FLUID TRANSFER SYSTEM AND COMPONENTS THEREFOR

Abstract

The invention relates to a fluid transfer system (1) for transferring medical substances or drugs. It further relates to components and parts of such a transfer system (1), in particular its connecting components (2, 6) and the parts equipped with such connecting components (2, 6), such as syringes (4), containers (vials) (8) or application systems. According to the invention, a screw connection of the connecting components (2, 6) to each other is provided with regard to a particularly good dosability of the applied holding forces. In addition, a needle cap (2) made of comparatively soft, elastic material is provided as a seal and sealing closure for the hollow needles (40, 42) provided as actual transfer channels in the connection component (2).

Claims

1. A connection component for a medical syringe with a needle system comprising a number of hollow needles arranged in, a tubular connection piece, with an elastic needle cap fastened inside the tubular connection piece and sealingly surrounding the distal tip(s) of each hollow needle of the needle system in an unloaded state, and with a flange jacket which surrounds the tubular connection piece and can rotate about the tubular connection piece and which is provided with a thread for connection to a further bonding component.

2. The connection component of claim 1, the needle system of which, is designed as a double needle system with a first hollow needle provided for a liquid transfer and with a second hollow needle provided for a gas transfer.

3. The connection component of claim 1, the flange jacket of which is rotatable about the needle system and about the elastic needle cap enclosing the needle system.

4. A syringe provided at its distal end with the tubular connection piece of claim 1.

5. A connecting component, in particular for a container for medical substances or medicaments or for a transfer system for medical substances or medicaments, for connection to the connection component of claim 1, with a connecting socket provided with a thread, in which a closing plug consisting of a polypropylene is arranged.

6. A container for medical substances or medicaments with the connecting component of claim 5.

7. The container of claim 6, comprising an outer cap surrounding the connecting component and provided with a disposable closure.

8. A fluid transfer system for transferring medical substances or drugs, comprising the connection component of claim 5 and, adapted thereto with respect to dimensioning and design of the connection pieces, a the connecting, component of claim 5.

Description

DESCRIPTION OF DRAWINGS

[0021] An embodiment of the invention is explained in more detail with reference to a drawing. Therein show:

[0022] FIG. 1 a longitudinal section of a medical syringe that can be connected to a container for drugs or medications via connection components of a fluid transfer system,

[0023] FIG. 2 the components as shown in FIG. 1 in longitudinal section in the connected state,

[0024] FIG. 3 an enlarged section of the components according to FIG. 2,

[0025] FIG. 4 a particularly preferred embodiment of a container for use in the liquid transfer system according to FIG. 1,

[0026] FIG. 5 in longitudinal, section, a particularly preferred embodiment of a first connection component for use in the fluid transfer system according to FIG. 1, in the state before the components are connected to each other,

[0027] FIG. 6 the connecting component according to FIG. 5 in longitudinal section with components connected to each other,

[0028] FIG. 7 a syringe adapter before assembly with an assigned syringe in longitudinal section,

[0029] FIG. 8 the syringe according to FIG. 7 with mounted syringe adapter,

[0030] FIG. 9 an infusion bag with adapter,

[0031] FIG. 10 the infusion bag provided with adapter according to FIG. 9 before assembly with an associated syringe in longitudinal section, and

[0032] FIG. 11 the syringe according to FIG. 10 with mounted infusion bag.

DETAILED DESCRIPTION

[0033] Identical parts are provided with the same reference signs in all figures. The invention will be explained below primarily with reference to the embodiment example in which a medical syringe is equipped with a first connection component of the type mentioned and a container for medical substances or medicaments is equipped with a second connection com ponent of the type described. However, other embodiments are of course also conceivable and covered by the present invention, in which other components of a medical system, for example an access interface to an intravenous application system or an adapter for an infusion bag (“IV bag”), with such a second connection component, or also an “inverse arrangement”, in which a medical syringe is provided with the second connection component and the respective other component, for example a container or an access interface, is provided with such a first connection component. Equally conceivable and encompassed by the present invention are, of course, other embodiments in the non-medical field in which liquid transfers must be carried out under reliable gas or material exclusion without the handling persons being exposed to an explosion, for example in applications in process engineering or for hazardous chemical processes and the like.

