Medical metering device

A metering device that improves the aseptic transfer of powder and reconstitution fluid into the metering device for medical use. In some implementations, the metering device comprises a housing, containing a metering chamber that defines a volume. The housing also has a connection portion, an extraction portion, and a metering member in fluid communication with the metering chamber. In other embodiments, the metering device additionally includes a dispensing aid that facilitates the dispensing of powder from a first container into the metering chamber through the connection portion. The connection portion is capable of insertion into a second container that contains fluid, thereby allowing a mixture of powder and fluid to form in the metering chamber. The mixture, then ready for use, is removable from the metering chamber through the extraction portion by an extraction device.

BACKGROUND OF THE INVENTION

Field of the Invention

The present disclosure generally relates to a device for mixing precise, predetermined proportions of powder, extracted from a storage source, with fluid to make a mixture. More specifically, and without limitation, the present disclosure relates to improving the aseptic transfer of lyophilized powder and reconstitution fluid into a metering device for medical used herein, the term reconstitution includes mixing a solid phase into a fluid phase resulting in a solution, a suspension, or a colloide.

Description of Related Prior Art

In the administration of medical treatment, patients often receive injections of reconstituted mixtures. A therapeutic mixture is the result of mixing powder, previously altered for preservation and storage, with liquid, thereby returning the powder to its approximate, original state. Drugs, for example, are often packed and stored in powder form in order to preserve their utility. By way of example, ampicillin, an antibiotic commonly used to treat bacterial infections, is commonly stored in powder form because, in liquid form, it has a short shelf life. For this reason, the administration of ampicillin requires dissolving a powder into liquid to form a solution.

Traditionally, to accomplish this mixing, a user—i.e., a health care provider or a patient—uses a syringe to withdraw a diluent (the mixing liquid) from a first container, and deliver the diluent into a second container where the powder is stored. Delivery of the diluent is accomplished by inserting the syringe into the second container. To ensure the diluent mixes completely with the powder, the syringe is ordinarily removed from the second container while the second container is manipulated or shaken to fully reconstitute the powder. Once the powder and diluent are fully incorporated into a solution, the user returns the syringe into the second container. The solution is then extracted from the second container, back into the syringe. Only then is the solution ready for injection into a patient. This cumbersome process suffers from several drawbacks.

For example, in preparing the mixture for injection into the patient, the syringe is the primary vehicle. Before the syringe is ready for injection, it is inserted into and removed from the first container. It is then inserted into and removed from the second container two times, once to inject the diluent and once to remove the mixture. With each step, the risk of contamination increases because the syringe can come into contact with non-sterile surfaces. Such unsanitary conditions could result in serious harm to the patient.

Further, because the traditional process involves introducing diluent into the powder container, the powder container can be used only once. As a result, multiple single-use containers are used to store powder, thereby increasing the complexity of storage and cost, as well as creating waste.

Yet further, the abovementioned process is unavoidable because prior art devices were incapable of drawing powder through the needle's narrow conduit, and into the syringe.

Even further, the abovementioned process suffers from the looping problem, which describes the problem of mixing different strength powders to achieve a specific, prescribed dosage. Traditionally, a powdered drug will have different formulations related to different strengths or potencies. This occurs because treatments differ between patients. Indeed, not each person using the same drug requires the same level of potency. A problem arises, however, when trying to generate a particular drug strength because of how the powder is stored. The potency of a drug is measured by international units (“IU”) and is a function of the amount used. A single drug can have several different IUs, each stored in different vials with identifying markings. If a prescription calls for a drug having a specific IU that does not match the IUs stored in the available vials, a user will have to mix powders from varying vials to achieve the prescribed drug. The problem is further complicated because different drug strengths are separated by predetermined intervals that may be inconsistent with the prescribed dosage. So, for example, if a prescription calls for a drug having 120 IU, and the drug is stored in two vials, one having 100 IU and the other having 50 IU, the precise dosage cannot be achieved. The user will therefore have to take a dosage with either a lower or higher potency than the one prescribed. This lessens the efficacy of the treatment.

