DE8714464U1 - Plastic tubing set, especially for peritoneal dialysis - Google Patents

Description

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Description

The invention relates to a sterilizable or sterilised plastic tube set, as is known from the state of the art (DE-GM 8533481.2, EP-OS 135517 and DE-AS 1300 635) and is used for a wide variety of applications in the medical field for transferring fluids from a storage container to a patient. Particularly for the treatment of patients with kidney disease using peritoneal dialysis (PD), the tube systems known to date need to be improved in terms of their structural design, their sterilizability and the dangers of secondary contamination. In peritoneal dialysis, up to 100 l of treatment fluid are introduced into the cavity and then discharged again with the help of a control device. The import and export of the treatment fluid must be monitored by safety devices. It is absolutely necessary that the treatment fluid is sterile and pyrogen-free.

The invention is therefore based on the object of creating a disposable tubing set that is safe from the point of view of increased sterility requirements and against secondary contamination, especially for peritoneal dialysis.

This task is solved by the features specified in the main claim, in that all hose sections, connectors, bags, filters, drip chambers are combined into a hose set and are »sterilizable« with ethylene oxide gas. Secondary contamination occurs particularly during sterilization. This risk is significantly reduced by the integrated pyrogen/sterile filter.

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The structural design, especially the bag, ensures that this ethylene oxide gas also reaches and sterilizes all internal cavities of the hose set.
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The inventive concept is explained in an embodiment using the attached drawing. Fig. 1 shows the complete hose set and Fig. 2 shows a section through the edge of a bag.

As can be seen from Fig. 1, the hose _set has a depyrogenation/sterile filter ₃ which has an inlet hose 12 on the non-sterile side and a vent hose 11 on the same side, as well as an outlet hose 5 on the clean side which opens into a first liquid bag 1. The liquid bag 1 serves to hold the solution which is to be introduced discontinuously into the patient's peritoneum and consists of an extruded film which is welded at the edges as shown in Fig. 2. This has intersecting ribbed profiling 21 on both inner sides which ensures gas sterilization and ensures that all areas of the bag 1 are flowed over by the gas even when the bag walls are placed close together. The outlet hose 6 of the first bag 1 leading to the patient is connected to a Y-distributor 7 of an inlet/outlet hose 8 which can be connected to the patient's peritoneum. This is connected via the Y-distributor 7 to an inlet tube 9, Io to a second bag 2 corresponding to the first bag 1 for receiving the fluid drained from the patient's peritoneum, including a drip chamber 4 between the tube sections 9 and 10.

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The second bag 2 has an outlet tube 13, 14, 15 for

discontinuous drainage of the bag liquid and •a hydrophobic, bacteria-proof small filter 17 at «a highest point. The small filter 17 ensures

that in case of a device defect (e.g. spinning of the

peristaltic pump) no dangerous negative pressure on the

peritoneum can be exercised.

The hose section 14 between the two hose sections 1 and 15 is a hose section which is suitable for being processed by a periosteal hose pump

Preferably, the first bag 1 has a connection 18 at its highest point for the possible introduction of medication. A small filter with a hydrophilic filter membrane is arranged in the outlet tube 5 of the depyrogenation/sterile filter 3, which can be used for the continuous or periodic supply of medication, in particular for the continuous infusion of hepharin. All tube ends are closed with connectors 19, 20, as are usual in medical device construction.

The hose set is sterilized by gassing it internally and externally with ethylene oxide gas and is packaged sterilized.

During operation of peritoneal dialysis, the tube 9 can be clamped off at 23 during the run-in phase of the treatment fluid from the bag 1. After a period of time for the treatment fluid to remain in the peritoneum, the fluid is pumped out again, whereby the tube 9 is clamped off by clamping elements 22 and the clamping elements ">.3 of the tube 9 are opened.

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The bags 1 and 2 have a capacity of approximately 3 litres, so that the total amount of treatment liquid must be discontinuously added and removed in individual portions.
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The drip chamber 4 integrated in the hose set and located closer to the patient outlet preferably has its own small filter 24 for ventilation. This small filter 24 promotes the flow in the narrow and wide hose set, so that a significant increase in performance at the patient outlet is recorded.

The first drip chamber 4 can additionally have an inlet 26 that can be closed with a connector 20 for the introduction of substances.

Preferably, a further drip chamber 25 is arranged at the end of the outlet hose, which prevents re-contamination.

By including the various filters and the drip chambers in the tubing set, the risk of secondary contamination at connection points is reduced to a manageable level.

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Claims (10)

Sartorius GmbH File SH 8604-XP Weender Landstraße 94-108 Kö/ek D-3400 Göttingen Plastic tubing set, especially for peritoneal dialysis Protection claims: 1. Sterilizable or sterilized plastic tube set with fluid bags and connection connectors at the tube ends for carrying out device-assisted fluid transfers for peritoneal dialysis, the individual parts being connected to form a unit by welding or gluing, characterized by the following combination: a) A ^{depyrogenation filter} ( ³ ) ^having an inlet tube (12, 20) for the solution to be introduced into the patient and, ^on the same side, a vent tube (11, 20) and an outlet tube (5) on the clean side which opens into a first liquid bag (1), V 9 mm with &igr; ■ * · » « re r · · b) the first fluid bag (1) serves to collect the fluid that is to be introduced discontinuously into the patient’s peritoneum and consists of an extruded film that is welded at the edges and has ribbed profiling (21) crossing on both inner sides to ensure gas sterilization, c) an outlet hose (6> of the first bag (1) is connected to a Y-distributor (7) of a Peritoneum of the patient connected to an inlet/outlet tube (8, 19), d) the inlet/ ^outlet hose (8,19) is connected to the Y-distributor (7) with an inlet hose (9, 10) and drip chamber (4) connected to a second bag (2) corresponding to the first bag (1) for collecting the fluid drained from the patient's peritoneum, 20 e) the second bag (2) has an outlet tube (13, 14, 15) for draining the bag liquid and a hydrophobic, bacteria-proof small filter (17) at a point remote from the two bag tubes (10, 13), f) all free hose ends at risk of contamination are equipped with connectors (19, 20) and the hose section consisting of hose sections (5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15), bags (1, 2), filters (3, 17, 16, 26), drip chamber (4) and connecting connectors (19, 20) The hose set is designed to be gas-sterilizable. SM 8604«&idgr;? &bull;«&bull;it« ¹ i ·« >·»».< &diams; · · · &igr; it t 6* · · t ) «tt Ar ·· ·· »· it it · 2. Hose set according to claim 1, characterized in that the first bag (1) has a connection (18) for the introduction of medication. 3i Hose set according to claim 1, characterized in _that behind the depyrogenation/sterililiter (3) downstream a hydrophilic small filter (16) for the introduction of medication is arranged or connected to a 4. Hose set according to claims 1 to 3, characterized in that a small filter is attached to the drip chamber (4) of the inlet hose (9, 10) leading from the patient's peritoneum and into the second bag (2). (24) is arranged for sterile ventilation. 5. Hose set according to claim 4, characterized in that an inlet (26) which can be closed with a connector (20) is additionally arranged on the drip chamber (4) of the inlet hose (9, 10) leading from the patient's peritoneum and into the second bag (2). 6. Hose set according to claim 1 to 5, characterized in characterized in that an additional drip chamber (25) is arranged at the end of the outlet tube (15) with which the fluid drained from the peritoneum is discarded to prevent re-contamination. SM 3604-IP