Stent with handle for the treatment of benign prostatic hyperplasia

Abstract

A stent configured to maintain patency of the prostatic urethra despite prostatic hyperplasia is disclosed. The stent may include a handle disposed outside the stent flow path in an undeflected position. When the handle is pulled, the handle may deflect to generally coincide with the central axis of the stent. A capturing device is disclosed that includes a tapered tip for moving through the working channel of a delivery device and a hook that can capture the stent handle and move within the tube to hold the stent handle and facilitate manipulation of the stent in and out of the working channel of the delivery device. A loading adapter with a tapered port that can be positioned on a delivery device to distribute compressive forces exerted by the stent port during loading into the working channel is disclosed.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Application No. 63 / 484,462, filed February 10, 2023, and U.S. Provisional Application No. 63 / 376,984, filed September 23, 2022, the entireties of which are incorporated herein by reference. [Background technology]

[0002] Benign prostatic hyperplasia (BPH) is a common benign condition affecting men and is a major nuisance for older men. In this condition, the prostate gland is enlarged but not cancerous. BPH is also called benign prostatic hypertrophy or prostatic obstruction.

[0003] The prostate is a fibromuscular, glandular organ located just below the bladder. As the prostate enlarges, the gland presses against the prostatic urethra, narrowing it. This weakens the bladder and prevents it from emptying completely. The narrowing of the prostatic urethra causes the symptoms seen in BPH. Approximately half of all men over the age of 50 will develop an enlarged prostate. By the time men reach their 70s and 80s, approximately 85-90% of them will experience urinary symptoms due to BPH.

[0004] The causes of BPH are not fully understood, but it is believed to be multifactorial and endocrinologically controlled. BPH begins in the transitional region of the prostatic urethra. Symptoms often include irritative and obstructive symptoms. In particular, the following symptoms may suggest BPH: urinary frequency, urgency, dysuria, urinary retention, incontinence, nocturia, and post-ejaculatory pain. Complications of BPH include bladder stones, urinary tract infections, hematuria, bladder decompensation, renal failure, and acute / chronic urinary retention.

[0005] Pharmacological approaches to treatment include the use of alpha-blockers such as phenoxybenzamine (nonselective), prazosin (short-acting), terazosin and doxazosin (long-acting), and (alpha-1a)-selective blockers such as tamsulosin, alfuzosin, and silodosin. Additionally, 5-alpha-reductase inhibitors and combination therapies are also used. Pharmacological approaches are not sufficiently effective and are often used as short-term treatments. Side effects of pharmacological approaches include orthostatic hypotension, dizziness, fatigue, retrograde ejaculation, rhinitis, and headache.

[0006] Traditional and more recent surgical treatments include office-based procedures such as transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP), laser therapy, other forms of energy for vaporizing the prostate, simple prostatectomy, prostatic stents, and prostatic urethral lift. TURP uses endoscopic radiofrequency ablation to relieve symptoms and improve urinary flow. However, TURP requires spinal or general anesthesia, a 4-6 week recovery period with at least 24 hours of catheterization, and potentially impotence, incontinence, bleeding, retrograde ejaculation, and transurethral resection (TUR) syndrome (vomiting, nausea, confusion, hypertension, etc.). Simple prostatectomy may be performed when the prostate exceeds 100 grams or when BPH occurs with large bladder stones. Laser therapy uses laser energy to ablate, vaporize, or remove the prostate, which has advantages such as minimal blood loss and the ability to be performed as an outpatient procedure. However, laser treatment may require a longer catheterization period after surgery and requires expensive laser fibers and generators. Other energy forms, including microwaves, focused ultrasound, water-induced thermotherapy, and electrovaporation, have also been tried with varying outcomes. Prostate balloon dilation has also been tried in the past with poor outcomes. Prostatic stents (both temporary and permanent) have also been used in the past. Poor outcomes and reduced use have been attributed to inadequate fixation, stent migration, and difficulty with removal. A technique called a prostatic urethral lift, which involves tying the prostate away from the urethra, has gained attention in recent years. While minimally invasive, the procedure still has several drawbacks, including the use of a temporary catheter, questionable durability of results, and potentially painful and tedious recovery for patients. Summary of the Invention

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

[0008] Stents can control and improve urine flow throughout the urethra without interfering with the urethra's natural expansion and contraction during urination. For example, the proximal region of the stent (the region closest to the internal urethral sphincter and bladder upon insertion), sometimes referred to as the tail region, can be configured with multiple atraumatic ends or leaflets to anchor the stent within the prostatic urethra and prevent proximal migration (e.g., migration into or toward 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 sphincter muscles. The distal region of the stent (the region closest to the external urethral sphincter upon insertion) can include diamond-shaped cells and a handle. The distal region can be configured to serve as a connection point for stent delivery and removal. For example, a removable member, such as a clamp, hook, or forceps-like grasping member, can be releasably attached to the handle to allow the stent to be pushed out of or pulled into the working channel of a delivery catheter or scope (such as a cystoscope) and / or rotated in a desired direction.

[0009] Stents can be constructed from any one or more of a variety of materials. For example, stents can be constructed from shape memory alloys (SMAs), flexible metals such as stainless steel, titanium, etc., and / or flexible polymers, including shape memory polymers (SMPs). In some embodiments, the stent material can include a coating to prevent degradation and fouling. The coating can be hydrophobic and / or hydrophilic in nature, such as silicone. In some embodiments, the coating can include polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). In some embodiments, the coating can include flexible silicone, hydrogels, mucoadhesive substrates, pressure-sensitive adhesives, and / or other suitable elastomers, such as synthetic rubber. In one or more embodiments, the coating can include a micropattern that can include and / or be formed from biologically derived protein structures (e.g., collagen, etc.).

[0010] In some embodiments, a method for inserting a urethral stent is disclosed. An image-guided flexible cystoscope or camera-equipped catheter may be utilized in combination with a mechanism for placing, removing, and / or repositioning the stent. The stent may be inserted into the flexible cystoscope through the distal (output) end of the scope.

[0011] A stent can be designed or sized for a particular patient with age, race, demographics, predisposition, urethral size, prostate size, anatomical variations, and other factors unique to that patient. For example, the length of the stent, or the length of each region of the stent, can be selected and configured to fit the particular anatomical size of the patient.

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

[0013] In some embodiments, the techniques described herein include: 1. A device configured to maintain patency of a prostatic urethra, the device comprising: a stent having a proximal end, a distal end, and a passageway configured between the proximal and distal ends to facilitate the flow of bodily fluid therebetween; a peripheral wall disposed around the passageway, the peripheral wall including a plurality of struts and a plurality of nodes connected to one another to form a plurality of cells; a handle positioned offset outside the passageway of the stent; Equipped with the stent is configured to expand from a compressed configuration to an expanded configuration within a body lumen; the handle is configured to be deflected when pulled axially from a position outside the passage to another position within the passage. Regarding the device.

[0014] In some embodiments, the techniques described herein include: The handle is disposed on the distal end of the stent.

[0015] In some embodiments, the techniques described herein include: The handle includes a curved portion that biases the handle toward the outside of the passageway.

[0016] In some embodiments, the techniques described herein include: The handle extends from a distal strut of the plurality of struts and is curved to extend in a direction generally perpendicular to the central longitudinal axis of the stent.

[0017] In some embodiments, the techniques described herein include: The device relates to a handle having a divot configured to engage a capture device for loading into a working lumen of a delivery device.

[0018] In some embodiments, the techniques described herein include: The divot is configured to protrude distally when the stent is deployed within the body lumen.

[0019] In some embodiments, the techniques described herein include: For devices, the divot is located generally along the central longitudinal plane of the stent.

[0020] In some embodiments, the techniques described herein include: The device further comprises a handle having a loop.

[0021] In some embodiments, the techniques described herein include: The handle is directed to a device having a straight portion that is generally perpendicular to the central longitudinal axis of the stent.

[0022] In some embodiments, the techniques described herein include: The handle is configured to deflect when pulled from a position outside the passageway to generally coincide with the central longitudinal axis of the stent.

[0023] In some embodiments, the techniques described herein include: The stent has a collapsibility gradient between the distal and proximal ends.

[0024] In some embodiments, the techniques described herein include: The device relates to a device in which the plurality of struts and the plurality of nodes form a ring.

[0025] In some embodiments, the techniques described herein include: The ring relates to a device that includes a plurality of the struts in a Z pattern.

[0026] In some embodiments, the techniques described herein include: The ring relates to a device that includes angled struts of the plurality of struts in a pattern of alternating distal and proximal angled struts.

[0027] In some embodiments, the techniques described herein include: The rings relate to devices that create different outward radial forces.

[0028] In some embodiments, the techniques described herein include: The central portion of the stent is directed to a device that exerts a greater outward radial force than the distal and proximal ends.

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

[0030] In some embodiments, the techniques described herein include: The diamond-shaped cell is for devices located closest to the handle.

[0031] In some embodiments, the techniques described herein include: The diamond-shaped cells distribute tension on the stent, thereby facilitating collapse of the stent.

[0032] In some embodiments, the techniques described herein include: The device is such that the handle is biased to a position flush with the peripheral wall when viewed in the axial direction.

[0033] In some embodiments, the techniques described herein include: 1. A method for loading a stent into a working lumen of a delivery device, the method comprising: coupling a stent handle to a capture device, the handle is positioned offset outwardly of a passageway for bodily fluids through the stent; Combining and deflecting the handle to another position in the passageway by pulling the handle axially with the capture device; storing the stent by retracting the handle with the capture device into the working lumen of the delivery device so that the stent is compressed to the diameter of the working lumen; The present invention relates to a method, including:

[0034] In some embodiments, the techniques described herein include: The handle is biased to a position flush with the peripheral wall of the stent.

[0035] In some embodiments, the techniques described herein include: The method further relates to a method in which coupling the handle of the stent to the capturing device includes capturing the handle with a hook of the capturing device.

[0036] In some embodiments, the techniques described herein include: 1. A method of delivering a stent into the prostatic urethra, the method comprising: deploying the stent within the prostatic urethra outside the working lumen of a delivery device by pushing the stent handle with a capture device; Releasing the handle of the stent from the capture device so that the handle can move away from the central longitudinal axis of the stent to engage the urethral wall; The present invention relates to a method, including:

[0037] In some embodiments, the techniques described herein include: the handle is configured to be placed proximal to the apex of the verumontanum.

[0038] In some embodiments, the techniques described herein include: 1. A capture device configured to grasp a stent, the capture device comprising: a tapered tip; a body distal to the tapered tip; Equipped with The body is directed to a capture device having a hook configured to engage the stent for manipulating the stent.

[0039] In some embodiments, the techniques described herein include: The hook relates to a capture device configured to be coupled with a stent handle of the stent.

[0040] In some embodiments, the techniques described herein include: The capture device further comprises a tube configured to be placed over the body to secure the stent to the hook.

[0041] In some embodiments, the techniques described herein include: the tapered tip includes a periphery that extends beyond an outer periphery of the body to expose a distally facing surface of the tapered tip; The distally facing surface of the tapered tip is configured to engage with the proximal end of the tube, thereby securing the stent handle of the stent to the hook.

[0042] In some embodiments, the techniques described herein include: The tapered tip has a width smaller than the opening into the tube so that there is lateral space on either side of the tapered tip through which the stent handle can pass while being secured by the hook.

[0043] In some embodiments, the techniques described herein include: 1. A method of capturing a handle of a stent with a capturing device, the method comprising: advancing the capture device out of the tube to expose a hook of the capture device; placing the handle of the stent within the hook; retracting the capture device so that the distally facing surface of the tip of the capture device contacts the proximal end of the tube so that the hook is positioned within the tube and can secure the handle; The present invention relates to a method, including:

[0044] In some embodiments, the techniques described herein include: The handle is secured to the hook within the tube and passes through an exterior space opposite the tip of the capture device to the stent.

