Systems, devices, and methods for enabling proper deployment and imaging of implants in the prostatic urethra.

Abstract

Systems, apparatus, 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 the 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 specifically, to the delivery of kinetic devices through the male urethra in a non-invasive and minimally invasive manner. Background Technology

[0002] There are numerous clinical reasons for placing implants into the prostatic urethra, such as for the treatment of urinary retention associated with benign prostatic hyperplasia (BPH), obstruction due to prostate cancer, bladder cancer, urinary tract injury, prostatitis, bladder sphincter dyssynergia, benign or malignant urethral stricture, and other conditions for which treatment is desired. Due to the naturally complex and tortuous anatomical geometry, patient-to-patient geometric and tissue variability, and the anatomical limitations associated with those conditions, it has proven challenging to place implants precisely and consistently into the prostatic urethral lumen. Furthermore, complex challenges exist in the design and / or manufacture of systems that are sufficiently flexible 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] This document provides several example embodiments of delivery systems and related methods for delivering or deploying implants within the prostatic urethra or other parts of the body. Embodiments of the delivery system may include: a delivery device insertable into the prostatic urethra; and a proximal control device 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 components, each having multiple functions described in more detail herein. Embodiments of the delivery system have imaging capabilities. Several embodiments of implants for use with the delivery system and various implantation placements of those implants are also described.

[0004] Other systems, apparatuses, methods, features, and advantages of the subject matter described herein will be apparent to those skilled in the art upon review of the following figures and detailed description. It is intended that all such additional systems, methods, features, and advantages are included within this specification, within the scope of the subject matter described herein, and protected by the appended claims. Where those features are not expressly stated in the claims, the features of the exemplary embodiments should not be construed in any way as limiting the appended claims. Attached Figure Description

[0005] By studying the accompanying drawings, the details of the subject matter described herein (regarding both its structure and operation) become readily apparent, where similar reference numerals denote similar parts. The components in the drawings are not necessarily to scale, but rather the emphasis is on illustrating the principles of the subject matter. Furthermore, all illustrations are intended to convey the concept, where relative dimensions, shapes, and other detailed attributes are depicted schematically rather than literally or precisely.

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

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

[0008] Figure 2A-2H This is a perspective view depicting an example embodiment of a delivery system during different stages of implant deployment.

[0009] Figures 3A-3C This is a perspective view depicting an example embodiment of a gripper component used within a delivery system.

[0010] Figure 4A-4J This is a partial cross-sectional view depicting an example embodiment of an anchored delivery element of a delivery system.

[0011] Figures 5A-5B This is a side view of an example embodiment of a delivery system depicting multiple stages of implant deployment.

[0012] Figure 6A and 6B These are, respectively, an internal side view and an internal perspective view depicting an example embodiment of the proximal control device.

[0013] Figure 6C This is a perspective view depicting an exemplary embodiment of a gear used in conjunction with a delivery system.

[0014] Figure 7A This is an interior top view depicting an example embodiment of the components of the proximal control device.

[0015] Figure 7B This is a perspective view depicting an example embodiment of a cam.

[0016] Figure 8 This is an internal side view depicting an example embodiment of the gear assembly.

[0017] Figures 9A-9F This is an internal perspective view depicting an example embodiment of the components of the proximal control device.

[0018] Figure 10AThis is a flowchart depicting an example embodiment of a method for delivering an implant.

[0019] Figure 10B This is a timing diagram illustrating an example embodiment of the steps for deploying an implant.

[0020] Figure 11A-12C This is a perspective view depicting an example embodiment of components within a proximal control device.

[0021] Figure 12D-12E This is a perspective view depicting an example embodiment of the distal end region of the outer tubular member.

[0022] Figure 13 Example cross-sectional view of male anatomy.

[0023] Figure 14A This is an example cross-sectional view of a male anatomy with an implant deployed therein, representing an example embodiment.

[0024] Figure 14B It is an example cross-sectional view of male anatomy, and Figure 14C It is along Figure 14B Example cross-sectional view of male anatomy taken from line 14C-14C.

[0025] Figure 14D This is an example cross-sectional view of a male anatomy with an implant deployed therein, representing an example embodiment. Figure 14E It is along Figure 14D Example cross-sectional view of male anatomy taken from line 14E-14E.

[0026] Figure 14F This is an example cross-sectional view of a male anatomy with an implant deployed therein, representing an example embodiment. Figure 14G It is along Figure 14G Example cross-sectional view of male anatomy taken from line 14F-14F. Detailed Implementation

[0027] Before describing this subject matter in detail, it should be understood that this disclosure is not limited to the specific embodiments described, as such embodiments are of course subject to variation. 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 this disclosure will be defined only by the appended claims.

[0028] The subject matter presented herein is described in the context of delivering or deploying one or more implants within the prostatic urethra. The purpose for deploying implants(s) ...

[0029] Figure 1A This 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 end region 104 is adapted for insertion through the urethral orifice into a patient's urethra (or other cavity or body cavity). The distal end region 104 preferably has a non-invasive configuration (e.g., relatively soft and rounded) to minimize irritation or trauma to the patient. The elongated delivery device 103 carries or accommodates one or more implants 102 (not shown) to be delivered or deployed within or adjacent to the prostatic urethra. A proximal end region 105 of the delivery device 103 is coupled to the proximal control device 200, which is held outside the patient and configured for use by a physician or other medical professional to control the delivery of one or more implants 102.

[0030] Example embodiments of delivery devices and related methods.

[0031] Figure 1B , 1C 1D and 1D are respectively a side view, an end view, and a perspective view depicting an example embodiment of implant 102 in a static configuration. The implantable device 102 is biased toward the static configuration depicted herein and can be in both a static configuration and a relatively elongated receiving (or delivery) configuration for receiving the implant 102 within a delivery device 103 (e.g., see...). Figure 3AThe implant 102 deforms between the two configurations. The receiving configuration can be a straight or linear state with minimal curvature. The stationary configuration has a relatively larger lateral width and a relatively shorter longitudinal length than the receiving configuration. Upon exiting the open end of the delivery device 103, the implant 102 is free to transform its shape back to the shape of the stationary configuration, although constraints imposed by the patient's urethral wall prevent the implant 102 from fully reaching the stationary configuration. Because the implant 102 is biased toward the stationary configuration, the implant 102 is configured to expand automatically when not constrained by the delivery device 103, and may be referred to as "self-expanding". For example, the shape of the implant 102 in its expanded state within the patient's urethra may be referred to as the expanded configuration, and will generally be the shape deformed from the stationary configuration due to surrounding tissue, although the expanded configuration may be the same as the stationary configuration.

[0032] Implant 102 can be configured in a variety of different ways, including any and all of those implant configurations described in U.S. Patent Publication 20150257908 and / or International Publication WO2017 / 184887, both of which are incorporated herein by reference for all purposes.

[0033] Implant 102 may be formed from one or more separate entities (e.g., wires, strips, tubular members) with different geometries. (Reference) Figure 1B-1D In one embodiment, the implant 102 has a main body formed solely of a single linear member configured in a predetermined shape. The implant 102 may have two or more annular structures 111 (in this embodiment, four are present: 111a, 111b, 111c, and 111d), wherein one or more interconnecting portions 112 extend between each pair of adjacent annular structures 111 (in this embodiment, there is one interconnecting portion between each adjacent pair, for a total of three interconnecting portions: 112a, 112b, and 112c). Each interconnecting portion 112 extends from one annular structure 111 to the next adjacent annular structure 111. Each interconnecting portion 112 may have a relatively straight shape (not shown) or a curved shape (e.g., semicircular or semi-elliptical), as in... Figure 1B-1D As shown in the image.

[0034] The annular structure 111 is configured to maintain the urethra in a fully or partially open state when expanded from a receiving configuration. The device 100 can be manufactured in various sizes, 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 portion 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 described herein, annular structure 111a has a relatively smaller width than structures 111b-111d, which have the same width. This accommodates prostatic urethra converging into a smaller geometry before the bladder neck.

[0035] Each annular structure 111 may be located or positioned in a single plane, and in some embodiments, the single plane may be oriented with an orthogonal axis perpendicular to the central axis 124 of the implant 102 (as in...). Figure 1B (As depicted herein). In other embodiments, the annular structure 111 may be located in multiple planes. The annular structure 111 may extend about a central axis 126 to form a complete circle (e.g., rotated 360 degrees), or may form a smaller 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.

[0036] As from Figure 1B-1D As can be seen, the geometry of implant 102 may have a cylindrical or substantially cylindrical profile with a circular or elliptical cross-section. In other embodiments, implant 102 may have a prismatic or substantially prismatic shape with a triangular or substantially triangular cross-section or other shapes.

[0037] The implant 102 may also include a distal engagement member 114 and a proximal engagement member 115, each 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 the ends of the implant 102 to move relative to each other, and / or allowing retrieval of the implant 102 after deployment, for example, in cases where a physician wishes to recapture the implant 102 and re-deploy it in a different location. In this embodiment, the distal engagement member 114 is a line-like extension from the annular structure 111a having a curved (e.g., S-like) shape for positioning the atraumatic end 116 (e.g., round, spherical, ballized) in a position suitable for engagement with the delivery device 103, and thereby allowing control of the distal end region of the implant 102. Similarly, the proximal engagement member 115 has a curved shape for positioning another atraumatic end 117 in a position suitable for engagement with the delivery device 103, thereby allowing control of the proximal end region of the implant 102. In other embodiments, the distal engagement member 114 and the proximal engagement member 115 may be omitted, and the delivery device 103 may 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 interconnection 112.

[0038] The delivery device 103 may include one or more elongated flexible members (e.g., 120, 130, 140, and 150 as described below), each having one or more internal cavities. The one or more elongated flexible members of the delivery device 103 may be solid or non-hollow members without internal cavities. Figure 2A This is a perspective view depicting an exemplary embodiment of the distal end region 104 of the 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 may vary and, in other embodiments, may include more or fewer tubular members.

[0039] In this embodiment, the first elongated tubular member 120 is the outermost tubular member and is flexible, yet still provides support for the member housed therein. The first tubular member 120 is referred to herein as the outer shaft 120 and may have one or more inner cavities. In this embodiment, the outer shaft 120 includes a first inner cavity 121 accommodating a second elongated tubular member 130, referred herein as the inner shaft 130. The outer shaft 120 and the inner shaft 130 are each controllable independently of each other. The inner shaft 130 is slidable distally and proximally within the cavity 121 and is shown herein as extending partially from the open distal end of the outer shaft 120.

[0040] In this embodiment, the outer axis 120 includes three additional cavities 122, 123, and 124. An illumination device (not shown) and an imaging device (not shown) may be housed in two of cavities 122-124 (e.g., cavities 122 and 123). The imaging device may utilize any desired type of imaging, such as optical or ultrasonic imaging. In one example embodiment, the imaging device utilizes a forward (distal) observation CMOS imager. The illumination device may be configured to provide adequate 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 ultrasonic imaging, the illumination device and its corresponding cavity may be omitted. The illumination device and / or imaging device may each be fixedly fastened to the distal end of cavities 122 and 123, or each may be slidable within cavities 122 and 123 to allow further distal advancement from the outer axis 120 and / or retraction into the outer axis 120. In one exemplary embodiment, the illumination device and the imaging device are mounted together, and for this purpose only a single cavity 122 or 123 exists. Other cavities (e.g., cavity 124) may be configured as irrigation or flushing ports from which fluid (such as saline) can be introduced into the urethra to flush the area and provide sufficient fluid to image the implant 102 and the surrounding prostatic urethral wall.

[0041] The outer shaft 120 has a proximal end (not shown) that is coupled to the proximal control device 200. The delivery device 103 may be configured to be steerable to guide through tortuous anatomical structures. Depending on the application, steerability may be unidirectional (e.g., using a single drawstring) or multidirectional (e.g., using two or more drawstrings arranged at different radial locations around the device 103). In some embodiments, a structure for steerability (e.g., a drawstring) extends from the distal end region 104 of the delivery device 103 (e.g., where the distal end of the drawstring is secured to a plate or other structure within the distal end region 104) to the proximal control device 200, which may be manipulated by a user to steer the delivery device 103. The steerable structure may be located in one or more cavities 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 this manner, and a force is applied to turn the delivery device 103 in the opposite direction to this bias. Other mechanisms may also be used to turn the delivery device 103. The steering mechanism may also be locked or adjusted during the deployment of the implant 102 to control the position of the implant 102 within the anatomical structure (e.g., forward steering during deployment can help place the implant 102 in a more desired anterior position).

