Urodynamic examination apparatus, system and method

Abstract

A urodynamic testing apparatus for receiving urine from a bladder is provided. The apparatus features a tubular element, a first fitting, a second fitting, and a sleeve element, wherein the sleeve element is used to select a path for the urine to travel within the sleeve element. The tubular element features opposite first and second ends and a port. The fittings are adapted to be received by the opposite two ends of the tubular element, thereby defining an apparatus chamber. The sleeve element is suspended within the chamber between the fittings, the sleeve element having a collapsed configuration and an expanded configuration. The collapsed configuration represents a no urine flow condition, and the expanded configuration represents a urine flow condition, wherein the urine flow condition of the sleeve element is a function of the pressure applied to the chamber via the port of the tubular element.

Description

[0001] This international patent application is filed pursuant to Section 363 of Title 35 of the United States Code and claims priority to U.S. Patent Application No. 62 / 633,652, filed February 22, 2018, and U.S. Patent Application No. 62 / 742,602, filed October 8, 2018, pursuant to Section 120 of Title 35 of the United States Code, respectively. The entire contents of the aforementioned two U.S. patent applications are incorporated herein by reference. Technical Field

[0002] This invention generally relates to urodynamic testing of male subjects, and more specifically, to improvements made to non-invasive urodynamic testing, such as improvements made to non-invasive urodynamic testing as shown and described in U.S. Patent No. 6,506,169 filed by Griffiths, which is incorporated herein by reference in its entirety and, where appropriate, includes resulting urodynamic testing devices, apparatuses, components or sub-components and / or methods. Background Technology

[0003] For urodynamic testing, the voiding pressure study (VPS) is the gold standard in diagnosis for determining the relationship between the pressure generated by the body and the rate of urine output. Healthcare providers, typically urologists, can infer the magnitude of outlet flow resistance at the bladder neck and urethra by simultaneously determining the pressure generated by the body during urination and the resulting urine output (i.e., expulsion) rate. This information, taken together, can indicate the underlying source of lower urinary tract symptoms and the likelihood of success for certain interventions. For example, if it is determined that a subject's lower urinary tract output flow produces high pressure, it can be inferred that the subject has high outlet resistance and surgery to reduce that resistance may be considered.

[0004] Traditional VPS involves the simultaneous measurement of three physiological parameters or signals: (1) placing a measuring catheter in the bladder to continuously measure bladder pressure; (2) placing a measuring catheter in the abdominal cavity to continuously measure abdominal pressure; and (3) collecting and continuously weighing the amount of urine output to determine the urine flow rate.

[0005] The body generates pressure to expel urine from two sources: (1) primarily the coordinated contraction of the bladder wall (i.e., the detrusor muscle), and (2) some subjects “bear down” and voluntarily contract their abdomen. A measuring catheter in the bladder makes it difficult to distinguish the pressure generated by the detrusor muscle from the pressure generated by abdominal contractions. To separate (i.e., identify) the pressure generated by the detrusor muscle, the abdominal pressure must be subtracted from the bladder pressure.

[0006] Figure 1 The diagram illustrates exemplary pressure relative to time during urination. The top graph represents the output of a pressure sensor in the bladder (Pves - bladder pressure), the middle graph represents the output of a pressure sensor in the abdominal cavity (Pabd - abdominal pressure), and the bottom graph represents the calculated difference (Pves - Pabd), which is the magnitude of the pressure generated by bladder wall contraction (Pdet - detrusor pressure). Figure 1 The relationship shown illustrates that the subjects experienced a significant amount of pressure during urination, but almost all of this pressure originated from abdominal contractions.

[0007] For patients suspected of having bladder outlet obstruction, the traditional VPS is a diagnostic method that is not fully utilized in the United States. This invasive test requires the insertion of a catheter, which is passed through the tip of the penis and the rectum, and involves the injection of sterile water into the catheter. It is estimated that less than 1% of patients treated for bladder outlet obstruction receive a traditional VPS.

[0008] The applicant, SRS Medical Systems, LLC (Massachusetts, USA), manufactured the CT3000 Plus Complete Urodynamic System, which is characterized by the use of... Bladder function monitoring / assessment device. This device and system support a non-invasive voiding pressure study known as the UroCuff bladder function test, which simultaneously measures urinary flow rate and bladder pressure (see SRS Medical Systems LLC, excerpted from Dr. Michael Drinnan and Dr. Clive Griffiths of Newcastle University, Principles of the UroCuff Test, P / N: 291-045, Version: A, the entire contents of which are incorporated herein by reference). Figure 2The study / research system 21 is intended to apply controlled regulated pressure to the pneumatic penile cuff 23 via an automatic pressure supply device or system 25 during the urination event, and to monitor / collect at the urethral outlet via the urine collection / flow rate system 27 during the selection of pressure supply in order to directly or indirectly determine the volumetric flow rate.

