Systems and Methods for Urinary Sensing

Abstract

A flexible sensor configured for use within the bladder is movable from a first position configured such that the sensor is not discharged from the bladder to a second position configured such that the sensor is inserted within the bladder. The sensor insertion tool includes an over-sheath and a push rod configured to be inserted within a first lumen of the over-sheath. The flexible sensor is positioned within the first lumen of the over-sheath, and then the push rod is partially inserted within the over-sheath behind the flexible sensor. The sensor insertion tool is then positioned at a location such as an opening of the bladder where the sensor is to be deployed.

Description

Technical Field

[0001] Incorporation by reference to priority applications Any application for which a claim of foreign or domestic priority is specified in the application data sheet filed together with this application is hereby incorporated by reference into this specification in accordance with 37 CFR §1.57.

[0002] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 350,305, filed on June 8, 2022, entitled "SYSTEMS AND METHODS FOR UROLOGICAL SENSING", and also claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 447,765, filed on February 23, 2023, entitled "SENSORS AND SOFTWARE FOR URODYNAMICS". Each of the foregoing applications is hereby incorporated by reference in its entirety into this specification.

Background Art

[0003] Sensors for urological sensing positioned within the bladder are known. However, there are areas where they can be improved.

Summary of the Invention

Problems to be Solved by the Invention

[0004] A flexible sensor configured for use within the bladder is movable from a first position configured such that the sensor is not expelled from or dislodged from the bladder to a second position configured such that the sensor is inserted into the bladder. The sensor is preferably biased to a first position where the sensor is circular or curved, but may be in any geometric position that prevents expulsion from the bladder, which is physically moved to a second position that is preferably straight and cylindrical to allow entry into the bladder through the urethra. The sensor is moved to the second position for insertion into the bladder, and after insertion, the biasing of the sensor returns the sensor to the first position.

[0005] The sensor insertion tool may comprise an over sheath (or "sheath") and a push rod that fits inside the lumen of the over sheath (or "first lumen"). The over sheath comprises an outer wall and a lumen configured to receive the sensor when the sensor is in a second position. The over sheath lumen may have a first distal section (or portion) with a distal cross-sectional area and a second proximal section with a proximal cross-sectional area smaller than the first distal cross-sectional area. When the sensor is positioned within the over sheath lumen, by pushing or (preferably pulling), the proximal end of the sensor is configured to be drawn through the first distal section of the over sheath lumen but not through the second proximal section, as the second proximal section is too small to receive the proximal end of the sensor. Thus, the proximal tip of the sensor abuts against the leading edge of the second proximal section of the lumen and cannot proceed further. This stops the sensor from moving within the second proximal section, thereby positioning the sensor such that its distal end is outside the distal end of the insertion tool and is appropriately positioned (if necessary) to be rotated, and the sensor is placed in a position suitable for being pushed through the urethra into the bladder. The interaction / engagement between the proximal end of the sensor and the edge of the second proximal section of the sheath can engage to enable conversion of the force into rotation, whereby rotation of the sheath is transmitted to the sensor in a converted manner, which can be provided by various symmetric or asymmetric shapes that rotate the sensor and its distal end.

[0006] The distal end of the sensor may have one or more symmetric or asymmetric features designed to be interlocked with the distal end of the sheath and to allow rotation of the sensor when the sheath is rotated. In one embodiment, such a structure, such as a key at the distal end of the sensor, is configured to be received within a structure such as a keyway on the distal end of the over-sheath, whereby the sensor and the insertion tool are connected and can rotate in conjunction before the sensor is deployed within the bladder. As described above, the proximal end of the sensor preferably has a structure or geometry that aligns with the structure or geometry of the second proximal section of the insertion tool lumen, which aids in the sensor and the insertion tool rotating in conjunction before the sensor is deployed within the bladder.

Means for Solving the Problems

[0007] In one embodiment, engagement features are used at the proximal and distal ends of the sensor. In this embodiment, the distance from the proximal tip to the distal tip of the sensor can be aligned with the distance between the end of the sheath and the opening of the second lumen within the sheath. This helps to ensure proper transfer of rotational force between the sheath handle and the sensor. This structure also allows for linear force transfer so that force can be reliably transferred from the sheath handle, through the sheath, to the sensor.

[0008] One or both of the end caps of the sensor, preferably the proximal end cap, can be configured to facilitate easy removal of the sensor using standard cystoscope tools such as a flexible cystoscope (endoscope) and flexible grasping forceps. This feature is useful for clinicians who prefer to remove the sensor via cystoscopy and shortens the time required for the clinician to grasp the end of the sensor when not using a retrieval string.

[0009] One handle can be positioned over the over-sheath and another handle can be positioned over the push rod. To insert (or deploy) the sensor into the bladder, the sensor is positioned (preferably by retraction) within the lumen of the over-sheath. The insertion tool is then moved into the urethra and positioned at an arrangement such as an opening to the bladder where the distal end of the sensor, preferably having a coude shape, can move through the male or female urethra into the bladder. If the user (such as a technician or physician) feels that the distal end of the sensor is not properly aligned at the bladder opening, the insertion tool may be rotated, thereby rotating the sensor and its distal tip. When the sensor is properly oriented for insertion, the user pushes the push rod into the over-sheath, which then pushes the sensor into the bladder. Once released from the sheath and entering the bladder, the sensor returns to its initial position.

Brief Description of the Drawings

[0010]

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DETAILED DESCRIPTION OF THE INVENTION

EXAMPLES

[0011] Sensors and Insertion Tools Disclosed is a urodynamic system that can include (1) a sensor as shown in FIGS. 1-2 and FIGS. 13-14, which in one embodiment is a flexible silicone rubber tube with an electronic device inside, for sensing pressure and volume, (2) one or more components of an insertion tool for delivering the sensor through the urethra into the bladder, and further additional components.

[0012] Figures 1 to 3A illustrate sensor 10 according to the present disclosure. Sensor 10 has a proximal end 12 that is closest to the clinician before insertion and a distal end 14 that is farthest from the clinician when inserted into the bladder and is the end first inserted into the bladder. Sensor 16 has a tube wall or a tubular body portion 16 including an oversheath 19. String 18 is connected to the proximal end 12 and is configured to be pulled (1) to draw sensor 10 into an insertion tool and (2) to pull sensor 10 out of the bladder. When sensor 10 is deployed in the bladder, string 18 preferably remains outside the patient's body.

[0013] Sensor 10 also includes internal electronics 20 positioned on and attached to a flexible circuit board 21, and a spine 22 connected to the back side of the flexible circuit board 21 (i.e., the side of the flexible circuit board 21 opposite the electronics 20). Spine 22 is preferably connected to the flexible circuit board 21 by welding. The spine (or shape memory spring) 22 is biased to a first curved position as shown in FIGS. 1 to 3, which biases the sensor to the first curved position.

[0014] FIG. 4 shows sensor 10 in a female bladder. FIG. 5 shows the components of a system 30 comprising an insertion tool 500 (described herein) for inserting sensor 10 into the bladder, a screen S for projecting data using a computer system 1000 (described herein) according to the present disclosure, and a urine flow measurement device 600 (described herein).

[0015] Figs. 6-7 show a side view and a top perspective view, respectively, of a urine flow meter 600 that is a scale having an electronic device configured to convert weight to volume. The urine flow meter 600 has a main body 602, a top 604, and an off / on indicator 608. As best shown in Fig. 7, the top 604 has a recess 610 configured to hold a beaker or other container for holding urine. The urine flow meter 600 weighs the urine and assists a clinician in analyzing urination events.

[0016] Figs. 8-11 illustrate a computer screen S showing the display of information derived from the computer system 1000 described below.

[0017] Figs. 12, 12A, and 12B are side views of the sensors of Figs. 1, 2, and 3, respectively. Figs. 13, 13A, and 13B are side views of the sensors of Figs. 1, 2, and 3, respectively, moved to their second straight position.

[0018] Fig. 14 is a top view of the sensors of Figs. 1, 12, and 13 in a first curved position. Fig. 15 is also a top view of the sensors of Figs. 1, 12, and 13 in the first curved position, a view in which the outer sheath is depicted as transparent so that the internal electronic device can be seen. In Figs. 14 and 15, the proximal end cap 24 and the distal end cap 26 are more readily visible. The proximal end cap 24 and the distal end cap 26 are attached to the tube, i.e., the outer sheath 19, such as by being pressed and fixed into the cavity 28 with an adhesive. The proximal end cap 24 has an opening 24A for attaching the string 18. The distal end cap 26 preferably has a coudé shape (e.g., a curved shape) so as to be easily inserted into the bladder.

[0019] The urine flow meter 600 is used to measure the amount of urine excreted and the change in amount (flow rate).

[0020] Sensor 10 One embodiment of sensor 10 may include the following.

[0021] A tubular outer housing (or "tube" or "outer housing" or "outer cover"), preferably made of silicone elastomer or rubber, but any suitable material may be used, the tube having a lumen (or "cavity") therethrough.

[0022] A flexible circuit board 21 having electronic components positioned inside the tube.

[0023] A power source, such as a battery, positioned within the tube and preferably connected to the flexible circuit board.

[0024] One or more electronic parameter sensors, such as pressure and / or volume sensors, positioned within the tube and preferably on the circuit board, receiving power from the power source.

[0025] In some embodiments, a fluid, such as silicone oil, fills the cavity between the tubular outer housing and the internal components. The fluid is preferably non - compressible and non - conductive.

[0026] A shape memory spring 22 positioned inside, partially, or outside the tube and made of steel, plastic, or other suitable material, or some combination of materials. In one embodiment, the shape memory spring 22 is welded to the bottom (i.e., the side without the circuit) of the flexible circuit board 21. Thus, instead of using, for example, Nitinol wire or injection molding to create a shape memory elastic housing, a flexible circuit board with a shape memory spring forms the specific shape of the sensor. In this case, the sensor has a generally circular or curved shape that prevents excretion or discharge from the bladder from occurring at any time. In some embodiments, the spring 22 may have a rectangular cross-sectional profile so as to provide an appropriate profile for pushability and conversion and transmission of linear force. This also provides additional support and rigidity for the protection of the flexible electronic circuit board.

[0027] The end caps 24, 26 for the tube are made of steel, plastic, silicone, or other suitable material. There are a distal end cap 26 and a proximal end cap 24.

[0028] A removal string 18 for pulling the sensor 10 out of the bladder. The removal string may or may not be attached to the end cap, and is preferably attached to the proximal end cap.

[0029] This sensor design enables reliable and low-cost manufacturing because the extruded sensor tubing can be manufactured simply and inexpensively compared to injection molding or Nitinol hand-assembly. This sensor design also provides reliability and strength because the shape memory spring 22 is designed to provide sufficient torsional rigidity, thus enhancing the durability of the flexible circuit board (FCB) 21 and any electronic components attached to the FCB via soldering or other means.

[0030] The shape memory of the sensor 10 should preferably be such that it is sufficient to straighten the sensor for delivery through the urethra. After being delivered inside the bladder, the sensor 10 springs back, i.e., returns, to its original circular or curved shape. To achieve this purpose, a combination of manufacturing methods including heat treatment, forming, and / or cold rolling of springs can be utilized.

[0031] An additional advantage of the design of the sensor 10 is that the shape memory spring 22 is flat and can be designed to fit with one or both end caps and also the tube by forming the desired geometric shape configuration at each part. For example, the fitting of the end caps can also be used to provide additional stability and pushability in supporting delivery. The side notches in the sensor housing will be used to achieve a highly reliable manufacture and stability of the circuit.

[0032] This technique can be used with both end caps where the spring can pass over the entire length of the sensor housing or move from one end cap to a rigid or semi-rigid battery mechanically coupled to the battery. In this embodiment, the force can be transmitted from one end cap to the battery, the spring, and the other end cap.

[0033] In one embodiment, the shape memory spring 22 can convert and transmit force between each of the end caps 24, 26 and act as a backbone or spine of the sensor 10. In another embodiment, the shape memory spring 22 can convert and transmit force from one of the end caps 24 or 26 to one or more components within the lumen of the tube. These embodiments are unique because they effectively enable the pushability of the catheter and allow the catheter to safely pass through the patient's urethra. In addition, the stiffness of the spring 22 allows for the utilization of optimal mechanical properties that cannot be achieved without significantly increasing the overall outer diameter of the sensor. By using the spring 22, the outer housing 16 of the sensor 10 can have its overall outer diameter reduced while maintaining flexibility. Ultimately, this design results in an optimal combination of a soft material on the exterior coupled with mechanical strength for pushability, such that any sensor can be very well inserted into the patient's urethra.

[0034] The shape memory spring 22 can also be made using a manufacturing process that forms a "leaf spring" such as a leaf spring. In such a process, it is also possible to use heat treatment of the spring 22 to be formed or work hardening, each of which is known in the art. Work hardening of the shape memory spring is less likely to induce magnetic properties in the spring and is most preferred in the present disclosure.

[0035] In some embodiments, the shape memory spring (or simply "spring") 22 can be coated entirely or partially with a material that prevents electrical contact with other components and prevents interaction with the circuit board. The coating material can also enable the shape memory spring to withstand corrosion and enhance the reliability of the spring. This coating can be a material that is resistant to oils such as mineral oil. The coating can be applied using any suitable method, including spray coating or dip coating.

[0036] In another embodiment, shape memory is obtained by using nitinol, which can provide optimal mechanical properties for a highly reliable configuration of the sensor.

[0037] Another option is to fabricate the tube 16 using injection molding. To achieve this, the mechanical properties and geometric shape of the material used in injection molding should be selected to provide an appropriate amount of rigidity and flexibility while meeting the requirements of the tube for repeated actuation, i.e., repeatedly stretching straight and bouncing back to a circular or curved shape. This may be similar to the manufacturing method of a "living hinge".

[0038] The end caps 24, 26 could be made from metal, rigid plastic, semi-rigid plastic, elastomer, soft rubber, silicone, or any suitable material. The end caps may consist of some combinations of these materials. The end caps can take various shapes as long as they support the insertion of the sensor using the insertion tool as described herein.

[0039] In some embodiments, the spring may be covered with an adhesive sheet. The adhesive sheet may be made of a non-conductive material to prevent electrical interaction with the circuit board. This adhesive sheet can be cut by any suitable method, such as using laser cutting or a punching method. This is beneficial because it is desirable to keep a portion of the flexible circuit board free from attachment to the spring to ensure the reliability and protection of the circuit. When the circuit board is in a circular configuration and is completely attached to the spring with an adhesive, when the sensor is straightened, the circuit board will be compressed and interfere with the adhesive. As a result, it may cause any of the following: peeling of the circuit from the spring 22, damage to the electrical components on the circuit board 21, or other undesirable reactions.

[0040] In addition to the coating, a double-sided adhesive sheet made of a non-conductive material can also prevent electrical interference between the spring and the FCB 21. In some cases, this can be manufactured in a way that rationalizes the assembly including partial creasing that allows selected portions of the sheet to be adhered while other portions remain non-adhesive.

[0041] The adhesive can include materials that are resistant to solvents, oils, or other harmful fluids. For example, mineral oil or silicone oil can be used as a lubricant due to their biocompatibility, but mineral oil and silicone oil can dissolve certain latexes, plastics, and other rubbery substances.

[0042] The attachment of the flexible circuit 21 to the spring 22 can also be achieved using a mechanical process. In such embodiments, the spring 22 can include features designed to interact with the circuit board to provide mechanical integration and reliable attachment regardless of the presence or absence of an adhesive. This can improve the flexibility of the sensor 10 and reduce bunching (or compression) of the circuit board when the spring is attached and straightened. These mechanical features can be vias or other holes designed and fabricated as part of the electronic circuit board, and pegs that can be formed on the spring.

[0043] Insertion tool The insertion tool (or "tool" or "insertion device") 500, described in more detail below, delivers the sensor 10 through the urethra into the bladder and generally consists of an outer housing 504 with a handle 506 and a push rod 530 with a handle as components.

[0044] The outer housing includes a channel or lumen through which the sensor can pass when being delivered to the bladder. The outer housing also includes a tip 516, which can be any suitable design including a straight tip, a coudé tip, a sheath tip, or a sheath tip having a sensor end cap interaction.

[0045] In addition to the sensor end cap interaction at the distal end of the sheath, the proximal sensor end cap can be designed in a symmetric or asymmetric pattern to enable locking and the transfer of the force into rotational conversion through interaction with a second lumen inside the sheath of the insertion tool. This provides two ways of interacting that transfer the force into rotation and enable successful insertion of the sensor.

