The present invention relates to a device for transferring a fluid to or from a fluid container have a sealing member.
Medical drugs and solvents are often supplied in glass or plastic containers, such as vials, bottles, or bags, which are sealed by a rubber, plastic or elastomeric bung, stopper, membrane, or puncturable cap. Such sealing members prevent deterioration or contamination of the drug, allow the contents of a container to be mixed by shaking, and prevent the contents of the container from leaking out and contaminating the surroundings. A cannula or a hollow spike defining a flow channel and an opening that communicates with the flow channel is usually inserted through such a sealing member to supply fluids to the container and to withdraw fluid therefrom.
Conventional devices used for accessing the containers utilize a piercing member that penetrates the sealing member of a container and defines an opening at a distal end of the piercing member. Typically, after the piercing member accesses the vial, the vial is inverted to withdraw the medicament from the container. Once the contents of the fluid container have drained to a level just under the outermost edge of the opening of the piercing member, no more fluid will be able to drain from the fluid container unless the piercing member is withdrawn slightly. Thus, often times the last few drops of the medicament (which may be very expensive and/or toxic) are not fully removed from the container, which results in waste and requires cleaning/disposal of the container. If the piercing member is retracted through the sealing member of the container to remove the remaining medicament in the container, toxic drug or medicament may leak out and contaminate the surrounding environment during such a procedure and non-filtered air containing undesirable particles such as dust, pollen, or bacteria may be drawn into the piercing member and contaminate the medicament therein. Accordingly, many conventional devices will be locked to the container or vial after the piercing member fully enters the vial. In some cases, containers are provided with an extra amount of the drug that is to be withdrawn to allow for the fact that not all of the drug will be withdrawn from the container. A user is then able to withdraw the recommended number of doses from the container, but doing so will increase the cost of each container of medical fluid, increase waste, and make cleaning or disposal of the container more complex. As sealing members are available in a wide variety of configurations, sizes, and thicknesses, designing a spike that is suitable for use with a plurality of different sealing members while optimizing the use of the drug in the vial in a safe and convenient manner is difficult.
In one aspect, a vial adapter includes a body having a component connection interface and a vial connection interface, with the component connection interface configured to engage a connection interface of a mating component, a pressure equalization assembly including a chamber configured to expand from a first volume to a second volume larger than the first volume, and a piercing member having a first end connected to the body and a second end positioned opposite the first end. The piercing member and the body define a fluid passageway and a pressure equalization passageway. The fluid passageway is in fluid communication with the component connection interface, the pressure equalization passageway is in fluid communication with the chamber of the pressure equalization assembly, and the piercing member defines first and second fluid ports in fluid communication with the fluid passageway and a pressure equalization port in fluid communication with the pressure equalization passageway. The second end of the piercing member includes a piercing point configured to pierce a closure of a vial, with the first and second fluid ports extending from a position intermediate the first and second ends of the piercing member to the second end of the piercing member. The first and second fluid ports and a portion of the piercing member define a V-shaped profile at the second end of the piercing member.
An open end of the V-shaped profile may face a radially outward direction relative to the piercing member. A bottom of the V-shaped profile may intersect with the piercing point of the piercing member. The first fluid port may be separated from the second fluid port by a partition wall positioned at the second end of the piercing member. A portion of the partition wall may be recessed radially inward relative to an outer surface of the piercing member. The first and second fluid ports may be configured to direct fluid radially outward relative to the piercing member. The first and second fluid ports may be elongate with a largest dimension of the first and second fluid ports extending in a direction from the first end of the piercing member to the second end of the piercing member. The first and second fluid ports may be configured to withdraw at least 98% of fluid from a vial. The first and second fluid ports may be configured to withdraw between 98% and 99.2% of fluid from a vial.
In a further aspect, a vial adapter includes a body having a component connection interface and a vial connection interface, with the component connection interface configured to engage a connection interface of a mating component, a pressure equalization assembly including a chamber configured to expand from a first volume to a second volume larger than the first volume, and a piercing member having a first end connected to the body and a second end positioned opposite the first end, with the piercing member and the body defining a fluid passageway and a pressure equalization passageway. The fluid passageway is in fluid communication with the component connection interface and the pressure equalization passageway is in fluid communication with the chamber of the pressure equalization assembly. The piercing member defines first and second fluid ports in fluid communication with the fluid passageway and a pressure equalization port in fluid communication with the pressure equalization passageway. The second end of the piercing member includes a piercing point configured to pierce a closure of a vial, with the first and second fluid ports extending from a position intermediate the first and second ends of the piercing member to the second end of the piercing member. The first and second fluid ports are configured to withdraw at least 98% of fluid from a vial.
The first and second fluid ports may be configured to withdraw between 98% and 99.2% of fluid from a vial. The first and second fluid ports and a portion of the piercing member may define a V-shaped profile at the second end of the piercing member. An open end of the V-shaped profile may face a radially outward direction relative to the piercing member. A bottom of the V-shaped profile may intersect with the piercing point of the piercing member. The first fluid port may be separated from the second fluid port by a partition wall positioned at the second end of the piercing member. A portion of the partition wall may be recessed radially inward relative to an outer surface of the piercing member. The first and second fluid ports may be configured to direct fluid radially outward relative to the piercing member. The first and second fluid ports may be elongate with a largest dimension of the first and second fluid ports extending in a direction from the first end of the piercing member to the second end of the piercing member. The vial adapter may further include a retractable sleeve receiving at least a portion of the piercing member. The retractable sleeve may extend from the first end of the piercing member to the second end of the piercing member.