[0009] After the bladder is naturally filled and distended by drinking fluids, the subject is positioned in the testing position. Bladder pressure is measured non-invasively using a pneumatic penile balloon (i.e., an item similar to a blood pressure cuff), rather than through an indwelling catheter.

[0010] The principle of this test is similar to blood pressure measurement. When the subject prepares to urinate, a sac is placed around the penis, and the subject is asked to directly or otherwise expel urine into a flow measurement device, flow measurement equipment, or flow measurement system. Once urination has begun, the sac inflates using an automatic pressure supply and control component / sub-component until the urine flow is interrupted due to the limitation imposed by the sac. Further inflation cycles can then be performed until urination is complete. At the point of interruption, the sac pressure at which the urine flow is interrupted is equal to the bladder pressure.

[0011] Once the test is complete, pressure-flow data are generated using a modified nomogram in a typical UroCuff bladder function test report. Figure 3 Nomograms are shown for two different subjects with a maximum flow rate of 3.1 ml / s. Although each of these subjects was classified as a "low flow rate" subject, the UroCuff bladder function test nomogram on the left shows that the first subject (A) had high bladder pressure (~173 cmH2O), while the nomogram on the right shows that the second subject (B) had low bladder pressure (~61 cmH2O). The first subject's improved voiding symptoms were likely due to a de-obstructive procedure.

[0012] The existing UroCuff protocol involves waiting for the subject to begin urinating. Once the subject urinates, the sac expands linearly at a rate of 10 cmH2O per second. The urine flow rate is continuously measured as the sac expands, and the protocol requires the sac to expand to a pressure that interrupts the urine flow. Once the urine flow is interrupted, the sac is completely deflated, and a second expansion cycle begins. The second expansion cycle again linearly increases the pressure in the sac until the urine flow is completely interrupted. This cycle is repeated until the subject empties their bladder to end urination and complete the test.

[0013] Figure 4A graph showing parameter values ​​changing over time is provided, illustrating the performance of four expansion cycles through monitoring and recording of applied pressure, urine outflow rate, and urine volume. The top graph shows the scrotum pressure and a series of four linear expansions (i.e., linear pressure increases to the urination pause / termination point), while the middle graph shows the urine flow rate. Comparisons of the relationships shown in the graphs indicate that as scrotum pressure increases, the urine flow rate decreases. The bottom graph shows the total urine volume.

[0014] right Figure 4 The analysis conducted in the study of the four expansions is shown in Figure 5 The graph shows the flow rate versus sac pressure for each inflation event or inflation sequence, and performs analysis to determine the pressure provided by the sac that causes the interruption of urine flow. This pressure is called the interruption pressure. In this example, the second inflation resulted in a maximum interruption pressure of 125 cmH2O, which is used to represent the data point of bladder pressure.

[0015] The existing UroCuff bladder function protocol has three drawbacks or at least challenges: (1) the use of penile sac inflation to cut off urine flow is usually uncomfortable for the subject (i.e., the application of interruption pressure is at least uncomfortable or even painful); (2) if the subject’s urine output is limited, this protocol can only include one or two inflation cycles, which will correspondingly limit the accuracy of data / measurements and related assessments; and (3) some subjects will instinctively generate abdominal pressure by pushing at the end of urination, which makes it difficult to determine the interruption pressure.

[0016] The applicant's current work anticipates three significant improvements to the existing UroCuff bladder function test. First, it provides an alternative method for penile sac expansion / contraction, characterized by a simplified (less is more) data acquisition approach. Second, it improves the estimation of detrusor contraction pressure (Pdet) and abdominal pressure (Pabd) through supplemental data acquisition using abdominal electromyography (EMG). Third, and most importantly, it provides a reliable and improved data acquisition method by placing a pneumatic penile sac alternative component distal to the urethra, thus eliminating the need for penile restraint facilitated by the pneumatic penile sac. Summary of the Invention

[0017] This application provides a urodynamic testing device for receiving urine from the bladder. The device is characterized by comprising: a tubular element, a first fitting and a second fitting, and a sleeve element for selecting the path of urine within the tubular element. The tubular element is characterized by opposite first and second ends and a port. The fitting is adapted to be received by opposite first and second ends of the tubular element, thereby defining a chamber for the device. The sleeve element is suspended within the chamber between the first and second fittings, and the sleeve element has a contraction structure and an expansion / opening structure. The contraction structure represents a state of no urine flow, and the expansion structure represents a state of urine flow, the urine flow state of the sleeve element being a function of the pressure applied to the chamber via the port of the tubular element.