[0046] Both the straight tip and the curved tip are similar to the urinary catheter tip, but have an angled tip with a key near the tip of the outer housing to enable the sensor to be delivered into the bladder. The design of the angled tip relative to the curved tip can provide greater advantages through column strength and mechanical rigidity or pushability when inserted into the patient's urethra. This is because the angled tip at the top of the outer housing is directly on a plane and can buckle under any force associated with the curved tip or straight tip during insertion. In this way, there can be advantages to the side ports for some patient anatomical structures such as the pinching sphincter.

[0047] The sheath tip utilizes the sensor end cap to perform the function of the tool tip. In this way, the sensor end cap can be designed as a straight tip or a curved tip and manufactured to simplify the insertion process. This can also integrate two separate components designed to provide optimal characteristics for insertion within the urethra such as navigation or pushability for difficult anatomical structures such as bladder voiding opening obstruction, and can be beneficial for both female and male anatomical structures.

[0048] The sheath tip can also provide an additional advantage in that it is unlikely to traumatize the tissue of the urethra if the sensor is deployed before the tool is properly positioned within the bladder. In this case, the sensor functions essentially as a urinary catheter and is pushed through the urethra into the bladder.

[0049] Regardless of the tip design, the material properties are selected to enable appropriate performance characteristics of the tool. This includes pushability, rigidity, followability, and flexibility. The outer housing of the tool can be extruded from TPU, TPE, other similar materials, or any suitable material. To reinforce the pushability of the tube, the tool can be reinforced with a braided wire or coil using stainless steel or a similar material.

[0050] The outer housing of the tool can also be marked with one or more markings to assist the clinician's understanding of the device placement using the depth of the insertion portion. The markings can be sized to accommodate different ideal insertion depths of the device, either using the anatomical requirements of that patient or the average values of multiple patients.

[0051] In some embodiments, this can include lower and upper limits based on the reported urethral length and statistical analysis from the published literature. This will assist the clinician's understanding regarding the proper positioning of the sensor within the bladder.

[0052] The outer housing of the insertion tool can be optimized to have the dimensions and mechanical properties of the sensor housing and pushrod that result in optimal device performance. This allows for a simple and easy insertion operation while reducing the outer diameter of the outer housing. This also enables the outer housing to be extruded and maintain kinkability and pushability while keeping the tubing dimensions at a very small value. This significantly reduces the cost and complexity of the device, as extrusion is much less expensive and requires less capital and time for manufacturing compared to braided or coiled tubing.

[0053] In some embodiments, the sheath can be designed to have an overall length and flexibility such that the tool can be fully inserted before the handle of the tool reaches the urethral opening. By having optimal flexibility, the sheath and sensor are unlikely to damage the patient's bladder. This is optimal for simplifying the clinician's training and ensuring that the sensor is placed within the bladder when deployed.

[0054] In some embodiments, the push rod can be injection molded from semi - rigid plastic or elastomer. This can also be molded into an asymmetric or non - uniform shape so as to obtain optimal mechanical properties of the device.

[0055] Deployment of the Sensor To prepare for insertion of the tool and sensor, the sensor is inserted into the first lumen of the outer housing (or "over - sheath") of the tool. In some embodiments, the pull string can be pre - positioned so that the clinician only needs to pull the string until the sensor is lubricated and locked within the insertion tool.

[0056] After the sensor is positioned in place, the sheath and sensor are prepared for insertion into the patient's urethra. The sheath and sensor are inserted until the tip of the sensor reaches the bladder. The clinician then uses the push rod to deploy the sensor into the bladder. In some embodiments, urine may flow around the push rod and out of the sheath. The push rod can also include a lumen to allow urine to flow through the push rod. This is particularly useful for the clinician to confirm proper placement of the sensor within the bladder.

[0057] Depth markings or length measurements can be on the outer housing tubing (such as by pad printing), which helps the clinician confirm that the sensor is properly placed within the bladder.

[0058] In another embodiment, the outer housing may incorporate a second lumen configured such that urine flows therethrough after a particular portion of the tool reaches the bladder. This may assist in the proper placement of the sensor as the user will know that the tool is in the proper position for insertion into the bladder. The second lumen may also be temporarily filled by a wire or other structure to ensure a reliable flow of urine by preventing the lubricant from clogging the second lumen. The wire or other structure is removed when the user senses that the tool is in the bladder, allowing urine to pass through the second lumen.

[0059] One embodiment of the insertion tool may be designed to further improve the pushability of the sensor and the insertion tool. This embodiment is similar to the sheath design, but by using an expandable sensor end cap that overlaps the inner diameter (ID) of the sheath, this design transmits force directly from the sheath to the end cap, whereas the sensor in the previously described sheath design does not have such an ability and relies on the transmission of force from the push rod to the sensor. In this embodiment, it may be possible to reduce the outer diameter (OD) of the sheath by leveraging this interaction between the sensor end cap and the sheath of the insertion tool.

[0060] In another embodiment of the over-sheath with end-cap interaction, the end-cap can be designed to provide accurate rotational positioning of the sensor end-cap and the sheath. One way to achieve this is to provide one or more keys and keyways within the end of the sheath and provide one or more corresponding mating features on the sensor end-cap that will allow for accurate rotational positioning of the sensor and the tool. This allows for the transfer of rotational force between the handle of the insertion tool sheath and the sensor end-cap. This can be valuable as in some cases the patient anatomy can be difficult to insert through and may require a curved or rounded tip. This version of the device allows the clinician to control the rotational orientation of the sensor end-cap (i.e., the tip) as it advances within the urethra.

[0061] Rotational positioning can be indicated to the clinician through one or more markings such as one or more features molded within the handle of the sheath, or lines or other markings on the insertion tool sheath added in any suitable manner such as co-extrusion or pad printing.

[0062] This embodiment also allows the sensor to be loaded into the insertion tool by pulling a string through rather than being pushed into the sheath by a push rod. The string can also be fixed to the proximal end of the push rod to prevent movement or premature deployment of the sensor.

Example

[0063] Sensor and Insertion Tool Integration of the Insertion Tool and the Sensor End-Cap (or Tip) The sensor and insertion tool of this Example 2 are the same as those of Example 1, except as described herein. The integration of the sensor distal tip (or insert, or end cap) with the insertion tool sheath allows for rotational orientation of the sensor using the handle or sheath of the insertion tool by gripping and rotating the insertion tool handle, and thus rotating the sensor including the distal tip. In this manner, the user can rotate the sensor by the same amount that the insertion tool is rotated and position the distal tip of the sensor in an appropriate position for insertion into the bladder. The sensor is then pushed into the bladder using a push rod that protrudes from the insertion tool without (or with minimal) trauma to the patient.

[0064] Figure 16 shows an alternative embodiment of a sensor 50 according to the present disclosure. The sensor 50 has a proximal end 52, a distal end 54, and a body portion 56 having an outer wall (or tube or outer sheath) 59 made of silicone rubber (or elastomer). The proximal end cap 74 has an opening 52A attached to a removal string 58. The removal string 58 is used in the same manner as the string 18 described previously. The proximal end cap 74 and the distal end cap 76 are attached to the tube 56 in the same manner as the end caps 24, 26 and the tube 16 described previously. As shown, the proximal end cap 74 has a narrow section 74A that fits into the cavity 78 of the tube 56, and the distal end cap 76 has a narrow section 76A that fits inside the cavity 78 of the tube 56.

[0065] The flexible circuit 71 holds the electronics 70, and the spine 72 is preferably attached to the flexible circuit board 71 on the side opposite the electronics 70 by welding the spine 72 to the flexible circuit board 71. The spine 72 is biased to a first curved position that biases the sensor 50 to a first curved position.

[0066] The spacer 80 is preferably made of plastic or other soft materials and covers the end 72A of the spine 72. This prevents the inner wall of the tube 56 from being torn by the end 72A.

[0067] This version of the upper electronics of the sensor 50 includes a Bluetooth wireless antenna 82, an LED 84, a microprocessor 86, a memory 88, a button 90 configured to turn the sensor 50 on and off, and a pressure sensor 92 that measures the pressure of urine in the bladder when the sensor 50 is positioned within the bladder. A power source 94, such as a battery, is positioned within the tube (or housing) 56 and supplies power to the electronic components 70 through the flexible circuit board 71.

[0068] Figures 17 and 18 are top views of the sensor 50. Figures 19 - 21 are isometric views of the sensor 50, and Figures 19 - 20 show the tube as transparent, so that the internal components of the sensor 50 can be seen better.

[0069] Figures 22 - 26 show close - up views of some internal components of the sensor 50 with the tube 56 shown as transparent.

[0070] Figure 27 shows a front view of the distal end cap of the sensor 50 where there is a narrow portion 76A inside the cavity 78 of the tube 56 and the curve, i.e., the Coudé tip, faces forward. Figure 28 is a close - up view of the proximal end cap 74. The opening 52A that connects to the removal string 58 may appear like a dual - flat coupling portion 52B. The dual - flat coupling portions 52B are on both sides of the proximal end cap 74 and are configured such that a clinician can grip the proximal end cap 74 with a tool such as forceps and pull it out from the bladder.

[0071] Figures 29 and 30 show an insertion tool 500 according to the present disclosure. The insertion tool 500 has an elongated body portion or sheath 502 with an outer wall 504 and has a sheath reinforcement 504 at its proximal portion, which is the portion of the sheath 502 closest to the handle 506. Inside the lumen 510, there is a visual indication 508 that allows a clinician to visually observe a drainage hole 512 through which a push rod passes, enabling urine to be discharged from the bladder through the drainage hole 512 when a sensor, such as sensor 50, is properly positioned within the bladder.

[0072] The D-lock 514 is a structure within or in the lumen 510 that mates with or otherwise connects to a proximal end cap, such as proximal end cap 74, thereby preventing the sensor 50 from advancing further into the lumen 510 and converting and transmitting a rotational force to the sensor 50 when the handle 506 and the insertion tool 500 are rotated and engaged with the proximal end cap 74. The insertion tool 500 further has a distal end (or sheath tip) 516 with a sheath tip insertion portion 518. The sheath tip insertion portion 518 is the portion of the sheath 500 into which a sensor, such as sensor 50, is inserted prior to insertion into the bladder. When the sensor 50 is inserted, its proximal end cap 74 is prevented from advancing by the D-lock 514. The distal end cap 76 has a protruding structure, such as a key or other protrusion, which is received within a sheath key insertion portion 518, which is a slot or keyway as shown. The distal end cap 76 extends outwardly from the sheath tip 516, and a rotational force is transmitted to the distal end cap 76 by the sheath tip insertion portion 518 when the handle 506 and the insertion tool 500 are rotated. In this way, the clinician can rotate the distal end cap 76 until it is aligned with the bladder opening.

[0073] Figure 31 shows a push rod 530 used with the insertion tool 500. The push rod 530 pushes a sensor such as sensor 50 from the lumen 510 into the bladder. The push rod 530 has a tip 536 and a stem 532 that preferably has a lumen 534 through which urine can pass. The stem 532 is preferably connected to a handle 538 that has a drainage hole 540.

[0074] When a sensor, such as sensor 50, is within the insertion tool 500 and properly positioned for deployment, the tip 536 and stem 532 of the push rod 530 are pushed by the clinician through the drainage hole 532 into the lumen 510 of the insertion tool 500. This pushes the sensor 50 out of the lumen 510 and into the bladder. Urine moving through the lumen 534 (if utilized) indicates that the sensor 50 is fully positioned within the bladder.

[0075] Figure 34 is a close-up view showing the lumen 510 and the D-lock 514. As shown, the lumen 510 has a large-diameter section 510A and a narrow-diameter section 510B through which the proximal end cap 74 of the sensor 50 cannot pass. Figure 32 is a close-up view showing the sheath tip insertion portion 518.

[0076] Figure 33 is an end view of the handle 506 where the drainage hole 512 and the visual indicator 508 are visible. As can be seen in the figure, the portion 510B of the lumen 510 has a curved top, a curved bottom, and a flat side.

[0077] Figure 35 shows a side view of the sensor 50 in a straight position when moved within the insertion tool 500. Figure 36 is a close-up view of the sheath tip 516 of the insertion device 500 showing the sheath tip insertion portion 518. Figure 37 is a close-up view showing the proximal end cap 74 and the retrieval string 58 of the sensor 50 positioned within the sheath of the insertion tool 500.

[0078] Figure 39 is a test protocol for the identified sensors 1, 2, and 3. Figures 40 to 49 show the results using the test protocol of Figure 39. Figure 50 shows the test protocol used on the identified sensors 1, 2, and 3. Figures 51 to 60 show the results using the test protocol of Figure 50. Figure 61 shows the test protocol for the identified sensors 1 and 3. Figure 62 shows the results using the test protocol of Figure 61. Figure 63 shows the test protocol executed on the identified sensors 4, 5, and 6. Figures 64 to 73 show the results using the test protocol of Figure 63.

[0079] Figure 74 shows the test protocol executed on the identified sensors 4 and 6. Figures 75 to 83 show the results using the test protocol of Figure 74. Figure 84 shows the test protocol executed on the sensor designated as sensor 8. Figures 85 to 86 show the results using the test protocol of Figure 84.

[0080] Figure 87 shows the test protocol executed on the sensor identified as sensor 10. Figures 88 to 89 show the results using the test protocol of Figure 87. Figure 90 shows the test protocol executed on the sensor identified as sensor 12. Figures 91 to 93 show the results using the test protocol of Figure 90.

[0081] Figures 94 to 94B show the sensor 50 having positive and negative connections 95 and 97 respectively, and the battery 94.

[0082] Figures 95 to 98 are diagrams of the sensor 50. Figure 99 shows a silicone rubber extrusion product that can be used as an outer sheath for the sensor 50. Figures 100 to 101A are diagrams showing a prototype of the sensor according to the present disclosure, in which a spine 72, a flexible circuit board 71, and an electronic device 70 positioned within a tube 56 are shown. Figures 102 to 103 show the spine 72. Figure 108 is a partial image of the spine 71. Figure 109 shows the positive electrode 95 of the battery 94. Figure 110 shows the negative electrode 97 of the battery 94.

[0083] Figures 111 to 115 show a possible assembly process of the sensor 50. In Figure 115, the electronic device 70 is connected to the flexible circuit board 71. In Figure 114, the spine 72 is connected to the flexible circuit board 71 by welding or the like. In Figure 113, the battery 94, the positive lead wire 95, and the negative lead wire 97 are connected. In Figure 112, the assembled flexible circuit board and the spine are inserted into the outer sheath 56. In Figure 11, the end caps 74 and 76 are attached, and the cavity 78 is filled with silicone oil at a pressure higher than atmospheric pressure.

[0084] Figures 116 to 119 are diagrams showing the positive contact for the battery. Figure 12 shows the leakage results for tests using different standard gauge injection needles. Figures 121 to 122 show the flexibility of sensors with different sensor designs. Figures 124 to 125 show close-up views of the outer sheath end without R (57A) and the outer sheath end with R (57B).

[0085] Figures 126 to 128 are assembly drawings forming a flexible circuit board 71 including the electronic device 70, the spine 72, and the battery 94. Figure 128 is a top view of the sensor 50. Figures 130 to 133 respectively show the positive and negative contacts 95 and 97 for the battery 94. Figures 135 to 142 show various components of the flexible circuit board 71.

[0086] Figures 144 - 147 show the placement of the distal end cap on the outer sheath 56 by using the silicone adhesive 83. Figures 148 - 149 show filling the cavity of the sensor 50 completely with silicone oil after applying the distal end cap 76.

[0087] Figures 150 - 151 show the experiment of adding the septum 300 to the distal end cap 76. Figures 152 - 153 show exemplary oils for testing purposes.

[0088] Figure 154 shows the end 72A of the spine 72 embedded in the spacer 84 made of soft plastic to prevent the end 72A from damaging the tube 56. Figures 155 - 157 show the stem 504 of the insertion tool 500. The stem 504 has an inner plastic part 504A surrounded by a braided wire 504B. Figure 157 shows the sensor inside the stem 504 and the Coudé distal end cap 76 extending therefrom. Figures 158 - 159 are diagrams showing further examples of the sensor 50 inside the stem 504. Figure 160 is a diagram explaining the process of pulling the sensor 50 into the insertion tool 500 and the force required to move the sensor 50.

[0089] Figures 161 - 164 show the bending analysis of the spine 72. Figures 165 - 169 show that there was no leakage when the sensor cavity 58 was filled completely with silicone oil using 25G, 23G, 32G, 20G, and 18G needles when the septum 300 was used at the distal end cap 76 of the sensor 50. Figure 170 is a diagram of the filling analysis using different standard gauge injection needles.

