Smooth urethral endoscope

Abstract

The invention discloses a urethral endoscope for a smooth insertion of a stent. The urethral endoscope and the method thereof can provide an optical element when a urethral stent is inserted and positioned. A deployment system is configured to simultaneously accommodate an implant and an optical system to facilitate direct insertion of the implant into a desired area. In some embodiments, this facilitates insertion of the implant without first inserting the implant into the bladder and / or pulling the implant from the bladder back to the urethra. Some embodiments may facilitate insertion of an implant with less number of insertion and removal of the endoscope and / or its sheath.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 443,399, filed on February 5, 2023, the contents of which are incorporated herein by reference in their entirety.

[0003] Technical field and background technology

[0004] The present invention, in one embodiment thereof, relates to a urethral endoscope for inserting an implant (eg, a stent), and more particularly, but not exclusively, to a urethral endoscope and method that can provide antegrade insertion and positioning of a urethral stent.

[0005] Applicant's U.S. Patent No. 11,571,290 appears to disclose that "an embodiment of a urological implant includes an implant having an elongated body with a longitudinal axis. Optionally, longitudinal ribs are symmetrically opposed to each other and connected to the elongated body. The longitudinal ribs are optionally elastically movable between a contracted state and an expanded state relative to the longitudinal axis of the spine to retract and / or support periurethral tissue. Optionally, the system includes an implant extraction handle. The extraction handle is optionally positioned at a proximal end of the elongated body and connected to the longitudinal ribs and is tensioned to promote and / or force the longitudinal support proximate the longitudinal axis. In some embodiments, the implant body includes longitudinally spaced apart arched members sequentially interconnected by arched ends along the length of a first longitudinal rib and a second longitudinal rib. Optionally, the arched members are elastically bendable to facilitate elastic contraction of the implant body under the action of a transverse compressive force."

[0006] Applicant's U.S. Patent No. 10,507,122 appears to disclose a "Urological (prostate) implant, system, and method for retracting and / or supporting periurethral tissue surrounding the prostatic urethra along the length of a prostate lobe, such as in a patient with BPH. The prostate implant includes independently actuatable distal retractors (including cranial angles) and proximal retractors (including caudal angles). The retractors may be connected by an elongated spine member and form a pair of curved wing-like structures having interconnecting members. The implant may also include tissue support members extending between elongated edge members connecting the retractors to the spine member, and tissue support members extending between the elongated edge members and the spine member. The tissue support members are sized and configured to support portions of the lateral lobes of the prostate when the spine member engages the anterior interlobar groove extending between the lateral lobes of the prostate and when the elongated edge member engages the posterolateral interlobar groove. The system and method include an implant manipulator removably connected to the elongated edge members of the implant for manipulating and forcing the caudal angles of the implant into close proximity for delivery into the subject."

[0007] U.S. Patent No. 7,507,247 appears to disclose that "a stent delivery system for placing a non-expandable stent in the urethra is described. The delivery system generally consists of a catheter with the stent mounted near the distal end of the catheter. The stent is held in place by a balloon or mechanical mechanism."

[0008] U.S. Patent No. 11,096,774 appears to disclose that "systems, devices, and methods for delivering an implant to the prostatic urethra are provided. Embodiments of the delivery system may include a delivery device for insertion into a patient and a proximal control device for controlling release of the implant from the delivery device."

[0009] U.S. Patent Publication No. 2012 / 0010645 appears to disclose "an expansion device for use in a body lumen, such as a urethra partially obstructed by an enlarged prostate, in the form of a curved member configured to be implanted around the lumen and increase the elasticity of the lumen, and a method of expanding such a lumen by implanting the expansion device outside the lumen, wherein at least a portion of the expansion device is embedded in the surrounding area to prevent clinically significant compression of the lumen. Additionally, there is provided an implantation device for such an expansion device in the form of a mounting device for carrying the expansion device; and a releasably connected removable stent, wherein the mounting device and the stent are configured to deliver the expansion device through a working channel to a desired location in the lumen and implant the expansion device through the lumen wall to a location around the lumen."

[0010] U.S. Patent No. 7,967,830 appears to disclose "a method and apparatus for introducing a first elongated medical device and a short guidewire connected together into a working site and remotely disconnecting them within the working site such that a secondary device including a catheter member can be introduced into the working site over the guidewire and / or a second guidewire can be introduced into the working site through a channel of a primary access device. A separation member can be provided to remotely disconnect the guidewire from the elongated medical device. In one example of this method, a guidewire and a primary access device (e.g., a sphincterotomy) are connected to the guidewire and introduced into the biliary system through a duodenoscope. In another example of this method, a prosthesis such as a valve or stent is placed within the working site and connected to a guidewire that is remotely disconnected within the working site, and after removal of the first delivery system, an auxiliary device such as a dilation balloon or a second prosthesis is introduced into the working site."

[0011] International Patent Publication No. WO2021072258 appears to disclose "devices and systems for managing and / or treating body tissue obstructing a hollow body cavity, including prostate lobe tissue obstructing the urethra, such as conditions including benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), benign prostatic obstruction (BPO), and related lower urinary tract symptoms (LUTS). The implant is maintained in a constrained configuration within a distal portion of an elongated sheath so that the implant can be deployed by a pusher coaxially disposed within the sheath. An implant engagement element helps maintain control of the implant during deployment."

[0012] U.S. Patent No. 11,690,744 appears to disclose that "a stent delivery system may include a delivery device and a tubular body having a lumen slidably fitting an outer diameter of the delivery device, and a draining stent having an anchoring mechanism, wherein the delivery device includes a constraining member configured to engage an exterior of the tubular body at a proximal end of the delivery device. A method of delivering a stent may include inserting the tubular body into a port of an endoscope, inserting a stent delivery device and a stent having an anchoring mechanism into the tubular body, wherein the delivery device includes a constraining member configured to engage and retain the tubular body at a proximal end of the delivery device, advancing the draining stent distally through the tubular body, sliding the tubular body proximally, and engaging the exterior of the tubular body with the constraining member."

[0013] U.S. Patent No. 9,907,686 appears to disclose "a system for implanting a prosthesis, comprising a prosthesis delivery device having a handle, an inner lumen, a nose cone, a central lumen, a prosthesis sheath distal to the central lumen for receiving the prosthesis to be implanted, and an outer lumen fixedly connected to the handle. The system may include a lumen control assembly operable to move the central lumen and the prosthesis sheath between a retracted position and an extended position." Summary of the Invention

[0014] According to one aspect of some embodiments of the present invention, a method for inserting a urethral implant is provided, comprising: storing an implant in a distal portion of a lumen of a delivery sheath; inserting the distal portion of the delivery sheath into a urethra; and inserting an optical element through a proximal portion of the lumen so as to observe outwardly from a distal opening of the lumen while the implant remains in the distal portion of the lumen.

[0015] According to some embodiments of the present invention, the method of inserting a urethral implant further comprises: holding the implant on a holder and retracting the delivery sheath to expose the implant within the urethra.

[0016] According to some embodiments of the present invention, the retainer extends from a proximal opening of the delivery sheath to the implant.

[0017] According to some embodiments of the present invention, the retainer comprises a tube, and the method of inserting a urethral implant further comprises grasping a proximal portion of the implant with a loop of wire passing through a proximal opening of the tube.

[0018] According to some embodiments of the present invention, the method of inserting a urethral implant further comprises: severing one leg of the loop wire and passing the wire through the tube to release the implant.

[0019] According to some embodiments of the present invention, the grasping is grasping at two proximal corners of the implant.

[0020] According to some embodiments of the invention, the implant expands upon said exposing.

[0021] According to some embodiments of the present invention, the method of inserting a urethral implant further comprises: retracting the optical element as the delivery sheath is retracted.

[0022] According to some embodiments of the present invention, the method of inserting a urethral implant further comprises: after the exposing, advancing the optical element.

[0023] According to some embodiments of the present invention, the advancing comprises causing a distal portion of the optical element to protrude from the distal opening of the lumen.

[0024] According to some embodiments of the present invention, the method of inserting a urethral implant further comprises: re-extending the delivery sheath after the retracting to return the implant into the distal opening of the lumen.

[0025] According to one aspect of some embodiments of the present invention, there is provided a system for inserting an implant into a urethra, comprising: a sheath having a distal portion configured for insertion into a urethra while a proximal portion remains outside the urethra; a retainer configured for retaining the implant in a distal portion of the sheath; a connector comprising a distal portion connected to the retainer; and a handle configured to facilitate release of the connector.

[0026] According to some embodiments of the present invention, the retainer extends through a lumen of the sheath from the implant to a proximal opening of the lumen.

[0027] According to some embodiments of the present invention, the implant is retained in the sheath in a folded state.

[0028] According to some embodiments of the present invention, the implant is configured to automatically expand upon exposure from the sheath.

[0029] According to some embodiments of the present invention, the system for inserting an implant into the urethra further comprises: a retraction mechanism in the handle, the retraction mechanism being configured to retract the sheath while holding the implant in place by the retainer, thereby exposing the implant within the urethra.

