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

Abstract

The subject matter described herein relates to systems, devices, and methods for delivering or deploying an implant into the prostatic urethra, and more particularly, for delivery through the tortuous bends of the male urethra in an atraumatic and minimally invasive manner. Systems, devices, and methods for retrieval of an implant from the prostatic urethra are provided. Embodiments of the retrieval system can include a device for insertion into a patient and a proximal control device for use in grasping a portion of the implant and withdrawing the implant into a lumen of the retrieval system.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 089,205, filed October 8, 2020, which is expressly incorporated herein by reference in its entirety for all purposes. (Statement of government-funded research)

[0002] This invention was made with government support under NIH SBIR Phase II R44DK124094 awarded by the National Institutes of Health. The government has certain rights in this invention.

[0003] The subject matter described herein relates to systems, devices, and methods for delivery or deployment of implants into the prostatic urethra, and more particularly, for delivery in an atraumatic and minimally invasive manner through the tortuous bends of the male urethra. [Background technology]

[0004] 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), obstruction from 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 naturally complex and tortuous anatomical geometry, interpatient geometric and anatomic variability, and anatomical limitations associated with these conditions. Furthermore, complex challenges are presented in the design and / or fabrication of systems with sufficient flexibility to deliver such implants in a minimally invasive manner. For these and other reasons, there is a need for improved systems, devices, and methods for delivering implants to the prostatic urethra. Summary of the Invention [Means for solving the problem]

[0005] 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 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 described in more detail herein. Delivery system embodiments have imaging capabilities. Several implant embodiments for use with the delivery systems are also described, as are various implant placements of those implants.

[0006] Other systems, devices, methods, features, and advantages of the subject matter described herein will be, or 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 absent express recitation of those features in the claims. The present invention provides, for example, the following. (Item 1) 1. A method for removing an implant from a patient's urethra, the method comprising: advancing a portion of a removal device within the patient's urethra to a position adjacent the implant, the removal device comprising an outer tubular member, an inner elongate tubular member within a lumen of the outer tubular member, and an elongate actuation member within a lumen of the inner elongate tubular member, the elongate actuation member having a proximal end coupled to a handle and a distal end comprising a hook; advancing a distal end of the elongated actuation member distal to the distal end of the outer tubular member and distal to the distal end of the inner elongated tubular member; grasping a portion of the implant with the hook; withdrawing the hook and at least a portion of the implant proximally into the lumen of the inner elongate tubular member such that a bend is formed in the implant; removing the implant through the lumen of the outer tubular member, the implant being in an axially elongated configuration while within the lumen of the inner elongate tubular member; A method comprising: (Item 2) Item 10. The method of item 1, wherein the implant has a first end, a second end, and a middle portion, and the hook grasps the implant at the middle portion. (Item 3) Item 10. The method of item 1, wherein the implant comprises an elongated wire and at least one enlarged end, and the hook grasps the elongated wire. (Item 4) Item 10. The method of item 1, wherein the inner elongate tubular member comprises a flexible distal region. (Item 5) Item 5. The method of item 4, wherein the flexible distal region comprises a laser-cut tube. (Item 6) Item 10. The method of claim 1, wherein the inner elongate tubular member is a hypotube. (Item 7) Item 11. The method of item 1, wherein the removal device further comprises a stiffening member disposed across a distal region of the inner elongate tubular member. (Item 8) Item 10. The method of claim 1, wherein a three-point bend is formed in the implant. (Item 9) Item 10. The method of item 1, wherein a bend is formed in the implant as a result of a force applied to the implant by the wall of the inner elongate tubular member and the hook. (Item 10) Item 10. The method of item 1, wherein the axially elongated shape comprises a double-lined structure of the implant. (Item 11) Item 10. The method of item 1, further comprising the step of visualizing the hook with an imaging device after the hook has been advanced distally beyond the distal end of the outer tubular member. (Item 12) Item 10. The method of item 1, wherein the hook and at least a portion of the implant are proximally removed by actuating the handle coupled to a proximal end of the elongated actuation member. (Item 13) Item 10. The method of claim 1, wherein the implant has an expanded helical shape. (Item 14) Item 2. The method according to item 1, wherein the tip of the hook has a width of about 0.015 inches to about 0.050 inches. (Item 15) Item 10. The method of claim 1, wherein the tip portion of the hook is narrower than the rear portion of the hook. (Item 16) 1. A system for retrieving an implant, the system comprising: a retrieval device; an outer tubular member having a distal end and a lumen; an inner elongate tubular member within the lumen of the outer tubular member; an elongated actuation member within the lumen of the inner elongated tubular member, the elongated actuation member having a proximal end coupled to a handle and a distal end including a hook; a proximal control device coupled to the inner tubular member and releasably coupled to the outer tubular member through a coupling mechanism; Equipped with The system, wherein the proximal control device is configured to longitudinally move the inner elongate tubular member, the outer tubular member, and the elongate actuation member, and is configured to move the elongate actuation member within the lumen of the inner elongate tubular member. (Item 17) Item 17. The system of item 16, wherein the implant has a first end, a second end, and an intermediate portion, and the hook is configured to grasp the implant at the intermediate portion. (Item 18) Item 17. The system of item 16, wherein the inner elongate tubular member comprises a flexible distal region. (Item 19) Item 17. The system of item 16, wherein the inner elongate tubular member is a hypotube. (Item 20) Item 17. The system of item 16, further comprising a stiffening member disposed across a distal region of the inner elongate tubular member. (Item 21) Item 19. The system of item 18, wherein the flexible distal region comprises a laser-cut tube. (Item 22) Item 17. The system of item 16, wherein the outer tubular member further comprises an imaging device located within a distal end region of the outer tubular member. (Item 23) Item 17. The system of item 16, wherein the proximal control device is configured to longitudinally move the inner elongate tubular member, the outer tubular member, and the elongate actuation member in parallel. (Item 24) Item 17. The system of item 16, wherein the implant has an expanded helical shape. (Item 25) Item 17. The system of item 16, wherein the hook tip has a width of about 0.015 inches to about 0.050 inches. (Item 26) Item 17. The system of item 16, wherein the tip portion of the hook is narrower than the rear portion of the hook. (Item 27) 1. A method for removing an implant from a patient's urethra, the method comprising: advancing a removal device within the patient's urethra to a position adjacent to the implant, the removal device comprising an outer tubular member, an inner elongate tubular member within a lumen of the outer tubular member, and an elongate actuation member within a lumen of the inner elongate tubular member, the elongate actuation member having a proximal end and a distal end, the distal end comprising opposed first and second jaws configured to open and close; advancing a distal end of the elongated actuation member distal to the distal end of the inner elongated tubular member; grasping a portion of the implant with the opposing first and second jaws; proximally withdrawing the elongated actuation member within the lumen of the inner elongated tubular member, wherein at least a portion of the implant assumes an axially elongated configuration within the lumen of the inner elongated tubular member; A method comprising: (Item 28) Item 28. The method of item 27, wherein the opposing first and second jaws grasp an enlarged end of the implant. (Item 29) Item 29. The method of item 28, wherein the enlarged end is a shape selected from the group consisting of a ball, a cylinder, and a cone. (Item 30) Item 29. The method of item 28, wherein when the opposing first and second jaws are in a closed configuration, the opposing first and second jaws have an opening at a distal end of the closed configuration. (Item 31) Item 31. The method of item 30, wherein the implant comprises an elongated wire and at least one enlarged end, the at least one enlarged end being grasped by the opposing first and second jaws, and the elongated wire extending through the opening at the distal end of the closed configuration. (Item 32) 28. The method of claim 27, wherein the implant is in an axially elongated shape while within the lumen of the outer tubular member. (Item 33) Item 33. The method of item 32, wherein the shape of the axial extension is substantially linear. (Item 34) 28. The method of claim 27, further comprising the step of visualizing the distal end of the elongated actuation member using an imaging device after the distal end of the elongated actuation member has been advanced distally beyond the distal end of the outer tubular member. (Item 35) 28. The method of claim 27, wherein the implant has an expanded helical shape. (Item 36) 1. A system for retrieving an implant, the system comprising: a retrieval device; an outer tubular member having a distal end and a lumen; an inner elongate tubular member within the lumen of the outer tubular member; an elongated actuation member within a lumen of the inner elongated tubular member, the elongated actuation member having a proximal end and a distal end, the distal end including first and second jaws configured to open and close; a proximal control device coupled to the elongated actuation member and the inner elongated tubular member and releasably coupled to the outer tubular member through a coupling mechanism; Equipped with The system, wherein the proximal control device is configured to longitudinally move the elongated actuation member, the inner elongated tubular member, and the outer tubular member, and is also configured to longitudinally move the elongated actuation member within the lumen of the inner tubular member. (Item 37) Item 37. The system of item 36, wherein the implant has a first end, a second end, and an intermediate portion, and at least one of the first and second ends is an enlarged atraumatic end. (Item 38) Item 38. The system of item 37, wherein the opposing first and second jaws are configured to grasp an enlarged atraumatic end of the implant. (Item 39) Item 37. The system of item 36, wherein the opposing first and second jaws have an opening at a distal end of the closed configuration when in the closed configuration. (Item 40) 40. The system of claim 39, wherein the implant comprises an elongated wire and at least one enlarged end, the opposing first and second jaws are configured to grasp the at least one enlarged end, and the opening at the distal end of the closed configuration is configured for the elongated wire to extend therethrough. (Item 41) Item 37. The system of item 36, wherein the outer tubular member further comprises an imaging device located within a distal end region of the outer tubular member. (Item 42) Item 37. The system of item 36, wherein the proximal control device is configured to longitudinally move the elongated member, inner elongated member, and outer tubular member in parallel. (Item 43) Item 37. The system of item 36, wherein the implant has an expanded helical shape. (Item 44) 1. A method for removing an implant from a patient's urethra, the method comprising: advancing a removal device within the patient's urethra to a position adjacent to the implant, the removal device comprising an outer tubular member, an inner elongate tubular member within a lumen of the outer tubular member, and an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end and a distal end, the distal end comprising a grasper; advancing a distal end of the elongated actuation member distal to the distal end of the inner elongated tubular member; grasping a portion of the implant with the grasper; proximally withdrawing the elongated actuation member within the lumen of the inner elongated tubular member, wherein at least a portion of the implant assumes an axially elongated configuration within the lumen of the inner elongated tubular member; A method comprising: (Item 45) Item 45. The method of item 44, wherein the grasper comprises opposing first and second jaws. (Item 46) Item 46. The method of item 45, wherein the opposing first and second jaws grasp an enlarged end of the implant. (Item 47) Item 46. The method of item 45, wherein when the opposing first and second jaws are in a closed configuration, the opposing first and second jaws have an opening at a distal end of the closed configuration. (Item 48) Item 48. The method of item 47, wherein the implant comprises an elongated wire and at least one enlarged end, the at least one enlarged end being grasped by the opposing first and second jaws, and the elongated wire extending through the opening at the distal end of the closed configuration. (Item 49) Item 46. The method of item 45, wherein the shape of the axial extension is substantially linear. (Item 50) Item 45. The method of item 44, wherein the grasper comprises a hook. (Item 51) Item 51. The method of item 50, wherein the implant has a first end, a second end, and a middle portion, and the hook grasps the implant at the middle portion. (Item 52) Item 51. The method of item 50, wherein the implant comprises an elongated wire and at least one enlarged end, and the hook grasps the elongated wire. (Item 53) Item 51. The method according to item 50, wherein the tip of the hook has a width of about 0.015 inches to about 0.050 inches. (Item 54) Item 51. The method of item 50, wherein the tip portion of the hook is narrower than the rear portion of the hook. (Item 55) Item 51. The method of item 50, wherein the inner elongate tubular member comprises a flexible distal region. (Item 56) Item 56. The method of claim 55, wherein the flexible distal region comprises a laser-cut tube. (Item 57) Item 51. The method of item 50, wherein the inner elongate tubular member is a hypotube. (Item 58) Item 51. The method of item 50, wherein the removal device further comprises a stiffening member disposed across a distal region of the inner elongate tubular member. (Item 59) Item 51. The method of item 50, wherein a bend is formed in the implant when the hook and a portion of the implant are withdrawn proximally within the lumen of the inner elongate tubular member. (Item 60) Item 60. The method of item 59, wherein the bend is a three-point bend. (Item 61) 60. The method of claim 59, wherein the bend is formed in the implant as a result of a plurality of forces applied to the implant by the wall of the inner elongate tubular member and the hook. (Item 62) Item 51. The method of item 50, wherein the axially elongated shape comprises a double-lined structure of the implant. (Item 63) 51. The method of claim 50, further comprising the step of visualizing the hook with an imaging device after the hook has been advanced distally beyond the distal end of the outer tubular member. (Item 64) Item 45. The method of item 44, wherein the implant has an expanded helical shape. (Item 65) 1. A system for retrieving an implant, the system comprising: a retrieval device; an outer tubular member having a distal end and a lumen; an inner elongate tubular member within the lumen of the outer tubular member; an elongated actuation member within a lumen of the inner elongated tubular member, the elongated actuation member having a proximal end and a distal end, the distal end including a grasper; a proximal control device coupled to the elongated actuation member and the inner elongated actuation member and releasably coupled to the outer tubular member through a coupling mechanism; Equipped with The system, wherein the proximal control device is configured to longitudinally move the elongated actuation member, the inner elongated tubular member, and the outer tubular member, and is also configured to longitudinally move the elongated actuation member within the lumen of the inner tubular member. (Item 66) Item 66. The system of item 65, wherein the grasper comprises opposing first and second jaws. (Item 67) Item 67. The system of item 66, wherein the implant has a first end, a second end, and an intermediate portion, and at least one of the first and second ends is an enlarged atraumatic end. (Item 68) Item 68. The system of item 67, wherein the opposing first and second jaws are configured to grasp an enlarged atraumatic end of the implant. (Item 69) Item 67. The system of item 66, wherein the opposing first and second jaws have an opening at a distal end of the closed configuration when in the closed configuration. (Item 70) 70. The system of claim 69, wherein the implant comprises an elongated wire and at least one enlarged end, the opposing first and second jaws are configured to grasp the at least one enlarged end, and the opening at the distal end of the closed configuration is configured for the elongated wire to extend therethrough. (Item 71) Item 66. The system of item 65, wherein the outer tubular member further comprises an imaging device located within a distal end region of the outer tubular member. (Item 72) Item 66. The system of item 65, wherein the proximal control device is configured to longitudinally move the elongated member, inner elongated member, and outer tubular member in parallel. (Item 73) Item 66. The system of item 65, wherein the grasper comprises a hook. (Item 74) Item 74. The system of item 73, wherein the implant has a first end, a second end, and an intermediate portion, and the hook is configured to grasp the implant at the intermediate portion. (Item 75) Item 74. The system of item 73, wherein the hook tip has a width of about 0.015 inches to about 0.050 inches. (Item 76) Item 74. The system of item 73, wherein the tip portion of the hook is narrower than the rear portion of the hook. (Item 77) Item 74. The system of item 73, wherein the inner elongate tubular member comprises a flexible distal region. (Item 78) Item 78. The system of item 77, wherein the flexible distal region comprises a laser-cut tube. (Item 79) Item 74. The system of item 73, wherein the inner elongate tubular member is a hypotube. (Item 80) Item 74. The system of item 73, wherein the system further comprises a stiffening member disposed across a distal region of the inner elongate tubular member. (Item 81) Item 66. The system of item 65, wherein the implant has an expanded helical shape. [Brief explanation of the drawings]

