Systems, devices, and methods for accurate deployment and imaging of implants in the prostatic urethra

Abstract

Systems, devices, and methods for delivering an implant into the prostatic urethra are provided. Embodiments of the delivery system may include a delivery device for insertion into a patient and a proximal control device for controlling release of the implant from the delivery device.

Description

Technical Field

[0001] The subject matter described herein relates to systems, devices, and methods for delivering or deploying implants into the prostatic urethra, and more particularly, through the tortuosity of the male urethra in an atraumatic and minimally invasive manner. Background Art

[0002] There are many clinical reasons for placing implants into the prostatic urethra, such as for the treatment of urinary retention associated with benign prostatic hyperplasia (BPH), obstruction from prostate cancer, bladder cancer, urethral injury, prostatitis, bladder sphincter dyssynergia, benign or malignant urethral strictures, and other conditions requiring treatment. Accurate and consistent placement of implants within the lumen of the prostatic urethra has proven challenging due to the naturally complex and tortuous anatomical geometry, patient-to-patient variations in geometry and tissue, and the anatomical limitations associated with these conditions. Furthermore, there are complex challenges in the design and / or manufacture of systems with sufficient flexibility to deliver such implants in a minimally invasive manner. For these and other reasons, there is a need for improved systems, devices, and methods for delivering implants into the prostatic urethra. Summary of the Invention

[0003] Provided herein are multiple example embodiments of delivery systems for delivering or deploying implants within the prostatic urethra or other parts of the body, and methods associated therewith. Embodiments of the delivery system may include a delivery device that is insertable into the prostatic urethra and a proximal control device that is coupled to the delivery device and configured to control the deployment of one or more implants from the delivery device. In some embodiments, the delivery device may include multiple tubular members, each having various functions described in more detail herein. Embodiments of the delivery system have imaging capabilities. Also described are multiple embodiments of implants for use with the delivery system, and various implant placements of these implants.

[0004] Other systems, devices, methods, features, and advantages of the subject matter described herein will be or will become apparent to one skilled in the art upon examination of the following figures and detailed description. All such additional systems, methods, features, and advantages are included within this description, are within the scope of the subject matter described herein, and are protected by the following claims. Features of the example embodiments should in no way be construed to limit the appended claims without expressly reciting those features in the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The details of the subject matter described herein, both its structure and operation, will become apparent by studying the accompanying drawings, in which like reference numerals refer to like parts. The components in the drawings are not necessarily drawn to scale; emphasis is instead placed on illustrating the principles of the subject matter. Furthermore, all illustrations are intended to convey concepts, in which relative sizes, shapes, and other detailed attributes may be schematic rather than literally or precisely illustrated.

[0006] Figure 1A is a block diagram depicting an example embodiment of a delivery system.

[0007] Figure 1B 、 1C 1D and 1D are side, end, and perspective views, respectively, depicting an example embodiment of an implant.

[0008] Figures 2A-2B are perspective views depicting example embodiments of a delivery system at various stages of implant deployment.

[0009] Figures 2C-2G is a perspective view depicting an example of a release mechanism.

[0010] Figures 2H-2J is a view depicting an alternative example of the release mechanism.

[0011] Figures 3A-3C is a perspective view depicting an example embodiment of a gripper component for use within a delivery system.

[0012] Figures 4A-4C is a perspective view depicting an example embodiment of an inner shaft.

[0013] Figures 4D-4E is a cross-sectional view depicting an example embodiment of an inner shaft.

[0014] Figures 5A-5B are side views depicting an example embodiment of a delivery system at various stages of implant deployment.

[0015] Figures 5C-5F is a perspective view depicting an example embodiment of a steering lock device.

[0016] Figures 5G-5H is a cross-sectional view depicting an example embodiment of a steering lock apparatus.

[0017] Figure 6A is a flow chart depicting an example embodiment of a method for delivering an implant.

[0018] Figure 6B is a timing diagram depicting an example embodiment of a sequence of steps for deploying an implant.

[0019] Figures 7A-8Cis a perspective view depicting an example embodiment of components within a proximal control device.

[0020] Figures 9A-9B is a perspective view of an example embodiment depicting a distal region of an outer tubular member.

[0021] Figures 10A-10B is a perspective view illustrating an example of a telescopic imaging module.

[0022] Figures 10C-10D is a perspective view depicting an example of a delivery system with a telescoping imaging module.

[0023] Figures 11A-11C is a perspective view of an example embodiment of a rotation adapter.

[0024] Figures 12A-12B are perspective views of example embodiments of a delivery system with an endoscope positioned in different locations.

[0025] Figure 13 is an example cross section of the male anatomy.

[0026] Figure 14A is an example cross-section of the male anatomy with an example embodiment of an implant deployed therein.

[0027] Figure 14B is an example cross section of the male anatomy, and Figure 14C It is along Figure 14B Example cross section of male anatomy taken along line 14C-14C.

[0028] Figure 14D is an example cross-section of the male anatomy having an example embodiment of an implant deployed therein, and Figure 14E It is along Figure 14D Example cross section of male anatomy taken along line 14E-14E.

[0029] Figure 14F is an example cross-section of the male anatomy having an example embodiment of an implant deployed therein, and Figure 14G It is along Figure 14G Example cross section of male anatomy taken along line 14F-14F.

[0030] Figure 15 is a side view of an example embodiment of a rotation adapter.

[0031] Figures 16A-16C is a perspective view of an example embodiment of an anti-rotation mechanism.

[0032] Figures 16D-16E is a cross-sectional view of an embodiment of the handle portion of the present invention.

[0033] Figure 16F is the coronal plane of an embodiment of the handle portion of the present invention.

[0034] Figure 16G is the transverse plane of an embodiment of the handle portion of the present invention. DETAILED DESCRIPTION

[0035] Before describing the present subject matter in detail, it should be understood that this disclosure is not limited to the particular embodiments described, as such embodiments may, of course, vary. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting, as the scope of the present disclosure will be limited only by the appended claims.

[0036] The subject matter presented herein is described in the context of delivering or deploying one or more implants in the prostatic urethra. The purpose of deploying an implant in the prostatic urethra may be different. The embodiments described herein are particularly suitable for the treatment of BPH, but they are not limited thereto. Other conditions to which these embodiments can be applied include, but are not limited to, the obstruction caused by treatment of prostate cancer, bladder cancer, urethral injury, prostatitis, bladder sphincter dyssynergia, and / or benign or malignant urethral strictures. In addition, these embodiments may have the applicability for deploying one or more implants in other locations of the urinary tract or bladder and other biological lumens, chambers, or spaces (such as the human vascular system, cardiac system, pulmonary system, or gastrointestinal tract, including positions in the heart, stomach, intestines, liver, spleen, pancreas, and kidneys).

[0037] Figure 1A FIG1 is a block diagram depicting an example embodiment of a delivery system 100 having an elongated delivery device 103 coupled to a proximal control device 200. A distal region 104 is adapted for insertion into a patient's urethra (or other lumen or body cavity) through the urethral opening. Distal region 104 preferably has an atraumatic configuration (e.g., relatively flexible and rounded) to minimize irritation or injury to the patient. Elongated delivery device 103 carries or houses one or more implants 102 (not shown) to be delivered or deployed within or adjacent to the prostatic urethra. A proximal region 105 of delivery device 103 is coupled to proximal control device 200, which remains external to the patient and is configured for use by a physician or other healthcare professional to control the delivery of one or more implants 102.

[0038] Example embodiments of delivery devices and related methods

[0039] Figure 1B 、 1C1D and 1D are side, end, and perspective views, respectively, of an exemplary embodiment of the implant 102 depicted in a rest configuration. The implantable device 102 is biased toward the rest configuration depicted herein and can be positioned between the rest configuration and a relatively more elongated received (or delivery) configuration for receiving the implant 102 within a delivery device 103 (e.g., see FIG. Figure 3A ). The contained configuration can be a straight or linear state with minimal curvature. The rest configuration has a relatively greater lateral width and a relatively shorter longitudinal length than the contained configuration. Upon exiting the open end of the delivery device 103, the implant 102 is free to transform its shape back to that of the rest configuration, although the constraints imposed by the patient's urethral walls may prevent the implant 102 from fully reaching the rest configuration. Because the implant 102 is biased toward the rest configuration, the implant 102 is configured to automatically expand when released from the constraints of the delivery device 103 and can be referred to as "self-expanding." The shape of the implant 102 in its deployed state, for example, within the patient's urethra, can be referred to as the deployed configuration and will generally be a shape deformed from the rest configuration by surrounding tissue, although the deployed configuration can be the same as the rest configuration.

[0040] The implant 102 can be configured in many different ways, including any and all of those implant configurations described in U.S. Patent Publication No. 2015 / 0257908 and / or International Publication No. WO 2017 / 184887, both of which are incorporated herein by reference for all purposes.

[0041] The implant 102 may be formed from one or more discrete bodies (eg, wires, ribbons, tubular members) of varying geometries. Figures 1B-1D In an embodiment of the present invention, the implant 102 has a body formed of only a single wire member set into a predetermined shape. The implant 102 can have two or more annular structures 111 (in this embodiment, there are four: 111a, 111b, 111c, and 111d), with one or more interconnecting members 112 extending between each pair of adjacent annular structures 111 (in this embodiment, there is one interconnecting member between each pair of adjacent annular structures, for a total of three: 112a, 112b, and 112c). Each interconnecting member 112 extends from one annular structure 111 to the immediately adjacent annular structure 111. Figures 1B-1D As shown, each interconnect 112 may have a relatively straight shape (not shown) or a curved (eg, semi-circular or semi-elliptical) shape.

[0042] The annular structures 111 are configured to maintain the urethra in a fully or partially open state when expanded from a contained configuration. The device 100 can be manufactured in various sizes as desired, such that the width (e.g., diameter) of each annular structure 111 is slightly larger than the width of the urethra, and the length of each interconnecting member 112 determines the spacing between the annular structures 111. The annular structures 111 can have the same or different widths. For example, in the embodiment depicted herein, annular structure 111a has a relatively smaller width than structures 111b-111d of the same width. This can accommodate a prostatic urethra that converges into a smaller geometry anterior to the bladder neck.

[0043] Each annular structure 111 can be located or positioned in a single plane, and in some embodiments, the single plane can be oriented to have a normal axis perpendicular to the central axis 124 of the implant 102 (e.g., Figure 1B ). In other embodiments, the annular structure 111 can lie in multiple planes. The annular structure 111 can extend around the central axis 126 to form a complete circle (e.g., a 360-degree rotation) or can form less than a complete circle (e.g., less than 360 degrees), as shown herein. Although not limited thereto, in many embodiments, the annular structure 111 extends between 270 degrees and 360 degrees.

[0044] from Figures 1B-1D As can be seen in the figure, the geometry of the implant 102 can have a cylindrical or substantially cylindrical profile with a circular or elliptical cross section. In other embodiments, the implant 102 can have a prismatic or substantially prismatic profile with a triangular or substantially triangular cross section, or other shapes.

[0045] The implant 102 may also include a distal engagement member 114 and a proximal engagement member 115, each of which is configured to engage with an element of the delivery device 103. Engagement with the delivery device 103 may serve one or more purposes, such as allowing controlled release of the implant 102, allowing movement of the ends of the implant 102 relative to each other, and / or allowing retrieval of the implant 102 after deployment, for example, in situations where a physician wishes to recapture the implant 102 and redeploy the implant 102 in a different position. In this embodiment, the distal engagement member 114 is a linear extension extending from the annular structure 111a having a curved (e.g., S-shaped) shape for positioning an atraumatic end 116 (e.g., round, spherical, balloon-shaped) in a position suitable for engagement with the delivery device 103 and thereby allowing control of the distal region of the implant 102. Similarly, the proximal engagement member 115 has a curved shape for positioning the other atraumatic end 117 in a position suitable for engagement with the delivery device 103 and thereby allowing for control of the proximal region of the implant 102. In other embodiments, the distal engagement member 114 and the proximal engagement member 115 can be configured so that the atraumatic ends 116 and 117 point in different directions. For example, the atraumatic ends 116 and 117 can point distally rather than proximally. In another embodiment, the atraumatic ends 116 and 117 can point in opposite directions (e.g., the atraumatic end 116 can point distally and the atraumatic end 117 can point proximally, or vice versa). In other embodiments, the distal engagement member 114 and the proximal engagement member 115 can be omitted, and the delivery device 103 can be coupled to the implant 102 at one or more other distal and / or proximal locations, such as on the annular structure 111 or the interconnect 112. Additionally, extensions with atraumatic ends (similar to distal engagement member 114 and proximal engagement member 115) can be attached to the middle of implant 102 to provide additional structure to control placement of the middle portion of the implant.

[0046] The delivery device 103 can include one or more elongated flexible members (e.g., 120, 130, 140, and 150, described below), each having one or more internal lumens. Alternatively, the one or more elongated flexible members of the delivery device 103 can be solid or non-hollow members without an internal lumen. Figure 2A is a perspective view of an example embodiment depicting a distal region 104 of a delivery device 103. In this embodiment, the delivery device 103 includes a first elongated tubular member 120, a second elongated tubular member 130, a third elongated tubular member 140, and a fourth elongated tubular member 150. The delivery device 103 can vary and can include more or fewer tubular members in other embodiments.

[0047] In this embodiment, the first elongated tubular member 120 is the outermost tubular member and is flexible, also providing support for the components contained therein. The first tubular member 120 is referred to herein as the outer shaft 120 and can have one or more inner lumens. In this embodiment, the outer shaft 120 includes a first inner lumen 121 that accommodates a second elongated tubular member 130, which is referred to herein as the inner shaft 130. The outer shaft 120 and the inner shaft 130 are each controllable independently of the other. The inner shaft 130 can slide distally and proximally within the lumen 121 and is shown here as partially extending from the open distal end of the outer shaft 120.

[0048] In this embodiment, outer shaft 120 includes three additional lumens 122, 123, and 124. An illumination device (not shown) and an imaging device (not shown) can be housed in two of lumens 122-124 (e.g., lumens 122 and 123). The imaging device can utilize any desired imaging modality, such as optical or ultrasound imaging. In one example embodiment, the imaging device utilizes a forward-looking (distal) CMOS imager. The illumination device can be configured to provide sufficient illumination for optical imaging and, in one embodiment, includes one or more light-emitting diodes (LEDs). In embodiments where illumination is not required, such as for ultrasound imaging, the illumination device and its corresponding lumen can be omitted, or the lumen can be used for alternative purposes, such as as an irrigation or flushing channel. The illumination device and / or imaging device can each be securely fixed at the distal tip of lumens 122 and 123, or each can slide within lumens 122 and 123 to allow for further distal advancement from and / or retraction into outer shaft 120. In one exemplary embodiment, the illumination and imaging devices are mounted together, and only a single lumen 122 or 123 is present for this purpose. The remaining lumen (e.g., lumen 124) can be configured as an irrigation or flushing port, from which fluid, such as saline, can be introduced into the urethra to flush the area and provide sufficient fluid to allow imaging of the implant 102 and the surrounding prostatic urethral wall. In one embodiment, the outer shaft can contain two separate lumens for fluid administration. One lumen can be used for irrigation, and the other lumen can be used for flushing.

[0049] The outer shaft 120 has a proximal end (not shown) coupled to the proximal control device 200. The delivery device 103 can be configured to be steerable to navigate tortuous anatomy. Depending on the needs of the application, the steerability can be unidirectional (e.g., using a single pull wire) or multidirectional (e.g., using two or more pull wires positioned at different radial locations around the device 103). In some embodiments, the steerability structure (e.g., the pull wire) extends from the distal region 104 of the delivery device 103 (e.g., where the distal end of the pull wire is secured to a plate or other structure within the distal region 104) to the proximal control device 200, where the pull wire can be manipulated by a user to steer the delivery device 103. The steering structure can be located within one or more lumens of the outer shaft 120 or can be coupled to or embedded within the sidewall of the outer shaft 120. The delivery device 103 can be biased to deflect (e.g., bend) in a particular lateral direction so that the device 103 automatically deflects in that manner and a force is imparted to steer the delivery device 103 in opposition to the biased deflection. Other mechanisms for steering the delivery device 103 can also be used. The steering mechanism can also be locked or adjusted during deployment of the implant 102 to control the position of the implant 102 within the anatomy (e.g., forward steering during deployment can help place the implant 102 in a more desired forward position).

