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

Abstract

To provide a system, a device, and a method for delivery of an implant into the prostatic urethra.SOLUTION: A delivery system 100 can include a delivery device for insertion into a patient and a proximal control device 200 for use in controlling release of the implant from the delivery device. The delivery device comprises: an outer tubular member; an inner tubular member which includes a first inner lumen and a second inner lumen and is slidable within the outer tubular member, the first inner lumen being conformed so as to house an elongation grasper member configured to connect to the proximal portion of the implant releasably; and a distal control member which is slidable in the second inner lumen and comprises a retainer configured to connect to the distal portion of the implant releasably.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to and the benefit of U.S. Provisional Application No. 62 / 432,542, filed December 9, 2016, which is incorporated herein by reference in its entirety for all purposes.

[0002] (Field) The subject matter described herein relates to systems, devices, and methods for the delivery or deployment of implants into the prostatic urethra, and more particularly, to delivery in an atraumatic and minimally invasive manner through the tortuous bends of the male urethra. [Background technology]

[0003] (background) Numerous clinical reasons exist for the placement of implants into the prostatic urethra, such as for the treatment of urinary retention associated with benign prostatic hyperplasia (BPH), prostate cancer, bladder cancer, urinary tract injuries, prostatitis, bladder sphincter dyssynergia, benign or malignant urethral strictures, and other conditions for which treatment is desired. Accurate and consistent placement of implants into the prostatic urethral lumen has proven difficult due to the necessarily complex and tortuous anatomical geometry, interpatient geometric and anatomic variability, and anatomical limitations associated with these conditions. Furthermore, complex challenges are presented in designing and / or fabricating systems with sufficient flexibility to deliver such implants in a minimally invasive manner. For these and other reasons, there is a need for improved systems, devices, and methods for delivering implants to the prostatic urethra. Summary of the Invention [Means for solving the problem]

[0004] (summary) Provided herein are several exemplary embodiments of delivery systems and associated methods for delivering or deploying implants within the prostatic urethra or other parts of the body. Delivery system embodiments can 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 can include multiple tubular components, each with various functions, as described in more detail herein. Several embodiments of implants for use with the delivery systems are also described.

[0005] Other systems, devices, methods, features, and advantages of the subject matter described herein will be, or will become, apparent to one of ordinary skill in the art upon examination of the following figures and detailed description. All such additional systems, methods, features, and advantages are intended to be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. Features of the exemplary embodiments should not be construed in any way as limiting the appended claims unless there is an express recitation of those features in the claims. The present specification also provides, for example, the following items: (Item 1) 1. A system for delivering an implantable device, the system comprising: a delivery device; an outer tubular member; an inner tubular member having a first inner lumen and a second inner lumen, the inner tubular member slidable within the outer tubular member, the first inner lumen adapted to house an elongate grasper member configured to releasably couple with a proximal portion of an implant; a distal control member slidable within the second inner lumen, the distal control member comprising a retainer configured to releasably couple with a distal portion of the implant; A system comprising: (Item 2) Item 10. The system of item 1, further comprising the implant. (Item 3) 3. The system of claim 2, wherein the implant is configured to maintain the prostatic urethra at least partially open. (Item 4) Item 4. The system of item 3, wherein the implant has a body comprising first and second ring-shaped structures and an interconnect extending between the first and second ring-shaped structures. (Item 5) 5. The system of claim 4, wherein the body of the implant is only a single wire. (Item 6) Item 3. The system of item 2, wherein the implant comprises a distal engagement member configured to releasably couple with the retainer. (Item 7) Item 3. The system of item 2, wherein the implant comprises a proximal engagement member configured to releasably couple with the elongate grasper member. (Item 8) Item 3. The system of item 2, wherein the implant comprises a wire-like distal engagement member extending proximally away from the distal-most portion of the implant. (Item 9) Item 3. The system of item 2, wherein the implant comprises a wire-like proximal engagement member. (Item 10) 3. The system of claim 2, wherein the first ring-shaped structure is the distal-most ring-shaped structure of the implant and has a relatively smaller width than the second ring-shaped structure. (Item 11) Item 10. The system of item 1, wherein the inner tubular member is slidable and rotatable relative to the distal control member, while the retainer is releasably coupled to a distal portion of the implant. (Item 12) Item 12. The system of item 11, further comprising an elongate member coupled to the retainer and having a proximal end operable by a user to enable release of the distal portion of the implant from the retainer. (Item 13) Item 13. The system of item 12, wherein the retainer is tubular and adapted to slide along the distal control member. (Item 14) Item 10. The system of item 1, wherein the distal control member comprises a recess adapted to receive a distal portion of the implant. (Item 15) Item 15. The system of item 14, wherein the retainer is movable to expose the recess while a distal portion of the implant is received within the recess. (Item 16) Item 16. The system of item 15, wherein the retainer comprises a slot. (Item 17) Item 10. The system of item 1, further comprising an elongate anchor member. (Item 18) Item 18. The system of item 17, wherein the elongate anchor member comprises an anchor configured to contact a bladder wall. (Item 19) Item 19. The system of item 18, wherein the anchor is an inflatable balloon. (Item 20) Item 19. The system of item 18, wherein the elongate anchor member comprises a plurality of balloons. (Item 21) Item 18. The system of item 17, wherein the elongate anchor member comprises a wireform member having a portion configured to automatically deflect upon deployment. (Item 22) Item 10. The system of item 1, wherein the elongate grasper member comprises a recess configured to releasably couple with a proximal portion of the implant. (Item 23) Item 23. The system of item 22, wherein the system is configured such that a proximal portion of the implant is free to release from the recess in the elongate grasper member when the recess is unconstrained by the first inner lumen. (Item 24) Item 10. The system of item 1, further comprising a proximal control device coupled to a proximal end region of the delivery device. (Item 25) 25. The system of claim 24, wherein the proximal control device is operable by a user to control deployment of the implant from the delivery device. (Item 26) 25. The system of claim 24, wherein the proximal control device comprises a housing and is configured to advance the elongate grasper member distally relative to the housing and the inner tubular member. (Item 27) 25. The system of claim 24, wherein the proximal control device comprises a housing and is configured to proximally retract and rotate the inner tubular member relative to the housing and the distal control member. (Item 28) Item 25. The system of item 24, wherein the proximal control device comprises a housing and is configured to retract the outer tubular member proximally relative to the housing. (Item 29) The proximal control device a user actuator; a first gear assembly coupled to the user actuator; a cam assembly coupled to the first gear assembly; a second gear assembly coupled to the cam assembly; and Item 25. The system of item 24, comprising: (Item 30) 30. The system of claim 29, wherein the first gear assembly is configured to control longitudinal movement of the elongated grasper member, the cam assembly is configured to control longitudinal movement of the inner tubular member, and the second gear assembly is configured to control rotation of the inner tubular member. (Item 31) 1. A system for delivering an implantable device, the system comprising: a delivery device comprising: a first elongated member having an inner lumen, an elongated grasper member slidable within the inner lumen and configured to hold a proximal portion of an implant; and a distal control member configured to hold a distal portion of the implant; a proximal control device coupled to a proximal end region of the delivery device, the proximal control device comprising a user actuator and a housing; A system comprising: (Item 32) Item 32. The system of item 31, wherein the proximal control device comprises a first gear assembly within the housing, and the proximal control device is configured to translate movement of the user actuator into movement within the first gear assembly. (Item 33) Item 32. The system of item 31, wherein the proximal control device comprises a switch that selects between movement of the first gear assembly in a first direction and movement of the first gear assembly in a second direction. (Item 34) Item 34. The system of item 33, wherein the user actuator is coupled to a yoke that is coupled to the first pawl and the second pawl. (Item 35) Item 35. The system of item 34, wherein the switch selectively engages either the first pawl or the second pawl with a pinion gear. (Item 36) Item 36. The system of item 35, wherein the proximal control device is configured such that rotation of the pinion gear causes rotation of a bevel gear. (Item 37) Item 37. The system of item 36, wherein the proximal control device is configured such that rotation of the bevel gear causes rotation of a reel coupled to the elongated grasper member. (Item 38) an input gear engaged with the bevel gear; a reel gear engaged with the input gear, the reel gear being coupled or integrated with the reel; Item 38. The system of item 37, further comprising: (Item 39) Item 39. The system of item 38, wherein the input gear is an intermittent gear, and rotation of the reel gear by the input gear causes rotation of the reel and longitudinal movement of the elongated grasper member. (Item 40) Item 34. The system of item 33, wherein movement of the first gear assembly in the first direction causes distal movement of the elongated grasper member, and movement of the first gear assembly in the second direction causes proximal movement of the elongated grasper member. (Item 41) Item 33. The system of item 32, wherein the proximal control device includes a cam assembly within the housing, the proximal control device configured to translate movement of the user actuator into movement within the cam assembly. (Item 42) Item 42. The system of item 41, wherein the cam assembly is coupled to the first elongated member. (Item 43) Item 43. The system of item 42, wherein the cam assembly is configured to move the first elongate member proximally relative to the housing. (Item 44) Item 44. The system of item 43, wherein the cam assembly comprises a rotatable cam having a slot, the first elongated member coupled with a guide member received within the slot. (Item 45) Item 45. The system of item 44, wherein the slot comprises an angled slot portion and a radial slot portion. (Item 46) Item 45. The system of item 44, wherein the cam assembly comprises an inner tube having a longitudinal slot, the guide member being received within the longitudinal slot. (Item 47) Item 42. The system of item 41, wherein the first gear assembly comprises a bevel gear having a first set of teeth that engage with teeth of another gear in the first gear assembly, the bevel gear coupled to the cam assembly such that movement of the bevel gear causes movement in the cam assembly. (Item 48) Item 42. The system of item 41, wherein the proximal control device comprises a second gear assembly. (Item 49) Item 49. The system of item 48, wherein movement in the cam assembly causes movement in the second gear assembly. (Item 50) Item 50. The system of item 49, wherein the second gear assembly is coupled to the first elongated member and configured to rotate the first elongated member relative to the housing. (Item 51) Item 51. The system of item 50, wherein the second gear assembly includes a central gear having an opening configured to receive the first elongate member such that rotation of the central gear causes rotation of the first elongate member. (Item 52) Item 52. The system of item 51, wherein the second gear assembly comprises a ring gear coupled to the cam assembly and coupled to the central gear via a planetary gear assembly. (Item 53) Item 53. The system of item 52, wherein the ring gear engages the planetary gear assembly such that rotation of the ring gear in a first direction causes a first directional rotation of the central gear and rotation of the ring gear in a second direction causes a second directional rotation of the central gear, the first directional rotation of the central gear being opposite to the second directional rotation. (Item 54) Item 33. The system of item 32, wherein the proximal control device comprises a releasable locking mechanism that prevents a proximal portion of the implant held by the elongate grasper member from exiting the inner lumen. (Item 55) Item 55. The system of item 54, wherein the locking mechanism comprises a movable tracking mechanism that interfaces with a groove in a bevel gear of the first gear assembly, and the proximal control device is configured such that movement of the bevel gear moves the tracking mechanism as the implant exits the inner lumen. (Item 56) Item 56. The system of item 55, wherein the proximal control device is configured such that the tracking mechanism is prevented from further movement prior to the proximal portion of the implant exiting the inner lumen. (Item 57) Item 57. The system of item 56, wherein the proximal control device comprises a release structure configured to be actuated by a user, the release structure configured to disengage the tracking mechanism from the bevel gear and allow a proximal portion of the implant to exit the inner lumen. (Item 58) Item 58. The system of item 57, wherein the release structure is a pull tab. (Item 59) Item 58. The system of item 57, wherein the release structure is coupled to the elongated grasper member. (Item 60) 32. The system of claim 31, further comprising the implant. (Item 61) 1. A method of delivering an implant, comprising: advancing a delivery device within a patient's body cavity, the delivery device comprising: a first tubular member that houses an implant; a distal control member slidable within the first tubular member and releasably coupled to a distal portion of the implant; and an elongated grasper member slidable within the first tubular member and releasably coupled to a proximal portion of the implant; creating relative movement between the elongate grasper member and the first tubular member to expose at least a portion of the implant from within the first tubular member; releasing a distal portion of the implant from the distal control member and a proximal portion of the implant from the elongated grasper member; A method comprising: (Item 62) Item 62. The method of item 61, wherein the body cavity is the prostatic urethra of a human. (Item 63) 62. The method of claim 61, wherein, upon release of the distal portion and the proximal portion, the implant is released from the delivery device in a state adapted to maintain the prostatic urethra at least partially open. (Item 64) Item 62. The method of item 61, wherein the implant has a body comprising first and second ring-shaped structures and an interconnect extending between the first and second ring-shaped structures. (Item 65) Item 65. The method of item 64, wherein causing relative movement includes distally advancing the elongate grasper member. (Item 66) Item 66. The method of item 65, further comprising rotating the first tubular member in a first direction relative to the distal control member during exposure of the first ring-shaped structure from the first tubular member. (Item 67) Item 67. The method of item 66, further comprising rotating the first tubular member in a second direction relative to the distal control member during exposure of the second ring-shaped structure from the first tubular member, the second direction being opposite to the first direction. (Item 68) Item 68. The method of item 67, wherein rotation of the first tubular member in the first and second directions occurs while the distal control member is releasably coupled to a distal portion of the implant. (Item 69) Item 66. The method of item 65, further comprising retracting the first tubular member proximally relative to the elongate grasper member and the distal control member to expose the interconnect from the first tubular member. (Item 70) Item 69. The method of item 68, further comprising proximally retracting the first tubular member while rotating the first tubular member. (Item 71) Item 70. The method of item 69, wherein the interconnect is curved. (Item 72) Item 62. The method of item 61, wherein a retainer couples a distal portion of the implant to the distal control member, the method including releasing the retainer and releasing the distal portion of the implant from the distal control member. (Item 73) Item 62. The method of item 61, further comprising exposing a proximal portion of the implant from within the first tubular member and releasing the proximal portion of the implant from the elongate grasper member. (Item 74) 75. The method of claim 61, further comprising anchoring the delivery device to a wall of the bladder before causing relative movement between the elongate grasper member and the first tubular member. 75. The method of claim 74, wherein anchoring the delivery device comprises inflating a balloon within the bladder. (Item 76) a proximal control device coupled to a proximal end region of the delivery device; Item 62. The method of item 61, wherein the method includes moving a user actuator of the proximal control device by the user, and moving the user actuator causes movement within a first gear assembly of the proximal control device. (Item 77) Item 77. The method of item 76, wherein the first gear assembly advances the elongate grasper member distally relative to the first tubular member. (Item 78) Item 77. The method of item 76, wherein the first gear assembly causes movement in a cam assembly and a second gear assembly. (Item 79) Item 79. The method of item 78, wherein movement within the cam assembly causes intermittent retraction of the first tubular member relative to the distal control member. (Item 80) Item 79. The method of item 78, wherein movement within the second gear assembly causes intermittent rotation of the first tubular member relative to the distal control member. (Item 81) Item 77. The method of item 76, wherein the user actuator is a first user actuator and the method includes actuating a second user actuator of the proximal control device. (Item 82) Item 82. The method of item 81, wherein actuating the second user actuator unlocks a locking mechanism and allows release of a distal portion of the implant from the distal control member and a proximal portion of the implant from the elongate grasper member. (Item 83) Item 82. The method of item 81, wherein actuating the second user actuator removes a retainer from a distal portion of the implant, rotates the distal control member, and disengages the distal portion of the implant from the distal control member. (Item 84) Item 62. The method of item 61, wherein the first tubular member is an inner tubular member slidably received within an outer tubular member of the delivery device.