[0007] Details of the subject matter described herein, both with respect to its structure and operation, may be apparent from 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 upon illustrating the principles of the present subject matter. Also, all illustrations are intended to convey concepts, and relative sizes, shapes, and other detailed attributes may be illustrated diagrammatically, rather than literally or precisely.

[0008] [Figure 1A] FIG. 1A is a block diagram depicting an exemplary embodiment of a delivery system.

[0009] [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.

[0010] [Figure 2A] 2A-2B are perspective views depicting an exemplary embodiment of a delivery system at different stages of implant deployment. [Figure 2B] 2A-2B are perspective views depicting an exemplary embodiment of a delivery system at different stages of implant deployment.

[0011] [Figure 2C] 2C-2G are perspective views depicting an embodiment of a release mechanism. [Figure 2D] 2C-2G are perspective views depicting an embodiment of a release mechanism. [Figure 2E] 2C-2G are perspective views depicting an embodiment of a release mechanism. [Figure 2F]2C-2G are perspective views depicting an embodiment of a release mechanism. [Figure 2G] 2C-2G are perspective views depicting an embodiment of a release mechanism.

[0012] [Figure 2H] 2H-2J are diagrams depicting an alternative embodiment of the release mechanism. [Figure 2I] 2H-2J are diagrams depicting an alternative embodiment of the release mechanism. [Figure 2J] 2H-2J are diagrams depicting an alternative embodiment of the release mechanism.

[0013] [Figure 3A] 3A-3C are perspective views depicting an exemplary embodiment of a grasper component used within a delivery system. [Figure 3B] 3A-3C are perspective views depicting an exemplary embodiment of a grasper component used within a delivery system. [Figure 3C] 3A-3C are perspective views depicting an exemplary embodiment of a grasper component used within a delivery system.

[0014] [Figure 4A] 4A-4C are perspective views depicting an exemplary embodiment of an inner shaft. [Figure 4B] 4A-4C are perspective views depicting an exemplary embodiment of an inner shaft. [Figure 4C] 4A-4C are perspective views depicting an exemplary embodiment of an inner shaft.

[0015] [Figure 4D] 4D-4E are cross-sectional views depicting an exemplary embodiment of an inner shaft. [Figure 4E] 4D-4E are cross-sectional views depicting an exemplary embodiment of an inner shaft.

[0016] [Figure 5A]5A-5B are side views depicting an exemplary embodiment of a delivery system at various stages of implant deployment. [Figure 5B] 5A-5B are side views depicting an exemplary embodiment of a delivery system at various stages of implant deployment.

[0017] [Figure 5C] 5C-5F are perspective views depicting an exemplary embodiment of a steering locking device. [Figure 5D] 5C-5F are perspective views depicting an exemplary embodiment of a steering locking device. [Figure 5E] 5C-5F are perspective views depicting an exemplary embodiment of a steering locking device. [Figure 5F] 5C-5F are perspective views depicting an exemplary embodiment of a steering locking device.

[0018] [Figure 5G] 5G-5H are cross-sections depicting an exemplary embodiment of a steering locking device. [Figure 5H] 5G-5H are cross-sections depicting an exemplary embodiment of a steering locking device.

[0019] [Figure 6A] FIG. 6A is a flowchart depicting an exemplary embodiment of a method for delivering an implant.

[0020] [Figure 6B] FIG. 6B is a timing diagram depicting an exemplary embodiment of a sequence of steps for deploying an implant.

[0021] [Figure 7] FIG. 7 is an exemplary cross section of the male anatomy.

[0022] [Figure 8A]FIG. 8A is an exemplary cross-section of the male anatomy into which an exemplary embodiment of an implant is deployed.

[0023] [Figure 8B] FIG. 8B is an exemplary cross section of the male anatomy.

[0024] [Figure 8C] FIG. 8C is an exemplary cross-section of the male anatomy taken along line 8C-8C of FIG. 8B.

[0025] [Figure 8D] FIG. 8D is an exemplary cross-section of the male anatomy into which an exemplary embodiment of the implant is deployed, and FIG. 8E is an exemplary cross-section of the male anatomy taken along line 8E-8E of FIG. 8D. [Figure 8E] FIG. 8D is an exemplary cross-section of the male anatomy into which an exemplary embodiment of the implant is deployed, and FIG. 8E is an exemplary cross-section of the male anatomy taken along line 8E-8E of FIG. 8D.

[0026] [Figure 8F] FIG. 8F is an exemplary cross-section of the male anatomy into which an exemplary embodiment of the implant is deployed, and FIG. 8G is an exemplary cross-section of the male anatomy taken along line 8F-8F of FIG. 8G. [Figure 8G] FIG. 8F is an exemplary cross-section of the male anatomy into which an exemplary embodiment of the implant is deployed, and FIG. 8G is an exemplary cross-section of the male anatomy taken along line 8F-8F of FIG. 8G.

[0027] [Figure 9A] 9A-9C are exemplary embodiments of retrieval devices. [Figure 9B] 9A-9C are exemplary embodiments of retrieval devices. [Figure 9C] 9A-9C are exemplary embodiments of retrieval devices.

[0028] [Figure 10A] 10A-10F are exemplary embodiments of the distal end of a retrieval device. [Figure 10B] 10A-10F are exemplary embodiments of the distal end of a retrieval device. [Figure 10C] 10A-10F are exemplary embodiments of the distal end of a retrieval device. [Figure 10D] 10A-10F are exemplary embodiments of the distal end of a retrieval device. [Figure 10E] 10A-10F are exemplary embodiments of the distal end of a retrieval device. [Figure 10F] 10A-10F are exemplary embodiments of the distal end of a retrieval device.

[0029] [Figure 11A] 11A-11B are exemplary embodiments of a retrieval device grasping an implant. [Figure 11B] 11A-11B are exemplary embodiments of a retrieval device grasping an implant.

[0030] [Figure 12] FIG. 12 is an exemplary embodiment of an alternative retrieval device.

[0031] [Figure 13A] 13A-13D depict perspective views of the distal end of the alternative retrieval device depicted in FIG. [Figure 13B] 13A-13D depict perspective views of the distal end of the alternative retrieval device depicted in FIG. [Figure 13C] 13A-13D depict perspective views of the distal end of the alternative retrieval device depicted in FIG. [Figure 13D] 13A-13D depict perspective views of the distal end of the alternative retrieval device depicted in FIG.

[0032] [Figure 14] FIG. 14 is a depiction of the forces applied to create a three-point bend.

[0033] [Figure 15A] 15A-15B are exemplary embodiments of hooks of a retrieval device. [Figure 15B] 15A-15B are exemplary embodiments of hooks of a retrieval device.

[0034] [Figure 15C] FIG. 15C is an exemplary cross section of a hook of a retrieval device. DETAILED DESCRIPTION OF THE INVENTION

[0035] Detailed Description 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. It is also 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.

[0036] The subject matter presented herein is described in the context of delivering or deploying one or more implants within the prostatic urethra. The purpose of deploying an implant within the prostatic urethra can vary. The embodiments described herein are particularly suited to the treatment of BPH, but are not limited to such. Other conditions for which these embodiments can 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 have applicability for the deployment of one or more implants within other biological lumens, cavities, or spaces, such as the human vasculature, cardiac system, pulmonary system, or gastrointestinal tract, including other locations in the urinary tract or bladder, as well as within the heart, stomach, intestines, liver, spleen, pancreas, and kidneys.

