EP3122310B1 - Transfer device for media, comprising a non-releasably lockable adapter - Google Patents
Transfer device for media, comprising a non-releasably lockable adapter Download PDFInfo
- Publication number
- EP3122310B1 EP3122310B1 EP15712326.6A EP15712326A EP3122310B1 EP 3122310 B1 EP3122310 B1 EP 3122310B1 EP 15712326 A EP15712326 A EP 15712326A EP 3122310 B1 EP3122310 B1 EP 3122310B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- adapter
- adapter part
- transfer device
- adapter component
- section
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Links
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/16—Holders for containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2055—Connecting means having gripping means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2065—Connecting means having aligning and guiding means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1406—Septums, pierceable membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/2013—Piercing means having two piercing ends
Definitions
- the dry substance is usually supplied in an injection bottle, a so-called vial.
- a connector transfer device
- the other container can, for.
- these connectors also known as adapters and composed of adapter parts
- the puncture needle starts from the bottom wall of the collar, in particular in the form of the steel cannula, and extends in the longitudinal direction of the hollow cylindrical body.
- Such a release leads to exposure of staff, patients and the environment. This enables the released substances to be absorbed via inhalation, the skin or orally.
- the release itself can e.g. B. via the formation of aerosols, splashes during preparation, leakage of the adapter, when removing the adapter or possibly caused by broken glass, as well as by injury from a contaminated cannula.
- the second reason is that the closure of the puncture needle has to be punctured centrally in order to ensure a leak-tight connection of the vial.
- vial adapters used according to the prior art, however, there is the risk that the vial will tilt when it is snapped into the collar. This results in a primarily eccentric puncture of the closure.
- the vial is then fully pushed in, the cannula is then forced into a central position. This leads to tension in the closure of the vial, which leads to Leaks next to the cannula can result. This can happen in the case of toxic substances such as B. cytostatics, lead to the endangerment of staff and patients.
- the corresponding adapters generally do not offer any aerosol or leak tightness.
- a transfer device consists of a cap-like outer guide part and a tubular inner guide part, which are telescopically displaceable with respect to one another.
- the origins of the inner guide part snap into recesses on the inside of the outer guide part. If the transfer device is pushed onto a vial, tongue-like elements extending from the inner guide part are bent outwards, with the result that the outer guide part is adjusted outward in the region of the recesses, so that the locking between the inner and outer guide parts is canceled. It is also disadvantageous that the transfer device can be removed from the vial after use without any problems, so that there is again a risk of injury to the user.
- a transfer device which comprises a needle holder with a transfer needle which is axially adjustable in a hollow cylindrical structure.
- the structure has a wall-shaped stop which can be placed on the opening of a storage container to be pierced and which is penetrated by the transfer needle when the transfer device is actuated.
- a transfer device after the DE 698 08 432 T2 has an actuator in order to be able to axially adjust a first part having a mandrel to a second part surrounding a closure of a bottle by turning.
- a fluid transfer device which comprises a sleeve-shaped guide structure with a needle holder with a puncture needle surrounded by this.
- the sleeve-shaped guide structure has a Embodiment axially extending movable sleeve strips, which have clamping elements for gripping a bead-like edge of a vial.
- a transfer device after the WO 2009/029390 A1 has an inner and an outer adapter part which are ultrasonically welded in the flange-like edge area.
- the transfer device surrounds a vial, which in turn is surrounded by an envelope with which the transfer device latches.
- the vial and connector can be separated, there is also the disadvantage of the risk of contamination by e.g. B. inhalation or through the skin or the formation of aerosols when removing the needle from the vial.
- the U.S. 5,364,386 A relates to an infusion device which has a first adapter part which surrounds a bottle, and a second adapter part which is displaceable along the first adapter part and which has a transfer element in the form of a cannula. There is the possibility that the first adapter part is connected to the second adapter part in two different positions.
- Subject of WO 2007/101798 A2 is a transfer device with a cylindrical first part and a cap-shaped second part which is displaceable relative to the first part.
- the first part surrounds a vial.
- Projections extend from the first and second parts and cooperate to hold the parts in a desired position relative to one another. There is the possibility that the projections can be brought into grip.
- Subject of EP 0 335 378 A2 is a liquid container comprising a tubular capsule with a cap which in turn houses a pressing element which is at Rotation of the cap causes a vial to be adjustable in the direction of a control device having a cannula in order to enforce the closure of the vial.
- Another transfer device is in DE6503460 A1 described.
- the present invention is inter alia.
- the underlying task is to provide a transfer device, i.e. a vial connector or adapter, which offers increased exposure security.
- One aspect is aimed at avoiding a hazardous leakage after the closure has been pierced.
- Another aspect of the invention is that an injury after the use of the transfer device by the transfer element such as needle, cannula, spike, perforation device is excluded.
- the invention provides that the first adapter part is permanently fixed to the bottle or around the bottle after the second adapter part has been moved along the first adapter part in the direction of the closure and the second adapter part is locked, and that the second adapter part has a hood or pot geometry with a cylindrical circumferential wall and an inner hollow cylindrical section running coaxially to this and surrounded by it, from which a sealing element extends, which seals the second adapter part against the first adapter part when the first and second adapter parts are assembled.
- Radially adjustable fixing elements can extend from the first adapter part, via which the first adapter part is permanently fixed to the bottle after the second adapter part has been moved along the first adapter part in the direction of the closure and the second adapter part locked if the transfer device is properly handled.
- the invention is characterized in that the first and second adapter parts surround the bottle in such a way that a closed envelope results, so that aerosol-tightness and leakage security is provided.
- the first adapter part is cup-shaped and receives the bottle body.
- the second adapter part, from which the transition element extends, likewise has a hood-shaped or pot-shaped geometry that can latch with the first adapter part.
- a seal can extend from the second adapter part in order to seal the first and second adapter parts with respect to the bottle.
- a transfer device is made available which, after use, that is to say after the closure has been pierced, can no longer be detached from the bottle, which is mainly referred to as a vial below. It can be provided that, before the transfer device is used, unintentional touching of the tip of the transfer element is excluded, so that the risk of injury is avoided.
- transition element is, for. B. can be a needle, a cannula, a spike or some other perforation device. So far is one There is no limitation of the invention. Rather, the term transfer element is intended to cover any suitable element that enables a medium transfer. Various terms are therefore also used, in particular puncture needle or cannula, without thereby restricting the teaching according to the invention.
- the invention is characterized in that the first adapter part comprises a shell section surrounding the bottle circumferentially and having a hollow cylinder geometry with an end edge running on the bottle closure side - also called a shell wall - a bottom section that at least partially covers the bottom of the bottle, preferably completely, and a holding section running at the front edge, from which the fixing elements, which can be tongue-like or web-like, extend, which can be pivoted, bent or spread in the radial direction of the first adapter part and which extend in the direction of the longitudinal axis of the first adapter part.
- the fixing elements can consequently be supported at the transition between the bottle neck and the bottle body, with the result that the first adapter part can no longer be detached from the vial.
- the holding section is a ring section running in the end edge region of the casing section, which z. B. can be fixed as clamped or glued to the edge of the jacket wall, which extends at least in sections along the inside of the jacket section and has first projections which extend in the axial direction and extend over the end edge.
- first projections which extend in the axial direction and extend over the end edge.
- second projections proceed from the outside of the jacket wall, which can be locked or locked in guides such as link slots of the second adapter part when the adapter parts are locked. The second projections cannot then be removed from the guides during normal handling of the transfer device.
- the second adapter part have an outer hollow cylindrical section and a boundary wall running transversely to its longitudinal axis, from which the puncture needle - i.e. the transfer element - starts or which is penetrated by the puncture needle.
- Each guide for one projection has a first section starting from the free end edge of the outer cylinder section and running in its longitudinal direction, which merges into a second section running transversely to the first section, in which the second projection guided in this can be fixed and locked , which protrudes radially from the outside of the jacket wall of the holding section of the first adapter part.
- the second section of the guide has a cross-sectional reduction in the axial direction, the axial extent of which is smaller than the axial extent between the maximum distance between the first and second protrusions.
- the axial extent between the boundary wall and the edge of the second section of the guide facing away from it should be at least equal to the maximum distance between distant sections of the first and second projections in the axial direction.
- the second adapter part must first be guided in the axial direction, i.e. in the longitudinal direction of the vial in the first section of the guide, i.e.
- At least the delimitation of the second section of the guide facing away from the delimitation wall, i.e. on the bottle side, forming the inner edge in the direction of the delimitation wall should run at least partially inclined to the longitudinal axis of the first adapter part and thus the transfer device and enclose an obtuse angle to the longitudinal axis.
- a proposal of the invention provides that the inner cross section of the hollow cylindrical section of the second adapter part corresponds to the outer cross section of the jacket section of the first adapter part.
- Safe guidance is also ensured by the overlapping of the adapter parts or by the previously explained axially extending guides such as link slots or by z. B. ensures long ribs that extend from one of the adapter parts or a sealing element connected to this, in particular from the second adapter part.
- an inner hollow cylindrical section runs coaxially to the outer hollow cylinder-shaped section of the second adapter part, with the one referred to as the first protective element preferably being arranged in a displaceable manner, with the tip of the when the first adapter part is not connected to the second adapter part Puncture needle runs between the protective element and the boundary wall of the outer hollow cylindrical section.
- the invention further provides that the second projection in the projection of the outside of the jacket section has a rectangular or trapezoidal geometry with a corner, which when the first and second adapter parts are fixed to one another interacts with a cross-sectional reduction of the second portion of the guide causing step to prevent loosening.
- a further embodiment of a transfer device which is no longer detachable from the vial after the closure has been pierced, provides that the first adapter part of the transfer device has a first, outer hollow cylindrical section extending on the bottle side and a first, extending from this inner hollow cylindrical section of smaller cross-section, that the first outer hollow cylindrical section axially extending the fixing elements forming tongue-shaped sections with radially inward projections in the respective free end area for gripping a section of the bottle, in particular its bead-like edge, and the second adapter part a second outer hollow cylindrical Has portion which is displaceable along the outside of the first outer hollow cylindrical portion of the first adapter part, that with the first outer hollow cylindrical portion of the first adapter part surrounded by the second outer hollow cylindrical portion an outwardly directed radial adjustment of the tongue-shaped portions is prevented or substantially prevented, and that from the second outer hollow cylindrical section of the second adapter part a third outer hollow cylindrical section of smaller cross section starts, within which a second inner hollow cylindrical section can be
- a transfer device which consists of the first adapter part, which can be fixed to a bottle or its neck, and a two-part second adapter part, which are axially displaceable to one another and to the first adapter part.
- the outer part of the second adapter part has the effect that when the hollow cylindrical section of larger cross section covers the first outer hollow cylindrical section of the first adapter part over a defined axial length, the tongue-shaped sections, in particular engaging behind the bead-like edge of the bottle, can no longer be adjusted outwards with the result that loosening from the bottle is impossible.
- the adapter parts lock in place in order to prevent the second adapter part from being pulled back.
- the outer part of the second adapter part latches to the first adapter part.
- a projection protruding radially inward from the second outer hollow cylindrical section of the second adapter part acts like a rib with a recess or step or an equivalent change in the geometry of the first hollow cylindrical section of the first Adapter part together in such a way that an axial displacement of the second adapter part to the first adapter part against the direction of penetration is prevented.
- the first and second adapter parts consequently form a rigid unit - viewed in the axial direction. If the first fuse is removed after the transfer device has been pushed onto a vial, the second adapter part can be shifted as a sub-unit in the direction of penetration, whereby the desired locking between the first and second adapter part takes place with the result that the tongue-shaped, the radially after inwardly protruding projections having fixing elements are no longer adjustable to the outside, so that a detachment from the bottle is excluded.
- the penetration needle cannot be adjusted relative to the outer part of the second adapter part. If the transfer device is fixed to the bottle by adjusting the second adapter part, i.e. after removing the first securing device, the second securing device is removed so that the second inner section is axially in the direction of the outer part of the second adapter part, which has the second and third outer hollow cylindrical section of the bottle is displaceable so that the cannula extending from the inner part of the second adapter part can pierce the closure.
- a protective element referred to as a second protective element, extends from the first inner section of the first adapter part, between the and the second inner section of the second adapter part when the transfer device is not in use the tip of the penetration needle runs.
- the adapter parts or their sections should be geometrically designed such that when the second adapter part is axially displaced to the first adapter part, the third outer section is guided on the outside and the second inner section of the second adapter part is guided along the first inner section of the first adapter part on the inside.
- the first fuse should have a geometry of a ring section which, when the transfer device is not in use, penetrates a slot running in the third outer section of the second adapter part and engages in a recess such as a groove in the outer wall of the first inner section of the first adapter part.
- the second inner section of the second adapter part has, on the puncture needle tip side, a base wall penetrated by the puncture needle and, facing away from the puncture needle tips, a preferably encircling flange section directed radially outward from its peripheral wall, in particular from the outer end region of the second inner section of the second adapter part, whose effective radial Extension is at least the same, preferably greater than the outer cross section of the third outer section of the second adapter part.
- This flange section serves as a handle in order to be able to axially adjust the second adapter part relative to the first adapter part or the inner section of the second adapter part relative to its outer section.
- the second securing device can also have a geometry of a second ring section, which is fixed between the free end edge of the third outer section and the flange section of the second inner section of the second adapter part when axially immovable between the first and second adapter parts.
- the first and / or second protective element by means of which the puncture needle tip, when the transfer device is not in use, against a unwanted contact is protected, is a disk element, wherein the first, preferably both the first and the second protective element, are axially displaceable in the first and second adapter part.
- first and second adapter parts are put together, they cannot be detached from one another when used properly, even if they have not yet been fixed on a bottle.
- a further development of the invention provides that with the first outer hollow cylindrical section of the first adapter part latched to the second outer hollow cylindrical section of the second adapter part in the use position of the transfer device between the second and third outer hollow cylindrical section of the second adapter part, the intermediate wall extending between the first outer hollow cylindrical section and the first inner hollow cylindrical section of the first adapter part extending intermediate wall rests.
- the second securing element remains between the third outer section and the second inner section of the second adapter part.
- the invention is characterized in that when the second part is adjusted in the penetration direction of the puncture needle, the second adapter part interacts with the first adapter part in such a way that adjustment of the second adapter part to the first adapter part against the penetration direction is prevented.
- the first and second adapter parts are designed in such a way that when they surround the bottle, they form a closed container, through which an escape of aerosol or, after piercing the closure, an escape of the medium present in the bottle to the outside is excluded, so that contamination z. B. by inhalation, through the skin, possibly. Oral, can not be done.
- the second element having the transition element can have a seal by means of which the second adapter part is sealed off from the bottle, in particular from both the bottle and the first adapter part.
- the invention is also characterized by a transfer device for removing or transferring a medium from or into a bottle with a bottle neck, which can be closed via a closure, comprising a first adapter part that can be positioned on the bottle and a first adapter part that interacts with the first adapter part
- a second adapter part which is displaceable in the longitudinal direction of the bottle and has a transition element for protruding through the closure, wherein when the first and second adapter parts are pushed into one another, they form a closed container surrounding the bottle.
- the second adapter part has a seal by means of which the second adapter part is sealed off from the first adapter part.
- the adapter parts are also inseparable.
- the insolubility of the adapter parts is achieved by the engagement of projections in recesses, which can only be displaced relative to one another in the direction of penetration of the transfer element such as cannula and can no longer be separated in the opposite direction.
- the latching can be done by tongue-like elements that have latching hooks, which in turn interact with corresponding elements.
- the tongue-like elements can have different lengths.
- the invention also includes sealing elements that prevent liquids, dusts, aerosols or the like from escaping from a closed space.
- These sealing elements can seal the adapter parts to one another or to one another.
- sealing elements are possible which have recesses, depressions, projections, which can also be circumferential and ring-shaped, or the like, in order to close off the space from the surroundings.
- the sealing elements can lie between the outer parts of the adapter, between the inner or the inner and outer parts of the adapter.
- the sealing elements can optionally also seal directly with respect to the bottle.
- the sealing elements can also be designed in such a way that guide channels are formed so that the adapter parts can be shifted into one another or bottles into the adapter parts more easily.
- the teaching according to the invention results, inter alia. the advantage that aerosol-tightness is already provided when the vial, i.e. the bottle, is pierced.
- the invention also enables a leakage leading to a hazard to be avoided after the closure has been pierced.
- the adapter remains in place prevents aerosols from occurring on the vial or around the vial, which result from the separation process. Aerosol-tightness is also ensured during use.
- Another advantage of the invention to be emphasized is that an injury after the use of the transfer device by the transfer element such as needle, cannula, spike, perforation device is excluded.