[0018] The first and second fittings may be configured to receive an outflow tube from an external urinary catheter, or alternatively, to receive or cooperatively engage with perineural tissue. Furthermore, one of the fittings is intended or adapted to be operatively coupled with a downstream testing component, such as a urine outflow tube or a urine flow rate determination device, without limiting the invention. Additionally, the interface of the fitting, the structure of the fitting, or the interface between the fitting and the tubular element is a leak-proof seal; or in one embodiment, such an interface is an O-ring or similar element.

[0019] The sleeve element can be suspended directly or indirectly relative to the fixing device. Anchoring elements are contemplated but not necessary. In advantageous cases, the sleeve element is a compliant element; for example, if not necessary, the sleeve element comprises thermoplastic material, and more specifically, in advantageous cases, the sleeve element comprises a shrink tube.

[0020] In addition to the urodynamic testing device, the present invention also provides a contemplated enhanced testing scheme. The contemplated enhanced urodynamic pressure profilometry method is characterized by applying a first pressure to a cavity containing urine expelled from the bladder and recording the first pressure without terminating the urine flow through the cavity, and determining the urine flow rate corresponding to the applied first pressure. Then, a second pressure is applied to the cavity containing urine expelled from the bladder and recorded without terminating the urine flow through the cavity, the second pressure being greater than or less than the first pressure by a selected pressure increment. The urine flow rate corresponding to the applied second pressure is determined in the same manner. Next, preferably a third pressure is applied to the cavity containing urine expelled from the bladder and recorded without terminating the urine flow through the cavity, the third pressure being greater than or less than the second pressure by a selected pressure increment. The urine flow rate corresponding to the applied third pressure is determined in the same manner. Finally, by estimating the applied pressure and the corresponding flow rate, one or both of the applied pressure and the maximum emptying flow rate corresponding to the absence of urine flow can be determined.

[0021] Finally, an enhanced urodynamic pressure profilometry method is characterized by applying a first pressure to a cavity containing urine expelled from the bladder and recording this first pressure while not terminating the flow of urine through the cavity and determining the urine flow rate corresponding to the applied first pressure. Simultaneously, multiple surface electrodes, as an important part of the EMG device / system, are placed and provided to the subject's abdomen, and voltages are selectively applied to the surface electrodes while recording the applied voltage and the voltages detected by the active abdominal muscles. More specific features and advantages derived from these summary characteristics become more apparent when considered in conjunction with the accompanying drawings and specific embodiments of this invention. Attached Figure Description

[0022] All the accompanying drawings provided and included in this invention are intended to facilitate and / or enhance the understanding of the basic teachings and / or fundamental concepts of the contemplated embodiments of the invention, and these drawings are incorporated into and constitute a part of this invention.

[0023] Although embodiments of the invention and related text are illustrated in the accompanying drawings, and these drawings describe the principles of the embodiments of the invention in conjunction with the specification, a better understanding of other embodiments of the disclosed systems, subsystems, components, subcomponents, devices, apparatuses, mechanisms, and methods, as well as many anticipated advantages, can be achieved by referring to the specific description of the invention and the accompanying drawings. It should be noted that the elements in the drawings are not necessarily proportional to each other, and similar reference numerals in the drawings denote corresponding similar parts / structures.

[0024] Provided in this application Figures 1 to 15 middle:

[0025] Figure 1 Exemplary voiding pressure study pressure component values ​​as a function of the subject's voiding time are shown, namely bladder, abdominal, and detrusor muscle pressure components;

[0026] Figure 2 The diagram schematically depicts the known procedure for studying voiding pressure; more specifically, it shows... Bladder function monitoring / assessment process;

[0027] Figure 3 Illustrative comparisons of applied pressure-urine flow dispersive plots are shown for each subject;

[0028] Figure 4 The diagram shows the application of four pressure cycles. Figure 2 The pressure applied (top), urine flow rate (middle), and urine output (bottom) of the test / cycle time function are shown in the process.

[0029] Figure 5 It shows the urine flow rate and Figure 4 The relationship between the applied pressure in each pressure cycle event and the events provided by each pressure cycle.

[0030] Figure 6 It shows Figure 5 The relationship, in which the dataset obtained through the improved bladder function testing procedure will be in Figure 6 The description / overlay is provided to demonstrate the predicted values ​​of the improved process;

[0031] Figure 7 The improved voiding pressure study process is illustrated schematically. More specifically, the bladder function monitoring / assessment process is characterized by replacing the penile sac feature of the UroCuff bladder function test with a urodynamic testing device.

[0032] Figure 8 A side view of the intended urodynamic testing device for receiving urine expelled from the bladder is shown.