[0050] The inner shaft 130 can include one or more inner lumens for accommodating one or more implants 102 and / or other components. In this embodiment, the inner shaft 130 includes a first lumen 131 in which the one or more implants 102 can be accommodated, and a second lumen 132 in which a third elongated tubular member 140 can be accommodated. In this embodiment, the third elongated tubular member 140 is configured to releasably couple with the distal region of the implant 102 and is referred to as a distal control member or tether 140. The distal control member 140 can be slidably advanced and / or retracted relative to the inner shaft 130. The distal control member 140 can include an inner lumen 141 that accommodates a fourth elongated tubular member 150, which is shown here as extending from the open distal end of the distal control member 140. The fourth elongated tubular member 150 is configured to anchor the delivery device 103 relative to the patient's anatomy, eg, to hold components of the delivery device 103 stationary relative to the anatomy during deployment of the implant 102 , and is referred to as the anchor delivery member 150 .

[0051] exist Figure 2AIn the depicted configuration, the anchor delivery member 150 extends from the lumen 141 of the distal control member 140, and the distal control member 140 along with the inner shaft 130 are shown extending from the lumen 121 of the outer shaft 120. When the delivery device 130 is advanced through the urethra, the anchor delivery member 150 is preferably completely contained within the distal control member 140, and the distal control member 140 along with the inner shaft 130 is extended from the urethra. Figure 2A The distal end 104 of the outer shaft 120 is retracted in the position shown so that they reside within the lumen 121 of the outer shaft 120 and do not extend from the open distal end of the lumen 120. In other words, in some embodiments, the open distal end of the outer shaft 120 forms the distal-most structure of the device 103 when initially advanced through the urethra. This facilitates steering the delivery device 103 by the outer shaft 120. The physician can advance the distal region 104 of the delivery device 103 near the desired implantation site or completely into the patient's bladder. The anchor delivery member 150 can be exposed from the open distal end of the distal control member 140 by advancing the anchor delivery member 150 further distally into the bladder, or, if already present within the bladder, by proximally retracting the other components of the delivery device 103. At this point, the anchor from the anchor delivery member 150 can be deployed in the bladder.

[0052] Figure 2B is a perspective view depicting the distal region 104 of the delivery device 103 with the various components deployed. In this embodiment, the anchor delivery member 150 includes an anchor 152 in the form of an expandable member or balloon.

[0053] Other embodiments of the anchor 152 are described in International Application No. PCT / US19 / 32637, filed May 16, 2019, which is incorporated herein by reference in its entirety. The anchor 152 expands (or otherwise transforms) to a size larger than the size of the bladder neck, such that the anchor 152 resists proximal retraction (e.g., under relatively light tension). In embodiments where the anchor 152 is a balloon, the balloon can be elastic or inelastic and can be inflated with an inflation medium (e.g., air or a liquid such as saline) introduced into the balloon 152 through one or more inflation ports 153. Here, three inflation ports 153 are located on the shaft of the anchor delivery member 150 and communicate with an inflation lumen extending proximally back to the proximal control device 200, which may include a port for inflation with a syringe. As the anchor 152 deploys, the physician can proximally retract the delivery system 100 until the anchor 152 makes contact with the bladder neck and / or bladder wall (if not already in contact).

[0054] The physician can use the imaging device of the outer shaft 120 to move the delivery device 103 proximally away from the anchor 152 until the physician positions it in the desired position within the urethra to begin deploying the implant 102. The retainer 142 on the distal control member 140 is releasably coupled to the distal engagement member 114 of the implant 102. The physician can position the retainer 142 at a location along the length of the urethra where the physician desires the distal end of the implant 102 to be deployed. This can include moving the distal control member 140 and the inner shaft 130 together proximally and / or distally relative to the anchor delivery member 150. In another embodiment, the position of the retainer 142 is fixed relative to the anchor 152, such that the longitudinal position of the implant 102 within the anatomy is set by the system independently of any manipulation by the physician. The coupling of the distal engagement member 114 to the retainer 142 also allows the physician to manipulate the radial orientation of the implant 102 by rotating the distal control member 140 and the inner shaft 130 together. Active or passive shaping of the distal control member 140 can allow for more desirable placement of the implant 102. For example, the member 140 can have a curvature that places the implant in a more anterior anatomical position. The curvature can be inherently set in the member 150 or actively imposed by the physician via a separate entity (such as a control wire). Once in the desired position and orientation, the physician can retract the inner shaft 130 proximally relative to the distal control member 140 to begin deploying the implant 102.

[0055] The distal engagement member 114 is held in place relative to the distal control member 140 by the retainer 142, and proximal retraction of the inner shaft 130 relative to the distal control member 140 causes the annular structures 111 to begin to deploy sequentially (111a, then 111b, then 111c, then 111d (not shown)). The distal control member 140 can remain stationary or move longitudinally relative to the urethra during deployment. In some embodiments, the distal control member 140 is steerable to allow angulation of the implant 102 to accommodate relatively tortuous anatomy. The steerability of the distal control member 140 can also enable relatively anterior placement of the implant relative to the bladder neck, which can potentially help improve flow outcomes. For example, see Figures 2C-2G as well as Figure 10C and 10D The distal control member 140 is shown. The mechanisms for achieving steerability are discussed elsewhere herein and are equally applicable to the distal control member 140. In these or other embodiments, the distal control member 140 can be significantly flexible to passively adapt to tortuous anatomy. In some embodiments, the distal control member 140 has a predefined curve to aid navigation.

[0056] To assist in deployment, the inner shaft 130 can be rotated clockwise and counterclockwise about the distal control member 140 (as indicated by arrow 134). Return to Reference Figures 1B-1C , implant 102 has a non-constant winding direction, advancing clockwise along annular structure 111a, then reversing to a counterclockwise direction along interconnecting member 112a for annular structure 111b, then reversing to a clockwise direction along interconnecting member 112b for annular structure 111c, and then reversing to a counterclockwise direction along interconnecting member 112c for annular structure 111d, until concluding at proximal engagement member 115. Depending on the winding direction of the portion of implant 102 that is about to exit the open distal end of lumen 131, if shaft 130 is not actively rotated during deployment of implant 102, the transition of implant 102 toward the rest configuration imparts a torque on shaft 130. This torque causes shaft 130 to passively rotate clockwise or counterclockwise, respectively (without user intervention). In certain embodiments described elsewhere herein, shaft 130 actively rotates during deployment. Thus, rotation of the inner shaft 130 relative to the distal control member 140 allows the delivery device 103 to rotate and follow the winding direction of the implant 102. In some embodiments, all of the annular structures 111 are wound in the same direction, either clockwise or counterclockwise (e.g., in the case of a full helical or spiral implant), or have no set winding direction.

[0057] In this or other embodiments, the distal region of the inner shaft 130 is configured to be relatively more flexible than the more proximal portion of the inner shaft 130, which can allow for avoiding excessive movement of the remainder of the device 103 during deployment, thereby achieving better visualization of the device 103 and less tissue contact. This configuration can also reduce the stress imparted by the device 103 on the implant 102 during delivery. For example, the portion of the inner shaft 130 that extends from the outer shaft 120 during deployment can be relatively more flexible than the portion of the inner shaft 130 that remains within the outer shaft 120, thereby allowing the inner shaft 130 to bend more easily when the implant 102 exits the inner lumen 131. This, in turn, can stabilize the delivery device 103 and allow the physician to obtain stable images during the delivery procedure.

[0058] In an alternative embodiment, if Figures 4A-4E As shown, the inner shaft 230 may include an outer torsion tube 233 ( Figures 4B-4E), one or more lumens for accommodating one or more implants 102 and / or other components, and one or more torsional supports 235. In this embodiment, the inner shaft 230 includes a first elongated tubular member 231a having a first lumen 231 in which one or more implants 102 can be accommodated. The first elongated tubular member 231a also has a second elongated tubular member 232a (or tether) having a second lumen 232 in which a third elongated tubular member 140 and a fourth elongated tubular member 240 can be accommodated, and the fourth elongated tubular member 240 can serve as an inflation lumen. In an alternative embodiment, the second elongated tubular member 232a (or tether) can be used for release / actuation, and the inflation lumen can be concentric with the tether. As Figure 4D and 4E As shown, the first elongated tubular member 231a and the second elongated tubular member 232a can be placed side by side and held in place by a torsional support 235. The torsional support 235 can be a small plate spaced apart within the outer torsion tube 233 from the proximal end to the distal end of the outer torsion tube 233. For example, the torsional supports 235 can be spaced apart by about 3 to about 6 inches, alternatively by about 2 to about 5 inches, or alternatively by about 1 to about 4 inches. The torsional support 235 can be coupled or otherwise secured in position relative to the outer torsion tube 233 to ensure that the axial and angular position of the outer torsion tube 233 can be maintained by the user. The first elongated tubular member 231a can be secured to the torsional support 235 to ensure that the first elongated tubular member 231a moves with the outer torsion tube 233. The second elongated tubular member 232a can be unsecured to the torsional support 235, such that the second elongated tubular member 232a can move axially and rotationally relative to the support plate and the outer torsion tube 233.

[0059] like Figure 4B As shown, the flexible tip 243 can be formed by securing the first elongated tubular member or implant delivery tube 231a so that its distal end 237 extends beyond the distal end 239 of the outer torsion tube 233 by about 0 cm to 1.5 cm, alternatively about 0 cm to 1.0 cm, alternatively about 0.2 cm to 1.0 cm.

[0060] The components of the inner shaft can be made of any suitable material. The first elongated tubular member or implant delivery tube 231a can be a braided tubular assembly with a lubricating lining. It can be made of laser-cut hypotube with a lubricating lining, a single polymer extrusion, or other suitable material. The outer torsion tube 233 can be made of laser-cut hypotube, a braided structure, a polymer extrusion, or other suitable material. The torsion support 235 can be a laser-cut sheet metal, a molded plastic component, an extruded material, or other suitable material.

[0061] Figure 2B The implant 102 is depicted after the three annular structures 111a, 111b, and 111c have been deployed. The shaft 130 continues to be retracted proximally until the entire implant 102, or at least all of the annular structures 111, have exited the lumen 131. If the physician is satisfied with the deployed position of the implant 102 and the deployed shape of the implant 102, the implant 102 can be released from the delivery device 103. The control wire 146 ( Figure 2B 140) extends the length of the control member 140, either in the same lumen as the anchor delivery member 150 or in a different lumen, and is coupled to the retainer 142. A control wire 146 can be routed into the member 140 through the opening 148.

[0062] Release of the distal end of the implant 102 may be accomplished by releasing the retainer 142. The retainer 142 may be a cylindrical structure or other sleeve that is linearly or rotationally actuated over a cavity or recess in which a portion of the implant 102 is housed. Figure 2B In an embodiment of the present invention, the retainer 142 includes an opening or slot that allows the distal engagement member 114 to pass therethrough. The retainer 142 can be rotated relative to the cavity or recess in which the distal engagement member 114 is housed (not shown) until the opening or slot is positioned over the member 114, at which point the member 114 is free to release from the distal control member 130. Rotation of the retainer 142 can be achieved by rotation of a rotatable shaft, rod, or other member coupled to the retainer 142 (and accessible at the proximal control device 200). Alternative embodiments of the retainer can be found in International Application No. PCT / US19 / 32637, filed May 16, 2019. Figures 2C-2F The entire contents of this International Application are incorporated herein by reference.

[0063] Figures 2C-2G 1 is a perspective view depicting another example embodiment of the system 100 having an alternative retainer 142 that can be secured in place with a tether lock. As in other embodiments, the retainer 142 slides distally and / or proximally relative to the distal control member 140. The distal engagement member 114 of the implant 102 can be received in a corresponding recess 143 ( Figure 2G ). The retainer 142 can be slid over the distal engagement member 114 while being received within the recess 143 until the retainer 142 abuts a portion of the member 140 having an opening 241 located near its distal end. A control wire 246 extends the length of the control member 140, either in the same lumen as the anchor delivery member 150 or in a different lumen, and is attached or coupled to the retainer 142 at its distal end 248. Figure 2EAs shown, control wire 246 passes out and back into opening 241 in distal control member 140, such that control member 246 forms a loop 247 that protrudes from the opening and extends along an axis that is perpendicular to the longitudinal axis of the distal control member and the longitudinal axis of retainer 142. Loop 247, positioned adjacent to and proximal to retainer 142, prevents retainer 142 from moving in a proximal direction on distal control member 140.

[0064] When the implant 102 is satisfactorily deployed within the urethra, e.g. Figure 2C In the state of , the control line 246 can be tensioned by pulling the control line 246 in the proximal direction (away from the implant 102). Figure 2F As seen in FIG, the tension pulls the ring 247 into the lumen of the distal control member 140, thereby removing the obstruction that prevents the retainer 142 from sliding proximally. Figure 2G As shown, after the ring is withdrawn into the lumen of distal control member 140 , retainer 140 is retracted proximally by pulling control wire 246 further proximally to expose engagement member 114 and allow it to be released from member 140 .

[0065] The control members 146, 246 may be made of Nitinol, Kevlar, stainless steel, suture, liquid crystal polymer (LCP), or any other stretchable material.

[0066] Figures 2H-2J Another example embodiment of the system 100 is illustrated having an alternative retainer 242 that can be fixed in place. As with the other embodiments described, the retainer 242 can be a cylindrical structure or other sleeve that is linearly or rotationally actuated over a cavity or recess in which a portion of the implant 102 is housed. The retainer 242 includes a cover 245 that is coupled to an outer tube 249 that extends to the control device 200. Figures 2H-2J In the exemplary embodiment, the retainer 242 includes an opening or slot (not shown) that allows the distal engagement member 114 to pass therethrough. Figure 2H A cover 245 is shown enclosing the recess 143 and adapted to retain the distal engagement member 114. The retainer 242 can be withdrawn proximally relative to the cavity or recess in which the distal engagement member 114 is received until an opening or slot is positioned over the member 114, at which point the member 114 is free to be released from the distal control member 130. Figure 2I , the cover 245 has been withdrawn by proximally actuating the outer tube 249. The withdrawal of the cover 245 of the retainer 242 can be achieved by proximally withdrawing the outer tube 249, which is accessible at the proximal control device 200. Figure 2Jis a cross section showing retainer 242 and an inflation lumen in communication with anchor 152. The inflated diameter of the anchor balloon may be between about 1 cm and 7 cm, alternatively between about 2 cm and 6 cm, alternatively between about 1 cm and 6 cm.

[0067] The release of the proximal end of the implant 102 is also controllable. Figure 3A 1 is a partial cross-sectional view depicting an example embodiment of the system 100, wherein a portion of the implant 102 is shown within the lumen 131 of the inner shaft 130. Here, the implant 102 is in a linear state prior to deployment, wherein the proximal engagement member 115 is coupled to a gripper 136, which is slidable distally and / or proximally within the lumen 131. The gripper 136 may include a distal region 137 on or coupled to a shaft 138. The gripper 136 is preferably controllable to rotate and longitudinally translate (e.g., push and pull) the implant 102 relative to the inner shaft 130.

[0068] Figure 3B and 3C 102 are perspective views of example embodiments of the distal region 137 of the gripper 136, depicted without and with the implant 102, respectively. The gripper 136 includes a recess (also referred to as a cavity or pocket) 139 for receiving and retaining the proximal engagement member 115. Here, the enlarged portion 115 is retained within the recess 139 by a distal necked region having a relatively small width. When within the inner lumen 131, the sidewalls of the inner shaft 130 retain the proximal engagement member 115 within the recess 139. When the distal region 137 exits the lumen 131 (either by retracting the inner shaft 130 relative to the gripper 136 or by advancing the gripper 136 relative to the inner shaft 130), the constraint imposed by the inner shaft sidewalls is no longer present, and the engagement member 115 is free to release from the gripper 136. Thus, when the physician is satisfied with the placement of the deployed implant 102, the distal engagement member 114 can be released by moving the retainer 142 and allowing the distal engagement member 114 to disengage from the control member 140, and the proximal engagement member 115 can be released by exposing the gripper 136 from within the inner shaft 130 and allowing the proximal engagement member 115 to disengage from the gripper 136.

[0069] The gripper 136 may also assist in loading the implant 102. In some embodiments, applying tension on the implant 102 with the gripper 136 (while opposite ends of the implant 102 are secured, for example, by the retainer 142) assists in transitioning the implant 102 from the rest configuration to a linear configuration suitable for inserting the implant 102 into the inner shaft 130.

[0070] The anchor delivery member 150 can have a variety of different configurations and geometries (e.g., including those that extend through the bladder wall in one direction, in two directions (e.g., left and right), or in three or more directions). Figure 2B and 4A Additional examples of anchor delivery members and anchors are described in International Application No. 4,4J, which was previously incorporated herein by reference in its entirety.

