EP3305270A1 - Spike port - Google Patents

Abstract

The present invention relates to a spike port (22) for a film pouch (40) for medical purposes made of two film layers bounding an interior space with a hollow portion (4) which can be welded to the film layers and a closure end (24). in which a closure (6) made of an elastomeric material is used. In order to provide the generic spike port with a sealing lid that can be produced more easily, it is proposed that a flange surface (28) is formed on the closure end (24), via which the stem portion (4) with an attached cap (32) Weld connection is connected.

Description

The present invention relates to a spike port for a foil bag for medical purposes made of two foil layers defining an interior space with a hollow portion which can be welded to the foil layers and a closure end into which a closure made of an elastomeric material is inserted.

A generic spike port is from the Scriptures WO 2014/154195 known. The disclosed therein as access plug element called spike port consists of a tube which is provided at its end facing away from the foil bag with a hollow collar and a sealing plug. The sealing plug should be used in a tight fit in the tube, in addition, an adhesive may be used to fix the sealing plug in its sealing position. However, a correspondingly tight clamping fit with an elastomeric material is very difficult to produce, and the assembly of the closure using a separate adhesive is very expensive.

It is the object of the present invention to provide the generic spike port with a more easily produced sealing closure.

The object is achieved for a generic spike port by a flange surface is formed at the closure end, via which the shaft portion is connected to an attached cap by a welded joint.

The welded connection according to the invention represents an additional securing of the closure. The spike port is thus no longer after the filling of the bag sealed only by the closure, but in addition also by the welding of the cap with the flange. The weld forms a seal of the bag contents that is particularly liquid and airtight compared to mechanical connections only. The welded joint is also a tamper evident closure that can not be opened nondestructively.

Since the spike port consists of only three parts, namely the one-piece plastic injection molded part of the closure and the cap, the production costs are minimized despite the improved sealing and quality of connection. There are no special additional assembly work for the assembly of parts longer required. Bonding with drying distances and times can be omitted.

The spike port with the shank portion and the closure end is pre-assembled in one piece to be welded to the films for producing a foil bag. For this purpose, the shaft portion is welded with its bag-side end with the edges of the film layers. The closure end with the closure is then located at the end of the spike port facing away from the foil bag and is easily accessible for filling, injections or withdrawals. The spike port can be easily and inexpensively conveyed by the automated conveyor systems in an automated production plant for the production of film bags and positioned in the position in which the welding with the film layers. This is especially true when the shaft portion has a circular cross-section in the connection region with the film layers.

According to one embodiment of the invention, the welding is carried out via an ultrasonic welding. Ultrasonic welding allows quality control during welding, for example by monitoring the weld depth, the contact pressure and the weld path during the process.

According to one embodiment of the invention, a melt nose is formed on the flange, the material is fused during welding with the material of the cap. The melting nose melts faster than the broader and thicker base material, so that initially only softens the material of the melt nose and connects with the material of the cap when exposed to process heat. The material of the flange surface remains in its original shape without thermal deformation.

According to one embodiment of the invention, the flange is formed in a three-dimensional spatial form. The three-dimensional spatial form enlarges the contact surface between the flange surface and the adjacent surfaces of the cap, thereby stabilizing the connection. The connection is better supported by the adapted shapes of the flange and the corresponding contact surface of the cap against any shear forces acting.

According to one embodiment of the invention, a support ring is formed on the side wall and / or the flange surface, on which the closure is placed. By the support surface projecting over the flange surface, the material of the closure is pressed in at this point. This results in a positive connection of the closure with the side wall and / or the flange surface. The closure is thus better kept.

According to one embodiment of the invention, in the region of the cap adjacent to the support ring on the surface of the cap facing the closure a Clamping nose formed. The additional clamping lug increases the clamping action of the support ring, the closure is held even more secure in its closed position.

According to one embodiment of the invention, the closure has a larger diameter than the cavity formed in the shaft portion.

According to one embodiment of the invention, the cap covers the closure to the outside only partially, so that an injection port remains free. In the elastomeric material of the closure can be easily pierced in this design, so that the removal of the bag contents from the foil bag is possible without the cap must be removed from the foil bag.

According to one embodiment of the invention, the inner diameter of the cavity formed in the shaft portion is greater than 5 mm. In the larger inner diameter of the shaft portion, the bag filling can be done only through the spike port, because this has an increased flow capacity. The larger inside diameter also reduces the risk of damaging the sidewalls of the shaft portion when the spike is connected to the spike port.

