WO2025076375A1

WO2025076375A1 - Catheter device and method

Info

Publication number: WO2025076375A1
Application number: PCT/US2024/049993
Authority: WO
Inventors: Jean V JOSEPH; Robert D. Mayer; Ronald W. Wood; Paula DOYLE
Original assignee: University of Rochester
Current assignee: University of Rochester
Priority date: 2023-10-06
Filing date: 2024-10-04
Publication date: 2025-04-10
Anticipated expiration: 2026-04-06

Abstract

A device for measuring intraurethral pressure comprises an elongate tube having at least first and second balloons on the elongate tube, one or more channels positioned within a lumen of the tube having at least first, second and third channels creating drain and balloon channels, and one or more sensors fluidly connected to the second balloon. In some embodiments, a fourth channel also extends to the second balloon. In some embodiments, the tube comprises a plurality of balloons positioned along its length. In some embodiments, the device can measure urethral pressure and/or bladder pressure. Also described is a method of measuring intraurethral pressure using the disclosed device.

Description

TITLE

Catheter Device and Method

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No. 63/588,420, filed October 6, 2023, which is hereby incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION

Childbirth and prostatectomy are two common medical procedural contexts resulting postoperatively in stress incontinence, affecting women and men, respectively. Stress incontinence is characterized by involuntary loss of urine during activities that increase abdominal pressure, such as sneezing, laughing, or sudden movements. In the field of female stress incontinence, various surgical treatments have been developed to enhance urinary control. These interventions typically involve increasing pressure and resistance within the urethra to prevent the uncontrolled flow of urine.

One widely used technique in female stress incontinence treatment is the placement of a sling around the urethra, suspending and bending the structure to create a valve-like action at the sling's flexure point. However, the optimal level of resistance within the urethra for effective continence remains uncertain. In men undergoing prostatectomy, the surgical removal of the prostate gland can significantly alter the biomechanical properties of the urinary system. This alteration may result in the inability to maintain voluntary control of urine, especially during sudden abdominal pressure changes.

Male anatomy differs significantly from female anatomy, and prostatectomy further modifies the biomechanical properties of urinary tract and surrounding areas by removing the prostatic tissue and reattaching the urethra to the bladder. These procedures may leave the patient with an inability to maintain voluntary control of urine, especially when there are transient pressure events in the abdomen associated with sneezing, laughter, exercise, or other sudden movements. Male anatomy is dramatically different than in women, and is altered with prostate surgery by the removal of a walnut-sized or larger structure around the urethra at the base of the bladder, the removal of prostatic urethra, and the reattachment (anastomosis) of the urethra to the bladder.

During prostatectomy, a layer of tissue immediately ventral to the rectum retracts on prostate removal. This divided tissue can be rejoined and used as additional connective tissue support for the rejoined urethra and bladder. However, even with this tissue support, it is not guaranteed that normal voiding function can be fully restored, despite apparent normal sphincter tone. To address this issue, techniques involving sutures from this tissue layer to the inside surface of the pelvis have been attempted to exert additional compression forces on the repaired urethra. Adjusting these sutures can reduce the urethral lumen's diameter, potentially improving postoperative continence. However, the optimal level of compression required for clinical success remains unknown, and excessive force may lead to acute outlet obstruction.

Thus, there is a need in the art for a novel catheter device that assesses and optimizes intraurethral compression forces during and after surgical procedures. The present invention meets this need.

SUMMARY OF THE INVENTION

Aspects of the present invention relate to a device for measuring intraurethral pressure including an elongate tube having a proximal opening, a distal solid end, and a structure forming a lumen therebetween, the elongate tube having interior and exterior surfaces and at least first and second lateral openings in the wall along its length, first and second balloons on elongate tube, each balloon positioned over one of the lateral openings and sealingly enclosing at least a portion the exterior surface of the tube, wherein each balloon has walls having interior and exterior surfaces forming an interior volume, and wherein a first balloon is positioned distal to a second balloon along the length of the tube, one or more channels positioned within the lumen of the tube, wherein a first channel extends from the proximal opening and passes through the distal solid end forming a distal opening, a second channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the first lateral opening and the interior volume of the first balloon, and a third channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the second lateral opening and the interior volume of the second balloon, and one or more sensors fluidly connected to the interior volume of the second balloon.

In some embodiments, the elongate tube includes a third lateral opening in the wall, and a fourth channel, wherein the fourth channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the third lateral opening and the interior volume of second balloon. In some embodiments, the first balloon has a spherical, conical or frustoconical shape, or combinations thereof, and is configured to be positioned in the neck of the bladder, and the second balloon has a spherical, conical, frustoconical, cylindrical with tapered ends, or ovular shape, and is configured to be positioned in the urethra. In some embodiments, the first balloon includes an elastic material, and the second balloon includes a substantially inelastic or non-distensible material. In some embodiments, the second balloon includes pleats in the walls of the balloon configured to allow the balloon to collapse neatly around the elongate tube. In some embodiments, the first balloon includes a gas, and the second balloon includes a fluid.

In some embodiments, the one or more sensors includes a pressure sensor. In some embodiments, the sensor includes a pressure sensor connected to the proximal end of the third channel. In some embodiments, the sensor includes a pressure sensor disposed within the third channel or the interior volume of the second balloon. In some embodiments, the sensor includes one or more resistive elements in contact with the wall of the balloon configured as a strain gauge pressure sensor. In some embodiments, the sensor includes one or more piezoelectric elements positioned within or upon the third channel or second balloon, the piezoelectric element connected to a conductive element that extends from the piezoelectric element through or upon the third channel and out or beside the proximal opening of the third channel.

In some embodiments, the device has a fourth lateral opening in the wall of the tube, a fifth channel having a proximal opening that extends from the proximal opening of the tube to a position along the length of the tube, and a third balloon positioned proximal on the length of the tube to the position of the second balloon, wherein the fifth channel fluidly connects with the fourth lateral opening and the interior volume of the third balloon. In some embodiments, the device has a sensor fluidly connected to the interior volume of the third balloon. In some embodiments, the device has a plurality of balloons positioned proximal to the third balloon. In some embodiments, the device has a plurality of sensors fluidly connected to the interior volumes of each balloon of the plurality of balloons.

In some embodiments, the tube has a length ranging between 3 cm and 100 cm, and a diameter ranging between 0.25 cm and 5 cm. In some embodiments, each channel of the one or more channels has a diameter ranging between 0.1 cm and 1.5 cm. In some embodiments, the first balloon has a diameter ranging between about 0.1 cm and 3 cm, and length ranging between 0.1 cm and 2 cm, and the second balloon has a diameter ranging between about 0.1 cm and 3 cm, and a length ranging between 0.1 cm and 3 cm. In some embodiments, the third balloon has a diameter ranging between about 0.1 cm and 3 cm, and a length ranging between 0. 1 cm and 3 cm, and is positioned between 0.1 cm and 5 cm proximal from the position of the second balloon. In some embodiments, the first balloon is positioned between 0.1 cm and 1 cm from the distal end of the tube, and the second balloon is positioned between 0.1 cm and 5 cm proximal from the position of the first balloon.

In some embodiments, the elongated tube further includes a pressure sensor positioned distal to the first balloon. In some embodiments, the device has one or more Luer locks attached to the proximal ends of the one or more channels. In some embodiments, the device has a polyester sheath surrounding for at least a portion of the tube, and wherein the one or more channels have a silicon material. In some embodiments, the device further includes one or more coatings on the exterior surfaces of the elongate tube or balloons. In some embodiments, the one or more coatings are selected from the group consisting of: lubricative coating, silicone coating, biocompatible coating, or any combination thereof. In some embodiments, the device includes one or more markings on the tube or the one or more balloons, wherein the one or more marking are selected from the group consisting of: radiopaque markings, near-infrared fluorescent markings, contrasting agent markings, graduation markings, directional markings, and size markings. Aspects of the present invention relate to a method of measuring intraurethral pressure having the steps of providing a device for measuring intraurethral pressure comprising an elongate tube having a proximal opening, a distal solid end, and a wall forming a lumen therebetween, the elongate tube having interior and exterior surfaces along its length; one or more balloons sealingly enclosing at least a portion the exterior surface of the tube, wherein each balloon has walls forming an interior volume and at least a first opening in the wall of the tube, and wherein a first balloon is positioned distal to a second balloon along the length of the tube, one or more channels positioned within the lumen of the tube, wherein a first channel extends from the proximal opening and passes through the distal solid end forming a distal opening, a second channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the first opening of the first balloon, a third channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the first opening of the second balloon, and one or more sensors fluidly connected to the interior volume of the second balloon, inserting the distal end of the elongate tube into the urethra of the subject, measuring pressure from the one or more sensors.

