WO2021185931A2

WO2021185931A2 - Improved continuous flushing catheter

Info

Publication number: WO2021185931A2
Application number: PCT/EP2021/056872
Authority: WO
Inventors: Matthew Mcintyre; Marshall Walker; Peter Falkner
Original assignee: CIC Fund Securitisation S.A.
Priority date: 2020-03-17
Filing date: 2021-03-17
Publication date: 2021-09-23
Also published as: WO2021185931A3

Abstract

The present invention includes an indwelling urinary catheter operable for flushing fluid through the urethra. The catheter has an elongated tubular catheter body, a discharge lumen disposed within the catheter body operable for discharging urine from a patient, a fluid flush lumen disposed within the catheter body operable to receive a flushing fluid, and at least one permeable sheath in fluid communication with the fluid flush lumen, wherein a plurality of protrusions of variable shapes, sizes, and arrangements are disposed on the outer surface of the sheath and are operable to create space between the catheter body and the urethra for improved flushing. Alternative embodiments include circumferential ridges and eluting pores disposed on the outer surface of the sheath wherein the distance and height between the ridges as well as the density of the eluting pores decrease in the direction of the proximal end of the sheath.

Description

Improved continuous flushing catheter

Field of the Invention

The present invention pertains to a catheter, and more particularly, to intra -urethra I or indwelling catheters capable of effluxing fluids.

General Background

A catheter-associated urinary tract infection (CAUTI) is one of the most common infections a person can contract in the hospital, according to the American Association of Critical- Care Nurses. Indwelling catheters, tubes inserted into the urethra that drain urine from a patient’s bladder into a collection bag, are the cause of this infection. Accordingly, there is a need for a catheter that is operable to prevent development of mature biofilm in the space between a catheter and the urethra through periodic urethral flushing.

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, 40% of all nosocomial infections and over 100,000 admissions to hospital within the USA annually are attributable to CAUTIs. 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 25% of hospitalized patients) means that the cumulative burden of CAUTIs on patients and hospitals is substantial. 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. Biofilms are resistant to antibiotics/antimicrobials due to the fact that these agents cannot penetrate sufficiently through the exopolysaccharide layer.

According to Centers for Disease Control and Prevention (CDC), there was no change in overall catheter-associated urinary tract infections (CAUTI) rates between 2009 and 2014. (see https://www.cdc.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.1 By not killing all of the bacteria effectively, any subsequent infection will be more difficult to eradicate due to the development of resistance.

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 the urethra that secrete protecting mucus. Several drug eluting urinary catheters are

¹ Walder, B.; Pitet, D.; Tramer, M.R. Prevention of bloodstream infections with central venous catheters treated with anti -infective agents depends on catheter type and insertion time: Evidence from a meta-analysis. Infect. Control Hosp. Epidemiol. 2002, 23, 748- m 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 the urethra; however, there is no continual washing of the periurethral space, where bacteria adhere, form biofilms and result in bacterial infections.

It is known in the art to provide a catheter with a semipermeable membrane that continuously flushes the interior of the urethra. For example, see PCT Patent Application Number PCT/US2017/026450, filed April 6, 2017, and published as WO/2018/144045 on August 9, 2018 (“the ‘450 Application”; said application is hereby incorporated by reference and attached hereto as an appendix). However, the catheter of the ‘450 Application has room for improvement in terms of optimizing the flow of flushing fluids inside of the urethra.

Brief summary of the invention

It is therefore one object of the present invention to provide an indwelling urinary catheter system operable for flushing fluid through the urethra having (1) an elongated tubular catheter body having a distal end and a proximal end; (2) a discharge lumen disposed within the catheter body that allows for the discharge of urine from a patient; (3) a fluid flush lumen disposed within the catheter body operable to receive a flushing fluid; and (4) at least one permeable sheath in fluid communication with the fluid flush lumen, wherein the permeable sheath includes a plurality of protrusions of variable shapes, sizes, and arrangements operable to create space between the catheter body and the urethra for improved flushing.

It is another object of the present invention to provide alternative embodiments of the permeable sheath that enhance the flowrate and efficiency of the flushing fluid through the urethra. In one alternative embodiment, the permeable sheath further comprises a plurality of catheter ridges disposed circumferentially along the outer surface of the permeable sheath and extend from the distal end of the permeable sheath to the proximal end of the permeable sheath in a spiral pattern. In another embodiment, the flowrate of the flushing fluid may be further improved by not only decreasing the distance between the catheter ridges but also the height of the catheter ridges as the catheter ridges extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

In an alternative embodiment, the flowrate of the flushing fluid may be improved by including a plurality of eluting pores in the permeable sheath that are operable for disbursing the flushing fluid from the fluid flush lumen into the urethral cavity where the number and density of these pores decreases as they extend along the permeable sheath towards the proximal end of the sheath.

