the elongated members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> extends parallel to a longitudinal axis, such as axis <NUM>.

Referring to <FIG>, functionality of the deflector member <NUM> will now be discussed. While the deflector member <NUM> is being discussed herein, it will be appreciated that each of the other example deflector members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> functions substantially the same as the deflector member <NUM>. As shown in <FIG>, the elongated member <NUM> of the deflector member <NUM> has an end portion <NUM> located opposite and proximally from the tooth <NUM> of the deflector member <NUM>. <FIG> further shows the deflector member <NUM> in a first position in solid line drawing, and in a second, deflected position <NUM>' in dashed line drawing. As shown, the deflected position <NUM>' corresponds to the deflector member <NUM> having been radially outwardly deflected about the end portion <NUM>. More specifically, deflected position <NUM>' preferably corresponds to the position of the deflector member <NUM> when the vial <NUM> (<FIG> and <FIG>) and the medical device <NUM> are being moved into a connected position with respect to each other. Thus, during this movement, the vial <NUM> causes the deflector member <NUM> to initially deflect radially outwardly, e.g., to the deflected position <NUM>', and then move back radially inwardly to the non-deflected position, shown in solid line drawing in <FIG>. In one example embodiment, each of the deflector members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are configured to be connectable with the vial <NUM> via a snap-fit mechanism. Accordingly, the deflector members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are preferably biased toward the non-deflected positions. As such, subsequent to moving radially inwardly, the teeth (see teeth <NUM>,<NUM> in <FIG>) advantageously maintain the connection between the vial <NUM> and the medical device <NUM>, thereby allowing for fluid communication between the vial <NUM> and the medical device <NUM>. Specifically, when the vial <NUM> is connected to the medical device <NUM>, at least a portion of the vial <NUM> is located between the teeth <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and the spike <NUM> in order to provide for a relatively secure connection between the adapter <NUM> and the vial <NUM>. See <FIG> for purposes of illustration. Although the disclosed concept has been discussed so far in conjunction with the adapter <NUM> having deflector members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to allow for connection to the vial <NUM>, it will be appreciated that suitable alternative connection mechanisms and/or adapters having different geometries (not shown) are contemplated herein.

Moreover, as shown in <FIG>, it will be appreciated that not all deflector members <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be configured to have the exact same geometry. For example, the deflector member <NUM> is longer than the deflector member <NUM>, which is located adjacent the deflector member <NUM>.

<FIG> is a rear isometric view of the medical device <NUM> and <FIG> is an enlarged view of a portion of the medical device <NUM> of <FIG>. As shown, the adapter <NUM> has an annular-shaped base portion <NUM>. The adapter <NUM> further comprises a number of attachment portions <NUM>, <NUM>, <NUM>, <NUM> (see also <FIG>) extending from the base portion <NUM> to the wall <NUM>. The adapter may comprise at least two attachment portions, preferably between two and six attachment portions, more preferably the adapter comprises four attachment portions <NUM>, <NUM>, <NUM>, <NUM>. The attachment portions <NUM>, <NUM>, <NUM>, <NUM> may be attached to the wall <NUM> at spaced apart isolated locations. The attachment portions <NUM>, <NUM>, <NUM>, <NUM> may be formed together, for example by injection molding. The base portion <NUM> generally surrounds the spike <NUM> and is preferably concentric with the wall <NUM>. However, suitable alternative arrangements are contemplated herein. Furthermore, the attachment portions <NUM>, <NUM>, <NUM>, <NUM> are configured to be selectively removed from the wall <NUM> responsive to rotation of the adapter <NUM> with respect to the body <NUM>. The attachment portions <NUM>, <NUM>, <NUM>, <NUM> are thus breakable from the wall <NUM> from which they were previously attached. Accordingly, the entire adapter <NUM>, in one example embodiment, is removably attached to wall <NUM> such that grasping and rotating the adapter <NUM> with respect to the tubular body <NUM> causes the adapter <NUM> to detach from the rest of the medical device <NUM>. Thus, the attachment portions <NUM>, <NUM>, <NUM>, <NUM> preferably provide the only location at which the adapter <NUM> is attached to the body <NUM>, and advantageously provide a relatively strong mechanism for attachment, but weak enough to allow for selective removal of the entire adapter <NUM> from the body <NUM>. The detachment of the adapter <NUM> from the medical device <NUM> is advantageously irreversible. The purpose of this attribute of the medical device <NUM> will be discussed below.

