DE7933323U1 - HOSE COUPLING - Google Patents

Description

Device for continuous ambulatory peritoneal dialysis and Hose coupling for it

The invention relates to an apparatus for continuous ambulatory peritoneal dialysis, and more particularly an improved solution container for this purpose as well as an improved hose coupling (luer lock assembly) for Use here as well as for other medical purposes.

The device according to the invention is particularly suitable for the continuous outpatient peritoneal j or Abdominal cavity dialysis, in which a dialysis solution is poured into the abdominal cavity of a patient, left in it for several hours and finally made to flow out of the abdominal cavity repeating this process on a virtually continuous basis. One way to do it Such a dialysis consists in that a dialysis solution container is connected to a catheter, which in turn is inserted into the patient's abdominal cavity, the clamping of the hose line between the container and the abdominal cavity is released to allow the solution to flow into the abdominal cavity, then the hose line is clamped again and the dialysis

lesion for several hours, ζ.Β »is left in the abdominal cavity for four hours, the clamping of the hose line then canceled again and the solution is allowed to flow back out of the abdominal cavity into the container 2, the dialysis solution container is separated from the catheter tube and a new dialysis solution container is connected to the latter and then the steps described above are repeated.

According to the invention, it has been found that the process described above can be improved while ensuring improved freedom of movement for the patient when a dialysis solution container in bag form, especially in the form of a flexible, collapsible bag. After the outflow of the Solution from the bag of this can be folded up and carried by the patient. An effective connection and separation between the dialysis solution bag and the patient's catheter tube can be achieved by using a tube coupling arrangement (luer lock connector system). It bears the hose going out from the solution bag has a first coupling piece, while the one running to the patient's abdominal cavity Catheter tube carries a complementary coupling piece. The need for this, in the absence of liquid to establish and maintain an essentially sterile (uncontaminated) condition of the hose coupling apparently; such a state can now according to the invention guaranteed.

It has been found to be advantageous to design the coupling piece worn by the patient as an element provided essentially for long-term use, while the coupling piece with it cooperating coupling piece carried by the hose going out from the solution container can be readily disposable after (one-time) use. It is necessary that the coupling connection is secure and liquid-tight in order to avoid contamination that leads to

<< Il «» 444> * 4

ft I 4 4 4 4 4

<III «· 4 4 4

• I II * "4". · 4

<I ι · <1 «4

• «• 4 I» 4 4 Μ «« 4 · 4

- 7 could lead to peritonitis.

When the dialysis solution bag carries the transfer tube or connection tube that extends from it and can be connected to the patient's catheter tube. it may be desirable to have a flow of dialysis solution out of the Bag to prevent its hose. By using a breakable connection that is connected to the hose line of the bag, a flow of the Solution from the bag into the tube until it breaks of the connection piece can be prevented.

The object of the invention is, in particular, to create an improved solution container for continuous ambulatory peritoneal dialysis, the container bo to be designed that it offers the patient considerable freedom of movement.

Another object of the invention is to provide a convenient means of preventing solution flow from the container into the transfer or connecting tube of the Container until a breakable element is broken, so that a connection can also be made without supplying liquid.

The invention also aims to provide a special one Hose coupling arrangement, through which the integrity of the connection is maintained and contamination safe is prevented*

This coupling is intended to ensure a sealing connection between the inner and outer coupling parts, so that leaks are avoided and a watertight bacterial barrier or block is offered on the connection.

In this coupling, one coupling piece should also be designed for long-term use (relatively

permanent), while the other coupling piece can be discarded after (one-time) use.

The solution container according to the invention should have a particle filter and a hose clamp, which are switched into the connecting hose extending from the container, see above that a simple but highly effective hose line is offered on the container, while the solution container itself should consist of a flexible, foldable plastic.

This object is achieved in a device for continuous ambulatory peritoneal dialysis, in which a solution container is connected to a flexible hose line with a Abdominal cavity of a patient inserted tubing connected | according to the invention solved by a flexible, collapsible dialysis solution container with a connecting stub going from it, through a stub going from the stub, flexible hose with a coupling piece attached to its end facing away from the container for connection to a coupling piece carried by the patient hose and a breakable element arranged in the hose, which normally blocks the passage through the hose, but after breaking a flow through the Hose allows.

