CN108404261B

CN108404261B - Medicine mixing device and method for mixing medicines

Info

Publication number: CN108404261B
Application number: CN201810124577.1A
Authority: CN
Inventors: A·斯坦德利; B·布奇恩; C·史蒂芬尼; C·康斯坦丁尤; J·T·沙尼翁
Original assignee: Windgap Medical Inc
Current assignee: Windgap Medical Inc
Priority date: 2017-02-09
Filing date: 2018-02-07
Publication date: 2021-06-04
Anticipated expiration: 2038-02-07
Also published as: CN108404261A; CA2994386A1; AU2018200957B2; AU2018200957A1

Abstract

The invention provides a medicine mixing device and a method for mixing medicines. The present invention contemplates a medication mixing device that may include a housing having a first chamber therein containing a first medication component and providing a second chamber containing a second medication component, and having a sealing structure selectively isolating the first chamber from the second chamber. The seal structure may include a first seal member having a first seal interface and a second seal member having a second seal interface, wherein a first compressive force may be applied to the first seal member and the second seal member such that the seal interfaces form a seal. The first compressive force may then be configured to allow the first and second seal members to maintain at least one degree of freedom relative to each other.

Description

Medicine mixing device and method for mixing medicines

Technical Field

The present invention relates generally to automatic and prefilled syringes, and more particularly to automatic syringes that are stored in a compact state but allow for preparation or mixing of various drug components prior to delivery of the drug components to a patient.

Background

It has been recognized that the shelf life of a drug can be significantly extended if the drug is stored as a dry drug separately from the diluent. Furthermore, these drugs are generally used in emergency situations where self-administration is preferred. However, the additional burden involved in dissolving dry drugs in liquid doses just prior to injection often requires the user to perform multiple cumbersome steps and often makes the process tricky because of dosage errors, loss of hands, leakage, high injection failure rates, and other known problems. To this end, it would be useful to have an easy-to-use auto-injector or pre-filled injector device that automates the drug preparation process while also providing a platform that minimizes user training and the chance of user failure.

Currently available systems typically include the use of cartridge-type designs with fluid bypass. The fluid is urged into the purgative cartridge by actuation to mix the fluid with additional fluid and/or dry medicament. However, problems exist in these cascading cartridges, where the bypass may leak or fluid escapes in the wrong direction through the cascading plunger. This is generally because the pressure in the system is linked to the need to have some pressure relief mechanism. The plungers are not generally intended to function as high pressure seals because they are required to translate, thereby limiting the amount of radial pressure the plungers can exert on the wall to obtain a suitable break-away force. As such, the seals they provide are often inadequate over long periods of time and can lead to sterility issues if not optimally designed. Such leakage during storage leads to premature contamination, while leakage during injection will reduce dosage accuracy and precision. Thus, a device having a sealed chamber that is not under constant pressure may also provide enhanced seal durability and extended life.

The invention described herein provides a solution in an attempt to solve the above-identified problems and thus improve the durability, sterility, dose control, precision, accuracy and directional freedom of the system upon actuation.

Disclosure of Invention

It has been recognized that various deficiencies of the prior art may be overcome by providing an automatic injection device having valves operable between separate and distinct chambers, wherein positive compression forces provided between the various valve components may enhance seal integrity and reduce leakage; and thus maintain lifetime and dose accuracy.

To achieve the above benefits, contemplated herein is a drug mixing device that may include a housing, wherein the housing includes a first chamber containing a first drug component and a second chamber containing a second drug component configured to mix with the first component.

The housing may further include a first displacement mechanism configured to selectively change the effective volume of the first chamber to urge the first drug component into the second chamber for mixing.

A sealing structure configured to isolate the first chamber from the second chamber may then be provided, wherein the sealing structure may include a first sealing member having a first sealing interface that may be mated against or opposite a second sealing member having a second sealing interface opposite the first sealing interface of the first sealing member. A first compressive force may then be applied to or between the first and second sealing members to provide a sealing force to the sealing interface to form a seal.

It will then be appreciated that these opposing first and second sealing interfaces may be configured to mate or engage in such a manner as to maintain at least one degree of freedom relative to one another, thereby allowing relative movement and corresponding operation of the valve thus formed in either the open or closed state.