[0030] According to some embodiments of the present invention, the retainer comprises a tube and the connector comprises a wire.

[0031] According to some embodiments of the present invention, a loop of the wire passes through a distal end of the tube and surrounds the implant, and wherein both free ends of the loop are exposed through a proximal opening of the tube.

[0032] According to some embodiments of the present invention, the handle is configured to facilitate severing one of the two free ends and passing the wire through the proximal opening of the tube and out of the retainer, thereby releasing the implant.

[0033] According to some embodiments of the present invention, the system for inserting an implant into the urethra further comprises an optical assembly having a distal portion that passes through the sheath while the implant is retained in the distal portion, and the retainer and the connector are attached to the implant, and the optical assembly having a proximal portion that is accessible from outside the sheath for viewing through a distal opening of the sheath.

[0034] According to some embodiments of the present invention, the handle further comprises a mechanism for re-extending the sheath to return the implant into the distal port portion of the sheath after the exposing. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Some embodiments of the present invention have been described herein by way of example only, with reference to the accompanying drawings. A detailed description will now be given with reference to the accompanying drawings. It should be emphasized that the details shown are merely examples and are intended to provide an illustrative discussion of the embodiments of the present invention. In this regard, the description with reference to the accompanying drawings will provide those skilled in the art with a clear understanding of how to practice the embodiments of the present invention.

[0036] In the attached figure:

[0037] Figure 1is an image of a delivery system according to an embodiment of the present invention with a catheter in an extended state;

[0038] Figure 2 is an image of a delivery system according to an embodiment of the present invention with a catheter in a partially extended state;

[0039] Figure 3 is an image of the proximal side of a delivery system according to an embodiment of the present invention;

[0040] Figure 4A is an image of the distal end of the delivery sheath and implant after retraction of the delivery sheath according to an embodiment of the present invention;

[0041] Figure 4B is an image of the distal end of the delivery sheath and implant after retraction of the delivery sheath according to an embodiment of the present invention;

[0042] Figure 5 is an image of a handle of an implant delivery system according to an embodiment of the present invention;

[0043] Figure 6A is a schematic diagram of a delivery system according to an embodiment of the present invention with a delivery sheath in an extended state;

[0044] Figure 6B is a schematic diagram of a cart and optical components according to an embodiment of the present invention;

[0045] Figure 7A and Figure 7B is a distal view and a close-up cross-sectional view of a delivery sheath according to an embodiment of the present invention;

[0046] Figure 8 is a schematic diagram of relevant areas of the urinary system associated with medical procedures related to embodiments of the present invention;

[0047] Figure 9 is a block diagram of an inserter system according to an embodiment of the present invention;

[0048] Figure 10A and Figure 10B is a flow chart of a method according to an embodiment of the present invention;

[0049] Figure 11A shows a delivery sheath in an extended state according to an embodiment of the present invention;

[0050] Figure 11B The delivery sheath 102 is shown in a retracted state according to an embodiment of the present invention;

[0051] Figure 11C and Figure 11DA delivery sheath according to an embodiment of the present invention is shown in an overall view and an expanded view, respectively, in a retracted state with an optical assembly in an advanced position;

[0052] Figure 12A shows a process for connecting an implant to a retainer tube according to an embodiment of the present invention;

[0053] Figure 12B shows a process for securing an implant to a retainer tube according to an embodiment of the present invention;

[0054] Figure 12C and Figure 12D The process of anchoring the connector at the handle according to the embodiment of the present invention is shown;

[0055] Figure 13 is a flow chart of a method of attaching an implant to a delivery system according to an embodiment of the present invention;

[0056] Figure 14A is a schematic diagram of a delivery system according to an embodiment of the present invention with a delivery sheath in an extended state;

[0057] Figure 14B is a schematic diagram of a delivery system having a delivery sheath according to an embodiment of the present invention, wherein the delivery sheath is shown as transparent in an extended state;

[0058] Figure 14C and Figure 14D is a close-up view of an optical assembly and a holder in a delivery system in an extended state according to an embodiment of the present invention;

[0059] Figure 15A is a schematic diagram of a delivery system according to an embodiment of the present invention with a delivery sheath in a retracted state;

[0060] Figure 15B is a schematic diagram of a delivery system having a delivery sheath according to an embodiment of the present invention, wherein the delivery sheath is shown transparent in a retracted state;

[0061] Figure 16A is a schematic diagram of a delivery system according to an embodiment of the present invention with a delivery sheath in a retracted state;

[0062] Figure 16B is a schematic diagram of a delivery system having a delivery sheath according to an embodiment of the present invention, wherein the delivery sheath is shown transparent in a retracted state;

[0063] 17A to 17C is a schematic diagram of a handle of a deployment system including an implant release module according to an embodiment of the present invention. DETAILED DESCRIPTION

[0064] Overview

[0065] The present invention, in one embodiment thereof, relates to a urethral endoscope for antegrade insertion of a stent, and more particularly, but not exclusively, to a urethral endoscope and method that provides optical elements during insertion and positioning of a urethral stent.

[0066] Benign prostatic hyperplasia (BPH) (enlarged prostate) is a common condition in older men. One treatment for BPH is for doctors to insert a stent into the patient's urethra using an endoscope.

[0067] The most common technique currently used to insert a urethral stent is the so-called retrograde insertion method. In this technique, an endoscope is first inserted into the bladder. The stent is then inserted through the endoscope into the bladder. The endoscope is then removed. Afterwards, an endoscope equipped with a video optics system is reinserted, and the stent is pulled back from the bladder into the urethra under visual observation.

[0068] One problem with this procedure is that a conventional endoscope is generally not capable of simultaneously passing through the stent and securing the video optics. This can result in cumbersome surgical procedures. For example, a retrograde insertion may require prior insertion of an optical endoscope to measure the prostate. After the initial insertion, the endoscope can be removed and a second insertion performed to place the stent in the bladder (e.g., blind insertion, without optics). The endoscope can then be removed again and the optical endoscope reinserted to visualize the position of the stent in the prostatic urethra as the stent is pulled from the bladder back into the urethra. Multiple insertions and removals of the endoscope, as well as insertion and removal of the stent from the bladder, may increase the time required for the procedure, prolong recovery time, and / or increase the risk of complications.

[0069] In some embodiments of the present invention, the deployment system is configured to simultaneously accommodate the implant and the optical system so that the implant can be inserted directly into the desired area. In some embodiments, this facilitates insertion of the implant without first inserting the implant into the bladder and / or retracting the implant from the bladder into the urethra. In some embodiments, the implant can be conveniently inserted without requiring multiple insertions and removals of an endoscope and / or its sheath, which can be inserted and / or removed fewer times (e.g., once or twice).

[0070] One aspect of some embodiments of the present invention relates to a system for inserting a urethral implant. Optionally, the system includes a sheath configured to be inserted into the urethra (e.g., the distal end of the sheath is inserted into the urethra, while the proximal portion remains outside the urethra), the sheath having a lumen for delivering an optical element and / or a holder for the implant and / or other objects (e.g., fluids, tools) into the urethra. The implant can be retained at the distal end and / or distal portion of the sheath, e.g., the distal 1 / 2 and / or the distal 1 / 4 and / or the distal 1 / 8 and / or the distal 1 / 16. For example, the implant can be secured by a holder, which can include, for example, a thin hollow tube and / or a wire passing through the hollow tube. Optionally, the wire can be connected to a proximal corner of the implant. For example, the wire can be wrapped around a proximal feature of the implant (e.g., wrapped around a metal wire of the implant and / or passed through a gap in a closed shape of the implant). Optionally, a wire secures the proximal corner to a distal end of the tube. Optionally, the free end of the loop can pass through the tube from the distal opening of the tube and / or exit from the proximal opening of the tube. Optionally, the free end of the loop can pass through the distal portion of the sheath and / or exit from the proximal opening of the sheath. The implant can be securely secured to the distal end of the tube under tension from the wire, for example, the ends of the wire can be connected to tension-retaining anchors.

[0071] In some embodiments, pulling the wire out of the tube (e.g., from its proximal end) releases the implant (e.g., within the distal urethra). For example, the first end of the wire can be released from its anchor (e.g., by selectively cutting the wire at the proximal end of the tube). The first end of the wire can then be pulled through the tube. Alternatively, the implant can be released by cutting and / or removing the wire, for example, by pulling the second end of the wire, pulling the first end of the wire out and through the tube. Optionally, a second tube with a second wire is secured to a second position on the implant. For example, the implant can include two proximal corners and / or each tube can be connected to a corresponding proximal corner. Optionally, the implant is released into the urethra by releasing both wires. For example, the implant can be released after it is positioned in the desired position. Using two retainers to secure the implant in two locations helps control the position and angle of the implant. To release the wire, the wire can be manually cut (e.g., with scissors, etc.) at the device outlet. Alternatively or additionally, the device may also be equipped with a built-in cutter for cutting the wire.