- the invention also relates to a kit consisting of a container with a medical agent, a bag with solvent for dissolving the medical agent and a transfer device for mixing the solvent with the medical agent.
- transfer devices are shown by means of which from a bottle or a bottle, a so-called vial, fluids such as dry substances or liquids such as water or solvents that are mixed for infusion or injection purposes before their use or administration. It can also be used for instillation or for solvent bags.
- fluids such as dry substances or liquids such as water or solvents that are mixed for infusion or injection purposes before their use or administration. It can also be used for instillation or for solvent bags.
- the application cases are given purely by way of example.
- Corresponding transfer devices are also referred to as connectors or adapters.
- a corresponding transfer device is required in order to perforate the closure of the bottle by means of a transfer element such as a puncture needle - such as a steel cannula.
- a transfer element such as a puncture needle - such as a steel cannula.
- the transfer devices shown in the figures have parts which are arranged telescopically and can be adjusted relative to one another and are also referred to as the first and second adapter parts.
- the transfer device is hereinafter referred to as the connector and the vial to be connected to this is referred to as the vial.
- the first adapter part is also known as the vial holder and the second adapter part as the cannula holder.
- transition element that establishes the connection to the interior of the vial is referred to below as a cannula, without this restricting the function and design.
- the connector 10 has a first adapter part 12 and a second adapter part 14 as essential elements.
- the first adapter part 12 has a pot geometry with a peripheral wall 16, referred to as a jacket wall, and a bottom wall 18, in order to receive a small bottle, that is to say vial 20, which can be pushed into the first adapter part 12.
- the bottom wall 18 ensures that the vial 20 remains in the first adapter part 12.
- the bottom wall 18 does not have to be completely closed for this purpose.
- a closed bottom wall 18 is provided in order to be able to provide a closed system which offers the possibility of an aerosol and leak tightness, as will be described below.
- a retaining element referred to as a ring element or ring section 22
- a ring element 22 which has elastic first projections compressible in the axial direction, some of which are identified by the reference numerals 24, 26 are.
- the ring element 22 engages around the end edge of the peripheral wall 16 in sections in order to ensure a fixation.
- the tongue-shaped elements 28, 30 run inclined to the longitudinal axis 32 of the first adapter part 12 and thus of the vial 20, as a result of which the first adapter part 12 is secured on the vial 20; because like that Figures 4 to 7 mediate, the tongue-shaped elements 28, 30 are supported, when the vial 20 is positioned in the first adapter part 12, on the connecting wall 38 which runs at an angle between the bottle neck 34 of the vial 20 and its cylindrical body 36 and is also referred to as a transition.
- the vial 20 can no longer be pulled out of the first adapter part 12.
- the first adapter part 12 is thus the vial holder.
- the bottle neck 34 has a circumferential bead 40 in the region of its opening.
- the opening of the vial 20 is closed by a stopper 42.
- an aluminum crimp cap is applied typically after the vial 20 has been closed with the stopper 42.
- a flip-off cap made of plastic can be located on this. This flip-off cap is pulled off the aluminum crimp cap, so that an opening is created in the middle of the aluminum crimp cap so that the sealing plug 42 is visible.
- the second adapter part 14 which can also be referred to as the upper adapter part or outer part, comprises a hollow cylindrical section 44 which, facing away from the vial, is bounded by a wall 46 which runs transversely to the longitudinal axis 32 and is also referred to as a boundary wall, which has a cylindrical extension 48 in the center, one of which is referred to as a cannula Penetration needle 50 goes out and on the other hand, a breakaway connector 52 is placed on the outside.
- the second adapter part 14 is thus the cannula holder.
- guide-forming recesses 56, 58 are formed ( Fig. 3 ), each of which is composed of an axially extending section 60 and a section 62 extending transversely to this and along the wall 46.
- a second projection 64, 66 projecting radially outward from the peripheral wall 16 of the first adapter part 12 ( Fig. 2 ) in order to be able to lock the first adapter part 12 to the second adapter part 14 in the manner described below.
- An inner hollow cylindrical section 68 runs coaxially to the outer hollow cylindrical section 44, within which the cannula 50 extends, but does not protrude beyond its end edge 70, as can be seen in particular from the Figures 4 to 7 results.
- a disk-shaped protective element 72 is received in a clamping manner from the inner hollow-cylindrical section 68, in the axial direction of the inner hollow cylindrical section 68 is adjustable.
- the protective element 72 represents a configuration that is not mandatory.
- the inner section 62 of the guide 56, 58 running transversely to the longitudinal axis 32 has a cross-sectional reduction in the axial direction formed by a step 76.
- the section 62 experiences a quasi "constriction", ie the distance between the free edge or corner 78 of the respective second projection 64, 66 and the apex area of the first projections 24, 26 is greater than the distance between the The apex of the step 76 and the opposite edge of the section 62.
- the first projections 24, 26 must consequently be compressed.
- the projections 24, 26 can relax again with the result that when the first adapter part 12 is turned the second adapter part 14 takes place in the direction of the step 76, the projection 64, 66 protruding from the outside of the jacket wall 16 prevents further rotation by interacting with the step 76.
- the first and second adapter parts 12, 14 are thus permanently connected to one another. It is likewise not possible to remove the vial 20.
- ribs 17, 19 running in the longitudinal direction can serve as guide rails over the jacket wall 16.
- connection of the cannula 50 to the interior of the vial 20 is self-explanatory from the Figures 4 to 7 clear.
- Fig. 4 the position is shown in which the second adapter part 14 is placed on the first adapter part 12.
- the second adapter part 14 with its outer hollow cylindrical section 44 surrounds the jacket wall 16 and is guided by it.
- the inner diameter of the hollow cylindrical section 44 and the outer diameter of the jacket wall 16 are correspondingly matched to one another.
- the guide ensures that the cannula can be displaced along the longitudinal axis 32 of the vial 20 when the first and second adapter parts 12, 14 are pushed into one another.
- the ribs 17, 19 running in the direction of the longitudinal axis serve to ensure that the adapter parts 12, 14 are aligned with one another in the correct position in order to be displaced with respect to one another. Moving is also made easier since a linear contact is produced between the adapter parts 12, 14.
- the ribs 17, 19 also prevent tilting.
- Fig. 5 the position shown is that the cannula 50 has penetrated the stopper 42 and the cannula tip 74 is connected to the interior of the vial 20.
- the projections 64, 66 protruding from the outside of the jacket wall 16 and preferably having an uneven trapezoidal geometry are located in the transition between the axially extending sections 60 of the guides 56, 58 and the sections 62 extending transversely thereto or second adapter part 14 rotated to the lower or first adapter part 12 ( Fig. 6 ), so that the second projections 64, 66 are adjusted along the sections 62 of the guides 56, 58 that extend along the wall 46.
- the first and second adapter parts 12, 14 are locked when the second projections 64, 66 have overcome the steps 76 in the sections 62 of the guides 56, 58 and are located in the respective end section 80 of the guides 56, 58. To overcome the steps 76, it is first necessary for the first projections 24, 26 axially projecting from the end edge of the ring element 22 to be compressed to the required extent.
- the lock is designed in such a way that it can only be released with an additional tool or with at least 300 N pull-off force, for example.
- the break-off connector 52 can be destroyed and the mixing procedure can take place between the medicament present in the vial 20 and a liquid that is located in a bag previously connected to the break-off connector 52.
- a Luer lock connection or similar is also required. possible.
- a syringe, bottle or similar container can also be located on the breakaway connector or the like, such as a Luer lock connection. The same applies to all embodiments.
- a second connector 100 can be seen which does not have all the features of the invention and which also consists of a vial holder running on the vial side as a first adapter part 112 and a second adapter part 114 having the cannula 50 as a cannula holder.
- the connector 100 is also designed in such a way that after it has been connected to the vial 20, an unwanted or uncontrolled detachment from the vial 20 is no longer possible, as will be explained below.
- the first or inner adapter part 112 comprises a first outer hollow cylindrical section 116 surrounding the bead 40 of the vial 20 when used properly 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, an intermediate wall 120 runs transversely, in particular perpendicular to the longitudinal axis 32 of the connector 100 and thus, in the state connected to the vial 20, to the longitudinal axis of the vial 20.
- the outer hollow cylindrical section 116 has tongue-shaped sections which are separated by axially extending slots 122 and are resilient to the required extent, two of which are identified by way of example with the reference numerals 124, 126.
- the tongue-shaped sections 124, 126 have inwardly projecting projections (see projection 128) at the end, which grip behind the bead-like edge 40 of the vial neck, when the first adapter part 112 is properly connected to the vial 20, as can be seen below with reference to the figures.
- the second or outer adapter part 114 consists of two parts which can be adjusted telescopically with respect to one another, namely an outer part 130 and an inner part 132 from which the puncture needle 50 extends.
- the outer part 130 comprises a section 134 designated as the second outer hollow cylindrical section and section 136 designated as the third outer hollow cylindrical section, which have diameters which differ from one another.
- the third outer hollow cylindrical section 136 is smaller in cross-section than the second outer hollow cylindrical section 134, the inner diameter of which is adapted to the outer diameter of the first outer hollow cylindrical section 116 of the first adapter part 112, which enables axial guidance.
- the inner diameter of the third outer hollow cylindrical section 136 is adapted to the outer diameter of the first inner hollow cylindrical section 118 of the first adapter part 112, which also results in axial guidance.
- first and second adapter parts 112, 114 are secured against axial displacement relative to one another by a first securing device 138, which preferably has the geometry of a ring section.
- the fuse 138 runs along a further partition 140 running between the second and third hollow cylindrical sections 134, 136 and extending parallel to the partition 120 and penetrates a slot in the third outer hollow cylindrical section 136 and extends partially in a recess aligned with the slot or groove in the first inner hollow cylindrical section 118 of the first adapter part 112.
- a second securing device 146 runs between the end edge 142 of the third outer cylinder section 136 and a flange-like extension extending from the inner or second part 132 of the second adapter part 112.
- the inner part 132 of the second adapter part 114 has a hollow cylindrical shape, the outer diameter of which matches the inner diameter of the first inner hollow cylindrical portion 118 of the first adapter part 112 is adapted, whereby an axial guidance is made possible. Furthermore, the second part 132 of the second adapter part 114 is secured with respect to the first inner hollow cylinder-shaped section 118 via interlocking sections, in particular a preferably circumferential rib 133, which protrudes over the circumferential wall of the hollow cylinder-shaped inner or second part 132 of the second adapter part 114 and in a correspondingly adapted recess 153 engages in the inside of the first inner hollow cylindrical section 118 of the first adapter part 112.
- the drawing also shows that a projection such as a clamping rib 147 protrudes from the inside of the second outer hollow cylindrical section 134 of the second adapter part 114 and engages in an adapted recess 148 of the first outer hollow cylindrical section 116 of the first adapter part 112 in such a way that a Loosening the adapter parts 112, 114 against the direction of penetration is not possible.
- a projection such as a clamping rib 147 protrudes from the inside of the second outer hollow cylindrical section 134 of the second adapter part 114 and engages in an adapted recess 148 of the first outer hollow cylindrical section 116 of the first adapter part 112 in such a way that a Loosening the adapter parts 112, 114 against the direction of penetration is not possible.
- a disk-shaped protective element 172 can be received in a clamping manner by the first inner hollow-cylindrical section 118 of the first adapter part 112, which can have an opening in the center in order not to hinder the penetration of the cannula 50 when the stopper 42 is penetrated.
- a membrane to be destroyed can also be provided.
- the connector 100 is aligned with the bottle neck 34 of the vial 20 such that the longitudinal axis of the connector 100 is aligned with the longitudinal axis 32 of the vial 20 is aligned.
- the second adapter part 114 is arranged to the first adapter part 112 due to the securing elements 138, 146 and the interlocking projections or clamping ribs in such a way that the first adapter part 112 can overcome the bead 40 of the bottle neck 34, that is, the tongue-shaped sections 124, 126 after can be spread on the outside in order to then spring back as soon as the bead 40 has been overcome and the projections 128 of the tongues 124, 126 can thus engage behind the bead 40.
- the positioning of the connector 100 after reaching behind the bead 40 is that Fig. 13 refer to.
- the first securing device 138 extending along the partition 140 and securing the first and second adapter parts 112, 114 against axial displacement is removed ( Fig. 14 ), so that an axial displacement of the second adapter part 114 takes place when there is further axial force.
- the holding force generated by the protrusion or protrusions 133 or also referred to as a rib clamping rib which connects the inner or second part 132 of the second adapter part 114 to the first inner hollow-cylindrical section 118 of the first adapter part 112, is overcome.
- the position is shown in which the second outer hollow cylindrical section 134 surrounds the first outer hollow cylindrical section 116 of the first adapter part 112 to such an extent that the tongue-shaped elements 124, 126, which can also be referred to as sections, can no longer be bent outward.
- the projection 147 which previously prevented the second adapter part 114 from being withdrawn to the first adapter part 112, engages behind a recess in the free edge area of the tongue-shaped elements 124, 126, adapted by a step-shaped cutout 148, which ensures that a retraction of the second adapter part 114, i.e. a axial adjustment against the direction of penetration is not possible.
- the second outer hollow cylindrical section 134 thus acts at the end as a clamping ring for the first outer hollow cylindrical section 116 of the first adapter part 112, which can also be referred to as a bell, whereby a after outwardly directed radial adjustment of the tongue-shaped elements 124, 126 is prevented. This creates a closed space before the stopper is pierced, so that no aerosols that arise through the opening of the vial can escape to the outside.
- the resulting locking is designed so that this can only be done with an additional tool or pulling forces of z. B. 300 N can be solved. This ensures that the connector 100 remains connected to the vial 20 even after use.
- the second securing device 146 is then removed so that the inner part 132 of the second adapter part 114, which has the cannula 50, can be adjusted in the penetration direction by exerting an axial force on the flange-like handle 144 in order to penetrate the stopper 42, as is shown in a comparison of FIG Figures 15-17 made clear.
- the disc-shaped protective element 172 is pressed by the inside transverse wall 150 of the inner part 132 penetrated by the cannula 50 to rest against the outside of the stopper 42 or the aluminum cap covering it on the outside.
- the projection or the clamping rib 133 protruding radially from the outer wall of the hollow cylindrical section of the inner part 132 of the second adapter part 114 engages in a recess present in the inner wall of the first inner hollow cylindrical section 118 of the first adapter part 112 or engages behind a step 152, in order to exclude a retraction of the inner part 132 of the second adapter part 114.
- the breakaway connector 52 on the previously z. B. a bag is applied, be destroyed in order to carry out the desired mixing procedure.
- FIG. 18 to 28 is an alternative to the embodiment of FIG Figures 1 to 7 can be seen, so that the same reference numerals are used in principle for the same elements.
- the representations of the corresponding transfer device 200 to be referred to as a connector are self-explanatory.
- the adapter parts cannot be detached by locking an outer or second adapter part 214 with the first adapter part 212 surrounding the vial 20.
- the first adapter part 212 has a pot geometry with a circumferential wall 216 and a bottom wall 218 in order to receive the vial 20.
- a ring element 222 is provided in the open edge area of the circumferential wall 216, from which web-shaped or tongue-shaped elements extend in the axial direction and are identified by way of example with the reference symbols 228 and 230.
- the tongue-shaped elements 228, 230 run inclined to the longitudinal axis 232 of the connector 200 and thus of the vial 20, whereby the first adapter part 212 and the vial 20 form a solid unit when the vial 20 is properly received by the first adapter part 212; because in this case, when the vial 20 is positioned in the first adapter part 212, the tongue-shaped elements 228, 230 are supported on the connecting wall 38 running between the bottle neck 34 of the vial 20 and its cylindrical body 36. Thus, the vial 20 can no longer be pulled out of the first adapter part 212.
- tongue-shaped elements 223, 231 From the ring element 222, which is connected, such as glued or welded, to the end edge of the cup-shaped first adapter part 212, further inwardly protruding tongue-shaped elements 223, 231 proceed, which according to the illustration according to, for example, FIG Fig. 25 abut against the circumferential surface, that is to say the cylindrical body 36 of the vial 20.
- the first adapter part 212 has latching depressions delimited by elevations on the circumferential side, like the sectional illustration according to FIG Fig. 20 made clear.
- two locking depressions are identified by the reference numerals 310, 312.
- the projections delimiting the latching depressions 310, 312 have a tooth-shaped geometry such that their flanks on the slide-in side with respect to the second adapter part 214, ie the upper boundaries in the drawings, run ramp-shaped in such a way that the second adapter part 214 can be pushed onto the first adapter part 212 or pushing the first adapter part 212 into the second adapter part 214 is made possible, since projections 322, 324 of tongue-shaped elements 314, 316, 318, 320 that extend in the axial direction of the second adapter part 214 slide along the corresponding flanks .
