Vesicoamniotic shunt deployment devices and methods of use

Abstract

Vesicoamniotic shunt deployment devices and related methods are generally described. A vesicoamniotic shunt may form a bypass connection between a fetal bladder and its amniotic sac to resume urine flow out of the bladder following a diagnosis of a lower urinary tract obstruction (LUTO). The deployment device may include a shaft, a trocar arranged coaxial to the shaft, and a handle at a distal end of the device. The device may include a trigger coupled to the shaft and the trocar, such that actuation of the trigger may linearly drive the shaft and the trocar, enabling highly controllable positioning of the shunt relative to the fetal bladder, reducing the risk of improper placement and dislodgement. In some embodiments, the surgeon may be able to deliver the vesicoamniotic shunt through a one-step trigger actuation, drastically reducing the complexity of the shunt placement procedure.

Description

WGS Ref. No.: C1233.70296WG00- 1 -VESICO AMNIOTIC SHUNT DEPLOYMENT DEVICES AND METHODS OF USERELATED APPLICATION

[0001] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application, U.S.S.N. 63 / 685219, filed August 20, 2024, which is incorporated herein by reference in its entirety.FIELD

[0002] Disclosed embodiments are related to vesicoamniotic shunt deployment devices and related methods.BACKGROUND

[0003] Fetal lower urinary tract obstruction (LUTO) is a life-threatening condition in which fetuses, often male, develop a blockage of the bladder in utero. Although rare, approximately 1 in 3,000 live births, the LUTO diagnosis is accompanied with a 45% fatality rate within the neonatal period. The diagnosis often occurs in response to a routine ultrasound at approximately 18-20 weeks gestation, or about halfway through pregnancy.

[0004] A fetus experiencing LUTO is typically unable to pass urine from the bladder into the amniotic sac, reducing the volume of amniotic fluid and accumulating urine within the bladder. LUTO diagnoses are often associated with improper organ development, including severe pulmonary disease, due to insufficient amniotic fluid. Thus, even if the fetus survives and the child is bom after a LUTO diagnosis, there may be increased risks of childhood morbidity due to organ dysfunction which persists well into childhood.SUMMARY

[0005] In some embodiments, a vesicoamniotic shunt deployment device includes an outer shaft extending from a proximal end to a distal end, a trocar arranged substantially inside of the outer shaft, the trocar having a sharp proximal end and a distal end, and a handle operatively coupled to the distal end of the outer shaft, the handle operatively coupled to the distal end of the trocar, wherein the handle comprises a trigger configured to axially displace the outer shaft in a first axial direction and the trocar in a second axial direction, the second axial direction being opposite the first axial direction.#14315340vl

[0006] In some embodiments, a method of deploying a vesicoamniotic shunt includes loading the vesicoamniotic shunt on a trocar, the trocar arranged substantially inside an outer shaft, positioning the vesicoamniotic shunt relative to a fetal bladder wall, and operating a trigger to axially displace the outer shaft in a first axial direction and the trocar in a second axial direction, the second axial direction being opposite the first axial direction to deposit the vesicoamniotic shunt in the fetal bladder wall.

[0007] It should be appreciated that the foregoing concepts, and additional concepts discussed below, may be arranged in any suitable combination, as the present disclosure is not limited in this respect. Further, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various nonlimiting embodiments when considered in conjunction with the accompanying figures.BRIEF DESCRIPTION OF DRAWINGS

[0008] The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures may be represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:

[0009] FIG. 1 illustrates a fetal lower urinary tract obstruction (LUTO) condition;

[0010] FIG. 2 illustrates a method of treatment for fetal LUTO according to prior art;

[0011] FIG. 3 illustrates fetal shunt dislodgment data according to prior art;

[0012] FIGs. 4A-4B illustrate a deployment device for a vesicoamniotic shunt according to some embodiments;

[0013] FIGs. 5A-5B illustrate the operation of a handle of a vesicoamniotic shunt deployment device according to some embodiments;

[0014] FIGs. 6A-6B illustrate a deployment device for a vesicoamniotic shunt according to other embodiments;

[0015] FIGs. 7A-7D illustrate a process of deploying a vesicoamniotic shunt according to some embodiments; and

[0016] FIG. 8 illustrates a vesicoamniotic shunt according to some embodiments.#14315340vlDETAILED DESCRIPTION

[0017] It should be understood that aspects of the invention are described herein with reference to the figures, which show illustrative embodiments. The illustrative embodiments described herein are not necessarily intended to show all aspects of the invention, but rather are used to describe a few illustrative embodiments. Thus, aspects of the invention are not intended to be construed narrowly in view of the illustrative embodiments. In addition, it should be understood that aspects of the invention may be used alone or in any suitable combination with other aspects of the invention.