[0045] In some embodiments, the techniques described herein include: a handle for controlling movement of the capture device to capture a stent, said handle comprising: a first interior space and one or more retention features disposed at openings within the first interior space; 1. A drive mechanism comprising a drive configured to be coupled to a capture device comprising a push wire and a button, the driver is configured to be disposed in the first interior space of the handle and includes a second interior space and one or more locking mechanisms configured to engage the one or more retention mechanisms to prevent advancement of the driver within the first interior space, and the button is configured to be disposed in the second interior space and includes a body and one or more grooves. a drive mechanism; the button is configured to be advanced within the second interior space of the drive portion so as to contact an inner surface of the drive portion that defines the second interior space, and the one or more grooves are configured to be positioned radially inward of the one or more locking mechanisms; the button is configured to be further advanced to apply a force to the driver, causing the one or more locking mechanisms to deflect radially inward from the one or more retention mechanisms and enter the one or more grooves of the button, thereby advancing the driver into the first interior space of the handle; The handle relates to a handle in which the drive portion advances in the first internal space of the handle, causing the push wire to advance the capture device.

[0046] In some embodiments, the techniques described herein include: The capture device is configured to be advanced from the tube to expose hooks that hold the handle of the stent, causing the handle of the stent to bend away from the hooks, allowing the stent to be delivered into the urethra.

[0047] In some embodiments, the techniques described herein include: The one or more retention features relate to a handle that includes a ramp.

[0048] In some embodiments, the techniques described herein include: The one or more locking mechanisms are on a handle that includes an enlarged edge that is complementary to the ramp surface.

[0049] In some embodiments, the techniques described herein include: 1. A method of controlling movement of a capture device using a drive mechanism on a handle, the method comprising: advancing a button into an interior space of the driver so that the button contacts an interior surface of the driver and positions one or more grooves of the button radially inward of one or more locking mechanisms of the driver; applying an axial force to the button and actuator to press the one or more locking mechanisms of the actuator against one or more retention mechanisms disposed in openings within the interior space of the handle, thereby deflecting the one or more locking mechanisms out of the one or more retention mechanisms and into the one or more grooves of the button; advancing the button and driver into the interior space of the handle to advance a push wire coupled to the driver and advance a capture device configured to capture a stent; The present invention relates to a method comprising:

[0050] In some embodiments, the techniques described herein include: wherein the one or more retention features further comprise an angled surface.

[0051] In some embodiments, the techniques described herein include: wherein the one or more locking mechanisms include an enlarged edge complementary to the ramp surface.

[0052] In some embodiments, the techniques described herein include: 1. A loading adapter for facilitating loading of a stent into a working channel of a delivery device, said loading adapter comprising: a port located off the central longitudinal axis of the loading adapter, the port is tapered to a narrower cross section in a distal direction; Port and a receiving region disposed on an opposite side of the loading adapter, the receiving area is configured to receive a proximal end of a delivery device and position the loading adapter on the proximal end of the delivery device. a receiving area; The port relates to a loading adapter configured to be coaxially positioned with a working channel of the delivery device to facilitate loading of the stent into the working channel.

[0053] In some embodiments, the techniques described herein include: Distal to the port is a loading adapter having a diameter corresponding to the diameter of the working channel.

[0054] In some embodiments, the techniques described herein include: The loading adapter further comprises a lumen having a constant diameter connecting the port and the receiving area.

[0055] In some embodiments, the techniques described herein include: The constant diameter of the lumen relates to a loading adapter that corresponds to the diameter of the lumen.

[0056] In some embodiments, the techniques described herein include: The taper of the port relates to a loading adapter that distributes the compressive forces on the stent as it is pulled through the port and collapsed.

[0057] In some embodiments, the techniques described herein include: 1. A method for loading a stent into a working channel of a delivery device using a loading adapter, the method comprising: placing a loading adapter over the proximal end of the delivery device; positioning the tapered port of the loading adapter coaxially with a working channel of a delivery device; pulling the stent into the tapered port such that a compressive force distributed by the tapered port compresses the stent to a size that fits into the working channel; and c. pulling the stent into the working channel.

[0058] In some embodiments, the techniques described herein include: the method further comprising rotating the loading adapter on the proximal end of the delivery device to position the tapered port coaxially with the working channel. [Brief explanation of the drawings]

[0059] [Figure 1] FIG. 1 illustrates a cross-sectional view of the male urethra and associated anatomical structures. [Figure 2A] FIG. 2A illustrates a schematic cross-section of the prostatic urethra and bladder in the case of a healthy prostate. [Figure 2B] FIG. 2B illustrates an enlarged prostate gland compressing the prostatic urethra. [Figure 2C] FIG. 2C illustrates an enlarged prostate gland with a urethral stent placed within the prostatic urethra to maintain its patency. [Figure 3] FIG. 3 illustrates an isometric view of a urethral stent configured to be placed within the prostatic urethra, as shown in FIG. [Figure 4] FIG. 4 illustrates an end view of the urethral stent of FIG. [Figure 5] FIG. 5 illustrates a side view of the urethral stent of FIG. [Figure 6] FIG. 6 illustrates a top view of the urethral stent of FIG. [Figure 7] FIG. 7 illustrates a bottom view of the urethral stent of FIG. [Figure 8A] FIG. 8A illustrates one embodiment of a delivery device (e.g., a cystoscope) suitable for delivering a urethral stent, such as the urethral stents of FIGS. 3-7, and illustrates the distal end of the delivery device (e.g., the end that is positioned outside the urethra during the stent delivery procedure). [Figure 8B] FIG. 8B illustrates an embodiment of a delivery device (e.g., a cystoscope) suitable for delivering a urethral stent, such as the urethral stents of FIGS. 3-7, showing the proximal end of the delivery device (e.g., the end that is positioned inside the urethra during the procedure). [Figure 9A] 9A illustrates a schematic diagram of a urethral stent configured for placement within the prostatic urethra, showing various configurations of the stent handle (e.g., basket hook, loop, hook). FIG. 9A illustrates the stent handle in an unflexed configuration, which may include a distal end (e.g., an end positioned away from the bladder) positioned axially in alignment with the circumferential wall of the stent formed by struts. [Figure 9B] Figure 9B illustrates a schematic diagram of a urethral stent configured for placement within the prostatic urethra, showing various configurations of the stent handle (e.g., basket hook, loop, hook). Figure 9B illustrates the stent handle retracted into the configuration shown in Figure 9C, which shows the handle generally aligned with the central longitudinal axis of the stent. [Figure 9C] FIG. 9C illustrates a schematic diagram of a urethral stent configured for placement within the prostatic urethra, showing various configurations of the stent handle (eg, basket hook, loop, hook). [Figure 9D]Figure 9D illustrates a schematic diagram of a urethral stent configured for placement within the prostatic urethra, showing various configurations of the stent handle (e.g., basket hook, loop, hook), and shows the stent being retracted into the working lumen of a delivery device in the handle, which allows the stent to collapse. [Figure 9E] Figure 9E illustrates a schematic diagram of a urethral stent configured for placement within the prostatic urethra, showing various positions of the stent handle (e.g., basket hook, loop, hook). Figure 9F illustrates the stent in a collapsed configuration and positioned in the working lumen of a delivery device. [Figure 10A] Figure 10A illustrates a schematic diagram of a capturing device with a hook for capturing (e.g., grasping, mating with) a stent handle. Figure 10A illustrates a side view of the capturing device. [Figure 10B] Figure 10B illustrates a schematic diagram of a capturing device with hooks for capturing (e.g., grasping, mating with) a stent handle. Figure 10B illustrates a top view of the capturing device. [Figure 11A] Figure 11A illustrates a schematic diagram of the capture device of Figures 10A and 10B cooperating with a tube to securely hold and secure a stent handle to the capture device, and Figure 11A illustrates the hooks of the capture device deployed from within the tube and coupled with the stent handle. [Figure 11B] Figure 11B illustrates a schematic diagram of the capturing device of Figures 10A and 10B, which cooperates with a tube to securely hold and secure the stent handle to the capturing device. Figure 11B illustrates the hooks of the capturing device retracted within the tube to secure the stent handle within the hooks. [Figure 11C]Figure 11C illustrates a schematic diagram of the capture device of Figures 10A and 10B cooperating with a tube to securely hold and secure a stent handle to the capture device, and Figure 11C is a top view of the retracted position of the capture device relative to the tube of Figure 11B (i.e., the advanced position of the tube relative to the capture device). [Figure 12A] 12A illustrates a schematic diagram of the capture device of FIGS. 10A-11C being moved through the working lumen of a delivery device. FIG. 12A illustrates the capture device being moved through the straight working lumen of a delivery device with a faceplate located at the proximal end (e.g., the end positioned within the urethra closest to the bladder). [Figure 12B] 12B illustrates a schematic diagram of the capture device of FIGS. 10A-11C being moved through the working lumen of a delivery device. FIG. 12B illustrates the capture device being moved through the working lumen of a delivery device with a bend (e.g., angle). [Figure 12C] 12C illustrates a schematic diagram of the capture device of FIGS. 10A-11C being moved through the working lumen of a delivery device. FIG. 12C illustrates the capture device being moved through the working lumen of a delivery device with a bend (e.g., angle). [Figure 13A] FIG. 13A illustrates a handle with a drive mechanism for advancing the capture device from the tube to deliver the stent to the prostatic urethra. [Figure 13B] FIG. 13B illustrates a capture device coupled to the drive mechanism of the handle via a push wire with a hook disposed within the tube that holds the stent handle. [Figure 13C] FIG. 13C illustrates the drive mechanism after an initial force has advanced the button, positioning one or more recesses in the button radially inward of the drive's retention feature. [Figure 13D] FIG. 13D illustrates the drive mechanism after additional force has been applied to advance the button further such that the retention features of the drive deflect into one or more recesses in the button. [Figure 13E] FIG. 13E illustrates that with the retention feature deflected into one or more recesses in the button, the driver is advanced relative to the handle, thereby advancing a push wire coupled to the capture device. [Figure 13F] FIG. 13F illustrates that the capture device is advanced to deliver the stent to the urethra by positioning the hooks of the capture device on the outside of the tube, which occurs by advancing the drive portion shown in FIG. 13E. [Figure 13G] FIG. 13G illustrates that a capture device with a hook coupled to a handle within the tube securely holds the handle when a force (eg, an axial force) is applied to the stent. [Figure 13H] FIG. 13H illustrates a handle with a drive mechanism coupled to the capture device in FIG. 13G, which maintains the position of the capture device despite the application of force to the stent. [Figure 14A] FIG. 14A illustrates a schematic diagram of a method for loading a stent into the working channel of a delivery device. [Figure 14B] FIG. 14B illustrates a schematic diagram of a method for loading a stent into the working channel of a delivery device. [Figure 14C] FIG. 14C illustrates a schematic diagram of a method for loading a stent into the working channel of a delivery device. [Figure 15A] FIG. 15A illustrates an additional schematic view of the loading method for the stent of FIGS. 14A-14C. [Figure 15B] FIG. 15B illustrates an additional schematic diagram of the loading method for the stent of FIGS. 14A-14C. [Figure 16A] FIG. 16A illustrates a schematic diagram of a loading adapter positioned at the proximal end of a delivery device (e.g., the end positioned within the urethra) to facilitate loading of a stent into the working lumen of the delivery device. [Figure 16B]FIG. 16B illustrates a schematic diagram of a loading adapter positioned at the proximal end of the delivery device (e.g., the end positioned within the urethra) to facilitate loading of the stent into the working lumen of the delivery device. [Figure 16C] FIG. 16C illustrates a schematic diagram of a loading adapter positioned at the proximal end of the delivery device (e.g., the end positioned within the urethra) to facilitate loading of the stent into the working lumen of the delivery device. [Figure 17A] FIG. 17A illustrates an additional schematic view of a loading adapter used to load a delivery device into the working lumen of a delivery device. [Figure 17B] FIG. 17B illustrates an additional schematic view of a loading adapter used to load a delivery device into the working lumen of a delivery device. [Figure 17C] FIG. 17C illustrates an additional schematic view of a loading adapter used to load a delivery device into the working lumen of a delivery device. [Figure 18A] FIG. 18A illustrates a schematic diagram of a method for loading a stent into a working channel of a delivery device using a loading adapter. [Figure 18B] FIG. 18B illustrates a schematic diagram of a method for loading a stent into the working channel of a delivery device using a loading adapter. [Figure 18C] FIG. 18C illustrates a schematic diagram of a method for loading a stent into the working channel of a delivery device using a loading adapter. [Figure 18D] FIG. 18D illustrates a schematic diagram of a method for loading a stent into the working channel of a delivery device using a loading adapter. [Figure 18E] FIG. 18E illustrates a schematic diagram of a method for loading a stent into the working channel of a delivery device using a loading adapter. [Figure 19A]FIG. 19A illustrates a schematic diagram of a method for delivering a stent into the prostatic urethra. [Figure 19B] FIG. 19B illustrates a schematic diagram of a method for delivering a stent into the prostatic urethra. [Figure 19C] FIG. 19C illustrates a schematic diagram of a method for delivering a stent into the prostatic urethra. [Figure 19D] FIG. 19D illustrates a schematic diagram of a method for delivering a stent into the prostatic urethra. [Figure 19E] FIG. 19E illustrates a schematic diagram of a method for delivering a stent into the prostatic urethra. [Figure 20A] FIG. 20A illustrates deflection of the stent handle. [Figure 20B] FIG. 20B illustrates a schematic diagram of a urethral stent positioned within the prostatic urethra between the bladder neck and the apex of the verumontanum. [Figure 20C] FIG. 20C illustrates a schematic diagram of a urethral stent positioned within the prostatic urethra between the bladder neck and the apex of the verumontanum. [Figure 21] FIG. 21 is a flow diagram illustrating a method for placing a urethral stent. [Figure 22A] FIG. 22A illustrates placement of a urethral stent according to the method of FIG. [Figure 22B] FIG. 22B illustrates placement of a urethral stent according to the method of FIG. [Figure 22C] FIG. 22C illustrates placement of a urethral stent according to the method of FIG. [Figure 22D] FIG. 22D illustrates placement of a urethral stent according to the method of FIG. [Figure 22E] FIG. 22E illustrates placement of a urethral stent according to the method of FIG. [Figure 22F] FIG. 22F illustrates placement of a urethral stent according to the method of FIG. [Figure 22G] FIG. 22G illustrates placement of a urethral stent according to the method of FIG. [Figure 22H]FIG. 22H illustrates placement of a urethral stent according to the method of FIG. [Figure 22I] FIG. 22I illustrates placement of a urethral stent according to the method of FIG. [Figure 22J] FIG. 22J illustrates placement of a urethral stent according to the method of FIG. [Figure 22K] FIG. 22K illustrates placement of a urethral stent according to the method of FIG. [Figure 22L] FIG. 22L illustrates placement of a urethral stent according to the method of FIG. [Figure 23] FIG. 23 is a flow diagram illustrating a method for retrieving a urethral stent. [Figure 24] FIG. 24 is a flow diagram illustrating a method for repositioning a urethral stent. [Figure 25] FIG. 25 is a flow diagram illustrating a method for repositioning a urethral stent. DETAILED DESCRIPTION OF THE INVENTION