In some embodiments, the method includes the steps of inflating the first balloon with a gas to at least partially occlude the urethra, and filling the second balloon with a liquid. In some embodiments, the method includes the step of relieving the bladder of fluid via the first channel. In some embodiments, the method has the step of measuring pressure in the bladder. In some embodiments, the method has the step of adjusting a suture tension for suture on a subject based on measurements from the device.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of embodiments of the invention will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings.

Fig. 1A depicts a side view of an exemplary device comprising one or more channels for measuring intraurethral pressure according to aspects of the present invention. Fig. IB depicts a side view of an exemplary first channel having a proximal opening and distal opening. Fig. 1C depicts a side view of an exemplary second channel having a proximal opening and fluidly connected to a first balloon. Fig. ID depicts an exemplary third channel having a proximal opening and fluidly connected to a second balloon. Fig. IE depicts an exemplary third and fourth channel, each having a proximal opening and each fluidly connected to the second balloon.

Fig. 2A shows a side view of an exemplary device prototype for measuring intraurethral pressure according to aspects of the present invention. Fig. 2B shows an enlarged side view of the distal end of an exemplary device prototype.

Fig. 3 depicts an illustrative computer architecture for a computer.

DETAILED DESCRIPTION

The disclosed invention introduces a novel device and method for optimizing intraurethral compression forces during surgical procedures, particularly in the treatment of postoperative stress incontinence following childbirth and prostatectomy. By allowing precise adjustment and measurement of compression forces within the urethra, the invention aims to enhance urinary control and improve continence outcomes in patients undergoing these medical interventions.

It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity many other elements found in related systems and methods. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.

Definitions Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although any methods and materials similar or equivalent to those described herein can be used in the practice for testing of the present invention, exemplary materials and methods are described herein. In describing and claiming the present invention, the following terminology will be used.

It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

The articles “a” and “an” are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.

“About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, or ±0.1% from the specified value, as such variations are appropriate. The terms “patient,” “subject,” “individual,” and the like are used interchangeably herein, and refer to any animal amenable to the systems, devices, and methods described herein. The patient, subject or individual may be a mammal, and in some instances, a human.

Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.

Device and Method for Measuring Intraurethral Pressure Aspects of the present invention relate to a device (e.g., a catheter device) for measuring urethral pressure to assess and optimize compression forces from nearby tissue before, during and after surgical procedures. The device is generally configured to be positioned within the urethra of a subject with a distal end of the device positioned at the neck of the bladder. The device is capable of occluding portions of the urinary tract with a first balloon positioned at the neck of the bladder and second balloon positioned within the urethra. The second balloon is configured to measure urethral pressure (e.g., urethral wall pressure, or compression force) with portions that are substantially inelastic or non-distensible that may perform as a sensor. The device is also capable of draining the bladder and/or introducing a fluid to or within the bladder (e.g. via a bladder flush). In some embodiments, the device may detect and/or measure a flow of fluid through the device. In some embodiments, the device may be configured to measure temperature and/or pressure from various locations in the subject (e.g., within the urethra and/or the bladder) with various sensors.

In some embodiments, the invention described herein provides a device and method for standardizing and baselining urethral pressure measurement in a subject. By measuring intraurethral pressure before, during, and after surgical procedures, the device helps a surgeon determine the ideal suture tension to maintain or restore natural anatomical position and structure of the urethra and nearby tissue. The device and method has potential applications in various clinical settings, including prostatectomy patient care, and standardized transurethral pressure control in female sling procedures for stress urinary incontinence (SUI). Additionally, the disclosed device and method may be used in research applications in various fields. Also contemplated herein are other uses for the device and method, including other procedures involving anastomosis, suturing, and/or ligature, and expanding the uses beyond surgical applications.

Referring now to Fig. 1A, shown is an exemplary device 100 for measuring intraurethral pressure according to aspects of the present invention. In some embodiments, device 100 may be referred to as a catheter device, or a double-balloon catheter. In some embodiments, device 100 comprises an elongate tube 102 having a proximal end 104 and a distal end 106 with the wall of the tube forming a lumen therethrough. Generally, tube 102 is a flexible and biocompatible elongate tubular structure configured to be positioned at least partially within the urinary tract of a subject to occlude the neck of the bladder (i.e., similar to a Foley catheter) and measure urethra pressure or compressive force with the one or more balloons.

The elongate tube 102 should be flexible enough to not cause trauma, pain or discomfort to a subject, yet rigid enough insert the device into the subject and position the one or more balloons within the urethra and/or bladder. In some embodiments, tube 102 comprises a proximal opening 108, a distal solid end 110, and an interior and exterior surface extending along the length of the tube.

In some embodiments, tube 102 comprises one or more ballons affixed or attached to exterior portions along the length of the tube. Fluidly connecting to and extending proximally away from each balloon is one or more channels positioned at least partially within tube 102. In some embodiments, tube 102 comprises one or more openings (e.g., lateral openings) for fluidly connecting the one or more channels to the one or more balloons. For example, in some embodiments, tube 102 comprises at least a first lateral opening 112, and a second lateral opening 114 proximal to first opening 112, each opening passing through the wall of tube 102.

In some embodiments, device 100 comprises one or more balloons connected to and/or extending outward radially from tube 102, wherein each balloon is positioned over one of the lateral openings (e.g. first lateral opening 112 or second lateral opening 114) and sealingly encloses at least a portion of the exterior surface of tube 102. Generally, each balloon of the one or more balloons comprises walls, each wall having an interior surface and exterior surface, and the interior surface forming an interior volume for each balloon. In some embodiments, the one or more balloons comprise a distal balloon configured to at least partially occlude the neck of the bladder, and a proximal balloon configured to measure urethral pressure or compression force. Any disclosed balloon may comprise any number of sensors configured to read or measure pressure exerted on at least a portion of each balloon, discussed further below.

In some embodiments, the one or more balloons comprise a first balloon 116 positioned distal to a second balloon 118 along the length of tube 102. In some embodiments, the first balloon 116 may have a generally rounded, spherical, conical, or frustoconical shape, and is dimensioned to fit into the neck of the bladder such that the neck of the bladder is occluded by the ballon when inflated. In some embodiments, the exterior surface of the first balloon 116 may be textured, and/or may comprise ridges, divots, and the like. In some embodiments, the second balloon 118 has an elongated shape (e.g., ovular or cylindrical) and is dimensioned to fit into the urethra such that the exterior surface of second balloon 118 contacts the walls of the urethra when the balloon is inflated. The first balloon 116 is generally flexible, expandable, elastic and/or compliant, whereas second balloon 118 is substantially inelastic, non-distensible and/or non-compliant. In some embodiments, second balloon 118 may be configured to expand only up to a specific size or shape to measure compression forces within the urethra. In some embodiments, second balloon 118 further comprises pleats in the walls of the balloon configured to allow the balloon to collapse neatly around tube 102. In some embodiments, device 100 further comprises a sheath 105 surrounding at least a portion of tube 102 and/or the one or more balloons (see Fig. 2B).

In some embodiments, device 100 comprises one or more channels positioned within the lumen of tube 102. Generally, each channel is a conduit or tube forming a lumen therethrough and configured for fluid movement, control and/or pressure measurement of fluid in the tube. Referring now to Fig. IB, in some embodiments, the one or more channels comprise a first channel 120 having a proximal opening 122 and extending from proximal opening 108 to distal solid end 110, passing through distal solid end 110 and forming a distal opening 124. In some embodiments, the first channel 120 is configured to fluidly connect the bladder to an external drain, pump and/or or fluid source and may be utilized to drain the bladder and/or introduce a fluid (e.g. a bladder flush, therapeutics, or any other solution) into the bladder. In some embodiments, first channel 120 is connected at proximal opening 120 to a pressure transducer or sensor for measuring pressure in the bladder. In some embodiments, proximal end 104 of tube 102 terminates into one or more branches, such as a trifurcation, each branch dedicated to at least one of the one or more of the channels. In some embodiments, any channel of the one or more channels (e.g., first channel 120) may be collapsible, such that if too much compression or force is applied to tube 102, the channel restricts flow of fluid through the channel. Referring now to Fig. 1C, in some embodiments, the one or more channels comprise a second channel 130 having a proximal opening 132 and extending from proximal opening 108 to a position along the length of tube 102, and fluidly connecting with first lateral opening 112 and the interior volume of first balloon 116. In some embodiments, the second channel 130 is configured to fluidly connect the interior volume of the first balloon 116 to an external source and/or pump to inflate/deflate the first balloon 116 by providing or removing one or more fluids fluid in or out of the balloon. Once inflated or deployed, the pressure of first balloon 116 may be measured with various sensor types and configurations discussed herein, for example a pressure sensor fluidly connected to proximal opening 108 of second channel 130. In some embodiments, the inflated first balloon 116 is configured to at least partially occlude the urethra (or any lumened structure), or the opening of the urethra into the bladder, or the bladder neck.

