Stress urinary incontinence treatment system and methods

Abstract

A system (100) for treating stress urinary incontinence in a patient includes a cystoscope (102) including a probe assembly (104) with a shaft (110) having a tip, an optical element (112) for capturing images, a display (118) or optical viewer for presenting the images; a rotatable sheath (400) with a shaft and at least one lumen configured to receive the cystoscope shaft, the sheath being rotatable about the cystoscope shaft: and a treatment needle (500) insertable through the sheath, the needle configured to inject a treatment agent into tissue, wherein the treatment agent comprises a non-animal stabilized hyaluronic acid.

Description

STRESS URINARY INCONTINENCE TREATMENT SYSTEM AND METHODSCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) and 37 C.F.R. § 1.78 to provisional application no. 63 / 710, 193 filed on October 22, 2024, titled “Urinary Incontinence Treatment System and Methods” and to provisional application no. 63 / 794,627 filed on April 25, 2025, titled “Urinary Incontinence Treatment System and Methods” all of which are hereby incorporated by reference herein in their entireties.BACKGROUND

[0002] Stress urinary incontinence (SUI) is a condition in which a person cannot control the voiding of the bladder and subsequent release of urine. SUI may be caused by a variety' of factors such as obesity, age, smoking, hormonal changes, certain physical activities, and childbirth. Current treatments include lifestyle modifications (e.g., weight loss, smoking cessation), medications, and invasive surgical procedures. Improved treatments are needed.BRIEF SUMMARY

[0003] Non-limiting embodiments of a system for treating stress urinary incontinence in a patient may include a cystoscope including a probe assembly with a shaft having a tip, an optical element for capturing images, and a display or optical viewer for presenting the images. A rotatable sheath with a shaft and at least one lumen configured to receive the cystoscope shaft may also be included, the sheath being rotatable about the cystoscope shaft. The system may also include a treatment needle insertable through the sheath, the needle configured to inject a treatment agent into tissue. The treatment agent may comprise a bulking agent, such as a non-animal stabilized hyaluronic acid.

[0004] In one embodiment, a method for treating stress urinary incontinence in a patient, includes: inserting a probe assembly into a urethra of a patient, the probe assembly including a shaft portion and a sheath disposed on the shaft portion and rotatable with respect to the shaft portion; inserting a treatment needle into a needle port of the sheath; extending at least a portion of the probe assembly into the bladder to a desired location without contacting the bladder wall; rotating the sheath to position the treatment needle relative to the bladder neck at a predetermined angular position; extending the treatment needle into mucosal tissue of the bladder neck at an injection site, the injection site being at the predetermined angular position; injecting a treatment agent into the mucosa to form a cushion at the injection site; withdrawing the treatment needle; and withdrawing the probe assembly from the urethra.

[0005] Optionally in some embodiments, the method further includes rotating and repositioning the sheath for subsequent injections at additional injections sites, each at a different predetermined angular position.

[0006] Optionally in some embodiments, the number of additional injection sites ranges from about two to about eight, varying based on the severity of stress urinary' incontinence in the patient.

[0007] Optionally in some embodiments, the method further includes purging the probe assembly by introducing an irrigant.

[0008] Optionally in some embodiments, the method further includes irrigating the bladder with a volume of irrigant to enable inspection of the anatomy via an optical element of the probe assembly.

[0009] Optionally in some embodiments, the predetermined angular position is in a range of about 4-5 o'clock, 7-8 o'clock, 1-2 o'clock, or 10-11 o'clock positions relative to the bladder neck.

[0010] Optionally in some embodiments, the treatment agent comprises non-animal stabilized hyaluronic acid.

[0011] In one embodiment, a system for treating stress urinary incontinence in a patient includes a cystoscope including a probe assembly with a shaft having a tip, an optical element for capturing images, and a display or optical viewer for presenting the images: a rotatable sheath with a shaft and at least one lumen configured to receive the cystoscope shaft, the sheath being rotatable about the cystoscope shaft; a treatment agent including a non-animal stabilized hyaluronic acid; and a treatment needle insertable through the sheath, the needle configured to inject the treatment agent into tissue.

[0012] In one embodiment, a stress urinary incontinence treatment system includes a cystoscope including a probe assembly with a cystoscope shaft having a tip and an optical element for capturing images, a sheath integrally formed with the cystoscope to create a disposable assembly, the sheath having a sheath shaft with a first lumen configured to receive the cystoscope shaft, a second lumen, and a needle port in communication with the second lumen. The sheath is rotatable about the cystoscope shaft. The system includes irrigation lines configured to provide fluid communication with the first lumen. The irrigation lines are fixed relative to the cystoscope and are non-rotatable with respect to the sheath. The system includes a treatment agent including a bulking agent; and a treatment needle insertable through the needle port and the second lumen, the treatment needle configured to inject the treatment agent into tissue.

[0013] Optionally, in some embodiments, the bulking agent includes non-animal stabilized hyaluronic acid (NASHA) and dextranomer microspheres.

[0014] Optionally, in some embodiments, the dextranomer microspheres have dimensions ranging from 80-250 micrometers in diameter.

[0015] Optionally, in some embodiments, the treatment needle includes a needle shaft having at least two sections of different diameters.

[0016] Optionally, in some embodiments, the system further includes a stop mechanism configured to prevent the treatment needle from extending more than 2 cm beyond a distal end of the sheath.

[0017] Optionally, in some embodiments, the sy stem further includes a stop mechanism configured to indicate an extension length of the treatment needle beyond a distal end of the sheath.

[0018] Optionally, in some embodiments, the system further includes a stop mechanism configured to indicate when the distal tip of the treatment needle has extended more than a predefined distance beyond a distal end of the sheath, such as about 2 cm.

[0019] Optionally, in some embodiments, the system further includes a valve disposed in the needle port, the valve including a main body with a main aperture and one or more sealing arms extending radially from the main body into the main aperture.

[0020] Optionally, in some embodiments, the sy stem further includes a seal disposed in the needle port, the seal including a main body with a main aperture extending therethrough and a shoulder extending longitudinally from a face of the main body.

[0021] In one embodiment, a stress urinary incontinence treatment system includes a cystoscope including a probe assembly with a cystoscope shaft having a tip and an optical element for capturing images; a handle assembly including a grip portion and a head portion; a sheath integrally coupled to the probe assembly through a probe hub and handle hub configuration to form a disposable assembly, the sheath having a first lumen configured to receive the cystoscope shaft and a second lumen configured to receive a treatment needle, the sheath being rotatable about the cystoscope shaft; an inflow port and an outflow port positioned on the handle assembly and in fluid communication with the first lumen through the probe hub and handle hub configuration. The inflow port and outflow port do not rotate with the sheath. The system includes a needle port in communication with the second lumen. The treatment needle is insertable through the needle port and the second lumen. The system includes a bulking agent configured to be received into and advanced through the treatment needle upon manual engagement with the handle assembly.

[0022] Optionally, in some embodiments, the grip portion has a gun-style shape with an actuator in a trigger position.

[0023] Optionally, in some embodiments, the actuator is configured to cause the system to capture still images or video via the optical element.

[0024] Optionally, in some embodiments, the inflow port and outflow port are both positioned at an end portion of the grip portion.

[0025] Optionally, in some embodiments, the system further includes a stop mechanism configured to prevent the treatment needle from extending more than 2 cm beyond a distal end of the sheath.

[0026] Optionally, in some embodiments, the probe hub includes a collar that at least partially surrounds a receptacle of the sheath circumferentially, and the receptacle is received within the collar to enable rotational movement of the sheath while maintaining fluid communication pathways.

[0027] In one embodiment, a method for treating stress urinary7incontinence in a patient includes providing a stress urinary incontinence treatment system including a cystoscope with an integrally formed sheath creating a disposable assembly. The sheath is rotatable about a cystoscope shaft and includes a needle port. The method includes inserting a treatment needle into the needle port. The treatment needle is prevented from extending more than 2 cm beyond a distal end of the sheath by a stop mechanism. The method includes inserting the cystoscope into a urethra of the patient and advancing the cystoscope distally until a distal tip of the cystoscope is adjacent to a bladder neck; irrigating a bladder through the irrigation lines; rotating the sheath to position the treatment needle at a predetermined angular position relative to the bladder neck; extending the treatment needle into mucosal tissue of the bladder neck; injecting a treatment agent including NASH A and dextranomer microspheres into the mucosa to form a cushion; and withdrawing the treatment needle.

