WO1996008219A1

WO1996008219A1 - Apparatus for measuring and collecting body fluid

Info

Publication number: WO1996008219A1
Application number: PCT/DK1995/000266
Authority: WO
Inventors: Gunnar Svendsen; Mark Kåre POULSEN
Original assignee: Pharma-Plast International A/S
Priority date: 1994-09-16
Filing date: 1995-06-23
Publication date: 1996-03-21
Also published as: AU2734495A; DK107394A

Abstract

A device for measuring and collecting body fluid comprises a measurement container (1) with at least one measurement chamber, wherein the measurement container is provided with a fluid inlet (2) and a fluid outlet (3), where, in connection with the fluid inlet (2) and in fluid communication therewith, a flow connection (4) is coupled, preferably a tubular connection, the distal end (5') of said connection preferably being provided with means for coupling with a catheter wherein the flow connection (4) has an exemplary, substantially circular internal cross section with a diameter of between 5.0 and 6.0 mm which allows the body fluid to fill the entire cross section due to its surface tension, and wherein the fluid connection is provided with means (6), preferably a pressure activatable and automatically closing valve which may be activated for opening to allow inflow of air into the flow connection.

Description

Apparatus for measuring and collecting body fluid

The invention relates to a device for measuring and collec¬ ting body fluid and comprising a measurement container with at least one measurement chamber, wherein the measurement container is provided with a fluid inlet and a fluid outlet, wherein said fluid inlet is coupled with the proximal end of a flow connection to be in fluid communication therewith, the distal end of said connection being provided with means for coupling with a catheter.

Such measurement and collection devices are used, e.g. in connection with urine measurement and collection, where, in this connection, a bladder catheter which is inserted into the urine bladder of a patient is coupled therewith. Hereby it is possible to read the patient's urine production at more accurately defined time intervals. This is of particular importance in case of recently operated persons in order to monitor their bladder function. In this connection, recently operated persons are checked more often than other patients.

In case of the known and commercially available devices of the kind disclosed above, however, it is a problem that it cannot be verified completely whether the urine amount found in the measurement device corresponds to the actual amount of urine produced by the patient. This is due to the fact that in practice, flexings and twistings of the tube occur whereby air pockets and pockets of fluid isolated therebetween may occur which cannot be discharged by the pressure prevailing in the bladder or by the existing pressure due to the difference in height (fluid column) between the urine bladder and an air pocket. It results that in such cases a residual amount of urine will still remain in the bladder which is not readily measurable unless a further effort is made to remove such air pockets prior to the reading, thus allowing urine in the bladder and the tube to find its way to the measurement container. Not until then is it possible to read the actual urine production. This is troublesome and time-consuming but nevertheless always indispensable for carrying out correct measurement. In case of recently operated patients this of very considerable consequence since the above-mentioned frequent reading of such patients' urine production will of course yield smaller amounts of urine read each time, while the urine still trapped in the tube and in the bladder still constitutes a relatively larger portion of the urine amount produced and may thus influence the diagnosis.

Thus, it is the object of the invention to provide a device of the type described in the introductory part which ensures in a simple and effective manner that the amount of fluid present in the measurement container substantially reflects the amount of fluid produced by the patient during the prescribed time interval, ensuring that air pockets do not occur in the flow communication and that the flow communica¬ tion proper may be substantially emptied in a simple and quick manner.

This is obtained with such a device which is characterized by at least a portion of the flow connection having an internal cross section which allows the body fluid to fill the flow cross section entirely due to its surface tension, and by the connection being provided with means which may be activated for opening to allow inflow of air in the flow connection.

Hereby the fluid's surface tension is used to ensure a continuous flow from e.g. the urine bladder, the internal diameter of the flow connection being small enough to allow the surface tension of the urine to cause complete filling of the flow cross section thereby avoiding the formation of isolated air pockets. Due to the continuous flow of urine from the bladder, accumulations of urine in the bladder is avoided. For discharging the amount of urine present in the flow connection means are provided which may be activated for opening to allow air to flow into the flow connection, said inflow of air effecting a pressure equalization whereby the flow communication relieves its contents into the measurement container. The flow connection is hereby closed against the environment between the activations of the means for opening to allow air to flow in.

Preferably, the portion of the air connection which is present between the means for opening to allow air to flow in and the inlet opening of the measurement container is provided with an internal cross section which allows the body fluid to fill the entire cross section due to its surface tension. Provided the activating means which allow air to flow in are arranged proximately to the distal end of the flow connection (preferably at a distance of about 15-25 cm) , it is not a requirement that the portion of the flow connec¬ tion which is situated between the catheter coupling means and the means for opening to allow inflow of air has such cross sectional dimensions.