[0060] Several factors may influence the onset and progression of benign prostatic hyperplasia (BPH), also known as benign prostatic hypertrophy. The most common factors are aging and changes in hormone balance. FIG. 1 illustrates a detailed cross-section of the male urethra 100. The prostate gland 102 is shown immediately below (e.g., below, distal to) the bladder 104. The region of the urethra 100 surrounded by the prostate gland 102 is the prostatic urethra 106, which is surrounded proximally by the opening of the bladder and distally by the membranous portion of the urethra 108. Below the membranous portion of the urethra 108, the urethra 100 becomes the spongy (penile) urethra 110 and continues to and terminates at the external urethral meatus 112. The internal urethral sphincter (not shown) is located at and surrounds 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 urine from the bladder 104 into the prostatic urethra 106. The external urethral sphincter (not shown) is located in the membranous portion of the urethra 108. 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.

[0061] FIG. 2A illustrates a normal prostatic urethra 106 connected to a bladder 104 and surrounded by a prostate gland 102. As shown in FIG. 2B, when the prostate gland 102 enlarges, the prostatic urethra 106 compresses and reduces its diameter. This leads to various symptoms observed in the progression of BPH, including, but not limited to, urinary frequency, urgency, nocturia, hesitancy, weak urinary stream, straining, and / or prolonged urination. An implantable device 200 for overcoming the symptoms of BPH is shown in FIG. 2C. The implantable device 200 is a urethral stent located entirely within the prostatic urethra 106, between the internal urinary sphincter 202 and the external urinary sphincter 204.

[0062] Disclosed herein are devices including stents that can be configured to adjust the diameter and opening of the prostatic urethra. Prostatic urethral stents can include a variety of generally artificial 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 dilate the urethra beyond its natural diameter.

[0063] FIG. 3 shows a perspective view of one such device in the form of a urethral stent 300. The urethral stent 300, i.e., the stent 300, may include a generally cylindrical shape with a plurality of nodes 302 (e.g., proximally facing nodes 302a and / or distally facing nodes 302b) and struts (e.g., angled struts 312 and / or longitudinal struts or bridges 310). In some embodiments, the nodes 302 and struts 310, 312 may be formed by cutting material from a cylindrical member. In some embodiments, the nodes 302 and struts 310, 312 may be formed using additive manufacturing, casting, cutting, injection molding, and / or other techniques. The nodes 302 may be generally triangular or arrowhead shaped. The nodes 312 may face toward the proximal end 306 or the distal end 308 of the stent, which may include some nodes 312 facing toward the proximal end 306 and other nodes 312 facing toward the distal end 308. The nodes 302 can form parallelogram-, trapezoid-, and / or quadrilateral-shaped cells by connecting longitudinal struts 310 and angled struts 312 to one another. The angled struts 312 can move circumferentially around the stent 300 and change direction. For example, one or more Z-shaped rings 311 (e.g., 1, 2, 3, 4, 5, 6, etc.) can be formed around the circumference of the stent 300 by attaching a forward angled strut 312 to a reverse angled strut 312, which in turn can be attached to a forward angled strut 312. As shown in Figure 3, the illustrated stent 300 includes three such Z-shaped rings 311, although more or less than three are possible. In some embodiments, the angled struts 312 may be curved. The distal end 308 of the stent may include a handle 324 (e.g., bucket handle, loop, arc).A handle 324 may extend from a curved and / or angled strut 312 (e.g., a leading strut, a distal-most strut, a distal surface strut) in the nose region 318, and in some embodiments, it can form a heart and / or a shield shape, as illustrated in the top and bottom views of FIGS. 6 and 7 . The handle 324 may be an extension of the strut 312 in the nose region 318. The handle 324 may extend from one strut 312 and loop with another strut 312. The handle 324 may include a divot 325 (e.g., a protrusion, fold, notch, bend, curve, or contour), which may be small relative to the dimensions of the handle 324. The divot 325 may be located in the center of the handle 324, including on a loop of the handle midway between the struts 312. The divot 325 can be located on a central longitudinal surface that divides the stent 300 into two longitudinal sections. The divot 325 can be configured to engage with an engagement feature, such as a hook, on another device. The struts 310, 312 can have a width in the circumferential direction of approximately 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, and / or 0.25 mm. The struts 310, 312 and / or nodes 302 can have a thickness in the radial direction of approximately 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. The struts 310, 312 and nodes 302 may form the circumferential wall of the stent 300, which may have a thickness (e.g., a uniform thickness) as described above. 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., struts 310, 312 and nodes 302) in the radial direction. The stent 300 may be electropolished.

[0064] The longitudinal struts 310 can connect with the angled struts 312 to form an acute angle and a complementary angle. The acute angles formed between the longitudinal struts 310 and the angled struts 312 of a particular cell can be equal in magnitude moving proximally from cell to cell, or they can decrease in magnitude as one moves proximally. For example, the acute angles formed between the longitudinal struts 310 and the angled struts 312 of cells in the body region 320 of the stent can be larger than the acute angles formed between the longitudinal struts and the angled struts of cells in the tail region 322 of the stent, thereby configuring the stent 300 to be stiffer (e.g., to exert a greater radial force) in the body region 320 compared to the tail region 322. In some embodiments, the longitudinal length of the cells increases proximally along the longitudinal axis of the stent 300 (toward the proximal end 306 of the stent). In some embodiments, the acute angles are equal and do not vary from cell to cell.

[0065] Circumferentially adjacently spaced cells may define longitudinal regions of the urethral stent 300. For example, the illustrated stent of Figure 3 may include nose, body, and tail regions 318, 320, and 322. Each region 318, 320, and 322 may be configured for a specific clinical and anatomical function, as described herein.

[0066] A nose region 318 of the stent 300 is disposed at the distal end 308 of the stent. Struts 311 in the nose region 318 are formed into a handle 324. The handle 324 may be used to attach to a deployment and / or extraction member (not shown) that may be used to manipulate (e.g., advance, retract, rotate, etc.) the stent 300, which may include pushing and / or pulling the stent 300 into and / or from the working lumen of a deployment device. Pulling the handle 324 (in a distal direction, away from the bladder when inserted) may provide leverage, compressing the stent 300 into a collapsed state so that it may be retracted into a working channel of a deployment device (e.g., a catheter, cystoscope, etc.), as described further below. The parallelogram or quadrilateral cell shape and the angular configuration formed by the angled struts 312 promote easier folding of the stent 300. The divots 325 in the handle 324 can provide coupling (e.g., attachment) points and / or areas for coupling (e.g., engaging) with another device (e.g., capture device, deployment device), which can promote even and symmetric distribution of pulling or pushing forces applied at the divots 325 on the stent 300. This geometry can promote smooth, symmetrical folding and / or expansion of the stent 300 during loading, deployment, and / or loading for cystoscope placement, as described herein.

[0067] Nose region 318 may include two diamond-shaped cells 327 formed from distally disposed angled struts 312. Diamond-shaped cells 327 may control the distribution of tension applied to stent 300 and handle 324, further ensuring smooth folding and expansion of stent 300 during loading, deployment, and / or removal.

[0068] The nose region 318 of the stent 300 allows a clinician to rotate and orient the stent 300 about its longitudinal axis. The shape of the handle 324 allows a clinician to orient the stent 300 relative to the anatomy of the patient's urethra 100. The handle 324 can be configured to place a divot 325 on the convex annular surface of a peripheral wall (e.g., the peripheral wall of the stent 300). The divot 325 can be positioned coaxially with the longitudinal struts 310.

[0069] In some embodiments, the outward radial force exerted by the stent 300 generally decreases along the proximal direction of the stent. The urethral stent 300 may be more collapsible along the proximal direction of the stent 300 (toward the bladder when inserted). For example, the stent 300 may be characterized by a collapsibility gradient. The body region 320 of the stent 300 may exert the greatest radial force and therefore be least collapsible when inserted into the prostatic urethra 108. The tail region 322 of the stent 300 may exert the least radial force and therefore be most collapsible when inserted into the prostatic urethra 108. In other embodiments, the outward radial force exerted by the stent 300 may be uniform along at least the body and tail regions 320, 322. Applying less force to the most proximal region (tail) 322 can have multiple functional benefits, including inhibiting migration into the bladder, facilitating advancement of the compressed stent 300 out of the working channel, and / or increasing the resting tone of the bladder neck and internal urethral sphincter, thereby potentially reducing patient anxiety and / or the risk of device-related retrograde ejaculation.

