Abstract: A vial adapter 4 for use with a pump dispenser 2 comprises a hollow tubular body 48 forming a cavity 46, which comprises a first connecting means 45 for connection with the pump dispenser 2 and an opposite second connecting means 61, 63 for coupling with a vial 7. A partition wall 49 separates the cavity 46 into two half-spaces 56a, 56b, with a piercing mandrel 57 being disposed on the partition wall 49 in the second half-space 56b, a cannula 58 of said piercing mandrel 57 being in fluid connection with the first half-space 56a. A coupling structure 50, 51 is provided on the partition wall 49 in the first half-space 56a, which is configured for coupling the cannula 58 of the piercing mandrel 57 with an inlet tube 30 of the pump dispenser 2 in a fluid-tight manner. As the inlet tube of the pump dispenser can be coupled with the vial adapter inside the vial adapter, the vial adapter together with the pump dispenser can be pre-assembled and packaged as a unit, to be delivered to customers as a ready-to-use unit. Both the vial adapter and the pre-assembled unit can be packaged reliably and in a cost-efficient manner.
Claims:1. A vial adapter (4) for use with a pump dispenser (2), comprising a hollow tubular body (48) having a first end (44) and a second end (64) opposite to the first end, wherein
a cavity (46) is formed inside the hollow tubular body (48),
a first connecting means (45) configured for connecting the vial adapter (4) with the pump dispenser (2) is provided at the first end (44),
a second connecting means (61, 63) configured for connecting the vial adapter (4) with a vial (7) is provided at the second end (64), and
a partition wall (49) perpendicular to an axial direction of the vial adapter (4) is provided inside the hollow tubular body (48), which separates the cavity (46) into a first half-space (56a) and a second half-space (56b), wherein
a piercing mandrel (57) configured for piercing a stopper (76) of the vial (7) for liquid transfer is disposed on the partition wall (49) in the second half-space (56b), a cannula (58) of said piercing mandrel (57) being in fluid connection with the first half-space (56a),
characterized in that
a coupling structure (50, 51) is provided on the partition wall (49) in the first half-space (56a), which is configured for coupling the cannula (58) with an inlet tube (30) of the pump dispenser (2) in a fluid-tight manner.
2. The vial adapter as claimed in claim 1, wherein
the coupling structure comprises an outer cylindrical wall (50) and an inner cylindrical wall (51) concentric to the outer cylindrical wall (50),
the cylindrical walls (50, 51) are disposed on the partition wall (49) and each protrude perpendicular from the partition wall (49) into the first half-space (56a), and
a cylindrical cavity (53) is formed between the two cylindrical walls (50, 51), which is configured for accommodating a front end (33) of the inlet tube (30) of the pump dispenser (20) in a fluid-tight manner.
3. The vial adapter as claimed in claim 2, wherein an upper edge (52) on the inner surface of the outer cylindrical wall (50) is beveled inward, for guiding bottom end (32) of the inlet tube (30) of the pump dispenser (2) into the cylindrical cavity (53).
4. The vial adapter as claimed in claim 2 or 3, wherein
a width of the cylindrical cavity (53) corresponds to a wall thickness of the bottom end (32) of the inlet tube (30) of the pump dispenser (2) and
a height of the cylindrical cavity (53) is dimensioned such that a free space (53a) remains between the front end (33) of the inlet tube (30) of the pump dispenser (2) and an upper surface of the partition wall (49), when the pump dispenser (2) is coupled to the vial adapter (4) by means of the first connecting means (45).
5. The vial adapter as claimed in claim 4, wherein
a wall thickness of the front end of the inlet tube (30) is smaller to form a lower portion (32) of the inlet tube (30), and
the height of the cylindrical cavity (53) is dimensioned such that the lower portion (32) of the inlet tube (30) does not completely dip into the cylindrical cavity (53) when the pump dispenser (2) is coupled to the vial adapter (4) by means of the first connecting means (45).
6. The vial adapter as claimed in claims 4 or 5, wherein an inner surface of the front end (33) of the inlet tube (30) is beveled, for guiding the front end of the inlet tube (30) into the cylindrical cavity (53) when the pump dispenser (2) is coupled to the vial adapter (4) by means of the first connecting means (45).
7. The vial adapter as claimed in any of claims 2 to 6, wherein a height of the outer cylindrical wall (50) above the partition wall (49) is larger than a height of the inner cylindrical wall (51) above the partition wall (49).
8. The vial adapter as claimed in any of the preceding claims, wherein a finger-rest (47) is provided on and formed integral with an outer surface of the hollow tubular body (48), which protrudes outward in radial direction from the outer surface of the hollow tubular body (48).
9. The vial adapter as claimed in claim 8, wherein the finger-rest comprises two wing-shaped protrusions (47) provided on diametral opposite sides on the outer surface of the hollow tubular body (48).
10. The vial adapter as claimed in any of the preceding claims, wherein
the piercing mandrel (57) does not protrude beyond the second end (64) of the vial adapter (4).