- the opposite flanks have a correspondingly inclined course, so that when the projections 322, 324 emanating from the tongue-shaped elements 314, 316 engage in a latching recess 310, 312, the adapter parts 312, 314 can no longer be pulled apart with the usual introduction of force.
- the axially extending tongue-like elements 314, 316, 318, 320 with the inwardly directed projections 322, 324 at their ends start from a ring element 326 which is fixed as welded in the opening area of the second adapter part 214.
- the second adapter part 214 has a bell-shaped geometry, like the sectional illustration in particular according to FIG Fig. 20 made clear.
- the ring-shaped element 326 has a bead-like edge 328, which is connected, such as welded, to the bell-like extension 330 of the second adapter part 214.
- the tongue-like elements 314, 316, 318, 320 are inclined in the direction of the interior of the second adapter part 214 and are designed to be resilient in such a way that the first and second adapter parts 212, 214 can easily be pushed into one another, but - as explained above - they are prevented from being pulled apart .
- the lock is designed in such a way that it can only be released with an additional tool or with at least 300 N pull-off force, for example.
- the inner wall of the cylindrical section of the second adapter part 214 is lined with a seal 332 which, when the adapter parts 212, 214 are assembled, rests in a sealing manner on the jacket wall 216 of the first adapter part 212. This creates a closed space. If the bottom wall 218 of the first adapter part 212 is also closed, the vial 20 is completely closed off from the environment. This is the preferred embodiment.
- seal 332 can have circumferential annular elevations 333.
- a stop preferably designed as a circumferential ring or web 217, extends from the jacket wall 216 and consequently extends radially from the circumferential wall.
- the free outer edge of the second adapter part 214 rests against the stop when the adapter parts 212, 214 have been properly assembled and the cannula 50 has thus penetrated into the vial 20 to the required extent.
- connection of the cannula 50 to the interior of the vial 20 is illustrated in a self-explanatory manner. So is in the Figure 23a ), b) the attachment of the first adapter part 212 surrounding the vial 20 to the second adapter part 214 is shown. the Figure 24a ), b) shows the connection. In the Figure 25a ), b) a position is shown in which the projections 322, 324 protruding from the tongue-like elements 314, 316, 318, 320 in their end region are already in a locking recess or recess 310 engage so that there is a locking position, but the plug 42 is not yet fully pierced.
- the Figure 26a ), b) reflect a position in which the first adapter part 212 has been pushed further into the second adapter part 214.
- the end position is shown in which the free edge of the second adapter part 214 rests against the annular projection 217 of the first adapter part 212, which serves as a stop.
- a stop is not a mandatory feature. Rather, an optical display such as a color marking can also serve to make the user recognizable that the adapter parts 212, 214 are pushed into one another to an extent that the stopper 42 is pierced by the cannula 50 to the required extent.
- the break-off connector 52 extending from the bottom wall 245 of the second adapter part 214 can then be removed.
- a connection between the adapter parts 212, 214 is also possible in that the locking recesses 310, 312 are sections of a thread into which the projections 322, 324 engage so that the first adapter part 212 is joined to the second adapter part 214 in the manner of a screw connection.
- the inner cylindrical section 268 moves internally protruding projection 270 engages behind the bead-like edge 40 of the vial 20.
- several projections or a circumferential projection can also be provided.
- FIG. 10 is an embodiment of the transfer device 200 of FIG Figures 18 to 28 refer to. Since the structure is basically the same, the same reference symbols are used for the same elements.
- the embodiment of the den Figures 20a and 20b to be removed transfer device differs from that of the Figures 18 to 28 to the effect that no inwardly directed projection extends from the inner hollow cylindrical section 268 and engages behind the bead-like edge 40 of the vial 20. Otherwise the same construction can be found.
- the circumferential or jacket wall 216 of the first adapter part 212 with the ring element 222 runs in the annular gap 269 running between the inner hollow cylindrical section 268 and the circumferential wall 244 when the adapter parts 212, 214 are assembled.
- the annular gap 269 thus offers a guide when the adapter parts 212, 214 are pushed together.
- a seal takes place between the ring element 222 and the annular gap 269 and thus between the adapter parts 212, 214.
- FIG. 29 to 39 An embodiment according to the invention of a transfer device to be referred to as a connector is the Figures 29 to 39 refer to.
- the same reference numerals are used for the same elements.
- the transfer device 400 there is basically an inseparability between a first adapter part 412 surrounding the vial 20 with the sealing plug 42 and a second adapter part 414 with a hood or cup-shaped geometry as soon as the first and second adapter parts 412, 414 are connected to one another by latching .
- the first and second adapter parts 412, 414 surround a closed space which surrounds the vial 20, the space already being closed before the cannula 50 proceeding from the second adapter part 414 penetrates the sealing plug 42.
- unsolvable means that loosening without tools or with the action of a pull-off force of less than 300 N is not possible.
- the first adapter part 412 has a pot geometry with a peripheral wall 216 and a bottom wall 218 in order to receive the vial 20.
- a peripheral wall 216 which is also referred to as the jacket wall
- detent depressions bounded by elevations emanate, two of which are identified by way of example with the reference numerals 310 and 312.
- the projections delimiting the latching depressions 310, 312 have a tooth-shaped geometry such that their flanks running in relation to the second adapter part 414, ie the upper delimitations in the drawings, run ramp-shaped.
- the tongue-shaped elements 416, 418, 420, 424, which form locking hooks with their radially inwardly projecting projections 423, 425, are based on a ring element 430 which is firmly connected to the second or outer adapter part 414, in particular by welding or gluing. Other types of fastening are also possible.
- the ring element 430 is preferably fixed in the inner area of a bell-like extension 432 of the second adapter part 414, such as in particular the Fig. 31 made clear.
- the tongue-shaped elements 416, 418, 420, 424 extending from the ring element 430 in the direction of the bottom wall 434 running transversely to the longitudinal axis of the adapter part 414 span a circumferential edge, that is to say an envelope which is adapted to the outer circumference of the first adapter part 412, so that when the first adapter part 412 with the vial 20 is inserted into the second or outer adapter part 414, there is no tilting, rather a secure axial guidance is ensured.
- a seal 436 extends from the inside of the second adapter part 414 and consists of an inner section 438 running in the longitudinal direction of the adapter part 414 and an outer section parallel to this and forming a gap 446 exists.
- the seal 436 has the geometry of a U with unequal legs, the shorter leg of which runs on the outside.
- an edge section 440 of an inner hollow cylindrical section 444 running coaxially to the circumferential wall 442 of the second adapter part 414, as also from FIG Fig. 32 is clearly evident.
- the seal 436 is glued to the hollow cylindrical section 444 or connected in some other suitable manner or otherwise fastened such as clamped.
- the outer side of the outer section 446 of the seal 436 runs in alignment with the outer surface of the hollow cylindrical section 444, as is also shown in FIG Fig. 32 can be seen.
- the inner surface of the inner section 438 of the seal 436 has longitudinal ribs 439 which serve to guide the vial 20. Furthermore, the inner section 438 is beveled on the inside starting from its edge (line 441), as in FIG Fig. 32 made clear. As a result, the vial 20 is also guided. At the same time, the vial 20 is sealed off, as in FIG Fig. 32 made clear. Furthermore, there are projections 447 on the outside of the outer section 446 of the seal 436, as a result of which a seal takes place between the first adapter part 412 and the second adapter part 414 in the area of the latching depressions 310, 312. This creates a seal between the first and second adapter part 412, 414 guaranteed. As mentioned, the seal also rests on the vial 20 or its inclined neck section (connecting wall 38).
- the interaction of the locking projections 423, 425 of the tongue-shaped locking elements 416, 418, 420, 424 with the locking depressions 310, 312 ensures, due to their geometry, that after the locking projections 423, 425 hook into one of the depressions 310, 312, the adapter parts 412 , 414 is no longer possible, rather before penetration of the plug 42, only a sliding into one another in the direction of penetration is permitted. This creates a closed space before the stopper is pierced, so that no aerosols that arise through the opening of the vial can escape to the outside.
- the penetration takes place by further pushing together to an extent that the cannula 50 penetrates the stopper 42 and the cannula 50 pierces the stopper 42 completely.
- the adapter parts 412, 414 can be pushed into one another until the lower edge of the second adapter part 414 or the ring element 430 running in this area comes to rest on a radially circumferential web 217 which protrudes from the circumferential wall 216 of the first adapter part 412, as also in connection with the embodiment of FIG Figures 18 to 28 the case is.
- FIG. 33 This is how in Fig. 33 the placement of the upper or second adapter part 414 on the lower or inner or first adapter part 412 is shown after the vial 20 has been inserted into the lower adapter part 412.
- FIG Fig. 38 the first adapter part 412 is pushed into the outer adapter part 414 to such an extent that the latter rests against the circumferential stop 217, that is to say that it can no longer be pushed into one another.
- the cannula 50 has penetrated the closure plug 42 to the required extent.
- the connector 52 can then be canceled in order to, for. B. initiate the mixing process via a hose of a solvent bag.
- a stop 217 is not absolutely necessary.
- the latching hooks can have different lengths, so that the bottom side of the adapter part 412 rests on the shorter hook.
- 10 Connector / transfer device 100 Connector / transfer device 12th first adapter part 112 first adapter part 14th second adapter part 114 second adapter part 16 Circumferential wall / jacket wall 116 outer hollow cylindrical section 17.19 Ribs 118 inner hollow cylindrical section 18th Bottom wall, section 120 Partition 20th Vial / bottle 122 Slots 22nd Retaining element / ring element / section 124 tongue-shaped section / element 24 Ledges 126 tongue-shaped section / element 26th Ledges 128 head Start 28 Element / fixing element 130 outer adapter part 30th Element / fixing element 132 inner hollow cylindrical section 32 Longitudinal axis 133 Rib / protrusion / clamping rib 34 Bottleneck 134 second outer hollow cylindrical section 36 cylindrical body 136 third outer hollow cylindrical section 38 Connection wall / transition 138 first backup 40 bead 140 Partition 42 Plug
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Description
Die Erfindung bezieht sich auf eine Transfervorrichtung zur Entnahme oder Übergabe eines Mediums aus einer oder in eine Flasche mit Flaschenhals, der über einen Verschluss verschließbar ist, umfassend
- ein an der Flasche positionierbares erstes inneres Adapterteil und
- ein mit dem ersten Adapterteil wechselwirkendes in Längsrichtung der Flasche verschiebbares äußeres zweites Adapterteil mit einem Überleitungselement, wie Nadel als Punktionsnadel, Kanüle, Spike oder Perforationseinrichtung, zum Durchstechen des Verschlusses.
- a first inner adapter part that can be positioned on the bottle and
- an outer second adapter part that interacts with the first adapter part and is displaceable in the longitudinal direction of the bottle and has a transfer element, such as a needle as a puncture needle, cannula, spike or perforation device, for piercing the closure.
Zahlreiche Medikamente zur Infusion, Injektion oder Instillation werden als trockene Substanzen geliefert und erst kurz vor der Anwendung/Verabreichung mit Wasser oder einem anderen Lösungsmittel zu einer Lösung oder Suspension angemischt. Andere flüssige Zubereitungen müssen vor Anwendung verdünnt werden.Numerous drugs for infusion, injection or instillation are supplied as dry substances and are only mixed with water or another solvent to form a solution or suspension shortly before use / administration. Other liquid preparations must be diluted before use.
Dabei wird die Trockensubstanz in der Regel in einer Injektionsflasche, einem sog. Vial, geliefert. Auch primär flüssige Medikamente werden in Vials angeboten. Um diese Flasche mit einem anderen Behälter oder einem Infusionsgerät zu verbinden, kann ein Konnektor (Transfervorrichtung) verwendet werden, in den der Kopf des Vials hineingedrückt wird und die Membran des Vials perforiert wird. Das andere Behältnis kann dabei z. B. eine andere Injektionsflasche, ein Infusionsbeutel, ein Lösungsmittelbeutel oder eine Spritze sein.The dry substance is usually supplied in an injection bottle, a so-called vial. Primarily liquid drugs are also offered in vials. To connect this bottle to another container or an infusion device, a connector (transfer device) can be used, into which the head of the vial is pressed and the membrane of the vial is perforated. The other container can, for. For example, another injection bottle, infusion bag, solvent bag, or syringe.
Nach dem Stand der Technik können diese auch als Adapter bezeichneten und aus Adapterteilen zusammengesetzten Konnektoren im Zentrum eine Stahlkanüle oder einen Kunststoffdorn aufweisen, der von einem einen hohlzylinderförmigen Körper bildenden Kragen umgeben ist, der auf den flanschartig ausgebildeten Rand mit insbesondere aus Aluminium bestehender Bördelkappe des Vials aufschnappt. Von der Bodenwandung des Kragens geht die Punktionsnadel insbesondere in Form der Stahlkanüle aus und erstreckt sich in Längsrichtung des hohlzylindrischen Körpers. Derartige Adapter entsprechen nicht mehr den heutigen Anforderungen an Vial-Adaptern, und zwar aus mehreren Gründen.According to the prior art, these connectors, also known as adapters and composed of adapter parts, can have a steel cannula or a plastic spike in the center, which is surrounded by a collar forming a hollow cylindrical body, which is attached to the flange-like edge with, in particular, a flanged cap of the vial made of aluminum snaps open. The puncture needle starts from the bottom wall of the collar, in particular in the form of the steel cannula, and extends in the longitudinal direction of the hollow cylindrical body. Such adapters no longer meet today's requirements for vial adapters, for several reasons.
Nach Vorschriften wie Technische Regeln für Gefahrstoffe (TRGS 525) der Bundesanstalt für Arbeitsschutz und Arbeitsmedizin und Zytostatika im Gesundheitsdienst (M620) der Berufsgenossenschaft für Gesundheitsdienst und Wohlfahrtspflege ist grundsätzlich eine Freisetzung von Gefahrstoffen, wie z. B. Arzneistoffen, zu vermeiden beziehungsweise zu reduzieren. Dies gilt insbesondere bei der Zubereitung von Gefahr- und Arzneistoffen.According to regulations such as Technical Rules for Hazardous Substances (TRGS 525) of the Federal Institute for Occupational Safety and Health and Cytostatics in the Health Service (M620) of the Employer's Liability Insurance Association for Health Service and Welfare, the release of hazardous substances, such as z. B. drugs to avoid or reduce. This applies in particular to the preparation of hazardous and medicinal substances.
Eine solche Freisetzung führt zur Exposition des Personals, der Patienten und der Umgebung. Dadurch ist eine Aufnahme der freigesetzten Stoffe über Inhalation, die Haut oder oral möglich. Die Freisetzung selbst kann z. B. über die Bildung von Aerosolen, von Spritzern bei der Zubereitung, Leckagen des Adapters, beim Entfernen des Adapters oder gegebenenfalls durch Glasbruch entstehen, sowie durch die Verletzung durch eine kontaminierte Kanüle.Such a release leads to exposure of staff, patients and the environment. This enables the released substances to be absorbed via inhalation, the skin or orally. The release itself can e.g. B. via the formation of aerosols, splashes during preparation, leakage of the adapter, when removing the adapter or possibly caused by broken glass, as well as by injury from a contaminated cannula.
Zum einen bieten die vorbekannten Vial-Adapter des Standes der Technik grundsätzlich keine Aerosol- und Leckage-Dichtigkeit.On the one hand, the previously known vial adapters of the prior art basically do not offer any aerosol and leak tightness.
Zum anderen ist auch eine Verletzungssicherheit mit kontaminierter Nadel nicht gegeben wie von der Unfallverhütungsvorschrift TRBA 250 gefordert. Gleichfalls wird eine Exposition durch die Abnahme des Adapters nicht vermieden.On the other hand, there is also no protection against injury with a contaminated needle, as required by the accident prevention regulation TRBA 250. Likewise, exposure by removing the adapter is not avoided.