[0090] Figures 171 to 172 show additional examples of the stem 504 of the insertion tool 500, which consists of an inner plastic tube 504A surrounded by a braided wire 504B. Figures 174 to 175 show further examples of the sensor 50 positioned within the stem 504 of the insertion tool 500. Figures 175 to 175A are top views of the sensor 50 exemplifying that it has returned to the correct shape after being bent.

[0091] Figures 176 to 178 show a plastic spacer 80 covering the end 72A of the spine 72. Figures 179 to 180 show the difference in the diameter of the spine 72 after 10 bending cycles. Figure 81 shows a material / oil test chart. Figures 182 to 184 show leakage results when the cavity 78 of the tube 56 is completely filled using various needles with or without a septum. Figure 185 shows a chart for needle size analysis.

[0092] Figures 186 to 189 show the sensor 50 being drawn into the insertion tool 500 and pushed out by the push rod 530. Figures 190 to 192 exemplify a distal spacer for the end 72A of the spine 72.

[0093] Figures 193 to 194 show the packaging of the sensor 50, the insertion tool 500, and the push rod 530. Figures 196 to 199 show the proximal end cap 74. Figure 200 exemplifies different insertion tools 500, with the top four being used by men and the bottom two being used by women.

[0094] Figures 201 to 202 show the tip 516 of the insertion tool and the keyway (or sheath tip insertion portion) 518.

[0095] The sensor distal end cap 76 preferably has a coodé-shaped tip and has a key protrusion (or key) formed therein. The key is configured to be received within a key groove (or slot) at the distal end of the insertion tool sheath. Any suitable manufacturing method may be used to fabricate the distal tip of the sensor, but it may be manufactured by injection molding the distal end cap 76 from 70A durometer silicone rubber to form the desired shape. The sheath of the insertion tool 500 may include a stainless steel ring at its distal end 516 having a key groove 518 covered with plastic applied using a reflow process. The key groove 518 within the sheath, however, may be formed in any suitable manner. The integration of the key of the distal end cap 76 and the key groove 518 is done by manually positioning the two structures adjacent to each other, and the bend in the coodé tip of the end cap 76 biases the key into the key groove 518. This fits the key into the key groove 518, whereby the sensor 50 and the insertion tool 500 rotate together, but allows the sensor 50 to be pushed forward of the insertion tool 500 and extruded from the insertion tool 500 into the bladder.

[0096] The sensor 50 also includes a proximal end (or proximal insertion portion, or proximal end cap) 74 that is inside the lumen of the insertion tool 500 when the sensor 50 is moved into the lumen of the sheath 504 of the insertion tool 500. The proximal end cap 74 has a shape that engages the geometry at the head of the second proximal section 514 (also called the D-lock) of the lumen of the insertion tool, whereby rotation of the insertion tool 500 converts and transmits a rotational force to the sensor 50. This allows the proximal end cap 74 of the sensor 50 to impart a rotational force to the sensor 50 when the handle 503 or sheath 504 of the insertion tool 500 is rotated. Thus, the sensor 50 can be rotated by a two-point connection with the insertion tool - a connection at one point at the distal end of the sensor and one point at the proximal end of the sensor - although only one connection may be used.

[0097] The distal end cap 76 and proximal end cap 74 of the sensor 50 may be attached to the sensor tube (or housing, or tube, or outer sheath, or sheath) 56 by overmolding, adhesion, or some other means of attaching a rigid or semi-rigid insert (proximal end cap and distal end cap) 74, 76 into the lumen 78 of the sensor tube 50, or by using extrusion with a custom-shaped die, or by using reflow with a custom-shaped mandrel. The durometer of the proximal end caps 74, 76 of the sensor 50 is also 70A, although any suitable material, hardness, or shape may also be used.

[0098] The insertion tool 500 has an 18Fr OD and a 16Fr ID in the first distal section where the sensor 50 is positioned and may have a smaller cross-sectional area in the second proximal lumen between the sensor 50 and the handle 503. This smaller cross-sectional area is configured to be too small for the proximal end cap 74 of the sensor 50 to pass through.

[0099] The combination of both the proximal and distal end caps 74, 76 within the sensor 50 and the insertion tool 500 enables a reliable transfer of rotational force from the handle 503 (or outer sheath 504) of the insertion tool 500 to the distal end 76 of the sensor 50. The curved distal tip 54 at the distal end cap 76 assists the clinician in passing the sensor 50 through the urethra and into the bladder. If the clinician is unable to properly orient the sensor 50, including the distal tip 54, by rotating it via rotation of the insertion tool 500, it may cause damage or trauma to the patient's anatomy when attempting to deploy the sensor into the bladder and may also prevent the clinician from successfully inserting the sensor into the bladder. This is useful for both male and female anatomies. The insertion tool 500 may be shorter and stiffer for use in females due to anatomical differences.

[0100] The sensor 50 may incorporate a rigid or semi-rigid material such as stainless steel to enable reliable shape memory via the spring 72. This can take various symmetric or asymmetric shapes to provide a spring constant suitable for the application. In some embodiments, the spring 72 can be heat-treated and / or rolled to produce the desired spring constant / return rate. The spring (or spine) 72 can also be incorporated into the circuit board 71 and welded to the battery 94. At the opposite end, the spine 72 can be attached to the plastic spacer 80 to prevent the potential of piercing the housing 56 of the sensor 50 and to maintain patient safety. In this embodiment, linear force can be converted and transmitted from the proximal end cap 74 of the sensor 50 to the distal end cap 76 of the sensor 50 by using the battery 94, the spine 72, and the plastic spacer 80.

[0101] The design of the sensor materials and components provides reliable integration with the insertion tool. For example, the spine 72 and housing 56 of the sensor utilize materials with properties that enable repeated, reliable memory to maintain the desired shape when in the initial position within the bladder, such that once positioned within the bladder, the sensor 50 does not move out of the bladder.

[0102] The spine 72 of the sensor is preferably made of 301 stainless steel (SS) and formed using a rolling process, although any suitable material and process can be utilized. The hardness and material of the sensor 50 and the spine 72 of the sensor must be such that they return to the desired first curved or circular shape and do not lose their shape memory after being straightened. If the sensor 50 does not maintain the proper shape and orientation, this can result in undesirable consequences such as movement out of the bladder and / or damage to the lower urinary tract.

[0103] Sensor 50 uses materials and an assembly process that also provide reliable linear force transfer when the sensor 50 is straightened. To assemble the sensor 50, the metal contacts may be laser welded (although any suitable method may be used) to the battery 94 and soldered (although any suitable method may be used) to the flexible electronic circuit board 71. The spine 72 of the sensor is laser welded (although any suitable method may also be used) to the battery contacts. The flexible electronic circuit 71 is then attached to the spine 72 to provide rigidity and support. At the distal end cap 76 of the sensor 50, the spine 72 of the sensor is attached to a small plastic spacer 80, whereby the spine 72 is pushed through or does not tear the outer wall (or housing) 56 of the sensor. The distal sensor end cap 76 is preferably attached to the plastic spacer 80 and the sensor housing 56, and linear force transfer using a rigid or semi-rigid component from the proximal end cap 74 to the distal end cap 76 is performed.

[0104] The materials and processes are selected to achieve the desired range of rebound (or memory) and strength of the sensor spine based on the strength and rigidity of the insertion tool sheath, whereby the desired level of curvature is obtained before the sensor is inserted into the sheath. These structures have both flexibility and pushability for the clinician to safely and reliably insert the sensor into the bladder.

[0105] The insertion tool 500 and the sensor 50 can be configured in such a way that they can be inserted without the push rod 530. In this embodiment, the mechanical properties of the sheath 56 and the sensor 50 can be optimized to provide the properties for insertion through the urethra into the bladder. This may enable the clinician to insert the device more ergonomically and handle it safely, as the tool is shorter and there is one less component of this tool to handle during the insertion process.

[0106] In some embodiments, the sheath 504 of the insertion tool 500 may utilize multiple durometer materials (e.g., harder at the proximal end and softer at the distal end), and further reinforcement by braiding or coiling the outer wall of the insertion tool sheath with different materials, such as steel, thicknesses, and patterns.

[0107] The proximal end cap 74 may also be shaped to enable quick and easy removal of the sensor 50 using standard cystoscopy tools, including flexible grippers or forceps. These may be utilized if a problem occurs with the removal string 58 connected to the proximal end cap 74 of the sensor. From the perspective of the size of forceps available during cystoscopy, a specially designed shelf or rim 52B with reduced thickness is implemented on the outer sheath 56 of the sensor or on the proximal end cap 74 in some embodiments, thereby enabling a trained urologist using generally available tools to quickly and easily remove the sensor. The design of such an end cap 74 enables quick and reliable removal using a standard flexible cystoscope and generally available tools.

[0108] The packaging 700 for the sensor 50 and the insertion tool 500 can be designed to facilitate an efficient and safe clinical workflow. This can enable a clinician to insert the sensor into a patient's bladder without touching the sensor body. This requires that the packaging 700 has a protective function but is flexible enough to allow pressing the sensor button through the packaging barrier to activate the sensor. This also requires support for the sensor 50 and the insertion tool 500, where the string 58 is pre-loaded in a reliable and effective manner and the coudé tip 54 of the distal end cap 76 is properly aligned with the distal end of the insertion tool 500 for insertion into the bladder. This helps to minimize potential contamination of the sensor and can reduce complications such as urinary tract infections and bacterial inoculation of the bladder. The packaging 700 can be designed to support both female and male insertion tools in the same shell / tray.

[0109] Each key / keyhole feature can be made from common materials (silicone, plastic) and reinforced by a rigid or semi-rigid material (such as a metal like stainless steel) to improve the strength of the engagement between the over-sheath and the sensor. This material can be incorporated into the design such that any metal is covered with a soft / flexible plastic such as TPE / TPU to minimize or eliminate potential trauma to the urethra and bladder during insertion and deployment into the bladder.

[0110] In some embodiments, there can be different designs of the insertion tool 500 for female and male anatomical structures. In this case, the female tool may be shorter than the male tool 500 to account for the shorter length of the urethra and to improve ease of insertion.

[0111] When the coudé or asymmetric sensor tip 54 on the end cap 76 is utilized, the sheath handle 503 may have visual and / or tactile indicators 508, which can provide the clinician with a reliable confirmation of the orientation of the sensor end cap 76 for proper insertion of the sensor 50 into male or female anatomical structures.

[0112] In both the female and male insertion tools 500, the design of the mechanical components may take into account the mechanical properties of the sheath to safely and reliably deliver the sensor 50 through the urethra and into the bladder. This includes the material and properties (durometer and material) of the sensor housing 56, the sensor spine 72 (material and spring constant) when considered together with the sheath 504 (material), and the sheath manufacturing method (braiding and / or coil winding). In some embodiments, the sheath 504 may include different braiding and / or coil winding patterns in different sections. This can provide the clinician with a higher or lower stiffness / flexibility that gives appropriate properties for insertion.

[0113] Loading of the sensor into the insertion tool As described above, the sensor is preferably loaded into the insertion tool by being drawn into the insertion tool lumen using a removal string attached to the proximal end of the sensor. By pulling on the removal string, the sensor is drawn into the first distal section of the insertion tool lumen. As previously described, the proximal end of the sensor cannot pass through the second proximal section of the insertion tool lumen and thus cannot advance beyond that point. When fully positioned within the insertion tool, the removal string is outside the proximal end of the insertion tool sheath, the proximal tip of the sensor (i.e., the most proximal portion of the proximal end) is positioned inside the leading end of the second proximal lumen of the insertion tool, and the distal end of the sensor is positioned outside the distal end of the insertion tool sheath. A key (if utilized) on the distal end of the sensor is positioned within a keyway at the distal end of the insertion tool, and the geometric structure (preferably rectangular) of the proximal tip of the proximal end of the sensor is received within and engaged with a mating structure (preferably a rectangular opening) at the leading end of the second proximal section of the insertion tool lumen.

[0114] Advancement (or push) rod The advancement rod 530 is described above and is designed to have both flexibility and pushability to enable reliable sensor deployment. It is a flexible tube with a handle having a lumen in the middle to allow urine to flow through the tube. This helps the clinician confirm that the device has been successfully deployed within the bladder.

[0115] The push rod 530 may also include a lumen passing through the handle throughout the length of the rod. This feature allows urine to flow out of the push rod handle through the push rod and helps the clinician confirm the placement of the sensor within the bladder.

[0116] Sensor performance and cavity filling The sensor uses a combination of silicone rubber, an adhesive, and silicone oil within the sensor cavity against the outer wall (or housing, or tube). The silicone oil has properties that minimize the ingress of fluid through the silicone outer wall and the adhesive. The silicone rubber is a porous material and thus it allows the absorption of certain substances and the movement of fluids (as used herein, fluid refers to liquid) and gases through the silicone rubber membrane. To enable reliable pressure sensing for the bladder sensor, the volume of the mass / fluid within the sensor housing (or cavity defined by the silicone rubber tube) must be a preset amount, otherwise the pressure measurement can be affected by the external environment and can cause sensor drift and loss of accuracy. This volume should be such that when combined with the other components of the sensor, a pressure higher than atmospheric pressure is created within the sensor cavity with a minimal amount or no air or gas remaining inside the sensor cavity. In this case, the higher pressure of the oil inside the sensor cavity acts to push out the air or gas inside the sensor cavity and tries to equilibrate with the external environment (atmospheric pressure). This is desirable as the reduction of the compressible gas within the sensor cavity results in a higher frequency response for the sensor compared to other cases.

[0117] By filling the sensor with a fluid (most preferably silicone oil, most preferably fluorosilicone oil containing hydrophobic properties and molecules larger than silicone rubber tubing) at a pressure lower than atmospheric pressure (e.g., less than 1 bar), air is allowed to move from the external environment into the sensor cavity (or housing) through the porous silicone tubing before the sensor is positioned within the bladder. In that case, air will enter the sensor cavity until the cavity reaches the equilibrium pressure with the external environment (e.g., atmospheric pressure). Thus, storage of such a sensor prior to use allowing air to enter the sensor housing can be either desirable or undesirable as it can lower the pressure reading. This is undesirable in some applications except when an attenuation effect, such as a low-pass filter, is desired.

[0118] A fluid (i.e., liquid) disposed in the sensor housing causes the sensor to be essentially non-compressible, while a gas such as air causes the sensor to be more easily compressed. Thus, when air is present within the sensor cavity (or housing), this can attenuate signals from the external environment of the bladder and can serve to vary the pressure reading sensed by an internal pressure sensor (preferably on a circuit board) within the sensor housing. Air can be used to act as an attenuation mechanism and can filter some aspects of the signal (low-pass filter). This feature can be useful when filtering is desired.

[0119] Filling the sensor cavity to a pressure higher than atmospheric level is generally beneficial for sensor performance and manufacturing. This enables simplifying assembly and reducing manufacturing time as the amount of fluid, such as silicone oil, can be easily measured in terms of volume or mass using tools like an electronic fluid dispenser and a scale. In this embodiment, air attenuates the signal received by the pressure sensor inside the sensor housing and reduces the frequency response of the pressure sensor compared to a similar system where additional fluid (i.e., liquid) replaces the air. Ultimately, there is a certain range of pressure / volume available where the pressure sensor senses pressure with a lower frequency response compared to a similar system with more fluid. Within this range, the more air there is inside the sensor housing, the lower the frequency response, and the more fluid there is inside the sensor, the higher the frequency response. In all embodiments, a sensor with air present inside the sensor housing has a lower frequency response compared to a sensor at the same pressure with no air in the cavity and only liquid. During manufacturing, including more fluid can be beneficial as it enables simple assembly, raises manufacturing yield because the required accuracy is low, and a two-step filling process can be used there. In this embodiment, a portion of the sensor cavity can be filled and sealed prior to the second step of applying excessive pressure to the sensor cavity. This can be used to allow the exact level of air to enter the cavity and to give the system a specified amount of attenuation (low-pass / high-pass filtering).