11. The vial adapter as claimed in claim 10, wherein
the second connecting means comprises a plurality of resilient legs (61) disposed along a circumference of the vial adapter (4) at the second end at equiangular spacing and spaced apart to each other via axial slots (62),
the resilient legs (61) each comprise a protrusion (63) beveled inward into the second half-space (56b), and
a height, where an inner diameter of a circle formed by the beveled protrusions (63) corresponds to an outer diameter of a cap (77) provided on a front end of the vial (7), corresponds to or is less than the height of a front end of the piercing mandrel (57) above the second end of the vial adapter (4).
12. The vial adapter as claimed in claim 11, wherein the height of the front end of the piercing mandrel (57) above the second end of the vial adapter (4) is in the range of 0.4 to 2.0 mm, more preferably in the range of 0.4 to 1.0 mm.
13. The vial adapter as claimed in claim 11, wherein the height of the front end of the piercing mandrel (57) above the level, where the inner diameter of a circle formed by the beveled protrusions (63) corresponds to the outer diameter of the cap (77) provided on a front end of the vial (7), is in the range of 0.4 to 2.0 mm, more preferably in the range of 0.4 to 1.0 mm.
14. A pump spraying unit (1), configured to be coupled to a vial (7), comprising
the vial adapter (4) as claimed in any of the preceding claims, and
a pump dispenser (2) coupled to the vial adapter (4) via the first connecting means (45).
15. The pump spraying unit as claimed in claim 14, wherein the pump dispenser (2) comprises a tube (24) that is pivotably supported on an operating button (22) or main body (21) of the pump dispenser (2), that is in fluid communication with a pump of the pump dispenser (2) and that comprises an outlet (26) for spraying liquid pumped out of the vial (7) via the outlet.
16. The pump spraying unit as claimed in claim 14 or 15, which is sealed, preferably under sterile conditions, in a pouch, container or blister package (10) including a plastic packaging foil (104).
, Description:Field of Invention
The present invention generally relates to drug delivery devices and containers, and more specifically relates to a vial adapter for a pump sprayer used to spray the contents of a medical vial as a fine mist in a sanitary, convenient and easy fashion without leakage. Moreover, the present invention relates to a pump spraying unit including such a vial adapter coupled to a pump dispenser and a medical vial.
Background of Invention
Pump-atomizing dispensers are well-known from the prior art and disclosed e.g. by US 20070051831 A1, US 6776312 B2 and US 5176654 A. For an efficient liquid transfer, the inlet tube of such pump dispensers dips deep into the inner volume of the vial. When not coupled to the vial, the inlet tube of such pump dispensers protrudes over quite a significant length from the main body of the pump dispenser. As such inlet tubes need to be quit long and flexible, this makes a packaging under sterile conditions difficult.
US 8210166 B2 discloses a multi-access adapter operable to dispense doses of a medicament in succession from a bulk container, such as a vial. The adapter may be used alone, or in combination with various discharge devices. One embodiment uses a compact vial adapter that can be locked onto the front end of a vial by means of a snap ring, which houses a piercing mandrel that does not protrude beyond a bottom end of the snap ring and is configured to dip into the inner volume of a vial only over a short distance. The vial adapter has a first port configured to be coupled to a medical syringe and a second port, on an end of the vial adapter opposite to the first port, that can be coupled to a spraying nozzle. Operating the piston of the syringe causes the contents of the vial sprayed as a fine mist. All three components, namely the vial, the vial adapter and the syringe, can be packaged under sterile conditions, e.g. in a blister package. However, operation of the adapter may be a little cumbersome, because the liquid cannot be pumped out of the vial by a pump dispenser. Moreover, packaging all three components in separate sterile packaging units results in additional waste and higher costs for packaging, which is not desirable.
US 6269976 B1 discloses a vial access spike adapter for a pump dispenser according to the preamble of claim 1, comprising a hollow tubular body having a first end and a second end opposite to the first end, wherein a cylindrical cavity is formed inside the hollow tubular body, a thread is provided at the first end and serves as first connecting means for connecting the vial adapter with the pump dispenser, a snap ring is provided is provided at the second end and serves as second connecting means for connecting the vial adapter with a vial, and a partition wall perpendicular to an axial direction of the vial adapter is provided inside the hollow tubular body, which separates the cavity into a first half-space and a second half-space, and wherein a piercing mandrel configured for piercing a stopper of the vial for liquid transfer is disposed on the partition wall in the second half-space, a cannula of said piercing mandrel being in fluid connection with the first half-space. The flexible inlet tube of the pump dispenser is relatively long and protrudes over quite a significant length from the main body of the pump dispenser so that it can dip deep into the inner volume of the vial when the vial adapter is locked on the front end of the vial. This makes a packaging of the pump dispenser or of the pump dispenser together with the vial adapter under sterile conditions difficult.
However, for the transfer of liquid medical solutions, such as drug solutions or liquids including a vaccine, at least the transfer device for liquid transfer out of the vial and the components required for coupling the transfer device with a medical vial, need to be packaged under sterile conditions, whereas the upper surface of the elastomeric stopper of a vial could be disinfected prior to actual use, e.g. by a swab. Ensuring sterile conditions makes, however, the handling of such transfer devices and components difficult.
Summary of Invention
It is an object of the present invention to provide simple and low-cost solutions for enabling the transfer of a liquid out of a medical vial and spraying the liquid as a fine mist in a sanitary, convenient and easy fashion without leakage.