[0006] Details of the subject matter described herein, both as to its structure and operation, may become apparent by examination of the accompanying figures, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed on illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, and relative sizes, shapes, and other detailed attributes may be illustrated schematically, rather than literally or precisely. [Brief explanation of the drawings]

[0007] [Figure 1A] FIG. 1A is a block diagram depicting an exemplary embodiment of a delivery system. [Figure 1B]1B, 1C, and 1D are side, end, and perspective views, respectively, depicting an exemplary embodiment of an implant. [Figure 1C] 1B, 1C, and 1D are side, end, and perspective views, respectively, depicting an exemplary embodiment of an implant. [Figure 1D] 1B, 1C, and 1D are side, end, and perspective views, respectively, depicting an exemplary embodiment of an implant. [Figure 2A] 2A-2H are perspective views depicting an exemplary embodiment of a delivery system at different stages of implant deployment. [Figure 2B] 2A-2H are perspective views depicting an exemplary embodiment of a delivery system at different stages of implant deployment. [Figure 2C] 2A-2H are perspective views depicting an exemplary embodiment of a delivery system at different stages of implant deployment. [Figure 2D] 2A-2H are perspective views depicting an exemplary embodiment of a delivery system at different stages of implant deployment. [Figure 2E] 2A-2H are perspective views depicting an exemplary embodiment of a delivery system at different stages of implant deployment. [Figure 2F] 2A-2H are perspective views depicting an exemplary embodiment of a delivery system at different stages of implant deployment. [Figure 2G] 2A-2H are perspective views depicting an exemplary embodiment of a delivery system at different stages of implant deployment. [Figure 2H] 2A-2H are perspective views depicting an exemplary embodiment of a delivery system at different stages of implant deployment. [Figure 3A] 3A-3C are perspective views depicting an exemplary embodiment of a grasper component in use within a delivery system. [Figure 3B]3A-3C are perspective views depicting an exemplary embodiment of a grasper component in use within a delivery system. [Figure 3C] 3A-3C are perspective views depicting an exemplary embodiment of a grasper component in use within a delivery system. [Figure 4A] 4A-4J are partial cross-sectional views depicting exemplary embodiments of anchor delivery members of a delivery system. [Figure 4B] 4A-4J are partial cross-sectional views depicting exemplary embodiments of anchor delivery members of a delivery system. [Figure 4C] 4A-4J are partial cross-sectional views depicting exemplary embodiments of anchor delivery members of a delivery system. [Figure 4D] 4A-4J are partial cross-sectional views depicting exemplary embodiments of anchor delivery members of a delivery system. [Figure 4E] 4A-4J are partial cross-sectional views depicting exemplary embodiments of anchor delivery members of a delivery system. [Figure 4F] 4A-4J are partial cross-sectional views depicting exemplary embodiments of anchor delivery members of a delivery system. [Figure 4G] 4A-4J are partial cross-sectional views depicting exemplary embodiments of anchor delivery members of a delivery system. [Figure 4H] 4A-4J are partial cross-sectional views depicting exemplary embodiments of anchor delivery members of a delivery system. [Figure 4I] 4A-4J are partial cross-sectional views depicting exemplary embodiments of anchor delivery members of a delivery system. [Figure 4J] 4A-4J are partial cross-sectional views depicting exemplary embodiments of anchor delivery members of a delivery system. [Figure 5] 5A-5B are side views depicting an exemplary embodiment of a delivery system at various stages of implant deployment. [Figure 6A] 6A and 6B are interior side and interior perspective views, respectively, depicting an exemplary embodiment of a proximal control device. [Figure 6B] 6A and 6B are interior side and interior perspective views, respectively, depicting an exemplary embodiment of a proximal control device. [Figure 6C] FIG. 6C is a perspective view depicting an exemplary embodiment of a gear for use with a delivery system. [Figure 7] 7A and 7B are internal top-down and top-down views depicting an exemplary embodiment of the components of the proximal control device and a perspective view depicting an exemplary embodiment of the cam. [Figure 8] FIG. 8 is an interior side view depicting an exemplary embodiment of a gear assembly. [Figure 9A] 9A-9F are internal perspective views depicting exemplary embodiments of components of a proximal control device. [Figure 9B] 9A-9F are internal perspective views depicting exemplary embodiments of components of a proximal control device. [Figure 9C] 9A-9F are internal perspective views depicting exemplary embodiments of components of a proximal control device. [Figure 9D] 9A-9F are internal perspective views depicting exemplary embodiments of components of a proximal control device. [Figure 9E] 9A-9F are internal perspective views depicting exemplary embodiments of components of a proximal control device. [Figure 9F] 9A-9F are internal perspective views depicting exemplary embodiments of components of a proximal control device. [Figure 10A] FIG. 10A is a flowchart depicting an exemplary embodiment of a method for delivering an implant. [Figure 10B] FIG. 10B is a timing diagram depicting an exemplary embodiment of a sequence of steps for deploying an implant. DETAILED DESCRIPTION OF THE INVENTION

[0008] (Detailed explanation) Before the present subject matter is described in detail, it is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary. Also, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting, as the scope of the present disclosure will be limited only by the appended claims.

[0009] 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 an implant within the prostatic urethra can vary. While the embodiments described herein are particularly suitable for treating BPH, they are not so limited. Other conditions for which these embodiments may be used include, but are not limited to, the treatment of obstruction from prostate cancer, bladder cancer, urinary tract injuries, prostatitis, bladder sphincter dyssynergia, and / or benign or malignant urethral strictures. Furthermore, these embodiments may also be applicable to the deployment of one or more implants within the human vascular system, cardiac system, pulmonary system, or gastrointestinal tract, including other locations in the urinary tract or bladder, as well as other biological lumens, cavities, or spaces, such as the heart, stomach, intestines, liver, spleen, pancreas, and kidneys.

[0010] FIG. 1A is a block diagram depicting an embodiment of an exemplary delivery system 100 having an elongated delivery device 103 coupled to a proximal control device 200. The distal end region 104 is adapted to be inserted through the urethral meatus into a patient's urethra (or other lumen or body cavity). The distal end region 104 preferably has an atraumatic configuration (e.g., relatively soft and rounded) to minimize irritation or trauma to the patient. The elongated delivery device 103 carries or stores 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 a proximal control device 200, which remains outside the patient's body and is configured to be used by a physician or other medical professional to control the delivery of the one or more implants 102.

[0011] Exemplary Embodiments of Delivery Devices and Associated Methods 1B, 1C, and 1D are side, end, and perspective views, respectively, depicting an exemplary embodiment of implant 102 in a rest configuration. The implantable device 102 is biased toward the rest configuration depicted here and is transformable between the rest configuration and a more elongated storage (or delivery) configuration (see, e.g., FIG. 3A ) for storing implant 102 within a delivery device 103. The storage configuration can be a straight or linearized state with minimal curvature. The rest configuration has a relatively larger lateral width and a relatively shorter longitudinal length than the storage configuration. Upon exiting the open end of delivery device 103, implant 102 is free to transition its shape back toward that of the rest configuration, although constraints imposed by the patient's urethral wall may prevent implant 102 from fully reaching the rest configuration. Because the implant 102 is biased toward the resting configuration, the implant 102 is configured to automatically expand upon release from the restraining force of the delivery device 103 and may be referred to as "self-expanding." For example, the shape of the implant 102 in its deployed state within the patient's urethra may be referred to as the deployed configuration, and the deployed configuration may be identical to the resting configuration, although in many cases it will be a shape that is deformed from the resting configuration by surrounding tissue.

[0012] The implant 102 can be configured in a number of different ways, including any and all of those implant configurations described in U.S. Patent Publication No. 20150257908 and / or International Publication No. WO2017 / 184887 (both of which are incorporated herein by reference for all purposes).