This device has a particulate filter filter) trained in the flexible hose line. This hose line also contains a manually operated one Hose clamp.

This device is provided with a hose coupling, which is characterized in that it has an inner coupling piece and an outer coupling piece which cooperates with this, that the inner coupling piece has one with a Axiolbore provided central tubular part which is at least partially enclosed by an outer sleeve with a substantially circular cross-section, which is a

■ ·

<■ · ■ α

Has internal thread that the AuQen coupling piece a Main pipe part, which is located in the area of its outer end carries a radially outwardly projecting flange, which in turn is dimensioned so that it is with a screw bend able to cooperate with the internal thread of said outer sleeve, and that a sealant for producing a Pressure contact seal with the inner (wall) surface of the Outer sleeve for interconnected coupling pieces and to create a waterproof bacterial barrier the hose coupling is provided.

In a special embodiment, the AuGen coupling piece is provided with an elastomeric element with such dimensions provided that it can be brought into pressure contact with the inner surface of the rigid outer shell of the inner coupling piece, so that a watertight bacteria barrier is guaranteed at the hose coupling. In addition, the elastomer Item to be soaked with a sterilizing device, or the The chamber formed by the outer sleeve can be filled with such an agent by the patient, whereby the preservation the sterile state of the device is supported.

In a modified embodiment, the outer wall part merges into the outer surface of the main pipe part, and it is provided with a backward tapering. As a result, when the two coupling pieces are screwed together, the pressure contact between the inner wall Reinforced the outer sleeve and outer wall surface of the inner and outer coupling piece.

In a further modification, the two coupling pieces are each made in one piece, made of the same material, with the outer coupling piece is made of stainless steel or titanium to ensure long-term use, while the inner coupling piece consists of an elastic plastic and, if necessary, can easily be discarded (after a single use). Of course, however, within

ti

f t ■ »·

■ ■ · ·

/ ft

- 10 -

A variety of suitable materials are used and / or grounded within the scope of the invention.

In the following, preferred embodiments of the invention are explained in more detail with reference to the accompanying drawings. Show it:

1 shows a diagrammatic representation of a solution container device with features according to the invention for continuous ambulatory peritoneal dialysis,

2 shows a view, on an enlarged scale, of the underside of an inner hose coupling piece according to the invention,

Fig. 3 is a partially cut-away side view of the Inren coupling piece according to Fig. 2,

Fig. 4 is a plan view of the coupling piece according to Fig. 2 and 3,

Fig. 5 is a plan view of an external coupling piece according to the invention,

Fig. 6 is a partially cut-away side view of the Coupling piece according to Fig. 5,

7 shows a partial sectional view, on a greatly enlarged scale, of the coupling piece according to FIG. 6,

8 shows a partially cut-away side view of an element for closing the outer coupling piece according to FIG. 6,

9 is a partially cut-away side view of a Closing element for the inner coupling piece

as ft β *

- 11 according to Fig. 3,

10 is a partially cut-away side view of another embodiment of an external coupling piece and

11 shows a partial sectional illustration on an enlarged scale an inner coupling piece and the outer coupling piece according to FIG. 10.

The dialysis solution bag IJ shown in FIG. 1 has from its one side 16 outgoing connection stubs 12 and 14, of which the stub 14 b «ii of the embodiment shown closed with an injection port 20 (injection site) 1st.

The bag or container 10 is preferably made of welded together at the edges of sheets of flexible K ^- nstetoff film. From the connecting piece 12 a flexible plastic hose 22 goes off, which is connected to the inlet 24 of a particle filter 26, the Auolaß 28 is connected to a flexible hose 30, in which a manually operated hose clamp 32 is turned on and the an inner coupling piece 34 carries at its outer end.