This problem is solved by a vial adapter for use with a pump dispenser as claimed in claim 1, and by a pump spraying unit including such a vial adapter as claimed in claim 14. Further advantageous embodiments are the subject-matter of the dependent claims.
According to the present invention there is provided a vial adapter for use with a pump dispenser, comprising a hollow tubular body having a first end and a second end opposite to the first end, wherein a cavity is formed inside the hollow tubular body, a first connecting means configured for connecting the vial adapter with the pump dispenser is provided at the first end, a second connecting means configured for connecting the vial adapter with a vial is provided at the second end, a partition wall perpendicular to an axial direction of the vial adapter is provided inside the hollow tubular body, which separates the cavity into a first half-space and a second half-space, and a piercing mandrel configured for piercing a stopper of the vial for liquid transfer is disposed on the partition wall in the second half-space, a cannula of said piercing mandrel being in fluid connection with the first half-space. According to the present invention a coupling structure is provided on the partition wall in the first half-space, which is configured for coupling the cannula with an inlet tube of the pump dispenser in a fluid-tight manner.
As the inlet tube of the pump dispenser can be coupled with the vial adapter inside the vial adapter, the vial adapter together with the pump dispenser can be pre-assembled and packaged as a unit, to be delivered to customers as a ready-to-use unit that simply needs to be coupled to a vial by pushing the second end of the vial adapter onto the front end of a vial for liquid transfer. This significantly eases use of such pump dispensers. Because neither the inlet tube nor the front end of the piercing mandrel protrudes beyond a bottom end of such a unit, the unit may also be packaged reliably in a simple and cost-effective manner according to the present invention, in particular in a simple pouch or packaging sealed by a thin plastic foil, wherein thin foils used for the packaging will not be damaged by the piercing mandrel or any other parts of the unit consisting of the pump dispenser coupled to the vial adapter. But also the vial adapter itself can be packaged reliably and in a simple and cost-effective manner according to the present invention, because also the piercing mandrel does not protrude beyond the bottom edge of the vial adapter. There will also be no risk that the front end of the pump dispenser inlet tube or piercing mandrel will be damaged during transport or storage, because it will not be exposed but protected by the perimeter of the afore-mentioned unit or vial adapter.
As the functions of piercing the vial stopper and supply of liquid to the pump dispenser are decoupled by means of the coupling structure, each of the two members can be designed specifically and more efficiently for the desired purpose according to the present invention.
It is the main purpose of the first and second connecting means to accomplish a stable and reliable coupling or connecting the vial adapter with the pump dispenser and vial adapter, respectively, and generally any kind of coupling may be used for this purpose. E.g. the coupling may be accomplished by threading, clamping, bonding or locking in a positive-fit manner or with frictional fit. Preferably, at least the coupling of the vial adapter with the pump dispenser is reversible, so that the pump dispenser may also be removed from the vial adapter for later re-use. Preferably, the pump dispenser is threaded on the first end of the vial adapter, whereas the vial adapter is preferably mechanically locked onto the front end of the vial. The partition wall is formed as a disk or plate of uniform thickness that is closed except a central hole, which serves to connect the inlet tube of the pump dispenser with the cannula of the piercing mandrel. The first half-space is of cylindrical shape and the coupling structure is disposed in the center and at the bottom of the first space, on a first surface of the partition wall. The coupling structure is long enough and properly configured to establish the fluid-tight coupling with the inlet tube of the pump dispenser so that no liquid is inadvertently spoiled inside the vial adapter, which facilitates later disposal of the vial adapter.
According to a further embodiment, the coupling structure may comprise an outer cylindrical wall and an inner cylindrical wall concentric to the outer cylindrical wall, wherein the cylindrical walls are disposed on the partition wall and each protrude perpendicular from the partition wall into the first half-space, and wherein a cylindrical cavity is formed between the two cylindrical walls, which is configured for accommodating a front end of the inlet tube of the pump dispenser in a fluid-tight manner. The front end of the inlet tube can thus be coupled with the coupling structure easily and reliably in a positive-fit manner or with frictional fit. By providing at least the front end of the inlet tube and/or the coupling structure with a little degree of flexibility and resiliency, the vial adapter may be configured for use with pump dispensers of even slightly different inlet tube dimensions, which also eases compensation of manufacturing tolerances and the like.
According to a further embodiment, an upper edge on the inner surface of the outer cylindrical wall may be beveled inward, for guiding bottom end of the inlet tube of the pump dispenser into the cylindrical cavity. This further assists in preventing damage of the inlet tube when coupling the pump dispenser with the vial adapter, because the front end of the inlet tube may gently slide into the cylindrical cavity of the coupling structure.
According to a further embodiment, a width of the cylindrical cavity may correspond to a wall thickness of the bottom end of the inlet tube of the pump dispenser to further ease establishing the afore-mentioned fluid-tight coupling of the inlet tube. Moreover, a height of the cylindrical cavity may be dimensioned such that a free space remains between the front end of the inlet tube of the pump dispenser and an upper surface of the partition wall, when the pump dispenser is coupled to the vial adapter by means of the first connecting means. Thus, pump dispensers with differing lengths of the inlet tube can be coupled reliably with the vial adapter, and this also helps to compensate for manufacturing tolerances and the like.