[0072] In some embodiments of the present invention, the sheath with the implant can be inserted simultaneously with the endoscopic optics. Alternatively or additionally, the sheath with the implant can be inserted without the optics, and then the optics can be inserted while the implant remains within the sheath. The delivery sheath, which can be inserted into the patient's urethra, can simultaneously enclose the hollow tube and the endoscopic optics. The procedure can be observed through the optics. In some embodiments, this has the advantage that the sheath may only need to be inserted once, as the entire procedure is accompanied by visual observation through the endoscopic optics. Additionally, the implant can be placed directly at the desired location. For example, this can avoid blindly inserting it into the bladder and then retracting it back into place.

[0073] In some embodiments, any or all of the sheath and / or the retainer tube and / or the retainer sleeve and / or optical assembly may be rigid and / or have controlled bendability and / or longitudinal stiffness and / or helical flexibility and / or uniaxial flexibility.

[0074] In some embodiments, the sheath and / or optical element of the system of the present invention may comprise various types of urethral endoscopes. For example, they may comprise some or all of the following general features:

[0075] length:

[0076] Depending on the design and application, the length of the inserted sheath and / or tube of the optical assembly can range from approximately 12 cm to 35 cm or more.

[0077] diameter:

[0078] The insertion sheath and / or tube of the optical assembly has a diameter in the range of 2 mm to 5 mm and / or 5 mm to 15 mm.

[0079] The insertion sheath and / or tube of the optical assembly may be semi-rigid or flexible, for example, easily bendable, thereby providing better maneuverability during surgery. Alternatively or additionally, the insertion sheath and / or tube of the optical assembly may be rigid.

[0080] The tube inserted into the sheath and / or optical assembly can be equipped with an optical system for visualization. They may use direct vision mirrors and / or fiber optics and / or newer imaging technologies such as charge-coupled devices (CCDs) or CMOS cameras.

[0081] Sheath material:

[0082] The sheath of a urethroscope is usually made of stainless steel, plastic, or a combination of materials.

[0083] In some embodiments, a lumen and / or working channel of a delivery sheath according to the present invention may have a diameter ranging from 2 to 3 mm and / or 3 to 6 mm and / or 3 to 5 mm. In some embodiments, the sheath may have a single lumen, or alternatively or additionally, the sheath may have two, three, or more lumens (e.g., working channels). Optionally, a retainer for a stent and / or optical assembly may be introduced into the urethra through a single lumen.

[0084] Exemplary embodiments

[0085] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those generally understood by those of ordinary skill in the art to which the present invention belongs. Although methods and materials similar or equivalent to the methods and materials described herein can be used in practicing or testing embodiments of the present invention, exemplary methods and / or materials are described below. In the event of a conflict, the patent specification (including definitions) shall prevail. In addition, materials, methods and examples are provided for reference only and are not intended to limit the present invention.

[0086] Some embodiments of the present invention have some or all of the following advantages:

[0087] 1) The implant can be inserted under visual observation.

[0088] 2) The implant can be placed directly at the desired location in an antegrade manner, i.e., without the need to insert the implant into the bladder and / or pull the implant back from the bladder to the desired location.

[0089] 3) The entire process (which in some embodiments may include further preliminary endoscope insertion after measurement) can be completed with only one endoscope insertion / removal.

[0090] 4) While holding the implant in view, the endoscopic catheter (also called a delivery sheath) and optical elements can be retracted until the implant remains in place.

[0091] 5) It can reduce damage to patient tissues.

[0092] 6) Patient recovery time may be shortened.

[0093] 7) Patient complications may be reduced.

[0094] 8) The implant may be secured by the tube and / or ring of the device, thereby increasing stability.

[0095] 9) The implant can be fixed at multiple points, which helps to better control the positioning of the implant in the patient's body (e.g., rotation around the longitudinal axis) and / or return the implant to the catheter.

[0096] Some embodiments of the present invention have been described herein by way of example only, with reference to the accompanying drawings. A detailed description will now be given with reference to the accompanying drawings. It should be emphasized that the details shown are merely examples and are intended to provide an illustrative discussion of the embodiments of the present invention. In this regard, the description with reference to the accompanying drawings will provide those skilled in the art with a clear understanding of how to practice the embodiments of the present invention.

[0097] Before explaining at least one embodiment of the present invention in detail, it should be understood that the application of the present invention is not necessarily limited to the structural details, arrangements and / or arrangements of components and / or methods set forth in the following description and / or shown in the drawings and / or embodiments. The present invention may have other embodiments or be practiced or implemented in various ways.

[0098] Figure 1 is an image of a delivery system according to an embodiment of the present invention wherein the catheter is in an extended state. In some embodiments, the delivery sheath 102 and / or an implant (e.g., a foldable implant 120) are inserted into the urethra, with the delivery sheath 102 extending distally. For example, during insertion, an implant (e.g., a foldable implant 120) may be housed in a folded form in a distal portion of the delivery sheath 102. Optionally, the handle 104 includes an extension controller (e.g., a control wheel 106) for extending the delivery sheath 102 distally and / or retracting the delivery sheath 102 proximally. Optionally, the delivery system includes a device for use with an optical system (e.g., as shown in the following figures (e.g., Figure 6B ) an infusion port 114 and / or a guide 116 of the optical assembly 608) shown in ).

[0099] In some embodiments, the handle 104 can include a release mechanism for the implant. For example, the implant can be held to the delivery system by a wire 110. For example, the wire 110 can be looped around a portion of the implant at a distal portion of the delivery sheath 102, and / or the free end of the wire can be retained by the controller handle 104, such as by one or more anchors 112. Optionally, a release mechanism includes a mechanism for severing the wire 110 and / or releasing the wire 110 from the anchor 112. For example, a portion of the wire 110 can be exposed and then severed to release the catheter.

[0100] Figure 2is an image of a delivery system according to an embodiment of the present invention with a catheter in a partially extended state. In some embodiments, in the partially extended state, the delivery sheath 102 has been retracted proximally to the handle 104. Optionally, retracting the delivery sheath 102 deploys a foldable implant 120. For example, when the delivery sheath 102 is in the extended state, the foldable implant 120 is shown fixed in a folded state to a distal portion of the delivery sheath 102. Optionally, when the delivery sheath 102 is retracted, the foldable implant 120 is fixed in the same position and / or exposed outside the distal end of the delivery sheath 102. Once the foldable implant 120 is released from the delivery sheath 102, the foldable implant 120 expands to the expanded state. Optionally, in Figure 2 In the partially retracted state shown, the foldable implant 120 is partially folded.

[0101] In some embodiments, the delivery sheath 102 is proximally retracted by rotating the control wheel 106 in a first direction and / or distally extended by rotating the control wheel 106 in a second direction opposite the first direction. Alternatively or additionally, a different control may be used to retract and / or extend the delivery sheath 102. For example, a control lever (e.g., a trigger) may be coupled to the grip 105 of the handle 104 to facilitate single-handed retraction of the delivery sheath 102 and / or another lever (e.g., the control wheel 106) for extending the delivery sheath 102.

[0102] In some embodiments, retracting the delivery sheath 102 also retracts the irrigation port 114 and a cart 122. For example, the irrigation port 114 and cart 122 are rigidly connected to the delivery sheath 102. Figure 2 In the exemplary embodiment of FIG. 1 , the irrigation port 114 is shown relative to Figure 1 The position shown is retracted proximally. Figure 2 In the exemplary embodiment of FIG. 1 , the cart 122 is shown as having been retracted proximally from the proximal end of the handle 104 .

[0103] Figure 3 is an image of the proximal side of a delivery system according to an embodiment of the present invention. In some embodiments, the delivery sheath 102 includes a lumen 124. For example, lumen 124 can have a proximal opening. For example, lumen 124 allows an article to be inserted through the delivery sheath 102 into the urethra. For example, an optical assembly (e.g., optical assembly 608 shown in Figures 6 and 7) can be included.

[0104] Figure 4Ais an image of the distal end of the delivery sheath 402 and implant 420 after the delivery sheath 402 has been retracted, according to an embodiment of the present invention. In some embodiments, the implant 420 is held in place by one or more retainer sleeves 432. For example, one or more proximal corners 434 (e.g., a pair of proximal corners 434) of the implant 420 can be connected to one or more retainer sleeves 432. For example, the proximal corners 434 can be attached to a distal end of the retainer sleeve 432. In some embodiments, attachment is achieved by tying the proximal corners 434 to the retainer sleeve 432 with a wire, for example, so that the wire rotates about the proximal corners 434 when tension is maintained on the wire. Optionally, a proximal portion of the retainer sleeve 432 is secured in an outer sleeve 430 that passes through a lumen 424 of the delivery sheath 402. For example, the outer sleeve 430 may include a flexible shrink sleeve for tightly securing the retainer sleeve 432 together and / or imparting controlled bendability and / or longitudinal stiffness and / or helical flexibility and / or uniaxial flexibility to facilitate insertion into the delivery sheath 602. Alternatively or additionally, the outer sleeve 430 and / or retaining sleeve 432 may be hard and / or rigid.

[0105] Figure 4B 4 is an image of the distal end of the delivery sheath 402 and implant 420 after retracting the delivery sheath 402 according to an embodiment of the present invention. Optionally, an optical system 408 is inserted into the same lumen as the implant 420. Figure 4B , a distal portion of an optical system 408 is visible in a distal portion of the delivery sheath 102. For example, the optical system 408 can be used to observe the deployment of the implant 420 in real time.