Brief description of the drawings

The foregoing and other objects, features, and advantages of the invention are apparent from the following detailed description taken in conjunction with the accompanying drawings in which like parts are given like reference numerals and, wherein:

FIG. 1 is cross section view of a traditional catheter for insertion into the bladder.

FIG. 2 is a front perspective view of a traditional 2-way urinary catheter.

FIG. 3 is a front perspective view of a traditional 3-way urinary catheter with a cutaway cross section of the catheter body.

FIG. 4A is a front perspective view of a traditional 2-way urinary catheter that includes a permeable membrane and a cutaway cross section of the catheter body.

FIG. 4B is a front perspective view of a traditional 2-way urinary catheter with a permeable membrane and a cutaway cross section of the membrane.

FIG. 5 depicts a perspective view of a continuous flow catheter in accordance with embodiments of the invention.

FIG. 6 depicts a perspective view of a continuous flow catheter in accordance with embodiments of the invention. FIG. 7 depicts a side view of a continuous flow catheter in accordance with embodiments of the invention for insertion into the bladder of a male.

FIG. 8 depicts a perspective view of a continuous flow catheter in accordance with embodiments of the invention.

FIG. 9 depicts a close-up view of a proximal portion of a continuous flow catheter in accordance with embodiments of the invention.

FIG. 10 depicts a close-up view of a middle portion of a continuous flow catheter in accordance with embodiments of the invention.

FIG. 11 depicts a close-up view of a distal portion of a continuous flow catheter in accordance with embodiments of the invention.

FIG. 12A is a cross section view of the placement of a catheter in a male.

FIG. 12B is a cross section view of the placement of a catheter in a female.

FIG. 13 depicts a perspective view of intraluminal flush catheter in accordance with embodiments of the invention.

FIG. 14 depicts a close-up perspective view of intraluminal flush valve in accordance with embodiments of the invention.

FIG. 15 depicts a perspective view of intraluminal flush catheter in accordance with embodiments of the invention.

FIG. 16 depicts a close-up perspective view of intraluminal flush valve in accordance with embodiments of the invention.

The images in the drawings are simplified for illustrative purposes and are not depicted to scale. Within the descriptions of the figures, similar elements are provided similar names and reference numerals as those of the previous figure(s). The specific numerals assigned to the elements are provided solely to aid in the description and are not meant to imply any limitations (structural or functional) on the invention.

The appended drawings illustrate exemplary configurations of the invention and, as such, should not be considered as limiting the scope of the invention that may admit to other equally effective configurations. It is contemplated that features of one configuration may be beneficially incorporated in other configurations without further recitation.

Detailed description

The embodiments of the disclosure will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout.

Urinary Catheters Known in the Art

Turning to the drawings, FIGS. 1-4B depict urinary catheters known in the art. There shown in FIG. 1 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 16 may be inserted through a patient's urethra and into the patient's bladder 10 for draining urine from the bladder and/or instilling fluid into the bladder through slots in the tip 12 of the catheter. A retaining device, such as the balloon 14, is used to maintain placement of the catheter in the bladder.

Turning to FIG. 2, a traditional 2-way urinary catheter is represented with a catheter body 201 having a distal end 202 and a proximal end 203 with the catheter body 201 connecting an opening or eyelet 204 at the distal end 202 to a drainage lumen 205 at the proximal end 203 of the catheter body 201 through which fluid may flow into the drainage lumen 205 when the catheter is used to drain fluid from the bladder. An inflatable tube section 206 with an inflation lumen 207 extends along the length of the catheter body 201 and communicates with the inflatable tube section 206. Inflation fluid, such as distilled water, is passed through inflation lumen 207 into the tube section 206 to inflate the tube section 206, and the inflation fluid is withdrawn from the tube section 206 into and through the inflation lumen 207 when it is desired to deflate the tube section 206.

Turning to FIG. 3, a traditional 3-way urinary catheter is represented that is essentially the same as the catheter shown in FIG. 2, except it includes an instillation lumen 309 that extends from the catheter body 301 at the proximal end 303. The fluid instilled into the catheter body 301 is passed through tube 311 in the catheter body 301 and into the bladder through the opening or eyelet 304 and then the fluid is subsequently drained through the opening or eyelet 308 through tube 312 in the catheter body 301 and out the drainage lumen 305. As shown in the cross section, the fluid instilled into the catheter body 301 passes through tube 311 in the catheter body. Inflation fluid is passed through inflation lumen 307 and through tube 310 to inflate the tube section 306. Fluid that is drained through eyelet 308 at the distal end 302 passes through tube 312 and out the drainage lumen 305.