[0018] Fetal LUTO is a condition in which the lower urinary tract or bladder outflow of a fetus is obstructed. LUTO is a severe but rare condition affecting mostly males, wherein up to 45% of affected fetuses do not survive the neonatal period. Obstruction of urine outflow causes urine accumulation within the bladder, distending the bladder (megacystis) and potentially causing renal issues (e.g., renal dysplasia with hydronephrosis) after birth. The lack of urine outflow (which typically forms the basis for amniotic fluid) into the amniotic sac can cause oligohydramnios, in which there is insufficient amniotic fluid surrounding the fetus.

[0019] Oligohydramnios is associated with a variety of poor fetal and maternal outcomes, including death of the fetus. In particular, a fetus may experience pulmonary hypoplasia, or incomplete lung development due to the insufficient volume of amniotic fluid. Other conditions, such as Potter’s sequence (including cranial anomalies and clubbed feet), congenital abnormalities, and premature death are often associated with oligohydramnios. Even if a fetus survives the LUTO diagnosis and undergoes a successful birth, there may be increased risks of childhood morbidity due to chronic renal dysfunction and other effects of oligohydramnios which persists well into childhood.

[0020] As shown in FIG. 1, a fetus 52 diagnosed with LUTO may exhibit an enlarged bladder 56, due to a blockage in the urinary tract preventing urine outflow into the amniotic sac 50. Thus, although urine flows freely from the fetus’s kidneys 58 to the bladder 56, the urine is accumulated within the bladder, causing megacystis or a distended bladder 56, as shown in FIG. 1 as well as oligohydramnios. A distended bladder 56 can often be identified through a common hypoechoic ultrasound finding in LUTO called a “keyhole” sign 56A.

[0021] A standard treatment for fetuses diagnosed with LUTO is a vesicoamniotic shunt (VAS) placement, in which a highly skilled operator (e.g., fetal surgeon) forms an#14315340vlopening in the fetal bladder to allow urine to flow out into the amniotic sac. There are other methods of draining the bladder, including fetoscopic approaches, but all methods form a bypass between the obstructed bladder and the amniotic sac. Redirecting the flow of urine out of the bladder reduces internal pressures on the bladder and increases the volume of amniotic fluid, helping the fetus continue proper development of critical organs such as the lungs.

[0022] In a typical shunt placement procedure, an operator first performs an amnioinfusion in the case of severe oligohydramnios / anhy dramnios. The operator then punctures the fetal bladder with a needle and trocar to gain access to the bladder, and then removes the trocar through the needle, permitting the bladder to partially drain into the amniotic sac, reducing the pressure on the bladder. The operator must then quickly load a shunt into the needle while not disturbing the trocar, advance the needle with a pushing device, and then attempt to position and deposit the shunt in the proper location on the fetal bladder wall.

[0023] The inventor has recognized that the positioning process is very complex, requiring the use of two highly coordinated hands performing asynchronous pushing and pulling motions on the instrument. Furthermore, the operator only has access to ultrasound feedback during the procedure, as other imaging modalities are not safe for the fetus. Thus, the inventor has recognized that with the limited resolution of the ultrasound, movement of the fetus, and limited deployment space, typical shunt placement procedures carry a substantial amount of risk. Successful deployment is therefore associated with not only high levels of operator skill, but also a multitude of operation conditions, which may or may not be in the favor of the operator. Furthermore, shunt placement procedures can only be conducted one time, enhancing the critical nature of the procedure.

[0024] FIG. 2 depicts a typical shunt placement procedure, wherein an operator positions a shunt 65 in the fetal bladder 56 with a series of complex laparoscopic tools 60. Conventional vesicoamniotic shunts are tubular catheters with double pigtail designs, where one pigtail is typically arranged in the fetal bladder, and the other is arranged in the amniotic sac, as shown in FIG. 2.

[0025] The inventor has recognized that conventional vesicoamniotic shunts and their associated deployment systems can pose significant risks, resulting in approximately 40% complication rate. Placement of conventional shunts is also associated with an approximately 20% risk of amniotic membrane rupture, which can result in fetal demise. Conventional#14315340vlshunts are also associated with high (40%-70%) risks of dislodgement and clogging due to very small catheter inner radii (e.g., 1.5 mm or 1.8 mm for two common shunts known in the art). FIG. 3 shows fetus survival data associated with two conventional shunts, exhibiting high mortality rates associated with shunt dislodgement.

[0026] The inventor has recognized that many of the poor outcomes associated with fetal shunt deployment are associated with the challenging and risky conventional methods of deploying vesicoamniotic shunts. Given the movement of the fetus, the highly sensitive environment, and the small length scales at play (LUTO is diagnosed at 8-16 weeks of development of the fetus), an extremely high level of skill and luck may be necessary to deliver the shunt across the fetal bladder.

[0027] In view of the foregoing, the inventor has recognized a need for a device that enables an operator to accurately position and deposit a shunt relative to a fetal bladder wall. The shunt deployment device may enable an operator to deploy a shunt through a one-step process, reducing the complexity, and therefore potential complications, of the placement procedure. Furthermore, the deployment device may be compatible with existing percutaneous laparoscopic techniques, reducing the need for highly specialized training. Of course, instances in which different benefits are offered by the systems and methods disclosed herein are also possible.

