Patent Application
20050171496
The present invention relates to a conduit device for conducting a fluid from a fluid source to a recipient, comprising a tubular portion having an inlet end and an outlet end, an inner side of said tubular portion being intended for contact with the fluid.
The invention furthermore relates to use of said conduit device as a hose member in connection with a collection bag, use of said conduit device as a hose member connecting a urinary catheter device with a urine collection bag, to a kit comprising such a conduit device and a collection bag, and to a urinary catheter arrangement comprising such a conduit device, a catheter device, and a collection bag.
Such conduit devices find widespread use within ia. the technical field of conducting and collecting body fluids. The conduit device may eg. form part of a kit or an arrangement, eg. a catheter arrangement for the relief of incontinence, and is e.g. utilized for connecting a urinary catheter device with a urine collection bag.
For instance, in the case of male urinary incontinence an external catheter device is generally placed externally on penis. The discharge spout of the catheter is connected with a hose member that in turn is connected with a urine collection bag. The wearer of the urinary catheter suitably places the urine collection bag in a position lower than the position of the urinary catheter to ensure that the urine effectively is drained off by gravity. To allow free movement of the wearer of the urinary catheter the urine collection bag is generally positioned at a part of the leg. Generally, it is preferred to position the urine collection bag at the shin to drain off urine in a standing as well as a sitting position. Furthermore, this position of the urine collection bag provides for the possibility of hiding it behind a trouser leg.
Basically, the same procedure is carried out in urinary catheterisation by insertion of one end of a catheter device through the urinary duct such that at least the tip thereof extends into the bladder. The other end of the catheter is connected with the inlet end of a hose member, the outlet end of which is connected with a collection bag as described in the above.
When using such catheter arrangements, the problem arises, following a discharge of urine, that the unbroken column of urine in the hose member gives rise to a considerable build-up of sub-pressure in the conduit device. This sub-pressure affects, in the case of an external urinary catheter device, the surface of the corona, and, in the case of a catheter device introduced into the bladder, the walls of the bladder, which may be sucked into abutment against the tip or inlet eyes of the catheter. In both of these cases, the wearer of the urinary catheter is subjected to discomfort, especially on extended exposure to the sub-pressure. In the case of external catheters, suction marks have been observed on the corona due the exposure to sub-pressure. In severe cases, oedema and subsequent infection can develop.
It has been suggested to overcome this problem by incorporating a vent or a valve in the urine collection bag or the lower part of the hose allowing the surrounding air to communicate with the interior of the catheter-hose-bag environment. Reference is made to e.g. U.S. Pat. No. 3,835,857 and U.S. Pat. No. 5,622,183. However, the position of a vent or valve in the bag or the lower part of the hose member entails the potential risk that urine, when the bag is full or about to be full, will escape the urine collection bag.
Although not concerned specifically with the same problem, WO 01/10362 discloses an arrangement for emptying a tubular conduit connecting a catheter and a urine measurement apparatus. This rather elaborate arrangement comprises a coupling element having a one-way valve and a double lumen hose, thereby preventing fluid to flow back to the bladder. By this arrangement, it is possible to empty the tubular conduit completely.
In connection with external catheter devices for the relief of male urinary incontinence, another suggestion is disclosed in U.S. Pat. No. 5,897,540 wherein a slit-shaped opening is provided in a condom-like device for drainage of uncontrolled urine release. The opening is provided for ventilation of the space entrapped between the device and the penis and is placed in the position of use at the main body of the penis well behind the corona. The opening is not provided with a filter or similar means. A further suggestion is disclosed in U.S. Pat. No. 4,656,675, which describes a condom-like device for draining off urine. The device is provided with a filter covering a hole positioned at a point close to the source of urine. The filter is capable of passing air but impervious to liquid at relative low pressures. A major drawback of this suggestion is that the filter is placed at an exposed position. The wearer of the device must be careful since the filter easily can be ripped off by abrasion or accident and the urine will tend to be conveyed through the hole in the device and not as intended through the hose member.
In Applicant's international application PCT/DK02/00862, not yet published, an external catheter device is disclosed, in which a membrane capable of selectively passing gases but retaining urine is fastened to the surface surrounding an aperture in the catheter. The membrane is at least partly protected by a shield.
As this arrangement entails that the amount of urine discharged from a wearer may be drained to a urine collection bag via a hose member without leaving a substantial amount of urine in the hose member giving rise to a sub-pressure at the surface of the corona, the arrangement thus provides a solution that functions satisfactorily when relieving male urinary incontinence by means of an external catheter device. However, this solution may not be applied in connection with other types of catheter devices. Furthermore, the arrangement is to some extent complicated to manufacture, and additionally, gases, ia. ambient air is introduced into the urine containing system, which entails a potential risk of infection. In addition, the collection bag is filled with gases when taking the arrangement into use.