In some embodiments, the first sealing member may be provided with a first aperture that may serve as an outlet or be in fluid communication with the first chamber, and wherein the second sealing member may be provided with a second aperture that provides fluid communication with the second chamber, wherein the first aperture and the second aperture may be selectively aligned. In some such embodiments, a degree of freedom may be provided as a sliding translation that selectively aligns the first and second apertures. Alternatively, a degree of freedom may be provided as a radial translation that selectively aligns the first and second apertures. In further such embodiments, the degree of freedom may be axial rotation that selectively aligns the first and second holes. In further such embodiments, the degree of freedom may be a linear translation that selectively aligns the first and second apertures.

In further embodiments, the first chamber may be formed using an inner vial, wherein a vial sleeve configured to carry the inner vial may be provided. In some such embodiments, an upper flange may be provided on the first sealing member between the inner vial and the vial sleeve, wherein a second compressive force is provided between the vial sleeve and the inner vial so as to compress the upper flange between the inner vial and the vial sleeve to seal the first drug component in the inner vial.

In some further embodiments, an intermediate support may be provided to receive the vial sleeve, wherein the second sealing component is provided by the intermediate support, and wherein the first compressive force is provided between the vial sleeve and the intermediate support by providing one or more radially inwardly directed protrusions that engage a top edge of the vial sleeve and bias the vial sleeve into the intermediate support, thereby creating the first compressive force.

It should then be appreciated that in some embodiments, rather than using a single displacement mechanism for both chambers, a second displacement mechanism may be provided that may be configured to selectively vary the effective volume of the second chamber.

In a further arrangement, the drug mixing device may be described as a device having a first chamber and a second chamber. A valve seal disposed between the first chamber and the second chamber may then be provided. The valve seal may include a first sealing member disposed about an aperture provided in the first chamber; a second seal member in direct contact with the first seal member, the second seal member providing an inlet in selective fluid communication with the second chamber; wherein a compressive force may be provided by various structural components or stored energy sources that may subsequently cause the opposing surfaces of the first and second sealing members to sealingly engage one another.

As previously described, the formed seal may be configured to maintain at least one degree of freedom between the first and second seal members such that the valve seal is changed between the closed and open configurations through the various translations previously described.

Also contemplated herein is a drug mixing method utilizing the above-described device, wherein in addition to providing the device, the method may include various steps, such as providing a first drug component to the first chamber; providing a second pharmaceutical component to the second chamber; moving a portion of the compression valve seal, whereby the movement aligns a first aperture and a second aperture formed in the compression valve seal, thereby forming a fluid path between the first chamber and the second chamber; and displacing the first drug component from the first chamber into the second chamber through the fluid path, thereby causing the first drug component to mix with the second drug component.

Drawings

Fig. 1A-1C show perspective external views of a drug mixing and delivery device illustrating various aspects of the invention through various stages of a first actuation step;

fig. 2A-2B show side cross-sectional views of the drug mixing and delivery device of fig. 1A-1C through various stages of a second actuation or delivery step;

fig. 3A shows an exploded view of the medication mixing and delivery device of fig. 1A-1C, showing a plurality of individual components used therein;

FIG. 3B shows an exploded view of the mixing subassembly circled by option A of FIG. 3A;

fig. 4A-4D illustrate side cross-sectional views of a mixing subassembly and a delivery assembly used in the drug mixing and delivery device of fig. 1A-1C;

FIG. 5 shows an enlarged cross-sectional view of the area circled by option B shown in FIG. 4B;

FIGS. 6A-6B show perspective views of a rotary valve and its operating principle, which can be adjusted for use with any of the embodiments described herein;

7A-7B illustrate perspective views of a radial valve and its operating principle, which can be adjusted for use with any of the embodiments described herein;

fig. 8 shows an exploded perspective view of an alternative embodiment of a drug mixing and delivery device having at least an alternative mixing assembly;

fig. 9A-9B show enlarged perspective and exploded perspective views of various components forming part of an alternative mixing assembly of the drug mixing and delivery device of fig. 8;

fig. 10A-10B show side and horizontal cross-sectional views of various components forming part of an alternative mixing assembly of the drug mixing and delivery device of fig. 8; and is

Fig. 11A-11B show side and horizontal cross-sectional views of various components forming part of an alternative mixing assembly of the drug mixing and delivery device of fig. 8 in a slightly axially rotated configuration.