[0106] In some embodiments, the delivery system can include a control handle (e.g., similar to handle 104) and / or a control wheel (e.g., similar to control wheel 106). For example, the control wheel can be used to control the extension or retraction of the delivery sheath 402 and / or the optical system 408. Additionally or alternatively, the system can be equipped with a trigger control for retracting the delivery sheath 402. For example, the trigger can be used to single-handedly retract the delivery sheath 402 and / or the optical system 408 and / or expose the implant 420. Alternatively or additionally, after extending the delivery sheath 402 via the trigger, the control wheel can be used to re-extend the delivery sheath 402 and / or return the implant 420 to the delivery sheath 402 (e.g., if the operator decides to reposition the implant).

[0107] In some embodiments, the optical system 408 may have an additional degree of freedom. For example, the optical system 408 may be repositioned within the delivery sheath 402. Alternatively, the default positions of the optical system 408 and the delivery sheath 402 may be as follows: Figure 4B 4, wherein the distal end of the optical system 408 is proximal to the distal opening of the lumen 424 of the delivery sheath 402. For example, when the optical system 408 is in the default position, the distal portion of the lumen 424 has room to accommodate the implant 420 in a folded state (e.g., when the delivery sheath 402 is inserted into the urethra). Optionally, the optical system 408 can be pushed further into the delivery sheath 402 to a more forward position. For example, during the advancement portion, the distal end of the optical system 408 may protrude beyond the distal opening of the lumen 424 (e.g., as shown in FIG. 4 ). Figure 11C and Figure 11D ). For example, this may be helpful to closely observe the implant 420 after deployment and / or before release from the retainer sleeve 432, e.g., to check whether the implant 420 is correctly positioned. In some embodiments, after the implant 420 is positioned, while the implant 420 is still connected to the retainer sleeve 432, the user can re-extend the delivery sheath 402 to refold the implant 420 and / or reinsert the implant 420 into the delivery sheath 402. For example, this may facilitate removal of the implant 420 and / or repositioning of the implant 420.

[0108] In some embodiments, the implant can be attached to one or more retainers (e.g., the proximal corner 434 of the implant 420 is connected to the retainer sleeve 432) and / or retained at the distal end of the device (e.g., a distal portion of the lumen 424). The retainer can be enclosed in a delivery sheath (e.g., the lumen 424 of the delivery sheath 402) and / or inserted into the urethra. The implant can be retained within the delivery sheath by the retainer, and / or the implant can be inserted into the urethra and / or retained in a compressed state within the delivery sheath (e.g., at a distal portion of the lumen 424 of the delivery sheath 402). Additionally or alternatively, the optical element (e.g., the optical system 408) can be inserted into the urethra through a lumen of a delivery sheath (e.g., through the lumen 424 of the delivery sheath 402).

[0109] Figure 5 is an image of a handle of an implant delivery system according to an embodiment of the present invention. In some embodiments, the implant can be stably secured to the retainer by a wire 510. For example, the retainer can include a tube (e.g., retainer sleeve 432) and / or a wire 510 that can pass through the tube and / or around the implant (e.g., its proximal corner 434, such as Figure 4A、 Figure 4B 、 Figure 11C 、 Figure 11D and / or Figure 12A ). Optionally, the free end of the wire 510 is tightened to the grip 505 of the handle 504 and / or fixed to the grip 505. Optionally, the wire 510 secures the implant to a distal end of the holder. In some embodiments, the wire 510 may comprise a standard surgical suture made, for example, from a synthetic polymer fiber.

[0110] In some embodiments, a first end of the wire 510 can be passed from the proximal end through the retainer (e.g., retainer sleeve 432) to the distal end. The first end of the wire can then optionally be looped around the implant (e.g., the proximal corner 434 of the implant 420). Optionally, the first end of the wire 510 can then be passed through the retainer back to the handle 504. In some embodiments, the wire 510 is tightened to secure the implant to the retainer. Alternatively or additionally, the wire can be looped around the implant and then both free ends can be passed through the retainer sleeve 432. Optionally, one free end of the wire 510 is secured by an anchor 512. Optionally, once the implant is positioned in the urethra, the implant can be released by cutting one leg of the wire 510 at the proximal portion of the device. The wire 510 can be cut manually (e.g., by cutting the protruding portion of the wire 510 with scissors, etc.), and / or using a cutter (e.g., a cutter built into the handle of the implant 504 of the system) to cut the wire 510. After the wire 510 is cut, it can be removed, for example, by pulling it out of the holder via the handle 504.

[0111] Figure 6A 602 is a schematic diagram of a delivery system according to an embodiment of the present invention with the delivery sheath in an extended state. In some embodiments, the delivery sheath 602 and / or the foldable implant is inserted into the urethra with the delivery sheath 602 extending distally. For example, during insertion, the foldable implant can be accommodated in a folded form within a distal portion of the delivery sheath 602. Optionally, the handle 604 includes a control wheel 606 for extending the delivery sheath 602 distally and / or retracting the delivery sheath 602 proximally. Optionally, the delivery system includes an irrigation port 614 and / or a guide 616 for a cart 622.

[0112] In some embodiments, the handle 604 can include a release mechanism for the implant. For example, the implant can be retained on the delivery system by a wire 610. For example, the wire 610 can be looped around a portion of the implant distal to the delivery sheath 602, and / or the free end of the wire can be retained on the controller handle 604, such as by one or more anchors 612. Optionally, a release mechanism includes a mechanism for severing the wire 610 and / or releasing the wire 610 from the anchor 612. For example, a portion of the wire 610 can be exposed and then severed to release the catheter.

[0113] In some embodiments, after insertion into the urethra, the delivery sheath 602 can be retracted proximally toward the handle 604 to a partially retracted position. Optionally, retracting the delivery sheath 602 deploys a foldable implant. For example, when the delivery sheath 602 is in the extended state, the foldable implant is secured in a folded configuration within a distal portion of the delivery sheath 602. Optionally, when the delivery sheath 602 is retracted, the foldable implant remains secured in the same position and / or is exposed at the distal end of the delivery sheath 602. Once the foldable implant is released from the delivery sheath 602, the foldable implant expands to an expanded state.

[0114] In some embodiments, the delivery sheath 602 can be proximally retracted by rotating the control wheel 606 in a first direction, and / or can be distally extended by rotating the control wheel 606 in a second direction opposite the first direction. Alternatively or additionally, different control devices can be used to retract and / or extend the delivery sheath 602. For example, a control lever (e.g., a trigger) can facilitate single-handed retraction of the delivery sheath 602, and / or another control lever (e.g., the control wheel 606) can be used to extend the delivery sheath 602.

[0115] In some embodiments, retracting the delivery sheath 602 also retracts the irrigation port 614 and a cart 622. For example, the irrigation port 614 and the cart 622 are rigidly connected to the delivery sheath 602.

[0116] Figure 6B6 is a schematic diagram of a cart and optical assembly according to an embodiment of the present invention. In some embodiments, the cart includes a transmission (e.g., a pinion rack meshing with a gear of the control wheel 606). The cart 622 is used to move the delivery sheath 602. For example, the cart 622 is rigidly connected to the delivery sheath 602 and / or the delivery sheath 602 is supported by the cart 622. Optionally, the optical assembly can be slidably engaged with the delivery sheath 602 and / or the cart 622. For example, the rod 626 of the optical assembly 608 can extend through the delivery sheath 602. Optionally, the optical assembly 608 can be engaged with the cart 622 in multiple positions. For example, a proximal portion of the optical assembly 608 can be held in a forward position by the cart 622, at which point the distal end of the optical assembly 608 (e.g., the distal end of the rod 626) extends from a distal opening of the delivery sheath 602. For example, the proximal portion of the optical assembly 608 can be held by the cart 622 in a rearward position, with the distal end of the optical assembly 608 (e.g., the distal end of the rod 626) positioned within the lumen of the delivery sheath 602. In some embodiments, the proximal portion of the optical assembly 608 can be held in an intermediate position, with the distal end of the optical assembly 608 flush with the distal end of the delivery sheath 602. In some embodiments, the optical assembly 608 can be manually moved relative to the cart 622 (e.g., a user manually grasps and / or pushes the optical assembly 608 into and / or out of the delivery sheath 602). Alternatively or additionally, an actuator can be provided to move the optical assembly 608 relative to the cart 622 and / or the delivery sheath 602. In some embodiments, the optical assembly 608 is secured to the cart 622 and / or the delivery sheath 602 (e.g., by simple friction and / or pressure), such that the optical assembly 608 moves with the cart 622 and / or the delivery sheath 602. Alternatively or additionally, any type of actuator may be present, such as a linear motor and / or a magnetic actuator and / or a sliding button and / or a spring-driven assembly. For example, a button may release a latch and / or allow a spring to push the delivery sheath 602 backward relative to the cart 622 and / or a linear actuator (e.g., a control wheel 606 and a rack and pinion system of the cart 622). Optionally, the position of the delivery sheath 602 and / or the cart 622 may be locked relative to a grip 605 of the controller handle 604. Optionally, the position of the optical assembly 608 may be locked relative to the delivery sheath 602 and / or the cart 622 and / or the grip 605.

