Patent Grant
12042468
The present invention claims priority of Indian patent application no. 202121029262 “Tray For Positioning A Medical Vial Together With A Vial Adapter In A Fixed Positional Relationship Relative To Each Other And Packaging Unit Comprising The Same”, filed on Jun. 29, 2021, the whole content of which is hereby incorporated by reference.
The present invention generally relates to drug delivery devices and containers, and more specifically relates to a tray for positioning a vial for medical or pharmaceutical applications together with a vial adapter in a fixed positional relationship relative to each other to enable the coupling of the vial adapter to the vial for liquid transfer in a simple manner. The present invention also relates to a packaging unit including such a tray, which packages a vial and a vial adapter, preferably under sterile conditions.
Trays and sterile packaging units for medical devices and storage containers, such as vials made of glass of plastic material, are well-known from the prior art.
Examples for such trays and methods for manufacturing thereof are disclosed e.g. in U.S. Pat. Nos. 4,730,726, 5,108,530, 5,165,539, 5,353,930 and 5,44,9071, and such trays may be made of plastic material e.g. by vacuum thermoforming or pressure thermo-forming of a thin plastic sheet or by means of plastic injection molding. Such trays may also include locking features for either locking lids of the tray with each other or locking a medical device or a storage container inside a cavity of the tray in order to provide a fixed position of the medical device or storage container during storage in the tray.
For the transfer of a liquid out of and/or into a vial, various transfer devices and assemblies are known from the prior art. Such transfer devices or assemblies will usually include locking members for locking the device or assembly to the front end of a vial in a transfer position and a piercing mandrel or similar stopper puncturing member to pierce or puncture, in the transfer position, an elastomeric stopper sealing the opening of the vial, for enabling the transfer of a liquid out of and/or into the vial. For medical applications, at least the transfer devices or assemblies need to be packaged under sterile conditions, whereas the upper surface of the vial stopper could be disinfected prior to actual use, e.g. by a swab. Ensuring sterile conditions makes, however, the handling of such transfer devices and assemblies difficult.
U.S. Pat. No. 8,752,598 B2 discloses an example of a liquid drug transfer assembly including a drug vial adapter having a drug vial adapter skirt, an upright drug vial adapter port and a drug vial adapter sleeve downward depending opposite the upright drug vial adapter port and in flow communication therewith. For enabling the transfer of a drug liquid, the drug vial adapter is slidingly disposed on the drug vial stopper puncturing member such that on mounting the liquid drug transfer assembly on the drug vial, the drug vial stopper puncturing member punctures the drug vial stopper to form a throughgoing puncture bore and the drug vial adapter sleeve lines the puncture bore. The drug vial adapter is packaged under sterile conditions in a special blister pack having a protective foil. Before removing the protective foil from the underside of the blister pack and positioning the drug vial adapter onto the front end of a vial, the upper surface of the vial stopper needs to be disinfected.
U.S. Pat. No. 10,278,897 B2 discloses in
In medical applications, it is usually desirable to prevent the patient from being exposed to the fluid which is being injected to or extracted from the patient, and it is desirable to insulate nurses and doctors from exposure to the liquid which may contain the patient's blood or waste products.
For enabling an efficient needleless or needle-free coupling of a syringe with a vial, US 2017/0143586 A1 discloses a similar vial adapter comprising an outer thread for a Luer lock thread of a syringe so that the vial adapter.
Often the male component of the syringe used to inject or withdraw the fluid, retains some of the fluid on the tip thereof, thus providing a risk to nurses and doctors of being exposed to the fluid. Wiping off this fluid prior to disconnecting the syringe is highly desirable. For enabling a safe and efficient wiping off of fluid in such applications, U.S. Pat. No. 6,651,956 B2 discloses a valve which includes a stem having a slit at an end thereof. The valve stem is located in a valve body and is deformable. When a tip of a syringe is engaged with the slit in the stem, the stem shifts in the valve body, a top portion thereof folds inward and the slit seals against the instrument and allows liquid to flow through the stem, to or from the instrument. When the tip of the syringe is removed again, the surface of the valve stem will not be contaminated with liquid.