Detailed Description

This application claims the benefit of the following patent applications: co-pending U.S. provisional patent application 62/456,727 filed on 9.2.2017; co-pending U.S. patent application 15/832,346 filed on 5.12.2017; co-pending U.S. patent application 15/034,967; PCT application PCT/US15/45761 filed on 8/18/2015; U.S. provisional patent application 62/204,940 filed on 8/13/2015; U.S. provisional patent application 62/126,011 filed on day 27 of month 2, 2015; U.S. provisional patent application 62/120,792 filed on 25/2/2015; U.S. provisional patent application 62/061,664 filed on 8/10/2015; and U.S. provisional patent application 62/038,386, filed on 8/18/2014, which are all incorporated herein by reference in their entirety.

As noted above, it has been recognized that various deficiencies of the prior art may be overcome by providing an automatic injection device having valves operable between separate and distinct chambers, wherein the positive compression force provided between the various valve components may enhance seal integrity and reduce leakage, and thereby preserve life and dose accuracy. To achieve these and other benefits, a drug mixing device 10 is contemplated herein, the components and embodiments of which are shown in fig. 1-7. The medication mixing device 10 may include a housing 12, wherein the housing 12 includes a first chamber and a second chamber containing components intended for mixing prior to delivery. It should be understood that the drug mixing device 10 may be actuated in a variety of states in a variety of ways, however, for purposes of illustration, fig. 1A-1B illustrate a first actuation method of initiating a mixing step in which the cap 14 is rotated relative to the housing 12 to initiate mixing of the components contained within the various chambers of the housing. At least in the above-mentioned related applications there is a detailed description of the actuation method.

Fig. 2A-2B show a side cross-sectional view of the drug mixing device 10 through a second delivery step, while fig. 4A-4D show the unmixed, pre-mixed open, mixed stages, and ejection states. These views better illustrate the first chamber 212 contained within the inner barrel 210 in which a first pharmaceutical component may be contained, preferably a liquid diluent or an injectable pharmaceutical suspension component.

These views also show a second chamber 272 included in a second vial 270, the second chamber being configured to contain a second pharmaceutical component formulated to mix with the first pharmaceutical component. It is also understood that the second pharmaceutical component may be provided as a dry component. In addition, the second pharmaceutical component may also be provided in a channel provided between the first and second chambers to ensure mixing when the first pharmaceutical component is delivered from the first chamber into the second chamber.

The drug mixing device 10 may further include a first displacement mechanism 204 that may be provided as a plunger, wherein the first displacement mechanism 204 may be configured to selectively change the effective volume of the first chamber 212 in order to urge the first drug component into the second chamber for mixing.

A sealing structure 230 configured to isolate the first chamber 212 from the second chamber 272 may then be provided, wherein the sealing structure 230 may include a first sealing member 280 having a first sealing interface 234 that may be mated against or against a second sealing member, shown herein as an intermediate support 240, wherein the intermediate support includes a second sealing interface 244 provided as an inner bottom surface thereof. As such, the second seal interface 244 opposes the first seal interface 234 of the first seal member 280. A first compressive force may then be applied to or between the first and second sealing members to provide a sealing force to the sealing interface to form a seal.

It will then be appreciated that these opposing first and second sealing interfaces may be configured to mate or engage in such a manner as to maintain at least one degree of freedom relative to one another, thereby allowing relative movement and corresponding operation of the valve thus formed in either the open or closed state. The degree of freedom may be described as a plane existing between the first seal member and the second seal member, wherein the first seal member and the second seal member may slide relative to each other in a rotational or radial manner.

In some embodiments, the first seal member 280 may be provided with a first aperture 214 that may serve as an outlet or be in fluid communication with the first chamber 212, and wherein the second seal member 240 may be provided with a second aperture 246 that is in fluid communication with the second chamber 272, wherein the first and second apertures may be selectively aligned by relative movement between the first and second seal members.

In some such embodiments, a degree of freedom may be provided as a sliding translation that selectively aligns the first and second apertures. Wherein in some such embodiments, sliding or translation may be provided as radial translation that selectively aligns the first and second apertures, as shown in fig. 7A-7B. In further such embodiments, a degree of freedom may be provided for axial rotation that selectively aligns the first and second holes, as shown in fig. 6A-6B.