Der zweite Grund ist, dass der Verschluss von der Punktionsnadel zentrisch punktiert werden muss, um einen leckdichten Anschluss des Vials sicherzustellen. Bei nach dem Stand der Technik verwendeten Vial-Adaptern besteht jedoch die Gefahr, dass das Vial beim Einschnappen in den Kragen verkippt ist. Dadurch kommt es zu einer primär exzentrischen Punktion des Verschlusses. Beim anschließend vollständigen Hineindrücken des Vials wird die Kanüle sodann in eine zentrische Position gezwungen. Dadurch kommt es zur Verspannung des Verschlusses des Vials, die zu Leckagen neben der Kanüle führen kann. Dies kann bei toxischen Substanzen, wie z. B. Zytostatika, zur Gefährdung von Personal und Patienten führen.The second reason is that the closure of the puncture needle has to be punctured centrally in order to ensure a leak-tight connection of the vial. In the case of vial adapters used according to the prior art, however, there is the risk that the vial will tilt when it is snapped into the collar. This results in a primarily eccentric puncture of the closure. When the vial is then fully pushed in, the cannula is then forced into a central position. This leads to tension in the closure of the vial, which leads to Leaks next to the cannula can result. This can happen in the case of toxic substances such as B. cytostatics, lead to the endangerment of staff and patients.
Unabhängig hiervon bieten die entsprechenden Adapter grundsätzlich keine Aerosolund Leckage-Dichtigkeit.Regardless of this, the corresponding adapters generally do not offer any aerosol or leak tightness.
Eine Transfervorrichtung nach
Aus der
Eine Transfervorrichtung nach der
Der
Eine Transfereinrichtung nach der
Auch diese Konstruktionen weisen den Nachteil auf, dass nach Benutzung der Transfervorrichtung ein problemloses Lösen von den Vials möglich ist.These constructions also have the disadvantage that, after the transfer device has been used, it is possible to detach it from the vials without problems.
Durch die Trennbarkeit von Vial und Konnektor ergibt sich des Weiteren der Nachteil der Gefahr einer Kontamination durch z. B. Einatmen oder über die Haut oder die Bildung von Aerosolen beim Entfernen der Nadel aus dem Vial.Because the vial and connector can be separated, there is also the disadvantage of the risk of contamination by e.g. B. inhalation or through the skin or the formation of aerosols when removing the needle from the vial.
Die
Gegenstand der
Gegenstand der
Eine weitere Transfervorrichtung ist in
Der vorliegenden Erfindung liegt u. a. die Aufgabe zu Grunde, eine Transfervorrichtung, also einen Vial-Konnektor oder -Adapter zur Verfügung zu stellen, der eine erhöhte Expositionssicherheit bietet.The present invention is inter alia. The underlying task is to provide a transfer device, i.e. a vial connector or adapter, which offers increased exposure security.
Nach einem weiteren Aspekt soll sichergestellt sein, dass ggfs. bereits beim Anstechen des Vials, also der Flasche, eine Aerosol-Dichtigkeit gegeben ist.According to a further aspect, it should be ensured that, if necessary, an aerosol-tightness already exists when the vial, that is to say the bottle, is pierced.
Ein Aspekt zielt darauf ab, dass nach Durchstechen des Verschlusses eine zu einer Gefährdung führende Leckage vermieden wird.One aspect is aimed at avoiding a hazardous leakage after the closure has been pierced.
Ein weiterer hervorzuhebender Aspekt ist, dass durch das Verbleiben des Adapters am Vial oder um das Vial herum, Aerosole, die durch den Trennvorgang entstehen, nicht austreten. Auch soll der Adapter eine Aerosol-Dichtigkeit während der Anwendung bieten.Another aspect to be emphasized is that by keeping the adapter on the vial or around the vial, aerosols that are created by the separation process do not escape. The adapter should also provide aerosol-tightness during use.
Auch ist ein Aspekt der Erfindung, dass eine Verletzung nach der Benutzung der Transfervorrichtung durch das Überleitelement wie Nadel, Kanüle, Spike, Perforationseinrichtung ausgeschlossen wird.Another aspect of the invention is that an injury after the use of the transfer device by the transfer element such as needle, cannula, spike, perforation device is excluded.
Zur Lösung eines oder mehrerer Aspekte sieht die Erfindung vor, dass das erste Adapterteil nach Verschieben des zweiten Adapterteils entlang des ersten Adapterteils in Richtung des Verschlusses und Verrasten des zweiten Adapterteils unlösbar an der Flasche oder um die Flasche herum fixiert ist, und dass das zweite Adapterteil eine Hauben- oder Topfgeometrie mit zylindrischer Umfangswandung und einen koaxial zu dieser verlaufenden und von dieser umgebenen inneren hohlzylindrischen Abschnitt aufweist, von dem ein bei zusammengesetztem ersten und zweiten Adapterteil das zweite Adapterteil gegenüber dem ersten Adapterteil abdichtendes Dichtelement ausgeht.To solve one or more aspects, the invention provides that the first adapter part is permanently fixed to the bottle or around the bottle after the second adapter part has been moved along the first adapter part in the direction of the closure and the second adapter part is locked, and that the second adapter part has a hood or pot geometry with a cylindrical circumferential wall and an inner hollow cylindrical section running coaxially to this and surrounded by it, from which a sealing element extends, which seals the second adapter part against the first adapter part when the first and second adapter parts are assembled.
Dabei können von dem ersten Adapterteil insbesondere radial verstellbare Fixierelemente ausgehen, über die das erste Adapterteil nach Verschieben des zweiten Adapterteils entlang des ersten Adapterteils in Richtung des Verschlusses und Verrasten des zweiten Adapterteils bei ordnungsgemäßer Handhabung der Transfervorrichtung unlösbar an der Flasche fixiert ist.Radially adjustable fixing elements can extend from the first adapter part, via which the first adapter part is permanently fixed to the bottle after the second adapter part has been moved along the first adapter part in the direction of the closure and the second adapter part locked if the transfer device is properly handled.
Insbesondere zeichnet sich die Erfindung dadurch aus, dass das erste und zweite Adapterteil die Flasche derart umgeben, dass sich eine geschlossene Umhüllende ergibt, so dass eine Aerosol-Dichtigkeit und Leckage-Sicherheit gegeben ist. Hierzu ist insbesondere das erste Adapterteil topfförmig ausgebildet und nimmt den Flaschenkörper auf. Das zweite Adapterteil, von dem das Überleitelement ausgeht, weist gleichfalls eine hauben- oder topfförmige Geometrie auf, die mit dem ersten Adapterteil verrasten kann. Zusätzlich kann von dem zweiten Adapterteil eine Dichtung ausgehen, um das erste und zweite Adapterteil gegenüber der Flasche abzudichten.In particular, the invention is characterized in that the first and second adapter parts surround the bottle in such a way that a closed envelope results, so that aerosol-tightness and leakage security is provided. For this purpose, in particular the first adapter part is cup-shaped and receives the bottle body. The second adapter part, from which the transition element extends, likewise has a hood-shaped or pot-shaped geometry that can latch with the first adapter part. In addition, a seal can extend from the second adapter part in order to seal the first and second adapter parts with respect to the bottle.
Erfindungsgemäß wird eine Transfervorrichtung zur Verfügung gestellt, die nach der Nutzung, also nach dem Durchstechen des Verschlusses nicht mehr von der vorwiegend als Vial bezeichneten Flasche nachstehend lösbar ist. Dabei kann vorgesehen sein, dass vor Benutzung der Transfervorrichtung ein ungewolltes Berühren der Spitze des Überleitelementes ausgeschlossen ist, so dass eine Verletzungsgefahr vermieden wird.According to the invention, a transfer device is made available which, after use, that is to say after the closure has been pierced, can no longer be detached from the bottle, which is mainly referred to as a vial below. It can be provided that, before the transfer device is used, unintentional touching of the tip of the transfer element is excluded, so that the risk of injury is avoided.
Zu dem Überleitelement ist anzumerken, dass es sich z. B. um eine Nadel, eine Kanüle, einen Spike oder eine sonstige Perforationseinrichtung handeln kann. Insoweit ist eine Beschränkung der Erfindung nicht gegeben. Vielmehr soll durch den Begriff Überleitelement jedes geeignete Element erfasst werden, das einen Mediumtransfer ermöglicht. Daher werden auch verschiedene Begriffe verwendet, insbesondere Punktionsnadel oder Kanüle, ohne dass hierdurch eine Einschränkung der erfindungsgemäßen Lehre erfolgt.It should be noted that the transition element is, for. B. can be a needle, a cannula, a spike or some other perforation device. So far is one There is no limitation of the invention. Rather, the term transfer element is intended to cover any suitable element that enables a medium transfer. Various terms are therefore also used, in particular puncture needle or cannula, without thereby restricting the teaching according to the invention.
Insbesondere zeichnet sich die Erfindung dadurch aus, dass das erste Adapterteil einen die Flasche umfangsseitig umgebenden eine Hohlzylindergeometrie mit flaschenverschlussseitig verlaufendem Stirnrand aufweisenden Mantelabschnitt - auch Mantelwandung genannt -, einen den Boden der Flasche zumindest abschnittsweise, vorzugsweise vollständig abdeckenden Bodenabschnitt sowie einen stirnrandseitig verlaufenden Halteabschnitt umfasst, von dem die Fixierelemente, die zungen- oder stegartig ausgebildet sein können, ausgehen, die in radialer Richtung des ersten Adapterteils schwenk- oder bieg- oder spreizbar sind und sich in Richtung der Längsachse des ersten Adapterteils erstrecken.In particular, the invention is characterized in that the first adapter part comprises a shell section surrounding the bottle circumferentially and having a hollow cylinder geometry with an end edge running on the bottle closure side - also called a shell wall - a bottom section that at least partially covers the bottom of the bottle, preferably completely, and a holding section running at the front edge, from which the fixing elements, which can be tongue-like or web-like, extend, which can be pivoted, bent or spread in the radial direction of the first adapter part and which extend in the direction of the longitudinal axis of the first adapter part.
Nach Einbringen des Vials in das erste Adapterteil können sich folglich die Fixierelemente am Übergang zwischen Flaschenhals und Flaschenkörper abstützen mit der Folge, dass das erste Adapterteil von dem Vial nicht mehr lösbar ist.After the vial has been introduced into the first adapter part, the fixing elements can consequently be supported at the transition between the bottle neck and the bottle body, with the result that the first adapter part can no longer be detached from the vial.
Bevorzugterweise ist vorgesehen, dass der Halteabschnitt ein im Stirnrandbereich des Mantelabschnitts verlaufender Ringabschnitt ist, der z. B. auf den Rand der Mantelwandung fixier- wie klemm- oder klebbar ist, der sich zumindest abschnittsweise entlang Innenseite des Mantelabschnitts erstreckt und über den Stirnrand sich erstreckende in axialer Richtung verformbare erste Vorsprünge aufweist. Durch Letztere wird die Möglichkeit eröffnet, dass das erste und zweite Adapterteil zueinander verriegelbar sind. Hierzu gehen nach einer Alternativen von der Außenseite der Mantelwandung zweite Vorsprünge aus, die in Führungen wie Kulissenschlitzen des zweiten Adapterteils bei verriegelten Adapterteilen verrast- bzw. verriegelbar sind. Aus den Führungen sind sodann die zweiten Vorsprünge bei üblicher Handhabung der Transfervorrichtung nicht entfernbar.It is preferably provided that the holding section is a ring section running in the end edge region of the casing section, which z. B. can be fixed as clamped or glued to the edge of the jacket wall, which extends at least in sections along the inside of the jacket section and has first projections which extend in the axial direction and extend over the end edge. The latter opens up the possibility that the first and second adapter parts can be locked to one another. For this purpose, according to an alternative, second projections proceed from the outside of the jacket wall, which can be locked or locked in guides such as link slots of the second adapter part when the adapter parts are locked. The second projections cannot then be removed from the guides during normal handling of the transfer device.
In Weiterbildung der Erfindung wird vorgeschlagen, dass das zweite Adapterteil einen äußeren hohlzylinderförmigen Abschnitt und eine quer zu dessen Längsachse verlaufende Begrenzungswandung aufweist, von der die Punktionsnadel - also das Überleitelement - ausgeht oder die von der Punktionsnadel durchsetzt ist.In a further development of the invention, it is proposed that the second adapter part have an outer hollow cylindrical section and a boundary wall running transversely to its longitudinal axis, from which the puncture needle - i.e. the transfer element - starts or which is penetrated by the puncture needle.
Jede Führung für jeweils einen Vorsprung weist einen vom freien Stirnrand des äußeren Zylinderabschnitts ausgehenden und in dessen Längsrichtung verlaufenden ersten Abschnitt auf, der in einen quer zu dem ersten Abschnitt begrenzungswandseitig verlaufenden zweiten Abschnitt übergeht, in dem der in diesem geführte zweite Vorsprung fixierbar wie verriegelbar ist, der radial von der Außenseite der Mantelwandung des Halteabschnitts des ersten Adapterteils absteht.Each guide for one projection has a first section starting from the free end edge of the outer cylinder section and running in its longitudinal direction, which merges into a second section running transversely to the first section, in which the second projection guided in this can be fixed and locked , which protrudes radially from the outside of the jacket wall of the holding section of the first adapter part.
Insbesondere ist vorgesehen, dass der zweite Abschnitt der Führung in axialer Richtung eine Querschnittsreduzierung aufweist, dessen axiale Erstreckung kleiner als axiale Erstreckung zwischen maximalem Abstand zwischen erstem und zweitem Vorsprung ist. Vor und hinter der axialen Querschnittsreduzierung sollte die axiale Erstreckung zwischen der Begrenzungswandung und abgewandtem Rand des zweiten Abschnitts der Führung zumindest gleich maximalem Abstand zwischen entfernt liegenden Abschnitten der ersten und zweiten Vorsprünge in axialer Richtung sein. Somit muss das zweite Adapterteil zunächst in axialer Richtung, also in Längsrichtung des Vials im ersten Abschnitt der Führung geführt, also in Richtung des ersten Adapterteils verstellt werden, um sodann durch Drehen die zweiten Vorsprünge in den von der Querschnittsreduzierung begrenzten Endabschnitt des zweiten Abschnitts der Führung einzubringen und dort zu fixieren, so dass eine Unlösbarkeit zwischen erstem und zweitem Adapterteil gegeben ist.In particular, it is provided that the second section of the guide has a cross-sectional reduction in the axial direction, the axial extent of which is smaller than the axial extent between the maximum distance between the first and second protrusions. Before and after the axial cross-sectional reduction, the axial extent between the boundary wall and the edge of the second section of the guide facing away from it should be at least equal to the maximum distance between distant sections of the first and second projections in the axial direction. Thus, the second adapter part must first be guided in the axial direction, i.e. in the longitudinal direction of the vial in the first section of the guide, i.e. adjusted in the direction of the first adapter part, in order to then rotate the second projections into the end section of the second section of the guide, which is limited by the cross-sectional reduction to be introduced and to be fixed there, so that there is no releasability between the first and second adapter part.
Dabei sollte zumindest die begrenzungswandabgewandte also flaschenseitig verlaufende, den inneren Rand bildende Begrenzung des zweiten Abschnitts der Führung in Richtung Begrenzungswandung zumindest abschnittsweise geneigt zur Längsachse des ersten Adapterteils und damit der Transfervorrichtung verlaufen und zu der Längsachse einen stumpfen Winkel einschließen.At least the delimitation of the second section of the guide facing away from the delimitation wall, i.e. on the bottle side, forming the inner edge in the direction of the delimitation wall should run at least partially inclined to the longitudinal axis of the first adapter part and thus the transfer device and enclose an obtuse angle to the longitudinal axis.
Um ein verkantungsfreies Führen des ersten Adapterteils zu dem zweiten Adapterteil zu ermöglichen, sieht ein Vorschlag der Erfindung vor, dass Innenquerschnitt des hohlzylinderförmigen Abschnitts des zweiten Adapterteils dem Außenquerschnitt des Mantelabschnitts des ersten Adapterteils entspricht.In order to enable the first adapter part to be guided to the second adapter part without tilting, a proposal of the invention provides that the inner cross section of the hollow cylindrical section of the second adapter part corresponds to the outer cross section of the jacket section of the first adapter part.
Eine sichere Führung wird auch durch die Überlappung der Adapterteile bzw. durch die zuvor erläuterten axiale verlaufenden Führungen wie Kulissenschlitze oder durch z. B. Langrippen gewährleistet, die von einem der Adapterteile oder einem mit diesem verbundenen Dichtungselement, insbesondere von dem zweiten Adapterteil ausgehen.Safe guidance is also ensured by the overlapping of the adapter parts or by the previously explained axially extending guides such as link slots or by z. B. ensures long ribs that extend from one of the adapter parts or a sealing element connected to this, in particular from the second adapter part.