An inner coupling piece 34 is with an outer coupling piece 36 connected, which is carried by the distal end of a patient catheter tube 38 which is in the abdominal cavity of the patient is inserted. Further details regarding the structure of the clutch assembly according to the invention from the inner coupling piece 34 and the outer coupling piece 36 are explained in more detail below with reference to FIGS. 2-9.

A breakable or predetermined breaking member 40 is turned on in the connection piece 12 and the hose line 22, namely in the inner passage. The breakable or predetermined breaking element, which is preferably made of a plastic

• I '' t »

Il 4 I (·

I It

I: ■ <>

t · · I <ll «< >

- 12 -

fills the inner passage of nozzle 12 and hose 22 from, whereby it is provided with a central bore «the is closed by a breakaway member 42. if the member 42 is broken off by hand, the Dlalyaelöeung contained in the solution bag 10 can be broken open by dua Element 40 and thus flow out through the hose 22. As a result of this configuration, the solution in the bag is retained in the bag until the element 40 is broken open on the connecting piece 12, because the solution is allowed to flow out of the bag 10 via the hose 22 after the element 40 is broken open can"

The tilter 26 is a partial filter with a pore size of about 5 μm and a comparatively large surface. The surface of each filter is advantageous

2 2

at least 4 cm and preferably about 7 cm. The filter 26 preferably consists of a hydrophilic filter membrane a vent in the form of hydrophobic membranes.

The hose clamp 32 can be of a type known per se and preferably opened and closed by hand will.

In certain cases patients may prefer a connection between the solution container and the catheter tube, in which the insertion and removal of a hollow connecting needle on the solution container is not necessary. if namely, if such a hollow needle is not used carefully, impurities can be introduced through it, which possibly cause peritonitis. Under these circumstances, the hose coupling according to the invention prove to be advantageous because with it a connection can be made with one less contamination is likely.

The inner coupling piece 34 illustrated in more detail in FIGS. 2-4 has a central tubular part 50 an axial bore 52, which is formed to form a

111

- 13 -

Insert or insertion piece 50a with a circular Cross-section extends backwards · The insert 50a is welded into a flexible hose line by means of soldering fluid shrink-wrapped, and it expands over shoulders 54 in Outward direction, so that it forms an outer shell 56 which the central tubular part 50 surrounds. The outer sleeve 56, which is provided with a knurled grip section 5B, is inserted Internal thread 60. The outer sleeve 50 is used to prevent contamination caused by contact Connect and disconnect the coupling, and it is provided with the internal thread 60, in which a flange 62 (Fig. 6) of the outer coupling piece 36 engages.

From Figures 5-7, in which the outer coupling piece 36, it can be seen that this coupling piece 36 has a main pipe portion 64 which is shown in FIG Area of its outer end 66 carries a flange 62 projecting radially outward. Around the pipe part 64 there is a hand-made, preferably one material, one therewith detectable ring 68 arranged, on which also a toothed, rearwardly extending nozzle is formed, which can be welded in the passage of the patient catheter tube 38. The outer surface of the ring 68 is knurled at 72 and therefore easier to grasp by hand. The connecting piece 70 is with the ring 68 over several shoulders connected, wherein the central pipe part 64 and the rearwardly extending stub 70 are provided with a common axial bore 76.

The flange 62 is shaped and dimensioned such that when the internal coupling 34 is connected to the external coupling 36, the central tubular portion 50 of the coupling 34 enters the bore 76 and the flange 62 can be guided along the thread 60 with a screwing movement while establishing a secure connection.

The diameter of the bore 76 tapers from the outer

- 14 -

end to a diameter which is smaller than the outer diameter of the central tube part 50, so that between the outer surface and the inner surface of the pipe section 64 a firm pressure contact can be established "

According to FIGS. 6 and 7, the tubular part 64 carries a number of projections or annular beads 7B, while over These annular bulges 7Θ an elastomeric element 80 is arranged around the tubular part 64 «the latter has one ■ Hingwulst 82 that meets outside and is intended for sealing purposes on. When the two coupling pieces 34 and 36 have been put together, the elastomeric element 80 enters the outer sleeve 56, whereby the annular bead 82 a seal is made on the inner surface of the outer sleeve 56. In addition to providing an effective seal to prevent contamination, the elastomeric element 80 also acts as a waterproof bacteria barrier which maintain the uniformity of the clutch assembly and thus prevent its contamination.