In the exemplary embodiment shown herein, the first chamber 212 may be formed using an inner column tube 210, wherein a column tube sleeve 220 configured to carry the inner column tube 210 may be provided. In some such embodiments, an upper flange 284 may be provided on the first sealing member 280 between the inner vial 210 and the vial sleeve 220, wherein a second compressive force is provided between the vial sleeve 220 and the inner vial 210 so as to compress the upper flange 284 between the inner vial 210 and the vial sleeve 220, thereby sealing the first drug component in the inner vial with the only outflow path through the aperture 214 when properly aligned. In some such embodiments, the vial sleeve 220 may have one or more radially inwardly biased or oriented protrusions 224 that may be configured to engage the top edge of the inner vial 210 and bias the vial downwardly into the interior of the vial sleeve 220, thus creating a first compressive force that sandwiches the upper flange 284 between the vial sleeve 220 and the bottom edge of the vial 220.

Additionally, the first sealing member may have a lower flange 288 that may be disposed between the column sleeve 220 and the inner edge of the intermediate support 240, wherein a compressive force provided between the column sleeve 220 and the interior of the intermediate support may then cause the lower flange 288 to be sandwiched or pressed between the lower edge of the column sleeve 220 and the inner surface of the intermediate support, and then thereby provide a double seal and prevent fluid from being delivered to the interior of the housing 12 between the column sleeve 220 and the housing 12 or between the column sleeve 220 and the intermediate support 240 when compressed in the inner column 210.

In some embodiments, the sealing member may also have profiles or

protrusions

290 and 294, respectively, that may be strategically placed to allow deformation around the respective surface and increase sealing reliability and evenly distribute sealing forces, particularly by translating against an opposing surface such as the vial inner wall or against the second seal engaging surface 244.

It should then be appreciated that in some embodiments, rather than using a single displacement mechanism for both chambers, a second displacement mechanism 250 may be provided that may be configured to selectively vary the effective volume of the second chamber. In the depicted embodiment, the second displacement mechanism 250 is provided as a plunger around the lower outer surface of the intermediate support 240, wherein the second displacement mechanism 250 extends into and mates with the inner circumferential surface of the second chamber 272. The intermediate body 240 and the plunger 250 may have

apertures

246 and 256, respectively, therethrough that, when aligned with the exit aperture 214 of the first chamber 212, together serve as a fluid pathway into the second chamber 272, allowing fluid to flow through them and mix with the second pharmaceutical component, which may be contained in the pathway or in the second chamber itself. In this way, the movement of the first drug component into the second chamber provides the necessary mixing of the first drug component and the second drug component.

As such, the drug mixing device 10 may be described as a device having a first chamber and a second chamber. A valve is provided by selective misalignment or alignment of the aperture 214 and the aperture 246.

Fig. 3A-3B illustrate exploded views of an autoinjector 10 according to at least one embodiment of the present invention. The exploded view shows various internal components within the housing 12 and the cover 14. An automatic injector 10 may be provided that includes a mixing assembly 200. The drug mixing system has at least one chamber for storing at least one drug component, such as a wet solvent, diluent, or suspending fluid. Drug mixing assembly 200 may also be provided with a second vial or container 270 about an end thereof that may contain at least one second drug component, such as a dry drug component, wherein the second vial is configured to receive the first drug component. As shown herein, the first and second chambers may be separate and distinct chambers, have different separation structures forming their respective volumes, and may be movable relative to each other.

As shown herein, the first and second chambers may be configured to translate toward and away from each other, slide radially relative to each other, and rotate relative to each other along a common axis, or any combination thereof.

The housing may include a preloaded energy source 122, shown here as a spring, or may be implemented as a compressed air chamber that, although not shown, may be modified by one skilled in the art. The spring may be configured to provide a driving force and a reaction force between the inner plunger shaft 112 and to transfer the driving force and reaction force to various components of the mixing assembly 200 at various stages, as will be discussed below. The mixing assembly 200 may be housed within the frame 110, wherein individual components of the mixing assembly 200 may be configured to selectively rotate within the housing 12. The spring may also be configured to provide one or more compressive forces to provide a seal against upper flange 284 and lower flange 288, respectively, as described above, in particular by transmitting the force through plunger shaft 112 to the upper edge or rim of inner barrel 210 or barrel sleeve 220.