[0120] Filling the sensor housing with a fixed volume of fluid at a pressure higher than atmospheric pressure (e.g., higher than 1 bar) causes air / gas bubbles to discharge from the sensor outer wall (or tube). The sensor housing reaches a pressure equilibrium point that can be higher than atmospheric pressure as long as (1) the mass / volume of the fluid in the housing does not leak from the porous silicone tube, and (2) the mass / volume of air / gas inside the sensor is small enough that the volume of the fluid in the sensor housing is larger than the volume of the sensor cavity. This helps improve yield in manufacturing and reduce the required precision, but requires additional components and assembly methods to ensure a standardized volume of liquid in each sensor housing. In some embodiments, since an improved frequency response is desired, the air / gas inside the sensor housing should be eliminated or minimized. To achieve this, the sensor is filled with an amount of fluid larger than the volume of the sensor cavity, and a pressure higher than atmospheric pressure is generated inside the sensor housing. In one embodiment, the sensor can be manufactured such that the pressure after air / gas is discharged from the cavity is as high as 1250 - 1400 hPa. Sensors subjected to this level of pressure, or higher, do not allow air / gas to enter the sensor housing under normal circumstances, which standardizes the frequency response characteristics of the internal pressure sensor and provides reliable, predictable pressure sensor readings with little drift and high accuracy.

[0121] To achieve adding a volume of fluid greater than the volume of the sensor cavity, an assembly process using two-stage fluid filling can be used. First, a volume of fluid less than the final desired volume is directly inserted into the sensor housing. The sensor distal end cap is then attached to the sensor tube by any suitable means such as an adhesive, which is left to dry so as to seal the distal tip to the sensor tube. The sensor housing can then be further filled using a syringe equipped with a needle that penetrates the distal end cap to add additional fluid to the sensor housing. The silicone rubber has self-sealing properties that can be punctured with a syringe and then sealed thereafter, but the addition of a septum (e.g., a rubber septum) can be used to further enhance reliability. The septum is typically a compression-molded rubber or elastomer that can withstand multiple punctures from a hypodermic needle and then self-seal. This maintains a reliable barrier that prevents the movement of fluid / gas through the septum and thus out of the sensor housing. Using a septum allows the sensor housing to be pressurized to a level that would not be possible with other methods, as puncturing the silicone rubber with a needle in the second stage of assembly could allow a permanent gap or opening to occur and fluid to leak out. In some embodiments, the septum can be integrated with the sensor distal end cap. In some embodiments, the septum can be integrated with both the sensor distal end caps and also a plastic spacer. Alternatively, the septum can be integrated with only the plastic spacer or attached in any suitable manner to the distal or proximal end of the sensor.

[0122] The adjacent material properties can be selected to be used with a specific needle size / shape to increase the filling accuracy. In this case, the amount of fluid volume within the sensor housing may not need to be measured, as the overpressure gradually decreases after reaching the target pressure due to leakage from the adjacent wall and / or silicone needle puncture. This provides an acceptable range of values (1250 - 1400 hPa) that aids in manufacturing, increases yield, and results in reduced required time / accuracy degradation.

[0123] The adjacent wall is fabricated by a compression molding technique that forms a "self-healing" function such that the needle can puncture the adjacent wall without creating holes that would compromise the mechanical integrity of the sensor cavity. In some embodiments, the adjacent wall is incorporated into the design of a spine spacer and may include a plurality of filling holes for a syringe to fill the sensor cavity with fluid.

[0124] In other embodiments, the adjacent wall is integrated into the sensor spacer and can be sealed prior to the final attachment of the sensor end cap. This can improve the reliability of the seal by shortening the distance required for the needle to move within the silicone and reduce the complexity of assembly. In this embodiment, a larger size needle can be utilized to increase the inflow rate of fluid into the sensor cavity.

[0125] When the sensor cavity is pressurized to a level that will still maintain a pressure higher than atmospheric pressure after expelling the compressible fluid and there is little or no loss of molecules of the residual fluid (such as silicone oil), the pressure within the sensor cavity remains stable, thereby extending the potential service life and / or storage life of the sensor. This can be beneficial for any commercial activity and can enhance the supply chain and logistics for the sensor. This also reduces or eliminates the need for calibration or recalibration of the sensor, and the pressure sensor (or pressure monitor), which is part of the sensor circuit, generates an accurate reading of the bladder pressure.

[0126] In one embodiment, the sensor can actively transmit the pressure of the sensor cavity to assist in manufacturing. In another embodiment, the method of filling the sensor with fluid receives a signal from a pressure sensor until a pressure threshold is reached at which the sensor cavity can delay or stop the filling of the fluid within the sensor cavity, and can be automated such that a closed loop is created by software that fills the cavity with fluid.

[0127] If desired, some embodiments of the sensor can incorporate the use of a compressible fluid such as air. This can function as a low-pass filter and can help remove unwanted artifacts from the signal from the internal pressure sensor of the sensor. This damping effect correlates with the amount of air within the sensor and the pressure of the sensor cavity and reduces the frequency response of the system. Conversely, a greater pressure within the sensor cavity may act to increase the frequency response of the system, which may be desirable in some situations.

[0128] The sensor can sense the condition inside the bladder and electronically transmit the data to a computing device having a processor and software configured to receive the data, analyze the data, compare the data with related data, display the data, and / or store the data, preferably by wireless communication.

[0129] Computer system FIG. 211 shows a computer system 1000 according to the present disclosure. The computer system 1000 has a processor 1002, the processor 1002 has a memory 1004, and communicates with one or more databases 1006. The database 1006 can store any urological data for any number of patients. This data can be accessed by the processor 1002 to compare the data for the patient 1010 for any purpose such as investigating trends or determining whether the data for the patient 1010 is abnormal or deviates from normal values.

[0130] Processor 1002 communicates with sensor 1008, which is any sensor that resides within the bladder of patient 1010, such as any of the sensors described in this disclosure. Sensor 1008 provides processor 1002 with urological data regarding patient 1010 for analysis. Processor 1002 may also communicate with a uroflowmeter 1012 that measures the weight of urine with respect to the onset of urination or determines the urine volume. Data from uroflowmeter 1012 may be included with data from sensor 1008 or analyzed separately.

[0131] Data from sensor 1008 and / or uroflowmeter 1012 may be compared with data from one or more databases 1006 and / or added to that data and stored in memory 1004 and / or one or more databases 1006.

[0132] Other devices 1014 are one or more other devices that may provide information to or receive information from processor 1002.

[0133] The clinician device 1018 is any suitable computing device, such as a tablet, desktop computer, mobile phone, etc. The clinician device 1018 can communicate directly with the processor 1002 or indirectly through the server 1016 with the processor 1002. The clinician device 1018 receives data from the processor 1002 and displays the data in any of the ways shown herein, so that the data can be easily organized and interpreted. The clinician device 1018 is configured to pre-fill the urological data of the patient 1010 into the report, thus saving significant time. By using the clinician device 1018, the clinician can review the report and electronically sign or verify it using the docu-sign (or electronic signature) function of the processor 1002, and then the report can be stored as an electronic health record (EHR) in either the memory 1004 or one or more databases 1006.

[0134] The patient device 1020 communicates indirectly with the processor 1002 and the clinician device 1018 via the server 1016. The patient device 1020 is any suitable device, such as a computer or mobile phone. The patient device 1020 can receive urological information from the clinician device 1018 or the processor 1002 and present it to the patient 1010 in any suitable way as shown in this disclosure.

[0135] Figure 203 shows a login screen for using the computer system according to this disclosure. Figures 204 to 210 and Figures 212 to 219 illustrate screens of information that can be generated by the computer system according to this disclosure.

[0136] As used herein, the terms "application" and "module" and like terms can refer to computer program instructions encoded on a computer storage medium for execution by, or to control the operation of, a data processing apparatus. Alternatively, or in addition, the program instructions can be generated to be encoded on an artificially-generated propagated signal, e.g., a machine-generated electrical, optical, or electromagnetic signal, that is configured to transmit information suitable for execution by a receiving apparatus by the data processing apparatus. The computer storage medium can be, or can include, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of the foregoing. Further, the computer storage medium can be, but is not limited to, the source or destination of computer program instructions encoded within an artificially-generated propagated signal. The computer storage medium is non-transitory and can be, or can include, one or more independent physical components or media (e.g., a solid-state memory that forms part of a device, disk, or other storage device).

[0137] As used herein, "database" refers to any suitable database for storing information, electronic files, or code to be utilized in implementing embodiments of the present disclosure. As used herein, "server" refers to any suitable server, computer, or computing device for performing functions to be utilized in implementing embodiments of the present disclosure.

[0138] As used herein, "processor" refers to a data processing device configured to execute computer program instructions encoded on a computer storage medium, the instructions controlling the operation of the engine. Alternatively, or in addition, the program instructions may be generated to encode information for transmission to a receiver device suitable for execution by the data processing device, and may be encoded on an artificially generated propagated signal, e.g., a mechanically generated electrical, optical, or electromagnetic signal.

[0139] "Memory" or "memories" can be, or can include, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or one or more combinations of substrates and devices. Further, a computer storage medium is not a propagated signal, but can be a source or destination of computer program instructions encoded within an artificially generated propagated signal. A computer storage medium can be, or can include, one or more separate physical components or media (e.g., a device, disk, or solid state memory forming part of another storage device). According to an example of the present disclosure, a non-transitory computer-readable medium containing a program can execute the functions of one or more methods, modules, engines, and / or other system components, as described herein.

[0140] A computer system 1000 with software, such as a patient and / or clinician application, designed to be used on any suitable computing device, such as a server, mobile device (tablet / phone), or computer. This software can operate on a processor that may or may not reside on a server. The processor has communication with or communicates with a memory and one or more databases, and the processor is configured to store data and execute software applications. Some aspects of the computer system 1000 include the following.

[0141] (1) The ability to integrate and synchronize data from sensors, uroflowmetry devices, and software, specifically the ability to temporally align this information with high accuracy. Devices connected to the server (which may be on a mobile device (tablet or phone)) synchronize using any suitable wired connection or wireless connection (such as Wi-Fi, cellular phone line, Bluetooth, etc.) when the sensor is external to the body.

[0142] (2) Visual data processing techniques that assist clinicians in reviewing and analyzing data may include one or more of the following.

[0143] (a) An analysis function that means the ability to view / analyze / write down findings for any one urinary filling / voiding cycle. Since the system / device standardizes reports and reduces operator variability, the repository can be used to develop algorithms that identify the characteristics of the presented data and assist clinicians in making waveform diagnoses. These waveforms specifically illustrate wireless uroflow dynamic data from human or animal patients without using a catheter.

[0144] (b) An overlay function that is capable of overlaying two or more urine filling / voiding cycles to assist in displaying / identifying trends. This may well include global analysis within the patient's body, which analyzes key metrics such as the average number of voids per day, the number of urine leakage episodes per day, and the number of nocturia episodes. Artificial intelligence / machine learning (AI / ML), statistical, and / or mathematical algorithms may be used to highlight various trends including decreased detrusor activity (DU), detrusor overactivity (DO), detrusor / sphincter dyssynergia (DSD), urine leakage, urinary incontinence, and other aspects of bladder filling / storage / voiding dysfunction.

[0145] (c) A comparison function that means the ability to directly compare two or more urine filling / voiding cycles to determine similarities and differences. This may also be used to generate a unique scoring mechanism for understanding and quantifying within-patient variability across multiple voiding cycles.

[0146] (d) A patient-to-repository comparison function that means the ability to analyze urine filling / voiding cycles from a patient that can be compared to a data repository to assist in the classification and identification of whether any particular form of bladder dysfunction is present. This information may be provided to the clinician as a suggestion to assist in the patient's diagnosis and save the clinician's time. This may also help to standardize metrics by leveraging reports from other patients, potentially including patients from other regions or other countries.

[0147] (e) An intra-patient comparison function that is the ability to analyze two or more urine filling / voiding cycles from the same patient to determine similarities and differences in the urine filling / voiding cycles. With multiple cycles, this will be found to be beneficial for confirming or negating a potential diagnosis through long-term monitoring and repeated measurements. The system of the present disclosure has the ability to do this in a single uroflowmetry evaluation or from the same patient, but at different times or periods of uroflowmetry evaluation.

[0148] A clinic or clinician data analysis and comparison function within a clinic or clinician that uses algorithms to compare the analysis with aggregated data in a data repository and determine various factors including clinic proficiency, clinician proficiency, faithful training, and other metrics. This type of data can also identify trends through analysis and determine the prevalence of specific urological diseases within a particular geographical area or the type of individual (such as age, ethnicity, or lifestyle). When such data is overlaid with aggregated medical records through electronic health record (EHR) integration, this can support trend analysis regarding risk factors for population health management and insurance companies. The systems, devices, and methods of this disclosure are not limited to the above functions; they can perform any suitable function or provide any suitable data.

[0149] Integration and generation of reports through the incorporation of data from a patient's medical records through EHR integration and further data from an event detection algorithm from data collected during urodynamic testing. The use of this information can assist in improving efficiency by pre-populating memos and evaluation plans for clinicians. This can be accomplished using templates and advanced signal processing or data science (AI / ML) techniques or by using generative AI capabilities (such as Chat GPT).

[0150] Software (or "app" or "application") resides on a processor (patient processor and / or clinician processor) that can communicate directly or indirectly wirelessly with a server to send / receive information, enable the use of AI / ML, support algorithm development, and facilitate the use of cloud-based software applications.

[0151] The server or processor can execute software designed to integrate with various EHR platforms to streamline clinical workflows. In some embodiments, these algorithms may incorporate natural language processing (NLP) techniques to generate reports that include proposed report notes for integration into the EHR. In other embodiments, this may also incorporate patient medical histories through various analytical means, including NLP.

[0152] Computer system 1000 can enable distributed and / or remote patient monitoring by collecting data from patients who may be at home or in some other form away from a hospital or healthcare provider. The data obtained can then be shared with clinicians who may or may not be in the same location as the patient to support telemedicine or remote care.

[0153] Sensor 50 is designed to communicate with clinician and patient software applications (or simply "software" or "app") that reside on the server or processor of a computing device. This software can be executed on the processor of the computing device to enable clinicians and patients to use the system.

[0154] The clinician app enables the clinician to communicate with the sensor wirelessly and prepare for bladder insertion. After the sensor 50 is removed from the bladder, data can be downloaded wirelessly from the memory within the sensor or via a wired connection. Additionally, data can be transmitted by the sensor while the sensor is in the bladder. One means of wireless communication is Bluetooth.

[0155] The clinician app also enables the clinician to manually input data such as voiding events, urine leakage events, urgency, other patient-reported symptoms or events, or related information.

[0156] The clinician app enables a clinician to visually observe on the screen of a computing device and analyze data collected by sensors, both the patient app and the clinician app, as well as a uroflowmeter. This can be used in a manner that utilizes ways of visualizing data, including the use of artificial intelligence and machine learning (AI / ML).

[0157] The clinician app may be used in conjunction with any designated clinical protocol to record data regarding a patient's behavior. The clinician app enables the clinician to provide a window by entering the type of event and even "start" and "stop". This results in data input that enables the aggregation and analysis of events between and within patients and helps to develop and train an ML model. These events may include urological events (such as urinary leakage) or other physiological events (such as jumping, standing up, coughing, ascending and descending stairs, etc.). This enables the refinement and enhancement of the accuracy of an ML model developed from a dataset.

[0158] The clinician app and the web app may also incorporate functions that simplify the reporting and analysis of urological events. This appears to be similar to other quick-sign platforms such as Docusign, where clinical reports are prepared and pre-enter the expected urination events that are to be confirmed, rejected, or corrected by the clinician reading the report. In this way, this input helps to "train" any ML model utilized by the company creating the report.

[0159] Clinical and web apps can also incorporate inputs from multiple devices synchronized in the cloud that can be used to streamline workflows and improve clinic efficiency. This is visually achieved by providing a rendering of relevant information and pre-populated inputs that can provide momentum to clinical responses or interventions (such as patient reports awaiting interpretation). The ability to sort and filter these parameters enables some degree of customization of the interface so that each clinician can consistently observe this data.

[0160] This web app may well incorporate a direct connection feature to an electronic health record (EHR) system, which provides a comprehensive interface to patient data. This can include past medical history, notes, tests, diagnostic labs, and messaging activities.

[0161] The clinician app may also enable the automation and measurement of key urodynamic parameters, including but not limited to the number of voids per day, the number of urinary leakage events, and other events. This can be used in conjunction with other visual features such as shading or coloration to help simplify clinician interpretation.

[0162] When the clinician app is connected via the EHR, the use of NLP techniques can assist in obtaining clinical insights from past patient notes and medical history and support comprehensive analysis using ML models.

