Patent Application
20220347430
The present invention relates to relieving urinary retention and the field of intermittent catheterization.
Embodiments provide an intermittent urinary catheterisation assembly for self-catheterisation. The intermittent urinary catheterisation system comprises an intermittent urinary catheter comprising a catheter tube. The catheter tube comprises an insertable portion intended for insertion into a user's urethra, a non-insertable portion not intended for insertion into the user's urethra, and a connecting portion being integral with or mounted to the non-insertable portion. The intermittent urinary catheter further comprises a conduit extending longitudinally within the catheter tube and defining at least part of a flow path from a distal insertion end of the catheter to a proximal outlet end thereof. The assembly further comprises a measuring system for determining at least one fluid parameter in the flow path. The measuring system comprises at least one sensor element configured to determine the at least one fluid parameter in the conduit and/or in a space in communication with the conduit and a signal processing device. In one aspect, the signal processing device comprises a housing with an engagement mechanism for detachably securing the signal processing device in relation to the connecting portion of the intermittent urinary catheter, in which case the assembly comprises an interface for connecting the signal processing device to the at least one sensor element. In another aspect, the measuring system is securely connected to or integrated with the non-insertable portion of the catheter tube without the need of a catheter tube connecting portion. An intermittent urinary catheter system and a method of intermittent urinary catheterisation are also disclosed.
The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.
Intermittent catheters are typically inserted by the user him- or herself and sits only in the urethra and bladder for as long as it takes to empty the bladder—e.g. for about 5-10 minutes. Intermittent catheters are commonly used every 4-6 hours to empty the bladder corresponding roughly to the interval that people having no urinary problems will usually go to the bathroom. Intermittent catheters are typically more rigid than indwelling catheters since they have to be inserted by the user him-/herself and since they do not need to sit in the urethra for days or weeks. An important feature for the intermittent catheter is to ease the insertion into the urethra. This is done by providing the intermittent catheter with a low frictious surface. Non-limiting examples of such are hydrophilic coated catheters which are subsequently wetted by a swelling media in order to produce a low friction surface, or oil or water-based gel which is applied to the catheter before insertion into the urethra.
Intermittent urinary catheters may be provided with a hydrophilic coating that needs to be wetted prior to use and thereby absorbs a considerable amount of liquid. Such a hydrophilic coating will provide a very lubricious surface that has very low-friction when the catheter is to be inserted. Hydrophilic coated catheters, where the coating absorbs a considerable amount of liquid for a low frictious surface (swelling degree>100%), will not be suitable for indwelling catheters, because the hydrophilic surface coating would stick inside the mucosa of the urethra if left inside the body for a longer period, due to the hydrophilic coating transforming from being highly lubricious when fully wetted to being adhesive when the hydration level of the coating is reduced.
This invention relates to intermittent urinary catheters that may be provided with a hydrophilic coating of the kind that is wetted prior to use to absorb a considerable amount of liquid and to provide a very lubricious surface.
Usually catheters used as urinary draining devices are from size 8 FR to size 18 FR. FR (or French size or Charriere (Ch)) is a standard gauge for catheters approximately corresponding to the outer circumference in mm. More accurately, the outer diameter of the catheter in mm corresponds to FR divided by 3. Thus 8 FR corresponds to a catheter with an outer diameter of 2.7 mm and 18 FR corresponds to a catheter with an outer diameter of 6 mm.
Intermittent urinary catheters typically range from CH 8-CH 16.
Intermittent urinary catheters are predominantly used for self-catheterisation by the user.
Embodiments provide an intermittent urinary catheter assembly and an intermittent urinary catheter that enable measurement of a fluid parameter for increased utility and convenience for the user. The intermittent urinary catheter assembly and intermittent urinary catheter provide a sensor element configured to determine the fluid parameter.
In a first aspect, embodiments provide an intermittent urinary catheterisation assembly for self-catheterisation comprising:
In a second aspect, embodiments provide an intermittent urinary catheter for use in an intermittent urinary catheterisation assembly according to the first aspect, comprising
wherein the connecting portion is configured to mate with the engagement mechanism of the assembly.
Thanks to the provision of the at least one sensor element and the signal processing device a user of an embodied intermittent urinary catheter assembly is enabled to determine at least one fluid parameter in the conduit of the intermittent urinary catheter and/or in a space in communication with the conduit. The at least one fluid parameter may be relevant for several aspects of intermittent catheterisation and provide information on, e.g., the fluid flow rate and/or amount of urine voided during intermittent catheterisation, the filing degree of the bladder prior to intermittent catheterisation, the hydration level of the user, the presence and/or concentration of one or more analytes. Accordingly, the user is provided with improved utility of the intermittent urinary catheter assembly and may be able to make informed choices based on the information determined by the at least one sensor element and signal processing device.
At least one of the at least one sensor element may be imbedded in or integral with the catheter tube. Alternatively or additionally at least one of the at least one sensor element may be comprised in the housing of the signal processing device. In each case, the interface allows the signal processing device to establish a data connection with the at least one sensor element internally in the housing of the signal processing device, or externally between the catheter tube and the signal processing device.
In embodiments, the intermittent urinary catheter is disposable.
The connecting portion of the intermittent urinary catheter in conjunction with the engagement mechanism enables detachable securement of the signal processing device in relation to the catheter tube. Accordingly, the intermittent urinary catheter may be disposed of after each intermittent catheterisation, while the signal processing device may be used a plurality of times for more effective use of resources.
In embodiments, when the connecting portion and the engagement mechanism are properly secured in relation to each other fluid communication between the conduit and the at least one sensor element is enabled.
In embodiments, the connecting portion of the catheter tube and the engagement mechanism of the measuring device comprise respective, mutually mating connection elements. In one embodiment, the engagement mechanism comprises resilient members configured to engage and at least partially surround, e.g., grooves at the outer circumference of the connecting portion of the catheter tube, which may provide improved tactile feedback for, e.g., physically impaired users. The engagement mechanism and connecting portion may also be embodied as, e.g., counterparts of a detachable click-lock for ease of manufacture, mutually attracting magnets for ease of attachment due to the attractive forces of the magnets working at a distance, or a frictional coupling where a protruding connecting portion of the catheter tube is forced into a receiving portion of the engagement mechanism or vice versa.