The mixing assembly 200 may be held within the frame using a frame cover 114, which may be formed separately from or integrally with the frame 110. The frame cover 114 prevents the mixing assembly 200 from being pushed through the frame 110 and completely out of the housing 12 after delivery or injection, and provides a counter force to the extension of the spring 122 to push the mixed first and second drug components from the second chamber 272.

The frame cover 114 may also help to retain the needle hub 314 as the needle passes through or pierces the hub, providing the hub to better maintain the sterility of the needle 310 during insertion into a user. Thus, when pushed downward, the bottom of the mixing assembly 200 is pushed out and held by the frame cover 114, while the needle 310 may pierce the needle sheath 314 and extend beyond the housing in order to deliver the mixed pharmaceutical components to the injection site.

As shown herein, a needle shield 150 and a needle shield spring 154 may be disposed between the frame 110 at the injection end of the housing 12 and the housing 12. The needle shield 150 may be used as a trigger for the second delivery step, as shown in fig. 2A-2B, and the needle shield spring 154 may be configured to bias the needle shield 150 axially downward so as to continuously limit the needle 310 from being improperly exposed before and after an injection. These functions are described in more detail in the related applications.

The frame 110 and portions of the mixing assembly 200 may be configured to rotate together within the housing when an axial torque force is applied between the cover 14 and the housing 12, as shown in fig. 1A-1C. The cover 14 may thus be connected in a radially fixed manner to the frame 110, which in turn is connected to certain components of the mixing assembly 200, and may also provide a driver interface 118 that is not only coupled in a radially fixed manner to an alternative portion of the mixing assembly 200 (such as to the inner plunger shaft 112), but is also rigidly connected to the housing 12. In this manner, axial torsional and reactive forces exerted between the cover and the housing may be transmitted into and cause actuation of certain components of the mixing assembly 200.

The mixing assembly may include the inner plunger shaft 112 and the inner plunger 204 that together function as the first displacement mechanism described above. The first displacement mechanism may be configured to reduce the effective volume of the first chamber, the first chamber initially containing the first medicament component, i.e. the liquid component of the medicament.

The plunger is configured to mate with an inner barrel 210 forming a first chamber. The inner vial may be housed within the vial sleeve 220, or alternatively, the vial sleeve 220 and the inner vial 210 may be integrally formed from a single material.

The vial sleeve 220 may then be mated with the rotary valve seal 280 located within the intermediate support 240. The intermediate support 240 may have a second displacement mechanism 250, i.e., a second plunger coupled thereto, configured to reduce the effective volume of a second chamber located within a second column tube 270.

The second barrel 270 may then have a delivery assembly 300 attached thereto, which may include a needle 310 or cannula and a needle guard 314 or other barrier configured to maintain sterility of the delivery assembly prior to use.

The vial sleeve may have one or more radially inwardly extending protrusions corresponding to the top edge of the glass vial. By inserting the glass vial and providing a downward or compressive force, wherein the radially inwardly extending projections of the vial sleeve will engage the upper edge of the vial itself and maintain the compressive force. The compressive force between the vial itself and the vial sleeve may be configured to sandwich the compression-sealed upper flange therebetween and thereby prevent fluid contained within the wetting chamber from escaping into the region between the vial and the vial sleeve. In some embodiments, the compression seal may further comprise an additional upward projection that extends into the interior cavity of the vial and serves as a stop for the plunger after injection. The upward projection may also have one or more projections that may be configured to interact or engage with corresponding grooves formed on the inner surface of the vial itself, thereby adding another series of seals to prevent leakage and premature contamination of the pharmaceutical product contained therein.

It should be appreciated that the various apertures and/or fluid paths may be misaligned in various ways, such as being disposed in the side wall, and axially displaced or disposed in the bottom end wall, as well as axially twisted or radially translated.

Fig. 6A-6B illustrate the working principle of the rotary valve seal 400 used in the above-described embodiment. A rotary valve may be formed in which a fluid path is established by rotating one bore relative to another. In this exemplary illustration, an aperture 214A may be provided in the bottom portion of the vial forming the chamber, and a second aperture 246A may be provided through the bottom engagement portion of the seal 400, which may be an inlet to the remainder of the fluid passage of the other chamber. Fig. 6A shows a closed configuration in which the two apertures are not aligned and there is no fluid communication. Fig. 6B shows an open configuration in which the two apertures are aligned and fluid communication is established. It will be appreciated that one or both of the components may be formed from a material having deformable properties, such as rubber or silicone, in order to form a better seal. In another embodiment, one of the components is rubber and the other is hard plastic. In another embodiment, each sealing surface is made of a combination of hard plastic and elastomeric material at one joint.