[0163] The clinician app can automatically create reports for the clinician's uroflowmetry evaluation that can be directly output to the EHR, or logged as a PDF file, or printed. In some embodiments, the reporting features can use AI and / or ML to generate text for reports that can be copy & pasted into the EHR or automatically fill in notes if enabled. In particular, the template can be pre-populated using metrics obtained from HER integration, also using algorithms for the analysis of current uroflowmetry tests, or using a generative AI platform with an LLM such as Chat GPT.

[0164] The clinician app can also integrate useful communication methods that enable the clinician to communicate with patients by conducting voice calls, video calls, text messages, emails, or other secure communication methods.

[0165] The patient app allows the patient to log any fluid inputs and symptoms experienced by the patient, similar to a digital voiding diary. Other uroflowmetry parameters can be cataloged by the patient using the app.

[0166] Both apps can communicate with sensors and also uroflowmeters using Bluetooth or other wireless protocols, and use any suitable wireless communication method such as Bluetooth, Wi-Fi, or a cellular phone line to send data to a server to store, analyze, display, and / or achieve other purposes.

[0167] The clinician web app enables clinicians to observe and analyze patient data obtained from tests through the use of a cloud-based data server that stores the data. This makes it easy for clinicians to perform simple, reliable access via any web browser, streamline reporting, and generate reports from any uroflowmetry test evaluation. This app may also incorporate various features that assist in medical diagnostics, including AI / ML, statistical, and / or mathematical algorithms.

[0168] Uroflowmeter The uroflowmeter 600 is designed to measure the amount of urine excreted and the change in the amount of urine excreted (i.e., the flow).

[0169] This data may be stored locally on the device for a period of time and may also be wirelessly transmitted to the device app for analysis, review, display, and / or storage. After the data is received by one or more apps, it may be wirelessly transmitted to a server or processor for storage, analysis, display, and / or other purposes. In some embodiments, the uroflowmeter and sensors may have a cellular phone line, Wi-Fi, or other antenna that enables them to directly transfer and upload data to a device such as a server without the need for a clinician app or patient app. The uroflowmeter may use any relevant means of wireless communication, including Bluetooth, Wi-Fi, and / or a cellular phone line.

[0170] Wireless remote measurement The sensor 50 can be designed to wirelessly transmit data in real time through the body while the sensor is within the bladder. This can be accomplished using various suitable wireless communications and can be done continuously, intermittently, or in response to a command. In some embodiments, this can be done by the sensor communicating directly with a smartphone, computer, or similar device. In other embodiments, this can be done using a wireless repeater to receive a signal from the sensor within the body and then transmit this signal to another device, such as one equipped with a clinician app or patient app.

[0171] Volume sensing Other methods of volume sensing modalities for the sensor 50 include the following.

[0172] Impedance. This measures the conductance of the fluid within the bladder using electrodes.

[0173] Vibration. This uses shock waves or pressure pulses sent from the sensor into the fluid within the bladder, and then the volume is sensed using the same or different sensors.

[0174] Optical methods. Various light waves are sent from the sensor within the bladder into the bladder and received by the sensor on the circuit of the sensor. It is possible to utilize infrared (IR) or visible light for the light waves.

[0175] Laser. The laser beam detects the fluid level and the bladder volume, and based on that information, the volume of the fluid within the bladder is calculated.

[0176] Acoustic (audio). This is similar to or the same as a sonar and can map the bladder structure and the volume of the fluid.

[0177] Ultrasound. The way it operates is known to those skilled in the art.

[0178] Pressure. The pressure sensing signal is processed, input features are identified, and incorporated into an ML / AI algorithm to predict the volume of fluid.

[0179] Each of these modalities can be used alone or in combination with other modalities to achieve the goal of providing a reliable estimate of the fluid volume in the bladder.

[0180] Enabling volume measurement by evaluating the area under the curve of the uroflowmetry trace, the derivative of the uroflowmetry pressure waveform, and measurements of other aspects of the waveform, and enabling volume estimation from pressure measurements within the bladder and volume / flow from an external uroflowmeter, using AI / ML, statistical, and / or mathematical algorithms. These algorithms can be developed to utilize one or more of any combination of signals from the sensing modalities listed above, in conjunction with pressure measurements or entirely separate from pressure measurements.

[0181] Disclosed herein is the use of a single sensor within the bladder and advanced signal processing techniques to identify and characterize the abdominal pressure waveform. This may enable the removal of abdominal pressure from bladder pressure to give detrusor pressure. This method can then be used to reconstruct the abdominal pressure waveform at a high level of accuracy. This eliminates the need to use a rectal catheter or vaginal catheter to measure abdominal pressure.

[0182] The use of a sensor to measure the force applied onto the sensor from the bladder wall can be utilized to estimate the amount of urine within the bladder. This can also be used to estimate the post-void residual volume and the time until the bladder is full. This signal can also be used to estimate or derive certain and well-verified uroflowmetry parameters including, but not limited to, the bladder contractility index (BCI), bladder wall thickness (BWT), detrusor contraction index, and other parameters, with or without advanced signal processing techniques.

[0183] The geometric shape and diameter of the sensor are sized to function with different amounts of urine in the bladder, such that the force on the bladder wall can enable volume estimation regardless of the volume. One example is that a sensor with a smaller diameter and / or longer length can enable higher resolution in a smaller bladder, while a sensor with a larger diameter and / or longer length is ideal for larger bladder measurements.

[0184] The use of software applications and signal processing techniques can be utilized to identify the offset of the pressure sensor and automatically calibrate the results to account for this from one or more urine filling / voiding cycles. This streamlines the interpretation process for the clinician and improves the reliability of the analysis.

[0185] Non-limiting examples of the present invention are presented below.

[0186] Example 1: A tool for inserting a sensor into the bladder, an over-sheath having a first lumen, and a push rod used to deploy the sensor.

[0187] Example 2: The tool according to Example 1, further comprising a handle at a first end of the over-sheath.

[0188] Example 3: The tool according to any one of Examples 1 - 3, further comprising a sensor positioned within the first lumen of the over-sheath.

[0189] Example 4: The tool according to any one of Examples 1 - 4, wherein the over-sheath is made of TPU.

[0190] Example 5: The tool according to any one of Examples 1 - 4, wherein the push rod comprises a handle.

[0191] Example 6: The tool according to any one of Examples 1 to 7, wherein the outer surface of the over-sheath includes depth markings configured to indicate an appropriate positioning of the tool for inserting the sensor into the bladder.

[0192] Example 7: The tool according to any one of Examples 1 to 8, wherein the over-sheath further comprises a second lumen configured to allow urine to flow therethrough after the tool has reached the bladder.

[0193] Example 8: The tool according to Example 10, wherein the second lumen is configured to prevent the second lumen from being blocked by a lubricant while positioning the tool in the bladder and is configured to be removed to allow urine to flow through the second lumen when the user is convinced that the tool is in the bladder, and the tool comprises a removable structure.

[0194] Example 9: The tool according to any one of Examples 1 to 8, wherein the push rod comprises a channel configured such that a string on the sensor can be positioned within this channel.

[0195] Some additional non-limiting examples of the sensor are presented below.

[0196] Example 1: A sensor configured to detect the state inside the bladder, a flexible outer cover having a lumen, a flexible circuit inside the flexible outer cover, a power source inside the flexible outer cover and communicating with the flexible circuit, one or more parameter sensors inside the flexible outer cover and communicating with the flexible circuit, the one or more parameter sensors being configured to measure at least one of (i) the volume of liquid in the bladder, (ii) the liquid discharge rate from the bladder, (iii) the pressure in the bladder, (iv) the volume of the bladder, (v) an abnormality in the bladder, and (vi) the chemical properties of urine in the bladder, and comprising one or more parameter sensors. A sensor configured to move from a first position where it is held within the bladder and configured not to be accidentally discharged, to a second position where the sensor is configured to be inserted into the bladder through the urethra.

[0197] Example 2: The flexible outer cover is made of silicone, the sensor described in Example 1.

[0198] Example 3: At least one of the one or more parameter sensors is on a flexible circuit, the sensor described in Example 1 or 2.

[0199] Example 4: The power source is a battery, the sensor described in any one of Examples 1 to 3.

[0200] Example 5: The power source is mechanically coupled to an electronic circuit, the sensor described in any one of Examples 1 to 4.

[0201] Example 6: Including a distal end to which a string is attached, the string is configured to remain outside the body when the sensor is positioned within the bladder, and the string can be pulled by the user or clinician to remove the sensor from the bladder, the sensor described in any one of Examples 1 to 5.

[0202] Example 7: Having a straight distal end, the sensor described in any one of Examples 1 to 6.

[0203] Example 8: Having a distal end in a conical shape, the sensor described in any one of Examples 1 to 6.

[0204] Example 9: Pre-filled with a non-compressible fluid and configured to enable the fluid to convert and transmit force to the electronic sensor, the sensor described in any one of Examples 1 to 8.

[0205] Example 10: Further comprising an antenna, the sensor described in any one of Examples 1 to 9.

[0206] Example 11: The sensor according to any one of Examples 1 to 10, configured to transmit by wireless communication.

[0207] Example 12: The sensor according to any one of Examples 1 to 11, configured to receive by wireless communication.

[0208] Example 13: The sensor according to any one of Examples 1 to 12, further comprising a processor and a memory configured to store measurement parameters.

[0209] Example 14: The sensor according to any one of Examples 1 to 13, further comprising software configured to analyze measurement parameters.

[0210] Example 15: The sensor according to any one of Examples 1 to 14, further comprising a shape memory spring positioned inside a flexible outer cover.

[0211] Example 16: The sensor according to Example 15, wherein the shape memory spring is made of metal or plastic.

[0212] Example 17: The sensor according to Example 16, wherein the shape memory spring is made of metal or steel.

[0213] Example 18: The sensor according to any one of Examples 1 to 17, which is circular or curved when in a first position and straight when in a second position.

[0214] Example 19: The sensor according to any one of Examples 1 to 18, comprising a semi-rigid end cap on a distal end of the sensor and a semi-rigid end cap on a proximal end of the sensor.

[0215] Example 20: The sensor according to Example 20, wherein each end cap is made of steel, plastic, or other material.

[0216] Example 21: The sensor according to Example 15 or 16, wherein the shape memory spring is flat (with a rectangular cross-section).

[0217] Example 22: A sensor as described in Example 15 or 16 or 21, further comprising a semi-rigid end cap on the distal end and a semi-rigid end cap on the proximal end, wherein the shape memory spring mates with each of the end caps.

[0218] Example 23: A sensor as described in Example 15 or 16 or 21 or 22, wherein the shape memory spring is coated with an electrically insulating material.

[0219] Example 24: A sensor as described in any one of Example 15 or 16 or 21 - 23, wherein the shape memory spring is coated with a material resistant to lubricating oil.

[0220] Example 25: A sensor as described in any one of Example 15 or 16 or 21 - 24, wherein the shape memory spring is coated with an adhesive.

[0221] Example 26: A sensor as described in any one of Example 1 - 25, designed to communicate with an external computing device having software operable on a processor, wherein the processor is configured by the software to view, analyze, store, and take notes on findings for one or more bladder filling and voiding cycles.

[0222] Example 27: The system as described in Example 26, wherein the software configures the processor to overlay two or more urine filling / voiding cycles and assist in identifying trends.

[0223] Example 28: The system as described in Example 26 or 27, wherein the processor uses an AI / ML algorithm to detect trends such as decreased detrusor muscle activity, detrusor muscle overactivity, urinary leakage incontinence, and / or other aspects of bladder filling / storage / voiding dysfunction.

[0224] Example 29: Compare data obtained by one or more parameter sensors with aggregated data in a data repository, and the software further configures the processor to (a) clinic proficiency, (b) clinician proficiency, (c) perform training faithfully, (d) determine one or more of (i) a specific geographic region, (ii) ACX, (iii) ethnicity, (iv) age, or (v) the prevalence of a specific urinary disease in a lifestyle, the system according to any one of Examples 26 - 28.

[0225] Example 30: A sensor according to any one of Examples 1 - 29, configured to utilize one or more of (a) one or more shock waves or pressure pulses, (b) one or more light waves, (c) one or more lasers, (d) one or more acoustic signals, (e) ultrasound, (f) conductivity, and (g) pressure to detect the volume and level of fluid in the bladder.

[0226] Some further non - limiting examples of the present disclosure are presented below.

[0227] Example 1: A tool for inserting a sensor into the bladder, an over - sheath having a first lumen, a push rod positioned within the first lumen, and a removable spacer positioned between the push rod and the over - sheath.

[0228] Example 2: The tool according to Example 1, further comprising a handle at a first end of the over - sheath.

[0229] Example 3: The tool according to Example 2, wherein the spacer is not positioned on the handle.

[0230] Example 4: The tool according to any one of Examples 1 - 3, further comprising a sensor positioned within the first lumen of the over - sheath.

[0231] Example 5: The over-sheath is a tool according to any one of Examples 1 to 4, made of TPU.

[0232] Example 6: The spacer is a tool according to any one of Examples 1 to 5, having a predetermined length.

[0233] Example 7: The push rod is a tool according to any one of Examples 1 to 6, comprising a handle.

[0234] Example 8: The removable spacer is a tool according to any one of Examples 1 to 7, positioned between the over-sheath handle and the push rod handle.

[0235] Example 9: The outer surface of the over-sheath is a tool according to any one of Examples 1 to 8, including depth markings configured to indicate proper positioning of the tool for inserting the sensor into the bladder.

[0236] Example 10: The over-sheath is a tool according to any one of Examples 1 to 9, further comprising a second lumen configured to allow urine to flow therethrough after the tool reaches the bladder.

[0237] Example 11: The second lumen is configured to prevent the second lumen from being blocked by a lubricant while positioning the tool in the bladder, and is configured to be removed to allow urine to flow through the second lumen when the user is convinced that the tool is in the bladder. The tool according to Example 10, comprising a removable structure.

[0238] Example 12: The push rod is a tool according to any one of Examples 1 to 11, comprising a channel configured such that a string on the sensor can be positioned within this channel.

[0239] Example 13: The tool is a tool according to any one of Examples 1 to 12, configured such that when the removable spacer is positioned on the over-sheath, the push rod cannot advance beyond the removable spacer.

[0240] Example 14: The tool is the tool according to any one of Examples 1 to 13, configured such that the push rod can push the sensor out of the over-sheath only after the spacer is removed.

[0241] Some further non-limiting examples of the present disclosure are shown below.

[0242] Example 1: A sensor configured to detect the condition inside the bladder, a flexible outer cover having a lumen, a flexible circuit inside the flexible outer cover, a power source inside the flexible outer cover and communicating with the flexible circuit, one or more parameter sensors inside the flexible outer cover and communicating with the flexible circuit, the one or more parameter sensors being configured to measure at least one of (i) the volume of liquid in the bladder, (ii) the rate of liquid discharge from the bladder, (iii) the pressure inside the bladder, (iv) the volume of the bladder, (v) abnormalities inside the bladder, and (vi) the chemical properties of urine inside the bladder, one or more parameter sensors; The sensor is configured to move from a first position where it is held inside the bladder and configured not to be accidentally discharged, to a second position where the sensor is configured to be inserted into the bladder through the urethra.

[0243] Example 2: The sensor according to Example 1, wherein the flexible outer cover is made of silicone.

[0244] Example 3: The sensor according to Example 1 or 2, wherein at least one of the one or more parameter sensors is on the flexible circuit.

[0245] Example 4: The sensor according to any one of Examples 1 to 3, wherein the power source is a battery.

[0246] Example 5: The power supply is the sensor according to any one of Examples 1 to 4, which is mechanically coupled to the electronic circuit.

[0247] Example 6: The sensor according to any one of Examples 1 to 5, including a distal end to which a string is attached, the string being configured to remain outside the body when the sensor is positioned within the bladder, and the string being pullable by a user or a clinician to remove the sensor from the bladder.

[0248] Example 7: The sensor according to any one of Examples 1 to 6, having a straight distal end.

[0249] Example 8: The sensor according to any one of Examples 1 to 6, having a spoon-shaped distal end.

[0250] Example 9: The sensor according to any one of Examples 1 to 8, pre-filled with a non-compressible fluid and configured to enable the fluid to convert and transmit force to the electronic sensor.

[0251] Example 10: The sensor according to any one of Examples 1 to 9, further comprising an antenna.

[0252] Example 11: The sensor according to any one of Examples 1 to 10, configured to transmit by wireless communication.

[0253] Example 12: The sensor according to any one of Examples 1 to 11, configured to receive by wireless communication.

[0254] Example 13: The sensor according to any one of Examples 1 to 12, further comprising a processor and a memory configured to store measurement parameters.