Referring now to Fig. ID, in some embodiments, the one or more channels comprise a third channel 140 having a proximal opening 142 and extending from proximal opening 108 to a position along the length of tube 102 and fluidly connecting with second lateral opening 114 and the interior volume of second balloon 118. In some embodiments, the third channel 140 is configured to fluidly connect the interior volume of the second balloon 118 to an external source and/or pump, and may be utilized to inflate/deflate the second balloon 118 by channeling a fluid into or out of the second balloon 118. In some embodiments, third channel 140 may be more rigid or have thicker sidewalls than the first channel 120 and/or second channel 130 to resist deformation or expansion and cause inaccurate pressure measurements. Various sensors (e.g., pressure sensors) may be configured to measure second balloon 118, third channel 140, opening 142 and/or fourth channel 150 as contemplated herein.

In some embodiments, device 100 further comprises a third lateral opening 154 in the wall of tube 102. In some embodiments, the one or more channels comprise a fourth channel 150 having a proximal opening 152 and extending from proximal opening 108 to a position along the length of tube 102, and fluidly connecting with third lateral opening 154 and the interior volume of second balloon 118. In some embodiments, fourth channel 150 is configured to fluidly connect the interior volume of the second balloon 118 to an external source and/or pump, and may be utilized to inflate/deflate the second balloon 118 by channeling a fluid into or out of the second balloon 118. In this two-channel configuration, the pressure of the second balloon 118 may be measured with third channel 140 and/or fourth channel 150 and the second balloon 118 may be inflated/deflated using third channel 140 and/or fourth channel 150. In some embodiments, second balloon 118 and the connected channels are filled with one or more fluids (e.g., a liquid). In some embodiments, third channel 130 and fourth channel 140 may be flushed with a fluid to ensure the removal of all bubbles from second balloon 118. In some embodiments, a pressure reading (e.g., intraurethral pressure) is captured after gas or bubbles have been removed second balloon 118 and the channels thereof.

Aspects of the present invention relate to one or more balloons for device 100 configured to position and immobilize the device within the subject and/or measure intraurethral pressure. In some embodiments, first balloon 116 is configured on the distal end of tube 102 and is configured to at least partially occlude the neck of the bladder and/or the urethra of the subject. In some embodiments, first balloon 116 is filled with a fluid (e g., a gas or liquid) to inflate the ballon. In some embodiments, second channel 130 may be fluidly connected to a pump, syringe, or the like, in order to inflate the balloon. In some embodiments, second balloon 118 is configured to measure intraurethral pressure and is filled with a fluid (e.g., a liquid). In some embodiments, the third channel 140 and/or fourth channel 150 are filled with a fluid, and are fluidly connected to one or more pressure sensors positioned at the proximal openings of the channels. In some embodiments, distal opening 124 of first channel 120 is positioned at least partially recessed into the distal end of first balloon 116, wherein first balloon 116 comprises a frustoconical shape and configured to direct fluid into distal opening 124.

In some embodiments, the device further comprises a third balloon positioned proximal on the length of tube 102 to second balloon 118 and configured to measure intraurethral pressure. In some embodiments, device 100 further comprises a fourth lateral opening in the wall of tube 102 for a channel to pass through and fluidly connect the third balloon. In some embodiments, device 100 further comprises a fifth channel having a proximal opening that extends from the proximal opening of tube 102 to a position along the length of tube 102. In some embodiments, the fifth channel fluidly connects with the fourth lateral opening and the interior volume of the third balloon.

In some embodiments, the device further comprises a plurality of balloons configured to measure intraurethral pressure. In some embodiments, the plurality of balloons is configured to measure intraurethral pressure from different positions along the length of tube 102, correlating to different portions or regions of the urethra. In some embodiments, the plurality of balloons is positioned proximally to first balloon 116, or second balloon 118 and/or third balloon, or replace the first balloon 116, second balloon 118 and/or third balloon. In some embodiments, the plurality of balloons, or measurement balloons, are arranged along a distal portion of tube 102 with equal spacing, or unequal spacing, or in a pattern or series. In some embodiments, the plurality of ballons provide a plurality or sampling of intraurethral pressure measurements or compressive forces.

In some embodiments, each balloon can be described as having at least a first and second configuration, at least an inflated and deflated configuration, or at least a deployed and non-deployed state. It should be appreciated that the one or more balloons must each be at least partially deflated when the device 100 is inserted into or removed from the subject to prevent damaging the subject. In some embodiments any disclosed balloon may comprise a substantially inelastic, non-distensible or rigid material and one or more pleats and/or folds such that when balloon is configured to the first or deflated configuration the balloon lays flat against tube 102. In some embodiments, first balloon 116 comprises a spherical, conical or frustoconical shape, or combinations thereof, and is configured to be positioned in the neck of the bladder. In some embodiments, second balloon 118, the third balloon, or the plurality of balloons comprise a spherical, conical, frustoconical, cylindrical with tapered ends, or ovular shape, and is configured to be positioned in the urethra. In some embodiments, a vacuum is applied to the one or more balloons through their respective conduits when inserting or removing the device from a subject.

Aspects of the present invention relate to the positioning and attachment of the one of or more balloons relative to the tube 102. In some embodiments, the one or more balloons may be attached to the tube 102 via any suitable method known to one of skill in the art. For example, in some embodiments, the one or more balloons may be attached to the tube 102 via a compression fit, adhesives, a tab and groove, a retaining portion or flange on the tube 102, heat bonding, laser welding, and the like. In some embodiments, the first balloon 116 is positioned at the distal end of the tube 102. In some embodiments, the second balloon 118 is positioned distal to the first balloon 116 and may be positioned at a distance of about 1 cm from the first balloon 116. It should be appreciated that the spacing between the first balloon 116 and the second balloon 118 permits the second balloon 118 to be positioned in a suitable location of the urethra for the measurement of urethral pressures in both men and women. In some embodiments, the spacing or balloon sizes may be adjusted to uniquely fit a patient or subject. In some embodiments, the third balloon may be positioned distal to the second balloon 118, at any suitable distance from the second balloon 118.

The overall concept of measurement and occlusion balloons arranged on tube 102 may be extrapolated to a device that may be slidably positioned along the length of any catheter or lumened surgical tool. In some embodiments, the one or more balloons may be positioned on a sleeve or sheath, wherein the sleeve or sheath is configured to fit over or slide onto existing catheters (for e.g. a Foley catheter). Any aspects of device 100 e.g., balloons, sensors, sensor configurations, openings and channels may be applied or configured on the sheath or sleeve.

Aspects of the present invention relate to one or more sensors for an exemplary device for measuring intraurethral pressure. In some embodiments, device 100 further comprises one or more sensors configured to read pressure from first balloon 116, second balloon 118, the third balloon, or the plurality of balloons. For example, in some embodiments, device 100 comprises a sensor configured to read pressure from second balloon 118. In some embodiments, the sensor comprises a pressure sensor disposed within the interior volume of second balloon 118, and/or on the inner or outer surface of the balloon, or within the wall of the balloon. In some embodiments, the sensor comprises one or more resistive elements in contact with the wall of second balloon 118 and configured as a strain gauge pressure sensor. In some embodiments, any disclosed balloon may comprise any pressure transducer used for intraurethral pressure that would be known by one of ordinary level of skill in the art. In some embodiments, device 100 further comprises a sensor configured to read pressure and or temperature from the distal end of tube 102. For example, in some embodiments, the sensor may be positioned anywhere on tube 102 distal to the first balloon 116. In some embodiments, the sensor is between first balloon 116 and opening 124, such that the sensor is positioned within the bladder and is configured to read intravesical pressures or temperatures. Any channels extending proximally in tube 102, and exiting the tube 102 may be connected to an external pressure sensing device, transducer, or sensor. In some embodiments, the one or more sensors further comprise leads or wires connected at one end to the one or more sensors and at the second end to an external pressure sensing device or sensor and passing through the one or more conduits. It should be appreciated that the one or more conduits may be positioned within or external to the tube 102 and/or channels 120, 130 , 140, or 150.