[0033] Figure 9 Show Figure 8 Top view of the equipment;

[0034] Figure 10 Show Figure 8 Front sectional view of the equipment;

[0035] Figure 11 Show Figure 8 Exploded 3D view of the equipment;

[0036] Figure 12A side view of another anticipated urodynamic testing device for receiving urine expelled from the bladder is shown;

[0037] Figure 13 Show Figure 12 Top view of the equipment;

[0038] Figure 14 Show Figure 12 A front sectional view of the equipment; and

[0039] Figure 15 Show Figure 12 Exploded 3D view of the equipment. Detailed Implementation

[0040] Before describing in detail the improved urodynamic pressure analysis method on one hand and the improved non-invasive voiding pressure study procedure characterized by a urodynamic testing device that receives urine from the bladder on the other hand, it is necessary to provide an overview of this invention. Furthermore, the following preamble will better foreshadow some details of this application.

[0041] In terms of the structure of this application's specification, the specification first describes, for example... Figure 6 The enhanced urodynamic pressure profiling methodologies and / or one or more of the anticipated improved urodynamic pressure high-value data acquisition methods are discussed. Subsequently, this specification theoretically proposes the anticipated improved and advantageous voiding pressure research procedure / apparatus. Figure 7 ) and the anticipated non-limiting and advantageous embodiments of urodynamic testing devices ( Figure 8 and the following content and Figure 12 (and the following content).

[0042] Theoretically, the applicant's aim is not to abandon the well-known and widely practiced UroCuff bladder function test, but rather to provide meaningful and advantageous improvements, modifications, and alternatives at one or both levels, including the methodology and test setup, test system, and test equipment. Furthermore, although the specification describes many details of the UroCuff test, the intended improvements are not necessarily limited to this, and the implementation of the methods / equipment disclosed herein can be applied to known VPS methods / schemes and mature VPS methods / schemes with minimal or no modifications.

[0043] The first anticipated alternative to known bladder function testing protocols involves known bladder function testing protocols and involves pressure profilometry. More specifically, the first anticipated alternative mentioned above involves the advantageous starting point of producing a distended / contracted manner. Specifically, the first anticipated alternative does not perform a series of distended processes (i.e., applying pressure) that interrupt (i.e., stop) the urine flow and then contract after each distended process (i.e., the reverse process of applying pressure). In the first anticipated alternative, a series of distended processes would produce one or more distended sequences, in which the applied pressure is increased and decreased to establish a relationship between pressure and flow, without resorting to multiple terminations of the urine flow using a penile sac, which would be problematic for the subject and also falls under known skewed datasets. By using the method of the present invention, namely, limiting pressure application to a subset of the pressure range defined by the interruption pressure and extrapolating the obtained dataset to determine the interruption pressure and maximum urinary flow rate, rather than repeatedly measuring, there is an improved subject experience and “better” data (i.e., at least equally good data) can be obtained in a shorter data acquisition period.

[0044] For example, in a manner that does not limit the invention, the applied pressure (e.g., scrotum pressure) may increase and decrease linearly at a rate of 10 cmH2O / s. The subject may initiate laminar flow, and once flow begins, the applied pressure increases to a maximum, for example, 60 cmH2O. When the recorded applied pressure is 60 cmH2O, the scrotum may linearly contract to a minimum pressure, for example, 30 cmH2O. This shortening expansion / contraction cycle may continue to repeat until the subject has completed urination.

[0045] Typically, in a manner that does not limit the invention, the contemplated improved urodynamic pressure profilometry method is characterized by applying and recording a first pressure to a cavity containing urine being expelled from the bladder without terminating the flow of urine through the cavity, and determining the urine flow rate corresponding to the first applied pressure. Subsequently, a second pressure is applied to the cavity containing urine being expelled from the bladder and recorded without terminating the flow of urine through the cavity; the second pressure can be made greater than or less than the first pressure by a selected pressure increment. The urine flow rate corresponding to the second applied pressure can be determined in the same manner. Next, but not necessarily, a third pressure can be applied to the cavity containing urine being expelled from the bladder instead of terminating the flow of urine through the cavity, and this third pressure can be recorded; the third pressure can be made greater than or less than the second pressure by a selected pressure increment. The urine flow rate corresponding to the third applied pressure can be determined in the same manner. Finally, by estimating the applied pressure and the corresponding flow rate, one or both of the applied pressure and the maximum urination flow rate corresponding to the absence of urine flow can be determined.

[0046] Best reference Figure 6 To understand the predicted values ​​of the scheme / method described in this invention, the figure shows the expansion sequence represented by lines (L) illustrating the pressure-flow relationship analysis between 30-60 cmH2O. Figure 5 The expansion analysis in the data is readily observable, allowing for reliable prediction of interruption pressure and maximum flow rate without relying on measurement / direct measurement.

[0047] A second anticipated alternative to known bladder function testing protocols involves, and aims to improve, accuracy. More specifically, this second anticipated alternative involves supplementing previous data acquisition and assessment using abdominal electromyography (EMG) to estimate the detrusor contraction pressure component and the abdominal pressure component. The UroCuff test currently reports interruption pressure, which is the pressure exerted by the sac on the penile urethra to interrupt urine flow. Furthermore, continuous monitoring of the relationship between sac pressure and urine flow rate allows for understanding how increases in outlet resistance affect the flow rate, thereby characterizing intrabladder pressure (i.e., bladder pressure).

