Intraluminal stent with handle for treating benign prostatic hyperplasia

Abstract

A stent is disclosed that is configured to maintain patency of the prostate urethra regardless of enlargement of the prostate. The bracket may include a handle that is disposed outside of the flow path of the bracket in the undeflected position. When the handle is pulled, the handle may deflect to substantially align with the central axis of the bracket. A capture device is disclosed that includes a tapered tip to navigate a working channel of a delivery device and a hook that can capture a stent handle and can be moved into a tube to retain the stent handle to facilitate access of a stent into and out of the working channel of the delivery device. A loading adapter having a tapered port is disclosed that can be disposed on a delivery device to distribute compressive forces exerted by the port on a stent during loading to a working channel.

Description

Cross - Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 484,462, filed Feb. 10, 2023, and U.S. Provisional Patent Application No. 63 / 376,984, filed Sep. 23, 2022, under 35 U.S.C. 119(e), the entire disclosures of each of which are hereby incorporated by reference. Background of the Invention

[0002] Benign prostatic hyperplasia (BPH) is a common benign condition that occurs in men and is bothersome in elderly patients. In this condition, the prostate gland is enlarged and not cancerous. Benign prostatic hyperplasia is also known as benign prostatic hypertrophy or benign prostatic obstruction.

[0003] The prostate is a fibromuscular and glandular organ located just below the bladder. As the prostate gland enlarges, it compresses and pinches the prostatic urethra. This causes the bladder to weaken and be unable to empty completely. The narrowing of the prostatic urethra results in the observed symptoms of BPH. Approximately half of men over the age of 50 will develop an enlarged prostate. By the time men reach 70 and 80 years old, about 85 - 90% of them will experience urinary tract symptoms caused by BPH.

[0004] Although the cause of BPH is not fully understood, it is thought to be multifactorial and under endocrine control. BPH develops in the transitional zone of the prostatic urethra. Symptoms typically include irritative and obstructive flow. Specifically, the following symptoms may suggest BPH: frequent urination, urgency, difficulty starting urination, retention, incontinence, nocturia, pain after ejaculation. Complications of BPH include bladder stones, urinary tract infections, hematuria, bladder decompensation, renal failure, and acute / chronic urinary retention.

[0005] Pharmacological methods of treatment include the use of alpha - blockers such as phenoxybenzamine (non - selective), prazosin (short - acting), terazosin and doxazosin (long - acting), as well as tamsulosin, alfuzosin, and silodosin (alpha1a - selective blockers). In addition, 5α - reductase inhibitors and combination therapies are also used. The effectiveness of pharmacological methods is insufficient and they are usually used as short - term treatments. Side effects of pharmacological methods include orthostatic hypotension, dizziness, fatigue, retrograde ejaculation, rhinitis, and headache.

[0006] Conventional and recent surgical treatments include transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP), laser therapy, other forms of energy to vaporize the prostate, simple prostatectomy, prostate stents, and office-based procedures such as prostatic urethral lift. For TURP, endoscopic electro-surgical resection is used to relieve symptoms and improve flow rate. However, TURP requires spinal or general anesthesia, and the recovery time is 4 - 6 weeks with catheterization for at least 24 hours. Additionally, TURP may cause impotence, incontinence, bleeding, retrograde ejaculation, and transurethral resection (TUR) syndrome (vomiting, nausea, confusion, hypertension, etc.). Simple prostatectomy may be performed when the prostate weighs over 100 grams or when BPH is associated with large bladder stones. With laser therapy, laser energy is used to ablate, vaporize, or remove the prostate, with the advantages of minimal bleeding and being able to be performed as an outpatient procedure. However, laser therapy may require longer postoperative catheterization times and requires costly laser fibers and generators. Other forms of energy (including microwave, focused ultrasound, water-induced thermotherapy, electro-vaporization, etc.) have also been tried with varying results. Transurethral balloon dilation of the prostate has also been attempted in the past with poor results. Prostate stents (temporary and permanent) have also been employed in the past. Poor fixation, migration, and difficulty in removal of the stents have led to poor outcomes / utilization. Recent developments include prostatic urethral lift - a technique that suspends the prostate away from the urethra. While the procedure is minimally invasive, it still has certain drawbacks such as the use of a temporary catheter, questions about the durability of the results, and the chance of patient recovery pain / trouble. SUMMARY OF THE INVENTION

[0007] Some embodiments disclosed herein relate to minimally invasive systems and methods for maintaining the patency of body cavities. One non-limiting indication is the treatment of benign prostatic hyperplasia (BPH). The device for such treatment may include a stent placed within the prostatic urethra. The device may be coated with polytetrafluoroethylene (PTFE), silicone, and / or other hydrophilic and / or hydrophobic coating materials. In some embodiments, the device may be coated with one or more therapeutic agents, including drugs such as α-1 blockers, 5α-reductase inhibitors, and / or combination therapies such as in an extended release coating. In some embodiments, the device is not coated with one or more therapeutic agents, such as drugs.

[0008] The stent can control and improve flow throughout the urethra without interfering with the natural dilation and collapse of the urethra during excretion. For example, the proximal region of the stent (closest to the internal urethral sphincter and bladder at the time of implantation), sometimes referred to as the caudal region, can be configured with multiple atraumatic ends or lobes to anchor the stent within the prostatic urethra and prevent proximal migration of the stent (e.g., into or towards the bladder). The middle region of the stent (sometimes referred to as the body region) can be positioned within the prostatic urethra, between the internal and external urethral sphincters. The distal region of the stent (closest to the external urethral sphincter at the time of implantation) can include diamond-shaped cells and a handle. The distal region can be configured to serve as a connection point for delivery and retrieval of the stent. For example, a detachable member (such as a clamp, hook, or forceps-like grasping member) can be releasably attached to the handle to push the stent out of or pull the stent into the working channel of a delivery catheter or endoscope (such as a cystoscope, etc.), and / or rotate the stent to a desired orientation.

[0009] The stent can be constructed of any one or more of a variety of materials. For example, the stent can be constructed of a shape memory alloy (SMA), a flexible metal such as stainless steel, titanium, and / or a flexible polymer including a shape memory polymer (SMP). In some embodiments, the stent material can include a coating to prevent degradation and encrustation. The coating can be hydrophobic and / or hydrophilic in nature, such as silicone. In some embodiments, the coating can include PTFE or expanded polytetrafluoroethylene (ePTFE). In some embodiments, the coating can include flexible silicone, hydrogel, a mucosal adhesion substrate, a pressure-sensitive adhesive, and / or other suitable elastomers such as synthetic rubber. In one or more embodiments, the coating can include a micropattern, which can include a bio-derived protein structure (e.g., collagen, etc.) and / or be formed by a bio-derived protein structure.

[0010] In some embodiments, a method of implanting a urethral stent is disclosed herein. An image-guided flexible cystoscope or catheter having a camera can be used in combination with a mechanism for deploying, retrieving, and / or repositioning the stent. The stent can be loaded into the flexible cystoscope from the distal (output) end of the scope.

[0011] The stent can be customized or sized for a particular patient, including age, race, demographics, predisposition, urethral size, prostate size, anatomical differences, and other factors unique to the patient. For example, the length of the stent or the length of each region of the stent can be selected and configured to match the specific anatomical dimensions of the patient.

[0012] In some embodiments, the device can include any combination of the following features or other features disclosed herein.

[0013] In some embodiments, the techniques described herein relate to a device for maintaining patency of the prostatic urethra, the device comprising: a stent including a proximal end, a distal end, a channel between the proximal end and the distal end, a peripheral wall, and a handle, the channel being configured to facilitate the flow of body fluid between the proximal end and the distal end, the peripheral wall surrounding the channel, the peripheral wall including a plurality of struts and a plurality of nodes, the plurality of struts and the plurality of nodes being coupled to each other to form a plurality of cells, the handle being biased to a position outside the channel of the stent, the stent being configured to expand from a compressed configuration to an expanded configuration within a body cavity; wherein the handle is configured to deflect when pulled in an axial direction from the position outside the channel to another position within the channel.

[0014] In some embodiments, the techniques described herein relate to a device wherein the handle is disposed on the distal end of the stent.

[0015] In some embodiments, the techniques described herein relate to a device wherein the handle includes a bend that biases the handle to a position outside the channel.

[0016] In some embodiments, the techniques described herein relate to a device wherein the handle extends from a distal strut of the plurality of struts and bends to extend in a direction generally perpendicular to a central longitudinal axis of the stent.

[0017] In some embodiments, the techniques described herein relate to a device wherein the handle includes a groove configured to engage a capture device for loading into a working lumen of a delivery device.

[0018] In some embodiments, the techniques described herein relate to a device wherein the groove is configured to project distally when the stent is disposed within the body cavity.

[0019] In some embodiments, the techniques described herein relate to a device wherein the groove is disposed generally along a central longitudinal plane of the stent.

[0020] In some embodiments, the techniques described herein relate to a device wherein the handle includes a loop.

[0021] In some embodiments, the techniques described herein relate to a device wherein the handle includes a straight portion generally perpendicular to a central longitudinal axis of the stent.

[0022] In some embodiments, the techniques described herein relate to a device wherein the handle is configured to deflect when pulled from a position outside the channel to generally align with a central longitudinal axis of the stent.

[0023] In some embodiments, the techniques described herein relate to a device comprising a collapsibility gradient between a proximal end and a distal end of a stent.

[0024] In some embodiments, the techniques described herein relate to a device, wherein the plurality of struts and the plurality of nodes form a circumferential ring.

[0025] In some embodiments, the techniques described herein relate to a device, wherein the circumferential ring comprises struts of the plurality of struts in a Z-pattern.

[0026] In some embodiments, the techniques described herein relate to a device, wherein the circumferential ring comprises angled struts of the plurality of struts in an alternating pattern of distally angled struts and proximally angled struts.

[0027] In some embodiments, the techniques described herein relate to a device, wherein the circumferential ring provides different outward radial forces.

[0028] In some embodiments, the techniques described herein relate to a device, wherein an intermediate portion of the stent provides a greater outward radial force than the outward radial forces provided by the distal end and the proximal end.

[0029] In some embodiments, the techniques described herein relate to a device, wherein the plurality of cells comprises diamond-shaped cells.

[0030] In some embodiments, the techniques described herein relate to a device, wherein the diamond-shaped cells are disposed near the handle.

[0031] In some embodiments, the techniques described herein relate to a device, wherein the diamond-shaped cells distribute tension on the stent to facilitate collapse of the stent.

[0032] In some embodiments, the techniques described herein relate to a device, wherein the handle is biased to a position coplanar with the outer peripheral wall when viewed from an axial direction.

[0033] In some embodiments, the techniques described herein relate to a method of loading a stent into a working lumen of a delivery device, the method comprising: coupling a handle of the stent to a capture device, the handle being biased to a position outside a channel for body fluid through the stent; deflecting the handle to another position in the channel by pulling the handle axially with the capture device; and retracting the stent by pulling the handle into the working lumen of the delivery device with the capture device such that the stent is compressed to the diameter of the working lumen.

[0034] In some embodiments, the techniques described herein relate to a method, wherein the handle is biased to a position coplanar with the outer peripheral wall of the stent.

[0035] In some embodiments, the techniques described herein relate to a method in which coupling the handle of a stent to a capture device includes capturing the handle in a hook of the capture device.

[0036] In some embodiments, the techniques described herein relate to a method of delivering a stent into the prostatic urethra, the method comprising: pushing the handle of the stent with a capture device to deploy the stent outside the working lumen of the delivery device into the prostatic urethra; and releasing the handle of the stent from the capture device to allow the handle to spring away from the central longitudinal axis of the stent to engage the wall of the urethra.

[0037] In some embodiments, the techniques described herein relate to a method in which the handle is configured to be proximal to the apex located at the verumontanum.

[0038] In some embodiments, the techniques described herein relate to a capture device configured to grasp a stent, the capture device comprising: a tapered tip; and a body distal to the tapered tip, the body including a hook configured to couple with the stent to manipulate the stent.