In addition to being configured to be connectable with the vial <NUM>, the adapter <NUM> is configured to be connectable with a needle hub, such as needle hub <NUM> shown in <FIG>. In one example embodiment, in order to provide for this connection, the adapter <NUM> further includes an annular-shaped wall <NUM> extending distally from the body <NUM>, shown in <FIG>, and through which the spike <NUM> extends. The external surface of the wall <NUM> may extend distally from the tubular body <NUM>. The wall <NUM> may have a threaded inner surface <NUM> configured to be threadably connected with the needle hub <NUM>. However, suitable other connection mechanisms between adapters and needle hubs are within the scope of the disclosed concept.

<FIG> show one process by which the disclosed concept may be employed. Simplified depictions, not drawn to scale, of a plunger <NUM>, a vial <NUM>, a medical device <NUM>, and additional components, are shown. It will be appreciated that these components function substantially the same as the medical device assembly <NUM>, vial <NUM>, and components to be used in conjunction therewith, and like numbers represent like components. As shown in <FIG>, first a spike cap <NUM> may be removed from the spike <NUM>. Next, as shown in <FIG>, the adapter <NUM>, e.g., and the deflector members <NUM>, <NUM>, are connected with the vial <NUM>. As the vial <NUM> and adapter <NUM> are being connected, the spike <NUM> pierces a septum or stopper <NUM> of the vial to provide a fluid pathway between an interior of the vial <NUM> and an interior of the medical device <NUM>. Next, as shown in <FIG>, the plunger <NUM> has been depressed in order to move a quantity of diluent <NUM> from the medical device <NUM> into the vial <NUM>, which contains a quantity of solid drug <NUM>. As shown in <FIG>, shaking of the vial <NUM> causes the diluent and solid drug to mix, resulting in a mixed reconstituted pharmaceutical composition <NUM>.

<FIG> depict the mixed reconstituted pharmaceutical composition <NUM> being aspirated back into the interior of the medical device <NUM> by the plunger <NUM>. In <FIG>, the adapter <NUM> and vial <NUM> have together been rotated off of, e.g., detached from, the spike <NUM>. Although a wall, similar to wall <NUM> above, has not been shown with the medical device <NUM>, it will be appreciated that detachment of the adapter <NUM> from the wall <NUM> may be achieved in a similar manner by which the adapter <NUM> is detached from the spike <NUM>. See, for example, discussion above with reference to the attachment portions <NUM>, <NUM>, <NUM>, <NUM> being detached from the wall <NUM> via rotation by a user. With the adapter <NUM> detached from the spike <NUM>, the needle hub <NUM> may readily be connected to the spike <NUM>, as shown in <FIG>. While shown in <FIG> as being connected to the spike <NUM> via a press-fit mechanism, it will be appreciated that the needle hub <NUM> may be connected to the spike <NUM>, or a suitable alternative portion of the adapter <NUM>, via any suitable alternative coupling mechanism, e.g., without limitation, via a threaded connection or being snap-fitted onto the spike <NUM>. Subsequently, removal of a needle shield <NUM> from the needle hub <NUM> presents a needle <NUM> prepared for use with a patient. Because the needle <NUM> has not been previously employed for use with creating the reconstituted pharmaceutical composition <NUM>, e.g., the needle <NUM> was not inserted into the stopper <NUM> and used to inject diluent and aspirate the reconstituted pharmaceutical composition <NUM> back into the medical device <NUM>, the needle <NUM> is advantageously in a safer condition for use with the patient. Specifically, problems of existing methods, such as burs being created by needles piercing stoppers and needles losing their sharpness as a result of piercing stoppers, are solved by employing the medical device <NUM>, e.g., and the medical device <NUM> discussed above, which use the spikes <NUM>, <NUM> for this function.