[0037] The subject matter presented herein further describes a method for removing an implant from the prostatic urethra. Although the implant is intended to be a permanent implant, removal is required under certain circumstances, such as initial implant misplacement, implant migration, safety issues, or efficacy issues. The removal method described herein is simple and does not cause any permanent tissue damage. The device can be removed acutely (during the procedure) or chronically (several years after implantation).

[0038] FIG. 1A is a block diagram depicting an exemplary embodiment of a delivery system 100 having an elongated delivery device 103 coupled to a proximal control device 200. A distal end region 104 is adapted to be inserted into a patient's urethra (or other lumen or body cavity) through the urethral meatus. 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 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 healthcare professional to control the delivery of the one or more implants 102. Exemplary Embodiments of Delivery Devices and Associated Methods

[0039] 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 relatively more elongated storage (or delivery) configuration (see, e.g., FIG. 3A ) for storing the implant 102 within the delivery device 103. The storage configuration may be straight or linear with little 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 the delivery device 103, the 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 the implant 102 from fully reaching the rest configuration. Because the implant 102 is biased toward the rest configuration, the implant 102 is configured to automatically expand when released from the constraints of the delivery device 103 and 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 rest configuration, although in many cases the shape will be deformed from the rest configuration by surrounding tissue.

[0040] The implant 102 can be configured in a number of different ways, including any of the implant configurations described in U.S. Patent Publication No. 2015 / 0257908 and / or International Publication No. WO2017 / 184887 (both of which are incorporated herein by reference for all purposes).

[0041] The implant 102 can be formed from one or more discrete bodies (e.g., wires, ribbons, tubular members) of various geometric shapes. Referring to the embodiment of FIGS. 1B-1D , the implant 102 has a main body formed from only a 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, i.e., 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 are four, i.e., 111a, 111b, 111c, and 111d) (one interconnect between each adjacent pair, for a total of three, i.e., 112a, 112b, and 112c). Each interconnect 112 extends from one ring-shaped structure 111 to the directly adjacent ring-shaped structure 111. Each interconnect 112 may have a relatively straight shape (not shown) or a curved (eg, semicircular or semi-elliptical) shape, as shown in FIGS. 1B-1D.

[0042] The ring-shaped structures 111 are configured to maintain the urethra in a fully or partially open state when expanded from the retracted configuration. The 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 interconnect 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 here, 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 to a smaller geometry before the bladder neck.

[0043] Each ring-shaped structure 111 can lie or lies in a single plane, and in some embodiments, that single plane can be oriented with a normal axis perpendicular to the central axis 124 of the implant 102 (as depicted in FIG. 1B ). In other embodiments, the ring-shaped structures 111 can lie in multiple planes. The ring-shaped structures 111 can extend around the central axis 126, forming a complete circle (e.g., a 360-degree rotation), or can form a less-than-complete circle (e.g., less than 360 degrees) as shown here. While not limited as such, in many embodiments, the ring-shaped structures 111 extend between 270 and 360 degrees.

[0044] 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 otherwise.

[0045] The implant 102 may also include a distal engagement member 114 and a proximal engagement member 115, each configured to engage with an element of the delivery device 103. Engagement with the delivery device 103 may serve one or more purposes, such as allowing controlled release of the implant 102, allowing movement of the ends of the implant 102 relative to one another, and / or allowing retrieval of the implant 102 after deployment, for example, in instances where a physician desires to recapture the implant 102 and redeploy it at a different location. In this embodiment, the distal engagement member 114 is a wire-like extension from the ring-shaped structure 111 a that has a curved (e.g., S-like) shape for positioning the atraumatic end 116 (e.g., round, 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 configured so that atraumatic ends 116 and 117 face in different directions. For example, atraumatic ends 116 and 117 can face distally instead of proximally. In another embodiment, atraumatic ends 116 and 117 can face in opposite directions (e.g., atraumatic end 116 can face distally and atraumatic end 117 can face proximally, or vice versa). 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 interconnect 112. Also, an extension having an atraumatic end (similar to distal engaging member 114 and proximal engaging member 115) can be attached in the middle of implant 102 to provide additional structure for controlling placement of the middle portion of the implant.

[0046] 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. Alternatively, one or more elongate flexible members of delivery device 103 can be solid or solid members without any inner lumens. 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.

[0047] In this embodiment, the first elongate tubular member 120 is the outermost tubular member and is flexible yet provides support for the members contained therein. The first tubular member 120, referred to herein as the outer shaft 120, 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.

[0048] 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 in two of the lumens 122-124 (e.g., 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) facing 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 can be omitted, or the lumen can be used for alternative purposes, for example, as an irrigation or flushing channel. The illumination device and / or imaging device can be fixedly secured at the distal ends of lumens 122 and 123, respectively, or can be slidable within lumens 122 and 123, respectively, to allow further advancement distally from and / or retraction into outer shaft 120. In one exemplary embodiment, the illumination device and imaging device are mounted together, and only a single lumen 122 or 123 exists for that purpose. The remaining lumen (e.g., lumen 124) can be configured as an irrigation or flushing port from which a fluid, such as saline, can be introduced into the urethra to flush the area and provide the appropriate fluid through which implant 102 and the surrounding prostatic urethral wall can be imaged. In one embodiment, the outer shaft may contain two separate lumens for fluid management. One lumen may be used for irrigation, and the other lumen may be used for flushing.

[0049] The outer shaft 120 has a proximal end (not shown) that is coupled to the proximal control device 200. The delivery device 103 can be configured to be steerable to navigate tortuous anatomical structures. 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 structures (e.g., pull wires) extend from the distal end region 104 of the delivery device 103 (e.g., the distal ends of the pull wires are anchored to a plate or other structure within the distal end region 104) to the proximal control device 200, where they can be manipulated by a user to steer the delivery device 103. The steering structures 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 to deflect (e.g., bend) in a particular lateral direction such that the device 103 automatically biases in that manner and the force applied to steer the delivery device 103 is opposite to 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).

[0050] 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 the 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, shown here extending from the open distal end of the distal control member 140. The fourth elongated tubular member 150 is configured to anchor the delivery device 103 relative to the patient's anatomy, 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.

[0051] 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. When delivery device 130 is advanced through the urethra, anchor delivery member 150 is preferably retracted completely within distal control member 140, and distal control member 140, along with inner shaft 130, is 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 to 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 distally further into the bladder, or, if already within 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.

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

[0053] Other embodiments of anchor 152 are described in International Application No. PCT / US19 / 32637, filed May 16, 2019, which is incorporated by reference in its entirety for all purposes. Anchor 152 expands (or otherwise transitions) to a size greater than that of the bladder neck such that anchor 152 resists proximal retraction (e.g., relatively light tension). In embodiments in which anchor 152 is a balloon, the balloon may 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 are located on the shaft of anchor delivery member 150 and communicate with an inflation lumen 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).

[0054] Using the imaging device on the outer shaft 120, the physician can move the delivery device 103 proximally, away from the anchor 152, until the physician is at the desired location within the urethra to begin deployment of the implant 102. A retainer 142 on the distal control member 140 releasably couples with the distal engagement member 114 of the implant 102. The physician can position the retainer 142 at a location along the length of the urethra where the physician desires the distal end of the implant 102 to deploy. This can 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, such 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 engagement member 114 to the retainer 142 also allows the physician to manipulate the radial orientation of the implant 102 by rotating the distal control member 140 and the inner shaft 130 together. Active or passive shaping of the distal control member 140 can allow for more desirable placement of the implant 102. For example, the member 140 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.

[0055] The distal engagement member 114 is held in place relative to the distal control member 140 by the retainer 142, and proximal retraction of the inner shaft 130 relative to the distal control member 140 causes the ring-shaped structures 111 to begin to deploy in sequence (111a, then 111b, then 111c, then 111d (not shown)). The distal control member 140 can remain stationary relative to the urethra during deployment or can be moved longitudinally. In some embodiments, the distal control member 140 is steerable to allow angulation of the implant 102 and to accommodate relatively tortuous anatomy. The steerability of the distal control member 140 can also effect relatively anterior placement of the implant relative to the bladder neck, potentially contributing to improved flow results. See, for example, the distal control member 140 as shown in FIGS. 2C-2G and 10C and 10D. Mechanisms for achieving steerability are discussed elsewhere herein and can similarly be applied to distal control member 140. In these or other embodiments, distal control member 140 can be significantly flexible to passively accommodate tortuous anatomy. In some embodiments, distal control member 140 has a predetermined curve to aid in navigation.

[0056] To assist in deployment, inner shaft 130 can be rotated clockwise and counterclockwise (as depicted by arrow 134) about distal control member 140. Referring again to FIGS. 1B-1C , implant 102 has a variable direction of twist, considered to begin at distal engagement member 114, proceeding clockwise along ring-shaped structure 111a until terminating at proximal engagement member 115, then reversing counterclockwise along interconnect 112a for ring-shaped structure 111b, then reversing clockwise along interconnect 112b for ring-shaped structure 111c, and then reversing counterclockwise along interconnect 112c for ring-shaped structure 111d. Depending on the direction of twist of the portion of implant 102 exiting the open distal end of lumen 131, the transition of implant 102 toward the resting configuration can impart a torque on shaft 130 if shaft 130 is not actively rotated as implant 102 is deployed. The torque can correspondingly rotate the shaft 130 passively (without user intervention) either clockwise or counterclockwise. 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 direction of winding of the implant 102. In some embodiments, all of the ring-shaped structures 111 are wound in the same direction, clockwise or counterclockwise (e.g., as in the case of a fully spiral or helical implant), or do not have a set direction of winding.

[0057] 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 remaining device 103 during deployment, resulting in better visualization and less tissue contact by the device 103. Such a configuration can also reduce stress imparted by the device 103 to the implant 102 during delivery. For example, the portion of the inner shaft 130 extending from the outer shaft 120 during deployment can be relatively more flexible than the portion of the inner shaft 130 that remains within the outer shaft 120, 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 deployment process.

[0058] In an alternative embodiment, as seen in FIGS. 4A-4E , the inner shaft 230 can include an outer torque-applying tube 233 ( FIGS. 4B-4E ), one or more lumens for storing one or more implants 102 and / or other components, and one or more torque-applying supports 235. In this embodiment, the inner shaft 230 includes a first elongate tubular member 231 a having a first lumen 231 in which one or more implants 102 can be stored. The first elongate tubular member 231 a also has a second elongate tubular member 232 a (or tether) having a second lumen 232 in which the third elongate tubular member 140 and the fourth elongate tubular member 240 can be stored, which can act as an inflation lumen. In an alternative embodiment, the second elongate tubular member 232 a (or tether) can be used for release / actuation, and the inflation lumen can be concentric with the tether. As seen in FIGS. 4D and 4E , first elongate tubular member 231 a and second elongate tubular member 232 a can be seated side-by-side and held in place by torque supports 235. Torque supports 235 can be small plates spaced apart within outer torque tube 233 from the proximal end to the distal end of outer torque tube 233. For example, torque supports 235 can be placed about 3 to about 6 inches apart, alternatively about 2 to about 5 inches apart, or alternatively about 1 to about 4 inches apart. Torque supports 235 can be bonded or otherwise secured in place relative to outer torque tube 233 to ensure that the axial and angular position of outer torque tube 233 can be maintained by the user. First elongate tubular member 231 a can be secured to torque supports 235 to ensure that first elongate tubular member 231 a moves with outer torque tube 233. The second elongate tubular member 232 a may not be fixed to the torque support 235 such that the second elongate tubular member 232 a may move axially and rotationally relative to the support plate and outer torque tube 233 .