Fig. 7A to 7B illustrate the working principle of the radial valve seal 500 used in the above embodiment. A radial valve may be formed in which the fluid path is established by sliding one bore radially relative to the other. In this exemplary illustration, an aperture 214B may be provided in the bottom portion of the vial forming the chamber, and a second aperture 246B may be provided through the bottom engagement portion of the seal 500, which may be an inlet to the remainder of the fluid passage of the other chamber. Fig. 7A shows a closed configuration in which the two apertures are not aligned and there is no fluid communication. Fig. 7B shows an open configuration in which the two apertures are aligned and fluid communication is established. It will be appreciated that one or both of the components may be formed from a material having deformable properties, such as rubber or silicone, in order to form a better seal. In another embodiment, one of the components is rubber and the other is hard plastic. In another embodiment, each sealing surface is made of a combination of hard plastic and elastomeric materials at one interface.

Fig. 8-11 illustrate alternative embodiments of drug mixing and delivery device 600 that include various alternative arrangements (i.e., in mixing assembly 700) such that at least one sealing compression force is no longer required. In particular, the mixing assembly 700 may include a vial sleeve 620 with a vial portion 624 integrally formed in the interior of the sleeve 620, thus eliminating the need for a separate and distinct vial as described in previous embodiments. It should be understood that this alternative embodiment still includes two separate and distinct chambers formed by vial 670 and vial sleeve 620, respectively, with associated separate and

distinct displacement mechanisms

604 and 650 configured to reduce the effective volume of their respective chambers.

Similar to the above embodiments, the drug mixing and delivery device includes a valve assembly 630 that operates between closed and open positions to retain a first drug component in the vial portion 624 for mixing with a second drug component located outside of the vial portion (i.e., in the second vial 670). Similarly, an outlet 634 may be disposed in selective alignment with an inlet or fluid path 654 to the second chamber, shown here as flowing through the second displacement mechanism 650.

The valve assembly is primarily formed from a bottom edge surface 628 of a vial sleeve 620 that abuts an opposing surface of the second displacement mechanism 650 or an inner surface of the corresponding intermediate support 640. The intermediate support 640 may provide structural support and function to the various components, including carrying at least a second displacement mechanism; various actuation features, such as tabs or protrusions, which are operated to open or close the valve assembly; and providing structural support to the vial sleeve to provide a compressive sealing force between itself and the vial sleeve and between vial sleeve 620 and the upper edge of second displacement mechanism 250, as shown herein.

The compressive force described above may be applied by providing tabs or springs 644 that may be biased inwardly such that when the column tube sleeve is inserted into the intermediate support to a certain depth of compression, the tabs 644 may flex to the central portion and engage corresponding lips provided on the outer surface of the column tube sleeve, thereby holding the column tube sleeve in a compressed arrangement against the back or opposing surface of the second displacement mechanism 650, or alternatively to the inner surface of the intermediate support (if provided, but not shown here).

As shown herein, the displacement mechanism 650 may be held in an axially fixed position relative to the intermediate support 640 by corresponding protrusions, lips, and/or grooves. As such, it can oppose and seal in response to compressive forces through vial sleeve 620. This compressive force (particularly when the outlet 634 is misaligned with the passage 654) may then result in a positive sealing force between the vial sleeve 620 and the opposing surface of the displacement mechanism.

In some embodiments, vial sleeve 620 may be formed of a thermoplastic that is overmolded over the glass vial portion. Alternatively, the entire vial sleeve may be formed of a unitary structure having a uniform material forming its structure. Similarly, the second displacement mechanism 650 may be a rubber material overmolded on or within the intermediate support 640.

Similar overmolding may be employed in any of the structures in any of the embodiments disclosed herein.

It should be understood that the plunger or valve member discussed in any of the embodiments herein may be formed from a suitable sealing substance, such as rubber, silicone, or virtually any malleable substance that can be individually tailored to be compatible with the substance of the first or second pharmaceutical components.