[0071] After the implant deployment procedure is complete, the anchor 152 can be collapsed or retracted to allow removal of the delivery device 103. For example, in embodiments where the anchor 152 is a balloon, the balloon is deflated and optionally retracted into the lumen of the device 103 and subsequently withdrawn from the bladder and urethra. In embodiments where the anchor 152 is a wire or other expandable member (e.g., as disclosed in International Application No. PCT / US19 / 32637, filed May 16, 2019), the delivery device 103 can be removed. Figure 4A

[00105] As described in connection with International Application Nos. 4-4G, previously incorporated by reference in its entirety for all purposes, the anchor 152 is retracted back into the lumen of the device 103 from which it was deployed, and the device 103 can then be withdrawn from the bladder and urethra. Retraction can be accomplished using fluid or pneumatic actuation, a screw-type mechanism, or other means.

[0072] Example embodiments of proximal control devices and associated methods

[0073] Figure 5A is a side view of an example embodiment depicting the delivery system 100 prior to deployment of the implant 102, and Figure 5B is a side view of this embodiment depicting the implant 102 in a deployed configuration (the anchor delivery member 150 and the distal control member 140 are not shown). In this embodiment, the proximal control device 200 is a handheld device having a handle 201, a first user actuator 202 (configured as a trigger in this example), a body 203, and a second user actuator 205. The longitudinal axis of the delivery device 103 is indicated by the dashed line 204. The proximal control device 200 may include a mechanism that is manually powered by actuation of the actuator 202 to cause relative movement of the components of the device 103. In other embodiments, the proximal control device 200 may alternatively utilize an electrically powered mechanism. The second user actuator 205 may be configured to control the steering of the delivery device 103. Here, as Figure 5G and 5HAs shown, the actuator 205 is configured as a rotatable wheel 225 that can wind or unwind the pull wire 221 within the delivery device 103 and cause the device 103 to deflect upward and downward, as depicted here. The second user actuator 205 includes an extension 212 having a paddle 206 extending from a first end 215 of the extension 212. Figure 5A As shown, before deployment, the extension 212 is closer to the handle 201, for example, the extension 212 is angled toward the handle 201. Figure 5B As shown, after the implant 102 has been at least partially deployed from the distal region 104 , the extension 212 is angled away from the handle 201 and angled or directed toward the distal region 104 . Figure 5B The dashed lines in also indicate that the distal end of the inner tubular member 120 can be deflected to enable placement of the implant more anteriorly. The proximal control device 200 can be configured to automatically prevent further deployment of the implant 102 after all of the annular structures 111 have been deployed from the inner lumen 131, but before the proximal engagement features 115 and recesses 139 are advanced from within the lumen 131. This provides the physician with an opportunity to verify that the implant 102 has been properly deployed and placed before releasing the implant 102 from the delivery device 103. A detailed description of the control device 200 and the parts and gear assemblies contained therein can be found, for example, in International Application No. PCT / US19 / 32637 filed on May 16, 2019. Figure 6A -9F, which International application was previously incorporated herein by reference in its entirety for all purposes.

[0074] The device may also include a steering lock that allows the user to lock the steering more anteriorly to place the implant in a more anterior position. As previously described, the device's steerability may include a pull wire 225 extending from the distal region 104 of the delivery device 103 to the proximal control device 200 (e.g., the distal end of the pull wire is secured to a plate or other structure within the distal region 104), where the user can manipulate the pull wire to steer the delivery device 103. The steering structure may be located within one or more lumens of the outer shaft 120, or may be coupled to or embedded within the sidewall of the outer shaft 120. The delivery device 103 may be biased to deflect (e.g., bend) in a particular lateral direction, such that the device 103 automatically deflects in that direction, and the force imparted to steer the delivery device 103 opposes the biasing force.

[0075] The steering lock is part of the extension 212 attached to the actuator 205. Figures 5C-5HAs shown, actuator 205 includes a rotatable wheel 225, an extension 212, a latch 209, and a crosspiece 207. The housing of actuator 205 can include two halves, a right handle half 205a and a left handle half 205b. Rotatable wheel 225 is suitable for winding and unwinding the pull cable and is located in and coupled to the housing. Extension 212 includes latch 209 and paddle 206, which extends from a first end 215 and terminates in a pawl 208, such that a gap exists between the pawl 208 and a second end 217 of extension 212. The second end 217 of extension 212 is attached to the left handle half 205b, and the first end is adjacent to a portion of the right handle half 205a. The second end 217 of extension 212 includes the pawl 208 and the gap. The steering lock also includes a crosspiece 207 extending from the right-hand half 205a of the housing near the first end 215 of the extension 212. A latch 209 is adapted to actuate or slide along the paddle 206. When the latch 209 is positioned over the second end 217, the pawl 208 frictionally engages the latch 209, thereby constraining the latch 209 to the second end 217.

[0076] In use, such as Figure 5E As shown, the user can disengage the latch 209 from the pawl 208 and move the latch 209 along the paddle 206 from the second end 217 to the first end 215 of the extension 212. Once the latch 209 is at the first end 215, the user can push the extension 212 in a direction toward the distal region 104 until the latch 209 contacts the crosspiece 207. The crosspiece 207 then frictionally engages the latch 209 and holds the extension 212 in an angled position toward the distal region 104, in a "locked" position. In the locked position, the rotatable wheel 225 cannot wind or unwind the pull wire 221, and the user cannot move (deflect and straighten) the distal region 104 of the outer tubular member 103. Figure 5F As shown, to release paddle 206 from the "locked" position, a user can release latch 209 from crosspiece 207 and slide latch 209 along paddle 206 from first end 215 to second end 217 of extension 212. When latch 209 is no longer frictionally engaged by crosspiece 207, extension 212 can passively return to a rest position in which, due to spring loading, extension 212 is angled toward handle 201 (i.e., away from distal end region 104). In the unlocked position, rotatable wheel 225 can wind and unwind pull wire 221, thereby moving (deflecting or straightening) distal end region 104 of outer tubular member 103.

[0077] Example embodiments of delivery methods

[0078] Figure 6Ais a flow chart depicting an example embodiment of a method 1000 for delivering an implant 102 using the system 100. The distal region of the outer shaft 120 is inserted into the urethra, preferably with the inner shaft 130, distal control member 140, and anchor delivery member 150 in a retracted state fully contained within the outer shaft 120 such that no portion extends from the open distal end of the outer shaft 120. After advancement into the urethra, at step 1002, the anchor delivery member 150 is advanced distally relative to the remainder of the delivery device 103 (e.g., components 120, 130, and 140) and used to deploy the anchor 152 within the bladder. In some embodiments, deployment of the anchor 152 can be by inflating one or more balloons (e.g., such as a Luer taper) by introducing an inflation medium via an injection (e.g., Luer taper) port. Figure 2B Longitudinal positioning (e.g., advancement and retraction) of the anchor delivery member 150 and / or any wire-like members can be accomplished manually by the user manipulating the proximal end of the anchor delivery member 150 and / or any wire-like members directly or with the proximal control device 200.

[0079] At step 1004, anchor 152 can be held taut against the bladder wall by applying a proximally directed force on device 200. Thus, anchor 152 can provide system 100 with a vertical coordinate from which to deploy implant 102 at a precise location. This feature can ensure that the implant is not placed too close to the bladder neck.

[0080] At 1006, if the distal control member 140 and inner shaft 130 have not already been advanced (e.g., step 1006 may occur before steps 1002 and / or 1004), the distal control member 140 and inner shaft 130 may then be advanced distally from within the outer shaft 120. The user may manipulate the position of the proximal control device 200 with the aid of imaging (as described herein) until the implant 102 is in the desired position. Once the implant 102 is in the desired position, the implant deployment procedure may begin. The steps of implant deployment may be performed automatically by the user actuating the proximal control device 200 (e.g., actuating the trigger 202, selecting the position of the switch 604, etc.), or these steps may be performed directly by manually manipulating each component of the delivery device 103, or by a combination of both as desired for a particular embodiment.

[0081] In some embodiments, deployment of the implant 102 from within the lumen 131 is accomplished entirely by (1) advancing the gripper 136 distally relative to the inner shaft 130 without movement of the inner shaft 130, while in other embodiments, deployment of the implant 102 from within the inner lumen 131 is accomplished entirely by (2) retracting the inner shaft 130 proximally relative to the gripper 136 without movement of the gripper 136. In some embodiments, deployment of the implant 102 is accomplished entirely by (3) a combination of both movements. In other embodiments, deployment of the implant 102 is accomplished entirely by (1), (2), or (3) in combination with one or more rotations of the inner shaft 130 relative to the distal control member 140 in one or more directions (e.g., clockwise or counterclockwise).

[0082] refer to Figure 6A and Figure 6B The timing diagram of FIG. 1 depicts an example embodiment of a sequence of steps 1008, 1010, and 1012 for deploying the implant 102. Figure 6A At step 1008, the first annular structure 111a is moved out of the lumen 131 of the inner shaft 130, at step 1010, the interconnecting member 112 is moved out of the lumen 131, and at step 1012, the second annular structure 111b is moved out of the lumen 131. Steps 1010 and 1012 may be repeated for each additional interconnecting member 112 and annular structure 111 present on the implant 102.

[0083] exist Figure 6B , step 1008 begins at the far left of the timing diagram, at T0. The expansion of the annular structure 111a corresponds to the duration labeled 1008, the expansion of the interconnect 123 corresponds to the time span 1010, and the expansion of the annular structure 111b corresponds to the time span 1012. One of ordinary skill in the art will recognize that the distinction between the expansion of the annular structure 111 and the expansion of the interconnect 112 is approximate, as the transition between those portions of the implant 102 can be gradual and does not necessarily have precise boundaries.

[0084] Reference Figure 6B The described embodiment is for an implant having an annular structure 111 with opposite winding directions (eg, clockwise, then counterclockwise, then clockwise, etc.). Figure 6B , three different motions are indicated. At the top is rotational motion of the inner shaft 130 in one direction (e.g., clockwise), in the middle is longitudinal motion of one or more components of the delivery device 103 (e.g., proximally or distally), and at the bottom is rotational motion of the inner shaft 130 in a direction opposite to the direction indicated at the top (e.g., counterclockwise). In embodiments where the annular structures 111 of the implant 102 are all wound in the same direction, the rotation of the inner shaft 130 will also be in only one direction.

[0085] From time T0 to T1, deployment of the implant 102 is accomplished by rotating the inner shaft 130, as shown in region 1031. Simultaneously, in region 1032, the grasper 136, and therefore the implant 102, is advanced distally without moving the outer shaft 120 longitudinally (neither distally nor proximally) or rotationally, and without moving the inner shaft 130 longitudinally (neither distally nor proximally).

[0086] From time T1 to T2, rotation of the inner shaft 130 is stopped, but the grasper 136 continues to be advanced distally without the shafts 120 and 130 moving longitudinally.

[0087] From time T2 to T4, the first interconnect 112 is deployed. In region 1033, from time T2 to T4, no distal advancement of the gripper 136 (and the implant 102) occurs. Deployment of the interconnect 112 is achieved by proximally retracting both the outer shaft 120 and the inner shaft 130 while holding the gripper 136 in place. This causes the interconnect 112 to exit the inner lumen 131 of the shaft 130.

[0088] Regarding the rotation of the inner shaft 130 , from time T2 to T3 , no rotation of the inner shaft 130 occurs. Within the proximal control device 200 , the interrupted portion of the ring gear 802 continues, and the central gear 816 does not rotate the shaft 130 .

[0089] In embodiments where the interconnect 112 is straight, it may be desirable to inhibit the rotation axis 130 as the interconnect 112 is unwound from time T2 to time T4. For embodiments where the interconnect 112 is curved, such as Figures 1B-1D In other embodiments, it may be desirable to initiate rotation of the inner shaft 130 during interconnect deployment. Figure 6B The deployment of the curved interconnect 112 is depicted, and from T3 - T4 , the inner shaft 130 is rotated in the opposite direction indicated by region 1034 .

[0090] At T4, deployment of the interconnect 112 is complete, and deployment of the second annular structure 111b begins. Proximal retraction of the shafts 120 and 130 is stopped, as indicated by the stop at region 1033. Distal advancement of the grasper shaft 138 is resumed at region 1035 of T4, without the outer shaft 120 moving either rotationally or longitudinally. As indicated by region 1034, the inner shaft 130 continues to rotate, but the inner shaft 130 does not move longitudinally.

[0091] These movements continue until time T5, at which point rotation of the inner shaft 130 ceases. Within the proximal control device 200, a discontinuity in the ring gear 802 is reached, and the gear 802 disengages from the planetary gears, and rotation of the sun gear 816 ceases. The user's depression of the trigger 202 continues from time T5 to T6, with the components operating in a similar motion as described from time T1 to T2. If another interconnect 112 and annular structure 111 were present, the sequence beginning at time T6 could be identical to the sequence described, beginning at time T2 and continuing until time T6.

[0092] In many of the embodiments described herein, deployment of all annular structures 111 can occur with a single, continuous depression of trigger 202. In all of these embodiments, proximal control device 200 can alternatively be configured such that repeated pulling of trigger 202 is required to deploy all annular structures 111 of implant 102.

[0093] During deployment, for example, after time T0 until full deployment of the proximal-most annular structure 112, if the physician wishes to recapture the implant 102, the physician may stop depressing the trigger 202. The trigger 202 may be spring-loaded or otherwise biased to return to the outermost position. Figure 6B .

[0094] If the physician is satisfied with the deployment, the distal engagement portion 114 and the proximal engagement portion 115 of the implant 102 can be released from the distal control member 140 and the gripper 136, respectively, at 1014. For example, in the proximal control device 200, the physician can pull the tab 910 to allow the trigger 202 to be depressed the remaining distance, which in turn can deploy the proximal engagement portion 115 of the implant 102 by distally advancing the gripper 136, proximally retracting the shafts 120 and 130, or both. The tab can be coupled to a control wire 146, and pulling the tab can pull the wire 146 and remove the retainer 142 from the distal engagement portion 114.

[0095] Then, if desired, the anchor 152 can be recaptured (e.g., by deflation of the balloon or retraction of the wire-like member) and withdrawn into the anchor delivery member 150. The anchor delivery member 150, distal control member 140, and inner shaft 130 can be retracted into the outer shaft 120 and then withdrawn from the urethra.

[0096] A more detailed description of the process by which components in the control device complete the above steps is provided in International Application No. PCT / US19 / 32637, filed on May 16, 2019, which was previously incorporated herein by reference in its entirety.

[0097] Example Embodiments of User Assembly of Proximal Controls

[0098] Reference again Figure 5A , the proximal control device 200 can include a movable (eg, retractable and / or advanceable) handle portion 1102 that can move relative to a more proximally located handle portion 1103 . Figure 5A The movable handle portion 1102 is depicted in a distally advanced position prior to deployment of the implant 102, and Figure 5B Portion 1102 is depicted in a proximal, retracted position after deployment of implant 102. Moveable portion 1102 can be fixed to and move with outer shaft 120, and can also move independently of inner shaft 130, distal control member 140, and anchor delivery member 150 (not shown).

[0099] refer to Figure 16A -G, the proximal control device 200 may include an anti-rotation mechanism that prevents the outer shaft 120 from rotating relative to the inner shaft 130 if rotation of the outer shaft 130 is not desired during implant delivery. The distal handle portion (or scope handle) 1102 may include a groove 1111 extending along the longitudinal axis of the distal handle portion 1102 and configured to receive a pawl 1113 attached to a post 1009 located on the inner surface of the distal section 1105 located proximal to the handle portion 1103. Figure 16D and 16E As seen in the figure, the struts 1009 are attached to the inner surface at a first end 1007 and extend laterally, terminating in a pawl 1113 at a second free end not attached to the inner surface. After the distal handle portion 1102 and / or the proximal handle portion are rotated so that the pawl 1113 is received within the groove 1111, the distal handle portion and the proximal handle portion 1103 are locked together. The distal handle portion 1102 cannot passively rotate relative to the proximal handle portion 1103, and the proximal handle portion 1103 cannot passively rotate relative to the distal handle portion 1102, and therefore, the outer shaft 120 cannot passively rotate relative to the inner shaft 130 during implant delivery and / or deployment. The pawl 1113 is deflectable. When it is desired to allow the outer shaft 120 to rotate relative to the inner shaft 130 (passively or actively), as Figure 16C As can be seen, additional force can be applied and the distal handle portion 1102 can be rotated, causing the pawl 1113 to deflect from the groove 1111 into the body of the distal handle portion 1102. For example, a user can override the anti-rotation mechanism by rotating the scope handle 1102 with their hand to disengage the pawl 1113. When the pawl 1113 is not received in the groove 1111, the distal handle portion 1102 and the proximal handle portion can rotate relative to each other, and therefore, the outer shaft 120 can rotate relative to the inner shaft 130.