According to a further embodiment, a wall thickness of the front end of the inlet tube may be smaller to form a lower portion of the inlet tube so that the inlet tube can slide even more gently into the cylindrical cavity for liquid-tight coupling. Moreover, the height of the cylindrical cavity may be dimensioned such that the lower portion of the inlet tube does not completely dip into the cylindrical cavity when the pump dispenser is coupled to the vial adapter by means of the first connecting means, which may further assist for compensation of manufacturing tolerances and the like.
According to a further embodiment, an inner surface of the front end of the inlet tube may be beveled, for guiding the front end of the inlet tube into the cylindrical cavity when the pump dispenser is coupled to the vial adapter by means of the first connecting means. This may further assist the front end of the inlet tube to slide more gently into the cylindrical cavity of the coupling structure.
According to a further embodiment, a height of the outer cylindrical wall above the partition wall may be larger than a height of the inner cylindrical wall above the partition wall. When the inlet tube approaches the coupling structure for coupling, thus the outer surface of the inlet tube will be guided first by the inner surface of the outer cylindrical wall and thus centered. Only after this centering will the inner surface of the inlet tube approach the top end of the inner cylindrical wall, to be guided further towards the final coupling position. Overall, the stepped profile of the coupling structure thus enables an even more gentle insertion of the inlet tube into the cylindrical cavity of the coupling structure for coupling.
According to a further embodiment, a finger-rest may be provided on and formed integral with an outer surface of the hollow tubular body, which protrudes outward in radial direction from the outer surface of the hollow tubular body. During use, when both the pump dispenser and the vial is coupled to the vial adapter, the finger-rest will be positioned automatically at a central position, in-between the vial and pump dispenser, which significantly enhances an ergonomic operation of the pump dispenser. Preferably, the finger-rest is provided at a position, which will be close to the bottom end of the pump dispenser when coupled with the vial adapter.
According to a further embodiment, the finger-rest may comprise two wing-shaped protrusions provided on diametral opposite sides on the outer surface of the hollow tubular body. During use the pump dispenser may thus be operated easily by grasping the finger-rest with the forefinger and middle finger and pushing a button of the pump dispenser with a thumb, to spray the contents of a medical vial via an outlet of the pump dispenser.
According to a further embodiment, the piercing mandrel does not protrude beyond the second end of the vial adapter. Hence, also the vial adapter itself can be packaged reliably and in a simple and cost-effective manner. There will be no risk that the front end of the piercing mandrel will be damaged during transport or storage, because it will not be exposed but protected by the perimeter of the afore-mentioned unit or vial adapter. Moreover, the vial adapter can be packaged reliably in a simple and cost-effective manner, in particular in a simple pouch or packaging sealed by a thin plastic foil, wherein thin foils used for the packaging will not be damaged by the piercing mandrel.
According to a further embodiment, the second connecting means may comprise a plurality of resilient legs disposed along a circumference of the vial adapter at the second end at equiangular spacing and spaced apart to each other via axial slots, wherein the resilient legs each comprise a protrusion beveled inward into the second half-space. Thus, the vial adapter can simply be locked by positive-fit on the front end of the vial, with the protrusions embracing a bottom of the rolled edge of the vial in the locked position. A height, where an inner diameter of a circle formed by the beveled protrusions corresponds to an outer diameter of a cap provided on a front end of the vial, may correspond to or preferably is a little less than the height of a front end of the piercing mandrel above the second end of the vial adapter. Thus, the vial adapter will be automatically centered on the vial first, before the piercing mandrel will start piercing the vial stopper, when the vial adapter is locked to the front end of a vial.
According to a further embodiment, the height of the front end of the piercing mandrel above the second end of the vial adapter may be in the range of 0.4 to 2.0 mm, more preferably in the range of 0.4 to 1.0 mm. These parameter ranges turned out to be ranges enabling a particular efficient automatic centering of the vial adapter and piercing mandrel at the beginning of coupling the vial adapter to the front end of a vial by simply pushing the vial adapter onto the vial.
According to a further embodiment, an efficient automatic centering of the vial adapter and piercing mandrel can be accomplished when the height of the front end of the piercing mandrel above the level, where the inner diameter of a circle formed by the beveled protrusions corresponds to the outer diameter of the cap provided on a front end of the vial, is in the range of 0.4 to 2.0 mm, more preferably in the range of 0.4 to 1.0 mm.
According to further related aspect of the present invention, there is provided a pump spraying unit, configured to be coupled to a vial, said pump spraying unit comprising a vial adapter as outlined above, and a pump dispenser coupled to the vial adapter via the first connecting means. The pump spraying unit can thus be delivered to customers as a pre-assembled unit offering all of the features and technical advantages outlined above.
According to a further embodiment, the pump dispenser may comprise a tube that is pivotably supported on an operating button or main body of the pump dispenser, that is in fluid communication with a pump of the pump dispenser, wherein the tube comprises an outlet for spraying liquid pumped out of the vial via the outlet of the tube.
According to a further embodiment, the pump spraying unit may be sealed, preferably under sterile conditions, in a pouch, container or blister package including a plastic packaging foil.