In some embodiments, the sensor comprises one or more piezoelectric elements positioned within third channel 140 or second balloon 118, or on the inner surface of the walls of third channel 140, or on the inner or outer surface of the walls of second balloon 118, or between layers of a second balloon 118 comprising more than one layer of material. In some embodiments, piezoelectric element is connected to a conductive element that extends from the piezoelectric element through or on a surface of third channel 140 and out through or adjacent to the proximal opening 142 of third channel 140. In some embodiments, the sensor may be formed via electronic or additive printing of piezoelectric elements onto the inside surface, onto the outside surface, or between two layers of the third channel 140 or the second balloon 118. The piezoelectric elements may comprise, for example, silver, gold, titanium, titanium oxide, copper, alloys, polymers, or any combination thereof. In some embodiments, the piezoelectric elements may be disposed in any suitable pattern including, but not limited to, vertical lines, horizontal lines, zigzag, coil, circles, concentric circles, a grid, and any combinations thereof. In some embodiments, the sensor may comprise a flexible resistor, transducer or sensor. In some embodiments, the sensor may be configured as strain gauge. In some embodiments, any sensor of device 100 may be electronically and communicatively connected to a computer 300 of the present invention. In some embodiments, device 100 comprises one or more flow sensors connected to any channel of the device. For example, a flow sensor connected to the first channel 122 for detecting or measuring flow through or across the channel. In some embodiments, device 100 comprises one or more temperature sensors connected to the tube 102, the first balloon 116, or the second balloon 118 for measuring the temperature of the urethra and/or bladder.

Various configurations and positions for the balloons, sensors, openings and channels relative to tube 102 have been described, however it should be appreciated that the configurations are not limited to these embodiments, and the balloons sensors, and openings may be placed in any positions on tube 102. In some embodiments, tube 102 comprises one or more probe openings along the length of the tube for sensing pressure on the exterior of tube 102.

Aspects of the present invention relate to one or more proximal connectors fluidly connected to tube 102 and/or the one or more channels of device 100. In some embodiments, device 100 further comprises one or more connectors attached to the proximal ends or proximal openings of the one or more channels. In some embodiments, device 100 further comprises one or more connectors attached to the proximal end or proximal opening 108 of the tube 102. In some embodiments, each channel of the one or more channels comprise one or more connectors attached to the proximal end or proximal opening of the channel. In some embodiments, the one or more connectors comprise one or more Luer locks. In some embodiments, device 100 and/or the one or more connectors may comprise any connector that would be known by one of ordinary level of skill in the art. Further, the one or more connectors may comprise any valved connector known by one of ordinary level of skill in the art. For example, device 100 may comprise electronically controlled valved connectors fluidly connected to any tube or channel of device 100, wherein the electronically controlled valve is electronically and/or communicatively connected to a computer (e.g., computer 300). In some embodiments, device 100 further comprises a pump fluidly connected to any tube, channel or balloon of the present invention.

Aspects of the present invention relate to one or more interior or exterior coatings for an exemplary device 100 for measuring intraurethral pressure. In some embodiments, device 100 further comprises one or more coatings on the interior and/or exterior surfaces of tube 102 or one or more balloons (e g., first balloon 116, second balloon 118, third balloon, plurality of balloons). In some embodiments, the balloons have the same coating as the tube. In some embodiments, the balloons have a different coating than the tube. In some embodiments, first balloon 116 comprises a coating, and second balloon 118 comprises a different coating. In some embodiments, the one or more coatings are selected from the group consisting of: lubricative coating, silicone coating, biocompatible coating, sulfated sugar compound, and any combination thereof. It should be appreciated that any lubricious and biocompatible coating known by one of ordinary level of skill in the art may be applied to any surface of device 100.

In some embodiments, the one or more balloons may be coated on either surface (e.g., the surface of the inside walls, or the surface of the outside walls of the balloon) with radiopaque and/or near-infrared fluorescent coatings to enhance intraoperative visualization during open or minimally invasive procedures. Alternatively, these contrast agents can be incorporated in the body of the device for the purpose of enhanced visualization and recording of the location of pressure assessment. Near infrared markings are particularly advantageous in minimally invasive procedures where surgeons have binocular vision and depth perception. In some embodiments, tube 102 or any balloon of the one or more balloons may comprises one or more graduations or markings, wherein the graduations or markings comprise any material such as radiopaque material, near-infrared fluorescent material, contrasting agents, directional markings, and size markings.

Aspects of the present invention relate to one or more materials for an exemplary device for measuring intraurethral pressure. Device 100 comprises an elongate tube 102 that forms the structure for a typical catheter device.. Similarly, device 100 may comprise any material known and applied in the art for catheters and the like. Examples may include, but are not limited to, plastic, metal, composite, polymer, Polyurethane, polyetherimide (Pebax), polyethylene terephthalate (PET), Nylon, Polypropylene, polyetheretherketone (PEEK), Polycarbonate, polyester, High-density polyethylene (HDPE), Thermoplastic elastomer (TPE), silicone, latex, polyvinyl chloride (PVC), rubber, or any combinations thereof. As defined herein, an inelastic or non-distensible material refers to any material that is capable of expanding or inflating up to a specific size. In some embodiments, first balloon 116 comprises an elastic material, and second balloon 118 comprises an inelastic or non-distensible material. In some embodiments, the third balloon, and/or the plurality of balloons proximal to the third balloon comprise an inelastic or non-distensible material. Examples of substantially elastic materials may include, but are not limited to, silicone, polyurethane, nylon, polyethylene terephthalate (PET) or any combinations thereof. Examples of substantially inelastic or non-distensible materials may include, but are not limited to, nylon, polyester, polyetherimide (Pebax), polypropylene, polyetheretherketone (PEEK), Polycarbonate, or any combinations thereof. In some embodiments, the device further comprises a sheath (e.g., a polyester sheath) surrounding at least a portion of tube 102, and wherein the one or more channels comprise or are formed from a silicon material. In some embodiments, first channel 120, second channel 130 and third channel 140 may comprise any material known to one of skill in the art. Examples may include, but are not limited to, silicone, latex, polyvinyl chloride (PVC), rubber, or any combinations thereof. It should be appreciated that first channel 120, second channel 130, and fourth channel 140 may comprise the same materials or may comprise different materials.

Aspects of the present invention relate to sizing and dimensions for an exemplary device 100 for measuring intraurethral pressure. It should be appreciated that the dimensions provided herein are for a typical catheter device sized for transurethral insertion, however the device may be appropriately sized for any intended use or procedure. In some embodiments, tube 102 has a length ranging between 3 cm and 100 cm, and a diameter ranging between 0.1 cm and 5 cm. In some embodiments, each channel of the one or more channels has a diameter ranging between 0.05 cm and 1.5 cm.

In some embodiments, first balloon 116, second balloon 118, third balloon, or the plurality of balloons have a length of about 0.1 cm to 3 cm, or is about 0.3 cm, 0.4, 0.5 cm, 0.6 cm, 0.7 cm, 0.8 cm, 0.9 cm, 1 cm, 1.5 cm, 1.6 cm, 1.7 cm, 1.8 cm, 1.9 cm, 2 cm, 2.1 cm, 2.2 cm, 2.3 cm, 2.4 cm 2.5 cm, 2.6 cm, 2.7 cm, 2.8 cm, 2.9 cm or 3 cm in length. In some embodiments, first balloon 116 has a diameter ranging between about 0.1 cm and 3 cm, and length ranging between 0.1 cm and 2 cm, and second balloon 118 has a diameter ranging between about 0.1 cm and 5 cm, and a length ranging between 0.1 cm and 3 cm. In some embodiments, the second balloon 118, the third balloon, or the plurality of balloons may have the same length or diameter, or may have different lengths or diameters.

In some embodiments, the third balloon is positioned between 0.1 cm and 5 cm proximal from the position of second balloon 118. In some embodiments, first balloon 116 is positioned between 0.1 cm and 2 cm from the distal end of tube 102, and second balloon 118 is positioned between 0.1 cm and 5 cm proximal from the position of first balloon 116. It should be appreciated that device 100 may be dimensioned to one or more sizes (e.g., small, medium large) to fit an appropriate subject, or be dimensioned to fit a specific application for a given subject, diagnosis, treatment or therapy, or for fitting a subject of a specific sex or age.

Aspects of the present invention relate to one or more indicators (e.g., visual or audible indicator) for device 100. In some embodiments device 100 comprises one or more indicators connected, attached to, or extending out from tube 102. In some embodiments, the one or more indicators are fluidly connected to any channel or balloon of the present invention. In some embodiments, the one or more indicators comprise visual indicators, audible indicators, or tactile indicators. For example, device 100 may comprise one or more indicators fluidly connected to the one or more channels or one or more balloons, configured to produce a visual indication if a pressure within the channel or balloon: is too low, is too high, is optimal. In some embodiments, device 100 further comprises a passive analog circuit electronically connected to the one or more indicators and configured to produce a visual indication. Similarly, in some embodiments, device 100 is configured to produce alerts or indication with a computer (e.g., computer 300 contemplated herein) and a user interface (UI) or graphical user interface (GUI). In some embodiments, the UI or GUI may be configured to display one or more pressure measurements, force measurements, alerts, pressure alerts, temperatures, temperature alerts, and/or flow measurement or alerts.