Integrating such a valve stem into a vial adapter of the kind discussed above is also known from the prior art.
It is an object of the present invention to provide safe and reliable solutions for enabling an efficient coupling of a medical device, such as a syringe, with a medical vial used for medical or pharmaceutical applications.
According to the present invention there is provided a tray for positioning a vial for medical or pharmaceutical applications together with a vial adapter in a fixed positional relationship relative to each other, said vial adapter comprising a piercing mandrel and being configured to be locked to a front end of the vial in a transfer position in which the piercing mandrel pierces a stopper of the vial for transfer of a liquid out of and/or into the vial, said tray comprising: a tray member having a vial cavity for accommodating at least a portion of the vial and a vial adapter cavity for accommodating at least a portion of the vial adapter, wherein the vial adapter cavity and the vial cavity each comprises retaining members, which are configured to position the vial adapter and the vial in an intermediate position, in which the vial adapter is positioned in a fixed position and predetermined orientation while the vial is positioned spaced apart from the vial adapter and in axial alignment with the vial adapter, wherein the retaining members further configured to guide a relative movement of the vial and vial adapter from the intermediate position to the transfer position while maintaining the axial alignment of the vial and vial adapter with each other.
The tray thus can be used as a jig, gauge or caliber to define the positional relationship between the vial adapter and vial in the intermediate position and to keep them in axial alignment during the transfer from the intermediate position to the transfer position. From the intermediate position the transfer position can be accomplished by a simple axial displacement of the vial and/or vial adapter, i.e. a displacement only in axial direction. In the transfer position, the vial adapter is locked to the front end of the vial and the piercing mandrel of the vial adapter pierces the vial stopper for liquid transfer, namely for enabling the transfer of liquid out of and/or into the vial, e.g. for administering a liquid solution stored in the vial.
The intermediate position may be identical with a storage position in which the vial and vial adapter are stored in the tray over an extended period of time. According to further embodiments, however, the storage position is different to the intermediate position, and it is also conceived that the tray is not used for long-time storage of the vial and/or vial adapter, but that the tray is used only for positioning the vial and vial adapter relative to each other short time before effecting the axial displacement of the vial and/or vial adapter from the intermediate position to the transfer position. The vial being positioned ‘spaced apart from the vial adapter’ shall mean in particular that the piercing mandrel does not yet contact the vial stopper, and that preferably a certain gap exists between the vial adapter and vial in the intermediate position.
In the intermediate position the vial and vial adapter are positioned in axial alignment with each other, which shall mean that the axial center lines of the vial and vial adapter, which are each generally of cylindrical shape, generally coincide. Of course, minor deviations from a perfect axial alignment between the vial and vial adapter may exist in the intermediate position, and most important is that the relative movement between of the vial and vial adapter is guided in such a manner that the piercing mandrel starts piercing or puncturing the vial stopper at its central piercing portion and the piercing mandrel remains centered during the further relative movement from the intermediate position to the transfer position. The main purpose of the tray is thus to enable a sufficient centering effect so that the piercing mandrel will pierce or puncture the vial stopper at a central position and so that the vial adapter can be properly locked to the front end of the vial.
For the transfer from the intermediate position to the transfer position, it is preferred if only one of the vial and vial adapter is moved relative to the other. Most preferably, the vial adapter is kept stationary by means of the tray, whereas the vial is moved in axial direction towards the vial adapter until finally the vial adapter is locked to the front end of the vial. Of course, however, also the vial may be kept stationary by means of the tray, whereas the vial adapter is moved in axial direction towards the vial. Any ‘mixed’ axial displacement between the afore-mentioned extreme cases may also be accomplished by means of the tray according to the present invention.
‘Maintaining the axial alignment of the vial and vial adapter with each other’ during the transfer from the intermediate position to the transfer position, of course, shall allow a certain misalignment between the vial and vial adapter, e.g. a minor lateral displacement, as long as a the tray enables a sufficient centering effect so that the piercing mandrel will pierce or puncture the vial stopper at a central position and so that the vial adapter can be properly locked to the front end of the vial.