With this background it is an object of the present invention to provide a conduit device of the kind mentioned in the introduction, in which the formation of a sub-pressure in the tubular portion is eliminated or at least substantially reduced, and which at the same time is simple and inexpensive to manufacture.
It is a further object of the invention to provide a conduit device that may be utilized with a large variety of designs of the fluid source and the recipient, respectively.
These and further objects are met by the provision of a conduit device of the kind stated in the introduction and which is furthermore characterized in that means are provided for adapting the surface tension of at least the fluid.
It turns out that the difference in surface tension between the inner side of the tubular portion and the fluid to be conducted therein is an important factor in the formation of a fluid column in the tubular portion and thus the resulting undesirable sub-pressure. In the case in which the conduit device is employed as a hose member forming the connection between a urinary catheter device and a urine collection bag, the fluid—urine—normally has a surface tension in the range of 55 to 65 dyn/cm (mN/m). In comparison, the polymer materials generally utilized for such hose members possess a substantially lower surface tension, typical examples being polyolefins, ethylene-vinyl acetate (EVA), PE, PE copolymer, PVC, PP etc. having a surface tension of typically less than 40 dyn/cm.
In conduit devices made from such traditional materials, the urine will form drops on the inner surface of the tubular portion. These drops form a plurality of more or less coherent columns that prevent emptying of the urine into the collection bag and thus causes sub-pressure in the inlet end of the tubular portion.
Without intending to limit the scope of the invention to a specific explanation, it is believed that in the conduit device according to the invention, in which means are provided for adapting the surface tension of at least the fluid, the tendency of the fluid to adhere to the inner side in the shape of drops is eliminated or at least substantially reduced. This prevents, in turn, that the fluid in the tubular portion forms the above-mentioned plurality of columns, without the need for introduction of gases from the surroundings. Consequently, the fluid is able to flow substantially easier in the conduit.
Said means may be provided as a surface active agent introduced into the fluid, said surface active agent being capable of reducing the surface tension of the fluid.
The surface active agent may be provided in the form of tablet in a dispensing unit positioned near or at the inlet end of the tubular portion.
Alternatively, the surface active agent may be incorporated in the tubular portion of the conduit device, such that the surface active agent is in contact with at least the inner side of the tubular portion. The surface active agent may be an additive dissolved in the material that makes up the tubular portion, or it may be in the form of smaller or larger separate accumulations of molecules scattered throughout said material.
As a further alternative, the surface active agent may be provided by means of a gel or by injection of a liquid surface active agent. The surface active agent can e.g. be chosen from the group of polyphenylene oxide-polyethylene oxide copolymers, polyethylene glycol esters etc., but any suitable material having the desired properties may be used.
In order to reduce the formation of columns even further and thus to enhance the flow through the tubular portion, at least one part of the tubular portion may have enlarged cross-sectional dimensions in relation to the remaining parts of the tubular portion, e.g. by making at least a part of the tubular portion corrugated.
The cross-section may include at least one incision. Hereby, it is believed that gases present in the tubular portion prevent fluid from entering and adhering to the inner side of the tubular portion in the area of the incision or incisions.
The incision or incisions may have a substantially V-shaped or U-shaped cross-section and/or extend in a spiral or curve.
Alternatively or additionally, the conduit device may include a cord member extending substantially throughout the length of the conduit device.
In a simple manner, any remaining fluid column may be eliminated in an embodiment, in which the outlet end of the tubular portion has a widened cross-section in relation to the remaining parts of the tubular portion.
The widened cross-section is preferably provided by at least one obliquely extending cut at the outlet end.
In addition to the means for adapting the surface tension of the fluid itself, means may, in a further embodiment, be provided for adapting the surface tension of the inner side of at least the tubular portion of the conduit device.
Such means may be provided by application of a material having a surface tension that is substantially the same or larger than the surface tension of the fluid on at least the inner side of the tubular portion. With this embodiment, the tubular portion may be made mainly from traditional materials having the desired properties with respect to flexibility, durability and ease of manufacture.
The material may comprise a continuous layer, or at least one longitudinally extending portion, thus securing that at least a part of the inner side of the tubular portion that is in contact with the fluid has a larger surface tension than the fluid, thus preventing the formation of fluid columns.
Alternatively, at least one sector of the tubular portion may be comprised of said material.
Advantageously, the material is applied by means of co-extrusion with the tubular portion. This embodiment is particularly simple to manufacture, using only well known techniques. Such techniques comprise, i.a., plasma treatment and corona treatment. Other techniques may equally be used such as coating, UV activation, shrinking and others.