[0042] The inner shaft 130 may include one or more cavities for receiving one or more implants 102 and / or other components. In this embodiment, the inner shaft 130 includes a first cavity 131 for receiving one or more implants 102 and a second cavity 132 for receiving a third elongated tubular member 140. In this embodiment, the third elongated tubular member 140 is configured to be releasably coupled to a distal end region of the implant 102 and is referred to as a distal control member or tether 140. The distal control member 140 may be slidably advanced and / or retracted relative to the inner shaft 130. The distal control member 140 may include a cavity 141 for receiving a fourth elongated tubular member 150, which is shown herein as extending from an 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, for example, keeping the components of the delivery device 103 stationary relative to the anatomy during the deployment of the implant 102, and is referred to as the anchor delivery member 150.

[0043] exist Figure 2AIn the configuration depicted, the anchor delivery member 150 extends from the cavity 141 of the distal control member 140, and the distal control member 140, together with the inner shaft 130, extends from the cavity 121 of the outer shaft 120. As the delivery device 130 advances through the urethra, the anchor delivery member 150 is preferably completely accommodated within the distal control member 140, and the distal control member 140, together with the inner shaft 130, extends from... Figure 2A The positions shown are retracted such that they are located within the cavity 121 of the outer shaft 120 and do not extend from the open distal end of the cavity 120. In other words, in some embodiments, the open distal end of the outer shaft 120 forms the most distal structure of the device 103 during initial advancement through the urethra. This facilitates steering of the delivery device 103 via the outer shaft 120. A physician can advance the distal end region 104 of the delivery device 103 to the vicinity of the desired implantation site or fully into the patient's bladder. The delivery member 150 can be exposed from the open distal end of the distal control member 140 by further distally advancing the anchor delivery member 150 into the bladder, or, if already present in the bladder, by proximally retracting the other components of the delivery device 103, by the anchor. At this point, the anchor from the anchor delivery member 150 can be deployed within the bladder.

[0044] The placement of these components within system 100 is not limited to... Figure 2A The described embodiments. In some embodiments, the outer axis 120 may be completely omitted. In such embodiments, visualization of the unfolding process can be achieved by external imaging (such as fluoroscopy), wherein the implant 102 and delivery device 103 may be radiopaque or may include radiopaque markers, and wherein the imaging cavity 122 and illumination cavity 123 (as well as the imaging device and illumination device) and the irrigation cavity are omitted. In some embodiments, instead of the distal control member 140 being slidably received within the inner axis 130, the distal control member 140 may be slidable within a cavity of the outer axis 120 (the same cavity or a different cavity receiving the inner axis 130). Similarly, unlike the anchor delivery member 150 which is slidably received within the distal control member 140, the anchor delivery member 150 may be slidable within a cavity of the outer shaft 120 (the same or different cavity receiving the inner shaft 130 and / or the anchor delivery member 150) or within a cavity of the inner shaft 130 (the same or different cavity receiving the distal control member 140). In some embodiments, the outer shaft 130 has a separate and distinct cavity for each of the members 130, 140, and 150, and may be configured to deploy the implant 102 around the members 140 and 150.

[0045] Figure 2BThis is a perspective view depicting the distal end region 104 of the delivery device 103, in which various components are unfolded. In this embodiment, the anchor delivery member 150 includes an anchor 152 in the form of an inflatable member or a balloon. Regarding... Figure 4A-4G Other embodiments of the anchor 152 are described. The anchor 152 expands (or otherwise transforms) to a size larger than the bladder neck, such that the anchor 152 resists proximal retraction (e.g., relatively light tension). In embodiments where the anchor 152 is a balloon, the balloon may be elastic or inelastic and is inflatable using an expansion medium (e.g., air or a liquid, such as saline), which is introduced into the balloon 152 through one or more expansion ports 153. Here, three expansion ports 153 are located on the axis of the anchor delivery member 150 and communicate with an expansion cavity that extends proximally back to a proximal control device 200, which may include a port for expansion using a syringe. When the anchor 152 is deployed, the physician may proximally retract the delivery system 100 until the anchor 152 contacts the bladder neck and / or wall (if not already in contact).

[0046] A physician can use the imaging device of the outer axis 120 to move the delivery device 103 proximally away from the anchor 152 until the physician is in the desired position within the urethra to initiate the deployment of the implant 102. A 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 in a position along the length of the urethra where the physician desires to deploy the distal end of the implant 102. This may involve moving the distal control member 140 and the inner axis 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 anatomical structure is set by the system, independent 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 axis 130 together. Active or passive shaping of the distal control member 140 allows for more ideal placement of the implant 102. For example, member 140 may have a curvature that places the implant in a more anterior anatomical position. This curvature may be inherently provided in member 150 or may be actively applied by a physician via a separate entity, such as a control line. Once in the desired position and orientation, the physician may retract the inner axis 130 proximally relative to the distal control member 140 to initiate the deployment of the implant 102.

[0047] The distal engagement member 114 is held in place by the retainer 142 relative to the distal control member 140, and the proximal retraction of the inner shaft 130 relative to the distal control member 140 causes the annular structure 111 to begin sequentially unfolding (111a, then 111b, then 111c, then 111d (not shown)). The distal control member 140 may remain stationary or move longitudinally relative to the urethra during unfolding. In some embodiments, the distal control member 140 is steerable to allow the implant 102 to be angled to accommodate relatively tortuous anatomy. Mechanisms for achieving steerability have been discussed elsewhere herein, and they may be similarly applied to the distal control member 140. In these or other embodiments, the distal control member 140 may be significantly flexible to passively accommodate tortuous anatomy. In some embodiments, the distal control member 140 has a predetermined curve to aid guidance.

[0048] To aid in deployment, the inner shaft 130 can rotate clockwise and counterclockwise about the distal control member 140 (as depicted by arrow 134). See again. Figure 1B-1C The implant 102 has a non-constant winding direction, which, when observed from the distal engagement member 114, proceeds clockwise along the annular structure 111a, then reverses along the interconnect 112a to a counterclockwise direction relative to the annular structure 111b, then reverses along the interconnect 112b to a clockwise direction relative to the annular structure 111c, and then reverses along the interconnect 112c to a counterclockwise direction relative to the annular structure 111d, until terminating at the proximal engagement member 115. Depending on the winding direction of the portion of the implant 102 about to exit the open distal terminal of the cavity 131, if the shaft 130 does not actively rotate as the implant 102 is deployed, a torque can be applied to the shaft 130 as the implant 102 is moved toward a stationary configuration. This torque can cause the shaft 130 to passively rotate clockwise or counterclockwise accordingly (without user intervention). In some embodiments described elsewhere herein, the shaft 130 actively rotates during deployment. The rotation of the inner shaft 130 relative to the distal control member 140 thus allows the delivery device 103 to rotate and follow the winding direction of the implant 102. In some embodiments, all the annular structures 111 are wound clockwise or counterclockwise in the same direction (e.g., in the case of a fully spiral or helical implant), or have no set winding direction.

[0049] In this or other embodiments, the distal end region of the inner shaft 130 is configured to be relatively more flexible than the proximal portion of the inner shaft 130. This allows for the avoidance of excessive movement of the rest of the device 103 during deployment, resulting in better visualization and less contact between the device 103 and tissue. Such a configuration also reduces the stress exerted by the device 103 on the implant 102 during delivery. For example, the portion of the inner shaft 130 extending from the outer shaft 120 during deployment may be relatively more flexible than the portion of the inner shaft 130 retained within the outer shaft 120, thus allowing the inner shaft 130 to bend more easily as the implant 102 exits the lumen 131. This, in turn, stabilizes the delivery of the device 103 and allows the physician to obtain a stable image of the scheduled procedure.

[0050] Figure 2B The implant 102 is depicted after the three annular structures 111a, 111b, and 111c have deployed. The shaft 130 continues to retract proximally until the entire implant 102, or at least all annular structures 111, has exited the cavity 131. If the physician is satisfied with the deployed position and shape of the implant 102, the implant 102 can be released from the delivery device 103.

[0051] Release of the distal end of implant 102 can be accomplished via release retainer 142. Retainer 142 may be a cylindrical structure or other sleeve that is linearly or rotatably actuated over a cavity or recess (in which a portion of implant 102 is received). Figure 2B In one embodiment, the retainer 142 includes an opening or slit allowing the distal engaging member 114 to pass through it. The retainer 142 is rotatable relative to a cavity or recess in which the distal engaging member 114 (not shown) is received until the opening or slit is positioned over the member 114, at which point the member 114 is freely released from the distal control member 130. Rotation of the retainer 142 can be accomplished by rotation of a rotatable shaft, rod, or other member coupled to the retainer 142 (and accessible at the proximal control device 200).

[0052] Figure 2C and 2DThis is a perspective view depicting another example embodiment of system 100, in which different embodiments of the retainer 142 are shown in more detail. Here, the retainer 142 slides distally and / or proximally relative to the distal control member 140. The distal engagement member 114 of the implant 102 may be received within a corresponding recess in the distal control member 140. The retainer 142 may slide over the distal engagement member 114 while being received within this recess until the retainer 142 abuts against a stepped portion of the member 140. A control line 146 extends along the length of the control member 140, either in the same cavity as the anchor delivery member 150 or in a different cavity. The control line 146 is coupled to the retainer 142 having an enlarged portion 147, from which the control line 146 can be routed into the member 140 through an opening 148.

[0053] The engaging member 114 can be placed within the recess, and the retainer 142 can advance over the engaging member 114 to secure the distal end of the implant 102 to the control member 140. When the implant 102 is satisfactorily deployed within the urethra, for example, in Figure 2C In this state, retainer 142 can be retracted proximally together with control line 146 to expose engagement member 114 and allow engagement member 114 to be released from member 140. Figure 2E and 2F This is a perspective view depicting another embodiment of system 100, with another configuration for retainer 142, said retainer 142 being configured to interact with about Figure 2C and 2D The procedure is similar to that described. The implant 102 is not shown here, but the recess 143 in which the distal engagement member 114 can be received is shown in more detail.

[0054] Figure 2G and 2H These are side and perspective views, respectively, of another example embodiment of system 100. In this embodiment, the inner axis 130 includes a flexible distal extension 160, within which an inner cavity 131 (not shown) is located. In this configuration, the open distal end of cavity 131 is located distal to the open distal end (not shown) of cavity 132, from which a distal control member 140 extends. Ceilings 122, 123, and 124 (not shown) are located on the outer axis 120, opposite the distal extension 160. The flexible distal extension 160 contributes to flexibility, stabilizing the delivery system and the image. The flexible extension 160 helps align the annular structure 111 planarly and helps guide the implant 102 (e.g., radially) toward the urethral wall during deployment.

[0055] The release of the proximal end of the implant 102 is also controllable. Figure 3AThis is a partial cross-sectional view depicting an example embodiment of system 100, wherein a portion of implant 102 is shown within an inner cavity 131 of inner shaft 130. Here, implant 102 is in a linear state prior to deployment, wherein proximal engagement member 115 is coupled to gripper 136, which is distally and / or proximally slidable within cavity 131. Gripper 136 may include a distal end region 137 on or coupled to shaft 138. Gripper 136 is preferably controllable to cause implant 102 to rotate and longitudinally translate (e.g., push and pull) relative to inner shaft 130.

[0056] Figure 3B and 3C These are perspective views depicting exemplary embodiments of the distal end region 137 of the gripper 136 with and without the implant 102. The gripper 136 includes a recess (also referred to as a cavity or pit) 139 for receiving and retaining the proximal engagement member 115. Here, the enlarged portion 117 is held within the recess 139 by a distal necking region having a relatively smaller width. When within the cavity 131, the sidewalls of the inner shaft 130 hold the proximal engagement member 115 within the recess 139. When the distal end region 137 leaves the cavity 131 (either by retraction of the inner shaft 130 relative to the gripper 136 or by advance of the gripper 136 relative to the inner shaft 130), the constraint imposed by the sidewalls of the inner shaft is no longer present, and the engagement member 115 is freely released from the gripper 136. Therefore, 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 disconnect from the control member 140, and the proximal engagement member 115 can be released by exposing the gripper 136 from the inner shaft 130 and allowing the proximal engagement member 115 to disconnect from the gripper 136.

[0057] The gripper 136 can also assist in loading the implant 102. In some embodiments, the tension applied to the implant 102 by the gripper 136 (while the opposite ends of the implant 102 are secured, for example, by the retainer 142) facilitates the transition of the implant 102 from a static configuration to a linear configuration suitable for insertion of the implant 102 into the inner shaft 130.