<FIG> shows the medical device assembly <NUM> connected to the vial <NUM>, with the diluent and solid drug mixed in the vial <NUM>, resulting in the reconstituted pharmaceutical composition <NUM>. <FIG> shows the medical device assembly <NUM> with the adapter <NUM> having been detached, in the manner discussed above, and with the reconstituted pharmaceutical composition <NUM> having been aspirated back into the body <NUM>. Furthermore, a needle hub <NUM> has been threadably connected to the threaded inner surface <NUM>. Accordingly, a needle <NUM>, which is connected to the needle hub <NUM>, is in a relatively safe condition for use with a patient, for the same reasons discussed above in connection with <FIG>. Thus, removal of a needle shield <NUM> (also shown in <FIG>) from the needle hub <NUM> exposes the relatively sharp and substantially bur-free needle <NUM> for use with a patient.

In accordance with another exemplary embodiment of the concept, <FIG> shows another medical device <NUM> that may be employed in a medical device assembly in substantially the same manner as the medical device <NUM> and medical device assembly <NUM>. However, as shown, the medical device <NUM> is different than the medical device <NUM>. First, the medical device <NUM> has four deflector members (only one deflector member <NUM> is indicated in <FIG>). Second, while the deflector member <NUM> has an elongated member <NUM> and a tooth <NUM> extending therefrom, the elongated member <NUM> has a through hole.

It will be appreciated that a method of reconstitution of a pharmaceutical composition includes providing the medical device assembly <NUM>, the medical device <NUM> containing a pharmaceutical composition such as a diluent, connecting the adapter <NUM> with the vial <NUM>, the vial <NUM> containing a solid drug, such as a lyophilized pharmaceutical, injecting a quantity of diluent from the medical device assembly <NUM> into the vial <NUM>, mixing the diluent and the solid drug in the vial to create a reconstituted pharmaceutical composition <NUM>, aspirating the reconstituted pharmaceutical composition <NUM> from the vial <NUM> into the body <NUM>, and detaching the adapter <NUM> from the body <NUM>. The method may also optionally include the steps of removing a spike cap from the spike <NUM>, and optionally injecting the reconstituted pharmaceutical composition <NUM> into a patient.

Accordingly, the disclosed concept provides for an improved (e.g., without limitation, safer, better in terms of imparting less pain to a patient) medical device assembly <NUM> and medical device <NUM>, <NUM>, <NUM> for the same, in which a solid drug such as a vaccine can be mixed with a pharmaceutical composition such as a diluent and thus a reconstituted pharmaceutical composition may be obtained and administered to a patient with a needle <NUM>, <NUM> that is substantially more sharp and relatively free of burs.

Claim 1:
A medical device (<NUM>, <NUM>) configured to be connected to a vial (<NUM>, <NUM>), the medical device (<NUM>, <NUM>) comprising:
a tubular body (<NUM>) defining a container for containing a composition (<NUM>, <NUM>);
a spike (<NUM>, <NUM>) located at a distal end (<NUM>) of the body (<NUM>), the spike (<NUM>, <NUM>) having at least one through hole (<NUM>) in fluid communication with the container;
an annular wall (<NUM>) extending distally from the body (<NUM>), the spike (<NUM>) extending through the annular wall (<NUM>); and
an adapter (<NUM>, <NUM>) for connection of the medical device (<NUM>, <NUM>) to the vial (<NUM>, <NUM>), the adapter (<NUM>, <NUM>) removably coupled to the spike (<NUM>) or the annular wall (<NUM>) and comprising an annular base portion (<NUM>) generally surrounding the spike (<NUM>, <NUM>),
characterized in that
a number of attachment portions (<NUM>, <NUM>, <NUM>, <NUM>) extend from the base portion (<NUM>) of the adapter (<NUM>, <NUM>), and each attachment portion (<NUM>, <NUM>, <NUM>, <NUM>) is connected to the spike (<NUM>) or the wall (<NUM>), wherein upon rotation of the adapter (<NUM>, <NUM>) with respect to the body (<NUM>), each attachment portion is irreversibly detached from the spike (<NUM>) or the wall (<NUM>), thereby allowing the adapter (<NUM>, <NUM>) to be removed from the medical device (<NUM>, <NUM>).