In a further aspect, a vial adapter includes a body having a component connection interface and a vial connection interface, with the component connection interface configured to engage a connection interface of a mating component, a pressure equalization assembly including a chamber configured to expand from a first volume to a second volume larger than the first volume, and a piercing member having a first end connected to the body and a second end positioned opposite the first end, with the piercing member and the body defining a fluid passageway and a pressure equalization passageway. The fluid passageway is in fluid communication with the component connection interface, and the pressure equalization passageway is in fluid communication with the chamber of the pressure equalization assembly. The piercing member defines first and second fluid ports in fluid communication with the fluid passageway and a pressure equalization port in fluid communication with the pressure equalization passageway. The second end of the piercing member includes a piercing point configured to pierce a closure of a vial, with the first and second fluid ports extending from a position intermediate the first and second ends of the piercing member to the second end of the piercing member. The first and second fluid ports are configured to withdraw at least 98% of fluid from the vial adapter and a vial connected to the vial adapter.
In another aspect, a vial adapter includes a body having a component connection interface and a vial connection interface, with the component connection interface configured to engage a connection interface of a mating component, a pressure equalization assembly including a chamber configured to expand from a first volume to a second volume larger than the first volume, and a piercing member having a first end connected to the body and a second end positioned opposite the first end, with the piercing member and the body defining a fluid passageway and a pressure equalization passageway. The fluid passageway is in fluid communication with the component connection interface, the pressure equalization passageway is in fluid communication with the chamber of the pressure equalization assembly, and the piercing member defines first and second fluid ports in fluid communication with the fluid passageway and a pressure equalization port in fluid communication with the pressure equalization passageway. The second end of the piercing member includes a piercing point configured to pierce a closure of a vial, with the first and second fluid ports extending from a position intermediate the first and second ends of the piercing member to the second end of the piercing member. The first fluid port is separated from the second fluid port by a partition wall positioned at the second end of the piercing member, with the piercing member defining a first cutting edge extending from the first fluid port to the piercing point and a second cutting edge extending from the second fluid port to the piercing point. The first and second cutting edges are spaced from the partition wall.
The first cutting edge may be spaced from the partition wall by a first planar portion and the second cutting edge is spaced from the partition wall by a second planar portion. The first and second planar portions may form a V-shaped profile. The partition wall may include a pointed end aligned with the piercing point in a direction extending along a longitudinal axis of the piercing member. The partition wall adjacent to the pointed end may be rounded.
For purposes of the description hereinafter, the terms such as “end”, “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting. Further, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary.
Referring to
In one aspect, the vial adapter 10 includes a retractable sleeve 28 surrounding the piercing member 22. The retractable sleeve 28 may extend from the first end 24 of the piercing member 22 to the second end 26 of the piercing member 22. The retractable sleeve 28 is configured to retract upon engagement of the retractable sleeve 28 with a vial and to prevent the escape of any fluids or vapors during attachment of the vial adapter 10 to a vial. The retractable sleeve 28 may be the same as the retractable sleeve 28 shown and described in U.S. Pat. No. 9,919,826, which is hereby incorporated by reference in its entirety. The vial adapter 10, however, may utilize any other suitable sleeve arrangement. The retractable sleeve 28 is not shown in
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The first and second fluid ports 34, 36 are configured to direct fluid radially outward relative to the piercing member 22. In particular, fluid from a syringe (not shown) that is connected to the component connection interface 14 via a syringe adapter (not shown) passes through the fluid passageway 30 and radially outward through the first and second fluid ports 34, 36 and onto the walls of the container. As shown in
Referring again to
In one example, the vial adapter 10 was tested to determine the residual drug loss utilizing the vial adapter 10 in connection with a syringe and syringe adapter to withdrawal fluid from a vial. 20 ml glass drug vials were filled with 10 ml of deionized water. The weight of the filled vial, the vial adapter 10, and syringe/syringe adapter were recorded. The water in the vial was withdrawn by inverting the vial and utilizing the vial adapter 10, syringe adapter, and syringe. All of the components were weighed after fluid withdrawal to calculate the residual water left in the vial. Ten samples were tested to determine the residual fluid loss. For the sample size (N=10), utilizing the vial adapter 10 to withdraw the fluid resulted in an average residual fluid loss in a vial of 0.1701 ml, a maximum fluid loss in a vial of 0.2524, and a minimum fluid loss in a vial of 0.0838. For the same test, the vial adapter 10 and the vial together as a system had an average residual fluid loss together of 0.1870 ml, a maximum fluid loss of the vial adapter 10 and the vial of 0.2662 ml, and a minimum fluid loss of the vial adapter 10 and the vial of 0.0987 ml.
While certain exemplary embodiments of the present invention have been shown and described herein with reference to certain preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention.
This application is the United States national phase of International Application No. PCT/US19/37471 filed Jun. 17, 2019, and claims priority to U.S. Provisional Application Ser. No. 62/686,144, entitled “Piercing Member for Vial Adapter” filed Jun. 18, 2018, the entire disclosures of which are hereby incorporated by reference in their entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2019/037471 | 6/17/2019 | WO |
Publishing Document | Publishing Date | Country | Kind |
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WO2019/245962 | 12/26/2019 | WO | A |
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