Medical mounting device for a CSTD sytem

Abstract

Disclosed is a mounting device for or of a CSTD system (1), for mounting the CSTD system (1) on a medical component (28), wherein the mounting device includes a separate mounting adapter (37) for one or more differently designed component ports (35) of the one or more differently designed medical components (28), said mounting adapter(s) being designed to establish a fluid connection between the CSTD system (1) and the associated component port (35).

Description

[0001] Medical assembly facility for a CSTD system

[0002] Description

[0003] The present disclosure relates to a preferably non-detachable mounting device for a CSTD system according to the preamble of claim 1 and to a medical system having such a mounting device.

[0004] Background of the invention

[0005] In medical technology, fluid line systems such as infusion sets, extracorporeal blood lines from / for dialysis machines or heart-lung machines and similar working devices are used, which are intended for the guidance of fluids such as blood, aqueous solutions, etc. and / or for the addition of medicinal substances and drugs. Such a medical fluid line system, for example an infusion set, is usually (but not necessarily always) a hose line system with a hose that is at least partially flexible, for example an infusion hose, one of the proximal (ieaway from the patient's body) end, particularly in the case of an infusion set with a coupling, for example in the form of a Luer Lock, a medical spike / thorn or similar connectors for connection, for example, to an infusion container such as an infusion bag or infusion bottle or to an infusion machine, and whose other distal end (i.e. facing the patient's body) has either a connection / connection coupling (e.g. constructed according to the Luer system) for an injection catheter or similar patient access or an infusion set-integrated patient access (injection catheter) itself.

[0006] A person skilled in the art understands a medical spike to be a rigid tube that is tapered at a distal end, preferably with a handle formed thereon, wherein at the proximal end of the rigid tube either a fluid line system as defined above is permanently connected or a connection coupling such as a Luer Lock is formed, to which, for example, a fluid line system as defined above can be connected. In some cases, such a spike can also be formed with a so-called injection port. Such an injection port is in some cases intended and designed to be penetrated by a syringe needle in order to inject a medical liquid / medicine via a hand-operated syringe, for example. Alternatively, such injection ports are also designed with couplings, in particular according to the Luer principle, in order to connect a syringe or the like directly to it.

[0007] The problem with such couplings is that they do not seal dry, especially when the fluid line system or the syringe / syringe needle is disconnected, but rather dripping of liquid is to be expected, which then contaminates the environment.

[0008] Therefore, so-called “vial-to-vein closed system drug-transfer devices” (CSTD systems) are generally known in the field of medical technology, i.e. closed / self-sealing vial liquid withdrawal / transmission devices, of which a concrete embodiment is disclosed by way of example in WO 2022 232405 A1 and whose basic mode of operation is shown in the attached Figs. 1 and 2.

[0009] According to Fig. 1, such a CSTD system has a first coupling adapter part (also referred to as the first dry-break connection component), which is provided or designed at a distal end section, for example, with a Luer Lock or similar coupling, in order to be connected, for example, to a vial containing a medicinal agent or to a fluid line system leading to the patient at a designated location. This first coupling adapter part forms or has a housing with an internal fluid channel that is open in the proximal direction, wherein this proximal opening is closed by means of a membrane or similar seal. Furthermore, the housing of the first coupling adapter part preferably forms an undercut on the inside.

[0010] The CSTD system cited as an example from this prior art further comprises a second coupling adapter part (also referred to as a dry-break syringe component) consisting of a housing forming inner undercuts, in which a piston with an inner channel is mounted for axial movement. A hollow needle is mounted for relatively axial movement in the inner channel, the proximal end of which, remote from the needle tip, is held by an anchor sleeve that rests against the housing or is inserted into a proximal central housing socket. At the distal end of the piston, the inner channel is closed by a membrane or similar seal, with the needle tip initially covered by this seal. Finally, elastic locking arms extending longitudinally in the distal and proximal directions are provided on the piston of the second coupling adapter part, the proximal and distal end sections of which are shaped into locking hooks.In addition, the anchor sleeve forms a connection, for example for a syringe, at its proximal end region facing away from the needle, which is not shown in Figs. 1 and 2.