[0039] In some embodiments, the techniques described herein relate to a capture device in which the hook is configured to couple with the stent handle of the stent.

[0040] In some embodiments, the techniques described herein relate to a capture device further comprising a tube configured to be disposed on the body to secure the stent to the hook.

[0041] In some embodiments, the techniques described herein relate to a capture device in which the tapered end includes a perimeter extending beyond the outer perimeter of the body to expose the distally facing surface of the tapered end, the distally facing surface of the tapered end being configured to engage the proximal end of the tube to secure the stent handle of the stent to the hook.

[0042] In some embodiments, the techniques described herein relate to a capture device in which the tapered end includes a width smaller than the opening of the access tube to provide lateral space on either side of the tapered end for the stent handle to pass through when the stent handle is secured by the hook.

[0043] In some embodiments, the techniques described herein relate to a method of capturing the handle of a stent with a capture device, the method comprising: pushing the capture device out of the tube to expose the hook of the capture device; positioning the handle of the stent in the hook; and retracting the capture device so that the distally facing surface of the tip of the capture device contacts the proximal end of the tube such that the hook is disposed in the tube to secure the handle.

[0044] In some embodiments, the techniques described herein relate to a method in which, when the handle is secured to the hook in the tube, the handle passes through the lateral space on the opposite side of the tip of the capture device to reach the stent.

[0045] In some embodiments, the techniques described herein relate to controlling the movement of a capture device to capture a handle of a stent, the handle comprising: a first internal space and one or more retention features disposed at an opening leading to the first internal space; an actuation mechanism comprising an actuator configured to be coupled to the capture device using a push wire and a button, the actuator configured to be disposed within the first internal space of the handle and comprising a second internal space and one or more locking features, the one or more locking features configured to engage the one or more retention features to prevent advancement of the actuator within the first internal space, and the button configured to be disposed within the second internal space and comprising a body and one or more grooves; wherein the button is configured to be advanced within the second internal space of the actuator to contact an inner surface of the actuator defining the second internal space and position the one or more grooves radially inward of the one or more locking features; wherein the button is configured to be further advanced to apply a force to the actuator such that the one or more locking features radially inwardly deflect away from the one or more retention features and into the one or more grooves of the button to enable advancement of the actuator within the first internal space of the handle; and wherein advancement of the actuator within the first internal space of the handle causes the push wire to advance the capture device.

[0046] In some embodiments, the techniques described herein relate to a handle wherein a capture device is configured to be advanced out of a tube to expose a hook that holds the stent handle, such that the stent handle is allowed to deflect out of the hook to permit delivery of the stent into the urethra.

[0047] In some embodiments, the techniques described herein relate to a handle wherein one or more retention features include angled surfaces.

[0048] In some embodiments, the techniques described herein relate to a handle wherein one or more locking features include flared edges complementary to the angled surfaces.

[0049] In some embodiments, the techniques described herein relate to a method of controlling the movement of a capture device with an actuation mechanism of a handle, the method comprising: advancing a button within an internal space of an actuator to contact an inner surface of the actuator and positioning one or more grooves of the button radially inward of one or more locking features of the actuator; applying an axial force to the button and the actuator to push the one or more locking features of the actuator against one or more retaining features disposed at an opening leading to the internal space of the handle such that the one or more locking features deflect away from the one or more retaining features and into the one or more grooves of the button; and advancing the button and the actuator within the internal space of the handle to advance a push wire coupled to the actuator, thereby advancing a capture device configured to capture a stent.

[0050] In some embodiments, the techniques described herein relate to a method in which one or more retaining features include angled surfaces.

[0051] In some embodiments, the techniques described herein relate to a method in which one or more locking features include flared edges complementary to the angled surfaces.

[0052] In some embodiments, the techniques described herein relate to a loading adapter for facilitating loading of a stent into a working channel of a delivery device, the loading adapter comprising: a port disposed outside a central longitudinal axis of the loading adapter, wherein the port tapers in a distal direction to a narrower cross-section; and a receiving region disposed on an opposite side of the loading adapter, the receiving region configured to receive a proximal end of the delivery device to position the loading adapter on the proximal end of the delivery device; wherein the port is configured to be coaxially aligned with the working channel of the delivery device to facilitate loading of the stent into the working channel.

[0053] In some embodiments, the techniques described herein relate to a loading adapter in which a distal side of the port includes a diameter corresponding to a diameter of the working channel.

[0054] In some embodiments, the techniques described herein relate to a loading adapter that further includes a cavity having a constant diameter connecting the port and the receiving region.

[0055] In some embodiments, the techniques described herein relate to a loading adapter in which the constant diameter of the cavity corresponds to a diameter of the working cavity.

[0056] In some embodiments, the techniques described herein relate to a loading adapter in which the taper of the port distributes a compressive force on the stent as the stent is pulled through the port and collapses.

[0057] In some embodiments, the techniques described herein relate to a method of loading a stent into a working channel of a delivery device using a loading adapter, the method comprising: disposing the loading adapter on the proximal end of the delivery device; coaxially aligning the tapered port of the loading adapter with the working channel of the delivery device; pulling the stent into the tapered port such that the compressive force distributed by the tapered port compresses the stent to a size for entry into the working channel; and pulling the stent into the working channel.

[0058] In some embodiments, the techniques described herein relate to a method that further comprises rotating the loading adapter on the proximal end of the delivery device to coaxially align the tapered port with the working channel. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] Figure 1 A cross-sectional view showing the male urethra and related anatomy is shown.

[0060] Figure 2A A schematic cross-section of the prostatic urethra and bladder in a healthy prostate is shown. Figure 2B Benign prostatic hyperplasia compressing the prostatic urethra is shown. Figure 2C Benign prostatic hyperplasia with a urethral stent positioned within the prostatic urethra to keep the prostatic urethra patent is shown.

[0061] Figure 3 An isometric view of a urethral stent configured to be positioned within the prostatic urethra, as Figure 2C shown.

[0062] Figure 4 Shows Figure 3 a front view of the urethral stent.

[0063] Figure 5 Shows Figure 3 a side view of the urethral stent.

[0064] Figure 6 Shows Figure 3 a top view of the urethral stent.

[0065] Figure 7 Shows Figure 3 a bottom view of the urethral stent.

[0066] Figure 8A and Figure 8B show an embodiment of a delivery device (e.g., a cystoscope) adapted to deliver a urethral stent (such as Figures 3 - 7 the urethral stent). Figure 8A Shows the distal end of the delivery device (e.g., the end disposed outside the urethra during stent delivery). Figure 8BShows the proximal end of the delivery device (e.g., the end disposed within the urethra during the procedure).

[0067] Figures 9A - 9E Shows a schematic diagram of a urethral stent configured to be positioned within the prostatic urethra and shows various states of the handle of the stent (e.g., basket hook, loop, hook). Figure 9A Shows the stent handle in an undeflected configuration, which may include a distal end (e.g., the end positioned away from the bladder) axially aligned with the peripheral wall of the stent formed by the struts. Figure 9B Shows the handle of the stent being pulled into Figure 9C the shown pull configuration, which shows the handle substantially aligned with the central longitudinal axis of the stent. Figure 9D Shows the stent being pulled into the working lumen of the delivery device at the handle, which can cause the stent to collapse. Figure 9E Shows the stent disposed in the working lumen of the delivery device in a collapsed configuration.

[0068] Figure 10A and Figure 10B Shows a schematic diagram of a capture device having a hook for capturing (e.g., grasping, coupling with) the stent handle. Figure 10A Shows a side view of the capture device. Figure 10B Shows a top view of the capture device.

[0069] Figures 11A - 11C Shows Figure 10A and Figure 10B a schematic diagram of the capture device cooperating with a tube to firmly hold and secure the stent handle to the capture device. Figure 11A Shows the hook of the capture device deployed from within the tube and coupled to the stent handle. Figure 11B Shows the hook of the capture device retracted into the tube to secure the stent handle within the hook. Figure 11C Shows from a top-down perspective Figure 11B the retracted position of the capture device relative to the tube (or the advanced position of the tube relative to the capture device).

[0070] Figures 12A - 12C Shows Figures 10A - 11C a schematic diagram of the capture device being navigated through the working lumen of the delivery device. Figure 12A Shows the capture device being navigated through the straight working lumen of the delivery device, with a panel disposed at the proximal end (e.g., the end disposed in the urethra closest to the bladder). Figure 12B and 12C Shows the capture device being navigated through the working lumen of the delivery device having a turn (e.g., an angle).

[0071] Figure 13AA handle with an actuating mechanism is shown, the actuating mechanism being for advancing a capture device from a tube to deliver a stent to the prostatic urethra. Figure 13B A capture device is shown, which is coupled to an actuator of the handle by a push wire having a hook, the hook being positioned within the tube and holding a stent handle.

[0072] Figure 13C The actuating mechanism is shown after an initial force has advanced a button to position one or more recesses of the button radially inward of a retaining feature of the actuator.

[0073] Figure 13D The actuating mechanism is shown after an additional force has been applied to further advance the button such that the retaining feature of the actuator deflects into one or more recesses of the button.

[0074] Figure 13E An actuator is shown in which a retaining feature is deflected into one or more recesses of a button and advanced relative to the handle to advance a push wire coupled to a capture device.

[0075] Figure 13F A capture device is shown being advanced such that a hook portion of the capture device is disposed outside the tube to deliver a stent to the urethra, which is caused by the advancement of the actuator shown in Figure 13E shown.

[0076] Figure 13G A capture device having a hook coupled to a handle within the interior of a tube is shown to securely hold the handle when a force (e.g., an axial force) is applied to the stent.

[0077] Figure 13H A handle is shown having an actuating mechanism coupled to a capture device in Figure 13G which holds the position of the capture device despite a force being applied to the stent.

[0078] Figures 14A - 14C A schematic view of a method of loading a stent into a working channel of a delivery device is shown.

[0079] Figure 15A and 15B show additional schematic views of a method of loading a stent into a Figures 14A - 14C delivery device.

[0080] Figures 16A - 16C A schematic view of a loading adapter disposed at the proximal end (e.g., the end to be positioned within the urethra) of a delivery device is shown to facilitate loading a stent into a working cavity of the delivery device.

[0081] Figures 17A - 17C An additional schematic view of a loading adapter for loading a delivery device into a working cavity of the delivery device is shown.

[0082] Figures 18A - 18E A schematic diagram showing a method of loading a stent into the working channel of a delivery device using a loading adapter.

[0083] Figures 19A - 19E A schematic diagram showing a method of delivering a stent into the prostatic urethra.

[0084] Figure 20A Shows the deflection of the stent handle.

[0085] Figure 20B and 20C A schematic diagram showing a urethral stent disposed between the apexes at the bladder neck and the verumontanum in the prostatic urethra.

[0086] Figure 21 Is a flowchart showing a method of deploying a urethral stent.

[0087] Figures 22A - 22L Shows according to Figure 21 The deployment of a urethral stent of the method.

[0088] Figure 23 Is a flowchart showing a method of retrieving a urethral stent.

[0089] Figure 24 Is a flowchart showing a method of repositioning a urethral stent.

[0090] Figure 25 Is a flowchart showing a method of repositioning a urethral stent. Detailed Description

[0091] Several factors are thought to influence the onset and progression of benign prostatic hyperplasia (BPH), also known as benign prostatic hypertrophy. The most common factors are aging and a shift in hormonal balance. Figure 1 A cross-section of the male urethra 100 is shown in detail. The prostate 102 is shown immediately below the bladder 104 (e.g., below, distal to the bladder). The region of the urethra 100 surrounded by the prostate 102 is the prostatic urethra 106, which is proximally bounded by the bladder opening and distally bounded by the membranous portion 108 of the urethra. Below the membranous portion 108 of the urethra, the urethra 100 becomes the spongy (penile) urethra 110 and continues to the external urethral orifice 112 and ends at the external urethral orifice 112. The internal urethral sphincter (not shown) is located at and around the junction between the bladder 104 and the proximal end 114 of the prostatic urethra 106. The internal urethral sphincter (not shown) controls the flow of fluid from the bladder 104 into the prostatic urethra 106. The external urethral sphincter (not shown) is located at the membranous portion 108 of the urethra. The external urethral sphincter (not shown) surrounds the junction between the distal end 116 of the prostatic urethra 106 and the proximal end 118 of the penile urethra 110.

