Systems and methods for wire-guided duct access

Abstract

A system includes a guidewire disposed within a lumen defined through a handle assembly. The guidewire is configured to be advanced from a retracted position to an advanced position. The system also includes an outer sheath configured to be moved from an extended position to a retracted position to deploy a stent within the body lumen. The system also includes a distal cutting element configured to create an access site in a wall of the body lumen and a stent deployment mechanism configured to cause movement of the outer sheath from the extended position to the retracted position to deploy the stent. Movement of the guidewire from the retracted position to the advanced position enables transition of the stent deployment mechanism from a locked configuration to an unlocked configuration wherein actuation of the stent deployment mechanism is permitted to retract the outer sheath.

Description

SYSTEMS AND METHODS FOR WIRE-GUIDED DUCT ACCESSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 584,141, filed September 20, 2023, the entire content of which is incorporated herein by reference.FIELD

[0002] The disclosure relates to stent deployment. More specifically, the disclosure relates to systems and methods for wire-guided duct access prior to stent deployment.BACKGROUND

[0003] Diseases and disorders of the gallbladder, pancreas, and bile ducts (i.e., pancreaticobiliary system) are associated with significant morbidity, mortality, and impaired quality of life. Obstructions, tumors, injuries, leakages, inflammation, infection, and lesions can occur in these structures, which can eventually lead to conditions such as biliary colic, cholecystitis, choledocholithiasis, cholelithiasis, pancreatitis, pancreatic duct stone formations, and chronic abdominal pain. Diseases of the pancreaticobiliary system may also be associated with nutritional disorders, such as malnutrition, obesity, and high cholesterol.

[0004] To treat a biliary obstruction, a clinician may perform a stent delivery procedure to place a stent across the body lumen to bypass the obstruction. In general, a stent delivery procedure may include placing an endoscope into the gastrointestinal tract and accessing the bile duct with a catheter. A guidewire may then be deployed through the catheter and into the bile duct. Once the guidewire is in place, a stent or other treatment device may be advanced over the guidewire into the bile duct. After the stent is placed in the bile duct, the clinician may withdraw the stent delivery system.SUMMARY

[0005] Provided in accordance with aspects of the present disclosure is a system for delivering a stent into a body lumen. The system includes a handle assembly and a guidewire disposed within a lumen defined through the handle assembly. The guidewire is configured to be advanced from a retracted position to an advanced position for placement within a body lumen. The system also includes an outer sheath defining a lumen configured to receive the guidewire for placement of the guidewire within the body lumen. The outer sheath is configured to be moved from an extended position to a retracted position to deploy a stentwithin the body lumen. The system also includes a distal cutting element and a stent deployment mechanism. The distal cutting element extends distally from the outer sheath and is configured to create an access site in a wall of the body lumen. The stent deployment mechanism is coupled to the handle assembly and is configured to cause movement of the outer sheath from the extended position to the retracted position to deploy the stent. Movement of the guidewire from the retracted position to the advanced position enables transition of the stent deployment mechanism from a locked configuration wherein actuation of the stent deployment mechanism is prevented to an unlocked configuration wherein actuation of the stent deployment mechanism is permitted to retract the outer sheath and deploy the stent.

[0006] In an aspect of the present disclosure, the stent deployment mechanism is a thumbwheel extending from the handle assembly and configured to rotate relative to the handle assembly to move the outer sheath to the retracted position.

[0007] In another aspect of the present disclosure, the thumbwheel is coupled to the outer sheath by a pull wire, and rotation of the thumbwheel retracts the pull wire around a pulley disposed within the handle assembly to move the outer sheath to the retracted position.

[0008] In another aspect of the present disclosure, the system also includes a locking mechanism removably coupled to the handle assembly and configured to engage the stent deployment mechanism to maintain the stent deployment mechanism in the locked configuration. Removal of the locking mechanism from engagement with the stent deployment mechanism transitions the stent deployment mechanism to the unlocked configuration.