Preferably the flow connection, at least the portion of the flow connection situated between the means for opening to allow inflow of air and the inlet opening of the measurement container, is constituted of a tube having a substantially circular internal cross section and an internal diameter of between 5.0 and 6.0 mm. On the basis of measurements of the surface tension of urine from a representative number of patiens, this internal diameter has proved to be useful for urine measurement and collection. In case of smaller cross sectional dimensions the flow resistance will be unacceptably high and in case of larger cross sectional dimensions the surface tension will be unable to ensure a filled cross section. In case of urine measurement and collection, at least said portion of the internal diameter of the flow connection is advantageously about 5.3 mm. In case of measurement and collection of other body fluids, other cross sectional dimensions of the flow connection may optionally be required. To ensure simple and effective air supply through the flow connection, the means for opening to provide air passage into the flow connection may be constituted of a pressure ac¬ tivatable and automatically closing valve. Hereby the air supply may be effected by one-hand operation and the auto¬ matically closing valve ensures that the valve is always closed between the pressure activations in connection with the readings.

According to a preferred embodiment the valve comprises a housing wherein a disc of an elastomeric material is located, where the disc is provided with a number of intersections which in a non-activated state of the disc close tightly, and which are opened when the disc is pressure influenced to allow passage of air into the flow connection. When relieved, the elasticity of the valve disc brings about the auto¬ matically closing effect as the valve disc reverts to its starting position. In this context a push button may be provided which is secured relative to the valve housing by means of an annular body which simultaneously secures the valve body. In the valve, ducts may be provided for inflowing air, said ducts debouching outside the pressure area and thus they are not blocked under the influence of pressure.

In order to prevent outflow of fluid and simultaneous to allow inflow of air, a filter is provided in the air flow path of the valve housing. Moreover, the filter prevents bacteria from entering into the flow connection.

A preferred embodiment of the invention will be described in the following with reference to the drawings, wherein

Fig. 1 shows a urine measurement and collection device, Fig. 2 is an exploded side view of a valve for use in connection with a device according to fig. 1,

Fig. 3 shows the valve seen in fig. 2 in its assembled state, Fig. 4 is a vertical, longitudinal sectional view through the valve seen in fig. 2 in an assembled state,

Fig. 5 is a vertical sectional view transversely to the flow direction of the valve seen in fig. 2,

Fig. 6 is a front view of a valve body used in connec¬ tion with the valve seen in figs 2-4,

Fig. 7 is a side view of the valve seen in fig. 6, and

Fig. 8 is a sectional view through the valve body seen in fig. 5 along the line A-A.

Figure l illustrates a urine measurement and collection device comprising a measurement container arrangement 1 with a first measurement chamber and with a second measurement chamber arranged interiorly of the first measurement chamber and in flow communication therewith, a fluid inlet 2 provided in connection with the second measurement chamber and a fluid outlet 3 provided in connection with the first measurement chamber. The measurement container is provided with calibra- tions. In flow communication with outlet 3 and suspended on the measurement container 1 a (not shown) collection bag is arranged. In flow communication with the inlet 2, the proximal end 5 of a flow connection 4 is mounted. At the distal end 5' of the flow connection, means are provided in the form of a socket for connection with a (not shown) catheter, e.g. a bladder catheter which is inserted into the bladder of a patient. Moreover, a test sampling valve 8 is provided which comprises a diaphragm which may be pierced with a needle. A clip 7 is arranged on the flow connection to squeeze it in order to enable it to block the flow passage. In the measurement container a (not shown) pressure equaliza¬ tion valve is provided. A measurement and collection device of this kind is described in detail in DK patent No. 158,130 and consequently reference should be made to this disclosure for a more detailed description of its functioning. The flow connection 4 consists of two tubular members 4' and 4'', respectively, an air inlet valve 6 being provided between said tubular members which in its non-activated state will be closed, but which may be activated when desired to open and thus to allow ambient air to flow into the tube 4' . Herein the device is provided with means in the form of flexible straps 9 connected to the measurement container 1 for suspension and fastening of the device onto e.g. a bed.

Figures 2 and 3 are exploded sideviews of a valve 6 in an assembled state, respectively. Figures 4 and 5 are sectional views of this valve. It will appear from these figures that the valve 6 comprises a housing 10 through which a duct 11 extends and wherein the one end of the housing is provided with means 12 for coupling with the distal end of the tubular member 4' and at its other end it is provided with an end portion 14 which, when mounted on the housing, secures a leaf valve 14 which prevents urine backflow. The end portion is provided with means for communication with the proximal end of the tubular member 4''. In the transversal direction of the duct 11 and in communication therewith the housing is provided with an opening 15. Transversally to the opening 15 a rib 16 extends whose function will be described in further detail in the following.