In Weiterbildung der Erfindung ist vorgesehen, dass koaxial zum äußeren hohlzylinderförmigen Abschnitt des zweiten Adapterteils ein innerer hohlzylinderförmiger Abschnitt verläuft, wobei vorzugsweise das ein als erstes Schutzelement bezeichnetes Schutzelement insbesondere verschiebbar angeordnet ist, wobei bei fehlender Verbindung des ersten Adapterteils mit dem zweiten Adapterteil die Spitze der Punktionsnadel zwischen dem Schutzelement und der Begrenzungswandung des äußeren hohlzylinderförmigen Abschnitts verläuft. Durch diese Maßnahme ist sichergestellt, dass bei nicht mit dem ersten Adapterteil verbundenem zweiten Adapterteil eine Verletzung durch die Punktionsnadel vermieden wird.In a further development of the invention it is provided that an inner hollow cylindrical section runs coaxially to the outer hollow cylinder-shaped section of the second adapter part, with the one referred to as the first protective element preferably being arranged in a displaceable manner, with the tip of the when the first adapter part is not connected to the second adapter part Puncture needle runs between the protective element and the boundary wall of the outer hollow cylindrical section. This measure ensures that if the second adapter part is not connected to the first adapter part, injury from the puncture needle is avoided.
Um ein sicheres Fixieren zu ermöglichen, also eine Unlösbarkeit zwischen den Adapterteilen sicherzustellen, sieht die Erfindung des Weiteren vor, dass der zweite Vorsprung in Projektion der Außenseite des Mantelabschnitts eine Rechteck- oder Trapezgeometrie mit einer Ecke aufweist, die bei zueinander fixiertem ersten und zweiten Adapterteil mit einer die Querschnittsreduzierung des zweiten Abschnitts der Führung bewirkenden Stufe wechselwirkt, um ein Lösen zu verhindern.In order to enable secure fixation, i.e. to ensure non-detachability between the adapter parts, the invention further provides that the second projection in the projection of the outside of the jacket section has a rectangular or trapezoidal geometry with a corner, which when the first and second adapter parts are fixed to one another interacts with a cross-sectional reduction of the second portion of the guide causing step to prevent loosening.
Eine weitere Ausführungsform einer erfindungsgemäßen Transfervorrichtung, die nach Durchstechen des Verschlusses von dem Vial nicht mehr lösbar ist, sieht vor, dass das erste Adapterteil der Transfervorrichtung einen flaschenseitig verlaufenden ersten äußeren hohlzylinderförmigen Abschnitt und einen von diesem ausgehenden ersten inneren hohlzylinderförmigen Abschnitt kleineren Querschnitts aufweist, dass der erste äußere hohlzylinderförmige Abschnitt axial verlaufende die Fixierelemente bildende zungenförmige Abschnitte mit im jeweiligen freien Endbereich radial nach innen ragende Vorsprünge zum Ergreifen eines Abschnitts der Flasche, insbesondere deren wulstartigen Rands, und das zweite Adapterteil einen zweiten äußeren hohlzylinderförmigen Abschnitt aufweist, der entlang Außenseite des ersten äußeren hohlzylinderförmigen Abschnitts des ersten Adapterteils verschiebbar ist, dass bei von dem zweiten äußeren hohlzylinderförmigen Abschnitt umgebenem ersten äußeren hohlzylinderförmigen Abschnitt des ersten Adapterteils ein nach außen gerichtetes radiales Verstellen der zungenförmigen Abschnitte unterbunden oder im Wesentlichen unterbunden ist, und dass von dem zweiten äußeren hohlzylinderförmigen Abschnitt des zweiten Adapterteils ein dritter äußerer hohlzylinderförmiger Abschnitt kleineren Querschnitts ausgeht, innerhalb dessen ein zweiter innerer hohlzylinderförmiger Abschnitt als zweites Teil des zweiten Adapterteils verschiebbar ist, von dem die Punktionsnadel ausgeht.A further embodiment of a transfer device according to the invention, which is no longer detachable from the vial after the closure has been pierced, provides that the first adapter part of the transfer device has a first, outer hollow cylindrical section extending on the bottle side and a first, extending from this inner hollow cylindrical section of smaller cross-section, that the first outer hollow cylindrical section axially extending the fixing elements forming tongue-shaped sections with radially inward projections in the respective free end area for gripping a section of the bottle, in particular its bead-like edge, and the second adapter part a second outer hollow cylindrical Has portion which is displaceable along the outside of the first outer hollow cylindrical portion of the first adapter part, that with the first outer hollow cylindrical portion of the first adapter part surrounded by the second outer hollow cylindrical portion an outwardly directed radial adjustment of the tongue-shaped portions is prevented or substantially prevented, and that from the second outer hollow cylindrical section of the second adapter part a third outer hollow cylindrical section of smaller cross section starts, within which a second inner hollow cylindrical section can be displaced as a second part of the second adapter part, from which the puncture needle extends.
Erfindungsgemäß wird eine Transfervorrichtung vorgestellt, die aus dem ersten, eine Flasche bzw. dessen Hals fixierbaren ersten Adapterteil und einem zweiteiligen zweiten Adapterteil besteht, die axial zueinander und zu dem ersten Adapterteil verschiebbar sind. Dabei bewirkt das äußere Teil des zweiten Adapterteils, dass dann, wenn der hohlzylinderförmige Abschnitt größeren Querschnitts den ersten äußeren hohlzylinderförmigen Abschnitt des ersten Adapterteils über eine festgelegte axiale Länge abdeckt, dass die insbesondere den wulstartigen Rand der Flasche hintergreifenden zungenförmigen Abschnitte nicht mehr nach außen verstellbar sind mit der Folge, dass ein Lösen von der Flasche ausgeschlossen ist. Gleichzeitig verrasten die Adapterteile, um ein Zurückziehen des zweiten Adapterteils zu verhindern.According to the invention, a transfer device is presented which consists of the first adapter part, which can be fixed to a bottle or its neck, and a two-part second adapter part, which are axially displaceable to one another and to the first adapter part. The outer part of the second adapter part has the effect that when the hollow cylindrical section of larger cross section covers the first outer hollow cylindrical section of the first adapter part over a defined axial length, the tongue-shaped sections, in particular engaging behind the bead-like edge of the bottle, can no longer be adjusted outwards with the result that loosening from the bottle is impossible. At the same time, the adapter parts lock in place in order to prevent the second adapter part from being pulled back.
Insbesondere ist vorgesehen, dass das äußere Teil des zweiten Adapterteils mit dem ersten Adapterteil verrastet. Vorzugsweise wirkt ein von dem zweiten äußeren hohlzylinderförmigen Abschnitt des zweiten Adapterteils radial nach innen ragender Vorsprung wie Rippe mit einer Aussparung oder Stufe oder einer gleichwirkenden Geometrieveränderung des ersten hohlzylinderförmigen Abschnitts des ersten Adapterteils derart zusammen, dass ein axiales Verschieben des zweiten Adapterteils zu dem ersten Adapterteils entgegen der Penetrationsrichtung unterbunden ist.In particular, it is provided that the outer part of the second adapter part latches to the first adapter part. Preferably, a projection protruding radially inward from the second outer hollow cylindrical section of the second adapter part acts like a rib with a recess or step or an equivalent change in the geometry of the first hollow cylindrical section of the first Adapter part together in such a way that an axial displacement of the second adapter part to the first adapter part against the direction of penetration is prevented.
In Weiterbildung der Erfindung wird vorgeschlagen, dass eine axiale Verstellung des zweiten Adapterteils zu dem ersten Adapterteil über eine erste entfernbare Sicherung und des zweiten inneren Abschnitts zu dem dritten äußeren Abschnitt des zweiten Adapterteils über eine zweite entfernbare Sicherung unterbunden ist.In a further development of the invention, it is proposed that an axial adjustment of the second adapter part to the first adapter part via a first removable fuse and of the second inner section to the third outer section of the second adapter part is prevented via a second removable fuse.
Bei vorhandenen Sicherungen bildet folglich das erste und zweite Adapterteil eine - in axialer Richtung betrachtet - starre Einheit. Wird die erste Sicherung, nachdem die Transfervorrichtung auf ein Vial geschoben worden ist, entfernt, kann das zweite Adapterteil als Untereinheit in Penetrationsrichtung verschoben werden, wodurch das gewünschte Verrasten zwischen dem ersten und zweiten Adapterteil mit dem Ergebnis erfolgt, dass die zungenförmigen, die radial nach innen ragenden Vorsprünge aufweisenden Fixierelemente nicht mehr nach außen verstellbar sind, so dass ein Lösen von der Flasche ausgeschlossen ist.In the case of existing fuses, the first and second adapter parts consequently form a rigid unit - viewed in the axial direction. If the first fuse is removed after the transfer device has been pushed onto a vial, the second adapter part can be shifted as a sub-unit in the direction of penetration, whereby the desired locking between the first and second adapter part takes place with the result that the tongue-shaped, the radially after inwardly protruding projections having fixing elements are no longer adjustable to the outside, so that a detachment from the bottle is excluded.
Bei entfernter erster Sicherung und bleibender zweiten Sicherung ist jedoch die Penetrationsnadel nicht zu dem äußeren Teil des zweiten Adapterteils verstellbar. Ist die Transfervorrichtung durch Verstellen des zweiten Adapterteils, also nach Entfernen der ersten Sicherung an der Flasche fixiert, wird die zweite Sicherung entfernt, so dass der zweite innere Abschnitt zu dem den zweiten und dritten äußeren hohlzylinderförmigen Abschnitt aufweisenden äußeren Teil des zweiten Adapterteils axial in Richtung der Flasche verschiebbar ist, so dass die von dem inneren Teil des zweiten Adapterteils ausgehende Kanüle den Verschluss durchstechen kann.When the first fuse is removed and the second fuse remains, however, the penetration needle cannot be adjusted relative to the outer part of the second adapter part. If the transfer device is fixed to the bottle by adjusting the second adapter part, i.e. after removing the first securing device, the second securing device is removed so that the second inner section is axially in the direction of the outer part of the second adapter part, which has the second and third outer hollow cylindrical section of the bottle is displaceable so that the cannula extending from the inner part of the second adapter part can pierce the closure.
Um bei nicht mit einer Flasche verbundenen Transfervorrichtung eine Verletzungsgefahr durch die Penetrationsspitze auszuschließen, sieht eine Weiterbildung vor, dass von dem ersten inneren Abschnitt des ersten Adapterteils ein als zweites Schutzelement bezeichnetes Schutzelement ausgeht, zwischen dem und dem zweiten inneren Abschnitt des zweiten Adapterteils bei unbenutzter Transfervorrichtung die Spitze der Penetrationsnadel verläuft.In order to exclude the risk of injury from the penetration tip when the transfer device is not connected to a bottle, a further development provides that a protective element, referred to as a second protective element, extends from the first inner section of the first adapter part, between the and the second inner section of the second adapter part when the transfer device is not in use the tip of the penetration needle runs.
Die Adapterteile bzw. deren Abschnitte sollten geometrisch derart ausgebildet sein, dass beim axialen Verschieben des zweiten Adapterteils zu dem ersten Adapterteil der dritte äußere Abschnitt außenseitig und der zweite innere Abschnitt des zweiten Adapterteils innenseitig entlang des ersten inneren Abschnitts des ersten Adapterteils geführt sind.The adapter parts or their sections should be geometrically designed such that when the second adapter part is axially displaced to the first adapter part, the third outer section is guided on the outside and the second inner section of the second adapter part is guided along the first inner section of the first adapter part on the inside.
Insbesondere sollte die erste Sicherung eine Geometrie eines Ringabschnitts aufweisen, der bei unbenutzter Transfervorrichtung einen in dem dritten äußeren Abschnitt des zweiten Adapterteils verlaufenden Schlitz durchsetzt und in eine auf diesen ausgerichtete Aussparung wie Nut in der Außenwandung des ersten inneren Abschnitts des ersten Adapterteils eingreift.In particular, the first fuse should have a geometry of a ring section which, when the transfer device is not in use, penetrates a slot running in the third outer section of the second adapter part and engages in a recess such as a groove in the outer wall of the first inner section of the first adapter part.
Bevorzugterweise ist vorgesehen, dass der zweite innere Abschnitt des zweiten Adapterteils punktionsnadelspitzenseitig eine von der Punktionsnadel durchsetzte Bodenwandung und punktionsnadelspitzenabgewandt einen von dessen Umfangswandung, insbesondere von äußerem Stirnbereich des zweiten inneren Abschnitts des zweiten Adapterteils radial nach außen gerichteten, vorzugsweise umlaufenden Flanschabschnitt aufweist, dessen wirksame radiale Erstreckung zumindest gleich, vorzugsweise größer als Außenquerschnitt des dritten äußeren Abschnitts des zweiten Adapterteils ist. Dieser Flanschabschnitt dient als Handhabe, um das zweite Adapterteil zu dem ersten Adapterteil bzw. den inneren Abschnitt des zweiten Adapterteils zu dessen äußerem Abschnitt axial verstellen zu können.It is preferably provided that the second inner section of the second adapter part has, on the puncture needle tip side, a base wall penetrated by the puncture needle and, facing away from the puncture needle tips, a preferably encircling flange section directed radially outward from its peripheral wall, in particular from the outer end region of the second inner section of the second adapter part, whose effective radial Extension is at least the same, preferably greater than the outer cross section of the third outer section of the second adapter part. This flange section serves as a handle in order to be able to axially adjust the second adapter part relative to the first adapter part or the inner section of the second adapter part relative to its outer section.
Des Weiteren ist vorgesehen, dass die zweite Sicherung ebenfalls eine Geometrie eines zweiten Ringabschnitts aufweisen kann, der bei axialer Unverschiebbarkeit zwischen dem ersten und zweiten Adapterteil zwischen freiem Stirnrand des dritten äußeren Abschnitts und dem Flanschabschnitt des zweiten inneren Abschnitts des zweiten Adapterteils fixiert ist.Furthermore, it is provided that the second securing device can also have a geometry of a second ring section, which is fixed between the free end edge of the third outer section and the flange section of the second inner section of the second adapter part when axially immovable between the first and second adapter parts.
In Weiterbildung ist vorgesehen, dass das erste und/oder zweite Schutzelement, mittels dessen die Punktionsnadelspitze bei unbenutzter Transfervorrichtung gegen ein ungewolltes Berühren geschützt ist, ein Scheibenelement ist, wobei das erste, vorzugsweise sowohl das erste als auch das zweite Schutzelement, axial verschiebbar in dem ersten bzw. zweiten Adapterteil angeordnet sind.In a further development, it is provided that the first and / or second protective element, by means of which the puncture needle tip, when the transfer device is not in use, against a unwanted contact is protected, is a disk element, wherein the first, preferably both the first and the second protective element, are axially displaceable in the first and second adapter part.
Des Weiteren kann durch Hinterschneidungen oder Schnappverbindungen sichergestellt werden, dass dann, wenn das erste und zweite Adapterteil zusammengesetzt sind, diese bei ordnungsgemäßer Benutzung voneinander nicht lösbar sind, auch dann, wenn ein Fixieren auf einer Flasche noch nicht erfolgt ist. Durch diese Maßnahmen wird ein geschlossenes System gebildet. Eine Verletzung durch die Punktionsnadel ist ausgeschlossen.Furthermore, by means of undercuts or snap connections, it can be ensured that when the first and second adapter parts are put together, they cannot be detached from one another when used properly, even if they have not yet been fixed on a bottle. These measures create a closed system. Injury from the puncture needle is excluded.
Eine Weiterbildung der Erfindung sieht vor, dass bei mit dem zweiten äußeren hohlzylinderförmigen Abschnitt des zweiten Adapterteils in Nutzstellung der Transfervorrichtung verrastetem ersten äußeren hohlzylinderförmigen Abschnitt des ersten Adapterteils zwischen zweitem und drittem äußeren hohlzylinderförmigen Abschnitt des zweiten Adapterteils verlaufende Zwischenwandung auf zwischen dem ersten äußeren hohlzylinderförmigen Abschnitt und dem ersten inneren hohlzylinderförmigen Abschnitt des ersten Adapterteils verlaufende Zwischenwandung aufliegt.A further development of the invention provides that with the first outer hollow cylindrical section of the first adapter part latched to the second outer hollow cylindrical section of the second adapter part in the use position of the transfer device between the second and third outer hollow cylindrical section of the second adapter part, the intermediate wall extending between the first outer hollow cylindrical section and the first inner hollow cylindrical section of the first adapter part extending intermediate wall rests.
Um das zweite Adapterteil, nachdem das erste Adapterteil im erforderlichen Umfang die Flasche, d. h. insbesondere dessen wulstartigen vom Flaschenhals ausgehenden Rand umgibt, zum Verrasten des ersten Adapterteils axial verschieben zu können, verbleibt das zweite Sicherungselement zwischen dem dritten äußeren Abschnitt und dem zweiten inneren Abschnitt des zweiten Adapterteils.To the second adapter part after the first adapter part to the required extent the bottle, d. H. in particular surrounds its bead-like edge extending from the bottle neck, to be able to move axially for locking the first adapter part, the second securing element remains between the third outer section and the second inner section of the second adapter part.