[0059] As seen in FIG. 4B, flexible tip 243 may be created by securing first elongated tubular member or implant delivery tube 231 a such that its distal end 237 extends beyond distal tip 239 of outer torque-applying tube 233 by approximately 0 cm to 1.5 cm, alternatively, approximately 0 cm to 1.0 cm, alternatively, approximately 0.2 cm to 1.0 cm.

[0060] The components of the inner shaft may be made from suitable materials. The first elongate tubular member or implant delivery tube 231a may be a braided tubular assembly with a lubricious liner. It may be made from a laser-cut hypotube with a lubricious liner, a single polymer extrusion, or other suitable material. The outer torquer tube 233 may be made from a laser-cut hypotube, a braided structure, a polymer extrusion, or other suitable material. The torquer support 235 may be a laser-cut metal plate, a molded plastic component, an extruded material, or other suitable material.

[0061] 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 and shape of the implant 102, the implant 102 can be released from the delivery device 103. A control wire 146 (not shown in FIG. 2B) extends within the length of the control member 140, either within the same lumen as the anchor delivery member 150 or within a different lumen, and is coupled to the retainer 142. The control wire 146 can be routed within the member 140 through an opening 148.

[0062] Release of the distal end of the implant 102 can be accomplished by releasing the retainer 142. The 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 the implant 102 is housed. In the embodiment of FIG. 2B, the retainer 142 includes an opening or slot that allows the distal engagement member 114 to pass therethrough. The retainer 142 can rotate relative to the cavity or recess in which the distal engagement member 114 (not shown) is housed until the opening or slot is positioned over the member 114, at which point the member 114 is free to release from the distal control member 130. Rotation of the retainer 142 can be accomplished by rotation of a rotatable shaft, rod, or other member coupled to the retainer 142 (and accessible in the proximal control device 200). Alternative embodiments of the retainer can be found in Figures 2C-2F of International Application No. PCT / US19 / 32637, filed May 16, 2019 (previously incorporated by reference in its entirety for all purposes).

[0063] 2C-2G are perspective views depicting another exemplary embodiment of system 100 with an alternative retainer 142 that can be secured in place with a tether lock. As in the other embodiments, 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 143 ( FIG. 2G ) in distal control member 140. Retainer 142 can slide over distal engagement member 114 while received within this recess 143 until retainer 142 abuts a portion of member 140 having an opening 241 located near its distal end. A control wire 246 extends within the length of control member 140, either within the same lumen as anchor delivery member 150 or within a different lumen, and is attached to or coupled to retainer 142 at its distal end 248. 2E, the control wire 246 passes out of and back into the opening 241 in the distal control member 140 such that the control wire 246 protrudes from the opening and forms a loop 247 that extends along an axis perpendicular to the longitudinal axis of the distal control member and the longitudinal axis of the retainer 142. The loop 247, located adjacent and proximal to the retainer 142, prevents the retainer 142 from moving proximally over the distal control member 140.

[0064] Upon satisfactory deployment of implant 102 within the urethra, for example, as in FIG. 2C , control wire 246 can be tensioned by pulling control wire 246 proximally (away from implant 102). As seen in FIG. 2F , the tension pulls loop 247 into the lumen of distal control member 140, thereby removing the obstruction preventing retainer 140 from sliding proximally. As seen in FIG. 2G , after the loop is withdrawn into the lumen of distal control member 140, retainer 140 is retracted proximally by further pulling control wire 246 proximally to expose engagement member 114 and allow its release from member 140.

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

[0066] 2H-2J illustrate another exemplary embodiment of the system 100 with an alternative retainer 242 that can be fixed in place. As with the other described embodiments, the retainer 242 can be a cylindrical structure or other sleeve that moves linearly or rotationally over a cavity or recess in which a portion of the implant 102 is stored. The retainer 242 includes a cover 245 coupled to an outer tube 249 that extends to the control device 200. In the embodiment of FIGS. 2H-2J, the retainer 242 includes an opening or slot (not shown) that allows the distal engagement member 114 to pass therethrough. FIG. 2H shows the cover 245 closed over a recess 143 adapted to retain the distal engagement member 114. The retainer 242 can be withdrawn proximally relative to the cavity or recess in which the distal engagement member 114 is stored until the opening or slot is positioned over the member 114, at which point the member 114 is free to release from the distal control member 130. As seen in FIG. 2I, cover 245 has been removed by proximally actuating outer tube 249. Removal of cover 245 of retainer 242 can be accomplished by proximally removing outer tube 249, which is accessible at proximal control device 200. FIG. 2J is a cross section showing retainer 242 and an inflation lumen in communication with anchor 152. The inflated diameter of the anchor balloon can be about 1 cm to 7 cm, alternatively about 2 cm to 6 cm, alternatively about 1 cm to 6 cm.

[0067] 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 linear state prior to deployment, with the proximal engagement member 115 coupled to a retainer 136 that is slidable distally and / or proximally within the lumen 131. The retainer 136 can include a distal end region 137 on or coupled to a shaft 138. The retainer 136 is preferably controllable to rotate and longitudinally translate (e.g., push and pull) the implant 102 relative to the inner shaft 130.

[0068] 3B and 3C are perspective views depicting an exemplary embodiment of the distal end region 137 of the retainer 136 without and with the implant 102, respectively. The retainer 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 115 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. When the distal end region 137 exits the inner lumen 131 (either by retracting the inner shaft 130 relative to the retainer 136 or by advancing the retainer 136 relative to the inner shaft 130), the constraint provided by the inner shaft sidewall is no longer present and the engaging member 115 is free to release from the retainer 136. Thus, when 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 retainer 136 from within the inner shaft 130 and allowing the proximal engaging member 115 to decouple from the retainer 136.

[0069] The retainer 136 can also assist in loading the implant 102. In some embodiments, applying a pulling force to the implant 102 with the retainer 136 (while the opposite end of the implant 102 is secured, for example, by a retainer 142) facilitates the transition of the implant 102 from a resting configuration to a linear configuration suitable for insertion of the implant 102 into the inner shaft 130.

[0070] 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 three or more directions across the bladder wall. Additional examples of anchor delivery members and anchors are described in Figures 2B and 4A-4J of International Application No. PCT / US19 / 32637, filed May 16, 2019 (previously incorporated by reference in its entirety for all purposes).

[0071] 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 in which anchor 152 is a balloon, the balloon is deflated and optionally retracted back into the lumen of device 103, followed by withdrawal from the bladder and urethra. In embodiments in which anchor 152 is a wire form or other expandable member (such as those described with reference to Figures 4A-4G of International Application No. PCT / US19 / 32637, filed May 16, 2019, previously incorporated by reference in its entirety for all purposes), anchor 152 is then retracted back into the lumen of device 103 from which it was deployed, and device 103 can then be withdrawn from the bladder and urethra. Retraction can be accomplished using fluid or pneumatic actuation, a screw-type mechanism, or otherwise. Exemplary Embodiments of Proximal Control Devices and Associated Methods

[0072] FIG. 5A is a side view depicting an exemplary embodiment of the delivery system 100 prior to deployment of the implant 102, and FIG. 5B is a side view depicting this embodiment with the implant 102 in a deployed configuration (anchor delivery member 150 and distal control member 140 are not shown). In this embodiment, the proximal control device 200 is a handheld device having a handle 201, a first user actuator 202 (configured as a trigger in this example), a main body 203, and a second user actuator 205. The longitudinal axis of the delivery device 103 is indicated by dashed line 204. The proximal control device 200 can include a mechanism that is manually powered by actuation of the actuator 202 to cause relative movement of the components of the device 103. In other embodiments, the proximal control device 200 can instead utilize an electrically powered mechanism. The second user actuator 205 can be configured to control steering of the delivery device 103. Here, as seen in Figures 5G and 5H, the actuator 205 is configured as a rotatable wheel 225 that can wind or unwind a pull wire 221 within the delivery device 103, causing deflection of the device 103 upward and downward, as depicted here. The second user actuator 205 includes an extension 212 having a paddle 206 extending from a first end 215 of the extension 212. As seen in Figure 5A, prior to deployment, the extension 212 is closer to the handle 201, e.g., the extension 212 is angled toward the handle 201. As seen in Figure 5B, after the implant 102 is at least partially deployed from the distal end region 104, the extension 212 is angled away from the handle 201 and angled or pointed toward the distal end region 104. 5B also indicates that the distal end of the inner tubular member 120 can be deflected to allow further anterior placement of the implant. The proximal control device 200 can be configured such that further deployment of the implant 102 is automatically prevented after all of the ring-shaped structures 111 have been deployed from the inner lumen 131, but prior to advancement of the proximal engagement features 115 and recesses 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. A detailed description of the control device 200 and the components and gear assemblies contained therein can be found, for example, in Figures 6A-9F of International Application No. PCT / US19 / 32637, filed May 16, 2019 (previously incorporated by reference in its entirety for all purposes).

[0073] The device may also include a steering lock, allowing the user to lock steering forward and place the implant in a more anterior position. As discussed above, the steerability of the device can include pull wires 225 extending from the distal end region 104 of the delivery device 103 (e.g., where the distal ends of the pull wires are anchored to a plate or other structure within the distal end region 104) to the proximal control device 200, where they can be manipulated by the user to steer the delivery device 103. The steering structures can be located within one or more lumens of the outer shaft 120, or can be coupled to or embedded within a sidewall of the outer shaft 120. The delivery device 103 can be biased to deflect (e.g., bend) in a particular lateral direction such that the device 103 automatically deflects in that manner, and the force applied to steer the delivery device 103 is opposite this biased deflection.

[0074] The steering lock is part of the extension 212 that is attached to the actuator 205. As seen in FIGS. 5C-5H , the actuator 205 includes a rotatable wheel 225, the extension 212, a latch 209, and a ledge 207. The housing of the actuator 205 may include two halves, a right handle half 205a and a left handle half 205b. The rotatable wheel 225 is adapted to wind and unwind the pull wire and is located within and coupled to the housing. The extension 212 includes the latch 209 and the paddle 206, which extends from a first end 215 and terminates at the detent 208 such that a gap exists between the detent 208 and the second end 217 of the extension 212. A second end 217 of extension 212 is attached to left handle half 205b, and a first end is adjacent a portion of right handle half 205a. Second end 217 of extension 212 includes a detent 208 and a gap. The steering lock also includes a ledge 207 extending from the right handle half 205a of the housing proximate to first end 215 of extension 212. A latch 209 is adapted to actuate or slide along paddle 206. When latch 209 is located on second end 217, detent 208 frictionally engages latch 209, thereby restraining latch 209 to second end 217.