SUMMARY

The present invention seeks to overcome the abovementioned problems. Accordingly, an object of the present invention is to provide a metering device and process for a simplified, aseptic transfer of powder and reconstitution fluid into the metering device for medical use.

In illustrative embodiments, the metering device comprises a housing, containing a metering chamber that defines a volume. The housing also has a connection portion, an extraction portion, and a metering member that are in fluid communication with, and provide multiple access points to, the metering chamber. Thus, another object of the present invention is allowing a mixture of powder and reconstitution fluid to form in the metering chamber as opposed to a vial, thereby streamlining the reconstitution process.

In other embodiments, the metering device further has, for example, a dispensing aid that facilitates the dispensing of powder into the metering chamber through the connection portion. In this way, powder can be withdrawn from a sterile connection portion, thereby allowing lyophilized powder to be stored in bulk. In some embodiments, the dispensing aid helps to maintain sterility in the transfer of powder by refreshing the metering chamber environment. Thus, another object of the invention is to reduce the need for single-use vials, thereby simplifying the aseptic storage of lyophilized powder.

This feature illustrates that yet another object of the invention is to solve the pooling problem, as described above. The instant invention resolves this problem, by allowing for bulk storage of powder that would otherwise be stored in a plurality of smaller vials. The increased storage capacity enables drug manufacturers to reduce the variance between stored drugs having different IUs, thereby reducing the cost associated with creating a particular formulation and storing it. Further, a precise dosage with a particular IU can be readily achieved because virtually any amount can be dispensed from bulk storage. In this way, the exact potency corresponding to a particular prescription can be achieved without mixing between vials of various sizes or dosages.

During use of an exemplary embodiment of the present invention, powder from a first container is drawn into the metering chamber through the connection portion. The connection portion is then inserted into a second container that contains a reconstitution fluid thereby allowing a mixture to form in the metering chamber. The mixture, then ready for injection, is removed from the metering chamber through the extraction portion. As demonstrated by this unique a process, yet another object of the invention is to reduce the steps necessary to form a sterile reconstituted mixture, thereby reducing the risk of contamination and, thus, minimizing the risk of harm to the patient.

Other embodiments of this disclosure are disclosed in the accompanying drawings, description, and claims. Thus, this summary is exemplary only, and is not to be considered restrictive.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The claimed subject matter is described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the subject innovation. It may be evident, however, that the claimed subject matter may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form in order to facilitate describing the subject innovation. Moreover, it is to be appreciated that the drawings may not be to scale. Moreover, the words “exemplary” or “illustrative” are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “exemplary” or “illustrative” is not necessarily to be construed as preferred or advantageous over other aspects or designs.

The present invention involves a metering device10for medical use. In an exemplary embodiment, the metering device10is an assembly that includes a housing20, a dispensing aid80, and an extraction device90. The metering device10can be made of glass or plastic, or of any other material suitable for use in accordance with the present disclosure.

In an exemplary embodiments shown inFIG. 1, the housing20includes a metering chamber30, connection portion40, and extraction portion50. The metering chamber, connection portion40, and extraction portion50are in fluid communication with each other, allowing powder and fluid to travel through different portions of the housing20. The housing20can be clear or opaque so that a user can view the contents disposed therein. Housing20may further comprise coloring or indicia to enhance the visualization of a powder or fluid moving through the housing.

FIG. 1further depicts the metering chamber30includes a reservoir having a volume for receiving powder and reconstitution fluid. The metering chamber30is shown having a generally cylindrical shape with an inner surface32having a circular cross-section, but it can also have other cross-sectional shapes, such as, for example, square, rectangular, trapezoidal, or frusto-conical. Distal boundaries of the metering chamber are defined on opposite ends by the connection portion40and a metering member60respectively. As discussed in further detail below, the metering member60is configured to adjust the volume of the metering chamber30. The metering member60is disposed within the metering chamber30and contacts the inner surface32of the metering chamber30in a sealing engagement. In this way, it creates a boundary of the metering chamber30so as to define a volume of the metering chamber30. In the exemplary embodiment ofFIG. 6, the metering chamber30is shown having a fixed volume with the extraction portion50disposed at a distal end of the metering chamber30. The extraction portion50can be covered by plug70that comprises, for example, an over-mold closure capable of being pierced by an extraction device90to allow for the extraction of reconstitution fluid air, powder, or mixtures thereof from the metering chamber30.

