Patent Description:
The present application relates generally to a drug transfer device and, more particularly, to a drug transfer device and system for transferring liquid medicament between containers. Such a drug transfer device is known from <CIT>.

Health care providers reconstituting, transporting, and administering hazardous drugs, such as cancer treatments, can put health care providers at risk of exposure to these medications and present a major hazard in the health care environment. For example, nurses treating cancer patients risk being exposed to chemotherapy drugs and their toxic effects. Unintentional chemotherapy exposure can affect the nervous system, impair the reproductive system, and bring an increased risk of developing blood cancers in the future. In order to reduce the risk of health care providers being exposed to toxic drugs, the closed transfer of these drugs becomes important.

Some drugs must be dissolved or diluted before they are administered, which involves transferring a solvent from one container to a sealed vial containing the drug in powder or liquid form, by means of a needle. Drugs may be inadvertently released into the atmosphere in gas form or by way of aerosolization, during the withdrawal of the needle from the vial and while the needle is inside the vial if any pressure differential between the interior of the vial and the surrounding atmosphere exists.

In one aspect, a drug transfer device includes a housing having a first end and a second end positioned opposite the first end, a vial attachment configured to secure the drug transfer device to a drug vial, a vial transfer member defining a passageway, with the vial transfer member configured to pierce a seal of a drug vial, a cannula received within the housing, with the cannula in fluid communication with the passageway of the vial transfer member and having a first end and a second end positioned opposite from the first end, a seal arrangement positioned within the housing, with the seal arrangement movable within the housing between a first position where the cannula is isolated from the first end of the housing and a second position where the cannula is configured to be in fluid communication with a mating connector received by the first end of the housing, and a connection member defining a passageway in fluid communication with the passageway of the vial transfer member, with the connection member configured to receive a mating connector.

The vial attachment may be secured to the second end of the housing. The second end of the cannula may be secured to the vial attachment, with the cannula extending from the vial attachment towards the first end of the housing with a first end of the cannula positioned intermediate the first and second ends of the housing. The connection member may extend from the vial attachment member. The passageway of the vial transfer member may include first and second passageways extending along a longitudinal direction of the vial transfer member, with the first passageway axially spaced from the second passageway and in fluid communication with the cannula and the second passageway in fluid communication with the passageway of the connection member. The seal arrangement may include a collet having a first end and a second end and a membrane received by the collet, with at least a portion of the collet received within the housing. The collet includes a body and a locking member connected to the body, with the collet is movable from a first position where the locking member is open to receive a mating connector to a second position where radially outward movement of the locking member is restricted. The connection member may include a membrane.

In a further aspect, a system for transferring a liquid medicament between containers includes a syringe adapter having a first end configured to be secured to a syringe barrel and a second end, an infusion adapter having a connection member and a container access member configured to be secured to an infusion container, and a drug transfer device. The drug transfer device including a housing having a first end configured to receive the connection member of the infusion adapter and a second end positioned opposite the first end, a vial attachment configured to secure the drug transfer device to a drug vial, a vial transfer member defining a passageway, with the vial transfer member configured to pierce a seal of a drug vial, a cannula received within the housing, with the cannula in fluid communication with the passageway of the vial transfer member and having a first end and a second end positioned opposite from the first end, a seal arrangement positioned within the housing, with the seal arrangement movable within the housing between a first position where the cannula is isolated from the first end of the housing and a second position where the cannula is configured to be in fluid communication with the infusion adapter when the infusion adapter is received by the first end of the housing, and a connection member defining a passageway in fluid communication with the passageway of the vial transfer member, with the connection member configured to receive the syringe adapter.

The system may include an air delivery pump in fluid communication with the first end of the syringe adapter. The system may include a drug measuring device and a controller in communication with the drug measuring device and the air delivery pump, with the controller configured to actuate the air delivery pump based on dosage information received from the drug measuring device. The air delivery pump may be in fluid communication with the first end of the syringe adapter via a delivery tube.

In a further aspect, a method for transferring liquid medicament between containers includes: securing a drug transfer device to a drug container comprising a liquid medicament; securing an infusion adapter to the drug transfer device; securing an infusion container to the infusion adapter; and introducing air into the drug container via the drug transfer device to transfer the liquid medicament from the drug container to the infusion container via the drug transfer device and the infusion adapter.