[0075] In use, as seen in FIG. 5E , a user can disengage latch 209 from detent 208 and move latch 209 along paddle 206 from second end 217 to first end 215 of extension 212. Once latch 209 is at first end 215, extension 212 can be pushed by the user in a direction toward distal end region 104 until latch 209 contacts ledge 207. Ledge 207 then frictionally engages latch 209, holding extension 212 in a position angled toward distal end region 104 in the “locked” position. In the locked position, rotatable wheel 225 cannot wind or unwind pull wire 221, and a user cannot move (deflect or straighten) distal end region 104 of outer tubular member 103. 5F , to release the paddle 206 from the “locked” position, a user can release the latch 209 from the ledge 207 and slide the latch 209 along the paddle 206 from the first end 215 to the second end 217 of the extension 212. Once the latch 209 is no longer frictionally engaged by the ledge 207, the extension 212 can passively return to a resting position in which the extension 212 is angled toward the handle 201 (i.e., away from the distal end region 104) due to the spring load. In the unlocked position, the rotatable wheel 225 can wind and unwind the pull wire 221, thereby moving (deflecting or straightening) the distal end region 104 of the outer tubular member 103. Exemplary Embodiments of Delivery Methods

[0076] 6A is a flow diagram depicting an exemplary embodiment of a method 1000 of delivering an implant 102 using system 100. The distal end region of outer shaft 120 is inserted into the urethra, preferably with inner shaft 130, distal control member 140, and anchor delivery member 150 fully contained within outer shaft 120 in a retracted state 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 remaining portions 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 FIG. 2B) by introduction of inflation medium through an infusion (e.g., Luer taper) port. Longitudinal positioning (e.g., advancement and retraction) of anchor delivery member 150 and / or any wireform member can be accomplished manually by a user manipulating the proximal end of anchor delivery member 150 and / or any wireform member, either directly or with proximal control device 200.

[0077] In step 1004, anchor 152 can be held in tension against the bladder wall by application of a proximally directed force to device 200. Anchor 152 can therefore provide a ordinate for system 100 to then deploy implant 102 at the correct location. This feature can ensure that the implant is not placed too close to the bladder neck.

[0078] At 1006, the distal control member 140 and inner shaft 130 can then be advanced distally from within the outer shaft 120, if they are not already so (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.

[0079] In some embodiments, deployment of the implant 102 from within the lumen 131 is accomplished completely by (1) advancing the retainer 136 distally relative to the inner shaft 130 while the inner shaft 130 is not moving, 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 retainer 136 while the retainer 136 is not moving. 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 (1), (2), or (3) in combination with one or more rotations of the inner shaft 130 in one or more directions (e.g., clockwise or counterclockwise) relative to the distal control member 140.

[0080] 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 6A and 6B. Referring initially to Figure 6A, 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.

[0081] 6B, step 1008 begins at the left end of the timing diagram at T0. The deployment of ring-shaped structure 111a corresponds to the duration marked 1008, the deployment of interconnect 123 corresponds to period 1010, and the deployment of ring-shaped structure 111b corresponds to 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, as the transition between those portions of implant 102 can be gradual and need not have precise boundaries.

[0082] The embodiment described with respect to Figure 6B relates to 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 Figure 6B: top is rotational motion of the inner shaft 130 in one direction (e.g., clockwise), middle is longitudinal motion (e.g., proximal or distal) of one or more components of the delivery device 103, and bottom is rotational motion of the inner shaft 130 in the opposite direction (e.g., counterclockwise) to that shown above. In embodiments in which the ring-shaped structures 111 of the implant 102 all wind in the same single direction, the rotation of the inner shaft 130 will also be in only one direction.

[0083] From time T0 to T1, deployment of the implant 102 is accomplished by rotating the inner shaft 130, as shown in region 1031. Simultaneously, in region 1032, the grasper 136, and therefore the implant 102, is advanced distally without moving the outer shaft 120 longitudinally (either distally or proximally) or rotationally, and without moving the inner shaft 130 longitudinally (either distally or proximally).

[0084] 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.

[0085] 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.

[0086] From time T2 to T3, there is no rotation of the inner shaft 130. Within the proximal control device 200, the discontinuous portion of the ring gear 802 continues and there is no rotation of the shaft 130 by the central gear 816.

[0087] In embodiments where the interconnect 112 is straight, it may then be desirable to refrain from rotating the shaft 130 while the interconnect 112 is deployed from time T2 to T4. For embodiments where the interconnect 112 is curved, such as the embodiment of Figures 1B-1D, it may be desirable to begin rotating the inner shaft 130 during interconnect deployment. Figure 6B depicts deployment for a curved interconnect 112, where from T3 to T4, the inner shaft 130 is rotated in the opposite direction as indicated by region 1034.

[0088] At T4, deployment of interconnect 112 is completed and deployment of second ring-shaped structure 111b begins. Proximal retraction of shafts 120 and 130 is stopped as indicated by the interruption in region 1033. Distal advancement of grasper shaft 138 resumes at T4 in region 1035, while outer shaft 120 is not moved rotationally or longitudinally. Rotation of inner shaft 130 continues as indicated in region 1034, but inner shaft 130 is not moved longitudinally.

[0089] These motions continue until time T5, at which point rotation of the inner shaft 130 is stopped. Within the proximal control device 200, an interruption in the ring gear 802 is reached, causing the gear 802 to disengage from the planetary gears and stopping rotation of the central gear 816. User depression of the trigger 202 continues from time T5 to T6, with components operating with motions similar to those described from time T1 to T2. If another interconnect 112 and ring-shaped structure 111 were present, the sequence beginning at time T6 could be the same as that described beginning at time T2 and continuing until time T6.

[0090] 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 depressing of the trigger 202 is required to deploy all of the ring-shaped structures 111 of the implant 102.

[0091] During deployment, if the physician desires to recapture the implant 102, for example, after time T0, until full deployment of the proximal-most ring-shaped structure 112, depression of the trigger 202 can be stopped. The trigger 202 can be spring-loaded or otherwise biased to return to the outermost position. See FIG. 6B.

[0092] 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 depressed all the way, 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 can be coupled to the control wire 146, and pulling the tab can pull the wire 146 and remove the retainer 142 from the distal engagement portion 114.

[0093] The anchor 152 can then be recaptured (e.g., by deflating the balloon or retracting the wireform member) if desired and withdrawn into the anchor delivery member 150. The anchor delivery member 150, distal control member 140, and inner shaft 130 can be retracted into the outer shaft 120 and then withdrawn from the urethra.

[0094] A more detailed description of the process by which the components in the control device perform the above steps is provided in International Application No. PCT / US19 / 32637, filed May 16, 2019, which is herein incorporated by reference in its entirety for all purposes. Exemplary Embodiments of User Assembly of Proximal Control Device

[0095] Referring again to Figure 5A, the proximal control device 200 can include a movable (e.g., retractable and / or advanceable) handle portion 1102 that can move relative to a more proximally located handle portion 1103. Figure 5A depicts the movable handle portion 1102 in a distally advanced position prior to deployment of the implant 102, and Figure 5B depicts the portion 1102 in a proximally retracted position after deployment of the implant 102. The movable portion 1102 can be secured to and moved with the outer shaft 120, and can be moved independently of the inner shaft 130, the distal control member 140, and the anchor delivery member 150 (not shown).

[0096] A more detailed description of embodiments of the proximal control device is provided in International Application No. PCT / US19 / 32637, filed May 16, 2019, previously incorporated by reference in its entirety for all purposes. Additional details may be found in U.S. Publication No. 2021 / 0145619, previously incorporated by reference in its entirety for all purposes. Exemplary Embodiments of Implant Placement

[0097] All embodiments of the system 100 described herein can be used to deliver the implant 102 to various locations proximal to the prostate or elsewhere in the human anatomy. FIG. 7 is a cross-section of the male anatomy to provide context for use in describing various examples of implantation locations within the prostatic urethra. Here, the prostate gland 1302 is centrally located, with the bladder wall 1304 and bladder 1305 located superiorly. The prostatic urethra 1306 extends inferiorly from the bladder 1305, past the ejaculatory ducts 1307, and through the prostate gland 1302. The prostatic urethra 1306 becomes the membranous urethra 1308 at the general location of the external urethral sphincter 1309 and continues to exit the body. The rectum is indicated by 1310.

[0098] 8A is a cross-section rotated from the perspective of FIG. 7 so that the posterior direction extends into the page and the anterior direction extends out of the page. Here, an exemplary embodiment of implant 102 is shown positioned within the prostatic urethra 1306. The implant 102 is generally positioned centrally within the prostatic urethra 1306 as viewed from this perspective, in other words, generally equidistant from the upper and lower edges of the prostate 1302. The placement of implant 102 can generally be offset either superiorly or inferiorly from the position shown here, at the discretion of a medical professional; however, a position within the prostatic urethra 1306 is generally preferred.

[0099] Figure 8B generally depicts the area of ​​the prostate gland 1302 from the same perspective as Figure 7, but in greater detail. Here, the prostate gland 1302 is enlarged, with the middle lobe 1402 projecting into the prostatic urethra 1306. Figure 8C is a cross-section taken along line 8C-8C in Figure 8B, showing the slit-like nature of the prostatic urethra 1306 in this enlarged prostate gland 1302, with the width of the urethra 1306 increasing as one progresses from the anterior to the posterior side.

[0100] FIG. 8D depicts an exemplary embodiment of a posteriorly placed implant 102 within the exemplary anatomical structure described with respect to FIG. 8B, and FIG. 8E is a cross-section taken along line 8E-8E of FIG. 8D. As can be seen, the implant 102 is generally placed along the posterior-most surface of the prostatic urethra 1306. The implant 102 is sized to have a maximum diameter that is less than the width of the prostatic urethra 1306 at its maximum central width (e.g., less than 50% of the width, less than 65% of the width, less than 80% of the width, etc.), such that the implant 102 can be described as substantially residing on the posterior side of the prostatic urethra 1306 and not contacting the anterior-most side of the urethra 1306. The implications of this placement are shown in FIG. 8E, where the opening through the prostate 1302 created by the implant 102 is primarily positioned on the posterior side of the prostate 1302 and urethra 1306.

