HK1161154B - Connector having a membrane, for connecting a syringe to a container or tubing - Google Patents

Description

Connector with membrane for connecting a syringe to a container or a hose line

Technical Field

The invention relates to a device for connecting a syringe to a container or a hose line, in particular for connecting a syringe to a container for receiving infusion solutions, injection solutions or enteral nutrient solutions and in particular for connecting a syringe to a hose line of the vascular system of an extracorporeal blood treatment device or to a hose line for accessing a vein. The invention also relates to a container and a hose line having such a device.

Background

DE-a-19728775 discloses an infusion bag with an infusion part and an extraction part. The injector is used to inject the drug via the injection needle and the extractor is used to extract the solution via the sharp needle. The injection member and the extraction member have a tubular joint member, and a protective cover configured as a break-away member closes the tubular joint member.

For connecting medical instruments, tapered connection devices with a tapered rod and a tapered sleeve, the tapers of which are standardized, are known in the medical arts. A non-lockable tapered connection with a standardized taper is known as a luer lock interface connector. A luer or luer lock interface connector with a tapered stem is referred to as a male connector, while a connector with a tapered sleeve is referred to as a female connector.

DE-a-10348016 discloses an infusion bag with connectors for infusion and extraction of liquids. The connector for injecting liquids allows a conventional syringe to be connected to a tapered connection, particularly a luer lock tapered connection without a syringe needle. The injection needle with small cross section is not needed, so that the effective substance with larger concentration can be injected quickly. There is also no risk of injury to the caregiver. There is also no risk of damaging the infusion bag. The screwing of the syringe and connector ensures that the connection does not loosen. The connector has a self-sealing diaphragm with a slit, which is pierced by the conical rod of the syringe. After the conical rod is pulled out, the membrane closes again and thus prevents the liquid from flowing out of the bag. Such connectors have been proven in practice. However, a prerequisite for the proper functioning of such a connector is that the membrane can be opened easily and reliably.

EP- ｃA-0681493 proposes ｃA connector for connecting syringes which functions on ｃA different principle from the one described above. This known connector has a hollow core which is arranged in a plug which sealingly closes the connector. The core has a plurality of lateral openings below its tip. The bung surrounding the core is pressed by the tapered rod of the syringe when the syringe is connected to the connector, causing the core to penetrate into the tapered rod. Thereby creating fluid communication between the syringe and the connector through the lateral opening of the core.

EP0309771a1 discloses a device for injecting a liquid into a channel of a cannula connection, which device has a membrane which is pierced by the cannula when the cone of a syringe is connected. The basic principle here is that: the conical rod of the syringe acts on a clamping sleeve surrounding the membrane, which clamping sleeve is supported on the lower flange of the membrane. Whereby the membrane is pushed onto the sleeve. The production and installation costs and expenditure of the known device are relatively high due to the additional clamping sleeve.

US7396051B2 discloses a connector device in which a hollow body passes through the membrane of one of the connectors, the hollow body being pushed forward into the cylinder of the other connector. But the cylinder is not a conical body of the syringe.

Disclosure of Invention

The object on which the invention is based is to provide a device which allows a syringe to be simply connected to a container or a hose line without the risk of damage, and which reliably seals the container or the hose line after removal of the syringe. This object is achieved by the features given in claim 1.

It is also an object of the invention to provide a container or a hose line with such a device which allows a syringe to be simply connected to the container or hose line without the risk of injury. This object is achieved by the features of claims 15 and 19.

The measures of the dependent claims constitute advantageous embodiments of the invention. The device according to the invention has a fitting to be connected to a container or a hose line, which fitting has a recess in which a diaphragm is arranged, by means of which the recess is closed. A hollow body with a tip is also arranged in the recess of the adapter piece in such a way that the membrane is pierced when the syringe is connected to the adapter piece.

The device according to the invention is characterized in that at least the pierced part of the membrane is arranged above the hollow body in the recess of the connector part, so that the part of the membrane to be pierced is pressed onto the tip of the hollow body when the syringe is connected to the connector part. This allows easy and safe piercing of the membrane without the risk of rotation of the membrane.

In the system according to the invention, which is composed of a syringe with a conical shaft and a device for connecting the syringe to a container or a hose line, the conical shaft and the hollow body of the syringe are arranged in such a way that the conical shaft of the syringe seals off from the hollow body when the syringe is connected to the device. The tip of the syringe presses the membrane directly onto the hollow body when the syringe is connected to the adapter piece. The tip of the syringe here acts directly on the membrane.