[0028] Optionally, in some embodiments, the method further includes a step of repeating the rotating, extending, injecting, and withdrawing steps at additional injection sites around the bladder neck.

[0029] Optionally, in some embodiments, the additional injection sites are positioned at predetermined angular positions including 4-5 o'clock, 7-8 o'clock, 1-2 o'clock, and 10-11 o'clock positions relative to the bladder neck.

[0030] Optionally, in some embodiments, a total number of injection sites ranges from about 2 to about 8 injection sites.

[0031] Optionally, in some embodiments, the step of injecting includes injecting approximately 0.4-0.5 mL of the treatment agent at each injection site.

[0032] Optionally, in some embodiments, the dextranomer microspheres have dimensions ranging from 80-250 micrometers in diameter.

[0033] In one embodiment, a stress urinary incontinence treatment system includes a bulking agent including NASHA; a cystoscope including a probe assembly with a cystoscope shaft having a tip and an optical element for capturing images; a handle assembly, which may be separate from the probe assembly, and including a grip portion and a head portion; a sheath integrally coupled to the probe assembly through a probe hub and handle hub configuration to form a disposable assembly, the sheath having a first lumen configured to receive the cystoscope shaft and a second lumen configured to receive a treatment needle, the sheath being rotatable about the cystoscope shaft; an inflow port and an outflow port positioned at an end portion of the grip portion and in fluid communication with the first lumen through the probe hub and handle hub configuration. The inflow port and outflow port do not rotate with the sheath. The system includes conduits extending from the inflow port and outflow port; an electrical connector disposed in the end portion of the grip portion; a needle port in communication with the second lumen. The treatment needle is insertable through the needle port and the second lumen. The bulking agent is configured to be received into and advanced through the treatment needle upon engagement with the handle assembly.

[0034] Optionally, in some embodiments, the grip portion has a gun-style shape with an actuator in a trigger position.

[0035] Optionally, in some embodiments, the actuator is configured to cause the system to capture still images or video via the optical element.

[0036] Optionally, in some embodiments, the system further includes a stop mechanism configured to prevent the treatment needle from extending more than 2 cm beyond a distal end of the sheath.

[0037] Optionally, in some embodiments, the system further includes a stop mechanism configured to indicate an extension length of the treatment needle beyond a distal end of the sheath.

[0038] Optionally, in some embodiments, the system further includes a stop mechanism configured to indicate when the distal tip of the treatment needle has extended more than a predefined distance beyond a distal end of the sheath, such as about 2 cm.

[0039] Optionally, in some embodiments, the probe hub includes a collar that at least partially surrounds a receptacle of the sheath circumferentially, and the receptacle is received withinthe collar to enable rotational movement of the sheath while maintaining fluid communication pathways.

[0040] Optionally, in some embodiments, the bulking agent further includes dextranomer microspheres having dimensions ranging from 80-250 micrometers in diameter.

[0041] Optionally, in some embodiments, the system further includes a valve disposed in the needle port, the valve including a main body with a main aperture and one or more sealing arms extending radially from the main body into the main aperture.

[0042] Optionally, in some embodiments, the system further includes a seal disposed in the needle port, the seal including a main body with a main aperture extending therethrough and a shoulder extending longitudinally from a face of the main body.

[0043] Optionally, in some embodiments, the treatment needle includes a needle shaft having at least two sections of different diameters.

[0044] Optionally, in some embodiments, the system further includes a display in electrical communication with the cystoscope via a cable connected to the electrical connector.

[0045] In one embodiment, a method for treating stress urinary incontinence in a patient includes providing a stress urinary incontinence treatment system including a treatment agent including NASHA; a cystoscope with a probe assembly having a cystoscope shaft with a tip and an optical element for capturing images, a handle assembly including a grip portion and a head portion, a sheath integrally coupled to the probe assembly through a probe hub and handle hub configuration to form a disposable assembly, the sheath having a first lumen configured to receive the cystoscope shaft and a second lumen configured to receive a treatment needle, the sheath being rotatable about the cystoscope shaft, an inflow port and an outflow port positioned at an end portion of the grip portion and in fluid communication with the first lumen through the probe hub and handle hub configuration. The inflow port and outflow port do not rotate with the sheath. The system includes conduits extending from the inflow port and outflow port, an electrical connector disposed in the end portion of the grip portion, and a needle port in communication with the second lumen; inserting the treatment needle through the needle port and the second lumen; inserting the cystoscope into a urethra of the patient and advancing the cystoscope distally until the distal tip of the cystoscope is adjacent to a bladder neck; irrigating a bladder through the inflow port; rotating the sheath to position the treatment needle at a predetermined angular position relative to the bladder neck; extending the treatment needle into mucosal tissue of the bladder neck; injecting the treatment agent into the mucosa to form a cushion; and withdrawing the treatment needle.

[0046] Optionally, in some embodiments, the grip portion has a gun-style shape with an actuator in a trigger position.

[0047] Optionally, in some embodiments, the actuator is configured to cause the system to capture still images or video via the optical element.

[0048] Optionally, in some embodiments, the stress urinary incontinence treatment system further includes a stop mechanism configured to prevent the treatment needle from extending more than 2 cm beyond a distal end of the sheath.

[0049] Optionally, in some embodiments, the stress urinary incontinence treatment system further includes a stop mechanism configured to indicate an extension length of the treatment needle beyond a distal end of the sheath.

[0050] Optionally, in some embodiments, the stress urinary incontinence treatment system further includes a stop mechanism configured to indicate when the distal tip of the treatment needle has extended more than a predefined distance beyond a distal end of the sheath, such as about 2 cm

[0051] Optionally, in some embodiments, the probe hub includes a collar that at least partially surrounds a receptacle of the sheath circumferentially, and the receptacle is received within the collar to enable rotational movement of the sheath while maintaining fluid communication pathways.

[0052] Optionally, in some embodiments, the treatment agent further includes dextranomer microspheres having dimensions ranging from 80-250 micrometers in diameter.

[0053] Optionally, in some embodiments, the stress urinary incontinence treatment system further includes a valve disposed in the needle port, the valve including a main body with a main aperture and one or more sealing arms extending radially from the main body into the main aperture.

[0054] Optionally, in some embodiments, the stress unnary incontinence treatment system further includes a seal disposed in the needle port, the seal including a main body with a main aperture extending therethrough and a shoulder extending longitudinally from a face of the main body.

[0055] Optionally, in some embodiments, the treatment needle includes a needle shaft having at least two sections of different diameters.

[0056] Optionally, in some embodiments, the stress urinary incontinence treatment system further includes a display in electrical communication with the cystoscope via a cable connected to the electrical connector.BRIEF DESCRIPTION OF THE DRAWINGS

[0057] FIG. 1 is a perspective view of an embodiment of a SUI treatment system in accordance with the present disclosure.

[0058] FIG. 2 is an elevation view of the SUI treatment system of FIG. 1.

[0059] FIG. 3 is a perspective view of a probe assembly of the SUI treatment system of FIG.1 in accordance with the present disclosure.

[0060] FIG. 4A is a perspective view of a rotatable sheath of the SUI treatment system of FIG. 1 in accordance with the present disclosure.

[0061] FIG. 4B is a detail view of the rotatable sheath of FIG. 4A, taken along line 5B-5B of FIG. 4A.

[0062] FIG. 5 A - FIG. 5F are vie s of a treatment needle of the SUI treatment system of FIG.1 in accordance with the present disclosure.

[0063] FIG. 6 is a flow chart of a method of treating a SUI condition with the SUI treatment system of FIG. 1 in accordance with the present disclosure.

[0064] FIG. 7 is a schematic view of the SUI treatment system treating a patient according to the method of FIG. 6 in accordance with the present disclosure.

[0065] FIG. 8 A - FIG. 9 are views of the SUI treatment system of FIG. 1 treating a patient according to the method of FIG. 6 in accordance with the present disclosure.

[0066] FIG. 10A is a perspective view of an embodiment of a SUI treatment system in accordance with the present disclosure.

[0067] FIG. 10B is a partially exploded section view of an embodiment of a sheath suitable for use with the SUI treatment system of FIG. 10A, or the SUI treatment system of FIG. 11, in accordance with the present disclosure.

[0068] FIG. 10C is a perspective view of a valve suitable for use with the sheath of FIG. 10B in accordance with the present disclosure.