[0101] FIG. 8F depicts an exemplary embodiment of an anteriorly placed implant 102 within the exemplary anatomy described with respect to FIG. 8B, and FIG. 8G is a cross-section taken along line 8G-8G of FIG. 8E. As can be seen here, the implant 102 is generally placed along the anterior-most surface of the prostatic urethra 1306. The implant 102 can be sized to have a maximum diameter that is less than the width of the prostatic urethra 1306 at its maximum central width (e.g., less than 50% of the width, less than 65% of the width, less than 80% of the width, etc.), such that the implant 102 can be described as substantially residing on the anterior side of the prostatic urethra 1306 and not contacting the posterior-most side of the urethra 1306. The implications of this placement are shown in FIG. 8G, where the opening through the prostate 1302 created by the implant 102 is positioned primarily on the anterior side of the prostate 1302 and urethra 1306. With both posterior and anterior placement, the implant 102 can still be placed approximately centered relative to the prostate gland 1302, as shown in FIG. 8A. Deployment of the implant 102 in the posterior or anterior position is generally at the discretion of the medical professional. Other placement variations can also be used, including a centered placement between the posterior-most and medial-most sides of the urethra 1306, as well as sizing variations in which the implant 102 has a relatively larger or smaller diameter relative to the prostate gland 1302 than shown here. Removal method

[0102] In one embodiment, the implant 102 can be removed by grasping the atraumatic end of the device and deforming the device from its expanded helical shape to a generally linear shape so that it can be withdrawn through the lumen of the catheter. Retrieval device 300, configured to be inserted through lumen 121 of outer tubular member 120 of delivery device 103, can be used for both acute and chronic retrieval of implant 102. As depicted in FIGS. 9A-9C , delivery device 103 can be used to remove implant 102. An elongate flexible tubular member 330 can be delivered through the first inner lumen 121 of outer tubular member 120. The elongate flexible tubular member 330 can be made of a polymer, such as PEEK. An actuation shaft 334 can be delivered through the lumen of elongate flexible tubular member 330. The actuation shaft 334 may have forceps cups or opposing jaws 338 a, b at a distal end and an actuation handle 336 configured to operate the opening and closing of the opposing jaws 338 a, b at a proximal end. The actuation shaft 334 may also be configured to move axially relative to the elongate flexible tubular member 330 when the device handle 336 is articulated. The distal end of the actuation shaft 334 can extend past the distal end of the elongate flexible tubular member 330, which can extend past the distal end of the outer tubular member 120 to grasp, for example, any of the round, spherical, cylindrical, frusto-conical, or ball-shaped atraumatic ends 116, 117 of the implant 102. The opposing jaws 338 a, b are configured to hold one of the atraumatic ends 116, 117 within a cavity defined by the opposing jaws 338 a, b in a closed configuration. As seen in Figures 10A-10F, the opposing jaws 338a, b may each further include a curved edge 342a, b in a distal region thereof such that when the opposing jaws 338a, b are in a closed configuration, an opening 340 is formed at the distal end thereof, the opening 340 communicating with a cavity defined by the opposing jaws 338a, b in the closed configuration.As seen in Figures 11A-11B, once either of the atraumatic ends 116, 117 is grasped, proximal removal of the articulation shaft 334 into the lumen of the elongate flexible tubular member 330 will result in straightening the implant 102 (i.e., pulling the implant into a generally linear configuration) so that the implant can be removed through the lumen 121 of the outer tubular member 120.

[0103] In another embodiment, the implant can be removed by grasping anywhere along its length, rather than grasping only the atraumatic end. Such a procedure can be performed in an in-clinic, outpatient procedure. A single-use retrieval device 400, configured to be inserted through the lumen 121 of the outer tubular member 120 of the delivery device 103, can be used for both acute and chronic retrieval of the implant 102. As seen in FIG. 12 , the retrieval device 400 includes an articulating handle 410, a semi-flexible sheath 414, and an actuation shaft 418 with a grasping hook 420 at its distal end. The semi-flexible sheath 414 may be a stainless steel tube with a laser-cut pattern in a distal region 416 for increased flexibility. The distal region 416 may be about 3 to about 8 inches, alternatively about 3 to about 7 inches, alternatively about 4 to about 7 inches, or alternatively about 3 to about 6 inches from the distal end of the semi-flexible sheath 414. The laser cut pattern can allow for steerability when used through the working length of the delivery device 103. Within the semi-flexible sheath 414 is an actuation shaft 418 configured to move axially relative to the sheath 410 when the device handle 410 is articulated. The actuation shaft 418 may also be semi-flexible so that it can flex and be steered when used through the working channel of the delivery device 103. A grasping hook 420 is located at the distal end of the actuation shaft 418. The atraumatic grasping hook 420 extends beyond the distal end of the sheath 414 and can be visible via an imaging device when the retrieval device handle is in the “open” position. The grasping hook 420 can be withdrawn and retracted into the sheath 414 when the articulation handle 410 is in the “closed” position.

[0104] As seen in FIGS. 15A-15C, the hook 420 may be shaped to allow visualization of the implant. As seen in FIG. 15C, the tip 428 of the hook may be narrower than the rear portion 430 of the hook. The hook 420 may have a cross-sectional shape in which the rear portion 430 of the cross-section is wider than the front portion 428. The width of the tip 428 of the hook may be about 0.015 inches to about 0.050 inches, alternatively about 0.010 inches to about 0.040 inches, alternatively about 0.01 inches to about 0.030 inches. The width of the front portion 428 of the hook may be about 1 / 3 to about 2 / 3, alternatively about 1 / 4 to about 3 / 4, alternatively about 1 / 2 narrower than the widest width of the rear portion 430.

[0105] The sheath 414 of the retrieval device 400 is intended to be inserted into the first inner lumen 121 of the outer tubular member 120 and manipulated to the implant 102 to be removed. The grasping hook 420 may grasp any portion of the implant 102. For example, the grasping hook 420 may grasp the implant at any location along the extension wire of the implant 102. The implant 102 is "grasped" when any portion of the implant 102 is inside the slot of the grasping hook 420 (see FIGS. 13A-13D). Once the implant is engaged by the grasping hook 420, the user may articulate the device handle 410. As seen in FIG. 14, articulation of the device handle 410 from the open position to the closed position applies a three-point bend to the grasped portion of the implant. The three-point bend can be caused by a force (see arrow in direction B) applied to the implant 102 by the outer wall 422 of the sheath 414 as the grasping hook 420 is withdrawn into the sheath 414 (see arrow in direction A). When force is applied to the device handle and the grasping hook is retracted, the implant effectively crimps due to the force of the three-point bend. The grasping hook 420 and implant 102 are also partially withdrawn into the semi-flexible sheath. This action can induce high strains, which can permanently deform the implant. Once the handle is fully articulated to the closed position and the implant is crimped and partially withdrawn into the sheath 414, the implant 102 can be pulled from the lumen 121 and removed from the patient. The mechanism of removal relies on the implant's "double wire structure," with the wires on each side of the crimped hook straightening into a generally linear shape as the retrieval device is pulled rearward through the scope working channel. The sheath 414 may be a hypotube, such as a laser-cut hypotube. In other embodiments, the sheath 414 may include a rigid member disposed across a distal region of the sheath 414, the rigid member having compressive support and being sufficiently rigid to apply two opposing forces to the implant 102 to form a three-point bend. The rigid member may be tubular or non-tubular in shape.

[0106] The embodiments described herein are restated and further elaborated upon in the following paragraphs without explicit reference to the figures.

[0107] In many embodiments, a method of removing an implant from a patient's urethra is described, the method including: advancing a portion of a removal device within the patient's urethra to a position adjacent to the implant, the removal device comprising an outer tubular member, an inner elongate tubular member within a lumen of the outer tubular member, and an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end coupled to a handle and a distal end comprising a hook; advancing the distal end of the elongate actuation member distal to the distal end of the outer tubular member and distal to the distal end of the inner elongate tubular member; grasping a portion of the implant with the hook; withdrawing the hook and at least a portion of the implant proximally into the lumen of the inner elongate tubular member such that a bend is formed in the implant; and withdrawing the implant through the lumen of the outer tubular member, the implant being in an axially elongated shape while within the lumen of the inner elongate tubular member.

[0108] In some embodiments, the implant has a first end, a second end, and an intermediate portion, and the hook grasps the implant at the intermediate portion.

[0109] In some embodiments, the implant comprises an elongated wire and at least one enlarged end, and the hook grasps the elongated wire.

[0110] In some embodiments, the inner elongate tubular member comprises a flexible distal region. In some embodiments, the flexible distal region comprises a laser cut tube.

[0111] In some embodiments, the inner elongate tubular member is a hypotube.

[0112] In some embodiments, the removal device further includes a stiffening member disposed over a distal region of the inner elongate tubular member.

[0113] In some embodiments, a three-point bend is formed in the implant.

[0114] In some embodiments, a bend is formed in the implant as a result of forces applied to the implant by the wall and hooks of the inner elongate tubular member.

[0115] In some embodiments, the axially elongated shape comprises a double line structure of the implant.

[0116] In some embodiments, the method further includes visualizing the hook with an imaging device after the hook has been advanced distally beyond the distal end of the outer tubular member.

[0117] In some embodiments, the hook and at least a portion of the implant are proximally withdrawn by actuating a handle coupled to the proximal end of the elongated actuation member.

[0118] In some embodiments, the implant has an expanded helical shape.

[0119] In some embodiments, the tips of the hooks have a width of about 0.015 inches to about 0.050 inches.

[0120] In some embodiments, the tip portion of the hook is narrower than the rear portion of the hook.

[0121] In many embodiments, a system for retrieving an implant is described, the system including an outer tubular member having a distal end and a lumen, an inner elongate tubular member within the lumen of the outer tubular member, an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end coupled to a handle and a distal end comprising a hook, and a proximal control device coupled to the inner tubular member and releasably coupled to the outer tubular member through a coupling mechanism, the proximal control device configured to longitudinally move the inner elongate tubular member, the outer tubular member, and the elongate actuation member, and also including a retrieval device configured to move the elongate actuation member within the lumen of the inner elongate tubular member.

[0122] In some embodiments, the implant has a first end, a second end, and an intermediate portion, and the hook is configured to grasp the implant at the intermediate portion.

[0123] In some embodiments, the inner elongate tubular member comprises a flexible distal region. In some embodiments, the flexible distal region comprises a laser cut tube.

[0124] In some embodiments, the inner elongate tubular member is a hypotube.

[0125] In some embodiments, the system further includes a stiffening member disposed over a distal region of the inner elongate tubular member.

[0126] In some embodiments, the outer tubular member further comprises an imaging device located within the distal end region of the outer tubular member.

[0127] In some embodiments, the proximal control device is configured to longitudinally move the inner elongate tubular member, the outer tubular member, and the elongate actuation member in tandem.

[0128] In some embodiments, the implant has an expanded helical shape.

[0129] In many embodiments, a method of removing an implant from a patient's urethra is described, the method including the steps of: advancing a removal device within the patient's urethra to a position adjacent to the implant, the removal device comprising an outer tubular member, an inner elongate tubular member within a lumen of the outer tubular member, and an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end and a distal end, the distal end comprising opposing first and second jaws configured to open and close; advancing the distal end of the elongate actuation member distal to the distal end of the inner elongate tubular member; grasping a portion of the implant with the opposing first and second jaws; and proximally withdrawing the elongate actuation member within the lumen of the inner elongate tubular member, wherein at least a portion of the implant assumes an axially elongated shape within the lumen of the inner elongate tubular member.

[0130] In some embodiments, the opposing first and second jaws grasp an enlarged end of the implant. In some embodiments, the shape of the enlarged end can be a ball, a cylinder, or a cone. In some embodiments, when the opposing first and second jaws are in a closed configuration, the opposing first and second jaws have an opening at a distal end of the closed configuration. In some embodiments, the implant includes an elongated wire and at least one enlarged end, where the at least one enlarged end is grasped by the opposing first and second jaws and the elongated wire extends through an opening at the distal end of the closed configuration.

[0131] In some embodiments, the implant is in an axially elongated shape while within the lumen of the outer tubular member, hi some embodiments, the axially elongated shape is generally linear.

[0132] In some embodiments, the method further includes visualizing the distal end of the elongated actuation member with an imaging device after the distal end of the elongated actuation member has been advanced distally beyond the distal end of the outer tubular member.

[0133] In some embodiments, the implant has an expanded helical shape.

[0134] In some embodiments, the tips of the hooks have a width of about 0.015 inches to about 0.050 inches.

[0135] In some embodiments, the tip portion of the hook is narrower than the rear portion of the hook.