The method may further include inverting the drug container prior to introducing air into the drug container. The method may further include: securing a syringe adapter to the drug transfer device; securing a syringe barrel to the syringe adapter; and injecting air into the drug container via the syringe barrel, the syringe adapter, and the drug transfer device to introduce the air into the drug container. The air may be introduced into the drug container via the drug transfer device via an air delivery pump. The method may include securing a delivery tube to the drug transfer device, with the delivery tube extending between the drug transfer device and the air delivery pump. The method may include: sending dosage information to a controller in communication with the air delivery pump; and actuating the air delivery pump based on the dosage information. The method may include measuring a volume and/or a weight of the infusion container via a drug measuring device, with the drug measuring device sending one or more of a volume measurement, weight measurement, and the dosage information to the controller; and actuating the air delivery pump via the controller until the infusion container receives a prescribed dosage of the liquid medicament.

The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of aspects of the disclosure taken in conjunction with the accompanying drawings, wherein:.

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 aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the scope of the present invention as defined by the appended claims.

It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.

Referring to <FIG>, a drug transfer device <NUM> according to one aspect of the present application includes a housing <NUM>, a vial attachment <NUM>, a vial transfer member <NUM>, a cannula <NUM>, a seal arrangement <NUM>, and a connection member <NUM>. The housing <NUM> has a first end <NUM> and a second end <NUM> positioned opposite the first end <NUM> and defines a central opening <NUM>. The vial attachment <NUM> is configured to secure the drug transfer device <NUM> to a drug container <NUM>, such as a drug vial. The vial attachment <NUM> includes protrusions <NUM> that are deflected radially outward upon engagement with the drug container <NUM> and return to their original position with the protrusions <NUM> positioned under a closure <NUM> of the drug container <NUM> thereby securing the drug transfer device <NUM> to the drug container <NUM>, as shown in <FIG> and <FIG>. The vial transfer member <NUM> defines a passageway <NUM> and is configured to pierce the closure or seal <NUM> of the drug container <NUM>. The vial transfer member <NUM> extends from a portion of the vial attachment <NUM>, although the vial transfer member <NUM> may also extend from the housing <NUM>. The cannula <NUM> is received within the housing <NUM> and is in fluid communication with the passageway <NUM> of the vial transfer member <NUM>. The cannula <NUM> has a first end <NUM> and a second end <NUM> positioned opposite from the first end <NUM>. The seal arrangement <NUM> is positioned within the housing <NUM>, with the seal arrangement <NUM> movable within the housing <NUM> between a first position where the cannula <NUM> is isolated from the first end <NUM> of the housing <NUM> and a second position where the cannula <NUM> is configured to be in fluid communication with a mating connector received by the first end <NUM> of the housing <NUM>. The connection member <NUM> defines a passageway <NUM> in fluid communication with the passageway <NUM> of the vial transfer member <NUM>, with the connection member <NUM> configured to receive and to be secured to a mating connector. The connection member <NUM> includes a membrane <NUM> that is configured to engage a membrane or seal of a mating connector.

Referring again to <FIG>, the vial attachment <NUM> is secured to the second end <NUM> of the housing <NUM>. The vial attachment <NUM> may be formed integrally with the housing <NUM> or may be formed separately from the housing <NUM> and attached to the housing <NUM>. The second end <NUM> of the cannula <NUM> is secured to the vial attachment <NUM> with the cannula <NUM> extending from the vial attachment <NUM> towards the first end <NUM> of the housing <NUM> with the first end <NUM> of the cannula <NUM> positioned intermediate the first and second ends <NUM>, <NUM> of the housing <NUM>. The connection member <NUM> extends from the vial attachment member <NUM>, although the connection member <NUM> may extend from the housing <NUM>. The connection member <NUM> extends from the vial attachment member <NUM> at a <NUM> degree angle relative to a longitudinal axis of the housing <NUM>, although other suitable angles may be utilized. The passageway <NUM> of the vial transfer member <NUM> includes first and second passageways <NUM>, <NUM> extending along a longitudinal direction of the vial transfer member <NUM>, with the first passageway <NUM> axially spaced from the second passageway <NUM> and in fluid communication with the cannula <NUM> and the second passageway <NUM> in fluid communication with the passageway <NUM> of the connection member <NUM>.