[0069] FIG. 10D is a perspective view of a seal suitable for use with the sheath of FIG. 10B in accordance with the present disclosure.

[0070] FIG. 11 is a perspective view of an embodiment of a SUI treatment system in accordance with the present disclosure.

[0071] FIG. 12 is a simplified block diagram of components of the SUI treatment system of FIG. 1, FIG. 10A, and / or FIG. 11 in accordance with the present disclosure.DETAILED DESCRIPTION

[0072] The disclosed systems and methods are adapted to treat stress urinary incontinence (SUI), particularly in female patients. The systems may be used by a healthcare provider toinject a treatment agent into the tissue, particularly the mucosa, of the urethra or bladder neck. The treatment agent may coapt the urethra by providing one or more bulking cushions. As used herein, ‘"coaptation’7refers to the process of joining or fitting together two or more tissue surfaces, particularly in the urethra or bladder neck. For example, following the treatment methods disclosed herein, a patient’s urethra or bladder neck may be coapted, such that the treated tissue can adequately seal the bladder against unplanned or involuntary urinary leakage or bladder voiding. One or more, including all, embodiments of the disclosed systems and methods may be adapted to treating stress-induced urinary incontinence (SUI).

[0073] In many embodiments, the treatment agent is a bulking agent. In many embodiments, the preferred bulking agent includes Non- Animal Stabilized Hyaluronic Acid (NASHA), which may include a suspension of cross-linked dextranomer microspheres. While the particular size may vary, the microspheres typically have dimensions ranging from 80-250 micrometers in diameter. In other embodiments, alternative bulking agents may lack crosslinked structures or components, e.g., crosslinked polymers. In other embodiments, other bulking agents may be used, including but not limited to: collagen, calcium hydroxylapatite, polydimethylsiloxane, polytetrafluoroethylene, autologous fat, carbon-coated zirconium beads, ethylene vinyl alcohol copolymer, and polyacrylamide hydrogel.

[0074] FIG. 1 - FIG. 3 show examples of a SUI treatment system 100. The SUI treatment system 100 includes a cystoscope 102 or ureteroscope that receives a rotatable sheath 400 (described in detail with respect to FIGS. 4A and 4B). A treatment needle 500 is received in a portion of the rotatable sheath 400. The sheath 400 and treatment needle 500 are rotatable about a cystoscope shaft 110 of the cystoscope 102 to align the treatment needle 500 with one or more treatment sites in a patient’s body. In the example shown in FIG. 1, the cystoscope 102 includes a probe assembly 104, a handle 120, and a display 118. The handle 120 may include one or more actuators 116a, 116b to power the device on or off, input data to the SUI treatment system, or change configurations thereof.

[0075] The probe assembly 104 includes a probe hub 106, an inflow port 108, a cystoscope shaft 110, an optical element 112, and an electrical connector 114. The probe assembly 104 captures images at the tip of the cystoscope shaft 110 and conveys the images to a display 118 or optical viewer (not shown) of the cystoscope 102.

[0076] The probe hub 106 may act as a base from which other features of the cystoscope 102 extend or attach. For example, as best shown in FIG. 3, the cystoscope shaft 110 extends away from the probe hub 106 in a longitudinal direction, terminating at a tip 130. The tip 130 of the cystoscope shaft 110 may include the optical element 112, non-limiting examples ofwhich may be a camera, fiber optic element, a lens, a light source, or combinations of these. The optical element 112 captures images of a patient’s anatomy which are relayed to the display 118 to guide a healthcare professional in the process of treating a patient with SUI symptoms.

[0077] The inflow port 108 includes a luer hub 132 that accepts a conduit 124 or irrigation syringe 128 which can be used to irrigate a treatment site 804 (see, e.g., FIG. 8A - FIG. 9).

[0078] An electrical connector 114 extends from the probe hub 106 and electrically couples the handle 120 and the probe assembly 104. For example, the images captured by the optical element 112 are transferred to the display 118 via the electrical connector 114. Similarly, the electrical connector 114 may provide power from the handle 120 to the optical element 112. In many embodiments, probe assembly 104 and sheath 400 may be single-use, while the handle 120 may be reusable.

[0079] Turning to FIG. 4A and FIG. 4B, an example of a sheath 400 is shown. The sheath 400 includes a hub 404, a sheath shaft 402 extending from the hub 404, a needle port 406, an outflow port 408. a first lumen 410, and a second lumen 412. In some embodiments, the outflow port 408 may be included with another portion of the SUI treatment system 100.

[0080] The sheath shaft 402 includes a first lumen 410 that extends from the hub 404 to a distal tip of the sheath 400. The first lumen 410 is of sufficient size to receive the cystoscope shaft 110. A clearance or annular space may be formed betw een an outer surface of the cystoscope shaft 110 and the inner surface of the first lumen 410. This annular space may be in fluid communication with the inflow port 108 to facilitate irrigation of a treatment site 804.

[0081] As best show n in FIG. 4B, the sheath shaft 402 may include a second lumen 412, which may be in fluid communication with the needle port 406 and extends from the needle port 406 to the tip 414 of the sheath 400. Either or both of the first lumen 410 and / or second lumen 412 may be in fluid communication with the outflow^ port 408 to enable the draining of fluid from the patient’s body.

[0082] When assembled with the cystoscope 102, the sheath 400 is rotatable about the cystoscope shaft 110 to enable the treatment needle 500 to be aligned with one or more treatment sites 804 or injection sites. Embodiments of the sheath 400 may rotate 360° about the cystoscope shaft 110 in response to manual engagement by an operator, e.g., clinician, performing a treatment procedure.

[0083] FIG. 5A - FIG. 5F are views of details of an example of a treatment needle 500 of the SUI treatment system 100. In the example shown, the treatment needle 500 includes a luerhub 132, a handle 502, and a needle shaft 504. The needle shaft 504 extends from the handle 502 in a longitudinal direction toward a tip 506. The needle lumen 508 extends within the needle shaft 504 from the luer hub 132 to the tip 506. In many embodiments, the tip 506 may include a cutback bevel 510. The tip 506 may include a main bevel 512, which may define a bevel angle 514 of about 8° to 12°, typically at 10°. The bevel angle 514 may vary', however, ranging in some examples from less than 8° to greater than 12°, including about 5°, 6°, 7°, 8°, 9°, 10°. 11°, 12°. 13°, 14°, 15°, 16°, or greater. The tip 506 is adapted to penetrate the mucosa of the bladder neck, while the needle lumen 508 delivers a treatment agent 134 to a treatment site 804.

[0084] With reference to FIG. 5 A - FIG. 5C, the treatment needle 500 may include a needle shaft 504 having at least two sections of different diameters. In some embodiments, a larger diameter section extends for a portion of the needle shaft 504 length closest to the handle 502, which may transition to a smaller diameter section at the tip 506. The transition may be gradual or stepwise in various embodiments. The smaller diameter at the tip 506 may provide precise injection control while minimizing tissue trauma during insertion into the mucosal tissue. The larger diameter portion along the needle shaft 504 length may reduce the force required by the user during injection of the treatment agent 134, which may be particularly advantageous for male stress urinary' incontinence treatments where longer probe lengths are necessary compared to female patient treatments.

[0085] FIG. 6 illustrates a non-limiting example method 600 for treating SUI with the systems disclosed herein. Although the example method 600 depicts a particular sequence of operations, the sequence may be altered without departing from the scope of the present disclosure. For example, some of the operations depicted may be performed in parallel or in a different sequence that does not materially affect the function of the method 600. In other examples, different components of an example device or system that implements the method 600 may perform functions at substantially the same time or in a specific sequence. Certain operations may also be omitted or supplemented. For instance, certain operations may be omitted, repeated, or supplemented in response to different conditions encountered before or during a treatment procedure, which may also vary from one patient to the next.

[0086] According to some examples, the method 600 includes purging the SUI treatment system 100 at operation 602. For example, the inflow port 108 may be opened and an irrigant such as a saline solution may be used to purge air from the SUI treatment system 100. The outflow port 408 is ty pically closed in the operation 602. An anesthetic may be applied to theouter surface of the sheath 400 to ease patient comfort. After the SUI treatment system 100 is purged, the inflow port 108 may be closed, e.g., by a valve 122.