[0013] The implant 102 can be formed from one or more discrete bodies (e.g., wires, ribbons, tubular members) of variable geometry. Referring to the embodiment of FIGS. 1B-1D , the implant 102 has a main body formed from only one single wire member set to a predetermined shape. The implant 102 can have two or more ring-shaped structures 111 (in this embodiment, there are four: 111a, 111b, 111c, and 111d), with one or more interconnects 112 extending between each pair of adjacent ring-shaped structures 111 (in this embodiment, there is one interconnect between each adjacent pair, for a total of three: 112a, 112b, and 112c). Each interconnect 112 extends from one ring-shaped structure 111 to an immediately adjacent ring-shaped structure 111. Each interconnect 112 can have a relatively straight shape (not shown) or a curved (eg, semicircular or semi-elliptical) shape, as shown in FIGS. 1B-1D.

[0014] The ring-shaped structures 111 are configured to hold the urethra fully or partially open when expanded from the retracted configuration. Device 100 can be manufactured in various sizes, as desired, such that the width (e.g., diameter) of each ring-shaped structure 111 is slightly larger than the width of the urethra, and the length of each interconnection 112 determines the spacing between the ring-shaped structures 111. The ring-shaped structures 111 can have the same or different widths. For example, in the embodiment depicted herein, ring-shaped structure 111a has a relatively smaller width than structures 111b-111d, which have the same width. This can accommodate the prostatic urethra, which converges into a smaller geometry before the bladder neck.

[0015] Each ring-shaped structure 111 can be located or positioned in a single plane, and in some embodiments, that single plane can be oriented with a normal axis perpendicular to the central access 124 of the implant 102 (as depicted in FIG. 1B). In other embodiments, the ring-shaped structures 111 can be positioned in multiple planes. The ring-shaped structures 111 can extend around the central axis 126 and form a perfect circle (e.g., a 360-degree turn), or, as shown here, can form a near-perfect circle (e.g., less than 360 degrees). While not limited as such, in many embodiments, the ring-shaped structures 111 extend between 270 and 360 degrees.

[0016] 1B-1D, the geometry of implant 102 can have a cylindrical or generally cylindrical profile with a circular or elliptical cross-section. In other embodiments, implant 102 can have a prismatic or generally prismatic shape with a triangular or generally triangular cross-section, or other.

[0017] The implant 102 can 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 can serve one or more purposes, such as allowing for controlled release of the implant 102, allowing movement of the ends of the implant 102 relative to each other, and / or allowing for retrieval of the implant 102 after deployment, for example, in instances where a physician desires to recapture the implant 102 and redeploy it to a different location. In this embodiment, the distal engagement member 114 is a wire-like extension from the ring-shaped structure 111 a having a curved (e.g., S-shaped) shape to position the atraumatic end 116 (e.g., rounded, spherical, ball-shaped) in a suitable location for engagement with the delivery device 103, thereby allowing control of the distal end region of the implant 102. Similarly, proximal engaging member 115 has a curved shape to position another atraumatic end 117 in a suitable location for engagement with delivery device 103, thereby allowing control of the proximal end region of implant 102. In other embodiments, distal engaging member 114 and proximal engaging member 115 can be omitted, and delivery device 103 can be coupled to implant 102 at one or more other distal and / or proximal locations, such as on ring-shaped structure 111 or interconnection 112.

[0018] Delivery device 103 can include one or more elongate flexible members (e.g., 120, 130, 140, and 150, as described below), each having one or more inner lumens. One or more elongate flexible members of delivery device 103 can be solid or solid members without an inner lumen. FIG. 2A is a perspective view depicting an exemplary embodiment of distal end region 104 of delivery device 103. In this embodiment, delivery device 103 includes first elongate tubular member 120, second elongate tubular member 130, third elongate tubular member 140, and fourth elongate tubular member 150. Delivery device 103 can vary and in other embodiments can include more or fewer tubular members.

[0019] In this embodiment, the first elongate tubular member 120 is the outermost tubular member and is flexible while providing support for the members contained therein. The first tubular member 120 is referred to herein as the outer shaft 120 and can have one or more inner lumens. In this embodiment, the outer shaft 120 includes a first inner lumen 121 that houses a second elongate tubular member 130, referred to herein as the inner shaft 130. The outer shaft 120 and the inner shaft 130 are each controllable independently of the other. The inner shaft 130 can slide distally and proximally within the lumen 121 and is shown here extending partially from the open distal end of the outer shaft 120.

[0020] In this embodiment, the outer shaft 120 includes three additional lumens 122, 123, and 124. An illumination device (not shown) and an imaging device (not shown) can be housed within either of the lumens 122 and 123. The imaging device can utilize any desired type of imaging modality, such as optical or ultrasound imaging. In one exemplary embodiment, the imaging device utilizes a forward (distal) looking CMOS imager. The illumination device can be configured to provide proper illumination for optical imaging and, in one embodiment, includes one or more light-emitting diodes (LEDs). In embodiments where illumination is not required, such as for ultrasound imaging, the illumination device and its respective lumen 122 or 123 can be omitted. The illumination device and / or imaging device can be fixedly secured to the distal end of the lumens 122 and 123, respectively, or can be slidable within the lumens 122 and 123, respectively, allowing for further distal advancement from and / or retraction into the outer shaft 120. In one exemplary embodiment, the illumination device and imaging device are both mounted, and only a single lumen 122 or 123 is present for that purpose. Lumen 124 can be configured as an irrigation or flushing port, through which a fluid, such as saline, can be introduced into the urethra to cleanse the area and provide proper fluid through which the implant 102 and surrounding prostatic urethral wall can be imaged.

[0021] The outer shaft 120 has a proximal end (not shown) that is coupled to the proximal control device 200. The delivery device 103 is steerable and can be configured to navigate tortuous anatomy. The steerability can be unidirectional (e.g., using a single pull wire) or multidirectional (e.g., using two or more pull wires arranged at different radial locations about the device 103) depending on the needs of the application. In some embodiments, the steerable structure (e.g., pull wires) extends from the distal end region 104 of the delivery device 103 (e.g., the distal ends of the pull wires are affixed to a plate or other structure within the distal end region 104) to the proximal control device 200, where it can be manipulated by a user to steer the delivery device 103. The steering structure can be located within one or more lumens of the outer shaft 120 or can be coupled to or embedded in a sidewall of the outer shaft 120. The delivery device 103 can be biased so that the device 103 automatically biases in a particular lateral direction and biases (e.g., bends) in that manner so that the force applied to steer the delivery device 103 is opposite this biased bias. Other mechanisms for steering the delivery device 103 can also be used. The steering mechanism may also be locked or adjusted during deployment of the implant 102 to control the position of the implant 102 within the anatomy (e.g., steering anteriorly during deployment can help place the implant 102 in a more desirable anterior position).

[0022] The inner shaft 130 can include one or more inner lumens for storing one or more implants 102 and / or other components. In this embodiment, the inner shaft 130 includes a first lumen 131 in which the one or more implants 102 can be stored and a second lumen 132 in which a third elongate tubular member 140 can be stored. In this embodiment, the third elongate tubular member 140 is configured to releasably couple with 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 can be slidably advanced and / or retracted relative to the inner shaft 130. The distal control member 140 can include an inner lumen 141 that stores a fourth elongate tubular member 150, which is shown extending from the open distal end of the distal control member 140. The fourth elongate tubular member 150 is configured to anchor the delivery device 103 relative to the patient's anatomy, for example, to keep components of the delivery device 103 stationary relative to the anatomy during deployment of the implant 102, and is referred to as the anchor delivery member 150.

[0023] 2A , anchor delivery member 150 extends from lumen 141 of distal control member 140, which, along with inner shaft 130, is shown extending from lumen 121 of outer shaft 120. As delivery device 130 is advanced through the urethra, anchor delivery member 150 is preferably fully retracted within distal control member 140, and distal control member 140, along with inner shaft 130, are retracted from the position shown in FIG. 2A such that they reside within lumen 121 of outer shaft 120 and do not extend from the open distal end of lumen 120. In other words, in some embodiments, the open distal end of outer shaft 120 forms the distal-most configuration of device 103 upon initial advancement through the urethra. This facilitates steering of delivery device 103 by outer shaft 120. The physician can advance distal end region 104 of delivery device 103 adjacent the desired implantation site or completely into the patient's bladder. Anchor delivery member 150 can be exposed from the open distal end of distal control member 140 either by advancing anchor delivery member 150 further distally into the bladder, or, if already in the bladder, by retracting other components of delivery device 103 proximally. At this point, the anchors from anchor delivery member 150 can be deployed within the bladder.

[0024] The placement of these components within system 100 is not limited to the embodiments described with respect to FIG. 2A . In some embodiments, outer shaft 120 can be omitted entirely. In such embodiments, visualization of the deployment procedure can be accomplished using external imaging, such as fluoroscopy, implant 102 and delivery device 103 can be radiopaque or can include radiopaque markers, and imaging and illumination lumens 122 and 123 (and imaging and illumination devices) and irrigation lumens are omitted. In some embodiments, instead of distal control member 140 being slidably received within inner shaft 130, distal control member 140 can be slidable within a lumen of outer shaft 120 (either the same lumen that receives inner shaft 130 or a different lumen). Similarly, instead of anchor delivery member 150 being slidably received within distal control member 140, anchor delivery member 150 can be slidable within a lumen of outer shaft 120 (either the same or a different lumen that receives inner shaft 130 and / or anchor delivery member 150) or a lumen of inner shaft 130 (either the same or a different lumen that receives distal control member 140). In some embodiments, outer shaft 130 can have separate and distinct lumens for each of members 130, 140, and 150 and can be configured to deploy implant 102 around members 140 and 150.

[0025] FIG. 2B is a perspective view depicting the distal end region 104 of delivery device 103 with various components deployed. In this embodiment, anchor delivery member 150 includes anchor 152 in the form of an expandable member or balloon. Other embodiments of anchor 152 are described with respect to FIGS. 4A-4G. Anchor 152 expands (or otherwise transitions) to a size greater than that of the bladder neck so that anchor 152 resists proximal retraction (e.g., relatively light tension). In embodiments in which anchor 152 is a balloon, the balloon can be elastic or inelastic and inflatable with an inflation medium (e.g., air or a liquid such as saline) introduced into balloon 152 through one or more inflation ports 153. Here, three inflation ports 153 communicate with an inflation lumen located on the shaft of anchor delivery member 150 and extending proximally back to proximal control device 200, which may include a port for inflation using a syringe. Upon deployment of anchors 152, the physician can retract delivery system 100 proximally until anchors 152 contact the bladder neck and / or wall (if not already in contact).

[0026] The physician can use the imaging device on the outer shaft 120 to move the delivery device 103 proximally away from the anchor 152 until the physician begins deploying the implant 102 at the desired location within the urethra. 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 at a location 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 shaft 130 together proximally and / or distally relative to the anchor delivery member 150. In another embodiment, the position of the retainer 142 is fixed relative to the anchor 152 so that the longitudinal position of the implant 102 within the anatomy is set by the system independent of any manipulation by the physician. The coupling of the distal engaging member 114 and the retainer 142 also allows the physician to manipulate the radial orientation of the implant 102 by rotating the distal control member 140 and the inner shaft 130 together. Active or passive shaping of the distal control member 140 can allow for more desirable placement of the implant 102. For example, the member 140 may have a curvature that places the implant in a more anterior anatomical location. This curvature may be inherently set within the member 150 or actively applied by the physician through a separate entity, such as a control wire. Once in the desired location and orientation, the physician can retract the inner shaft 130 proximally relative to the distal control member 140 to begin deployment of the implant 102.