[0048] By simultaneously measuring the subject's abdominal surface electromyography (EMG), it is possible to accurately determine whether the subject has abdominal strain during the voiding phase of the study. Modified or enhanced UroCuff bladder function testing protocols can be created in which one or more surface EMG sensors can be placed on the abdomen during the voiding study for simultaneous sensing and recording.

[0049] Without limiting the scope of this application, the anticipated enhanced urodynamic pressure profilometry method is typically characterized by applying a first pressure to a cavity through which urine is expelled from the bladder without terminating the flow of urine through the cavity, recording the first pressure, and determining the urine flow rate corresponding to the applied first pressure. Simultaneously, multiple surface electrodes, as an important part of the EMG device / system, are placed and provided to the subject's abdomen, and voltages are selectively applied to the surface electrodes while recording the applied voltage and the voltages detected by abdominal muscle activity. This combination of steps can be repeatedly performed in the context of a conventional UroCuff bladder function test or in the context of an improved urodynamic pressure profilometry method as previously described.

[0050] Turn now Figure 2 and Figure 7 The bladder function testing system itself, known testing systems, and suitable testing systems are shown separately. Examining and comparing the shown testing systems reveals a key starting point relevant to the invention's purpose: the applicant has abandoned the method of clamping the penis and urethra using a penile sac. While the devices / systems used for applying pressure, recording, etc., and for determining and recording urine flow rates in other system components and / or parts remain conventional / developed technologies, the applicant provides alternatives, substitutes, substitutes, and / or alternative solutions for manipulating urine flow in the bladder by applying pressure without violating known bladder function testing procedures.

[0051] Continue to refer to Figure 7 Alternative research system 30, conceptually, involves device 32 positioned distal or downstream of the urethra as a key part of the schematic process illustrated in the figure. This testing system approach offers three distinct advantages: (1) improved patient comfort; (2) ease of placement by medical personnel; and (3) direct compression of urine flow without involving penile tissue. The desired distal or downstream flow modulation can be achieved in various ways.

[0052] For example, in a manner that does not limit the invention, a known or suitable penile clamp can be operatively combined with a standard external male catheter or urisheath, also known as a Texas catheter or condom catheter. Traditionally, such catheters (e.g., the 26-30 mm Hollister long-wear male external catheter) are used for male patients suffering from incontinence or urinary leakage. The external male catheter is placed around or near the penis to form a urinary tight seal with the penis. The catheter comprises a tube extending distal to the condom, which typically terminates at a urine drainage bag. If the patient experiences urinary leakage, urine will flow through the tube into the drainage bag.

[0053] In this case, the drainage tube of the external male catheter is equipped with, or may be equipped with, a pneumatic penile balloon, through which the subject urinates. When the penile balloon inflates, pressure is applied to the drainage tube according to the selected bladder function testing protocol, and the urine flow is restricted by the applied external pressure. The disadvantages, or at least limitations, of this method are: (1) the large diameter of the standard urinary catheter (i.e., an inner diameter of approximately 0.375 inches) requires physical compression of the tube to affect the flow rate; and (2) the rigidity of the outlet tube limits the direct pressure applied to the interior of the urethra.

[0054] An anticipated, beneficial, and non-limiting method for distal or downstream flow regulation involves the use of an external male catheter for fluid sealing through the outer surface of the penis and operably coupled to a urodynamic testing device via a drainage tube. Figure 8 The following describes a beneficial and non-limiting urodynamic testing device for indirect association with the penile urethra. As will be mentioned later, the envisioned device allows pressure-regulated urine to flow through the device to facilitate the acquisition of bladder function test data and to facilitate the assessment of the bladder / lower urinary tract.

[0055] Another anticipated, beneficial, and non-limiting approach to distal or downstream flow modulation involves providing a urodynamic testing device suitable for cooperative engagement with the subject's periurethral tissues. Figure 12 The following sections describe a beneficial and non-limiting urodynamic testing device that integrates directly with the penile urethra. As will be mentioned later, the envisioned device allows pressure-regulated urine to flow through it to facilitate the acquisition of bladder function test data and to facilitate the assessment of the bladder / lower urinary tract.

[0056] Firstly, refer to the overall picture separately. Figure 8 and Figure 10 On the other hand, refer to Figure 12 and Figure 14 As shown in the figures, alternative embodiments of a urodynamic testing apparatus for receiving urine from the bladder are illustrated in the front view and cross-sectional view, namely apparatus 40 and apparatus 40'. Apparatus 40 and 40' receive urine at urine inlet ends 42 and 42' and distribute the received urine at urine outlet ends 44 and 44'.