[0011] According to Fig. 2, to achieve an outwardly closed / self-sealing fluid connection with, for example, a vial or a fluid line system, the distal Luer Lock connection is coupled to the vial or the fluid line system. The first coupling adapter part is thus connected to the vial / fluid line system in a fluid-tight manner. The syringe mentioned as an example is then coupled to the proximal connection of the second coupling adapter part in a fluid-tight manner. Finally, the second coupling adapter part or the piston mounted therein is placed onto the membrane of the first coupling adapter part, and the housing of the second coupling adapter part is moved towards the housing of the first coupling adapter part until the locking arms are engaged in the undercuts of the first and second coupling adapter parts.During this sliding movement, the needle pierces the membrane of the first and second coupling adapter parts and establishes a fluid connection between the vial / fluid line system and the syringe.

[0012] To disconnect, the locking arms are disengaged from all undercuts using a button on the second coupling adapter part, and the housing of the second coupling adapter part is retracted relative to the first coupling adapter part, which simultaneously pulls the needle out of the two sealingly adjacent membranes. Only now do the two membranes separate from each other, preventing any liquid from dripping from the syringe or the vial / fluid line system. An important component of such CSTDs are the two coupling adapter parts (dry connections / dry breaks), which enable the safe transfer of liquid (medicine) and form a dry seal after the connection is separated / disconnected, thus protecting the environment from contamination (e.g., through leaks or the formation of drops on the surfaces of the coupling partners / coupling adapter parts after the connection is separated).These CSTD coupling adapter parts can be installed on various products, not just a vial and a syringe. Among other things, the above-described first coupling adapter part (dry-break connection component) could also be connected, for example, via the Luer-Lock connector formed thereon to a Luer-Lock injection port of an infusion set of the present type, particularly to a medical spike, in order to subsequently connect a syringe with the corresponding second coupling adapter part.

[0013] (counter adapter / dry-break syringe component). It can then be assumed that both coupling adapter parts of the CSTD system will close dry after disconnection, and the internal channels of both coupling adapter parts will remain tightly closed.

[0014] However, it has been shown that the user must connect the known CSTD system of the above-described design to the injection port of a known medical spike via the Luer Lock connection at the distal end of the first coupling adapter part. This Luer Lock connection can in principle be disconnected and therefore poses a potential risk of contamination of the surrounding area by fluid dripping from the injection port. Therefore, known CSTD systems are not suitable for making an injection port on an infusion set contamination-proof.

[0015] It is also possible, for example, to form the spike with the first coupling adapter part of a CSTD system as a one-piece, in particular as a single piece of material. However, this has the disadvantage that different spike designs would have to be provided, for example, for spikes with a CSTD injection port (located at least laterally on the spike) or spikes with a CSTD infusion set connection (located at the rear end of the spike), which would be expensive and complex. Brief description of the disclosure

[0016] In view of this problem of the prior art, which the applicant has recognized, the object of the present disclosure is to provide a mounting device for a CSTD system that can be cost-effectively adapted to different connection designs for medical components such as spikes, injection ports of infusion sets, or the like. It is advantageous if this mounting device presents a reduced contamination risk to the environment compared to the prior art.

[0017] This object is achieved by a medical assembly device having the features of claim 1. Advantageous aspects of the assembly device are the subject of the subclaims, which may also be claimed individually and separately from the other aspects.

[0018] The basic idea according to the present disclosure essentially consists in providing a mounting adapter, in particular a mounting adapter set containing a plurality of mounting adapters designed differently from one another, each with an individual mounting section, adapted to a specific connecting structure of a plurality of connecting structures of the respective medical component, such as a spike, and a standard mounting section which is adapted to the standard coupling of the first coupling adapter part (dry-break connection component) of a CSTD system and thus represents the cost-effective interface between the first coupling adapter part (dry-break connection component) of the CSTD system and the (each differently designed) connecting structure of the respective medical component, such as a spike.In other words, the mounting adapter allows a number of different connection designs to be combined with a number of different standard couplings.

