Patent Issued for Modular vial adapter (USPTO 11033459)

2021 JUL 01 (NewsRx) -- By a News Reporter-Staff News Editor at Hospital & Nursing Home Daily -- From Alexandria, Virginia, NewsRx journalists report that a patent by the inventors Ariagno, Scott Richard (Inverness, IL, US), Roush, Daniel Edward (Niles, IL, US), filed on December 13, 2017, was published online on June 15, 2021.

The patent’s assignee for patent number 11033459 is Shire Human Genetic Therapies Inc. (Lexington, Massachusetts, United States).

News editors obtained the following quote from the background information supplied by the inventors: “Drug vials are routinely used in hospitals and other medical settings for storing medications in the form of liquids and powders. A drug vial generally includes a glass or plastic container and a closure for containing fluid content within. The closure is typically formed of metal crimped over a rubber stopper and a flange, so as to positively hold the stopper in place over the opening of the vial. The rubber stopper, generally formed of an elastomeric material such as butyl rubber or the like, is pierceable, allowing for a user to gain access to the fluid content. For example, in order to access the contents within the vial, a user typically uses a syringe fitted with a needle to pierce the rubber stopper of the vial and withdraw the fluid. However, such methods of obtaining the contents from the vial present drawbacks, such as accidental sticking with the needle or leakage of the fluid by way of a gap between the needle and the rubber stopper. The leakage of fluid may result in inaccurate withdrawal and subsequent administration of the medication, which can lead to ineffective treatment. The inadvertent fluid leakage may be particularly troublesome when the liquid chemical is a hazardous drug, such as a carcinostatic agent, wherein inadvertent leakage of can put the user, such as a health care provider or patient, at risk of exposure to these medications.

“In an attempt to address the drawbacks of conventional needle withdrawal, vial adapters have been introduced to permit drug preparation and withdrawal. Vial adapters generally include a fitting portion having claws or the like for fitting a vial therein, a metallic or resin made (plastic-made) needle provided with a liquid passage, and a connector for connection to a syringe or other fluid delivery device, wherein the fitting portion, needle, and connector are integrally formed with one another as a single unit. Although current adapters allow for the withdrawal of fluid content from vials, such adapters suffer from various shortcomings.

“For example, vials are available in a range of sizes, including, but not limited to 8 mm, 11 mm, 13 mm, 17 mm, 20 mm, 28 mm, and 32 mm closure openings, as well as varying thickness of the stopper feature. Most adapters, however, are designed to function only on a single vial closure size. Accordingly, some current adapters, which are manufactured to fit a specific vial closure size, fail to securely attach to vial closures having diameters that are outside of their tolerance (i.e., smaller or larger than the vial closure size that such adapters are intended to fit). Accordingly, the use of current adapters is limited to the size of vial for which they were manufactured. A further consideration is the expense incurred by hospitals or other medical facilities as a result of the need to stock various types and sizes of adapters. For example, there is generally no universal vial size, as different medications and treatment are provided in varying doses. Thus, vials of many flange sizes and closure sizes are available and are frequently found in medical care facilities. Typically a hospital must stock a variety of adapters to be assured of having the correct adapter available that will properly interconnect with the multiple vial closures that exist. Thus, a hospital must maintain a stock of adapters for each possible size of closure, resulting in a logistical problem, as well as increased expense.”

As a supplement to the background information on this patent, NewsRx correspondents also obtained the inventors’ summary information for this patent: “The present invention is directed to a vial adapter for interconnecting a vial and a fluid delivery device or apparatus. The vial adapter has a modular design consisting of separately constructed components cooperatively arranged with one another. The modular construction allows for rapid manufacturing reconfigurations of one or more components with minimal costs to create new vial adapter configurations that meet specific needs. In particular, the present invention includes separately formed (i.e., separately manufactured) components which, when assembled to one another, form a fully functional vial adapter configured to engage a vial, including fluid content therein, and further interconnect the vial with a delivery device, such as a syringe or, in some instances, an injector or pump assembly (e.g., infusion device).