[0100] Figure 7A is an interior view of an exemplary embodiment of the movable portion 1102 of the proximal control 200, taken from the Figures 5A-5B Compare to the opposite view. The proximal region 105 of the delivery device 103 is shown coupled to the housing 1103 of the movable portion 1102 on the right, and the multi-faceted shaft 708 is shown on the left. (The shaft 708 can be multi-faceted to allow for an interference fit with the hub 707, although other configurations and securing techniques can be used such that the shaft 708 is cylindrical (e.g., secured to the hub 707 with an adhesive). The coupling mechanism 1106 is mounted or formed within the housing 1103 and will be referenced. Figure 11B -11E is described in more detail. Housing 1103 also includes imaging hardware 1202, which will be referred to Figures 12A-9B Describe it in more detail.

[0101] Figure 7B It is from Figure 7A A closer perspective depicts an internal view of the coupling mechanism 1106. Here, the coupling mechanism 1106 includes a user actuator 1107, which in this embodiment is configured as a latch slidable within a track 1108 provided by a housing 1109. Figure 7C The coupling mechanism 1106 is depicted with the proximal side of the housing 1109 removed to allow viewing of the internal components. Figure 7D Depicts Figure 7C The coupling mechanism 1106, wherein the latch 1107 is also removed, and Figure 7E Depicts Figure 7D 1106 of the coupling mechanism 1106, with the housing 1109 removed to further simplify the description.

[0102] The latch 1107 is coupled to a resiliently deflectable member 1110 disposed within the housing 1109. Movement of the latch 1107 from the leftmost position to the rightmost position (as depicted here) causes the member 1110 to flex against the inclined surface 1119. The member 1110 is directed toward a straight configuration (e.g., Figure 11C 11D), and the release of latch 1107 in the rightmost position allows latch 1107 to return to the leftmost position due to the elastic action of member 1110. Member 1110 can be configured as desired based on the needs of the application. For example, in this embodiment, member 1110 is a nitinol wire.

[0103] When in the leftmost position, member 1110 may be received within one or more recesses in rotation adapter 1112. Figure 7EIn an embodiment, there are two grooves 1114 and 1115, each of which can receive a member 1110, so that when the rotation adapter 1112 is rotated, the member 1110 can slide in the grooves 1114 and 1115, but any longitudinal movement (advancement and / or retraction) of the rotation adapter 1112 will cause the member 1110 to move as well.

[0104] Prior to use in an implantation procedure, the proximal end of the inner shaft 130 is coupled to the rotation adapter 1112, which in turn is coupled to the polygonal shaft 708, which in turn is connected to the proximal portion 1103 of the proximal control device 200. The outer shaft 120 is coupled to the movable portion 1102, but the portions 1103 and 1102 are separate and not coupled together. A medical professional or other user can advance the distal end of the inner shaft 130 into the movable portion 1102 of the proximal control device 200 until the grooves 1114 and / or 1115 of the rotation adapter 1112 engage the deflectable member 1110. Insertion of the inner shaft 130 through the portion 1102 can be facilitated by Figure 7B The distal end 1118 of the rotational adapter 1112 can be tapered or necked in one or more areas to aid in such insertion by deflecting the member 1110 until the first groove 1115 abuts against it, at which point the member 1110 snaps into place. When the wire 1110 engages one of the grooves 1114 or 1115, the movable portion 1102 couples with the proximal portion 1103 of the proximal control device 200. In certain embodiments, at this point, the proximal control device 200 is assembled and ready for implantation.

[0105] Example embodiments of imaging devices and uses

[0106] In certain exemplary embodiments, the coupling of the movable portion 1102 (which is fixed to the outer shaft 120) to the rotation adapter 1112 (which is in turn fixed to the polygonal shaft 708, the guide member 706, and the inner shaft 130) causes the outer shaft 120 to track the movement of the inner shaft 130. Figure 2A The imaging device and the lighting device (see Figures 9A-9B) can be placed in one or more lumens 122-124 at the distal end of the outer shaft 120. These devices can be mounted at the distal end of their respective lumens (or a shared lumen), a short distance proximal to the distal end of the inner shaft 130, from which the implant 102 is withdrawn during delivery. As the inner shaft 130 moves proximally in the longitudinal direction, the outer shaft 120 also moves proximally in the longitudinal direction, maintaining the same spacing between their opposing distal ends. Conversely, as the inner shaft 130 moves distally, the outer shaft 120 also moves distally, maintaining the same spacing (i.e., at the same speed). In this way, the system 100 allows the delivery of the implant 102 from the inner shaft 130 to be imaged at a constant spacing from the distal end of the inner shaft 130. Because the grooves 1114 and 1115 are annular (e.g., extending around the circumference of the rotation adapter 1112), rotation of the inner shaft 130 is permitted without causing similar rotation of the outer shaft 120. The deflectable member 1110 simply slides along the corresponding groove 1114 or 1115.

[0107] If a user or medical professional desires to position an imaging device at a different spacing from the distal end of inner shaft 130, coupling mechanism 1106 can be used to release the coupling between movable portions 1102 and 1103, and movable portion 1102 can be moved so that a different groove engages deflectable member 1110. For example, disengaging groove 1115 and engaging groove 1114 will increase the spacing between the imaging device at the distal end of outer shaft 120 and the distal end of inner shaft 130, thereby allowing the user to image with a relatively wider field of view. This feature provides the user with the ability to adjust the field of view. Coupling mechanism 1106 can be coupled in a first position corresponding to a first of grooves 1114 and 1115, and if the imaging field of view is not optimal, the user can disengage mechanism 1106 and switch to a second position corresponding to the other of grooves 1114 and 1115. Although only two grooves 1114 and 1115 are present in the embodiments described herein, any number of one, two, three, four, or more grooves may be used, each groove being selectable independently of the others and each corresponding to a different position and field of view. The ability for the imaging and illumination devices to automatically move in synchronization with the longitudinal movement of the inner shaft 130 during deployment may be used with any of the embodiments described herein.

[0108] Figure 8A A housing 1203 for the imaging hardware 1202 is depicted. Figure 8B The components inside the housing 1203 are depicted, and Figure 8C The components are depicted from a closer perspective. Figure 9A is a perspective view depicting the proximal side of the distal end region of the outer tubular member 120, and Figure 9B1 is a perspective view depicting the distal end region of the outer tubular member 120. The first bus 1204, in this embodiment in the form of a ribbon cable, is located at its distal end ( Figure 9A ) is connected to the imaging device 1220 in the distal region 1224 of the outer tubular member 120 (not shown). The first bus 1204 can be routed through a lumen (e.g., one of the lumens 122-124) of the outer tubular member 120 and have its proximal end connected to one or more contacts ( Figure 8C ), in this example, there are four contacts 1205-1208 for power, ground, received signal and clock.

[0109] The second bus 1210 (also in the form of a ribbon cable in this embodiment) is connected at its distal end ( Figure 9A ) is connected to the lighting device 1222 in the distal region tip 1224. The second bus 1210 can pass through the same or a different lumen (e.g., one of the lumens 122-124) of the outer tubular member 120 and have its proximal end connected to one or more contacts ( Figure 8C ), in this example, two contacts 1211 and 1212 for power and ground. These contacts are located on a printed circuit board 1216, which may have additional imaging hardware (not shown) coupled thereto, including passive RLC components and active components (e.g., transistors, diodes, and / or semiconductor chips). The output circuitry that transmits the received image may be a wired circuit that outputs the image to a display via a cable, or a wireless circuit that wirelessly transmits the image to a local receiver with a display. Figures 9A-9B Also shown is an irrigation port lumen 1223. The order of positions of the imaging device 1220, illumination device 1222, and irrigation port lumen 1223 may be rearranged from those described and shown herein.

[0110] In an alternative embodiment, the imaging device may be part of a telescoping module.A user or medical professional may desire to move the imaging device because, for example, all or part of the scope's view of the implant is blocked by tissue. Figures 10A-10B is a perspective view depicting the distal side of the distal region of the outer tubular member 120. The telescopic imaging module 2220 may include a camera and a light source, such as an LED, mounted to at least one, alternatively at least two, alternatively at least three, elongated members 2223 extending from the lumen 2224 of the outer tubular member 120. The telescopic imaging module may extend from about 0 to about 5.0 cm, alternatively about 0.25 cm to about 5.0 cm, alternatively about 0.5 to about 4.0 cm from the distal region tip 2224 of the outer tubular member 120. Figures 10C-10DAs seen in FIG, the telescopic imaging module 2220 can be advanced proximally through the implant without affecting the delivery system or the position of the implant 102. Thus, the final position of the implant 102 can be assessed before the implant 102 is released from the delivery device 103. Additionally, after the implant 102 is released from the delivery device 103, the telescopic imaging module 2220 can be allowed to further assess the positioning of the implant 102 relative to key anatomical landmarks, such as the external urinary sphincter and the bladder neck, without the risk of the larger outer tubular member 120 passing through the implant 120.

[0111] As described in other embodiments, one or more busses can be routed through the lumen of the outer tubular member 120. The distal ends of the one or more busses are connected to the telescopic imaging module 2220. The proximal ends of the one or more busses are connected to one or more contacts, such as for power, ground, received signals, and / or clocks. These contacts are located on a printed circuit board, which may have additional imaging hardware (not shown) coupled thereto, including passive RLC components and active components (e.g., transistors, diodes, and / or semiconductor chips). The output circuitry for transmitting the received image can be a wired circuit that outputs the image to a display via a cable, or a wireless circuit that wirelessly transmits the image to a local receiver with a display.

[0112] In an alternative embodiment, if Figures 11A-11C As can be seen, the imaging device can be adjustable in the proximal and distal directions relative to the position of the implant 102 and / or delivery system to temporarily view different portions of the implant 102. The imaging device and delivery system can be connected by a spring-loaded connection, such as a rotation adapter 2112. As previously described with respect to Figure 7E As explained, the proximal end of the inner shaft 130 is coupled to a rotation adapter, which in turn is coupled to the polygonal shaft 708, which in turn is coupled to the proximal portion 1103 of the proximal control device 200. Figures 11A-11B As shown, in an alternative embodiment, the rotation adapter 2112 includes a distal member 2114, a proximal member 2116, a sliding member 2118, and a spring 2120. The distal member 2114 is coupled to the inner shaft 130 and can have a tapered shape that tapers from the proximal end to the distal end. The sliding member 2118, located adjacent to and proximal to the distal member 2114, has an annular or ring-like shape. An imaging device (not shown) can be coupled to an annular groove 2122 of the sliding member 2118. The spring 2120 is located between the sliding member 2118 and the proximal member 2116, proximal to and adjacent to the sliding member 2118. The proximal member 2116 is located proximal to and adjacent to the spring 2120 and is coupled to the polyhedral shaft 708.

[0113] In use, the scope connected to the sliding member 2118 is pulled back in the proximal direction and the spring 2120 is manually compressed by the user by grasping the outside handle 1102 and pulling the handle rearward relative to the delivery system handle 1103. (See Figures 11A-11B When the scope is released, the spring 2120 will decompress and the scope will return to its rest position (where the spring 2120 is uncompressed). Figure 12A As a result, when the scope is in the default (resting) position, the bottom of the last ring of the implant 102 is not within the scope's field of view, and the user cannot see the bottom of the last ring relative to the anatomy. Figure 12B As can be seen, the field of view now includes the bottom of the last ring of the implant 102, and the user is able to better assess the placement of the implant 102 before releasing the implant 102 from the delivery device.

[0114] In an alternative embodiment, a spring 2120 is located between the distal member 2114 and the sliding member 2118. In use, the scope can be advanced in a distal direction by compressing the spring 2120. When the scope is released, the spring 2120 will decompress and the scope will return to its rest position (with the spring 2120 decompressed).

[0115] In alternative embodiments, the rotary adapter may be electrically conductive and designed to connect to receive power from an external source, or to connect to a printed circuit board of an imaging device. Figure 15 As shown, the rotation adapter may include an electrical contact plate or ring 2130. For example, the electrical contact plate or ring may be included in the sliding member 2118. A bus, for example in the form of a ribbon cable, may be connected at its proximal end to the electrical contact plate or ring and at its distal end to a light source, such as an LED, mounted to the distal end of the inner shaft 130 or the distal control member or tether 140. Thus, electrical energy is transmitted via the inner shaft 130 or the tether shaft 140. In an alternative embodiment, the electrical contact plate or ring may be included in the rotation adapter 1112, as shown in FIG. Figure 7E As stated.

[0116] Example Embodiments of Implant Placement

[0117] All of the embodiments of the system 100 described herein may be used to deliver the implant 102 to various locations near the prostate, or other locations within the human anatomy. Figure 13Figure 1 is a cross-section of the male anatomy, providing context for describing various examples of prostatic intraurethral implant placement. Here, the prostate 1302 is centrally located, while the bladder wall 1304 and bladder 1305 are located above. The prostatic urethra 1306 extends downward from the bladder 1305, past the ejaculatory duct 1307, and through the prostate 1302. The prostatic urethra 1306 becomes the membranous urethra 1308 at the approximate location of the external urethral sphincter 1309 and continues out of the body. The rectum is indicated by 1310.

[0118] Figure 14A It is from Figure 13 13. The cross-section of the implant 102 is shown rotated so that the viewpoint extends into the page in the posterior direction and out of the page in the anterior direction. Here, an example embodiment of the implant 102 is shown positioned within the prostatic urethra 1306. When viewed from this perspective, the implant 102 is positioned approximately in the center of the prostatic urethra 1306, in other words, approximately equidistant from the upper and lower edges of the prostate 1302. The placement of the implant 102 is generally determined by a medical professional and can be offset upward or downward from the position shown here, however, a position within the prostatic urethra 1306 is generally preferred.

[0119] Figure 14B From Figure 13 The same perspective depicts the area of ​​the prostate 1302, but with greater detail. Here, the prostate 1302 is magnified, with the median lobe 1402 protruding into the prostatic urethra 1306. Figure 14C It is along Figure 14B 14C and illustrates the slit-like nature of the prostatic urethra 1306 in this magnified prostate 1302, with the width of the urethra 1306 widening as it progresses from the anterior to the posterior side.

[0120] Figure 14D Depicts relative to Figure 14B An example embodiment of a posteriorly placed implant 102 within the described example anatomical structure, and Figure 14E It is along Figure 14D 14E-14E. As can be seen here, the implant 102 is positioned generally along the most posterior surface of the prostatic urethra 1306. The implant 102 is sized to have a maximum diameter that is less than the width of the prostatic urethra 1306 at its maximum center width (e.g., less than 50% of the width, less than 65% of the width, less than 80% of the width, etc.) such that the implant 102 can be described as being positioned substantially on the most posterior side of the prostatic urethra 1306 and not in contact with the most anterior side of the urethra 1306. The implications of this placement are discussed in detail below. Figure 14E, where the opening through the prostate 1302 created by the implant 102 is primarily located on the posterior side of the prostate 1302 and urethra 1306.

[0121] Figure 14F Describes about Figure 14B An example embodiment of an anteriorly placed implant 102 within the described example anatomical structure, and Figure 14G It is along Figure 14E 14G-14G. As can be seen here, the implant 102 is positioned generally along the anterior-most surface of the prostatic urethra 1306. The implant 102 can be sized to have a maximum diameter that is less than the width of the prostatic urethra 1306 at its maximum center width (e.g., less than 50% of the width, less than 65% of the width, less than 80% of the width, etc.) such that the implant 102 can be described as residing substantially on the anterior side of the prostatic urethra 1306 and not in contact with the posterior-most side of the urethra 1306. The implications of this placement are discussed in detail below. Figure 14G 1306, wherein the opening created by the implant 102 through the prostate 1302 is primarily located on the anterior side of the prostate 1302 and urethra 1306. For both posterior and anterior placements, the implant 102 can still be placed approximately centrally relative to the prostate 1302, as shown in FIG. Figure 14A As shown. The deployment of the implant 102 in a posterior or anterior position is generally determined by a medical professional. Other variations of placement may also be used, including placement centrally located between the most posterior and medial sides of the urethra 1306, as well as variations in size such that the implant 102 has a relatively larger or smaller diameter relative to the prostate 1302 than shown here.