In embodiments, the at least one fluid parameter comprises at least one of: pressure, fluid flow rate, particle size, particle count, particle distribution, particle concentration, particle characteristics, analyte concentration, refractive index, conductivity, temperature, absorption spectrum, refraction spectrum, viscosity, pH. Each parameter may be used to determine information relevant to the user. A sensed pressure and/or fluid flow rate may be used to determine, e.g., a urine fluid flow rate, a pressure in the bladder, an initial pressure in the bladder prior to urine voiding, a measure of the degree of expansion of the bladder, the amount of urine evacuated during intermittent catheterisation, and/or if urine voiding has suddenly stopped. The different particle characteristics allow derivation of information regarding the condition of the user. For instance, certain particle sizes/counts/distributions/concentrations may be indicators of a condition or disease. For example, a relatively high amount of protein in the urine could be signs of damage to the glomeruli. Fluid parameters such as analyte concentration, absorption spectra (colour) and conductivity may be used to determine a hydration level of the user, which in turn may help the user to prevent or alleviate dehydration, which helps to prevent infection of the bladder and/or urinary tract. The particle characteristics and spectra may also be used to establish presence and concentration of cells in the urine such as leukocytes. Any more than trace amounts of leukocytes in the urine may indicate a urinary tract- or bladder infection. Such conditions are particularly relevant to detect for users of intermittent urinary catheters as they are generally relatively exposed to such infections due to the repeated introduction of an intermittent urinary catheter in the urethra.
In embodiments, the signal processing device comprises wired or wireless connection means for connecting to- and transmitting data to another electronic device such as, e.g., a portable electronic device such as a smartphone or laptop, or a stationary computer or server for further data analysis and/or output.
In embodiments, the measuring system comprises data output means. The data output means may comprise a visual output unit possibly with resolution of colour. The visual output unit may be integrated in the housing of the signal processing device or in an external device with data connection to the signal processing device. In embodiments, the data output means comprises tactile feedback means. The tactile feedback means may particularly comprise a vibrator. The tactile feedback is able to provide feedback to the user without requiring visual contact with the intermittent urinary catheterisation assembly. Such feedback is particularly advantageous in relation to intermittent catheterisation as it is commonly done by the user him- or herself and visual inspection of the intermittent catheterisation assembly may be difficult and/or inconvenient. In one embodiment, the measuring system is configured to provide tactile feedback to the user in response to detection of a fluid flow rate, and/or a derivative thereof, below a first threshold in the conduit, and/or provide tactile feedback in response to detection of a fluid flow rate, or a derivative thereof, above a second threshold in the conduit for increased user convenience.
In embodiments, the intermittent urinary catheter is configured to rest in the user's urethra for a period of time not exceeding 15 minutes. This allows the intermittent urinary catheter to comprise, e.g., coatings that do not allow the extended duration of catheterisation inquired for indwelling catheterisation.
In embodiments, at least an outer surface of the insertable portion of the catheter tube comprises a hydrophilic surface coating. Such hydrophilic coating allows particularly convenient intermittent urinary catheterisation.
The hydrophilic coating may be provided only on the insertable part of the catheter. The hydrophilic surface coating is of the kind which, when hydrated or swelled using a swelling medium, reduces the friction on the surface area of the catheter which is intended to be inserted into the urinary channel of a user corresponding to the insertable part of the catheter.
An intermittent hydrophilic catheter differs from an indwelling catheter also in that the hydrophilic surface coating of such a catheter is not suitable for indwelling use, because the surface coating tends to stick inside the mucosa of the urethra if left inside the body for a period exceeding 5-20 minutes, due to the hydrophilic coating transforming from being highly lubricious when fully wetted (95% weight water) to being adhesive when the hydration level of the coating is reduced (<75% weight water).
In embodiments, the catheter tube is a single-lumen tube, of which the conduit constitutes the sole passage between the distal insertion end and the proximal outlet end of the intermittent urinary catheter. Such single-lumen tube catheters are generally not applicable for indwelling use because of the lack of a passage for conducting air to the balloon of an indwelling- or Foley urinary catheter.
In embodiments, at least one of the at least one sensor element is comprised in the signal processing device. This allows the at least one sensor element in the signal processing device to be re-used while the intermittent urinary catheter is conveniently disposed of. In one embodiment, the signal processing device comprises wired or wireless connection means for connecting to- and transmitting data to another electronic device such as, e.g., a portable electronic device such as a smartphone or laptop, or a stationary computer or server. In one embodiment, the signal processing device comprises data output means as those described above.
In embodiments, the measuring system comprises a measurement substructure embedded in or integral with the catheter tube, the measurement substructure being configured to allow measurement of the at least one fluid parameter in conjunction with the at least one sensor element. Accordingly, the measurement substructure may be required for measuring the at least one fluid parameter without forming part of the at least one sensor element. In some embodiments, the at least one sensor element is comprised in the housing of the signal processing device and configured to interact with the measurement substructure. Accordingly, the measurement substructure may be exposed to the flow path and enable measurement of the at least one fluid parameter, while the at least one sensor element is not exposed to the flow path and determine the at least one fluid parameter by way of interaction with the measurement substructure.
In embodiments, the measurement substructure comprises one or more electrically conducting elements, and the at least one sensor element comprises, or is in electrical communication with, a voltmeter and/or ampere meter for measurements of fluid parameters being electrical potentials or currents. Such measurements may enable derivation of information regarding fluid flow and/or fluid charge (ion charge and concentration).
In embodiments, the measurement substructure comprises a flow restrictor in the conduit and at least one pressure communication path, and the at least one sensor element comprises a pressure sensor configured to measure a pressure in the at least pressure communication path. Accordingly, the flow restrictor exposed to urine may be conveniently disposed of, while the pressure sensor possibly guarded against contact with urine may be reused.