As shown in FIGS. 4A and 4B, it is also known in the art to incorporate an additional lumen to any of the foregoing catheter embodiments that is in fluid communication with a permeable or semi-permeable membrane along the outer surface of the catheter body.

Referring to Fig. 4A, the drainage lumen 404 extends through tube 414 in the catheter body 401 from the distal end 402 to the proximal end 403. The drainage lumen 404 communicates with an opening or eyelet 405 in the catheter body 401 at the distal end 402 of the catheter body 401 through which the fluid may flow into the drainage lumen 404 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 406 constructed from a semipermeable membrane is formed over the catheter body 401. An instillation lumen 410 extends from the catheter body 401 at the proximal end 403. The instillation lumen 410 connects with the sleeve portion 406 using tube 413 that runs through the length of the catheter body 401. The fluid instilled into the catheter body 401 through the tube 413 is continuously effluxed from the sleeve portion 406 through the semipermeable membrane in a circumferential controlled delivery to continuously irrigate the periurethral space and the catheter body 401 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 409 and through tube 412 in the catheter body 401 to inflate the tube section 408. Turning to Fig. 4B, a cross section cutaway of the sleeve portion 406 illustrates that the sleeve circumferentially surrounds the catheter body 401. In the preferred embodiment, the sleeve 406 is manufactured as a continuous part over the catheter body 401. It may be secured to the catheter body 401 using methods known in the art such as adhesive attachment or heat press melting. Additionally, the sleeve 406 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 406 exits through the urethral opening and may be collected by a sponge or padded surface.

The fluid instilled into the catheter body 401 and effluxed out of the semipermeable membrane sleeve 406 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 410 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 410 and out of the semipermeable membrane of the sleeve portion 406. 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 401.

It is further contemplated that a drug eluting portion could be located within the tip 411 of catheter body 401 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. Embodiments of the Present Invention

The embodiments of the present invention improve upon the catheters known in the art by providing a catheter with a flushing mechanism that is configured to maximize the prevention of biofilm build-up in the periurethral space.

Turning to FIGS. 5-6, a catheter 100 in accordance with embodiments of the present invention is provided, which is of similar design to the catheter body 401 depicted in FIGS. 4A- 4B and those catheter body configurations disclosed in the Application PCT App. No. PCT/US2017/026450 (Pub. No. WO2018144045). The catheter 100 has a catheter body 102 having a distal end 104 opposite a proximal end 106. Like the urinary catheters known in the art and described above, the present invention includes a discharge lumen 108 disposed within the catheter body 102 that is operable for the discharge of urine from a patient. Additionally, the present invention utilizes an inflatable tube section 112 operable to keep the catheter inside of the patient’s body, which is in fluid communication with an inflation lumen 113 disposed within and extending along the length of the catheter body 102. Also like the urinary catheters previously discussed, the present invention includes a fluid flush lumen 114 disposed within the catheter body 102 that is operable to receive a flushing fluid 126 (as shown in FIGS. 9- 11) and is in fluid communication with a permeable sheath 116 disposed along an outer surface of the catheter body 102. The flushing fluid 126 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.

The permeable sheath 116 has a distal end 118 opposite a proximal end 120. Unlike prior urinary catheters, the embodiments of the present invention include a permeable sheath 116 that is operable to create a volumetric space between the catheter body 102 and the surrounding lining of the urethra. The space is created by including one or more protrusions 121 disposed on the outer surface of the permeable sheath 116. In the preferred embodiment, these protrusions 121 are formed and integrated into the sheath 116 such that the protrusions 121 and the sheath 116 are a contiguous body made form the same material. As shown in FIGS. 5-6, these protrusions 121 may come in a variety of shapes, sizes, and arrangements so long as they are operable to create a volumetric space between the permeable sheath 116 and the lining of the urethra to allow for an increased flowrate of the flushing fluid 126. FIGS. 5-6 illustrate some non exclusive examples of the shape and arrangement these protrusions may take. In FIG. 5, the protrusions 121 take the form of a plurality of raised lumps along the surface of the permeable sheath. In FIG. 6, the protrusions 121 take the form of a plurality of longitudinal ridges extending along the length of the permeable sheath.

