Patent Description:
The traditional Foley-type catheter is well known in the art and comprises an inflatable balloon disposed within the patient's bladder and a discharge tube extending through the urethra to the exterior. The Foley-type catheter provides passive urinary drainage, and the ability to clamp the catheter closed at a location exterior of the patient.

Urethral catheters, such as Foley-catheters, are used to drain urine from the bladder. A urinary tract infection (also called "UTI") is an infection in the urinary system, which includes the bladder and kidneys. When a urinary catheter is inserted into the bladder, germs can migrate along the catheter and cause an infection in the bladder or kidney; resulting in a catheter-associated urinary tract infection (or "CAUTI"). CAUTis are the most common of hospital-acquired infections. In fact, <NUM>% of all nosocomial infections and over <NUM>,<NUM> admissions to hospital within the USA annually are attributable to CAUTIs. <NUM> Outcomes associated with CAUTIs include bacteremia and sepsis. While morbidity that is attributable to a single episode of catheterization is limited, the high frequency of catheter use (around <NUM>% of hospitalized patients) means that the cumulative burden of CAUTIs on patients and hospitals is substantial. <NUM>
<NUM> <NPL>. <NUM> <NPL>.

When sterile urinary catheters are inserted into the bladder, components in urine, blood, or surrounding tissue, such as polysaccharides, ions, and glycoproteins, are deposited on the surface of the device allowing the formation of biofilms. Biofilms are highly structured and actively growing bacterial communities that consist of multiple bacterial layers protected by a thick exopolysaccharide layer<NUM>. Biofilms are resistant to antibiotics/antimicrobials due to the fact that these agents cannot penetrate sufficiently through the exopolysaccharide layer. <NUM> <NPL>.

According to Centers for Disease Control and Prevention (CDC), there was no change in overall catheter-associated urinary tract infections (CAUTI) rates between <NUM> and <NUM>. (see https://www. gov/hai/surveillance/). This is not surprising, as while a variety of approaches for prevention of biofilm formation include the use of biocoatings, impregnating materials with antibiotics, antimicrobials or other materials as well as catheters capable of eluting antibiotics and/or antimicrobials have been used, none have been fully effective. Further, one of the major complications associated with antibiotic based coatings is the development of resistance. For example, one approach has been to attach active biocides such as antibiotics to biomaterial surfaces, or to impregnate them into the biomaterial itself by coating device surfaces or impregnating device surfaces with antibiotics such as ciprofloxacin, gentamicin, norfloxacin, and nitrofurazone. When used in clinical studies, the uncontrolled release profiles of the drugs resulted in the elution of initial high local concentrations that may initially damage the cells followed by concentrations that are not inhibitory. <NUM> By not killing all of the bacteria effectively, any subsequent infection will be more difficult to eradicate due to the development of resistance. <NUM> <NPL>.

Looking at the physiology of the urethra, UTIs are generally avoided because the act of urination (voiding) flushes everything, including bacteria. Further, there are glands in urethra that secretes protecting mucus. Several drug eluting urinary catheters are known in the prior art. Drug-eluting urinary catheters generally consist of three parts - the catheter tube, a polymer coating that binds the drug to the tube and releases the drug. The drug is slowly and continuously released into the bladder or along urethra; however, there is no continual washing of the periurethral space, where bacteria adhere, form biofilms and result in bacterial infections.

It would therefore be useful to magnify the effect of the glands in the urethra that protect from infection in the context of catheters.

<CIT> discloses a catheter applicable, in particular, in urology. Its purpose is to allow local medications to be administered by spreading them, preferably slowly. It is characterized by the fact that the catheter is constituted by a conduit ending in a cannula to which is attached a container opening into a capacity closed by a dialytic membrane, a balloon inflatable with the liquid to be injected, which balloon prevents the exit of the catheter from the capacity into which it has been introduced.

<CIT> relates to a catheter, in particular a balloon catheter, having a fluid-carrying element, such as a drainage tube, with an inner lumen for carrying away body fluid, and having an expansion element, such as a balloon of variable cross section, for fixing the catheter in a body cavity. The fluid-carrying element has a wall portion of an open-pore material, which is in fluidic communication with the inner lumen and through which the body fluid can be aspirated into the inner lumen by applying a negative pressure to a proximal end of the fluid-carrying element.

<CIT> discloses an urethral catheter construction having a third tubular extension or finger which will permit injections of antibiotics or an anesthetic onto the outer wall of the catheter through a very thin porous rubber outer membrane.