[0092] Figure 2A shows the prostatic urethra 106 that is connected to the bladder 104 and surrounded by the prostate 102 under normal conditions. As Figure 2B shown, when the prostate 102 enlarges, the prostatic urethra 106 is compressed to a reduced diameter. This results in various symptoms observed in the progression of BPH, including but not limited to frequent urination, urgency, nocturia, interrupted urine flow, weak urine stream, straining to urinate, and / or prolonged urination time. Figure 2C shows an implant device 200 for overcoming BPH symptoms. The implant device 200 is a urethral stent that is fully located within the prostatic urethra 106, between the internal urethral sphincter 202 and the external urethral sphincter 204.

[0093] Devices including a stent are disclosed herein, and the stent can be configured to adjust the diameter and opening of the prostatic urethra. A prostatic urethral stent can include various conventional prosthetic devices, including a tubular member configured to maintain or improve the patency of at least a portion of the urethra, such as the prostatic urethra. In some embodiments, the device can improve the patency of the prostatic urethra, but not the membranous urethra or the penile urethra. The stents described herein can be configured to maintain patency, but not extend the urethra beyond its natural diameter.

[0094] Figure 3 A perspective view of one such device in the form of a urethral stent 300 is shown. The urethral stent 300 or the stent 300 can include a generally cylindrical shape having a plurality of nodes 302 (e.g., proximally-directed nodes 302a and / or distally-directed nodes 302b) and struts (e.g., angled struts 312 and / or longitudinal struts or bridges 310). In some embodiments, the nodes 302 and the struts 310, 312 can be formed by removing material from a cylindrical member. In some embodiments, the nodes 302 and the struts 310, 312 can be formed by additive manufacturing, casting, machining, molding, and / or using other techniques. The nodes 302 can be generally triangular or arrow-shaped. The nodes 312 can point towards the proximal end 306 or the distal end 308 of the stent, which can include some nodes 312 pointing towards the proximal end 306 and other nodes 312 pointing towards the distal end 308. The nodes 302 can connect the longitudinal struts 310 and the angled struts 312 to each other to form parallelogram, trapezoid, and / or quadrilateral units. The angled struts 312 can vary in orientation as they circumferentially move around the stent 300. For example, a forward-angled strut 312 can be attached to a reverse-angled strut 312 and continuously attached to a forward-angled strut 312, which can form one or more Z-shaped loops 311 (e.g., one, two, three, four, five, six, etc.) around the circumference of the stent 300. The shown stent 300 includes three such Z-shaped loops 311, asFigure 3 as shown, but may include more or fewer than three. In some embodiments, the angled struts 312 may be curved. The distal end 308 of the stent may include a handle 324 (e.g., a bucket handle, a loop, an arc). The handle 324 may extend from the curved and / or angled struts 312 at the nose region 318 (e.g., the leading stent, the most distal stent, the distal face stent), and in certain embodiments, may form a heart shape and / or a shield shape, as Figure 6 and Figure 7 shown in the top and bottom views of. The handle 324 may be a continuation of the strut 312 located in the nose region 318. The handle 324 may extend from one strut 312 and wrap around to another strut 312. The handle 324 may include a groove 325 (e.g., a protrusion, an indentation, a notch, a bend, a curve, a contour), which may be small relative to the size of the handle 324. The groove 325 may be disposed in the middle of the handle 324 and may include being disposed in the annular portion of the handle, at the midpoint between the struts 312. The groove 325 may be disposed on the central longitudinal plane that divides the stent 300 into two longitudinal halves. The groove 325 may be configured to cooperate with the connection features (such as hooks) of another device. The widths of the struts 310, 312 may be circumferential and may be approximately 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm. The struts 310, 312 and / or the nodes 302 may have a thickness of about 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm and / or 0.30 mm, and this thickness may be in the radial direction. The struts 310, 312 and the nodes 302 may form the circumferential wall of the stent 300, and this circumferential wall may have the aforementioned thickness (e.g., a uniform thickness). The width of the struts 310, 312 in the circumferential direction may be less than the thickness of the struts 310, 312 and / or the nodes 302. The width of the struts 310, 312 in the circumferential direction may be less than the thickness of the circumferential wall of the stent 300 (e.g., the struts 310, 312 and the nodes 302) in the radial direction. The stent 300 may be electropolished.

[0095] The longitudinal struts 310 can be connected to angled struts 312 to form an acute angle and another angle complementary to the acute angle. The acute angle formed between the longitudinal struts 310 and the angled struts 312 in a particular cell can be equal or decrease during movement from cell to cell in the proximal direction. For example, the acute angle formed between the longitudinal struts 310 and the angled struts 312 in the cells in the body region 320 of the stent can be greater than the acute angle formed between the longitudinal struts and the angled struts in the cells in the tail region 322 of the stent, which can configure the stent 300 to be stiffer (e.g., exert a greater radial force) in the body region 320 than in the tail region 322. In some embodiments, the longitudinal length of the cell increases when moving in the proximal direction (towards the proximal end 306 of the stent) along the longitudinal axis of the stent 300. In some embodiments, the acute angles are equal and do not change from cell to cell.

[0096] Adjacent circumferentially positioned cells can form a longitudinal region of the urethral stent 300. For example, Figure 3 The illustrated stent can include a nose region 318, a body region 320, and a tail region 322. Each region 318, 320, 322 can be configured for specific clinical and anatomical functions as described herein.

[0097] The nose region 318 of the stent 300 is located at the distal end 308 of the stent. The struts 331 at the nose region 318 are formed as a handle 324. The handle 324 can be used to attach to a deployment and / or retrieval member (not shown), which can be used to manipulate (e.g., advance, retract, rotate, etc.) the stent 300, which can include pushing and / or pulling the stent 300 into and / or out of the working lumen of a deployment device. Pulling on the handle 324 (in the distal direction, away from the bladder when implanted) can cause a lever action of the handle 324 and compression of the stent 300 to a collapsed position such that it can be pulled into the working channel of a deployment device (e.g., a catheter, a cystoscope, etc.), as will be further described subsequently. The parallelogram or quadrilateral cell shape and the angled structure formed by the angled struts 312 facilitate easier collapse of the stent 300. The grooves 325 of the handle 324 can provide a coupling (e.g., attachment) point and / or area for coupling (e.g., engaging) with another device (e.g., a capture device, a deployment device), which can facilitate the uniform and symmetric distribution of the pulling or pushing force applied at the grooves 325 to the stent 300. As will be discussed herein, this geometry can facilitate smooth, symmetric collapse and / or expansion of the stent 300 during loading into a cystoscope, deployment, and / or retrieval.

[0098] The nasal region 318 may include two diamond-shaped units 327 formed by distally positioned angled struts 312. The diamond-shaped units 327 help control the tension distribution applied to the stent 300 and the handle 324 to further ensure smooth collapse and expansion of the stent 300 during loading, deployment, and / or retrieval.

[0099] The nasal region 318 of the stent 300 may enable a clinician to rotationally orient the stent 300 about its longitudinal axis. The shape of the handle 324 may enable a clinician to orient the stent 300 relative to the anatomy of the patient's urethra 100. The handle 324 may be configured to position the groove 325 on a projected annular plane of the peripheral wall (e.g., the peripheral wall of the stent 300). The groove 325 may be axially aligned with the longitudinal strut 310.

[0100] In some embodiments, the outward radial force provided by the stent 300 generally decreases along the proximal direction of the stent. The urethral stent 300 may be more collapsible in the proximal direction of the stent 300 (toward the bladder when implanted). For example, the stent 300 may be characterized by a collapse gradient. The body region 320 of the stent 300 may provide the greatest radial force and thus the least collapsibility when implanted within the prostatic urethra 108. The tail region 322 of the stent 300 may provide the least radial force and thus the greatest collapsibility when implanted within the prostatic urethra 108. In other embodiments, the outward radial force provided by the stent 300 may be uniform at least along the body region 320 and the tail region 322. Providing a smaller force at the closest region (tail) 322 may have various functional benefits, which may resist migration toward the bladder, easily push the compressed stent 300 out of the working channel, and / or allow a higher resting tension of the bladder neck and internal sphincter, which may reduce patient discomfort and / or the risk of device-related retrograde ejaculation.

[0101] The body region 320 and the tail region 322 of the stent 300 may provide sufficient radial force to counteract or partially counteract the compressive force on the prostatic urethra 108 from an enlarged prostate (such as the prostate of an individual with BPH). The outward radial force provided by the body region 320 and the tail region 322 of the stent may help keep the prostatic urethra 108 open during bladder emptying. The body region 320 and the tail region 322 may be configured to only counteract the compressive force on the urethra from the enlarged prostate. The stent 300 may be configured such that when fully expanded, the urethra only returns to the natural diameter of the urethra without exceeding that natural diameter. The stent 300 may not expand the diameter of the urethra to be greater than its natural diameter. The natural diameter of the urethra may correspond to the diameter of the stent 300 without the compressive force of the prostate acting on the stent 300. For example, the prostatic urethra 108 can be dilated to have a diameter that matches (e.g., is equal to) the diameter of other non-prostatic regions of the urethra, such as the corpus spongiosum or penile urethra 110. Controlling the dilated diameter of the stent 300 such that the stent 300 does not dilate the urethra beyond its natural diameter can provide physiologically relevant advantages. The controlled dilated diameter can provide less pressure on the wall of the prostatic urethra 108, which in turn can reduce inflammation, fibrosis, and / or epithelialization within the prostatic urethra 108. This can in turn lead to shorter patient recovery times and / or better long-term stent tolerance.

[0102] In this document, a local compressive force is applied to stents 300 of different sizes as an alternative to the radial force, and the force required to squeeze the diameter of the stent 300 in half is measured. In some embodiments, the outward radial forces provided by the rings 311 in each of the nose region 318, body region 320, and tail region 322 of the large stent 300 are 2.5 N, 2.4 N, and 2.1 N, respectively. In some embodiments, the outward radial forces provided by the rings 311 in each of the nose region 318, body region 320, and tail region 322 of the medium stent 300 are 3.0 N, 2.8 N, and 2.5 N, respectively. In some embodiments, the outward radial forces provided by the rings 311 in each of the body region 320 and tail region 322 of the small stent 300 are 2.2 N and 1.9 N, respectively. The outward radial forces of the nose region, body region, and tail region of the stent 300 can be at least in the range of 1.5 - 3.0 N.

[0103] The tail region 322 of the stent 300 can expand outwardly such that the lobules 329 formed by the nodes 302 and angled struts 312 at the proximal end 306 can engage the soft tissue of the prostatic urethra 108 near and / or at the internal urethral sphincter 202 or the bladder neck. The proximal nodes 302 can act as atraumatic anchors that contact the wall of the prostatic urethra 108 to prevent proximal (bladder direction) migration of the stent 300 once implanted. The stent 300 can include a plurality of such lobules 329 (e.g., four) formed at the proximal end 306 of the stent 300. The four lobules 329 can advantageously provide rotational stability of the stent 300 within the prostatic urethra 108 by contacting the tissue of the prostatic urethra at four circumferential positions during deployment and / or retrieval.

[0104] The size of the stent 300 can be set to match the specific anatomy of the patient. For example, the length of the prostatic urethra 108 of the patient can be determined, and then a urethral stent 300 having a length equal to or less than the length of the prostatic urethra can be selected. In one embodiment, the length of the stent 300 can be determined by the length of the stent tail region 322. In other words, stents 300 of different lengths can have the same nose region 318 and body region 320, but different tail regions 322. For example, the tail region 322 of a longer stent can be formed by longer longitudinal struts 310, or it can include more cells than the tail region 322 of a shorter stent. The length of the stent 300 can be changed by varying (e.g., increasing or decreasing) the distance between adjacent rings 311, which can include changing the length of the longitudinal struts 310. The lengthening of the stent 300 can be changed by varying (e.g., increasing or decreasing) the number of rings 311 and extending the length of the longitudinal struts 310 between these rings 311.