Turning to FIGS. 7-11 , another embodiment of the continuous flow catheter in accordance with embodiments of the invention is shown. In FIG. 7, the catheter body 102 is being inserted into the bladder of a male and illustrates the position and placement of the permeable sheath 116 within the periurethral space. FIG. 8 is a perspective illustration of the catheter shown in FIG. 7. For this embodiment, circumferential ridges 122 are disposed along the outer surface of the permeable sheath 116. These circumferential ridges 122 extend from the distal end 118 of the permeable sheath 116 to the proximal end 120 of the permeable sheath 116 in a spiral pattern. It is preferred, but not required, that the catheter ridges 122 decrease in distance apart as the ridges 122 extend along the length of the permeable sheath 116 from the distal end 118 of the permeable sheath 116 to the proximal end 120 of the permeable sheath 116. Additionally, it is preferred, but not required, that the catheter ridges 122 decrease in height as the ridges 122 extend along the length of the permeable sheath 116 from the distal end 118 of the permeable sheath 116 to the proximal end 120 of the permeable sheath 116.

As shown in greater detail in FIGS. 9-11 , the permeable sheath 116 is further defined by a plurality of eluting pores 124. The eluting pores 124 decrease in number and density along the length of the permeable sheath 116 from the distal end 118 of the permeable sheath 116 to the proximal end 120 of the permeable sheath 116. The eluting pores 124 are operable to receive a flow of flushing fluid 126 from the fluid flush lumen 114 and direct the flow of the flushing fluid 126 into the space between the catheter body 102 and the patient’s urethra to prevent biofilm formation and bacterial adhesion to the urethra and catheter 100. In an alternative embodiment, the permeable sheath 116 may be sectioned generally into thirds - a distal catheter third 128, a middle catheter third 130, and a proximal catheter third 132, as illustrated in FIGS. 9-11. In the distal catheter third 128, as illustrated in FIG. 11 , the catheter ridges 122 are widely separated and spiraled based on a calculated distance, and the eluting pores 124 on the ridges 122 and valleys between the ridges 122 are highly concentrated. In the middle catheter third 130, as illustrated in FIG. 10, the catheter ridges 122 start narrowing based on the calculated distance between each other, and the eluting pores 124 begin to decrease in number. The number of eluting pores 124 in the middle catheter third 130 may have two-thirds the number of eluting pores 124 in the distal catheter third 128. In the proximal catheter third 132, as illustrated in FIG. 9, catheter ridges 122 are spaced closely together at a calculated distance, and the eluting pores 124 are even more limited, and may be reduced to one-third the number of eluting pores 124 in the distal catheter third 128.

The generation of the fluid reservoir around the catheter exterior is via both a higher concentration of pores 124 along the proximal catheter third 128 and increased space between the external circumferential ridges 122. The flushing fluid 124 is then funneled into increasingly narrow channels between the ridges 122 with diminishing numbers of pores 124 and decreasing ridge height as the catheter approaches the urinary meatus (also known as the external urethral orifice). The net result is increasing fluid pressure and shear force along both the urethral and catheter walls sufficient to impede biofilm formation and extrude extant biofilm.

The continuous flushing mechanism of the present invention is configured to maximize the prevention of biofilm utilizing principles of fluid dynamics. Biofilm formation and bacterial adhesion to the urethra and catheter 100, consequent as they are to the close apposition of their respective surfaces, can be diminished by decreasing points of contact by the presence of spaced external catheter ridges 122. Embodiments of the present invention include protrusions 121 configured to create space between the urethra and the catheter as well as catheter ridges 122 configured for ridge tapering and spiraling in increasingly tight formation proximally to provide funneling of the flushing fluid 124. The sum of these effects is intended to increase fluid exit velocity which, based on Bernoulli’s equation describing velocity changes with respect to cylinder diameter changes, increases shear force algorithmically where it is needed most. The design also utilizes the concept of vortex formation in a cylinder, as described by the Taylor-Culick equation describing parallel cylinder laminar flow.

Further illustrations of how these catheters are positioned within the different anatomies are shown in FIG. 12A and 12B. The male anatomy of FIG. 12 A results in a larger portion of the catheter body in the periurethral space than the female counterpart. FIG. 12B shows the bladder 701 , rectum 702, pubic bone 703, prostate 704, urethra 705 and the catheter 706. The catheter 706 must also be fed past the prostate 704 in males before it can be retained in the bladder 701. The female anatomy of FIG. 12B results in a shorter portion of the catheter body needed to fill the periurethral space. FIG. 12B shows the bladder 707, rectum 708, pubic bone 709, vagina 710, urethra 711 and catheter 712. The permeable sheath 116 for the embodiments of the present invention can be customized to accommodate the varying difference in lengths of the periurethral space between the male and female anatomies.