[0028] In some embodiments, a vesicoamniotic or fetal bladder shunt deployment device may include a device handle, an outer shaft, and a trocar. The device handle may be positioned external to the mother and fetus, enabling an operator (e.g., fetal surgeon) to laparoscopically and percutaneously access the fetal bladder through a proximal end of the device. The device trocar may be axially moveable relative to the handle. In some embodiments, a shunt may be pre-loaded on the trocar prior to the procedure, enabling the operator to deliver the shunt quickly and efficiently relative to the multi-step techniques described previously. The shunt may be expandible and hollow, such that it may be loaded on the trocar in a compact configuration.

[0029] In some embodiments, the shaft of the deployment device may be fixed to the handle, whereas in other embodiments, the shaft of the deployment device may be axially movable relative to the handle, as will be described in greater detail below. The deployment device may include a trigger to enable an operator to urge the trocar and / or shaft in a desired direction. The trigger may be coupled to the trocar and / or shaft in a manner that allows#14315340vltrigger actuation to drive the trocar and / or shaft in the desired direction to deploy the shunt. For example, the trigger may be coupled to the trocar and the shaft in a scissor assembly, enabling movement of both of the trocar and the shaft by trigger actuation. In some embodiments, actuation of the trigger may reveal the pre-loaded shunt and enable an operator to position and deposit the shunt in a desired position across the fetal bladder wall to support urine outflow into the amniotic sac.

[0030] In some embodiments, an operator may use ultrasound feedback during the deployment procedure to visualize the proximal end of the device and the fetal bladder. The shunt, and optionally, portions of the outer shaft, may include echogenic portions which may exhibit high contrast on ultrasound images. In some embodiments, the proximal end of the trocar may also exhibit high contrast on the ultrasound images. For example, the proximal end of the trocar is formed of an echogenic material. In another example, the proximal end of the trocar includes echogenic portions. In this way, the operator may be able to identify the shunt during the placement procedure. The echogenic portion of the shunt may also enable the alignment of the shunt with the fetal bladder wall, to promote proper shunt placement, as will be described in greater detail below.

[0031] The devices of the present disclosure may be formed of any suitable material compatible with conventional percutaneous laparoscopic procedures. For example, the trocar may be formed of a metallic (e.g., steel) material for improved rigidity during the procedure. The material composition of the device may also be compatible with sonographic visualization of the procedure. In some embodiments, the deployment device may be a single-use, disposable instrument, whereas in other embodiments, portions of the device may be disposable, while others may be sterilizable for re-use.

[0032] As used herein, the term “proximal” refers to a portion of the device intended to be nearer to the anatomical site (e.g., fetal bladder) or a direction towards the anatomical site. Conversely, the term “distal” refers to a portion of the device intended to be further away from the anatomical site or a direction away from the anatomical site. For example, for a device with a handle intended to be operated outside of a patient and a tip intended to be positioned within a patient, the handle may be arranged at a distal end of the device and the tip may be arranged at a proximal end of the device.

[0033] Turning to figures 4A-8, specific non-limiting embodiments are described in further detail. It should be understood that the various systems, components, features, and#14315340vlmethods described relative to these embodiments may be used either individually and / or in any desired combination as the disclosure is not limited to only the specific embodiments described herein.

[0034] FIGs. 4A-4B depict a deployment device 100 for placing a shunt 150 according to some embodiments. The deployment device may have an outer tubular shaft 110 sized and shaped akin to shafts conventionally used in laparoscopic procedures. Accordingly, the shaft 110 may have a long tubular structure, with a handle 120 at its distal end and an opening at its proximal end 110A. As shown in FIGs. 4A-4B, in some embodiments, the shaft 110 and handle 120 may be fixed together such that movement of the handle 120 in any direction (e.g., proximally into the patient and / or fetus) may result in movement of the shaft 110 in the same direction and for the same magnitude. Accordingly, the position and orientation of the shaft 110 may be directly controlled with the position and orientation of the handle 120.

[0035] In some embodiments, the device 100 may include a trocar 130 arranged at least partially within the shaft. The trocar 130 may be coaxially arranged inside of the shaft 110. The trocar may include a sharp tip 130A for piercing tissue at its proximal end. The sharp tip of the trocar may be any suitable shape conventionally used to pierce tissue with low risk of tugging at the nearby tissue. For example, the sharp tip 130A of the trocar may be in the form of a pointed tip, a barbed tip, and / or an arrowhead- shaped tip. In some embodiments, as shown in FIG. 4A, a shunt 150 may be pre-loaded on a proximal portion of the trocar 130. In this way, the shunt delivery process may be expedited by using the same device to reach the bladder and to deliver or position the shunt.

[0036] The trocar 130 may extend from its sharp proximal end 130A to a distal end 130B, positioned within the handle 120. The distal end 130B of the trocar may be operatively coupled to a trigger 140 of the device. In some embodiments, the trigger 140 may be actuated to linearly displace the trocar along the shaft 110. The trigger 140 may be coupled to the handle 120 at one end, as represented by pin joint 145A in FIG. 4A. The levered arrangement of the trigger 140 may amplify a force (e.g., a squeezing force) applied by an operator to actuate the trigger, although other non-levered arrangements (e.g., buttons, knobs, sliders, wheels) are also contemplated.