According to one embodiment of the invention, the shaft portion has a recess in the shaft wall at its bag-side end. Such a recess is particularly advantageous if the shaft portion of the spike port is welded to the film material of the film bag so that it protrudes at its bag-side end with the end of the shaft portion over the welding zone with the film material of the film bag into the interior of the film bag Without this projecting section with the film material of the film bag is welded. The welding line is thus further away from the unsupported foil during the welding process, and the welding tool can remain two-dimensional. With such a positioning of the spike port in the foil bag, the liquid filled in the foil bag could no longer completely leak out when hanging down the foil bag for infusion with downwardly hanging ports because the end of the shaft section extends beyond the furthest inward sealing zone of the foil layers with the shaft portion of the spike port protrudes by one degree. If the level of the liquid present in the film bag has reached the upper edge of the end of the shaft section projecting into the bag, the residual liquid can no longer run off the port, and this liquid residue would have to remain unused in the bag since it can no longer run off. If the recess is so large that the liquid in the bag can pass through the recess into the interior of the shaft section, the suspended foil bag can be emptied at least as far as the lower edge of the recess.

For complete emptying of the film bag, it is advantageous to position the recess so far away from the protruding into the bag end of the shaft portion or the recess so long that they reach to the furthest inward sealing zone of the film layers with the shaft portion of the spike Comes close to ports. The recess may for example be formed as an elongated or spirally extending slot, or the recess is formed as a circular, oval or polygonal opening. In order for the shaft section to protrude into the interior of the film bag, it is advantageous to extend the shaft section in relation to a version which only extends into the region of the seal with the film layers. The reaching into the interior of the film bag shaft portion is for the sealing of the spike port advantageous with the film layers of the film bag. The sealed with the shaft portion films lie flat against the outer surface of the shaft portion during the sealing process in the sealing zone. The regions of the film layers adjoining the sealing surfaces are also supported against the adjoining tool surfaces in the region of the shaft section projecting into the interior of the film bag so that the film layers do not fold three-dimensionally in the region adjacent to the interior of the film bag during the sealing process and can warp, but lie flush on the outer circumference of the reaching into the interior of the film bag shaft portion. In order to obtain a better support of the film adjacent to the sealing surface, for example, a protrusion of the shaft portion of only 5 mm may be sufficient to improve the seal quality significantly. Due to the smoother contact of the film material to the outer surfaces of the shaft portion also in the surrounding area of the sealing zone during the sealing process, a higher quality of the seal results with a lower reject rate and a better durability of the foil pouches. The longer trained shaft portion also prevents punctured into the port syringe needles with the tip accidentally pierce the side walls of the foil bag, since the syringe needle is better managed in the longer shaft portion.

According to one embodiment of the invention, the spike port is made of a dimensionally stable plastic. With the dimensionally stable plastic is meant a plastic that retains its shape during welding, without having to be supported by a Mandrene. Non-rigid hoses, as known from the prior art, are easily deformed by the welding tool and also by hand. The elimination of the Mandrene simplifies production. As a plastic, for example, a polypropylene can be used, not by Softener is weakened in its dimensional stability. Without the plasticizer, the plastic is cheaper. In order to achieve sufficient dimensional stability, wall thicknesses of, for example, more than 0.4 mm make sense.

According to one embodiment of the invention, the spike port described above is used in a foil bag. This results in the advantages described above.

According to one embodiment of the invention, an additional injection port is provided in the foil bag, wherein the injection end forms a receiving space in which the closure is inserted in a sealing fit, the side wall of the receiving space has an inwardly directed projection at its end facing away from the shaft portion, which leaves an injection opening free, against which the closure is partially positively supported in its sealing position, and the closure is already positioned before welding the injection port with the film layers in its sealing position in the receiving space.

By the projection of the closure is held in its sealing position. The projection is also preferably circular in a circular cross-section of the receiving space. The projection is dimensioned so that on the one hand a good supporting effect for the closure results, but on the other hand also gives a sufficiently large injection port to pierce with an injection needle through the elastomeric material of the closure can, for example, a drug or other To be able to inject additive into the bag contents. Depending on the method of mounting the closure, the injection opening must also be so large that the closure can be pressed in compressed form through the injection opening into the receiving space.