[0122] Without explicit reference to the accompanying drawings, the embodiments described herein are restated and expanded upon in the following paragraphs. In many exemplary embodiments, a system for delivering an implantable device is provided, wherein the system includes a delivery device comprising: an outer tubular member; an inner tubular member having a first inner lumen and a second inner lumen, the inner tubular member slidable within the outer tubular member, wherein the first inner lumen is adapted to receive an elongated gripper member configured to releasably couple with a proximal portion of the implant; and a distal control member slidable within the second inner lumen, wherein the distal control member includes a retainer configured to releasably couple with a distal portion of the implant.

[0123] In some embodiments, the implant is configured to maintain the prostatic urethra in an at least partially open state. In some embodiments, the implant has a body comprising a first annular structure and a second annular structure and an interconnect extending between the first annular structure and the second annular structure. The body of the implant can be just a wire. The implant can include a distal engagement member configured to releasably couple with a retainer and / or a proximal engagement member configured to releasably couple with an elongated gripper member. In some embodiments, the implant includes a linear distal engagement member and / or a linear proximal engagement member extending proximally from the distal-most portion of the implant. In some embodiments, the first annular structure can be the distal-most annular structure of the implant and has a relatively smaller width than the second annular structure.

[0124] In some embodiments, when retainer is releasably coupled with the distal portion of the implant, the inner tubular member can slide and rotate relative to the distal control member. The system can also include a slender member that is coupled with the retainer and has a proximal end that can be manipulated by a user to allow the distal portion of the implant to be released from the retainer. In some embodiments, the retainer is tubular and is suitable for sliding along the distal control member. The distal control member can include a recess that is suitable for receiving the distal portion of the implant, and the retainer can be moved to expose the recess when the distal portion of the implant is received in the recess. In some embodiments, the retainer includes a groove that the implant can pass through.

[0125] In some embodiments, the system includes an elongated anchoring member. The elongated anchoring member may include an anchor configured to contact the bladder wall. The anchor may be an inflatable balloon or multiple inflatable balloons. In some embodiments, the elongated anchoring member includes a wire-like member having a portion configured to automatically deflect upon deployment.

[0126] In some embodiments, the elongated gripper member comprises a recess configured to releasably couple with the proximal portion of the implant. In some embodiments, the system is configured such that the proximal portion of the implant is free to release from the recess of the elongated gripper member when the recess is not constrained by the first inner lumen.

[0127] In some embodiments, a proximal control device is included and coupled to a proximal region of the delivery device. The proximal control device can be manipulated by a user to control deployment of the implant from the delivery device. In some embodiments, the proximal control device includes a housing and is configured to distally advance the elongated gripper member relative to the housing and the inner tubular member, and / or to proximally retract and rotate the inner tubular member relative to the housing and the distal control member, and / or to proximally retract the outer tubular member relative to the housing.

[0128] In many embodiments, a system for delivering an implantable device is provided, wherein the system includes: a delivery device comprising a first elongated member having an inner lumen, an elongated gripper member slidable within the inner lumen and configured to retain a proximal portion of the implant, and a distal control member configured to retain a distal portion of the implant; and a proximal control device coupled to a proximal region of the delivery device, the proximal control device comprising a user actuator and a housing.

[0129] In many embodiments, a method of delivering an implant is provided, the method comprising: advancing a delivery device within a body cavity of a patient, wherein the delivery device comprises: a first tubular member housing the implant, a distal control member, and an elongated gripper member that can slide within the first tubular member and releasably couple with a proximal portion of the implant, the elongated gripper member being slidable within the first tubular member and releasably coupled with the proximal portion of the implant; causing relative movement between the elongated gripper member and the first tubular member to expose at least a portion of the implant from within the first tubular member; and releasing the distal portion of the implant from the distal control member and releasing the proximal portion of the implant from the elongated gripper member.

[0130] In some embodiments, the body cavity is a human prostatic urethra. In some embodiments, upon releasing the distal portion and the proximal portion, the implant is released from the delivery device in a state adapted to maintain the prostatic urethra in an at least partially open state.

[0131] In some embodiments, the implant has a body comprising a first annular structure and a second annular structure and an interconnect extending between the first annular structure and the second annular structure, and causing the relative motion can include distally advancing the elongated gripper member. In some embodiments, the method further comprises rotating the first tubular member in a first direction relative to a distal control member during exposure of the first annular structure from the first tubular member. In some embodiments, the method further comprises rotating the first tubular member in a second direction relative to the distal control member during exposure of the second annular structure from the first tubular member, the second direction being opposite to the first direction. Rotation of the first tubular member in the first and second directions can occur when the distal control member is releasably coupled to the distal portion of the implant.

[0132] In some embodiments, the method further comprises proximally retracting the first tubular member relative to the elongated grasper member and the distal control member to expose the interconnect from the first tubular member. In some embodiments, the method further comprises rotating the first tubular member while proximally retracting the first tubular member. In these embodiments, the interconnect can be curved.

[0133] In some embodiments, a retainer couples a distal portion of the implant to a distal control member, and the method includes releasing the retainer to release the distal portion of the implant from the distal control member.

[0134] In some embodiments, the control wire is coupled to the retainer at its distal end and extends proximally within the length of the control member. The control wire exits and returns to an opening located near the distal end of the distal control member, forming a loop. The loop, located adjacent to and proximal to the retainer, prevents the retainer from moving proximally on the distal control member.

[0135] In some embodiments, the retainer is coupled to an elongated tubular member that extends proximally to a proximal control device. The proximal control device is adapted to proximally withdraw the elongated tubular member so that the retainer can be proximally withdrawn or moved, thereby releasing the distal portion of the implant from the distal control member.

[0136] In some embodiments, the method further comprises exposing a proximal portion of the implant from within the first tubular member to release the proximal portion of the implant from the elongated grasper member.

[0137] In some embodiments, the method further comprises anchoring the delivery device against the bladder wall prior to causing relative movement between the elongated grasper member and the first tubular member. In some embodiments, anchoring the delivery device comprises inflating a balloon in the bladder.

[0138] In some embodiments, the first tubular member is an inner tubular member slidably received within an outer tubular member of the delivery device.

[0139] In many embodiments, a system for delivering an implant is described. The system includes an outer tubular member including an imaging device located in a distal region of the outer tubular member; an inner tubular member within the outer tubular member, wherein the inner tubular member includes a first elongated tubular member having a lumen adapted to receive at least a portion of an implant, a second elongated tubular member having a lumen, and at least one support member defining a plane generally perpendicular to a longitudinal axis of the inner tubular member; and one or more structures slidably advanceable within the lumen of the second elongated tubular member to deploy the implant from within the inner tubular member.

[0140] In some embodiments, the system further comprises a proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device is configured to longitudinally move the inner tubular member and the outer tubular member simultaneously.

[0141] In some embodiments, the system includes an implant, wherein the implant is configured to maintain the prostatic urethra in an at least partially open state. In some embodiments, the implant has a body comprising a first annular structure and a second annular structure and an interconnect extending between the first annular structure and the second annular structure.

[0142] In some embodiments, the one or more structures include an elongated gripper member configured to releasably couple with the proximal portion of the implant; and a distal control member configured to releasably couple with the distal portion of the implant. In some embodiments, the distal control member includes a retainer configured to releasably couple with the distal portion of the implant, wherein the implant includes a distal engagement member configured to releasably couple with the retainer. In some embodiments, the system further includes an elongated member coupled with the retainer and having a proximal end that can be manipulated by a user to allow the distal portion of the implant to be released from the retainer. In some embodiments, the retainer is tubular and adapted to slide along the distal control member.

[0143] In some embodiments, the system further comprises an elongated anchoring member. In some embodiments, the elongated anchoring member comprises an anchor configured to contact the bladder wall.

[0144] In some embodiments, the inner tubular member comprises at least two supports. In some embodiments, each of the at least two supports is separated by about 3 to about 6 inches.

[0145] In some embodiments, the at least one support is fixedly attached to the inner tubular member.

[0146] In some embodiments, the at least one support is fixedly attached to the first elongated tubular member.

[0147] In some embodiments, the second elongated tubular member is movable relative to the at least one support.

[0148] In some embodiments, the first elongated tubular member further comprises a lubricating lining.

[0149] In some embodiments, the first elongated tubular member is made of hypotube, a braided material, or a polymer extrusion.

[0150] In some embodiments, the inner tubular member is made of hypotube, braided material, or polymer extrusion.

[0151] In some embodiments, the at least one support member is a laser cut metal sheet, a molded plastic part, or an extruded material.

[0152] In many embodiments, a method for imaging delivery of an implant is described. The method includes the steps of advancing a delivery device within a patient's urethra, wherein the delivery device includes: an outer tubular member including an imaging device located in a distal region of the outer tubular member; an inner tubular member within the outer tubular member, wherein the inner tubular member includes a first elongated tubular member having a lumen adapted to accommodate at least a portion of an implant, a second elongated tubular member having a lumen, and at least one support member defining a plane generally perpendicular to a longitudinal axis of the inner tubular member; and one or more structures slidably advanceable within the lumen of the second elongated tubular member to deploy the implant from within the inner tubular member, wherein the outer tubular member, the inner tubular member, and the one or more structures are each coupled to a proximal control device external to the patient's body; and longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member.

[0153] In some embodiments, the urethra is a prostatic urethra, and the method further comprises the steps of: while the inner tubular member is longitudinally retracted, simultaneously (a) longitudinally retracting the outer tubular member relative to the proximal control device, and (b) imaging the at least partially deployed implant using an imaging device associated with a distal region of the outer tubular member. In some embodiments, the outer tubular member is longitudinally retracted at the same speed as the inner tubular member. In some embodiments, the method further comprises the steps of: rotating the inner tubular member relative to the proximal control device to at least partially deploy the implant from the inner tubular member; and while rotating the inner tubular member, simultaneously (a) maintaining the outer tubular member in a rotationally fixed position relative to the proximal control device, and (b) imaging the at least partially deployed implant using the imaging device.

[0154] In some embodiments, the method further comprises the step of releasing the implant from the delivery device.

[0155] In some embodiments, the method further comprises the step of illuminating the implant with an illumination device at the distal region of the outer tubular member.

[0156] In some embodiments, the inner tubular member comprises at least two supports. In some embodiments, each of the at least two supports is separated by about 3 to about 6 inches.

[0157] In some embodiments, the at least one support is fixedly attached to the inner tubular member.

[0158] In some embodiments, the at least one support is fixedly attached to the first elongated tubular member.

[0159] In some embodiments, the second elongated tubular member is movable relative to the at least one support.

[0160] In some embodiments, the first elongated tubular member further comprises a lubricating lining.

[0161] In some embodiments, the first elongated tubular member is made of hypotube, a braided material, or a polymer extrusion.

[0162] In some embodiments, the inner tubular member is made of hypotube, braided material, or polymer extrusion.

[0163] In many embodiments, a system for delivering an implant is described, the system comprising a delivery device. The system may include: an outer tubular member comprising an imaging device associated with a distal region of the outer tubular member; an inner tubular member positioned within the outer tubular member, wherein the inner tubular member comprises a first elongated tubular member having a lumen adapted to receive at least a portion of an implant and a second elongated tubular member having an opening in the distal region communicating with the lumen; and one or more structures slidably advanceable within the lumen of the second elongated tubular member to cause deployment of the implant, the one or more structures comprising a retainer configured to releasably couple with the distal portion of the implant, wherein the retainer is coupled to an elongated member extending proximally within the lumen of the second elongated tubular member, wherein the elongated member passes out of and back into the opening to form a loop that prevents the retainer from moving in a proximal direction.

[0164] In some embodiments, the system further comprises a proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device is configured to longitudinally move the inner tubular member and the outer tubular member simultaneously.

[0165] In some embodiments, the imaging device is located in the distal region of the outer tubular member.

[0166] In some embodiments, the one or more structures include an elongated gripper member configured to releasably couple with a proximal portion of the implant; and a distal control member configured to releasably couple with a distal portion of the implant. In some embodiments, the elongated gripper member includes a recess configured to releasably couple with the proximal portion of the implant. In some embodiments, the system is configured such that the proximal portion of the implant is free to release from the recess of the elongated gripper member when the recess is not constrained by the first inner lumen.

[0167] In certain embodiments, retainer is configured to releasably couple with the distal portion of implant, and wherein implant comprises the distal engaging member that is configured to releasably couple with retainer.In certain embodiments, elongated member has the proximal end that can be manipulated to allow the distal portion of implant to release from retainer by the user.In certain embodiments, distal control member comprises the recess that is suitable for receiving the distal portion of implant.In certain embodiments, retainer is movable to expose recess when the distal portion of implant is received in recess.In certain embodiments, retainer comprises groove.

[0168] In some embodiments, the implant includes a proximal engagement member that is configured to releasably couple with the elongated gripper member. In some embodiments, the proximal control device is configured to rotate and longitudinally move the inner tubular member relative to the distal control member, while the distal control member is releasably coupled to the distal portion of the implant. In some embodiments, the proximal control device is configured to rotate the inner tubular member without rotating the outer tubular member. In some embodiments, the retainer is tubular and is adapted to slide along the distal control member.

[0169] In some embodiments, the elongated member has a proximal end that is manipulable by a user to draw the loop into the lumen of the second elongated tubular member and allow the distal portion of the implant to be released from the retainer.

[0170] In some embodiments, the elongated member is made of a material selected from the group consisting of: Nitinol, Kevlar, stainless steel, suture, and liquid crystal polymer.

[0171] In some embodiments, the elongated member is made of a stretchable material.

[0172] In many embodiments, a method of imaging the delivery of an implant is described. The method includes the steps of advancing a delivery device within the urethra of a patient, wherein the delivery device includes an outer tubular member, an inner tubular member within the outer tubular member, and one or more structures, the outer tubular member including an imaging device associated with a distal region of the outer tubular member, wherein the inner tubular member includes a first elongated tubular member and a second elongated tubular member, the first elongated tubular member having a lumen adapted to accommodate at least a portion of the implant, the second elongated tubular member having an opening in the distal region communicating with the lumen, and the one or more structures slidably advanceable within the lumen of the second elongated tubular member to cause deployment of the implant, the one or more structures including a structure that maintains and a second elongated tubular member extending proximally within the lumen of the second elongated tubular member, wherein the elongated member extends outwardly into the lumen of the second elongated tubular member and into the opening to form a loop that prevents the retainer from moving in a proximal direction, wherein the outer tubular member, the inner tubular member, and the one or more structures are each coupled to a proximal control device outside the patient's body; longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; and releasing the implant from the delivery device by pulling the elongated member in a proximal direction, wherein the loop is withdrawn into the lumen of the second elongated tubular member and the retainer moves in a proximal direction.

[0173] In some embodiments, the urethra is a prostatic urethra, and the method further comprises the steps of: while the inner tubular member is longitudinally retracted, simultaneously (a) longitudinally retracting the outer tubular member relative to the proximal control device, and (b) imaging the at least partially deployed implant using an imaging device associated with a distal region of the outer tubular member. In some embodiments, the outer tubular member is longitudinally retracted at the same speed as the inner tubular member. In some embodiments, the method further comprises the steps of: rotating the inner tubular member relative to the proximal control device to at least partially deploy the implant from the inner tubular member; and while rotating the inner tubular member, simultaneously (a) maintaining the outer tubular member in a rotationally fixed position relative to the proximal control device, and (b) imaging the at least partially deployed implant using the imaging device.

[0174] In some embodiments, the imaging device is located in the distal region of the outer tubular member.

[0175] In some embodiments, the method further comprises the step of illuminating the implant with an illumination device at the distal region of the outer tubular member.

[0176] In some embodiments, the retainer is tubular and adapted to slide along the second elongated tubular member.

[0177] In some embodiments, the second elongated tubular member includes a recess adapted to receive a distal portion of the implant.

[0178] In some embodiments, the retainer is movable to expose the recess when the distal portion of the implant is received within the recess.

[0179] In some embodiments, the retainer includes a slot.

[0180] In many embodiments, a system for delivering an implant is described. The system includes an outer tubular member comprising first and second lumens and a distal end; an imaging module mounted to at least one elongated member extending through the second lumen, wherein the imaging module is configured to be positioned distally of the distal end of the outer tubular member when the at least one elongated member is advanced distally; and an inner tubular member positioned within the first lumen of the outer tubular member, wherein the inner tubular member is adapted to receive at least a portion of the implant.