[0037] In some embodiments, the levered arrangement of the trigger may be structured to confer a mechanical advantage to the operator’s hands. In other words, the#14315340vllevered arrangement may reduce the force threshold necessary for operating the device. Such a mechanical advantage may be particularly useful for fetal interventionalists with smaller and less forceful hands.

[0038] In some embodiments, the trocar 130 may be coupled to the trigger 140 through a linkage assembly, as shown in FIG. 4A. The trigger 140 may therefore be connected to a link 142 through a pin joint 145B, which may permit pivoting of the trigger 140 and link 142 about the central axis of the pin joint 145B. The link 142 may also be coupled to the distal end 130B of the trocar, as shown in FIG. 4A.

[0039] In some embodiments, a return assembly may be employed to help return the trigger to its original position (and / or an intermediate position) to help retract the trocar. In some embodiments, the trigger may be manually moveable between an actuated position (driving the trocar in a proximal direction) and a non-actuated position (driving the trocar in a distal direction) to permit the operator full control over the axial position of the trocar.

[0040] Accordingly, during operation of the device 100, an operator (e.g., fetal surgeon) may apply a force to the trigger 140 along the indicated arrow of FIG. 4B. The force may pivot the trigger 140 about pin joint 145A and subsequently rotate the link 142 about pin joint 145C. Due to the rigid structure of the link 142, the trocar 130 may be urged in a proximal direction along the indicated arrow of FIG. 4B. Thus, the operator may be able to axially translate the trocar 130 in a proximal direction relative to the shaft 110 with a simple trigger actuation (e.g., trigger squeeze).

[0041] In some embodiments, actuation of the trigger 140 may urge the proximal end of the trocar 130A further out of the proximal end 110A of the shaft, as shown in FIGs. 4A- 4B. In some embodiments, the shunt 150 pre-loaded on the trocar 130 may self-deploy when the shunt 150 is sufficiently positioned outside of the shaft 110, as shown in FIG. 4B. The shunt 150 may be formed of an expandable material, as will be discussed in more detail below, such that without the pressure of the inner walls of the shaft 110, the shunt 150 may return to its original shape.

[0042] To deploy a shunt, an operator may first puncture through the maternal tissue, amniotic sac wall, and fetal bladder wall to position the proximal end of the device within the fetal bladder. In some embodiments, the proximal end 110A of the shaft and / or the proximal end of the trocar 130A may help pierce the tissue. For example, the sharp tip 130A of the trocar may extend beyond the proximal end 110A of the shaft prior to trigger actuation, as#14315340vlshown in FIG. 4A, enabling the operator to pierce through tissue to arrive at the bladder and the proximal end 110A of the shaft may also include a sharpened end (as opposed to the blunt end shown) to form a consistent transition between the proximal end of the trocar 130A and the proximal end 110A of the shaft. During puncturing, the shunt 150 may remain within the shaft and loaded on the trocar 130, as shown in FIG. 4A. In this way, the shunt may be delivered to the fetal bladder with the deployment device, reducing the number of steps of the procedure, and subsequently reducing the complexity and potential complications of the procedure.

[0043] In some embodiments, the operator may employ the use of ultrasound for guidance of the device during the procedure. Once the proximal end of the device is confirmed to be within the fetal bladder through ultrasound feedback, the operator may apply partial pressure to the trigger to axially and proximally translate the trocar relative to the shaft, exposing the shunt 150, as shown in FIG. 4B. The operator may then continue applying pressure to the trigger while simultaneously retracting the handle 120 in a distal direction to help deposit the shunt in the bladder wall. The operator may rely on ultrasound feedback in positioning the shunt to ensure proper placement for urine drainage. Once the device is fully retracted from the mother and the fetus, the operator may continue monitoring the ultrasound feedback of the bladder to evaluate function of the shunt.

[0044] FIGs. 5A-5B depict a handle 120 according to some embodiments. As shown in FIGs. 5A-5B, the handle 120 may have a curved outer surface to enable ergonomic and comfortable operation. In some embodiments, the trigger 140 may be shaped and sized to align with the handle body 120 for additional ergonomic function and ease of use, as shown in FIG. 5B. As described in greater detail above, actuating the trigger 140, as indicated by the arrow of FIG. 5B, may result in a proximal translation of the trocar 130 out of the handle body 120 to help deliver the shunt (not shown) to a fetal bladder wall.

[0045] The inventor has appreciated that in some instances, given the movement of the fetus, the highly sensitive environment, and the small length scales at play (LUTO is diagnosed at 8-16 weeks of development), an extremely high level of skill and luck may be necessary to deliver the shunt across the fetal bladder. The simultaneous action of retracting the device while engaging the trigger may be very challenging with high risks of failure. Thus, the inventor has recognized an improvement to the above-noted system that enables an operator to accurately position a shunt relative to a fetal bladder wall through a one-step#14315340vlprocess, reducing the complexity, and therefore potential complications, of the placement procedure.