<CIT> discloses a no-sepsis urinary catheter, comprising three lumens, each in fluid communication with a drainage tip for receiving urine from the bladder, a retention balloon for retaining the catheter within the bladder, and a microporous bacteriostasis balloon for the diffusion by osmosis of a pharmaceutical agent for the killing and prevention of bacteria growth within and around the bladder to preclude the development of sepsis therein.

<CIT> discloses a catheter having an outer sheath made of a porous polymer material such as expanded polytetrafluoroethylene (ePTFE). The sheath has a porosity to allow anti-microbial or anti-bacterial medicament or other medicaments or liquids to pass through the sheath. A medicament lumen is provided passing through the elongated tube of the catheter from the catheter's proximal or out of patient end to openings along the catheter tube wall. Medicament is passed from the proximal end of the catheter through the medicament lumen and expelled through the openings into the area between the sheath and the catheter's main tube. There, the medicament or other liquid passes through the sheath into contact with the patient's body lumen. In the preferred embodi¬ ment, the catheter is a Foley urinary catheter.

The present invention is defined in independent claim <NUM>. It is one object of the present invention to provide an indwelling urinary catheter system having (<NUM>) an elon¬ gated tubular catheter body having a distal end and a proximal end; (<NUM>) at least one sleeve portion constructed substantially out of a semipermeable membrane surrounding at least one portion of the catheter body; (<NUM>) at least one lumen to instill fluid into the catheter body; and (<NUM>) a means to continuously efflux the instilled fluid through the semi¬ permeable membrane of at least one sleeve resulting in the circumferential egress of fluid out of the semipermeable membrane around the catheter body. The catheter may further include a drainage lumen extending through the catheter body from just short of the distal end to the proximal end and an opening or eyelet in the catheter body just short of the distal end of the catheter body to permit urine to drain from a patient's bladder into the drainage lumen. The catheter body is disposed within the urethra of the patient and a retaining mechanism, such as an inflatable balloon, is disposed within the patient's blad¬ der to retain the catheter in position. The fluid instilled into the catheter body and effluxed from the sleeve portion(s) may include, but is not limited to, antiseptics, antibiotics or an¬ timicrobials, and/or combinations thereof to prevent biofilm formation on the exterior sur¬ face of the catheter body. The fluid may also include certain therapeutic agents used in intravesical therapy, such as immunotherapy agents or chemotherapeutic agents. The fluid may also include agents for patient comfort, such as antispasmodics and pain medi¬ cines. All such agents can be effluxed directly into the bladder through the semipermeable sleeve portion around the catheter tip placed within the bladder.

It is another object of the present invention to provide different embodiments of the urinary catheter system that match the particular anatomical characteristics of a patient with respect to male or female anatomy. For example, a retention collar may be positioned on the catheter body for female patients or a space may be provided for the prostate for male patients.

For the purposes of the present invention, the term "semipermeable" is intended to encompass not only those materials that are semipermeable by their nature (i.e. those that allow certain substances to pass through it while not allowing other materials to pass through it) but materials that may be made semipermeable by creating pores of a predetermined size that would allow certain substances to pass through it while not allowing other materials to pass through it.

Turning to the drawings, there shown in <FIG> is a traditional catheter for insertion into a cavity, duct, or a vessel to permit injection or withdrawal of fluids into or from the cavity, duct, or vessel, or to establish patency of a passageway. For example, the catheter body <NUM> may be inserted through a patient's urethra and into the patient's bladder <NUM> for draining urine from the bladder and/or instilling fluid into the bladder through slots in the tip <NUM> of the catheter. A retaining device, such as the balloon <NUM>, is used to maintain placement of the catheter in the bladder.

Turning to <FIG>, a traditional <NUM>-way urinary catheter is represented with a catheter body <NUM> having a distal end <NUM> and a proximal end <NUM> with the catheter body <NUM> connecting an opening or eyelet <NUM> at the distal end <NUM> to a drainage lumen <NUM> at the proximal end <NUM> of the catheter body <NUM> through which fluid may flow into the drainage lumen <NUM> when the catheter is used to drain fluid from the bladder. An inflatable tube section <NUM> with an inflation lumen <NUM> extends along the length of the catheter body <NUM> and communicates with the inflatable tube section <NUM>. Inflation fluid, such as distilled water, is passed through inflation lumen <NUM> into the tube section <NUM> to inflate the tube section <NUM>, and the inflation fluid is withdrawn from the tube section <NUM> into and through the inflation lumen <NUM> when it is desired to deflate the tube section <NUM>.