On an annular flange 18 in the opening 15, a valve body 19 made of a flexible material is located. Immediately above the valve body 10 a filter material is arranged. This filter prevents bacteria from entering the system and simultaneously impedes fluid outflow. Its location above the valve body ensures uninterrupted, clear passage through the filter. In a position of the filter between the valve body and the flow passage duct 11, there will be a risk of vapour condensation which has passed through the filter, where this condensate will prevent the flow of air through the filter. A push button 20 is arranged above the valve body 19 and the filter 17 for pressure influencing and opening the valve. The push button is secured by an annular securing'means 21, the push button 20 and and the fastening means being so designed that the ambient air may flow into the valve body when the push button is pressure-influenced. The annular fastening means 21 further secures the edge of the valve body 19 against the flange 18 while simultaneously securing the filter element against the valve body. The rib 16 limits the travelling of the push button 16 and thereby ensures that no damage of the filter material and the valve body occurs and that the push button is not caused to occupy a position where it is locked below the edge of the securing portion.

Figures 6, 7 and 8, which are a front view and sectional sideviews, respectively, of the flexible valve body 19, illustrates that the latter is provided with four through- going slits 24. The slits are arranged annularly outside the central abutment area of the push button 20. By pressure influencing the push button 20 it will stretch the valve body 19 as the latter is secured at its outer edge, and thus cause opening of the slits 24 so as to allow air to flow through the ducts 22 in the annular fastening element 21, on through the ducts 23 in the push button 20, through the filter 17, through the slits in the valve body and via the duct 11 into the tube 4'. In the side of the valve body facing the filter element an annular recess 25 is provided. This recess ensures a sufficiently large filter surface for passage by opening of the valve.

Claims

C l a i m s

1. A device for measuring and collecting body fluid and comprising a measurement container (1) with at least one measurement chamber, wherein the measurement chamber (1) is provided with a fluid inlet (2) and a fluid outlet (3), wherein, in connection with the fluid inlet (2) and in flow communication therewith, the proximal end of a flow connec¬ tion (4) is coupled, the distal end of said flow connection being provided with means for coupling with a catheter, c h a r a c t e r i z e d in that at least a portion of the flow connection (4) has an internal cross section which allows the body fluid to fill the entire cross section due to its surface tension, and that the flow connection (4) is provided with means (6) to be activated for opening to allow inflow of air into the flow connection.

2. Device according to claim 1, c h a r a c t e r i z e d in that the portion of the flow connection (4) between the means for opening for air inflow and the inlet opening of the measurement container in substantially its entire length has an internal cross section which allows the body fluid to fill this cross section completely due to its surface tension.

3. Device according to claim 1 or 2, c h a r a c t e ¬ r i z e d in that the flow communication (4) , at least the portion of the flow connection (4) between the means for opening for air inflow and the inlet opening of the measure¬ ment container, is constituted of a tube having a substanti- ally circular internal cross section and an internal diameter of between 5.0 and 6.0 mm.

4. Device according to claim 1-3, c h a r a c t e r i ¬ z e d in that the flow connection (4) , at least the portion of the flow connection (4) situated between the means for opening for air inflow and the inlet opening of the measure- ment container has an internal cross sectional dimension of about 5.3 mm.

5. Device according to claims 1-4, c h a r a c t e r i - z e d in that the means (6) for activating to allow air inflow are located proximally to the distal end of the flow connection (4) .

6. Device according to claims 1-5, c h a r a c t e r i - z e d in that the means (6) for opening to allow air passage into the tube are constituted of a pressure ac¬ tivatable and automatically closing valve inserted into the flow connection (4) .

7. Device according to claim 6, c h a r a c t e r i z e d in that the valve (6) comprises a housing (10) wherein a disc (19) of an elasto eric material is arranged, said disc being provided with a number of intersections (24) and which, in a non-activated state of the disc (19) , closes tightly against the surroundings and which, when pressure influenced, opens the disc and allows passage of air into the tube.

8. Device according to claim 7, c h a r a c t e r i z e d in that the valve comprises a push button (20) and an annular body (21) which secures the push button (20) relative to the housing (10) and simultaneously secures the valve body (29) relative to the housing (10) .

9. Device according to claims 6-8, c h a r a c t e r i - z e d in that ducts (22,23) are provided in the valve for inflowing air, said ducts debouching outside the pressure area and thus, they are not blocked when the valve is pressure influenced.

10. Device according to claims 6-9, c h a r a c t e r i ¬ z e d in that a filter (17) is arranged in the valve which prevents the outflow of fluid but permits the inflow of air.