The cavities of the tray member are preferably sufficiently deep so that the vial adapter and vial each does not protrude beyond an upper surface of the tray member, when the vial adapter and vial is accommodated inside the vial adapter cavity and vial cavity, respectively, so that e.g. a packaging foil may be bonded to the upper surface of the tray member to provide a packaging unit. Both cavities are generally of cylindrical shape, corresponding to the outer profile of the vial adapter and vial, respectively. Preferably, the vial adapter cavity is large enough to fully accommodate the vial adapter in the intermediate position, whereas a portion of the vial may extend beyond a front end of the vial cavity in the intermediate position, e.g. being exposed in an intermediate cavity between the vial adapter cavity and vial cavity for enabling access to the vial body with the fingers of a user or grippers of a robot.
Preferably the tray member has a planar upper surface, wherein the vial cavity and the vial adapter cavity is each open toward the planar upper surface of the tray member. Thus, both cavities can be easily sealed, e.g. by adhesive bonding of a packaging foil on the planar upper surface of the tray member. The planar upper surface of the tray member preferably encircles both cavities, i.e. the vial cavity and the vial adapter cavity, so that both cavities can be sealed sterile against the environment, if required, and the tray can be used for long-time storage of the vial and vial adapter.
According to the present invention, the retaining members may each be formed simply by a bottom of the vial cavity and vial adapter cavity itself. The bottoms of the cavities then serve for establishing the axial alignment between the vial and vial adapter in the intermediate position and maintaining this axial alignment during the transfer from the intermediate position to the transfer position. During the transfer from the intermediate position to the transfer position, the bottoms of the cavities will then also be used for guiding the relative movement of the vial and vial adapter. Preferably, the bottoms of the cavities are each curved corresponding to the outer profile of the vial and vial adapter, respectively.
According to a further embodiment, the retaining members comprise pairs of protrusions formed on opposite side-walls of the vial adapter cavity and vial cavity, respectively, which are configured for contacting side-surfaces of the vial adapter and vial, respectively, for positioning the vial adapter and vial. By contacting side-surfaces of the vial adapter and vial, respectively, the protrusions may control and keep constant the level of the vial and vial adapter, respectively, in the tray member during the transfer from the intermediate position to the transfer position. The retaining members, particularly the protrusions, may retain the vial and vial adapter in the vial cavity and vial adapter cavity, respectively, in a positive-fit manner. Such a positive fit may be sufficient to also fix the axial positions of the vial and vial adapter, respectively, in the intermediate position. When the vial and/or vial adapter is moved in axial direction for the transfer from the intermediate position to the transfer position, a certain friction between the retaining members and the vial/vial adapter may be caused. However, such friction is low enough to enable a sliding movement of the vial/vial adapter from the intermediate position to the transfer position without exerting high axial forces.
According to a further embodiment, a height of contact regions of the protrusions with the side-surfaces of the vial adapter and vial, respectively, above a bottom of the vial adapter cavity and vial cavity, respectively, is larger than the height of a center line of the vial adapter and vial above the bottom of the vial adapter cavity and vial cavity. The protrusions may thus serve to delimit the level of the vial and vial adapter, respectively, in a direction perpendicular to their axial direction, for preventing a significant lateral displacement of the vial and vial adapter, respectively, in the direction perpendicular to their axial direction during the transfer from the intermediate position to the transfer position, to thereby maintain the axial alignment, as outlined above.
According to a further embodiment, the opposite side-walls on which the protrusions are formed are each upright and planar side-walls. Thus, the vial and vial adapter can each be accommodated in cylindrical volumes formed between the bottom of the respective cavity and associated protrusion. Preferably, the upright and planar side-walls are a little flexible so that the protrusions can move a little outward when the vial and vial adapter are inserted from above into the respective cavity. And preferably, the upright and planar side-walls will then flex back to their home position once the vial and vial adapter has been inserted from above into the respective cavity, to secure the level of the vial and vial adapter, respectively.