[0181] In some embodiments, the system further comprises: one or more structures slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member; and a proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device is configured to simultaneously longitudinally move the inner tubular member and the outer tubular member. In some embodiments, the one or more structures comprise an elongated gripper member configured to releasably couple with a proximal portion of the implant; and a distal control member configured to releasably couple with a distal portion of the implant. In some embodiments, the distal control member comprises a retainer configured to releasably couple with the distal portion of the implant, wherein the implant comprises a distal engagement member configured to releasably couple with the retainer. In some embodiments, the implant comprises a proximal engagement member configured to releasably couple with the elongated gripper member.

[0182] In some embodiments, the implant is configured to maintain the prostatic urethra in an at least partially patent state.In some embodiments, the implant has a body comprising a first annular structure and a second annular structure and an interconnect extending between the first annular structure and the second annular structure.

[0183] In some embodiments, the distal region of the outer tubular member further comprises an illumination device.

[0184] In some embodiments, the imaging module includes a camera and a light source. In some embodiments, the light source is at least one LED.

[0185] In some embodiments, the imaging module is mounted to at least two elongated members.

[0186] In some embodiments, the imaging module is mounted to at least three elongated members.

[0187] In some embodiments, the imaging module is configured to be positioned between about 0 cm and about 5 cm distal to the distal end of the outer tubular member.

[0188] In many embodiments, a method of imaging delivery of an implant is described. The method includes the steps of advancing a delivery device within a patient's urethra, wherein the delivery device includes an outer tubular member comprising first and second lumens and a distal end, an imaging module mounted to at least one elongated member extending through the second lumen, an inner tubular member extending through the first lumen and housing at least a portion of the implant, and one or more structures slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member, wherein the outer tubular member, the inner tubular member, and the one or more structures are each coupled to a proximal control device external to the patient's body; longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; extending the imaging module distally beyond the distal end of the outer tubular member; and imaging the at least partially deployed implant.

[0189] In some embodiments, the urethra is a prostatic urethra.

[0190] In some embodiments, the method further comprises the step of releasing the implant from the delivery device.

[0191] In some embodiments, the outer tubular member is longitudinally retracted at the same speed as the inner tubular member.

[0192] In some embodiments, the method further comprises the steps of rotating the inner tubular member relative to the proximal control device to at least partially deploy the implant from the inner tubular member; and while rotating the inner tubular member, simultaneously (a) maintaining the outer tubular member in a rotationally fixed position relative to the proximal control device, and (b) imaging the at least partially deployed implant with an imaging device.

[0193] In some embodiments, the implant has a body including a first annular structure and a second annular structure and an interconnect extending between the first annular structure and the second annular structure, wherein the second annular structure is proximal to the first annular structure.

[0194] In some embodiments, the imaging module can visualize placement of the second annular structure after extending distally of the distal end of the outer tubular member. In some embodiments, the method further comprises the step of releasing the implant from the delivery device after imaging.

[0195] In some embodiments, the imaging module extends distally from about 0 cm to about 5 cm toward the distal end of the outer tubular member.

[0196] In many embodiments, a system for delivering an implant is described. The system includes an outer tubular member; an inner tubular member positioned within the outer tubular member, wherein the inner tubular member is adapted to receive at least a portion of an implant; one or more structures slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member; a proximal control device including a rotation adapter, the proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism; and an imaging device coupled to the rotation adapter, wherein the proximal control device is configured to simultaneously longitudinally move the inner tubular member and the outer tubular member.

[0197] In some embodiments, the system further comprises an implant. In some embodiments, the implant has a body comprising a first annular structure and a second annular structure and an interconnect extending between the first annular structure and the second annular structure. In some embodiments, the one or more structures comprise: an elongated gripper member configured to releasably couple with a proximal portion of the implant; and a distal control member configured to releasably couple with a distal portion of the implant. In some embodiments, the distal control member comprises a retainer configured to releasably couple with the distal portion of the implant, wherein the implant comprises a distal engagement member configured to releasably couple with the retainer. In some embodiments, the implant comprises a proximal engagement member configured to releasably couple with the elongated gripper member. In some embodiments, the proximal control device is configured to rotationally and longitudinally move the inner tubular member relative to the distal control member while the distal control member is releasably coupled to the distal portion of the implant. In some embodiments, the proximal control device is configured to rotate the inner tubular member without rotating the outer tubular member. In some embodiments, the system further comprises a slender member coupled to a retainer, the slender member having a proximal end that can be manipulated by a user to allow the distal portion of the implant to be released from the retainer. In some embodiments, the retainer is tubular and is adapted to slide along a distal control member. In some embodiments, the distal control member comprises a recess adapted to receive the distal portion of the implant. In some embodiments, the retainer is movable to expose the recess when the distal portion of the implant is received in the recess.

[0198] In some embodiments, the distal region of the outer tubular member further comprises an illumination device.

[0199] In some embodiments, the distal region of the inner tubular member is distal to the distal end region of the outer tubular member by a separation distance, and wherein the proximal control device is configured to simultaneously longitudinally move the outer and inner tubular members without changing the separation distance.

[0200] In some embodiments, the proximal end of the inner tubular member is coupled to a rotation adapter.

[0201] In some embodiments, the rotation adapter includes a distal member, a sliding member, a spring, and a proximal member, wherein the imaging device is coupled to the sliding member. In some embodiments, the sliding member includes an annular groove, and wherein the imaging device is coupled to the annular groove. In some embodiments, the spring is positioned between the distal member and the sliding member. In some embodiments, the spring is positioned between the sliding member and the proximal member. In some embodiments, the sliding member includes a conductive plate or ring.

[0202] In some embodiments, the rotary adapter is electrically conductive.

[0203] In some embodiments, the rotary adapter further comprises a conductive electrical plate or ring.

[0204] In some embodiments, the rotation adapter is electrically connected to the light source.In some embodiments, the light source is mounted on the distal end of the inner tubular member or on the distal end of one or more structures that are slidably advanceable within the inner tubular member.

[0205] In some embodiments, the rotation adapter is electrically connected to the imaging device.

[0206] In some embodiments, the imaging device is longitudinally advanceable relative to the distal end of the inner tubular member.

[0207] In some embodiments, the imaging device is longitudinally retractable relative to the distal end of the inner tubular member.

[0208] In many embodiments, a method of imaging the delivery of an implant is described. The method includes the steps of advancing a delivery device within a patient's urethra, wherein the delivery device includes an outer tubular member, an inner tubular member positioned within the outer tubular member and housing at least a portion of an implant, one or more structures slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member, and an imaging device, wherein the outer tubular member, the inner tubular member, the one or more structures, and the imaging device are each coupled to a proximal control device external to the patient's body, and wherein the proximal control device includes a rotation adapter coupled to the imaging device; longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; longitudinally moving the imaging device relative to a distal end of the inner tubular member; and imaging the at least partially deployed implant with the imaging device.

[0209] In some embodiments, the urethra is a prostatic urethra.

[0210] In some embodiments, the method further comprises the step of releasing the implant from the delivery device.

[0211] In some embodiments, the outer tubular member is longitudinally retracted at the same speed as the inner tubular member.

[0212] In some embodiments, the method further comprises the steps of rotating the inner tubular member relative to the proximal control device to at least partially deploy the implant from the inner tubular member; and while rotating the inner tubular member, simultaneously (a) maintaining the outer tubular member in a rotationally fixed position relative to the proximal control device, and (b) imaging the at least partially deployed implant with an imaging device.

[0213] In some embodiments, the method further comprises the step of illuminating the implant with an illumination device at the distal region of the outer tubular member.

[0214] In some embodiments, the implant has a body comprising a first annular structure and a second annular structure and an interconnect extending between the first annular structure and the second annular structure, wherein the second annular structure is proximal to the first annular structure. In some embodiments, an imaging device can visualize the placement of the second annular structure after partial deployment. In some embodiments, after the implant is partially deployed, the imaging device is withdrawn proximally relative to the second annular structure. In some embodiments, after the implant is partially deployed, the imaging device is advanced distally relative to the second annular structure. In some embodiments, the imaging device is advanced longitudinally relative to the distal end of the inner tubular member. In some embodiments, the imaging device is retracted longitudinally relative to the distal end of the inner tubular member.

[0215] In some embodiments, the method further comprises the step of releasing the implant from the delivery device after imaging.

[0216] In many embodiments, a system for delivering an implant is described. The system includes an outer tubular member; an inner tubular member positioned within the outer tubular member, wherein the inner tubular member is adapted to receive at least a portion of an implant; one or more structures slidably advanceable within a lumen of the inner tubular member to deploy the implant from within the inner tubular member; and a proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device includes a pull wire and an actuator, the actuator including a rotatable wheel, an extension, a latch, and a crosspiece, wherein the pull wire extends through at least a portion of the outer tubular member, wherein the rotatable wheel is adapted to wind and unwind the pull wire and is positioned within a housing, wherein the extension has a first side and a second side and extends from the housing, wherein the latch is housed within the extension and is slidable from the first side to the second side of the extension, and wherein the crosspiece is disposed on the housing and is adapted to frictionally engage the latch.

[0217] In some embodiments, winding the pull wire around the rotatable wheel causes deflection of the outer tubular member.

[0218] In some embodiments, unwinding the pull wire from the rotatable wheel results in straightening of the outer tubular member.

[0219] In some embodiments, the extension is movable from a first position to a second position by rotating at least a portion of the housing. In some embodiments, when the extension is in the first position, the rotatable wheel is capable of winding or unwinding the pull wire. In some embodiments, in the first position, the extension is angled away from the distal end of the outer tubular member. In some embodiments, when the extension is in the second position, the rotatable wheel is unable to wind or unwind the pull wire. In some embodiments, when the extension is in the second position, the latch is frictionally engaged by the crosspiece. In some embodiments, in the second position, the extension is angled toward the distal end of the outer tubular member.

[0220] In some embodiments, the extension further comprises a paddle terminating in a pawl. In some embodiments, the latch is slidable along the paddle.

[0221] In some embodiments, the crosspiece is located on the right hand side of the housing.

[0222] In some embodiments, the extension is attached to the left hand side of the housing.

[0223] In some embodiments, the pull wire extends through the lumen of the outer tubular member.

[0224] In some embodiments, the pull wires are coupled to or embedded in the sidewall of the outer tubular member.

[0225] In some embodiments, the distal end of the pull wire is secured to the outer tubular member in a distal region of the outer tubular member.

[0226] In various embodiments, a method of delivering an implant is described. The method includes the following steps: (a) advancing a delivery device within a patient's urethra, wherein the delivery device includes: an outer tubular member, an inner tubular member within the outer tubular member, one or more structures, and a proximal control device, wherein the inner tubular member is adapted to receive at least a portion of the implant, the one or more structures being slidably advanceable within the lumen of the inner tubular member to deploy the implant from within the inner tubular member, the proximal control device being coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device includes a pull wire and an actuator, the actuator including a rotatable wheel, an extension, a latch, and a crosspiece, wherein the pull wire extends through at least a portion of the outer tubular member, wherein the rotatable wheel is adapted to wind and unwind the pull wire and is located within a housing, wherein , the extension having first and second sides and extending from the housing, and wherein the latch is housed within the extension and is slidable from the first side to the second side of the extension, and wherein the crosspiece is disposed on the housing and is adapted to frictionally engage the latch; (b) longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; and (c) releasing the implant from the delivery device, wherein, during at least one of steps (a), (b), or (c) or between steps (a) and (b) or (b) and (c), the outer tubular member is deflected by winding a pull wire around a rotatable wheel, and wherein, after the outer tubular member is deflected, the outer tubular member is locked in the deflected position by frictionally engaging the latch with the crosspiece.

[0227] In some embodiments, during the advancing step (a), the outer tubular member is deflected and locked in the deflected position.

[0228] In some embodiments, between steps (a) and (b), the outer tubular member is deflected and locked in the deflected position.

[0229] In some embodiments, during the retracting step (b), the outer tubular member is deflected and locked in the deflected position.

[0230] In some embodiments, between steps (b) and (c), the outer tubular member is deflected and locked in the deflected position.

[0231] In some embodiments, during the releasing step (c), the outer tubular member is deflected and locked in the deflected position.

[0232] In some embodiments, the extension is movable from a first position to a second position by rotating at least a portion of the housing. In some embodiments, when the extension is in the first position, the rotatable wheel is unlocked and the pull wire can be wound or unwound. In some embodiments, when the extension is in the second position, the rotatable wheel is locked and the pull wire cannot be wound or unwound. In some embodiments, when the extension is in the second position, the latch is frictionally engaged by the crosspiece. In some embodiments, the method further includes the step of unlocking the outer tubular member from the deflected position by disengaging the latch from the crosspiece, wherein the extension returns to the first position.

[0233] In some embodiments, the pull wire extends through the lumen of the outer tubular member.

[0234] In some embodiments, the pull wires are coupled to or embedded in the sidewall of the outer tubular member.

[0235] In some embodiments, the distal end of the pull wire is secured to the outer tubular member in a distal region of the outer tubular member.

[0236] In many embodiments, a system for delivering an implant is described. The system includes an outer tubular member including an imaging device associated with a distal region of the outer tubular member; an inner tubular member positioned within the outer tubular member, wherein the inner tubular member includes a first elongated tubular member having a lumen adapted to receive at least a portion of an implant and a second elongated tubular member having an opening in the distal region communicating with the lumen; and one or more structures slidably advanceable within the lumen of the second elongated tubular member to cause deployment of the implant, the one or more structures including a retainer configured to releasably couple to the distal portion of the implant, wherein the retainer is coupled to a third elongated tubular member extending proximally to a proximal control device.

[0237] In some embodiments, the proximal control device is adapted to proximally withdraw the third elongated tubular member.

[0238] In some embodiments, the retainer is configured to releasably couple with a distal portion of the implant, wherein the implant includes a distal engagement member configured to releasably couple with the retainer.

[0239] In some embodiments, a proximal control device is coupled to the inner tubular member and the one or more structures and is releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device is configured to longitudinally move the inner and outer tubular members simultaneously.

[0240] In some embodiments, the one or more structures include an elongated grasper member configured to releasably couple with a proximal portion of the implant and a distal control member configured to releasably couple with a distal portion of the implant.

[0241] In some embodiments, the elongated member has a proximal end that is manipulable by a user to allow the distal portion of the implant to be released from the retainer.

[0242] In various embodiments, a method of delivering an implant is described. The method includes the steps of advancing a delivery device within a patient's urethra, wherein the delivery device includes: an outer tubular member including an imaging device associated with a distal region of the outer tubular member; an inner tubular member within the outer tubular member, wherein the inner tubular member includes a first elongated tubular member having a lumen adapted to accommodate at least a portion of the implant and a second elongated tubular member having an opening in the distal region communicating with the lumen; and one or more structures slidably advanceable within the lumen of the second elongated tubular member to cause deployment of the implant, the one or more structures including a retainer configured to releasably couple with the distal portion of the implant, wherein the retainer is coupled to a third elongated tubular member extending proximally to a proximal control device; longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; and releasing the implant from the delivery device by withdrawing the third elongated tubular member in a proximal direction, wherein the retainer moves in the proximal direction.

[0243] In some embodiments, the retainer is adapted to slide along the second elongated tubular member.

[0244] In some embodiments, the second elongated tubular member includes a recess adapted to receive a distal portion of the implant.

[0245] In some embodiments, the retainer is movable to expose the recess when the distal portion of the implant is received within the recess.

[0246] In many embodiments, a system for delivering an implant is described. The system includes an outer tubular member; an inner tubular member positioned within the outer tubular member, wherein the inner tubular member is adapted to receive at least a portion of an implant; one or more structures slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member; and a proximal control coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control is configured to longitudinally move the inner tubular member and the outer tubular member simultaneously, wherein the proximal control includes a movable handle portion movable relative to a proximal handle portion, and wherein the movable handle portion includes a recess configured to receive a detent coupled to an inner surface of the proximal handle portion.

[0247] In some embodiments, the detent is located on an inner surface of the distal section of the proximal handle portion.

[0248] In some embodiments, the pawl is deflectable.

[0249] In some embodiments, the proximal handle portion further comprises a bracket having a first end and a second end, wherein the first end of the bracket is attached to an inner surface of the proximal handle portion, and wherein the bracket terminates in a detent at the second end.

[0250] In some embodiments, the proximal handle portion is rotatable about the movable handle portion.

[0251] In some embodiments, rotation of the proximal handle may move the pawl out of the recess.

[0252] In some embodiments, the system further comprises an implant.