In embodiments, the measurement substructure comprises a window being defined by a high optical transparency relative to the surrounding catheter tube for interaction with at least one sensor element in the form of a light emitter and/or optical sensor.
In embodiments, the measurement substructure comprises an optically reflecting element, and the at least one sensor element comprises a light emitter and optical sensor for determining at least one fluid parameter in the form of an optical spectrum.
In embodiments, the measurement substructure comprises an assay with at least one predefined molecular probe, the at least one molecular probe being predefined on the basis of its binding properties and/or chemical reactivity with one or more substances or bio-molecules possibly found in urine. In some embodiments, the assay emits light with a characteristic spectrum in response to binding to and/or chemical reaction with the at least one predefined molecular probe. In some embodiments, binding to and/or chemical reaction with the at least one predefined molecular probe causes a characteristic change in a recorded optical spectrum. As examples, the one or more substances or bio-molecules detected for may be Nitrite or Leucocytes.
In embodiments, the measurement substructure comprises a resilient member configured to deflect as a function of the fluid flow rate in the conduit, and the at least one sensor element comprises a camera adapted to image the deflection of the resilient member.
In embodiments, the measuring system comprises:
In such embodiments, the at least one sensor element in the housing of the signal processing device is not exposed to liquid in the conduit allowing it to be stored and reused without a particular need for cleaning the at least one sensor element.
In embodiments, the barrier element is embedded in the catheter tube allowing convenient disposal of the barrier element possibly having been in contact with urine in the conduit.
In embodiments, the barrier element comprises a liquid impermeable flexible barrier. Such a liquid impermeable flexible barrier is advantageous in that it allows a pressure to be communicated across the barrier element without liquid crossing the barrier. Accordingly, a pressure sensor may detect a pressure in the conduit without liquid communication with the conduit. The liquid impermeable flexible barrier may be made from, e.g., natural or artificial rubber, Gore-Tex (R), or polymer such as, e.g., a technical plastic (TP) or a thermoplastic elastomer.
In embodiments, the barrier element comprises a gas conduit configured to establish a gaseous buffer between the flow path and the signal processing device for effective communication of a pressure between the flow path and the at least one sensor element of the signal processing device. In one embodiment, the gaseous buffer is atmospheric air.
In embodiments, at least one of the at least one sensor element is embedded in or integrally formed with the catheter tube. In this case, the interface for connecting the signal processing device to the at least one sensor element is configured to connect the signal processing device to the catheter tube. The interface may comprise, e.g., corresponding electrically conducting elements on each of the signal processing device and the catheter tube arranged to establish electrical contact when the housing of the signal processing device is detachably secured to the intermittent urinary catheter.
By having the at least one sensor element imbedded in or integrally formed with the catheter tube, increased accuracy of determination of the at least one fluid parameter may be obtained as arrangement of the at least one sensor element relative to the conduit of the catheter tube is determined at production level. In some embodiments, a first relatively simple sensor element is embedded in or integrally formed with the catheter tube, while a second relatively complicated sensor element is arranged in the housing of the signal processing device allowing the relatively simple sensor to be disposed of with the catheter tube and the relatively complicated sensor to be re-used with the signal processing device.
In embodiments, the at least one fluid parameter comprises a pressure, wherein:
The combination of a flow restrictor and at least one pressure gauge in fluid communication with the flow path may allow the signal processing device or other device connected to the signal processing device to determine a fluid flow in the flow path in a relatively simple manner with increased accuracy relative to other ways of determining a fluid flow rate. Further, the fluid flow rate in the flow path is particularly useful in relation to intermittent urinary catheterisation. One reason for this is that sudden changes in the fluid flow rate may indicate that tissue of, e.g., the bladder has blocked liquid from entering the conduit at the distal insertion end and that repositioning of the intermittent urinary catheter will help to continue voiding and emptying of the bladder. Such considerations generally do not apply to an indwelling or Foley catheter, which commonly comprises a balloon at the distal insertion end for retaining the indwelling or Foley catheter in the bladder of the patient, the balloon preventing tissue from blocking entry of liquid.
The fluid flow rate may be determined on the basis of at least the pressure measured by the at least one pressure sensor and a pre-determined pressure/fluid flow rate dependency of the flow restrictor. A predetermined pressure/fluid flow rate dependency of the conduit as a whole may additionally or alternatively be used for deriving the flow rate. Additionally, the at least one pressure sensor of present embodiments enables measurement of a static pressure in the conduit or a space in communication with the conduit such as, e.g., the bladder of the user, if the flow path is cut-off downstream of the pressure gauge. The flow path may be cut-off by means of, e.g., a valve in communication with the flow path or the finger of the user at an outlet of the intermittent urinary catheter assembly. The flow restrictor may be embedded in or integrally formed with the catheter tube, or it may be comprised in the signal processing device.
In embodiments:
In present context, the terms ‘upstream’ and ‘downstream’ refer to the flow path having a direction from the distal insertion end of the intermittent urinary catheter towards the proximal outlet end of the intermittent urinary catheter. These terms apply analogously to extensions of the flow path in fluid communication with the flow path. Accordingly, upstream refers to a flow direction towards the distal insertion end of the intermittent urinary catheter and downstream refers to a flow direction away from the distal insertion end of the intermittent urinary catheter.
The different liquid coefficients of friction may be provided by different degrees of surface roughness. In present context, the term ‘liquid coefficient of friction’ is to be understood as a coefficient of friction defined between the given surface and liquid water (or urine). In present embodiments, the flow restrictor comprises an area of increased liquid friction causing a pressure drop across the flow restrictor. The third and fourth liquid coefficients of friction are preferably pre-defined leading to pre-defined pressure drop/fluid flow rate dependency.