According to a further embodiment, the vial cavity comprises at least two pairs of protrusions formed on opposite side-walls of the vial cavity, and at least one pair of protrusions is still in contact with side-surfaces of the vial in the transfer position. The at least one pair of protrusions may then be used for guiding the relative movement of vial and vial adapter and maintain the centering effect even at the final stage of the transfer from the intermediate position to the transfer position.
According to a further embodiment, the tray member further comprises guiding protrusions for maintaining the axial alignment between the vial and vial adapter during the relative movement between the vial and the vial adapter in the cavities from the intermediate position to the transfer position. These guiding protrusions may be different to the afore-mentioned retaining members to that the centering effect and guiding effect can be accomplished by means of different parts of the tray member.
According to a further embodiment, a bottom of the vial cavity is curved with a radius of curvature corresponding to an outer radius of a vial body of the vial and the profile of a bottom of the vial adapter cavity corresponds to an outer profile of the vial adapter, so that the bottoms of the cavities can be used directly as retaining members, as outlined above.
According to a further embodiment, the vial cavity further comprises axial position limiting members configured for delimiting an axial movement of the vial inside the vial cavity in the storage position. The axial position of the vial can thus be defined precisely and in a simple manner, in order to ensure that the vial and vial adapter are spaced apart from each other in the intermediate position. These axial position limiting members may be formed as protrusions on the bottom and/or side-walls of the vial cavity and/or vial adapter cavity. Preferably, the axial position limiting members are formed integrally with the bottom and/or side-walls of the vial cavity and/or vial adapter cavity.
According to a further embodiment, the axial position limiting members are more flexible than the retaining members of the vial cavity. When the vial slides over the axial position limiting members during the transfer from the intermediate position to the transfer position, the axial position limiting members will thus not cause a significant displacement of the vial in a direction perpendicular to the axial direction of the vial.
According to a further embodiment, the vial adapter has a stepped outer contour and the vial adapter cavity comprises a plurality of cavities of different widths and a plurality of stop surfaces that delimit an axial displacement of the vial adapter away from the vial by abutment with the stepped outer contour of the vial adapter.
According to a further embodiment, the tray member further comprises an intermediate cavity formed between the vial adapter cavity and the vial cavity, wherein a bottom end of the vial adapter is spaced apart from the front end of the vial in the intermediate position. The intermediate cavity may thus enable a certain minimum axial distance between the vial and vial adapter in the intermediate position, so that the outer surface of the vial stopper may be disinfected by means of a sterilizing swab before the transfer from the intermediate position to the transfer position.
According to a further embodiment, the intermediate cavity comprises a portion that is sufficiently wide to enable access to a vial body of the vial by means of fingers of a user or by means of grippers or the like of a robot in the intermediate position, for driving the relative movement of the vial and vial adapter, and/or for removal of the vial together with the vial adapter locked to the front end of the vial in the transfer position from the tray member by means of fingers of a user or grippers of a robot.
According to a further embodiment, the tray member further comprises a rear end cavity, where a bottom of the vial is sufficiently exposed to enable access to the bottom for a finger of a user or a manipulation member of a robot for driving the axial movement of the vial from the intermediate position to the transfer position.
According to a further embodiment, the tray member is made of plastic material, in particular by vacuum thermoforming or pressure thermo-forming of a plastic sheet or by means of plastic injection molding. Or the tray member may be made of paper or cardboard with a thin film of plastic or bioplastic arranged on inner surfaces of the vial adapter cavity and vial cavity. Or the tray member is simply made of paper or cardboard without a thin film of plastic or bioplastic arranged on inner surfaces of the vial adapter cavity and vial cavity. Preferably, the retaining members are formed integrally with the tray member.
According to a further embodiment, the tray member may comprise a vial adapter tray member having a vial adapter storage cavity for long-time storage of the vial adapter, wherein the vial adapter storage cavity and the vial adapter cavity is each configured for enabling a transfer of the vial adapter from the vial adapter storage cavity into the vial adapter cavity to position the vial adapter in the intermediate position.
According to a further embodiment, the vial adapter tray member may be connected with the tray member via a hinge so that the vial adapter tray member can be pivoted about the hinge for positioning the vial adapter storage cavity vertical above the vial adapter cavity for enabling a transfer of the vial adapter from the vial adapter storage cavity into the vial adapter cavity to position the vial adapter in the intermediate position.