[0046] FIGs. 6A-6B depict a shunt deployment device 200 according to some embodiments. The device 200 may include an outer tubular shaft 210 coaxially arranged with a trocar 230, as shown in FIG. 6A. The trocar 230 may be substantially inside of the outer shaft 210. Similar to the trocar 130 of device 100, trocar 230 may extend between a sharp proximal end 230A and a distal end 230B, housed within a handle 220 of the device 200. In some embodiments, the proximal end 230A of the trocar may be positioned outside of the shaft 210 to allow the sharp proximal end of the trocar to pierce through tissue. The shaft may also extend between a proximal end 210A and a distal end 210B housed in the handle 220, as shown in FIG. 6A. The shaft 210 may be axially translatable relative to the handle 220 of the device 200, in contrast to the shaft configuration of device 100 of FIGs. 4A-4B. Thus, both the trocar 230 and the shaft 210 may be axially translatable relative to the handle 220. In some embodiments, a shunt 250 may be pre-loaded on the trocar 230 to reduce the number of steps and tools needed to deliver the shunt to the fetal bladder wall.

[0047] It should be appreciated that the trocar 230 of FIGs. 6A-6B may also include a sharp tip akin to the trocar 130 of FIGs. 4A-4B. Accordingly, the sharp tip of the trocar may be any suitable shape conventionally used to pierce tissue with low risk of tugging at the nearby tissue. For example, the sharp tip 230A of the trocar may be in the form of a pointed tip, a barbed tip, and / or an arrowhead- shaped tip. In some embodiments, the shaft 210 may also include a sharp proximal end 210A configured to pierce through tissue.

[0048] Device 200 may include a trigger 240 coupled to the handle 220 at pin joint 245A, permitting the trigger 240 to pivot relative to the handle 220. The trigger 240 may be coupled to two links, 242 and 244, each of which may be operably coupled to one of the shaft 210 and the trocar 230. For example, as shown in FIG. 6A, a link 242 may extend between a pin joint 245B on the trigger 240 and a pin joint 245C on the distal portion of the trocar 230. In this way, pivoting the trigger 240 toward the handle 220 may urge the trocar 230 in a proximal direction, based on the angle of link 242 relative to the trigger 240. Furthermore, a link 244 may extend between a pin joint 245D on the trigger 240 and a pin joint 245E on a distal portion of the shaft 210. In some embodiments, the trigger may be coupled to the shaft and the trocar through a scissor assembly. Accordingly, pivoting the trigger 240 toward the handle 220 may urge the shaft in a distal direction, based on the angle of link 244 relative to#14315340vlthe trigger 240. Thus, as shown in FIG. 5B, actuation of the trigger (e.g., squeezing the trigger) may simultaneously urge the trocar 230 in a proximal direction while retracting the shaft 210 in a distal direction.

[0049] In some embodiments, actuation of the trigger may drive the trocar and the shaft in sequence, such that an operator may actuate the trigger, causing the proximal movement of the trocar, followed by the distal movement of the shaft, revealing the shunt. For example, as shown in FIG. 6A, the trigger 240 may include an optional slot 243 sized and shaped for pin joint 245D. To initiate the sequence, the operator may first apply a force to the trigger 240, driving the link 242 and the associated trocar 230 in a proximal direction and driving the pin joint 245D in a proximal direction along optional slot 243. Once the joint 245D reaches the proximal-most point in the slot 243, the joint 245D may then abut against the slot 243 and the link 244 may be urged to rotate, driving the shaft 210 in a distal direction. In this way, the shaft 210 movement may occur sequentially after the trocar 230 movement. It should be appreciated that other methods of achieving sequential shaft and trocar movement are also contemplated, as the present disclosure is not so limited.

[0050] Accordingly, the one-step trigger actuation may result in movement of the trocar and the shaft either simultaneously or sequentially. In either configuration, the shunt may remain in position relative to the bladder wall.

[0051] It should be appreciated that in some embodiments, a return assembly may be employed to help return the trigger to its original position (and / or an intermediate position) to help retract the trocar and expel the shaft back to their original positions. For example, the operator may release the trigger and rely on a spring-based return assembly to return the trigger back to its unactuated position. In some embodiments, the trigger may be manually moveable between an actuated position and a non-actuated position to permit the operator full control over the axial position of the trocar such that releasing the trigger may not result in the trigger returning to its unactuated position.

[0052] In some embodiments, the shunt 250 may include an echogenic portion 260 with increased contrast during ultrasound imaging. In this way, the operator may be able to directly visualize the position of the shunt during the delivery process to further facilitate proper shunt placement. In some embodiments, the shunt 250 may have a generally hollow structure, including a saddle portion arranged in between a pair of bulbous portions. When the shunt is properly placed across a tissue wall, the saddle portion may span the opening#14315340vlwithin the wall, while the bulbous portions, extending radially beyond the opening of the wall, may significantly reduce the risk of dislodgement. Shunt 250 is described in greater detail relative to FIG. 8. It should be appreciated that the device 200 may be employed to deliver any suitable expandable shunt and that shunt 250 is a non-limiting example of a vesicoamniotic shunt.