In embodiments, the third liquid coefficient of friction is brought about by the inner surface of the through-going passage forming protrusions and/or ribs for simple manufacture of the flow restriction. In embodiments, the third liquid coefficient of friction is brought about by a hydrophilic adhesion layer leading to turbulence in liquid flow past the flow restriction. In one embodiment, changes of cross-sectional area along the through-going passage lead to the third liquid coefficient of friction. The cross-sectional area of the through going passage may be larger or smaller than a first maximum cross-sectional area of the conduit. If the cross-sectional area of the through going passage is larger than the first maximum cross-section area of the conduit, this enables a more well-defined drag along the through-going passage and/or a more well-defined pressure drop across the flow restriction due to a reduced Reynolds number.
In embodiments:
The different cross-sectional areas enable a pre-defined pressure/fluid flow rate dependency of the flow restrictor. In some embodiments, the second minimum cross-sectional area of the through-going passage of the flow restrictor is sized to be in the range of 5-95% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter.
In embodiments, the second minimum cross-sectional area of the through-going passage of the flow restrictor is sized to be in the range of 17-95% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter enabling a pressure/fluid flow rate dependency providing a relatively large pressure variation depending on the flow rate for ease of measurement.
In embodiments, the flow restrictor comprises an orifice plate or orifice tube. In this case, the flow restrictor results in a pressure drop across the orifice plate or orifice tube being relatively simple to implement. The pressure drop/fluid flow rate dependency is defined at least in part by the difference between the first and second cross-sectional areas, i.e. the larger the difference in cross-sectional areas, the larger the pressure drop will vary in response to a change in flow rate.
In present context, the term ‘orifice tube’ is to be understood as an orifice plate elongated in the direction parallel to the general flow-direction through the orifice. In this way, the orifice tube forms a further extending flow restrictor than an orifice plate.
In embodiments, the second minimum cross-sectional area of the through-going passage of the orifice plate or tube is sized to be in the range of 30-95% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter. While the difference between the first and second cross-sectional areas results in a pressure drop for determining the fluid flow, it has also been found to generally decrease the fluid flow rate in the flow path leading to increased voiding time. Present embodiments provide an advantageous compromise between accuracy of measurement and amount of voiding time prolongation.
In embodiments, the second minimum cross-sectional area of the through-going passage of the orifice plate or tube is sized to be in the range of 60-90% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter for an improved optimisation between accuracy of measurement and amount of voiding time prolongation.
In embodiments, the flow restrictor comprises a venturi. A venturi generally results in a relatively low pressure drop across the flow restrictor resulting in a relatively small increase of voiding time as compared to, e.g., an orifice plate or tube, while a fluid flow rate dependent pressure drop is measurable at the second minimum cross-sectional area of the venturi. A venturi may also be referred to as a venturi tube.
In embodiments, the flow restrictor in the form of, e.g., an orifice plate, orifice tube or venturi is a measurement substructure embedded in or integral with the catheter tube as further described above.
In embodiments, the second minimum cross-sectional area of the through-going passage of the venturi is sized to be in the range of 17-80% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter. Present interval of difference between the first and second cross-sectional areas have proven to be an improved compromise between accuracy of measurement and increase in voiding for a venturi flow restrictor.
In embodiments, the second minimum cross-sectional area of the through-going passage of the venturi is sized to be in the range of 17-60% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter. The embodied interval has turned out to be a further improved compromise between accuracy of measurement and increase in voiding for a venturi flow restrictor.
In embodiments, the venturi has a second liquid coefficient of friction at least at the circumference of the second minimum cross-sectional area of the through going passage of the venturi, at least part of the internal lumen of the intermittent urinary catheter has a first liquid coefficient of friction, and the second liquid coefficient of friction is smaller than the first liquid coefficient of friction. The difference in liquid coefficients of friction may be brought about by a difference in surface roughness. The relatively small second liquid coefficient of friction in the through going passage of the venturi reduces the drag and pressure drop across the venturi without compromising accuracy of measurement. Accordingly, less increase in voiding time may be achieved for the same accuracy of measurement.
In embodiments, the at least one pressure gauge comprises:
wherein the signal processing device is configured to determine a fluid flow rate on the basis of a difference between a first pressure determined by the first pressure gauge and a third pressure determined by the third pressure gauge. Present embodiments are particularly advantageous in combination with flow restrictors increasing the fluid flow in the through-going passage, such as a venturi and allow for determining the fluid flow rate for a relatively large range of fluid flow rates.
In embodiments, the at least one pressure gauge comprises:
wherein the signal processing device is configured to determine a fluid flow rate on the basis of a difference between a first pressure determined by the first pressure gauge and a second pressure determined by the second pressure gauge. Present embodiments are particularly advantageous in combination with flow restrictors primarily resulting in a pressure drop across the flow restrictor such as an orifice plate or tube and allow for determining the fluid flow rate for a relatively large range of fluid flow rates.
In embodiments, at least one fluid parameter comprises fluid flow rate, and the signal processing device is configured to determine a static pressure in the conduit or in a space in fluid communication with the conduit on the basis of the flow rate allowing simultaneous determination of the fluid flow rate and the static pressure. Accordingly, an initial static pressure in, e.g., the bladder of the user may be determined on the basis of an initial flow rate and does not require cutting off the flow path.
In embodiments, the measuring system is configured to continuously determine a loss of pressure in the fluid flow along a predetermined length of the conduit and to determine a fluid flow rate on the basis of the loss of pressure for convenient determination of the fluid flow rate.
In embodiments, the measuring system is configured to continuously determine a fluid flow rate of fluid through the conduit and to integrate the flow rate over time to obtain a measure of a total volume of urine voided from the bladder. The total volume of voided urine is particularly useful to know for a user of an intermittent urinary catheter and provides an indication whether or not further voiding is needed. The total volume of voided urine may also be an indicator of the health of the user.
In embodiments, the at least one fluid parameter comprises a pressure, and wherein at least the conduit of the intermittent urinary catheter has a pre-defined characteristic pressure drop, the measuring device comprises at least one pressure gauge in fluid communication with the flow path, and wherein the signal processing device is configured to determine a fluid flow rate on the basis of at least the pre-defined characteristic pressure drop and a pressure determined by the at least one pressure gauge. The pre-defined characteristic pressure drop is utilised to determine the characteristic pressure drop/fluid flow rate dependency and allows the fluid flow rate to be determined. The pre-defined characteristic pressure drop may be pre-determined on the basis of a reference measurement on the embodied intermittent urinary catheter, or the embodied intermittent urinary catheter may be a standardised intermittent urinary catheter wherein the pre-defined characteristic pressure drop is based on a reference measurement on another standardised intermittent urinary catheter.