[0027] The distal engagement member 114 is held in place relative to the distal control member 140 by a retainer 142, and proximal retraction of the inner shaft 130 relative to the distal control member 140 causes the ring-shaped structures 111 to begin sequential deployment (111a, then 111b, then 111c, then 111d (not shown)). The distal control member 140 can remain stationary during deployment or be moved longitudinally relative to the urethra. In some embodiments, the distal control member 140 is steerable to allow the angulation of the implant 102 to accommodate relatively tortuous anatomy. Mechanisms for achieving steerability are discussed elsewhere herein and can be similarly applied to the distal control member 140. In these or other embodiments, the distal control member 140 is significantly flexible and can passively accommodate to tortuous anatomy. In some embodiments, the distal control member 140 has a predetermined curve to aid in navigation.

[0028] To aid in deployment, inner shaft 130 can be rotated clockwise and counterclockwise (as depicted by arrow 134) about distal control member 140. Referring back to Figures 1B-1C, implant 102 has a non-constant winding direction, as viewed starting from distal engagement member 114, that is, antegrade clockwise along ring-shaped structure 111a, then retrograde counterclockwise along interconnection 112a for ring-shaped structure 111b, then retrograde clockwise along interconnection 112b for ring-shaped structure 111c, then retrograde counterclockwise along interconnection 112c for ring-shaped structure 111d, until terminating at proximal engagement member 115. Depending on the winding direction of the portion of the implant 102 exiting the open distal end of the lumen 131, the transition of the implant 102 toward the resting configuration may impart a torque on the shaft 130 if the shaft 130 is not actively rotated as the implant 102 is deployed. Such a torque may rotate the shaft 130 passively (without user intervention) in either a clockwise or counterclockwise direction, as appropriate. In certain embodiments described elsewhere herein, the shaft 130 is actively rotated during deployment. 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 of the ring-shaped structures 111 are wound in the same direction, i.e., clockwise or counterclockwise (e.g., as in the case of a full spiral or helical implant), or have no set winding direction.

[0029] In this or other embodiments, the distal end region of the inner shaft 130 is configured to be relatively more flexible than a more proximal portion of the inner shaft 130, which can avoid excessive movement of the rest of the device 103 during deployment, resulting in better visualization and less tissue contact by the device 103. Such a configuration can also reduce stress imparted on the implant 102 by the device 103 during delivery. For example, during deployment, the portion of the inner shaft 130 extending from the outer shaft 120 can be relatively more flexible than the portion of the inner shaft 130 that remains within the outer shaft 120, thus allowing the inner shaft 130 to flex more easily as the implant 102 exits the inner lumen 131. This, in turn, can stabilize the delivery device 103 and allow the physician to obtain stable images of the appointment process.

[0030] 2B depicts the implant 102 after the three ring-shaped structures 111a, 111b, and 111c have been deployed. Proximal retraction of the shaft 130 continues until the entire implant 102, or at least all of the ring-shaped structures 111, have exited the lumen 131. When the physician is satisfied with the deployed position of the implant 102 and the deployed shape of the implant 102, the implant 102 can be released from the delivery device 103.

[0031] Release of the distal end of implant 102 can be accomplished by releasing retainer 142. Retainer 142 can be a cylindrical structure or other sleeve that acts linearly or rotationally over a cavity or recess in which a portion of implant 102 is housed. In the embodiment of FIG. 2B , retainer 142 includes an opening or slot that allows distal engagement member 114 to pass therethrough. Retainer 142 can rotate relative to the cavity or recess in which distal engagement member 114 (not shown) is housed until an opening or slot is positioned over member 114, freeing member 114 from distal control member 130. Rotation of retainer 142 can be accomplished by rotation of a rotatable shaft, rod, or other member coupled with retainer 142 (and accessible in proximal control device 200).

[0032] 2C and 2D are perspective views depicting another exemplary embodiment of system 100, in which different embodiments of retainer 142 are shown in further detail. Here, retainer 142 slides distally and / or proximally relative to distal control member 140. Distal engagement member 114 of implant 102 can be received within a corresponding recess in distal control member 140. Retainer 142 can slide over distal engagement member 114 while received within this recess until retainer 142 abuts a stepped portion of member 140. Control wire 146 extends within the length of control member 140, either within the same lumen as anchor delivery member 150 or a different lumen. Control wire 146 is coupled to retainer 142 with an enlarged portion 147, from which control wire 146 can be routed through opening 148 in member 140.

[0033] Engaging member 114 can be placed within the recess, and retainer 142 can be advanced over engaging portion 114 to secure the distal end of implant 102 and control member 140. Upon satisfactory deployment of implant 102 within the urethra, for example, in the state of FIG. 2C , retainer 142 can be retracted proximally using control wire 146 to expose engaging member 114 and enable its release from member 140. FIGS. 2E and 2F are perspective views depicting another embodiment of system 100 with another configuration for retainer 142 that operates in a similar manner to that described with respect to FIGS. 2C and 2D . Here, implant 102 is not shown, and recess 143 in which distal engaging member 114 can be received is shown in further detail.

[0034] 2G and 2H are side and perspective views, respectively, of another exemplary embodiment of system 100. In this embodiment, inner shaft 130 includes a flexible distal extension 160 within which inner lumen 131 (not shown) is located. In this configuration, the open distal end of lumen 131 is located distal to the open distal end of lumen 132 (not shown), from which distal control member 140 extends. Lumens 122, 123, and 124 (not shown) are located on the outer shaft 120 opposite distal extension 160. Flexible distal extension 160 contributes to flexibility, stabilizes the delivery system, and stabilizes images. Flexible extension 160 helps align ring-shaped structure 111 in a planar manner and helps guide (e.g., radially orient) implant 102 toward the urethral wall during deployment.

[0035] Release of the proximal end of the implant 102 is also controllable. Figure 3A is a partial cross-sectional view depicting an exemplary embodiment of the system 100, in which a portion of the implant 102 is shown within the inner lumen 131 of the inner shaft 130. Here, the implant 102 is in a linearized state prior to deployment using a proximal engagement member 115 coupled to a grasper 136 that is slidable distally and / or proximally within the lumen 131. The grasper 136 can include a distal end region 137 on or coupled to a shaft 138. The grasper 136 is preferably controllable to rotate and longitudinally translate (e.g., push and pull) the implant 102 relative to the inner shaft 130.

[0036] 3B and 3C are perspective views depicting an exemplary embodiment of the distal end region 137 of the grasper 136 without and with the implant 102, respectively. The grasper 136 includes a recess (also referred to as a cavity or pocket) 139 for receiving and retaining the proximal engaging member 115. Here, the enlarged portion 117 is retained within the recess 139 by a distal reduced-diameter region having a relatively smaller width. While within the inner lumen 131, the sidewall of the inner shaft 130 maintains the proximal engaging member 115 within the recess 139. Once the distal end region 137 exits the inner lumen 131 (either by retracting the inner shaft 130 relative to the grasper 136 or by advancing the grasper 136 relative to the inner shaft 130), the restraining force exerted by the inner shaft sidewall is no longer present, and the engaging member 115 is free to release from the grasper 136. Thus, once the physician is satisfied with the placement of the deployed implant 102, the distal engaging member 114 can be released by moving the retainer 142 and allowing the distal engaging member 114 to decouple from the control member 140, and the proximal engaging member 115 can be released by exposing the grasper 136 from within the inner shaft 130 and allowing the proximal engaging member 115 to decouple from the grasper 136.

[0037] The grasper 136 can also assist in loading the implant 102. In some embodiments, applying a tensile force on the implant 102 with the grasper 136 (while the opposite end of the implant 102 is anchored, e.g., by a retainer 142) facilitates the transition of the implant 102 from a resting configuration to a linearized configuration suitable for insertion of the implant 102 into the inner shaft 130.

[0038] Anchor delivery member 150 can have a number of different configurations and geometries (including, for example, extending in one direction across the bladder wall, in two directions (e.g., left and right) across the bladder wall, or in more than two directions across the bladder wall). FIGS. 4A-4B are cross-sectional views depicting exemplary embodiments of anchor delivery member 150 at various stages of deployment within a patient's body. In FIG. 4A , anchor delivery member 150 is advanced through urethra 401 until open distal end 151 is past the bladder neck and within bladder 402, although in this and other embodiments, end 401 can be stopped prior to entering bladder 402. Here, two tethering arms 408 a and 408 b are retracted within an inner lumen of anchor delivery member 150. In other embodiments, tethering arms 408 can each be retracted within a separate lumen within member 150. Tethering arm 408 can be advanced distally relative to anchor delivery member 150 (or anchor delivery member 150 can be advanced into bladder 402 and retracted proximally relative to tethering arm 408) such that, upon exiting open distal end 151, deflectable portions 410a and 410b transition laterally and contact the bladder wall, forming anchor 152, as depicted in FIG. 4B.

[0039] Tethering arms 408 can be formed from a shape-retaining material that is biased toward the resting configuration of FIG. 4B . The distal ends of tethering arms 408 can each have an atraumatic end (e.g., rounded, spherical, ball-shaped) as depicted here, or alternatively, the distal ends of arms 408 can be curved away from the bladder wall for additional atraumatic effect. In other embodiments, only one tethering arm 408 is used. FIG. 4C is a cross-sectional view depicting another exemplary embodiment of anchor delivery member 150. Here, deflectable portions 410a and 410b have a generally straight or linearized shape and deflect distally and / or proximally from a shared shaft 412 that is slidable relative to anchor delivery member 150. In all of the anchoring embodiments described herein, one or more deflectable portions can deflect from a shared shaft (as depicted here) or from separate shafts (as depicted in FIGS. 4A-4B ).

[0040] 4D-4E are partial cross-sectional views depicting another exemplary embodiment of anchor delivery member 150. FIG. 4D depicts this embodiment in which anchor 152 is in a state of partial deployment from open distal end 151 of anchor delivery member 150. FIG. 4E depicts anchor 152 after full deployment within bladder 402. Here, 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, anchors 152 are biased toward the resting configuration depicted in FIG. 4E and automatically transition toward this configuration once exposed from within the inner lumen of anchor delivery member 150. Hinges 422 can each be implemented as a living hinge, for example, defined by a reduced or more relatively flexible section of the device, as depicted in FIG. Other hinge configurations can also be utilized.

[0041] In another embodiment, a pull wire or other member 424 is attached to one or more of the posts 421 and / or hinges 422c and extends proximally of the proximal control device 200. In FIG. 4E, the pull member 424 is shown in dashed lines to indicate that it is optional. Proximal retraction of the pull member 424 in the proximal control device 200 deflects the structural arrangement laterally to the configuration depicted in FIG. 4E. This arrangement provides a significant locking force while tension is maintained on the pull member 424.

[0042] FIG. 4F is a partial cross-sectional view depicting another exemplary embodiment of anchor delivery member 150. Here, shape-retaining element 430 is advanced from within the inner lumen of anchor delivery member 150, where it was in a relatively straight or linearized shape. Upon exiting open distal end 151, the distal portion of element 430 automatically transitions toward laterally expanded shape 432, which in this embodiment is in the shape of a coil or spiral. FIG. 4G depicts another exemplary embodiment in which laterally expanded shape 432 has multiple loops and resembles the number "8" or a bow tie. Many different shapes can be utilized for laterally expanded shape 432 in addition to those depicted here. In all of the anchoring embodiments, the distal end of the wire or element exposed to body tissue can have a rounded or enlarged atraumatic end (as depicted in FIGS. 4F and 4G).