[0034] The fluid transfer system 1 according to the invention will thus be explained in the following on the basis of a medical syringe 4 provided with a first connection component 2 and a container 8 for medical substances or medicaments provided with a second connection component 6. In FIG. 1, the components, i.e., the syringe 4 and the container 8, are shown in longitudinal section in a separate, still separated state; FIGS. 2 and 3 show the components analogously (FIG. 3 in sections) in longitudinal section after the combination has been produced.

[0035] The syringe 4 comprises a cylindrical or tubular hollow body 10 forming a syringe housing, in which a plunger 12 whose outer dimensions are precisely adapted to the inner contour of the hollow body 10 is displaceably guided. The piston 12 is arranged at the end on an actuating plunger 16 guided in a sealing manner through a cover plate 14, which in turn is provided with a pusher plate 20 at its free end 18. The piston 12 divides the internal volume of the hollow body 10 into a distal partial volume 22 intended for receiving liquid and a proximal partial volume 24 intended for receiving gases or aerosols, the volume contents of which can be varied by positioning the piston 12 within the hollow body 10. The first connection component 2 is arranged at the distal end 26 of the hollow body 10 and thus of the distal partial volume 22.

[0036] The first connection component 2, which is regarded as independently inventive and which in the embodiment example is designed integrally with the hollow body 10 but could also be designed as a separate, retrofittable component, comprises a distal end plate 30 which sealingly closes off the distal partial volume 22 of the hollow body. The end plate 30 forms a needle holder for a needle system 32 and, on its side facing away from the partial volume 22, a tubular connecting piece 34 surrounding the needle system 32 for establishing a connection with the second connection component 6.

[0037] In the embodiment example, the needle system 32 is designed as a double needle system and comprises a first hollow needle 40 provided for liquid transfer and a second hollow needle 42 provided for gas transfer. The first hollow needle 40 projects with its inner end 44 into the partial volume 22 and thus forms a liquid channel for liquid exchange. The second hollow needle 42, on the other hand, is connected on the inside to a gas channel 46, which is guided in the manner of a bypass along the inner wall of the hollow body 10 into the proximal partial volume 24. Via the second hollow needle 42, gas or aerosol can thus be transferred from the distal needle tip 48 thereof into the proximal partial volume 24 in the manner of an encapsulated embodiment or can be guided from the latter towards the needle tip 48. Analogous to the mode of operation described in WO2016199133A1, liquid can thus be transferred from the container 4 into the distal partial volume 22 when the container 4 is connected and, at the same time, gas can be transferred from the proximal partial volume 24 into the container 4 without substances being discharged to the outside and with pressure compensation taking place automatically.

[0038] The first and second hollow needles 40, 42 protrude with their distal needle tips 48, 50 from the open end of the tubular connection nozzle 34. In order to ensure reliable encapsulation of the system, an elastic, comparatively easily deformable needle cap 52 is also fastened inside the connection socket 34, which sealingly encloses the distal tips 48, 50 of the hollow needles 40, 42 of the needle system in the unloaded state. In the particularly preferred embodiment shown in the embodiment example, the needle cap 52 consists of a thermoplastic elastomer (TPE). When a connection is made with the second connection component 6, in particular by pressing it against a contact plate provided, the needle cap 52 deforms, with the distal tips 48, 50 piercing the needle cap 52 and thus being exposed, so that an exchange of media is made possible.

[0039] On the outside, the connecting nozzle 34 is surrounded by a connecting sleeve 56 mounted on a circumferential rib 54. This is rotatably mounted about the needle system 32 and has an actuating rim 58, via which the user can effect a rotation, and a flange jacket 60, which is provided on the inside with a thread 62. In the embodiment, the thread 62 in combination with the flange jacket 60 is designed as a component of a Luer connection. In the embodiment example, the thread 62 is designed with only one thread or thread turn but can of course also have further threads and/or thread turns.

[0040] The container 8 for medical substances or medicines, also referred to as a vial, also shown in longitudinal section in FIG. 1, is correspondingly provided with a second connecting component 6 designed for connection to the first connecting component 2. This comprises a connecting socket 72 provided with a thread 70, in which a closure plug 74 made of the particularly preferred material PP Purell HP 570, which is considered to be independently inventive with regard to the choice of material, is arranged. The connecting piece 72 provided with the thread 70 is designed to match the flange jacket 60 and its thread 62, so that these components form a Luer connection with each other.