In embodiments, the measuring device comprises a valve configured to allow a variable cross-sectional area of fluid flow in fluid communication with the flow path. This allows the user to vary the fluid flow rate in the flow path by adjusting the valve. In one embodiment, the valve is variable between a set of different pre-determined cross-sectional areas. In this embodiment, the valve may serve as a flow restrictor in combination with a pressure gauge. In this case, the flow rate may be determined on the basis of at least the pre-determined cross-sectional area of the valve and a pressure determined by the pressure gauge. Accordingly, if more accuracy of measurement is desired, the user may reduce the pre-determined cross-sectional area, and if a larger fluid flow rate is desired the user may increase the pre-determined cross-sectional area.
In embodiments, the valve is configured to automatically vary the cross-sectional area for the fluid flow on the basis of a determined fluid flow rate or pressure in the flow path. In this case, the valve may serve as a flow restrictor and the valve can automatically increase the cross-sectional area to increase the fluid flow rate in response to a measured fluid flow rate or pressure below a first threshold value, and automatically decrease the cross-sectional area to increase accuracy of measurement in response to a measured fluid flow rate or pressure above a second threshold value. This allows automatic optimisation of the relationship between accuracy of measurement and voiding time.
In a third aspect, embodiments provide a catheter system comprising a disposable intermittent urinary catheter according to any embodiment of the second aspect and a package for accommodating the intermittent urinary catheter therein in a sterile condition alleviating the need for sterilising the intermittent urinary catheter after removal from the package.
In embodiments, at least the insertable portion of the catheter tube comprises a hydrophilic surface coating, wherein the package accommodates an amount of a liquid swelling medium. Accordingly, the liquid swelling medium is able to activate the hydrophilic surface coating to achieve a very lubricious surface that has very low-friction when the catheter is to be inserted already in the package. In embodiments, the package comprises a gas-impermeable barrier enclosing an inner cavity accommodating the intermittent urinary catheter for improved shelf-life of the catheter system. In one embodiment, the liquid swelling medium is a water-based substance, such as sterile water, saline-solution, or any water-based liquid.
In a fourth aspect, embodiments provide an intermittent urinary catheterisation assembly comprising:
Thanks to the provision of the at least one sensor element and the signal processing device a user of an embodied intermittent urinary catheter assembly is enabled to determine at least one fluid parameter in the conduit of the intermittent urinary catheter and/or in a space in communication with the conduit. The at least one fluid parameter may be relevant for several aspects of intermittent catheterisation and provide information on, e.g., the flow and/or amount of urine expelled during intermittent catheterisation, the filing degree of the bladder prior to intermittent catheterisation, the hydration level of the user, the presence and/or concentration of one or more analytes. Accordingly, the user is provided with improved utility of the intermittent urinary catheter assembly and may be able to make informed choices based on the information determined by the at least one sensor element and signal processing device. Further, thanks to the provision of the measuring system being securely connected to or integrated with the non-insertable portion of the catheter tube a user is able to determine the at least one fluid parameter without establishment of a connection between the catheter tube and measuring system.
At least one of the at least one sensor element may be imbedded in or integral with the catheter tube. Alternatively or additionally at least one of the at least one sensor element may be comprised in a housing of the signal processing device.
In embodiments, the at least one fluid parameter comprises at least one of: pressure, fluid flow rate, particle size, particle count, particle distribution, particle concentration, particle characteristics, analyte concentration, refractive index, conductivity, temperature, absorption spectrum, refraction spectrum, viscosity, pH. Each parameter may be used to determine information relevant to the user. A sensed pressure and/or fluid flow rate may be used to determine, e.g., a urine fluid flow rate, a pressure in the bladder, an initial pressure in the bladder prior to urine evacuation, a measure of the degree of expansion of the bladder, the amount of urine evacuated during intermittent catheterisation, and/or if urine evacuation has suddenly stopped. The different particle characteristics allow derivation of information regarding the condition of the user. For instance, certain particle sizes/counts/distributions/concentrations/characteristics may be indicators of a condition or disease. For example, a relatively high amount of protein in the urine could be signs of damage to the glomeruli. Fluid parameters such as analyte concentration, absorption spectra (colour) and conductivity may be used to determine a hydration level of the user, which in turn may help the user to prevent or alleviate dehydration, which helps to prevent infection of the bladder and/or urinary tract. The particle characteristics and spectra may also be used to establish presence and concentration of cells in the urine such as leukocytes. Any more than trace amounts of leukocytes in the urine may indicate a urinary tract or bladder infection. Such conditions are particularly relevant to detect for users of intermittent urinary catheters as they are generally relatively exposed to such infections due to the repeated introduction of an intermittent urinary catheter in the urethra.
In embodiments, the signal processing device comprises wired or wireless connection means for connecting to- and transmitting data to another electronic device such as, e.g., a portable electronic device such as a smartphone or laptop, or a stationary computer or server for further data analysis and/or output.
In embodiments, the measuring system comprises data output means. The data output means may comprise a visual output unit possibly with resolution of colour. In embodiments, the data output means comprises tactile feedback means. The tactile feedback means may particularly comprise a vibrator. The tactile feedback is able to provide feedback to the user without requiring visual contact with the intermittent urinary catheterisation assembly. Such feedback is particularly advantageous in relation to intermittent catheterisation as it is commonly done by the user him- or herself and visual inspection of the intermittent catheterisation assembly may be difficult and/or inconvenient. In one embodiment, the measuring system is configured to provide tactile feedback to the user in response to detection of a fluid flow rate, and/or a derivative thereof, below a first threshold in the conduit, and/or provide tactile feedback in response to detection of a fluid flow rate, or a derivative thereof, above a second threshold in the conduit for increased user convenience.