Further, in some embodiments, the metering chamber30may have one or more vents (not shown) for alleviating pressure, especially when the metering chamber is pre-filled with a protective gas for sterility. The vent can be disposed at any position on the metering chamber30, or the extraction portion50can be used a vent. Alternatively, in some embodiments, the connection portion40has a broad opening that can provide a venting means for the metering chamber30.

In the exemplary embodiment shown inFIG. 4, the connection portion40is configured to direct powder and reconstitution fluid into the metering chamber30. The connection portion40includes an end piece44and a piercing portion42. The end piece44provides a platform to stabilize a container or the dispensing aid80when disposed thereon. In some embodiments, the piercing portion42is comprised of a needle, such as, for example, a blunt cannula or a Nokor needle. However, any suitable conduit capable of transferring powder can be used. The piercing portion42can be enclosed by a cap46in order to maintain a sterile, hazard-free condition prior to use.

FIG. 4further depicts that the piercing portion42is capable of being inserted through a sealed closure110of a first container100holding powder. As is common with the storage of sterile material for medical use, the first container100, in one embodiment, is a vial containing, at its opening, a closure110comprised of, for example an elastomer such as rubber, silicon, or other suitable material. For use in accordance with the present invention, the closure110need only be capable of being pierced by the piercing portion42while maintaining an otherwise sterile environment for the contents therein disposed. Yet further, inFIG. 4, the vial is shown being fully inverted to allow gravity to assist in dispensing, but other configurations have been considered. As discussed in further detail below; after the piercing portion42is inserted into the first container100, the dispensing aid80is activated in order to encourage powder, disposed within the first container100, to pass through the piercing portion42into the metering chamber30. After withdrawing powder from the first container100, the piercing portion42is removed therefrom and inserted into a second container200containing a reconstitution fluid, such as, for example, a diluent, a solvent, or an external place for a suspension.

FIG. 1,FIG. 4, andFIG. 5depict an embodiment of the present invention wherein the extraction portion50is connected to the housing20and is in fluid communication with the metering chamber30. It provides an outlet for the removal of fluid from the metering chamber30. In one embodiment, the extraction portion50protrudes from the housing20, for example perpendicular to a longitudinal axis of the metering chamber30between the connection portion40and the metering member60. But the extraction portion50can be positioned at different locations on the housing20, and have different configurations. For example, the extraction portion50can be disposed at the bottom of the metering chamber30as shown inFIG. 6. It can also be disposed on the housing20in like manner as the embodiment shown inFIG. 4, but not projecting outwardly from the housing20. Instead, the extraction portion50can comprise an aperture in the metering chamber30that is covered by, for example, an over mold closure capable of being pierced by an extraction device90to facilitate removal of fluid air, powder, or mixtures thereof from the metering chamber30. In the embodiment, the extraction portion50comprises a port52that provides access to the metering chamber30. The port52is configured to receive a plug70. The connection between the port52and plug70can be accomplished by a luer taper, though other suitable connecting mechanisms can be used, such as, for example, threads or a snap-fit engagement. The plug70can be made, for example, from elastomer, but it can also be formed from thermoplastic such as, for example, polyethylene terephthalate (“PET”). A sealing sponge-like structure may be utilized with any appropriate material.

