WO2001010362A1

WO2001010362A1 - Tubular conduit for urine collecting receptacle

Info

Publication number: WO2001010362A1
Application number: PCT/DK2000/000431
Authority: WO
Inventors: Børge STISEN
Original assignee: Maersk Medical A/S
Priority date: 1999-08-06
Filing date: 2000-08-02
Publication date: 2001-02-15
Also published as: DK173857B1; AU6261800A; DK199901104A

Abstract

The invention relates to an apparatus for conducting liquid, comprising a tubular conduit (7) comprising at least two separate lumens (A, B) each having a first and a second end, where the first ends are adapted for connection to an inlet opening (9) of a receptacle (10); a coupling element (13) with a chamber (103) whereto the at least two lumens are connected such that a communication between the two lumens is provided through the chamber, and where the chamber has an inlet opening (2) to which a liquid source can be connected. The invention is characterized in that the coupling element comprises a one-way valve (6) allowing fluid to flow from the source of liquid through the inlet opening and into the chamber, but prevents that liquid flows from the chamber and out through the inlet opening, which makes possible complete emptying of the tubular conduit for liquid and prevents retrograde flow of liquid towards the liquid source.

Description

Title: tubular conduit for urine collecting receptacle

The present invention relates to a tubular conduit adapted for conducting a liquid from a liquid source to a given location, where the tubular conduit is adapted such that it allows complete emptying of the tubular conduit for liquid and prevents that liquid flows back towards the liquid source. Such a tubular conduit can advantageously be used between a urine catheter and a urine drainage receptacle.

A traditional type of apparatus for collecting urine is the urine-meter, as described m for example the brochure "UnoMeter 500 - simple, safe and accurate urine measure- ment" (03-97 GB) published by Maersk Medical A/S. Such a urine-meter is traditionally connected to a catheter, introduced into a patient's bladder, using a tube with a circular inner cross-section. The tube and the catheter are connected to each other using a connecting element which can be integral with either the tube or the catheter. The tube of the described urine-meter has an inner diameter of 7 mm. This diameter is chosen such that m principle it should be possible to empty the tube by moving it, such that the urine runs downwardly and into the chamber of the urine-meter. The condition for this to happen is that air can move from the chamber up into the connecting element between the catheter and the tube, as the cavity m the connecting element does not communicate with the exterior. In praxis it is not possible or very difficult to empty the tube m this way. If the tube never the less has to be emptied, which is necessary for properly measuring the hour-diuresis, this is done by de- connecting the tube from the catheter, this allowing air to be introduced into the tube from the free end thereof. From a bacteriological point of view this is inconvenient as a direct communication is established between the ex^¬ terior and the patients urinary tract via the relative short distance through the catheter; further more, it is bothersome just as it may result m the spilling of urine .

The problem could be solved partly by a manually operated valve on the connecting element between the catheter and the tube, but this solution would result m potentially contaminated air from the surrounding being introduced into the closed system resulting m an increased risk of infection.

Tubular conduits with more than one lumen are very well known per se, for example from the medical field, however, this has always been for the purpose of separating the flow of different fluids; the mixmg-up of the liq- uids by "short-circuiting" two lumens at both ends thereof has neither been desirable nor relevant.

When, for example, urine flows from the catheter into the tube, the lumens will to a greater or lesser extend be filled and the urine will be conducted to the collecting chamber of the urine meter. When the flow of urine stops, typically more urine will be located m one of the lumens as compared with the other.

As m praxis, there will always be located different amounts of urine m the lumens, the urine m one of the lumens will "take over" and pull the urine m the second lumen backwardly and thereafter out through the first lu- men. This "siphoning" is possible as the lumens are connected at one end thereof via the connecting element between the catheter and the tube as well as the ether ends of the lumens are vented via an opening m the urine me- ter's collecting chamber.

An attempt to solve the above-described problem using this principle has been provided by a urine-collecting device as described m US patent 3,583,401 and indicated m the preamble of claim 1.

A different problem relating to the known urine collecting devices is that urine can flow backwardly from the collecting receptacle to the bladder, this increasing the risk that germs can be introduced into the bladder through the tubular conduit and the urine catheter. An attempt to solve this problem has been made by providing a one-way valve corresponding to the inlet of the tubular conduit into the collecting receptacle, for example as shown in the above-mentioned brochure "UnoMeter 500 - simple, safe and accurate urine measurement" where the collecting receptacle has been provided with an integrated one-way valve.

