TRANSFER DEVICE
20200297582 · 2020-09-24
Assignee
Inventors
Cpc classification
A61J1/2051
HUMAN NECESSITIES
A61J1/2089
HUMAN NECESSITIES
International classification
Abstract
A transfer device (10) for removing or transferring a medium out of or into a bottle (20) having a bottle neck (34) that can be closed by means of a closure (42), including a first adapter part (12), which can be positioned on the bottle, and a second adapter part (14), which interacts with the first adapter part, which can be displaced in the longitudinal direction of the bottle, and has a conducting element (50) for piercing the closure. After the second adapter part (14) has been displaced along the first adapter part in the direction of the closure (42) and the second adapter part has been locked, the first adapter part (12) is non-releasably fastened to or around the bottle (20).
Claims
1. A transfer device (10, 100, 200, 400) for the withdrawal or deliver of a medium out of or into a bottle (20) with a neck (34), that is sealable by a closure (42), comprising a first adapter component (12, 112, 212, 412) that can be positioned on the bottle, and a second adapter component ((14, 114, 214, 414), which interacts with the first adapter component, is moveable in the longitudinal direction of the bottle, and comprises a delivery element (50) for piercing the closure, wherein after moving the second adapter component (14, 114, 214, 414) along the first adapter component (12, 112, 212, 412) in the direction towards the closure (42) and locking the second adapter component, the first adapter component is secured in position non-detachably at the bottle (20) or around the bottle, and wherein the first adapter component (12, 212) comprises a casing wall (16, 216), which surrounds the bottle (20) along its circumference, has a hollow-cylindrical geometry with a front edge extending on the bottle-closure side, a bottom section (18, 218) that covers the bottom of the bottle at least in sections, as well as a holding section in a form of a ring element (222) that is situated on the front-edge side along the casing wall, from which originate tongue- or ledge-like position-securing elements (28, 30, 228, 230), which extend in the direction of and are inclined relative to the longitudinal axis (32) of the first adapter component, whereby, when the bottle (20) is positioned in the first adapter component, the position-securing elements are supported or can be supported at the bottle or at the transition (38) between the bottle neck (34) and the circumferential wall of the bottle, and wherein tongue-shaped elements (223, 231) originate from the holding element and are in contact with the cylindrical body (36) of the bottle.
2. The transfer device according to claim 1, wherein, when the transfer device (10, 100, 200, 400) is secured in position at or around the bottle (20), the first and the second adapter components (12, 112, 212, 412; 14, 114, 214, 414) form a surrounding sealed envelope that surrounds the bottle at least in the area of the closure element (42).
3. The transfer device according to claim 1, wherein the interior cross-section of the hollow-cylindrical section (44) of the second adapter component (14) corresponds to the exterior cross-section of the casing wall (16) so as to guide the first adapter component (12) during the latter's axial displacement.
4. The transfer device according to claim 1, wherein the second adapter component (214, 414), preferably its outer hollow-cylindrical section (244), when it is in a position in which it surrounds the first adapter component (216, 412), is sealed with respect to the first adapter component, preferably with respect to the latter's casing wall (216) and/or the bottle (20).
5. The transfer device according to claim 4, wherein the second adapter component (214, 414) or its hollow-cylindrical section (244) comprise on the inside a sealing element (332, 436) that effects sealing, with an in particular hollow-cylindrical geometry, which preferably is embodied as an insert.
6. The transfer device according to claim 1, wherein, from the second adapter component (214, 414) originates at least one first latching element (314, 316, 318, 320, 416, 418, 420, 424), which preferably is embodied as an axially extending bendable tongue element with a latching projection (322, 324, 423, 425) at its end side, with the latching projection extending in the direction of the longitudinal axis of the second adapter component (214, 414) or of the transfer device (200, 400), and preferably engaging in latching depressions (310, 312), bordered by tooth-like projections, of the first adapter component (216, 412).
7. The transfer device according to claim 1, wherein from the casing wall (216) of the first adapter component (216, 412) protrudes a limit stop, such as a circumferential annular projection (217), with which, when the first and the second adapter components (212, 214 ,412, 414) are properly connected, the latter is in contact with.
8. The transfer device according to claim 1, wherein when the first and the second adapter components (212, 214, 412, 414) have been at least partially pushed into each other, they form a sealed container that surrounds the bottle (20).