When the syringe is connected to the device, the conical rod of the syringe seals not only against the hollow body but also against the connector piece of the device with a preferably conical connection piece, so that the two parts seal reliably against one another, which is very important in particular when providing cytostatics.

Since the tip of the syringe is advantageously spaced apart from the preferably slotted membrane, accidental opening of the membrane is avoided when two containers with the device according to the invention need to be sterilized and when there is a risk of deformation due to overpressure in the containers.

In a preferred embodiment, at least the pierced part of the membrane and the hollow body are arranged in the recess of the connector at a distance from one another. In principle, however, the tip of the hollow body can also contact the membrane. It is only decisive that the membrane is not damaged by the tip of the hollow body before the syringe is connected to the adapter piece.

In a particularly preferred embodiment, the hollow body for piercing the membrane is designed as a sleeve with a grinding disk. Thus, the hollow body does not have to have lateral openings or slots. The liquid may flow in the axial direction into the lumen of the cannula.

A particularly preferred embodiment of the invention provides for: the hollow body is fixed in the recess of the adapter part to a circular disk body, which preferably has a plurality of openings. The openings in the circular disk body are preferably holes which are arranged distributed around the circumference of the hollow body. The advantages of this embodiment are: the container to which the device is attached can be filled through the opening. Another advantage is that: if necessary, additional liquid, for example insulin or heparin, can in principle also be injected directly through the opening, if necessary, by means of a syringe with an injection needle (cannula).

In order to sealingly receive the conical rod of the syringe, the membrane is preferably slotted. This makes it easier to pierce the self-sealing membrane, in particular a hollow body made of plastic. The diaphragm can be reclosed after the tapered rod of the syringe is withdrawn, thereby preventing liquid from flowing out of the container or the hose line. However, it is also possible that no gap is provided for the membrane when the hollow body (core) is a metal core.

The adapter preferably has external threads for connection to a Luer lock syringe (Luer-LockSyring) that can be securely threaded onto the adapter. The fitting may also be provided without external threads so that only a threadless luer syringe may be attached.

In a particularly preferred embodiment, the joint part comprises a lower part and an upper part, which are fixed in a snap-fit manner. In this embodiment, a disk body for fixing the hollow body is preferably arranged on the upper end of the lower part. The membrane is preferably held clamped between the upper part and the lower part. Thereby simplifying installation. The adapter is also constructed in one piece.

The diaphragm preferably has a disk-shaped upper section, on which an annular lower section adjoins. The annular lower section of the membrane is preferably held in this embodiment clamped between the upper and lower parts of the connecting piece, while the disk-shaped upper section is pierced by the tip of the hollow body when the syringe is connected.

The membrane preferably has a groove-shaped depression on the upper side, which ensures on the one hand a secure guidance of the conical rod of the syringe and on the other hand a secure sealing of the membrane after the conical rod has been pulled out.

Advantageously, the gap-closing break-off element of the device according to the invention is designed as a flat grip part, so that it can be grasped with the thumb and forefinger, whereby the handling is simplified. The break-away element can be connected to the connector element of the device via an annular breaking zone, whereby the break-away element, although a stable hold is achieved, can be broken away relatively easily.

The inventive device is advantageously an injection-molded part that can be produced in large quantities and at low cost.

The container for medical liquids according to the invention is characterized in that the device according to the invention is connected to the container. For this purpose, the structure of the adapter piece of the device can be designed differently. Can be bonded and/or welded. The container may be a bag, in particular an infusion bag or an injection bag or a bag for containing enteral nutrient solution, and the connector may be configured as a closure to be welded or glued to the bag. The container may also be a bottle, the device may be configured as a sealing cap, or the adapter of the device may be configured as an adapter for closing the bottle.

The hose line for medical liquid of the present invention is characterized in that the device of the present invention is connected to the hose line. The glue line may be, for example, a component of the vascular system of an extracorporeal blood treatment apparatus or a glue line for accessing a vein.

Drawings

Various embodiments of the invention are further described below with reference to the accompanying drawings. The attached drawings are as follows:

FIG. 1 is a side view of one embodiment of the apparatus of the present invention;

FIG. 2 is a cross-sectional view of the device of FIG. 1 taken along line A-A;

FIG. 3 is a cross-sectional view of the device of FIG. 2 taken along line C-C;

FIG. 4 is an enlarged view A of a portion of FIG. 2;

FIG. 5 is a perspective view of the lower part of the device;

fig. 6 is a cross-sectional view of the device of fig. 1 to 5 with a syringe attached;

FIG. 7 is a partial cross-sectional view of an infusion or injection bag having a device of the invention;

FIG. 8 is a cross-sectional view of a second embodiment of the apparatus of the present invention;

FIG. 9 is a cross-sectional view of the device of FIG. 8 with the syringe attached;

FIG. 10 is a cross-sectional view of a third embodiment of the apparatus of the present invention;

FIG. 11 is a cross-sectional view of the device of FIG. 10 with the syringe attached;

FIG. 12A fourth embodiment of the device of the invention, an

Fig. 13 shows a fifth embodiment of the device according to the invention.