[0136] In many embodiments, a system for retrieving an implant is described, the system including an outer tubular member having a distal end and a lumen, an inner elongate tubular member within the lumen of the outer tubular member, an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end and a distal end, the distal end having first and second jaws configured to open and close, and a proximal control device coupled to the elongate actuation member and the inner elongate tubular member and releasably coupled to the outer tubular member through a coupling mechanism, the proximal control device configured to longitudinally move the elongate actuation member, the inner elongate tubular member, and the outer tubular member, and also configured to longitudinally move the elongate actuation member within the lumen of the inner tubular member.

[0137] In some embodiments, the implant has a first end, a second end, and an intermediate portion, and at least one of the first and second ends is an enlarged atraumatic end. In some embodiments, the opposing first and second jaws are configured to grasp the enlarged atraumatic end of the implant.

[0138] In some embodiments, the first and second opposing jaws have an opening at a distal end of the closed configuration when in the closed configuration. In some embodiments, the implant includes an elongated wire and at least one enlarged end, the first and second opposing jaws are configured to grasp the at least one enlarged end, and the opening at the distal end of the closed configuration is configured for the elongated wire to extend therethrough.

[0139] In some embodiments, the outer tubular member further comprises an imaging device located within the distal end region of the outer tubular member.

[0140] In some embodiments, the proximal control device is configured to longitudinally move the elongate member, the inner elongate member, and the outer tubular member in tandem.

[0141] In some embodiments, the implant has an expanded helical shape.

[0142] In many embodiments, a method of removing an implant from a patient's urethra is described, the method including the steps of: advancing a removal device within the patient's urethra to a position adjacent to the implant, the removal device comprising an outer tubular member, an inner elongate tubular member within a lumen of the outer tubular member, and an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end and a distal end, the distal end comprising a grasper; advancing the distal end of the elongate actuation member distal to the distal end of the inner elongate tubular member; grasping a portion of the implant with the grasper; and proximally withdrawing the elongate actuation member within the lumen of the inner elongate tubular member, wherein at least a portion of the implant assumes an axially elongated shape within the lumen of the inner elongate tubular member.

[0143] In some embodiments, the grasper comprises opposing first and second jaws. In some embodiments, the opposing first and second jaws grasp an enlarged end of the implant. In some embodiments, when the opposing first and second jaws are in a closed configuration, the opposing first and second jaws have an opening at a distal end of the closed configuration. In some embodiments, the implant comprises an extension wire and at least one enlarged end, the at least one enlarged end being grasped by the opposing first and second jaws, and the extension wire extending through an opening at the distal end of the closed configuration. In some embodiments, the shape of the axial extension is generally linear.

[0144] In some embodiments, the retainer comprises a hook. In some embodiments, the implant has a first end, a second end, and a middle portion, and the hook grasps the implant at the middle portion. In some embodiments, the implant comprises an elongated wire and at least one enlarged end, and the hook grasps the elongated wire. In some embodiments, the inner elongated tubular member comprises a flexible distal region. In some embodiments, the flexible distal region comprises a laser-cut tube. In some embodiments, the inner elongated tubular member is a hypotube. In some embodiments, the removal device further comprises a rigid member disposed over the distal region of the inner elongated tubular member. In some embodiments, when the hook and a portion of the implant are withdrawn proximally within the lumen of the inner elongated tubular member, a bend is formed in the implant. In some embodiments, the bend is a three-point bend. In some embodiments, the bend is formed in the implant as a result of multiple forces applied to the implant by the wall of the inner elongated tubular member and the hook. In some embodiments, the axially elongated shape comprises a double-lined structure of the implant. In some embodiments, the method further includes visualizing the hook with an imaging device after the hook has been advanced distally beyond the distal end of the outer tubular member.

[0145] In some embodiments, the implant has an expanded helical shape.

[0146] In some embodiments, the tips of the hooks have a width of about 0.015 inches to about 0.050 inches.

[0147] In some embodiments, the tip portion of the hook is narrower than the rear portion of the hook.

[0148] In many embodiments, a system for retrieving an implant is described, the system including an outer tubular member having a distal end and a lumen, an inner elongate tubular member within the lumen of the outer tubular member, an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end and a distal end, the distal end including a grasper, and a proximal control device coupled to the elongate actuation member and the inner elongate actuation member and releasably coupled to the outer tubular member through a coupling mechanism, the proximal control device configured to longitudinally move the elongate actuation member, the inner elongate tubular member, and the outer tubular member, and also configured to longitudinally move the elongate actuation member within the lumen of the inner tubular member.

[0149] In some embodiments, the grasper comprises opposing first and second jaws. In some embodiments, the implant has a first end, a second end, and a middle portion, and at least one of the first and second ends is an enlarged atraumatic end. In some embodiments, the opposing first and second jaws are configured to grasp the enlarged atraumatic end of the implant. In some embodiments, the opposing first and second jaws have an opening at a distal end of the closed configuration when in the closed configuration. In some embodiments, the implant comprises an extension wire and at least one enlarged end, and the opposing first and second jaws are configured to grasp the at least one enlarged end, and the opening at the distal end of the closed configuration is configured for the extension wire to extend therethrough.

[0150] In some embodiments, the outer tubular member further comprises an imaging device located within the distal end region of the outer tubular member.

[0151] In some embodiments, the proximal control device is configured to longitudinally move the elongate member, the inner elongate member, and the outer tubular member in tandem.

[0152] In some embodiments, the grasper comprises a hook. In some embodiments, the implant has a first end, a second end, and a middle portion, and the hook is configured to grasp the implant at the middle portion. In some embodiments, the inner elongate tubular member comprises a flexible distal region. In some embodiments, the inner elongate tubular member is a hypotube. In some embodiments, the system further includes a rigid member disposed over a distal region of the inner elongate tubular member. In some embodiments, the flexible distal region comprises a laser-cut tube. In some embodiments, the implant has an expanded helical shape. In some embodiments, the tip of the hook has a width of about 0.015 inches to about 0.050 inches. In some embodiments, the tip portion of the hook is narrower than the rear portion of the hook.

[0153] Systems, devices, and methods are provided for retrieval of an implant from the prostatic urethra. Embodiments of the retrieval system can include a device for insertion into a patient and a proximal control device for use in grasping a portion of the implant and withdrawing the implant into a lumen of the retrieval system.

[0154] Aspects of the invention are set out in independent claims and preferred features are set out in dependent claims. Preferred features of each aspect may be provided in combination with each other within particular embodiments and may also be provided in combination with other aspects. Additional notes