[0070] The body and tail regions 320, 322 of the stent 300 can provide sufficient radial force to counteract or partially counteract compressive forces on the prostatic urethra 108 from an enlarged prostate, such as the prostate gland in a patient with BPH. The outward radial force provided by the stent's body and tail regions 320, 322 can hold the prostatic urethra 108 open during urination. The body and tail regions 320, 322 may be configured simply to counteract compressive forces exerted on the urethra by the enlarged prostate. The stent 300 can be configured such that, when fully expanded, the urethra only recoils to its natural diameter, but no further. The stent 300 cannot expand the diameter of the urethra beyond its natural diameter. The natural diameter of the urethra may correspond to the diameter of the stent 300 if the compressive forces of the prostate gland were not acting on the stent 300. For example, the prostatic urethra 108 may be expanded to have a diameter that is compatible with (e.g., equal to) the diameter of other non-prostatic regions of the urethra, such as the corpus spongiosum or penile urethra 110. Controlling the expanded diameter of the stent 300 so that the stent 300 does not expand the urethra beyond its native diameter may provide physiologically relevant benefits. A controlled expanded diameter may reduce pressure on the walls of the prostatic urethra 108, which may result in reduced inflammation, fibrosis, and / or epithelialization within the prostatic urethra 108. This may shorten the patient's recovery time and / or improve the long-term tolerance of the stent.

[0071] As a proxy for radial force, localized compressive forces were applied to stents 300 of different sizes, and the force required to crush the diameter of the stent 300 in half was measured. In some embodiments, the outward radial forces exerted by the rings 311 in the nose, body, and tail regions 318, 320, and 322 of the large stent 300 were 2.5 N, 2.4 N, and 2.1 N, respectively. In some embodiments, the outward radial forces exerted by the rings 311 in the nose, body, and tail regions 318, 320, and 322 of the medium stent 300 were 3.0 N, 2.8 N, and 2.5 N, respectively. In some embodiments, the outward radial forces exerted by the rings 311 in the body and tail regions 320 and 322 of the small stent 300 were 2.2 N and 1.9 N, respectively. The outward radial force of the nose, body, and tail regions of the stent 300 can be in the range of at least 1.5N to 3.0N.

[0072] The outward expansion of the tail region 322 of the stent 300 allows leaflets 329 formed from the nodes 302 and angled struts 312 at the proximal end 306 to engage the soft tissue of the prostatic urethra 108 near and / or at the internal urethral sphincter 202, i.e., bladder neck. The proximal nodes 302 may prevent proximal (toward the bladder) migration of the stent 300 once inserted by acting as an atraumatic anchor in contact with the wall of the prostatic urethra 108. The stent 300 may include multiple (e.g., four) such leaflets 329 formed at the proximal end 306 of the stent 300. Advantageously, the four leaflets 329 may contact prostatic urethral tissue at four circumferential locations to provide rotational stability of the stent 300 within the prostatic urethra 108 during deployment and / or removal.

[0073] The stent 300 can be sized to fit a patient's particular anatomy. For example, after determining the length of a patient's prostatic urethra 108, a urethral stent 300 can be selected that has a length equal to or less than the length of the prostatic urethra. In some embodiments, the length of the stent 300 can be determined by the length of the stent's tail region 322. In other words, stents 300 of different lengths can have the same nose region 318 and body region 320, but the tail regions 322 can be different. For example, the tail region 322 of a longer stent can be formed with longer longitudinal struts 310 or can include more cells than the tail region 322 of a shorter stent. The length of the stent 300 can be varied by changing (e.g., increasing or decreasing) the distance between adjacent annuli 311, which can include changing the length of the longitudinal struts 310. The length of the stent 300 can be varied by varying (eg, increasing or decreasing) the number of rings 311 and the number of longitudinal struts 310 extending between those rings 311 .

[0074] Additionally, in some embodiments, the tail region 322 of the stent 300 may flare to a larger diameter at its proximal end. For example, the outer and inner diameters of the proximal portion of the tail region 322 may be larger than the distal portion of the tail region 322. In some embodiments, the outer and inner diameters of the stent 300 increase gradually and / or uniformly along the proximal direction of the stent 300. The flared region of the stent 300 can be achieved by placing the stent 300 on a conical mandrel or another device and heat treating the stent 300 to obtain the desired expanded shape.

[0075] FIG. 4 shows an end view of stent 300. As shown, handle 324 does not obstruct the internal space (e.g., flow passage) formed by stent 300, allowing unimpeded flow therethrough when expanded within the urethra. By maintaining a circular shape, stent 300 allows unimpeded flow of bodily fluids therethrough when expanded within a patient's urethra. FIG. 5 shows a side view of stent 300. From a side view, handle 324 may resemble a leg, with leg-like divots 325 extending horizontally (e.g., distally, which may include a direction parallel to the central longitudinal axis of stent 300) toward distal end 308. Leg-like struts appear to rise vertically and bend at the knee to connect with angled struts 312 that extend to form one side of diamond-shaped cells 327. Stent 300 may taper in diameter, at least from body 320 to distal end 308. In some embodiments, the stent 300 can taper in diameter from the proximal end 306 to the distal end 308 (e.g., the proximal end 306 can be larger than the distal end 308, or the distal end 308 can be larger than the proximal end 306). From a side view, the handle 324 can project from (e.g., extend in the same direction as) the angled struts 312 in the nose region 318 and curve before extending in a direction (e.g., perpendicular, particularly generally perpendicular to the central longitudinal axis of the stent 300) to position the divot 325 on the convex annular surface defined by the peripheral wall of the stent 300, which may include being flush with the convex plane of the peripheral wall of the stent 300. The handle 324 can project from and connect to two angled struts 312 located on opposite sides of the stent 300, thereby forming a loop in the divot 325. The curve in the handle 324 can bias the handle 324 into the position shown, such that the handle 324 is generally out of the flow path and / or the divots and / or other features in the handle 324 are generally positioned in the convex annular surface of the peripheral wall of the stent 300.

[0076] 6 and 7 show top and bottom views, respectively, of the stent 300. The nose region 318 of the stent 300 can have a generally heart-like and / or shield-like shape, and the nose region includes a handle 324. The heart-shaped handle 324 can assist in folding and expanding the stent 300 within the prostatic urethra 108. As shown, in some variations, the curve in the handle 324 can prevent the handle 324 from extending distally until it reaches a divot 325. As shown, the handle 324 can form a loop by extending straight inward (e.g., perpendicular to the central longitudinal axis of the stent 300), which can include connecting two halves of the handle 324 at the divot 325. The distal-most portion of the handle 324 can be generally straight (e.g., oriented perpendicular to the central longitudinal axis of the stent 300), except for the divot 325.

[0077] FIG. 8A illustrates one exemplary embodiment of a delivery device 700 suitable for delivering the urethral stents described herein. In the illustrated embodiment, a cystoscope is provided as the delivery device 700. The cystoscope 700 includes a handpiece 704, a distally terminating catheter tube 702. An eyepiece 706 is disposed at the distal end 708 of the handpiece. The catheter tube 702 includes multiple channels formed therein, which terminate proximally at a proximal end 718. As shown in FIG. 8B, the catheter tube 702 includes a working channel 710, two illumination channels 712, and a camera channel 714, all of which extend and are exposed to the proximal end 718 for their respective functions. The eyepiece 706 is optically coupled to the camera 714 so that the surgeon can visualize the interior of the lumen into which the catheter tube 702 is inserted. Port 716 may be fluidly coupled to working channel 710 to provide access for irrigation, aspiration, and control wires disposed within working channel 710 .

[0078] FIG. 9A provides a schematic illustration of a urethral stent (e.g., stent 300) having a handle, diamond-shaped cells, and multiple Z-shaped rings formed from alternating angled struts, as described herein. In some embodiments, the expanded stent outer diameter may be 10 mm, the combined length of the body and tail regions may be 24 mm, and the overall length from the handle to the proximal leaflet may be 30.5 mm. In some embodiments, the expanded stent outer diameter may be 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm, or may be within a range bounded by either of the two aforementioned values. In some embodiments, the expanded stent outer diameter may be less than 8 mm or greater than 20 mm. In some embodiments, the length of the body to tail regions can be between 10 mm and 35 mm, and / or can be about 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, 22 mm, 24 mm, 26 mm, 28 mm, 30 mm, 32 mm, 34 mm, or 35 mm. In some embodiments, the overall length of the stent can be between 15 mm and 45 mm, and / or can be 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, the effective overall length of the stent can be varied by increasing the spacing between the Z-shaped rings and / or adding additional Z-shaped rings to the stent.

[0079] When expanded, the diameter of the stent can vary depending on the position along its length. For example, the stent can have its largest diameter in the body region and smaller diameters in the nose and tail regions. The diameter of the stent can taper linearly from its largest diameter to a smaller diameter, or it can be shaped with a bulge formed in the body region. The larger diameter / bulge can anchor the stent within the prostatic urethra, which may 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), through 11 mm in the center (body region), to 9 mm at the proximal end (tail region).

[0080] A stent can be formed by cutting openings in the wall of a cylindrical tube, placing the tube on a mandrel to the desired diameter, and then heat-treating the tube to form the stent. In some embodiments, the initial cylindrical tube may be larger than the desired diameter of the stent, so the stent can be heat-treated to reduce the diameter of the cylindrical tube. Alternatively, a smaller diameter cylindrical tube can be used to form the stent. The smaller diameter cylindrical tube can be first cut to form the desired wall pattern and openings, and then the tube can be expanded over a mandrel to bring the tube to the desired final stent diameter. The stent can then be heat-treated on the mandrel to the final stent diameter.

[0081] The delivery device for the stent into the prostatic urethra 106 may be an instrument such as a cystoscope 700, as described above with reference to Figures 8A and 8B. The diameter of the working channel 710 of the cystoscope 700 is typically about 2.0 mm to 2.5 mm. Therefore, it may be preferable to form the stent from an initial tube having an outer diameter of about 2.0 mm, expand it, and heat-set it on a mandrel to the final desired diameter. In this way, the stent may, in some cases, be more easily collapsed to the small diameter (e.g., about 2.0 mm to 2.5 mm) of the cystoscope's working channel 710.

[0082] 9B-9E illustrate steps of a method for loading a stent into a working channel of a delivery device, such as a cystoscope (e.g., cystoscope 700). In FIGS. 9B and 9C, the stent handle is pulled, horizontal, and straight toward the direction of pulling. As the stent handle is pulled, it can move (e.g., deflect) from a position generally outside the central flow channel of the stent to be positioned within the central flow channel of the stent, which may include being positioned on the central longitudinal axis of the stent. As the stent handle is pulled, it can move (e.g., deflect) from an angled configuration to a generally straight configuration extending distally (e.g., generally parallel to the central longitudinal axis of the stent). As described herein, the curve of the handle can bias the handle to a position generally outside the central flow channel until pulled. In FIG. 9D, the handle is shown being retracted into the working channel of the cystoscope. As shown by the lateral, inward-pointing arrows, the distal end of the stent is compressed and folded upon entry into the working channel. As shown in FIG. 9E , in some embodiments, the stent can be configured to be compressed to fit within the working channel of a cystoscope, which can include having an outer diameter no greater than 2.2 mm (e.g., the diameter of the working channel). In some embodiments, when compressed and folded within the working channel of a cystoscope, the outer diameter of the stent can be no greater than 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, or 2.5 mm. In some embodiments, when compressed, the stent can have a diameter of only 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 3.0 mm, 3.5 mm, or 4 mm. The diamond shape of the cells formed by the struts and / or the angled strut folding allows the stent to be folded to lengthen the stent, including as long as about 38 mm, as shown in FIG. 9E.