Although both of the above solutions have been known for many years, their mutually oppositely directed functional properties have prevented that these solutions could be realised m one and the same device for simultaneous solving of the above-identifled problems.

Thus a need exists for an improved device which both provides that a tubular conduit between, for example, a catheter and a urine meter can be fully emptied without the need for detaching the tube or m other ways to make an opening into the closed catheter/tube system, and that germs cannot make their way into the bladder through the urine catheter. ~c)

The present invention is based on the recognition that a valve arranged in the urine collecting receptacle will prevent the free communication between two conduits which empty into the receptacle, thus preventing that the con- 0 duits are vented to the surroundings through the vent of the urine collecting receptacle.

More specifically, the present invention solves the above problem by partly using a tubular conduit having at least 5 two lumens between two points, for example between a catheter and a vented urine meter, wherein the lumens corresponding to the respectively ends of the tubular conduit are connected with each other, i.e. "short- circuited", partly by providing the end of the tubular 0 conduit, which is adapted to connect with a urine catheter, with a one-way valve preventing retrograde flow of urine to the bladder.

By the term "a tubular conduit having at least two lu- 5 mens" is to be understood both a number of individual tubes as well as a single tube having at least to internal lumens, just as the conduit (s) could have any desirable cross-sectional configuration.

0 In principle the present invention can be realised by two different embodiments, one in which the tubular conduit is an integral with the collecting unit, and another m whicn the tubular conduit is adapted to be connected with the collecting unit.

In the following the invention will be described with reference to the drawings illustrating the preferred em- oodiment, where:

Fig. 1 shows a device for collecting urine from a patient, where the connecting tube as well as the associ- ated two coupling devices are represented in sectional view corresponding to the longitudinal axis of the coupling element and the tube;

Fig. 2A shows a longitudinal cross-section through the chamber part;

Fig. 2B shows the side of the chamber part facing the cover part;

Fig. 3A shows a longitudinal cross-section through the cover part;

Fig. 3B shows the side of the cover part facing the chamber part, and with the valve element in place;

Fig. 4 shows as an example the tube arranged with an even slope between the urine catheter and the collecting receptacle;

Fig. 5 shows two examples m which the tube is arranged with a "hill-top" between the urine catheter and the collecting receptacle; and Fig. 6 shows three examples m which the tube is arranged with a "valley" between the urine catheter and the collecting receptacle.

In all the figures like reference numerals refer to like or corresponding elements.

Fig. 1 shows a device for collecting urine from a patient, comprising a metering receptacle 10 with an inlet opening 9, whereto urine is substantially continuously supplied over a period of time via a tubular conduit 7 and a catheter (not shown) introduced into the patient and coupled to the proximal end of the tubular conduit. The metering receptacle 10 is adapted for being attached to, for example, a hospital bed by hangers (not shown) , such that it is oriented horizontally when correctly mounted. The metering receptacle comprises a connecting element 14 adapted for attachment to a urme-collectmg receptacle (not shown), typically m the form of a bag. The metering receptacle 10 has m its upper wall 11 a small opening 12 towards the surroundings allowing pressure equalizing by which the lumens of the tubular conduit are vented to the surroundings (see below) . The opening 12 does not have to be formed as a separate or permanent opening but could, for example, be integrated with a valve arrangement (not shown) , which can open and close for the supply of liquid to the metering receptacle and/or open and close for the ventilation. The vent opening can also be equipped with a filter. The term vent opening as used m claim 1 also covers these different possibilities. In order to prevent that the conduit kinks the connection with the metering receptacle can be formed with an anti-Kink element 8 which as shown can be m the form of a helix arranged around the conduit 7.

The conduit ^~ is formed with two lumens A and B and is corresponding to its first, distal end attached to the inlet opening 9 of the metering receptacle and corresponding to its second, proximal end attached to a coupling element 13 with an inner chamber, such that both lumens are communicating with both the metering recepta- cle 10 and the chamber and thus establish to separate flow conduits between the chamber and the metering receptacle. The snown coupling element and the shown conduit have a general longitudinal axis m the plane of the paper. In Fig. 1 is the terms "air" and "fluid" used to m- dicate that air and fluid flows and lumen A and B respectively, however, the opposite could also be the case depending upon the actual circumstances.

The coupling element comprises three portions: a valve housing 3, a first coupling element 4 for coupling the tubular conduit to the valve housing, and a second coupling element 1 for coupling, for example, a urine catheter to the valve housing.