If desired, the elastomeric element 80 can be impregnated with a commercially available sterilizing agent, or the The chamber defined by the outer sleeve 56 can be filled with such a sterilant by the patient. The outer coupling piece 36, with the exception of the elastomeric element 80, is preferably produced by injection molding as a one-piece molded part, and the elastomeric element 80 can be formed in a subsequent injection molding operation in the manufacture of the clutch assembly. On similar ones Way also consists of the entire inner coupling piece 34 a one-piece molded part.

In Figures 10 and 11 a modified embodiment of the outer coupling piece 202 is shown, wherein parts of the outer coupling piece 202 and the inner coupling piece corresponding to the parts of the coupling pieces 36 and 34 210 are denoted by the same reference numerals as before.

- 15 -

The coupling piece 202 points in a visible direction Main pipe part 64, which in the area of its outer earth with a radially protruding flange 62 is provided. The pipe part 64 merges into a ring 204 which can be grasped by hand which continues from the pipe part 64 in the rearward direction and on which a toothed, rear connection piece 70 is integral is molded. the one with a flexible plastic tube can be connected or welded, i.e. when shown Embodiment can be used in the passage of the patient catheter tube. In the rear portion of the outer surface of the ring 204 is a knurled portion 72 for Provided to facilitate the grasping of this ring by hand. The connector 70 is, as mentioned, connected to the ring 204, and the pipe part 64 and the connecting piece 70 are penetrated by a coaxial bore 76.

The inner coupling piece 210 for use in the outer coupling piece 202 according to FIG. 10 corresponds to the coupling piece 34 according to FIG is made of an elastomeric material. For this purpose, the outer sleeve 213 can be molded separately and then be attached to the inner coupling piece, or it can be an integral part of the elastomeric material if desired manufactured element are provided.

The outer surface area 204 of the outer coupling piece is flared outwardly at 206 in the rearward direction so that the pressure contact between inner surface 212 of the Reinforced outer sleeve 213 of connector 210 and the outer surface when the two coupling pieces are screwed together.

The flange 62 is shaped and dimensioned so that when the inner coupling piece 210 is connected to the outer coupling piece 202, the central tubular part 50 of the coupling piece 210 enters the bore 76 and the flange 62 is securely connected to a screw

- 16 -

Movement along the internal thread 60 shifted. The inner surface 212 of the outer sleeve 213 engages with a tight fit

conical on surface 206 of outer surface portion 204, where>

'ή. this contact when screwing the two coupling Vi

pieces becomes even more intimate. Due to the pressure contact between Inner surface of outer sleeve 213 and outer surface 206 or a pressure seal is thus produced, by means of which leakage is avoided and a watertight bacterial barrier is ensured.

When the male coupling 202 is connected to a catheter tube that extends into the abdominal cavity of the Patient, the coupling 202 should preferably be made of a more durable or durable material exist. To this end, the coupling 202 can be made from stainless steel or titanium.

In certain cases the patient may wish to disconnect the clutch when the dialysis solution gets into his abdominal cavity has been introduced. For this purpose, according to FIG. 0, a closure cap 90 is provided for closing the outer cooling piece, which is provided with a closed upper part 92 and a sidewall 94 drawn downwardly. The latter forms a bore 96 with a diameter corresponding to the diameter of the opening of the outer sleeve 56, and in the inner wall surface of the side wall part 94 a thread 90 corresponding to the internal thread 60 is provided. In addition, the closure cap 90 is provided with a central tubular part 50b. A knurled section serves to make it easier to hold the cap 90 in place.

According to FIG. 9, a cap 102 for covering the inner coupling sleeve has a similar configuration like the Auflen coupling case 36, only with the difference, that they do not have a pipe socket going out in the reverse seal 70 has. The sections of the outer coupling cover

• 9

- 17 -

corresponding areas of the closure cap according to FIG. 9 are denoted by the same reference numerals as before. The bore 76 is not continuous, but closed at the end of 104. It can be seen that the inner coupling piece 34 can also be attached to the patient's catheter tube 38 be provided, while the outer coupling piece 36 on The outer end of the hose 30 is attached.