Since the injection port consists only of two parts, namely the one-piece plastic injection-molded part and the closure, the production costs are minimized. There are no special additional assembly work for the assembly of parts longer required. Bonding with drying distances and times can be omitted.

The injection port is ready pre-assembled to be welded to the films to make a film bag. For this purpose, the shaft portion is welded with its bag-side end with the edges of the film layers. The receiving space with its closure is then located at the end of the injection port facing away from the foil bag and is easily accessible for injections. The injection port can be easily and inexpensively conveyed by the automated conveyor systems in an automated production plant for the production of film bags and positioned in the position in which the welding with the film layers.

Thus, while the injection port is welded to the film layers with a closed end, the spike port may be first welded to the film layers with an open end to make the film bag through it and then close it , The inventively equipped injection port and the spike port in this way form a port system with which a cost-effective bag making, easy and fast filling through the spike port, a secure closure and a simple injection of liquids in the foil bag the injection port is possible.

According to one embodiment of the invention, the spike port protrudes at its bag-side end into the interior of the film bag with the end of the shaft section beyond the welding zone with the film material of the film bag. As already explained above, this results in a smoother installation of the films on the shaft section of the injection port in the region of the sealing zone and the regions adjacent thereto. The wiping of the contents worsened by the projection of the shaft portion in the interior of the film bag can be remedied by the above-described recess in the side wall of the shaft portion.

According to one embodiment of the invention, the film bag on a spike port, which projects at its bag-side end with the end of the shaft portion on the welding zone with the film material of the film bag out into the interior of the film bag. In addition to the spike port, the film bag may also have a correspondingly designed injection port, in order to achieve an improved quality of the sealed connection for this as well.

According to one embodiment of the invention, the foil bag as a further connection to a welded to the film tube, the outwardly facing end is subsequently closed with a conventional plug. About the only subsequently closable tube, the foil bag can be filled, for example, even after its complete production. The subsequently closable hose makes it possible, depending on the customer's request, to place any plugs on the hose. The sealable tube can be made of a soft plastic, which, however, must be supported during welding with a mandrene so that it does not change its shape during the welding process.

It is expressly understood that the above-described embodiments of the inventions can be combined with each other alone, but also in any combination with the subject of claim 1.

Further advantageous modifications and embodiment of the invention can be taken from the following objective description and the drawings.

Fig. 1:

eine Längsschnitt-Ansicht durch einen Injektions-Port,

Fig. 2:

eine Längsschnitt-Ansicht durch einen Spike-Port,

Fig. 3:

eine vergrößerte Ansicht des Anbindungsbereichs der in Fig. 2 gezeigten Kappe,

Fig. 4:

eine Ansicht auf einen Spike-Port mit einer alternativen Kappenform,

Fig. 5:

eine vergrößerte Ansicht des Anbindungsbereichs der in Fig. 4 gezeigten Kappe,

Fig. 6:

eine Ansicht auf einen Folienbeutel,

Fig. 7:

eine Schnittansicht auf einen Injektions-Port mit verlängertem Schaftabschnitt,

Fig. 8:

eine Schnittansicht auf einen Spike-Port mit verlängertem Schaftab-schnitt,

Fig. 9:

eine Ansicht auf einen Folienbeutel, der mit verlängerten Injektions- und Spike-Ports ausgestattet ist, und

Fig. 10:

eine Ansicht auf einen Folienbeutel mit einem Injektions-Port und einem zusätzlichen Schlauch.

The invention will be described in more detail with reference to an embodiment. Show it:

Fig. 1:

a longitudinal sectional view through an injection port,

Fig. 2:

a longitudinal section through a spike port,

3:

an enlarged view of the connection area of in Fig. 2 shown cap,

4:

a view of a spike port with an alternative cap shape,

Fig. 5:

an enlarged view of the connection area of in Fig. 4 shown cap,

Fig. 6:

a view of a foil pouch,

Fig. 7:

a sectional view of an injection port with extended shaft portion,

Fig. 8:

a sectional view of a spike port with extended shaft section,

Fig. 9:

a view of a foil bag, which is equipped with extended injection and spike ports, and

Fig. 10:

a view of a foil bag with an injection port and an additional hose.