[0041] To produce the connection of the connection components 2, 6 to one another on the media side, as shown in the overall view in FIG. 2 and in enlarged sections in FIG. 3, the syringe 4 provided with the first connection component 2 is first brought into contact with the container 8 provided with the second connection component 6 in such a way that the thread 62 of the flange jacket 60 engages with the thread 70 of the connection socket 72. This creates a threaded connection between these components, which can be further tightened by rotation of the flange shell 60, i.e. actuation of the actuation rim 58. This further moves the first connector element 2, as seen in the longitudinal direction of the syringe 4, towards the second connector component 6 and thus the container 8. As soon as the end surface of the needle cap 52 comes into contact with the connecting plug 74 serving as a contact plate, the needle cap 52 begins to deform due to its elastic design, and the distal needle tips 48, 50 begin to penetrate the needle cap 52. As the threaded connection is further tightened, the distal needle tips 48, 50 completely penetrate the needle cap 52 and begin to penetrate the sealing plug 74.

[0042] When the screw connection is further actuated to the end position shown in FIGS. 2 and 3, the distal needle tips 48, 50 also completely penetrate the sealing plug 74. In this state, the first hollow needle 40 forms an open fluid channel and enables fluid exchange between the interior of the container 8 and the distal partial volume 22, and gas exchange between the proximal partial volume 24 and the interior of the container 8 is enabled via the second hollow needle 42 and the gas channel 46 connected to it. For lossless and encapsulated fluid transfer from the container 8 into the distal partial volume 22 of the syringe 4, starting from an initial state in which the piston 12 is positioned immediately adjacent to the distal end 26 of the hollow body 10, the piston 12 can now be moved within the hollow body 10 away from its distal end 26. This causes fluid to flow from the interior of the container 8 into the distal partial volume 22 of the syringe 4. At the same time, the gas in the proximal partial volume 24 is compressed so that it flows into the interior of the container 8 via the gas channel 46 and the second hollow needle 42 to equalize the pressure. This enables a safe and encapsulated exchange of media between syringe 4 and container 8 without liquid or gas escaping into the environment.

[0043] After removing the intended quantity of liquid from the container 8, the components are separated again by loosening the screw connection. The hollow needles 40, 42 of the needle system 32 are pulled out of the interior of the container 8 as seen in the longitudinal direction of the syringe 4. As soon as the needle tips 48, 50 have been completely withdrawn from the sealing plug 74, the latter resumes its original shape due to the choice of material and seals the interior of the container 8 from the outside again. As soon as the end surface of the needle cap 52 is also lifted off the sealing plug 74, which serves as a contact plate, the needle cap 52 begins to resume its original shape due to its material properties, so that the needle tips 48, 50 are again completely positioned in their interior space and thus the needle cap 52 again completely encloses the needle tips 48, 50. Thus, after the components have been separated from one another, complete enclosure of the interior of the container 8 on one side and of the interior of the hollow body 10 is again provided.

[0044] A particularly preferred design of the vial or container 8, which is considered to be independently inventive, is shown in longitudinal section in FIG. 4. As can be seen from the lateral view in FIG. 4a and also from the representation of the assembled article in perpective view in FIG. 4b, the container in this embodiment comprises an outer closure cap 76 surrounding the connection component 6 and provided with a one-way closure 78. In the embodiment example, the one-way closure 78 comprises a seal lid 80 that can be torn off, or alternatively or additionally, for example, a sealed seal lid 80 that is removed when the container 8 is opened for the first time. This design permits problem-free and reliable identification of whether or not the container 8 has already been used for liquid transfer, and thus facilitates the assignment of whether the container 8 has already been “opened” and should thus preferably be used for further liquid withdrawal until it is completely emptied and should thus be disposed of.

[0045] A very particularly advantageous design of the first connecting component 2, which is considered to be independently inventive, is shown in enlarged longitudinal section in FIG. 5 (state before the components are connected to one another) and in FIG. 6 (state with components connected to one another). As can be seen from this illustration, in this embodiment a spring element 82, in this example a spiral spring 84, is arranged as a further component within the needle cap 52. In this embodiment, the spiral spring 84 is arranged inside the needle cap 52, surrounding the needle system 32. On the one hand, it is supported on the cover plate 30 of the distal partial volume 22, in which the needles 40, 42 of the needle system 32 are held, and on the other hand, on the cover surface of the needle cap 52. In the embodiment shown, the needle cap 52 is also made in two parts and comprises, in addition to the actual cap body 86, a needle guard 88 attached distally thereto, whereby in this embodiment the spiral spring 84 is supported on the base of the needle guard 88.