[0087] According to some examples, the method 600 includes inserting the treatment needle 500 into the needle port 406 at operation 604. The treatment needle 500 is inserted partially into the needle port 406, but not extending past the tip 414 out of the second lumen 412.

[0088] In clinical practice, the disclosed SUI treatment system 100 is operated according to a procedural protocol for optimal device positioning and needle deployment. The procedure begins by advancing the probe assembly 104 and sheath 400 through the urethra until the tip 414 of the sheath 400 is positioned even with the bladder neck 802 (show n forexample starting at FIG. 8A). Once this initial positioning is achieved, the treatment needle 500 is advanced out of the second lumen 412 of the sheath 400, with the needle tip 506 protruding approximately 1.5-2 cm into the bladder without contacting the bladder wall.

[0089] In some embodiments, a stop mechanism configured to prevent the needle tip 506 from extending more than 2 cm beyond a distal end of the sheath 400 may be included to ensure consistent, precise placement of the needle tip 506 in a manner that avoids over-extending the needle tip 506 into the bladder or adjacent tissue. The stop mechanism may be a mechanical or hard stop including one or more structural features within the probe assembly 104. For example, the mechanical stop mechanism may be a hard stop mechanism such as a boss, flange, or other structural feature that mechanically prevents the needle tip 506 from extending more than 2 cm beyond a distal end of the sheath 400. In some embodiments, the stop mechanism may be a soft stop that provides a tactile, auditory, or visual indication of the depth to which the needle tip 506 has been extended beyond the end of the sheath 400. For example, in some embodiments, the treatment needle 500 may include visible markings along the needle shaft 504 to assist with precise positioning measurements. In another example, the SUI treatment system may issue a series of auditory indications (e.g., beeps) or haptic indications (e.g., vibration pulses, clicks) of increasing frequency as the user approaches a target insertion of 2 cm. In another example, the SUI treatment system may speak an insertion depth, e.g., “1 mm,” “2 mm,” etc.). The SUI treatment system may also indicate to a user if the needle tip 506 has extended past a target depth (e.g.. more than 2 cm). Examples may also include a stop mechanism configured to indicate when the needle tip 506 has extended more than a predefined distance, e.g., about 2 cm, beyond a distal end of the sheath 400. Any SUI treatment system may include a hard stop, a soft stop, or any combination thereof. The increments at which the indications of insertion depth occur may be as low as 1 mm or up to about 5 - 10 mm. For example, the SUI treatment system may issue beeps or clicks at 1, 2, 3,4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 etc. mm of insertion depth of the needle tip 506 past the distal end of the shaft 400.

[0090] Following the initial needle extension, the SUI treatment system 100 is repositioned by drawing it back until the needle tip 506 at its extended position aligns with the bladder neck 802. The bladder neck 802 serves as an anatomical reference point and measuring marker to establish the proper axial position within the urethra for subsequent injection procedures.

[0091] After proper rotational positioning is achieved, the treatment needle 500 is withdrawn back into the second lumen 412 and then carefully inserted into the mucosal tissue of the bladder neck 802 at the selected injection site. The needle tip 506 is advanced parallel to the mucosal wall to ensure proper depth penetration while avoiding placement that is either too superficial or too deep to achieve therapeutic effect. The treatment agent 134, such as NASHA, is then injected to form a cushion 814 in the mucosa at a location that provides optimal coaptation of the urethra. This procedural sequence may be repeated at multiple injection sites around the bladder neck 802 by rotating the sheath 400 to different angular positions (e.g., 4-5 o'clock. 7-8 o'clock, 1-2 o'clock, or 10-11 o'clock positions, etc.). The indicator 416 on the sheath 400 provides visual guidance to the healthcare provider regarding the rotational position of the treatment needle 500), with the number of injection sites ranging from about 2 to about 8 depending on the severity of the patient’s stress urinary incontinence condition.

[0092] According to some examples, the method 600 includes inserting one or more components of the SUI treatment system 100, e.g., the sheath 400 and cystoscope 102 coupled therewith, longitudinally through the lumen defined by the urethra until at least a distal tip of such components extends into the bladder neck 802 at operation 606. See also, FIG. 7, which shows a schematic view of the external genitalia or vulva 706 of a female patient including the urethral opening 702 and vaginal opening 704 after insertion of a distal tip (e.g., tip 414) of a sheath 708 (or sheath 400 or sheath 1022 - see also FIG. 11) of a SUI treatment system 710 through the urethral opening 702. As further shown in FIG. 7, embodiments of the SUI treatment system 710 may include a display 712 that is separate from a handle assembly 714. Such embodiments in which the display 712 and handle assembly 714 are discrete components may also include a connecting cable 716, as further shown in FIGS. 10A and 11.

[0093] According to some examples, the method 600 includes irrigating the bladder at operation 608. The inflow port 108 may be opened such that an irrigant can flow therefrom, through the clearance between the cystoscope shaft 110 and the first lumen 410 and into thebladder. The bladder may be inspected via the optical element 112 and display 118 in the operation 608. In many examples, about 150-200 mL of irrigant is injected into the bladder. The irrigant may also distend the urethra allowing the probe to be advanced more easily into the patient’s body with a lower enough force to prevent tissue damage.

[0094] According to some examples, the method 600 includes withdrawing the SUI treatment system 100 in the operation 610. For example, while the tip 414 is within the bladder, the treatment needle 500 may be extended approximately 1.5-2 cm into the bladder, but not touching the bladder wall. In operation 610, the SUI treatment system 100 may be retracted until the needle tip 506 is in line with the bladder neck.

[0095] According to some examples, the method 600 includes rotating the sheath 400 at operation 612. In the operation 612, the treatment needle 500 is retracted into the second lumen 412 such that the tip 506 does not protrude past the tip 414. The sheath 400 may be rotated to a desired position relative to the bladder neck, for example the 7-8 o'clock position. See, e.g., FIG. 8A and FIG. 8B. The sheath 400 may include an indicator 416 to guide the healthcare provider on the position of the treatment needle 500 when it is retracted.

[0096] According to some examples, the method 600 includes extending the treatment needle 500 into mucosa of the bladder neck 802 at operation 614. For example, the treatment needle 500 may be extended until the tip 506 penetrates the mucosa at an injection site such as a first injection site 806, second injection site 808, third injection site 810, fourth injection site 812. etc. The treatment needle 500 may be extended parallel to the mucosal wall to prevent the treatment agent 134 from being placed too superficially or too deeply to be of therapeutic effect.

[0097] According to some examples, the method 600 includes injecting the treatment agent 134 at operation 616. For example, a treatment syringe 126 may be coupled to the luer hub 132 of the treatment needle 500. The treatment syringe 126 may contain a treatment agent 134 such as NASHA. The plunger may be depressed, forcing the treatment agent into the mucosa. In certain non-limiting examples, approximately 0.4-0.5 mL of the treatment agent 134 may be injected at each injection site. The treatment agent 134 forms a cushion 814 in the mucosa. The amount of treatment agent 134 injected at each site may be adjusted in response to images obtained at the treatment site during the procedure.

[0098] According to some examples, the method 600 includes withdrawing the treatment needle 500 at operation 618. For example, the treatment needle 500 may be withdrawn until the tip 506 is received within the second lumen 412. The method 600 may then return to the operation 612 and the sheath 400 (and the treatment needle 500) may be rotated to a newinjection site. In various executions of the operation 618, the treatment needle 500 may be placed in about the 4-5 o'clock position, 1-2 o'clock position, and / or 10-11 o'clock position with respect to the bladder neck. See, e.g., FIG. 8A - FIG. 9. In some embodiments, only one injection site is used. In others, the number of injection sites may range from about 2 to about 8 injections, including three, four, five, six, seven injections, or more. The number of injections may depend on the severity of SUI experienced by a given patient.

[0099] According to some examples, the method 600 includes withdrawing the SUI treatment system 100 from the urethra at operation 620, this completing the SUI treatment procedure.

[0100] With reference to FIG. 10A, an embodiment of a SUI treatment system 1000 is shown. The SUI treatment system 1000 is similar to the SUI treatment system 100 in many respects. For example, the SUI treatment system 1000 includes a cystoscope 1002 with a probe assembly 1004 and a handle assembly 1020.

[0101] The probe assembly 1004 includes a cystoscope shaft 110 with a probe hub 1006 at one end of the cystoscope shaft 110. The cystoscope shaft 110 includes an optical element 112 at a tip 130 thereof. The tip 130 is at an end of the cystoscope shaft 110 opposite the probe hub 1006.