9. The transfer device according to claim 1, wherein the inner hollow-cylindrical section (268) of the second adapter component (214) at its end comprises at least one inward directed projection (270), which, when the adapter components (212, 214) have been properly connected, engages behind the collar-like rim (40) of the bottle (20).
10. The transfer device according to claim 1, wherein, when the first and the second adapter components (12,112; 14,114) have been pushed into each other, they are inseparably connected during regular use.
11. The transfer device according to claim 1, wherein during an adjustment of the second adapter component (14, 11.4, 214, 414) in the penetration direction of the puncture needle (50), the first adapter component (12, 112, 212, 414) interacts with the second adapter component in such a manner, that an adjustment of the second adapter component relative to the first adapter component against the penetration direction is prevented.
12. The transfer device according to claim 1, wherein the second adapter component (414) possesses a hood-or cup-shaped geometry with a cylindrical circumferential wall (442) and, extending coaxial to the latter, an inner hollow-cylindrical section (444), from which originates the sealing element (436) which, when the first and the second adapter components (212, 414) have been assembled, seals the second adapter component against the first adapter component.
13. The transfer device according to claim 5, wherein the sealing element (436) possesses a U-shaped geometry with a non-isosceles cross-section, with an inner and an outer leg, in between which extends in sections the inner hollow-cylindrical section (444).
14. The transfer device according to claim 6, wherein the tongue elements (314, 316, 320, 322, 416, 418, 420, 424) span a cylindrical envelope that extends coaxially relative to the circumferential wall (244, 442) of the second adapter component (214, 414), and starting from the annular element (326, 430) extend in the direction of the bottom wall (245, 434) of the second adapter component (214, 414).
Description
[0071] The figures show:
[0072]
[0073]
[0074]
[0075]
[0076]
[0077]
[0078]
[0079]
[0080]
[0081]
[0082]
[0083]
[0084]
[0085]
[0086]
[0087]
[0088]
[0089]
[0090]
[0091]
[0092]
[0093]
[0094]
[0095]
[0096]
[0097]
[0098]
[0099]
[0100]
[0101]
[0102]
[0103]
[0104]
[0105]
[0106]
[0107]
[0108]
[0109]
[0110]
[0111]
[0112] The figures, in which identical elements always have the same reference labels, show transfer devices, by means of which fluids as well as dry substances or liquids such as water or solvents, which for infusion or injection purposes are blended prior to their use or administration, are delivered from a bottle or a small bottle, a so-called vial. Use for the purpose of instillation or for solvent bags is also possible. Apart from that, the possible applications are purely exemplary. Transfer devices of this type are also referred to as connectors or adapters. In order to connect the bottle to another container or an infusion device, a corresponding transfer device is needed to perforate the seal of the small bottle by means of a puncture needle, such as a steel cannula, to subsequently be able to deliver the fluid to be withdrawn from the small bottle via the transfer device for example to an injection bottle, an infusion bag, a solving agent bag, or to a syringe.
[0113] The transfer devices shown in the figures possess components, which are arranged telescopically and are adjustable relative to each other, and which are referred to as the first and the second adapter components. For simplicity's sake, the transfer device will be referred to as a connector and the small bottle to be connected to the former will be referred to as a vial hereinafter. The first adapter component may also be referred to as a vial holder and the second adapter component as a cannula holder.
[0114] Further, the delivery element creating the connection to the interior of the vial will be referred to as a cannula hereinafter, without this representing a limitation with respect to function or design.
[0115] With respect to the specified geometries of the components it should be noted that these should be understood to be purely provided as examples and that variations are possible if the basic principles of the invention can still be realized. Apart from that, the figures are self-explanatory and show the characteristic features of the invention in an easily discernable manner.
[0116] The connector 10 of
[0117] As can be seen in the detailed representation of
[0118] From the region of the ring element 22 that extends in the interior of the casing wall 16 originate ledge- or tongue-shaped elements that extend in the axial direction and are also referred to as position-securing elements, some of which are marked with the reference labels 28, 30. As is particularly evident in the exploded view of
[0119] With respect to the vial 20 it should also be noted that the bottle neck 34 in the area of its opening comprises a circumferential collar 40. The opening of the vial 20 is closed by a plug 42. Further it should be noted that typically after sealing the vial 20 with the sealing plug 42, an aluminum crimp cap is applied. On top of this may be located a plastic flip-off cap. This flip-off cap is pulled off the aluminum crimp cap, creating an opening in the centre of the aluminum crimp cap, through which the closure plug 42 is visible.