“The modular vial adapter of the present disclosure generally includes a spike member including a distal tip configured to engage and penetrate a seal provided on a closure of the vial for access to fluid content within. The spike member may include a dual-lumen design, in which at least a first lumen in communication with the distal tip providing a fluid pathway through the spike member for transport of fluid content from the vial while a second lumen provides a venting pathway allowing atmospheric air to enter an interior space of the vial to prevent negative pressure buildup.

“The vial adapter further includes a separately formed port member configured to be directly coupled to the spike member. The port member includes a channel extending therethrough and in communication with the fluid pathway of the first lumen of the spike member to receive the fluid content from the vial. The port member further includes a connecter assembly configured to be releasably coupled to the delivery device and to provide fluid content via the channel. For example, the connector assembly may include a Luer-Lock or Luer-Slip connection fitting configured to be releasably coupled to a delivery device having a corresponding Luer-Lock or Luer-Slip connection fitting. In some embodiments, the connector assembly may include a delivery device-specific connection fitting, wherein the delivery device comprises a pump and/or injector assembly, such as an infusion pump.

“The vial adapter further includes a separately formed skirt member configured to be coupled to and retain at least a portion of each of the spike member and port member. The skirt member includes a cavity shaped and/or sized to receive and engage the closure of the vial within. Upon positioning of the vial closure within the cavity (i.e., upon a user placing the vial into engagement with the adapter), the distal tip of the spike member is configured to penetrate the seal of the vial and fluid content within the vial is available for transfer to the delivery device via the fluid pathway from the distal tip of the spike member through the channel of the port member and out of the connecter assembly of the port member.

“The vial adapter of the present disclosure allows for the interchangeability of components to provide numerous combinations of a vial adapter to thereby to accommodate the varying vial flange and closure sizes currently offered, as well as other variations, such as the type of delivery device to be used and the specific contents provided in the vial. In particular, depending on the specific needs or requirements, individual components can be swapped out and changed to account for different vial closure sizes, different thicknesses of the rubber stop, different connection fittings required depending on the delivery device to be used, and the like. For example, in order to account for different vial closure sizes (i.e., diameters of the vial closure), the skirt member may be interchangeable with one of a plurality of other skirt members (while the spike member and port member configurations remain the same), wherein the plurality of other skirt members may include different dimensions (e.g., cavities with different volumes). In order to account for different delivery devices to be used with the adapter, the port member may be interchangeable with one of a plurality of other port members (while the spike member and skirt member configurations remain the same), wherein the plurality of other port members may include different connector assembly connection fittings (e.g., Luer-Lock fitting, Luer-Slip fitting, push-to-connect fitting, Interlink-style bayonet or septum fitting, etc.). In order to control the flow rate of fluid content from the vial, the spike member may be interchangeable with one of a plurality of other spike members (while the port member and skirt member configurations remain the same), wherein the plurality of other spike members may include different venting assemblies (e.g., vent filters of different pore size to control rate of flow of fluid content from the vial, to control ingress of various size particles, or to control egress of fluid under pressure).

“Accordingly, the modular vial adapter of the present invention addresses the shortcomings of current vial adapters. The modular design, consisting of separately constructed components cooperatively arranged with one another, allows for rapid manufacturing reconfigurations of one or more components with minimal costs to create new vial adapter configurations that meet specific needs, thereby benefitting both end-users and manufacturing strategy. In particular, individual components can be swapped out and changed to depending on the specific needs or requirements, which may include, for example, different vial closure sizes, different thicknesses of the rubber stop, different connection fittings required depending on the delivery device to be used, and the like.

“For a thorough understanding of the present disclosure, reference should be made to the following detailed description, including the appended claims, in connection with the above-described drawings. Although the present disclosure is described in connection with exemplary embodiments, the disclosure is not intended to be limited to the specific forms set forth herein. It is understood that various omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient.”