Due to the interaction between outer sleeve 56 and elastomeric element 80 or outer sleeve 211 and outer cone 206, contamination through contact is prevented in the coupling arrangement, while a good seal and a watertight bacteria barrier are ensured when the coupling is connected Contamination is prevented.

Although only two currently preferred embodiments of the invention are shown and described above, Various changes and modifications are of course possible for those skilled in the art without departing from the scope of the invention is deviated.

Claims (12)

fcaxtcr Trav'jnol Lab., In (T * .. ""; · '::.' (New) claims for protection, 1. Hose coupling consisting of an inner coupling piece (34) and an outer coupling piece (36) cooperating with it in a sealing manner, the inner coupling piece a central tube part (50) with an axial bore (52) and at least a part of the tube part (50) of an outer sleeve (56) with a substantially circular cross-section is enclosed, which has an internal thread (60) and wherein the outer coupling piece has a main pipe part (64) with radially outwardly projecting has flange-shaped projections (62) which are dimensioned so that they with a screwing movement with the internal thread (60) of the outer sleeve (56) of the inner coupling piece (34) are able to interact, characterized in that between the outer sleeve (56) and the pipe part (64) is provided with a further seal, which is a waterproof bacteria barrier. 2. Hose coupling according to claim 1, characterized in that the seal is an elastomeric element (80) which surrounds the main pipe part (64) of the outer coupling piece (36) and that with the outer sleeve (56) produces a pressure contact seal. 3. Hose coupling according to claim 1, characterized in that the outer coupling piece (202) has a has rigid outer wall portion (204) which is so fitted that it is a pressure contact seal with the inner surface (212) the outer sleeve made of an elastomeric material (213) is able to produce. 4. Hose coupling according to claim 3, characterized in that the outer wall part (204) has a cone or conical surface (206) extending backwards and widening calibration outward, which, when the two coupling pieces (210; 202) are screwed together, an increased pressure contact between the inner surface of the outer sleeve (214) and the outer wall part (204) ensured. 5. Hose coupling consisting of an inner coupling piece (34) for a tight connection with an external coupling piece with a central, towards the free end towards conically tapering pipe part (50), the one Has an axial bore (52) and is enclosed by an outer sleeve (56) at least up to a certain height is, which defines an annular space together with the pipe part and that on the inner wall of the outer sleeve Threaded area is formed, characterized in that the thread area of the inner wall towards the free edge of the outer sleeve, a smooth area designed as a sealing surface without threads connects. 6. Hose coupling according to claim 5, characterized in that the axial length of the outer sleeve (56) is greater than the axial length of the central tubular part (50). 7. Hose coupling according to claim 5 or 6, characterized in that the inner coupling piece (34) is made of elastic plastic. 8. Hose coupling according to one of claims 5, 6 or 7, characterized in that the inner coupling 1> I X piece can be connected via a hose to a container that contains a peritoneal solution. 9. Hose coupling consisting of an external coupling piece (36), with a main pipe part (64), into which an inner coupling piece (34) can be inserted in a sealing manner, wherein the main pipe part (64) at its free end axially outwardly protruding flange-H-shaped projections (62) having a mating thread of the internal coupling piece (34) cooperate, thereby indicating that the outer wall of the main pipe part (64) in a region which is remote from the free end and the projections (62), an enlarged one Has diameter and is designed as a sealing surface. 10. Hose coupling according to claim 9, characterized in that the main pipe part (64) is designed to be elastically deformable in the area of the sealing surface. 11th Hose coupling according to Claim 9 or 10, characterized I mark η et that the outer coupling piece (36) is connected to a container via a hose line can be connected, which contains a peritoneal solution. 12. Hose coupling according to claim 9 or 10, characterized characterized in that the outer coupling piece (36) consists of titanium.