[0120] The second adapter component 14, also referred to as upper adapter component or outer component, comprises a hollow-cylindrical section 44, which on the side opposite the vial is delimited by a wall 46, which extends across the longitudinal axis 32 and is also referred to as a boundary wall, which centrically comprises a cylindrical extension 48, from which not only originates the penetration needle 50 that is also referred to as cannula but onto which is also attached a snap-off connector 52 on its outside. Consequently, the second adapter component 14 is the cannula holder.
[0121] Embodied in the inner wall 54 of the hollow-cylindrical section 44 of the second adapter component 14 are recesses 56, 58 that form guides (
[0122] An inner hollow-cylindrical section 68 extends coaxial relative to the outer hollow-cylindrical section 44 and within the former extends the cannula 50, but the latter does not protrude beyond the former's front edge 70, as is evident in particular in
[0123] But it is also possible that instead of for example the disk shaped protective element 72, a membrane, for example, originates from the front edge 70 of the inner hollow-cylindrical section 68, whereby the membrane is destroyed when the adapter components 12, 14 are assembled or during an axial displacement of the second adapter component 14 towards the vial 20 and thus towards the first adapter component 12.
[0124] As is evident in the graphic representations of
[0125] In order to support an axial guidance between the adapter components 12, 14 when they are telescoped together, ribs 17, 19 extending in the longitudinal direction over the casing wall 16 can serve as guide rails.
[0126] Connecting the cannula 50 to the interior of the vial 20 is shown in
[0127]
[0128] In this, the interlocking is achieved so that it can only be released with an additional tool or with a pulling force of at least for example 300 N.
[0129] After the connection to the vial 20 has been ensured, the snap-off connector 52 can be destroyed and the mixing procedure between the medicinal product present in the vial 20 and a liquid, present in a bag that was previously connected to the snap-off connector 52, may proceed. In principle, it is also possible to employ a Luer fitting or similar device. Connected to the snap-off connector, or similar device such as a Luer fitting, may also be a syringe, bottle, or similar container. The corresponding applies to all embodiments.
[0130]
[0131] The first or inner adapter component 112 comprises a first outer hollow-cylindrical section 116 that during correct usage surrounds the collar 40 of the vial 20, and an inner hollow-cylindrical section 118, which has a smaller diameter than the outer hollow-cylindrical section 116. Between the hollow-cylindrical sections 116, 118 extends an intermediate wall 120, which extends across, in particular perpendicular to, the longitudinal axis 32 of the connector 100, and thus, when the vial 20 is connected, to the longitudinal axis of the vial 20.
[0132] The outer hollow-cylindrical section 116 comprises tongue-shaped sections, which are separated by axially extending slits 122, and which are resilient to the required degree, two of which are marked by the reference labels 124, 126 in an exemplary manner. On their end side, the tongue-shaped sections 124, 126 comprise projections that protrude inward (compare projection 128), and which engage behind the collar-like rim 40 of the vial neck when the first adapter component 112 has been properly connected to the vial 20, as is illustrated in the figures below.
[0133] The second or outer adapter component 114 consists of two parts that are adjustable relative to each other in a telescopic manner, in particular of an outer part 130 and an inner part 132, from which originates the puncture needle 50. The outer part 130 comprises a section 134, also referred to as second outer hollow-cylindrical section, and a section 136 that is designates as third outer hollow-cylindrical section, which possess different diameters. In this, the cross-section of the third outer hollow-cylindrical section 136 is smaller than that of the second outer hollow-cylindrical section 134, which has an interior diameter that is adapted to the exterior diameter of the first outer hollow-cylindrical section 116 of the first adapter component 112, which facilitates an axial guidance. Moreover, the inner diameter of the third outer hollow-cylindrical section 136 is adapted to fit the outer diameter of the first hollow-cylindrical section 118 of the first adapter component 112, which also results in an axial guidance.