According to the exemplary embodiment shown inFIG. 1, at least a portion of the metering member60is disposed within the metering chamber30. It sealingly engages the inner surface32of the metering chamber30in order to act as a boundary. In the embodiment, the metering member60is a stopper, movable within the metering chamber30to allow a user to adjust the volume of the metering chamber30. This accommodates a user's need for various, precise doses. To this end, the metering chamber30can have marks (not shown) disposed thereon corresponding to different volumes. The metering member60can also include, for example, a handle (not shown) extending to an outside of the housing20to allow easy adjustment of the metering member60. In this way, the metering member60may have a piston-rod configuration. Additionally, in one embodiment, the metering chamber30is flexible and the metering member60comprises a clamp or an O-ring configured to provide an adjustable volume of the metering chamber60. Alternatively, housing20could have a surface shaped or modified to improve grip, for example with ribs, bumps, concavities or surface roughening. In an alternative embodiment, the metering member60can be selectively fixed by a locking mechanism to avoid accidental movement. The metering member60can be fixed, or locked in place, either by a user or, for example, by a pharmacist to prevent inadvertent movement of the metering member. This feature allows a user to measure a precise dosage without risking a change in the metering chamber30volume. The metering member may be positionable by virtue of a mechanism such as, for example, a screw thread or a ratcheting connection with the metering chamber or chamber entrance.

FIG. 2depicts an exemplary embodiment of the dispensing aid80.FIG. 7depicts a cross section of the exemplary dispending80shown inFIG. 2. The dispensing aid80facilitates removal of powder from the first container100into the metering chamber30through the connection portion40. In one embodiment, the dispensing aid80is configured to surround the connection portion40. For example,FIG. 4depicts the dispensing aid80having a planar end82and an annular rim84projecting from, and extending circumferentially around, the planar end82. The planar end82further has an opening86disposed in its center through which the piercing portion42protrudes. The annular rim secures the dispensing aid80to both the first container100and the connection portion40to prevent the unwarranted dislodgment or removal therefrom. In some instances, annular rim84has a recess or a protrusion along at least a portion of the inner wall to allow for a snap fit onto connection portion40. In some embodiments, annual rim84may have at least a portion of a screw thread to mate with connection portion40. In other embodiments, the attachment between annual rim84and connection portion40may be a friction fit. Further, planar end82and the annular rim84cooperate to secure an inverted container in place to allow steady, measured dispensing. However, according to the exemplary embodiment, the dispensing aid80is optionally removable from both the connection portion40and first container100. Alternatively, dispensing aid80can be fixed to either the connection portion40or the first container100. Additionally, the dispensing aid80can have other shapes and configurations in accordance with the present invention. For example, the dispensing aid80need not fully encircle the connection portion40or the first container100. It can, for example, have a C-shape or any other shape so long as it is capable of encouraging the dispensing of powder from the first container100into the metering chamber30through the piercing portion42.

In the exemplary embodiment shown inFIG. 4, when activated, the dispensing aid80encourages powder from the first container100to flow into the piercing portion42, and, further, into the metering chamber30. Activation of the dispensing aid80is necessary because the particulate matter that makes up the powder does not necessarily operate in like manner as a fluid. When housed in an inverted vial and introduced to a piercing device such as a piercing portion42, for example, the powder may not pass through the piercing portion42absent coaxing. The dispensing aid80provides such coaxing in a number of different ways.

For instance, in one embodiment, the dispensing aid80can be configured to vibrate at an accelerated rate so as to jostle otherwise static powder, encouraging the powder to fall through the piercing portion42into the metering chamber30. This occurs when vibrational and gravitational forces overcome the static, frictional forces that bind particles of powder together, allowing the powder to move more freely. To accomplish the vibration, the dispensing aid80can include a battery powered piezoelectric vibration unit that can be activated manually by a button, onboard switch, or remote, or, for example, it can be set to activate automatically when a sensor indicates to a control unit that the piercing portion42is inserted into the first container100. Alternatively, insertion of the piercing portion42into the first container100could activate the dispensing aid80by triggering a button or a pressure sensitive switch, as shown inFIG. 8. Vibration may also be induced mechanically by using, for example, a spring such as a clock spring. The spring may be wound by means of torqueable portions of the dispensing aid or other moveable mechanism. When released, the spring energy may drive a vibrating mechanism, for example a small cantilever or adjacent moveable surfaces having opposing ridges.