Turning to <FIG>, a traditional <NUM>-way urinary catheter is represented that is essentially the same as the catheter shown in <FIG>, except it includes an instillation lumen <NUM> that extends from the catheter body <NUM> at the proximal end <NUM>. The fluid instilled into the catheter body <NUM> is passed through tube <NUM> in the catheter body <NUM> and into the bladder through the opening or eyelet <NUM> and then the fluid is subsequently drained through the opening or eyelet <NUM> through tube <NUM> in the catheter body <NUM> and out the drainage lumen <NUM>. As shown in the cross section, the fluid instilled into the catheter body <NUM> passes through tube <NUM> in the catheter body. Inflation fluid is passed through inflation lumen <NUM> and through tube <NUM> to inflate the tube section <NUM>. Fluid that is drained through eyelet <NUM> at the distal end <NUM> passes through tube <NUM> and out the drainage lumen <NUM>.

Referring to <FIG>, the catheter of the present invention includes an elongated tubular catheter body <NUM> having a distal end <NUM> and a proximal end <NUM>. A drainage lumen <NUM> extends through tube <NUM> in the catheter body <NUM> from the distal end <NUM> to the proximal end <NUM>. The drainage lumen <NUM> communicates with an opening or eyelet <NUM> in the catheter body <NUM> at the distal end <NUM> of the catheter body <NUM> through which the fluid may flow into the drainage lumen <NUM> when the catheter is used to drain a fluid from a cavity, duct, or vessel (e.g., draining urine from a person's bladder). A sleeve portion <NUM> constructed from a semipermeable membrane is formed over the catheter body <NUM>. An instillation lumen <NUM> extends from the catheter body <NUM> at the proximal end <NUM>. The instillation lumen <NUM> connects with the sleeve portion <NUM> using tube <NUM> that runs through the length of the catheter body <NUM>. The fluid instilled into the catheter body <NUM> through the tube <NUM> is continuously effluxed from the sleeve portion <NUM> through the semipermeable membrane in a circumferential controlled delivery to continuously irrigate the periurethral space and the catheter body <NUM> to prevent formation of biofilm and further ensuing bacterial infection. The fluid may include, but is not limited to, antiseptics, antibiotics or antimicrobials and/or combinations thereof to prevent biofilm formation on the exterior surface of the catheter body. Inflation fluid is passed through inflation lumen <NUM> and through tube <NUM> in the catheter body <NUM> to inflate the tube section <NUM>.

Turning to <FIG>, a cross section cutaway of the sleeve portion <NUM> illustrates that the sleeve circumferentially surrounds the catheter body <NUM>. In the preferred embodiment, the sleeve <NUM> is manufactured as a continuous part over the catheter body <NUM>. It may be secured to the catheter body <NUM> using methods known in the art such as adhesive attachment or heat press melting. Additionally, the sleeve <NUM> is preferably constructed from a non-elastic material to allow the effluxed fluid to irrigate the periurethral space without putting pressure on the urethra. In the preferred embodiment, the fluid effluxed from the sleeve <NUM> exits through the urethral opening and may be collected by a sponge or padded surface. Ideally around <NUM>-<NUM> of fluid a day would be effluxed resulting in a collection rate in the sponge or padded surface of about 20ccs per hour. This is manageable in a hospital care setting with intermittent replacement of the sponge or padded surface.

Referring to <FIG>, in the preferred embodiment a retaining mechanism near the distal end <NUM> of the catheter body <NUM> is generally an inflatable tube section <NUM> with an inflation lumen <NUM> that extends the length of the catheter body <NUM> through tube <NUM> and communicates with the inflatable tube section <NUM>. Inflation fluid, such as distilled water, is passed through inflation lumen <NUM> into the tube section <NUM> to inflate the tube section <NUM>, and the inflation fluid is withdrawn from the tube section <NUM> into and through the inflation lumen <NUM> when it is desired to deflate the tube section <NUM>. When the inflatable tube section <NUM> is not inflated, it lies substantially parallel along the central axis of the catheter body <NUM>, forming a cylinder having a diameter that substantially matches the outer diameter of the catheter body <NUM>.