Claims

1. A medication mixing device, comprising:

a housing;

a first chamber having an outlet and disposed within the housing, the first chamber containing a first pharmaceutical component;

a second chamber having an inlet and disposed within the housing;

a second pharmaceutical component disposed within the housing outside of the first chamber;

characterized in that the drug mixing device comprises:

a sealing structure isolating the first chamber from the second chamber, the sealing structure further comprising:

a first seal member having a first seal interface;

a second seal member having a second seal interface opposite the seal interface of the first seal member;

wherein a first compressive force applied to the first and second sealing components causes the sealing interface to form a seal; and

at least one tab engaged with the first chamber and configured to provide a compressive force around the first and second sealing members.

2. The medication mixing device of claim 1, wherein the first sealing member is provided with a first aperture in fluid communication with the outlet of the first chamber, and wherein the second sealing member is provided with a second aperture providing fluid communication with the inlet of the second chamber.

3. The medication mixing device of claim 2, wherein the compressive force allows the first and second seal components to maintain at least one degree of freedom that is a sliding translation that selectively aligns the first and second apertures.

4. The medication mixing device of claim 1, wherein the compressive force allows the first and second seal members to maintain at least one degree of freedom that is a radial translation that selectively aligns the outlet of the first chamber with the inlet of the second chamber.

5. The medication mixing device of claim 1, wherein at least one tab engages with a corresponding lip around a sidewall of the first chamber to generate the compressive force.

6. The medication mixing device of claim 3, wherein the degree of freedom is a linear translation that selectively aligns the first aperture with the second aperture.

7. The medication mixing device of claim 1, wherein the first chamber comprises:

an inner column tube forming an interior volume of the first chamber; and

a column tube sleeve carrying the inner column tube.

8. The medication mixing device of claim 7, wherein the inner vial and the vial sleeve are integrally formed.

9. The medication mixing device of claim 5, wherein a portion of the second seal component is attached to a portion of an intermediate support, and wherein the intermediate support structurally supports the at least one tab such that upon insertion of the first chamber into the intermediate support, the first chamber presses the first seal component against the second seal component, the compressive force being maintained by engagement of the at least one tab with a corresponding lip on the sidewall of the first chamber.

10. A medication mixing device, the device comprising:

a housing;

a first chamber disposed within the housing;

a second chamber disposed within the housing;

a valve seal disposed between the first chamber and the second chamber, characterized in that the valve seal further comprises:

a first sealing member disposed around an aperture provided in the first chamber;

a second seal member in direct contact with the first seal member, the second seal member providing an inlet in selective fluid communication with the second chamber; and

a pair of tabs engaged with the first chamber and configured to provide a compressive force around the first and second sealing members, thereby forming a seal;

wherein the seal formed maintains at least one degree of freedom between the first and second seal members that enables the valve seal to be changed between a closed configuration and an open configuration.

11. The medication mixing device of claim 10, wherein the degree of freedom is a radial translation, wherein the radial translation selectively aligns the aperture disposed in the first seal member with the inlet of the second seal member.

12. The medication mixing device of claim 10, wherein the degree of freedom is a planar translation, wherein the planar translation selectively aligns the aperture disposed in the first seal member with the inlet of the second seal member.

13. The medication mixing device of claim 10, further comprising an intermediate support having a portion of the second sealing member attached to a first portion of the intermediate support and connected to the pair of tabs at a second portion.

14. The medication mixing device of claim 10, wherein a sidewall of the first chamber has a lip configured to engage with the pair of tabs.

15. A medication mixing device, comprising:

a housing;

a second chamber having an inlet and disposed within the housing;

characterized in that the drug mixing device comprises:

a first seal member having a first seal interface;

at least one tab engaged with the first chamber and configured to provide a compressive force around the first and second sealing members;

wherein the compressive force applied to the first and second sealing members by the at least one tab causes the sealing interface to form a seal; and

wherein a seal formed by the compressive force of the at least one tab allows the first and second seal components to maintain at least one degree of freedom relative to each other.

16. The medication mixing device of claim 15, wherein the degree of freedom is linear translation, axial rotation, or radial translation.

17. The medication mixing device of claim 15, further comprising a second tab forming a pair of tabs, and wherein the pair of tabs are integrated with an intermediate support configured with the pair of tabs to provide the compressive force about the first and second seal members.