Overview on Drawings
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:
Fig. 1 shows a pump spraying unit according to the present invention in a schematic exploded view;
Fig. 2 shows details of coupling the components of the pump spraying unit of Fig. 1 in a schematic exploded view;
Figs. 3a to 3e show a vial adapter according to the present invention in a perspective top and bottom view, in a plan view and bottom view and in a side-view;
Fig. 3f shows the vial adapter of Figs. 3a to 3e in a schematic cross-section;
Fig. 4a shows a partial cross-section of a pump spraying unit according to the present invention when locked onto the front end of a vial and with the piercing mandrel of the vial adapter piercing a vial stopper;
Fig. 4b is a perspective view of the pump spraying unit of Fig. 4b;
Fig. 5a shows a packaging unit for packaging a pump spraying unit according to the present invention in a schematic partial cross-section; and
Fig. 5b shows the packaging unit of Fig. 5a in an exploded view with the pump spraying unit removed from the main body of the packaging unit after removal of a sealing foil.
In the drawings, the same reference numerals designate identical or substantially equivalent elements or groups of elements.
Detailed description of preferred embodiments
The general shape of a medical vial for use with a pump spraying unit according to the present invention is shown Fig. 2. The vial 7 that is preferably made of glass but may also be made of plastic material has a cylindrical vial body 70 with a closed bottom and a conical shoulder 73 that is followed by a narrow neck 74 and a wider rolled edge 75 that defines a filling opening 75a of the vial 7. The cylindrical shape of such a vial precisely defines a center line.
The filling opening 75a is sealed by an elastomeric stopper 76 that has a central piercing portion, to be pierced or punctured by the piercing mandrel 57 of the vial adapter 4, and a central channel 76b through which the piercing mandrel 57 extends into the inner volume of the vial 7 when the vial adapter 4 is locked to the front end of the vial 7 to establish a channel for the transfer of liquid out of the vial 7 via the vial adapter 4. A cylindrical metal cap 77 is used to hold the stopper 76 in place at the front end of the vial 7. A bottom edge 77c of the metal cap 77 grips behind the bottom of the rolled edge 75 of the vial 7, to hold the stopper 76 in place when the cylindrical metal cap 77 is crimped over the rolled edge 75. A circular central opening 78 is defined in the upper surface 77a of the metal cap 77 and exposes the central piercing portion 76a of the stopper 76.
Fig. 1 shows an example of a vial adapter 4 according to the present invention for use with a pump dispenser 2. The vial adapter 4 is formed as a hollow tubular body 48 having a first end 44 and a second end 64 opposite to the first end 44. The hollow tubular body 48 comprises an upper coupling portion 40 for connecting the vial adapter 4 with the pump dispenser 2, a central main body 41 with a coupling structure for coupling with an inlet tube 30 of the pump dispenser 2, and a lower coupling portion 42 for connecting the vial adapter 4 with a vial 7. An outer thread 45 is provided on a cylindrical upper portion 44 of the tubular body 48 and serves as a first connecting means for connecting the vial adapter 4 with the pump dispenser 2 by threading the pump dispenser 2 on the cylindrical upper portion 44. A skirt or snapping ring 60 formed by a plurality of resilient legs 63 is provided at the bottom end of the tubular body 48. More specifically, the skirt 60 is formed by a plurality of resilient legs 61 disposed along a circumference of the tubular body 48 at the second end at equiangular spacing and spaced apart to each other via axial slots 62. The resilient legs 61 each comprise a protrusion 63 beveled inward into the lower half-space 56b of the tubular body 48. When the vial adapter 4 is locked on the front end of a vial 7, as shown in Fig. 4a, the locking protrusions 63 grip behind the bottom of the rolled edge 75 of the vial 7 and the bottom edge of the metal cap 77. Thus, the resilient legs 61 serve as a second connecting means for connecting the vial adapter 4 with a vial 7.
A partition wall 49 extending perpendicular to an axial direction of the vial adapter 4 is provided inside the hollow tubular body 48 and separates the cavity 46 into a first (upper) half-space 56a and a second (lower) half-space 56b. A piercing mandrel 57 is disposed on the partition wall 49 in the second half-space 56b. The piercing mandrel 57 is configured for piercing the stopper 76 of the vial 7 for liquid transfer out of the vial and towards the pump dispenser 2. The piercing mandrel 57 forms a cannula 58 that is in fluid connection with the first half-space 56a of the tubular body 48 via a central hole in the center of the partition wall 49.
The resilient legs 61 of the skirt 60 can be flexed radially outwards. When the vial adapter 4 is pushed onto the front end of the vial 7, the bottom bevels of the protrusions 63 will finally get in contact with the outer perimeter of the metal cap 77 crimped onto the front end of the vial 7 and slide along the outer edge of the metal cap 77, and thus the resilient legs 61 start spreading apart. When the vial adapter 4 is pushed further onto the front end of the vial 7, the resilient legs 61 will continue to be spread apart and finally the piercing mandrel 57 will start piercing or puncturing the elastomeric stopper 76 sealing the opening at the front end of the vial 7. When the vial adapter 4 is pushed further onto the front end of the vial 7, finally the protrusions 63 will grip behind the bottom edge of the metal cap 77 and the piercing mandrel 57 will have fully penetrated or punctured the vial stopper 76, thus enabling a liquid transfer out of the vial 7 in the transfer position shown in Fig. 4a. As can be concluded from Figs. 4a and 2, in the transfer position the piercing mandrel 57 extends through the piercing portion 76a and central channel 76b of the stopper 76 into the inner volume of the vial 7. The piercing mandrel 57 does not extend up to the bottom 71 of the vial 7, but rather extends only a relatively short distance into the inner volume of the vial 7. For establishing the liquid transfer, it may be sufficient, if the piercing mandrel 57 extends up to the neck 74 or shoulder 73 into the inner volume of the vial 7.