[0057] Devices 40, 40' include tubular elements 46, 46' characterized by opposite first ends 48, 48' and second ends 50, 50' and ports 52, 52', and the devices further include first fittings 54, 54' and second fittings 56, 56' adapted to be received by opposite first ends 48, 48' and second ends 50, 50' of the tubular elements 46, 46', thereby defining device chambers 58, 58'. Within chambers 58, 58', sleeve elements 60, 60' for selecting the path of urine are suspended between the first fittings 54, 54' and the second fittings 56, 56'. Where advantageous but not necessary, such elements may extend through one of the fittings and to the outside of that fitting, or through each of the fittings and to the outside of each fitting. As described in detail below, this sleeve element has a contraction structure and an expansion structure, the contraction structure representing a state of no urine flow and the expansion structure representing a state of urine flow, the urine flow state of the sleeve element being a function of the pressure applied to the chamber through the port of the tubular element.

[0058] The device or its variant shown in the figure is operably combined with one or both of a flow rate determination device and a controlled pressure application device, wherein the flow rate determination device is used to determine the flow rate of urine flowing from the sleeve element, and the controlled pressure application device is used to selectively apply pressure to the chamber (i.e., establish selective pressure in the chamber) and apply pressure to the sleeve element as urine flows through. Furthermore, the bladder function testing system characterized by the intended device or its variant is not limited to the general approach of the target test parameters / population data and fitting functions and techniques / mechanisms for processing and / or evaluating one or more of the acquired data shown in this application or otherwise disclosed, for processing and / or evaluating the acquired data.

[0059] The cross-section of the tubular element is advantageously, but not necessarily, circular and possesses sufficient rigidity to maintain its shape and chamber integrity within a working test pressure range up to approximately 200 cmH2O. It is well known that for... Figure 8 and Figure 12In some embodiments, it is known to be advantageous to form acrylic or polycarbonate into tubular shapes using McMaster Carr (McMaster Carr 8532K15, nominally 0.75 inch OD).

[0060] The sampling port can be easily made to use, for example Figure 8 The tap shown is in the form of a female Luer connector that passes through the sidewall of the component, or the sampling port is made in the form of... Figure 12 The Y-extension of the tubular element is shown as a branch of the element. In all cases, a conventional interface for applying pressure from a pressure source to the chamber of the device via the tubular element is considered suitable.

[0061] Now for special reference Figures 8 to 11 The fittings of the device are received in a sealed manner at opposite ends of a tubular element and / or through opposite ends of a tubular element. Advantageously, but not necessarily, the interface between the fitting and the tubular element / for the interface between the fitting and the tubular element is characterized by a leak-proof seal, such as a leak-proof adhesive sealant. Although this application contemplates and illustrates a "sliding" fitting, the fitting is not necessarily so limited.

[0062] One of the first and second accessories is adapted to be operatively combined with a urine drainage catheter or to be operatively combined with a flow rate determination device. By means of one accessory being adapted, the other accessory is advantageously adapted to be operatively combined with an external urinary catheter.

[0063] Special Reference Figures 12 to 15 , Figure 8 In the illustrated embodiment, fittings 54' and 56' of device 40' are received in a sealed manner at and / or through opposite ends 48' and 50' of tubular element 46'. The interface between the fitting and the tubular element / the interface for the fitting and the tubular element is preferably characterized as a leak-proof seal, but this does not constitute a limitation of the invention. In particular, as shown in the figure, the opening is preferably characterized by an O-ring 80, but this is not mandatory. Furthermore, the opening can also be characterized by a mechanical fastener; in particular, as shown in the figure, an advantageous but not mandatory feature of the opening could be a slotted spring pin 82.

[0064] Please continue to refer to this. Figure 8In one embodiment, one of the first and second fittings is adapted to be operably combined with a urinary drainage tube or to be operably combined with a flow rate determining device. By adapting one fitting in this way, the other fitting is advantageously adapted to engage cooperatively with perineural tissue or, depending on the circumstances, to accommodate perineural tissue within the fitting. Figure 8 Unlike the device shown, the instant apparatus of the present invention is directly connected to the penile urethra via a urethral coupling device (UED), which, in a beneficial but not essential case, is disclosed by Kron et al. in U.S. Patent Application No. 9,277,884 and / or in one or more patent families derived therefrom, the entire contents of each of the aforementioned patent applications being incorporated herein by reference.

[0065] Sleeve element 60' is typically suspended within chamber 58' of device 40' via fittings 54', 56', or adaptations of these elements. More specifically, the sleeve element extends between each fitting via indirect fastenings or anchoring relative to the fittings, such as anchoring elements in the form of connector 84. Figure 14 Theoretically, this sleeve element is a flow extension for urine (that is, the sleeve element can be as follows:) Figure 12 (As shown) a direct device in the fluid passage of a urethral connection device or similar element, which is different from (such as) Figure 8 (Indirect device for the urination tubing of the external catheter in the illustrated embodiment).