The claims supplied by the inventors are:

“1. A modular vial adapter for interconnecting a vial with a delivery device, the modular vial adapter comprising: a spike member comprising a base and a distal tip extending therefrom, the spike member further comprising at least: a first lumen extending from the base to the distal tip and providing a fluid pathway therethrough; and a second lumen separate from the first lumen and having a first open end proximate the base and a second open end proximate the distal tip, the first open end being positioned external to the modular vial adapter such that the second lumen provides a vent pathway for allowing atmospheric air to enter an interior space of the vial to prevent negative pressure buildup when fluid content is transported from the vial via the fluid pathway of the first lumen; a separately formed port member comprising a first end defining a base directly coupled to the base of the spike member and an opposing second end defining a connector assembly, the port member further comprising a channel extending therethrough from the first end to the second end and in fluid communication with the fluid pathway of the first lumen of the spike member upon coupling of spike member base with the port member base; and a separately formed skirt member comprising a proximal end defining a base including a recess having a bore extending therethrough, wherein the recess is shaped and/or sized for receiving and retaining portions of the spike member and port member therein, the skirt member further comprising at least one side wall extending from the base and terminating at an open distal end to define a cavity shaped and/or sized to receive and engage a closure on a vial, wherein, upon positioning of a vial closure within the cavity of the skirt member, the distal tip of the spike member is configured to penetrate a seal of the vial and fluid content within the vial is available for transfer to a delivery device releasably coupled to at least the connector assembly of the port member via the fluid pathway from the distal tip of the spike member through the channel of the port member and out of the connecter assembly of the port member, and wherein, when the spike member, port member, and skirt member are unassembled, the port member is interchangeable with one of a plurality of other port members, each of the plurality of other port members having at least one of different dimensions, characteristics, components, and materials.

“2. The modular vial adapter of claim 1, wherein, prior to assembly of the spike member, port member, and skirt member with one another, the spike member is interchangeable with one of a plurality of other spike members.

“3. The modular vial adapter of claim 2, wherein the plurality of other spike members have at least one of different dimensions, characteristics, components, and materials.

“4. The modular vial adapter of claim 1, wherein, prior to assembly of the spike member, port member, and skirt member with one another, the skirt member is interchangeable with one of a plurality of other skirt members.

“5. The modular vial adapter of claim 4, wherein the plurality of other skirt members have at least one of different dimensions, characteristics, components, and materials.

“6. The modular vial adapter of claim 1, wherein, when the spike member and port member are received in the recess, the position of distal tip of the spike member is maintained within the cavity for engagement with the vial seal upon receipt of the vial closure within the cavity of the skirt member.

“7. The modular vial adapter of claim 6, wherein the connector assembly of the port member extends through the bore defined in the recess of the skirt member to thereby allow the connector assembly to be coupled to the delivery device for subsequent transport of fluid content from the vial.

“8. The modular vial adapter of claim 6, wherein the at least one side wall comprises at least one detent extending from an inner surface thereof, the at least one detent is configured to engage the closure of the vial to retain the closure within the cavity once positioned therein.

“9. The modular vial adapter of claim 6, wherein the skirt member comprises an external surface having one or more grip portions.

“10. The modular vial adapter of claim 1, wherein the vent pathway allows for atmospheric air to enter the interior space of the vial to prevent negative pressure buildup when fluid content is transported from the vial via the fluid pathway provided by the first lumen.

“11. The modular vial adapter of claim 1, further comprising a vent filter coupled to the second open end of the second lumen.

“12. The modular vial adapter of claim 11, wherein the filter comprises a hydrophobic material having a pore size of 0.1 microns to 5 microns.

“13. The modular vial adapter of claim 1, wherein the connector assembly of the port member comprises a delivery device-specific connection fitting, wherein the delivery device comprises a pump and/or injector assembly.

“14. The modular vial adapter of claim 1, wherein the channel of the port member comprises a channel opening formed on a distal end thereof opposite the connector assembly and adjacent to the base, wherein the channel opening is shaped and/or sized to receive and retain a separately formed fluid filter membrane within.

“15. The modular vial adapter of claim 14, wherein the filter comprises a material having a pore size of 5 microns to 150 microns.

“16. The modular vial adapter of claim 1, wherein the skirt comprises at least one protrusion extending from a proximal end thereof and configured to engage a corresponding and mating geometry of a delivery device for maintaining alignment and limiting rotation of the assembled adapter in a visible, tactile, or audible manner.”

For additional information on this patent, see: Ariagno, Scott Richard. Modular vial adapter. U.S. Patent Number 11033459, filed December 13, 2017, and published online on June 15, 2021. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=11033459.PN.&OS=PN/11033459RS=PN/11033459

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