[0105] In addition, in some embodiments, the tail region 322 of the stent 300 can be expanded to a larger diameter at its proximal end. For example, the outer and inner diameters of the proximal portion of the tail 322 can be greater than the outer and inner diameters of the distal portion of the tail 322. In some embodiments, the outer and inner diameters of the stent 300 gradually increase and / or increase uniformly along the proximal direction of the stent 300. The expanded region of the stent 300 can be obtained by placing the stent 300 on a tapered mandrel or another device and thermally shaping the stent 300 to obtain the desired expanded shape.

[0106] Figure 4 A end view of the stent 300 is shown. As shown, the handle 324 may not block the internal space (e.g., flow path) formed by the stent 300, which can allow unobstructed flow therethrough when expanded in the urethra. When expanded in the patient's urethra, the stent 300 can maintain a circular shape to enable unobstructed fluid flow therethrough. Figure 5A side view of the stent 300 is shown. From the side view, the handle 324 may have a leg-like profile, where the foot-shaped groove 325 extends horizontally towards the distal end 308 (e.g., in the distal direction, which may include in a direction parallel to the central longitudinal axis of the stent 300). The leg-like struts appear to rise vertically and bend at the knees to connect to the angled strut 312, and the angled strut 312 extends to form one side of the diamond cell 327. The diameter of the stent 300 may taper from at least the body 320 to the distal end 308. In some embodiments, the diameter of the stent 300 may decrease from the proximal end 306 to the distal end 308 (e.g., the proximal end 306 may be larger than the distal end 308, or the distal end 308 may be larger than the proximal end 306). From the side view, the handle 324 may project from the angled strut 312 of the nose portion 318 (e.g., continuing in the same direction), bend, and then extend in one direction (e.g., perpendicular to the central longitudinal axis of the stent 300, such as substantially perpendicular to the central longitudinal axis of the stent 300) to position the groove 325 on the projected annular plane defined by the peripheral wall of the stent 300, which may include being coplanar with the projected plane of the peripheral wall of the stent 300. The handle 324 may project from two angled struts 312 disposed on opposite sides of the stent 300 and connect to form a loop at the groove 325. The curve in the 324 may bias the handle 324 to the shown position, and the handle 324 is generally outside the flow path and / or the groove and / or other features of the handle 324 are generally disposed in the projected annular plane of the peripheral wall of the stent 300.

[0107] Figure 6 and Figure 7 The top view and bottom view of the stent 300 are shown respectively. The nose region 318 of the stent 300 (which includes the handle 324) may have a generally heart-shaped and / or shield-shaped configuration. The heart-shaped handle 324 may contribute to the collapsibility and expandability of the stent 300 within the prostatic urethra 108. As shown, in some variations, the curve in the handle 324 may stop the distal extension of the handle 324 until the groove 325. As shown, the handle 324 may extend straight inwards (e.g., perpendicular to the central longitudinal axis of the stent 300) to form a loop, which may include connecting the two halves of the handle 324 at the groove 325. Except for the groove 325, the furthest distal portion of the handle 324 may be generally straight (e.g., perpendicularly oriented with respect to the central longitudinal axis of the stent 300).

[0108] Figure 8AAn exemplary embodiment of a delivery device 700 adapted to deliver the urethral stent described herein is shown. In the illustrated embodiment, a cystoscope is provided as the delivery device 700. The cystoscope 700 includes a catheter 702 that terminates distally in a handpiece 704. An eyepiece 706 is located at the distal end 708 of the handpiece. The catheter 702 includes a plurality of channels formed therein that terminate proximally at a proximal end 718. As Figure 8B shown, the catheter 702 includes a working channel 710, two illumination channels 712, and a camera channel 714, all of which extend to and are exposed at the proximal end 718 for their respective functions. The eyepiece 706 is optically coupled to the camera 714 such that an operator can view the interior of the lumen into which the catheter 702 has been inserted. A port 716 may be fluidly coupled to the working channel 710 to provide irrigation, aspiration, and access to a control wire located within the working channel 710.

[0109] Figure 9A A schematic diagram of a urethral stent (e.g., stent 300) as described herein is provided, having a handle, diamond-shaped cells, and a plurality of Z-rings formed by alternating angled struts. In some embodiments, the expanded outer diameter of the stent may be 10 mm, the combined length of the body and tail regions may be 24 mm, and the total length from the handle to the proximal lobes may be 30.5 mm. In some embodiments, the expanded diameter of the stent may be 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 mm, or within a range defined by any two of the foregoing values. In some embodiments, the expanded diameter of the stent may be less than 8 mm or greater than 20 mm. In some embodiments, the body-tail region length may be between 10 mm and 35 mm, and / or about 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, or 35 mm. In some embodiments, the total length of the stent may be between 15 mm and 45 mm, and / or about 15 mm, 18 mm, 21 mm, 24 mm, 27 mm, 30 mm, 33 mm, 36 mm, 39 mm, 42 mm, or 45 mm. In some embodiments, increasing the spacing between the Z-rings and / or adding additional Z-rings to the stent may be used to achieve different effective total lengths of the stent.

[0110] When expanded, the diameter of the stent can vary along its length. For example, the stent can have its maximum diameter in the body region and smaller diameters in the nose and tail regions. The stent diameter can taper linearly from the maximum diameter to the smaller diameter, or it can be shaped to form a bulge in the body region. The larger diameter / bulge can help anchor the stent within the prostatic urethra, which can include preventing antegrade and / or retrograde migration of the stent over time. In some embodiments, the stent can taper from an 8 mm diameter at the distal end (nose region) to an 11 mm diameter at the central portion (body region), and then taper to a 9 mm diameter at the proximal end (tail region).

[0111] The stent can be formed by cutting openings in the wall of a cylindrical tube, setting the tube on a mandrel to have a desired diameter, and then thermally shaping the tube to form the stent. In some embodiments, the initial cylindrical tube can be larger than the desired diameter of the stent, and the stent can be thermally shaped to have a diameter smaller than the cylindrical tube. Alternatively, a smaller diameter cylindrical tube can be used to form the stent. The smaller diameter cylindrical tube can be initially cut to form a desired wall pattern and openings, and then the tube can be expanded on a mandrel to impart the desired final stent diameter. The stent can then be thermally shaped on the mandrel to set the final diameter of the stent.

[0112] As referenced above Figure 8A and Figure 8B discussed, the delivery device for the stent to the prostatic urethra 106 can be an instrument such as a cystoscope 700. The diameter of the working channel 710 of the cystoscope 700 is typically about 2.0 - 2.5 mm. Thus, it may be advantageous to form the stent from an initial tube having an outer diameter of about 2.0 mm and then expand and thermally shape it on a mandrel to the final desired diameter. In this way, in certain cases, the stent can be more easily collapsed to the small diameter (e.g., about 2.0 - 2.5 mm) of the cystoscope working channel 710.

[0113] Figures 9B - 9E Method steps for loading the stent into the working channel of a delivery device such as a cystoscope (e.g., cystoscope 700) are shown. In Figure 9B and 9CIn [description], the handle of the stent is pulled, straightened horizontally upward and in the pulling direction. When the handle of the stent is pulled, the handle of the stent can move (e.g., deflect) from a position generally outside the central flow path of the stent to a position disposed within the central flow path of the stent, which can include being disposed on the central longitudinal axis of the stent. When the handle of the stent is pulled, the handle of the stent can move (e.g., deflect) from an angled configuration to a generally straight configuration extending in the distal direction (e.g., generally parallel to the central longitudinal axis of the stent). As described herein, the curve in the handle can bias the handle to a position generally outside the central flow path until it is pulled. In Figure 9D In [description], the handle of the stent is pulled and drawn into the working channel of the cystoscope. As Figure 9D shown, in some embodiments, the handle is shown being drawn into the working channel of the cystoscope. As indicated by the laterally inwardly directed arrow, the distal end of the stent is compressed and collapsed as it enters the working channel. As Figure 9E shown, in some embodiments, the stent can be configured to be compressed and fit within the working channel of the cystoscope, which can include having an outer diameter of no more than 2.2 mm (e.g., the diameter of the working channel). In some embodiments, when compressed and collapsed into the working channel of the cystoscope, the outer diameter of the stent can be no more than 2.0, 2.1, 2.2, 2.3, 2.4, or 2.5 mm. In some embodiments, when compressed, the diameter of the stent can be only 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 3.0, 3.5, or 4 mm. Due to the diamond shape of the cells formed by the struts and / or the collapse of the angled struts, the collapse of the stent can make the stent longer, which can include becoming as long as about 38 mm, as Figure 9E shown.

[0114] Reference Figure 10A and Figure 10B schematically shows a capture device 730 (loading device, holding device, control device, deployment device, retrieval device) engaged with the handle 324 of the stent 300 shown in Figures 3 through 7 . Figure 10AA side view of a capture device 730 engaged with a handle 324 is shown. The capture device 730 may include a hook 734 (e.g., a claw, notch, recess, groove). The hook 734 may be coupled (e.g., captured, held, latched) to the handle 324 (e.g., groove 325 of the handle 324) to manipulate the stent 300, which may include loading the stent 300 into the working channel of a delivery device, positioning the stent 300 from the working channel of the delivery device into the urethra, and / or retrieving the stent 300 from the urethra. The capture device 730 may include a body 376 (e.g., a hook body, cylinder), which may include the hook 734 (e.g., the hook 734 may be formed in the body 376). The body 376 may be coupled (e.g., connected) to a push member 738 (e.g., a push wire). The push wire 738 may extend in a distal direction 740 away from the patient being treated. The hook 734 may be a notch formed in the body 736 and capable of capturing and retaining the handle 324 of the stent 300. The capture device 730 may include a tip 732 (e.g., a head, end, bullet tip, bullet head, arrow head). The tip 732 may be disposed on an end (e.g., proximal end) of the body 376. The tip 732 may extend from the body 376 in a proximal direction 742, which is oriented towards the patient's bladder during the procedure. The tip 732 may taper in a distal-proximal direction. For example, when viewed from the side as in Figure 11B the tip 732 may widen in the distal direction 740 (e.g., away from the bladder), such that the distal portion of the tip 732 is wider than the proximal portion of the tip 732. The tip 732 may be pointed, which may include pointing in the proximal direction 742. For example, the tip 732 may include a pointed tip, bullet-shaped head, arrow-shaped head, and / or conical head pointing in the proximal direction 742. When viewed from the side as in Figure 11B the distal portion of the tip 732 (e.g., the portion of the tip 732 adjacent to the body 376) may have a height greater than the height of the body 736, which may expose the distally-facing surface 733 (e.g., the neck edge 733) of the tip 732. The tip 732 may include a rounded edge and / or corner, which may avoid tissue damage and / or the capture device 730 inadvertently catching on features of the delivery device and / or other devices. In some variations, the furthest distal portion of the tip 732 may be flat (e.g., disposed in a plane substantially perpendicular to the central longitudinal axis of the capture device 730).

[0115] Figure 10B A top view of the capture device 730 and the stent handle 324 shown in Figure 10A is shown. It can be seen that the width of the tip 732 in the top view may be greater than Figure 10AThe height of the distal portion of the tip 732 in the side view is narrow. This narrower width can provide space for the handle 324. As Figure 10B shown, the width of the tip 732 can vary along its length in the proximal-distal direction. The width of the tip 732 can gradually increase in the distal direction to a maximum width and then gradually decrease in the distal direction. The tip 732 can have a width that bulges outward in the middle portion and tapers away from the middle portion distally and proximally. The tip 732 can include a middle portion that is larger relative to the distal and proximal portions.