[0066] The desired and advantageous property of the sleeve element is compliance, but this does not constitute a limitation of the invention. In the "out-of-the-box" state or condition (i.e., the static state), the sleeve element (i.e., the portion spanning its anchoring end) has a minimal cross-sectional area, which essentially opens the sleeve element during a typical urination event, and allows urine to fill and pass through it, thereby defining an "active" cavity for the urine passage. Applying pressure to the cavity through the port of the tubular element of the device causes the sleeve element to respond, i.e., the cavity collapses due to changes in the flow rate of urine.

[0067] For example, the sleeve element (i.e., the urinary passage) preferably comprises a thermoplastic material, but this is not a limitation of this application. More specifically, the sleeve element comprises a heat-shrinkable material, but this is not necessary. More specifically, the heat-shrinkable material may be selected from Nordson Medical, Inc., Colorado, USA, specifically Nordson part number 103-0042. This material has an expansion inner diameter of approximately 0.140 inches and a nominal wall thickness of 0.00025 inches. Advantageously, the sleeve element has highly compliant walls, a static / closed structure (i.e., in a flat / near-flat state), and an active state characterized by an expansion diameter (e.g., up to approximately 0.140 inches) due to the passage of urine.

[0068] Here, it should be emphasized again that, in addition to the aforementioned advantages of the urodynamic testing device of the present invention, the urine drainage tube, such as a conventional 0.125-inch to 0.250-inch inner diameter polyethylene tube, can be conveniently connected to the urine discharge section of the device via its fittings. This allows for two options to more accurately measure urine flow rate and total urine volume.

[0069] First, the distal end of the drainage tube can be placed close to the urine scale so that urine is drawn to the scale without loss. Alternatively, the distal end of the drainage tube can be suspended so that it can be placed directly in the urine beaker on the scale, with the distal end above the discharged urine. This can be achieved, for example, by attaching the distal end of the drainage tube to a small polystyrene foam float or similar object located in the urine beaker.

[0070] Secondly, the drainage tube can be connected to a non-contact fluid flow meter, for example, the UF32210 clamp-on ultrasonic flow sensor from Strain Measurement Devices, but this does not limit the invention. This flow sensor measures urine flow in real time in a non-invasive manner, while the urine can still be fed to a scale for detailed calculations or directly drained into the toilet for direct treatment.

[0071] Therefore, in the context of improved bladder function testing / testing equipment, the device disclosed in this invention can overcome the disadvantages of the conventional method of determining urine flow rate by the free flow of urine on a supported urine scale, wherein: (1) urine does not fall onto the urine scale and is therefore not included in the flow rate and urination volume; (2) the force of urine impacting the scale may cause disturbances to the weight of the urine and cause "interference" in the flow rate calculation; and (3) the time it takes for urine to flow to the urine scale will cause a delay in the relationship between pressure and flow rate.

[0072] Based on several application documents, this specification describes and details the applicant's inventive subject matter. Since the structures of elements, and / or components, sub-components, and / or mechanisms of the system disclosed in this specification can be implemented in other specific ways without departing from the spirit and essential characteristics of the invention, certain specific ways are indicated in the specification, and the embodiments described and detailed in this specification are to be considered illustrative and non-limiting in all respects. Furthermore, although this specification has proposed theoretical steps or sequences and / or schemes of operation, and has to some extent referenced alternative works, systems, components, etc., associated with them, the contemplated sequence / scheme is not limited thereto. Therefore, the scope of the invention is defined by the language of the appended claims and includes non-substantive equivalents.

Claims

1. A urodynamic testing device for receiving urine from the bladder, the device comprising: a. A tubular element characterized by opposite first and second ends and a port; b. A first fitting and a second fitting, the first fitting and the second fitting being adapted to be received by the opposite first and second ends of the tubular element, thereby defining a chamber for the device; and c. A sleeve element for selecting the path of urine, the sleeve element being suspended between the first and second fittings within the chamber, the sleeve element having a contraction structure, a compression structure, and an expansion structure, the contraction structure representing a state of no urine flow, the expansion structure representing a state of urine flow, and the compression structure generating an operating condition for the device, the operating condition being characterized in that, during urodynamic testing, the scaling of the urine path through the sleeve element is proportional to the sleeve element response due to chamber pressurization.

2. The urodynamic testing device according to claim 1, wherein the first accessory and the second accessory are adapted to accommodate periurethral tissue within the accessory.

3. The urodynamic testing device according to claim 1, wherein the interface of each of the first and second fittings relative to the tubular element is characterized by a spring pin.