Intrinsic sphincter deficiency is defined in women by a low maximum urethral closure pressure of 30 cm of water and or Valsalva leak point pressure <60 cm of water [Pajoncini, C., et al., Neurourol Urodyn, 2003. 22(4): p. 264-8.] The conditions under which leakage occurs using these criteria have been described [Fritel, X., A. Fauconnier, and A. Pigne, J Urol, 2008. 180(1): p. 223-6], Age accounts for 57% of the variance in maximal urethral closure pressure [Pipitone, F., et al. Neurourol Urodyn, 2021. 40(8): p. 1869-1879], Studies have also investigated the pathophysiology of urinary incontinence in women [Delancey, J.O.L. and J.A. Ashton-Miller, Gastroenterology, 2004. 126(1 Suppl 1): p. S23-32],

In men, maximal urethral pressure ranged from 88.7 to 55 cm of water and maximal urethral pressure during voluntary contraction from 221.4 to 166.3 cm of water [Hammerer, P., et al., J Urology. 156(5): p. 1741-1743.] Intraurethral pressures in men also varies with age [Abrams, P.H. and M.J. Torrens, Urologia Internationalis, 2010. 32(2-3): p. 137-145.] A preoperative maximum urethral closure pressure 80 cm of water predicted recovery of continence at 24 weeks after open retropubic radical prostatectomy [Bakula, M., et al., Neurourol Urodyn, 2022. 41(6): p. 1431-1439.] Radical retropubic prostatectomy resulted in a decrease in maximal urethral closure pressure from 68.1 to 53.1 cm of water [Hammerer, P. and H. Huland, J Urology, 1997. 157(1): p. 233-236.] Slings and periurethral balloons are in use for postoperative incontinence management [Gacci, M., et al., J Clin Med, 2023. 12(3): p. 1190.] and comprise another setting where intraprocedural monitoring of achieved pressures could be beneficial.

Aspects of the present invention relate to the measurement and differentiation of urethral (e.g., intraurethral, transurethral) compression forces or pressure in a subject. In some embodiments, device 100 captures measurements before, during and after a procedure, providing a baseline for the surgeon to return to upon completion of the procedure. In some embodiments, device 100 can distinguish or indicate normal urethral pressures vs abnormal urethral pressures through one or more pressure or force ranges, threshold values, and/or indicators contemplated herein. In some embodiments, these values or ranges are particular to a given subject. For example, a range of 88 cm H2O to 55 cm H2O indicates or represents normal urethral pressure in men, while a range of 221 cm H2O to 167 cm H2O indicates or represents a normal maximal urethral pressure during voluntary contraction in men. It should be appreciated that normal urethral pressures vary with age, gender, disease, and other factors.

In some embodiments, the disclosed device and method may be used to measure, estimate, or calculate any of: intravesical pressure, abdominal pressure, detrusor pressure, urethral pressure at rest, urethral pressure with the bladder at a given volume, urethral pressure during bladder contractions, urethral pressure during the process of voiding, intraluminal urethral pressure, urethral pressure profile, resting UPP, stress UPP, maximum urethral pressure (MUP), urethral closure pressure profile (UCPP), maximum urethral closure pressure (MUCP), functional profile length, functional profile length (on stress), pressure “transmission” ratio, normal urethral closure mechanism, incompetent urethral closure mechanism, urethral relaxation incompetence, leak point pressures, detrusor leak point pressure, or abdominal leak point pressure, voiding cystometry, premicturition pressures, or any other pressures as described in Haylen et al. [Haylen, B.T., et al., Neurourol Urodyn, 2010. 29(1): p. 4-20],

In some embodiments, the disclosed device may be used to measure any disclosed metric and determine or calculate a urethral pressure profile with the sensors recording pressures during withdrawal and reinsertion, or during withdrawal of tube 102 from a subject. In some embodiments, the device may be used to measure leak pressure. In some embodiments, the measured metrics may be used to produce nomograms for a subject, or for many subjects, or a urethral pressure profile. In some embodiments, aggregate data from device 100 may be used to determine optimum urethral pressure values for a range of subjects.

Aspects of the present invention relate to an exemplary method of measuring intraurethral pressure. In some embodiments, the method of measuring intraurethral pressure comprises the steps of: providing a catheter device (e.g., device 100), inserting the distal end of the elongate tube into the urethra of the subject, and measuring pressure from the one or more sensors fluidly connected to the interior volume of the second balloon. In some embodiments, the method further comprises the steps of positioning the first balloon in the neck of the bladder, inflating the first balloon with a gas to at least partially occlude the bladder neck and urethra and by so doing immobilize the elongate tube in a fixed position with respect to the first balloon, and filling the second balloon with a liquid. In some embodiments, the method further comprises the step of relieving the bladder of fluid via the first channel. In some embodiment, the method further comprises detecting and/or measuring fluid flow through the first channel.

In some embodiments, the step of measuring pressure from the second balloon may be performed before, during, or after, and/or in conjunction with any surgical intervention and/or procedure known by one of ordinary level of skill in the art. In some embodiments, the method further comprises the step of informing the user to modulate the pressure in the first balloon and/or the second balloon. In some embodiments, the method further comprises the step of producing an alert, or indicating a threshold value or pressure has been reached, or not reached. In some embodiments, the method further comprises the step of ceasing all alerts when an optimal pressure is reached.

Applications of the disclosed device and method include improved continence of prostatectomy patients after surgery. In some embodiments, the disclosed device and method produces a standardized/optimal transurethral pressure when tensioning a female sling for stress urinary incontinence (SUI). In some embodiments, the disclosed device and method may be used before, during, or after, and/or in conjunction with any of: surgical intervention, incontinence surgical intervention, female stress incontinence surgical intervention, prostatectomy, robot-assisted radical prostatectomy, Retzius-sparing robot-assisted prostatectomy, prostatic surgery, and reattachment (anastomosis) of the urethra to the bladder. In some embodiments, the disclosed device and method may be used before, during or after urethral stricture repair. It should be appreciated that control of the closure pressures of an incision by placing the second balloon 118 in the defect area of the subject during hypospadias surgeries may result in enhanced perfusion and successful restoration of normal voiding. It should be noted that this usually a pediatric urology procedure, and would require smaller dimensions and spacing of pressure measurement and distances tailored to the site of the abnormal opening OR along the length of the urethra (i.e., the dimensions of the tube or balloons of device 100 are adjusted to fit the specific procedure or subject, including opening size, sex, age, orifice, length of urethra, weight of subject).

In some embodiments, the disclosed device and method may be used to treat any of: incontinence, female stress incontinence, post-operative incontinence, stress urinary incontinence (SUI), and/or incontinence as a result of pregnancy, childbirth, aging, menopause, obesity, chronic coughing, endoscopic surgery, prostate surgery, and pelvic surgery. In some embodiments, the disclosed device and method may be used in urological procedures such as stricture and hypospadias repair. In some embodiments, the disclosed device and method may be used for other procedures involving anastomosis, suturing and/or ligature such as laryngectomy, colostomy, phlebectomy, endoscopic surgery, prostate surgery, and pelvic surgery, and/or other similar procedures. In some embodiments, the disclosed device and method may be used to measure intravesical bladder pressures, and may therefore be used for urodynamics research and to diagnose and/or treat bladder diseases.

In some embodiments, the disclosed device and method measures and optimizes ligature compression pressure between an upper and lower bound for a subject. In some embodiments, the disclosed device and method produces upper and lower bounds for ligature compression pressure for a subject. In some embodiments, the device and method include automatically adjusting the ligature compression pressure based on the upper and lower bounds (i .e., adjusting the pressures of the one or more balloons).

In some embodiments, the disclosed device and method may be utilized for optimization of prostatectomy surgical procedures (such as robot-assisted prostatectomies) by measuring intraurethral pressures preoperatively, intraoperatively, and postoperatively. In some embodiments, preoperative measurement of intraurethral pressure may enable the identification of subject at risk of postoperative incontinence (thereby providing health care professionals with necessary information for surgical planning). In some embodiments, intraoperative measurement and adjustment of urethral pressure during the reattachment and adjacent reconstruction procedures may enhance postoperative recovery of continence in prostatectomy surgical procedures. In some embodiments, the disclosed device and method may enable the identification of the range of intraoperative pressures necessary to achieve postoperative continence.

