A needleless vial stopper for a vial defining a vial opening includes a body having a first end and a second end positioned opposite the first end, with the body including a sealing portion and a flange extending radially outward from the sealing portion. The sealing portion is configured to be received by the vial opening and form a seal with the vial. The body defines an opening having a first open position prior to insertion of the sealing portion into the vial opening, a closed position after insertion of the sealing portion into the vial opening, and a second open position when engaged with a luer of a needleless syringe.

BACKGROUND OF THE INVENTION

Field of the Disclosure

The present disclosure relates generally to a needleless vial stopper.

Description of the Related Art

Medication vials require a needle to access the medication contained within the vial. Using a needle for vial access, however, requires multiple steps, including removing the needle from the packaging, attaching the needle to a needle-free IV luer syringe, removing the needle cover, inserting the needle into the medication vial, removing the needle, replacing the cap on the needle, removing the needle from the syringe, and disposing of the needle. Further, using a needle to draw or add solution to a medication vial is not ideal, because the outside needle diameter has to be small enough such that it does not make a significant hole in the vial stopper during insertion to prevent stopper leakage after removing the needle from the vial stopper. This outside needle diameter restriction translates to an even smaller inside diameter (fluid path) for the needle, which increases the flow resistance (lower flow rate) during transfer of fluid between the syringe and the vial. The restricted flow rate increases the total time the clinician or pharmacist needs to transfer the medication and also increase the hand forces required to actuate the plunger rod of the syringe.

One solution to eliminate the use of needles is to utilize a needle-free vial spike adapter. The vial spike adapter provides vial access using a needle-free IV luer syringe. The needle-free vial spike adapter includes a valve element that opens when engaged with the needle-free IV luer syringe. Needle-free vial spike adapters, however, add additional costs compared to the use of a needle.

SUMMARY OF THE INVENTION

In one aspect or embodiment, a needleless vial stopper for a vial defining a vial opening includes a body having a first end and a second end positioned opposite the first end, with the body including a sealing portion and a flange extending radially outward from the sealing portion. The sealing portion is configured to be received by the vial opening and form a seal with the vial. The body defines an opening having a first open position prior to insertion of the sealing portion into the vial opening, a closed position after insertion of the sealing portion into the vial opening, and a second open position when the body is engaged with a luer of a needleless syringe.

The sealing portion may be oval-shaped in a cross-section extending perpendicular to a longitudinal axis of the body. The sealing portion may be circular in a cross-section extending perpendicular to a longitudinal axis of the body. The sealing portion may include an annular sealing rib. The opening of the body may have a width of 0.0-0.020 inches when the opening is in the first open position. The flange may be configured to engage a top surface of a neck of the vial.

The body may define a first passageway extending from the first end of the body to a position intermediate the first and second ends of the body and a second passageway extending from the second end of the body to a position intermediate the first and second ends of the body. The first passageway and the second passageway may each comprise a frustoconical surface. The opening of the body may be positioned between the first passageway and the second passageway. The sealing portion may include a transverse passageway extending in a direction perpendicular to a longitudinal axis of the body. The transverse passageway may extend across an entire diameter of the sealing portion. A maximum diameter of the sealing portion of the body may be larger than a diameter of the vial opening of the vial. The opening of the body may be configured such that fluid can flow through the opening in the first and second open positions of the opening and cannot flow through the opening in the closed position of the opening. The body may be formed from an elastomeric material.

In a further aspect or embodiment, a needleless vial stopper for a vial defining a vial opening includes a body having a first end and a second end positioned opposite the first end, with the body including a sealing portion and a flange extending radially outward from the sealing portion. The sealing portion is configured to be received by the vial opening and form a seal with the vial. The body defines a frangible section configured to define an opening through the body upon engagement with a luer of a needleless luer syringe, with the opening configured to move to a closed position when not engaged with the luer of the needleless luer syringe.

DETAILED DESCRIPTION

Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less. The ranges and/or ratios disclosed herein represent the average values over the specified range and/or ratio.