[0043] Upon completion of the implant deployment procedure, anchor 152 can be collapsed or retracted to allow removal of delivery device 103. For example, in embodiments where anchor 152 is a balloon, the balloon is deflated and optionally retracted into the lumen of device 103, followed by removal from the bladder and urethra. In embodiments where anchor 152 is a wireform or other expandable member (such as those described with respect to FIGS. 4A-4G ), anchor 152 can be retracted into the lumen of deployed device 103, followed by removal from the bladder and urethra. Retraction can be accomplished using fluid or pneumatic actuation, a screw-type mechanism, or otherwise.

[0044] In Figure 2B, anchor 152 is a generally spherical balloon with anchor delivery member 150 extending through the center. In other embodiments, balloon anchor 152 can be laterally offset or positioned on only one side of anchor delivery member 150. Figure 4H is a partial cross-sectional view depicting an exemplary embodiment with a laterally offset balloon 152. Here, laterally offset balloon 152 applies a force to the side of bladder neck 403, urging anchor delivery member 150 (and delivery device 103) in direction 450.

[0045] In other embodiments, device 103 can include two or more balloons that can be independently inflated in different lateral directions. Independent inflation of one or more balloons while maintaining one or more remaining balloons in a deflated state can allow the user to change the angle of the delivery catheter relative to the anatomy, thus enabling deployment of an implant within anatomy with significant curvature. FIG. 4I depicts another exemplary embodiment in which a first anchor balloon 152a is inflated to a larger size than a second anchor balloon 152b located on the opposite side of member 150. As a result of the force exerted on the bladder wall, member 150 is tilted in direction 451 away from the smaller balloon 152b. Selection of the appropriate balloon or balloons for inflation can be performed by the physician, and the inflation and deflation process can be repeated until the physician achieves the desired angular orientation of device 103 within the anatomy at which the remainder of the delivery procedure can be performed. Delivery member 150 can be a flexible or rigid shaft pre-shaped in a manner that will not interfere with the ability of implant 102 to be placed in the desired anatomical location. For example, a curvature in member 150 just proximal to the balloon mounting location may allow implant 102 to be placed more anteriorly without constraint from the bladder neck.

[0046] In some embodiments, a shaped or substantially elastic balloon can be inflated co-located with the bladder neck. Figure 4J depicts an exemplary embodiment in which balloon 152 is inflated at bladder neck 403. Here, balloon 152 includes a first lobe 155 formed within bladder 402 and a second lobe 156 formed within urethra 401. This configuration can be used to anchor member 150 directly across bladder neck 403.

[0047] Exemplary Embodiments of Proximal Control Devices and Associated Methods FIG. 5A is a side view depicting an exemplary embodiment of delivery system 100 prior to deployment of implant 102, and FIG. 5B is a side view depicting this embodiment with implant 102 in a deployed configuration (anchor delivery member 150 and distal control member 140 are not shown). In this embodiment, proximal control device 200 is a handheld device having a handle 201, a user actuator 202 (configured as a trigger in this example), and a main body 203. The longitudinal axis of delivery device 103 is indicated by dashed line 204. Proximal control device 200 can include a manual mechanism whereby actuation of actuator 202 causes relative movement of components of device 103. In other embodiments, proximal control device 200 can instead utilize a motorized mechanism.

[0048] 6A is an internal view of the proximal control device 200, depicting various mechanical assemblies or subassemblies 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 motion on the implant 102: distal advancement (e.g., pushing) of the implant 102 along the axis 204, proximal retraction (e.g., pulling) of the implant 102 and / or inner shaft 130 along the axis 204, and rotation (e.g., rotating) of the inner shaft 130 about the axis 204. In other embodiments, depending on the desired delivery function, the proximal control device 200 can be configured to perform any subset of one or two of the aforementioned types of motion, to perform these types of motion but imparted on different components, or to perform other types of motion not described herein.

[0049] In this embodiment, proximal control device 200 includes a longitudinally translatable member 601, in this embodiment configured as a yoke. Yoke 601 is coupled to trigger 202 such that a recess in trigger 202 causes proximal longitudinal translation of yoke 601. Yoke 601 is coupled to two proximally located ratchet members 602 and 603, in this embodiment configured as pawls. Pawl 602 has a set of teeth that oppose corresponding teeth on pawl 603, and the teeth of each pawl 602 and 603 can interface or engage with complementary teeth on gear 605 (see FIG. 6B), herein referred to as a pinion gear, that is part of first gear assembly 600.

[0050] Switch 604 is user-accessible and can be biased between two positions, with each position engaging only one of pawls 602 and 603 with pinion gear 605. Pawls 602 and 603 are each deflectable and biased (e.g., with a spring) toward engagement with pinion gear 605. In this embodiment, placing switch 604 in the downward position moves pawl 602 out of engagement with pinion gear 605 and moves pawl 603 into engagement with pinion gear 605. Proximal movement of yoke 601 and pawl 603 rotates pinion gear 605 counterclockwise. Placing switch 604 in the upward position reverses the engagement, placing pawl 602 into engagement with pinion gear 605, and proximal movement of yoke 601 and pawl 602 rotates pinion gear 605 clockwise.

[0051] In this embodiment, first gear assembly 600 includes pinion gear 605, second gear 610, third gear 612, and fourth gear 614. In other embodiments, first gear assembly 600 can be implemented using more or fewer gears than those described herein to achieve the same or similar functionality.

[0052] The pinion gear 605 is engaged with a second gear 610, which is oriented perpendicular to the pinion gear 605. The pinion gear 605 has teeth protruding from a radial edge of the gear 605, while the second gear 610 has teeth protruding from both the distal and proximal faces of the gear 610, referred to herein as the bevel gear 610. Counterclockwise rotation of the pinion gear 605 will cause the bevel gear 610 to rotate in a first direction, and clockwise rotation of the pinion gear 605 will cause the bevel gear 610 to rotate in a second, opposite direction. The direction of rotation of the bevel gear 610, in turn, determines whether the implant 102 is retracted proximally or advanced distally relative to the housing 203.

[0053] 6B is a perspective view depicting the interior of this embodiment of proximal control device 200 in greater detail. Proximally facing teeth on bevel gear 610 engage with teeth on gear 612, referred to as the input gear. The teeth of input gear 612 are engaged with teeth on gear 614. Gear 614 is coupled or integrated with reel 616, which is configured to store or hold grasper shaft 138. As can be seen in the embodiment of FIGS. 9A-9B, reel 616 can include an optional groove or channel 617 into which grasper shaft 138 can be received. Rotation of reel 616 causes grasper shaft 138 to wind onto or unwind from reel 616, depending on the direction of rotation. Winding of grasper shaft 138 onto reel 616 corresponds to proximal retraction of implant 102 (e.g., into inner shaft lumen 131), while unwinding of grasper shaft 138 from reel 616 corresponds to distal advancement of implant 102 (e.g., out of inner shaft lumen 131). In the embodiment of Figures 9A-9B, channel 617 is a helical channel that extends multiple times around the circumference of reel 616. In the embodiment depicted in Figure 6B, channel 617 is omitted.

[0054] In some embodiments, the input gear 612 can be configured as an intermittent gear, where one or more teeth are absent so that rotation of the input gear 612 will not consistently result in a corresponding rotation of another gear. An example of such an input gear 612 is depicted in the perspective view of FIG. 6C. From this depicted perspective view, the input gear 612 has teeth 620 spaced at regular intervals on the left side 621 of the gear's radial edge. Teeth 620 are also regularly spaced on the right side 622 of the gear's radial edge, except for an area 623 where no teeth are present. A smooth-surfaced hub 624 is present adjacent this intermittent area 623. The right side 622 of the input gear 612 is configured to engage with the reel gear 614. The placement of the intermittent region 623 is predetermined so that successive depressions of the trigger 202 by the user (and thus successive rotations of the pinion gear 605, bevel gear 610, and input gear 612) do not translate into successive rotations of the reel gear 614. Instead, the reel gear 614 will only be rotated when engaged with the portion of the input gear 612 having teeth 620, and will not be rotated while the intermittent region 623 traverses the reel gear 614. The placement of the intermittent region 623 allows for a pause in the longitudinal translation (e.g., distal and / or proximal) of the grasper shaft 138. The intermittent region 623 is specifically placed so that longitudinal translation occurs only during a certain portion of the delivery sequence.

[0055] In this embodiment, placing the switch 604 in the downward position translates a user pressing the trigger 202 into a pushing movement of the implant 102, while placing the switch 604 in the upward position translates a user pressing the trigger 202 into a pulling movement of the implant 102 and / or inner shaft 130. In other embodiments, these switch positions can be reversed to produce the opposite movement.

[0056] FIG. 7A is a top-down view depicting cam assembly 702 of proximal control device 200. Cam assembly 702 includes an outer slotted tube or cam 703, an inner slotted tube 704, and a guide member 706. The cam assembly can be positioned within yoke 601. FIG. 7B is a perspective view depicting this embodiment of cam 703. Cam 703 is coupled to bevel gear 610 such that rotation of bevel gear 610 also rotates cam 703. Inner slotted tube 704 is mounted within proximal control device 200 so that it does not rotate when cam 703 rotates. Guide member 706 can be configured as an arm or strut member that sits within and follows both slot 710 in cam 703 and slot 714 in inner tube 704. Guide member 706 is coupled to hub 802 (FIG. 8), which is located within inner slotted tube 704, and thus is coupled to inner shaft 130. Rotation of bevel gear 610 causes rotation of cam 703, which in turn causes guide member 706 to follow the path or routing of slot 710 in cam 703. Because guide member 706 extends through slot 714 in inner tube 704, which is non-rotatable, rotation of cam 703 moves guide member 706 only longitudinally, not radially.

[0057] Slot 710 can have one or more angled slot segments and / or one or more radial slot segments. In the embodiment depicted here, slot 710 has multiple angled segments (e.g., slot segments 717a, 717b, and 717c) and multiple radial segments (e.g., slot segments 719a, 719b, 719c, and 719d). Other shapes can be used as well and connected together to form a desired path. Angled slot segments 717 can have a constant or variable slope, and in some embodiments, these sloped slot segments can vary such that the slope reverses from positive to negative (like a "V").

[0058] The angled slot portion 717 can be an opening or groove in the cam 703 with a non-perpendicular and non-parallel angle (relative to the longitudinal axis 204) that causes the guide member 706 to move along the longitudinal axis 204 during rotation. The radial slot portion 719, in most embodiments, is parallel to the longitudinal axis 204 so that rotation of the cam 703 causes the radial slot portion 719 to move relative to the guide member 706 while preventing the guide member 706 from moving longitudinally (proximally or distally). The radial slot portion 719 corresponds to a pause in the delivery sequence; the trigger 202 continues to be depressed, and other components of the delivery device 103 move, but the inner shaft 130 remains in the same relative position.

[0059] In FIG. 7A, the guide member 706 is located at its distal-most position within the radial slot portion 719a (FIG. 7B). To retract the inner shaft 130, the cam 703 is rotated in a counterclockwise direction 720. There is no longitudinal movement of the inner shaft 130 while the cam 703 rotates the radial slot portion 719a past the guide member 706. When the guide member 706 reaches the angled slot portion 717a, it begins to retract proximally with the inner shaft 130. This process is repeated as the guide member 706 moves through a series of radial slot portions 719a (e.g., pauses in retracting the shaft 130) and angled slot portions 717a (e.g., retracting the shaft 130). In some embodiments, the guide member 706 can be selectively coupled to the outer shaft 120 to effect longitudinal movement of that component. For example, proximally retracting the inner shaft 130 may similarly retract the outer shaft 120, for example, to allow a physician to continue imaging the deployment process. Similar embodiments utilizing cam assemblies that may be used in conjunction with the embodiments described herein are described in incorporated International Publication No. WO 2017 / 184887.