[0083] 10A and 10B, a capturing device 730 (loading device, holding device, control device, placement device, retrieval device) is schematically illustrated engaged with the handle 324 of the stent 300 shown in FIGS. 3-7. FIG. 10A illustrates a side view of the capturing device 730 engaged with the handle 324. The capturing device 730 may include a hook (fastener, notch, recess, groove) 734. The hook 734 may couple with (e.g., capture, hold, or seize) the handle 324 (e.g., the divot 325 of the handle 324) to manipulate the stent 300, which may include loading the stent 300 into a working channel of a delivery device, deploying 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 can include a body 736 (e.g., a hook body, a cylinder), which can include a hook 734 (e.g., the hook 734 can be formed within the body 736). The body 736 can be coupled (e.g., attached) to a push member (e.g., a push wire). The push wire 738 can extend in a distal direction 740, away from the patient being treated. The hook 734 can be a notch formed in the body 736 and can capture and hold the handle 324 of the stent 300. The capture device 730 can include a tip 732 (e.g., a head, end, bullet tip, arrowhead). The tip 732 can be positioned at an end (e.g., a proximal end) of the body 736. The tip 732 can extend from the body 736 in a proximal direction 742 that is directed toward the patient's bladder during the procedure. The tip 732 can be tapered in the distal-to-proximal direction. For example, when viewed from the side, as in FIG. 11B , tip 732 may flare in a distal direction 740 (e.g., away from the bladder) such that a distal portion of tip 732 is wider than a proximal portion of tip 732. Tip 732 may be pointed and may include pointing in proximal direction 742. For example, tip 732 may include a pointed head, a bullet-shaped head, an arrow-shaped head, and / or a conical head that points in proximal direction 742.11B , the distal end of tip 732 (e.g., the portion of tip 732 disposed adjacent body 736) may be taller than the distal end of body 736, thereby exposing a distally facing surface 733 (e.g., neck edge 733) of tip 732. Tip 732 may include rounded edges and / or corners to avoid tissue damage and / or capture device 730 from unintentionally catching on features of a delivery device and / or other devices. The distal-most portion of tip 732 may, in some variations, be flat (e.g., disposed in a plane generally perpendicular to the central longitudinal axis of capture device 730).

[0084] FIG. 10B shows a top view of the capture device 730 and stent handle 324 shown in FIG. 10A. As can be seen, the width of the tip 732 in the top view may be narrower than the height of the distal portion of the tip 732 in the side view of FIG. 10A. This narrow width can provide space for the handle 324. As can be seen in FIG. 10B, 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 distally, reaching a maximum width before gradually decreasing distally. The tip 732 can bulge outward at a midsection and have a width that tapers distally and proximally from the midsection. The tip 732 can include a larger midsection relative to the distal and proximal sections.

[0085] 11A-11C, capturing device 730 is illustrated with tube 744 (e.g., a cannula). Tube 744 may be disposed over push wire 738 and / or body 736 of capturing device 730, which may include being disposed over hook 734. Tube 744 may include opening 746 (e.g., a proximal opening). Body 736 and push wire 738 may be manipulated within tube 744 to advance capturing device 730 through opening 746 so that hook 734 is disposed outside of tube 744, and / or retract through opening 746 so that hook 734 is disposed inside of tube 744. Push wire 738 may be sufficiently rigid to transmit mechanical movement to body 736. As shown in FIG. 11A, a proximal portion of body 736 of capturing device 730 is pushed out of opening 746, exposing hook 734. The exposed hook 734 can be coupled to the handle 324 of the stent 300, which can be performed outside the patient's body for a stent delivery procedure, or can be performed within the urethra when retrieving a previously delivered stent.

[0086] 11B, capture device 730 and tube 744 are moving relative to one another. Retraction of body 736 within tube 744 also positions hook 734 within tube 744. Distal-facing surface 733 may retract until it contacts tube 744, preventing further retraction, which may be referred to as a closed state. In some embodiments, push wire 738 may be pulled (e.g., by a clinician pulling on the distal end of push wire 738) to retract body 736 with hook 734 within tube 744. With distal-facing surface 733 in contact with the proximal end of tube 744, stent handle 324 may be securely held by hook 734. In some embodiments, in this retracted (e.g., closed) state, as shown in FIG. 11B, the proximal end of tube 744 may be tightly engaged with distal-facing surface 733, leaving little or no gap between them. Engagement of tip 732 (e.g., distally facing surface 733 of tip 732) and a proximal face of tube 744 (e.g., the portion of tube 744 that defines opening 476) can secure (e.g., capture) handle 324 onto hook 734 disposed inside tube 744. In some embodiments, the gap between body 736 and tube 744 can be small enough to prevent handle 324 from disengaging from hook 734.

[0087] FIG. 11C is a top view of the engagement in the retracted (e.g., closed) state shown in FIG. 11B. As can be seen, the narrow width of tip 732 provides a lateral space between tip 732 and the wall of tube 744 that defines opening 746, allowing handle 324 to pass through. The exterior of tip 732, in some embodiments, does not contact tube 744, thereby providing lateral space for handle 324. For example, in some embodiments, tip 732 may contact only two portions (e.g., approximately 180 degrees apart) of the proximal end of tube 744 that form opening 746. With tip 732 engaged with tube 744, the handle can be securely held by hook 734. In the closed state, hook 734 interfaces with tube 744 to capture and hold handle 324 in place. With the body 736 advanced through the opening 746, the handle 324 can be released from the hook 734, thereby exposing the hook 734, as shown in the deployed (e.g., open) state in FIG. 11A.

[0088] The tip 732 can provide a number of advantages, some of which are illustrated in FIGS. 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 a faceplate disposed around the opening to the working channel. These faceplates can be partially folded into the working channel, forming a small edge near the exit of the working channel. FIG. 12A illustrates the loading device 730 disposed within the proximal end of the working channel 710 of the cystoscope 700, with the faceplate 752 disposed at the opening to the working channel 710. A small edge 754 (e.g., a lip) can be formed between the faceplate 752 and the inner surface of the working channel 710. The shape of the tip 732 can reduce the risk of the capture device 730 getting caught on the edge 754 of the faceplate 752. For example, if the tip 732 is squared and / or has sharp corners, the tip 732 may catch on the small edge 754, or at least the small edge 754 may add resistance to movement of the capture device 730. A tip 732 with a pointed shape may reduce or even prevent catch on the edge 754, which may be due, at least in part, to the proximal-most portion of the tip 732 being positioned away from the sidewall and edge 754 of the working channel 710. In some variations, the working channel 710 may include a curve (e.g., a bend, a change in direction), which may be proximal to the proximal end 742. A faceplate 752 may be attached to the proximal end of the working channel 710 of the cystoscope 700. As shown, a tip 732 with a pointed head may allow the capture device to pass safely through the working channel 710 and avoid catch on the edge 754 of the faceplate 752. As shown in FIG. 12B, flexible push wire 738 and covering tube 744 bend at a location between push wire 738 and body 736, allowing them to traverse the bend in working channel 710.As shown in FIG. 12C, the shape of tip 732 may allow a capturing device to pass over edge 754 and out the proximal opening of working channel 710.

[0089] 13A-13H , the drive mechanism 760 is described. The drive mechanism 760 can hold (e.g., restrain, maintain) the position of the capture device 730 relative to the tube 744, which can include using a hook 734 within the tube 744 to hold the tip 732 against the proximal end of the tube 744. When actuated, the drive mechanism 760 can position the hook 734 outside of the tube 744 by advancing the loading mechanism 730 relative to the tube 744. In some embodiments, when actuated, the drive mechanism 760 can position the distally facing surface 133 at the proximal end of the tube 744 by retracting the loading mechanism 730 relative to the tube 744, such that the hook 734 is positioned within the tube 744.

[0090] As shown in FIG. 13A , the drive mechanism 760 can include a handle 762 having an interior space 764 (e.g., a first open-ended linear interior space, cavity, pocket) that can at least partially receive (e.g., house) a driver 766. The driver 766 can be coupled to a push wire 738 (e.g., a 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 driver 766 can include a lumen 768 (e.g., a second open linear opening, cavity, pocket) that can at least partially receive (e.g., house) a button 770. The outer periphery of the driver 766 can match the inner periphery of the handle 762 that defines the lumen 764, thereby allowing the driver 766 to translate (e.g., translate longitudinally) within the lumen 764. The outer periphery of the portion of button 770 configured to be positioned inside lumen 768 of driver 766 may match the inner periphery of driver 766 that defines lumen 768, thereby allowing button 770 to translate (e.g., translate longitudinally) within lumen 768 of driver 766.

[0091] The driver 766 and the handle 762 may include complementary features (e.g., surfaces) that interlock (e.g., contact, engage) to prevent advancement of the driver 766, thereby preventing the push wire 738 and loading device 130 from advancing relative to the tube 744 and maintaining the hook 734 inside the tube 744. For example, the driver 766 may include one or more locking features 772 (e.g., one or more surfaces, angled surfaces, flanges, flared edges, tabs, hooks, beveled edges, lips). The one or more locking features 772 may be located at a distal portion (e.g., distal end) of the driver 766, which may include being located on the outer periphery of the driver 766. The one or more locking features 772 may extend radially outward relative to the longitudinal axis of the driver. The handle 762 may include one or more retention features 778 (e.g., surfaces, angled surfaces, beveled edges, lips). One or more retention features 778 can be disposed at the opening to the lumen 764 of the handle 762. For example, the one or more retention features 778 can include a beveled edge at the opening to the lumen of the handle 762. The one or more locking features 775 of the driver 766 can cooperate with the one or more retention features 778 of the handle 762 to prevent advancement of the driver 766 within the lumen 764 of the handle 762, thereby preventing advancement of the capture device 730 relative to the tube 744 and retaining the hook 734 within the tube 744. If a proximal axial force is applied to the stent 300, engagement of the one or more locking features 775 of the driver 766 with the one or more retention features 778 of the handle 762 can prevent advancement of the driver 766 and corresponding proximal advancement of the push wire 738 and capture device 730, preventing the hook 734 from advancing from the tube 744 and releasing the stent 300. By applying a proximal axial force to the driver 766 via the push wire 738, one or more locking mechanisms 775 of the driver 766 may be pushed into one or more retention mechanisms 778 of the handle 762, thereby urging the one or more locking mechanisms 775 radially inward, but the body of the button 770 may prevent the one or more locking mechanisms 775 from deflecting radially inward.However, button 770 may include one or more grooves 776 (e.g., recesses, grooves, pockets, cavities) that may be located on a side (e.g., opposite side) of the body portion of button 770. Button 770 may be pushed further into lumen 768 of driver 766 to position one or more grooves 776 radially inward of one or more locking mechanisms 772 of driver 766. Button 770 may be pushed into lumen 768 until it contacts the inner surface of driver 766 that defines lumen 768, thereby positioning one or more grooves 776 radially inward of one or more locking mechanisms 772 of driver 766 and advancing button 770 and driver 766 proximally together. With one or more grooves 776 located radially inward of one or more locking mechanisms 772, button 770 and driver 766 may be pushed together. One or more locking mechanisms 772 of the driver 766 are pressed against one or more retention mechanisms 778 of the handle 762, one or more locking mechanisms 775 are forced (e.g., deflected) radially inward into one or more grooves 776 of the button 770, the driver 766 is advanced proximally within the lumen 764 of the handle 762 to advance the push wire 738, and the supplemental device 730 is moved relative to the tube 744 until the hook 734 is positioned outside the tube 744, releasing the stent 300 for delivery into the urethra.