As shown in Figs. 1 and 3f, the piercing mandrel 57 does not protrude beyond the bottom end 64 of the skirt 60 of the vial adapter 4. The vial adapter 4 can thus be packaged safely, e.g. in a blister pack, without the risk of piercing a plastic sealing foil of the blister pack. More specifically, the height of the front end of the piercing mandrel 57 above the bottom end 64 of the vial adapter 4 (or above a plane spanned by the annular bottom end 64 of the vial adapter 4) is preferably in the range of 0.4 to 2.0 mm, more preferably in the range of 0.4 to 1.0 mm.
As can be concluded from Figs. 1 and 3f, a height, where an inner diameter of a circle formed by the beveled protrusions 63 corresponds to an outer diameter of the metal cap 77 of the vial 7, corresponds to or is less than the height of a front end of the piercing mandrel 57 above the bottom of the skirt 60 of the vial adapter 4. More specifically, the height of the front end of the piercing mandrel 57 above the level, where the inner diameter of a circle formed by the beveled protrusions 63 corresponds to the outer diameter of the metal cap 77 provided on a front end of the vial 7, is preferably in the range of 0.4 to 2.0 mm, more preferably in the range of 0.4 to 1.0 mm.
This ensures that the bottom skirt 60 of the vial adapter 4 will first be centered on the metal cap 77 of the vial, as the bottom ends of the beveled protrusions 63 first get in contact with the outer perimeter of the metal cap 77 when the vial adapter 4 is pushed onto the front end of the vial 7. After this auto-centering of the vial adapter 4, the resilient legs 61 begin being spread apart as the vial adapter 4 is pushed further onto the vial 7, as the bottom ends of the beveled protrusions 63 start sliding along the outer perimeter of the metal cap 77 when the vial adapter 4 is pushed further onto the front end of the vial 7. Only then will the piercing mandrel 57 start piercing the stopper 76 of the vial 7. Hence, the afore-mentioned spatial relationship between the front end of the piercing mandrel 57 and the bottom end 64 of the skirt 60 of the vial adapter 4 ensures that the piercing mandrel 57 automatically pierces or punctures the stopper 76 of the vial at its center. Hence, the piercing mandrel 57 will not (or not significantly) be flexed sideward when it pierces or punctures the vial stopper 76 so that it may be sufficient for a liquid transfer if the piercing mandrel 57 just extends a relative short distance into the channel 76b of the stopper and into the inner volume of the vial 1. In other words, the piercing mandrel 57 of the vial adapter 4 according to the present invention may be relatively short.
As shown in Fig. 3f, a coupling structure is provided on the upper surface of the partition wall 49 and protrudes into the upper half-space 56a of the tubular body 48. The coupling structure is formed by an outer cylindrical wall 50 and an inner cylindrical wall 51 concentric to the outer cylindrical wall 50. The cylindrical walls 50, 51 each protrude perpendicular from the partition wall 49 into the first half-space 56a. A cylindrical cavity 53 is formed between the two cylindrical walls 50, 51. The cavity 53 serves for accommodating a front end 33 of the inlet tube 30 of the pump dispenser 20 in a fluid-tight manner, as shown in Fig. 2. The width of this cylindrical cavity 53 corresponds to the thickness of the front end 33 of the inlet tube 30 of the pump dispenser 20, for fluid-tight engagement.
As shown in Fig. 3f, an upper edge 52 on the inner surface of the outer cylindrical wall 50 may be beveled inward so that the bottom end 32 of the inlet tube 30 of the pump dispenser 2 will be guided smoothly into the cylindrical cavity 53, when the pump dispenser 2 is threaded on the cylindrical portion 44 of the vial adapter 4.
The width of the cylindrical cavity 53 may correspond to a wall thickness of the bottom end 32 of the inlet tube 30 of the pump dispenser 2. Moreover, a height of the cylindrical cavity 53 may be dimensioned such that a free space 53a remains between the front end 33 of the inlet tube 30 of the pump dispenser 2 and an upper surface of the partition wall 49, when the pump dispenser 2 is threaded on the vial adapter 4, as shown in Fig. 2. Thus, a compression or crushing of the front end 33 of the inlet tube 30 is reliably prevented, which further assists to accommodate the front end 33 of the inlet tube 30 of the pump dispenser 20 in the cylindrical cavity 53 in a fluid-tight manner.
As shown in Fig. 1, the wall thickness of the front end 33 of the inlet tube 30 may be smaller in the lower portion 32 of the inlet tube 30 as compared to the upper portion 31, so that the lower portion 32 may be a little flexible, so that the front end 33 of the inlet tube 30 may slide smoothly into the cylindrical cavity 53, when the pump dispenser 2 is put and threaded on the cylindrical portion 44 of the vial adapter 4.