[0116] Turning to Figures 11A - 11C , the capture device 730 is shown as having a tube 744 (e.g., a cannula). The tube 744 can be disposed above the pusher wire 738 and / or the body 736 of the capture device 730, which can include being disposed above the hook 734. The tube 744 can include an opening 746 (e.g., a proximal opening). The body 736 and the pusher wire 738 can be manipulated within the tube 744 to advance the capture device 730 through the opening 746 such that the hook 734 is disposed outside the tube 744 and / or retracted through the opening 746 such that the hook 734 is disposed inside the tube 744. The pusher wire 738 can be rigid enough to transmit mechanical motion to the body 736. As Figure 11A shown, the proximal portion of the body 736 of the capture device 730 is pushed out of the opening 746 to expose the hook 734. The exposed hook 734 can be coupled to the handle 324 of the stent 300, which can be done outside the patient for a stent delivery procedure or inside the urethra when retrieving a previously delivered stent.

[0117] In Figure 11B , the capture device 730 and the tube 744 have been manipulated relative to each other. The body 736 has been retracted into the tube 744 to position the hook 734 inside the tube 744. The distally facing surface 733 can be retracted until it contacts the tube 744 to prevent further retraction, which can be referred to as the closed state. In some embodiments, the pusher wire 738 can be pulled (e.g., by a clinician pulling at the distal end of the pusher wire 738) to retract the body 736 together with the hook 734 into the tube 744. In the case where the distally facing surface 733 contacts the proximal end of the tube 744, the stent handle 324 can be firmly held by the hook 734. In some embodiments, in Figure 11BIn the retracted (e.g., closed) state shown, the proximal end of the tube 744 can be in close engagement with the distally facing surface 733, leaving a small gap or no gap therebetween. The engagement between the tip 732 (e.g., the distally facing surface 733) and the proximal end of the tube 744 can prevent the hook 734 from slipping out of the tube 744. In some embodiments, the distal surface of the body 736 (e.g., the portion of the body 736 that defines the opening 476) and the proximal surface of the tube 744 (e.g., the portion of the tube 744 that defines the opening 476) can fix (e.g., capture) the handle 324 on the hook 734 disposed inside the tube 744. In some embodiments, the gap between the body 736 and the tube 744 can be small enough to prevent the handle 324 from escaping the hook 734.

[0118] Figure 11C is Figure 11B A top view of the engagement in the retracted (e.g., closed) state shown. It can be seen that the narrow width of the tip 732 can provide lateral space between the tip 732 and the wall of the tube 744 that defines the opening 746, and this lateral space can allow the handle 324 to pass through. In some embodiments, the sides of the tip 732 may not contact the tube 744 to provide lateral space for the handle 324. For example, in some embodiments, the tip 732 may only contact two portions (e.g., generally 180 degrees apart) of the proximal end of the tube 744 that form the opening 746. In the case where the tip 732 engages the tube 744, the handle can be firmly held by the hook 734. In the closed state, the hook 734 works with the tube 744 to capture and hold the handle 324 in place. As shown in FIG. 11D, the handle 324 can be released from the hook 734, where the body 736 is advanced out of the opening 746 to expose the hook 734. Figure 11A of the closed ( Figure 11A open) state.

[0119] The tip 732 can provide a number of benefits, some of which are shown in Figures 12A - 12C The capture device 730 can be configured to be compatible with most commercially available cystoscopes or delivery devices. For example, some cystoscopes have panels disposed around the opening into the working channel. These panels can be partially folded into the working channel, which can form a small edge near the exit of the working channel. Figure 12AIllustrated is a loading device 730 disposed within the proximal end of the working channel 710 of a cystoscope 700, where a panel 752 is located at an opening leading into the working channel 710. A small edge 754 (e.g., a lip) can be formed between the panel 752 and the inner surface of the working channel 710. The shape of the tip 732 can help reduce the risk that the capture device 730 will get stuck on the edge 754 of the panel 752. For example, if the tip 732 is square and / or has sharp corners, the tip 732 may get stuck at the small edge 754, or the small edge 754 will at least impose resistance to the movement of the capture device 730. The tip 732 having a pointed shape can reduce the likelihood of getting stuck on the edge 754 and even prevent getting stuck on the edge 754, which can be at least partially attributed to the proximal most portion of the tip 732 being positioned away from the sidewall of the working channel 710 and the edge 754. In some variations, the working channel 710 can include a bend (e.g., a bend, a change in direction), which can be near the proximal end 742. The panel 752 can also be attached to the proximal end of the working channel 710 of the cystoscope 700. As shown, the tip 732 with a pointed head can help the capture device successfully navigate through the working channel 710 and not get stuck on the edge 754 of the panel 752. As shown, the tip 732 can have a pointed head, which can have a diameter similar to the inner diameter of the working channel 710. As Figure 12B shown, the flexible push wire 738 and the overtube 744 can bend at a location between the push wire 738 and the body 736 to enable navigation of the bend in the working channel 710. As Figure 12C shown, the shape of the distal end 732 can enable the capture device to navigate past the edge 454 and out of the proximal opening of the working channel 710.

[0120] Reference Figures 13A - 13H is made to the actuation mechanism 760. The actuation mechanism 760 can hold (e.g., restrict, maintain) the position of the capture device 730 relative to the tube 744, which can include holding the tip 732 on the proximal end of the tube 744 using a hook 734 in the tube 744. The actuation mechanism 760 can advance the loading device 730 relative to the tube 744 when actuated to position the hook 734 outside the tube 744. In some embodiments, the actuation mechanism 760 can retract the loading device 730 relative to the tube 744 when actuated to position the distally facing surface 133 on the proximal end of the tube 744 such that the hook 734 is disposed within the tube 744.

[0121] As Figure 13AAs shown, the actuation mechanism 760 can include a handle 762 having an internal space 764 (e.g., a straight internal space, cavity, recess with an open first end) that can at least partially receive (e.g., accommodate) an actuator 766. The actuator 766 can be coupled to a push wire 738 (e.g., the distal end of the push wire 738). The push wire 738 can pass through the handle and extend proximally to the body 736 of the capture device 730. The actuator 766 can include an internal space 768 (e.g., a second open straight opening, cavity, recess) that can at least partially receive (e.g., accommodate) a button 770. The outer perimeter of the actuator 766 can correspond to the inner perimeter of the handle 762 that defines the internal space 764, which can allow the actuator 766 to translate (e.g., translate in the longitudinal direction) within the internal space 764. The outer perimeter of the portion of the button 770 configured to be disposed inside the internal space 768 of the actuator 766 can correspond to the inner perimeter of the actuator 766 that defines the internal space 768, which can allow the button 770 to translate (e.g., translate in the longitudinal direction) within the internal space 768 of the actuator 766.

[0122] The actuator 766 and the handle 762 may include complementary features (e.g., surfaces) that engage (e.g., contact, engage) to prevent advancement of the actuator 766, which may prevent advancement of the push wire 738 and the load device 130 relative to the tube 744 to hold the hook 734 within the tube 744. For example, the actuator 766 may include one or more locking features 772 (e.g., one or more surfaces, one or more angled surfaces, one or more flanges, one or more flared edges, one or more tabs, one or more hooks, one or more beveled edges, one or more lips). The one or more locking features 772 may be provided on the distal portion (e.g., distal edge) of the actuator 766, which may include being provided at the outer periphery of the actuator 766. The one or more locking features 772 may flare radially outward relative to the longitudinal axis of the actuator. The handle 762 may include one or more retaining features 778 (e.g., one or more surfaces, one or more angled surfaces, one or more beveled edges, one or more edges). The one or more retaining features 778 may be provided at the opening leading to the internal space 764 of the handle 764. For example, the one or more retaining features 778 may include a beveled edge at the opening leading to the internal space of the handle 764. One or more locking features 775 of the actuator 766 may engage one or more retaining features 778 of the handle 762 to prevent the actuator 766 from advancing within the internal space 764 of the handle 762, which may prevent the capture device 730 from advancing relative to the tube 744 to hold the hook 734 within the tube 744. If an axial force in the proximal direction is applied to the bracket 300, the engagement between one or more locking features 775 of the actuator 766 and one or more retaining features 778 of the handle 762 may prevent advancement of the actuator 766 and the corresponding proximal advancement of the push wire 738 and the capture device 730 to avoid the hook 734 being pushed out of the tube 744 to allow release of the bracket 300. By applying an axial force in the proximal direction to the actuator 766 via the push wire 738, one or more locking features 775 of the actuator 766 may be pushed into one or more retaining features 778 of the handle 762, which may radially inwardly push the one or more locking features 775, but the body of the button 770 may impede the radially inward deflection of the one or more locking features 775. However, the button 770 may include one or more grooves 776 (e.g., recesses, channels, cavities, chambers), which may be provided on the side (e.g., top, bottom, side) of the button 770. The one or more grooves 776 may receive the radially inward deflection of the one or more locking features 775.The button 770 can be pushed into the internal space 768 of the actuator 766 until the outer surface (e.g., opposite sides) of the body portion of the button 770 contacts the inner surface of the actuator 766 that defines the internal space 768. This can position one or more grooves 776 radially inward of one or more locking features 772 of the actuator 766 and couple the proximal advancement of the button 770 and the actuator 766 together. With one or more grooves 776 aligned radially inward of one or more locking features 772 of the actuator 766, the button 770 and the actuator 766 can be pushed together, thereby pushing one or more locking features 772 of the actuator 766 against one or more retaining features 778 of the handle 762, which can push the handle 762 toward the button 770. In some embodiments, the actuator 766 includes a button 770 that is configured to engage one or more locking features 775 (e.g., one or more protrusions) on the outer surface of the button 770. In some embodiments, the button 770 includes one or more grooves 776, and one or more locking features 775 are configured to engage one or more grooves 776. One or more locking features 775 are configured to engage one or more grooves 776 to prevent proximal advancement of the actuator 766 within the internal space 764 of the handle 762. To remove the hook 734 from the internal space of the tube 744, the user can radially inwardly deflect (e.g., radially inwardly squeeze) one or more locking features 775 (e.g., one or more protrusions) into one or more grooves 776 of the button 770 to allow proximal advancement of the actuator 766 within the internal space 764 of the handle 762, so as to advance the push wire 738 and the capture device 730 relative to the tube 744 such that the hook 734 is disposed outside the tube 744 to release the stent 300 for delivery into the urethra.

[0123] The capture device 730, the tube 744, and the actuation mechanism 760 can be used with a delivery device such as a cystoscope 700 to deliver the stent 300 into the prostatic urethra 106. The capture device 730 coupled to the actuation mechanism 760 by the push wire 738 can be inserted into the working channel 710 through a port 716 on the handpiece 704 at the distal end 708 of the cystoscope 700. The push wire 738 and the body 736 of the loading device 130 can be disposed within the tube 744. By pushing the push wire 738 connected to the actuation mechanism 760, the capture device 730 can be advanced into the catheter 702. The tube 744 can be advanced together with the capture device 730. The capture device 730 and the tube 744 can be advanced through the working channel 710 until they are advanced out of the proximal end 718 of the cystoscope 700.

[0124] As Figures 13A - 13HAs shown, the actuation mechanism 760, the tube 744, and the capture device 730 can cooperate to firmly capture and release the stent 300. In Figure 13A , the actuator 766 is disposed within the internal space 764 of the handle 762, where one or more locking features 778 engage one or more retaining features 779. The button 770 is disposed within the internal space 768 of the actuator 766, where the groove 776 is exactly outside (e.g., distally) the opening of the internal space 768. As Figure 13A shown, the state of the actuation mechanism 760 where one or more locking features 778 engage one or more retaining features corresponds to Figure 13B the state of the capture device 730 shown, where the tube 744 abuts the distally facing surface 733 of the tip 732, and where the handle 324 of the stent 300 is firmly held by the hook 734 of the capture device 730 disposed within the tube 744. The engagement of one or more retaining features 778 on the handle 762 with one or more locking features 772 of the actuator 766 can apply tension on the push wire 738 and prevent the accidental release of the handle 324. The engagement of one or more retaining features 778 of the handle 762 with one or more locking features 772 of the actuator 766 can prevent the advancement of the actuator 766 within the internal space 764 of the handle 762, such that the push wire 738 prevents the relative advancement of the capture device 730 relative to the tube 744 to firmly hold the hook 734 coupled to the handle 324 of the stent 746 within the tube 744.