[0134] For placing the connector 100 onto the vial 20, the first and second adapter components 112, 114 are secured against an axial movement relative to each other by a first safety 138, which preferably possesses the geometry of an annular section. The safety 138 extends along a further intermediate wall 140, which extends between the second and the third hollow-cylindrical sections 134, 136 and in parallel to the intermediate wall 120, passes through a slot in the third outer hollow-cylindrical section 136, and extends partially in a recess or groove, which is aligned with the slot, in the first inner hollow-cylindrical section 118 of the first adapter component 112 . A second safety 146 extends between the front edge 142 of the third outer cylinder section 136 and a flange-like widening originating from the inner or second part 132 of the second adapter component 112 .
[0135] The inner part 132 of the second adapter component 114 has a hollow-cylindrical shape, with an outer diameter that is adapted to fit the inner diameter of the first inner hollow-cylindrical section 118 of the first adapter component 112, which facilitates an axial guidance. Moreover, the second part 132 of the second adapter component 114 is secured relative to the first inner hollow-cylindrical section 118 by inter-engaging sections, in particular by a preferably circumferential rib 133, which protrudes above the circumferential wall of the hollow-cylindrical inner or second part 132 of the second adapter component 114, and engages in a correspondingly matched recess 153 in the inner side of the first inner hollow-cylindrical section 118 of the first adapter component 112.
[0136] It is also apparent in the drawing that from the inner side of the second outer hollow-cylindrical section 134 of the second adapter component 114 protrudes a projection such as a clamping rib 147, which engages in a matched recess 148 of the first outer hollow-cylindrical section 116 of the first adapter component 112 in such a way that a disconnection of the adapter components 112, 114 against the penetration direction is no longer possible. Thus prior to attaching the connector 100 to the vial 20, one is handling a unit that consists of the first and the second adapter components 112, 114.
[0137] To prevent a user from coming in contact with the tip 74 of the cannula 50, in an optional configuration otherwise in accordance with the embodiment example of
[0138]
[0139] In the illustration of
[0140] Subsequently, the first safety 138, which extends along the intermediate wall 140 and secures the first and the second adapter components 112, 114, against an axial movement, is removed (
[0141]
[0142] Thus, the second outer hollow-cylindrical section 134 acts on the end side as a clamping ring for the first outer hollow-cylindrical section 116, also to be referred to as bell, of the first adapter component 112, which prevents the tongue-shaped elements 124, 126 to be adjusted radially outward. This creates a closed space prior to the plug being pierced, so that no aerosols being generated by the opening of the vial can reach the surroundings.
[0143] The locking provided in this manner is realized so that it can only be released by an additional tool or pull-off forces of for example 300 N. This ensures that the connector 100 remains connected to the vial 20 after use.
[0144] Subsequently the second safety 146 is removed, so that the inner part 132 of the second adapter component 114, which contains the cannula 50, can be moved in the penetration direction by an axial application of force onto the flange-like handle 144 in order to penetrate the plug 42, as a comparison of
[0145] After the second adapter component 114 has been properly secured in place, the snap-off connector 52, onto which a bag has been attached prior to this, can be destroyed to carry out the desired mixing process.
[0146]
[0147] In the transfer device or connector 200 the inseparability of the adapter components is achieved by interlocking an outer or second adapter component 214 with the first adapter component 212 that surrounds the vial 20. This results in the advantage, that when the adapter components 212, 214 have been assembled, they enclose a contained space, in which the perforated closure plug 42 of the vial 20 is located.
[0148] The first adapter component 212 possesses a cup-like geometry with a circumferential wall 216 and a bottom wall 218 to accommodate the vial 20. Likewise, in the open edge area of the circumferential wall 216 is provided an annular element 222, from which originate ledge-shaped or tongue-shaped elements extending in the axial direction, which as an example are labelled 228 and 230. As is most evident in
[0149] From the ring element 222, which is joined, such as glued or welded, to the front edge of the cup-shaped first adapter component 212, additionally originate inward protruding further tongue-shaped elements 223, 231, which in accordance with the illustration of
[0150] The first adapter component 212 comprises along its circumference latching depressions that are bordered by ridges, as is shown in the sectional view of
[0151] The axially extending tongue-like elements 314, 316, 318, 320, with the inward facing projections 322, 324 at their ends, originate from an annular element 326, which is fixed in position, e.g. welded, in the opening region of the second adapter component 214. In this area, the second adapter component 214 possesses a bell-shaped geometry, as is most evident in the sectional view of
[0152] In addition, the interior wall of the cylindrical section of the second adapter component 214 is lined with a sealing element 332, which, when the adapter components 212, 214 have been connected, is in sealing contact with the casing wall 216 of the first adapter component 212. This creates an enclosed space. If the bottom wall 218 of the first adapter component 212 is also closed, the vial 20 is isolated from the surroundings on all sides. This is the preferred configuration.