[0053] To deploy a shunt, an operator may first position the proximal ends of the shaft 210A and trocar 230A in the fetal bladder. The operator may then use ultrasound feedback to verify the position of the device relative to the fetal bladder wall. In some embodiments, the operator may align the echogenic portion 260 of the shunt 250 to the fetal bladder wall while the shunt is still positioned within the shaft 210. In this way, the operator may adjust the position of the shunt 250 without accidentally engaging the shunt to the bladder wall. Once the operator is satisfied with the position of the shunt relative to the bladder wall (verified through synchronous ultrasound feedback) the operator may actuate the trigger 240 to move the shaft 210 in a distal direction and the trocar 230 in a proximal direction, as shown in FIG. 6B. Accordingly, the simultaneous (or sequential) movements of the shaft and the trocar may reveal the shunt in the same position as prior to the trigger actuation. For example, as shown in FIG. 6A-6B, the shunt 250 may remain centrally positioned relative to a line L. In this way, the operator may only need to operate the trigger 240 one time to achieve proper positioning of the shunt in the bladder wall. The device 200 may then be manually retracted from the mother and the fetus by distally moving the handle 220, permitting the trocar 230 to pass through the hollow lumen of the shunt, and leaving the shunt deployed in the fetal bladder wall.

[0054] It should be appreciated that FIGs. 4A-4B and FIGs. 6A-6B are schematic representations of the devices 100 and 200 and are non-limiting in the shapes, sizes, and / or arrangements of structures. For example, the handles of the deployment devices may include various ergonomic and functional features consistent with medical devices. Accordingly, the specific arrangements shown in the figures are for illustrative purposes only.

[0055] Furthermore, the linkage systems of the triggers of the devices may include numerous other elements to axially translate the necessary components of the devices. It should also be appreciated that although linkages are described relative to devices 100, 200, the device may employ any suitable arrangement or combination of arrangements to couple the trigger to the suitable components (e.g., trocar or trocar and shaft) of the device. For#14315340vlexample, the trocar and / or shaft of the device may be coupled to the trigger through a rack and pinion assembly, a gear assembly, a lead screw assembly, a cam assembly, a slider-crank assembly, and / or any other suitable mechanical and / or electromechanical methods of linearly displacing the trocar through operation of the trigger, as the present disclosure is not so limited. The device may be manually driven, or, in some embodiments, may employ the use of a motor to achieve the desired deployment procedure.

[0056] FIGs. 7A-7D show a close-up view of a deployment process using device 200 of FIGs. 6A-6B according to some embodiments. The device 200 may include an axially moveable trocar 230 arranged coaxially within an axially moveable shaft 210. The trocar may have a sharp proximal end 230A configured to pierce through tissue. In some embodiments, the proximal end 230A of the trocar 230 may be arranged outside of the shaft 210, as shown in FIGs. 7A-7B, to permit the proximal end 230A of the trocar to pierce through maternal tissue 40, amniotic fluid 50, the fetal bladder wall 52 (including the fetal skin for visual clarity), and into the fetal bladder 56. As described previously, the fetal bladder 56 may be distended with a large volume of accumulated urine.

[0057] Once the proximal end of the device is arranged within the fetal bladder 56, as shown in FIG. 7B, the operator may use ultrasound feedback to position a shunt 250, pre- loaded on the trocar and having an echogenic portion 260, relative to the bladder wall 52. In other words, the operator may determine the optimal location of the shunt 250 relative to the bladder wall 52 when the shunt 250 is still arranged in its compact configuration within the shaft 210. In this way, risks of early deployment, accidental engagement of the shunt with nearby tissue, and / or improper seating of the shunt 250 may be significantly reduced. It should be appreciated that the echogenic portion 260 of the shunt 250 (and, in some embodiments, echogenic portions of the proximal ends of the trocar and / or the shaft) may be identifiable with ultrasound imaging even when the shunt 250 is seated within the shaft 210. In some embodiments, the device may also include echogenic markers along a portion of the shaft (e.g., the proximal portion of the shaft 210), to provide ultrasound feedback to the operator regarding the position of the shaft relative to the bladder wall, ensuring proper placement in the fetal bladder.

[0058] In some embodiments, once the operator is satisfied with the position of the shunt relative to the bladder wall 52 (e.g., the saddle portion of the shunt being aligned with the bladder wall), the operator may actuate a trigger of the device to urge the trocar 230 in a#14315340vlproximal direction and the shaft 210 in a distal direction, as shown in FIG. 7C. Thus, the operator’s trigger actuation may reveal the shunt 250 in substantially the same position relative to the bladder wall 52 as when the shunt 250 was arranged within the shaft 210. The shunt 250 is therefore properly positioned with a single trigger actuation, according to some embodiments. It should be appreciated that the shunt 250 may expand upon deployment, as shown in FIG. 7C, but that the central point of the shunt may remain unchanged from its undeployed configuration.