[0125] Figure 13C A force 774 (e.g., a thrust force) applied to the button 770 is shown. The force 774 can cause the button 770 to advance within the internal space 768 of the actuator 764 until it contacts a surface of the actuator 764, such as the inner surface of the internal space 764 of the actuator 766, which can couple the proximal advancement of the button 770 and the actuator 764 together. As a result of the force 774, one or more grooves 776 of the button 770 can be positioned radially inward (e.g., radially aligned, close) of the locking features 772 of the actuator 762.

[0126] As Figure 13DAs shown, continuously applying force 774 to button 770 transfers force 774 to actuator 776, which can push one or more locking features 772 of actuator 766 against one or more retaining features 778 of handle 762. One or more locking features 772 of actuator 766 can deflect inward (e.g., radially inward) from contact with one or more retaining features 778 (e.g., angled surfaces) in the direction of arrow 777 into one or more grooves of button 770 such that one or more locking features 772 and one or more retaining features 778 are not engaged to prevent actuator 766 from advancing within the internal space 764 of handle 762.

[0127] As Figure 13E shown, continuously applying force 774 to button 770 can cause button 770 and actuator 766 to translate proximally within the internal space 764 of handle 762. Actuator 766 can be further pushed into internal space 764, thereby causing translational movement of pusher wire 736 coupled to actuator 766 in the proximal direction 755. Thus, as Figure 13F shown, the translational movement causes body 736 of capture device 730 to be pushed out of conduit opening 746 at the proximal end of tube 744 such that hook 734 is disposed outside of tube 744. As Figure 13F shown, with hook 734 disposed outside of tube 744, handle 324 of stent 300 can be released from hook 734 to deliver stent 300 into the urethra.

[0128] Actuation mechanism 760 can prevent inadvertent release of stent handle 324. For example, as Figure 13G shown, an axial force 781 (e.g., proximal axial force, pulling force) can be applied to stent 300 and / or tip 372. Force 781 can be transferred from capture device 730 through pusher wire 738 to actuator 766. However, as Figure 13H shown, in the case where one or more grooves 776 of button 770 are not aligned with one or more locking features 772 of actuator 766, the body of button 770 can prevent one or more locking features 772 from deflecting inward such that one or more locking features 772 remain engaged with one or more retaining features 778 of handle 762 to prevent advancement of actuator 766 within internal space 764 and advancement of capture device 730 relative to tube 744 despite the presence of axial force 781.

[0129] Referring Figures 14A - 14C to, a method of loading stent 300 into working channel 710 of cystoscope 700 is schematically illustrated. In Figure 14AIn this case, the handle 324 of the stent 300 is firmly captured by the hook 734 of the capture device 730 disposed within the tube 744, where the proximal end of the tube 744 engages the distally facing surface 733 of the tip 732. Figures 13A - 13H The handle 762 of the illustrated actuation mechanism 760 can be pulled by a clinician to retract the stent 300 into the working channel 710. As Figure 14A shown, the captured stent 300 can first be retracted into the working channel 710 to contact the edge 748 of the opening 746. The handle 324 can deflect when pulled to extend distally. As Figure 14B shown, as the handle 762 is pulled further, the stent 300 can be partially drawn into the working channel 710. When the stent 300 is drawn into the working channel 710 of the cystoscope 700, the stent 300 can collapse by contacting the edge 748. The stent 300 can be compressed to a size (e.g., diameter) that fits within the working channel 710. As Figure 14C shown, as the handle 762 is pulled further, the stent 300 can be fully loaded within the working channel 710, which can include the stent 300 collapsing within the working channel 710.

[0130] In some cases, the stent loading processes and methods described with reference to Figures 14A - 14C may damage the stent 300. When the handle 324 is drawn into the working channel 710 by the capture device 730, the stent 300 is pressed against the edge 748 at the opening 746 at the mouth of the working channel 710. The edge 748 can be approximately right-angled and can contact a point (e.g., the leading angled strut 312) on the stent 300, which may concentrate the force on the stent 300. The individual forces at the contact point may not be evenly distributed, so the force at one point may be large enough to cause permanent deformation of the structure of the stent 300, including some of the longitudinal struts 310 and angled struts 312. This can result in a deformed and / or bent stent 300, which may have a negative impact on the performance of the stent 300. This force concentration effect is shown in Figures 14A - 14C as follows. Figure 15A and 15B show another exemplary method of deploying the stent 300 within the working channel 710. As Figure 15A shown, the stent 300 is shown being drawn into the working channel 710 by a force 783 applied to the handle 324 through an opening in the proximal end 718. The working channel 710 can have an edge 748 (e.g., a generally right-angled edge) at the opening leading into the working channel 710, which can compress the stent 300, as shown in the schematic of Figure 15B As described above, the edge 748 can concentrate the force on the stent 300, which can include non-uniform concentration, which can damage the stent 300.

[0131] Figures 16A - 16C Shown is a loading adapter 780 (e.g., a loading tool, a funnel adapter) that can make it easier to load the stent 300 into the working cavity 110 and / or distribute pressure more evenly (e.g., reduce stress concentration) on the stent 300 to compress (e.g., collapse) the stent 300 for placement in the working cavity 110. The loading adapter 780 can include a port 782 (e.g., an opening, a funnel, a mouth). The port 782 can include a tapered cross-section that can taper gradually in the proximal-distal direction. The side of the port 782 to be disposed beside the working channel 710 can have the same (e.g., substantially the same) size (e.g., diameter) and / or shape as the working channel 710. The inner wall of the loading adapter 780 defining the port 782 can be tapered, which can define a receiving cross-section with gradually decreasing dimensions (e.g., decreasing in the distal direction) into the working cavity 710. The distal portion of the port 782 can be smaller than the proximal portion of the port 782. The loading adapter 780 can include a lumen 784 (e.g., a channel). The lumen 784 can have a consistent size and / or shape. The size and / or shape of the lumen 784 can be the same as the working channel 710, including a proximal opening leading to the working channel 710. The lumen 784 can be connected to the port 782 and can match the working channel 710 at the proximal end of the cystoscope 718 in size. The lumen 784 and the port 782 can be coaxially aligned. Since the proximal opening leading to the working channel 710 may be offset from the central longitudinal axis of the cystoscope 700, the port 782 and / or the lumen 784 can be offset from the central longitudinal axis of the loading adapter 780. Figure 8A and Figure 8B Shown, to load the stent 300 into the working channel 710, the loading adapter 780 can be placed (e.g., placed over) the proximal end 718 of the cystoscope 700. The loading adapter 780 can be configured for use with other commercially available delivery devices or cystoscopes. Alternatively, different adapters 780 can be constructed for different cystoscopes. The loading adapter 780 can include a receiving space 786 (a mating feature, a key feature, a receiving space, a cavity, a recess, a channel) to mate with the proximal end 718 of the cystoscope. The receiving space 786 can be disposed on the side of the loading adapter 780 opposite the port 782. The receiving space 786 can be connected to the port 782, which can include connection through the inner lumen 784. The receiving space 786 can receive the proximal end of the cystoscope to facilitate placement of the loading adapter 780 (e.g., placed over) on the proximal end of the cystoscope. The loading adapter 780 can be placed on the cystoscope and rotated to coaxially align the opening leading to the working channel 710 with the port 782. As Figure 16AAs shown, the capture device 730a can be configured to pass through and exit the working channel 710. The capture device 730a can include a fixture (e.g., a fixture-like structure, a gripper, a holder) that grips the handle 324 of the bracket 300. The capture device 730 described herein can be configured to pass through and exit the working channel 710. The capture device 730a and / or the capture device 730 can be used to coaxially align the working channel 710 and the port 782.

[0132] As Figure 16B shown, the bracket 300 can be pulled into the loading adapter 780 by a pulling force 785 applied to the bracket handle 324, which can come from the capture device 730a and / or the capture device 730. The opening leading to the port 782 (e.g., the distal opening) can be larger than the working channel 710, which can include significantly larger than the working channel 710. The diameter of the opening can be as large as or even larger than the diameter of the bracket 300. In some embodiments, the diameter of the opening of the port 782 can be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 mm, or even larger than 20 mm. The bracket 300 can be pulled into the port 782, and the nose end 318 (or the distal end 308) of the bracket 300 can first start to be compressed by the angled wall (e.g., the tapered wall) of the loading adapter 780 that defines the port 782. Then, the body section 320 of the bracket 300 can be gradually compressed, followed by the tail end 322 (or the proximal end 306). The pulling force 785 applied to the handle 324 that pulls the bracket 300 into the port 782 can also pull the loading adapter 780 against the cystoscope (e.g., the proximal side of the cystoscope). When the bracket 300 is pulled into the port 782, the taper (e.g., a gradual taper) of the port 782 can distribute (e.g., evenly distribute, uniformly distribute) the compressive force on the bracket 300, which can avoid the stress concentration discussed herein that may exist without using the loading adapter 780. Compared with the all-at-once method without using the loading adapter 780 as described herein, the taper of the port 782 can facilitate the gradual compression (e.g., collapse) of the bracket 300 when the bracket 300 is further pulled into the port 782. The taper of the port 782 can facilitate smooth and consistent loading on the bracket 300 to facilitate collapse. When the bracket 300 reaches the distal portion (e.g., the distal end) of the port 782, the bracket 300 can be fully compressed (e.g., fully collapsed). As Figure 16A shown, the loading adapter 780 can include a funnel port 782 having a tapered shape (e.g., the narrow portion of the funnel shape), and the bracket 300 can be compressed to a size that allows it to be placed into the working channel 710. Compared with not using the loading adapter 780, the loading adapter 780 can facilitate a more uniform distribution of the compressive force, as Figures 14A - 14C and Figure 15A and15B As shown. As Figure 16C shown, when the tail of the stent 300 enters the funnel port 782, the nasal tip may have collapsed to the size of the working channel 710. Further pulling the stent 300 will cause the nasal tip 318 to smoothly enter the working channel 710, followed by the main body 320 and the tail 322 smoothly and consistently. Using the loading adapter 780 can avoid damage to the stent 300 when loading the stent 300 into the working channel 710. In this way, bending or deformation of the stent 300 can be avoided.

[0133] As Figures 17A - 17C shown, when the stent 300 is pulled into the port 782, the loading adapter 780 can automatically align the stent 300 for coaxial positioning relative to the port 782 and / or the working channel 710. When the stent 300 is pulled into the port 782 by the capture device 730 or 730a, the central longitudinal axis of the stent 300 may not be coaxially aligned with the central longitudinal axis of the port 782, as Figure 17A shown. However, when the stent 300 is pulled into the port 782, the tapered cross-section (e.g., wall) of the port 782 can center the stent 300 relative to the port 782, which can include coaxially aligning the stent 300, the port 782, and / or the working channel 710, as Figure 17B and 17C shown. The tapered wall of the port 782 can push the edge or strut of the stent 300 that first contacts the port 782 to coaxially align the stent 300, the port 782, and / or the working channel 710. In this way, misalignment can be corrected.