In accordance with an embodiment of the invention, a catheter 100 with intraluminal flush is provided. Referring to the embodiments illustrated in FIGS. 13 to 16, the catheter 100 includes a catheter body 102, said body 102 having a distal end 104 opposite a proximal end 106 and further including a drainage lumen 105. The drainage lumen 105 defines an interior passage 108a that is operable for the discharge of urine from a patient. The interior passage 108a is further operable for the discharge of a clean flush fluid from the patient. An inflatable tube section 110 is disposed at the distal end 104 of the catheter body 102 and is operable to seal the bladder of the patient from the patient’s urethra. The inflatable tube section 110 is operable to prevent unwanted removal of catheter 100 from the patient. An intraluminal flush fluid lumen 112a is disposed within the catheter body 102. The intraluminal fluid flush lumen 112a has a distal end 114a opposite a proximal end 106. The intraluminal fluid flush lumen 112a is operable for the injection of a clean flush fluid, such as water or saline, into the drainage lumen 105. An intraluminal flush valve 118a is disposed at the distal end 114 of the intraluminal fluid flush lumen 112a. The intraluminal flush valve 118a may be a check valve, for example. The intraluminal flush valve 118a is operable to prevent urine from entering the intraluminal flush fluid lumen 112a and traveling down into clean flush fluid. More specifically, valve 118a is a one-way valve, which only opens when the pressure of clean flush fluid coming down the intraluminal fluid flush lumen 112a exceeds a certain pressure (this pressure can vary based on the design of the valve). The intraluminal flush valve 118a is further operable receive a clean flush fluid and redirect the clean flush fluid into the catheter lumen 102 and out of the proximal end 106 of the catheter lumen 102 in the direction 120a of a patient’s urine discharge. In operation, intraluminal flush fluid flows up the intraluminal flush fluid lumen 112a, travels through the intraluminal flush valve 118a, and returns back to the proximal end of the catheter body 102 via drainage lumen 105, thereby cleaning the interior of drainage lumen 105 of any residual urine.

In one embodiment, an external access port with a unidirectional valve allows for sterile fluid to be injected into the urine drainage tube, flushing urine distally through the catheter into the collection bag. The unidirectional valve prevents the intraluminal flushing fluid from mixing with the sterile extraluminal fluid eluting along the periurethral portion of the catheter. Force generated by periodic intraluminal flushing is operable to prevent bacterial adhesion and formation of biofilm on the interior surface of the catheter in much the same way that urination performs this function naturally.

On Fig. 14 catheter ridges 122 and eluting pores 124 are shown. These catheter ridges and pores are described in more detail with regard to Figs. 5-11.

In one embodiment, the catheter body 102 is of similar design to catheter body 401 as disclosed in PCTApp. No. PCT/US2017/026450 (Pub. No. WO2018144045), or any of the other catheter designs disclosed in said reference, and the intraluminal flush fluid lumen 112a and the flush valve 118a are incorporated into the body of any such catheter in a manner similar to that described herein.

This disclosure further encompasses the following embodiments, which are non limiting. Embodiment 1 : A catheter with continuous flush comprising: a. a catheter body having a distal end opposite a proximal end; b. a discharge lumen disposed within the catheter body, said discharge lumen operable for the discharge of urine from a patient; c. an inflation lumen disposed within the catheter body, said inflation lumen operable for fluid communication with an inflatable tube section disposed at the distal end of the catheter body, said inflatable tube section operable to seal the bladder of the patient from the patient’s urethra, said inflatable tube further operable for the passage of urine from the bladder into the discharge lumen; d. a permeable sheath disposed along an outer surface of the catheter body, said permeable sheath having a distal end opposite a proximal end, said permeable sheath having a plurality of protrusions disposed on the outer surface of the permeable sheath, said protrusions are operable to create a volumetric space between said outer surface of the permeable sheath and the lining of the urethra; and e. a fluid flush lumen disposed within the catheter body, said fluid flush lumen operable to receive a flushing fluid, said fluid flush lumen operable for fluid communication with said permeable sheath.

Embodiment 2: The catheter of embodiment 1 wherein the protrusions are longitudinal ridges.

Embodiment 3: The catheter of embodiment 1 or 2 wherein the protrusions are lumps.

Embodiment 4: The catheter of any of the preceding embodiments wherein the protrusions are circumferential ridges.

Embodiment 5: The catheter of any of the preceding embodiments wherein the distance between the protrusions decreases as the protrusions extend from the distal end of the permeable sheath to the proximal end of the permeable sheath. Embodiment 6: The catheter of any of the preceding embodiments wherein the height of the protrusions decreases as the protrusions extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

Embodiment 7: The catheter of any of the preceding embodiments further comprising a plurality of eluting pores defined by the permeable sheath, said plurality of eluting pores operable to receive a flow of flushing fluid from the fluid flush lumen and direct the flow of the flushing fluid into the space between the catheter and the patient’s urethra.