The fluid instilled into the catheter body <NUM> and effluxed out of the semipermeable membrane sleeve <NUM> of the catheter body may be pushed through the device using various mechanisms, including but not limited to, a pressure and flow regulating valve to control rate of flow for a specific fluid at a specific pressure that is installed at the effluxing instillation lumen <NUM> or using a pump tension device, such as a plastic ball that is blown up and then pushes fluid out at a constant rate. It is also contemplated that an intravenous (IV) pump operating at a continuous rate may also be used to move fluid through the instillation lumen <NUM> and out of the semipermeable membrane of the sleeve portion <NUM>. Again, the rate would be predetermined based on the semipermeable membrane material as well as the molecular weight cut off (MWCO) of the agent instilled into the catheter and effluxed through the semipermeable membrane to ensure that the agent is being pushed with sufficient pressure and at a sufficient rate to effectively continuously wash the periurethral space around the catheter body <NUM>.

It is further contemplated that a drug eluting portion could be located within the tip <NUM> of catheter body <NUM> that goes into the bladder that could be used to deliver drugs to the bladder itself, such as an antispasmodic, pain medicines, antibiotics, antiseptics, antimicrobials and combinations thereof.

Turning to <FIG>, an alternative embodiment of the present invention is represented with an elongated tubular catheter body <NUM> having a distal end <NUM> and a proximal end <NUM>. A drainage lumen <NUM> extends through tube <NUM> in the catheter body <NUM> from the distal end <NUM> to the proximal end <NUM>, and the drainage lumen <NUM> communicates with an opening or eyelet <NUM> in the catheter body <NUM> at the distal end <NUM> of the catheter body <NUM> through which the fluid may flow into the drainage lumen <NUM> when the catheter is used to drain a fluid from a cavity, duct, or vessel (e.g., draining urine from a person's bladder). The retaining mechanism in this example is an inflatable tube section <NUM> with an inflation lumen <NUM> that extends though the length of the catheter body <NUM> though tube <NUM> and communicates with the inflatable tube section <NUM>. Inflation fluid, such as distilled water, is passed through inflation lumen <NUM> into the tube section <NUM> to inflate the tube section <NUM>, and the inflation fluid is withdrawn from the tube section <NUM> into and through the inflation lumen <NUM> when it is desired to deflate the tube section <NUM>. When the inflatable tube section <NUM> is not inflated, it lies substantially parallel along the central axis of the catheter body <NUM>, forming a cylinder having a diameter that substantially matches the outer diameter of the catheter body <NUM>.

A sleeve portion <NUM> constructed from a semipermeable membrane is formed over the catheter body <NUM> above the tube section <NUM>. An instillation lumen <NUM> extends from the catheter body <NUM> at the proximal end <NUM>. The instillation lumen <NUM> connects with the sleeve portion <NUM> using tube <NUM> that runs through the length of the catheter body <NUM>. The fluid instilled into the catheter body <NUM> through the tube is continuously effluxed from the sleeve portion <NUM> through the semipermeable membrane and into the bladder.

Turning to <FIG>, a cross section cutaway of the sleeve portion <NUM> illustrates that the sleeve circumferentially surrounds the catheter body <NUM>. In the preferred embodiment, the sleeve <NUM> is manufactured as a continuous part over the catheter body <NUM>. It may be secured to the catheter body <NUM> using methods known in the art such as adhesive attachment or heat press melting. The fluid effluxed through the sleeve <NUM> includes, but is not limited to, certain therapeutic agents used in intravesical therapy, such as immunotherapy agents or chemotherapeutic agents, as well as antispasmodic agents and numbing agents such as lidocaine. The semipermeable membrane of the sleeve <NUM> allows certain substances to pass through it but not others, such as allowing fluids to efflux out of the sleeve <NUM> but not allowing bacteria or other contaminants into the sleeve <NUM>. The semipermeable membrane also allows the use of a small amount of fluid everywhere circumferentially along the length of the catheter body portion in the bladder as well as into the bladder space. The pore size of the semipermeable membrane is predetermined based on the agent instilled into the catheter and effluxed from the semipermeable membrane to ensure that the agent may pass through the semipermeable membrane of the sleeve <NUM> and may be effluxed with sufficient pressure and at a sufficient rate to effectively continuously wash the bladder with the fluid. This method is a superior mechanism to deliver therapies such as antispasmodic agents and numbing agents than an instillation performed using a traditional catheter. With a traditional catheter, instillations are performed on an intermittent basis wherein the medicine is delivered through a single lumen catheter and then removed. The patient then voids the bladder to remove the medicine. The present invention allows the medicine to be slowly effluxed into the bladder at a continuous rate. This is especially useful after transurethral surgery on a patient. The catheter of the present invention can be placed shortly after surgery so that a drug, such as an antispasmodic or pain medication, may be effluxed from the sleeve <NUM> for the next four to six hours, resulting in steady patient pain and discomfort management.