[0058] The anchor delivery member 150 may have a variety of different configurations and geometries (e.g., those that extend across the bladder wall in one direction, across the bladder wall in two directions (e.g., left and right), or across the bladder wall in three or more directions). Figures 4A-4B This is a cross-sectional view depicting an example embodiment of an anchor delivery member 150 in multiple deployment stages within a patient's body. Figure 4AIn this embodiment, the anchor delivery member 150 has advanced through the urethra 401 until the open distal end 151 passes the bladder neck and is within the bladder 402, although in this and other embodiments, the end 401 may stop before entering the bladder 402. Here, two anchoring arms 408a and 408b are received within the lumen of the anchor delivery member 150. In other embodiments, each anchoring arm 408 may be received in a separate lumen within the member 150. The anchoring arms 408 may advance distally relative to the anchor delivery member 150 (or the anchor delivery member 150 may advance into the bladder 402 and retract proximally relative to the anchoring arms 408), such that upon exiting the open distal end 151, the deflectable portions 410a and 410b laterally transition into contact with the bladder wall, forming the anchor 152, as in Figure 4B As depicted in the text.

[0059] Anchor arm 408 may be formed of shape-retensioning material, the shape-retensioning material being oriented towards Figure 4B The anchor arm 408 is biased in a static configuration. The distal ends of each anchor arm 408 may have a non-invasive terminal (e.g., rounded, spherical, or balled), as depicted herein, and or alternatively, the distal ends of the arms 408 may bend away from the bladder wall to increase non-invasiveness. In other embodiments, only one anchor arm 408 is used. Figure 4C This is a cross-sectional view depicting another example embodiment of the anchor delivery member 150. Here, deflectable portions 410a and 410b have generally straight or linear shapes and deflect from a common axis 412, which is slidable distally and / or proximally relative to the anchor delivery member 150. In all anchoring embodiments described herein, one or more deflectable portions may deflect from a common axis (such as that depicted herein) or from a separate axis (such as that depicted herein). Figures 4A-4B (The deflection described in the text)

[0060] Figure 4D-4E This is a partial cross-sectional view depicting another example embodiment of the anchor delivery member 150. Figure 4D This embodiment is depicted in which the anchor 152 is in a state of being partially unfolded from the open distal end 151 of the anchor delivery member 150. Figure 4E An anchor 152 is depicted after full deployment within the bladder 402. Here, the anchor 152 includes laterally deflectable struts 420a, 420b, 421a, and 421b connected by hinges 422a, 422b, and 422c. Specifically, laterally deflectable struts 420a and 421a are connected by hinge 422a, laterally deflectable struts 420b and 421b are connected by hinge 422b, and struts 421a and 421b are connected by hinge 422c. Again, the anchor 152 is oriented towards... Figure 4EThe static configuration depicted is biased, and automatically shifts toward this configuration once exposed from within the cavity of the anchor delivery member 150. Hinges 422 may each be implemented as active hinges, such as in... Figure 4E As depicted, for example, it is defined by a reduced or relatively more flexible section of the device. Other hinge configurations may also be utilized.

[0061] In another embodiment, a pull wire or other component 424 is attached to one or more of the support rod 421 and / or hinge 422c, and extends proximally to the proximal control device 200. Figure 4E In the diagram, the pulling member 424 is shown in dashed lines to indicate that it is optional. Proximal retraction of the pulling member 424 at the proximal control device 200 causes the structural arrangement to deflect laterally. Figure 4E In the configuration depicted, this arrangement provides a significant locking force while maintaining tension on the pulling member 424.

[0062] Figure 4F This is a partial cross-sectional view depicting another example embodiment of the anchor delivery member 150. Here, the shape retensioning element 430 has advanced from the inner cavity of the anchor delivery member 150, where it is a relatively straight or linear shape. Upon exiting the open distal end 151, the distal portion of the element 430 automatically changes toward a laterally expanding shape 432, which in this embodiment is in the shape of a coil or helix. Figure 4G Another example embodiment is depicted, in which the lateral expansion shape 432 has multiple loops and resembles the number "8" or a bow tie. Besides the shape depicted here, many different shapes can be used for the lateral expansion shape 432. In all anchoring embodiments, the distal end of the line or element exposed to body tissue may have a rounded or enlarged non-traumatic end (as in...). Figure 4F and 4G (As depicted in the text).

[0063] After the implant deployment process is complete, the anchor 152 can be collapsed or retracted to allow removal of the delivery device 103. For example, in an embodiment where the anchor 152 is a balloon, the balloon is deflated and optionally retracted back into the cavity of the device 103, and subsequently withdrawn from the bladder and urethra. In embodiments where the anchor 152 is in the form of a wire or other inflatable member (e.g., regarding...), Figure 4A-4G As described above, anchor 152 retracts back into the cavity of device 103 (from which it was previously deployed), and device 103 can then be withdrawn from the bladder and urethra. Retraction can be accomplished using fluid or pneumatic actuation, threaded mechanisms, or other methods.

[0064] exist Figure 2BIn this embodiment, the anchor 152 is a generally spherical balloon, wherein the anchor delivery member 150 extends through the center. In other embodiments, the balloon anchor 152 may be laterally offset or positioned only on one side of the anchor delivery member 150. Figure 4H This is a partial cross-sectional view depicting an example embodiment of a balloon 152 with lateral offset. Here, the laterally offset balloon 152 applies force to the side of the bladder neck 403 and forces the anchor delivery member 150 (and delivery device 103) in direction 450.

[0065] In other embodiments, device 103 may include two or more balloons that can be independently inflated in different lateral directions. Independent inflation of one or more balloons and maintaining one or more remaining balloons in a deflated state allows the user to change the angle of the delivery catheter relative to the anatomy, and thereby allows the implant to deploy in anatomy with significant curvature. Figure 4I Another example embodiment is depicted, in which the first anchoring balloon 125a is inflated to a larger size than the second anchoring balloon 152b located on the opposite side of the member 150. Due to the force applied to the bladder wall, the member 150 is tilted away from the smaller balloon 152b in direction 451. A physician may select appropriate balloons or multiple balloons for inflation, and the inflation and deflation process may be repeated until the physician achieves the desired angular orientation of the device 103 within the anatomical structure, at which point the remaining delivery process can be performed. The delivery member 150 may be a pre-formed flexible or rigid shaft, such that it does not impede the ability to place the implant 102 in the desired anatomical position. For example, curvature in the member 150 just proximal to the balloon placement position may allow the implant 102 to be placed further forward without being restricted by the bladder neck.

[0066] In some embodiments, a shaped or substantially elastic balloon may be inflated at the same location as the bladder neck. Figure 4J An exemplary embodiment is depicted, wherein a balloon 152 is inflated at the bladder neck 403. Here, the balloon 152 includes a first flap 155 formed in the bladder 402 and a second flap 156 formed in the urethra 401. This configuration can be used to directly anchor the member 150 to the bladder neck 403.

[0067] Example embodiments of proximal control devices and related methods.

[0068] Figure 5A This is a side view depicting an example embodiment of the delivery system 100 before the implant 102 is deployed; and Figure 5BThis is a side view depicting this embodiment in which the implant 102 is in an deployed configuration (anchor delivery member 150 and 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 main body 203, and a second user actuator 205. The longitudinal axis of the delivery device 103 is indicated by a dashed line 204. The proximal control device 200 may include a mechanism manually driven by the 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 instead utilize an electric mechanism. The second user actuator 205 may be configured to control the steering of the delivery device 103. Here, the actuator 205 is configured as a rotatable wheel that can wind or unwind a drawwire (not shown) within the delivery device 103, causing the device 103 to deflect upward and downward, as shown here.

[0069] Figure 6A This is an internal view of the proximal control device 200, depicting various mechanical components or sub-components within the main housing 203 of the control device 200. In this embodiment, the proximal control device 200 is configured to perform three types of movements on the implant 102: advance (e.g., push) of the implant 102 distally along axis 204, retraction (e.g., pull) of the implant 102 and / or the inner shaft 130 proximally along axis 204, and rotation (e.g., rotation) of the inner shaft 130 about axis 204. In other embodiments, depending on the desired delivery function, the proximal control device 200 may be configured to perform one or any subset of two of the aforementioned types of movements, perform these types of movements but assigned to different components, or perform other types of movements not mentioned herein.

[0070] In this embodiment, the proximal control device 200 includes a longitudinally translatable member 601, which is configured as a yoke in this embodiment. The yoke 601 is coupled to a trigger 202 such that pressing the trigger 202 causes a proximal longitudinal translation of the yoke 601. The yoke 601 is coupled to two proximal ratchet members 602 and 603, which, in this embodiment, are configured as pawls. Pawl 602 has a set of teeth that correspond to the teeth on pawl 603, and the teeth of each pawl 602 and 603 are compatible with a gear 605 (see...). Figure 6B The complementary teeth on the gear 605 intersect or engage, and the gear 605 is referred to herein as a pinion, which is part of the first gear assembly 600.

[0071] A user can access and switch the converter 604 between two positions, each responsible for engaging only one of the claws 602 and 603 with the pinion 605. Each of the claws 602 and 603 is deflectable and biased (e.g., using a spring) toward engagement with the pinion 605. In this embodiment, placing the converter 604 in the downward position moves the claw 602 out of engagement with the pinion 605 and moves the claw 603 into engagement with the pinion 605. Proximal movement of the yoke 601 and the claw 603 causes the pinion 605 to rotate counterclockwise. Placing the converter 604 in the upward position reverses the engagement and positions the claw 602 to engage with the pinion 605, and proximal movement of the yoke 601 and the claw 602 causes the pinion 605 to rotate clockwise.

[0072] In this embodiment, the first gear assembly 600 includes a pinion 605, a second gear 610, a third gear 612, and a fourth gear 614. In other embodiments, the first gear assembly 600 may be implemented to achieve the same or similar function using more or fewer gears than those described herein.

[0073] A pinion 605 engages with a second gear 610 oriented perpendicular to the pinion 605. The pinion 605 has teeth projecting from the radial edge of the gear 605, while the second gear 610 has teeth projecting from both the distal and proximal sides of the gear 610; the second gear 610 is referred to herein as a face gear 610. Counterclockwise rotation of the pinion 605 causes the face gear 610 to rotate in a first direction, and clockwise rotation of the pinion 605 causes the face gear 610 to rotate in a second opposite direction. The direction of rotation of the face gear 610 then determines whether the implant 102 retracts proximally or advances distally relative to the housing 203.

[0074] Figure 6B This is a perspective view depicting the interior of this embodiment of the proximal control device 200 in more detail. The proximal teeth on the face gear 610 engage with teeth on gear 612, referred to as the input gear. The teeth of the input gear 612 engage with teeth of gear 614. Gear 614 is coupled to or integrated with a reel 616, which is configured to receive or retain the gripper shaft 138. (As shown in...) Figures 9A-9BAs can be seen in the embodiments, the reel 616 may include optional slots or channels 617 in which the gripper shaft 138 may be received. Depending on the direction of rotation, rotation of the reel 616 causes the gripper shaft 138 to wind onto or unwind from the reel 616. Winding the gripper shaft 138 onto the reel 616 corresponds to proximal retraction of the implant 102 (e.g., into the inner shaft cavity 131), while unwinding the gripper shaft 138 from the reel 616 corresponds to distal advancement of the implant 102 (e.g., away from the inner shaft cavity 131). Figures 9A-9B In one embodiment, channel 617 is a spiral channel that extends multiple times around the perimeter of reel 616. Figure 6B In the embodiment depicted, channel 617 is omitted.

[0075] In some embodiments, the input gear 612 may be configured as an interrupted gear, wherein one or more teeth are absent, such that rotation of the input gear 612 will not always result in a corresponding rotation of another gear. Examples of such an input gear 612 are... Figure 6C The perspective view depicts the input gear 612. According to the angle depicted here, the input gear 612 has teeth 620 spaced at regular intervals on the left side 621 of the gear's radial edge. Teeth 620 also exist at regular intervals on the right side 622 of the gear's radial edge, except for a toothed region 623. A smooth-surfaced hub 624 is present adjacent to this interrupted region 623. The right side 622 of the input gear 612 is configured to engage with the winding gear 614. The placement of the interrupted region 623 is predetermined such that continuous pressing of the trigger 202 by the user (and therefore continuous rotation of the pinion 605, face gear 610, and input gear 612) does not translate into continuous rotation of the winding gear 614. Instead, the winding gear 614 can only be rotated when engaged with a portion of the input gear 612 having teeth 620, and the winding gear 614 will not rotate when the interrupted region 623 crosses the winding gear 614. The placement of the interruption region 623 allows for pauses in the longitudinal translation (e.g., distal and / or proximal) of the gripper axis 138. The interruption region 623 is specifically positioned such that the longitudinal translation occurs only during certain portions of the delivery sequence.