Detailed Description

Fig. 1 to 6 show a first embodiment of the device for connecting a syringe to a container according to the invention. Figures 1 and 2 show a side view and a cross-sectional view of the device of the invention, in which a syringe has not yet been connected to the device.

The device 1 according to the invention is designed as an injector for injecting an active substance into a container containing a medical fluid, in particular an infusion bag or an infusion solution bag. The device of the invention thus relates to a connector 1.

The connector 1 is an injection-molded part made of polypropylene and has a fitting 2 with a channel-shaped recess 3, which in the position of use consists of a bag-side lower part 4 and an interface-side upper part 5. The lower part 4 of the socket 2 has a substantially cylindrical lower section 6 and an upper section 7, the lower section 6 having a smaller outer diameter than the upper section 7. The lower section 6 can be inserted or pushed into the connecting tube of the film bag and welded or glued to the connecting tube. The lower section can also be welded or glued directly into the film bag without a connecting tube.

The upper part 5 and the lower part 4 of the connector 1 are snap-connected. For this purpose, the outer wall of the cylindrical upper section 7 of the lower part 4 of the joint element 2 has a circumferential collar 8, which, when the two part elements 4, 5 are pressed together, snaps into a circumferential groove 9 on the inner wall of the upper part 5 of the joint element 2. The lower edge 10 of the upper part 5 is supported on a circumferential projection 11 on the lower end of the cylindrical upper section 7 of the lower part 4.

A self-sealing diaphragm 12 made of an elastic material, which is also referred to as a septum, is held clamped between the lower part 4 and the upper part 5 of the fitting 2 under elastic deformation thereof. The diaphragm 12 has an annular lower section 13 which is clamped between the lower part 4 and the upper part 5 of the joint element 2. An annular lower section 13 of the diaphragm 12 adjoins a disk-shaped upper section 14. A through-opening 15 is provided in the center of the disk-shaped upper section 14 of the membrane 12. The membrane may be provided with only one transversely extending slit, or with a cross-shaped or star-shaped slit. The slit preferably extends over almost the entire cross section of the disk-shaped upper section 14 of the diaphragm. The upper side of the disk-shaped upper section 14 of the membrane 12 is provided centrally with a groove-shaped depression 16.

Above the membrane 12, the connector part 2 is designed as a connecting part having an internal cone 17 and an external thread 18. The inner cone 17 and the outer thread 18 correspond to the conical shaft of a luer lock conical connection of a conventional luer lock syringe, so that the conical shaft of the luer lock syringe can be pushed into the inner cone of the connection piece in a sealing manner and can be screwed securely onto the connector piece.

A cap-shaped break-off element 20 is connected to the connector part 2 of the connector 1 via an annular breaking region 19, which closes the channel-shaped recess 3 of the connector part 2. The disconnect 20 constitutes the initial seal of the connector. The break-off member has a lower rotationally symmetrical base portion 20A and an upper flat handle portion 20B. The flat handle portion 20B is provided with a recess 21 forming a downwardly pointing arrow indicating that the connector is an injection piece.

When a luer lock syringe is connected to the connector, the membrane 12 is pierced. For this purpose, the connector 1 has a hollow body 22 with a tip 23. The pointed hollow body forms a sleeve 22 with a grinding disk 23, which has two lateral grinding surfaces 23A and 23B opposite one another.

The ground sleeve 22 is fixed in the center of a circular disk body 24 which is formed on the upper end of the lower part 4 of the adapter body 2. The circular disk body 24 has a plurality of holes 25 arranged distributed around the circumference of the sleeve 22.

The sleeve 22 extends from the circular disk body 24 of the lower part 4 of the coupling body 2 into a cylindrical recess 26, which is surrounded by the annular lower section 13 of the diaphragm 12. Only a narrow gap 27 remains here between the underside of the disk-shaped upper section 14 of the diaphragm 12 and the tip 23 of the sleeve 22.

In order to prevent the lower part 4 from rotating in the upper part 5 of the joint element 2, the lower part 4 has an external toothing 28 above the circumferential collar 8 and the upper part 5 has a corresponding internal toothing 29, the external and internal toothings meshing with one another when the two parts are joined.