[0102] The handle assembly 1020 includes a grip portion 1028 and a head portion 1030. The grip portion 1028 is suitable to be gripped by a user’s hand.

[0103] A rotatable sheath 1022 is receivable on the cystoscope shaft 110. The sheath 1022 is described in greater detail with respect to FIG. 10B - FIG. 10D. The sheath 1022 includes a needle port 406 suitable to receive a needle shaft 504 as discussed above with respect to the SUI treatment system 100 and the method 600. The sheath 1022 is similar to the sheath 400 in some respects. For example, the sheath 1022 is rotatable about the cy stoscope shaft 110. The sheath 1022 also includes a first lumen 410 and a second lumen 412 similar to the sheath 400. However, as discussed herein, the sheath 1022 does not include an outflow port 408, as the outflow7port 408 in the SUI treatment system 1000 is disposed on the handle assembly 1020.

[0104] In the preferred embodiment illustrated in FIG. 11, the sheath 1022 may be integrally coupled to the probe assembly 1004 through the probe hub 1006 and handle hub 1024 configuration, forming a unified disposable assembly. This integral coupling represents a distinguishing feature compared to conventional systems where the sheath and probe components require separate handling and assembly steps. The receptacle 1044 of the sheath 1022 is received within the collar 1042 of the probe hub 1006, creating a secure connectionthat enables rotational movement while maintaining fluid communication pathways for irrigation and drainage functions.

[0105] In contrast, the embodiment depicted in FIG. 1 and FIG. 2 utilizes a configuration wherein the sheath 400 may be separately provided and manually positioned over the cystoscope shaft 110 by the healthcare provider prior to the medical procedure. In this arrangement, the user fits the sheath 400 onto the probe assembly 104, with the first lumen 410 of the sheath 400 receiving the cystoscope shaft 110. The sheath 400 in this embodiment may be designed as a single-use component, while the cystoscope 102 with its handle 120 and display 118 may be configured for multiple uses.

[0106] The attachment methods in these embodiments provide different advantages in clinical practice. The integral coupling approach of the SUI treatment system 1100 shown for example in FIG. 11 may reduce setup time and potential assembly errors, while the separate fitting approach of the FIG. 1 and FIG. 2 embodiment may offer flexibility in component selection and cost management through selective reuse of certain system elements.

[0107] In the embodiment shown, the grip portion 1028 has a gun-style shape with an actuator 116a in a trigger position. The actuator 116a is particularly adapted to be actuated by a user’s finger such as an index finger. The functions of the actuator 116a may be as described with respect to the SUI treatment system 100. In some embodiments, the actuator 116a may cause the SUI treatment system 1000 to record either or both of a still image or a video. In some embodiments, a single press of the actuator 116a may cause the SUI treatment system 1000 to acquire a still image via the optical element 112 (e.g., an image of a patient’s anatomy or treatment site 804. In some embodiments, pressing and the holding the actuator 116a may cause the SUI treatment system 1000 to capture video (or a sequence of still images) of the treatment site 804.

[0108] In alternative embodiments, the actuator 116a may be configured for various other applications beyond image and video capture. For instance, the actuator 116a may be adapted to control injection functions of the treatment agent 134, potentially providing automated or semi -automated delivery of the treatment agent through the treatment needle 500, though such applications may require additional components and control systems not specifically detailed in this disclosure. In some embodiments, the actuator 116a may control automated rotation of the device to the different rotational treatment positions, e.g., to assure consistent, even placement of the treatment agent in the urethral tissue. Additionally, the actuator 116a may be employed to adjust light intensity parameters of the optical element 112, enabling the healthcare provider to optimize illumination conditions during the procedure for enhancedvisualization of the treatment site 804. The actuator 116a may also be configured to control brightness and contrast parameters of the display 118, allowing real-time adjustment of display characteristics to improve image clarity and visibility during the treatment procedure. In some cases, the actuator 1 16a may be programmed to cycle through different operational modes, such as switching between live imaging, recorded playback, and system configuration settings. The actuator 116a may further be adapted to control irrigation flow' rates through the inflow port 108, providing the healthcare provider with convenient control over bladder distension and visualization conditions during the procedure. In various embodiments, any SUI treatment system disclosed herein may include more than one actuator 116 such as an actuator 116a, 116b, etc., with each actuator having different functions. In some embodiments, two different actuators may have the same functions or overlapping sets of functions. In some embodiments, two or more actuators may be placed in different locations on the device to enable actuation thereof with different user grips. For example, an actuator 116a may be a trigger-style button adapted for actuation by an index finger of a user. In another example, an actuator 116b may be placed in a location adapted to be actuated by a thumb of the user when the SUI treatment device is in use.

[0109] The SUI treatment system 1000 includes a display 1 18 that shows procedure images 1036. The procedure images 1036 may be still images and / or video, and may be either live or pre-recorded (e.g., captured as discussed with respect to the actuator 116a).

[0110] One way in which the SUI treatment system 1000 differs from the SUI treatment system 100 is that the display 118 is separate from the handle assembly 1020. In some embodiments, the cystoscope 1002 may be a disposable, single use device, while the display 118 is suitable to be used multiple times. The cystoscope 1002 and the display 118 may be in electrical communication via a cable 1026. The cable 1026 may connect to an end portion 1032 of the handle assembly 1020. or another suitable portion thereof. The cable 1026 may have an electrical connector 114 at one or both ends to connect the display 118 and the cystoscope 1002. In some embodiments, such as shown for example in FIG. 10A, the cable 1026 may include a strain relief 1034 at one or more ends, to help reduce the possibility of kinked, pulled, or broken wires in the cable. In some embodiments, the cystoscope 1002 and the display 118 may be in wireless communication with one another, and the cable 1026 may be optional.[OHl] Another difference between the SUI treatment system 100 and the SUI treatment system 1000 is the placement of the inflow port 108 and the outflow port 408. In the SUI treatment system 1000, the inflow port 108 and / or the outflow port 408 may protrude from thehandle assembly 1020 of the cystoscope 1002. In the example shown, the inflow port 108 protrudes from the head portion 1030 and the outflow port 408 protrudes from the grip portion 1028. In various embodiments, the positions of the inflow port 108 and outflow port 408 may be reversed. In various embodiments, the inflow port 108 and / or outflow port 408 may be located on other portions of the handle assembly 1020, without restriction. A benefit of the locations of the inflow port 108 and the outflow port 408 on the handle assembly 1020 is that the management of the conduits 124 is simplified during a procedure, compared to the SUI treatment system 100. For example, in the SUI treatment system 100, the outflow port 408 is coupled to the sheath 1022 and rotates with the sheath 1022. This rotation may cause tangled or kinked conduits 124. By coupling both the inflow port 108 and the outflow port 408 to the handle assembly 1020, such possibility of tangling is reduced or eliminated.

[0112] Turning to FIG. 10B, the sheath 1022 is described in further detail. The sheath 1022 includes an elongate main body 1038 that extends along a longitudinal axis 1040. The elongate main body 1038 includes the first lumen 410 and the second lumen 412 which extend along at least a portion of the longitudinal axis 1040. As described with respect to the sheath 400. the first lumen 410 is adapted to receive a cystoscope shaft 110, and the second lumen 412 is adapted to receive the needle shaft 504. The first lumen 410 terminates at one end at a tip 414 and at an opposite end at a receptacle 1044. The receptacle 1044 is received in the probe hub 1006. The probe hub 1006 is formed of a collar 1042 that surrounds, at least partially, the receptacle 1044 circumferentially.

[0113] The receptacle 1044 is suitable to receive the shaft of the cystoscopes of the SUI treatment system 100 and / or SUI treatment system 1000, while making fluid connections to the inflow' port 108 and / or outflow port 408 and enabling the sheath 1022 to rotate about the longitudinal axis 1040 to facilitate the execution of the method 600. For example, to enable the sheath 1022 to rotate while still providing fluid connection to the inflow port 108 and the outflow port 408 (e.g., to provide for the inflow and outflow of an irrigant), the handle hub 1024 and the probe hub 1006 cooperate to provide fluid connections betw een the sheath 1022 (e.g., via the receptacle 1044) and the handle assembly 1020 (and thus the inflow port 108 and the outflow port 408) while still enabling the sheath 1022 to rotate as desired to accomplish the method 600 or other procedures.