The Retzius sparing robot assisted radical prostatectomy (RS-RARP) procedure is reported to be less likely to cause stress urinary incontinence compared with the more frequently performed conventional robot-assisted radical prostatectomy (C- RARP) [Kadono, Y., Nohara, T., Kawaguchi, S. et al. Investigating the mechanism underlying urinary continence using dynamic MRI after Retzius-sparing robot-assisted radical prostatectomy. Sci Rep 12, 3975 (2022)]. The RS-RARP procedure avoids dissection of the anterior compartment, leaving the bladder attachments undisturbed. Dynamic magnetic resonance imaging demonstrated preoperatively that when abdominal pressure was increased, the rectum moves forward and compresses the membranous urethra, a movement preserved by RS-RARP. However, C-RARP resulted postoperatively in increased abdominal pressure leading to bladder compression, expansion of the urethra and urine flow. Achieved intraurethral pressures during these maneuvers has not been measured. The disclosed device and method may be used with these procedures to assess and optimize intraurethral pressures. The present invention enables measurement of intraurethral pressures pre- and post-operatively; preoperative use may enable identifying patients at risk of postoperative incontinence and alter surgical planning. Intraoperative measurement and adjustment of urethral pressure during the reattachment and adjacent reconstruction procedures is expected to enhance postoperative recovery of continence in one or both of these surgical procedures. For example, in some embodiments, the preoperative and RS-RARP achieved pressures will provide guidance to identify the range of intraoperative pressures necessary to achieve postoperative continence.

Although exemplary surgical interventions and/or procedures are provided, it should be appreciated that the device and method is not limited to uses in conjunction with surgical interventions and/or procedures. A general concept is disclosed herein of sleeving a conduit, or inserting a member with inflatable or expandable structures into a conduit, at least partially occluding at least one end of the conduit with a balloon or inflatable structure, measuring wall forces (e g., pressure, radial forces, compressive forces, strains) in one or more locations within the conduit, detecting flow through the conduit, and constructing, repairing and/or maintaining nearby structure or material to the conduit in order to maintain or restore natural or intended position and structure can be broadly interpreted for numerous uses in many different fields. In some embodiments, the device and method may be used in engineering or construction applications wherein a conduit (e.g., a flexible conduit) experiences compression forces wherein a wall pressure and/or flow may be measured during construction or repair.

Computing Device

In some aspects of the present invention, software executing the instructions provided herein may be stored on a non-transitory computer-readable medium, wherein the software performs some or all of the steps of the present invention when executed on a processor.

Aspects of the invention relate to algorithms executed in computer software. Though certain embodiments may be described as written in particular programming languages, or executed on particular operating systems or computing platforms, it is understood that the system and method of the present invention is not limited to any particular computing language, platform, or combination thereof. Software executing the algorithms described herein may be written in any programming language known in the art, compiled, or interpreted, including but not limited to C, C++, C#, Objective-C, Java, JavaScript, MATLAB, Python, PHP, Perl, Ruby, Visual Basic or Lab VIEW. It is further understood that elements of the present invention may be executed on any acceptable computing platform, including but not limited to a server, a cloud instance, a workstation, a thin client, a mobile device, an embedded microcontroller, a television, or any other suitable computing device known in the art.

Parts of this invention are described as software running on a computing device. Though software described herein may be disclosed as operating on one particular computing device (e.g. a dedicated server or a workstation), it is understood in the art that software is intrinsically portable and that most software running on a dedicated server may also be run, for the purposes of the present invention, on any of a wide range of devices including desktop or mobile devices, laptops, tablets, smartphones, watches, wearable electronics or other wireless digital/cellular phones, televisions, cloud instances, embedded microcontrollers, thin client devices, or any other suitable computing device known in the art.

Similarly, parts of this invention are described as communicating over a variety of wireless or wired computer networks. For the purposes of this invention, the words “network”, “networked”, and “networking” are understood to encompass wired Ethernet, fiber optic connections, wireless connections including any of the various 802.11 standards, cellular WAN infrastructures such as 3G, 4G/LTE, or 5G networks, Bluetooth®, Bluetooth® Low Energy (BLE) or Zigbee® communication links, or any other method known in the art by which one electronic device is capable of communicating with another. Tn some embodiments, elements of the networked portion of the invention may be implemented over a Virtual Private Network (VPN).

Fig. 3 and the following discussion are intended to provide a brief, general description of a suitable computing environment in which the invention may be implemented. While the invention is described above in the general context of program modules that execute in conjunction with an application program that runs on an operating system on a computer, those skilled in the art will recognize that the invention may also be implemented in combination with other program modules.

Generally, program modules include routines, programs, components, data structures, and other types of structures that perform particular tasks or implement particular abstract data types. Moreover, those skilled in the art will appreciate that the invention may be practiced with other computer system configurations, including handheld devices, multiprocessor systems, microprocessor-based or programmable consumer electronics, minicomputers, mainframe computers, and the like. The invention may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

Fig. 3 depicts an illustrative computer architecture for a computer 300 for practicing the various embodiments of the invention. The computer architecture shown in Fig. 3 illustrates a conventional personal computer, including a central processing unit 350 (“CPU”), a system memory 305, including a random access memory 310 (“RAM”) and a read-only memory (“ROM”) 315, and a system bus 335 that couples the system memory 305 to the CPU 350. A basic input/output system containing the basic routines that help to transfer information between elements within the computer, such as during startup, is stored in the ROM 315. The computer 300 further includes a storage device 320 for storing an operating system 325, application/program 330, and data.

The storage device 320 is connected to the CPU 350 through a storage controller (not shown) connected to the bus 335. The storage device 320 and its associated computer-readable media provide non-volatile storage for the computer 300. Although the description of computer-readable media contained herein refers to a storage device, such as a hard disk or CD-ROM drive, it should be appreciated by those skilled in the art that computer-readable media can be any available media that can be accessed by the computer 300.

By way of example, and not to be limiting, computer-readable media may comprise computer storage media. Computer storage media includes volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. Computer storage media includes, but is not limited to, RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory technology, CD-ROM, DVD, or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by the computer.

According to various embodiments of the invention, the computer 300 may operate in a networked environment using logical connections to remote computers through a network 340, such as TCP/IP network such as the Internet or an intranet. The computer 300 may connect to the network 340 through a network interface unit 345 connected to the bus 335. It should be appreciated that the network interface unit 345 may also be utilized to connect to other types of networks and remote computer systems.

The computer 300 may also include an input/output controller 355 for receiving and processing input from a number of input/output devices 360, including a keyboard, a mouse, a touchscreen, a camera, a microphone, a controller, a joystick, or other type of input device. Similarly, the input/output controller 355 may provide output to a display screen, a printer, a speaker, or other type of output device. The computer 300 can connect to the input/output device 360 via a wired connection including, but not limited to, fiber optic, Ethernet, or copper wire or wireless means including, but not limited to, Wi-Fi, Bluetooth, Near-Field Communication (NFC), infrared, or other suitable wired or wireless connections.

As mentioned briefly above, a number of program modules and data files may be stored in the storage device 320 and/or RAM 310 of the computer 300, including an operating system 325 suitable for controlling the operation of a networked computer. The storage device 320 and RAM 310 may also store one or more applications/programs 330. In particular, the storage device 320 and RAM 310 may store an application/program 330 for providing a variety of functionalities to a user. For instance, the application/program 330 may comprise many types of programs such as a UI, a GUI, word processing application, a spreadsheet application, a desktop publishing application, a database application, a gaming application, internet browsing application, electronic mail application, messaging application, and the like. According to an embodiment of the present invention, the application/program 330 comprises a multiple functionality software application for providing word processing functionality, slide presentation functionality, spreadsheet functionality, database functionality and the like.

The computer 300 in some embodiments can include a variety of sensors 365 for monitoring the environment surrounding and the environment internal to the computer 300. These sensors 365 can include a Global Positioning System (GPS) sensor, a photosensitive sensor, a gyroscope, a magnetometer, thermometer, a proximity sensor, an accelerometer, a microphone, biometric sensor, barometer, humidity sensor, radiation sensor, pressure sensor, force sensor, strain sensor, flow sensor, or any other suitable sensor.

The computer 300 in some embodiments may produce notifications and/or alerts. In some embodiments, the notifications and/or alerts are sent to a user, or UI. In some embodiments, the notifications and/or alerts comprise any of upper and lower bound signaling (e.g., “apply more pressure”, “apply less pressure”, pressure in range”), pressure alerts, configuration alerts, power status alerts, and the like. In some embodiments, the notifications and/or alerts comprise audible, visual and/or tactile alerts and/or UI feedback.