In embodiments, the intermittent urinary catheter assembly further comprises a package assembly for accommodating the intermittent urinary catheter and the signal processing device, wherein the signal processing device is operatively connected to or operatively integrated with the intermittent urinary catheter in the package assembly when the package assembly is in a closed state. In this case, the intermittent urinary catheter assembly will be able to determine the at least one fluid parameter without requiring establishment of operational connection between the intermittent urinary catheter and the signal processing device after opening of the package. In one embodiment, the intermittent urinary catheter is stored in the package assembly in a ready-to-use condition allowing insertion of the intermittent urinary catheter and determination of the at least one fluid parameter directly upon removal of the assembly from the package requiring less handling prior to insertion.
In embodiments, the intermittent urinary catheter is configured to rest in the user's urethra for a period of time not exceeding 15 minutes. This allows the intermittent urinary catheter to comprise, e.g., coatings that do not allow extended duration of catheterisation required for indwelling catheterisation.
In embodiments, at least an outer surface of the insertable portion of the catheter tube comprises a hydrophilic surface coating. Such hydrophilic coating allows particularly convenient intermittent urinary catheterisation. In embodiments, the package assembly comprises an amount of liquid swelling medium for activation of the hydrophilic surface to provide the intermittent urinary catheter assembly in a ready-to-use state when the package assembly is in a closed state.
The hydrophilic coating may be provided only on the insertable part of the catheter. The hydrophilic surface coating is of the kind which, when hydrated or swelled using a swelling medium, reduces the friction on the surface area of the catheter which is intended to be inserted into the urinary channel of a user corresponding to the insertable part of the catheter.
An intermittent hydrophilic catheter differs from an indwelling catheter in that the hydrophilic surface coating of such a catheter is not suitable for indwelling use, because the surface coating tends to stick inside the mucosa of the urethra if left inside the body for a period exceeding 5-20 minutes, due to the hydrophilic coating transforming from being highly lubricious when fully wetted (95% weight water) to being adhesive when the hydration level of the coating is reduced (<75% weight water).
In some embodiments of the fourth aspect, at least an outer surface of the insertable portion of the catheter tube comprises a hydrophilic surface coating, and the urinary catheter assembly comprises a package assembly comprising an outer package for accommodating the intermittent urinary catheter and the signal processing device, an amount of liquid swelling medium, and a gas- and/or liquid impermeable inner barrier, wherein the inner barrier in a closed state of the outer package is arranged to prevent the liquid swelling medium from reaching the signal processing device. Accordingly, the hydrophilic coating of the intermittent urinary catheter assembly is allowed to be provided in a ready-to-use state without exposing the signal processing device to the liquid swelling medium when the package assembly is in a closed state.
In embodiments, the catheter tube is a single-lumen tube, of which the conduit constitutes the sole passage between the distal insertion end and the proximal outlet end of the intermittent urinary catheter. Such single-lumen tube catheters are generally not applicable for indwelling use because of the lack of a passage for conducting air to the balloon of an indwelling or Foley urinary catheter.
In embodiments, the measuring system comprises a measurement substructure embedded in or integral with the catheter tube, the measurement substructure being configured to allow measurement of the at least one fluid parameter in conjunction with the at least one sensor element. Accordingly, the measurement substructure may be required for measuring the at least one fluid parameter without forming part of the at least one sensor element. In some embodiments, the at least one sensor element is comprised in the signal processing device and configured to interact with the measurement substructure. Accordingly, the measurement substructure may be exposed to the flow path and enable measurement of the at least one fluid parameter, while the at least one sensor element is not exposed to the flow path and determine the at least one fluid parameter by way of interaction with the measurement substructure.
In embodiments, the measurement substructure comprises one or more electrically conducting elements, and the at least one sensor element comprises, or is in electrical communication with, a voltmeter and/or ampere meter for measurements of fluid parameters being electrical potentials or currents. Such measurements may enable derivation of information regarding fluid flow, fluid charge (ion charge and concentration).
In embodiments, the measurement substructure comprises a flow restrictor in the conduit and at least one pressure communication path, and the at least one sensor element comprises a pressure sensor configured to measure a pressure in the at least one pressure communication path.
In embodiments, the measurement substructure comprises a window being defined by a high optical transparency relative to the surrounding catheter tube for interaction with at least one sensor element in the form of a light emitter and/or optical sensor.
In embodiments, the measurement substructure comprises an optically reflecting element, and the at least one sensor element comprises a light emitter and optical sensor for determining at least one fluid parameter in the form of an optical spectrum.
In embodiments, the measurement substructure comprises an assay with at least one predefined molecular probe, the at least one molecular probe being predefined on the basis of its binding properties and/or chemical reactivity with one or more substances or bio-molecules possibly found in urine. In some embodiments, the assay emits light with a characteristic spectrum in response to binding to and/or chemical reaction with the at least one predefined molecular probe. In some embodiments, binding to and/or chemical reaction with the at least one predefined molecular probe causes a characteristic change in a recorded optical spectrum. As examples, the one or more substances or bio-molecules detected for may be Nitrite or Leucocytes.
In embodiments, the measurement substructure comprises a resilient member configured to deflect as a function of the fluid flow rate in the conduit, and the at least one sensor element comprises a camera adapted to image the deflection of the resilient member.
In embodiments, at least one of the at least one sensor element is embedded in or integrally formed with the catheter tube. By having the at least one sensor element imbedded in or integrally formed with the catheter tube, increased accuracy of determination of the at least one fluid parameter may be obtained as arrangement of the at least one sensor element relative to the conduit of the catheter tube is determined at production level.