[0019] Preferably, this mounting adapter can be permanently connected to the medical component, for example by gluing or welding, regardless of the currently prevailing connecting structure of the medical component, since the actual function of the connecting structure of the medical component, namely to connect a fluid line to it or to serve as an injection port, is now taken over by the first coupling adapter part (dry-break connection component) of the CSTD system.Accordingly, the standard mounting portion and the associated standard coupling of the first coupling adapter part (dry-break connection component) of the CSTD system can preferably be designed to be non-detachable, so that the connection interface between the medical component, such as a spike and, for example, a syringe or a fluid line, is shifted to the coupling between the first coupling adapter part (dry-break connection component) and the second coupling adapter part (dry-break syringe component).

[0020] Short description of the characters

[0021] The disclosure is explained in more detail below using preferred embodiments with reference to the accompanying figures.

[0022] They show:

[0023] Figs. 1 and 2 a CSTD system of known structure and known function,

[0024] Fig. 3 shows a first embodiment of a mounting system in cooperation with a spike according to the disclosure,

[0025] Fig. 4 shows a second embodiment of a mounting system in cooperation with a spike according to the disclosure,

[0026] Fig. 5 is an enlarged view of the mounting system in cooperation with the housing of a first coupling adapter part of a CSTD system according to a first embodiment,

[0027] Fig. 6 is an enlarged view of the mounting system in cooperation with the housing of a first coupling adapter part of a CSTD system according to a second embodiment,

[0028] Fig. 7 is an enlarged view of the mounting system in cooperation with the housing of a first coupling adapter part of a CSTD system according to a third embodiment and

[0029] Fig. 8 alternative (second and third) embodiments of a mounting system.

[0030] Description of the figures In Fig. 1, a liquid extraction and transmission device 1 (generally known by the abbreviation CSTD system) is shown, which belongs to the state of the art mentioned at the beginning, to which reference is hereby expressly made again.

[0031] This CSTD system 1 comprises a first coupling adapter part 3 with a housing 4, in which an axially extending through-flow fluid channel or fluid channel component 5 is formed or inserted, which is closed at a proximal flange side 7 by a membrane 9. The fluid channel component 5, together with the housing 4, forms a (Luer Lock) coupling 6 at the distal end section of the first coupling adapter part 3, with which the first coupling adapter part 3 is / can be connected to a medical device, such as a medical fluid line system. The housing 4 or the fluid channel component 5 of the first coupling adapter part 3 also forms a number of locking elements in the form of undercuts 11.

[0032] The known CSTD system 1 further comprises a second coupling adapter part 13 with a housing 15 which forms a number of locking elements in the form of undercuts 16, a piston 17 which is mounted in the housing 15 so as to be relatively displaceable, a hollow needle 19 which is mounted in the piston 17 so as to be relatively displaceable and which is held in the housing 15 at its proximal end section (facing away from the needle tip) by means of a holding anchor or anchor sleeve 20, and a number of elastically deformable locking arms 21 which are fixed or formed on the piston 17 and are provided and designed to engage in a locking manner both with the undercuts 11 of the first coupling adapter part 3 and with the undercuts 16 of the second coupling adapter part 13.

[0033] For the relatively displaceable mounting of the hollow needle 19 in the piston 17, the latter has a (central) through-channel 23 which is closed by a membrane 27 on a distal coupling or flange side 25 of the second coupling adapter part 13.

[0034] Fig. 2 shows the function of the CSTD system 1 according to Fig. 1.

[0035] Accordingly, to establish a fluid connection between the first and second coupling adapter parts 3, 13, the membrane 27 of the second coupling adapter part 13 is pressed sealingly against the membrane 9 of the first coupling adapter part 3 in a first movement time window. In a second movement time window, the housing 15 of the second coupling adapter part 13 is moved further forward in the direction of the housing 4 of the first coupling adapter part 3, whereby this further forward movement in a second movement time window causes the hollow needle 19 to pierce both adjacent membranes 9, 27, thereby establishing a fluid connection between the through-fluid channel 5 and the hollow needle 19. The movement of the second coupling adapter part 13 in the second movement time window ends with the locking arm 21 engaging in the undercuts 11 and 16 of the two coupling adapter parts 3, 13.