To inject the active substance, the connector disconnect 20 is twisted or bent to unscrew or break the disconnect 20, exposing the self-sealing membrane 12. A conventional luer lock syringe may then be screwed onto the connector 2.

Fig. 6 shows the connector 1 after the disconnect 20 is broken, and the luer lock syringe 28 is screwed onto the connector, thereby establishing liquid communication between the syringe and the connector. When the luer lock syringe 28 is screwed on, the front end of the conical shaft 29 of the syringe 28 strikes against the groove-shaped recess 16 in the disk-shaped section 14 of the membrane 12. When the syringe is screwed on, the conical rod is pushed further forward, which presses the disk-shaped upper section 14 of the membrane 12 downward, so that the underside of the membrane strikes against the tip 23 of the sleeve 22. When the syringe is screwed on, the conical rod is pushed further, the sleeve 22 pierces the pre-slit membrane 12 and the sleeve 22 penetrates into the cylindrical recess 30 of the conical rod 29. When the syringe is fully screwed on, a narrow gap 31 remains between the tapered rod 29 of the syringe 28 and the circular disk 24 of the lower part 4 of the adapter member 2. When the syringe 28 is unscrewed, the conical rod 29 is pulled back again, and the disk-shaped upper section 14 of the membrane 12 can thus be returned to its initial position, so that the connector is reliably closed. Since the diaphragm 12 is pre-slit, the tip 23 of the sleeve 22 can penetrate into the diaphragm 12 without damaging the diaphragm. This ensures that the membrane closes the connector again in a sealing manner when the syringe is unscrewed.

Fig. 7 shows an infusion or injection bag 32 with a connector 1 attached. The bag 32 includes two film layers 32A and 32B that are welded to each other at edges 32C. Fig. 7 shows only one section of the bag. The connector 1 is welded into the upper edge of the bag. The lower part 4 of the socket 2 of the connector 1 is pushed into the connecting tube 32D and welded thereto under sterile conditions. Before the lower part 4 and the upper part 5 are connected, the bag 32 can be filled with infusion solution, injection solution or enteral nutrient solution through the hole 25 in the lower part 4 of the connector 2 before the connector 1 is mounted.

Other embodiments of the device of the present invention will now be described which differ from the connector described in figures 1 to 6 only in the construction of the socket. The connector of figures 1 to 6 is for attachment to a bag and the device described below is for attachment to a bottle or hose line. Since the various connectors differ only in the structure of the socket 2, only the differences from the first embodiment of the connector of the present invention will be described below. Corresponding parts are designated with the same reference numerals in the figures.

Fig. 8 and 9 show a cross-sectional view of an embodiment of the connector 1' according to the invention. Fig. 8 shows the connector 1' before the syringe is connected, and fig. 9 shows the connector after the syringe 28 is connected. The lower section of the lower part 4 of the connector is in this embodiment constructed as a boat 33 which can be welded or glued to the film bag. Such a boat is known to the skilled person and forms a flat body with lateral tabs 33A and 33B.

Fig. 10 shows an embodiment of the device 1 "according to the invention, which is intended to be connected to a bottle. Fig. 11 shows the device 1 "attached to a bottle 34. The bottle 34 is a bottle conventionally used for containing medical liquids, which is hermetically closed by means of a stopper 35.

The device of the invention configured for connection to an adapter has a sharp needle 36 for piercing the stopper 35 of the bottle 34. The spike 36 extends downwardly from the cylindrical upper section 7 of the lower part 4 of the device. A cylindrical part 37, which is likewise integrally formed on the upper section 7 of the lower part 4, surrounds the spike 36. The cylindrical part 37 has a plurality of webs 38 on the inside and is provided with a plurality of slits 39, so that it can be slipped over the closure of the bottle 34. Here, the stopper 35 of the bottle is pierced so that the liquid can be extracted by means of the luer lock syringe 28.

Fig. 12 shows another embodiment of the inventive device 1' ″ for connection to a glue line 40, for example for entering a vein. In this embodiment, the lower section 6 of the lower part 4 of the device is designed as a hollow-cylindrical connecting piece 41, which is dimensioned in such a way that the glue line 40 can be pushed onto the connecting piece 41 and welded or adhesively bonded thereto. In other respects, the embodiment of fig. 12 does not differ in structure or manner of operation from the above-described embodiment.

Fig. 13 shows another embodiment of the device 1 "" of the invention, which is configured as a sealing cap for a bottle. The closure has a circular cover portion 42 to which a cylindrical side portion 43 is attached. A flange 44 for securing the cap to the bottle head is provided on the lower edge of the side portion 43.