[0117] In some embodiments, the optical assembly 608 is a conventional urethral telescope, for example, including a light post 627 and / or a lens and / or a hollow shaft 626 and / or an eyepiece 628. Alternatively or additionally, the system can include a different type of optical system, for example, including a camera. In some embodiments, the cart 622 includes an irrigation port 614 that communicates with the lumen of the delivery sheath 602. For example, the irrigation port 614 can include a connector, such as a tubing connector and / or a connector for a standard stopcock 618. Optionally, the irrigation port 614 can include a valve or cap to close the opening of the irrigation port 614 when desired.

[0118] Figure 7A and Figure 7B is a distal view and a close-up cross-sectional view of a delivery sheath according to an embodiment of the present invention. In some embodiments, the outer sleeve 430 and / or the rod 626 pass through a lumen 624 of the delivery sheath 602. For example, the lumen 624 can be wide enough to allow the rod 626 and the outer sleeve 430 to slide independently and / or pass through each other. Optionally, the cart 622 and / or the delivery sheath 602 include a stabilizer for the rod 626 and / or the outer sleeve 430. For example, the cart 622 can include a catheter that fits snugly around the rod 626, thereby stabilizing the rod 626 while allowing it to slide longitudinally. For example, the cart 622 can be connected to and / or house a portion of the optical assembly 608. For example, a distal portion of the delivery sheath 602 can include a stabilizer (e.g., a guide hole and / or guide rod) to stabilize the movement of the outer sleeve 430 and / or the catheter (e.g., to ensure smooth longitudinal sliding within the delivery sheath 602 and / or the distal opening of the delivery sheath 602 without horizontal deflection).

[0119] Figure 8 The figure is a schematic diagram of some relevant areas of the urinary system relevant to the medical procedures related to the present invention. The figure schematically illustrates a cross-section of the male urethra. The urethra connects the bladder to the urethral opening and serves to expel urine and semen from the body. Furthermore, the prostatic urethra joins the ejaculatory duct at its midsection and serves to transport semen from the seminal vesicles to the ejaculatory duct. The prostatic urethra originates at the bladder neck and extends through the prostate, extending approximately 3 cm. It begins almost perpendicular to the bladder (in a caudal direction) and then curves forward.

[0120] Figure 9 is a block diagram of an inserter system according to an embodiment of the present invention.

[0121] In some embodiments, the system has multiple configurations. For example, in an extended configuration, a delivery sheath 902 can be extended distally, away from a grip 105 of the handle. For example, in a retracted configuration, the delivery sheath 902 can be retracted proximally, toward the grip 905 of the handle. In some embodiments, in the extended configuration, the implant 920 is retained within the delivery sheath 902 for insertion into the urethra. For example, during insertion, the implant 920 (e.g., a foldable implant and / or a non-foldable implant) can be contained within the delivery sheath 902. Optionally, the handle 104 includes a manipulator 906 for controlling the extension of the delivery sheath 902. For example, the manipulator 906 can include a manual lever and / or a control wheel and / or a button to control an automatic actuator and / or trigger.

[0122] In some embodiments, the implant 920 is manipulated by a retainer 932. For example, the retainer 932 can include the connector 910. Optionally, the handle of the system (e.g., grip 905) can include a release mechanism 903 for the implant. For example, the implant can be secured to the delivery system via a connector 910. Optionally, a release mechanism 903 includes a mechanism for releasing the connector 910.

[0123] In some embodiments, in the retracted configuration, the delivery sheath 902 is retracted proximally toward the handle 905. Optionally, retracting the delivery sheath 902 exposes the implant 920. For example, when the delivery sheath 902 is in the extended state, the implant 920 is secured to the distal portion of the delivery sheath 902. Optionally, when the delivery sheath 902 is retracted, the implant 920 remains secured in the same position and / or is exposed beyond the distal end of the delivery sheath 902.

[0124] In some cases, the implant 920 is manipulated by one or more retainers 932. For example, the implant 920 (e.g., one or more proximal corners thereof) can be connected to the retainer 932 via the connector 910. For example, the retainer can include a sleeve through which the connector (e.g., a wire) passes, and the implant 920 can be connected to the retainer 932 via the wire. In some embodiments, the connection is achieved by tying the implant 920 to the retainer sleeve 432 with a wire that surrounds the implant and / or maintains tension. Optionally, the retainer 932 passes through a lumen of the delivery sheath 902. For example, the retainer 932 can have controlled bendability and / or longitudinal stiffness and / or helical flexibility and / or uniaxial flexibility to facilitate insertion into the delivery sheath 602. Alternatively or additionally, the retainer 932 can be rigid and / or stiff. Optionally, an optical system 908 is inserted into the urethra through the same lumen of the delivery sheath as the implant 920. For example, the optical system 908 can be used to observe the deployment of the implant 920 in real time.

[0125] In some embodiments, the delivery system can include a manipulator 906 (e.g., a control wheel and / or a trigger and / or a switch). For example, the manipulator 906 can be used to control the extension and / or retraction of the delivery sheath 902 and / or the optical system 908. For example, the system can be equipped with a trigger for releasing a spring mechanism to retract the delivery sheath 902. Alternatively or additionally, the system can include a switch for controlling a motor and / or a linear actuator that drives the retraction and / or extension of the delivery sheath 902. For example, the trigger and / or switch can be used to retract the delivery sheath 902 and / or the optical system 908 and / or expose the implant 920 in a single hand. Alternatively or additionally, after extending the delivery sheath 902 via a trigger and / or switch, a control wheel can be used to re-extend the delivery sheath 902 and / or return the implant 920 to the delivery sheath 902 (e.g., if the operator decides to reposition the implant).

[0126] In some embodiments, the optical system 908 can have an additional degree of freedom. For example, the optical system 408 can be repositioned within the lumen of the delivery sheath 902. Optionally, in the default position of the optical system 908, the distal end of the optical system 908 is proximate to the distal opening of the lumen of the delivery sheath 902. For example, when the optical system 908 is in the default position, the distal portion of the lumen has space for storing the implant 920. Optionally, the implant 920 is foldable, and / or the space is used to store the implant 920 in a folded state. For example, when the delivery sheath 902 is inserted into the urethra, the implant 920 is stored in the lumen. Optionally, the optical assembly 608 can be further advanced into the delivery sheath 602 to an advanced position. For example, in the advanced position, the distal end of the optical assembly 608 can extend beyond the distal opening of the lumen of the sheath 902. For example, this may be helpful to closely observe the implant 920 after deployment and / or before release from the retainer 932, e.g., to check whether the implant 920 is properly positioned. In some embodiments, after the implant 920 is positioned, while the implant 920 is still attached to the retainer 932, the user can re-extend the delivery sheath 902 to reinsert the implant 920 into the delivery sheath 902. This may facilitate removal of the implant 920 and / or repositioning of the implant 920, for example.

[0127] In some embodiments, the optical element (eg, optical system 908 ) can be inserted through a lumen of a delivery sheath 902 into a urethra.

[0128] In some embodiments, the implant can be stably secured to the retainer 932 via a connector 910. For example, the retainer 932 can include a tube and / or a wire (e.g., connector 910) that can be passed through the tube and / or wrapped around the implant (e.g., a proximal corner thereof). Optionally, the free end of the wire (e.g., connector 910) is tightened to secure it to the handle grip 905. Optionally, a wire 510 secures the implant to a distal end of the retainer. In some embodiments, the wire 510 can include a standard surgical suture made, for example, of a synthetic polymer fiber.

[0129] Figure 10A and Figure 10Bis a flow chart of a method according to an embodiment of the present invention. In some embodiments, at block 1042, the implant may be retained at the distal end of a sheath. Optionally, at block 1044, the sheath and its attached implant may be placed into the prostatic urethra of a subject. Alternatively or additionally, while the sheath is in the urethra, the implant may be passed from the proximal end to the distal end of the sheath. An optical system may be inserted into the sheath (e.g., through a proximal opening of the sheath) before or after the sheath is inserted into the urethra, while the implant remains within the sheath. In some embodiments, the distal end of the optical system may be retained at the proximal end of the implant. At block 1046, while the implant is secured in place (e.g., by a retainer), the sheath may be retracted (e.g., using a control wheel) to expose the implant in the urethra. Optionally, the optical system may move with the sheath. Alternatively or additionally, the optical system may remain in place while the sheath is moved. In some embodiments, the optical system may be used to visually monitor all or part of the surgical procedure.