[0036] As stated above, the hollow needle is held at its proximal end by the anchor sleeve 20, which at the same time also represents a connection / connector for, for example, a syringe and whose sleeve interior is in fluid communication with the fluid channel 5 of the first coupling adapter part 3 via the hollow needle 19.

[0037] Separating / deconnecting both coupling adapter parts 3, 13 takes place in exactly the reverse order, wherein after disengaging the locking arms 21 by subsequently moving the second coupling adapter part 13 away from the first coupling adapter part 3, first (i.e. according to the above second movement time window) the hollow needle 19 is pulled out of the two membranes 9, 27 and then (i.e. according to the above first movement time window) the two membranes 9, 27 are lifted away from each other.

[0038] Fig. 3 now shows a medical spike 28 according to a first preferred embodiment of the disclosure, as it is used, for example, for connecting an infusion container (not further shown).

[0039] This spike 28 has a tube 29 tapered at its free end, which extends into a handle 31 and, at its end facing away from the tip, is either firmly connected to a fluid line 33 or has a coupling, for example, according to the Luer principle, for optionally coupling the fluid line 33. In the area of ​​the handle 31, an injection port 35 is formed, which opens into the spike tube 29 via a channel running in the handle 31.

[0040] The figure below shows an exploded view of the following components:

[0041] - the spike 28 - the fluid line 33

[0042] - a mounting adapter 37,

[0043] - a first coupling adapter part (dry-break connection component) 3

[0044] - a membrane 9

[0045] Accordingly, the injection port 35 according to this preferred embodiment is designed as a bore in the handle 31. Accordingly, the mounting adapter 37 is essentially designed as an insert tube with an individual mounting section 37a whose outer diameter is adapted to the handle bore, preferably for a press fit. Further preferably, the individual

[0046] The mounting section 37a may be glued or welded (additionally or alternatively) into the grip bore. To define the insertion depth, the mounting adapter 37 has a stop collar, which rests against the outside of the grip 31 when the maximum insertion depth is reached. This collar also separates the customized mounting section 37a from a standard mounting section 37b of the mounting adapter 37, which in this case essentially corresponds to the part of the insertion tube protruding from the bore.

[0047] In this embodiment, this one standard mounting section 37b is designed as a smooth tube piece with a predetermined outer diameter different (larger) than the outer diameter of the individual mounting section 37a.

[0048] The first coupling adapter part (dry-break connection component) 3 preferably corresponds in its construction to the above-described prior art according to Figs. 1 and 2, but can have any other construction, possibly known from the prior art. A crucial difference compared to the design according to Figs. 1 and 2, however, lies in the structural design of the coupling 6, with which the first coupling adapter part (dry-break connection component) 3 is brought into engagement with the injection port 35 or the mounting adapter 37 on the spike 28.

[0049] In this case, the first coupling adapter part (dry-break connection component) 3 has an axial insertion bore as a coupling 6 with an inner diameter that is slightly smaller than the outer diameter of the standard mounting section 37b in order to form a press fit with it. This connection can also be glued or welded (additionally or alternatively). The middle illustration in Fig. 3 shows the finished assembled state of the spike 28 according to the disclosure. Accordingly, a seal 39 is inserted into the handle bore 35, on which the collar of the mounting adapter 37 rests directly to achieve a sealing effect. It can also be seen that the smooth tube section 37b is not exactly cylindrical, but takes on a conical shape in order to expand the insertion bore 6 on the first coupling adapter part (dry-break connection component) 3 with increasing insertion travel.

[0050] Fig. 4 shows a medical spike 28 according to a second preferred embodiment of the disclosure, which is designed or provided with a connection according to the CSTD principle on its rear tube section, i.e. the tube section facing away from the pointed tube end, in order to be able to connect a medical fluid line system, such as an infusion set, to it. In this preferred embodiment, the injection port described above is closed by a blind plug 41 not described in more detail. The internal structure of the spike 28 essentially corresponds to the spike according to Fig. 3, so that reference can be made to the above description at this point. As an alternative to the blind plug 41 shown, it is of course also possible to close the injection port via a vent connection with a vent cap and a filter that is integrated into the vent flap.