[0076] In this embodiment, placing the transducer 604 in the lower position converts the user pressing the trigger 202 into pushing the implant 102, while placing the transducer 604 in the upper position converts the user pressing the trigger 202 into pulling the implant 102 and / or the inner shaft 130. In other embodiments, these transducer positions can be reversed to result in opposite movements.

[0077] Figure 7AThis is a top view depicting the cam assembly 702 of the proximal control device 200. The cam assembly 702 includes an outer slit tube or cam 703, an inner slit tube 704, and a guide member 706. The cam assembly can be positioned within the yoke 601. Figure 7B This is a perspective view depicting this embodiment of cam 703. Cam 703 is coupled to face gear 610 such that rotation of face gear 610 also causes cam 703 to rotate. Inner slit tube 704 is mounted within proximal control device 200 such that inner slit tube 704 does not rotate when cam 703 rotates. Guide member 706 may be configured as an arm or strut member, said guide member 706 being located within both slit 710 in cam 703 and slit 714 in inner tube 704, and following both slit 710 in cam 703 and slit 714 in inner tube 704. Guide member 706 and hub 802 located within inner slit tube 704 ( Figure 8 The connection is made to the inner shaft 130 (e.g., by means of a spindle, which in some embodiments may include a multifaceted shaft 708 and a rotary adapter 1112, as per [reference to...]). Figure 11E (Described). The rotation of the face gear 610 causes the cam 703 to rotate, which in turn causes the guide member 706 to follow the path or route of the slit 710 in the cam 703. Because the guide member 706 extends through the slit 714 in the non-rotatable inner tube 704, the rotation of the cam 703 causes the guide member 706 to move only in the longitudinal direction and not in the radial direction.

[0078] Slit 710 may have one or more inclined slit portions and / or one or more radial slit portions. In the embodiments described herein, slit 710 has multiple inclined portions (e.g., slit portions 717a, 717b, and 717c) and multiple radial portions (e.g., slit portions 719a, 719b, 719c, and 719d). Other shapes may also be used and linked together to form a desired path. Inclined slit portions 717 may have a constant or variable slope, and in some embodiments, these inclined slit portions may vary such that the slope reverses from positive to negative (similar to a "V").

[0079] The inclined slit portion 717 may be an opening or slot in the cam 703 having a non-perpendicular and non-parallel angle (relative to the longitudinal axis 204), which causes the guide member 706 to move along the longitudinal axis 204 during rotation. In most embodiments, the radial slit portion 719 is parallel to the longitudinal axis 204, such that rotation of the cam 703 causes the radial slit portion 719 to move relative to the guide member 706, while the guide member 706 does not move in the longitudinal direction (proximal or distal). The radial slit portion 719 may correspond to a pause in the delivery sequence, wherein the trigger 202 continues to be pressed down, and other components of the delivery device 103 move, but the inner shaft 130 remains in the same relative position.

[0080] exist Figure 7A In the middle, the guide member 706 is located at the farthest end within the radial slit portion 719a ( Figure 7B For the retraction of the inner shaft 130, the cam 703 rotates counterclockwise 720. There is no longitudinal movement of the inner shaft 130 as the cam 703 rotates the radial slit portion 719a past the guide member 706. When the guide member 706 reaches the inclined slit portion 717a, it begins to retract proximally along with the inner shaft 130. This process is repeated as the guide member 706 moves through a series of radial slit portions 719 (e.g., pauses during shaft 130 retraction) and inclined slit portions 717 (e.g., shaft 130 retraction). In some embodiments, the guide member 706 may be selectively coupled to the outer shaft 120 to cause longitudinal movement of that component. For example, the outer shaft 120 may also retract proximally as the inner shaft 130 retracts proximally, for example, to allow the physician to continue imaging the unfolding process. (See, for example, regarding...) Figure 11A-11E (The description of the cam assembly is provided.) Similar embodiments that can be used with the embodiments described herein are described in the incorporated International Publication WO2017 / 184887.

[0081] The proximal control device 200 can also be configured to rotate the inner shaft 130 relative to the distal control member 140 during the expulsion of the implant 102 from the inner cavity 131. Figure 8 This is a side view depicting an example embodiment of a second gear assembly 800, configured to convert rotation of the face gear 610 into rotation of a hub 707, which is then coupled to an inner shaft 130, in some embodiments via a multifaceted shaft 708 located in the middle (e.g., see...). Figure 6A and 11A ) and rotary adapter 1104 (for example, see Figure 11E This is accomplished in a manner that... The gear assembly 800 is located on the distal side of the cam assembly 702 (see...). Figure 6A and 7AThe gear assembly 800 may include a first gear 802 coupled to the cam 703, such that rotation of the cam 703 causes rotation of the gear 802. In this embodiment, the gear 802 has an annular or ring-like shape, having a first set of radially inwardly projecting teeth 804 and an interrupted region 806. The gear 802 may have a second set of radially inwardly projecting teeth (not shown), having an interrupted region located in a plane different from the teeth 804.

[0082] The gear assembly 800 may also include conversion gears 810, 812, and 814, which may also be referred to as planetary gears, that convert the rotation of gear 802 to a centrally located gear 816. In this example, a first set of teeth 804 engages with gear 810, which in turn engages with the central gear 816, causing the central gear 816 to rotate in a first direction. The central gear 816 has a bore in which a hub 707 is rotatably secured but freely sliding longitudinally. Thus, the rotation of gear 802 is converted into the rotation of hub 707, which in turn causes the inner shaft 130 to rotate. A second set of teeth (not shown) of gear 802 engages with gear 812, which in turn engages with gear 814, which in turn engages with the central gear 816, causing the central gear 816 to rotate in the opposite direction. Based on the positioning of the first and second sets of teeth and the interrupted areas in multiple planes, the constant rotation of the ring gear 802 in one direction can be converted into the timed rotation of the central gear 816 in the same direction, the timed rotation in the opposite direction, or the complete non-rotation of the central gear 816.

[0083] The delivery sequence of the three stages can be described relative to corresponding features of implant 102. Each annular structure 111 and interconnect 112 is pushed by gripper 136. In some embodiments, implant 102 may also be rotated by gripper 136. In some embodiments, the total longitudinal pushing distance traveled by gripper 136 (provided by reel 616) during implant delivery is approximately equal to the superimposed circumference of all annular structures 111 of embodiments of implant 102. The combined movement of pushing and rotation ensures that, despite the lateral force applied to the prostatic urethra, the annular structures 111 of implant 102 are lowered in a plane to provide sufficient radial force to open the lumen. Each interconnect 112 of implant 102 is subjected to a pulling phase (without rotation) by hub and cam. Thus, the total axial pulling distance traveled by hub within cam is approximately equal to the total longitudinal length of implant 102. During the delivery sequence, the pulling phase and the pushing / rotating phase do not occur simultaneously; they are mutually exclusive.

[0084] The proximal control device 200 can be configured to automatically prevent further deployment of the implant 102 after all the annular structures 111 have deployed from the inner cavity 131, but before the proximal engagement feature 115 and the recess 139 have advanced from within the cavity 131. This provides the physician with the opportunity to verify that the implant 102 has been correctly deployed and positioned before releasing it from the delivery device 103.

[0085] Figures 9A-9F This is an interior perspective view depicting an example embodiment of a proximal control device 200, which has a locking or locking mechanism 900 for preventing premature release of the implant 102. The locking mechanism 900 engages with a groove or channel 902 in the proximal surface of the face gear 610, as shown in... Figures 9A-9B As shown in the diagram. The longitudinally, laterally, and radially inwardly movable tracking mechanism 904 has a head portion with a protrusion 905, which is distally biased such that the protrusion 905 presses into a groove 902 and tracks within the groove 902. As the face gear 610 is rotated by the pinion 605 (not shown), the tracking mechanism 904 follows the helical groove 902 and moves radially inward. This movement continues until the implant 102 is almost fully deployed, but the proximal engagement member 115 remains held within the cavity 131 by the gripper 136. At this point, the protrusion 905 enters a relatively deeper portion 906 (e.g., a cavity) of the groove 902, which securely captures the tracking mechanism 904. Further rotation of the face gear 610 causes the tracking mechanism 904 to move laterally or rotate in a semi-circular arc. Figure 9C-9D The position shown in the figure is such that the arm 907 of the tracking mechanism 904 is prevented from moving further laterally by the fixed body 915. This prevents the face gear 610 from rotating further, which in turn prevents all gears from rotating and prevents the user from continuing to pull the trigger 202.

[0086] If the physician is satisfied with the placement of implant 102, they pull the unlocking actuator or tab 910 proximally, allowing the user to access the unlocking actuator or tab 910 from outside the housing 203. The unlocking tab 910 is directly or indirectly connected to a control line 146, which is responsible for releasing the retainer 142, as per [relevant information]. Figure 2C and 2DDescribed. Therefore, proximal movement of the unlocking tab 910 causes proximal movement of the retainer 142, allowing release of the distal engagement member 114 of the implant 102 from the delivery device 103. The unlocking tab 910 can also be engaged with the tracking mechanism 904, such that proximal retraction of the tab 910 withdraws the protrusion 905 from the slot 902. This action unlocks the device 200, and the user is free to continue pressing the trigger 202, which in turn feeds the reel 616 forward to further unwind the gripper shaft 138, and causes the proximal engagement member 115 and the recess 139 of the implant 102 to disengage from the cavity 131 of the shaft 130. At this stage, both the distal engagement member 114 and the proximal engagement member 115 of the implant 102 are exposed, and the implant 102 is free to disengage or be released from the device 103.

[0087] The proximal control device 200 can be configured to rotate the distal control member 140 relative to other components of the delivery device 103 to facilitate removal of the distal engagement member 114 from the distal control device 140. Figure 9E In the embodiment depicted, the second cam 940 is rotatable within the body 941. A distal control member 140 (not shown) is fastened to the cam 940 (e.g., using a set screw) such that rotation of the cam 940 causes rotation of the distal control member 140. The cam 940 has two inclined surfaces 944a and 944b that contact two rigid members (e.g., pins) 946a and 946b, respectively, which are fixed to the body 941 and located on opposite sides of the cam 940. The cam 940 is rotatable but longitudinally fixed relative to the body 941. Pulling the unlocking tab 910 moves the body 941 and members 946a and 946b proximally. The cam 940 cannot move proximally, so contact of member 946 on the inclined surface 944 causes the cam 940 to rotate, which in turn rotates the distal control member 140. Therefore, the retraction of tab 910 releases retainer 142 and rotates distal control member 140, which no longer covers distal engagement member 114 of implant 102 (implant 102 now expands to contact the urethra). Rotation facilitates the removal of distal engagement member 114 from recess 143 of member 140 and ensures complete disengagement.

[0088] In some embodiments, the distal control member 140 has a pre-formed bend (not shown) proximal to the retainer 142. When attached to the distal engagement member 114, the distal control member 140 deforms from this pre-formed bend shape (e.g., as in...). Figure 2B , 2G(as depicted in 2H), and thus biased to return to this pre-set bent shape, which also assists in the disengagement of member 140 from implant 102 (instead of or in embodiments where device 200 is attached therein to rotate member 140).

[0089] A stop surface 912 is present on the tracking mechanism 904, and the stop surface 912 is opposite to another stop surface 914 on the fixed body 915. Figure 9B In the position of the tracking mechanism 904 shown, these opposing stop surfaces 912 and 914 prevent the unlocking tab 910 from retracting proximally because the body 915 is a separate component held in a stationary position (e.g., by the housing 203). Lateral movement of the tracking mechanism 904 (e.g., in a semicircular arc) continues until it stops at stop surface 912 and beyond stop surface 914, as shown in Figure 9D As shown in the figure. This feature prevents premature unlocking of the implant 102 by retracting the unlocking tab 910 proximally before the implant 102 is fully deployed.