In embodiments, the at least one fluid parameter comprises a pressure, and:
The combination of a flow restrictor and at least one pressure gauge in fluid communication with the flow path may allow the signal processing device or other device connected to the signal processing device to determine a fluid flow in the flow path in a relatively simple manner with increased accuracy relative to other ways of determining a fluid flow rate. Further, the fluid flow rate in the flow path is particularly useful in relation to intermittent urinary catheterisation. One reason for this is that sudden changes in the fluid flow rate may indicate that tissue of, e.g., the bladder has blocked liquid from entering the conduit at the distal insertion end and that repositioning of the intermittent urinary catheter will help to continue voiding and emptying of the bladder. Such considerations generally do not apply to an indwelling or Foley catheter, which commonly comprises a balloon at the distal insertion end for retaining the indwelling or Foley catheter in the bladder of the patient, the balloon preventing tissue from blocking entry of liquid.
The fluid flow rate may be determined on the basis of at least the pressure measured by the at least one pressure sensor and a pre-determined pressure/fluid flow rate dependency of the flow restrictor. A predetermined pressure/fluid flow rate dependency of the conduit as a whole may additionally or alternatively be used for deriving the flow rate. Additionally, the at least one pressure sensor of present embodiments enables measurement of a static pressure in the conduit or a space in communication with the conduit such as, e.g., the bladder of the user, if the flow path is cut-off downstream of the pressure gauge. The flow path may be cut-off by means of, e.g., a valve in communication with the flow path or the finger of the user at an outlet of the intermittent urinary catheter assembly. The flow restrictor may be embedded in or integrally formed with the catheter tube, or it may be comprised in the signal processing device.
In embodiments:
The different liquid coefficients of friction may be provided by different degrees of surface roughness. In present context, the term ‘liquid coefficient of friction’ is to be understood as a coefficient of friction defined between the given surface and liquid water (or urine). In present embodiments, the flow restrictor comprises an area of increased liquid friction causing a pressure drop in the flow path. The third and fourth liquid coefficients of friction are preferably pre-defined leading to pre-defined pressure drop/fluid flow rate dependency.
In embodiments, the third liquid coefficient of friction is brought about by the inner surface of the through-going passage forming protrusions and/or ribs for simple manufacture of the flow restriction. In embodiments, the third liquid coefficient of friction is brought about by a hydrophilic adhesion layer leading to turbulence in liquid flow past the flow restriction. In one embodiment, changes of cross-sectional area along the through-going passage lead to the third liquid coefficient of friction. The cross-sectional area of the through going passage may be larger or smaller than a first maximum cross-sectional area of the conduit. If the cross-sectional area of the through going passage is larger than the first maximum cross-section area of the conduit, this enable a more well-defined drag along the through-going passage and/or a more well-defined pressure drop across the flow restriction due to a reduced Reynolds number.
In embodiments:
The different cross-sectional areas enable a pre-defined pressure/fluid flow rate dependency of the flow restrictor. In some embodiments, the second minimum cross-sectional area of the through-going passage of the flow restrictor is sized to be in the range of 5-95% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter.
In embodiments, the second minimum cross-sectional area of the through-going passage of the flow restrictor is sized to be in the range of 17-95% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter enabling a pressure/fluid flow rate dependency providing a relative large pressure variation depending on the flow rate for ease of measurement.
In embodiments, wherein the flow restrictor comprises an orifice plate or orifice tube. In this case, the flow restrictor results in a pressure drop across the orifice plate or orifice tube being relatively simple to implement. The pressure drop/fluid flow rate dependency is defined at least in part by the difference between the first and second cross-sectional areas, i.e. the larger the difference in cross-sectional areas, the larger the pressure drop will vary in response to a change in flow rate.
In embodiments, the second minimum cross-sectional area of the through-going passage of the orifice plate or tube is sized to be in the range of 30-95% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter. While the difference between the first and second cross-sectional areas results in a pressure drop for determining the fluid flow, it has also been found to generally decrease the fluid flow rate in the flow path leading to increased voiding time. Present embodiments provide an advantageous compromise between accuracy of measurement and amount of voiding time prolongation.
In embodiments, the second minimum cross-sectional area of the through-going passage of the orifice plate or tube is sized to be in the range of 60-90% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter for an improved optimisation between accuracy of measurement and amount of voiding time prolongation.
In embodiments, the flow restrictor comprises a venturi. A venturi generally results in a relatively low pressure drop across the flow restrictor resulting in a relatively small increase of voiding time as compared to, e.g., an orifice plate or tube, while a fluid flow rate dependent pressure drop is measurable at the second minimum cross-sectional area of the venturi. A venturi may also be referred to as a venturi tube.
In embodiments, the flow restrictor in the form of, e.g., an orifice plate, orifice tube or venturi is a measurement substructure embedded in or integral with the catheter tube as further described above.
In embodiments, the second minimum cross-sectional area of the through-going passage of the venturi is sized to be in the range of 17-80% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter. Present interval of difference between the first and second cross-sectional areas have proven to be an improved compromise between accuracy of measurement and increase in voiding for a venturi flow restrictor.
In embodiments, the second minimum cross-sectional area of the through-going passage of the venturi is sized to be in the range of 30-60% of the size of the first maximum cross-sectional area of the internal lumen of the intermittent urinary catheter for an even better compromise between accuracy of measurement and increase in voiding for a venturi flow restrictor.
In embodiments, the venturi has a second liquid coefficient of friction at least at the circumference of the second minimum cross-sectional area of the through going passage of the venturi, wherein at least part of the internal lumen of the intermittent urinary catheter has a first liquid coefficient of friction, and wherein the second liquid coefficient of friction is smaller than the first liquid coefficient of friction. The difference in liquid coefficients of friction may be brought about by a difference in surface roughness. The relatively small second liquid coefficient of friction in the through going passage of the venturi reduces the drag and pressure drop across the venturi without compromising accuracy of measurement. Accordingly, less increase in voiding time may be achieved for the same accuracy of measurement.
In embodiments, the at least one pressure gauge comprises:
and wherein the signal processing device is configured to determine a fluid flow rate on the basis of a difference between a first pressure determined by the first pressure gauge and a third pressure determined by the third pressure gauge. Present embodiments are particularly advantageous in combination with flow restrictors increasing the fluid flow rate at in the through-going passage, such as a venturi and allow for determining the fluid flow rate for a relatively large range of fluid flow rates.