[0114] With respect to FIG. 10B and FIG. 10C, the needle port 406 of the sheath 1022 (or the sheath 400) may receive or include a valve 1046. The valve 1046 includes a relatively (to its diameter) thin main body 1050. A main aperture 1048 is formed in the main body 1050. The main aperture 1048 is selectively closeable by one or more sealing arms 1052 extendingradially from the main body 1050 into the main aperture 1048. The valve 1046 may be formed of an elastomeric material, such that when the needle shaft 504 is received in the needle port 406, the sealing arms 1052 flex to enable the needle shaft 504 to pass thereby, while at the same time sealing against the needle shaft 504 to prevent or reduce the passage of fluid over the outer surface of the needle shaft 504. When the needle shaft 504 is not inserted into the valve 1046, the sealing arms 1052 may contact one another, or the main body 1050 to prevent or reduce the passage of a fluid through the valve 1046.

[0115] With respect to FIG. 10B and FIG. 10D, the needle port 406 of the sheath 1022 (or the sheath 400) may receive a seal 1054. The seal 1054 includes a main body 1056. The main body 1056 may be cylindrically shaped. A main aperture 1060 may extend through the main body 1056 and be suitable to receive a portion of the needle shaft 504 or other portion of the treatment needle 500. The main body 1056 may have a shoulder 1058 extending longitudinally from a face of the main body 1056, such as a proximal or distal face. The seal 1054 helps prevent the passage of fluid out of the sheath 1022 or sheath 400 when the treatment needle 500 is inserted in the needle port 406. The shoulder 1058 may cooperate with a portion of the treatment needle 500 to help accomplish such sealing. The seal 1054 may be made of a similar material as that of the valve 1046 (e.g., an elastomer) or may be a different material.

[0116] With reference to FIG. 11, an embodiment of a SUI treatment system 1100 is shown. The SUI treatment system 1100 is similar to the SUI treatment system 100 and the SUI treatment system 1000 in many respects. For example, the SUI treatment system 1100 includes a cystoscope 1102 with a probe assembly 1004 and a handle assembly 1120. The SUI treatment system 1100 includes a sheath 1022 as described with respect to the SUI treatment system 1000. The SUI treatment system 1100 also includes a gun-style handle assembly 1120 similar to the SUI treatment system 1000 and the SUI treatment system 100. The handle assembly 1120 includes an actuator 116a with functions as described with respect to the SUI treatment system 100 and / or SUI treatment system 1000. Similar to the SUI treatment system 1000, the SUI treatment system 1100 may be in electrical communication with a separate display 118, either via a cable 1026 and / or electrical connector 114, or wirelessly.

[0117] One way in which the SUI treatment system 1100 differs from the SUI treatment system 1000 is that the inflow port 108, the outflow port 408, and the electrical connector 114 for the cable 1026 may all be located at an end portion 1032 of the grip portion 1028 of the handle assembly 1020. For example, the inflow port 108 and / or outflow port 408 may eachinclude respective conduits 124 that extend from the end portion 1032. Respective valves 122 may be coupled to the respective conduits 124 to control the inflow and / or outflow of fluid (e.g., an irrigant) from the SUI treatment system 1100. The SUI treatment system 1100 may have certain benefits over other cystoscopes in that placing the inflow port 108 and the outflow port 408 at the end portion 1032 positions the conduits 124 out of the way of the clinician providing the method 600. As with the SUI treatment system 1100, the placement of the inflow port 108 and outflow port 408 on the handle assembly 1020 enables the sheath 1022 to rotate with respect to the cystoscope shaft 110 without kinking or tangling the conduits 124. As with the SUI treatment system 1000, the probe hub 1006 and the handle hub 1024 cooperate to pass the fluid between the inflow port 108 and / or outflow port 408 while enabling the sheath 1022 to rotate as desired to provide a clinician to execute the method 600.

[0118] FIG. 12 is a simplified block diagram of components of a computing system 1200 of the SUI treatment system 100, the SUI treatment system 1000, the SUI treatment system 1100, or any system disclosed herein. For example, the computing system 1200 may be included in one or more of the cystoscope 102, cystoscope 1002, the cystoscope 1102, the display 118, etc. For example, the processing element 1202 and the memory component 1206 may be located at one or in several computing systems 1200. This disclosure contemplates any suitable number of such computing systems 1200. For example, the cystoscope 102, cystoscope 1002. the cystoscope 1102. the display 118, etc. may be in communication with a desktop computing system, a mainframe, a blade, a mesh of computing systems 1200, a laptop or notebook computing system 1200, a tablet computing system 1200, an embedded computing system 1200, a system-on-chip, a single-board computing system 1200, or a combination of two or more of these. Where appropriate, a computing system 1200 may include one or more computing systems 1200; be unitary or distributed; span multiple locations; span multiple machines; span multiple data centers; or reside in a cloud, which may include one or more cloud components in one or more networks. A computing system 1200 may include one or more processing elements 1202, an input / output VO interface 1204, one or more external devices 1210, one or more memory component 1206, and a network interface 1208. Each of the various components may be in communication with one another through one or more buses or communication networks, such as wired or wireless networks, e.g., a network. The components in FIG. 12 are exemplary only. In various examples, the computing system 1200 may include additional components and / or functionality not shown in FIG. 12.

[0119] The processing element 1202 may be any type of electronic device capable of processing, receiving, and / or transmitting instructions. For example, the processing element 1202 may be a central processing unit, microprocessor, processor, or microcontroller.Additionally, it should be noted that some components of the computing system 1200 may be controlled by a first processing element 1202 and other components may be controlled by a second processing element 1202, where the first and second processing elements may or may not be in communication with each other.

[0120] The I / O interface 1204 allows a user to enter data in to computing system 1200, as well as provides an input / output for the computing system 1200 to communicate with other devices or services. The I / O interface 1204 can include one or more input buttons, touch pads, touch screens, and so on.

[0121] The external devices 1210 are one or more devices that can be used to provide various inputs to the computing systems 1200, e.g., mouse, microphone, keyboard, trackpad, sensing element (e.g., a thermistor, humidity sensor, light detector, etc. The external devices 1210 may be local or remote and may vary as desired. In some examples, the external devices 1210 may also include one or more additional sensors.

[0122] The memory components 1206 are used by the computing system 1200 to store instructions for the processing element 1202 such as the instructions for controlling the display 118, user preferences, alerts, etc. The memory components 1206 may be, for example, magneto-optical storage, read-only memory, random access memory, erasable programmable memory, flash memory, or a combination of one or more types of memory components.

[0123] The network interface 1208 provides communication to and from the computing system 1200 to other devices. The network interface 1208 includes one or more communication protocols, such as. but not limited to Wi-Fi. Ethernet. Bluetooth, etc. The network interface 1208 may also include one or more hardwired components, such as a Universal Serial Bus (USB) cable, or the like. The configuration of the network interface 1208 depends on the types of communication desired and may be modified to communicate via Wi-Fi, Bluetooth, etc.

[0124] The display 118 provides a visual output for the computing system 1200 and may be varied as needed based on the device. The display 118 may be configured to provide visual feedback to a user and may include a liquid crystal display screen, light emitting diode screen, plasma screen, or the like. In some examples, the display 118 may be configured to act as an input element for the user through touch feedback or the like.

[0125] The use of NASHA as a treatment agent for stress urinary7incontinence (SUI), may provide several unexpected advantages over other treatment agents, including certain bulking agents. NASHA may demonstrate superior biocompatibility and longevity compared to other synthetic materials, potentially reducing the need for repeat treatments. The cross-linked structure of NASHA may provide enhanced volumetric stability, maintaining its bulking properties over extended periods while allowing for natural tissue integration. In some cases. NASHA may exhibit reduced inflammatory response compared to other bulking agents, which may contribute to improved patient comfort and faster recovery times following the injection procedure.

[0126] The viscoelastic properties of NASHA may offer particular benefits in treating SUI by providing dynamic support to the urethral tissues during physical activities that typically trigger incontinence episodes. Unlike rigid bulking materials, NASHA may adapt to the natural movement and compression of urethral tissues during coughing, sneezing, or exercise, while still maintaining sufficient structural support to prevent involuntary' urine leakage. The gel-like consistency of NASHA may also facilitate more precise injection control, allowing healthcare providers to achieve optimal placement and distribution of the treatment agent within the mucosal tissue of the bladder neck.