[0130] In some embodiments, at block 1044, the user checks the positioning of the implant. For example, the user can advance the optical element to more closely observe the implant and / or its position in the urethra. At block 1048, if the caregiver chooses to remove the implant and / or reposition the implant, this

[0131] Can be completed by deployment system.For example, in frame 1050, re-advance sheath to above described implant, keep implant in place (for example, using described retainer) simultaneously.After described implant is put back into described sheath, it can be moved to new position and / or exposed again.In certain embodiments, once implant has been positioned (frame 1044) and / or exposed (frame 1046) (for example, implant is no longer located in sheath far-end), optical system can be further advanced into sheath and / or the far-end of optical system can be pushed out from sheath far-end.This helps to observe described implant more closely, to check whether it is correctly installed.In certain embodiments, in frame 1052, implant can be released from endoscope, for example, after implant is correctly positioned (frame 1044) and / or exposed (frame 1046), can release (frame 1052).For example, can release implant by cutting one end of the wire loop that implant is fixed on retainer and / or pulling the other end of wire, thereby line is pulled out from catheter. After the procedure, at block 1054, the endoscope may be removed from the urethra and / or the implant may be left in place.

[0132] 11A to 11D The system status at various stages of implant insertion according to an embodiment of the present invention is shown.

[0133] Figure 11AThe delivery sheath 102 is shown in an extended state according to an embodiment of the present invention. In the extended state, the delivery sheath 102 optionally encases the implant (e.g., implant 420) and / or retains the implant within the catheter. Optionally, the delivery sheath 102 is inserted into the urethra with the delivery sheath 102 extended. In some embodiments, the optical assembly 608 is coupled to the deployment system during insertion into the urethra (e.g., the rod 626 of the optical assembly 608 is inserted into the delivery sheath 102), for example, to guide insertion. Alternatively or additionally, the optical assembly 608 is separated from the deployment system until the delivery sheath 102 is at least partially inserted into the urethra.

[0134] Figure 11B The delivery sheath 102 is shown in a retracted state according to an embodiment of the present invention. In some embodiments, when the delivery sheath 102 is located within the urethra, the delivery sheath 102 is retracted while holding the handle grip 105 steady. For example, holding the handle grip 105 steady can hold the implant 420 steady. Pulling back the delivery sheath 102 can optionally expose the implant 420 (e.g., Figure 11B ). In some embodiments, once exposed, the implant 420 is expanded into the urethra. Optionally, the delivery sheath 102 is retracted by rotating the control wheel 106. Alternatively or additionally, the delivery sheath 102 can be retracted with the same hand that grips the handle grip 105 (e.g., single-handedly), for example, using a trigger.

[0135] Figure 11C and Figure 11D The delivery sheath 102 is shown in a retracted state according to an embodiment of the present invention in an overall view and an expanded view, wherein the optical assembly 608 is in an advanced position. In some embodiments, the optical assembly 608 can be pushed further forward (e.g., Figure 11C and Figure 11D For example, pushing the proximal portion of the optical assembly 608 (e.g., light post 627 and / or eyepiece 628) of certain embodiments distally into the cart 122 may cause the distal end of the optical assembly (e.g., the distal end of the hollow shaft 626) to be pushed out of the distal end of the delivery sheath 102. In some embodiments, this may allow the operator to better observe the positioning of the implant 420.

[0136] In some embodiments, the implant 420 is retained on the retainer sleeve 432 at one or more points (e.g., retaining the two proximal corners 434) by a connector. For example, the connector may include a wire 110 that passes through the retainer sleeve 432 and around the proximal corners 434. Optionally, tensioning the wire 110 secures the implant 420 to the retainer sleeve 432. Optionally, the implant 420 is secured to the retainer sleeve 432 so that the implant 420 can be adjusted to the correct position as needed. For example, retaining the implant 420 to the retainer sleeve 432 can facilitate rotating the implant 420 about its longitudinal axis (e.g., by rotating the outer sleeve 430 about its axis from the proximal end of the controller handle 104, which can be done by grasping two corners of the implant 420 to facilitate rotating the implant 420) and / or exposing the implant 420 (e.g., by holding the implant 420 stable while retracting the delivery sheath 102) and / or returning the implant 420 to the delivery sheath 102 (e.g., by extending the delivery sheath 102 while holding the implant 420 stable). Optionally, at this point (e.g., with the implant 420 still connected to the retainer sleeve 432), the delivery sheath 102 is re-extended and the implant 420 is reintroduced into the delivery sheath 102. Reintroducing the implant 420 into the delivery sheath 102 can facilitate removal and / or repositioning of the implant 420.

[0137] 12A to 12D Utilization of a wire loop to connect an implant to a retainer tube is shown in accordance with an embodiment of the present invention.

[0138] Figure 12A The process of connecting an implant 1220 to a retainer tube is shown according to an embodiment of the present invention. In some embodiments, multiple retainer tubes 1232 are connected to multiple locations on the implant 1220. Optionally, a loop of wire 1210 is used for connection. For example, the wire 1210 is wrapped around a portion of the implant 420.

[0139] Figure 12B 12. The process of securing the implant 1220 to the retainer tube 1232 is shown according to an embodiment of the present invention. Optionally, the free end of the loop passes through the distal end of the retainer sleeve 432. Optionally, the retainer sleeve 432 is secured in the outer sleeve 1230. In some embodiments, tightening the wire 1210 can pull the corner 1234 of the implant 1220 toward the retainer tube and / or pull the corner 1234 toward the outer tube 1230. Optionally, this pulls the implant 1220 into a folded state and / or a partially folded state. In some embodiments, the wire 1210 passes through the distal opening into the retainer tube 1232 and / or the outer tube 1230 and / or the delivery sheath 1202.

[0140] Figure 12C and Figure 12D The process of anchoring the connector at the handle according to an embodiment of the present invention is shown. In some embodiments, the wire 1210 passes through the retainer tube 1232 and / or the outer tube 1230 and / or the delivery sheath. For example, the wire 1210 (e.g., the two free ends of the loop) passes from the proximal end of the retainer tube 1232 and / or the outer tube 1230 and / or the delivery sheath 1202 to the handle 1204 of the system. Optionally, at the handle 1204, the wire 1210 is tightened from the proximal end, pulling the implant 1220 toward the distal end of the retainer tube 1232. Then, optionally, one or both proximal / free ends of the wire 1210 are anchored to the handle 1204 of the system. One of the two free ends is optionally exposed for cutting (by an internal cutting device and / or by manual cutting from the outside of the handle 1204). When the operator is ready to release the implant 1220, he optionally cuts the exposed end of the wire 1210 and / or pulls the anchor 1256 out of the handle 1204, thereby pulling the wire out of the tube and / or releasing the implant.

[0141] Figure 13 13 is a flow chart of a method for attaching an implant to a delivery system according to an embodiment of the present invention. In some embodiments, at block 1362, the implant is attached to a distal portion of a retainer located at a distal portion of a sheath. For example, the retainer can have controllable bendability and / or longitudinal stiffness and / or helical flexibility and / or uniaxial flexibility to facilitate insertion and / or retention of the implant through a delivery sheath while allowing it to snake its way into the body. For example, the retainer can include a flexible tube and / or the implant can be connected to the retainer via a wire (e.g., by wrapping the wire around the implant). In some embodiments, at block 1364, the proximal portion of the retainer and / or the connector (e.g., the free end of the wire) can be passed through the delivery sheath to its proximal end. In some embodiments, at block 1366, the connector is anchored to the proximal end 1366 of the delivery sheath (e.g., by tensioning and / or anchoring the wire to a handle of the delivery system to secure the implant to the retainer). Optionally, once the implant is positioned within the body, the implant can be released by loosening the proximal and distal ends of the connector at block 1368. For example, a section of the wire can be cut at the handle of the device. Alternatively, the connector (e.g., the wire) can be manually cut or removed, for example, by pulling it out of the holder via the handle, thereby disengaging the connector and / or releasing the implant at block 1368.

[0142] Figure 14A 14 is a schematic diagram of a delivery system according to an embodiment of the present invention with a delivery sheath in an extended state. In some embodiments, the delivery sheath 1402 and / or a foldable implant is inserted into the urethra with the delivery sheath 1402 extending distally. For example, during insertion, a foldable implant can be accommodated in a folded form within the distal portion of the delivery sheath 1402. Optionally, the handle 1404 includes a control wheel 14014 for extending the delivery sheath 1402 distally and / or retracting the delivery sheath 1402 proximally. Optionally, the delivery system includes an irrigation port 1414.

[0143] In some embodiments, the optical assembly 1408 is a conventional urethral telescope including, for example, a light post 1427 and / or a lens and / or a hollow rod (e.g., Figure 14B 1426) and / or an eyepiece 1428. Alternatively or additionally, the system can include a different type of optical system, for example, including a camera. In some embodiments, the cart 1422 includes an irrigation port 1414 that communicates with the lumen of the delivery sheath 1402. For example, the irrigation port 1414 can include a connector, such as a tubing connector and / or a connector for a standard stopcock 1418. Optionally, the irrigation port 1414 can include a valve or cap to close the opening of the irrigation port 1414 when desired.