In Weiterbildung der Erfindung ist vorgesehen, dass bei zwischen dem dritten äußeren Abschnitt und zweiten inneren Abschnitt des zweiten Adapterteils vorhandenem zweiten Sicherungselement der dritte äußere Abschnitt und der zweite innere Abschnitt derart verrastet sind, dass ein axiales Verstellen entgegen Penetrationsrichtung der Penetrationsnadel unterbunden ist.In a further development of the invention it is provided that, when the second securing element is present between the third outer section and the second inner section of the second adapter part, the third outer section and the second inner section are locked in such a way that axial adjustment against the penetration direction of the penetration needle is prevented.
Optional zeichnet sich die Erfindung dadurch aus, dass beim Verstellen des zweiten Teils in Penetrationsrichtung der Punktionsnadel das zweite Adapterteil mit dem ersten Adapterteil derart wechselwirkt, dass ein Verstellen des zweiten Adapterteils zu dem ersten Adapterteil entgegen der Penetrationsrichtung unterbunden ist.Optionally, the invention is characterized in that when the second part is adjusted in the penetration direction of the puncture needle, the second adapter part interacts with the first adapter part in such a way that adjustment of the second adapter part to the first adapter part against the penetration direction is prevented.
Dabei sind das erste und zweite Adapterteil derart ausgebildet, dass diese bei Umgeben der Flasche ein geschlossenes Behältnis bilden, durch das ein Ausdringen von Aerosol oder nach Durchstechen des Verschlusses ein Austreten von dem in der Flasche vorhandenen Medium nach außen ausgeschlossen ist, so dass eine Kontamination z. B. durch Einatmen, über die Haut, ggfs. oral, nicht erfolgen kann. Dabei kann das das Überleitelement aufweisende zweite Element eine Dichtung aufweisen, durch die das zweite Adapterteil gegenüber der Flasche, insbesondere sowohl gegenüber der Flasche als auch dem ersten Adapterteil abgedichtet ist.The first and second adapter parts are designed in such a way that when they surround the bottle, they form a closed container, through which an escape of aerosol or, after piercing the closure, an escape of the medium present in the bottle to the outside is excluded, so that contamination z. B. by inhalation, through the skin, possibly. Oral, can not be done. The second element having the transition element can have a seal by means of which the second adapter part is sealed off from the bottle, in particular from both the bottle and the first adapter part.
Mit anderen Worten zeichnet sich die Erfindung auch aus durch eine Transfervorrichtung zur Entnahme oder Übergabe eines Mediums aus einer oder in eine Flasche mit Flaschenhals, der über einen Verschluss verschließbar ist, umfassend ein an der Flasche positionierbares erstes Adapterteil und ein mit dem ersten Adapterteil wechselwirkendes in Längsrichtung der Flasche verschiebbares zweites Adapterteil mit einem Überleitelement zum Durchstehen des Verschlusses, wobei bei ineinandergeschobenem ersten und zweiten Adapterteil diese ein die Flasche umgebenes geschlossenes Behältnis bilden. Dabei ist vorgesehen, dass das zweite Adapterteil eine Dichtung aufweist, durch die eine Abdichtung des zweiten Adapterteils gegenüber dem ersten Adapterteil erfolgt. Eine Unlösbarkeit der Adapterteile ist gleichfalls gegeben.In other words, the invention is also characterized by a transfer device for removing or transferring a medium from or into a bottle with a bottle neck, which can be closed via a closure, comprising a first adapter part that can be positioned on the bottle and a first adapter part that interacts with the first adapter part A second adapter part which is displaceable in the longitudinal direction of the bottle and has a transition element for protruding through the closure, wherein when the first and second adapter parts are pushed into one another, they form a closed container surrounding the bottle. It is provided that the second adapter part has a seal by means of which the second adapter part is sealed off from the first adapter part. The adapter parts are also inseparable.
In Weiterbildung der Erfindung ist vorgesehen, dass die Unlösbarkeit der Adapterteile über das Eingreifen von Vorsprüngen in Aussparungen erreicht wird, die nur in Penetrationsrichtung des Überleitelements wie Kanüle gegeneinander zu verschieben sind und in umgekehrter Richtung nicht mehr getrennt werden können.In a further development of the invention it is provided that the insolubility of the adapter parts is achieved by the engagement of projections in recesses, which can only be displaced relative to one another in the direction of penetration of the transfer element such as cannula and can no longer be separated in the opposite direction.
Die Verrastung kann durch zungenartige Elemente erfolgen, die Rasthaken aufweisen, die ihrerseits mit korrespondierenden Elementen wechselwirken. Die zungenartigen Elemente können unterschiedliche Längen aufweisen.The latching can be done by tongue-like elements that have latching hooks, which in turn interact with corresponding elements. The tongue-like elements can have different lengths.
Die Erfindung umfasst auch Dichtelemente, die den Austritt von Flüssigkeiten, Stäuben, Aerosolen o.Ä. aus einem geschlossenen Raum unterbinden. Dabei können diese Dichtelemente die Adapterteile zueinander oder untereinander abdichten. Als mögliche Ausgestaltung sind Dichtungselemente möglich, die Aussparungen, Vertiefungen, Vorsprünge, die auch umlaufend und ringförmig sein können, oder ähnliches aufweisen, um den Raum gegen die Umgebung abzuschließen. Die Dichtelemente können zwischen den äußeren Teilen der Adapter liegen, zwischen den inneren oder den inneren und äußeren Teilen der Adapter. Die Dichtelemente können gegebenenfalls auch unmittelbar gegenüber der Flasche abdichten.The invention also includes sealing elements that prevent liquids, dusts, aerosols or the like from escaping from a closed space. These sealing elements can seal the adapter parts to one another or to one another. As a possible configuration, sealing elements are possible which have recesses, depressions, projections, which can also be circumferential and ring-shaped, or the like, in order to close off the space from the surroundings. The sealing elements can lie between the outer parts of the adapter, between the inner or the inner and outer parts of the adapter. The sealing elements can optionally also seal directly with respect to the bottle.
Ebenfalls können die Dichtelemente derart ausgestaltet sein, dass sich Führungsrinnen ausbilden, damit die Adapterteile ineinander oder Flaschen in die Adapterteile leichter verschoben werden können.The sealing elements can also be designed in such a way that guide channels are formed so that the adapter parts can be shifted into one another or bottles into the adapter parts more easily.
Weitere Ausgestaltungen ergeben sich aus den Ansprüchen.Further refinements result from the claims.
Durch die erfindungsgemäße Lehre ergibt sich u. a. der Vorteil, dass bereits beim Anstechen des Vials, also der Flasche, eine Aerosol-Dichtigkeit gegeben ist.The teaching according to the invention results, inter alia. the advantage that aerosol-tightness is already provided when the vial, i.e. the bottle, is pierced.
Auch ermöglicht die Erfindung, dass nach Durchstechen des Verschlusses eine zu einer Gefährdung führende Leckage vermieden wird.The invention also enables a leakage leading to a hazard to be avoided after the closure has been pierced.
Durch das Verbleiben des Adapters können am Vial oder um das Vial herum Aerosole, die durch den Trennvorgang entstehen, nicht auftreten. Auch ist eine Aerosol-Dichtigkeit während der Anwendung gegeben.The fact that the adapter remains in place prevents aerosols from occurring on the vial or around the vial, which result from the separation process. Aerosol-tightness is also ensured during use.
Ein weiterer hervorzuhebender Vorteil der Erfindung ist es, dass eine Verletzung nach der Benutzung der Transfervorrichtung durch das Überleitelement wie Nadel, Kanüle, Spike, Perforationseinrichtung ausgeschlossen wird.Another advantage of the invention to be emphasized is that an injury after the use of the transfer device by the transfer element such as needle, cannula, spike, perforation device is excluded.
Gegenstand der Erfindung ist auch ein Kit, bestehend aus einem Behältnis mit einem medizinischen Mittel, einem Beutel mit Lösungsmittel zum Lösen des medizinischen Mittels sowie einer Transfervorrichtung zum Mischen des Lösungsmittels mit dem medizinischen Mittel.The invention also relates to a kit consisting of a container with a medical agent, a bag with solvent for dissolving the medical agent and a transfer device for mixing the solvent with the medical agent.
Die Erfindung ist durch die Ansprüche definiert.The invention is defined by the claims.
Weitere Einzelheiten, Vorteile und Merkmale der Erfindung ergeben sich auch aus der nachfolgenden Beschreibung von der Zeichnung zu entnehmenden bevorzugten Ausführungsbeispielen.Further details, advantages and features of the invention also emerge from the following description of preferred exemplary embodiments, which can be taken from the drawing.
Es zeigen:
- Fig. 1
- eine Explosionsdarstellung einer ersten Ausführungsform einer Transfervorrichtung,
- Fig. 2
- ein erstes Adapterteil der Transfervorrichtung gemäß
Fig. 1 , - Fig. 3
- ein zweites Adapterteil der Transfervorrichtung gemäß
Fig. 1 , - Fig. 4a), 4b)
- die Transfervorrichtung gemäß
Fig. 1 in Draufsicht und im Schnitt entlang der Linie C-C, - Fig. 5a), 5b)
- die Transfervorrichtung gemäß
Fig. 1 in Draufsicht und im Schnitt entlang der Linie D-D, - Fig. 6a), 6b)
- die Transfervorrichtung gemäß
Fig. 1 in Draufsicht und im Schnitt entlang der Linie E-E, - Fig. 7a), 7b)
- die Transfervorrichtung gemäß
Fig. 1 in Draufsicht und im Schnitt entlang der Linie F-F, - Fig. 8
- eine Seitenansicht einer zweiten Ausführungsform einer Transfervorrichtung,
- Fig. 9
- die Transfervorrichtung gemäß
Fig. 8 in Draufsicht, - Fig. 10
- die Transfervorrichtung gemäß
Fig. 8 und 9 im Schnitt entlang der Linie A-A, - Fig. 11a), 11b)
- die Transfervorrichtung gemäß
Fig. 8 mit zugeordnetem Vial in Draufsicht und im Schnitt entlang der Linie B-B, - Fig. 12 a), 12b)
- die Transfervorrichtung gemäß
Fig. 8 in Draufsicht und im Schnitt entlang der Linie C-C, - Fig. 13a), 13b)
- die Transfervorrichtung gemäß
Fig. 8 in Draufsicht und im Schnitt entlang der Linie D-D, - Fig. 14a), 14b)
- die Transfervorrichtung gemäß
Fig. 8 in Draufsicht und im Schnitt entlang der Linie E-E, - Fig. 15a), 15b)
- die Transfervorrichtung gemäß
Fig. 8 in Draufsicht und entlang der Linie F-F, - Fig. 16a), 16b)
- die Transfervorrichtung gemäß
Fig. 8 in Draufsicht und im Schnitt entlang der Linie G-G, - Fig. 17a), 17b)
- die Transfervorrichtung gemäß
Fig. 8 in Draufsicht und im Schnitt entlang der Linie H-H, - Fig. 18
- eine Alternative zu der Ausführungsform der Transfervorrichtung gemäß der
Fig. 1 bis 7b ), dargestellt in Draufsicht, - Fig. 19
- eine Seitenansicht der Transfervorrichtung gemäß
Fig. 18 , - Fig. 20
- einen Schnitt entlang der Linie A-A in
Fig. 18 , - Fig. 20a, 20b
- eine Variante der Transfervorrichtung gemäß
Fig. 18 im Schnitt sowie ein Detail, - Fig. 21
- ein Detail der
Fig. 20 , - Fig. 22
- eine Explosionsdarstellung der Transfervorrichtung gemäß der
Fig. 18 bis 21 , - Fig. 23a), 23b)
- die Transfervorrichtung gemäß
Fig. 22 in Draufsicht und im Schnitt entlang der Linie B-B, - Fig. 24a), 24b)
- die Transfervorrichtung gemäß
Fig. 22 in Draufsicht und im Schnitt entlang der Linie C-C, - Fig. 25a), 25b)
- die Transfervorrichtung gemäß
Fig. 22 in Draufsicht und im Schnitt entlang der Linie D-D, - Fig. 26a), 26b)
- die Transfervorrichtung gemäß
Fig. 22 in Draufsicht und im Schnitt entlang der Linie E-E, - Fig. 27a), 27b)
- die Transfervorrichtung gemäß
Fig. 22 in Draufsicht und im Schnitt entlang der Linie F-F, - Fig. 28a), 28b)
- die Transfervorrichtung gemäß
Fig. 22 in Draufsicht und im Schnitt entlang der Linie G-G,
- Fig. 29
- eine weitere Ausführungsform einer Transfervorrichtung als Alternative zu der der
Fig. 18 bis 28b ), dargestellt in Draufsicht, - Fig. 30
- eine Seitenansicht der Transfervorrichtung gemäß
Fig. 29 , - Fig. 31
- einen Schnitt entlang der Linie A-A in
Fig. 29 , - Fig. 32
- ein Detail der
Fig. 31 , - Fig. 33a), 33b)
- die Transfervorrichtung gemäß
Fig. 29 in Draufsicht und im Schnitt entlang der Linie C-C,bis 32 - Fig. 34a), 34b)
- die Transfervorrichtung gemäß der
Fig. 29 in Draufsicht und im Schnitt entlang der Linie D-D,bis 32 - Fig. 35a), 35b)
- die Transfervorrichtung gemäß der
Fig. 29 in Draufsicht und im Schnitt entlang der Linie E-E,bis 32 - Fig. 36a) 36b)
- die Transfervorrichtung gemäß der
Fig. 29 in Draufsicht und im Schnitt entlang der Linie F-F,bis 32 - Fig. 37a), 37b)
- die Transfervorrichtung gemäß der
Fig. 29 in Draufsicht und im Schnitt entlang der Linie G-G,bis 32 - Fig. 38a), 38b)
- die Transfervorrichtung gemäß der
Fig. 29 in Draufsicht und im Schnitt entlang der Linie H-H undbis 32 - Fig. 39
- die Transfervorrichtung der
Fig. 29 in Explosionsdarstellung.bis 32
- Fig. 1
- an exploded view of a first embodiment of a transfer device,
- Fig. 2
- a first adapter part of the transfer device according to
Fig. 1 , - Fig. 3
- a second adapter part of the transfer device according to
Fig. 1 , - Fig. 4a), 4b)
- the transfer device according to
Fig. 1 in plan view and in section along the line CC, - Fig. 5a), 5b)
- the transfer device according to
Fig. 1 in plan view and in section along the line DD, - Fig. 6a), 6b)
- the transfer device according to
Fig. 1 in plan view and in section along the line EE, - Fig. 7a), 7b)
- the transfer device according to
Fig. 1 in plan view and in section along the line FF, - Fig. 8
- a side view of a second embodiment of a transfer device,
- Fig. 9
- the transfer device according to
Fig. 8 in plan view, - Fig. 10
- the transfer device according to
Figures 8 and 9 in section along the line AA, - Fig. 11a), 11b)
- the transfer device according to
Fig. 8 with assigned vial in plan view and in section along line BB, - Fig. 12 a), 12b)
- the transfer device according to
Fig. 8 in plan view and in section along the line CC, - Fig. 13a), 13b)
- the transfer device according to
Fig. 8 in plan view and in section along the line DD, - Fig. 14a), 14b)
- the transfer device according to
Fig. 8 in plan view and in section along the line EE, - Fig. 15a), 15b)
- the transfer device according to
Fig. 8 in plan view and along the line FF, - Fig. 16a), 16b)
- the transfer device according to
Fig. 8 in plan view and in section along the line GG, - Fig. 17a), 17b)
- the transfer device according to
Fig. 8 in plan view and in section along the line HH, - Fig. 18
- an alternative to the embodiment of the transfer device according to FIG
Figures 1 to 7b ), shown in plan view, - Fig. 19
- a side view of the transfer device according to
Fig. 18 , - Fig. 20
- a section along the line AA in
Fig. 18 , - Figures 20a, 20b
- a variant of the transfer device according to
Fig. 18 in section as well as a detail, - Fig. 21
- a detail of the
Fig. 20 , - Fig. 22
- an exploded view of the transfer device according to FIG
Figures 18 to 21 , - Fig. 23a), 23b)
- the transfer device according to
Fig. 22 in plan view and in section along the line BB, - Fig. 24a), 24b)
- the transfer device according to
Fig. 22 in plan view and in section along the line CC, - Fig. 25a), 25b)
- the transfer device according to
Fig. 22 in plan view and in section along the line DD, - Fig. 26a), 26b)
- the transfer device according to
Fig. 22 in plan view and in section along the line EE, - Fig. 27a), 27b)
- the transfer device according to
Fig. 22 in plan view and in section along the line FF, - Fig. 28a), 28b)
- the transfer device according to
Fig. 22 in plan view and in section along the line GG,
- Fig. 29
- a further embodiment of a transfer device as an alternative to that of
Figures 18 to 28b ), shown in plan view, - Fig. 30
- a side view of the transfer device according to
Fig. 29 , - Fig. 31
- a section along the line AA in
Fig. 29 , - Fig. 32
- a detail of the
Fig. 31 , - Fig. 33a), 33b)
- the transfer device according to
Figures 29 to 32 in plan view and in section along the line CC, - Fig. 34a), 34b)
- the transfer device according to the
Figures 29 to 32 in plan view and in section along the line DD, - Fig. 35a), 35b)
- the transfer device according to the
Figures 29 to 32 in plan view and in section along the line EE, - Fig. 36a) 36b)
- the transfer device according to the
Figures 29 to 32 in plan view and in section along the line FF, - Fig. 37a), 37b)
- the transfer device according to the
Figures 29 to 32 in plan view and in section along the line GG, - Fig. 38a), 38b)
- the transfer device according to the
Figures 29 to 32 in plan view and in section along the line HH and - Fig. 39
- the transfer device of the
Figures 29 to 32 in exploded view.