[0059] It should be appreciated that the shunt 250 may be delivered through a one- handed trigger actuation of the device, eliminating the need for the operator to manually retract the device while positioning the shunt, as may be the case for conventional shunt deployment systems, as well as device 100 of FIGs. 4A-4B. Thus, the operator may only be tasked with maintaining the handle still in space while actuating the trigger to deliver the shunt, without the need to conduct highly sensitive backward and forward motions with limited visibility due to poor ultrasound resolution. Accordingly, the shunt may be centrally positioned against the bladder wall based on the operator’s adjustments in a more automated manner, reducing the need for exceptional skill and luck during the procedure.

[0060] To remove the device, as shown in FIG. 7D, the operator may retract the trocar 230 through the central lumen of the shunt 250, which may have a larger radial clearance due to shunt expansion, permitting the trocar 230 to pass distally through the expanded shunt 250 with limited risk of accidentally engaging with the trocar. Removing the trocar 230 while retaining the expanded shunt 250 within the bladder wall may allow urine to flow out of the bladder 56 and into the amniotic sac 50 through the shunt 250. In some embodiments, the percutaneous insertion site may be sutured 30, as shown in FIG. 7D.

[0061] FIG. 8 shows a shunt 250 according to some embodiments. The shunt 250 may be formed of a specifically arranged braided material to accommodate proper expansion and contraction to enable the shunt to fit within the small diameter of a device shaft. The shunt may be formed of a nitinol composition to lock in a particular expanded configuration. It should be appreciated that the shunt may have a coating to reduce the risks of metal toxicity, adherence, and rejection, including, but not limited to, a silicone coating achieved through a spray-coating process.

[0062] The shunt 250 may have a substantially hollow structure, including a saddle portion 254 arranged in between two bulbous portions 252. In some embodiments, the#14315340vlbulbous portions may be radially larger than the saddle portion 254. As also shown in FIG. 7D, the saddle portion may be shaped to traverse an opening through a tissue wall, whereas the bulbous portions are shaped to significantly reduce the risk of dislodgement across the tissue wall. The radius of the bulbous portions may be larger than the radius of the opening of the tissue wall, such that the bulbous portions may abut against the tissue wall, with limited risk of being able to be pulled out through the opening. Thus, the shunt 250 may be arranged such that the saddle portion 254 may traverse the bladder wall opening, and a first bulbous portion may abut against an inner face of the bladder wall, and a second bulbous portion may abut against an outer face of the bladder wall. In this way, the shunt may remain within the fetal bladder wall, permitting urine flow into the amniotic sac, with limited risk of dislodgement.

[0063] Once the fetus is bom and the operator determines that the shunt may be removed, the shunt may be manipulated in a particular configuration (e.g., twisted) to help return the shunt back into its compacted configuration, such that it may readily pass through the bladder wall and be removed from the baby. Accordingly, the shunts of the present disclosure may be removed postnatally.

[0064] In some embodiments, the shunt 250 may have a minimum saddle diameter DI of approximately 5 mm, which may be larger than inner diameters of conventional vesicoamniotic shunts, which may be on the order of 1.5 mm or 1.8 mm. The larger saddle diameter of shunt 250 may reduce the risk of blockages and clogs, increase the outflow of urine into the amniotic sac, and reduce the risk of accidental kinks or twists within the shunt, blocking urine flow.

[0065] In some embodiments, the shunt 250 may include an echogenic portion 260 to enable visualization of the shunt during deployment. For example, the echogenic portion 260 may be formed of a radiopaque material to enable ultrasound visualization during deployment. In some embodiments, the echogenic portion 260 of the shunt may be etched directly into the shunt material, whereas in other embodiments, the echogenic portion 260 may comprise a coating or treatment of the shunt. In some embodiments, the proximal ends of the shaft and the trocar may include echogenic portions to further facilitate ultrasound visualization of the deployment process.#14315340vl

[0066] It should be appreciated that any suitable method of rendering a portion of the shunt and / or device to be echogenic is contemplated, and that the present disclosure is not limited by the material composition, position, and / or quality of the echogenic portion.

[0067] It should also be appreciated that the description of shunt 250 described herein is illustrative and non-limited. Thus, shunt deployment devices of the present disclosure may be used to deliver any suitable shunt, including shunts with features represented by FIG. 8. In other words, the shunt deployment devices of the present disclosure may be used to deliver any suitable conventional stent or shunt, in addition to the shunt 250 described herein. Accordingly, the shunt deployment devices are the present disclosure are not limited by the shunts they are used to deliver.

[0068] While the present teachings have been described in conjunction with various embodiments and examples, it is not intended that the present teachings be limited to such embodiments or examples. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents, as will be appreciated by those of skill in the art. Accordingly, the foregoing description and drawings are by way of example only.