[0090] The proximal control device 200 may also include an emergency release mechanism that allows removal of the partially deployed implant 102 from the patient. The unlocking tab 910 can be disconnected from the tracking mechanism 904 by disengaging a notch in the deflectable arm 920 from a pawl 922 at the base of the tracking mechanism 904. In other embodiments, the notch and pawl features are reversible. An emergency release button 924 with a beveled surface 925 is positioned below the arm 920 (see [link]). Figures 9A-9B Actuation of the release button 924 (e.g., by pushing) causes the two deflector arms 920 of the ramp surface 925 to move upward and disengages the notch from the pawl 922, as in Figure 9E As depicted in the diagram. In this state, even when the stop surfaces 912 and 914 are in relative positions, the unlocking tab 910 remains disconnected from the tracking mechanism 904 and can retract freely proximally. The proximal retraction of the unlocking tab 910 retracts the control line 146 and releases the distal engagement member 114 of the implant 102 from the distal control member 140. At this time, the partially deployed implant 102 remains attached to the gripper 136, which can retract proximally into the outer shaft 120 and then be completely removed from the patient.

[0091] Example embodiments of delivery methods.

[0092] Figure 10AThis is a flowchart depicting an example embodiment of a method 1000 for delivering implant 102 using system 100. The distal end region of the outer shaft 120 is inserted into the urethra, preferably wherein the inner shaft 130, the distal control member 140, and the anchor delivery member 150 are in a retracted state and completely 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., members 120, 130, and 140) and is used to deploy the anchor 152 within the bladder. In some embodiments, deployment of the anchor 152 may be the inflating of one or more balloons (e.g., as in...). Figure 2B and Figure 4H-4J As depicted in the text, the expansion is achieved by introducing an expansion medium through an injection port (e.g., a Luer cone). Figure 6A A conduit 650 for balloon inflatation is depicted. In other embodiments, the deployment of the anchor 152 may be achieved by one or more linear members advancing the anchor delivery member 150, causing it to deflect into a position opposite the bladder wall (e.g., Figure 4A-4G The longitudinal positioning (e.g., forward and retraction) of the anchor delivery member 150 and / or any linear member can be manually accomplished by the user (directly or using the proximal control device 200) manipulating the proximal end of the anchor delivery member 150 and / or any linear member.

[0093] At step 1004, the anchor 152 is held under tension against the bladder wall by applying a proximal-directed force to the device 200. Therefore, the anchor 152 provides a longitudinal coordinate for the system 100 from which the implant 102 can be deployed in a precise position. This feature ensures that the implant is not placed too close to the bladder neck.

[0094] At 1006, the distal control member 140 and the inner shaft 130 can then be advanced distally from within the outer shaft 120 if they have not already been advanced distally (e.g., step 1006 may occur before steps 1002 and / or 1004). The user can manipulate the position of the proximal control device 200 by means 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 process can begin. The steps for implant deployment can be performed automatically by the user actuating the proximal control device 200 (e.g., actuation of the trigger 202, selection of position for the converter 604, etc.), or these steps can be performed directly by manually manipulating each component of the delivery device 103, or by a combination of both, as desired for a particular implementation.

[0095] In some embodiments, the deployment of the implant 102 from the cavity 131 is accomplished by (1) advancing the grasper 136 distally relative to the inner axis 130 without moving the inner axis 130. In other embodiments, the deployment of the implant 102 from the cavity 131 is accomplished by (2) retracting the inner axis 130 proximally relative to the grasper 136 without moving the grasper 136. In some embodiments, the deployment of the implant 102 is accomplished by (3) a combination of two movements. In yet another embodiment, the deployment of the implant 102 is accomplished by a combination of (1), (2), or (3) with one or more rotations of the inner axis 130 relative to the distal control member 140 in one or more directions (e.g., clockwise or counterclockwise).

[0096] refer to Figure 10A and Figure 10B The timing diagram illustrates an example embodiment of the sequence of steps 1008, 1010, and 1012 for deploying implant 102. First, refer to... Figure 10A At step 1008, the first annular structure 111a is disengaged from the cavity 131 of the inner shaft 130; at step 1010, the interconnect 112 is disengaged from the cavity 131; and at step 1012, the second annular structure 111b is disengaged from the cavity 131. Steps 1010 and 1012 may be repeated for each additional interconnect 112 and annular structure 111 present on the implant 102.

[0097] exist Figure 10B In this sequence, step 1008 begins at T0 on the far left of the timing diagram. The unfolding of the ring structure 111a corresponds to the duration marked 1008, the unfolding of the interconnect 123 corresponds to the time span 1010, and the unfolding of the ring structure 111b corresponds to the time span 1012. Those skilled in the art will understand that the distinction between the unfolding of the ring structure 111 and the unfolding of the interconnect 112 is approximate, because the transitions between those portions of the implant 102 can be gradual and do not necessarily have precise boundaries.

[0098] about Figure 10B The described embodiment is for an implant having a ring structure 111 having opposite winding directions (e.g., clockwise, then counterclockwise, then clockwise, etc.). Figure 10BThe diagram indicates three different movements. At the top is a rotational movement of the inner shaft 130 in one direction (e.g., clockwise), in the middle is a longitudinal movement of one or more components of the delivery device 103 (e.g., proximal or distal), and at the bottom is a rotational movement of the inner shaft 130 in the opposite direction to that indicated at the top (e.g., counterclockwise). In embodiments where the annular structure 111 of the implant 102 is entirely wound in the same direction, the rotation of the inner shaft 130 will also be in only one direction.

[0099] From time T0 to T1, the deployment of implant 102 is accomplished by rotating the inner shaft 130, as indicated in region 1031. Simultaneously, in region 1032, the gripper 136, and thus implant 102, advances distally without causing longitudinal (neither distal nor proximal) or rotational movement of the outer shaft 120, and without causing longitudinal (neither distal nor proximal) movement of the inner shaft 130. By way of example, within the proximal control device 200, rotational movement of the inner shaft 130 is accomplished by the user pressing the trigger 202 (via the yoke and pawl) to convert into rotation of the pinion 605 and face gear 610, without corresponding longitudinal movement of both the inner shaft 130 and the outer shaft 120. The rotation of the face gear 610 also causes the cam 703 of the cam assembly 702 to rotate ( Figures 7A-7B The guide member 706 is located in the radial slit portion (e.g., 7191a), and therefore neither of the shafts 120 nor 130 moves longitudinally. Rotation of the cam 703 also causes the second gear assembly 800 ( Figure 8 The inner shaft 130 is rotated. The forward movement of the gripper 136 is caused by the face gear 610 rotating the input gear 612, which in turn rotates the reel gear 614. Figures 6A-6B This causes the spool 616 to rotate and to unwind the gripper shaft 138 distally.

[0100] From time T1 to T2, the rotation of the inner shaft 130 stops, but the distal advance of the gripper 136 continues, while shafts 120 and 130 do not move longitudinally. By way of example, within the proximal control device 200, the user continues to press the trigger 202, and the cam 703, together with the guide member 706, continues to rotate in the radial slit portion (e.g., 719a). The rotation of the cam 703 continues to rotate the annular gear 802 of the second gear assembly 800, but at this point, reaching the interrupted portion (without teeth) of the annular gear 802, none of the planetary gears 810, 812, and 814 rotate, and thus the rotation of the central gear 816 and the inner shaft 130 stops. In this embodiment, the unfolding of the first annular structure 111a is completed at time T2.

[0101] From time T2 to T4, the first interconnect 112 unfolds. In region 1033, from time T2 to T4, no distal advance of the gripper 136 (and implant 102) occurs. The unfolding of the interconnect 112 is completed by the proximal retraction of both the outer shaft 120 and the inner shaft 130, while the gripper 136 remains in place. This causes the interconnect 112 to leave the inner cavity 131 of the shaft 130. By way of example, in the proximal control device 200, the user continues to press the trigger 202, and the face gear 610 continues to rotate, as do the cam 703 and the input gear 612. Upon reaching the interruption portion 623 in the input gear 612, and the rotation of the input gear 612 no longer causes the rotation of the reel gear 614, and therefore the distal advance of the gripper shaft 138 stops. Within the cam assembly 702, the guide member 706 transitions from a radial slit portion (e.g., 719a) to an inclined slit portion (e.g., 717a), and rotation of the cam 703 causes the guide member 706 to move proximally. When the guide member 706 is coupled to shafts 120 and 130, these shafts 120 and 130 also move proximally.

[0102] 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 there is no rotation of the shaft 130 caused by the central gear 816.

[0103] In embodiments where the interconnect portion 112 is straight, it is desirable that rotation of the shaft 130 is suppressed from time T2 to T4, while the interconnect portion 112 unfolds. For embodiments where the interconnect portion 112 is curved, such as... Figure 1B-1D In some embodiments, it is desirable that rotation of the inner shaft 130 begins during the unfolding of the interconnection. Figure 10B The unfolding of the bendable interconnect 112 is depicted, and from T3 to T4, the inner shaft 130 rotates in the opposite direction indicated by region 1034. By way of example, within the proximal control device 200, the user continues to press the trigger 202, and this movement is translated into a ring gear 802, which has a region in which its teeth engage with planetary gears, which are responsible for the movement of the central gear 816 in the opposite direction. The rotation of the central gear 816 in the opposite direction thus begins, and the inner shaft 130 similarly rotates in the opposite direction from this time T0 to T1, which facilitates the unfolding of the interconnect 112 and initiates the rotation of the inner shaft in a direction suitable for winding the second annular structure 111b in the opposite direction.

[0104] At T4, the unfolding of the interconnect 112 is complete, and the unfolding of the second annular structure 111b begins. As indicated by the abort in region 1033, the proximal retraction of shafts 120 and 130 stops. The distal advance of the gripper shaft 138 restarts at T4 in region 1035, while the outer shaft 120 neither rotates nor moves longitudinally. As indicated in region 1034, the rotation of the inner shaft 130 continues, but the inner shaft 130 does not move longitudinally. By way of example, within the proximal control device 200, the user continues to press the trigger 202. The rotation of the cam 703 continues, but the guide member 706 reaches the second radial slit portion (e.g., 719b), and the proximal movement of the guide member 706 stops (the retraction of shafts 120 and 130 also stops). The rotation of the central gear 816 continues. The interrupted portion 623 of the input gear 612 is stopped, and the gear 620 re-engages with the reel gear 614, causing both the reel gear 614 and the reel 616 to start rotating again, and thus the distal advance of the gripper shaft 138 also begins.

[0105] These movements continue until time T5, at which point the rotation of the inner shaft 130 stops. Within the proximal control device 200, the interrupted portion of the annular gear 802 is reached, and gear 802 disengages from the planetary gears, and the rotation of the central gear 816 stops. From time T5 to T6, the user continues to press the trigger 202, and the component operates with movements similar to those described from time T1 to T2. If another interconnection 112 and annular structure 111 are present, the sequence starting at time T6 can be the same as the sequence described starting at time T2 and continuing until time T6. This process can be repeated as needed until all annular structures 111 of the implant 102 are deployed. In some embodiments, further pressing of the trigger 202 can be achieved by a locking mechanism 900 ( Figures 9A-9B Stop to prevent premature unfolding and release of the proximal engagement portion 115.

[0106] In many of the embodiments described herein, deployment of all annular structures 111 can occur by a single, continuous press of trigger 202. In all of these embodiments, the proximal control device 200 may, conversely, be configured such that repeated pulling of trigger 202 is required to deploy all annular structures 111 of implant 102.

[0107] During deployment, for example, after time T0 until the deployment of the nearest lateral annular structure 112 is complete, if the physician wishes to recapture the implant 102, the trigger 202 can be stopped from being pressed. The trigger 202 may be spring-loaded or otherwise biased to return to its outermost position. The physician can adjust the converter 604 from a position corresponding to deployment to a different position corresponding to recapture. This adjustment of the converter 604 will disengage from the claw 603 and engage the claw 602. The physician can then press the trigger 202 again, and this press will translate into a reverse motion of the face gear 610, which in turn translates into a reverse motion of the remaining parts of the first gear assembly 600, cam 703, and second gear assembly 800. For example, if the converter 604 is adjusted at any time between time T0 and T6, the next press of the trigger 202 will cause the event sequence to be reversed. Figure 10B The movement proceeds from right to left. Since these movements are simply the reverses of the movements already described, they will not be repeated here.