The valve housing comprises m the shown embodiment three parts: a chamber part with an outlet opening, a cover part with an inlet opening and a valve element (shown respectively closed 6 and open 5) secured between the chamber part ano the cover part. These parts will be de- scribed m greater detail below. To the chamber parts outlet opening is attached the first connecting element 4 which again is connected with the conduit 7, and to the cover parts inlet opening is attached the second connect- mg element 1, which m the shown embodiment comprises a sample port 2 for taking samples. This port comprises a membraⁿe which can be formed witn a slit such that a sample car be taken without using a needle. Tne second con- nectmg element is typically a coupling organ formed as a conical connecting piece which can be pushed into the open end of a catheter facing away from the patient.

In a preferred embodiment the first connecting element 4 is manufactured a material with a higher flexibility than the material from which the chamber part is manufactured, but with a lower flexibility than the material from wnich the conduit 7 is manufactured, such that an anti-kmk connection is provided between the conduit and the valve housing. The different parts can be assembled using any convenient technique, for example gluing or welding.

With reference to Figs. 2A, 2B, 3A and 3B the valve hous- mg will be described. Compared with Fig. 1 are Figs. 2A and 2B rotated 180 degrees with respect to the general plane of the cover part. As indicated above the valve housing comprises a chamber part 100 with a chamber 103 and a connecting piece 101 providing an outlet opening 102, a cover part 200 with a connecting piece 201 providing an inlet opening 202 as well as a valve element 60 (shown broken line) attached between the chamber part and the cover part.

The valve element comprises a flat membrane manufactured from a flexible material such as rubber or silicone and comprises a first portion 61 attached between the valve housings chamber part and cover part and a second free portion 62 which is moveable relative to the valve housings chamber part and cover part and which covers the inlet opening 202 when the valve element is m its closed position (shown full line m Fig. 1) . The free portion 62 comprises a first surface facing the cover part and a second surface facing away there from. The first surface and the cover part is adapted m such a way that a tight seal is established when the membrane abuts the cover part, this preventing that liquid can pass from the cham- Per 103 to the connecting piece 201 and thereby to the attached catheter (not shown) . This will happen when the pressure is higher m the chamber than m the catheter whereby the valve will protect against retrograde flow of urine. When the pressure m the catheter is higher than the pressure m the chamber the valve will open and urine can pass from the catheter through the chamber and the conduit 7 to the metering receptacle 10 and the collecting receptacle. This kind of valve is often called a "flap" or "leave" valve.

In order to secure that the valve element is safely mounted m the valve housing the membranes first portion 61 is provided with one or more openings 63 through which gripping means can be arranged. In the shown embodiment the gripping means is formed as to pair of male and female elements arranged on the cover part and the chamber part respectively. Each of the female elements is arranged on an inner surface of the chamber part facing the cover part and comprises a distally open cylinder 104 with a distal, circular abutment surface 105. The male elements comprise pointed projections arranged on the in^¬ ner surface 104 of the cover part and are provided with a number of correspondingly pointed flanges 105. The pro- jections maximum widths correspond to the inner diameter of the cylinders. The male and female elements are adapted such that they will grip the membranes first portion between the cylinders abutment surfaces and the cover parts inner surface when assembled, with the male elements arranged through the openings of the membrane and gripping the side of tne cylinders open distal ends 106. By this arrangement it is secured that the valve element is safely attached between the two parts.

In the preferred embodiment a connecting conduit with a circular cross-section 301 (see Fig. 1) and an internal flat partition wall 302 arranged between opposed portions of the conduit is used, whereby two half-moon or D-shaped lumens A and B are established. An outer circular cross- section provides a simple attachment to both the coupling element and the metering receptacle using a short tubular connecting piece 19 into which the conduit is mounted, but it would also be possible to form both the coupling element and the metering receptacle with a half-moon or D-shaped connecting piece mounted m each lumen. The end of the conduit which is mounted m the metering receptacle should further be adapted to provide a good release function, i.e. prevent that liquid due to capillary ac- tion will stay the lumens. This can conveniently be provided by the downwardly oriented protrusions seen m Fig. 1, or by the distal opening of the lumens having a larger cross-sectional area, for example by an obliquely cut end surface.

In the above is described an embodiment with a multi lumen conduit having two lumens, but it would be possible to use more than two lumens, just as it would be possible to use separate conduits for each lumen. The latter would result a more complicated attachment of the conduits to the coupling element respectively the metering receptacle .