[0127] Additionally, NASHA may demonstrate favorable degradation characteristics that may allow for gradual replacement by natural tissue over time, potentially providing long-term therapeutic benefits while minimizing the risk of complications associated with permanent implant materials. The biocompatible nature of NASHA may reduce the likelihood of adverse reactions or rejection, making it suitable for a broader range of patients, including those who may not be candidates for more invasive surgical procedures. In some embodiments, the combination of NASHA with dextranomer microspheres may provide synergistic effects, where the microspheres may enhance the structural integrity of the treatment while the NASHA component provides the desired viscoelastic properties for optimal urethral support.

[0128] The description of certain embodiments included herein is merely exemplary in nature and is in no w ay intended to limit the scope of the disclosure or its applications or uses. In the included detailed description of embodiments of the present systems and methods, reference is made to the accompanying drawings which form a part hereof, and which are shown by way of illustration specific to embodiments in which the described systems and methods may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice presently disclosed systems and methods, and it is to be understood that other embodiments may be utilized, and that structural and logical changes may be madewithout departing from the spirit and scope of the disclosure. Moreover, for the purpose of clarity, detailed descriptions of certain features will not be discussed when they would be apparent to those with skill in the art so as not to obscure the description of embodiments of the disclosure. The included detailed description is therefore not to be taken in a limiting sense, and the scope of the disclosure is defined only by the appended claims.

[0129] From the foregoing it will be appreciated that, although specific embodiments of the invention have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention.

[0130] The particulars show n herein are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present disclosure and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of various embodiments of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary' for the fundamental understanding of the invention, the description taken w ith the drawings and / or examples making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

[0131] As used herein and unless otherwise indicated, the terms “a” and ‘"an” are taken to mean “one”, “at least one” or “one or more”. Unless otherwise required by context, singular terms used herein shall include pluralities and plural terms shall include the singular.

[0132] Unless the context clearly requires otherwise, throughout the description and the claims, the words ‘comprise’, ‘comprising’, and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to”. Words using the singular or plural number also include the plural and singular number, respectively. Additionally, the words “herein,” “above,” and “below” and words of similar import, when used in this application, shall refer to this application as a whole and not to any' particular portions of the application.

[0133] All relative, directional, and ordinal references (including top, bottom, side, front, rear, first, second, third, and so forth) are given by way of example to aid the reader's understanding of the examples described herein. They should not be read to be requirements or limitations, particularly as to the position, orientation, or use unless specifically set forth in the claims. Connection references (e.g., attached, coupled, connected, j oined, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, connection references do notnecessarily infer that two elements are directly connected and in fixed relation to each other, unless specifically set forth in the claims.

[0134] Of course, it is to be appreciated that any one of the examples, embodiments or processes described herein may be combined with one or more other examples, embodiments and / or processes or be separated and / or performed amongst separate devices or device portions in accordance with the present systems, devices and methods.

[0135] Finally, the above discussion is intended to be merely illustrative of the present system and should not be construed as limiting the appended claims to any particular embodiment or group of embodiments. Thus, while the present system has been described in particular detail with reference to exemplary7embodiments, it should also be appreciated that numerous modifications and alternative embodiments may be devised by those having ordinary skill in the art without departing from the broader and intended spirit and scope of the present system as set forth in the claims that follow. Accordingly, the specification and drawings are to be regarded in an illustrative manner and are not intended to limit the scope of the appended claims.

Claims

CLAIMSWhat is claimed is:

1. A method for treating stress urinary incontinence in a patient, comprising:inserting a probe assembly into a urethra of a patient, the probe assembly including: a shaft portion and a sheath disposed on the shaft portion and rotatable with respect to the shaft portion;inserting a treatment needle into a needle port of the sheath;extending at least a portion of the probe assembly into the bladder to a desired location without contacting the bladder wall;retracting the probe assembly and rotating the sheath to position the treatment needle relative to the bladder neck at a predetermined angular position;extending the treatment needle into mucosal tissue of the bladder neck at an injection site, the injection site being at the predetermined angular position;injecting a treatment agent into the mucosa to form a cushion at the injection site; withdrawing the treatment needle; andwithdrawing the probe assembly from the urethra.

2. The method of claim 1, further comprising rotating and repositioning the sheath for subsequent injections at additional injections sites, each at a different predetermined angular position.

3. The method of claim 2, wherein the number of additional injection sites ranges from about two to about eight, varying based on the severity of stress urinary incontinence in the patient.

4. The method of claim 1, further comprising purging the probe assembly by introducing an irrigant.

5. The method of claim 1, further comprising irrigating the bladder with a volume of irrigant to enable inspection of the anatomy via an optical element of the probe assembly.

6. The method of claim 1, wherein the predetermined angular position is in a range of about 4-5 o'clock, 7-8 o'clock, 1-2 o'clock, or 10-11 o'clock positions relative to the bladder neck.

7. The method of claim 1, wherein the treatment agent comprises NASHA.

8. The method of any of any one of claims 1-7, wherein the treatment agent further comprises dextranomer microspheres.

9. A system for treating stress urinary incontinence in a patient, comprising:a cystoscope including:a probe assembly with a shaft having a tip,an optical element for capturing images, anda display or optical viewer for presenting the images;a rotatable sheath with a shaft and at least one lumen configured to receive the cystoscope shaft, the sheath being rotatable about the cystoscope shaft;a treatment agent comprising a NASHA; anda treatment needle insertable through the sheath, the needle configured to inject the treatment agent into tissue.

10. A stress urinary incontinence treatment system, comprising:a cystoscope including:a probe assembly with a cystoscope shaft having a tip and an optical element for capturing images,a sheath integrally formed with the cystoscope to create a disposable assembly, the sheath having:a sheath shaft with a first lumen configured to receive the cystoscope shaft,a second lumen, wherein the sheath is rotatable about the cystoscope shaft, anda needle port in communication with the second lumen;irrigation lines configured to provide fluid communication with the first lumen, wherein the irrigation lines are fixed relative to the cystoscope and are non-rotatable with respect to the sheath;a treatment agent comprising a bulking agent; anda treatment needle insertable through the needle port and the second lumen, the treatment needle configured to inject the treatment agent into tissue.

11. The stress urinary incontinence treatment system of claim 10, wherein the bulking agent comprises NASHA.

12. The stress urinary incontinence treatment system of any one of claim 10-11, wherein the bulking agent further comprises dextranomer microspheres.

13. The stress urinary incontinence treatment system of claim 12, wherein the dextranomer microspheres have dimensions ranging from 80-250 micrometers in diameter.

14. The stress urinary incontinence treatment system of claim 10, wherein the treatment needle comprises a needle shaft having at least two sections of different diameters.

15. The stress urinary incontinence treatment system of claim 10, further comprising a stop mechanism configured to prevent the treatment needle from extending more than 2 cm beyond a distal end of the sheath.

16. The stress urinary incontinence treatment system of claim 10, further comprising a stop mechanism configured to indicate an extension length of the treatment needle beyond a distal end of the sheath.

17. The stress urinary incontinence treatment system of claim 10, further comprising a stop mechanism configured to indicate when the distal tip of the treatment needle has extended more than a predefined distance beyond a distal end of the sheath.

18. The stress urinary incontinence treatment system of claim 10, further comprising a valve disposed in the needle port, the valve comprising a main body with a main aperture and one or more sealing arms extending radially from the main body into the main aperture.

19. The stress urinary incontinence treatment system of claim 18, further comprising a seal disposed in the needle port, the seal comprising a main body with a main aperture extending therethrough and a shoulder extending longitudinally from a face of the main body.

20. A stress urinary incontinence treatment system, comprising:a cystoscope including:a probe assembly with a cystoscope shaft having a tip and an optical element for capturing images;a handle assembly including a grip portion and a head portion;a sheath integrally coupled to the probe assembly through a probe hub and handle hub configuration to form a disposable assembly, the sheath having a first lumen configured to receive the cystoscope shaft and a second lumen configured to receive atreatment needle, the sheath being rotatable about the cystoscope shaft;an inflow port and an outflow port positioned on the handle assembly and in fluid communication with the first lumen through the probe hub and handle hub configuration, wherein the inflow port and outflow port do not rotate with the sheath;a needle port in communication with the second lumen, wherein the treatment needle is insertable through the needle port and the second lumen; anda bulking agent configured to be received into and advanced through the treatment needle upon manual engagement with the handle assembly.