[0060] The proximal control device 200 can also be configured to rotate the inner shaft 130 relative to the distal control member 140 during extrusion of the implant 102 from within the inner lumen 131. FIG. 8 is a side view depicting an exemplary embodiment of a second gear assembly 800 configured to translate rotation of the bevel gear 610 into rotation of a hub 707 coupled to the inner shaft 130. The gear assembly 800 is located distal to the cam assembly 702 (see FIGS. 6A and 7A ). The gear assembly 800 can 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 with a first set of radially inwardly projecting teeth 804 and an intermittent region 806. Gear 802 may have a second set of radially inwardly projecting teeth (not shown) with an intermittent area that lies in a different plane than teeth 804 .

[0061] Gear assembly 800 may also include translational gears 810, 812, and 814, which may also be referred to as planetary gears, which transmit the rotation of gear 802 to centrally located gear 816. In this example, a first set of teeth 804 engages gear 810, which in turn engages central gear 816, causing it to rotate in a first direction. Central gear 816 has an opening through which hub 707 is rotationally fixed but freely slides longitudinally. Thus, rotation of gear 802 is translated into rotation of hub 707, which in turn rotates inner shaft 130. A second set of teeth of gear 802 (not shown) engages gear 812, which in turn engages gear 814, which in turn engages central gear 816, causing central gear 816 to rotate in the opposite direction. Depending on the location of the first and second sets of teeth and the intermittent regions in various planes, a constant rotation of ring gear 802 in one direction can be converted into a timed rotation of central gear 816 in the same direction, in the opposite direction, or no rotation of central gear 816 at all.

[0062] The three-stage delivery sequence can be described with respect to the corresponding features of the implant 102. Each ring-shaped structure 111 and interconnection 112 undergoes a pushing motion by the grasper 136. In some embodiments, the implant 102 can be rotated by the grasper 136 as well. In some embodiments, the total longitudinal pushing distance traveled by the grasper 136 (provided by the reel 616) in an implant delivery approximately equals the combined circumference of all ring-shaped structures 111 of an embodiment of the implant 102. The combined pushing and rotating motion can ensure that the ring-shaped structure 111 of the implant 102 remains flat and provides sufficient radial force to open the cavity, despite lateral forces exerted on the prostatic urethra. Each interconnection 112 of the implant 102 undergoes a pulling phase (without rotation) by the hub and cam. Therefore, the total axial pulling distance traveled by the hub inside the cam approximately equals the total longitudinal length of the implant 102. The pulling and pushing / rotating steps do not occur simultaneously during the delivery sequence, i.e., they are mutually exclusive.

[0063] The proximal control device 200 can be configured to automatically prevent further deployment of the implant 102 after all of the ring-shaped structure 111 has been deployed from the inner lumen 131, but prior to advancement of the proximal engagement feature 115 and recess 139 from within the lumen 131. This provides the physician with an opportunity to verify that the implant 102 has been properly deployed and placed prior to releasing the implant 102 from the delivery device 103.

[0064] 9A-9F are internal perspective views depicting an exemplary embodiment of the proximal control device 200 with a locking or locking mechanism 900 to prevent premature release of the implant 102. The locking mechanism 900 interfaces with a groove or channel 902 in the proximally-facing surface of the bevel gear 610, as shown in FIGS. 9A-9B. A tracking mechanism 904, movable longitudinally, laterally, and radially inward, has a head portion with a protrusion 905 that is biased distally to press into and track the groove 902. As the bevel gear 610 is rotated by the pinion gear 605 (not shown), the tracking mechanism 904 follows the spiral groove 902 and moves radially inward. This movement continues until the implant 102 is nearly fully deployed, while the proximal engagement member 115 is still retained within the inner lumen 131 by the grasper 136. At this point, protrusion 905 enters a relatively deeper portion 906 of groove 902 (e.g., cavity), which securely captures tracking mechanism 904. Further rotation of bevel gear 610 causes tracking mechanism 904 to move laterally, or rotate in a semicircular arc, to the position depicted in FIGS. 9C-9D , with arm 907 of tracking mechanism 904 prevented from further lateral movement by fixed body 915. Further rotation of bevel gear 610 is prevented, which in turn prevents rotation of all gears and prevents the user from continuing to pull trigger 202.

[0065] Once the physician is satisfied with the placement of the implant 102, a unlocking actuator or tab 910, accessible to the user on the outside of the housing 203, is pulled proximally. The unlocking tab 910 is directly or indirectly coupled to the control wire 146, which is responsible for releasing the retainer 142, as described with respect to FIGS. 2C and 2D . Thus, proximal movement of the unlocking tab 910 moves the retainer 142 proximally, allowing release of the distal engaging member 114 of the implant 102 from the delivery device 103. The unlocking tab 910 can also be coupled to a tracking mechanism 904 such that proximal retraction of the tab 910 unscrews the protrusion 905 from within the groove 902. This action unlocks device 200, and the user is free to continue depressing trigger 202, which in turn feeds reel 616 forward, further unwinding grasper shaft 138 and causing proximal engaging member 115 and recess 139 of implant 102 to exit inner lumen 131 of shaft 130. At this stage, both distal engaging member 114 and proximal engaging member 115 of implant 102 are exposed, and implant 102 is free to disengage or release from device 103.

[0066] 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. In the embodiment depicted in FIG. 9E , the second cam 940 is rotatable within the body 941. The distal control member 140 (not shown) is fixed (e.g., with a set screw) to the cam 940 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, fixed to the body 941 and located on either side of the cam 940. The cam 940 is rotatable but fixed longitudinally relative to the body 941. Pulling the unlocking tab 910 moves the body 941 and members 946a and 946b proximally. Cam 940 cannot move proximally, so contact of member 946 on angled surface 944 rotates cam 940, which in turn rotates distal control member 140. Retraction of tab 910 thus releases retainer 142 and rotates distal control member 140, which exposes distal engaging member 114 of implant 102 (which is now expanded in contact with the urethra). Rotation can aid in removal of distal engaging member 114 from recess 143 of member 140, ensuring complete disengagement.

[0067] In some embodiments, distal control member 140 has a preset bend (not shown) proximal to retainer 142. When distal control member 140 is attached to distal engagement member 114 (e.g., as depicted in FIGS. 2B, 2G, and 2H), it is deformed from this preset bend shape and thus biased to return to this preset bend shape, which can also aid in disengaging member 140 from implant 102 (either instead of, or in addition to, embodiments in which device 200 rotates member 140).

[0068] A stop surface 912 is present on the tracking mechanism 904 opposite another stop surface 914 on the fixed body 915. In the position of the tracking mechanism 904 shown in FIG. 9B , these opposing stop surfaces 912 and 914 prevent the unlocking tab 910 from being retracted proximally because the body 915 is a separate component that is held in a static position (e.g., by the housing 203). Lateral movement of the tracking mechanism 904, for example, in a semicircular arc, continues until the stop surface 912 breaks and passes the stop surface 914, as shown in FIG. 9D . This feature prevents premature unlocking of the implant 102 by retracting the unlocking tab 910 proximally before the implant 102 is fully deployed.

[0069] The proximal control device 200 can also include an emergency release mechanism that allows for removal of the partially deployed implant 102 from the patient. The unlocking tab 910 can be decoupled from the tracking mechanism 904 by disengaging the notch in the deflectable arm 920 from the detent 922 on the base of the tracking mechanism 904. In other embodiments, the notch and detent features can be reversed. An emergency release button 924 having a sloped surface 925 is positioned directly below the arm 920 (see FIGS. 9A-9B ). Actuation, for example, by depressing the release button 924, causes the sloped surface 925 to deflect the arm 920 upward, as depicted in FIG. 9E , disengaging the notch from the detent 922. In this state, the unlocking tab 910 is decoupled from the tracking mechanism 904 and is free to retract proximally, even while the stop surfaces 912 and 914 are in opposing positions. Proximal retraction of the unlocking tab 910 retracts the control wire 146, releasing the distal engagement member 114 of the implant 102 from the distal control member 140. At this point, the partially deployed implant 102 is still attached to the grasper 136, which can be retracted proximally into the outer shaft 120 and then completely removed from the patient.

[0070] Exemplary Embodiments of Delivery Methods 10A is a flow diagram depicting an exemplary embodiment of a method 1000 of delivering implant 102 using system 100. The distal end region of outer shaft 120 is inserted into the urethra, along with inner shaft 130, distal control member 140, and anchor delivery member 150, preferably in a retracted state completely contained within outer shaft 120 such that no portion extends beyond the open distal end of outer shaft 120. After advancement into the urethra, in step 1002, anchor delivery member 150 is advanced distally relative to the remainder of delivery device 103 (e.g., members 120, 130, and 140) and used to deploy anchor 152 within the bladder. In some embodiments, deployment of anchor 152 can be inflation of one or more balloons (e.g., as depicted in FIGS. 2B and 4H-4J) by introduction of inflation medium through an injection (e.g., Luer taper) port. 6A depicts tubing 650 for balloon inflation. In other embodiments, deployment of anchor 152 can be the advancement of one or more wire form members from anchor delivery member 150 such that they deflect into a position against the bladder wall (e.g., FIGS. 4A-4G). Longitudinal positioning (e.g., advancement and retraction) of anchor delivery member 150 and / or any wire form members can be accomplished by a user manually manipulating the proximal ends of anchor delivery member 150 and / or any wire form members, either directly or with proximal control device 200.

[0071] In step 1004, anchor 152 can be held against the bladder wall by application of a proximally directed force on device 200. Anchor 152 can thus provide a ordinate from which system 100 can deploy implant 102 in a precise location. This feature can ensure that the implant is not placed too close to the bladder neck.

[0072] At 1006, the distal control member 140 and inner shaft 130 can then be advanced distally from within the outer shaft 120 if they have not already been advanced (e.g., step 1006 can occur prior to steps 1002 and / or 1004). The user can manipulate the position of the proximal control device 200 using imaging (as described herein) until the implant 102 is in the desired position. Once the implant 102 is in the desired position, the implant deployment procedure can begin. The steps for implant deployment can be performed automatically by user actuation of the proximal control device 200 (e.g., actuation of the trigger 202, selection of a position for the switch 604, etc.), or the steps can be performed directly by manual manipulation of the components of the delivery device 103, or by a combination of the two, as desired for a particular implementation.

[0073] In some embodiments, deployment of the implant 102 from within the lumen 131 is accomplished completely by (1) advancing the grasper 136 distally relative to the inner shaft 130 while the inner shaft 130 remains stationary, while in other embodiments, deployment of the implant 102 from within the inner lumen 131 is accomplished completely by (2) retracting the inner shaft 130 proximally relative to the grasper 136 while the grasper 136 remains stationary. In some embodiments, deployment of the implant 102 is accomplished completely by (3) a combination of both movements. In still other embodiments, deployment of the implant 102 is accomplished completely by one or more rotations of the inner shaft 130 relative to the distal control member 140 in one or more directions (e.g., clockwise or counterclockwise) in combination with (1), (2), or (3).

[0074] An exemplary embodiment of the sequence of steps 1008, 1010, and 1012 for deploying the implant 102 will be described with reference to the timing diagrams of Figures 10A and 10B. Referring initially to Figure 10A, in step 1008, the first ring-shaped structure 111a is withdrawn from the lumen 131 of the inner shaft 130, in step 1010, the interconnect 112 is withdrawn from the lumen 131, and in step 1012, the second ring-shaped structure 111b is withdrawn from the lumen 131. Steps 1010 and 1012 can be repeated for each additional interconnect 112 and ring-shaped structure 111 present on the implant 102.