In embodiments, the at least one pressure gauge comprises:
and wherein the signal processing device is configured to determine a fluid flow rate on the basis of a difference between a first pressure determined by the first pressure gauge and a second pressure determined by the second pressure gauge. Present embodiments are particularly advantageous in combination with flow restrictors primarily resulting in a pressure drop across the flow restrictor such as an orifice plate or tube, allow for determining the fluid flow rate for a relatively large range of fluid flow rates.
In embodiments, the measuring system is configured to continuously determine a loss of pressure in the fluid flow along a predetermined length of the conduit and to determine a fluid flow rate on the basis of the loss of pressure, which allows determination of the fluid flow rate without the necessity of a dedicated flow restrictor.
In embodiments, the measuring system is configured to continuously determine a fluid flow rate of fluid through the conduit and to integrate the flow rate over time to obtain a measure of a total volume of urine voided from the bladder. The total volume of voided urine is particularly useful to know for a user of an intermittent urinary catheter and provides an indication whether or not further voiding is needed. The total volume of voided urine may also be an indicator of the health of the user.
In embodiments, the at least one fluid parameter comprises a pressure, wherein at least the conduit of the intermittent urinary catheter has a pre-defined characteristic pressure drop, the measuring device comprises at least one pressure gauge in fluid communication with the flow path, and wherein the signal processing device is configured to determine a fluid flow rate on the basis of at least the pre-defined characteristic pressure drop and a pressure determined by the at least one pressure gauge. The pre-defined characteristic pressure drop is utilised to determine the characteristic pressure drop/fluid flow rate dependency and allows the fluid flow rate to be determined. The pre-defined characteristic pressure drop may be pre-determined on the basis of a reference measurement on the embodied intermittent urinary catheter, or the embodied intermittent urinary catheter may be a standardised intermittent urinary catheter wherein the pre-defined characteristic pressure drop is based on a reference measurement on another standardised intermittent urinary catheter.
In embodiments, the measuring device comprises a valve configured to allow a variable cross-sectional area of fluid flow in fluid communication with the flow path. This allows the user to vary the fluid flow rate in the flow path by adjusting the valve. In one embodiment, the valve is variable between a set of different pre-determined cross-sectional areas. In this embodiment, the valve may serve as a flow restrictor in combination with a pressure gauge. In this case, the flow rate may be determined on the basis of at least the pre-determined cross-sectional area of the valve and a pressure determined by the pressure gauge. Accordingly, if more accuracy of measurement is desired, the user may reduce the pre-determined cross-sectional area, and if a larger fluid flow rate is desired the user may increase the pre-determined cross-sectional area.
In embodiments, the valve is configured to automatically vary the cross-sectional area for the fluid flow on the basis of a determined fluid flow rate or pressure in the flow path. In this case, the valve may serve as a flow restrictor and the valve can automatically increase the cross-sectional area to increase the fluid flow rate in response to a measured fluid flow rate or pressure below a first threshold value, and automatically decrease the cross-sectional area to increase accuracy of measurement in response to a measured fluid flow rate or pressure above a second threshold value. This allows automatic optimisation of the relationship between accuracy of measurement and voiding time.
The intermittent urinary catheter assembly 1 of
In one embodiment, the intermittent urinary catheter 3 is configured to rest in the user's urethra for a period of time not exceeding 15 minutes and at least an outer surface of the insertable portion 7 of the catheter tube 5 comprises a hydrophilic surface coating. The illustrated catheter tube 5 is a single-lumen tube, of which the conduit constitutes the sole passage between the distal insertion end 13 and the proximal outlet end 15.
In the embodiment of
In
Generally, in determining the fluid flow rate, the signal processing device 19 determines the flow rate using the flow characteristics of the orifice tube, which may be derived using Bernoulli's principle to yield:
Q=K1√(ΔP)
in which K1 is a specific constant measured for urine, the dimensions of the flow path and the extension thereof including the first maximum cross-sectional area of the internal lumen and the second minimum cross-sectional area of the trough-going passage 27. ΔP is the difference between the first and second pressures, and Q is the fluid flow rate. The signal processing device 19 may have a set of pre-determined values for K1, each pre-determined value for K1 corresponding to a specific type and size of intermittent urinary catheter 3. The signal processing device 19 is in some embodiments configured to recognise the type and size of intermittent urinary catheter 3 and automatically select the correct pre-determined value for K1, and in some embodiments the signal processing device 19 comprises means for receiving user input regarding the type and size of intermittent urinary catheter 3.
In the embodiment of
In embodiments, the signal processing device 19 comprises a data processing unit 35 and a power source, such as a battery or photovoltaic system.
Q=K2ΔP
where K2 is another specific constant depending the third and fourth coefficients of friction as well as other types of flow loss in the flow path and the extension thereof. Again, the signal processing device 19 may have a set of pre-determined values for K2, each pre-determined value for K2 corresponding to a specific type and size of intermittent urinary catheter 3. The signal processing device 19 is in some embodiments configured to recognise the type and size of intermittent urinary catheter 3 and automatically select the correct pre-determined value for K2, and in some embodiments the signal processing device 19 comprises means for receiving user input regarding the type and size of intermittent urinary catheter 3.
In the illustrated example in
In one embodiment, the valve 37 is variable between a set of different pre-determined cross-sectional areas by turning the valve 37 between a set of pre-determined degrees of rotation, which may be marked, e.g., by visual indicators on the valve 37 or clicks. In this embodiment, the valve 37 also serves as a flow restrictor 37 in combination with the pressure gauge 17. The fluid flow rate is then determined on the basis of at least the pre-determined cross-sectional area of the valve 37 and a pressure measured by the pressure gauge 17. In one embodiment, the signal processing device 19 has a user interface (not shown) that allows the user to input, e.g., the degree of rotation of the valve 37 for determination of the fluid flow rate.
| Number | Date | Country | Kind |
|---|---|---|---|
| PA 2019 70408 | Jun 2019 | DK | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/DK2020/050192 | 6/25/2020 | WO |