The fluid instilled into the catheter body and effluxed out of the semipermeable membrane of the sleeve portion <NUM> over the catheter body <NUM> and into the bladder may be pushed through the device using various mechanisms, including but not limited to, a pressure and flow regulating valve to control rate of flow for a specific fluid at a specific pressure that is installed at the effluxing instillation lumen port <NUM> or using a pump tension device, such as a plastic ball that is blown up and it then pushes fluid out at a constant rate. It is also contemplated that an intravenous (IV) pump operating at a continuous rate may also be used to move fluid through the instillation lumen and out of the semipermeable membrane of the sleeve portion <NUM>. Again, the rate would be predetermined based on the agent instilled into the catheter and effluxed from the semipermeable membrane to ensure that the agent is being pushed with sufficient pressure and at a sufficient rate to effectively continuously wash the bladder space.

Turning to <FIG>, another embodiment of the present invention uses both sleeve portions of <FIG>. This results in a <NUM> way catheter capable of both effluxing fluid to continuously irrigate the periurethral space as well as effluxing fluid to continuously wash the bladder space.

As shown in <FIG> an elongated tubular catheter body <NUM> having a distal end <NUM> and a proximal end <NUM>. A drainage lumen <NUM> extends through tube <NUM> in the catheter body <NUM> from the distal end <NUM> to the proximal end <NUM>, and the drainage lumen <NUM> communicates with an opening or eyelet <NUM> in the catheter body <NUM> at the distal end <NUM> of the catheter body <NUM> through which the fluid may flow into the drainage lumen <NUM> when the catheter is used to drain a fluid from a cavity, duct, or vessel (e.g., draining urine from a person's bladder). A first sleeve portion <NUM> constructed from a semipermeable membrane is formed over the catheter body <NUM>. An instillation lumen <NUM> extends from the catheter body <NUM> at the distal end <NUM>. The instillation lumen <NUM> connects with the first sleeve portion <NUM> using tube <NUM> that runs through the length of the catheter body <NUM>. The fluid instilled into the catheter body <NUM> through the tube is continuously effluxed from the sleeve portion <NUM> through the semipermeable membrane in a circumferential controlled delivery to continuously irrigate the periurethral space and the catheter body <NUM> to prevent formation of biofilm and further ensuing bacterial infection. The fluid may include, but is not limited to, antiseptics, antibiotics or antimicrobials and/or combinations thereof to prevent biofilm formation on the exterior surface of the catheter body.

A second sleeve portion <NUM> constructed from a semipermeable membrane is formed over the catheter body <NUM> above the tube section <NUM>. An instillation lumen <NUM> extends from the catheter body <NUM> at the distal end <NUM>. The instillation lumen <NUM> connects with the sleeve portion <NUM> using tube <NUM> that runs through the length of the catheter body <NUM> The fluid instilled into the catheter body <NUM> through the tube <NUM> is continuously effluxed from the sleeve portion <NUM> through the semipermeable membrane and into the bladder itself.

The fluid effluxed through the sleeve <NUM> includes, but is not limited to, certain therapeutic agents used in intravesical therapy such as immunotherapy agents or chemotherapeutic agents, antispasmodic agents and numbing agents, such as lidocaine.

The fluid instilled into the catheter body and effluxed out of the semipermeable membrane of the sleeve portions <NUM> and <NUM> may be pushed through the device using various mechanisms, including but not limited to, pressure and flow regulating valves to control rate of flow for a specific fluid at a specific pressure that is installed at the effluxing instillation lumen ports <NUM> and <NUM>, or using a pump tension device, such as a plastic ball that you blow up and it then pushes fluid out at a constant rate. It is also contemplated that an intravenous (IV) pump operating at a continuous rate may also be used to move fluid through the instillation lumens <NUM> and <NUM> and out of the semipermeable membrane of the sleeve portions <NUM> and <NUM>, respectively. Again, the rate would be predetermined based on the agent instilled into the catheter and effluxed from the semipermeable membrane to ensure that the agent is being pushed with sufficient pressure and at a sufficient rate to effectively continuously wash the periurethral and bladder spaces.