[0092] The capturing device 730, tube 744, and drive mechanism 760 can be used with a delivery device, such as the cystoscope 700, to deliver the stent 300 into the prostatic urethra 106. The capturing device 730, coupled to the drive mechanism 760 via a 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 body 736 of the loading device 130 can be disposed inside the tube 744. The capturing device 730 can be advanced into the catheter tube 702 by pushing the push wire 738, which is connected to the drive mechanism 760. The tube 744 can be advanced using the capturing device 730. The capturing device 730 and tube 744 can be advanced through the working channel 710 until they exit the proximal end 718 of the cystoscope 700.

[0093] As shown in Figures 13A-13H, the drive mechanism 760, tube 744, and capture device 730 cooperate to securely capture and release the stent 300. In Figure 13A, the drive member 766 is disposed within the interior space 764 of the handle 762, and one or more locking mechanisms 778 are engaged with one or more retention mechanisms 779. The button 770 is disposed within the interior space 768 of the drive member 766, and the groove 776 is disposed just outside (e.g., distal to) the opening of the interior space 768. The state of the drive mechanism 760 shown in Figure 13A, with one or more locking mechanisms 778 engaged with one or more retention mechanisms, corresponds to the state of the capture device 730 shown in Figure 13B, in which the tube 744 abuts the distally facing surface 733 of the tip 732, and the handle 324 of the stent 300 is securely held by the hook 734 of the capture device 730 disposed within the tube 744. Engagement of one or more retaining mechanisms 778 on handle 762 with one or more locking mechanisms 772 on driver 766 can apply tension to push wire 738 and prevent accidental release of handle 324. Engagement of one or more retaining mechanisms 778 on handle 762 with one or more locking mechanisms 772 on driver 766 can prevent advancement of driver 766 in lumen 764 of handle 762, such that push wire 738 prevents advancement of capture device 730 relative to tube 744 and securely maintains hook 734 coupled to handle 324 of stent 746 within tube 744.

[0094] 13C shows a force 774 (e.g., a pressing force) being applied to button 770. Force 774 can advance button 770 into lumen 768 of driver 764 until it contacts a surface 764 of the driver, such as the inner surface of lumen 764 of driver 766, thereby advancing button 770 and driver 764 proximally together. As a result of the application of force 774, one or more grooves 776 of button 770 can be positioned radially inward (e.g., radially aligned, adjacent) of locking mechanism 772 of driver 762.

[0095] 13D , continued application of force 774 to button 770 can transfer force 774 to driver 776, thereby forcing one or more locking features 772 of driver 776 against one or more retention features 778 of handle 762. One or more locking features 772 of driver 766 can deflect inward (e.g., radially inward) in the direction of arrow 777 from contacting one or more retention features 778 (e.g., angled surfaces) into one or more grooves in button 770, disengaging one or more locking features 772 from one or more retention features 778 and preventing driver 766 from advancing into lumen 764 of handle 762.

[0096] As shown in FIG. 13E, continued application of force 774 to button 770 causes button 770 and driver 766 to translate proximally within lumen 764 of handle 762. Driver 766 can be pushed further into interior space 764, causing push wire 738 coupled to driver 766 to translate in proximal direction 755. As a result, as shown in FIG. 13F, the translation pushes body 736 of capture device 730 out of opening 746 at the proximal end of tube 744, disposing hook 734 outside tube 744. With hook 734 disposed outside tube 744, handle 324 of stent 300 can be released from hook 734, thereby delivering stent 300 into the urethra, as shown in FIG. 13F.

[0097] The drive mechanism 760 can prevent inadvertent release of the stent handle 324. For example, as shown in FIG. 13G, an axial force 781 (e.g., a proximal axial force, a pulling force) can be applied to the stent 300 and / or tip 372. The force 781 can be transmitted from the capture device 730 via the push wire 738 to retract the driver 766. However, as shown in FIG. 13H, if one or more grooves 776 of the button 770 are not aligned with one or more locking mechanisms 772 of the driver 766, the body of the button 770 can prevent the one or more locking mechanisms 772 from deflecting inward, such that the one or more locking mechanisms 772 remain engaged with one or more retention mechanisms 778 of the handle 762, thereby preventing the driver 766 from advancing into the lumen 764 and the capture device 730 from advancing relative to the tube 744, regardless of the axial force 781.

[0098] 14A-14C, a method of loading a stent 300 into a working channel 710 of a cystoscope 700 is schematically illustrated. In FIG. 14A, the handle 324 of the stent 300 is securely captured by a hook 734 of a capturing device 730 disposed on a tube 744, with the proximal end of the tube 744 engaging the distally facing surface 733 of the tip 732. The handle 762 of a drive mechanism 760, shown in FIGS. 13A-13H, can be pulled by the clinician to retract the stent 300 into the working channel 710. As shown in FIG. 14A, the captured stent 300 can initially retract to contact the edge 748 of the opening 746 in the working channel 710 of the cystoscope 700. The handle 324 can be deflected to extend distally when pulled. As shown in FIG. 14B, continuing to pull on handle 762 may cause stent 300 to be partially retracted into working channel 710. As stent 300 is retracted into working channel 710 of cystoscope 700, stent 300 may be collapsed by contact with end 748. Stent 300 may be compressed to fit within the dimensions (e.g., diameter) of working channel 710. As shown in FIG. 14C, continuing to pull on handle 762 may cause stent 300 to be fully loaded inside working channel 710, which may include stent 300 being collapsed within working channel 710.

[0099] In some cases, the stent loading process and method described with reference to FIGS. 14A-14C may cause damage to the stent 300. When the handle 324 is pulled into the working channel 710 by the capture device 730, the stent 300 is forced against the edge 748 of the opening 746 at the opening of the working channel 710. The edge 748, which may be approximately perpendicular, may result in a contact point on the stent 300 (e.g., the leading angled strut 312), which may concentrate forces on the stent 300. Because the individual forces at the contact points may not be uniformly distributed, the force at a single point may be large enough to cause permanent deformation of the structure of the stent 300, including several longitudinal and angled struts 310 and 312. This may cause the stent 300 to become distorted and / or bent, which may adversely affect the performance of the stent 300. This force concentration phenomenon is illustrated in Figures 15A and 15B, where a force 783 applied to the handle 324 is shown pulling the stent 300 into the working channel 710 through an opening in the proximal end 718. As shown in the schematic diagram of Figure 15B, the working channel 710 may have an edge 748 (e.g., a generally right-angled edge) that may compress the stent 300 at the opening in the working channel 710. As explained, the edge 748 can concentrate forces on the stent 300, which may include an uneven concentration that damages the stent 300.

[0100] 16A-16C illustrate a loading adapter 780 (e.g., a loading tool, a funnel adapter) that can facilitate loading of the stent 300 into the working lumen 110 and / or compress (e.g., collapse) the stent 300 for placement within the working lumen 110 by more evenly distributing compressive forces (e.g., reducing stress concentrations) on the stent 300. The loading adapter 780 can include a port 782 (e.g., an opening, a funnel, an aperture). The port 782 can include a tapered cross-section, which can include a gradual taper in the proximal-to-distal direction. The side of the port 782 that is disposed adjacent to the working channel 710 can include the same (e.g., approximately the same) dimensions (e.g., diameter) and / or shape as the working channel 710. The inner wall of the loading adapter 780 defining the port 782 may be tapered to define a receiving cross-section that gradually decreases in size (e.g., gradually decreases in size distally) to the size of the working lumen 710. The distal portion of the port 782 may be smaller than the proximal portion of the port 782. The loading adapter 780 may include a lumen 784 (e.g., a channel). The lumen 784 may include a certain size and / or shape. The size and / or shape of the lumen 784 may be the same as the working channel 710, and it may include a proximal opening to the working channel 710. The lumen 784 may be connected to the port 782 and may be dimensionally compatible with the working channel 710 of the proximal end 718 of the cystoscope. The lumen 784 and the port 782 may be coaxially arranged. The proximal opening to the working channel 710 can be offset from the central longitudinal axis of the cystoscope 700, and the port 782 and / or lumen 784 can be positioned off the central longitudinal axis of the loading adapter 780. As shown in Figures 8A and 8B, the loading adapter 780 can be placed (e.g., slipped over) the proximal end 718 of the cystoscope 700 to load the stent 300 into the working channel 710. The loading adapter 780 can also be manufactured to be placed on other delivery devices or cystoscopes available on the market.That is, different adapters 780 can be manufactured for different cystoscopes. The loading adapter 780 can include a receiving space 786 (mating feature, key feature, receiving space, cavity, recess, channel) that mates with the proximal end 718 of the cystoscope. The receiving space 786 can be located 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 being connected via the lumen 784. The receiving space 786 can receive the proximal end of the cystoscope, thereby facilitating the loading adapter 780 being positioned (e.g., slipped over) the proximal end of the cystoscope. The loading adapter 780 can be placed on the cystoscope and rotated to position the opening to the working channel 710 coaxially with the port 782. 16A, capturing device 730a can be positioned through working channel 710 and out of working channel 710, and the capturing device 730a can include a clamp (e.g., a clamp-like structure, grip, grasping forceps) for grasping handle 324 of stent 300. Capturing device 730 described herein can be positioned through working channel 710 and out of working channel 710. Capturing device 730a and / or capturing device 730 can be used in a coaxial arrangement between working channel 710 and port 782.

[0101] 16B, the stent 300 can be pulled from the capturing device 730a and / or capturing device 730 into the loading adapter 780 by a pulling force 785 applied to the stent handle 324. The opening (e.g., the distal opening) to the port 782 can be larger, including significantly larger, than the working channel 710. The diameter of the opening can be the same as or even larger than the diameter of the stent 300. In some embodiments, the diameter of the opening of the port 782 can be 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, or even larger than 20 mm. As the stent 300 is drawn into the port 782, the nose end 318 (i.e., distal end 308) of the stent 300 may first begin to be compressed by the angled (e.g., tapered) walls of the loading adapter 780 that define the port 782. Gradually, the body portion 320 of the stent 300 may then be compressed, followed by the tail end 322 (i.e., proximal end 306). The pulling force 785 applied to the handle 324 that pulls the stent 300 into the port 782 may also pull the loading adapter 780 against the cystoscope (e.g., the proximal face of the cystoscope). The taper (e.g., gradual taper) of the port 782 may distribute (e.g., evenly distribute, uniformly distribute) the compressive force on the stent 300 as it is drawn into the port 782, thereby avoiding the stress concentrations described herein that may exist without the use of the loading adapter 780. In contrast to the all-at-once approach described herein, which does not use a loading adapter 780, the taper of port 782 can promote gradual compression (e.g., folding) of stent 300 as stent 300 is pulled further into port 782. The taper of port 782 can promote folding to facilitate smooth and consistent loading of stent 300. Once stent 300 reaches the distal portion (e.g., narrowed portion) of port 782, stent 300 can be compressed to dimensions that allow for placement within working channel 710.As shown in FIGS. 14A-14C, 15A, and 15B, the loading adapter 780 can promote a more even distribution of compressive forces compared to when the loading adapter 780 is not used. As shown in FIG. 16C, when the tail portion of the stent 300 enters the funnel port 782, the nose end may already be compressed to approximately the dimensions of the working channel 710. Further pulling on the stent 300 causes the nose end 318 to smoothly enter the working channel 710, followed by the body 320 and tail 322 smoothly and consistently entering the working channel. Using the loading adapter 780 can avoid damage to the stent 300 when it is loaded into the working channel 710. Thus, bending or deformation of the stent 300 can be avoided.