4. A urodynamic testing device for receiving urine from the bladder, the device comprising: a. A rigid tubular element, characterized by opposite first and second ends and a port; b. A first fitting and a second fitting, the first fitting and the second fitting being adapted to be received by the opposite first and second ends of the rigid tubular element to define a chamber for the device, the fitting of the first fitting and the second fitting being adapted to accommodate periurethral tissue within the fitting, the chamber being pressurized via the port of the rigid tubular element during urodynamic testing; as well as c. A sleeve element for selecting the path of urine, the sleeve element being suspended between the first and second fittings within the chamber, the sleeve element having a contraction structure, a compression structure, and an expansion structure, the expansion structure corresponding to a first operating state for the device, the contraction structure corresponding to a second operating state for the device, the first operating state of the device being characterized by a urine path passing through the sleeve element, the second operating state of the device being characterized by no urine path passing through the sleeve element, the compression structure generating an operating state for the device characterized in that, during urodynamic testing, the contraction of the urine path through the sleeve element is proportional to the sleeve element response due to chamber pressurization.

5. The urodynamic testing device according to any of the preceding claims, wherein the sleeve element is expandable.

6. The urodynamic testing device according to any of the preceding claims, wherein the sleeve element is characterized by an expandable cross-section.

7. The urodynamic testing device according to any of the preceding claims, wherein the sleeve element is characterized by an expandable cross-section, the expandable cross-section of the sleeve element being associated with the first operating condition of the device.

8. The urodynamic testing device according to any of the preceding claims, wherein the sleeve element is characterized by an expandable cross section, the expandable cross section of the sleeve element being associated with the first operating state of the device, and the non-expandable cross section of the sleeve element being associated with the non-operating state of the device.

9. A urodynamic testing device for receiving urine from the bladder, the device comprising: a. A rigid tubular element, characterized by opposite first and second ends and a port; b. A first fitting and a second fitting, the first fitting and the second fitting being adapted to be received by the opposite first and second ends of the rigid tubular element, thereby defining a chamber for the device, the chamber being pressurized via the port of the rigid tubular element during urodynamic testing; as well as c. An expandable sleeve element for selecting the path of urine, the sleeve element being suspended in the chamber between the first and second fittings in a non-expanded state, the expandable sleeve element having an unfolding structure, a compression structure, and a contraction structure, the unfolding structure corresponding to a first operating state for the device, the contraction structure corresponding to a second operating state for the device, the first operating state of the device being characterized by urine passing through the expanded expandable sleeve element, the second operating state of the device being characterized by the expanded expandable sleeve element causing contraction and no urine path passing through, the compression structure generating an operating state for the device characterized in that, during urodynamic testing, the scaling of the urine path through the sleeve element is proportional to the sleeve element response due to chamber pressurization.

10. The urodynamic testing device according to any of the preceding claims, wherein the tubular element is characterized by a circular cross-section.

11. The urodynamic testing device according to any of the preceding claims, wherein the first accessory and the accessory in the second accessory are adapted to be operably combined with a urine drainage tube.

12. The urodynamic testing device according to any of the preceding claims, wherein the first accessory and the second accessory are adapted to be operatively combined with a flow rate determination device.

13. The urodynamic testing device according to any of the preceding claims, wherein the first accessory and the second accessory are adapted to be operatively combined with an external catheter.

14. The urodynamic testing device according to any of the preceding claims, wherein the first accessory and the second accessory are adapted to engage with the periurethral tissue in a cooperative manner.

15. The urodynamic testing device according to any of the preceding claims, wherein the interface of each of the first and second fittings relative to the tubular element is characterized by a leak-proof seal.

16. The urodynamic testing device according to any of the preceding claims, wherein the interface of each of the first and second fittings relative to the tubular element is characterized by an O-ring.

17. The urodynamic testing device according to any of the preceding claims, wherein the interface of each of the first and second fittings relative to the tubular element is characterized by a mechanical fastener.

18. The urodynamic testing device according to any of the preceding claims, wherein the sleeve element comprises thermoplastic.

19. The urodynamic testing device according to any of the preceding claims, wherein the sleeve element comprises a contractile tube.

20. The urodynamic testing device according to any of the preceding claims, wherein the sleeve element is directly anchored to each of the first and second fittings.

21. The urodynamic testing device according to any of the preceding claims, wherein the sleeve element is indirectly anchored to each of the first and second fittings.

22. The urodynamic testing device according to any of the preceding claims, wherein the sleeve element extends through one of the first and second fittings and extends to the outside of that fitting.

23. The urodynamic testing device according to any of the preceding claims, wherein the sleeve element extends through each of the first and second fittings and extends to the outside of each fitting.

24. The urodynamic testing device according to any of the preceding claims, which is operable in combination with one or both of a flow rate determination device and a controllable pressure application device, wherein the flow rate determination device is used to determine the flow rate of urine flowing from the sleeve element, and the controllable pressure application device is used to selectively apply pressure to the chamber and to the sleeve element as urine flows through.

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