21. The stress urinary incontinence treatment system of claim 20, wherein the grip portion has a gun-style shape with an actuator in a trigger position.

22. The stress urinary incontinence treatment system of claim 21, wherein the actuator is configured to cause the system to capture still images or video via the optical element.

23. The stress urinary incontinence treatment system of claim 20, wherein the inflow port and outflow port are both positioned at an end portion of the grip portion.

24. The stress urinary incontinence treatment system of claim 20, further comprising a stop mechanism configured to prevent the treatment needle from extending more than 2 cm beyond a distal end of the sheath.

25. The stress urinary incontinence treatment system of claim 20, further comprising a stop mechanism configured to indicate an extension length of the treatment needle beyond a distal end of the sheath.

26. The stress urinary incontinence treatment system of claim 20, wherein the probe hub comprises a collar that at least partially surrounds a receptacle of the sheath circumferentially, and the receptacle is received within the collar to enable rotational movement of the sheath while maintaining fluid communication pathways.

27. A method for treating stress urinary incontinence in a patient, comprising:providing a stress urinary incontinence treatment system including:a cystoscope with an integrally formed sheath creating a disposable assembly, wherein the sheath is rotatable about a cystoscope shaft and includes a needle port, inserting a treatment needle into the needle port;inserting the cystoscope into a urethra of the patient and advancing the cystoscopedistally until a distal tip of the cystoscope is adjacent to a bladder neck;irrigating a bladder through the irrigation lines;rotating the sheath to position the treatment needle at a predetermined angular position relative to the bladder neck;extending the treatment needle into mucosal tissue of the bladder neck;inj ecting a treatment agent into the mucosal tissue to form a cushion; and withdrawing the treatment needle.

28. The method of claim 27, further comprising a step of repeating the rotating, extending, injecting, and withdrawing steps at additional injection sites around the bladder neck.

29. The method of claim 28, wherein the additional injection sites are positioned at predetermined angular positions comprising 4-5 o'clock, 7-8 o'clock, 1-2 o'clock, and 10-11 o'clock positions relative to the bladder neck.

30. The method of claim 29, wherein a total number of injection sites ranges from about 2 to about 8 injection sites.

31. The method of claim 28, wherein the step of injecting comprises injecting approximately 0.4-0.5 mL of the treatment agent at each injection site.

32. The method of claim 27, wherein the treatment agent comprises NASHA and dextranomer microspheres.

33. The method of claim 32, wherein the dextranomer microspheres have dimensions ranging from 80-250 micrometers in diameter.

34. A stress urinary incontinence treatment system, comprising:a bulking agent;a cystoscope including:a probe assembly with a cystoscope shaft having a tip and an optical element for capturing images;a handle assembly including a grip portion and a head portion;a sheath integrally coupled to the probe assembly through a probe hub and handle hub configuration to form a disposable assembly, the sheath having a first lumen configured to receive the cystoscope shaft and a second lumen configured to receive a treatment needle, the sheath being rotatable about the cystoscope shaft;an inflow port and an outflow port positioned at an end portion of the grip portion and in fluid communication with the first lumen through the probe hub and handle hub configuration, wherein the inflow port and outflow port do not rotate with the sheath:conduits extending from the inflow port and outflow port;an electrical connector disposed in the end portion of the grip portion;a needle port in communication with the second lumen, wherein the treatment needle is insertable through the needle port and the second lumen, wherein the bulking agent is configured to be received into and advanced through the treatment needle upon engagement with the handle assembly.

35. The stress urinary incontinence treatment system of claim 34, wherein the grip portion has a gun-style shape with an actuator in a trigger position.

36. The stress urinary incontinence treatment system of claim 35, wherein the actuator is configured to cause the system to capture still images or video via the optical element.

37. The stress urinary incontinence treatment system of claim 34, further comprising a stop mechanism configured to prevent the treatment needle from extending more than 2 cm beyond a distal end of the sheath.

38. The stress urinary incontinence treatment system of claim 34, further comprising a stop mechanism configured to indicate an extension length of the treatment needle beyond a distal end of the sheath.

39. The stress urinary incontinence treatment system of claim 34, further comprising a stop mechanism configured to indicate when the distal tip of the treatment needle has extended more than a predefined distance beyond a distal end of the sheath.

40. The stress urinary incontinence treatment system of claim 34, wherein the probe hub comprises a collar that at least partially surrounds a receptacle of the sheath circumferentially, and the receptacle is received within the collar to enable rotational movement of the sheath while maintaining fluid communication pathways.

41. The stress urinary incontinence treatment system of any of claims 34-40, wherein the bulking agent comprises NASHA.

42. The stress urinary incontinence treatment system of claim 41, wherein the bulking agent further comprises dextranomer microspheres having dimensions ranging from 80-250 micrometers in diameter.

43. The stress urinary incontinence treatment system of claim 34, further comprising a valve disposed in the needle port, the valve comprising a main body with a main aperture and one or more sealing arms extending radially from the main body into the main aperture.

44. The stress urinary incontinence treatment system of claim 43, further comprising a seal disposed in the needle port, the seal comprising a main body with a main aperture extending therethrough and a shoulder extending longitudinally from a face of the main body.

45. The stress urinary incontinence treatment system of claim 34, wherein the treatment needle comprises a needle shaft having at least two sections of different diameters.

46. The stress urinary incontinence treatment system of claim 34, further comprising a display in electrical communication with the cystoscope via a cable connected to the electrical connector.

47. A method for treating stress urinary incontinence in a patient, comprising:providing a stress urinary' incontinence treatment system including:a treatment agent;a cystoscope with a probe assembly having a cystoscope shaft with a tip and an optical element for capturing images,a handle assembly including a grip portion and a head portion, a sheath integrally coupled to the probe assembly through a probe hub and handle hub configuration to form a disposable assembly, the sheath having a first lumen configured to receive the cystoscope shaft and a second lumen configured to receive a treatment needle, the sheath being rotatable about the cystoscope shaft,an inflow port and an outflow' port positioned at an end portion of the grip portion and in fluid communication with the first lumen through the probe hub and handle hub configuration, wherein the inflow port and outflow port do not rotate with the sheath.conduits extending from the inflow' port and outflow' port,an electrical connector disposed in the end portion of the grip portion, and a needle port in communication with the second lumen;inserting the treatment needle through the needle port and the second lumen;inserting the cystoscope into a urethra of the patient and advancing the cystoscope distally until the distal tip of the cystoscope is adjacent to a bladder neck;irrigating a bladder through the inflow port;rotating the sheath to position the treatment needle at a predetermined angular position relative to the bladder neck;extending the treatment needle into mucosal tissue of the bladder neck;injecting the treatment agent into the mucosal tissue to form a cushion; and withdrawing the treatment needle.

48. The method of claim 47, wherein the grip portion has a gun-style shape with an actuator in a trigger position.

49. The method of claim 48, wherein the actuator is configured to cause the system to capture still images or video via the optical element.

50. The method of claim 47, wherein the stress urinary incontinence treatment system further comprises a stop mechanism configured to prevent the treatment needle from extending more than 2 cm beyond a distal end of the sheath.

51. The method of claim 47, further comprising a stop mechanism configured to indicate an extension length of the treatment needle beyond a distal end of the sheath.

52. The method of claim 47, wherein the probe hub comprises a collar that at least partially surrounds a receptacle of the sheath circumferentially, and the receptacle is received within the collar to enable rotational movement of the sheath while maintaining fluid communication pathways.

53. The method of any of claims 47-52, wherein the treatment agent comprises NASHA.

54. The method of claim 53, wherein the treatment agent further comprises dextranomer microspheres having dimensions ranging from 80-250 micrometers in diameter.

55. The method of claim 47, wherein the stress urinary' incontinence treatment system further comprises a valve disposed in the needle port, the valve comprising a main body with a main aperture and one or more sealing arms extending radially from the main body into the main aperture.

56. The method of claim 55, wherein the stress urinary incontinence treatment system further comprises a seal disposed in the needle port, the seal comprising a main body with a main aperture extending therethrough and a shoulder extending longitudinally from a face of the main body.

57. The method of claim 47, wherein the treatment needle comprises a needle shaft having at least two sections of different diameters.

58. The method of claim 47, wherein the stress urinary incontinence treatment system further comprises a display in electrical communication with the cystoscope via a cable connected to the electrical connector.

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