According to a further embodiment, the vial adapter tray member is a tray member insert that includes the vial adapter cavity and is configured to be inserted into a positioning cavity of the tray member as an independent member, and wherein, when the tray member insert is inserted into the positioning cavity of the tray member, the vial adapter is positioned in the intermediate position.
According to a further embodiment, the tray member insert comprises locking means for locking the tray member insert to the tray member, for positioning the tray member insert in the positioning cavity of the tray member.
According to a further aspect of the present invention there is provided a packaging unit for packaging a vial for medical or pharmaceutical applications together with a vial adapter, comprising a tray member as outlined above, and a packaging foil, wherein the vial adapter is accommodated in the vial adapter cavity, the vial is accommodated at least partially in the vial cavity so that it is spaced apart from the vial adapter and in axial alignment with the vial adapter, and the tray member is sealed by the packaging foil. The packaging unit may be used for sterile packaging the vial and vial adapter.
According to a further embodiment, the tray member comprises a planar upper surface and the packaging foil is adhesively bonded to the upper surface of the tray member.
According to a further embodiment, the vial adapter storage cavity is sealed by a second packaging foil. Preferably, the vial adapter storage cavity is sterile sealed by a second packaging foil.
The invention will now be described by way of example and with reference to the accompanying drawings, from which further features, advantages and problems to be solved will be-come apparent. In the drawings:
In the drawings, the same reference numerals designate identical or substantially equivalent elements or groups of elements.
The vial adapter 4 consists basically of a valve body 40 and a coupling body 42. The valve body 40 includes a valve of the type disclosed in U.S. Pat. No. 6,651,956 B2, the whole content of which is hereby incorporated by reference. The valve stem 46 is accommodated in the cavities of the first and second cylindrical portion 48, 50 and abuts against the conical portion 49 and the bottom of cavity formed by the cylindrical wall 53 of the connecting ring 41, which connects the valve body 40 to the skirt 60, e.g. by bonding or ultrasonic welding. A slit is formed in the front end of the elastomeric valve member 45, which is exposed in the front opening 44 of the first cylindrical portion 48. An outer thread 43 on the first cylindrical portion 48 enables the coupling with a Luer thread of a syringe. When a syringe is coupled to the first cylindrical portion 48 by threading, the tip of the syringe will penetrate the slit and enter the central channel 47 of the valve member 45 for liquid transfer.
The coupling body 42 of the vial adapter 4 is configured to be locked to the front end of a vial in a transfer position, such as of the general configuration disclosed e.g. in U.S. Pat. No. 8,752,598 B2. The coupling body 42 includes a skirt 60 consisting of a plurality of curved segments that are disposed along the circumference of the skirt 60 at equiangular intervals and interrupted by axial slots 62. The segments form resilient legs 61 that can be flexed radially outwards. On the inner surfaces of the resilient legs 61 locking protrusions 63 are formed. The coupling body 42 includes a top wall 55 with a central piercing mandrel 57 that comprises a central cannula or lumen 58 that is in fluid communication with the central channel 47 of the valve member 45 via the mouth 58a.
When the vial adapter 4 is pushed onto the front end of a vial of the kind shown in
The general shape of a vial to be accommodated in a tray according to the present invention is shown in the cross-sectional view of
For storing a vial adapter 4 in a fixed positional relationship relative to such a vial that enables the establishment of the transfer position (when the vial adapter 4 is locked on the front end of a vial 7) by means of a relative movement of the vial adapter 4 and vial 7 only in axial direction, according to the present invention a tray 1 as shown in
As shown in
As shown in
As shown in
As shown in
As shown in
As shown in
As shown in
As shown in
As shown in
As shown in
For coupling the vial adapter 4 with the vial 7, firstly the packaging foil 8 needs to be removed from the tray 1.