The sealing cap 1 "" of the invention has a port system (port system)45 comprising an injection location 46 for injecting liquid and an extraction location 47 for extracting liquid. Both the injection position 46 and the extraction position 47 are closed by means of a break 48, 49, which indicates with arrows 50, 51, respectively, that the two positions of the harbour system are the injection position or the extraction position.

In this embodiment, the cap portion 42 and the cylindrical side portion 43 constitute a fitting of the device 1 "" of the invention, which fits over a bottle not shown in fig. 13.

In the filling position 46, the circular cap part 42 of the sealing cap 1 "", has a recess 3', in which a self-sealing diaphragm 12' is arranged, by means of which the recess is closed. The membrane is the same as described in the previous embodiments. In this embodiment, the membrane 12' is also pressed against the tip of the hollow body 22' arranged below the membrane 12' when the syringe is connected to the closure. In this embodiment, however, the tip 23' of the hollow body 22' is located directly below the membrane 12' and is not spaced therefrom.

The hollow body 22 'for piercing the membrane 12' during connection of the syringe is formed on a circular disk body 24 'which is located together with the membrane in the recess 3' of the cover part 42 of the closure cap. The diaphragm 12' and the hollow body 22' are held together with the disk body 24 ' in the recess 3' in a clamping manner by a projecting circumferential collar 52, which engages under the disk body 24 '. The lower section of the diaphragm is supported on an upper protruding collar 53 in the recess 3 'of the sealing cap 42 and the disk body is supported on a lower protruding collar 54 in the recess 3' of the sealing cap 42. The disk body and the cover portion of the seal cover may be bonded or welded. The extraction position 47 of the sealing cap does not have the socket according to the invention in this embodiment. The extraction position of the sealing cap will therefore not be described further.

Claims (12)

1. A system comprising a syringe (28) with a conical stem (29) and a device (1, 1', 1 "') for connecting the syringe to a container or a hose line, the device comprising:

a fitting (2) to be connected to a container or a hose line, the fitting having a recess (3, 3') in which a membrane (12, 12') is arranged;

a disconnect member (20) closing the gap (3) of the socket member (2), the disconnect member being connected to the upper end portion of the socket member; and

a hollow body (22, 22') with a tip (23, 23') which is arranged in the recess of the fitting (2);

the membrane (12) and the hollow body are arranged in the recess (3) of the connector (2) such that the membrane is pierced when the syringe is connected to the connector, wherein the membrane (12) is arranged above the hollow body (22) in the recess (3) of the connector (2) such that the membrane is pressed by the syringe onto the tip (23) of the hollow body (22) when the syringe is connected to the connector (2), and the membrane (12) and the hollow body (22) are arranged in the recess (3) of the connector (2) at a distance from one another,

the membrane (12) is slotted for sealingly receiving the conical rod of the syringe and the system is designed such that the slot is penetrated by the conical rod of the syringe when the latter is inserted, and the conical rod and the hollow body of the syringe are arranged such that the conical rod of the syringe is sealed with respect to the hollow body when the syringe is connected to the device.

2. System according to claim 1, characterized in that the hollow body (22) is fixed in the interspace (3) of the coupling piece (2) on a circular disc body (24) having a plurality of openings (25).

3. System according to claim 2, characterized in that the openings in the circular disc body (24) are a plurality of holes (25) arranged distributed around the circumference of the hollow body (22).

4. System according to one of claims 1 to 3, characterized in that the fitting (2) has an external thread (18) for connecting a luer lock syringe.

5. System according to claim 2 or 3, characterized in that the joint element (2) comprises a lower part (4) and an upper part (5), which are snappingly fixed, the disc body (24) being provided on the upper end of the lower part (4).

6. System according to one of claims 1 to 3, characterized in that the membrane (12) has a groove-shaped depression (16) on the upper side.

7. System according to one of claims 1 to 3, characterized in that the disconnection element (20) is configured as a flat handle portion which is connected to the upper end of the connector element (2) by means of an annular fracture zone (19).

8. System according to claim 1, characterized in that the hollow body is configured as a sleeve (22) with a grinding disc (23).

9. System according to claim 5, characterized in that the membrane (12) is clampingly held between the lower part (4) and the upper part (5) of the joint element (2).

10. System according to claim 5, characterized in that the membrane (12) has a disk-shaped upper section (14) on which an annular lower section (13) adjoins.

11. System according to claim 9, characterized in that the membrane (12) has a disk-shaped upper section (14) on which an annular lower section (13) adjoins.

12. System according to claim 10 or 11, characterized in that the annular lower section (13) of the membrane (12) is clampingly held between the lower part (4) and the upper part (5) of the joint piece (2).