[0253] In many embodiments, a method of delivering an implant is described. The method includes the steps of advancing a delivery device within a patient's urethra, wherein the delivery device includes an outer tubular member, an inner tubular member within the outer tubular member, one or more structures, and a proximal control device, wherein the inner tubular member is adapted to receive at least a portion of an implant, the one or more structures being slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member, the proximal control device being coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device is configured to longitudinally move the inner tubular member and the outer tubular member simultaneously, wherein a mechanism in the proximal control device prevents rotation of the outer tubular member relative to the inner tubular member, longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member, and releasing the implant from the delivery device.

[0254] In some embodiments, the proximal control device includes a movable handle portion movable relative to the proximal handle portion, and wherein the mechanism includes a groove on the movable handle portion, the groove being configured to receive a pawl coupled to the inner surface of the proximal handle portion. In some embodiments, the pawl is deflectable. In some embodiments, the pawl is located on the inner surface of the distal section of the proximal handle portion. In some embodiments, the proximal handle portion further includes a bracket having a first end and a second end, wherein the first end of the bracket is attached to the inner surface of the proximal handle portion, and wherein the bracket terminates in the pawl at the second end. In some embodiments, the proximal handle portion is rotatable about the movable handle portion. In some embodiments, rotation of the proximal handle can dislodge the pawl from the groove. In some embodiments, the method further includes the step of releasing the mechanism to allow the outer tubular member to rotate relative to the inner tubular member. In some embodiments, the releasing mechanism includes removing the pawl from the groove. In some embodiments, the pawl is removed from the groove by rotating the proximal handle portion about the movable handle portion.

[0255] In many embodiments, a system for delivering an implant is provided, wherein the system includes a delivery device comprising: an outer tubular member comprising an imaging device located in a distal region of the outer tubular member; an inner tubular member located within the outer tubular member, wherein the inner tubular member is adapted to accommodate at least a portion of an implant; one or more structures that are slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member; and a proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device is configured to simultaneously move the inner tubular member and the outer tubular member longitudinally.

[0256] In certain embodiments, the inner tubular member comprises a first elongated tubular member with a lumen suitable for accommodating at least a portion of the implant, a second elongated tubular member with a lumen, and at least one support member, which defines a plane roughly perpendicular to the longitudinal axis of the inner tubular member. The inner tubular member can comprise two, alternatively three, alternatively four, alternatively five, alternatively six, alternatively seven, alternatively eight or more support members. The support member can be fixedly attached to the inner tubular member. The support member can also be fixedly attached to the first elongated tubular member. The second elongated tubular member can move relative to the support member. The support member can be separated by approximately 3 to approximately 6 inches.

[0257] In some embodiments, the system further comprises an implant. The implant can be configured to maintain the prostatic urethra in an at least partially open state. In some embodiments, the implant has a body comprising a first annular structure, a second annular structure, and an interconnect extending between the first annular structure and the second annular structure.

[0258] In some embodiments, the one or more structures include: an elongated gripper member configured to releasably couple with a proximal portion of the implant; and a distal control member configured to releasably couple with a distal portion of the implant. In some embodiments, the distal control member includes a retainer configured to releasably couple with the distal portion of the implant, wherein the implant includes a distal engagement member configured to releasably couple with the retainer. In some embodiments, the implant includes a proximal engagement member configured to releasably couple with the elongated gripper member. In some embodiments, the implant includes a linear distal engagement member extending proximally from the distal-most portion of the implant. In some embodiments, the implant includes a linear proximal engagement member.

[0259] In some embodiments, the proximal control device is configured to rotate and longitudinally move the inner tubular member relative to the distal control member while the distal control member is releasably coupled to the distal portion of the implant. In some embodiments, the proximal control device is configured to rotate the inner tubular member without rotating the outer tubular member.

[0260] In some embodiments, the system may include an anti-rotation mechanism that prevents rotation of the outer tubular member. The system may include a delivery device comprising an outer tubular member; an inner tubular member positioned within the outer tubular member, wherein the inner tubular member is adapted to receive at least a portion of an implant; one or more structures slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member; and a proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device is configured to simultaneously longitudinally move the inner tubular member and the outer tubular member, wherein the proximal control device includes a movable handle portion movable relative to a proximal handle portion, and wherein the movable handle portion includes a recess configured to receive a detent coupled to an inner surface of the proximal handle portion. The proximal handle portion may further include a bracket having a first end and a second end, wherein the first end of the bracket is attached to the inner surface of the proximal handle portion, and wherein the bracket terminates in a detent at the second end. The detent is deflectable. The proximal handle portion is rotatable about the movable handle portion, and additional rotational force applied to the proximal handle portion or the movable handle portion may move the pawl out of the recess.

[0261] In some embodiments, the method includes advancing a delivery device within a patient's urethra, wherein the delivery device comprises: an outer tubular member; an inner tubular member positioned within the outer tubular member, wherein the inner tubular member is adapted to receive at least a portion of an implant; one or more structures slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member; and a proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device is configured to simultaneously longitudinally move the inner tubular member and the outer tubular member, wherein a mechanism in the proximal control device prevents rotation of the outer tubular member relative to the inner tubular member; longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; and releasing the implant from the delivery device. The proximal control device comprises a movable handle portion movable relative to a proximal handle portion, and wherein the mechanism comprises a recess on the movable handle portion configured to receive a detent coupled to an inner surface of the proximal handle portion. The proximal handle portion may further comprise a bracket having a first end and a second end, wherein the first end of the bracket is attached to an inner surface of the proximal handle portion, and wherein the bracket terminates in a pawl at the second end. The pawl is deflectable. The proximal handle portion is rotatable about the movable handle portion, and rotation of the proximal handle may dislodge the pawl from the recess. The method may further comprise the step of releasing the mechanism to allow the outer tubular member to rotate relative to the inner tubular member. Releasing the mechanism comprises removing the pawl from the recess by rotating the other of the movable handle portion and the proximal handle portion about the proximal handle portion or the movable handle portion.

[0262] In some embodiments, the system further comprises a steering lock. The system comprises a delivery device comprising an outer tubular member; an inner tubular member positioned within the outer tubular member, wherein the inner tubular member is adapted to receive at least a portion of an implant; one or more structures slidably advanceable within a lumen of the inner tubular member to deploy the implant from within the inner tubular member; and a proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device comprises a pull wire and an actuator, the actuator comprising a rotatable wheel, an extension, a latch, and a crosspiece, wherein the pull wire extends through at least a portion of the outer tubular member, wherein the rotatable wheel is adapted to wind and unwind the pull wire and is positioned within a housing, wherein the extension has a first side and a second side and extends from the housing, wherein the latch is housed within the extension and is slidable from the first side to the second side of the extension, and wherein the crosspiece is disposed on the housing and is adapted to frictionally engage the latch. Winding of the pull wire around the rotatable wheel causes deflection of the outer tubular member, and unwinding of the pull wire from the rotatable wheel causes straightening of the outer tubular member. The extension is movable from a first position to a second position by rotating at least a portion of the housing. When the extension is in the first position, the rotatable wheel is able to wind or unwind the pull wire. When the extension is in the second position, the rotatable wheel is unable to wind or unwind the pull wire. In the first position, the extension is angled away from the distal end of the outer tubular member. In the second position, the extension is angled toward the distal end of the outer tubular member, and when the extension is in the second position, the latch is frictionally engaged by the crosspiece.

[0263] In some embodiments, the method includes steering and locking the outer tubular member during delivery of the implant. The method includes the steps of: (a) advancing a delivery device within the patient's urethra, wherein the delivery device includes: an outer tubular member; an inner tubular member within the outer tubular member, wherein the inner tubular member is adapted to accommodate at least a portion of the implant; one or more structures that are slidably advanceable within the lumen of the inner tubular member to deploy the implant from within the inner tubular member; and a proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device includes a pull wire and an actuator, the actuator including a rotatable wheel, an extension, a latch, and a crosspiece, wherein the pull wire extends through at least a portion of the outer tubular member, wherein the rotatable wheel is adapted to wind and unwind the pull wire and is located within a housing, wherein the extension has The invention further comprises a method of: (a) longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; and (c) releasing the implant from the delivery device, wherein during at least one of steps (a), (b), or (c), or between steps (a) and (b), or (b) and (c), the outer tubular member is deflected by winding a pull wire around a rotatable wheel, and wherein, after deflection of the outer tubular member, the outer tubular member is locked in the deflected position by frictionally engaging the latch with the crosspiece. Winding the pull wire around the rotatable wheel causes deflection of the outer tubular member, and unwinding the pull wire from the rotatable wheel causes straightening of the outer tubular member. The extension is movable from the first position to the second position by rotating at least a portion of the housing. When the extension is in the first position, the rotatable wheel is capable of winding or unwinding the pull wire. When the extension is in the second position, the rotatable wheel is not capable of winding or unwinding the pull wire. In the first position, the extension is angled away from the distal end of the outer tubular member. In the second position, the extension is angled toward the distal end of the outer tubular member, and when the extension is in the second position, the latch is frictionally engaged by the crosspiece. The method may also include the step of unlocking the outer tubular member from the deflected position by disengaging the latch from the crosspiece, wherein the extension returns to the first position.

[0264] In some embodiments, the method includes steering and locking the outer tubular member during or after advancement of the delivery device during delivery of the implant. The method includes the steps of: (a) advancing a delivery device within the patient's urethra, wherein the delivery device includes: an outer tubular member; an inner tubular member positioned within the outer tubular member, wherein the inner tubular member is adapted to accommodate at least a portion of the implant; one or more structures slidably advanceable within the lumen of the inner tubular member to deploy the implant from within the inner tubular member; and a proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device includes a pull wire and an actuator, the actuator including a rotatable wheel, an extension, a latch, and a crosspiece, wherein the pull wire extends through at least a portion of the outer tubular member, wherein the rotatable wheel is adapted to wind and unwind the pull wire and is positioned within a housing, which wherein the extension has first and second sides and extends from the housing, and wherein the latch is housed within the extension and is slidable from the first side to the second side of the extension, and wherein the crosspiece is disposed on the housing and is adapted to frictionally engage the latch; (b) longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; and (c) releasing the implant from the delivery device, wherein during or after advancing step (a), for example, prior to retracting the inner tubular member, the outer tubular member is deflected by winding a pull wire around a rotatable wheel, and wherein after deflection of the outer tubular member, the outer tubular member is locked in the deflected position by frictionally engaging the crosspiece. Winding the pull wire around the rotatable wheel causes deflection of the outer tubular member, and unwinding the pull wire from the rotatable wheel causes straightening of the outer tubular member. The extension is movable from the first position to the second position by rotating at least a portion of the housing. When the extension is in the first position, the rotatable wheel is able to wind or unwind the pull wire. When the extension is in the second position, the rotatable wheel is unable to wind or unwind the pull wire. In the first position, the extension is angled away from the distal end of the outer tubular member. In the second position, the extension is angled toward the distal end of the outer tubular member, and when the extension is in the second position, the latch is frictionally engaged by the crosspiece. The method may also include the step of unlocking the outer tubular member from the deflected position by disengaging the latch from the crosspiece, wherein the extension returns to the first position.

[0265] In some embodiments, the method includes steering and locking the outer tubular member during delivery of the implant during or after partial deployment of the implant. The method includes the steps of: (a) advancing a delivery device within the patient's urethra, wherein the delivery device includes: an outer tubular member; an inner tubular member within the outer tubular member, wherein the inner tubular member is adapted to accommodate at least a portion of the implant; one or more structures that are slidably advanceable within the lumen of the inner tubular member to cause the implant to deploy from within the inner tubular member; and a proximal control device that is coupled to the inner tubular member and the one or more structures and is releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device includes a pull wire and an actuator, the actuator including a rotatable wheel, an extension, a latch, and a crosspiece, wherein the pull wire extends through at least a portion of the outer tubular member, wherein the rotatable wheel is adapted to wind and unwind the pull wire and is located within a housing, wherein the extension has a first The invention further comprises a method of: (a) longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; (b) longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; and (c) releasing the implant from the delivery device, wherein, during or after retracting the inner tubular member and the one or more structures, the outer tubular member is deflected by winding a pull wire around a rotatable wheel to at least partially deploy the implant in step (b), e.g., prior to releasing the implant, and wherein, after deflecting the outer tubular member, the outer tubular member is locked in the deflected position by frictionally engaging the latch with the crosspiece. Winding the pull wire around the rotatable wheel causes deflection of the outer tubular member, and unwinding the pull wire from the rotatable wheel causes straightening of the outer tubular member. The extension is movable from the first position to the second position by rotating at least a portion of the housing. When the extension is in the first position, the rotatable wheel is able to wind or unwind the pull wire. When the extension is in the second position, the rotatable wheel cannot wind or unwind the pull wire. In the first position, the extension is angled away from the distal end of the outer tubular member. In the second position, the extension is angled toward the distal end of the outer tubular member, and when the extension is in the second position, the latch is frictionally engaged by the crosspiece. The method may also include the step of unlocking the outer tubular member from the deflected position by disengaging the latch from the crosspiece, wherein the extension returns to the first position.

[0266] In some embodiments, the method includes steering and locking the outer tubular member during release of the implant. The method includes the steps of: (a) advancing a delivery device within the patient's urethra, wherein the delivery device includes: an outer tubular member; an inner tubular member positioned within the outer tubular member, wherein the inner tubular member is adapted to accommodate at least a portion of the implant; one or more structures slidably advanceable within the lumen of the inner tubular member to deploy the implant from within the inner tubular member; and a proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device includes a pull wire and an actuator, the actuator including a rotatable wheel, an extension, a latch, and a crosspiece, wherein the pull wire extends through at least a portion of the outer tubular member, and wherein the rotatable wheel is adapted to wind and unwind the pull wire. and positioned within a housing, wherein the extension has first and second sides and extends from the housing, wherein the latch is housed within the extension and is slidable from the first side to the second side of the extension, and wherein the crosspiece is disposed on the housing and is adapted to frictionally engage the latch; (b) longitudinally retracting the outer tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; and (c) releasing the implant from the delivery device, wherein during the step of releasing the implant in step (c), the outer tubular member is deflected by winding a pull wire around a rotatable wheel, and wherein, after the outer tubular member is deflected, the outer tubular member is locked in the deflected position by frictionally engaging the crosspiece. Winding the pull wire around the rotatable wheel causes the outer tubular member to deflect, and unwinding the pull wire from the rotatable wheel causes the outer tubular member to straighten. The extension is movable from the first position to the second position by rotating at least a portion of the housing. When the extension is in the first position, the rotatable wheel is able to wind or unwind the pull wire. When the extension is in the second position, the rotatable wheel is unable to wind or unwind the pull wire. In the first position, the extension is angled away from the distal end of the outer tubular member. In the second position, the extension is angled toward the distal end of the outer tubular member, and when the extension is in the second position, the latch is frictionally engaged by the crosspiece. The method may also include the step of unlocking the outer tubular member from the deflected position by disengaging the latch from the crosspiece, wherein the extension returns to the first position.

[0267] In some embodiments, the system also includes a slender member coupled to a retainer, the slender member having a proximal end that can be manipulated by a user to allow the distal portion of the implant to be released from the retainer. In some embodiments, the retainer is tubular and is adapted to slide along the distal control member. In some embodiments, the distal control member includes a recess adapted to receive the distal portion of the implant. In some embodiments, the retainer is movable to expose the recess when the distal portion of the implant is received in the recess. In some embodiments, the retainer includes a groove.

[0268] In some embodiments, the system further comprises an elongated anchoring member. In some embodiments, the elongated anchoring member comprises an anchor configured to contact the bladder wall. In some embodiments, the anchor is an expandable balloon. In some embodiments, the elongated anchoring member comprises a plurality of balloons. In some embodiments, the elongated anchoring member comprises a linear member having a portion configured to automatically deflect upon deployment. The expanded diameter of the anchor balloon can be between approximately 1 cm and 7 cm, or between approximately 2 cm and 6 cm, alternatively between approximately 1 cm and 6 cm.

[0269] In some embodiments, the elongated gripper member comprises a recess configured to releasably couple with the proximal portion of the implant. In some embodiments, the system is configured such that the proximal portion of the implant is free to release from the recess of the elongated gripper member when the recess is not constrained by the first inner lumen.

[0270] In some embodiments, the distal region of the outer tubular member further comprises an illumination device.

[0271] In some embodiments, the second portion includes: a first flexible bus having a first end electrically connected to a printed circuit board within the second portion and a second end electrically connected to the imaging device; and a second flexible bus having a first end electrically connected to the printed circuit board within the second portion and a second end electrically connected to the lighting device.