In a preferred embodiment, the material is provided as an additive to the material of the tubular portion, the additive being capable of migrating to at least the inner side of the tubular portion.
In a further development of the preferred embodiment, the tubular portion includes a protective layer or coating on the outer side. This feature ensures that the additive does not interfere with any further operations, such as welding, for e.g. connecting the tubular portion with other elements.
The material may comprise a hydrophilic polymer, such as polyethylene-vinyl alcohol copolymer, ethylene-vinyl acetate copolymer having a high content of vinyl acetate, polyether esters, acrylate copolymers, polyether amides, polyurethanes etc., but may comprise any suitable material having the desired properties.
Preferably, the material also comprises at least one polyphenylene oxide, polyethylene oxide copolymer, alkyl- and/or arylsulphonates, polyethylene glycol ester, fatty acid ester, fluorosurfactant and/or siliconesurfactant. More preferably, the material comprises at least one of PEG 400 distearate, PEG 400 dilaurate, Standapol (trademark of Cognis, Germany), preferably Standapol 1345 and/or Standapol 1480, Pluronic (trademark of BASF Corporation, Germany), preferably Pluronic L10, Atmer (Trademark of Uniqema, the Netherlands), preferably Atmer 100, and/or Zonyl (trademark of Dupont, USA), preferably Zonyl FSO-100 and/or Zonyl FSN-100.
Alternatively, the means may be provided by surface treatment of the inner side of the tubular portion, e.g. by corona treatment or similar surface treatment affecting the surface tension of the inner side of the tubular portion.
In another aspect of the intention, use of the conduit device as a hose member in connection with a collection bag is provided.
In a further aspect of the invention, a kit comprising a conduit device and a collection bag is provided.
In still another aspect of the invention, use of the conduit device as a hose member connecting a urinary catheter device with a urine collection bag, is provided.
In a still further aspect of the invention, a urinary catheter arrangement is provided, said urinary catheter arrangement comprising a catheter device, a conduit device, and a collection bag, the catheter device being an external urinary catheter for the relief of urinary incontinence, or a urinary catheter for insertion into the bladder.
In the following the invention will be described in further detail with reference to the schematic drawings, in which
a and 11b show, on a larger scale, details of embodiments of the conduit device according to the invention;
Throughout the various figures of the drawings, elements having the same or analogous function in the various embodiments of the conduit device of the invention have been indicated by identical reference numerals.
The conduit device according to the invention is suitable for conducting any fluid. More specifically it is suitable for conducting body fluid, in particular urine.
The conduit device shown in FIGS. 1 to 10 of the drawings may advantageously be utilized as a hose member in a urinary catheter arrangement, e.g. as shown in
As shown in
The tubular portion 2 is flexible but nevertheless resistant to forces resulting from eg. the user's movements which could lead to twisting and kinking of the tubular portion 2, thus blocking the flow of urine between the fluid source and the recipient. In the embodiment shown in FIGS. 2 to 5, the tubular portion has a shape corresponding substantially to a hollow cylinder, the inner and outer surfaces being mainly even, whereas the cross-sectional dimensions of the tubular portion in the embodiments shown in FIGS. 7 to 9 have inner and/or outer surfaces that are not mainly even. In this respect, it should furthermore be noted that the concept ‘tubular’ should be regarded as embracing any element of arbitrary outer dimensions having a through-going cavity of any cross-section.
The main constituent of the tubular portion 2 could be any suitable polymer that fulfils the demands with respect to flexibility, ease of manufacture etc., one example being eg. ethylene-vinyl acetate. As will be described in detail in the following, means are provided for adapting the surface tension of at least the fluid and possibly that of the inner side, ie. the side that in use is in contact with the fluid, of at least the tubular portion 2 such that the surface tension of at least the inner side is substantially the same or larger than the surface tension of the fluid. The means are not necessarily present in the tubular portion only. As will be described in further detail in connection with the embodiment of
Various means for achieving the adaptation and/or for enhancing the effect are illustrated in FIGS. 2 to 11 of the drawings.
The material may also be applied in one or more longitudinally extending portions on the inner side 4 of the tubular portion. In the embodiment shown in
By forming at least a part of the tubular portion of a material having a different surface tension than the remaining parts, the formation of fluid columns is rendered almost impossible due to the difference in surface tension. However, out of considerations regarding manufacture and ia. strength and flexibility properties, this material should constitute less than approximately half the area of the entire tubular portions.