With reference to Figs. 4 through 6 the function of the tubular conduit according to the present invention will be described. As can be seen, a catheter 20 is attached to the inlet opening of the connecting element 13. As de- scribed m the introduction above, m praxis more urme will always be located m one lumen as compared with the other when the flow of urme stops, such that two columns of urme with unequal length and weight will be located m the respective lumens A and B. Due to the combined ef- feet of gravity and capillary action the longer column m lumen A will "take over" and flow towards the collecting receptacle 10. As the two columns are connected via the chamber m the valve housing (see Fig. 1) and as the short column in lumen B is vented via the opening 9 m the metering receptacle 10, the two columns will behave like a single column such that the shorter column m lumen B will be pulled backwardly towards the connecting element and subsequently through the lumen A towards the metering receptacle. In case the conduit is arranged with a uniform slope as shown Fig. 4 it will be self- emptying, i.e. all liquid will flow into the receptacle without any additional action.

In Fig. 5 is shown an example m which the tubular con- duit is arranged with a "hill-top". If the free distal end of the longest liquid column is located at a level below the coupling element 13 as shown m the upper situation the conduit will be self-emptying due to the siphoning action. In case the free end of the longest of the liquid columns is located at a level below the coupling element 13 as shown m the lower situation the conduit will not be self-emptying . However, this is no prob- lem as _t only demands that the conduit and the connecting element 13 s elevated until a situation as shown m Fig. 4 or Fig. 5 upper situation arises. The conduit will hereafter be emptied completely.

In Fig. 6 is shown an example which the tubular conduit is arranged with a "valley". If the free end of the longest liquid column is located at a level below the coupling element 13 as shown m the upper situation the conduit will also m this case be self-emptying due to the siphoning action. In case the free end of the longest of the liquid columns is located at a level m which it will have to flow "uphill" as shown in the lower two situations the conduit will not be self-emptying. However, this is no problem as it only demands that the con- duit and the connecting element 13 is elevated until a situation as shown m Fig. 4 or Fig. 6 upper situation arises. The conduit will hereafter be emptied completely.

During experimentation it has been found that a cross- sectional area for each of the lumens corresponding to an inner diameter of from 4 to 6 mm for a circular conduit works well. A suitable material for the conduit is soft PVC . Other suitable materials for the different elements described above are described m the above-cited brochure "UnoMeter 500 - simple, safe and accurate ur e measurement" , see page 4. In the above the invention has been described with reference to use m connection with a metering receptacle and a urme catheter, however, the invention could find use wherever a liquid is transported a tubular conduit to- wards a vented receptacle, and where emptying of the conduit hitherto has posed a problem.

Claims

1. Apparatus for conducting liquid, comprising:

- a tubular conduit (7) comprising at least to separate lumens (A, B) each having a first and a second end, where the first ends are adapted for connection to an inlet opening (9) of a receptacle (10);

- a coupling element (13) comprising a chamber (103) whereto the at least two lumens are connected such that a communication between the two lumens is provided through the chamber, and where the chamber has an inlet opening (2) to which a liquid source can be connected; characterized m that the coupling element comprises a one-way valve (6) allowing fluid to flow from the source of liquid through the chambers inlet opening and into the chamber, but prevents that liquid flows from the chamber and out through the chambers inlet opening.

2. Apparatus according to claim 1, characterized m that the tubular conduit is a single multi-lumen conduit with at _^east two lumens.

3. Apparatus according to claim 1 or 2, characterized m that the tubular conduit has just two lumens, preferably formed as two D-formed lumens m a conduit with an outer circular configuration.

4. Apparatus according to any of the previous claims, characterized m that the liquid source is a urme cathe- ter.

5. Apparatus according to any of the previous claims, characterized m that the one-way valve comprises a gen- erally flat membrane which can be moved between an open position allowing fluid to flow the chambers inlet opening and into the chamber, and a closed position preventing liquid from flowing from the chamber and out through the chambers inlet opening.

6. Apparatus according to claim 5, characterized in that the membrane comprises a first portion attached relative to the coupling element and comprising an opening, and a second portion which can be moved between a first and a second position.

7. Apparatus according to claim 6, characterized m that the coupling element comprises at least one attachment means arranged through at least one opening in the membrane .

8. Apparatus for collecting liquid, combination with an apparatus for conducting liquid according to any of the previous claims, comprising: a receptacle (10) with an inlet opening (9) and a vent opening (12); wherein the first ends of the lumens are connected to the inlet opening such that liq^¬ uid can be conducted from the liquid source to the recep- tacle through each of the at least two lumens.

9. Apparatus according to claim 8, characterized m that the receptacle (10) is an apparatus for measuring the supply of a liquid from a patient, especially urme.

10. Apparatus according to any of the previous claims, combination with a urme catheter.