Numerated Embodiments

Embodiment 1 : A device for measuring intraurethral pressure, comprising: an elongate tube having a proximal opening, a distal solid end, and a structure forming a lumen therebetween, the elongate tube having interior and exterior surfaces and at least first and second lateral openings in the wall along its length; first and second balloons on the elongate tube, each balloon positioned over one of the lateral openings and sealingly enclosing at least a portion the exterior surface of the tube, wherein each balloon comprises walls having interior and exterior surfaces forming an interior volume, and wherein a first balloon is positioned distal to a second balloon along the length of the tube; one or more channels positioned within the lumen of the tube, wherein a first channel extends from the proximal opening and passes through the distal solid end forming a distal opening, a second channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the first lateral opening and the interior volume of the first balloon, and a third channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the second lateral opening and the interior volume of the second balloon; and one or more sensors fluidly connected to the interior volume of the second balloon.

Embodiment 2: The device of embodiment 1, wherein the elongate tube further comprises a third lateral opening in the wall, and a fourth channel, wherein the fourth channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the third lateral opening and the interior volume of second balloon.

Embodiment 3: The device of any one of embodiments 1-2, wherein the first balloon comprises a spherical, conical or frustoconical shape, or combinations thereof, and is configured to be positioned in the neck of the bladder, and the second balloon comprises a spherical, conical, frustoconical, cylindrical with tapered ends, or ovular shape, and is configured to be positioned in the urethra.

Embodiment 4: The device of any one of embodiments 1-3, wherein the first balloon comprises an elastic material, and the second balloon comprises a substantially inelastic or non-distensible material.

Embodiment 5: The device of any one of embodiments 1-4, wherein the second balloon further comprises pleats in the walls of the balloon configured to allow the balloon to collapse neatly around the elongate tube. Embodiment 6: The device of any one of embodiments 1-5, wherein the first balloon comprises a gas, and the second balloon comprises a fluid.

Embodiment 7: The device of any one of embodiments 1-6, wherein the one or more sensors comprises a pressure sensor.

Embodiment 8: The device of any one of embodiments 1-7, wherein the sensor comprises a pressure sensor connected to the proximal end of the third channel.

Embodiment 9: The device of any one of embodiments 1-8, wherein the sensor comprises a pressure sensor disposed within the third channel or the interior volume of the second balloon.

Embodiment 10: The device of any one of embodiments 1-9, wherein the sensor comprises one or more resistive elements in contact with the wall of the balloon configured as a strain gauge pressure sensor.

Embodiment 11 : The device of any one of embodiments 1-10, wherein the sensor comprises one or more piezoelectric elements positioned within the third channel or second balloon, the piezoelectric element connected to a conductive element that extends from the piezoelectric element through the third channel and out the proximal opening of the third channel.

Embodiment 12: The device of any one of embodiments 1-1 Ifurther comprising a fourth lateral opening in the wall of the tube, a fifth channel having a proximal opening that extends from the proximal opening of the tube to a position along the length of the tube, and a third balloon positioned proximal on the length of the tube to the position of the second balloon, wherein the fifth channel fluidly connects with the fourth lateral opening and the interior volume of the third balloon. Embodiment 13: The device of any one of embodiments 1 -12, further comprising a sensor fluidly connected to the interior volume of the third balloon.

Embodiment 14: The device of any one of embodiments 1-13, further comprising a plurality of balloons positioned proximal to the third balloon.

Embodiment 15: The device of any one of embodiments 1-14, further comprising a plurality of sensors fluidly connected to the interior volumes of each balloon of the plurality of balloons.

Embodiment 16: The device of any one of embodiments 1-15, wherein the tube has a length ranging between 3 cm and 100 cm, and a diameter ranging between 0.25 cm and 5 cm.

Embodiment 17: The device of any one of embodiments 1-16, wherein each channel of the one or more channels has a diameter ranging between 0.1 cm and 1.5 cm.

Embodiment 18: The device of any one of embodiments 1-17, wherein the first balloon has a diameter ranging between about 0.1 cm and 3 cm, and length ranging between 0.1 cm and 2 cm, and the second balloon has a diameter ranging between about 0.1 cm and 3 cm, and a length ranging between 0.1 cm and 3 cm.

Embodiment 19: The device of any one of embodiments 1-18, wherein the third balloon has a diameter ranging between about 0.1 cm and 3 cm, and a length ranging between 0.1 cm and 3 cm, and is positioned between 0. 1 cm and 5 cm proximal from the position of the second balloon.

Embodiment 20: The device of any one of embodiments 1-19, wherein the first balloon is positioned between 0.1 cm and 1 cm from the distal end of the tube, and the second balloon is positioned between 0.1 cm and 5 cm proximal from the position of the first balloon. Embodiment 21 : The device of any one of embodiments 1-20, wherein the elongated tube further comprises a pressure sensor positioned distal to the first balloon.

Embodiment 22: The device of any one of embodiments 1-21, further comprising a polyester sheath surrounding at least a portion of the tube, and wherein the one or more channels comprise a silicon material.

Embodiment 23: The device of any one of embodiments 1-22, further comprising one or more coatings on the exterior surfaces of the elongate tube or balloons.

Embodiment 24: The device of any one of embodiments 1-23, wherein the one or more coatings are selected from the group consisting of: lubricative coating, silicone coating, biocompatible coating, sulfated sugar compound, or any combination thereof.

Embodiment 25: The device of any one of embodiments 1-24, further comprising one or more markings on the tube or the one or more balloons, wherein the one or more markings selected from the group consisting of: radiopaque markings, near-infrared fluorescent markings, contrasting agent markings, graduation markings, directional markings, and size markings.

Embodiment 26: A method of measuring intraurethral pressure, comprising the steps of: providing a device for measuring intraurethral pressure comprising an elongate tube having a proximal opening, a distal solid end, and a wall forming a lumen therebetween, the elongate tube having interior and exterior surfaces along its length; one or more balloons sealingly enclosing at least a portion the exterior surface of the tube, wherein each balloon comprises walls forming an interior volume and at least a first opening in the wall of the tube, and wherein a first balloon is positioned distal to a second balloon along the length of the tube; one or more channels positioned within the lumen of the tube, wherein a first channel extends from the proximal opening and passes through the distal solid end forming a distal opening, a second channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the first opening of the first balloon, a third channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the first opening of the second balloon, and one or more sensors fluidly connected to the interior volume of the second balloon; inserting the distal end of the elongate tube into the urethra of the subject; measuring pressure from the one or more sensors.

Embodiment 27: The method of embodiment 26, further comprising the steps of: inflating the first balloon with a gas to at least partially occlude the urethra; filling the second balloon with a liquid.

Embodiment 28: The method of any one of embodiments 26-27, further comprising the step of relieving the bladder of fluid via the first channel.

Embodiment 29: The method of any one of embodiments 26-28, further comprising the step of measuring pressure in the bladder.

Embodiment 30: The method of any one of embodiments 26-29, further comprising the step of adjusting a suture tension for suture on a subject based on measurements from the device.

EXPERIMENTAL EXAMPLES

The invention is further described in detail by reference to the following experimental examples. These examples are provided for purposes of illustration only, and are not intended to be limiting unless otherwise specified. Thus, the invention should in no way be construed as being limited to the following examples, but rather, should be construed to encompass any and all variations which become evident as a result of the teaching provided herein. Without further description, it is believed that one of ordinary skill in the art can, using the preceding description and the following illustrative examples, make and utilize the present invention and practice the claimed methods. The following working examples therefore are not to be construed as limiting in any way the remainder of the disclosure.

Disclosed in this example is a prototype of a novel urethral catheter device for control of urethral compression force for the correction of stress incontinence in women with stress incontinence in the postoperative prostatectomy patient. In some embodiments, the device may be used to determine a urethral pressure profile for a patient.

Historically urethral pressure profiles are determined with sensors recording pressures during withdrawal and reinsertion, or during withdrawal of a catheter. Patients are asked to cough or execute a Valsalva maneuver, and leaks noted. Patients are typically seated but can be evaluated in the supine position. Patients are awake during surgeries and are anesthetized and supine or in the Trendelenberg position (feet higher than head). In the seated position, abdominal pressures are increased resulting in elevated bladder pressures. Maximum urethral pressure is usually determined by varying the position of the sensor. The disclosed device may be used intraoperatively to measure the urethral pressure achieved as a result of surgical techniques where currently there is no explicit feedback, providing a means to determine optimal values for individual patients.

Individual patients display different urethral pressures that are complexly determined and vary as a function of assessment. Optimization of intraoperative methods will rely on measuring intraoperative achieved values with a given instrumental method and the outcomes of the procedure, i.e. observations of incontinence episodes and explicit measurement of leak point pressures. From the outset, providing measurement feedback to the surgeon is expected to reduce variability in outcomes for individual surgeons, and would provide guidance to surgeons to enhance their success rate. Typically the first step is to measure what pressures are generated for the particular surgical procedure; these initial observations provide a baseline moving into other procedures or trials that monitor other important patient parameters, ultimately leading to nomograms that suggest optimum target values for individual patients.