Referring toFIGS.1-8, a needleless vial stopper10for a vial12defining a vial opening14, includes a body20having a first end22and a second end24positioned opposite the first end22. The body20includes a sealing portion26and a flange28extending radially outward from the sealing portion26, with the sealing portion26configured to be received by the vial opening14and form a seal with the vial12. The body20defines an opening30having a first open position prior to insertion of the sealing portion26into the vial opening14, a closed position after insertion of the sealing portion26into the vial opening14, and a second open position when the body20is engaged with a luer32of a needleless syringe34. Accordingly, the needleless vial stopper10is configured to allow access to the contents of the vial12, when the needleless vial stopper10is positioned within the vial opening14, without the use of a needle. As shown inFIGS.7and8, engaging the needleless vial stopper10with the luer32of the needleless syringe34opens the opening30to the second open position to allow fluid communication between the needleless syringe34and the vial12. When the luer32of the needleless syringe34is withdrawn from the needleless vial stopper10, the needleless vial stopper10returns to the closed position to seal the vial opening14. The flange28of the body20is configured to engage a top surface of a neck16of the vial12.

As shown inFIG.6, in one aspect or embodiment, the sealing portion26is oval in a cross-section extending perpendicular to a longitudinal axis L of the body20. Due to the oval shape of the sealing portion26, when the sealing portion26is inserted into the vial opening14of the vial12, the sealing portion26is compressed to fit the circular or cylindrical shape of the vial opening14thereby creating a biasing force acting to close the opening30. Inserting the luer32of the needleless syringe34into the needleless vial stopper10opens the opening30with the opening30closing upon withdrawal of the luer32of the needleless syringe34due to the forces caused by compression of the sealing portion26within the vial opening14. In further aspects or embodiments, the sealing portion26may have other suitable shapes, such as a circular shape. In one aspect or embodiment, a maximum diameter of the sealing portion26of the body20is larger than a diameter of the vial opening14of the vial12.

Referring toFIGS.1-4, the sealing portion26includes an annular sealing rib36. In one aspect or embodiment, the annular sealing rib36is semi-spherical. The annular sealing rib36tapers in width in a circumferential direction. The annular sealing rib36may include one or more tapered portions38,40. In one aspect or embodiment, the annular sealing rib36includes a first tapered portion38and a second tapered portion40positioned 180 degrees from the first tapered portion38.

Referring toFIGS.1-6, the opening30of the body20has a width of 0.000-0.020 inches when the opening30is in the first open position. After insertion of the sealing portion26within the vial opening14of the vial12, the opening30is closed and/or further biased to the closed position. The opening30of the body20is configured such that fluid can flow through the opening30in the first and second open positions of the opening30and cannot flow through the opening30in the closed position of the opening30. In one aspect or embodiment, the body20defines a first passageway56extending from the first end22of the body20to a position intermediate the first and second ends22,24of the body20, and the body20defines a second passageway58extending from the second end24of the body20to a position intermediate the first and second ends22,24of the body20. The first passageway56and the second passageway58each include a frustoconical surface60, although other suitable arrangements may be utilized. The opening30of the body20is positioned between the first passageway56and the second passageway58. Further, in one aspect or embodiment, the sealing portion26includes a transverse passageway62extending in a direction perpendicular to the longitudinal axis L of the body20. The transverse passageway62extends across an entire diameter of the sealing portion26, although other suitable arrangements may be utilized. The body20may be formed from an elastomeric material.

In a further aspect or embodiment, rather than providing the opening30, the body20defines a frangible section (not shown) configured to define an opening through the body upon engagement with the luer of the needleless luer syringe34, with the opening configured to move to a closed position when not engaged with the luer32of the needless luer syringe34. In other words, the body20may define a small section material that is perforated and/or frangible such that an opening is formed upon insertion of the luer of the needleless luer syringe into the frangible section.

While this disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims. To the extent possible, one or more features of any aspect or embodiment discussed above can be combined with one or more features of any other aspect or embodiment.