As shown in Fig. 1, the inner surface of the front end 33 of the inlet tube 30 may be beveled, to further assist guiding the front end of the inlet tube 30 into the cylindrical cavity 53 when the pump dispenser 2 is put and threaded on the cylindrical portion 44 of the vial adapter 4.
To ensure that the front end 33 of the inlet tube 30 is first captured and centered by the outer cylindrical wall 50 before it slides into the cylindrical cavity 53 formed between the two cylindrical walls 50 and 51, the height of the outer cylindrical wall 50 above the partition wall 49 may be larger than the height of the inner cylindrical wall 51 above the partition wall 49.
As shown in Figs. 3a to 3f, a finger-rest 47 may be provided on and formed integral with the outer surface of the hollow tubular body 48. The finger-rest 47 protrudes outward in radial direction from the outer surface of the hollow tubular body 48. The finger-rest comprises two wing-shaped protrusions 47 provided on diametral opposite sides on the outer surface of the hollow tubular body 48.
The pump dispenser 2 may be a standard component available on the market. For medical applications, it may be stored in a sterile packaging, e.g. a sterile blister pack. More preferably, the pump dispenser 2 is stored in a sterile packaging together with the vial adapter 4, preferably already connected with each other, e.g. by threading. Preferably, the total length of the tube 24 of the pump dispenser 2, if provided, may be such that it does not extend beyond the bottom edge of the vial adapter 4, when the pump dispenser 2 is connected to the vial adapter 4. For this purpose, it may be helpful if the tube 24 is a telescopic tube 24. Thus, the unit consisting of the pump dispenser 2 connected to the vial adapter 4 is of generally cylindrical shape and can thus be packaged easily, particularly in a blister pack.
The vial 7 may also be provided under sterile conditions, e.g. packaged in a sterile blister pack. For establishing the pump spraying unit 1 shown in Figs. 4a and 4b, first the packaging of the unit consisting of the pump dispenser 2 connected to the vial adapter 4 and the packaging storing the vial 7 is opened. Then, the vial adapter 4 is pushed and locked on the front end of the vial 7, as outlined above.
As the unit consisting of the pump dispenser 2 connected to the vial adapter 4 and the vial 7 has been stored preferably under sterile conditions, the pump spraying unit 1 of Fig. 4a is ready for use.
If the vial 7 should not be stored under sterile conditions, it might be necessary to disinfect only the central exposed portion 76a of the vial stopper 76, e.g. by means of a disinfecting swab, before coupling the vial adapter 4 with the vial 7. The pump spraying unit 1 may thus be obtained quickly, reliably and under sterile conditions.
As the piercing mandrel 57 extends only a short distance into the inner volume of the vial 7, the vial 7 needs to be held upside down in use, as shown in Figs. 4a and 4b. I.e. in the use-position, the vial 7 forms the top portion of the pump spraying unit 1 so that liquid can be supplied to the pump dispenser 2 even if the vial 7 is nearly empty.
The pump dispenser is a standard component and may be of the general type disclosed e.g. in US 6269976 B1 or US 6776312 B2. For use, the pump spraying unit 1 is held by a user’s thumb pushing against the bottom 71 of the vial, whereas the user’s forefinger and middle finger rest against the finger rest 47. By actuating the operating button 22 of the pump dispenser 22 and pushing it towards the main body 21, liquid is transferred via the piercing mandrel 57 and the inlet tube 30 towards the pump dispenser 22, from where it is pumped via the tube 24 towards the outlet 26, where the contents of the vial 7 may be sprayed as a fine mist. The pump spraying unit 1 can be operated in a sanitary, convenient and easy fashion without leakage.
As shown in Fig. 4b, the tube 24 may be pivoted in a direction perpendicular to the axial direction of the pump spraying unit 1, so that the contents of the vial 7 may be sprayed as a fine mist deep into the throat of a person, e.g. for treatment of a tonsillitis.
The pump spraying unit 1 may be used to spray any type of medical liquid. The liquid may be in particular a medical drug or a vaccine.
The pump spraying unit 1 may be delivered to customers packaged in a packaging. Figs. 5a and 5b show an example of such a packaging 10. In this example, the packaging 10 is formed by a cylindrical main body 100 formed by a cylindrical, tapered side-wall, which is closed at its first end by a closed, planar bottom 101 and which includes an annular, flat flange 102 at its open second end opposite to the first end. A plastic packaging foil 104 may be adhesively bonded to the flange 102, ready to be torn-off by grasping a flap 105 provided at a perimeter of the sealing foil 104.
The main body 100 may be formed by deep-drawing or thermo-forming a thin plastic sheet but may also be formed by plastic injection-molding or other techniques. As an alternative, the main body 100 may also be made of paper or cardboard. A thin film of plastic or bioplastic may be arranged on inner surfaces of the main body 100 to enable even the storage of the pump spraying unit 1 under sterile conditions. DE 102011122211 A1 discloses an example of such a compound packaging material including a substrate made of paper or cardboard that is coated by a thin film of plastic or bioplastic, and the whole contents of DE 102011122211 A1 is hereby incorporated by reference. Of course, the main body 100 may also be made simply of paper, cardboard or any other material without such a thin film, e.g. if it should not be necessary to package the pump spraying unit 1 under sterile conditions.