[0153]
[0154] As above in the embodiment example of
[0155] In addition, from the casing wall 216 originates an end stop that preferably is embodied as a circumferential ring or ledge 217, and consequently extends radially from the circumferential wall. The free outer edge of the second adapter component 214 is in contact with the end stop when the adapter components 212, 214 have been connected properly and thus the cannula 50 has penetrated the vial 20 to the required degree.
[0156]
[0157]
[0158] Naturally the end stop is not an absolutely required feature. An optical display such as a colour mark can also serve to signal to the user that the adapter components 212, 214 have been pushed together to such a degree that the plug 42 has been pierced by the cannula 50 to the required degree.
[0159] After the adapter components 212, 214 have been pushed together properly, the snap-off connector 52 originating from the bottom wall 245 of the second adapter component can be removed.
[0160] With respect to the latching recesses or depressions 310, 312 and the latching projections 322, 324 it should be noted that according to an alternative configuration a connection between the adapter components 212, 214 can also be realized if the latching recesses 310, 312 are sections of threads into which the projections 322, 324 engage, so that the first adapter component 212 is connected to the second adapter component 214 in a kind of screw connection. However, inseparability is also provided, since in the final state at least the one projection 270 protruding inward from the inner cylindrical section 268 will engage behind the collar-like rim 40 of the vial 20. Naturally it is also possible for several projections or a circumferential projection to be provided.
[0161]
[0162] Thus the annular gap 269 represents a guidance when the adapter components 212, 214 are being pushed together. Simultaneously a seal is formed between the annular element 222 and the annular gap 269 and consequently between the adapter components 212, 214.
[0163] An embodiment of a transfer device to be referred to as connector that is an alternative to that of
[0164] Essentially inseparable is to be understood to mean that a disengagement is not possible without tools or without a pulling force of less than 300 N.
[0165] The first adapter component 412 possesses a cup-like geometry with a circumferential wall 216 and a bottom wall 218, to accommodate the vial 20. From the circumferential wall 216, also referred to as casing wall, originate latching depressions bordered by ridges, two of which have been marked with the labels 310 and 312 as an example. The projections that border the latching depressions 310, 312 possess a tooth-like geometry of such a nature so that their flanks that extend on the insertion side with respect to the second adapter component 414, i.e. the respective upper borders in the drawings, extend in a ramp-like manner. This facilitates pushing the second adapter component 414 onto the first adapter component 412, or pushing the first adapter component 412 into the second adapter component 414 without problems, as will be explained below. The structure of the latching depressions 310, 312 and the projections that border them are easily discernable in
[0166] In order to prevent a separation of the assembled first and second adapter components 412, 414, i.e. the components being pulled apart against the penetration direction of the cannula 50, the latching depressions 310, 312 interact with radially inward protruding projections 423, 425 of axially extending tongue-shaped elements of the second adapter component 414, some of which are marked by the reference labels 416, 418, 420, 424 as an example. The tongue-shaped elements 416, 418, 420, 424, which with their radially inward protruding projections 423, 425 form latching hooks, originate from an annular element 430 that is firmly bonded with the second or outer adapter component 414, in particular by welding or adhesive bonding. Other methods of attachment are also feasible.