[0102] 17A-17C, as the stent 300 is drawn into the port 782, the loading adapter 780 can automatically align the stent 300 so that it is coaxially disposed relative to the port 782 and / or the working channel 710. As shown in FIG. 17A, when the stent 300 is drawn into the port 782 by the capture device 730 or 730a, the central longitudinal axis of the stent 300 may not be coaxial with the central longitudinal axis of the port 782. However, as the stent 300 is drawn into the port 782, the tapered cross section (e.g., walls) of the port 782 can center the stent 300 relative to the port 782, which may include coaxially disposing the stent 300, the port 782, and / or the working channel 710, as illustrated in FIGS. 17B and 17C. The tapered walls of the port 782 allow the stent 300, port 782, and / or working channel 710 to be coaxially aligned by first pushing the end or strut of the stent 300 against the port 782. Thus, misalignment can be corrected.

[0103] 18A-18E show the stent loading process with a capture device 730, a tube 744, a funnel adapter 780, a handle 762 with a drive mechanism 760, and a working channel 710 of a delivery device (e.g., a cystoscope 700). The loading adapter 780 can be positioned at the proximal end of the delivery device (e.g., a cystoscope 700). The loading adapter 780 can be manipulated (e.g., rotated) to coaxially position a port 782 and the proximal opening of the working lumen 710. In FIG. 18A, the capture device 730 is pushed out of the working channel 710 and through the port 782 of the loading adapter 780. The port 782 is attached to the proximal end 718 of the cystoscope 700. In some embodiments, as described herein, prior to deploying the loading adapter 780, the capturing device 730 is advanced through the working channel 710, thereby coaxially aligning the port 782 and the working channel 710. The capturing device 730 (e.g., body 736) can be advanced relative to the tube 744 so that the hook 734 is exposed outside the tube 744 to capture the handle 324 of the stent 300. The capturing device 730 can be advanced relative to the tube 744 using techniques described herein (e.g., FIGS. 13A-13H). The clinician can position the stent handle 324 on the hook 734 of the capturing device 730.

[0104] 18B, capture device 730 and tube 744 can be moved relative to one another, as described with reference to FIGS. 11A and 11C, to place distally facing surface 733 in contact with the proximal end of tube 744 and / or place hook 734 within tube 744, securely coupling capture device 730 to handle 324 of stent 300. In some embodiments, button 770 of drive mechanism 760 can be pulled to translate driver 766 (coupled to capture device 730 by push wire 738) from the configuration illustrated in FIG. 13E to the configuration shown in FIG. 13C, in which one or more locking features 722 of driver 766 engage one or more retention features 778 of handle 762. One or more locking mechanisms 722 of the driver 766 deflect into one or more grooves 776 of the button 770, coupling the translational movement of the driver 766 and the button 770, and pulling on the button 770 can facilitate movement from the configuration illustrated in FIG. 13E to the configuration illustrated in FIG. 13C. Distal movement of the driver 766 can correspondingly move the capturing device 730 distally via a push wire 738 coupled to the capturing device 730. In some embodiments, the illustrated configuration can be achieved by advancing the tube 744 relative to the capturing device. With the stent handle 324 captured by the capturing device 730 and tube 744, the capturing device 730 and tube 744 can be retracted distally to pull the stent 300 through a port 782 of the loading adapter 780 and into the working channel 710 of a 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., the 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.

[0105] In FIG. 18C, the stent 300 is pulled further into the port 782, causing a portion of the stent 300 at the nose end to collapse and be pulled into the lumen 784 of the loading adapter 780. The tail end also partially collapses due to compression from the tapered port 782 of the loading adapter 780. In FIG. 18D, continued pulling can collapse the stent 300 to a size that will fit into the working channel 710. As shown in FIG. 18D, the stent 300 may be partially within the lumen 784 and partially within the working channel 710. In FIG. 18E, the stent 300 has been fully pulled into the working channel 710. At this point, the tail 322 of the stent 300 may be slightly inside the working channel 710 or may be 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 folded downward and collapsed so that the collapsed handle 324 is retracted into the working channel. As shown in FIGS. 18B-18D , the handle 324 can be deflected to align the handle 324 with the central longitudinal axis of the stent 300, as described herein. The overall length of the collapsed stent with the collapsed handle can be about 38 mm, and the diameter can be about 2.2 mm. In some embodiments, the overall length of the collapsed stent with the collapsed handle is between about 22 mm and 52 mm, i.e., about 22 mm, 25 mm, 28 mm, 31 mm, 34 mm, 37 mm, 40 mm, 43 mm, 46 mm, 49 mm, or 52 mm.

[0106] 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 illustrate the process of delivering a loaded stent into a patient's prostatic urethra. In Figure 19A, a force is applied against the capturing device 730 and transmitted to the stent 300, moving the stent 300 proximally toward the proximal opening of the working lumen 710. For example, the handle 762 can be advanced by the clinician relative to the delivery device (e.g., the cystoscope 700), causing the push wire 738 to advance the capturing device 730 and tube 744. With the stent handle 324 captured, the stent 300 can be advanced proximally within the working lumen 710 by advancing the capturing device 730 and tube 744. In FIG. 19B, the tail end 322 of the stent 300 is pushed out of the working channel 710 and immediately begins to expand, allowing the tail end 322 of the stent 300 to contact the urethra for positioning. In FIG. 19C, the main body 320 of the stent 300 is pushed out of the working channel 710, allowing the stent 300 to expand. In FIG. 19D, the entire stent 300, including the handle 324, is pushed out of the working channel 710. With the handle 324 still captured by the hook 734, the clinician can adjust the axial and radial position of the stent 300 within the urethra. Visualization, such as fluoroscopy, can guide the delivery procedure. In FIG. 19E, the hook body 736 is partially pushed out of the tube 744 to expose the hook 734, as described with reference to FIGS. 13A-13F. Thus, the stent handle 324 is released and returns to its original shape while constrained within the urethra. As described herein, the handle 324 can hold the stent 300 in place by engaging the wall of the urethra. This process is driven using a drive mechanism 760 at the distal end 708 of the cystoscope 700.

[0107] The handle 324 of the stent 300 may also facilitate retrieval of the deployed stent by providing a connection point to a control mechanism, such as capture device 730 or 730a. Once the control mechanism is inserted into the prostatic urethra and contacts the stent handle, the stent can be retracted into the working channel of the deployment device by retracting the control device through the working channel and retracting the stent into the working channel, as shown in at least FIGS. 11A-11C and 14A-14C. During retrieval, the handle may swing outward to align with the longitudinal axis of the stent, as shown in FIG. 20A. Once inserted into the prostatic urethra, the handle automatically moves to a collapsed position, pointing downward. A handle with a divot in its center can be used to secure the stent within the prostatic urethra. For example, the divot can be positioned to contact, engage, and / or abut the distal end 116 of the prostatic urethra 106 (e.g., the apex of the verumontanum). In some embodiments, the stent 300 is positioned such that the divots and / or handles contact, fit into, and / or abut the verumontanum more proximal to the distal end 116. The divots and / or handles may be positioned proximal to the apex 116 (e.g., folded back, contacting, proximally embedded) at the verumontanum. The proximal ends (e.g., tips of the leaflets or tails) of the stent 300 may be embedded or abut against the proximal end 114 of the prostatic urethra 116 or the bladder neck to prevent the stent from migrating proximally. The overall length of the stent is selected to fit the overall length of the prostatic urethra.

[0108] The clinician can measure the length of the prostatic urethra and then select a stent with a length approximately equal to or slightly shorter than the length of the prostatic urethra. In some embodiments, the overall length of the stent is 15 mm, 20 mm, or 25 mm. The length of the stent is selected to match the length of the prostatic urethra to ensure that the handle can act as an anchor and rest against the apex of the prostatic urethra while the distal leaflet rests against the bladder neck.

[0109] Figure 21 is a flow diagram illustrating one embodiment of a method 800 for placing a urethral stent, such as any of the stents described herein, in the prostatic urethra. A delivery device (e.g., cystoscope 700) such as the delivery device of Figures 8A and 8B or any other delivery device is provided. A urethral stent, such as any of the stents described herein, is loaded into and positioned near the distal end of the catheter body of the delivery device. The stent is releasably attached to an elongate control member, such as capture device 730 or 730a described herein, that extends through the working channel of the delivery device and is secured to the stent at the distal end of the control member and stent handle.

[0110] The method 800 begins at block 802. In block 804, the delivery device and control member are advanced proximally through the urethra toward the bladder 104 (see FIGS. 22A and 22B). The delivery device and control member are advanced until the proximal end 718 of the delivery device and control member are slightly within the bladder 104 (see FIG. 22C). In block 806, the delivery device and control member are withdrawn distally, positioning the proximal end 718 of the delivery device immediately adjacent the bladder neck within the prostatic urethra 106 (see FIG. 22D). In block 808, a portion of the proximal or tail segment of the stent 300 is deployed by advancing the control member relative to the delivery device and distally retracting the delivery device, thereby partially pushing the stent 300 out of the working channel 710 of the delivery device and into the prostatic urethra 106 (see FIG. 22E). The deployed portion of the tail segment of the stent 300 may expand within the bladder and be pushed into the bladder neck (see FIG. 22F). In block 810, the delivery device is further retracted while holding the control member in a fixed position or pushing the control member proximally until the proximal end of the proximal segment is positioned in the proximal prostatic urethra (see FIG. 22G). The remaining length of the stent 300 may then be deployed in the same manner by pulling the delivery device while holding or pushing the control member (see FIGS. 22H-22I). Thereafter, in block 812, the control member may be separated from the stent handle 324 (see FIG. 22J), and the control member and delivery device may be retracted distally (see FIG. 22K) and withdrawn from the urethra, leaving the stent 300 deployed in the prostatic urethra 106 (see FIG. 22L). The control member can be separated from the stent 300 (e.g., stent handle 324) by rotating the control member, releasing the gripping members (e.g., the clamps on control member 730a), disengaging one from the other, and / or using any other coupling and detachment methods described herein. The method 800 ends at block 814.

[0111] 23 is a flow diagram illustrating an embodiment of a method 900 for retrieving a urethral stent, such as any of the stents 300 described herein, in a prostatic urethra 106. A delivery device, such as the delivery device of FIGS. 8A and 8B, or any other delivery device, is provided. A urethral stent, such as any of the stents 300 described herein, is placed within the patient's prostatic urethra. A control member (e.g., capture device 730 or 730a) configured to releasably couple to the stent is provided within the working channel of the delivery device.

[0112] Method 900 begins at block 902. In block 904, a delivery device is advanced proximally through the urethra toward the bladder. The delivery device is advanced until the distal end of the catheter is adjacent to or near the distal end / nose segment or handle of the stent. In block 906, a 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 nose segment of the stent handle, which may be performed using any of the techniques described herein with respect to capture device 730 or 730a coupled to stent handle 324 of stent 300. Thereafter, in block 908, the control member is withdrawn distally (toward the distal end of the delivery device), thereby retracting the control member and stent into the working channel of the delivery device. Alternatively or additionally, the delivery device may be advanced proximally (toward the bladder) to capture the stent in the working channel of the delivery device. Contact between the inner wall of the working channel and the stent causes the stent to collapse radially as it moves distally into the working channel. Once the stent is partially or completely captured within the working channel, the stent and delivery device may be withdrawn and removed from the urethra at block 910. Method 900 ends at block 912.

[0113] 24 is a flow diagram illustrating an embodiment of a method 1000 for repositioning a urethral stent, such as any of the stents 300 described herein, in the prostatic urethra 106. A delivery device, such as the delivery device of FIG. 8A or 8B, or any other delivery device, is provided. A urethral stent, such as any of the stents described herein, is placed within the patient's prostatic urethra.