Embodiment 8: The catheter of embodiment 7 wherein the density of the eluting pores decreases from the distal end of the permeable sheath to the proximal end of the permeable sheath.

Embodiment 9: A catheter with continuous flush comprising: a. a catheter body having a distal end opposite a proximal end; b. a discharge lumen disposed within the catheter body, said discharge lumen operable for the discharge of urine from a patient; c. an inflation lumen disposed within the catheter body, said inflation lumen operable for fluid communication with an inflatable tube section disposed at the distal end of the catheter body, said inflatable tube section operable to seal the bladder of the patient from the patient’s urethra, said inflatable tube further operable for the passage of urine from the bladder into the discharge lumen; d. a permeable sheath disposed along an outer surface of the catheter body, said permeable sheath having a distal end opposite a proximal end, said permeable sheath having a plurality of circumferential ridges disposed along the outer surface of the permeable sheath, said circumferential ridges extending from the distal end of the permeable sheath to the proximal end of the permeable sheath in a spiral pattern; and e. a fluid flush lumen disposed within the catheter body, said fluid flush lumen operable to receive a flushing fluid, said fluid flush lumen operable for fluid communication with said permeable sheath.

Embodiment 10: The catheter of embodiment 9 wherein the distance between the circumferential ridges decreases as the circumferential ridges extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

Embodiment 11 : The catheter of embodiment 9 or 10 wherein the height of the circumferential ridges decreases as the circumferential ridges extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

Embodiment 12: The catheter of any of the embodiment 9 to 11 further comprising a plurality of eluting pores defined by the permeable sheath, said plurality of eluting pores operable to receive a flow of flushing fluid from the fluid flush lumen and direct the flow of the flushing fluid into the space between the catheter and the patient’s urethra.

Embodiment 13: The catheter of any of the embodiment 9 to 12 wherein the density of the eluting pores decreases from the distal end of the permeable sheath to the proximal end of the permeable sheath.

Embodiment 14: The catheter of any of the embodiment 9 to 13 wherein the permeable sheath of the catheter body is further defined by a distal catheter third, a middle catheter third, and a proximal catheter third extending from the distal end of the permeable sheath to the proximal end of the permeable sheath, wherein said middle catheter third section has two-thirds the number of pores of said distal catheter third section, and wherein said proximal catheter third section has one- third the number of pores of said distal catheter third section.

Embodiment 15: A catheter with continuous flush comprising: a. a catheter body having a distal end opposite a proximal end; b. a discharge lumen disposed within the catheter body, said discharge lumen operable for the discharge of urine from a patient; c. an inflation lumen disposed within the catheter body, said inflation lumen operable forfluid communication with an inflatable tube section disposed at the distal end of the catheter body, said inflatable tube section operable to seal the bladder of the patient from the patient’s urethra, said inflatable tube further operable for the passage of urine from the bladder into the discharge lumen; d. a permeable sheath disposed along an outer surface of the catheter body, said permeable sheath having a distal end opposite a proximal end, said permeable sheath having a plurality of eluting pores defined by the permeable sheath, said plurality of eluting pores operable to receive a flow of flushing fluid from the fluid flush lumen and direct the flow of the flushing fluid into the space between the catheter and the patient’s urethra; and e. a fluid flush lumen disposed within the catheter body, said fluid flush lumen operable to receive a flushing fluid, said fluid flush lumen operable for fluid communication with said permeable sheath.

Embodiment 16: The catheter of embodiment 15 wherein the density of the eluting pores decreases from the distal end of the permeable sheath to the proximal end of the permeable sheath.

Embodiment 17: The catheter of embodiment 15 or 16 wherein the permeable sheath of the catheter body is further defined by a distal catheter third, a middle catheter third, and a proximal catheter third extending from the distal end of the permeable sheath to the proximal end of the permeable sheath, wherein said middle catheter third section has two-thirds the number of pores of said distal catheter third section, and wherein said proximal catheter third section has one-third the number of pores of said distal catheter third section.

Embodiment 18: The catheter of any of the embodiment 15 to 17 wherein the permeable sheath further comprises a plurality of circumferential ridges disposed along the outer surface of the permeable sheath, said circumferential ridges extending from the distal end of the permeable sheath to the proximal end of the permeable sheath in a spiral pattern.