[0069] While several embodiments of the present invention have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the functions and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the present invention. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the teachings of the present invention is / are used. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the invention may be practiced otherwise than as specifically described and claimed. The present invention is directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles,#14315340vlmaterials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the scope of the present invention.#14315340vl

Claims

CLAIMSWhat is claimed is:

1. A vesicoamniotic shunt deployment device comprising: an outer shaft extending from a proximal end to a distal end; a trocar arranged substantially inside of the outer shaft, the trocar having a sharp proximal end and a distal end; and a handle operatively coupled to the distal end of the outer shaft, the handle operatively coupled to the distal end of the trocar, wherein the handle comprises a trigger configured to axially displace the outer shaft in a first axial direction and the trocar in a second axial direction, the second axial direction being opposite the first axial direction.

2. The vesicoamniotic shunt deployment device of claim 1, wherein the trigger is configured to simultaneously displace the outer shaft and the trocar.

3. The vesicoamniotic shunt deployment device of claim 1, wherein the trigger is configured to sequentially displace the outer shaft and the trocar.

4. The vesicoamniotic shunt deployment device of claim 1, wherein the outer shaft is operatively coupled to the trigger through a first link, and wherein the trocar is coupled to the trigger through a second link.

5. The vesicoamniotic shunt deployment device of claim 1, wherein the outer shaft is operatively coupled to the trigger with at least one of the following: a linkage assembly, a rack and pinion assembly, a gear assembly, a lead screw assembly, a cam assembly, a slider-crank assembly, or a motorized assembly, and wherein the trocar is operatively coupled to the trigger with at least one of the following: a linkage assembly, a rack and pinion assembly, a gear assembly, a lead screw assembly, a cam assembly, a slider-crank assembly, or a motorized assembly.#14315340vl6. The vesicoamniotic shunt deployment device of claim 1, further comprising a shunt arranged on the trocar, the shunt having a saddle portion arranged in between a pair of bulbous portions.

7. The vesicoamniotic shunt deployment device of claim 6, wherein the saddle portion of the shunt comprises an echogenic material, and wherein the shunt is coated with a silicone material.

8. The vesicoamniotic shunt deployment device of claim 1, wherein the trigger is operatively coupled to the distal end of the outer shaft, and wherein the trigger is operatively coupled to the distal end of the trocar.

9. The vesicoamniotic shunt deployment device of claim 1, wherein the first axial direction is a distal direction, and wherein the second axial direction is a proximal direction.

10. A method of deploying a vesicoamniotic shunt, the method comprising: loading the vesicoamniotic shunt on a trocar, the trocar arranged substantially inside an outer shaft; positioning the vesicoamniotic shunt relative to a fetal bladder wall; and operating a trigger to axially displace the outer shaft in a first axial direction and the trocar in a second axial direction, the second axial direction being opposite the first axial direction to deposit the vesicoamniotic shunt in the fetal bladder wall.

11. The method of claim 10, wherein the step of operating the trigger further comprises simultaneously displacing the outer shaft and the trocar.

12. The method of claim 10, wherein the step of operating the trigger further comprises sequentially displacing the outer shaft and the trocar.

13. The method of claim 10, further comprising piercing through maternal and fetal tissue with a sharp proximal end of the trocar.#14315340vl14. The method of claim 10, wherein the step of positioning the vesicoamniotic shunt relative to a fetal bladder wall comprises: visualizing the vesicoamniotic shunt with ultrasound feedback; visualizing the proximal end of the trocar with ultrasound feedback; and adjusting the vesicoamniotic shunt according to the ultrasound feedback.

15. The method of claim 10, wherein the step of depositing the vesicoamniotic shunt comprises: depositing a saddle portion of the vesicoamniotic shunt in the fetal bladder wall; depositing a first of a pair of bulbous portions of the vesicoamniotic shunt at an inner face of the fetal bladder wall; and depositing a second of the pair of bulbous portions of the vesicoamniotic shunt at an outer face of the fetal bladder wall, the saddle portion being arranged in between the pair of bulbous portions.

16. The method of claim 15, wherein the saddle portion of the vesicoamniotic shunt comprises an echogenic material, and wherein the vesicoamniotic shunt is coated with a silicone material.

17. The method of claim 10, further comprising retracting the trocar from the fetal bladder wall through an inner lumen of the vesicoamniotic shunt.

18. The method of claim 10, wherein the step of operating the trigger comprises: operating at least one of a linkage assembly, a rack and pinion assembly, a gear assembly, a lead screw assembly, a cam assembly, a slider-crank assembly, or a motorized assembly to axially displace the outer shaft; and operating at least one of a linkage assembly, a rack and pinion assembly, a gear assembly, a lead screw assembly, a cam assembly, a slider-crank assembly, or a motorized assembly to axially displace the trocar.#14315340vl19. The method of claim 10, further comprising releasing the trigger to axially displace the trocar in the first axial direction and the outer shaft in the second axial direction.

20. The method of claim 10, wherein the first axial direction is a distal direction, and wherein the second axial direction is a proximal direction.#14315340vl

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