[0108] If the physician is satisfied with the deployment process, at 1014, the distal engagement portion 114 and proximal engagement portion 115 of the implant 102 can be released from the distal control member 140 and the gripper 136, respectively. By way of example, in the proximal control device 200, the physician can pull the tab 910 to allow the remaining travel of the trigger 202, which in turn deploys the proximal engagement portion 115 of the implant 102 via distal advance of the gripper 136, proximal retraction of axes 120 and 130, or both. The tab 910 can be coupled to the control line 146, and pulling the tab 910 pulls the line 146 and removes the retainer 142 from the distal engagement portion 114.

[0109] The anchor 152 can then be recaptured (e.g., by deflation of the balloon or retraction of the linear member) and withdrawn into the anchor delivery member 150 (if desired). The anchor delivery member 150, the distal control member 140, and the inner shaft 130 can retract into the outer shaft 120 and then be withdrawn from the urethra.

[0110] Example embodiment of the user component of the proximal control device.

[0111] Refer again Figure 5A The proximal control device 200 may include a movable (e.g., retractable and / or advanceable) handle portion 1102, which is movable relative to a handle portion 1103 located more proximal to the side. Figure 5A A movable stem portion 1102 is depicted in a distal forward position before the implant 102 is deployed, and Figure 5BA portion 1102 is depicted in the proximal retracted position after the implant 102 has been deployed. The movable portion 1102 is secured to the outer shaft 120 and moves with the outer shaft 120, and is also movable independently of the inner shaft 130, the distal control member 140 and the anchor delivery member 150 (not shown).

[0112] Figure 11A This is an interior view of an example embodiment of the movable portion 1102 of the proximal control device 200, which is from... Figures 5A-5B Compared to a reversed view, the proximal end region 105 of the delivery device 103 is shown on the right side as it engages with the housing 1103 of the movable portion 1102, and a multifaceted shaft 708 is shown on the left side. The shaft 708 may be multifaceted to allow an interference fit with the hub 707, although other configurations and fastening techniques may be used such that the shaft 708 is cylindrical (e.g., fastened to the hub 707 using adhesive). A coupling mechanism 1106 is mounted or formed within the housing 1103 and will... Figure 11B-11E A more detailed description is provided. Imaging hardware 1202 is also included within the housing 1103, which will... Figures 12A-12E The imaging hardware 1202 will be described in more detail.

[0113] Figure 11B From the comparison Figure 11A An internal view of the coupling mechanism 1106 taken from a closer angle. Here, the coupling mechanism 1106 includes a user actuator 1107, which in this embodiment is configured as a latch that slides within a track 1108 provided by the housing 1109. Figure 11C The connecting mechanism 1106 is depicted, wherein the proximal side of the housing 1109 is removed to allow view of the internal components. Figure 11D Depicting Figure 11C The connecting mechanism 1106, in which the latch 1107 has also been removed, and Figure 11E Depicting Figure 11D The connecting mechanism 1106, wherein, for further simplification, the housing 1109 is removed.

[0114] The latch 1107 is engaged with a resiliently deflectable member 1110 housed within the housing 1109. Movement of the latch 1107 from its leftmost to its rightmost position (as depicted herein) causes the member 1110 to bend against the inclined surface 1119. The member 1110 is biased toward a straight configuration (as shown in...). Figure 11C-11D (As shown in the diagram), and releasing latch 1107 in the rightmost position allows latch 1107 to return to the leftmost position via the elastic action of member 1110. Member 1110 can be configured as desired according to application requirements. For example, in this embodiment, member 1110 is a nitinol wire.

[0115] When in the leftmost position, component 1110 can be received in one or more slots in the rotary adapter 1112. Figure 11E In one embodiment, there are two slots 1114 and 1115, each of which can receive a member 1110 such that as the rotary adapter 1112 rotates, the member 1110 can slide in the slots 1114 and 1115, but any longitudinal movement (forward and / or retraction) of the rotary adapter 1112 will result in a similar movement of the member 1110.

[0116] Prior to implantation, the proximal end of the inner shaft 130 is coupled to a rotation adapter 1112, which in turn is coupled to a multifaceted shaft 708, which in turn is coupled to a proximal portion 1103 of the proximal control device 200. The outer shaft 120 is coupled to a movable portion 1102, but 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 slots 1114 and / or 1115 of the rotation adapter 1112 engage with the deflectable member 1110. The inner shaft 130 can be inserted through portion 1102 by means of... Figure 11B One or more slopes 1120 depicted in the figure are completed. The distal end 1118 of the rotary adapter 1112 may taper or neck in one or more areas to assist this insertion, which is done by deflecting the member 1110 until the first slot 1115 is in close proximity to the member 1110, at which point the member 1110 will snap into the slot. When the line 1110 engages with one of the slots 1114 or 1115, the movable portion 1102 is coupled to the proximal portion 1103 of the proximal control device 200. In some embodiments, the proximal control device 200 is assembled at this time and ready for use during the implantation process.

[0117] Imaging apparatus and example embodiments of its use.

[0118] In some example embodiments, the connection between the movable portion 1102 (which is fastened to the outer shaft 120) and the rotary adapter 1112 (which is subsequently fastened to the multifaceted 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. (See also: Regarding...) Figure 2A The described imaging device and illumination device (see Figure 12D-12EOne or more cavities 122-124 can be placed at the distal end of the outer shaft 120. These devices can be mounted at the distal end of their respective cavities (or in a common cavity), positioned proximally spaced from the distal end of the inner shaft 130 (from which the implant 102 departs 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 interval between them relative to their distal ends. Conversely, as the inner shaft 130 moves distally, the outer shaft 120 also moves distally, maintaining the same interval (i.e., at the same rate). Thus, the system 100 allows the implant 102 to be delivered from the inner shaft 130 to image at a constant interval from the distal end of the inner shaft 130. Because the slots 1114 and 1115 are annular (e.g., extending similarly annularly around the periphery of the rotation adapter 1112), rotation of the inner shaft 130 is allowed without causing a similar rotation in the outer shaft 120. The deflectable member 1110 simply slides along the corresponding groove 1114 or 1115.

[0119] If a user or medical professional wishes to place the imaging device at different intervals separated from the distal end of the inner axis 130, a coupling mechanism 1106 can be used to release the connection between movable portions 1102 and 1103, and to move movable portion 1102 such that different slots engage with deflectable member 1110. For example, disengaging from slot 1115 and engaging from slot 1114 increases the interval between the imaging device at the distal end of the outer axis 120 and the distal end of the inner axis 130, thus 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. The coupling mechanism 1106 can be engaged in a first position corresponding to the first of slots 1114 and 1115, and if the imaging field of view is poor, the user can disengage the mechanism 1106 and switch to a second position corresponding to the other of slots 1114 and 1115. Although only two slots 1114 and 1115 exist in the embodiments described herein, any number of one, two, three, four, or more slots can be used, each selectable independently from the others, and each corresponding to a different position and field of view. The ability of the imaging and illumination device to move automatically in sync with the longitudinal movement of the inner axis 130 during deployment can be used with any of the embodiments described herein.

[0120] Figure 12A The housing 1203 for the imaging hardware 1202 is depicted. Figure 12B The components inside the housing 1203 are depicted, and Figure 12C These components are depicted from a closer perspective. Figure 12D It is a perspective view depicting the proximal side of the distal end region of the outer tubular member 120, and Figure 12EThis is a perspective view depicting the distal side portion of the distal end region of the outer tubular member 120. The first bus 1204 (which in this embodiment is in the form of a ribbon cable) is located at its distal end ( Figure 12D The imaging device 1220 is connected to the distal end region 1224 of the outer tubular member 120 (not shown). The first bus 1204 may be routed through a cavity of the outer tubular member 120 (e.g., one of cavities 122-124) and its proximal end is connected to one or more contacts. Figure 12C In this example, there are four contacts 1205-1208, used for power supply, ground, receiving signals, and clock.

[0121] The second bus 1210 (which in this embodiment is also in the form of a ribbon cable) at its distal end ( Figure 12D The second bus 1210 is routed through the same or different cavities (e.g., one of cavities 122-124) of the outer tubular member 120, and its proximal end is connected to one or more contacts. Figure 12C In this example, there are 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 to it, including passive RLC components and active components (e.g., transistors, diodes, and / or semiconductor chips). The output circuitry for transmitting the received image may be a wired circuitry that outputs the image to a display via a cable, or a wireless circuitry that wirelessly transmits the image to a local receiver with a display. A flushing port cavity 1223 is also shown. Figure 12D-12E The order of the positions of the imaging device 1220, the illumination device 1222, and the flushing port cavity 1223 can be rearranged from the positions described and shown herein.

[0122] Example implementation of implant placement.

[0123] All embodiments of the system 100 described herein can be used to deliver the implant 102 to a variety of locations near the prostate or other locations within the human anatomy. Figure 13 This is a cross-sectional view of male anatomy, providing background for various examples used to depict the implantation site within the prostatic urethra. Here, the prostate 1302 is located centrally, while the bladder wall 1304 and bladder 1305 are located superiorly. The prostatic urethra 1306 extends downward from the bladder 1305, passes through the ejaculatory duct 1307, and passes through the prostate 1302. The prostatic urethra 1306 becomes the membranous urethra 1308 at the general location of the external urethral sphincter 1309 and continues out of the body. The rectum is indicated by 1310.

[0124] Figure 14A From Figure 13 The viewpoint is rotated to align the cross-section so that the rearward direction extends into the page while the forward direction extends out of the page. Here, an example embodiment of implant 102 is shown positioned within prostatic urethra 1306. Viewed from this angle, implant 102 is generally centrally positioned within prostatic urethra 1306; in other words, the distances separated from the upper and lower edges of prostate 1302 are generally equidistant. The placement of implant 102 is generally determined by a medical professional and may be offset or lowered from the position shown herein, but a position within prostatic urethra 1306 is generally preferred.

[0125] Figure 14B From and Figure 13 The angle generally follows the same direction, depicting the area of ​​the prostate 1302, but with more detail. Here, the prostate 1302 is enlarged, with the middle lobe 1402 protruding into the prostatic urethra 1306. Figure 14C It is along Figure 14B The cross section taken by line 14C-14C shows the nature of a slit-like prostatic urethra 1306 in the enlarged prostate 1302, wherein the width of the urethra 1306 widens as it travels from the anterior to the posterior side.

[0126] Figure 14D Describing about Figure 14B An example embodiment of a post-positioned implant 102 within an example anatomical structure is described, and Figure 14E It is along Figure 14D The cross-section is taken along line 14E-14E. As can be seen here, the implant 102 is generally positioned along the posterior surface of the prostatic urethra 1306. The implant 102 is sized to have a maximum diameter at its maximum center width smaller than the width of the prostatic urethra 1306 (e.g., less than 50%, less than 65%, less than 80%, etc.), such that the implant 102 can be described as being substantially located on the posterior side of the prostatic urethra 1306 and not in contact with the anterior side of the urethra 1306. This placement is illustrated in... Figure 14E As shown, the opening created by the implant 102 through the prostate 1302 is primarily located on the posterior side of the prostate 1302 and the urethra 1306.

[0127] Figure 14F Describing about Figure 14B An example embodiment of an implant 102 placed anteriorly within an example anatomical structure is described, and Figure 14G It is along Figure 14EThe cross-section is taken from line 14G-14G. As can be seen here, the implant 102 is generally positioned along the anterior surface of the prostatic urethra 1306. The implant 102 may be sized to have a maximum diameter at its maximum center width smaller than the width of the prostatic urethra 1306 (e.g., less than 50%, less than 65%, less than 80%, etc.), such that the implant 102 can be described as being substantially located on the anterior side of the prostatic urethra 1306 and not in contact with the posterior side of the urethra 1306. This placement is illustrated in... Figure 14G As shown, the opening created by the implant 102 through the prostate 1302 is primarily located anterior to the prostate 1302 and the urethra 1306. Using both posterior and anterior placement, the implant 102 can still be positioned relatively centrally relative to the prostate 1302, as in... Figure 14A As shown herein. The deployment of the implant 102 in the posterior or anterior position is generally determined by a medical professional. Other placement variations may also be used, including placement centrally located between the posterior and medial sides of the urethra 1306, and dimensional variations may be used such that the implant 102 has a diameter that is relatively larger or smaller than that shown herein relative to the prostate 1302.

[0128] The embodiments described herein are restated and expanded in the following paragraphs without explicit reference to the accompanying drawings. 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 cavity and a second inner cavity, the inner tubular member being slidable within the outer tubular member, wherein the first inner cavity is adapted to receive an elongated grasping member configured for releasable engagement with a proximal portion of the implant; and a distal control member slidable within the second inner cavity, wherein the distal control member includes a retainer configured for releasable engagement with a distal portion of the implant.