[0144] In some embodiments, the delivery system includes a guide 1416 for an optical assembly 1408. For example, the guide 1416 includes a slot through which the optical assembly's light beam 1427 can pass. The guide 1416 is shaped and dimensioned such that when the cart 1422 and the delivery sheath 1402 are in the extended position, the guide 1416 prevents distal movement of the optical assembly 1408, thereby preventing distal advancement of the optical assembly 1408. For example, when the cart 1422 and / or the delivery sheath 1402 are in the extended position, the optical assembly can be locked in a rearward position. This can prevent, for example, a user from inadvertently advancing the rod 1426 of the optical assembly 1408 into a distal portion of the delivery sheath 1402 and / or ejecting it from the distal end of the delivery sheath 1402. For example, in some embodiments, when the implant is positioned within the delivery sheath 1402, the push rod 1426 may interfere with the implant stored in the distal portion of the delivery sheath 1402 and / or interfere with the delivery of the implant.

[0145] Figure 14B FIG is a schematic diagram of a delivery system with a delivery sheath according to an embodiment of the present invention, wherein the delivery sheath is shown transparent in an extended state. Figure 14BIn the illustration, the left side housing of the handle 1404 has been removed to reveal the internal structure of the exemplary delivery system. In some embodiments, the cart includes a transmission (e.g., a rack and pinion that meshes with the gear of the control wheel 1406). In some embodiments, the delivery sheath 1402 is moved using a cart 1422. For example, the cart 1422 is rigidly connected to the delivery sheath 1402 and / or the delivery sheath 1402 is supported by the cart 1422.

[0146] Optionally, the optical assembly 1408 can be slidably engaged with the delivery sheath 1402 and / or the cart 1422. For example, the rod 1426 of the optical assembly 1408 can pass through the delivery sheath 1402. Optionally, the optical assembly 1408 can be engaged with the cart 1422 in multiple positions. For example, in 14A to 14D 1402. In some embodiments, the proximal portion of the optical assembly 1408 is in a rearward position, with the distal end of the optical assembly 1408 (e.g., the distal end of the rod 1426) positioned within the lumen of the delivery sheath 1402. In some embodiments, the optical assembly 1408 can be manually moved relative to the cart 1422 (e.g., a user manually grasps and / or pushes the optical assembly 1408 into and / or out of the delivery sheath 1402). Alternatively or additionally, an actuator can be provided that moves the optical assembly 1408 relative to the cart 1422 and / or the delivery sheath 1402. In some embodiments, the optical assembly 1408 is retained on the cart 1422 and / or the delivery sheath 1402 (e.g., by simple friction and / or pressure), such that the optical assembly 1408 moves with the cart 1422 and / or the delivery sheath 1402.

[0147] In some cases, the implant is held in place by one or more retainer sleeves 1432. For example, one or more proximal corners of the implant can be attached to one or more retainer sleeves 1432. For example, the proximal corners can be attached to the distal end of the retainer sleeve 1432. In some embodiments, attachment is achieved by tying the proximal corners to the retainer sleeve 1432 with a string that surrounds the proximal corners. Optionally, a proximal portion of the retainer sleeve 1432 is secured within an outer sleeve 1430 that passes through the lumen of the delivery sheath 1402. For example, the outer sleeve 1430 can include a flexible shrink sleeve that securely holds the retainer sleeves 1432 together and / or imparts controlled bendability and / or longitudinal stiffness and / or helical flexibility and / or uniaxial flexibility to facilitate insertion into the delivery sheath 1402. Alternatively or additionally, the outer sleeve 1430 and / or retainer sleeve 1432 can be rigid and / or stiff. In some embodiments, the delivery system can include a secondary sheath 1401. For example, the secondary sheath 1401 can be positioned within the sheath 1402 and / or around the shaft 1426 and / or the outer sleeve 1430.

[0148] In some embodiments, when the delivery sheath 1402 is in the extended position, a gap exists between the distal end of the retainer 1432 and the distal end of the delivery sheath 1402. For example, the length of the gap can be between 1 mm and 5 mm and / or between 5 mm and 50 mm. For example, an implant can be stored within the delivery sheath in the gap between the distal end of the retainer 1432 and the distal end of the delivery sheath 1402.

[0149] In some embodiments, any type of actuator can be present, such as a linear motor and / or a magnetic actuator and / or a sliding button and / or a spring-driven assembly. For example, a button can release a latch and / or allow a spring to push the delivery sheath 1402 backward relative to the cart 1422 and / or a linear actuator (e.g., the control wheel 1406 and the rack and pinion system of the cart 1422). Optionally, the position of the delivery sheath 1402 and / or the cart 1422 can be locked relative to the grip 1405 of the controller handle 1404. Optionally, the position of the optical assembly 1408 can be locked relative to the delivery sheath 1402 and / or the cart 1422 and / or the grip 1405.

[0150] Figure 14C and Figure 14D is a close-up view of the optical assembly and holder in the delivery system in an extended state according to an embodiment of the present invention. Figure 14C and Figure 14D In the illustrated embodiment, the left side housing of handle 1404 and sheaths 1401 and 1402 have been removed to reveal the internal structure of an exemplary delivery system. In some embodiments, the system may include an insertion guide 1474 and / or a proximal conduit 1472. For example, insertion guide 1474 and / or proximal conduit 1472 may stabilize the proximal portion of rod 1426 and / or sleeve 1430 and / or sheath 1401 and / or sheath 1402 relative to handle 1404. This may facilitate smooth and / or precise extension and / or retraction of sheath 1401 and / or sheath 1402, for example. This may facilitate smooth and / or precise advancement and / or movement of rod 1426, for example. Optionally, guide 1417 may provide a fluid path between port 1414 and the lumen of sheath 1401 and / or sheath 1402.

[0151] Figure 15A 14 is a schematic diagram of a delivery system according to an embodiment of the present invention with a delivery sheath in a retracted state. In some embodiments, after insertion into the urethra, the delivery sheath 1402 is retracted. For example, retracting the delivery sheath can deploy the implant into the urethra.

[0152] Figure 15BFIG is a schematic diagram of a delivery system having a delivery sheath according to an embodiment of the present invention, wherein the delivery sheath is shown transparent in a retracted state. Figure 14B In the illustration, the left side housing of the handle 1404 has been removed to expose the internal structure of the exemplary delivery system.

[0153] In some embodiments, after insertion into the urethra, the delivery sheath 1402 can be retracted proximally toward the handle 1404 to a partially retracted position. Optionally, retracting the delivery sheath 1402 deploys a foldable implant. For example, when the delivery sheath 1402 is in the extended state, the foldable implant is secured in a folded configuration within a distal portion of the delivery sheath 1402. Optionally, when the delivery sheath 1402 is retracted, the foldable implant is secured in the same position and / or is exposed beyond the distal end of the delivery sheath 1402. For example, once the foldable implant is released from the delivery sheath 1402, the foldable implant can be expanded to an expanded state.

[0154] In some embodiments, the delivery sheath 1402 can be proximally retracted by rotating the control wheel 1406 in a first direction, and / or distally extended by rotating the control wheel 1406 in a second direction opposite the first direction. Alternatively or additionally, different control devices can be used to retract and / or extend the delivery sheath 1402. For example, a control lever (e.g., a trigger) can be provided to facilitate single-handed retraction of the delivery sheath 1402, and / or another control lever (e.g., control wheel 1406) can be provided to extend the delivery sheath 1402. Optionally, the control wheel 1406 can be moved from the left side to the right side of the handle 1405, and / or from the left side to the right side (to facilitate use by right-handed and / or left-handed users). Optionally, the control wheel 1406 can be removed, for example, to facilitate efficient storage and / or transport of the system.

[0155] In some embodiments, retracting the delivery sheath 1402 also retracts the irrigation port 1414 and the cart 1422. For example, the irrigation port 1414 and the cart 1422 are rigidly connected to the delivery sheath 1402.

[0156] exist Figure 15A and Figure 15BIn an exemplary embodiment, the optical assembly 1408 is in a rearward position relative to the cart 1422. In some embodiments, when the cart 1422 is in the retracted position, the guide 1416 does not impede the advancement of the optical assembly. In some embodiments, when the cart 1422 and / or the sheath 1402 are retracted, the optical assembly 1408 moves rearward with the cart and / or the sheath 1402. For example, as the sheath 1402 moves, the rod 1426 can remain in the same position (e.g., a retracted position) relative to the sheath 1402. Alternatively or additionally, the optical assembly 1408 may not move with the sheath 1402 and / or the cart 1422. For example, as the sheath 1402 is retracted, the rod 1426 can advance relative to the sheath 1402.

[0157] Figure 16A is a schematic diagram of a delivery system according to an embodiment of the present invention with a delivery sheath in a retracted state.

[0158] Figure 16B FIG is a schematic diagram of a delivery system having a delivery sheath according to an embodiment of the present invention, wherein the delivery sheath is shown transparent in a retracted state. Figure 14B In the illustration, the left side housing of the handle 1404 has been removed to expose the internal structure of the exemplary delivery system.

[0159] exist Figure 16A and Figure 16B In an exemplary embodiment, the optical assembly 1408 is in an advanced configuration. For example, when the cart 1422 and / or sheath 1402 are in the retracted position, the optical assembly 1408 can be advanced and / or slid distally. This can provide, for example, better visualization of a deployed implant. For example, this can push the distal end of the rod 1426 out of the distal opening of the sheath 1402.