In den Figuren, in denen grundsätzlich gleiche Elemente mit gleichen Bezugszeichen versehen sind, sind Transfervorrichtungen dargestellt, mittels derer von einer Flasche bzw. einem Fläschchen, einem sogenannten Vial, Fluide wie trockene Substanzen oder Flüssigkeiten wie Wasser oder Lösungsmittel, die zu Infusions- oder Injektionszwecken vor ihrer Anwendung bzw. Verabreichung angemischt werden, übergeleitet werden. Ein Einsatz für die Instillation oder für Lösungsmittelbeutel ist gleichfalls möglich. Im Übrigen sind die Anwendungsfälle rein beispielhaft genannt. Entsprechende Transfervorrichtungen werden auch als Konnektoren oder Adapter bezeichnet. Um die Flasche mit einem anderen Behälter oder einem Infusionsgerät zu verbinden, wird eine entsprechende Transfervorrichtung benötigt, um mittels eines Überleitelements wie einer Punktionsnadel - wie Stahlkanüle - den Verschluss des Fläschchens zu perforieren, um sodann über die Transfervorrichtung das dem Fläschchen zu entnehmende Fluid z. B. einer Injektionsflasche, einem Infusionsbeutel, einem Lösungsmittelbeutel oder einer Spritze zuführen zu können.In the figures, in which basically the same elements are provided with the same reference numerals, transfer devices are shown by means of which from a bottle or a bottle, a so-called vial, fluids such as dry substances or liquids such as water or solvents that are mixed for infusion or injection purposes before their use or administration. It can also be used for instillation or for solvent bags. Incidentally, the application cases are given purely by way of example. Corresponding transfer devices 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 required in order to perforate the closure of the bottle by means of a transfer element such as a puncture needle - such as a steel cannula. B. an injection bottle, an infusion bag, a solvent bag or a syringe.
Die den Figuren zu entnehmenden Transfervorrichtungen weisen teleskopartig angeordnete und zueinander verstellbare Teile auf, die auch als erstes und zweites Adapterteil bezeichnet werden. Aus Gründen der Vereinfachung wird die Transfervorrichtung nachstehend als Konnektor und das mit diesem zu verbindende Fläschchen als Vial bezeichnet. Das erste Adapterteil wird auch als Vialhalter und das zweite Adapterteil als Kanülenhalter benannt.The transfer devices shown in the figures have parts which are arranged telescopically and can be adjusted relative to one another and are also referred to as the first and second adapter parts. For the sake of simplicity, the transfer device is hereinafter referred to as the connector and the vial to be connected to this is referred to as the vial. The first adapter part is also known as the vial holder and the second adapter part as the cannula holder.
Des Weiteren wird nachstehend das die Verbindung zum Inneren des Vials herstellende Überleitelement als Kanüle bezeichnet, ohne dass hierdurch eine Beschränkung auf Funktion und Gestaltung erfolgt.Furthermore, the transition element that establishes the connection to the interior of the vial is referred to below as a cannula, without this restricting the function and design.
Bezüglich der angegebenen Geometrien der Bauteile ist anzumerken, dass diese rein beispielhaft dahingehend zu verstehen sind, dass auch Abweichungen möglich sind, sofern die Grundprinzipien der Erfindung verwirklicht werden können. Im Übrigen sind die Figuren selbsterklärend. In diesen sind die die Erfindung prägenden Merkmale klar erkennbar.With regard to the specified geometries of the components, it should be noted that these are to be understood purely as examples to the effect that deviations are also possible, provided that the basic principles of the invention can be implemented. The figures are also self-explanatory. In these the features characterizing the invention are clearly recognizable.
Der Konnektor 10 gemäß der
Wie aus der Detaildarstellung der
Von dem im Inneren der Mantelwandung 16 verlaufenden Bereich des Ringelements 22 gehen steg- oder zungenförmige sich in axialer Richtung erstreckende auch als Fixierelemente bezeichnete Elemente aus, von denen einige mit den Bezugszeichen 28, 30 gekennzeichnet sind. Wie insbesondere die Explosionsdarstellung nach
Zu dem Vial 20 ist ergänzend anzumerken, dass der Flaschenhals 34 im Bereich seiner Öffnung einen umlaufenden Wulst 40 aufweist. Die Öffnung des Vials 20 wird durch einen Stopfen 42 verschlossen. Des Weiteren ist anzumerken, dass typischerweise nach Verschließen des Vials 20 mit dem Verschlussstopfen 42 eine Aluminium-Bördelkappe aufgebracht wird. Auf dieser kann sich eine Flipp-Off-Kappe aus Kunststoff befinden. Diese Flipp-Off-Kappe wird von der Aluminium-Bördelkappe abgezogen, so dass in der Mitte der Aluminium-Bördelkappe eine Öffnung entsteht, so dass der Verschlussstopfen 42 sichtbar ist.In addition to the
Das auch als Adapteroberteil oder Außenteil zu bezeichnende zweite Adapterteil 14 umfasst einen hohlzylinderförmigen Abschnitt 44, der vialabgewandt von einer quer zur Längsachse 32 verlaufenden auch als Begrenzungswandung bezeichnete Wandung 46 begrenzt wird, der mittig einen zylindrischen Fortsatz 48 aufweist, von dem einerseits eine als Kanüle bezeichnete Penetrationsnadel 50 ausgeht und auf den andererseits außenseitig ein Abbrechkonnektor 52 aufgesetzt ist. Das zweite Adapterteil 14 ist somit der Kanülenhalter.The
In der Innenwandung 54 des hohlzylinderförmigen Abschnitts 44 des zweiten Adapterteils 14 sind Führungen bildende Vertiefungen 56, 58 ausgebildet (
Koaxial zu dem äußeren hohlzylinderförmigen Abschnitt 44 verläuft ein innerer hohlzylinderförmiger Abschnitt 68, innerhalb der sich die Kanüle 50 erstreckt, jedoch über dessen Stirnrand 70 nicht vorsteht, wie sich insbesondere aus den
Es besteht auch die Möglichkeit, dass z. B. anstelle des scheibenförmigen Schutzelementes 72 vom Stirnrand 70 des inneren hohlzylinderförmigen Abschnitts 68 z. B. eine Membran ausgeht, die beim Zusammensetzen der Adapterteile 12, 14 bzw. dem axialen Verschieben des zweiten Adapterteils 14 in Richtung des Vials 20 und damit des ersten Adapterteils 12 zerstört wird.There is also the possibility that z. B. instead of the disk-shaped
Wie die zeichnerische Darstellung gemäß
Um eine axiale Führung zwischen den Adapterteilen 12, 14 beim Zusammenschieben dieser zu unterstützen, können über der Mantelwandung 16 als Führungsschienen dienende in Längsrichtung verlaufende Rippen 17, 19 dienen.In order to support an axial guidance between the
Das Konnektieren der Kanüle 50 mit dem Inneren des Vials 20 wird selbsterklärend aus den
In
Die Verriegelung ist dabei so ausgeführt, dass diese nur mit einem zusätzlichen Werkzeug bzw. mit mindestens zum Beispiel 300 N Abzugskraft gelöst werden kann. Nachdem der Anschluss mit dem Vial 20 sichergestellt ist, kann der Abbrechkonnektor 52 zerstört werden und die Mischprozedur zwischen dem in dem Vial 20 vorhandenen Medikament und einer Flüssigkeit erfolgen, die sich in einem zuvor mit dem Abbrechkonnektor 52 verbundenen Beutel befindet. Grundsätzlich ist auch ein Luer-Lock-Anschluss o. Ä. möglich. Am Abbrechkonnektor oder dergleichen wie Luer-Lock-Anschluss kann sich auch eine Spritze, Flasche oder ähnliches Behältnis befinden. Entsprechendes gilt für sämtliche Ausführungsformen.The lock is designed in such a way that it can only be released with an additional tool or with at least 300 N pull-off force, for example. After the connection with the
Den
Das erste oder innere Adapterteil 112 umfasst einen bei ordnungsgemäßer Benutzung den Wulst 40 des Vials 20 umgebenden ersten äußeren hohlzylinderförmigen Abschnitt 116 und einen inneren hohlzylinderförmigen Abschnitt 118, der einen kleineren Durchmesser als der äußere hohlzylinderförmige Abschnitt 116 aufweist. Zwischen den hohlzylinderförmigen Abschnitten 116, 118 verläuft eine quer, insbesondere senkrecht zur Längsachse 32 des Konnektors 100 und damit in mit dem Vial 20 verbundenen Zustand zur Längsachse des Vials 20 verlaufende Zwischenwandung 120.The first or
Der äußere hohlzylinderförmige Abschnitt 116 weist durch axial verlaufende Schlitze 122 getrennte und im erforderlichen Umfang federnde zungenförmige Abschnitte auf, von denen zwei beispielhaft mit den Bezugszeichen 124, 126 gekennzeichnet sind. Die zungenförmigen Abschnitte 124, 126 weisen endseitig nach innen ragende Vorsprünge (siehe Vorsprung 128) auf, die den wulstartigen Rand 40 des Vialhalses hinterfassen, wenn das erste Adapterteil 112 ordnungsgemäß mit dem Vial 20 verbunden ist, wie nachstehend anhand der Figuren erkennbar ist.The outer hollow
Das zweite oder äußere Adapterteil 114 besteht aus zwei teleskopartig zueinander verstellbaren Teilen, und zwar aus einem äußeren Teil 130 und einem inneren Teil 132, von dem die Punktionsnadel 50 ausgeht. Das äußere Teil 130 umfasst einen als zweiten äußeren hohlzylinderförmigen Abschnitt bezeichneten Abschnitt 134 und als dritten äußeren hohlzylinderförmigen Abschnitts bezeichneten Abschnitt 136, die voneinander abweichende Durchmesser aufweisen. Dabei ist der dritte äußere hohlzylinderförmige Abschnitt 136 querschnittsmäßig kleiner als der zweite äußere hohlzylinderförmige Abschnitt 134, dessen Innendurchmesser an den Außendurchmesser des ersten äußeren hohlzylinderförmigen Abschnitts 116 des ersten Adapterteils 112 angepasst ist, wodurch eine axiale Führung ermöglicht wird. Des Weiteren ist der Innendurchmesser des dritten äußeren hohlzylinderförmigen Abschnitts 136 an den Außendurchmesser des ersten inneren hohlzylinderförmigen Abschnitts 118 des ersten Adapterteils 112 angepasst, wodurch gleichfalls eine axiale Führung erfolgt.The second or
Zum Aufsetzen des Konnektors 100 auf das Vial 20 sind das erste und zweite Adapterteil 112, 114 über eine vorzugweise die Geometrie eines Ringabschnitts aufweisende erste Sicherung 138 gegen ein axiales Verstellen zueinander gesichert. Die Sicherung 138 verläuft entlang einer zwischen dem zweiten und dritten hohlzylinderförmigen Abschnitts 134, 136 verlaufenden und sich parallel zu der Zwischenwandung 120 erstreckenden weiteren Zwischenwandung 140 und durchsetzt einen Schlitz in dem dritten äußeren hohlzylinderförmigen Abschnitt 136 und erstreckt sich teilweise in einer auf den Schlitz ausgerichteten Aussparung oder Nut in dem ersten inneren hohlzylinderförmigen Abschnitt 118 des ersten Adapterteils 112. Des Weiteren verläuft zwischen Stirnrand 142 des dritten äußeren Zylinderabschnitts 136 und einer von dem inneren oder zweiten Teil 132 des zweiten Adapterteils 112 ausgehenden flanschartigen Erweiterung eine zweite Sicherung 146.To place the
Das innere Teil 132 des zweiten Adapterteils 114 weist eine Hohlzylinderform auf, deren Außendurchmesser an den Innendurchmesser des ersten inneren hohlzylinderförmigen Abschnitts 118 des ersten Adapterteils 112 angepasst ist, wodurch eine axiale Führung ermöglicht wird. Des Weiteren ist das zweite Teil 132 des zweiten Adapterteils 114 gegenüber dem ersten inneren hohlzylinderförmigen Abschnitts 118 über ineinandergreifende Abschnitte, insbesondere eine vorzugsweise umlaufende Rippe 133 gesichert, die über der Umfangswandung des eine Hohlzylinderform aufweisenden inneren oder zweiten Teils 132 des zweiten Adapterteils 114 vorsteht und in eine entsprechend angepasste Aussparung 153 in der Innenseite des ersten inneren hohlzylinderförmigen Abschnitts 118 des ersten Adapterteils 112 eingreift.The
Des Weiteren ergibt sich aus der Zeichnung, dass von der Innenseite des zweiten äußeren hohlzylinderförmigen Abschnitts 134 des zweiten Adapterteils 114 ein Vorsprung wie Klemmrippe 147 abragt, die in eine angepasste Ausnehmung 148 des ersten äußeren hohlzylinderförmigen Abschnitts 116 des ersten Adapterteils 112 eingreift derart, dass ein Lösen der Adapterteile 112, 114 entgegen der Penetrationsrichtung nicht möglich ist. Somit findet sich vor Aufsetzen des Konnektors 100 auf das Vial 20 eine Einheit vor, die aus dem ersten und zweiten Adapterteil 112, 114 besteht.The drawing also shows that a projection such as a clamping
Damit ein Nutzer mit der Spitze 74 der Kanüle 50 nicht in Berührung gelangen kann, kann nach einer nicht zwingenden Ausgestaltung des Weiteren entsprechend dem Ausführungsbeispiel der
Anhand der
In
Anschließend wird die sich entlang der Zwischenwandung 140 erstreckende und das erste und zweite Adapterteil 112, 114 gegen ein axiales Verstellen sicherende erste Sicherung 138 entfernt (
In der
Der zweite äußere hohlzylinderförmige Abschnitt 134 wirkt somit endseitig als Klemmring für den auch als Glocke zu bezeichnenden ersten äußeren hohlzylinderförmigen Abschnitt 116 des ersten Adapterteils 112, wodurch ein nach außen gerichtetes radiales Verstellen der zungenförmigen Elemente 124, 126 verhindert wird. Dadurch entsteht ein geschlossener Raum vor dem Durchstechen des Stopfens, so dass keine Aerosole, die durch die Öffnung des Vials entstehen, nach außen dringen.The second outer hollow
Die hierdurch gegebene Verriegelung wird dabei so ausgeführt, dass diese nur mit einem zusätzlichen Werkzeug bzw. Abzugskräfte von z. B. 300 N gelöst werden kann. Somit ist sichergestellt, dass der Konnektor 100 auch nach der Benutzung mit dem Vial 20 verbunden bleibt.The resulting locking is designed so that this can only be done with an additional tool or pulling forces of z. B. 300 N can be solved. This ensures that the
Sodann wird die zweite Sicherung 146 entfernt, so dass das die Kanüle 50 aufweisende innere Teil 132 des zweiten Adapterteils 114 durch axiale Krafteinwirkung auf die flanschartige Handhabe 144 in Penetrationsrichtung verstellt werden kann, um den Stopfen 42 zu penetrieren, wie ein Vergleich der
Nachdem das zweite Adapterteil 114 ordnungsgemäß fixiert ist, kann sodann der Abbrechkonnektor 52, auf den zuvor z. B. ein Beutel aufgebracht ist, zerstört werden, um die gewünschte Mischprozedur durchzuführen.After the
Den
Bei der Transfervorrichtung bzw. dem Konnektor 200 erfolgt eine Unlösbarkeit der Adapterteile durch Verrasten eines äußeren oder zweiten Adapterteils 214 mit dem das Vial 20 umgebenden ersten Adapterteils 212. Dabei ergibt sich der Vorteil, dass bei zusammengesetzten Adapterteilen 212, 214 diese einen geschlossenen Raum umgeben, in dem sich der durchstochene Verschlusstopfen 42 des Vials 20 befindet.In the case of the transfer device or the
Das erste Adapterteil 212 weist eine Topfgeometrie mit einer Umfangswandung 216 und einer Bodenwandung 218 auf, um das Vial 20 aufzunehmen. Gleichfalls ist im offenen Randbereich der Umfangswandung 216 ein Ringelement 222 vorgesehen, von dem steg- oder zungenförmige sich in axialer Richtung erstreckende Elemente ausgehen, die beispielhaft mit dem Bezugszeichen 228 und 230 gekennzeichnet sind. Wie insbesondere die
Von dem Ringelement 222, das mit dem Stirnrand des topfförmigen ersten Adapterteils 212 verbunden wie verklebt oder verschweißt ist, gehen des Weiteren nach innen ragende weitere zungenförmige Elemente 223, 231 aus, die entsprechend der Darstellung gemäß beispielhaft der