[0046] In the state shown in FIG. 5 before the components are connected to each other, the spiral spring 84 is relaxed. However, as a result of the deformation of the needle cap 52 due to contact with the other connecting element 6, the spring element 82 is deformed together with the needle cap 52 and thereby pretensioned; this state is shown in FIG. 5. After completion of the fluid transfer and after separation of the components, the spring element 82 relaxes again and thus supports the desired deformation of the needle cap 52 until it resumes its original shape completely enclosing the exposed tips 48,50 of the needle system 32.

[0047] The medical syringe 4 described above, which is equipped with the first connection component 2, can be used, for example, for transferring fluids between different containers of the container 8 type or also for transferring fluids from such a container 8 to an intravenous (IV) access. In such applications, the medical syringe 4 is respectively connected via its connection component 2 to the associated second connection component 6 of the respective container 8 or to an access interface of the intravenous access, so that liquid can be drawn from the respective container 8 into the distal partial volume 22 of the syringe 4 or dispensed therefrom into a corresponding container 8 or the IV access.

[0048] Alternatively, however, and in an embodiment considered to be independently inventive, after filling with the liquid transferred as a medicament or active ingredient, the syringe 4 can also be prepared for direct injection of the liquid and thus as an injection syringe. For this purpose, a syringe adapter 90 considered to be independently inventive is provided, as shown—in each case in longitudinal section together with the end region of the syringe 4—in FIG. 7 before and in FIG. 8 after assembly with the syringe 4.

[0049] As shown, the syringe adapter 90 shown in longitudinal section in FIGS. 7, 8 is designed for assembly to the medical syringe 4 using the first connection component 2 thereof. For this purpose, the syringe adapter 90 is correspondingly provided with a further connection component 92 suitably designed for connection to the first connection component 2. Analogous to the variants described above, this comprises a connection piece 96 provided with a thread 94, which—like the corresponding components of the second connection component 6—is designed to match the flanged sheath 60 of the first connection component 2 and its thread 62, so that these components form a Luer connection with one another.

[0050] A contact element 98 is arranged within the connection socket 96 for establishing a media-side connection with the needle system 32. The contact element 98 is substantially formed by a plug-like base body 100 having a cavity or hollow space 102 for receiving the needle tip 50 of the first hollow needle 40 provided for fluid transfer, and another cavity or hollow space 104 for receiving the needle tip 48 of the second hollow needle 42 connected on the media side to the gas channel 46. Encapsulated gas exchange is not provided in this case, and accordingly the further cavity 104 is of the blind hole type and is not connected to any further media channels.

[0051] In contrast, the cavity 102 is designed and provided as a transfer space for transferring the fluid fed from the distal partial volume 22 of the syringe 4 via the hollow needle 40. For this purpose, the proximal end of a transfer needle 106 opens into the cavity 102, which is arranged within a hollow body 108 of cylindrical or tubular design forming the housing of the syringe adapter 90. A needle holder 112 is attached to the front or distal end 110 of the hollow body 108, in which the hollow needle 114 intended for injection of the active agent is mounted in a hearing sleeve 116. The needle holder 112 could be made in one piece with the hollow body 108 forming the housing. In the embodiment example, however, the needle holder 112 is designed as a separate component in an embodiment that is considered to be independently inventive. The needle holder 112 is attached or attachable to the hollow body 108 forming the housing, but could also be designed to be screwed on by means of a thread, for example a Luer thread. The hollow body 108 is surrounded on the outside by a needle protection sleeve 118 which can be displaced in the longitudinal direction.

[0052] In a further alternative embodiment, which is also considered to be independently inventive, the syringe 4 can also be used for injecting the liquid into an infusion bag (“IV bag”) after filling with the liquid transferred as a drug or active ingredient. This allows the active ingredient or drug to be added to the actual infusion fluid, for example, or to be provided directly as an infusion fluid. From the infusion bag, the active ingredient can then be applied via an intravenous application system.

[0053] To make this possible, an adapter 120, which is considered to be independently inventive, is provided for an infusion bag 122, as shown together with the infusion bag 122 in perspective view in FIG. 9 and—in each case in longitudinal section together with the end region of the syringe 4—in FIG. 10 before and in FIG. 11 after assembly with the syringe 4.