[0255] Example 14: The sensor according to any one of Examples 1 to 13, further comprising software configured to analyze measurement parameters.

[0256] Example 15: The sensor according to any one of Examples 1 to 14, further comprising a shape memory spring positioned inside the flexible outer cover.

[0257] Example 16: The sensor according to Example 15, wherein the shape memory spring is made of metal or plastic.

[0258] Example 17: The sensor according to Example 16, wherein the shape memory spring is made of metal or steel.

[0259] Example 18: The sensor according to any one of Examples 1 to 17, which is circular or curved when in the first position and straight when in the second position.

[0260] Example 19: The sensor according to any one of Examples 1 to 18, comprising a semi-rigid end cap on the distal end of the sensor and a semi-rigid end cap on the proximal end of the sensor.

[0261] Example 20: The sensor according to Example 20, wherein each end cap is made of steel, plastic, or other material.

[0262] Example 21: The sensor according to Example 15 or 16, wherein the shape memory spring is flat.

[0263] Example 22: The sensor according to Example 15 or 16, or 21, further comprising a semi-rigid end cap on the distal end and a semi-rigid end cap on the proximal end, and the shape memory spring fits with each of the end caps.

[0264] Example 23: The sensor according to Example 15 or 16 or 21 or 22, wherein the shape memory spring is coated with an electrically insulating material.

[0265] Example 24: The sensor according to any one of Examples 15 or 16 or 21 to 23, wherein the shape memory spring is coated with a material resistant to lubricating oil.

[0266] Example 25: The shape memory spring is the sensor according to any one of Examples 15 or 16 or 21 to 24, which is coated with an adhesive.

[0267] Example 26: An external computing device having software operable on a processor and designed to communicate with the sensor according to any one of Examples 1 to 25, wherein the processor is configured by the software to view, analyze, store, and take notes on findings for one or more bladder filling and voiding cycles.

[0268] Example 27: The software configures the processor to overlay two or more urine filling / voiding cycles and assist in identifying trends, for the system according to Example 26.

[0269] Example 28: The processor uses AI / ML, statistical, and / or mathematical algorithms to detect trends such as decreased detrusor muscle activity, detrusor overactivity, urinary incontinence, and / or other aspects of bladder filling / storage / voiding dysfunction, for the system according to Example 26 or 27.

[0270] Example 29: Compare the data obtained by one or more parameter sensors with the aggregated data in the data repository, and the software further configures the processor to determine one or more of (a) clinic proficiency, (b) clinician proficiency, (c) faithful performance of training, (d)(i) a specific geographic region, (ii) ACX, (iii) ethnicity, (iv) age, or (v) the prevalence of a specific urological disease in a lifestyle, for the system according to any one of Examples 26 to 28.

[0271] Example 30: The sensor is configured to utilize one or more of (a) one or more shock waves or pressure pulses, (b) one or more light waves, (c) one or more lasers, (d) one or more acoustic signals, (e) ultrasound, (f) conductivity, and (g) pressure to detect the volume and level of fluid in the bladder, for the sensor according to any one of Examples 1 to 29.

[0272] Some further non - limiting examples of the present disclosure are presented below.

[0273] Example 1: A sensor configured to detect the internal state of the bladder, A flexible outer cover having a lumen, a distal end, and a proximal end, wherein the distal end has a key configured to be received within a keyway formed in the distal end of an insertion tool, the flexible outer cover; A flexible circuit inside the flexible outer cover; A power source inside the flexible outer cover and in communication with the flexible circuit; One or more parameter sensors inside the flexible outer cover and in communication with the flexible circuit, the one or more parameter sensors being configured to measure at least one of (i) the volume of liquid in the bladder, (ii) the rate of liquid discharge from the bladder, (iii) the pressure in the bladder, (iv) the volume of the bladder, (v) abnormalities in the bladder, and (vi) the chemical properties of urine in the bladder, the one or more parameter sensors; The sensor is configured to move from a first position where it is held within the bladder and configured not to be accidentally discharged, to a second position where the sensor is configured to be inserted into the bladder through the urethra.

[0274] Example 2: The sensor according to Example 1, wherein the flexible outer cover is made of silicone.

[0275] Example 3: The sensor according to Example 1 or 2, wherein at least one of the one or more parameter sensors is on the flexible circuit.

[0276] Example 4: The sensor according to any one of Examples 1 - 3, wherein the power source is a battery.

[0277] Example 5: The sensor according to any one of Examples 1 - 4, wherein the power source is mechanically coupled to an electronic circuit.

[0278] Example 6: A sensor according to any one of Examples 1 to 5, including a distal end to which a string is attached, the string being configured to remain outside the body when the sensor is positioned within the bladder, and the string being pullable by a user or clinician to remove the sensor from the bladder.

[0279] Example 7: A sensor according to any one of Examples 1 to 6, having a straight distal end.

[0280] Example 8: A sensor according to any one of Examples 1 to 6, having a distal end in the shape of a curve.

[0281] Example 9: A sensor according to any one of Examples 1 to 8, pre-filled with a non-compressible fluid and configured to enable the fluid to convert and transmit force to an electronic sensor.

[0282] Example 10: A sensor according to any one of Examples 1 to 9, further comprising an antenna.

[0283] Example 11: A sensor according to any one of Examples 1 to 10, configured to transmit by wireless communication.

[0284] Example 12: A sensor according to any one of Examples 1 to 11, configured to receive by wireless communication.

[0285] Example 13: A sensor according to any one of Examples 1 to 12, further comprising a processor and a memory configured to store measurement parameters.

[0286] Example 14: A sensor according to any one of Examples 1 to 13, further comprising software configured to analyze measurement parameters.

[0287] Example 15: A sensor according to any one of Examples 1 to 14, further comprising a shape memory spring positioned inside a flexible outer cover.

[0288] Example 16: The shape memory spring is the sensor according to Example 15, made of metal or plastic.

[0289] Example 17: The shape memory spring is the sensor according to Example 16, made of metal or steel.

[0290] Example 18: The sensor is circular or curved when in the first position, and straight when in the second position, and is the sensor according to any one of Examples 1 to 17.

[0291] Example 19: The sensor includes a semi-rigid end cap on the distal end of the sensor and a semi-rigid end cap on the proximal end of the sensor, and is the sensor according to any one of Examples 1 to 18.

[0292] Example 20: Each end cap is made of steel, plastic, or other materials, and is the sensor according to Example 20.

[0293] Example 21: The shape memory spring is flat and is the sensor according to Example 15 or 16.

[0294] Example 22: The distal end and a semi-rigid end cap on the distal end are further provided with a semi-rigid end cap on the proximal end, and the shape memory spring fits with each of the end caps, and is the sensor according to Example 15 or 16, or 21.

[0295] Example 23: The shape memory spring is coated with an electrically insulating material and is the sensor according to Example 15 or 16 or 21 or 22.

[0296] Example 24: The shape memory spring is coated with a material resistant to lubricating oil and is the sensor according to any one of Examples 15 or 16 or 21 to 23.

[0297] Example 25: The shape memory spring is coated with an adhesive and is the sensor according to any one of Examples 15 or 16 or 21 to 24.

[0298] Example 26: The sensor is configured to communicate with an external computing device having software operable on a processor, the processor being configured by software to view, analyze, store, and / or take notes on findings for one or more bladder filling and voiding cycles, the sensor according to any one of Examples 1 - 25.

[0299] Example 27: The software configures the processor of the sensor according to Example 26 to overlay two or more urine filling / voiding cycles and assist in identifying trends.

[0300] Example 28: The processor of the sensor according to Example 26 or 27 uses an AI / ML algorithm to detect trends such as decreased detrusor muscle activity, detrusor muscle overactivity, urinary leakage incontinence, and / or other aspects of bladder filling / storage / voiding dysfunction.

[0301] Example 29: The processor is further configured to compare data acquired by the sensor with aggregated data in a data repository, and the software further configures the processor to determine one or more of (a) clinic proficiency, (b) clinician proficiency, (c) faithful performance of training, (d)(i) a particular geographic region, (ii) an ACX, (iii) ethnicity, (iv) age, or (v) the prevalence of a particular urological disease in a lifestyle, the sensor according to any one of Examples 26 - 28.

[0302] Example 30: The sensor according to any one of Examples 1 - 29 is configured to utilize one or more of (a) one or more shock waves or pressure pulses, (b) one or more light waves, (c) one or more lasers, (d) one or more acoustic signals, (e) ultrasound, (f) conductivity, and (g) pressure to detect the volume and level of fluid in the bladder.

[0303] Example 31: The sensor according to any one of Examples 1 - 30 further includes a proximal end configured to be connected to a removal string.

[0304] Example 32: The sensor according to Example 31, further comprising a withdrawal string attached to the proximal end.

[0305] Example 33: The distal end is made of silicone rubber, and the sensor according to any one of Examples 1 to 32.

[0306] Example 34: The distal end has a durometer of 70 Shore A, and the sensor according to any one of Examples 1 to 33.

[0307] Example 35: The proximal end is made of silicone rubber, and the sensor according to any one of Examples 31 to 34.

[0308] Example 36: The proximal end has a durometer of 60 to 78 Shore A, and the sensor according to any one of Examples 31 to 35.

[0309] Example 37: The distal end has a coude shape, and the sensor according to any one of Examples 1 to 36.

[0310] Example 38: When the distal tip is positioned to be disposed within the bladder, the sensor according to Example 37 has an upward bend between 5° and 15°.

[0311] Example 39: The distal end is attached to the sensor flexible outer cover with an adhesive, and the sensor according to any one of Examples 1 to 39.

[0312] Example 40: The proximal end is attached to the sensor flexible outer cover with an adhesive, and the sensor according to any one of Examples 31 to 39.

[0313] Example 41: The flexible outer cover includes silicone rubber, and the sensor according to any one of Examples 1 to 40.

[0314] Example 42: The silicone rubber is extruded, and the sensor according to Example 41.

[0315] Example 43: The flexible outer cover is the sensor according to any one of Examples 1 to 42, having a durometer of 30 to 80 Shore A.

[0316] Example 44: The flexible outer cover is the sensor according to any one of Examples 1 to 43, having a wall thickness of 0.05” to 0.20”.

[0317] Example 45: The flexible outer cover is the sensor according to any one of Examples 1 to 44, further including a metal braided wire positioned on a flexible tube.

[0318] Example 46: The sensor according to Example 45, further including plastic or silicone rubber overmolded on the metal braided wire.

[0319] Example 47: The sensor according to Example 46, wherein the overmold is silicone rubber.

[0320] Example 48: The sensor according to any one of Examples 45 to 47, wherein the metal braided wire is made of stainless steel.

[0321] Example 49: The sensor according to any one of Examples 31 to 48, wherein the proximal end has a tip portion configured to engage a second proximal lumen of an insertion tool in which the sensor is positioned.

[0322] Example 50: The sensor according to Example 49, wherein the tip portion of the proximal end has a rectangular shape and is configured to be received in a rectangular inlet of a second proximal lumen of the insertion tool.

[0323] Example 51: The sensor according to any one of Examples 1 to 50, wherein the inside of the flexible outer cover is defined as a cavity or housing and contains a fluid that is a liquid.

[0324] Example 52: The sensor according to Example 51, wherein the housing contains the fluid and air.

[0325] Example 53: The sensor according to Example 51, wherein the housing contains the fluid.

[0326] Example 54: The sensor according to Example 51 or 52, wherein the fluid is silicone oil.

[0327] Example 55: The sensor according to any one of Examples 53 to 54, wherein the pressure inside the housing is greater than atmospheric pressure.

[0328] Example 56: The sensor according to any one of Examples 52 to 55, wherein the fluid is fluorosilicone oil.

[0329] Example 57: The sensor according to any one of Examples 1 to 56, wherein none of the parameter sensors is exposed to the environment outside the sensor housing.

[0330] Example 58: The sensor according to any one of Examples 1 to 57, further comprising a partition wall.

[0331] Example 59: The sensor according to Example 58, wherein the partition wall is positioned at the distal end of the sensor.

[0332] Example 60: The sensor according to Example 59, wherein the partition wall is formed as part of the distal end of the sensor.

[0333] Example 61: The sensor according to any one of Examples 58 to 60, wherein the partition wall is made of compression molded rubber or elastomer.

[0334] Example 62: The sensor according to any one of Examples 52 to 61, wherein the fluid is placed inside the sensor housing to partially fill the housing, the second end is then attached to a flexible outer cover, and the housing is further filled with fluid by pushing a syringe needle through the distal end and injecting additional fluid into the housing through the syringe.

[0335] Example 63: The sensor according to any one of Examples 52 to 62, wherein at least some of the air is removed from the sensor housing after the fluid is placed inside the housing.

[0336] Example 64: The sensor according to Example 63, wherein air is removed using a syringe together with the needle.

[0337] Example 65: The sensor according to Example 64, wherein the needle of the syringe is pushed through at the distal end to remove air.

[0338] Example 66: The sensor according to any one of Examples 62 - 65, wherein the housing volume is filled with about 90% fluid before attaching the second end.

[0339] Example 67: The sensor according to any one of Examples 53 - 66, wherein the pressure inside the housing is 1200 - 1400 hPa, or 1200 - 1300 hPa.

[0340] Example 68: A system comprising an insertion tool and any one of the sensors according to Examples 1 - 67 positioned therein.

[0341] Example 69: The system according to Example 68, wherein the insertion tool has a distal end, a proximal end, and a lumen configured to receive the sensor.

[0342] Example 70: The system according to Example 69, wherein the insertion tool comprises a handle at its proximal end.

[0343] Example 71: The system according to Example 68 or 70, wherein the lumen has a first distal section having a first cross - sectional area and a second proximal section having a second cross - sectional area smaller than the first cross - sectional area.

[0344] Example 72: The system according to Example 71, wherein the second cross - sectional area is too small to pass the proximal end of the sensor therethrough.

[0345] Example 73: The system according to Example 71 or 72, wherein the first cross - sectional area is circular.

[0346] Example 74: The system according to any one of Examples 71 - 73, wherein the second cross - sectional area is rectangular or rectangular with rounded edges.

[0347] Example 75: The system according to any one of Examples 71-74, wherein the proximal end of the sensor has a tip configured to be received in a second proximal section of the lumen of the insertion tool.

[0348] Example 76: The system according to any one of Examples 69-75, wherein the proximal end of the insertion tool comprises a keyway for receiving a key on the distal end of the sensor.

[0349] Example 77: The system according to any one of Examples 68-76, further comprising a push rod configured to push the sensor out of the insertion tool.

[0350] Example 78: An insertion tool having a lumen configured to at least partially receive any of the sensors described in Examples 1-67.

[0351] Example 79: The insertion tool according to Example 78, having a distal end, a proximal end, and a lumen configured to receive a sensor.

[0352] Example 80: The insertion tool according to Example 78 or 79, having a handle at its proximal end.

[0353] Example 81: The insertion tool according to any one of Examples 78-80, wherein the lumen has a first distal section having a first cross-sectional area and a second proximal section having a second cross-sectional area smaller than the first cross-sectional area.

[0354] Example 82: The insertion tool according to Example 81, wherein the second cross-sectional area is too small to pass the proximal end of the sensor therethrough.

[0355] Example 83: The insertion tool according to Example 81 or 82, wherein the first cross-sectional area is circular.

[0356] Example 84: The insertion tool according to any one of Examples 81-83, wherein the second cross-sectional area is rectangular or rectangular with rounded edges.

[0357] Example 85: An insertion tool according to any one of Examples 81-84, wherein a proximal end of the sensor has a tip configured to be received in a second proximal section of the lumen of the insertion tool.

[0358] Example 86: An insertion tool according to any one of Examples 79-85, wherein a distal end of the insertion tool comprises a key groove configured to receive a key on the distal end of the sensor.

[0359] Further non-limiting examples of the present disclosure are as follows.

[0360] Example 1: A casing for holding a urinary sensor kit before deployment, the kit having a top, a bottom, and a foam at the bottom, the foam being configured to hold a sensor having a string at its proximal end, and having a first indentation configured such that the proximal end of the sensor and the string are positioned within the lumen of the insertion tool; a second indentation connected to the first indentation and configured to hold the insertion tool; a third indentation connected to the second indentation and configured as a handle of the insertion tool; and a fourth indentation not connected to the first, second, or third indentation and configured to hold a push rod.

[0361] Example 2: The casing according to Example 1, further comprising a sensor, an insertion tool, a handle of the insertion tool, and a push rod.