[0129] In some embodiments, the implant is configured to maintain the prostatic urethra in a state of at least partial opening. In some embodiments, the implant has a body including first and second annular structures and an interconnect extending between the first and second annular structures. The body of the implant may be a single line. The implant may include a distal engagement member configured to releasably engage with a retainer and / or a proximal engagement member configured to releasably engage with an elongated grasping member. In some embodiments, the implant includes a line-like distal engagement member and / or a line-like proximal engagement member, the line-like distal engagement member extending proximally away from the most distal portion of the implant. In some embodiments, the first annular structure may be the most distal annular structure of the implant and have a relatively smaller width than the second annular structure.

[0130] In some embodiments, the inner tubular member is slidable and rotatable relative to the distal control member, while the retainer is releasably coupled to the distal portion of the implant. The system may also include an elongated member coupled to the retainer, the elongated member having a proximal end that can be manipulated by a user to allow release of the distal portion of the implant from the retainer. In some embodiments, the retainer is tubular and adapted to slide along the distal control member. The distal control member may include a recess adapted to receive the distal portion of the implant, and the retainer may be movable to not cover the recess while the distal portion of the implant is received within the recess. In some embodiments, the retainer includes a slit through which the implant can pass.

[0131] In some embodiments, the system includes an elongated anchor member. The elongated anchor 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 anchor member includes a linear member having a portion configured to automatically deflect upon deployment.

[0132] In some embodiments, the elongated gripper member includes a recess configured to releasably engage with a proximal portion of the implant. In some embodiments, the system is configured such that when the recess is not confined by a first cavity, the proximal portion of the implant is freely released from the recess of the elongated gripper member.

[0133] In some embodiments, a proximal control device is included, and the proximal control device is coupled to a proximal end region of the delivery device. The proximal control device may be user-operable to control the deployment of the implant from the delivery device. In some embodiments, the proximal control device includes a housing and is configured to advance an elongated gripper member distally relative to the housing and the inner tubular member, and / or to retract and rotate the inner tubular member proximally relative to the housing and the distal control member, and / or to retract the outer tubular member proximally relative to the housing.

[0134] In some embodiments, the proximal control device includes: a user actuator; a first gear assembly coupled to the user actuator; a cam assembly coupled to the first gear assembly; and a second gear assembly coupled to the cam assembly. In some embodiments, the first gear assembly is configured to control longitudinal movement of the elongated gripper member, the cam assembly is configured to control longitudinal movement of the inner tubular member, and / or the second gear assembly is configured to control rotation of the inner tubular member.

[0135] In many embodiments, a system for delivering an implantable device is provided, wherein the system includes: a delivery device including a first elongated member having an inner cavity, an elongated gripper member slidable within the inner cavity and configured to hold a proximal portion of the implant, and a distal control member configured to hold a distal portion of the implant; and a proximal control device coupled to a proximal end region of the delivery device, the proximal control device including a user actuator and a housing.

[0136] In some embodiments, the proximal control device includes a first gear assembly within the housing, configured to convert movement of a user actuator into movement within the first gear assembly. In some embodiments, the proximal control device includes a transducer that selects between movement of the first gear assembly in a first direction and movement of the first gear assembly in a second direction. In some embodiments, the user actuator is coupled to a yoke, which is coupled to a first pawl and a second pawl. The transducer can selectively engage either the first pawl or the second pawl with a pinion. The proximal control device can be configured such that rotation of the pinion causes rotation of a face gear. The proximal control device can be configured such that rotation of the face gear causes rotation of a reel coupled to an elongated gripper member.

[0137] In some embodiments, the system further includes an input gear engaging with a face gear and a reel gear engaging with the input gear, the reel gear being coupled to or integrated with a reel. In some embodiments, the input gear is an interrupted gear, and rotation of the reel gear caused by the input gear results in rotation of the reel and longitudinal movement of the elongated gripper member. In some embodiments, movement of the first gear assembly in a first direction results in distal movement of the elongated gripper member, and movement of the first gear assembly in a second direction results in proximal movement of the elongated gripper member.

[0138] In some embodiments, the proximal control device includes a cam assembly within the housing, configured to translate movement of a user actuator into movement within the cam assembly. The cam assembly may be coupled to a first elongated member and configured to move the first elongated member proximally relative to the housing. In some embodiments, the cam assembly includes a rotatable cam with a slit, the first elongated member coupled to a guide member received within the slit. In some embodiments, the slit includes an inclined slit portion and a radial slit portion. The cam assembly may include an inner tube with a longitudinal slit, wherein the guide member is received within the longitudinal slit.

[0139] In some embodiments, the first gear assembly includes a face gear having a first set of teeth that engages with the teeth of another gear in the first gear assembly, wherein the face gear is coupled to a cam assembly such that movement of the face gear causes movement in the cam assembly.

[0140] In some embodiments, the proximal control device includes a second gear assembly, and movement in the cam assembly causes movement in the second gear assembly. The second gear assembly may be coupled to a first elongated member and may be configured to rotate the first elongated member relative to the housing. The second gear assembly may include a central gear having a bore configured to receive the first elongated member, such that rotation of the central gear causes rotation of the first elongated member. In some embodiments, the second gear assembly includes a ring gear coupled to the cam assembly and coupled to the central gear via a planetary gear assembly. The ring gear may engage with the planetary gear assembly such that rotation of the ring gear in a first direction causes rotation of the central gear in a first direction, and rotation of the ring gear in a second direction causes rotation of the central gear in a second direction, the rotation of the central gear in the first direction being opposite to the rotation in the second direction.

[0141] In some embodiments, the proximal control device includes a releasable locking mechanism that prevents the proximal portion of the implant, held by an elongated gripper member, from leaving the cavity. In some embodiments, the locking mechanism includes a movable tracking mechanism that engages with a slot in a face gear of a first gear assembly, the proximal control device being configured such that movement of the face gear as the implant leaves the cavity causes movement of the tracking mechanism. The proximal control device may be configured to prevent further movement of the tracking mechanism before the proximal portion of the implant leaves the cavity.

[0142] In some embodiments, the proximal control device includes a release mechanism configured to be actuated by a user, wherein the release mechanism is configured to disengage the tracking mechanism from the face gear to allow the proximal portion of the implant to exit the cavity. The release mechanism may be a pull tab and may be coupled to an elongated gripper member.

[0143] In many embodiments, a method of delivering an implant is provided, the method comprising: advancing a delivery device within a patient's body cavity, wherein the delivery device includes a first tubular member for receiving the implant, a distal control member slidable within the first tubular member and releasably coupled to a distal portion of the implant, and an elongated gripper member slidable within the first tubular member and releasably coupled to a 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 the proximal portion of the implant from the elongated gripper member.

[0144] In some embodiments, the body cavity is the human prostatic urethra. In some embodiments, upon release of the distal and proximal portions, the implant is released from the delivery device in a state adapted to maintain the prostatic urethra in a state of at least partial opening.

[0145] In some embodiments, the implant has a body including first and second annular structures and an interconnect extending between the first and second annular structures, and causing relative movement may include advancing an elongated grasping member distally. In some embodiments, the method further includes rotating the first tubular member relative to a distal control member in a first direction while the first annular structure is exposed from the first tubular member. In some embodiments, the method further includes rotating the first tubular member relative to the distal control member in a second direction, opposite to the first direction, while the second annular structure is exposed from the first tubular member. The rotation of the first tubular member in the first and second directions may occur when the distal control member is releasably coupled to a distal portion of the implant.

[0146] In some embodiments, the method further includes retracting the first tubular member proximally relative to the elongated gripping member and the distal control member to expose the interconnect from the first tubular member. In some embodiments, the method further includes rotating the first tubular member while retracting it proximally. In these embodiments, the interconnect may be curved.

[0147] In some embodiments, the retainer connects 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.

[0148] In some embodiments, the method further includes exposing a proximal portion of the implant from within the first tubular member to release the proximal portion of the implant from the elongated gripper member.

[0149] In some embodiments, the method further includes anchoring the delivery device against the bladder wall before causing relative movement between the elongated gripping member and the first tubular member. In some embodiments, anchoring the delivery device includes inflating a balloon within the bladder.

[0150] In some embodiments, the proximal control device is coupled to the proximal end region of the delivery device, and the method includes a user moving a user actuator of the proximal control device, wherein moving the user actuator causes movement in a first gear assembly of the proximal control device. In some embodiments, the first gear assembly causes an elongated gripping member to advance distally relative to a first tubular member. In some embodiments, the first gear assembly causes movement in a cam assembly and a second gear assembly. In some embodiments, movement in the cam assembly causes intermittent retraction of the first tubular member relative to a distal control member. In some embodiments, movement in the second gear assembly causes intermittent rotation of the first tubular member relative to the distal control member.

[0151] In some embodiments, the user actuator is a first user actuator, and the method includes actuating a second user actuator of the proximal control device. In some embodiments, actuating the second user actuator unlocks the locking mechanism and allows release of the distal portion of the implant from the distal control member and the proximal portion of the implant from the elongated gripper member. In some embodiments, actuating the second user actuator removes the retainer from the distal portion of the implant and rotates the distal control member to disengage the distal portion of the implant from the distal control member.

[0152] In some embodiments, the first tubular member is an inner tubular member that is slidably received within an outer tubular member of the delivery device.

[0153] In many embodiments, a system for delivering an implant is provided, wherein the system includes a delivery device comprising: an outer tubular member including an imaging device located in a distal end region of the outer tubular member; an inner tubular member within the outer tubular member, wherein the inner tubular member is adapted to receive at least a portion of the implant; one or more structures slidably advanceable within the inner tubular member to cause the implant to unfold 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 by means of a coupling mechanism, wherein the proximal control device is configured to move the inner tubular member and the outer tubular member longitudinally simultaneously.

[0154] In some embodiments, the system further includes an implant. The implant may be configured to maintain the prostatic urethra in a state of at least partial opening. In some embodiments, the implant has a body including first and second annular structures and an interconnect extending between the first and second annular structures.

[0155] In some embodiments, one or more structures include: an elongated gripper member configured to be releasably coupled to a proximal portion of the implant; and a distal control member configured to be releasably coupled to a distal portion of the implant. In some embodiments, the distal control member includes a retainer configured to be releasably coupled to a distal portion of the implant, wherein the implant includes a distal engagement member configured to be releasably coupled to the retainer. In some embodiments, the implant includes a proximal engagement member configured to be releasably coupled to the elongated gripper member. In some embodiments, the implant includes a line-like distal engagement member extending proximally away from the distal portion of the implant. In some embodiments, the implant includes a line-like proximal engagement member.

[0156] In some embodiments, the proximal control device is configured to rotate and move longitudinally relative to the distal control device, while the distal control device 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.

[0157] In some embodiments, the system further includes an elongated member coupled to the retainer and having a proximal end that can be manipulated by a user to allow release of a distal portion of the implant from the retainer. In some embodiments, the retainer is tubular and adapted to slide along a distal control member. In some embodiments, the distal control member includes a recess adapted to receive a distal portion of the implant. In some embodiments, the retainer is movable to not cover the recess while the distal portion of the implant is received within the recess. In some embodiments, the retainer includes a slit.

[0158] In some embodiments, the system further includes an elongated anchor member. In some embodiments, the elongated anchor member includes an anchor configured to contact the bladder wall. In some embodiments, the anchor is an inflatable balloon. In some embodiments, the elongated anchor member includes a plurality of balloons. In some embodiments, the elongated anchor member includes a linear member having a portion configured to automatically deflect upon deployment.

[0159] In some embodiments, the elongated gripper member includes a recess configured to releasably engage with a proximal portion of the implant. In some embodiments, the system is configured such that when the recess is not confined by a first cavity, the proximal portion of the implant is freely released from the recess of the elongated gripper member.

[0160] In some embodiments, the proximal control device includes a first portion and a second portion, the first portion including a first housing with a handle, and the second portion including a second housing, the second portion being slidable relative to the first portion. In some embodiments, an inner tubular member is fastened to the first housing, and an outer tubular member is fastened to the second housing. In some embodiments, release of the coupling mechanism allows the first portion to be disconnected from the second portion. In some embodiments, the coupling mechanism includes a deflectable member that can be received within a groove in a shaft portion of the first portion of the proximal control device.

[0161] In some embodiments, the groove is annular and extends around the periphery of the shaft portion, wherein the shaft portion is fastened to an inner tubular member. In some embodiments, the shaft portion includes a plurality of grooves, each adapted to receive a deflectable member. In some embodiments, the deflectable member is slidable within the groove, such that the shaft portion is rotatable while the deflectable member is received within the groove.