[0114] Method 1000 begins at block 1002. In block 1004, the stent is first retrieved into the working channel of a delivery device, for example, according to the method described above with respect to Figures 13A-13H. The stent may be retrieved into the working channel using capture device 730 or 730a. Then, in block 1006, the delivery device and captured stent are repositioned to a new desired location. For example, the delivery device and stent may be placed in the proximal prostatic urethra or any other desired location. In block 1008, the stent is then deployed, for example, according to the method described above with respect to Figure 21. Method 1000 may end at block 1010.

[0115] FIG. 25 is a flow diagram illustrating another embodiment of a method 1100 for repositioning a stent without storing the stent within the working channel of the endoscope. Method 1100 begins at block 1102. In block 1104, the tip of the endoscope is advanced into the lumen of the stent. In block 1106, the end of the endoscope is deflected to engage the struts of the stent. For example, controls at the distal end of the endoscope can be used to deflect the proximal end of the endoscope (e.g., upward or downward). Such controls are used to advance the endoscope through the patient's vasculature. However, in this embodiment, deflection of the endoscope is used to deflect the proximal end of the endoscope to secure or engage the struts of the stent. Once engaged, in block 1108, the operator can push or pull the stent proximally or distally by applying a linear force to the endoscope. The operator can visualize the movement of the stent relative to the mucosa of the urethral lumen, thereby estimating linear movement. Once the stent is in the desired location, method 1100 ends at block 1110. This technique allows the stent to be repositioned without having to pull it back into the working channel of the endoscope.

[0116] The stents described herein can be further described by their length, expanded diameter, collapsed diameter, angle values, and strut / wall thickness. Various values ​​and combinations of values ​​are possible, but should not be limited to the following examples. In some embodiments, the stent has an outer diameter and an expanded diameter ranging from about 8 mm to about 12 mm. The overall length of the stent can range from about 15 mm to about 45 mm. The nose segment of the stent can have a length of about 10 mm, the body segment can have a length of about 15 mm, and the length of the tail segment can be selected so that the overall length of the stent fits the patient's anatomy. For example, the tail segment can have a length of about 5 mm to about 30 mm. The acute angles within the cells of the stent can range from 5 to 85 degrees, 10 to 60 degrees, or 20 to 50 degrees. The obtuse angles within the stent can range from 95 to 175 degrees, 120 to 170 degrees, or 110 to 150 degrees. The strut and wall thickness of the stent can range between 0.025 mm and 1.0 mm.

[0117] [Other Considerations] It is contemplated that various combinations or subcombinations of the specific features and aspects of the above-disclosed embodiments may fall within the scope of one or more of the present inventions. Furthermore, any particular feature, aspect, method, property, attribute, quality, attribute, element, etc., disclosed herein with respect to an embodiment may be used in all other embodiments described herein. Accordingly, it is to be understood that various features and aspects of the disclosed embodiments may be combined with or substituted for one another to form varying modes of the disclosed invention. Accordingly, it is to be understood that the scope of the invention disclosed herein should not be limited to the specific disclosed embodiments described above. Furthermore, the invention is susceptible to various modifications and alternative forms, specific examples of which have been shown in the drawings and described in detail herein. However, it is to be understood that the invention is not limited to the particular forms or methods disclosed; on the contrary, the invention is intended to 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 recited. The methods disclosed herein involve specific acts performed by the practitioner. However, they may also include any third-party instructions to these actions, either explicitly or implicitly. For example, an action such as "insert a device proximate the distal end of the prostatic urethra" includes "instructing to insert a device proximate the distal end of the prostatic urethra." Ranges disclosed herein also encompass any and all overlapping ranges, subranges, and combinations thereof. Phrases such as "up to," "at least," "greater than," "less than," "between," etc., include the specified numerical values. As used herein, numerical values ​​preceded by words such as "approximately," "about," and "substantially" include the recited numerical values ​​and also represent an amount near the recited amount that still performs the desired function or achieves the desired result.For example, the terms "approximately," "about," and "substantially" can refer to amounts that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount.

Claims

1. 1. A device configured to maintain patency of a prostatic urethra, the device comprising: a stent having a proximal end, a distal end, and a passageway configured between the proximal and distal ends to facilitate the flow of bodily fluid therebetween; a peripheral wall disposed around the passageway, the peripheral wall including a plurality of struts and a plurality of nodes connected to one another to form a plurality of cells; a handle positioned offset outside the passageway of the stent; Equipped with the stent is configured to expand from a compressed state to an expanded state within a body lumen; the handle is configured to be deflected when pulled axially from a position outside the passage to another position within the passage. device.

2. The handle is disposed at the distal end of the stent. The device of claim 1 .

3. the handle includes a curved portion that biases the handle toward the outer side of the passageway.

3. A device according to claim 1 or 2.

4. The handle extends from a distal strut of the plurality of struts and is curved to extend in a direction generally perpendicular to a central longitudinal axis of the stent. A device according to any one of claims 1 to 3.

5. the handle includes a divot configured to engage a capture device that loads into the working lumen of the delivery device; A device according to any one of claims 1 to 4.

6. The divot is configured to protrude distally when the stent is deployed within the body lumen. The device of claim 5.

7. the divots are generally disposed along a central longitudinal plane of the stent.

7. A device according to claim 5 or 6.

8. The handle comprises a loop. A device according to any one of claims 1 to 7.

9. the handle having a straight portion that is generally perpendicular to the central longitudinal axis of the stent; A device according to any one of claims 1 to 8.

10. The handle is configured to be deflected when pulled from a position outside the passageway to generally coincide with a central longitudinal axis of the stent. A device according to any one of claims 1 to 9.

11. The stent has a graded collapsibility between the distal end and the proximal end. A device according to any one of claims 1 to 10.

12. the plurality of struts and the plurality of nodes form a ring. A device according to any one of claims 1 to 11.

13. The ring includes a plurality of the struts in a Z pattern. The device of claim 12.

14. the ring includes angled struts among the plurality of struts in an alternating pattern of distally angled struts and proximally angled struts; The device of claim 12.

15. The rings exert different outward radial forces. A device according to any one of claims 12 to 14.

16. the central portion of the stent exerts an outward radial force greater than the outward radial force exerted by the distal and proximal ends; A device according to any one of claims 1 to 15.

17. the plurality of cells comprises diamond-shaped cells. A device according to any one of claims 1 to 16.

18. the diamond-shaped cells are located closest to the handle; 18. The device of claim 17.

19. The diamond-shaped cells facilitate the folding of the stent by distributing tension on the stent.

19. A device according to claim 17 or 18.

20. The handle is biased to a position where it is flush with the peripheral wall when viewed in the axial direction. A device according to any one of claims 1 to 19.

21. 1. 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 positioned offset outside of a passage of bodily fluid through the stent; deflecting the handle to another position in the passageway by pulling the handle axially with the capture device; storing the stent by retracting the handle with the capture device into the working lumen of the delivery device so that the stent is compressed to the diameter of the working lumen.

22. The handle is biased to a position flush with the peripheral wall of the stent.

22. The method of claim 21.

23. coupling the handle of the stent to the capturing device includes capturing the handle with a hook of the capturing device.

23. The method of claim 21 or 22.

24. 1. A method of delivering a stent into the prostatic urethra, the method comprising: deploying the stent within the prostatic urethra outside the working lumen of a delivery device by pushing the handle of the stent with a capture device; Releasing the handle of the stent from the capture device so that the handle can move away from the central longitudinal axis of the stent to engage the urethral wall; A method comprising:

25. the handle is configured to be positioned proximal to the apex of the verumontanum.

25. The method of claim 24.

26. 1. A capture device configured to grasp a stent, the capture device comprising: a tapered tip; a body distal to the tapered tip; Equipped with The body includes a hook configured to engage the stent for manipulating the stent. Capture device.

27. The hook is configured to be coupled to a stent handle of the stent.

27. The capture device of claim 26.

28. further comprising a tube configured to be disposed over the body to secure the stent to the hook.

28. A trapping device according to claim 26 or 27.

29. the tapered tip has a periphery that extends beyond an outer periphery of the body to expose a distally facing surface of the tapered tip; the distally facing surface of the tapered tip is configured to engage the proximal end of the tube to secure a stent handle of the stent to the hook.

29. The capture device of claim 28.

30. The tapered tip has a width smaller than the opening to the tube so that a lateral space is provided on both sides of the tapered tip through which the stent handle can pass when the stent handle is fixed by the hook.

30. The capture device of claim 29.

31. 1. A method of capturing a handle of a stent with a capturing device, the method comprising: advancing the capture device out of the tube to expose a hook of the capture device; placing the handle of the stent within the hook; retracting the capture device so that the distally facing surface of the tip of the capture device contacts the proximal end of the tube so that the hook is positioned within the tube and can secure the handle; A method comprising:

32. The handle is secured to the hook within the tube and passes through an exterior space opposite the tip of the capture device to the stent.

32. The method of claim 31 .

33. a handle for controlling movement of the capture device to capture a stent, said handle comprising: a first lumen and one or more retention features disposed at openings within the first lumen; a drive mechanism including a drive portion configured to be coupled to a capture device including a push wire and a button; the driver is configured to be disposed in the first lumen of the handle and includes a second lumen and one or more locking mechanisms configured to prevent advancement of the driver within the first lumen by engaging the one or more retention mechanisms; the button is configured to be disposed in the second lumen and includes a body and one or more grooves; the button is configured to be advanced within a second lumen of the driver so as to contact an inner surface of the driver defining the second lumen and to position the one or more grooves radially inward of the one or more locking mechanisms; the button is configured to be further advanced to apply a force to the driver, thereby deflecting the one or more locking features radially inward from the one or more retention features and entering the one or more grooves of the button, thereby advancing the driver into the first lumen of the handle; advancement of the driver in the first lumen of the handle causes the push wire to advance the capture device; handle.

34. The capture device is configured to be advanced from the tube to expose hooks that hold the stent handle, thereby deflecting the stent handle away from the hooks and allowing the stent to be delivered into the urethra.

34. The handle of claim 33.

35. the one or more retention features comprise an inclined surface; A handle according to claim 33 or 34.

36. the one or more locking mechanisms include an enlarged edge complementary to the ramp surface; 36. A handle according to claim 35.

37. 1. A method of controlling movement of a capture device using a drive mechanism on a handle, the method comprising: advancing a button into the lumen of the driver so that the button contacts an inner surface of the driver and positions one or more grooves of the button radially inward of one or more locking features of the driver; applying an axial force to the button and the actuator to urge the one or more locking mechanisms of the actuator against one or more retention mechanisms disposed in openings within the lumen of the handle, thereby deflecting the one or more locking mechanisms out of the one or more retention mechanisms and into the one or more grooves of the button; advancing the button and the driver into the lumen of the handle to advance a push wire coupled to the driver and advance a capture device configured to capture a stent; A method comprising:

38. the one or more retention features further comprising a ramped surface; 38. The method of claim 37.

39. the one or more locking mechanisms include an enlarged edge complementary to the ramp surface; 39. The method of claim 38.

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

41. The distal side of the port has a diameter corresponding to the diameter of the working channel.

41. The loading adapter of claim 40.

42. a lumen having a constant diameter connecting the port and the receiving area; 42. A loading adapter according to claim 40 or 41.

43. the constant diameter of the lumen corresponds to the diameter of the lumen; 43. The loading adapter of claim 42.

44. The taper of the port distributes the compressive forces on the stent as it is pulled through the port and collapsed. A loading adapter according to any one of claims 40 to 43.

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

46. and rotating the loading adapter on the proximal end of the delivery device to position the tapered port coaxially with the working channel.

46. ​​The method of claim 45.

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