[0362] Example 3: The casing according to Example 1 or Example 2, wherein the first indentation is curved and configured such that the sensor is in its first curved position when in the first indentation.

[0363] Example 4: The casing according to any one of Examples 1-3, wherein the foam is made of a molded material.

[0364] Example 5: The casing according to any one of Examples 1 to 4, which is harder than the foam and has an outer shell made of metal or plastic.

[0365] The present invention has been described above with reference to a number of exemplary embodiments and examples. It should be understood that the specific embodiments shown and described herein are illustrative of the invention and its best mode and are not intended in any way to limit the scope of the invention as set forth in the claims. The features of the various embodiments may exist alone or may be combined in any combination. Further, unless otherwise specified, the various illustrated steps of the method may be performed sequentially or simultaneously and need not be performed in the order illustrated. It will be understood that changes or modifications may be made to the exemplary embodiments without departing from the scope of the invention. These and other changes or modifications are intended to be included within the scope of the invention as expressed in the appended claims.

Description of the reference numerals

[0366] S screen 1, 2, and 3 sensors 10 sensors 12 proximal end 14 distal end 16 sensors 16 tubular body portion 18 string 19 tube wall, or oversheath 20 internal electronics 21 flexible circuit board 22 spine 22 shape memory spring 24 proximal end cap 24A opening 26 distal end cap 28 cavity 30 system 50 sensors 52 proximal end 52A opening 54 Distal end 56 Body part 56 Tube 58 Removal string 59 Outer wall (or tube or outer sheath) 70 Electronic device 71 Flexible circuit board 72 Spine 72A End part 74 Proximal end cap 74A Narrow section 76 Distal end cap 76A Narrow section 78 Cavity 80 Spacer 82 Bluetooth wireless antenna 83 Silicone adhesive 84 LED 86 Microprocessor 88 Memory 90 Button 92 Pressure sensor 94 Power supply 94 Battery 95 and 97 Positive and negative connection parts 300 Partition wall 500 Insertion tool 503 Handle 504 Stem 504A Inner plastic part 504B Braided wire 508 Visual indication 510 Inner cavity 510A Large-diameter section 510B Narrow-diameter section 512 Drain hole 514 D-lock 516 Tip 516 Distal end (or sheath tip) 518 Sheath tip insertion part 530 Push rod 532 Stem 532 Drain hole 534 Inner cavity 536 Tip 538 Handle 540 Drain hole 600 Urine flow measurement device 600 Urine flow meter 602 Main body part 604 Top 608 Off / On indicator 610 Depression 700 Packaging 1000 Computer system 1002 Processor 1004 Memory 1006 Database 1008 Sensor 1010 Patient 1012 Urine flow meter 1014 Device 1016 Server 1018 Clinician device 1020 Patient device

Claims

1. A tool for inserting a sensor into the bladder, comprising: an over-sheath having a first lumen; and a push rod used for deploying the sensor.

2. The tool according to claim 1, further comprising a handle at a first end of the over-sheath.

3. The tool according to claim 1 or 2, further comprising a sensor positioned within the first lumen of the over-sheath.

4. The tool according to any one of claims 1 to 3, wherein the over-sheath is made of TPU.

5. The tool according to any one of claims 1 to 4, wherein the spacer has a predetermined length.

6. The tool according to any one of claims 1 to 5, wherein the push rod comprises a handle.

7. The tool according to any one of claims 1 to 6, wherein an outer surface of the over-sheath includes depth markings configured to indicate proper positioning of the tool for inserting the sensor into the bladder.

8. The tool according to any one of claims 1 to 7, wherein the over-sheath further comprises a second lumen configured to allow urine to flow therethrough after the tool reaches the bladder.

9. The tool according to claim 8, wherein the second lumen is configured to prevent the second lumen from being blocked by a lubricant while positioning the tool within the bladder, and is configured to be removed to allow urine to flow through the second lumen when the user is convinced that the tool is within the bladder.

10. The tool according to any one of claims 1 to 9, wherein the push rod comprises a channel configured to allow a string on the sensor to be positioned within the channel.

11. A sensor configured to detect a state inside the bladder, comprising: a flexible outer cover having a lumen; a flexible circuit inside the flexible outer cover; a power source inside the flexible outer cover and communicating with the flexible circuit; One or more parameter sensors that are inside the flexible outer cover and communicate with the flexible circuit, wherein the one or more parameter sensors are configured to measure at least one of: (i) the volume of liquid in the bladder, (ii) the rate of liquid discharge from the bladder, (iii) the pressure in the bladder, (iv) the volume of the bladder, (v) abnormalities in the bladder, and (vi) the chemical properties of urine in the bladder. The sensor is configured to move from a first position where it is held within the bladder and configured not to be accidentally discharged, to a second position where the sensor is configured to be inserted into the bladder through the urethra. **Claim 12** The sensor according to claim 11, wherein the flexible outer cover is made of silicone. **Claim 13** The sensor according to claim 11 or 12, wherein at least one of the one or more parameter sensors is on the flexible circuit. **Claim 14** The sensor according to any one of claims 11 to 13, wherein the power source is a battery. **Claim 15** The sensor according to any one of claims 11 to 14, wherein the power source is mechanically coupled to the electronic circuit. **Claim 16** Including a distal end to which a string is attached, the string being configured to remain outside the body when the sensor is positioned within the bladder, and the string being pullable by a user or clinician to remove the sensor from the bladder. The sensor according to any one of claims 11 to 15. **Claim 17** The sensor according to any one of claims 11 to 16, having a straight distal end. **Claim 18** The sensor according to any one of claims 11 to 16, having a curved distal end. **Claim 19** The sensor according to any one of claims 11 to 18, pre-filled with a non-compressible fluid and configured to enable the fluid to convert and transmit force to the electronic sensor. **Claim 20** The sensor according to any one of claims 11 to 19, further comprising an antenna. **Claim 21** The sensor according to any one of claims 11 to 20, configured to transmit by wireless communication. **Claim 22** The sensor according to any one of claims 1 to 21, configured to receive by wireless communication. **Claim 23** The sensor according to any one of claims 11 to 22, further comprising a processor and a memory configured to store measurement parameters.

24. The sensor according to any one of claims 11 to 23, further comprising software configured to analyze measurement parameters.

25. The sensor according to any one of claims 11 to 24, further comprising a shape memory spring positioned inside the flexible outer cover.

26. The sensor according to claim 25, wherein the shape memory spring is made of metal or plastic.

27. The sensor according to claim 26, wherein the shape memory spring is made of steel.

28. The sensor according to any one of claims 11 to 27, wherein the sensor is circular or curved when in the first position and straight when in the second position.

29. The sensor according to any one of claims 11 to 28, comprising a semi-rigid end cap on the distal end of the sensor and a semi-rigid end cap on the proximal end of the sensor.

30. The sensor according to claim 29, wherein each end cap is made of steel, plastic, or other material.

31. The sensor according to any one of claims 24 to 26, wherein the shape memory spring is flat and has a rectangular cross-section.

32. The sensor according to claim 25 or 26 or 31, further comprising a distal end and a semi-rigid end cap on the distal end, a semi-rigid end cap on the proximal end, and the shape memory spring fitting with each of the end caps.

33. The sensor according to claim 25 or 26 or 31 or 32, wherein the shape memory spring is coated with an electrically insulating material.

34. The sensor according to any one of claims 25 or 26 or 31 to 33, wherein the shape memory spring is coated with a material resistant to lubricating oil.

35. The sensor according to any one of claims 25 or 26 or 31 to 34, wherein the shape memory spring is coated with an adhesive.

36. An external computing device having software operable on the processor, the processor configured by software to view, analyze, store, and take notes of findings for one or more bladder filling and voiding cycles, the sensor according to any one of claims 11 to 35.

37. The sensor according to claim 36, wherein the software configures the processor to overlay two or more urine filling / voiding cycles and assist in identifying trends.

38. The sensor according to claim 36 or 37, wherein the processor uses an AI / ML algorithm to detect trends such as decreased detrusor muscle activity, detrusor overactivity, urinary leakage incontinence, and / or other aspects of bladder filling / storage / voiding dysfunction.

39. Compare the data obtained by the one or more parameter sensors with the aggregated data in the data repository, and the software further configures the processor to (a) clinic proficiency, (b) clinician proficiency, (c) perform training faithfully, (d) (i) a specific geographical area, (ii) ACX, (iii) ethnicity, (iv) age, or (v) determine one or more of the prevalence of specific urological diseases in lifestyle, the sensor according to any one of claims 36 to 38.

40. To detect the volume and level of fluid in the bladder, configured to utilize one or more of (a) one or more shock waves or pressure pulses, (b) one or more light waves, (c) one or more lasers, (d) one or more acoustic signals, (e) ultrasound, (f) conductivity, and (g) pressure, the sensor according to any one of claims 11 to 39.

41. A tool for inserting a sensor into the bladder, An over-sheath having a first lumen, A push rod positioned within the first lumen, A tool comprising a removable spacer positioned between the push rod and the over-sheath.

42. The tool according to claim 41, further comprising a handle at a first end of the over-sheath.

43. The tool according to claim 42, wherein the spacer is not positioned on the handle.

44. The tool according to any one of claims 41 to 43, further comprising a sensor positioned within the first lumen of the oversheath.

45. The tool according to any one of claims 41 to 44, wherein the oversheath is made of TPU.

46. The tool according to any one of claims 41 to 45, wherein the spacer has a predetermined length.

47. The tool according to any one of claims 41 to 46, wherein the push rod comprises a handle.

48. The tool according to any one of claims 41 to 47, wherein the removable spacer is positioned between the oversheath handle and the push rod handle.

49. The tool according to any one of claims 41 to 48, wherein an outer surface of the oversheath includes depth markings configured to indicate proper positioning of the tool for inserting the sensor into the bladder.

50. The tool according to any one of claims 41 to 49, wherein the oversheath further comprises a second lumen configured to allow urine to flow therethrough after the tool reaches the bladder.

51. The tool according to claim 50, wherein the second lumen is configured to prevent the second lumen from being blocked by a lubricant while positioning the tool within the bladder and is configured to be removed to allow urine to flow through the second lumen when the user is convinced that the tool is within the bladder. The tool has a removable structure.

52. The tool according to any one of claims 41 to 51, wherein the push rod comprises a channel configured such that a string on the sensor can be positioned within the channel.

53. The tool according to any one of claims 41 to 52, wherein the tool is configured such that the push rod cannot advance beyond the removable spacer when the removable spacer is positioned on the oversheath.

54. The tool according to any one of claims 41 to 53, wherein the tool is configured such that the push rod can extrude the sensor from the oversheath only after the spacer is removed.

55. A sensor configured to detect the condition inside the bladder, a flexible outer cover having a lumen, a flexible circuit inside the flexible outer cover, a power source inside the flexible outer cover and communicating with the flexible circuit, one or more parameter sensors inside the flexible outer cover and communicating with the flexible circuit, the one or more parameter sensors being configured to measure at least one of (i) the volume of liquid in the bladder, (ii) the liquid discharge rate from the bladder, (iii) the pressure in the bladder, (iv) the volume of the bladder, (v) abnormalities in the bladder, and (vi) the chemical properties of urine in the bladder, and one or more parameter sensors, the sensor is configured to move from a first position where it is held in the bladder and configured not to be accidentally discharged, to a second position where the sensor is configured to be inserted into the bladder through the urethra.

56. The sensor according to claim 55, wherein the flexible outer cover is made of silicone.

57. The sensor according to claim 55 or 56, wherein at least one of the one or more parameter sensors is on the flexible circuit.

58. The sensor according to any one of claims 55 to 57, wherein the power source is a battery.

59. The sensor according to any one of claims 55 to 58, wherein the power source is mechanically coupled to the electronic circuit.

60. including a distal end to which a string is attached, the string being configured to remain outside the body when the sensor is positioned in the bladder, and the string being pullable by a user or clinician to remove the sensor from the bladder. The sensor according to any one of claims 55 to 59.

61. The sensor according to any one of claims 55 to 60, having a straight distal end.

62. The sensor according to any one of claims 55 to 60, having a Coudé-shaped distal end.

63. The sensor according to any one of claims 55 to 62, pre-filled with a non-compressible fluid and configured to allow the fluid to convert and transmit force to the electronic sensor.

64. The sensor according to any one of claims 55 to 63, further comprising an antenna.

65. The sensor according to any one of claims 55 to 64, configured to transmit by wireless communication.

66. The sensor according to any one of claims 55 to 65, configured to receive by wireless communication.

67. The sensor according to any one of claims 55 to 66, further comprising a processor and a memory configured to store measurement parameters.

68. The sensor according to any one of claims 55 to 67, further comprising software configured to analyze measurement parameters.

69. The sensor according to any one of claims 55 to 68, further comprising a shape memory spring positioned inside the flexible outer cover.

70. The sensor according to claim 69, wherein the shape memory spring is made of metal or plastic.

71. The sensor according to claim 69 or 70, wherein the shape memory spring is made of steel.

72. The sensor according to any one of claims 55 to 71, which is circular or curved when in the first position and straight when in the second position.

73. The sensor according to any one of claims 55 to 72, comprising a semi-rigid end cap on the distal end of the sensor and a semi-rigid end cap on the proximal end of the sensor.

74. The sensor according to claim 73, wherein each end cap is made of steel, plastic, or other material.

75. The sensor according to any one of claims 62 to 71, wherein the shape memory spring is flat.

76. The sensor according to any one of claims 55 to 75, further comprising a semi-rigid end cap on the distal end and a semi-rigid end cap on the proximal end, and the shape memory spring fits with each of the end caps.

77. The sensor according to any one of claims 69 to 76, wherein the shape memory spring is coated with an electrically insulating material.

78. The sensor according to any one of claims 69 to 77, wherein the shape memory spring is coated with a material resistant to lubricating oil.

79. The sensor according to any one of claims 69 to 78, wherein the shape memory spring is coated with an adhesive.

80. An external computing device having software operable on a processor, the processor being configured by the software to view, analyze, store, and take notes of findings for one or more bladder filling and voiding cycles, the sensor according to any one of claims 55 to 79.

81. The system of claim 80, wherein the software configures the processor to overlay two or more urine filling / voiding cycles and assist in identifying trends.

82. The system of claim 80 or 81, wherein the processor uses AI / ML, statistical, and / or mathematical algorithms to detect trends such as reduced detrusor muscle activity, detrusor overactivity, urinary leakage incontinence, and / or other aspects of bladder filling / storage / voiding dysfunction.

83. Compare the data obtained by the one or more parameter sensors with aggregated data in a data repository, and the software further configures the processor to (a) clinic proficiency, (b) clinician proficiency, (c) perform training faithfully, (d) (i) a specific geographic region, (ii) ACX, (iii) ethnicity, (iv) age, or (v) determine one or more of the prevalence of specific urological diseases in lifestyle, the system according to any one of claims 55 to 82.

84. The sensor according to any one of claims 55 to 83, configured to utilize one or more of (a) one or more shock waves or pressure pulses, (b) one or more light waves, (c) one or more lasers, (d) one or more acoustic signals, (e) ultrasound, (f) conductivity, and (g) pressure to detect the volume and level of fluid within the bladder.

85. A sensor configured to detect the internal state of the bladder, A flexible outer cover having a lumen, a distal end, and a proximal end, the distal end having a key configured to be received within a key groove formed in the distal end of the insertion tool, the flexible outer cover; A flexible circuit inside the flexible outer cover; A power source inside the flexible outer cover and in communication with the flexible circuit. One or more parameter sensors that are inside the flexible outer cover and communicate with the flexible circuit, wherein the one or more parameter sensors are configured to measure at least one of: (i) the volume of liquid in the bladder, (ii) the rate of liquid discharge from the bladder, (iii) the pressure in the bladder, (iv) the volume of the bladder, (v) abnormalities in the bladder, and (vi) the chemical properties of urine in the bladder. A sensor configured to move from a first position, where the sensor is held within the bladder and configured not to be accidentally discharged, to a second position, where the sensor is configured to be inserted into the bladder through the urethra.

86. The sensor according to claim 85, wherein the flexible outer cover is made of silicone.

87. The sensor according to claim 85 or 86, wherein at least one of the one or more parameter sensors is on the flexible circuit.

88. The sensor according to any one of claims 85 to 87, wherein the power source is a battery.

89. The sensor according to any one of claims 85 to 88, wherein the power source is mechanically coupled to the electronic circuit.

90. Including a distal end to which a string is attached, the string being configured to remain outside the body when the sensor is positioned within the bladder, and the string being pullable by a user or clinician to remove the sensor from the bladder. The sensor according to any one of claims 85 to 89.