[0051] The figure below in Fig. 4 also shows an exploded view of the following components:

[0052] - the Spike 28

[0053] - the blind plug 41 together with sealing element 39

[0054] - the mounting adapter 37,

[0055] - the first coupling adapter part (dry break connection component) 3

[0056] - the membrane 9

[0057] In this embodiment, the rear connection is formed with or as the first coupling adapter part (dry-break connection component) 3. For this purpose, the individual mounting section 37a of the mounting adapter 37 is adapted to the original connection 35' of the medical spike 28 and, for example, has the shape of a Luer Lock, which is brought into operative engagement with the Luer Lock connection of the spike 28. If necessary, this coupling point can be made securely indetachable by gluing or welding.

[0058] Depending on the connecting structure of the first coupling adapter part (dry-break connection component) 3, the standard mounting section 37b of the mounting adapter 37 is designed as a smooth expansion tube, which is press-fitted into an axial insertion bore serving as a coupling 6. This coupling point is also glued or welded if necessary to ensure it cannot be removed.

[0059] For the design of the standard mounting section 37b of the mounting adapter 37, different possibilities are conceivable depending on the design of the first coupling adapter part (dry break connection component) 3 or its coupling 6:

[0060] 1. Press fit / press connection according to Fig. 5

[0061] A press fit can be used if the first coupling adapter part (dry-break connection component) 3 is made, for example, of a soft / possibly elastic, preferably semi-crystalline plastic (e.g., polypropylene) compared to the mounting adapter 37, and the mounting adapter 37 is made of a rigid / hard / inflexible plastic compared to the first coupling adapter part (dry-break connection component) 3. Preferably, in addition to the press fit, a form fit can be provided, for example, by forming an undercut 43 on the inside of the insertion bore 6 on the first coupling adapter part (dry-break connection component) 3 and radial projections 45 on the outside of the standard mounting section 37b of the mounting adapter 37, which engage with the undercuts when a defined insertion depth is reached.

[0062] 2. Press fit + bonding with undercuts as shown in Fig. 6

[0063] If the single press fit cannot generate sufficient connection force, additional adhesive can be used to generate more connection force. The adhesive is located in a partially created gap 47 (parallel to the press fit section) between the first coupling adapter part (dry-break connection component) 3 and the standard mounting section 37b of the mounting adapter 37. The standard mounting section 37b should still be made of rigid plastic and the first coupling adapter part (dry-break connection component) 3 should be made of soft, preferably semi-crystalline plastic (such as polypropylene). In the event that the material does not bond well with adhesive (e.g.In the case of polypropylene, the adhesive does not adhere well to polypropylene), undercuts can also be created in the material, particularly of the first coupling adapter part (dry-break connection component) 3, so that the adhesive fills the undercuts and a positive connection is created.

[0064] 3. Bonding / gluing according to Fig. 7

[0065] If both parts are made of hard plastic, a welded or adhesive bond (without interference fit or undercuts) can be used (exclusively). Both solvent-based and adhesive bonding can be used.

[0066] Finally, it should be noted that the aforementioned spike represents only one possible medical component for which the disclosed mounting device for a CSTD system can be applied. Other medical components or devices include, for example, infusion containers, preferably bottles, ampoules, etc. with a bottle holder, whereas the mounting device in this case can be a bottle adapter or a corresponding diaphragm valve, which is plugged directly onto the bottle neck, for example, of the infusion container, in a known manner. This is shown as an example in Fig. 8. Accordingly, the bottle adapter can be designed with a spike or an insertion mandrel surrounded by a clamping sleeve intended for preferably elastic plugging onto the bottle neck.At an end portion of the adapter opposite the spike tip, a sleeve 37b is formed which is fluidly connected to the spike mandrel and serves as a standard mounting portion to which a first coupling adapter part (dry break connection component) 3 can be or is connected as described above.