[0075] 10B, step 1008 begins at the far left of the timing diagram at T0. The deployment of ring-shaped structure 111a corresponds to the duration of time marked 1008, the deployment of interconnect 123 corresponds to time period 1010, and the deployment of ring-shaped structure 111b corresponds to time period 1012. Those skilled in the art will recognize that the distinction between the deployment of ring-shaped structure 111 and the deployment of interconnect 112 is approximate because the transition between those portions of implant 102 can be gradual and need not have a precise demarcation.

[0076] The embodiment described with respect to FIG. 10B is for an implant with ring-shaped structures 111 having opposite winding directions (e.g., clockwise, then counterclockwise, then clockwise, etc.). Three different motions are shown in FIG. 10B. The top is rotational motion of the inner shaft 130 in one direction (e.g., clockwise), the middle is longitudinal motion (e.g., proximal or distal) of one or more components of the delivery device 103, and the bottom is rotational motion of the inner shaft 130 in the opposite direction (e.g., counterclockwise) to that shown in the top. In embodiments where the ring-shaped structures 111 of the implant 102 are all wound in the same single direction, the rotation of the inner shaft 130 will also be in only one direction.

[0077] From time T0 to T1, deployment of the implant 102 is accomplished by rotating the inner shaft 130, as shown in region 1031. Simultaneously, in region 1032, the grasper 136, and therefore the implant 102, is advanced distally without longitudinal (either distally or proximally) or rotational movement of the outer shaft 120, and without longitudinal movement of the inner shaft 130 (either distally or proximally). By way of example, within the proximal control device 200, rotational movement of the inner shaft 130 is accomplished by the user depressing the trigger 202, which is translated (through a yoke and pawl) into rotation of the pinion gear 605 and bevel gear 610, without corresponding longitudinal movement of both the inner shaft 130 and outer shaft 120. Rotation of bevel gear 610 also rotates cam 703 (FIGS. 7A-7B) of cam assembly 702 while guide member 706 is within radial slot portion (e.g., 719a), thus preventing longitudinal movement of either shaft 120 or 130. Rotation of cam 703 also causes second gear assembly 800 (FIG. 8) to rotate inner shaft 130. Advancement of grasper 136 occurs by bevel gear 610 rotating input gear 612, which in turn rotates reel gear 614 (FIGS. 6A-6B), rotating reel 616 and causing grasper shaft 138 to unwind distally.

[0078] From time T1 to T2, rotation of inner shaft 130 is stopped, but distal advancement of grasper 136 continues while shafts 120 and 130 do not move longitudinally. As an example, within proximal control device 200, a user continues to press trigger 202, and cam 703 continues to rotate, carrying guide member 706 within radial slot portion (e.g., 719a). Rotation of cam 703 continues to rotate ring gear 802 of second gear assembly 800, but this time, it reaches an intermittent portion (with no teeth) of ring gear 802, and none of planet gears 810, 812, and 814 are rotated; therefore, rotation of central gear 816 and inner shaft 130 is stopped. In this embodiment, deployment of first ring-shaped structure 111a is completed at time T2.

[0079] From time T2 to T4, deployment of the first interconnect 112 occurs. In region 1033, from time T2 to T4, no distal advancement of the grasper 136 (and implant 102) occurs. Deployment of the interconnect 112 is accomplished by proximal retraction of both the outer shaft 120 and the inner shaft 130 while holding the grasper 136 in place. This causes the interconnect 112 to exit the inner lumen 131 of the shaft 130. As an example, in the proximal control device 200, as the user continues to press the trigger 202, the bevel gear 610 continues to rotate, as do both the cam 703 and the input gear 612. An intermittent portion 623 in the input gear 612 is reached, and rotation of the input gear 612 no longer causes rotation of the reel gear 614, and therefore distal advancement of the grasper shaft 138 is stopped. Within cam assembly 702, guide member 706 transitions from a radial slot portion (e.g., 719a) to an angled slot portion (e.g., 717a), and rotation of cam 703 moves guide member 706 proximally. When guide member 706 is coupled to shafts 120 and 130, shafts 120 and 130 also move proximally.

[0080] With respect to 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 intermittent portion of the ring gear 802 continues and there is no rotation of the shaft 130 by the central gear 816.

[0081] In embodiments where the interconnect 112 is straight, it may be desirable to prevent the shaft 130 from rotating while the interconnect 112 is deployed from time T2 to T4. In embodiments where the interconnect 112 is curved, such as the embodiment of FIGS. 1B-1D, it may be desirable to initiate rotation of the inner shaft 130 during interconnect deployment. FIG. 10B depicts deployment for a curved interconnect 112; from T3 to T4, the inner shaft 130 is rotated in the opposite direction, as indicated by region 1034. As an example, in the proximal control device 200, the user continues to press the trigger 202, and this motion is transmitted to the ring gear 802, which has a region with teeth that engages with the planetary gears responsible for moving the central gear 816 in the opposite direction. Rotation of the central gear 816 in the opposite direction therefore commences, and the inner shaft 130 is likewise rotated in the opposite direction to that of time T0 to T1, which promotes deployment of the interconnect 112 and initiates rotation of the inner shaft in the direction appropriate for the counter-wound second ring-shaped structure 111b.

[0082] At T4, deployment of the interconnect 112 is complete and deployment of the second ring-shaped structure 111b begins. Proximal retraction of the shafts 120 and 130 is stopped, as indicated by the middle of region 1033. Distal advancement of the grasper shaft 138 resumes at T4 in region 1035, while the outer shaft 120 is not moved rotationally or longitudinally. Rotation of the inner shaft 130 continues, as indicated in region 1034, but the inner shaft 130 is not moved longitudinally. As an example, in the proximal control device 200, the user continues to depress the trigger 202. Rotation of the cam 703 continues, but the guide member 706 reaches the second radial slot portion (e.g., 719b), and proximal movement of the guide member 706 stops (as does retraction of the shafts 120 and 130). Rotation of the central gear 816 continues. The intermittent portion 623 of the input gear 612 breaks and the teeth 620 re-engage with the reel gear 614, causing both the reel gear 614 and the reel 616 to begin rotating again, and thus distal advancement of the grasper shaft 138 also begins.

[0083] These motions continue until time T5, at which point rotation of the inner shaft 130 is stopped. Within the proximal control device 200, an intermittent portion of the ring gear 802 is reached, the gear 802 disengages from the planetary gears, and rotation of the central gear 816 is stopped. Depression of the trigger 202 by the user continues from time T5 to T6, and the components operate with similar motion as described from time T1 to T2. If another interconnect 112 and ring-shaped structure 111 is present, the sequence beginning at time T6 may be identical to that described as beginning at time T2 and continue until time T6. This process is repeated as necessary until all ring-shaped structures 111 of the implant 102 have been deployed. In some embodiments, further depression of the trigger 202 can be stopped by a locking mechanism 900 ( FIGS. 9A-9B ), preventing premature deployment and release of the proximal engagement portion 115.

[0084] In many embodiments described herein, deployment of all of the ring-shaped structures 111 can occur with a single sequential depression of the trigger 202. In all of these embodiments, the proximal control device 200 can instead be configured such that repeated pulling of the trigger 202 is required to deploy all of the ring-shaped structures 111 of the implant 102.

[0085] During deployment, if the physician desires to recapture the implant 102, for example, after time T0 but before deployment of the proximal-most ring-shaped structure 112 is completed, depression of the trigger 202 can be stopped. The trigger 202 can be spring-loaded or otherwise biased to return to its outermost position. The physician can adjust the switch 604 from a position corresponding to deployment to a different position corresponding to recapture. This adjustment of the switch 604 will disengage the pawl 603 and engage the pawl 602. The physician can again depress the trigger 202, and such depression will translate into reverse motion of the bevel gear 610, which in turn will translate into reverse motion of the first gear assembly 600, the cam 703, and the rest of the second gear assembly 800. For example, if the switch 604 is adjusted any time between times T0 and T6, a next depression of the trigger 202 will reverse the sequence of events from right to left in FIG. 10B . As these movements are simply the reversal of those already described, they will not be repeated here.

[0086] When the physician is satisfied with the deployment, at 1014, the distal and proximal engagement portions 114, 115 of the implant 102 can be released from the distal control member 140 and the grasper 136, respectively. As an example, in the proximal control device 200, the physician can pull the tab 910, allowing the trigger 202 to be fully depressed, which in turn can deploy the proximal engagement portion 115 of the implant 102, either by distal advancement of the grasper 136, proximal retraction of the shafts 120 and 130, or both. The tab 910 can be coupled to the control wire 146, and pulling the tab 910 can pull the wire 146, removing the retainer 142 from the distal engagement portion 114.

[0087] The anchor 152 is then recaptured (e.g., by deflating the balloon or retracting the wireform member) and, if desired, withdrawn into the anchor delivery member 150. The anchor delivery member 150, distal control member 140, and inner shaft 130 can be retracted into the outer shaft 120 and then withdrawn from the urethra.

[0088] The embodiments described herein are restated and developed in the following paragraphs without explicit reference to the Figures. In many exemplary embodiments, a system for delivering an implantable device is provided, the system including a delivery device including an outer tubular member, an inner tubular member having a first inner lumen and a second inner lumen, the inner tubular member slidable within the outer tubular member, the first inner lumen adapted to house an elongate grasper member configured to releasably couple with a proximal portion of the implant, and a distal control member slidable within the second inner lumen, the distal control member including a retainer configured to releasably couple with a distal portion of the implant.

[0089] In some embodiments, the implant is configured to maintain the prostatic urethra at least partially open. In some embodiments, the implant has a body including first and second ring-shaped structures and an interconnect extending between the first and second ring-shaped structures. The body of the implant can be only a single wire. The implant can include a distal engagement member configured to releasably couple with the retainer and / or a proximal engagement member configured to releasably couple with the elongated grasper member. In some embodiments, the implant includes a wire-like distal engagement member and / or a wire-like proximal engagement member extending proximally away from a distal-most portion of the implant. In some embodiments, the first ring-shaped structure is the most distal ring-shaped structure of the implant and can have a relatively smaller width than the second ring-shaped structure.

[0090] In some embodiments, the inner tubular member is slidable and rotatable relative to the distal control member, while the retainer is releasably coupled to a distal portion of the implant. The system can further include an elongate member coupled to the retainer and having a proximal end manipulated by a user to enable 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 can include a recess adapted to receive the distal portion of the implant, and the retainer can be movable to expose the recess, while the distal portion of the implant is received within the recess. In some embodiments, the retainer includes a slot through which the implant can pass.

[0091] In some embodiments, the system includes an elongate anchor member. The elongate anchor member can include an anchor configured to contact the bladder wall. The anchor can be an inflatable balloon or multiple inflatable balloons. In some embodiments, the elongate anchor member includes a wire form member having a portion configured to automatically deflect when deployed.

[0092] In some embodiments, the elongate grasper member includes a recess configured to releasably couple with a proximal portion of the implant, hi some embodiments, the system is configured such that when the recess is unconstrained by the first inner lumen, the proximal portion of the implant is free to release from the recess of the elongate grasper member.

[0093] In some embodiments, a proximal control device is included and coupled to the proximal end region of the delivery device. The proximal control device can be manipulable by a user to control deployment of the implant from the delivery device. In some embodiments, the proximal control device includes a housing and is configured to distally advance the elongate grasper member relative to the housing and the inner tubular member, and / or to proximally retract and rotate the inner tubular member relative to the housing and the distal control member, and / or to proximally retract the outer tubular member relative to the housing.

[0094] 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 grasper 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.

[0095] In many embodiments, a system for delivering an implantable device is provided, the system including a delivery device including a first elongated member having an inner lumen, an elongated grasper member slidable within the inner lumen and configured to hold a proximal portion of the implant, 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.