Measuring urethral pressures simultaneously in two positions has been described [Tan-Kim, J., M.M. Weinstein, and C.W. Nager, Int Urogynecol J, 2010. 21(6): p. 685-91] and balloon tipped catheters have been studied for measuring urethral pressures [Walter, J.S., et al. J Spinal Cord Medicine. 32(5): p. 578-82.]

Referring now to Fig. 2A & 2B, shown is a prototype of an exemplary catheter device. In an attempt to address the problem of finding the optimal range of compressive forces required for clinical success, a prototype device was developed and fabricated to illustrate the essential features required to assess the intraurethral compression force exerted by external adjustment of the length of the suture material while the patient is in the (supine) Trendelenburg position. In some embodiments, the device comprises a three-way silicone rubber foley catheter comprising three channels: one for inflation of the retention bulb, one for the removal of urine, and one for introduction of a bladder flush or other solution to the bladder lumen. The latter was sealed at the end, and an opening created below the retention bulb of the catheter. (See Fig. 2A and Fig. 2B) This opening is surrounded by a cylindrical balloon optimal for the measurement of pressure generated by the urethral wall. In some embodiments, this balloon may be in a conformation similar to those commonly used in vascular stenting procedures, and may be made of polyester of limited elasticity, or materials that permit accurate assessment of pressure exerted around its circumference or on its walls.

In some embodiments, a method of using the device involves positioning the retention balloon in the bladder, and pulling on the retention balloon into the base or neck of the bladder. In some embodiments, the pressure measurement balloon is long enough and appropriately placed for the repeatable application of pressure generated by suture (sling) shortening.

Applications of the invention include improved continence of prostatectomy patients after surgery. The device and method provide a means for standardized/optimal transurethral pressure when tensioning a female sling for stress urinary incontinence (SUI). The disclosed device has particular and unexpected success in the practice of female urology, where slings are adjusted by surgeons accustomed to practicing this art relying on only fingertip pressure or surgical tradition to snug these slings into place. Furthermore, the force applied in this case (e.g., the force on the sling) is not the force of interest, i.e., the compressive force on the urethra achieved indirectly by sling shortening. Further, in minimally invasive procedures, like robotic surgery, there is no haptic feedback to the surgeon, and the device and method provide standardized and repeatable measurements during the procedure.

The disclosures of each and every patent, patent application, and publication cited herein are hereby each incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.

Claims

CLAIMS What is claimed is:

1. A device for measuring intraurethral pressure, comprising: an elongate tube having a proximal opening, a distal solid end, and a structure forming a lumen therebetween, the elongate tube having interior and exterior surfaces and at least first and second lateral openings in the wall along its length; first and second balloons on the elongate tube, each balloon positioned over one of the lateral openings and sealingly enclosing at least a portion the exterior surface of the tube, wherein each balloon comprises walls having interior and exterior surfaces forming an interior volume, and wherein a first balloon is positioned distal to a second balloon along the length of the tube; one or more channels positioned within the lumen of the tube, wherein a first channel extends from the proximal opening and passes through the distal solid end forming a distal opening, a second channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the first lateral opening and the interior volume of the first balloon, and a third channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the second lateral opening and the interior volume of the second balloon; and one or more sensors fluidly connected to the interior volume of the second balloon.

2. The device of claim 1, wherein the elongate tube further comprises a third lateral opening in the wall, and a fourth channel, wherein the fourth channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the third lateral opening and the interior volume of second balloon.

3. The device of claim 1 or 2, wherein the first balloon comprises a spherical, conical or frustoconical shape, or combinations thereof, and is configured to be positioned in the neck of the bladder, and the second balloon comprises a spherical, conical, frustoconical, cylindrical with tapered ends, or ovular shape, and is configured to be positioned in the urethra.

4. The device of claim 1 or 2, wherein the first balloon comprises an elastic material, and the second balloon comprises a substantially inelastic or non-distensible material.

5. The device of claim 1 or 2, wherein the second balloon further comprises pleats in the walls of the balloon configured to allow the balloon to collapse neatly around the elongate tube.

6. The device of claim 1 or 2, wherein the first balloon comprises a gas, and the second balloon comprises a fluid.

7. The device of claim 1 or 2, wherein the one or more sensors comprises a pressure sensor.

8. The device of claim 7, wherein the sensor comprises a pressure sensor connected to the proximal end of the third channel.

9. The device of claim 7, wherein the sensor comprises a pressure sensor disposed within the third channel or the interior volume of the second balloon.

10. The device of claim 7, wherein the sensor comprises one or more resistive elements in contact with the wall of the balloon configured as a strain gauge pressure sensor.

11. The device of claim 7, wherein the sensor comprises one or more piezoelectric elements positioned within the third channel or second balloon, the piezoelectric element connected to a conductive element that extends from the piezoelectric element through the third channel and out the proximal opening of the third channel.

12. The device of claim 1 or 2, further comprising a fourth lateral opening in the wall of the tube, a fifth channel having a proximal opening that extends from the proximal opening of the tube to a position along the length of the tube, and a third balloon positioned proximal on the length of the tube to the position of the second balloon, wherein the fifth channel fluidly connects with the fourth lateral opening and the interior volume of the third balloon.

13. The device of claim 12, further comprising a sensor fluidly connected to the interior volume of the third balloon.

14. The device of claim 12, further comprising a plurality of balloons positioned proximal to the third balloon.

15. The device of claim 14, further comprising a plurality of sensors fluidly connected to the interior volumes of each balloon of the plurality of balloons.

16. The device of claim 1 or 2, wherein the tube has a length ranging between 3 cm and 100 cm, and a diameter ranging between 0.25 cm and 5 cm.

17. The device of claim 1 or 2, wherein each channel of the one or more channels has a diameter ranging between 0.1 cm and 1.5 cm.

18. The device of claim 1 or 2, wherein the first balloon has a diameter ranging between about 0.1 cm and 3 cm, and length ranging between 0.1 cm and 2 cm, and the second balloon has a diameter ranging between about 0.1 cm and 3 cm, and a length ranging between 0.1 cm and 3 cm.

19. The device of claim 12, wherein the third balloon has a diameter ranging between about 0.1 cm and 3 cm, and a length ranging between 0.1 cm and 3 cm, and is positioned between 0.1 cm and 5 cm proximal from the position of the second balloon.

20. The device of claim 1 or 2, wherein the first balloon is positioned between 0.1 cm and 1 cm from the distal end of the tube, and the second balloon is positioned between

0.1 cm and 5 cm proximal from the position of the first balloon.

21. The device of claim 1 or 2, wherein the elongated tube further comprises a pressure sensor positioned distal to the first balloon.

22. The device of claim 1 or 2, further comprising a polyester sheath surrounding at least a portion of the tube, and wherein the one or more channels comprise a silicon material.

23. The device of claim 1 or 2, further comprising one or more coatings on the exterior surfaces of the elongate tube or balloons.

24. The device of claim 23, wherein the one or more coatings are selected from the group consisting of: lubricative coating, silicone coating, biocompatible coating, sulfated sugar compound, or any combination thereof.

25. The device of claim 1 or 2, further comprising one or more markings on the tube or the one or more balloons, wherein the one or more markings selected from the group consisting of: radiopaque markings, near-infrared fluorescent markings, contrasting agent markings, graduation markings, directional markings, and size markings.

26. A method of measuring intraurethral pressure, comprising the steps of: providing a device for measuring intraurethral pressure comprising an elongate tube having a proximal opening, a distal solid end, and a wall forming a lumen therebetween, the elongate tube having interior and exterior surfaces along its length; one or more balloons sealingly enclosing at least a portion the exterior surface of the tube, wherein each balloon comprises walls forming an interior volume and at least a first opening in the wall of the tube, and wherein a first balloon is positioned distal to a second balloon along the length of the tube; one or more channels positioned within the lumen of the tube, wherein a first channel extends from the proximal opening and passes through the distal solid end forming a distal opening, a second channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the first opening of the first balloon, a third channel extends from the proximal opening to a position along the length of the tube and fluidly connects with the first opening of the second balloon, and one or more sensors fluidly connected to the interior volume of the second balloon; inserting the distal end of the elongate tube into the urethra of the subject; measuring pressure from the one or more sensors.

27. The method of claim 26, further comprising the steps of: inflating the first balloon with a gas to at least partially occlude the urethra; filling the second balloon with a liquid.

28. The method of claim 27, further comprising the step of relieving the bladder of fluid via the first channel.

29. The method of claim 26, further comprising the step of measuring pressure in the bladder.

30. The method of claim 26, further comprising the step of adjusting a suture tension for suture on a subject based on measurements from the device.