[0067] Another possibility for a medical component would be a medical fluid line, such as an infusion set with an injection port. In this case, the mounting device according to Fig. 8 would be designed as the injection port itself, i.e., in concrete terms, for example, as a T- or Y-shaped line piece with two coaxially aligned connection nozzles for fluid lines and a sleeve (injection port) aligned at an angle to the connection nozzles, which serves as the standard mounting section 37b.

[0068] As already indicated at the beginning, the assembly device according to the disclosure is intended to provide the possibility of applying different CSTD systems to different medical components, possibly with different connecting structures. This means that preferably not just a single mounting adapter with a specific connecting structure is provided, but rather a mounting adapter set consisting of a plurality of mounting adapters, each with different / different individual mounting sections 37a and / or each with different / different standard mounting sections 37b, which in turn are each adapted to possibly previously known connecting structures of the medical components and the CSTD systems.In this way, by selecting a suitable mounting adapter from the mounting adapter set, a variety of CSTD systems can be coupled with a variety of medical components without having to change their structural design.

Claims

Patent claims 1. Mounting device for a or a CSTD system for mounting the CSTD system (1) to a medical component (28), characterized in that the mounting device for one or more mutually differently constructed component connections (35, 35') of the one or more mutually differently constructed medical components (28) each comprises a mounting adapter (37) which is designed to establish a fluid connection between the CSTD system (1) and the respective component connection (35, 35').

2. Mounting device according to claim 1, characterized in that the mounting device comprises a mounting adapter (37) for each of a plurality of differently constructed connecting couplings (6) of the CSTD system (1).

3. Mounting device according to claim 2, characterized in that the mounting adapter (37) has an individual mounting section (37a) which is adapted to the respective component connection (35, 35') and a standard mounting section (37b) which is adapted to the connection coupling (6) of the respective CSTD system (1) independently of the individual mounting section (37a) and has a different construction and / or dimension than the individual mounting section (37a).

4. Mounting device according to claim 3, characterized in that the mounting adapter (27) is formed as a sleeve and the mounting sections (37a, 37b) are formed on two mutually opposite sleeve end regions.

5. Mounting device according to claim 4, characterized in that the mounting sections (37a, 37b) are separated from one another by a radially outwardly extending circumferential collar.

6. Mounting device according to claim 3, characterized in that the mounting adapter (27) is a medical bottle or ampoule neck slip-on or medical diaphragm valve device, the individual mounting section (37a) of which is designed as a flexible, preferably elastically expandable clamping sleeve and the standard mounting section (37b) of which is designed as a sleeve which is fluidically connected to a spike or mandrel which is located in the interior of the clamping sleeve.

7. Mounting device according to claim 3, characterized in that the mounting adapter (27) is a medical T- or Y-fluid line piece, the individual mounting section (37a) of which is formed as two preferably coaxial connection nozzles for one medical fluid line each and the standard mounting section (37b) of which is formed as a sleeve which is aligned at an angle to the two connection nozzles and has a fluid connection to the two connection nozzles.

8. Medical system with - a medical component, preferably a spike (28), an infusion container, an ampoule or a fluid line system, in particular an infusion set, - a first coupling adapter part (3) of a CSTD system (1) and - a mounting device according to one of claims 1 to 7.

9. Medical system according to claim 8, characterized in that the first coupling adapter part (3) of the CSTD system (1) has a housing in which a receiving bore (6) for the mounting adapter (37) is formed as a connection to the medical component, preferably the spike (28).

10. Medical system according to claim 9, characterized in that the housing, at least in the region of the receiving bore (6), consists of a material which is more easily deformable than the mounting adapter (37).

11. Medical system according to claim 9 or 10, characterized in that a space (47), preferably in the form of a recess, is formed in the receiving bore (6) and is intended to receive an adhesive substance.

12. Medical system according to one of claims 7 to 9, characterized in that the mounting adapter (37) is press-fitted and / or glued and / or locked into the receiving bore (6).

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