[0272] In some embodiments, an imaging module is mounted to at least one elongated member that extends through the lumen of the outer tubular member. The imaging module is configured to be positioned distally of the distal end of the outer tubular member when the at least one elongated member is advanced distally. The imaging module can include a camera and a light source. The imaging module can be mounted to at least one, two, three, or more elongated members. The imaging module can be configured to be positioned between approximately 0 cm and approximately 5 cm distal to the distal end of the outer tubular member.

[0273] In some embodiments, the proximal control device includes a rotational adapter coupled to the imaging device. The proximal control device is coupled to the inner tubular member and the one or more structures and is releasably coupled to the outer tubular member via a coupling mechanism. The rotational adapter may include a distal component, a sliding component, a spring, and a proximal component. The imaging device may be coupled to the sliding component of the rotational adapter. The spring may be positioned between the distal component and the sliding component, thereby enabling the imaging device to be propelled in a distal direction when the spring is compressed. Alternatively, the spring may be positioned between the sliding component and the proximal component, thereby enabling the imaging device to be propelled in a proximal direction when the spring is compressed.

[0274] In some embodiments, the rotary adapter can also be electrically conductive. The rotary adapter can include an electrically conductive plate or ring. In some embodiments, the sliding member can include an electrically conductive plate or ring. The rotary adapter can also be connected to a light source or imaging device.

[0275] In some embodiments, the distal region of the inner tubular member is distal to the distal region of the outer tubular member by a separation distance, and wherein the proximal control device is configured to simultaneously longitudinally move the outer and inner tubular members without changing the separation distance.

[0276] In certain embodiments, the size of the implant is adapted to fit completely within the prostatic urethra. In certain embodiments, the delivery system can be used to deliver the implant to a forward position within the prostatic urethra. In certain embodiments, the delivery system can be used to deliver the implant to a rearward position within the prostatic urethra.

[0277] In many embodiments, a method of imaging delivery of an implant is provided, the method comprising: advancing a delivery device within a patient's urethra, wherein the delivery device comprises: an outer tubular member, an inner tubular member within the outer tubular member and housing at least a portion of an implant, and one or more structures slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member, the outer tubular member including an imaging device located in a distal region of the outer tubular member, wherein the outer tubular member, the inner tubular member, and the one or more structures are each coupled to a proximal control device outside the patient's body; longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; and as the inner tubular member is longitudinally retracted, simultaneously (a) longitudinally retracting the outer tubular member relative to the proximal control device, and (b) imaging the at least partially deployed implant with the imaging device located at the distal region of the outer tubular member. In some embodiments, the urethra is a prostatic urethra.

[0278] In some embodiments, a method for imaging delivery of an implant is provided, the method comprising: advancing a delivery device within a patient's urethra, wherein the delivery device comprises: an outer tubular member comprising an imaging device associated with a distal region of the outer tubular member; an inner tubular member within the outer tubular member, the inner tubular member comprising a first elongated tubular member having a lumen suitable for accommodating at least a portion of the implant, a second elongated tubular member having a lumen, and at least one support member defining a plane substantially perpendicular to a longitudinal axis of the inner tubular member; and one or more structures slidably advanceable within the lumen of the second elongated tubular member to deploy the implant from within the inner tubular member, wherein the outer tubular member, the inner tubular member, and the one or more structures are each coupled to a proximal control device external to the patient's body; and longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member. The method may further include the steps of: (a) longitudinally retracting the outer tubular member relative to the proximal control device, and (b) imaging the at least partially deployed implant with an imaging device while the inner tubular member is longitudinally retracted.

[0279] In some embodiments, a method of imaging delivery of an implant is provided, the method comprising: advancing a delivery device within the urethra of a patient, wherein the delivery device comprises an outer tubular member comprising a first and second lumen and a distal end, an imaging module mounted to at least one elongated member extending through the second lumen, an inner tubular member within the first lumen and housing at least a portion of the implant, and one or more structures slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member, wherein the outer tubular member, the inner tubular member, and the one or more structures are each coupled to a proximal control device external to the patient's body; longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; extending the imaging module distally beyond the distal end of the outer tubular member; and imaging the at least partially deployed implant.

[0280] In some embodiments, a method of imaging delivery of an implant is provided, the method comprising: advancing a delivery device within the urethra of a patient, wherein the delivery device comprises: an outer tubular member, the outer tubular member comprising an imaging device associated with a distal region of the outer tubular member; an inner tubular member within the outer tubular member, wherein the inner tubular member comprises a first elongated tubular member and a second elongated tubular member, the first elongated tubular member having a lumen adapted to accommodate at least a portion of the implant, the second elongated tubular member comprising an opening in the distal region communicating with the lumen; and one or more structures slidably advanceable within the lumen of the second elongated tubular member to deploy the implant, the one or more structures comprising The method further comprises: a method comprising: releasably coupling a retainer to a distal portion of an implant, wherein the retainer is coupled to an elongated member extending proximally within a lumen of a second elongated tubular member, wherein the elongated member passes out of and back into an opening to form a loop that prevents the retainer from moving in a proximal direction, wherein the outer tubular member, the inner tubular member, and the one or more structures are each coupled to a proximal control device outside the patient's body; longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; and releasing the implant from a delivery device by pulling the elongated member in a proximal direction, wherein the loop is withdrawn into the lumen of the second elongated tubular member and the retainer moves in a proximal direction. The method may further comprise the steps of simultaneously (a) longitudinally retracting the outer tubular member relative to the proximal control device, and (b) imaging the at least partially deployed implant with an imaging device associated with a distal region of the outer tubular member as the inner tubular member is longitudinally retracted.

[0281] In some embodiments, a method for imaging delivery of an implant is provided, the method comprising: advancing a delivery device within a patient's urethra, wherein the delivery device comprises an outer tubular member, an inner tubular member positioned within the outer tubular member and housing at least a portion of an implant, one or more structures slidably advanceable within the inner tubular member to deploy the implant from within the inner tubular member, and an imaging device, wherein the outer tubular member, the inner tubular member, the one or more structures, and the imaging device are each coupled to a proximal control device external to the patient's body, and wherein the proximal control device comprises a rotational adapter coupled to the imaging device; longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy the implant from the inner tubular member; longitudinally moving (e.g., retracting or advancing) the imaging device relative to a distal end of the inner tubular member; and imaging the at least partially deployed implant with the imaging device.

[0282] In some embodiments, the method further comprises releasing the implant from the delivery device. In some embodiments, the method further comprises releasing the implant from the delivery device such that the implant is completely within the prostatic urethra.

[0283] In some embodiments, the implant is released in an expanded state, wherein the diameter of the implant in the expanded state is smaller than the minimum width of the prostatic urethra from which the implant is released.

[0284] In some embodiments, the implant is released such that the implant contacts the most posterior tissue surface of the prostatic urethra. In some embodiments, the implant is released such that the implant does not contact the most anterior tissue surface of the prostatic urethra.

[0285] In some embodiments, the implant is released such that the implant contacts the most anterior tissue surface of the prostatic urethra. In some embodiments, the implant is released such that the implant does not contact the most posterior tissue surface of the prostatic urethra.

[0286] In some embodiments, a method of imaging delivery of an implant is provided, the method comprising: advancing a delivery device within a patient's urethra, wherein the delivery device comprises: an outer tubular member comprising an imaging device located in a distal region of the outer tubular member; an inner tubular member within the outer tubular member, wherein the inner tubular member comprises a first elongated tubular member and a second elongated tubular member, the first elongated tubular member having a lumen adapted to accommodate at least a portion of the implant, the second elongated tubular member having an opening in the distal region communicating with the lumen; and one or more structures slidably advanceable within the lumen of the second elongated tubular member to deploy the implant, the one or more structures comprising a retainer configured to releasably couple to the distal portion of the implant, wherein the retainer is coupled to an elongated member extending within a lumen of a second elongated tubular member, wherein the elongated member passes out and back into the opening to form a loop that prevents the retainer from moving in a proximal direction, wherein the outer tubular member, the inner tubular member, and the one or more structures are each coupled to a proximal control device outside the patient's body; longitudinally retracting the inner tubular member relative to the proximal control device and the one or more structures to at least partially deploy an implant from the inner tubular member; while the inner tubular member is longitudinally retracted, simultaneously (a) longitudinally retracting the outer tubular member relative to the proximal control device, and (b) imaging the at least partially deployed implant with an imaging device located at a distal region of the outer tubular member; and releasing the implant from the delivery device by pulling the elongated member in a proximal direction, wherein the loop is withdrawn into the lumen of the second elongated tubular member and the retainer is moved in a proximal direction.

[0287] In some embodiments, the outer tubular member is longitudinally retracted at the same speed as the inner tubular member.

[0288] In some embodiments, the method further comprises rotating the inner tubular member relative to the proximal control device to at least partially deploy the implant from the inner tubular member, and while rotating the inner tubular member, simultaneously (a) maintaining the outer tubular member in a rotationally fixed position relative to the proximal control device, and (b) imaging the at least partially deployed implant with an imaging device.

[0289] In some embodiments, the method further comprises the steps of inserting the inner tubular member into the outer tubular member prior to advancing the delivery device into the patient's urethra, wherein the inner tubular member is coupled to the first portion of the proximal control device and the outer tubular member is coupled to the second portion of the proximal control device; and coupling the first portion of the proximal control device to the second portion of the proximal control device. In some embodiments, coupling the first portion of the proximal control device to the second portion of the proximal control device comprises coupling a deflectable member of the second portion to a recess of the first portion.

[0290] In some embodiments, the method further comprises illuminating the implant with an illumination device at the distal region of the outer tubular member.

[0291] In many embodiments, a method of user assembling a proximal control device is provided, the method comprising: inserting an inner tubular member into an outer tubular member, wherein the inner tubular member is coupled to a first portion of the proximal control device and the outer tubular member is coupled to a second portion of the proximal control device; and coupling the first portion of the proximal control device to the second portion of the proximal control device with a coupling mechanism, wherein the inner tubular member is longitudinally and rotationally movable relative to the first portion of the proximal control device, wherein the first portion is coupled to the second portion such that longitudinal movement of the inner tubular member causes longitudinal movement of the second portion and the outer tubular member, and wherein the first portion is coupled to the second portion such that rotational movement of the inner tubular member does not cause rotational movement of the second portion and the outer tubular member.

[0292] In some embodiments, the first portion can be coupled to the second portion in more than one position, and the method includes: coupling the first portion of the proximal control to the second portion of the proximal control with the coupling mechanism in a first position; decoupling the first portion of the proximal control from the second portion of the proximal control; and coupling the first portion of the proximal control to the second portion of the proximal control with the coupling mechanism in a second position.

[0293] In some embodiments, the first position corresponds to a first distance between the distal end of the inner tubular member and the distal end of the outer tubular member, and the second position corresponds to a second distance between the distal end of the inner tubular member and the distal end of the outer tubular member, wherein the first and second distances are different. In some embodiments, the second distance is greater than the first distance, and the second position corresponds to a relatively wider imaging field of view compared to the first position.

[0294] In many embodiments, a method of delivering an implant is provided, the method comprising: advancing a delivery device within the urethra of a patient; deploying the implant from the delivery device to a position completely within the prostatic urethra of the patient, wherein the implant transitions from an unexpanded state to an expanded state upon deployment; and removing the delivery device from the patient while the implant remains in the prostatic urethra in an expanded state, the expanded state maintaining a passage through the prostatic urethra, the diameter of the implant in the expanded state being less than a minimum width of the prostatic urethra adjacent the implant, wherein, after removal of the delivery device, the implant contacts a posterior-most tissue surface of the prostatic urethra.

[0295] In some embodiments, after removal of the delivery device, the implant contacts the posterior-most tissue surface of the prostatic urethra and does not contact the anterior-most tissue surface of the prostatic urethra.

[0296] In many embodiments, a method of delivering an implant is provided, the method comprising: advancing a delivery device within the urethra of a patient; deploying the implant from the delivery device to a position completely within the prostatic urethra of the patient, wherein the implant transitions from an unexpanded state to an expanded state upon deployment; and removing the delivery device from the patient while the implant remains in the prostatic urethra in the expanded state, maintaining a passage through the prostatic urethra, wherein a diameter of the implant in the expanded state is less than a minimum width of the prostatic urethra adjacent the implant, wherein, after removal of the delivery device, the implant contacts the most anterior tissue surface of the prostatic urethra.

[0297] In some embodiments, after removal of the delivery device, the implant contacts the anterior-most tissue surface of the prostatic urethra and does not contact the posterior-most tissue surface of the prostatic urethra.

[0298] All features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and interchangeable with features, elements, components, functions, and steps from any other embodiment. If a feature, element, component, function, or step is described with respect to only one embodiment, it should be understood that such feature, element, component, function, or step can be used with every other embodiment described herein unless expressly stated otherwise. Therefore, this paragraph serves at all times as a prerequisite basis and written support for introducing claims that combine features, elements, components, functions, and steps from different embodiments, or substitute features, elements, components, functions, and steps from one embodiment for features, elements, components, functions, and steps from another embodiment, even if the following description does not expressly state that such combination or substitution is possible in a particular case. It is expressly acknowledged that explicitly enumerating every possible combination and substitution would be unduly cumbersome, especially considering that the permissibility of each such combination and substitution would be readily recognized by one of ordinary skill in the art.

[0299] As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0300] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. However, it should be understood that the embodiments are not limited to the specific forms disclosed, but rather, the embodiments are intended to cover all modifications, equivalents, and alternatives falling within the spirit of the present disclosure. In addition, any features, functions, steps, or elements of the embodiments may be recited in or added to the claims, and a negative limitation of the scope of the invention of the claims may be defined by not including such features, functions, steps, or elements within the scope.

Claims

1. A system for delivering an implant, the system comprising a delivery device comprising: an outer tubular member; an inner tubular member positioned within the outer tubular member, wherein the inner tubular member is adapted to receive at least a portion of an implant; one or more structures slidably advanceable within the lumen of the inner tubular member to deploy the implant from within the inner tubular member; and A proximal control device coupled to the inner tubular member and the one or more structures and releasably coupled to the outer tubular member via a coupling mechanism, wherein the proximal control device includes a pull wire and an actuator, the actuator including a rotatable wheel, an extension, a latch, and a crosspiece, wherein the pull wire extends through at least a portion of the outer tubular member, wherein the rotatable wheel is adapted to wind and unwind the pull wire and is located within a housing, wherein the extension has a first side and a second side and extends from the housing, and wherein the latch is housed within the extension and is capable of sliding from the first side to the second side of the extension, and wherein the crosspiece is disposed on the housing and is adapted to frictionally engage the latch.

2. The system according to claim 1, wherein: The actuator includes a rotatable wheel located within the housing, the rotatable wheel being configured to rotate in a first direction to apply tension to the pull wire and to rotate in a second direction to release tension on the pull wire, the steering lock being configured to prevent the rotatable wheel from rotating when the steering lock is in a locked configuration.

3. The system according to claim 2, wherein: The steering lock includes: (1) an extension extending from the housing, (2) a latch movably coupled to the extension and configured to move between a locked position and an unlocked position, and (3) a crosspiece disposed on the housing and adapted to engage the latch when the latch is in the locked position to place the steering lock in a locked configuration and to disengage the latch when the latch is in the unlocked position to place the steering lock in an unlocked configuration.

4. The system according to claim 3, wherein: The extension is movable from a first position to a second position by rotating at least a portion of the housing to apply tension to the puller wire to deflect the outer tubular member.

5. The system according to claim 4, wherein: When the extension is in the second position and the latch is in the locked position and engaged with the crosspiece, the steering lock is in a locked configuration and the rotatable wheel is unable to unspool the cable.

6. The system according to claim 4, wherein: When the extension is in the first position, the extension is angled away from the distal end of the outer tubular member.

7. The system according to claim 4, wherein: In the second position, the extension is angled toward the distal end of the outer tubular member.

8. The system according to claim 7, wherein: The latch is frictionally engaged by the crosspiece when the extension is in the second position and the latch is in the locked position.

9. The system according to claim 1, wherein: The extension further includes a paddle and a pawl, and wherein the pawl frictionally engages the latch when the latch is on the second side of the extension.

10. The system according to claim 9, wherein: The latch is slidable along the paddle.

11. The system according to claim 1, wherein: The housing includes a first portion and a second portion rotatable relative to the first portion, wherein the crosspiece is located on the first portion and the extension extends from the second portion.

12. The system according to claim 1, wherein: The pull wire extends through the lumen of the outer tubular member.

13. The system of claim 1, wherein: The pull wire is coupled to or embedded in the sidewall of the outer tubular member.

14. The system according to claim 1, wherein: The distal end of the pull wire is secured to the outer tubular member in a distal region of the outer tubular member.

Images