[0134] In Figures 18A - 18E , a stent loading process is shown, where the capture device 730, the tube 744, the funnel-shaped adapter 780, the handle 762 with the actuating mechanism 760, and the working channel 710 of the delivery device (e.g., the cystoscope 700). The loading adapter 780 can be provided at the proximal end of the delivery device (e.g., the cystoscope 700). The loading adapter 780 can be manipulated (e.g., rotated) to coaxially align the port 782 and the proximal opening of the working cavity 710. In Figure 18A , the capture device 730 is pushed out of the working channel 710 and through the port 782 of the loading adapter 780, and the loading adapter 780 is fitted on the proximal end 718 of the cystoscope 700. In some embodiments, as described herein, before placing the loading adapter 780, the capture device 730 can be advanced from the working channel 710 to assist in coaxially aligning the port 782 and the working channel 710. The capture device 730 (e.g., the main body 736) can be advanced forward relative to the tube 744 such that the hook 734 is exposed outside the tube 744 to capture the handle 324 of the stent 300. The capture device 730 can use the techniques described herein (e.g., Figures 13A - 13HAdvance relative to tube 744. The clinician can position the stent handle 324 in the hook 734 of the capture device 730.

[0135] As Figure 18B shown, the capture device 730 and the tube 744 can be moved relative to each other to position the distally facing surface 733 in contact with the proximal end of the tube 744 and / or to position the hook 734 within the tube 744, as described with reference to Figure 11A and 11C to securely couple the capture device 730 with the handle 324 of the stent 300. In some embodiments, the button 770 of the actuation mechanism 760 can be pulled to translate the actuator 766 (which is coupled to the capture device 730 via the push wire 738) from the Figure 13E configuration shown to the Figure 13C configuration shown, where one or more locking features 722 of the actuator 766 engage one or more retaining features 778 of the handle 762. Deflection of one or more locking features 722 of the actuator 766 into one or more grooves 776 of the button 770 can couple the translational movement of the actuator 766 and the button 770 to facilitate movement from the Figure 13E configuration shown to the Figure 13C configuration shown by pulling the button 770. Distal movement of the actuator 766 can cause a corresponding distal movement of the capture device 730 via the push wire 738 coupled to the capture device 730. In some embodiments, the tube 744 can be advanced relative to the capture device to be placed in the configuration shown. In the case where the stent handle 324 is captured by the capture device 730 and the tube 744, the capture device 730 and the tube 744 can be retracted distally to pull the stent 300 through the port 782 of the loading adapter 780 and into the working channel 710 of the delivery device (e.g., cystoscope 700). The handle 762 can be pulled distally to pull the stent 300 through the port 782 of the loading adapter 780 and into the working channel 710 of the delivery device (e.g., cystoscope 700). The nose end of the stent 300 initially contacts the port 782. The tapered port 782 of the loading adapter 780 can facilitate loading of the stent 300 as described herein.

[0136] In Figure 18C the stent 300 is further pulled into the port 782 such that a portion at the nose end of the stent 300 collapses and is pulled into the lumen 784 of the loading adapter 780. Due to compression from the tapered port 782 of the loading adapter 780, the tail end also partially collapses. In Figure 18D as continued pulling occurs, the stent 300 can collapse to a size to be received within the working channel 710. As Figure 18D shown, the stent 300 can be partially within the lumen 784 and partially within the working channel 710. InFigure 18E In this case, the stent 300 is fully pulled into the working channel 710. At this point, the tail 322 of the stent 300 can be slightly inside the working channel 710 or flush with the surface of the working channel 710. When loading the stent 300 into the working channel 710 of a delivery device (such as a cystoscope 700), the handle 324 can be pushed down and folded so that the folded handle 324 is pulled into the working channel. As Figures 18B - 18D shown, the handle 324 can be deflected to a position where the handle 324 is aligned with the central longitudinal axis of the stent 300, as described herein. The total length of the collapsed stent with the folded handle can be approximately 38 mm, and the diameter can be approximately 2.2 mm. In some embodiments, the total length of the collapsed stent with the folded handle is between approximately 22 mm and 52 mm, or approximately 22 mm, 25 mm, 28 mm, 31 mm, 34 mm, 37 mm, 40 mm, 43 mm, 46 mm, 49 mm, or 52 mm.

[0137] When the stent 300 is loaded, the loading adapter 780 can be removed from the proximal end 718 of the cystoscope 700. Figures 19A - 19E The process of delivering the loaded stent into the prostatic urethra of a patient is shown. In Figure 19A this case, a force is pushed on the capture device 730 and transmitted to the stent 300 to move the stent 300 proximally towards the proximal opening of the working cavity 710. For example, the handle 762 can be advanced by a clinician relative to the delivery device (such as a cystoscope 700), which can cause the push wire 738 to advance the capture device 730 and the tube 744. The advancement of the capture device 730 and the tube 744 that capture the stent handle 324 can cause the stent 300 to advance proximally in the working cavity 710. In Figure 19B this case, the distal end 322 of the stent 300 is pushed out of the working channel 710 and immediately begins to expand its shape, which can contact the urethra for positioning. In Figure 19C this case, the distal end 322 of the stent 300 has fully expanded and contacted the urethra. In Figure 19D this case, the proximal end 320 of the stent 300 has fully expanded and contacted the urethra. In Figure 19E this case, the stent 300 has fully expanded and contacted the urethra. In Figure 19C this case, the body 320 of the stent 300 is pushed out of the working channel 710, and the stent 300 expands. In Figure 19D this case, the entire stent 300 including the handle 324 is pushed out of the working channel 710. Using the handle 324 still captured by the hook 734, the clinician can adjust the axial and radial positions of the stent 300 in the urethra. Visualization (such as fluoroscopy) can guide the delivery procedure. In Figure 19E this case, the hook body 736 is partially pushed out of the tube 744 to expose the hook 734, as referenced Figures 13A - 13FAs described above, the stent handle 324 is released under the constraint within the urethra and rebounds towards its original shape. As described herein, the handle 324 can engage the wall of the urethra to hold the stent 300 in place. This process is actuated by an actuation mechanism 760 at the distal end 708 of the cystoscope 700.

[0138] The handle 324 of the stent 300 can also facilitate retrieval of the deployed stent by providing a connection point to a control mechanism, such as a capture device 730 or 730a. Once the control mechanism is inserted into the prostatic urethra and connected to the stent handle, the stent can be pulled into the working channel of the deployment device by pulling the control device through the working channel and pulling the stent into the working channel, as shown in at least Figures 11A - 11C and FIGS. 14A - 14C. During retrieval, the handle can swing outward such that it aligns with the longitudinal axis of the stent, as shown in Figure 20A FIGS. Once implanted in the prostatic urethra, the handle automatically moves to a folded position, pointing downward. The handle has a groove at its center that can be used to anchor the stent in the prostatic urethra. For example, the groove can be positioned to contact, embed, and / or abut the distal end 116 of the prostatic urethra (e.g., the prostatic apex of the prostate). In some embodiments, the stent 300 is positioned such that the groove and / or the handle contact, embed, and / or abut the verumontanum (which is closer to the distal end 116). The groove and / or the handle can be disposed proximal (e.g., folded behind, in contact with, proximally embedded) to the apex 116 at the verumontanum. The proximal end of the stent 300 (e.g., the leaflet or tail tip) can abut or embed against the proximal end 114 of the prostatic urethra 106 or the wall of the bladder neck to prevent proximal migration of the stent. The overall length of the stent is selected to match the total length of the prostatic urethra.

[0139] A clinician can measure the length of the prostatic urethra and then select a stent having a length approximately equal to or slightly less than the length of the prostatic urethra. In some embodiments, the total length of the stent is 15, 20, or 25 mm. The length of the stent is selected to match the length of the prostatic urethra to ensure that the handle can be used as an anchor and abut against the apical edge of the prostatic urethra while the distal lobes abut against the bladder neck.

[0140] Figure 21 FIG. is a flow chart showing one embodiment of a method 800 for deploying a urethral stent (such as any stent described herein) in the prostatic urethra. A delivery device is provided, such as Figure 8A and Figure 8Ba delivery device (e.g., cystoscope 700) or any other delivery device. Load a urethral stent (such as any of the stents described herein) into the distal end of the catheter body of the delivery device and position it near the distal end. The stent is releasably attached to an elongate control member, such as the capture device 730 or 730a described herein, which extends through the working channel of the delivery device and is fixed to the stent at the distal end of the control member and at the handle of the stent.

[0141] Method 800 begins at block 802. At block 804, the delivery device and the control member are advanced in the proximal direction toward the bladder 104 (see Figure 22A and B) through the urethra. The delivery device and the control member are advanced until the proximal end 718 of the delivery device and the control member is slightly within the bladder 104 (see Figure 22C ). At block 806, the delivery device and the control member are retracted in the distal direction to position the proximal end 718 of the delivery device within the prostatic urethra 106, adjacent to the bladder neck (see Figure 22D ). At block 808, a portion of the proximal or tail section of the stent 300 is deployed by advancing the control member relative to the delivery device while retracting the delivery device distally, which causes the stent 300 to partially exit the working channel 710 of the delivery device and enter the prostatic urethra 106 (see Figure 22E ). The deployed portion of the tail section of the stent 300 expands within the bladder and can be pressed into the bladder neck (see Figure 22F ). At block 810, the delivery device is further retracted while holding the control member in a fixed position or while pushing the control member proximally until the proximal end of the proximal section is positioned at the proximal prostatic urethra (see Figure 22G ). The remaining length of the stent 300 can then be deployed in a similar manner by pulling the delivery device while holding or pushing the control member (see Figures 22H - 22I ). At block 812, the control member can then be separated from the stent handle 324 (see Figure 22J ), and then the control member and the delivery device can be retracted distally (see Figure 22K ) and withdrawn from the urethra, thereby positioning the stent 300 within the prostatic urethra 106 (see Figure 22L ). The control member is separated from the stent 300 (e.g., stent handle 324) by rotating a control component, releasing a grasping component (e.g., the clamp of control member 730a), unhooking one from the other, and / or using any other coupling and decoupling methods described herein. Method 800 ends at block 814.

[0142] Figure 23is a flowchart illustrating one embodiment of a method 900 for retrieving an urethral stent (such as any of the stents 300 described herein) in a prostatic urethra 106. A delivery device (such as Figure 8A and Figure 8B 's delivery device or any other delivery device) is provided. An urethral stent (such as any of the stents 300 described herein) is located within the patient's prostatic urethra. A control member (e.g., capture device 730 or 730a) configured to releasably couple to the stent is disposed within the working channel of the delivery device.

[0143] Method 900 begins at block 902. At block 904, the delivery device is advanced through the urethra in a proximal direction toward the bladder. The delivery device is advanced until the distal end of the catheter is adjacent to or near the distal end / nasal segment or handle of the stent. At block 906, the control member is advanced through the working channel of the delivery device to the proximal end of the working channel. The control member is attached to the stent nasal segment at the handle of the stent, which can be performed using any of the techniques described herein with reference to the capture device 730 or 730 described in connection with the stent handle 324 of the stent 300. At block 908, the control member is then withdrawn distally (toward the distal end of the delivery device), thereby pulling the control member and the stent into the working channel of the delivery device. Alternatively or additionally, the delivery device can be advanced proximally (toward the bladder) to capture the stent within the working channel of the delivery device. Contact between the inner periphery within the working channel and the stent causes the stent to radially collapse as it moves distally and into the working channel. Once the stent has been partially or fully captured within the working channel, at block 910, the stent and the delivery device can be removed and withdrawn from the urethra. Method 900 ends at block 912.

[0144] Figure 24 is a flowchart showing one embodiment of a method 1000 for repositioning an urethral stent (such as any of the stents 300 described herein) in a prostatic urethra 106. A delivery device is provided, such as Figure 8A or Figure 8B 's delivery device or any other delivery device. An urethral stent (such as any of the stents described herein) is located within the patient's prostatic urethra.

[0145] Method 1000 begins at block 1002. At block 1004, the stent is initially retrieved into the working channel of the delivery device, for example, according to the method described above with respect to Figures 13A - 13H The stent can be retrieved into the working channel using the capture device 730 or 730a. At block 1006, the delivery device and the captured stent are then repositioned to a new desired location. For example, the delivery device and the stent can be positioned proximal to the prostatic urethra, or at any other desired location. At block 1008, then, for example, according to the method described above with respect to Figure 21The method described above deploys a stent. At block 1010, method 1000 may end.