Referring to <FIG>, the seal arrangement <NUM> includes a collet <NUM> having a membrane <NUM> received by the collet <NUM>, with at least a portion of the collet <NUM> received within the housing <NUM>. The collet <NUM> includes a body <NUM> and a locking member <NUM> connected to the body <NUM>, with the collet <NUM> movable from a first position (<FIG>) where the locking member <NUM> is open to receive a mating connector to a second position (<FIG>) where radially outward movement of the locking member <NUM> is restricted. The seal arrangement <NUM> also includes a spring <NUM> to bias the seal arrangement <NUM> towards the first end <NUM> of the housing <NUM>.

As discussed in more detail below, the drug transfer device <NUM> is configured to facilitate the transfer of liquid medicament from the drug container <NUM> to a separate drug container, such as an infusion container <NUM> while ensuring the sealed and closed transfer of the liquid medicament.

Referring to <FIG>, a system <NUM> for transferring drugs between containers, according to one aspect of the present application, includes a syringe adapter <NUM>, an infusion adapter <NUM>, and the drug transfer device <NUM> discussed above in connection with <FIG>. The syringe adapter <NUM> has a first end <NUM> configured to be secured to a syringe barrel <NUM> and a second end <NUM> positioned opposite the first end <NUM>. The syringe adapter <NUM> may be one of the syringe adapters shown and described in <CIT>, which is hereby incorporated by reference in its entirety. The infusion adapter <NUM> has a connection member <NUM> and a container access member <NUM> configured to be secured to the infusion container <NUM>, such as an IV bag. The connection member <NUM> and the container access member <NUM> define a first passageway <NUM>. The infusion adapter <NUM> also includes a port <NUM> in fluid communication with a second passageway <NUM> defined by the container access member <NUM>. The first end <NUM> of the housing <NUM> of the drug transfer member <NUM> is configured to receive the connection member <NUM> of the infusion adapter <NUM>. The seal arrangement <NUM> of the drug transfer device <NUM> is movable within the housing <NUM> between the first position where the cannula <NUM> is isolated from the first end <NUM> of the housing <NUM> and the second position where the cannula <NUM> is configured to be in fluid communication with the infusion adapter <NUM> when the infusion adapter <NUM> is received by the first end <NUM> of the housing <NUM>, as shown in <FIG>. The connection member <NUM> of the drug transfer device <NUM> is configured to receive the syringe adapter <NUM>.

Referring again to <FIG>, the system <NUM> is utilized by securing the drug container <NUM> to the vial attachment <NUM> of the drug transfer device <NUM>, securing the connection member <NUM> of the infusion adapter <NUM> to the first end <NUM> of the housing <NUM> of the drug transfer device <NUM>, and securing the syringe adapter <NUM> to the connection member <NUM> of the drug transfer device <NUM>. The syringe barrel <NUM> is secured to the syringe adapter <NUM> and the infusion container <NUM> is secured to the infusion adapter <NUM>. With the drug container <NUM> inverted, as shown in <FIG>, a plunger <NUM> of the syringe barrel <NUM> is depressed to inject air into the drug container <NUM> via the syringe adapter <NUM> and the drug transfer device <NUM>, which forces the liquid medicament from the drug container <NUM> through the first passageway <NUM> of the vial transfer member <NUM>, through the cannula <NUM>, through the first passageway <NUM> of the connection member <NUM> of the infusion adapter <NUM>, and into the infusion container <NUM>.

Referring to <FIG> and <FIG>, a system <NUM> for transferring drugs between containers, according to one aspect of the present application, is shown. The system <NUM> of <FIG> is similar to the system <NUM> of <FIG>, except, rather than manually injecting air via the syringe barrel <NUM>, the system <NUM> utilizes an air delivery pump <NUM>, a delivery tube <NUM>, a controller <NUM>, and a drug measuring device <NUM>. The air delivery pump <NUM> is in fluid communication with the first end <NUM> of the syringe adapter <NUM> via the delivery tube <NUM> and is configured to deliver air to the drug container <NUM> to transfer liquid medicament from the drug container <NUM> to the infusion container <NUM> in the same manner as the syringe barrel <NUM> described above. The controller <NUM> is in communication with the drug measuring device <NUM> and the air delivery pump <NUM>. The controller <NUM> may be physically connected to the drug measuring device <NUM> and the air delivery pump <NUM> via a communication line and/or connected wirelessly. The controller <NUM> is configured to actuate the air delivery pump <NUM> based on dosage information received from the drug measuring device <NUM>. The drug measuring device <NUM> may be the drug measuring device from the BD Cato® system available from Becton, Dickinson and Company. The controller <NUM> includes at least one processor, or any other like computing device for controlling one or more aspects of the system <NUM>.