[0167] In this, the annular element 430 is fixed in position in the interior area of preferably a bell-shaped widening 432 of the second adapter component 414, as is illustrated in particular in
[0168] For the purpose of sealing the first adapter component 412 against the second adapter component 414 during the interlocking, a sealing element 436 originates from the inside of the second adapter component 414. The sealing element consists of an inner section 438 that extends in the longitudinal direction of the adapter component 414 and a parallel outer section 446, whereby a gap exists between the sections. The sealing element 436 possesses a cross section with the geometry of a non-isosceles U, with the shorter leg extending on the outside. In the gap extends the edge section 440 of an inner hollow-cylindrical section 444 that extends coaxially to the circumferential wall 442 of the second adapter component 414, as is also clearly shown in
[0169] As is shown in
[0170] In the interaction of the latching projections 423, 425 of the tongue-shaped latching elements 416, 418, 420, 424 with the latching depressions 310, 312, their respective geometries ensure that after the latching projections 423, 425 have engaged in one of the depressions 310, 312 it is no longer possible to pull the adapter components 412, 414 apart, rather that before the plug 42 has been penetrated, only a pushing together in the penetration direction is possible. This creates a sealed space prior to the piercing of the plug, so that no aerosols created during the opening of the vial can escape to the surroundings.
[0171] Penetration is achieved by continued pushing together to such an extent that the cannula 50 is pushed through the plug 42, whereby the cannula 50 penetrates through the plug 42 completely. In this, a pushing together of the adapter components 412, 414 is possible until the lower edge of the second adapter component 414, or rather the annular element 430 extending in this area, comes into contact with a radially circumferential ledge 217, which protrudes from the circumferential wall 216 of the first adapter component 412, as is also the case in connection with the embodiment example of
[0172] The interaction between the first and the second adapter components 412, 414 up to the time when the cannula 50 has completely penetrated the closure plug 42 is shown in a self-explanatory fashion in
[0173]
[0174]
[0175] The further figures illustrate the continued pushing together of the adapter components 412, 414, whereby in
[0176] But we also have to emphasize another configuration of the embodiments shown in
TABLE-US-00001 10 Connector/transfer device 12 First adapter component 14 Second adapter component 16 Circumferential wall/Casing wall 17, 19 Ribs 18 Bottom wall or section 20 Vial/Small bottle 22 Holding element/Annular element/section 24 Projections 26 Projections 28 Element/Position-securing element 30 Element/Position-securing element 32 Longitudinal axis 34 Bottle neck 36 Cylindrical body 38 Connecting wall/transition 40 Collar 42 Plug/closure plug 44 Hollow-cylindrical section 46 Wall/boundary wall 48 Extension 50 Penetration needle/cannula 52 Snap-off connector 54 Inner wall 56 Depression/guide 58 Depression/guide 60 Section 62 Section 64 Projection 66 Projection 68 Inner hollow-cylindrical section 70 Front edge 72 Protective element 74 Cannula tip/tip 76 Step 78 Edge/corner 80 End section 100 Connector/transfer device 112 First adapter component 114 Second adapter component 116 Outer hollow-cylindrical section 118 Inner hollow-cylindrical section 120 Intermediate wall 122 Slots 124 Tongue-shaped section/element 126 Tongue-shaped section/element 128 Projection 130 Outer adapter component 132 Inner hollow-cylindrical section 133 Rib/Projection/Clamping rib 134 Second outer hollow-cylindrical section 136 Third outer hollow-cylindrical section 138 First safety 140 Intermediate wall 147 Projection/Clamping rib 150 Transverse wall 152 Step 142 Front edge 144 Section 146 Safety 148 Cut-out 153 Recess 172 Protective element 200 Connector/transfer device 212 Adapter component 214 Adapter component 216 Casing wall 217 Ledge/projection 218 Bottom wall/section 222 Annular element/section 223 Tongue-shaped element 228 Element/position-securing element 230 Element/position-securing element 231 Further tongue-shaped element 244 Circumferential wall 245 Boundary/bottom wall 268 Inner hollow-cylindrical section 269 Annular gap 270 Projection 310 Latching depression/recess 312 Latching depression/recess 314 Element 316 Element 318 Element 320 Element 322 Projection 324 Projection 326 Annular element 328 Edge 330 Widening 332 Sealing element 333 Annular ridges 400 Connector/transfer device 412 Adapter component 414 Adapter component 416 Tongue-shaped element 418 Tongue-shaped element 420 Tongue-shaped element 423 Projection 424 Tongue-shaped element 425 Projection 430 Annular element 432 Widening 434 Bottom wall 436 Sealing element 438 Inner section 439 Longitudinal ribs 440 Edge section 441 Line 442 Circumferential wall 444 Hollow-cylindrical section 446 Outer section 447 Projections