In an alternative embodiment, the dispensing aid80can comprise a vacuum mechanism to withdraw powder and like substances from the vial. For example, a vacuum or pump can be attached to the metering device via the dispensing aid80to create a pressure differential between the metering chamber and the vial, thereby drawing powder into the metering chamber. The vacuum can be attached to one of either the dispensing aid80or, alternatively, the extraction portion50, but in either case, air must be withdrawn from the metering chamber30to create a vacuum that draws powder into it.

In yet another embodiment, the dispensing aid80can comprise a pressure mechanism to withdraw powder and like substances from the vial. For instance, a protective gas, e.g., nitrogen, can be introduced into the first container100containing powder. The increased pressure in the first container100forces powder down through the connection portion40into the metering chamber30. The gas can be introduced into the first container100through an opening in the dispensing aid80, but, alternatively, it can be introduced through the extraction portion50. In the latter case, a co-axial needle would need to be used to allow for two conduits—i.e., one for the protective gas to enter the first container100, and another for the powder to exit it.

Both of the alternative, exemplary embodiments that use a dispensing aid80comprising either a vacuum or a pressure mechanism increase the sterility of powder transfer by refreshing the metering chamber environment while introducing powder into it. This is true because both the presence of a vacuum and the introduction of a protective gas into an enclosed environment enhances its sterility by removing harmful bacteria and contaminants. Thus, when air is removed from the metering chamber30to create a vacuum and powder is introduced therein, the air is refreshed and sterility is maintained. Also, when a protective gas is introduced into the first container100forcing powder into the metering chamber30, some amount of protective gas is also introduced into the metering chamber30, thereby maintaining a sterile environment.

In accordance with an exemplary embodiment shown inFIG. 5, during operation, the metering device10is positioned under an inverted first container100containing, for example, lyophilized powder. The piercing portion42of the metering device10is inserted into the first container100. At which point, the dispensing aid80is activated, drawing powder from the vial, through the piercing portion42, and into the metering chamber30. As discussed above, optionally, the volume of the metering chamber30can be adjusted to achieve a precise dose of powder by moving the metering member60within the metering chamber30.

After removing the piercing portion42from the first container100, the metering device10is positioned under an inverted second container200containing a reconstitution fluid. Optionally, the dispensing aid80can be removed from the metering device10. The piercing portion42is then inserted into the second container200containing diluent, thereby causing fluid to flow into the metering chamber30and, thus, forming a reconstituted mixture.

The plug70is then removed from the extraction portion50, and the mixture is extracted from the metering chamber30through the port52by, for example, an extraction device90. The extraction device90, now in receipt of the reconstituted mixture, is then ready for injection into a patient. According to the exemplary embodiment shown inFIG. 3andFIG. 5, the extraction device90is a syringe, but other extracting means can be employed. In the exemplary embodiment, the syringe has a luer tip92for engagement with the port52.

Although the exemplary embodiment of the present invention shown inFIG. 5depicts use of the metering device10to mix one powder with one reconstituted fluid, other uses have been contemplated. For example, in accordance with the present invention, the metering device10could be used to combine any combination of two or more powders with one or more reconstitution fluids.

References to powder should be understood to include any particle based substance, including, for example, flakes, spheres, or rods.

While the foregoing drawings and descriptions set forth functional aspects of the disclosed systems, no particular arrangement of these functional aspects should be inferred from these descriptions unless explicitly stated or otherwise clear from the context. Similarly, it will be appreciated that the various steps identified and described above may be varied, and that the order of steps may be adapted to particular applications of the techniques disclosed herein. All such variations and modifications are intended to fall within the scope of this disclosure. As such, the depiction and/or description of an order for various steps should not be understood to require a particular order of execution for those steps, unless required by a particular application, or explicitly stated or otherwise clear from the context.