In one aspect, as shown in <FIG>, the system <NUM> is utilized by scanning the drug container <NUM> and the infusion container <NUM> utilizing the drug measuring device <NUM>, such as by scanning a bar code, RFID tag, or other suitable arrangement, and determining an amount of medicament to transfer for a prescribed dosage, which may be stored by the drug measuring device <NUM> as the dosage information. The volume and/or weight of the infusion container <NUM> is measured by the drug measuring device <NUM> and a determination is made whether the infusion container <NUM> includes the prescribed dosage. The air delivery pump <NUM> is actuated via the controller <NUM> with the drug measuring device <NUM> continuing to measure the volume and/or weight of the infusion container <NUM> until the prescribed dosage is attained. In one aspect, the controller <NUM> actuates the air delivery pump <NUM> a set time based upon the desired volume of liquid medicament that needs transferred from the drug container <NUM> to the infusion container <NUM>.

According to one aspect of the present application, a method for transferring liquid medicament between containers includes securing the drug transfer device <NUM> to the drug container <NUM> including the liquid medicament, securing the infusion adapter <NUM> to the drug transfer device <NUM>, securing the infusion container <NUM> to the infusion adapter <NUM>, and introducing air into the drug container <NUM> via the drug transfer device <NUM> to transfer the liquid medicament from the drug container <NUM> to the infusion container <NUM> via the drug transfer device <NUM> and the infusion adapter <NUM>. The method may include inverting the drug container <NUM> prior to introducing air into the drug container <NUM>.

In one aspect, the method includes: securing the syringe adapter <NUM> to the drug transfer device <NUM>; securing the syringe barrel <NUM> to the syringe adapter <NUM>; and injecting air into the drug container <NUM> via the syringe barrel <NUM>, the syringe adapter <NUM>, and the drug transfer device <NUM> to introduce the air into the drug container <NUM>.

In a further aspect, air is introduced into the drug container <NUM> via the drug transfer device <NUM> via an air delivery pump <NUM>. The method may further include securing the delivery tube <NUM> to the drug transfer device <NUM>, with the delivery tube <NUM> extending between the drug transfer device <NUM> and the air delivery pump <NUM>. In one aspect, the method also includes sending dosage information to the controller <NUM> in communication with the air delivery pump <NUM> and actuating the air delivery pump <NUM> based on the dosage information.

In another aspect, the method includes measuring a volume and/or a weight of the infusion container <NUM> via the drug measuring device <NUM>, with the drug measuring device <NUM> sending one or more of a volume measurement, weight measurement, and the dosage information to the controller <NUM>, and actuating the air delivery pump <NUM> via the controller <NUM> until the infusion container <NUM> receives the prescribed dosage of the liquid medicament.

Claim 1:
A drug transfer device (<NUM>) comprising:
a housing (<NUM>) having a first end (<NUM>) and a second end (<NUM>) positioned opposite the first end (<NUM>);
a vial attachment (<NUM>) configured to secure the drug transfer device (<NUM>) to a drug vial;
a vial transfer member (<NUM>) defining a passageway (<NUM>), the vial transfer member (<NUM>) configured to pierce a seal (<NUM>) of a drug vial;
a seal arrangement (<NUM>) positioned within the housing (<NUM>), the seal arrangement (<NUM>) movable within the housing (<NUM>) between a first position where the cannula (<NUM>) is isolated from the first end (<NUM>) of the housing (<NUM>) and a second position where the cannula (<NUM>) is configured to be in fluid communication with a mating connector received by the first end (<NUM>) of the housing (<NUM>); and
a connection member (<NUM>), characterized in that the connection member (<NUM>) defines a passageway (<NUM>) in fluid communication with the passageway (<NUM>) of the vial transfer member (<NUM>), the connection member (<NUM>) configured to receive a mating connector; the drug transfer device further comprising a cannula (<NUM>) received within the housing (<NUM>), the cannula (<NUM>) being in fluid communication with the passageway (<NUM>) of the vial transfer member (<NUM>), the cannula (<NUM>) having a first end (<NUM>) and a second end (<NUM>) positioned opposite from the first end (<NUM>).