A slightly different manner of achieving the adaptation of the surface tension of the inner side of at least the tubular portion 2 is illustrated in the embodiment shown in
In a further embodiment, not illustrated, the means for altering the surface tension of the inner side of the tubular portion are provided by surface treatment of the inner side of the tubular portion, e.g. by means of corona treatment or similar surface treatment affecting the surface tension of the inner side of the tubular portion. A non-exhaustive list of examples of such treatments could be plasma treatment, chemical surface treatment etc.
Basically, the surface tension altering means are provided as a surface active agent added to the fluid, said surface active agent being capable of reducing the surface tension of the fluid. Such surface tension reducing agents are known per se and are preferably chosen from the group of polyphenylene oxide-polyethylene oxide copolymers, polyethylene glycol esters etc.
It is noted that the means for adapting the surface tension may be applied to the fluid only. However, it is preferred that such means, to be described in the following, are combined with means for adapting the surface tension of the inner side of at least a part of the tubular portion of the conduit device, as has been described in the above. It is particularly advantageous if the means, e.g. in the form of a material applied to the tubular portion, affects both the fluid and the inner side of the tubular member. For instance, material applied to the tubular material washes out into the fluid and thus affects the surface tension of both the inner side and the fluid, possibly in connection with a migration of the material within the tubular portion.
Alternatively, the surface active agent may be incorporated in the tubular portion of the conduit device, such that the surface active agent is in contact with at least the inner side of the tubular portion. This may be carried out in the manner indicated in FIGS. 2 to 4 and described in connection with the embodiment of
The surface active agent may be an additive dissolved in the material that makes up the tubular portion, or it may be in the form of smaller or larger separate accumulations of molecules scattered throughout said material.
As a further alternative, the surface active agent may be provided in the form of a gel or by injection into the lumen of the tubular portion of a liquid surface active agent.
In order to enhance the effect of the surface tension adaptation described in the above, the cross-section of the tubular portion may be designed in such a manner that the fluid is prevented from forming coherent fluid columns in the tubular portion. It is to be understood, however, that other parameters affect the flow through the conduit device as well. Hence, the position of use of the conduit device with regard to the fluid source and the recipient, respectively, has a noticeable influence on the flow, as gravity to some extent forces the fluid to flow downwards when the fluid source is situated at a high level than the recipient. Furthermore the flow is affected by the inner diameter of at least the tubular portion and by the roughness of the inner surface. In turn, the gravitational forces are affected by the inner diameter and the roughness of the inner surface. Consequently, in order to optimise the flow through the conduit device, all of the above parameters have to be considered.
In
In the embodiment shown in
a and 11b illustrate embodiments, by which the risk of fluid columns remaining in the conduit device is reduced even further by ensuring that the fluid accommodated in the tubular portion 2 flows off to the recipient. By forming the outlet end 2b of the tubular portion 2 with a widened cross-section in relation to the remaining parts of the tubular portion 2, any fluid column present in the tubular portion cannot exist in the outlet area due to the combined effect of the surface tension adaptation between the conduit device and the fluid passed therein and the widened outlet of the tubular portion. The widened cross-section of the outlet may in a simple manner be provided as shown in
The conduit device according to the invention may e.g. form part of a kit that further includes a collection bag. The kit may be used for conducting and receiving any fluid, but is particularly advantageous with body fluids, e.g. as wound drains or urinary catheterization.
As discussed in the above, the conduit device as described in connection with the embodiments of FIGS. 1 to 11 may advantageously be used as a hose member connecting a urinary catheter device with a urine collection bag.
In
In
The influence of a number of additives on the surface tension properties of a thermoplastic (EVA) was tested. The compositions were mixed in a Brabender mixer in 1/2 hour at 130° C. and 60 rpm; after which the compositions were extruded into sheets between two PET-foils. With reference to table 1 below, the surface tension properties of each composition sheet were measured in terms of the contact angle between the tangent to the surface of a drop of water and the material surface in the point where these two surfaces meet. It was not possible to measure contact angles less than 30°; at this value, the water completely wets the material surface.
As may be seen, the test showed that PEG-400 dilaurate, Standapol and Atmer show excellent skill in raising the surface tension of the thermoplastic. However, PEG-400 distearate, Pluronic and, to a certain extent, Pebax also lowered the value of the contact angle.
This decrease of the contact angle may result from the surface tension properties of both the water and the thermoplastic composition or the water only. The surface tension properties of the water may change if the surface tension altering additives are being supplied to the water from the tubular portion.
The invention should not be regarded as being limited to the embodiment described in the above but various modifications of and combinations between the various embodiments may be carried out without departing from the scope of the following claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| PA 2002 01071 | Jul 2002 | DK | national |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/DK03/00469 | Jul 2003 | US |
| Child | 11031344 | Jan 2005 | US |