[0054] The infusion bag 122 according to FIG. 9, also referred to as “IV bag”, is provided for connection to an intravenous application system, with which a liquid, for example a drug or also an isotonic liquid or the like, held in the infusion bag 122 can be administered to a patient as an infusion. The infusion bag 122 is provided with a connector 124 via which an exchange of media, in particular the introduction or removal of fluid into/from the interior of the infusion bag 122 is possible. In order to enable the use of the syringe 4 for liquid transfer into (or, if required, out of) the infusion bag 122, the adapter 120 is provided, which is shown in FIGS. 9 to 11 in a state already mounted on the connector 124 of the infusion bag.

[0055] The adapter 120 shown in longitudinal section in FIGS. 10, 11 is designed as shown for mounting on the medical syringe 4 using its first connector component 2. For this purpose, the adapter 120 is accordingly provided with a further connection component 126 suitably designed, for connection to the first connection component 2. Analogous to the variants described above, this comprises a connecting socket 130 provided, with a thread 128, which—like the corresponding components of the second connecting component 6 and the corresponding components of the further connecting component 92—is designed to be adapted to the flange jacket 60 of the first connecting component 2 and its thread 62, so that these components form a Luer connection with one another.

[0056] A contact element 132 is arranged within the connection socket 130 for establishing a media-side connection with the needle system 32. In a similar embodiment to the aforementioned contact element 98, the contact element 132 is substantially formed by a base body 134 having a cavity or hollow 136 for receiving the needle tip 50 of the first hollow needle 40 provided for fluid transfer and another cavity or hollow 138 for receiving the needle tip 48 of the second hollow needle 42 connected to the gas channel 46 on the media side. No encapsulated gas exchange is provided in this case, and accordingly the further cavity 138 is in the nature of a blind hole and is not connected to any further media channels.

[0057] In contrast, the cavity 136 is designed and provided as a transfer space for transferring the fluid fed from the distal partial volume 22 of the syringe 4 via the hollow needle 40. For this purpose, the cavity 136 goes into a media channel 142 arranged in a connection piece 140 or a grommet in the manner of an axial central bore, the free end 144 of which communicates on the media side with the interior of the infusion bag 122.

REFERENCE LIST

[0058] 1 Fluid transfer system

[0059] 2 first connection component

[0060] 4 Medical syringe

[0061] 6 second connection component

[0062] 8 Container for medical substances or medicines

[0063] 10 Hollow body

[0064] 12 Piston

[0065] 14 Cover plate

[0066] 16 Actuating plunger

[0067] 18 free end

[0068] 20 Handle plate

[0069] 22,24 partial volume

[0070] 26 distal end

[0071] 30 end plate

[0072] 32 needle system

[0073] 34 connecting piece

[0074] 40,42 hollow needle

[0075] 44 inner end

[0076] 46 Gas channel

[0077] 48,50 needle tip

[0078] 52 needle cap

[0079] 54 rib

[0080] 56 connecting sleeve

[0081] 58 Actuating rim

[0082] 60 Flange jacket

[0083] 62 Thread

[0084] 70 Thread

[0085] 72 Connecting sleeve

[0086] 74 Sealing plug

[0087] 76 Closing cap

[0088] 78 One-way cap

[0089] 80 Sealing cap

[0090] 82 Spring element

[0091] 84 Coil spring

[0092] 86 Cap body

[0093] 88 Needle protection body

[0094] 90 Syringe adapter

[0095] 92 Connecting component

[0096] 94 Thread

[0097] 96 Connecting piece

[0098] 98 Contact element

[0099] 100 Base body

[0100] 102, 104 Cavity

[0101] 106 Transfer needle

[0102] 108 hollow body

[0103] 110 distal end

[0104] 112 needle holder

[0105] 114 hollow needle

[0106] 116 bearing sleeve

[0107] 118 needle guard

[0108] 120 adapter

[0109] 122 Infusion bag

[0110] 124 Connector

[0111] 126 Connecting component

[0112] 128 Thread

[0113] 130 Connecting piece

[0114] 132 Contact element

[0115] 134 Basic body

[0116] 136, 138 cavity

[0117] Connecting piece

[0118] 142 media channel

[0119] 144 Free end