[0096] In some embodiments, the proximal control device includes a first gear assembly within the housing, and the proximal control device is configured to translate movement of the user actuator into movement within the first gear assembly. In some embodiments, the proximal control device includes a switch 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 that is coupled to the first pawl and the second pawl. The switch can selectively engage either the first pawl or the second pawl with the pinion gear. The proximal control device can be configured such that rotation of the pinion gear causes rotation of the bevel gear. The proximal control device can be configured such that rotation of the bevel gear causes rotation of a reel coupled to the elongated grasper member.

[0097] In some embodiments, the system further includes an input gear engaged with the bevel gear and a reel gear engaged with the input gear, the reel gear being coupled or integrated with the reel. In some embodiments, the input gear is an intermittent gear, and rotation of the reel gear by the input gear causes rotation of the reel and longitudinal movement of the elongated grasper member. In some embodiments, movement of the first gear assembly in a first direction causes distal movement of the elongated grasper member, and movement of the first gear assembly in a second direction causes proximal movement of the elongated grasper member.

[0098] In some embodiments, the proximal control device includes a cam assembly within the housing, the proximal control device configured to translate movement of the user actuator into movement within the cam assembly. The cam assembly can be coupled to the first elongate member and configured to move the first elongate member proximally relative to the housing. In some embodiments, the cam assembly includes a rotatable cam having a slot, the first elongate member coupled to a guide member received in the slot. In some embodiments, the slot includes an angled slot portion and a radial slot portion. The cam assembly can include an inner tube having a longitudinal slot, the guide member received in the longitudinal slot.

[0099] In some embodiments, the first gear assembly includes a bevel gear having a first set of teeth that engage with teeth of another gear in the first gear assembly, and the bevel gear is coupled to the cam assembly such that movement of the bevel gear causes movement in the cam assembly.

[0100] In some embodiments, the proximal control device includes a second gear assembly, such that movement within the cam assembly can cause movement within the second gear assembly. The second gear assembly can be coupled to the first elongated member and can be configured to rotate the first elongated member relative to the housing. The second gear assembly can include a central gear having an aperture 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 can engage the planetary gear assembly such that rotation of the ring gear in a first direction causes a first directional rotation of the central gear and rotation of the ring gear in a second direction causes a second directional rotation of the central gear, the first directional rotation of the central gear being opposite to the second directional rotation.

[0101] In some embodiments, the proximal control device includes a releasable locking mechanism that prevents a proximal portion of the implant held by the elongated grasper member from exiting the inner lumen. In some embodiments, the locking mechanism includes a movable tracking mechanism that interfaces with a groove in a bevel gear of the first gear assembly, and the proximal control device is configured such that movement of the bevel gear moves the tracking mechanism as the implant exits the inner lumen. The proximal control device can be configured such that the tracking mechanism is prevented from further movement prior to the proximal portion of the implant exiting the inner lumen.

[0102] In some embodiments, the proximal control device includes a release structure configured to be actuated by a user to disengage the tracking mechanism from the bevel gear and allow the proximal portion of the implant to exit the inner lumen. The release structure can be a pull tab and can be coupled to the elongated grasper member.

[0103] In many embodiments, a method of delivering an implant is provided, comprising: advancing a delivery device within a patient's body cavity, the delivery device including a first tubular member housing that stores 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 grasper member slidable within the first tubular member and releasably coupled to a proximal portion of the implant; causing relative motion between the elongated grasper 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 grasper member.

[0104] In some embodiments, the body cavity is a prostatic urethra of a human. 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 at least partially open.

[0105] In some embodiments, the implant has a body including first and second ring-shaped structures and an interconnect extending between the first and second ring-shaped structures, and causing relative motion can include distally advancing the elongate grasper member. In some embodiments, the method further includes rotating the first tubular member in a first direction relative to the distal control member during exposure of the first ring-shaped structure from the first tubular member. In some embodiments, the method further includes rotating the first tubular member in a second direction relative to the distal control member during exposure of the second ring-shaped structure from the first tubular member, the second direction being opposite the first direction. Rotation of the first tubular member in the first and second directions can occur while the distal control member is releasably coupled to a distal portion of the implant.

[0106] In some embodiments, the method further includes retracting the first tubular member proximally relative to the elongate grasper member and the distal control member to expose the interconnect from the first tubular member. In some embodiments, the method further includes retracting the first tubular member proximally while rotating the first tubular member. In these embodiments, the interconnect can be curved.

[0107] In some embodiments, a retainer couples a distal portion of the implant to the distal control member, and the method includes releasing the retainer and releasing the distal portion of the implant from the distal control member.

[0108] In some embodiments, the method further includes exposing a proximal portion of the implant from within the first tubular member and releasing the proximal portion of the implant from the elongate grasper member.

[0109] In some embodiments, the method further includes anchoring the delivery device to a wall of the bladder before causing relative motion between the elongate grasper member and the first tubular member, hi some embodiments, anchoring the delivery device includes inflating a balloon within the bladder.

[0110] In some embodiments, a proximal control device is coupled to a proximal end region of the delivery device, and the method includes moving a user actuator of the proximal control device by a user, where moving the user actuator causes movement within a first gear assembly of the proximal control device. In some embodiments, the first gear assembly advances an elongated grasper member distally relative to the first tubular member. In some embodiments, the first gear assembly causes movement within a cam assembly and a second gear assembly. In some embodiments, movement within the cam assembly causes intermittent retraction of the first tubular member relative to the distal control member. In some embodiments, movement within the second gear assembly causes intermittent rotation of the first tubular member relative to the distal control member.

[0111] 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, allowing release of a distal portion of the implant from the distal control member and a proximal portion of the implant from the elongated grasper 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, disengaging the distal portion of the implant from the distal control member.

[0112] 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.

[0113] It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substituted with those from any other embodiment. When a feature, element, component, function, or step is described with respect to only one embodiment, it should be understood that the feature, element, component, function, or step can be used in conjunction with all other embodiments described herein, unless expressly stated otherwise. This paragraph therefore serves as a precursor and written support for the introduction of claims that, where appropriate, combine features, elements, components, functions, and steps from different embodiments or substitute features, elements, components, functions, and steps from one embodiment for another (even if the following description does not explicitly state that such combinations or substitutions are possible in a particular instance). In particular, it is expressly recognized that an explicit enumeration of all possible combinations and substitutions would be an undue burden, given that the permissibility of such combinations and substitutions would be readily recognized by those skilled in the art.

[0114] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context dictates otherwise.

[0115] While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof are shown in the drawings and described in detail herein. It should be understood, however, that these embodiments are not limited to the particular forms disclosed; on the contrary, these embodiments cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any feature, function, step, or element of the embodiments may be recited or added to the claims, as well as a negative limitation that defines the scope of the claimed invention by any feature, function, step, or element not within its scope.

Claims

1. 1. A system for delivering an implantable device, the system comprising: Implants and a delivery device comprising: an elongated member; an elongated grasper member slidable relative to the elongated member and configured to hold a proximal portion of the implant; and a distal control member slidable relative to the elongated member and configured to hold a distal portion of the implant, the elongated member configured to house the elongated grasper member and the distal control member; a proximal control device coupled to a proximal end region of the delivery device, the proximal control device comprising a user actuator and a housing; wherein the implant is deformable, the implant is in a linear configuration when the implant is constrained within the elongate member, the implant is configured to self-expand upon deployment from the elongate member, and the distal control member is provided with a retainer that is releasably coupled to the implant such that rotation of the elongate member and the distal control member also rotates the implant when the retainer is coupled to the implant.

2. 2. The system of claim 1, wherein the proximal control device comprises a first gear assembly within the housing, the proximal control device configured to translate movement of the user actuator into movement in the first gear assembly.

3. The system of claim 1 , wherein the proximal control device comprises a switch that selects between movement of the first gear assembly in a first direction and movement of the first gear assembly in a second direction.

4. The system of claim 3 , wherein the user actuator is coupled to a yoke coupled to the first pawl and the second pawl.

5. The system of claim 4 , wherein the switch selectively engages either the first pawl or the second pawl with a pinion gear.

6. The system of claim 5 , wherein the proximal control device is configured such that rotation of the pinion gear causes rotation of a bevel gear.

7. The system of claim 6 , wherein the proximal control device is configured such that rotation of the bevel gear causes rotation of a reel coupled to the elongated grasper member.

8. an input gear engaged with the bevel gear; a reel gear engaged with the input gear, the reel gear being coupled or integrated with the reel; The system of claim 7 further comprising:

9. 9. The system of claim 8, wherein the input gear is an intermittent gear, and rotation of the reel gear by the input gear causes rotation of the reel and longitudinal movement of the elongated grasper member.

10. 4. The system of claim 3, wherein movement of the first gear assembly in the first direction causes distal movement of the elongated grasper member, and movement of the first gear assembly in the second direction causes proximal movement of the elongated grasper member.

11. The system of claim 2 , wherein the proximal control device includes a cam assembly within the housing, the proximal control device configured to translate movement of the user actuator into movement in the cam assembly.

12. The system of claim 11 , wherein the cam assembly is coupled to the extension member.

13. The system of claim 12 , wherein the cam assembly is configured to move the extension member proximally relative to the housing.

14. The system of claim 13 , wherein the cam assembly comprises a rotatable cam having a slot, the extension member being coupled with a guide member received within the slot.

15. The system of claim 14 , wherein the slot comprises an angled slot portion and a radial slot portion.

16. The system of claim 14 , wherein the cam assembly comprises an inner tube having a longitudinal slot, the guide member being received within the longitudinal slot.

17. 12. The system of claim 11, wherein the first gear assembly comprises a bevel gear having a first set of teeth that engage with teeth of another gear in the first gear assembly, the bevel gear coupled with the cam assembly such that movement of the bevel gear causes movement in the cam assembly.

18. The system of claim 11 , wherein the proximal control device comprises a second gear assembly.

19. 20. The system of claim 18, wherein movement in the cam assembly causes movement in the second gear assembly.

20. 20. The system of claim 19, wherein the second gear assembly is coupled to the elongated member and configured to rotate the elongated member relative to the housing.

21. 21. The system of claim 20, wherein the second gear assembly comprises a central gear having an aperture configured to receive the elongated member such that rotation of the central gear causes rotation of the elongated member.

22. 22. The system of claim 21, wherein the second gear assembly comprises a ring gear coupled to the cam assembly and coupled to the central gear via a planetary gear assembly.

23. 23. The system of claim 22, wherein the ring gear engages the planetary gear assembly such that rotation of the ring gear in a first direction causes a first directional rotation of the central gear and rotation of the ring gear in a second direction causes a second directional rotation of the central gear, the first directional rotation of the central gear being opposite to the second directional rotation.

24. The system of claim 2 , wherein the proximal control device comprises a releasable locking mechanism that prevents the proximal portion of the implant held by the elongate grasper member from exiting the elongate member.

25. 25. The system of claim 24, wherein the locking mechanism comprises a movable tracking mechanism that interfaces with a groove in a bevel gear of the first gear assembly, and the proximal control device is configured such that movement of the bevel gear moves the tracking mechanism when the implant exits the elongated member.

26. 26. The system of claim 25, wherein the proximal control device is configured such that the tracking mechanism is prevented from further movement prior to a proximal portion of the implant exiting the elongate member.

27. 27. The system of claim 26, wherein the proximal control device comprises a release structure configured to be actuated by a user, the release structure configured to disengage the tracking mechanism from the bevel gear, thereby allowing the proximal portion of the implant to exit the elongated member.

28. 28. The system of claim 27, wherein the release structure is a pull tab.

29. 28. The system of claim 27, wherein the release structure is coupled to the elongated grasper member.

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