Embodiment 19: The catheter of any of the embodiment 15 to 18 wherein the distance between the circumferential ridges decreases as the circumferential ridges extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

Embodiment 20: The catheter of any of the embodiment 15 to 18 wherein the height of the circumferential ridges decreases as the circumferential ridges extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

Embodiment 21 : A catheter of any of the embodiment 1 to 20 to with intraluminal flush, the catheter comprising: a. a catheter body having a distal end opposite a proximal end, said catheter body defining an interior passage, said interior passage operable for the discharge of urine from a patient, said interior passage further operable for the discharge of a clean flush fluid; b. a drainage lumen disposed within the catheter body; c. an inflatable tube section disposed at the distal end of the catheter body, said inflatable tube section operable to seal the bladder of the patient from the patient’s urethra, said inflatable balloon further operable for the passage of urine from the bladder into the drainage lumen; d. an intraluminal flush fluid lumen disposed within the catheter body, said intraluminal fluid flush lumen having a distal end opposite a proximal end, said intraluminal fluid flush lumen operable for the injection of a clean flush fluid into the interior passage of the drainage lumen; and e. an intraluminal flush valve disposed at the distal end of the said intraluminal fluid flush lumen, said intraluminal flush valve operable to prevent urine from entering the intraluminal flush fluid lumen, said intraluminal flush valve further operable receive a clean flush fluid and redirect the clean flush fluid into the drainage lumen and out of the proximal end of the catheter body in the direction of a patient’s urine discharge.

For the purposes of promoting and understanding of the principles of the invention, reference has been made to the preferred embodiments illustrated in the drawings, and specific language has been used to describe these embodiments. However, this specific language intends no limitation of the scope of the invention, and the invention should be construed to encompass all embodiments that would normally occur to one of ordinary skill in the art. The particular implementations shown and described herein are illustrative examples of the invention and are not intended to otherwise limit the scope of the invention in any way. For the sake of brevity, conventional aspects of the system (and components of the individual operating components of the system) may not be described in detail. Furthermore, the connecting lines, or connectors shown in the various figures presented are intended to represent exemplary functional relationships and/or physical or logical couplings between the various elements. It should be noted that many alternative or additional functional relationships, physical connections or logical connections may be present in a practical device. Moreover, no item or component is essential to the practice of the invention unless the element is specifically described as “essential” or “critical.” Numerous modifications and adaptations will be readily apparent to those skilled in this art without departing from the spirit and scope of the present invention.

Claims

1. A catheter with continuous flush comprising: a. a catheter body having a distal end opposite a proximal end; b. a discharge lumen disposed within the catheter body, said discharge lumen operable for the discharge of urine from a patient; c. an inflation lumen disposed within the catheter body, said inflation lumen operable for fluid communication with an inflatable tube section disposed at the distal end of the catheter body, said inflatable tube section operable to seal the bladder of the patient from the patient’s urethra, said inflatable tube further operable for the passage of urine from the bladder into the discharge lumen; d. a permeable sheath disposed along an outer surface of the catheter body, said permeable sheath having a distal end opposite a proximal end, said permeable sheath having a plurality of protrusions disposed on the outer surface of the permeable sheath, said protrusions are operable to create a volumetric space between said outer surface of the permeable sheath and the lining of the urethra; and e. a fluid flush lumen disposed within the catheter body, said fluid flush lumen operable to receive a flushing fluid, said fluid flush lumen operable for fluid communication with said permeable sheath.

2. The catheter of claim 1 wherein the protrusions are longitudinal ridges.

3. The catheter of claim 1 wherein the protrusions are lumps.

4. The catheter of claim 1 wherein the protrusions are circumferential ridges.

5. The catheter of claim 1 wherein the distance between the protrusions decreases as the protrusions extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

6. The catheter of claim 1 wherein the height of the protrusions decreases as the protrusions extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

7. The catheter of claim 1 further comprising a plurality of eluting pores defined by the permeable sheath, said plurality of eluting pores operable to receive a flow of flushing fluid from the fluid flush lumen and direct the flow of the flushing fluid into the space between the catheter and the patient’s urethra.

8. The catheter of claim 7 wherein the density of the eluting pores decreases from the distal end of the permeable sheath to the proximal end of the permeable sheath.

9. A catheter with continuous flush comprising: a. a catheter body having a distal end opposite a proximal end; b. a discharge lumen disposed within the catheter body, said discharge lumen operable for the discharge of urine from a patient; c. an inflation lumen disposed within the catheter body, said inflation lumen operable for fluid communication with an inflatable tube section disposed at the distal end of the catheter body, said inflatable tube section operable to seal the bladder of the patient from the patient’s urethra, said inflatable tube further operable for the passage of urine from the bladder into the discharge lumen; d. a permeable sheath disposed along an outer surface of the catheter body, said permeable sheath having a distal end opposite a proximal end, said permeable sheath having a plurality of circumferential ridges disposed along the outer surface of the permeable sheath, said circumferential ridges extending from the distal end of the permeable sheath to the proximal end of the permeable sheath in a spiral pattern; and e. a fluid flush lumen disposed within the catheter body, said fluid flush lumen operable to receive a flushing fluid, said fluid flush lumen operable for fluid communication with said permeable sheath.