For initializing the coupling of the vial adapter 4 with the vial 7, the vial 7 is pushed in axial direction towards the vial adapter 4, as shown in
The piercing mandrel 57 of the vial adapter 4 will thus start piercing the stopper 76 of the vial at its center. When the vial adapter 7 is pushed further toward the vial adapter 4, the bottom bevels of the protrusions 63 of the resilient legs 61 will finally slide along the outer edge of the metal cap 77 of the vial 7 and thus start spreading the resilient legs 61 apart. At the same time, the piercing mandrel 57 will start piercing or puncturing the elastomeric stopper 76 of the vial 7. The piercing mandrel 57 thus assists in maintaining the axial alignment between the vial 7 and vial adapter 4, so that the rear vial retaining protrusions 36a may finally get out of contact with the outer surface of the vial body 70. When the vial 7 is pushed further toward the vial adapter 4, finally the locking protrusions 63 of the vial adapter will grip behind the bottom edge of the metal cap 77 of the vial 7 and the piercing mandrel 57 will have fully penetrated or punctured the vial stopper 76, thus enabling a liquid transfer into and/or out of the vial 7 in the transfer position shown in
In the transfer position of
As can be concluded from
As the vial adapter 4 and the vial 7 may be stored in the sterile packaging unit under sterile conditions, the assembly is ready for use after removal from the tray 1, and, if required, only the front end of the vial adapter 4 needs to be disinfected again, e.g. by means of a disinfecting swab, before coupling the vial adapter 4 with a medical device, such as a syringe by means of the thread 43. The transfer position may be obtained quickly and reliably, because the tray 1 enables an intuitive operation and because the axial alignment between the vial adapter 4 and vial 7 can be maintained reliably during all stages of operation.
The above description has assumed the preferred case that the vial adapter 4 rests stationary in the vial adapter cavity 12, while its orientation is maintained by means of the vial adapter retaining protrusions 37a, 37b, as outlined above. However, as will become apparent to the skilled person when studying the above description, the transfer position may also be reached starting with the intermediate position by any other suitable relative motion between the vial adapter 4 and vial 7, including the extreme reverse case that the vial 7 is kept stationary in the vial cavity while the vial adapter 4 is pushed toward the stationary vial 7 and including ‘mixed cases’ where both the vial 7 and the vial adapter 4 are moved in axial direction towards each other. During the axial displacement from the intermediate position to the final transfer position, preferably both the vial adapter and the vial do not move in a direction perpendicular to the axial direction.
For establishing the transfer position, first the packaging foil 8 needs to be removed, as shown in
After peeling-off the second packaging foil 8a, both the vial adapter 4 and the vial 7 are partially exposed in the intermediate position shown in
Different to the previous embodiments, the storage position of the vial adapter 4 is different to the intermediate position. As shown in
After removal of the packaging foil 8, at least the vial 7 in the vial cavity 11 may be exposed partially, as shown in
After peeling-off the second packaging foil 8a, both the vial adapter 4 and the vial 7 are partially exposed in the position shown in
As will become apparent to the skilled person when studying the above description, a tray according to the present invention may be used for the storage/positioning of any kind of transfer adapter enabling a liquid transfer into and/or out of a medical container and for the storage/positioning of any other kind of medical container except vials, such as cartridges or syringe bodies.
Of course, a vial adapter as outlined above may also be coupled with additional units for liquid transfer when positioned/stored in a tray according to the present invention. As an example for such a combination of a vial adapter with an additional unit,
While the preferred embodiments of the present invention have been described so as to enable one skilled in the art to practice the device of the present invention, it is to be understood that variations and modifications may be employed without departing from the concept and intent of the present invention as defined in the appended claims. Accordingly, the preceding description is intended to be exemplary and should not be used to limit the scope of the invention. The scope of the invention should be determined only by reference to the appended claims.
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| 349263-001-0001 | Nov 2021 | IN |
| 345663-001-0001 | Apr 2022 | IN |
| 346307-001 | May 2022 | IN |
| 6014868 | Oct 2016 | JP |
| 300745291 | May 2014 | KR |
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| Entry |
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| First Office Action for related U.S. Appl. No. 29/810,540 mailed Apr. 13, 2023. |
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| Number | Date | Country | |
|---|---|---|---|
| 20220409485 A1 | Dec 2022 | US |