Turning to <FIG>, a cross section cutaway of the sleeve portions <NUM> and <NUM> illustrates that the sleeve circumferentially surrounds the catheter body <NUM>. In the preferred embodiment, the sleeve portions <NUM> and <NUM> are manufactured as continuous parts over the catheter body <NUM>. They may be secured to the catheter body <NUM> using methods known in the art such as adhesive attachment or heat press melting.

Turning to <FIG>, the differences in anatomy for the placement of a urinary catheter are shown. The male anatomy of <FIG> results in a larger portion of the catheter body in the periurethral space than the female counterpart. <FIG> shows the bladder <NUM>, rectum <NUM>, pubic bone <NUM>, prostate <NUM>, urethra <NUM> and the catheter <NUM>. The catheter <NUM> must also be fed past the prostate <NUM> in males before it can be retained in the bladder <NUM>. The female anatomy of <FIG> results in a shorter portion of the catheter body needed to fill the periurethral space. <FIG> shows the bladder <NUM>, rectum <NUM>, pubic bone <NUM>, vagina <NUM>, urethra <NUM> and catheter <NUM>.

Taking these anatomical differences into consideration, <FIG> shows the distal end of the catheter of <FIG> as used for female anatomy whereas <FIG> shows the distal end of the catheter of <FIG> as used for male anatomy. The sleeve portion <NUM> of <FIG> is shorter than the sleeve portion <NUM> of <FIG>. Additionally, there is a larger space <NUM> between the sleeve portion <NUM> and the inflatable portion <NUM> than the space <NUM> between the sleeve portion <NUM> and the inflatable portion <NUM>, which accommodates placement of the catheter in the presence of the prostate.

As shown in <FIG>, one embodiment of the invention shown in <FIG> with sleeve portion <NUM>, catheter body <NUM>, retaining device <NUM>, drainage eyelet <NUM> and alternative instillation eyelet <NUM> may have various shapes to the end that is inserted into the bladder. For example, <FIG> shows a couvelaire tip, <FIG> shows a dufour tip and <FIG> shows a coude tip.

As shown in <FIG>, one embodiment of the invention shown in <FIG> with sleeve portions <NUM> and <NUM>, catheter body <NUM>, retaining device <NUM>, drainage eyelet <NUM> and alternative instillation eyelet <NUM> may have various shapes to the end that is inserted into the bladder. For example, <FIG> shows a couvelaire tip, <FIG> shows a dufour tip and <FIG> shows a coude tip.

It is necessary for the fluid to be effluxed continuously at a basal rate to effect the continual washing of the periurethral space, where bacteria adhere, to prevent formation of biofilms and resulting bacterial infections. However, it is also contemplated that the fluid may be continuously effluxed from the semipermeable membrane(s) in a peristaltic wave action along the length of the catheter body in addition to the basal rate.

Claim 1:
A urinary catheter assembly comprising:
an elongate catheter body (<NUM>; <NUM>; <NUM>) having a proximal end (<NUM>; <NUM>; <NUM>) and a distal end (<NUM>; <NUM>; <NUM>);
a first sleeve portion (<NUM>; <NUM>; <NUM>) comprising a semipermeable membrane, wherein the first sleeve portion (<NUM>; <NUM>; <NUM>) is disposed on an outer surface of at least one portion of the catheter body (<NUM>; <NUM>; <NUM>); and
a first instillation lumen (<NUM>; <NUM>; <NUM>) at the proximal end (<NUM>; <NUM>; <NUM>) of the catheter body (<NUM>; <NUM>; <NUM>), wherein the first instillation lumen (<NUM>; <NUM>; <NUM>) is in fluid communication with the first sleeve portion (<NUM>; <NUM>; <NUM>);
characterized in that the urinary catheter assembly further comprises:
a pump in fluid communication with said first instillation lumen (<NUM>; <NUM>; <NUM>);
wherein the pump is operable to continuously move a first fluid through the first instillation lumen (<NUM>; <NUM>; <NUM>) to the first sleeve portion (<NUM>; <NUM>; <NUM>) and to continuously and circumferentially efflux the first fluid out of the semipermeable membrane of the first sleeve portion (<NUM>; <NUM>; <NUM>).