10. The catheter of claim 9 wherein the distance between the circumferential ridges decreases as the circumferential ridges extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

11. The catheter of claim 9 wherein the height of the circumferential ridges decreases as the circumferential ridges extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

12. The catheter of claim 9 further comprising a plurality of eluting pores defined by the permeable sheath, said plurality of eluting pores operable to receive a flow of flushing fluid from the fluid flush lumen and direct the flow of the flushing fluid into the space between the catheter and the patient’s urethra.

13. The catheter of claim 12 wherein the density of the eluting pores decreases from the distal end of the permeable sheath to the proximal end of the permeable sheath.

14. The catheter of claim 13 wherein the permeable sheath of the catheter body is further defined by a distal catheter third, a middle catheter third, and a proximal catheter third extending from the distal end of the permeable sheath to the proximal end of the permeable sheath, wherein said middle catheter third section has two- thirds the number of pores of said distal catheter third section, and wherein said proximal catheter third section has one- third the number of pores of said distal catheter third section.

15. A catheter with continuous flush comprising: a. a catheter body having a distal end opposite a proximal end; b. a discharge lumen disposed within the catheter body, said discharge lumen operable for the discharge of urine from a patient; c. an inflation lumen disposed within the catheter body, said inflation lumen operable for fluid communication with an inflatable tube section disposed at the distal end of the catheter body, said inflatable tube section operable to seal the bladder of the patient from the patient’s urethra, said inflatable tube further operable for the passage of urine from the bladder into the discharge lumen; d. a permeable sheath disposed along an outer surface of the catheter body, said permeable sheath having a distal end opposite a proximal end, said permeable sheath having a plurality of eluting pores defined by the permeable sheath, said plurality of eluting pores operable to receive a flow of flushing fluid from the fluid flush lumen and direct the flow of the flushing fluid into the space between the catheter and the patient’s urethra; and e. a fluid flush lumen disposed within the catheter body, said fluid flush lumen operable to receive a flushing fluid, said fluid flush lumen operable for fluid communication with said permeable sheath.

16. The catheter of claim 15 wherein the density of the eluting pores decreases from the distal end of the permeable sheath to the proximal end of the permeable sheath.

17. The catheter of claim 16 wherein the permeable sheath of the catheter body is further defined by a distal catheter third, a middle catheter third, and a proximal catheter third extending from the distal end of the permeable sheath to the proximal end of the permeable sheath, wherein said middle catheter third section has two- thirds the number of pores of said distal catheter third section, and wherein said proximal catheter third section has one- third the number of pores of said distal catheter third section.

18. The catheter of claim 15 wherein the permeable sheath further comprises a plurality of circumferential ridges disposed along the outer surface of the permeable sheath, said circumferential ridges extending from the distal end of the permeable sheath to the proximal end of the permeable sheath in a spiral pattern.

19. The catheter of claim 18 wherein the distance between the circumferential ridges decreases as the circumferential ridges extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

20. The catheter of claim 18 wherein the height of the circumferential ridges decreases as the circumferential ridges extend from the distal end of the permeable sheath to the proximal end of the permeable sheath.

21 . A catheter with intraluminal flush, the catheter comprising: a. a catheter body having a distal end opposite a proximal end, said catheter body defining an interior passage, said interior passage operable for the discharge of urine from a patient, said interior passage further operable for the discharge of a clean flush fluid; b. a drainage lumen disposed within the catheter body; c. an inflatable tube section disposed at the distal end of the catheter body, said inflatable tube section operable to seal the bladder of the patient from the patient’s urethra, said inflatable balloon further operable for the passage of urine from the bladder into the drainage lumen; d. an intraluminal flush fluid lumen disposed within the catheter body, said intraluminal fluid flush lumen having a distal end opposite a proximal end, said intraluminal fluid flush lumen operable for the injection of a clean flush fluid into the interior passage of the drainage lumen; and e. an intraluminal flush valve disposed at the distal end of the said intraluminal fluid flush lumen, said intraluminal flush valve operable to prevent urine from entering the intraluminal flush fluid lumen, said intraluminal flush valve further operable receive a clean flush fluid and redirect the clean flush fluid into the drainage lumen and out of the proximal end of the catheter body in the direction of a patient’s urine discharge.