[0160] 17A to 17C is a schematic diagram of a handle of a deployment system including an implant release module according to an embodiment of the present invention.

[0161] In some embodiments, the implant is attached to a distal portion of a retainer located at the distal portion of the sheath. For example, the retainer can have controlled bendability and / or longitudinal stiffness and / or helical flexibility and / or uniaxial flexibility to facilitate insertion and / or retention of the implant through the delivery sheath while allowing it to snake along a path into the body. For example, the retainer can include a flexible tube and / or the implant can be connected to the retainer by a wire. For example, one or more loops of wire can be passed around a portion of the implant. In some embodiments, the proximal portion of the retainer and / or the connector can pass through the delivery sheath to its proximal end. For example, one end of each wire loop can be gathered into a first wire bundle 1711a, and a second end of each wire loop can be gathered into a second wire bundle 1711b. Optionally, the first wire bundle 1711a and the second wire bundle 1711b pass through the handle 1704 of the delivery system.

[0162] In some embodiments, the connector is anchored to the proximal end of the delivery sheath (e.g., first wire harness 1711a and / or second wire harness 1711b are connected to one or more anchors 1756 and / or handle 1704 of the delivery system). For example, tension on the wire can secure the implant to the holder.

[0163] In some embodiments, once the implant is positioned within the body, the implant can be released by disconnecting the proximal end of the connector. For example, the first wire harness 1711a can be cut. Optionally, the handle includes a cutter assembly. 17A to 17C In an exemplary embodiment, the cutter includes a control (e.g., button 1780) and / or a cutting tool (e.g., blade 1782). Optionally, manually pressing button 1780 advances blade 1782 to sever wire 1711a. Optionally, wire 1711a is secured in place by guides 1788 so that it cannot move out of the path of blade 1782. Optionally, second wire 1711b is positioned so that it is not in the path of blade 1782 and / or cannot be cut.

[0164] In some embodiments, after one end of the loop is released (e.g., by cutting wire 1711a), the loop detaches from the implant, thereby releasing the implant. For example, when one end of the loop is cut and / or disconnected from anchor 1756, the other end (e.g., wire 1711b) can be pulled away from the implant. For example, anchor 1756 can be pulled away from handle 1704. Pulling the second end of the wire (e.g., wire 1711b) can pull the free end of the wire (e.g., wire 1711a) through the implant and / or away from the implant. For example, pulling wire 1711b after cutting wire 1711b can pull the free end of wire 1711a (e.g., the severed end) through the sheath and / or through the opening in the implant (through which the wire was previously passed) and / or out of the sheath. This optionally disables the loop and / or releases the implant. Optionally, an adjustment nut 1776 is provided and / or engaged with the anchor 1756 to facilitate tightening the line.

[0165] Figure 17A An exemplary optical assembly 1708 is shown including an eyepiece 1728 and a rod 1726. An exemplary cart 1722 is shown.

[0166] In some embodiments, two rings secure the implant in two locations, one at each location on one of the two retainers. Figure 17C In the embodiment, the harness 1711a includes two wires 1710a and 1710a', which are the first leg of the first loop and the first leg of the second loop, respectively. Optionally, the first loop secures the first portion of the implant to a first retainer, and / or the second loop secures the implant to a second retainer. For example, the harness 1711b includes two wires 1710b and 1710b', which are the second leg of the first loop and the second leg of the second loop, respectively.

[0167] It is anticipated that during the life of the patent to which this application matures, many related technologies will be developed, and the scope of these terms is intended a priori to include all such new technologies.

[0168] As used herein, the term "about" refers to ±10%.

[0169] The terms "includes," "comprising," "including," "having" and their conjugations mean "including but not limited to."

[0170] The term “consisting of” means “including and limited to.”

[0171] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially change the basic and novel characteristics of the claimed composition, method or structure.

[0172] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0173] Throughout this application, various embodiments of the present invention may be presented in range format. It should be understood that descriptions in range format are provided for convenience and brevity only and should not be considered as rigid limitations on the scope of the invention. Therefore, descriptions of ranges should be considered to have specifically disclosed all possible subranges and individual values ​​within those ranges. For example, descriptions of ranges such as 1 to 6 should be considered to have specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual values ​​within those ranges, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the width of the range.

[0174] The numerical ranges mentioned herein are intended to encompass any referenced numerals (fractions or integers) within the range. The phrases "range / range between..." and "range / range from..." are used interchangeably herein to encompass the first and second specified numerals and all fractions and integers between them.

[0175] It should be understood that, for the sake of clarity, certain features of the present invention are described in the context of separate embodiments, but these features may also be provided in combination in a single embodiment. Conversely, for the sake of brevity, various features of the present invention are described in the context of a single embodiment, but these features may also be provided separately, or in any suitable subcombination, or in any other embodiment of the present invention in a suitable manner. Certain features described in the context of individual embodiments should not be considered essential features of those embodiments, unless the embodiment cannot be implemented without these elements.

[0176] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, to the same extent as if each individual publication, patent, or patent application were expressly and individually indicated to be incorporated herein by reference. In addition, the citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art for the present invention. Even if section headings are used, they should not be construed as limitations of the present invention.

Claims

1. A method for inserting a urethral implant, characterized in that The method of inserting a urethral implant comprises: storing an implant in a distal portion of a lumen of a delivery sheath; inserting the distal portion of the delivery sheath into a urethra; An optical element is inserted through a proximal portion of the lumen to facilitate viewing outwardly from a distal opening of the lumen while the implant resides in the distal portion of the lumen.

2. The method of inserting a urethral implant according to claim 1, wherein: The method of inserting a urethral implant also includes retaining the implant on a retainer and retracting the delivery sheath to expose the implant within the urethra.

3. The method of inserting a urethral implant according to claim 2, wherein: The retainer extends from a proximal opening of the delivery sheath to the implant.

4. The method of inserting a urethral implant according to claim 3, wherein: The retainer includes a tube, and the method of inserting a urethral implant further includes grasping a proximal portion of the implant with a loop of wire passed through a proximal opening of the tube.

5. The method of inserting a urethral implant according to claim 4, wherein: The method of inserting a urethral implant further includes severing one leg of the loop wire and passing the wire through the tube to release the implant.

6. The method of inserting a urethral implant according to claim 4, wherein: The grasping is done at the two proximal corners of the implant.

7. The method for inserting a urethral implant according to any one of claims 2 to 6, characterized in that The implant expands upon the exposure.

8. The method for inserting a urethral implant according to any one of claims 2 to 6, characterized in that The method of inserting a urethral implant further includes retracting the optical element as the delivery sheath is retracted.

9. The method for inserting a urethral implant according to any one of claims 2 to 6, characterized in that: The method of inserting a urethral implant further includes, after the exposing, advancing the optical element.

10. The method of inserting a urethral implant according to claim 9, wherein: The advancing includes protruding a distal portion of the optical element from the distal opening of the lumen.

11. The method for inserting a urethral implant according to any one of claims 2 to 6, characterized in that The method of inserting a urethral implant further includes re-extending the delivery sheath after the retracting to return the implant to the distal opening of the lumen.

12. A system for inserting an implant into the urethra, characterized in that The system for inserting an implant into the urethra comprises: a sheath having a distal portion configured for insertion into a urethra while a proximal portion remains external to the urethra; a retainer configured to retain the implant in a distal portion of the sheath; a connector including a distal portion connected to the retainer; and A handle is configured to facilitate release of the connector.

13. The system for inserting an implant into the urethra according to claim 12, wherein The retainer extends through a lumen of the sheath from the implant to a proximal opening of the lumen.

14. The system for inserting an implant into the urethra according to claim 12, wherein: The implant is retained in a folded state within the sheath.

15. The system for inserting an implant into the urethra according to claim 14, wherein The implant is configured to automatically expand upon exposure from the sheath.

16. The system for inserting an implant into the urethra according to claim 12, wherein: The system for inserting an implant into the urethra further includes a retraction mechanism in the handle for retracting the sheath while holding the implant in place by the retainer, thereby exposing the implant within the urethra.

17. A system for inserting an implant into the urethra according to any one of claims 12 to 16, characterized in that The retainer comprises a tube, and the connector comprises a wire.

18. The system for inserting an implant into the urethra according to claim 17, wherein A loop of the wire passes through a distal end of the tube and surrounds the implant, and wherein both free ends of the loop are exposed through a proximal opening of the tube.

19. The system for inserting an implant into the urethra according to claim 18, wherein The handle is configured to facilitate severing one of the two free ends and passing the wire through the proximal opening of the tube and out of the retainer, thereby releasing the implant.

20. The system for inserting an implant into the urethra according to any one of claims 12 to 16, wherein: The system for inserting an implant into the urethra also includes an optical assembly having a distal portion that passes through the sheath while the implant is retained in the distal portion, and the retainer and the connector are attached to the implant, and the optical assembly having a proximal portion that is accessible from the exterior of the sheath for viewing through a distal opening of the sheath.

21. A system for inserting an implant into the urethra according to any one of claims 12 to 16, characterized in that The handle further includes a mechanism for re-extending the sheath to return the implant into the distal port portion of the sheath after the exposing.

Images