[0162] In some embodiments, the second portion includes a flexible bus having a first end electrically connected to a printed circuit board and a second end electrically connected to an imaging device within the second portion.

[0163] In some embodiments, the distal end region of the outer tubular member further includes a lighting device.

[0164] In some embodiments, the second portion includes: a first flexible bus having a first end electrically connected to a printed circuit board and a second end electrically connected to an imaging device within the second portion; and a second flexible bus having a first end electrically connected to a printed circuit board and a second end electrically connected to an illumination device within the second portion.

[0165] In some embodiments, the distal end region of the inner tubular member is spaced apart from the distal end region of the outer tubular member, and wherein the proximal control device is configured to move the outer tubular member and the inner tubular member longitudinally simultaneously without changing the spaced distance.

[0166] In some embodiments, the proximal control device includes: a user actuator; a first gear assembly coupled to the user actuator; a cam assembly coupled to the first gear assembly; and a second gear assembly coupled to the cam assembly. In some embodiments, the first gear assembly is configured to control longitudinal movement of an elongated gripper member, the cam assembly is configured to control longitudinal movement of an inner tubular member, and the second gear assembly is configured to control rotation of the inner tubular member.

[0167] In some embodiments, the implant is sized to fit perfectly within the prostatic urethra. In some embodiments, the delivery system can be used to deliver the implant to an anterior position within the prostatic urethra. In some embodiments, the delivery system can be used to deliver the implant to a posterior position within the prostatic urethra.

[0168] In many embodiments, a method of imaging the delivery of an implant is provided, the method comprising: 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 end region of the outer tubular member; an inner tubular member located within the outer tubular member and receiving at least a portion of the implant; and one or more structures slidably advanceable within the inner tubular member to cause deployment of 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 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 simultaneously (a) retracting the outer tubular member longitudinally relative to the proximal control device, and (b) imaging the at least partially deployed implant using the imaging device located in a distal end region of the outer tubular member. In some embodiments, the urethra is a prostatic urethra.

[0169] In some embodiments, the method further includes releasing the implant from the delivery device. In some embodiments, the method further includes releasing the implant from the delivery device such that the implant is completely within the prostatic urethra.

[0170] In some embodiments, the implant is released while in an expanded state, the diameter of which is smaller than the minimum width of the prostatic urethra in which the implant is released.

[0171] In some embodiments, the implant is released such that it contacts the final tissue surface of the prostatic urethra. In some embodiments, the implant is released such that it does not contact the foremost tissue surface of the prostatic urethra.

[0172] In some embodiments, the implant is released such that it contacts the foremost tissue surface of the prostatic urethra. In some embodiments, the implant is released such that it does not contact the posterior tissue surface of the prostatic urethra.

[0173] In some embodiments, the outer tubular member retracts longitudinally at the same rate as the inner tubular member.

[0174] In some embodiments, the method further includes: 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 the inner tubular member is rotating, 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 an imaging device.

[0175] In some embodiments, the method further includes the steps of: 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. In some embodiments, coupling the first portion of the proximal control device to the second portion of the proximal control device includes coupling a deflectable member of the second portion to a slot in the first portion.

[0176] In some embodiments, the method further includes illuminating the implant using an illumination device at the distal end region of the outer tubular member.

[0177] In many embodiments, a method for a user to assemble 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 using a coupling mechanism, wherein the inner tubular member is longitudinally and rotatably 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.

[0178] In some embodiments, the first portion may be coupled to the second portion in more than one position, and the method includes: coupling the first portion of the proximal control device to the second portion of the proximal control device, wherein the coupling mechanism is in a first position; disconnecting the first portion of the proximal control device from 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, wherein the coupling mechanism is in a second position.

[0179] In some embodiments, the first position corresponds to a first distance between the distal ends of the inner tubular member and the outer tubular member, and the second position corresponds to a second distance between the distal ends of the inner tubular member and the outer tubular member, wherein the first distance and the second distance are different. In some embodiments, the second distance is greater than the first distance and corresponds to a relatively wider imaging field of view at the second position compared to the first position.

[0180] In many embodiments, a method of delivering an implant is provided, the method comprising: advancing a delivery device within a patient's urethra; deploying the implant from the delivery device to a position fully within the patient's prostatic urethra, wherein, during deployment, the implant changes from a non-displaced state to a displaced state; and removing the delivery device from the patient while the implant remains in the displaced state within the prostatic urethra, the displaced state maintaining passage through the prostatic urethra, the diameter of the implant in the displaced state being smaller than the minimum width of the prostatic urethra adjacent to the implant, wherein, after removal of the delivery device, the implant contacts the last tissue surface of the prostatic urethra.

[0181] In some embodiments, after the delivery device is removed, the implant contacts the last tissue surface of the prostatic urethra and does not contact the foremost tissue surface of the prostatic urethra.

[0182] In many embodiments, a method of delivering an implant is provided, the method comprising: advancing a delivery device within a patient's urethra; deploying the implant from the delivery device to a position fully within the patient's prostatic urethra, wherein, during deployment, the implant changes from a non-displaced state to a displaced state; and removing the delivery device from the patient while the implant remains in the displaced state within the prostatic urethra, the displaced state maintaining passage through the prostatic urethra, the diameter of the implant in the displaced state being smaller than the minimum width of the prostatic urethra adjacent to the implant, wherein, after removal of the delivery device, the implant contacts the anterior tissue surface of the prostatic urethra.

[0183] In some embodiments, after the delivery device is removed, the implant contacts the foremost tissue surface of the prostatic urethra but not the last tissue surface of the prostatic urethra.

[0184] All features, elements, components, functions, and steps relating to any embodiment provided herein are intended to be freely combinable and may utilize those alternatives from any other embodiment. If certain features, elements, components, functions, or steps are described with respect to only one embodiment, they should be understood to be usable with every other embodiment described herein, unless expressly stated otherwise. Therefore, this paragraph serves as a prior basis and written support for introducing claims at any time that combine features, elements, components, functions, and steps from different embodiments, or substitute features, elements, components, functions, and steps from another embodiment for features, elements, components, functions, and steps from one embodiment, even if such combinations or substitutions are not expressly stated in the following description in particular circumstances. It should be clearly acknowledged that explicitly listing every possible combination and substitution would be cumbersome, especially considering that those skilled in the art will readily recognize the permissibility of each and all such combinations and substitutions.

[0185] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural indications unless the context clearly indicates otherwise.

[0186] While the embodiments are prone to various modifications and alternative forms, specific examples of the embodiments have been illustrated in the accompanying drawings and described in detail herein. However, it should be understood that these embodiments are not limited to the specific forms disclosed; rather, they will cover all modifications, equivalents, and alternatives falling within the spirit of this disclosure. Furthermore, any feature, function, step, or element of the embodiments, as well as negative limitations, may be recorded or added to the claims, such negative limitations defining the inventive scope of the claims by features, functions, steps, or elements not included in that scope.

Claims

1. A system for delivering an implant, the system comprising a delivery device, the delivery device comprising: An outer tubular member, including an imaging device located in the distal end region of the outer tubular member; An inner tubular member is located within the outer tubular member and includes a first inner cavity and a second inner cavity, wherein the first inner cavity is adapted to receive at least a portion of the implant; One or more structures are slidably advanceable within the inner tubular member to cause the implant to unfold from within the inner tubular member; 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; and The implant, The proximal control device is configured to cause the inner tubular member and the outer tubular member to move longitudinally simultaneously. Wherein, the one or more structures include: An elongated gripper component, housed within the first cavity and configured for releasable engagement with a proximal portion of the implant; and A distal control member, which is housed within the second cavity and configured to be releasably coupled to the distal portion of the implant, The proximal control device comprises a first part and a second part. The first part includes a first housing with a handle. The second part includes a second housing and is slidable relative to the first part. The inner tubular member is fastened to the first housing, and the outer tubular member is fastened to the second housing.

2. The system of claim 1, wherein, The implant is configured to maintain the prostatic urethra in a state of at least partial opening.

3. The system of claim 2, wherein, The implant has a body comprising first and second annular structures and an interconnect extending between the first and second annular structures.

4. The system of claim 1, wherein, The distal control member includes a retainer configured to be releasably coupled to the distal portion of the implant, wherein the implant includes a distal engagement member configured to be releasably coupled to the retainer.

5. The system of claim 1, wherein, The implant includes a proximal engagement member configured to be releasably coupled to the elongated gripper member.

6. The system of claim 1, wherein, The implant includes a distal engagement member similar to a thread, which extends proximally away from the most distal portion of the implant.

7. The system of claim 1, wherein, The implant includes a proximal junction member similar to a thread.

8. The system of claim 1, wherein, The proximal control device is configured to rotate and move longitudinally relative to the distal control member, while the distal control member is releasably coupled to the distal portion of the implant.

9. The system of claim 8, wherein, The proximal control device is configured to rotate the inner tubular member without rotating the outer tubular member.

10. The system of claim 4 further includes an elongated member coupled to the retainer and having a proximal end that can be manipulated by a user to allow release of the distal portion of the implant from the retainer.

11. The system of claim 10, wherein, The retainer is tubular and adapted to slide along the distal control member.

12. The system of claim 1, wherein, The distal control member includes a recess adapted to receive the distal portion of the implant.

13. The system of claim 4, wherein, The distal control member includes a recess adapted to receive the distal portion of the implant, and wherein the retainer is movable to not cover the recess while the distal portion of the implant is received within the recess.

14. The system of claim 13, wherein, The retainer includes a slit.

15. The system according to claim 1 further includes an elongated anchor member.

16. The system of claim 15, wherein, The elongated anchor member includes an anchor configured to contact the bladder wall.

17. The system of claim 16, wherein, The anchor is an inflatable balloon.

18. The system of claim 16, wherein, The elongated anchor component includes multiple balloons.

19. The system of claim 15, wherein, The elongated anchor member includes a linear member having a portion configured to automatically deflect when deployed.

20. The system of claim 1, wherein, The elongated gripper component includes a recess configured to releasably engage with the proximal portion of the implant.

21. The system of claim 20, wherein, The system is configured such that when the recess is not restricted by the first inner cavity, the proximal portion of the implant is freely released from the recess of the elongated gripper member.

22. The system of claim 1, wherein, The release of the coupling mechanism allows the first part to be disconnected from the second part.

23. The system of claim 22, wherein, The coupling mechanism includes a deflectable member that can be received in a groove in the shaft portion of the first part of the proximal control device.

24. The system of claim 23, wherein, The groove is annular and extends around the periphery of the shaft portion, wherein the shaft portion is fastened to the inner tubular member.

25. The system of claim 23, wherein, The shaft portion includes a plurality of slots, each adapted to receive the deflectable member.

26. The system of claim 23, wherein, The deflectable member is slidable within the groove, making the shaft portion rotatable, while the deflectable member is received within the groove.

27. The system of claim 1, wherein, The second portion includes a 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.

28. The system of claim 1, wherein, The distal end region of the outer tubular member also includes a lighting device.

29. The system according to claim 1, wherein, The distal end region of the outer tubular member further includes a lighting device, and wherein the second portion includes: A first flexible bus having a first end electrically connected to a printed circuit board and a second end electrically connected to the imaging device within the second portion; and The second flexible bus has a first end electrically connected to the printed circuit board and a second end electrically connected to the lighting device within the second portion.

30. The system according to claim 1, wherein, The distal end region of the inner tubular member is spaced away from the distal end region of the outer tubular member, and the proximal control device is configured to move the outer tubular member and the inner tubular member longitudinally simultaneously without changing the spaced distance.

31. The system according to claim 1, wherein, The proximal control device includes: User actuator; The first gear assembly is connected to the user actuator; A cam assembly, connected to the first gear assembly; and The second gear assembly is connected to the cam assembly.

32. The system according to claim 31, wherein, The first gear assembly is configured to control the longitudinal movement of the elongated gripper member, the cam assembly is configured to control the longitudinal movement of the inner tubular member, and the second gear assembly is configured to control the rotation of the inner tubular member.

33. The system according to claim 1, wherein, The implant is sized to fit perfectly within the prostatic urethra.

34. The system according to claim 33, wherein, The delivery system can be used to deliver the implant to an anterior position within the prostatic urethra.

35. The system according to claim 33, wherein, The delivery system can be used to deliver the implant to a posterior position within the prostatic urethra.

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