[0155] Exemplary embodiments are described in the following numbered appendices. Appendix 1. A method for removing an implant from a patient's urethra, the method comprising: advancing a portion of a removal device within the patient's urethra to a position adjacent to the implant, the removal device comprising an outer tubular member, an inner elongate tubular member within a lumen of the outer tubular member, and an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end coupled to a handle and a distal end comprising a hook; advancing the distal end of the elongate actuation member distal to the distal end of the outer tubular member and distal to the distal end of the inner elongate tubular member; grasping a portion of the implant with the hook; withdrawing the hook and at least a portion of the implant proximally into the lumen of the inner elongate tubular member such that a bend is formed in the implant; and withdrawing the implant through the lumen of the outer tubular member, the implant being in an axially elongated shape while within the lumen of the inner elongate tubular member. Appendix 2. The method of Appendix 1, wherein the implant has a first end, a second end, and an intermediate portion, and the hook grasps the implant at the intermediate portion. Appendix 3. The method of Appendix 1, wherein the implant comprises an elongated wire and at least one enlarged end, and the hook grasps the elongated wire. Clause 4. The method of clause 1, wherein the inner elongate tubular member comprises a flexible distal region. Clause 5. The method of Clause 4, wherein the flexible distal region comprises a laser-cut tube. Clause 6. The method of clause 1, wherein the inner elongate tubular member is a hypotube. Clause 7. The method of Clause 1, wherein the removal device further comprises a rigid member disposed over a distal region of the inner elongate tubular member. Clause 8. The method of clause 1, wherein a three-point bend is formed in the implant. Clause 9. The method of clause 1, wherein the bend is formed in the implant as a result of a force applied to the implant by the wall and hook of the inner elongate tubular member. Appendix 10. The method of Appendix 1, wherein the axially elongated shape comprises a double-lined structure of the implant. Clause 11. The method of clause 1, further comprising the step of visualizing the hook with an imaging device after the hook has been advanced distally beyond the distal end of the outer tubular member. Clause 12. The method of clause 1, wherein the hook and at least a portion of the implant are proximally removed by actuating a handle coupled to a proximal end of the elongated actuation member. Appendix 13. The method of Appendix 1, wherein the implant has an expanded spiral shape. Appendix 14. The method of Appendix 1, wherein the tip of the hook has a width of about 0.015 inches to about 0.050 inches. Appendix 15. The method of Appendix 1, wherein the tip portion of the hook is narrower than the rear portion of the hook. Appendix 16. A system for retrieving an implant, the system comprising: an outer tubular member having a distal end and a lumen; an inner elongate tubular member within the lumen of the outer tubular member; an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end coupled to a handle and a distal end comprising a hook; and a proximal control device coupled to the inner tubular member and releasably coupled to the outer tubular member through a coupling mechanism, the proximal control device configured to longitudinally move the inner elongate tubular member, the outer tubular member, and the elongate actuation member, and also configured to move the elongate actuation member within the lumen of the inner elongate tubular member. Clause 17. The system of clause 16, wherein the implant has a first end, a second end, and an intermediate portion, and the hook is configured to grasp the implant at the intermediate portion. Clause 18. The system of clause 16, wherein the inner elongate tubular member comprises a flexible distal region. Clause 19. The system of clause 16, wherein the inner elongate tubular member is a hypotube. Clause 20. The system of clause 16, further comprising a rigid member disposed across a distal region of the inner elongate tubular member. Clause 21. The system of clause 18, wherein the flexible distal region comprises a laser-cut tube. Clause 22. The system of clause 16, wherein the outer tubular member further comprises an imaging device located within the distal end region of the outer tubular member. Clause 23. The system of clause 16, wherein the proximal control device is configured to longitudinally move the inner elongate tubular member, the outer tubular member, and the elongate actuation member in parallel. Clause 24. The system of clause 16, wherein the implant has an expanded spiral shape. Item 25. The system of item 16, wherein the hook tip has a width of about 0.015 inches to about 0.050 inches. Clause 26. The system of clause 16, wherein the tip portion of the hook is narrower than the rear portion of the hook. Appendix 27. A method of removing an implant from a patient's urethra, the method comprising: advancing a removal device within the patient's urethra to a position adjacent to the implant, the removal device comprising an outer tubular member, an inner elongate tubular member within a lumen of the outer tubular member, and an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end and a distal end, the distal end comprising first and second opposing jaws configured to open and close; advancing the distal end of the elongate actuation member distal to the distal end of the inner elongate tubular member; grasping a portion of the implant with the first and second opposing jaws; and proximally withdrawing the elongate actuation member within the lumen of the inner elongate tubular member, wherein at least a portion of the implant assumes an axially elongated configuration within the lumen of the inner elongate tubular member. 28. The method of claim 27, wherein the opposing first and second jaws grasp the enlarged end of the implant. Clause 29. The method of clause 28, wherein the enlarged end is a shape selected from the group consisting of a ball, a cylinder, and a cone. Clause 30. The method of clause 28, wherein when the opposing first and second jaws are in the closed configuration, the opposing first and second jaws have an opening at a distal end of the closed configuration. Addendum 31. The method of Addendum 30, wherein the implant comprises an elongated wire and at least one enlarged end, the at least one enlarged end being grasped by opposing first and second jaws, and the elongated wire extending through an opening at the distal end in the closed configuration. Item 32. The method of item 27, wherein the implant is in an axially elongated shape while within the lumen of the outer tubular member. 33. The method of claim 32, wherein the shape of the axial extension is substantially linear. Clause 34. The method of clause 27, further comprising the step of visualizing the distal end of the elongated actuation member using an imaging device after the distal end of the elongated actuation member has been advanced distally beyond the distal end of the outer tubular member. Addendum 35. The method of Addendum 27, wherein the implant has an expanded spiral shape. Appendix 36. A system for retrieving an implant, the system comprising: an outer tubular member having a distal end and a lumen; an inner elongate tubular member within the lumen of the outer tubular member; an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end and a distal end, the distal end comprising first and second jaws configured to open and close; and a proximal control device coupled to the elongate actuation member and the inner elongate tubular member and releasably coupled to the outer tubular member through a coupling mechanism, the proximal control device configured to longitudinally move the elongate actuation member, the inner elongate tubular member, and the outer tubular member, and also configured to longitudinally move the elongate actuation member within the lumen of the inner tubular member. Addendum 37. The system of Addendum 36, wherein the implant has a first end, a second end, and an intermediate portion, and at least one of the first and second ends is an enlarged atraumatic end. Clause 38. The system of clause 37, wherein the opposing first and second jaws are configured to grasp the enlarged atraumatic end of the implant. Clause 39. The system of clause 36, wherein the opposing first and second jaws, when in the closed configuration, have an opening at a distal end of the closed configuration. Addendum 40. The system of Addendum 39, wherein the implant comprises an elongated wire and at least one enlarged end, the opposing first and second jaws are configured to grasp the at least one enlarged end, and the opening at the distal end of the closed configuration is configured for the elongated wire to extend therethrough. Clause 41. The system of clause 36, wherein the outer tubular member further comprises an imaging device located within the distal end region of the outer tubular member. Clause 42. The system of clause 36, wherein the proximal control device is configured to longitudinally move the elongate member, the inner elongate member, and the outer tubular member in parallel. Addendum 43. The system of Addendum 36, wherein the implant has an expanded spiral shape. Appendix 44. A method of removing an implant from a patient's urethra, the method comprising: advancing a removal device within the patient's urethra to a position adjacent to the implant, the removal device comprising an outer tubular member, an inner elongate tubular member within a lumen of the outer tubular member, and an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end and a distal end, the distal end comprising a grasper; advancing the distal end of the elongate actuation member distal to the distal end of the inner elongate tubular member; grasping a portion of the implant with the grasper; and proximally withdrawing the elongate actuation member within the lumen of the inner elongate tubular member, wherein at least a portion of the implant assumes an axially elongated configuration within the lumen of the inner elongate tubular member. Clause 45. The method of clause 44, wherein the grasper comprises opposing first and second jaws. Clause 46. The method of clause 45, wherein the opposing first and second jaws grasp the enlarged end of the implant. Clause 47. The method of clause 45, wherein when the opposing first and second jaws are in the closed configuration, the opposing first and second jaws have an opening at a distal end of the closed configuration. Addendum 48. The method of Addendum 47, wherein the implant comprises an elongated wire and at least one enlarged end, the at least one enlarged end being grasped by opposing first and second jaws, and the elongated wire extending through an opening at the distal end in the closed configuration. Item 49. The method of item 45, wherein the shape of the axial extension is substantially linear. Clause 50. The method of clause 44, wherein the gripper comprises a hook. Clause 51. The method of clause 50, wherein the implant has a first end, a second end, and an intermediate portion, and the hook grasps the implant at the intermediate portion. Clause 52. The method of clause 50, wherein the implant comprises an elongated wire and at least one enlarged end, and the hook grasps the elongated wire. Item 53. The method of item 50, wherein the tip of the hook has a width of about 0.015 inches to about 0.050 inches. Item 54. The method of item 50, wherein the tip portion of the hook is narrower than the rear portion of the hook. Clause 55. The method of clause 50, wherein the inner elongate tubular member comprises a flexible distal region. Clause 56. The method of clause 55, wherein the flexible distal region comprises a laser-cut tube. Clause 57. The method of clause 50, wherein the inner elongate tubular member is a hypotube. Clause 58. The method of clause 50, wherein the removal device further comprises a rigid member disposed across a distal region of the inner elongate tubular member. Clause 59. The method of clause 50, wherein a bend is formed in the implant when the hook and a portion of the implant are withdrawn proximally within the lumen of the inner elongate tubular member. Item 60. The method of item 59, wherein the bend is a three-point bend. Clause 61. The method of clause 59, wherein the bend is formed in the implant as a result of multiple forces applied to the implant by the walls and hooks of the inner elongate tubular member. Item 62. The method of item 50, wherein the axially elongated shape comprises a double-lined structure of the implant. Clause 63. The method of clause 50, further comprising the step of visualizing the hook with an imaging device after the hook has been advanced distally beyond the distal end of the outer tubular member. Item 64. The method of item 44, wherein the implant has an expanded spiral shape. Appendix 65. A system for retrieving an implant, the system comprising: an outer tubular member having a distal end and a lumen; an inner elongate tubular member within the lumen of the outer tubular member; an elongate actuation member within the lumen of the inner elongate tubular member, the elongate actuation member having a proximal end and a distal end, the distal end comprising a grasper; and a proximal control device coupled to the elongate actuation member and the inner elongate actuation member and releasably coupled to the outer tubular member through a coupling mechanism, the proximal control device configured to longitudinally move the elongate actuation member, the inner elongate tubular member, and the outer tubular member, and also configured to longitudinally move the elongate actuation member within the lumen of the inner tubular member. Clause 66. The system of clause 65, wherein the grasper comprises opposing first and second jaws. Addendum 67. The system of Addendum 66, wherein the implant has a first end, a second end, and an intermediate portion, and at least one of the first and second ends is an enlarged atraumatic end. Addendum 68. The system of Addendum 67, wherein the opposing first and second jaws are configured to grasp the enlarged atraumatic end of the implant. Clause 69. The system of clause 66, wherein the opposing first and second jaws, when in the closed configuration, have an opening at a distal end of the closed configuration. Addendum 70. The system of Addendum 69, wherein the implant comprises an elongated wire and at least one enlarged end, the opposing first and second jaws are configured to grasp the at least one enlarged end, and the opening at the distal end of the closed configuration is configured for the elongated wire to extend therethrough. Addendum 71. The system of Addendum 65, wherein the outer tubular member further comprises an imaging device located within the distal end region of the outer tubular member. Clause 72. The system of clause 65, wherein the proximal control device is configured to longitudinally move the elongate member, the inner elongate member, and the outer tubular member in parallel. Clause 73. The system of clause 65, wherein the grasper comprises a hook. Addendum 74. The system of Addendum 73, wherein the implant has a first end, a second end, and an intermediate portion, and the hook is configured to grasp the implant at the intermediate portion. Item 75. The system of item 73, wherein the hook tip has a width of about 0.015 inches to about 0.050 inches. Clause 76. The system of clause 73, wherein the tip portion of the hook is narrower than the rear portion of the hook. Clause 77. The system of clause 73, wherein the inner elongate tubular member comprises a flexible distal region. Clause 78. The system of clause 77, wherein the flexible distal region comprises a laser-cut tube. Item 79. The system of item 73, wherein the inner elongate tubular member is a hypotube. Clause 80. The system of clause 73, further comprising a rigid member disposed across a distal region of the inner elongate tubular member. Addendum 81. The system of Addendum 65, wherein the implant has an expanded spiral shape.

[0156] 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. If a feature, element, component, function, or step is described with respect to only one embodiment, it should be understood that that feature, element, component, function, or step can be used with all other embodiments described herein unless expressly stated otherwise. This paragraph therefore serves as a preliminary basis and written support for the introduction of claims that combine features, elements, components, functions, and steps from different embodiments or substitute features, elements, components, functions, and steps from one embodiment with those of another embodiment, even if the subsequent description does not explicitly state that such combinations or substitutions are possible in a particular instance. In particular, it is expressly acknowledged that an explicit enumeration of all possible combinations and substitutions would be unduly burdensome, given that the permissibility of all such combinations and substitutions would be readily recognized by those skilled in the art.

[0157] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0158] 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, but on the contrary, these embodiments are intended to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, negative limitations may be recited in or added to the claims that define the scope of any feature, function, step, or element of the embodiments, as well as any feature, function, step, or element that does not fall within the scope of the claimed invention.

Claims

1. 1. A system for retrieving an implant, the system comprising: a retrieval device; an outer tubular member having a distal end and a lumen; an inner elongate tubular member within the lumen of the outer tubular member; an elongated actuation member within a lumen of the inner elongated tubular member, the elongated actuation member having a proximal end and a distal end, the distal end including a grasper; a proximal control device coupled to the elongated actuation member and the inner elongated tubular member and releasably coupled to the outer tubular member through a coupling mechanism; Equipped with the implant has a first end, a second end, and a middle portion, and the grasper is configured to grasp the middle portion of the implant; the proximal control device is configured to longitudinally move the elongated actuation member, inner elongated tubular member, and outer tubular member, and to longitudinally move the elongated actuation member within the lumen of the inner elongated tubular member to enable the elongated actuation member to at least partially withdraw the implant into the inner elongated tubular member, and the distal end of the inner elongated tubular member is configured to apply opposing forces to the implant to create a double-line configuration of the implant, with portions of the implant on either side of the grasper forming a generally linear shape so that the implant can be pulled proximally through the outer tubular member.

2. The system described in claim 1, wherein at least one of the first and second ends is an enlarged atraumatic end.

3. The system of claim 1 , wherein the outer tubular member further comprises an imaging device located within a distal end region of the outer tubular member.

4. The system of claim 1 , wherein the proximal control device is configured to longitudinally move the elongated actuation member, the inner elongated tubular member, and the outer tubular member in tandem.

5. The system of claim 1 , wherein the grasper comprises a hook.

6. The system of claim 5, wherein the hook tips have a width between 0.015 inches and 0.050 inches.

7. The system of claim 5 , wherein a tip portion of the hook is narrower than a rear portion of the hook.

8. The system of claim 5 , wherein the inner elongate tubular member comprises a flexible distal region.

9. The system of claim 8 , wherein the flexible distal region comprises a laser-cut tube.

10. The system of claim 5 , wherein the inner elongate tubular member is a hypotube.

11. The system of claim 5 , further comprising a stiffening member disposed across a distal region of the inner elongate tubular member.

12. The system of claim 1 , wherein the implant has an expanded helical shape.

13. The system described in claim 1, wherein the distal end of the inner elongated tubular member has a compressive support such that the distal end of the inner elongated tubular member can apply a counter force to the implant sufficient to create a double line structure of the implant.

14. The system described in claim 1, wherein the distal end of the inner elongated tubular member is configured to apply two opposing forces to the implant, thereby forming a three-point bend in the implant and resulting in a double-line structure of the implant.

15. The system described in claim 1, wherein the outer wall of the distal end of the inner elongated tubular member is configured to apply the opposing force to the implant when the elongated actuation member removes the implant into the inner elongated tubular member.

Images