In Fig. 1 a longitudinal sectional view through an injection port 2 is shown. The injection port 2 has a shank portion 4 which can be welded to the foil layers of a foil bag. The injection port 2 has a receiving space 8 into which a closure 6 made of an elastomeric material is inserted. In the exemplary embodiment, the closure 6 fills the entire receiving space 8. The lateral wall of the receiving space 8 is formed in the region of the injection opening 12 as a projection 10 which is formed in the embodiment as a ring because of the round receiving space. The projection 10 protrudes by a measure on the inner surface of the side wall of the receiving space 8, so that a positive engagement of the closure 6 results in the projection 10. However, the projection 10 does not close off the receiving space 8 at the end facing away from the foil bag, but still leaves sufficient free space for the injection opening 12.

In the exemplary embodiment, a separating membrane 14 is inserted between the closure 6 and the hollow interior of the shaft portion 4. When a film bag equipped with the injection port 2 is filled with a liquid, the separation membrane 14 prevents the liquid from coming into contact with the elastomeric material of the shutter 6.

The receiving space 8 with the decision located thereon and the injection port 12 forms the injection end 16 of the injection port 2. With the end of the shaft portion 4 facing the film bag, the injection port 2 can be welded to the foil layers of a foil bag.

Like from the Fig. 1 it can be seen, the thickness of the side wall 18 is about 20 to 40% of the inner diameter of the cavity located in the shaft portion 4.

The side wall 18 of the shaft portion 4 is guided at its end facing the injection end 16 to the outside to provide a transition to the enlarged diameter of the receiving space 8. In the transition region, the side wall 18 forms an annular surface 20, against which the closure 6 is supported on the bag side. The separating membrane 14 is located in the transition region from the receiving space 8 to the shaft portion 4.

In Fig. 2 an embodiment of a spike port 22 is shown. The spike port 22 has a bag-side shaft portion 4, which is welded to the film layers. At its end facing away from the bag, there is a closure end 24. After closure of the film bag, a closure 6 is placed on the closure end 24, which closure may in particular consist of an elastomeric material. To secure the closure 6 sufficiently, this is the embodiment pressed with a cap 32 on the flange 28. In the exemplary embodiment, the closure 6 has a larger diameter than the inner diameter of the cavity in the shaft section 4. In the transition region from the side wall 18 to the flange surface 28, there is a support ring 26 which punctures the surface of the closure 6 facing the shaft section 4. On the inner surface of the cap 32 is a clamping lug 34 which compresses the closure 6 of the support ring 26 opposite side and holds form-fitting. The combination of the support ring 26, the clamping lug 34 and the corresponding shape of the closure 6 already provides a good mechanical security of the closure 6 when it is held by the cap 32. The holder of the closure 6 is in the exemplary embodiment outside the continuation of the cavity formed in the shaft portion 4 in the direction of the closure end 24th

The cap 32 is connected to the spike port 22 via the flange surface 28. In the contact region between the flange surface 28 and the corresponding inner surface of the cap 32, a molten lip 30 is formed in the embodiment, which primarily melts with a welding of the cap 32 with the flange surface 28 and a fusion bond with the material of the cap 32 is received. The separate fusion connection of the cap 32 with the flange surface 28 of the spike port 22 results in additional securing and sealing of the closure 6.

The configuration of the connection zone between the cap 32 and the flange surface 28 is in Fig. 3 shown in an enlarged view.

In Fig. 4 an alternative embodiment of a cap 32 is shown. The cap 32 has a lid portion 36, which the injection port 12 as a tamper-evident closure covers. Over a weakening zone 38, the lid portion 36 can be separated from the rest of the cap 32 when the corresponding foil bag is taken into use.

In Fig. 5 Again, an enlarged version of the connection zone between the flange 28 and the cap 32 is shown. This can be at the in Fig. 4 shown embodiment of the cap are identical to the in Fig. 2 shown embodiment of the cap 32nd

In Fig. 6 Finally, there is a view of the film bag 40, which is provided in the embodiment with an injection port 2 and a spike port 22. From the view in Fig. 6 It can be clearly seen that the injection port 2 and the spike port 22 can be easily integrated into a corresponding structure of a foil bag.

In Fig. 7 is a sectional view of an injection port 2 with extended shaft portion 4 is shown. At the lower end of the shaft portion 4, a slot-shaped recess 44 is formed.

Fig. 8 shows a sectional view of a spike port 22 with extended shaft portion 4. There is a slot-shaped recess 44 is formed at the lower end of the shaft portion 4.