Das erste Adapterteil 212 weist umfangsseitig von Erhebungen begrenzte Rastvertiefungen auf, wie die Schnittdarstellung gemäß
Die axial verlaufenden zungenartigen Elemente 314, 316, 318, 320 mit den an ihren Enden nach innen gerichteten Vorsprüngen 322, 324 gehen von einem Ringelement 326 aus, das im Öffnungsbereich des zweiten Adapterteils 214 fixiert wie angeschweißt ist. In diesem Bereich weist das zweite Adapterteil 214 eine glockenförmige Geometrie auf, wie die Schnittdarstellung insbesondere gemäß
Des Weiteren ist die Innenwandung des zylindrischen Abschnitts des zweiten Adapterteils 214 mit einer Dichtung 332 ausgekleidet, die bei zusammengesetzten Adapterteilen 212, 214 dichtend an der Mantelwandung 216 des ersten Adapterteils 212 anliegt. Somit ergibt sich ein geschlossener Raum. Ist die Bodenwandung 218 des ersten Adapterteils 212 gleichfalls geschlossen, so ist das Vial 20 vollumfänglich gegenüber der Umgebung verschlossen. Dies ist die bevorzugte Ausgestaltung.Furthermore, the inner wall of the cylindrical section of the
Aus der
Wie bei dem Ausführungsbeispiel der
Des Weiteren geht von der Mantelwandung 216 ein vorzugsweise als umlaufender Ring oder Steg 217 ausgebildeter Anschlag aus, erstreckt sich folglich radial von der Umfangswandung. An dem Anschlag liegt der freie äußere Rand des zweiten Adapterteils 214 dann an, wenn die Adapterteile 212, 214 ordnungsgemäß zusammengefügt und somit die Kanüle 50 im erforderlichen Umfang in das Vial 20 eingedrungen ist.Furthermore, a stop, preferably designed as a circumferential ring or
In den
Die
Selbstverständlich ist ein Anschlag nicht zwingendes Merkmal. Vielmehr kann auch eine optische Anzeige wie eine Farbmarkierung dazu dienen, um dem Benutzer erkennbar zu machen, dass die Adapterteile 212, 214 in einem Umfang ineinander geschoben sind, dass der Stopfen 42 von der Kanüle 50 im erforderlichen Umfang durchstochen ist.Of course, a stop is not a mandatory feature. Rather, an optical display such as a color marking can also serve to make the user recognizable that the
Nach ordnungsgemäßem Zusammenschieben der Adapterteile 212, 214 kann sodann der von der Bodenwandung 245 des zweiten Adapterteils 214 ausgehende Abbrechkonnektor 52 entfernt werden.After the
Bezüglich der Rastaussparungen oder -vertiefungen 310, 312 und der Rastvorsprünge 322, 324 ist anzumerken, dass nach einer Alternativen eine Verbindung zwischen den Adapterteilen 212, 214 auch dadurch möglich ist, dass die Rastaussparungen 310, 312 Abschnitte eines Gewindes ist, in die die Vorsprünge 322, 324 eingreifen, so dass das erste Adapterteil 212 mit dem zweiten Adapterteil 214 in Art einer Schraubverbindung zusammengefügt wird. Eine Unlösbarkeit ist jedoch gleichfalls gegeben, da im Endzustand zumindest der eine von dem inneren zylindrischen Abschnitt 268 nach innen abragende Vorsprung 270 den wulstartigen Rand 40 des Vials 20 hintergreift. Selbstverständlich können auch mehrere Vorsprünge oder ein umlaufender Vorsprung vorgesehen sein.With regard to the locking recesses or
Den
Eine erfindungsgemäße Ausführungsform einer als Konnektor zu bezeichnenden Transfervorrichtung ist den
Dem Grunde nach unlösbar bedeutet, dass ein Lösen ohne Werkzeuge bzw. beim Einwirken einer Abzugskraft von weniger als 300 N nicht möglich ist.Basically unsolvable means that loosening without tools or with the action of a pull-off force of less than 300 N is not possible.
Das erste Adapterteil 412 weist eine Topfgeometrie mit einer Umfangswandung 216 und einer Bodenwandung 218 auf, um das Vial 20 aufzunehmen. Von der auch als Mantelwandung bezeichneten Umfangswandung 216 gehen von Erhebungen begrenzte Rastvertiefungen aus, von denen zwei beispielhaft mit dem Bezugszeichen 310 und 312 gekennzeichnet sind. Die die Rastvertiefungen 310, 312 begrenzenden Vorsprünge weisen eine zahnförmige Geometrie derart auf, dass deren in Bezug auf das zweite Adapterteil 414 einschubseitig verlaufenden Flanken, d. h. die in den zeichnerischen Darstellungen jeweils oberen Begrenzungen, rampenförmig verlaufen. Hierdurch ist ein problemloses Aufschieben des zweiten Adapterteils 414 auf das erste Adapterteil 412 bzw. das Hineinschieben des ersten Adapterteils 412 in das zweite Adapterteil 414 möglich, wie nachstehend erläutert wird. Die Struktur der Rastvertiefungen 310, 312 und die diese begrenzenden Vorsprünge sind in der
Damit bei zusammengesetztem ersten und zweiten Adapterteil 412, 414 ein Lösen, d. h. ein Auseinanderziehen entgegen der Penetrationsrichtung der Kanüle 50 nicht mehr möglich ist, wirken mit den Rastvertiefungen 310, 312 radial nach innen ragende Vorsprünge 423, 425 von in axialer Richtung des zweiten Adapterteils 414 verlaufenden zungenförmigen Elementen, von denen einige beispielhaft mit den Bezugszeichen 416, 418, 420, 424 gekennzeichnet sind. Die zungenförmigen Elemente 416, 418, 420, 424 die mit ihren radial nach innen ragenden Vorsprüngen 423, 425 Rasthaken bilden, gehen von einem Ringelement 430 aus, das mit dem zweiten oder äußeren Adapterteil 414 insbesondere durch Schweißen oder Kleben stoffschlüssig verbunden ist. Andere Befestigungsarten sind gleichfalls möglich.So that when the first and
Das Ringelement 430 wird dabei im Innenbereich vorzugsweise einer glockenartigen Erweiterung 432 des zweiten Adapterteils 414 fixiert, wie insbesondere die
Um das erste Adapterteil 412 gegenüber dem zweiten Adapterteil 414 beim Zusammenstecken abzudichten, geht innenseitig von dem zweiten Adapterteil 414 eine Dichtung 436 aus, die aus einem in Längsrichtung des Adapterteils 414 verlaufenden inneren Abschnitt 438 und einem parallel hierzu und zu diesem einen Spalt bildenden äußeren Abschnitt 446 besteht. Die Dichtung 436 weist im Schnitt die Geometrie eines ungleichschenkligen U's auf, dessen kürzerer Schenkel außenseitig verläuft. In dem Spalt erstreckt sich ein Randabschnitt 440 eines koaxial zur Umfangswandung 442 des zweiten Adapterteils 414 verlaufenden inneren hohlzylinderförmigen Abschnitt 444, wie gleichfalls aus der
Wie der
Durch das Zusammenwirken der Rastvorsprünge 423, 425 der zungenförmigen Rastelemente 416, 418, 420, 424 mit den Rastvertiefungen 310, 312 ist aufgrund deren Geometrie sichergestellt, dass nach Verhaken der Rastvorsprünge 423, 425 in eine der Vertiefungen 310, 312 ein Auseinanderziehen der Adapterteile 412, 414 nicht mehr möglich ist, vielmehr vor Penetration des Stopfens 42 ausschließlich ein Ineinanderschieben in Penetrationsrichtung zugelassen wird. Dadurch entsteht ein geschlossener Raum vor dem Durchstechen des Stopfens, so dass keine Aerosole, die durch die Öffnung des Vials entstehen, nach außen dringen.The interaction of the locking
Das Penetrieren erfolgt durch weiteres Zusammenschieben in einem Umfang, dass die Kanüle 50 den Stopfen 42 durchsetzt und dabei die Kanüle 50 den Stopfen 42 vollständig durchsticht. Dabei ist ein Ineinanderschieben der Adapterteile 412, 414 solange möglich, bis der untere Rand des zweiten Adapterteils 414 bzw. das in diesem Bereich verlaufende Ringelement 430 an einem radial umlaufenden Steg 217 zum Anliegen kommt, der von der Umfangswandung 216 des ersten Adapterteils 412 abragt, wie dies auch im Zusammenhang mit dem Ausführungsbeispiel der
Das Zusammenwirken des ersten und zweiten Adapterteils 412, 414, bis dass die Kanüle 50 den Verschlussstopfen 42 vollständig penetriert hat, ergibt sich aus den
So wird in
Aus der
Aus den weiteren Figuren ergibt sich das weitere Ineinanderschieben der Adapterteile 412, 414, wobei in der
Auf eine weitere hervorzuhebende Ausgestaltung der den
Claims (11)
- A transfer device (400) for the withdrawal or delivery of a medium out of or into a bottle (20) with a neck (34), that is sealable by a closure (42), comprising- an inner first adapter component (412) that can be positioned on the bottle, and- a second adapter component (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,characterized in that
whereby after moving the second adapter component (414) along the first adapter component (412) in the direction of the closure (42) and locking of the second adapter component, the first adapter component is secured in position non-detachably at the bottle (20) or around the bottle, and in that the second adapter component (414) possesses a hood- or cup-shaped geometry with a cylindrical circumferential wall (442) and, extending coaxial to and surrounding by the latter, an inner hollow-cylindrical section (444), from which originates a sealing element (436) which, when the first and the second adapter components (412, 414) have been assembled, seals the second adapter component against the first adapter component. - The transfer device according to claim 1,
characterized in that
the sealing element (436) possesses a U-shaped geometry having non-isosceles legs in section, with an inner and an outer leg, in between which extends in sections the inner hollow-cylindrical section (444). - The transfer device according to claim 1 or 2,
characterized in that
the second adapter component (414), in its position when surrounding the first adapter component (412), is sealed against the first adapter component by the sealing element (436) embodied as an insert. - The transfer device of at least one of the preceding claims,
characterized in that
the cylindrical circumferential wall (442) comprises first latching elements (416, 418, 420, 423, 424, 425) or the latter originate from the second adapter component or an element connected to the latter, and in that the first latching elements interact with second latching elements (310, 312) of the first adapter component (412), extending on the casing wall side, in such a manner that an adjustment of the second adapter component relative to the first adapter component against the penetration direction of the puncture needle (50) is prevented. - The transfer device of at least one of the preceding claims,
characterized in that
from the second adapter component (414) originates at least one first latching element (418, 420, 424), which preferably is embodied as an axially extending bendable tongue element with a latching projection (423, 425) at its end side, with the latching projection extending in the direction of the longitudinal axis of the second adapter component (414) or of the transfer device (400), and preferably engaging in latching depressions (310, 312), bordered by tooth-like projections, of the first adapter component (412). - The transfer device of at least claim 5,
characterized in that
the at least one tongue element (416, 418, 420, 424) originates from an annular element (430), as the element, that is joined, such as welded, to the outer hollow-cylindrical section (442) of the second adapter component (414). - The transfer device of at least one of the preceding claims,
characterized in that
from the casing wall (216) of the first adapter component (412) protrudes a limit stop, such as a circumferential annular projection (217), with which, when the first and the second adapter components (412, 414) are properly connected, the latter is in contact with. - The transfer device of at least one of the preceding claims,
characterized in that
when the transfer device (400) is secured in position at or around the bottle (20), the first and the second adapter components (412, 414) form a surrounding sealed envelope that surrounds the bottle at least in the area of the closure element (42). - The transfer device of at least one of the preceding claims,
characterized in that
when the first and the second adapter components (412, 414) have been at least partially pushed into each other, they form a sealed container that surrounds the bottle (20). - The transfer device of at least one of the preceding claims,
characterized in that
during an adjustment of the second adapter component (414) in the penetration direction of the puncture needle (50), the first adapter component (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. - A Kit, consisting of a container with a medical agent, a bag with a dissolving agent for dissolving the medical agent, as well as a transfer device, of at least one of the preceding claims, for mixing the dissolving agent with the medical agent.
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PL15712326T PL3122310T3 (en) | 2014-03-27 | 2015-03-20 | Transfer device for media, comprising a non-releasably lockable adapter |
EP21176118.4A EP3895680A1 (en) | 2014-03-27 | 2015-03-20 | Transfer device |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102014104281.6A DE102014104281B3 (en) | 2014-03-27 | 2014-03-27 | transfer device |
PCT/EP2015/055922 WO2015144581A2 (en) | 2014-03-27 | 2015-03-20 | Transfer device |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP21176118.4A Division-Into EP3895680A1 (en) | 2014-03-27 | 2015-03-20 | Transfer device |
EP21176118.4A Division EP3895680A1 (en) | 2014-03-27 | 2015-03-20 | Transfer device |
Publications (2)
Publication Number | Publication Date |
---|---|
EP3122310A2 EP3122310A2 (en) | 2017-02-01 |
EP3122310B1 true EP3122310B1 (en) | 2021-08-25 |
Family
ID=52807785
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP15712326.6A Active EP3122310B1 (en) | 2014-03-27 | 2015-03-20 | Transfer device for media, comprising a non-releasably lockable adapter |
EP21176118.4A Pending EP3895680A1 (en) | 2014-03-27 | 2015-03-20 | Transfer device |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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EP21176118.4A Pending EP3895680A1 (en) | 2014-03-27 | 2015-03-20 | Transfer device |
Country Status (16)
Country | Link |
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US (2) | US10716736B2 (en) |
EP (2) | EP3122310B1 (en) |
JP (3) | JP7046601B2 (en) |
KR (4) | KR102115719B1 (en) |
AU (1) | AU2015238584B2 (en) |
CA (1) | CA2948042C (en) |
DE (1) | DE102014104281B3 (en) |
DK (1) | DK3122310T3 (en) |
EA (1) | EA033927B1 (en) |
ES (1) | ES2898630T3 (en) |
IL (4) | IL282376B (en) |
LT (1) | LT3122310T (en) |
PL (1) | PL3122310T3 (en) |
PT (1) | PT3122310T (en) |
UA (1) | UA117960C2 (en) |
WO (1) | WO2015144581A2 (en) |
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KR102481494B1 (en) | 2011-12-22 | 2022-12-26 | 아이씨유 메디칼 인코퍼레이티드 | A medical fluid transfer system, a fluid transfer method, an electronic medical fluid transfer system, and a method of using an electronic medical fluid transfer system |
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JP6710758B2 (en) | 2015-12-04 | 2020-06-17 | アイシーユー・メディカル・インコーポレーテッド | Electronic medical fluid transfer device for transferring medical fluid |
USD851745S1 (en) | 2016-07-19 | 2019-06-18 | Icu Medical, Inc. | Medical fluid transfer system |
EP3487468A4 (en) | 2016-07-25 | 2020-03-25 | ICU Medical, Inc. | Systems, methods, and components for trapping air bubbles in medical fluid transfer modules and systems |
WO2018039065A1 (en) | 2016-08-22 | 2018-03-01 | Eli Lilly And Company | Secured medication transfer system |
WO2018064206A1 (en) * | 2016-09-30 | 2018-04-05 | Icu Medical, Inc. | Pressure-regulating vial access devices and methods |
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