91. The sensor according to any one of claims 85 to 90, having a straight distal end.

92. The sensor according to any one of claims 85 to 90, having a distal end in a Coudé shape.

93. The sensor according to any one of claims 85 to 92, pre-filled with a non-compressible fluid and configured to enable the fluid to transmit a force to the electronic sensor.

94. The sensor according to any one of claims 85 to 93, further comprising an antenna.

95. The sensor according to any one of claims 85 to 94, configured to transmit by wireless communication.

96. The sensor according to any one of claims 85 to 95, configured to receive by wireless communication.

97. The sensor according to any one of claims 85 to 96, further comprising a processor and a memory configured to store measurement parameters. **Claim 98** The sensor according to any one of claims 85 to 97, further comprising software configured to analyze measurement parameters. **Claim 99** The sensor according to any one of claims 85 to 98, further comprising a shape memory spring positioned inside the flexible outer cover. **Claim 100** The sensor according to claim 99, wherein the shape memory spring is made of metal or plastic. **Claim 101** The sensor according to claim 99 or 100, wherein the shape memory spring is made of metal or steel. **Claim 102** The sensor according to any one of claims 85 to 101, wherein the sensor is circular or curved when in the first position and straight when in the second position. **Claim 103** The sensor according to any one of claims 85 to 102, comprising a semi-rigid end cap on the distal end of the sensor and a semi-rigid end cap on the proximal end of the sensor. **Claim 104** The sensor according to claim 103, wherein each end cap is made of steel, plastic, or other material. **Claim 105** The sensor according to any one of claims 99 to 104, wherein the shape memory spring is flat. **Claim 106** The sensor according to any one of claims 99 to 105, further comprising a distal end and a semi-rigid end cap on the distal end, a semi-rigid end cap on the proximal end, and the shape memory spring fitting with each of the end caps. **Claim 107** The sensor according to any one of claims 99 to 106, wherein the shape memory spring is coated with an electrically insulating material. **Claim 108** The sensor according to any one of claims 99 to 107, wherein the shape memory spring is coated with a material resistant to lubricating oil. **Claim 109** The sensor according to any one of claims 99 to 108, wherein the shape memory spring is coated with an adhesive. **Claim 110** The sensor is configured to communicate with an external computing device having software operable on a processor, the processor being configured by software to view, analyze, store, and / or take notes of findings regarding one or more bladder filling and voiding cycles, the sensor according to any one of claims 85 to 109.

111. The sensor according to claim 110, wherein the software configures the processor to overlay two or more urine filling / voiding cycles and assist in identifying trends.

112. The sensor according to claim 110 or 111, wherein the processor uses an AI / ML algorithm to detect trends such as decreased detrusor muscle activity, detrusor overactivity, urinary incontinence, and / or other aspects of bladder filling / storage / voiding dysfunction.

113. The processor is further configured to compare data obtained by the sensor with aggregated data in a data repository, and the software further configures the processor to (a) clinic proficiency, (b) clinician proficiency, (c) perform training faithfully, (d) (i) a specific geographical area, (ii) ACX, (iii) ethnicity, (iv) age, or (v) determine one or more of the prevalence of specific urological diseases in lifestyle, the system according to any one of claims 110 to 112.

114. The sensor according to any one of claims 85 to 113, configured to utilize one or more of (a) one or more shock waves or pressure pulses, (b) one or more light waves, (c) one or more lasers, (d) one or more acoustic signals, (e) ultrasound, (f) conductivity, and (g) pressure to detect the volume and level of fluid in the bladder.

115. The sensor according to any one of claims 85 to 113, further comprising a proximal end configured to be connected to a removal string.

116. The sensor according to claim 115, further comprising a removal string attached to the proximal end.

117. The sensor according to any one of claims 85 to 116, wherein the distal end is made of silicone rubber.

118. The distal end is the sensor according to any one of claims 85 to 117 having a durometer of 70 Shore A.

119. The proximal end is the sensor according to any one of claims 85 to 118 made of silicone rubber.

120. The proximal end is the sensor according to any one of claims 85 to 119 having a durometer of 60 to 78 Shore A.

121. The distal end is the sensor according to any one of claims 85 to 120 having a Coudé shape.

122. The distal tip has an upward bend between 5° and 15° when positioned to be deployed within the bladder, the sensor according to claims 85 to 120.

123. The distal end is the sensor according to any one of claims 85 to 122 attached to the sensor flexible outer cover with an adhesive.

124. The proximal end is the sensor according to any one of claims 85 to 123 attached to the sensor flexible outer cover with an adhesive.

125. The flexible outer cover is the sensor according to any one of claims 85 to 124 including silicone rubber.

126. The silicone rubber is the sensor according to claim 125 extruded.

127. The flexible outer cover is the sensor according to any one of claims 85 to 126 having a durometer of 30 to 80 Shore A.

128. The flexible outer cover is the sensor according to any one of claims 85 to 127 having a wall thickness of 0.05” to 0.20”.

129. The flexible outer cover is the sensor according to any one of claims 85 to 128 further including a metal braided wire positioned over a flexible tube.

130. The sensor according to claim 129 further including plastic or silicone rubber overmolded on the metal braided wire.

131. The overmold is the sensor according to claim 130 silicone rubber.

132. The metal braided wire is the sensor according to any one of claims 129 to 131 made of stainless steel.

133. The proximal end has a tip, the tip being configured to engage a second proximal lumen of an insertion tool in which the sensor is positioned, the sensor according to any one of claims 85 to 132.

134. The tip of the proximal end has a rectangular shape and is configured to be received in the rectangular inlet of the second proximal lumen of the insertion tool. The sensor according to claim 133.

135. The inside of the flexible outer cover is defined as a cavity or housing and contains a fluid that is a liquid. The sensor according to any one of claims 85 to 134.

136. The housing contains a fluid and air. The sensor according to claim 135.

137. The housing contains a fluid. The sensor according to claim 135.

138. The fluid is silicone oil. The sensor according to claim 136 or 137.

139. The pressure inside the housing is greater than atmospheric pressure. The sensor according to any one of claims 85 to 138.

140. The fluid is fluorosilicone oil. The sensor according to any one of claims 136 to 139.

141. None of the parameter sensors are exposed to the environment outside the sensor housing. The sensor according to any one of claims 85 to 140.

142. The sensor according to any one of claims 85 to 141, further comprising a partition wall.

143. The partition wall is positioned at the distal end of the sensor. The sensor according to claim 142.

144. The partition wall is formed as part of the distal end of the sensor. The sensor according to claim 143.

145. The partition wall is made of compression molded rubber or elastomer. The sensor according to any one of claims 142 to 144.

146. The fluid is placed inside the sensor housing to partially fill the housing, and the second end is then attached to the flexible outer cover. The housing is further filled with fluid by pushing a syringe needle through the distal end and injecting additional fluid into the housing through the syringe. The sensor according to any one of claims 135 to 145.

147. At least some of the air is removed from the sensor housing after the fluid is placed inside the housing. The sensor according to claim 146.

148. The air is removed using a syringe with a needle. The sensor according to claim 147.

149. The needle of the syringe is the sensor according to claim 148, which is pushed through the distal end to remove the air.

150. The sensor according to any one of claims 135 to 149, wherein the housing volume is filled with about 90% of fluid before attaching the second end.

151. The sensor according to any one of claims 135 to 150, wherein the pressure inside the housing is 1200 - 1400 hPa, or 1200 - 1300 hPa.

152. A system comprising an insertion tool and any one of the sensors according to claims 85 to 151 positioned therein.

153. The system according to claim 152, wherein the insertion tool has a distal end, a proximal end, and a lumen configured to receive the sensor.

154. The system according to claim 152, wherein the insertion tool has a handle at its proximal end.

155. The system according to claim 153 or 154, wherein the lumen has a first distal section having a first cross-sectional area and a second proximal section having a second cross-sectional area smaller than the first cross-sectional area.

156. The system according to claim 155, wherein the second cross-sectional area is too small to pass the proximal end of the sensor therethrough.

157. The system according to claim 155 or 156, wherein the first cross-sectional area is circular.

158. The system according to any one of claims 155 to 157, wherein the second cross-sectional area is rectangular or rectangular with rounded edges.

159. The system according to any one of claims 153 to 158, wherein the proximal end of the sensor has a tip configured to be received in the second proximal section of the lumen of the insertion tool.

160. The system according to any one of claims 153 to 159, wherein the proximal end of the insertion tool has a key groove for receiving a key on the distal end of the sensor.

161. The system according to any one of claims 152 to 160, further comprising a push rod configured to push the sensor out of the insertion tool.

162. An insertion tool having a lumen configured to at least partially receive any one of the sensors according to claims 85 to 151.

163. The insertion tool according to claim 162, having a distal end, a proximal end, and a lumen configured to receive said sensor.

164. The insertion tool according to claim 162 or 163, comprising a handle at its proximal end.

165. The insertion tool according to any one of claims 162 to 164, wherein said lumen has a first distal section having a first cross-sectional area and a second proximal section having a second cross-sectional area smaller than said first cross-sectional area.

166. The insertion tool according to claim 165, wherein said second cross-sectional area is too small to pass the proximal end of said sensor therethrough.

167. The insertion tool according to claim 165 or 166, wherein said first cross-sectional area is circular.

168. The insertion tool according to any one of claims 165 to 167, wherein said second cross-sectional area is rectangular or rectangular with rounded edges.

169. The insertion tool according to any one of claims 163 to 168, wherein the proximal end of said sensor has a tip configured to be received in said second proximal section of the lumen of said insertion tool.

170. The insertion tool according to any one of claims 163 to 169, wherein the distal end of said insertion tool comprises a keyway configured to receive a key on the distal end of said sensor.

171. A computer system configured to analyze urinary data, comprising: (a) a processor; (b) a memory communicating with said processor; (c) one or more databases communicating with said processor, wherein said processor is configured to store data in said one or more databases and operate one or more software applications resident on said processor or on a server; one or more databases; (d) a urine flow meter used to measure the amount of excreted urine and changes in said amount; and (e) a sensor positioned within a patient's body, wherein said computer system integrates and synchronizes data from said sensor, urine flow meter, and one or more databases.

172. The computer system according to claim 171, further comprising a server and one or more electronic devices communicating with the server, wherein the devices synchronize with the server using any suitable wired or wireless connection.

173. The computer system according to claim 171, wherein the processor is on a mobile phone, a tablet, or a computer.

174. The computer system according to claim 172, wherein the one or more devices communicate with the processor.

175. The computer system according to claim 171, wherein the processor is further configured to perform data processing technique visualization to enable a clinician to view, analyze, and identify memo findings for any one urine filling / voiding cycle.

176. The computer system according to claim 175, wherein the processor is further configured to standardize reports and reduce operator variability by storing a repository in the memory or the one or more databases, and the processor identifies characteristics of data presented to assist a clinician in performing waveform diagnosis.

177. The computer system according to claim 176, wherein the waveform is wireless uroflowmetry data from a human or animal patient without using a catheter.

178. The computer system according to claim 171, wherein the processor is further configured to overlay two or more urine filling / voiding cycles to identify trends.

179. The computer system according to claim 178, wherein the overlay further includes patient analysis analyzing average urine volume per day, number of urine leakage times per day, and number of nocturia events.

180. The computer system according to claim 171, comprising artificial intelligence / machine learning (AI / ML), statistics, and / or mathematical algorithms to emphasize trends including detrusor underactivity (DU), detrusor overactivity (DO), detrusor / sphincter dyssynergia (DSD), urine leakage, urinary incontinence, and bladder filling / storage / voiding dysfunction.

181. The computer system according to claim 171, wherein the processor is further configured to compare two or more urine filling / voiding cycles to determine similarities and differences.

182. The computer system according to claim 181, wherein the processor generates a scoring mechanism for quantifying patient variability over a plurality of micturition cycles.

183. The computer system according to claim 171, wherein the processor is further configured to analyze a urine filling / voiding cycle from a patient that can be compared to the memory or the one or more databases to classify and identify whether any form of bladder dysfunction is present.

184. The computer system according to claim 171, wherein the processor is configured to assist in the diagnosis of the patient and provide information as a proposal to the clinician to save time for the clinician.

185. The computer system according to claim 184, wherein the metrics are standardized by utilizing reports from other patients potentially including patients from other regions or other countries.

186. The computer system according to claim 171, further comprising an intra-patient comparison function operated by the processor, wherein two or more urine filling / voiding cycles from the same patient are analyzed to determine similarities and differences in the urine filling / voiding cycles.

187. The computer system according to claim 171, wherein multiple cycles are utilized to confirm or refute a potential diagnosis through long-term monitoring and repeated measurements.

188. The computer system according to claim 187, further including the ability to do this in a single uroflowmetry evaluation or from the same patient, but at different times or periods of uroflowmetry evaluation.

189. The computer system according to claim 171, wherein the processor analyzes the data from the clinic or clinician, compares the analysis with the aggregated data in the data repository, and provides an intra-clinic or intra-clinician comparison function to determine clinic proficiency, clinician proficiency, faithful performance of training, and other metrics.

190. The computer system according to claim 171, wherein the processor is further configured to identify trends through analysis and determine the prevalence of specific urological diseases within a specific geographical region or the type of individuals by age, ethnicity, or lifestyle.

191. The computer system of claim 171, wherein the processor is further configured to overlay data on health records aggregated through electronic health record (EHR) integration and identify trends and risk factors. **Claim 192** The computer system of claim 171, wherein the processor is further configured to generate a report through incorporation of data from (a) data from a patient's medical records through EHR integration and (b) data from an event detection algorithm from data collected during a urodynamic examination. **Claim 193** The computer system of claim 171, wherein the processor is further configured to pre-fill a memo and evaluation plan for a clinician using templates and advanced signal processing or data science (AI / ML) techniques, or using a generative AI function (such as ChatGPT). **Claim 194** The computer system of claim 171, incorporating a patient's medical history stored by a mentor through natural language processing (NLP) information and including natural language processing (NLP) information. **Claim 195** A method of filling a sensor positioned within the bladder of a human or animal, the sensor comprising (a) an outer wall made of silicone elastomer or rubber defining a cavity, (b) electronics within the cavity, (c) a proximal end cap on the proximal end of the outer wall, and (d) a distal end cap on the distal end of the outer wall, the method comprising the step of filling the cavity with silicone oil. **Claim 196** The method of claim 195, wherein the pressure within the cavity is higher than atmospheric pressure. **Claim 197** The method of claim 196, wherein the pressure within the cavity is maintained higher than atmospheric pressure for up to one year. **Claim 198** The method of claim 196, wherein the pressure within the cavity is maintained higher than atmospheric pressure for up to 1.5 years. **Claim 199** The method of claim 196, wherein the pressure is maintained higher than atmospheric pressure for up to two years. **Claim 200** The method according to any one of claims 195 to 199, wherein there is no air within the cavity. **Claim 201** The method according to any one of claims 195 to 199, wherein there is some air within the cavity. **Claim 202** The method according to any one of claims 195 to 201, wherein the oil is fluorosilicone oil.

203. The method according to any one of claims 195 to 200 or 202, wherein the cavity is filled with silicone oil in (a) a first step in which the cavity is partially filled, and (b) a second step in which the cavity is completely filled.

204. The method according to any one of claims 195 to 205, wherein the volume of the silicone oil inside the cavity is larger than the volume of the cavity without silicone oil.

205. The method according to any one of claims 195 to 204, wherein the pressure inside the cavity is between 1250 and 1400 hPa.

206. The method according to any one of claims 195 to 205, further comprising: (a) introducing silicone oil into the cavity through the open end of the sensor; (b) attaching an end cap to the open end to seal it; and (c) passing a syringe through the end cap and using the syringe to inject further silicone oil into the cavity.

207. The method according to claim 206, wherein the end cap is attached to the open end with an adhesive.

208. The method according to claim 206 or 207, wherein the open end is the distal end and the end cap is the distal end cap.

209. The method according to any one of claims 195 to 208, further comprising removing excess air by passing a syringe through the proximal end cap or the distal end cap.

210. The method according to any one of claims 195 to 209, wherein the distal end cap or the proximal end cap further comprises a partition wall.

211. The method according to any one of claims 205 to 210, wherein the open end is sealed using a partition wall.

212. The method according to claim 210 or 211, wherein the partition wall is integrated with a sensor spacer.

213. The method according to claim 212, wherein the sensor spacer covers the end of the spine of the sensor.

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