Fig. 9 shows a view of a foil bag, which is equipped with extended injection and spike ports 2, 22. The ends of the shaft portions 4 protrude into the interior of the film bag 40 and are over a measure of the sealing zone with the weld line 44 over. Even with the in Fig. 9 recognizable water level 46 of the liquid contained in the film bag 40, which has fallen below the upper edges of the projecting into the bag interior ends of the shaft portions 4, this can still on the recesses 42 in the shaft portions 4 of the injection and the spike ports 2, 22 automatically from the Drain the foil bag.

In Fig. 10 a film bag is shown in which a spike port 22 is welded to the film layers of the film bag 40. In addition to the spike port 22, a hose 50 welded to the film is present as a further connection, the outwardly pointing end 52 of which is closed with a conventional plug 54 which has been placed on the end 52 after the tube 50 has been welded into the foil bag 40 , The conventional plug 54 is an injection plug in the embodiment.

The embodiment described above is only illustrative of the invention. The invention is not limited to the embodiment described above. It is not difficult for the person skilled in the art to modify the exemplary embodiment in a manner which seems to be suitable in order to adapt it to a specific application.

Claims (17)

Spike port (22) for a film bag (40) for medical purposes made of two film layers bounding an interior space with a hollow section (4) which is weldable to the film layers and a closure end (24) into which a closure (6) is used from an elastomeric material, characterized in that at the closure end (24) a flange surface (28) is formed, via which the shaft portion (4) with an attached cap (32) is connected by a welded connection. Spike port (22) according to claim 1, characterized in that the welding is carried out via an ultrasonic welding. Spike port (22) according to claim 1, characterized in that on the flange surface (28) has a melting nose (30) is formed, whose material is fused at the welding with the material of the cap (32). Spike port (22) according to one of the preceding claims, characterized in that the flange surface (28) is formed in a three-dimensional spatial form. Spike port (22) according to any one of the preceding claims, characterized in that on the side wall (18) and / or the flange surface (28) a support ring (26) is formed, on which the closure (6) is placed. Spike port (22) according to one of the preceding claims, characterized in that in the area adjacent to the support ring (26) of the cap (32) on the closure (6) facing surface of the cap (32) has a clamping nose (34) is formed. Spike port (22) according to any one of the preceding claims, characterized in that the closure (6) has a larger diameter than the cavity formed in the shaft portion (4). Spike port (22) according to one of the preceding claims, characterized in that the cap (32) only partially covers the closure (6) to the outside, so that an injection opening (12) remains free. Spike port (22) according to one of the preceding claims, characterized in that the inner diameter of the shaft section (4) formed in the cavity is greater than 5 mm. Spike port (22) according to any one of the preceding claims, characterized in that the shank portion (4) has at its bag-side end a recess (42) in the shaft wall. Spike port (22) according to one of the preceding claims, characterized in that the spike port (22) is made of a dimensionally stable plastic. Foil bag (40) with a spike port (22), characterized in that the spike port (22) is designed according to the characterizing features of one or more of claims 1 to 11. Foil bag (40) according to claim 12, characterized in that in the foil bag (40) an additional injection port (2) is present with an injection end, wherein the injection end forms a receiving space (8) into which the closure (6) in sealing fit is used, the side wall of the receiving space (8) at its the shaft portion (4) facing away from an inwardly directed projection (10) which leaves an injection opening (12), against which the closure (6) but in his Seal is partially positively supported, and the closure (6) is already positioned before welding the injection port (2) with the film layers in its sealing position in the receiving space (8). Foil bag (40) according to claim 12, characterized in that the spike port in its shank portion (4) has a smaller inner diameter than the injection port (2). Foil bag (40) according to any one of claims 12 to 14, characterized in that the spike port (22) at its bag-side end with the end of the shaft portion (4) via the welding zone with the film material of the film bag (40) out into the interior of the film bag (40) protrudes. Film bag (40) according to any one of claims 12 to 15, characterized in that the film bag (40) has an injection port (2) at its bagside end with the end of the shaft portion (4) over the welding zone with the film material of Foil bag (40) protrudes into the interior of the film bag (40). Film bag (40) according to any one of claims 11 to 15, characterized in that the film bag (40) as a further connection welded to the film Hose (50), the outwardly facing end (52) is subsequently closed with a conventional plug (54).

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