[0146] Figure 25 FIG. 4 is a flowchart showing another embodiment of method 1100 for repositioning a stent without retracting the stent into the working channel of an endoscope. Method 1100 begins at block 1102. At block 1104, the tip of the endoscope is advanced into the lumen of the stent. At block 1106, the end of the endoscope is deflected to engage the stent struts. For example, a controller at the distal end of the endoscope can be used to deflect the proximal end of the endoscope (e.g., up or down). Such a controller is used to steer the endoscope through the patient's vasculature. However, in this embodiment, the endoscope deflection is used to deflect the proximal end of the endoscope so that it locks onto or engages the struts of the stent. Once engaged, at block 1108, the operator can apply a linear force to the endoscope to push or pull the stent in the proximal or distal direction. The operator can observe the movement of the stent relative to the mucosa of the urethral lumen, thereby allowing an estimate of the linear movement. Once the stent is positioned in the desired location, method 1100 ends at block 1110. This technique allows the stent to be repositioned without the need to retract the stent back into the working channel of the endoscope.

[0147] The stents described herein can be further described by their length, expanded diameter, collapsed diameter, angle values, and strut / wall thickness. A variety of values and combinations of values are possible and should not be limited to the following examples. In some embodiments, the stent has an outer expanded diameter in the range of about 8 mm to about 12 mm. The total length of the stent can be in the range of about 15 mm to about 45 mm. The nose section of the stent can have a length of about 10 mm, and the body can have a length of about 15 mm, and the length of the tail can be selected such that the total stent length matches the patient's anatomy. For example, the tail section can have a length in the range of about 5 mm to about 30 mm. The acute angle within the stent unit can be in the range of 5 degrees to 85 degrees, 10 degrees to 60 degrees, or 20 degrees to 50 degrees. The obtuse angle within the stent can be in the range of 95 degrees to 175 degrees, 120 degrees to 170 degrees, or 110 degrees to 150 degrees. The struts and wall thickness of the stent can be in the range of 0.025 mm to 1.0 mm. Other Considerations

[0148] It is contemplated that various combinations or sub - combinations of the specific features and aspects of the embodiments disclosed above can be made and still fall within one or more of the inventions. Additionally, any specific feature, aspect, method, property, characteristic, quality, attribute, element, etc. disclosed herein in connection with an embodiment can be used in all other embodiments set forth herein. Accordingly, it should be understood that the various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form different modes of the disclosed invention. Thus, it is intended that the scope of the invention disclosed herein should not be limited by the specific disclosed embodiments above. Further, although the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. However, it should be understood that the invention is not limited to the specific forms or methods disclosed, but rather the invention will cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various described embodiments and the appended claims. Any method disclosed herein need not be performed in the order described. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third - party instructions, whether explicit or implicit, of those actions. For example, an action such as "insert the device distally proximate to the prostatic urethra" includes "instruct to insert the device distally proximate to the prostatic urethra". The scope disclosed herein also includes any and all overlaps, sub - ranges, and combinations thereof. Language such as "up to", "at least", "greater than", "less than", "between" includes the recited numbers. Numbers following terms such as "approximate", "about", and "substantially" as used herein include the recited number and also denote a quantity that is close to the recited amount and still performs the desired function or achieves the desired result. For example, the terms "approximate", "about", and "substantially" can refer to a quantity within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the recited amount.

Claims

1. A device configured to maintain patency of the prostatic urethra, the device comprising: a stent including a proximal end, a distal end, a passage between the proximal end and the distal end, a peripheral wall, and a handle, the passage being configured to facilitate fluid flow between the proximal end and the distal end, the peripheral wall surrounding the passage, the peripheral wall including a plurality of struts and a plurality of nodes, the plurality of struts and the plurality of nodes being interconnected to form a plurality of cells, the handle being biased to a position outside the passage of the stent, the stent being configured to expand from a compressed configuration to an expanded configuration within a body cavity; wherein the handle is configured to deflect when pulled axially from a position outside the passage to another position within the passage.

2. The device according to claim 1, wherein, The handle is disposed at the distal end of the stent.

3. The device according to claim 1 or 2, wherein the handle includes a bend that biases the handle to a position outside the passage.

4. The device according to any one of the preceding claims, wherein the handle extends from a distal strut of the plurality of struts and is bent to extend in a direction generally perpendicular to the central longitudinal axis of the stent.

5. The device according to any one of the preceding claims, wherein the handle includes a groove configured to engage a capture device for loading into a working lumen of a delivery device.

6. The device according to claim 6, wherein the groove is configured to project distally when the stent is disposed within the body cavity.

7. The device according to any one of claims 5 or 6, wherein the groove is disposed generally along a central longitudinal plane of the stent.

8. The device according to any one of the preceding claims, wherein the handle includes a loop.

9. The device according to any one of the preceding claims, wherein the handle includes a straight portion generally perpendicular to the central longitudinal axis of the stent.

10. The device according to any one of the preceding claims, wherein the handle is configured to deflect when pulled from a position outside the passage to align generally with the central longitudinal axis of the stent.

11. The device according to any one of the preceding claims, including a collapsibility gradient between the proximal end and the distal end of the stent.

12. The device according to any one of the preceding claims, wherein the plurality of struts and the plurality of nodes form a circumferential ring.

13. The device according to claim 12, wherein the circumferential ring includes struts of the plurality of struts in a Z pattern.

14. The device according to claim 12, wherein the circumferential ring includes angled struts of the plurality of struts in an alternating pattern of distally angled struts and proximally angled struts.

15. The device according to any one of claims 12 - 14, wherein the circumferential ring provides different outward radial forces.

16. The device according to any one of the preceding claims, wherein an intermediate portion of the stent provides a greater outward radial force than the outward radial forces provided by the distal end and the proximal end.

17. The device according to any one of the preceding claims, wherein the plurality of units includes diamond-shaped units.

18. The device according to claim 17, wherein the diamond-shaped units are disposed near the handle.

19. The device according to claims 17 and 18, wherein the diamond-shaped units distribute tension on the stent to facilitate collapse of the stent.

20. The device according to any one of the preceding claims, wherein, When viewed in the axial direction, the handle is biased to a position coplanar with the peripheral wall.

21. A method of loading a stent into a working cavity of a delivery device, the method comprising: coupling a handle of the stent to a capture device, the handle being biased to a position outside a channel of the stent for body fluid; pulling the handle having the capture device in the axial direction to deflect the handle to another position in the channel; and retracting the stent by pulling the handle having the capture device into the working cavity of the delivery device such that the stent is compressed to the diameter of the working cavity.

22. The method according to claim 21, wherein, The handle is biased to a position coplanar with the peripheral wall of the stent.

23. The method according to claim 21 or 22, wherein coupling the handle of the stent to the capture device includes capturing the handle in a hook of the capture device.

24. A method of delivering a stent into the prostatic urethra, the method comprising: pushing a handle of the stent with a capture device to deploy the stent outside the working cavity of the delivery device into the prostatic urethra; and releasing the handle of the stent from the capture device to allow the handle to spring away from the central longitudinal axis of the stent to engage the wall of the urethra.

25. The method according to claim 24, wherein the handle is configured to be disposed proximal to the apex at the verumontanum.

26. A capture device configured to grasp a stent, the capture device comprising: a tapered tip; and a body distal to the tapered tip, the body including a hook configured to couple with the stent to manipulate the stent.

27. The capture device according to claim 26, wherein the hook is configured to couple with a stent handle of the stent.

28. The capture device according to claim 26 or 27, further comprising a tube configured to be disposed on the body to secure the stent to the hook.

29. The capture device according to claim 28, wherein the tapered end includes a perimeter extending beyond an outer perimeter of the body to expose a distally facing surface of the tapered end, the distally facing surface of the tapered end being configured to engage a proximal end of the tube to secure a stent handle of the stent to the hook.

30. The capture device according to claim 29, wherein the tapered end includes a width smaller than an opening into the tube to provide lateral space on either side of the tapered end for the stent handle to pass through when the stent handle is secured by the hook.

31. A method of capturing a handle of a stent with a capture device, the method comprising: advancing the capture device out of a tube to expose the hook of the capture device; Position the handle of the stent in the hook; and retract the capture device so that the distally facing surface of the tip of the capture device contacts the proximal end of the tube, such that the hook is disposed in the tube to secure the handle.

32. The method according to claim 31, wherein when securing the hook in the tube, the handle reaches the stent through a lateral space on the opposite side of the tip of the capture device.

33. A device for controlling the movement of a capture device to capture the handle of a stent, the handle comprising: a first internal space and one or more retaining features provided at an opening leading to the first internal space. An actuation mechanism comprising an actuator configured to be coupled to the capture device using a push wire and a button, the actuator being configured to be disposed in the first internal space of the handle and comprising a second internal space and one or more locking features, the one or more locking features being configured to engage the one or more retaining features to prevent advancement of the actuator in the first internal space, and the button being configured to be disposed in the second internal space and comprising a body and one or more grooves; wherein the button is configured to advance in the second internal space of the actuator to contact the inner surface of the actuator defining the second internal space and position the one or more grooves radially inward of the one or more locking features; wherein the button is configured to be further advanced to apply a force to the actuator, such that the one or more locking features deviate radially inward from the one or more retaining features and into the one or more grooves of the button, to enable the actuator to advance in the first internal space of the handle; and wherein advancement of the actuator in the first internal space of the handle causes the push wire to advance the capture device.

34. The handle according to claim 33, wherein, The capture device is configured to be advanced out of the tube to expose the hook holding the stent handle, such that the stent handle is allowed to deviate from the hook to allow delivery of the stent into the urethra.

35. The handle according to claim 33 or 34, wherein, The one or more retaining features include angled surfaces.

36. The handle according to claim 35, wherein, The one or more locking features include flared edges complementary to the angled surfaces.

37. A method of controlling the movement of a capture device using an actuation mechanism of a handle, the method comprising: advancing a button in an internal space of an actuator to contact the inner surface of the actuator and position one or more grooves of the button radially inward of one or more locking features of the actuator; applying an axial force to the button and the actuator to push the one or more locking features of the actuator against one or more retaining features provided at an opening leading to the internal space of the handle, such that the one or more locking features deviate from the one or more retaining features and into the one or more grooves of the button; and advancing the button and the actuator in the internal space of the handle to advance a push wire coupled to the actuator, thereby advancing a capture device configured to capture a stent.

38. The method according to claim 37, wherein, The one or more retaining features include angled surfaces.

39. The method according to claim 38, wherein the one or more locking features include a flared edge complementary to the angled surface.

40. A loading adapter for facilitating loading of a stent into a working channel of a delivery device, the loading adapter comprising: a port disposed outside a central longitudinal axis of the loading adapter, wherein the port tapers in a distal direction to a narrower cross-section; and a receiving area disposed on an opposite side of the loading adapter, the receiving area being configured to receive a proximal end of the delivery device to position the loading adapter on the proximal end of the delivery device; wherein the port is configured to be coaxially aligned with the working channel of the delivery device to facilitate loading of the stent into the working channel.

41. The loading adapter according to claim 40, wherein a distal side of the port has a diameter corresponding to a diameter of the working channel.

42. The loading adapter according to claim 40 or 41, characterized in that, It further includes a cavity with a constant diameter communicating the port and the receiving area.

43. The loading adapter according to claim 42, wherein The constant diameter of the cavity corresponds to the diameter of the working cavity.

44. The loading adapter according to any one of claims 40 - 43, characterized in that, When the stent is pulled through the port and collapses, the taper of the port distributes a compressive force on the stent.

45. A method of loading a stent into a working channel of a delivery device using a loading adapter, the method comprising: positioning the loading adapter on the proximal end of the delivery device; coaxially aligning a tapered port of the loading adapter with the working channel of the delivery device; pulling the stent into the tapered port such that the compressive force distributed by the tapered port compresses the stent to a size for entry into the working channel; and pulling the stent into the working channel.

46. The method according to claim 45, further comprising rotating the loading adapter on the proximal end of the delivery device to coaxially align the tapered port with the working channel.

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