The packaging foil 104 shown in Fig. 5a may also be a Tyvek®-foil or similar foil to enable a sterilization of the content and whole inner volume of the packaging 1, if required, by a vapor or steam flowing into the inner volume of the packaging 10 via the packaging foil 104.
After removal of the packaging foil 104 from the flange 102 of the main body 100, the pump spraying unit 1 can be removed out of the packaging 10, as shown in Fig. 5b. The vial adapter 4 may then be pushed onto the front end of a vial (not shown) for coupling, to enable the transfer of liquid out of the vial via the pump dispenser 2 and the outlet 26, as outlined above.
Of course, a pump spraying unit and/or a vial adapter as outlined above may also be stored / packaged in any other kind of packaging, such a pouch or container.
As the piercing mandrel of the vial adapter does not protrude beyond the bottom end 64 of the vial adapter 4, the pump spraying unit and/or a vial adapter can be packaged easily and reliably in many different kinds of packaging, including a packaging with a sealing foil of the type shown in Figs. 5a and 5b. In such a case the piercing mandrel will not deteriorate the packaging, e.g. by piercing or damaging the sealing foil 104 shown in Fig. 5a.
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.
List of reference numerals
1 pump dispenser unit
2 pump dispenser
4 vial adapter
7 vial
10 packaging
20 collar
21 main body
22 operating button
23 outlet member
24 tube
25 collar
26 outlet
30 inlet tube
31 upper portion
32 lower portion
33 beveled front end
34 transfer channel
40 upper coupling portion
41 main body
42 lower coupling portion
44 cylindrical portion
45 thread
46 cavity
47 finger rest
48 tube
49 partition wall
50 outer cylinder
51 inner cylinder
52 chamfered edge
53 double-wall cavity
53a free space
54 transfer channel
55 top wall
56a first (upper) half-space
56b second (lower) half-space
57 piercing mandrel
57a stem of piercing mandrel 57
58 cannula
59 inlet channel
60 skirt
61 resilient leg
62 slot
63 locking protrusion
64 bottom end
70 vial body
71 vial bottom
73 shoulder
74 neck
75 rolled edge of vial
75a mouth of vial 7
76 rubber stopper
76a piercing portion
76b channel
77 metal cap
77a upper ring
77b side-wall
77c locking ring
78 central hole
100 main body
101 bottom
102 flange
104 sealing foil
105 flap
| # | Name | Date |
|---|---|---|
| 1 | 202121029684-TRANSLATIOIN OF PRIOIRTY DOCUMENTS ETC. [01-07-2021(online)].pdf | 2021-07-01 |
| 2 | 202121029684-STATEMENT OF UNDERTAKING (FORM 3) [01-07-2021(online)].pdf | 2021-07-01 |
| 3 | 202121029684-OTHERS [01-07-2021(online)].pdf | 2021-07-01 |
| 4 | 202121029684-FORM FOR SMALL ENTITY(FORM-28) [01-07-2021(online)].pdf | 2021-07-01 |
| 5 | 202121029684-FORM FOR SMALL ENTITY [01-07-2021(online)].pdf | 2021-07-01 |
| 6 | 202121029684-FORM 1 [01-07-2021(online)].pdf | 2021-07-01 |
| 7 | 202121029684-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [01-07-2021(online)].pdf | 2021-07-01 |
| 8 | 202121029684-EVIDENCE FOR REGISTRATION UNDER SSI [01-07-2021(online)].pdf | 2021-07-01 |
| 9 | 202121029684-DRAWINGS [01-07-2021(online)].pdf | 2021-07-01 |
| 10 | 202121029684-DECLARATION OF INVENTORSHIP (FORM 5) [01-07-2021(online)].pdf | 2021-07-01 |
| 11 | 202121029684-COMPLETE SPECIFICATION [01-07-2021(online)].pdf | 2021-07-01 |
| 12 | 202121029684-Proof of Right [15-07-2021(online)].pdf | 2021-07-15 |
| 13 | 202121029684-FORM-26 [15-07-2021(online)].pdf | 2021-07-15 |
| 14 | 202121029684-FORM 3 [18-12-2021(online)].pdf | 2021-12-18 |
| 15 | Abstract1..jpg | 2022-01-12 |
| 16 | 202121029684-RELEVANT DOCUMENTS [10-06-2022(online)].pdf | 2022-06-10 |
| 17 | 202121029684-POA [10-06-2022(online)].pdf | 2022-06-10 |
| 18 | 202121029684-FORM FOR SMALL ENTITY [10-06-2022(online)].pdf | 2022-06-10 |
| 19 | 202121029684-FORM 13 [10-06-2022(online)].pdf | 2022-06-10 |
| 20 | 202121029684-EVIDENCE FOR REGISTRATION UNDER SSI [10-06-2022(online)].pdf | 2022-06-10 |
| 21 | 202121029684-AMENDED DOCUMENTS [10-06-2022(online)].pdf | 2022-06-10 |
| 22 | 202121029684-Power of Attorney [02-08-2022(online)].pdf | 2022-08-02 |
| 23 | 202121029684-FORM28 [02-08-2022(online)].pdf | 2022-08-02 |
| 24 | 202121029684-Form 1 (Submitted on date of filing) [02-08-2022(online)].pdf | 2022-08-02 |
| 25 | 202121029684-Covering Letter [02-08-2022(online)].pdf | 2022-08-02 |