[0009] In another aspect of the present disclosure, the system also includes an interference sleeve disposed on the guidewire and configured to engage the locking mechanism to prevent disengagement of the locking mechanism from the stent deployment mechanism. Movement of the guidewire from the retracted position to the advanced position disengages the interference sleeve from the locking mechanism to permit disengagement of the locking mechanism from the stent deployment mechanism.

[0010] In still another aspect of the present disclosure, the distal cutting element includes an electrocautery electrode configured to apply electrosurgical energy to the wall of the body lumen.

[0011] In still yet another aspect of the present disclosure, the system also includes an inner tubular member configured to advance through the access site in the wall of the body lumen. The outer sheath is disposed coaxially along at least a portion of the inner tubular member.

[0012] In another aspect of the present disclosure, the stent is disposed between the inner tubular member and the outer sheath to maintain the stent in an undeployed configuration.

[0013] In another aspect of the present disclosure, the system also includes an anchoring component disposed at a distal portion of the inner tubular member and configured to retain a distal portion of the stent in place along the inner tubular member as the outer sheath is moved toward the retracted position. Upon movement of the outer sheath to the retracted position, the stent releases from the anchoring component and expands into a deployed configuration within the body lumen.

[0014] Another system for delivering a stent into a body lumen is provided in accordance with the present disclosure and includes a handle assembly and a guidewire disposed within a lumen defined through the handle assembly. The guidewire is configured to be advanced distally from the handle assembly for placement through the access site and within the body lumen. The system also includes an outer sheath defining a lumen configured to receive the guidewire for placement of the guidewire within the body lumen. The outer sheath is configured to be moved from an extended position to a retracted position to deploy a stent within the body lumen. The system also includes a distal cutting element and a stent deployment mechanism. The distal cutting element extends distally from the outer sheath and is configured to create an access site in a wall of the body lumen. The stent deployment mechanism is coupled to the handle assembly and rotation of the stent deployment mechanism distally advances the guidewire through the access site and into the body lumen. Continued rotation of the stent deployment mechanism relative to the handle assembly moves the outer sheath from the extended position to the retracted position to deploy the stent subsequent to distal advancement of the guidewire.

[0015] In an aspect of the present disclosure, the distal cutting element is configured to apply electrosurgical energy to tissue to create the access site in the wall of the body lumen, and distal advancement of the guidewire terminates delivery of the electrosurgical energy to the distal cutting element.

[0016] In another aspect of the present disclosure, the handle assembly includes at least one of a visual indicator, a haptic indicator, or an audible indicator configured to generate an indication based on a position of the guidewire.

[0017] In still another aspect of the present disclosure, the distal cutting element is electrically coupled to an electrosurgical energy source via an electrical lead extending throughthe handle assembly. The electrical lead is configured to be manipulated to deflect the distal cutting element.

[0018] In yet another aspect of the present disclosure, the stent deployment mechanism is coupled to the outer sheath by a pull wire. Rotation of the stent deployment mechanism to distally advance the guide wire removes slack in the pull wire and the continued rotation of the stent deployment mechanism retracts the pull wire to move the outer sheath from the extended position to the retracted position to deploy the stent.

[0019] Another system for delivering a stent into a body lumen is provided in accordance with the present disclosure and includes a handle assembly and a guidewire disposed within a lumen defined through the handle assembly. The guidewire is configured to be advanced distally from the handle assembly for placement through the access site and within the body lumen. The system also includes an outer sheath defining a lumen configured to receive the guidewire for placement of the guidewire within the body lumen. The outer sheath is configured to be moved from an extended position to a retracted position to deploy a stent within the body lumen. The system also includes an electrocautery electrode extending distally from the outer sheath and a stent deployment mechanism coupled to the handle assembly. The electrocautery electrode is configured to apply electrosurgical energy to tissue to create an access site through a wall in the body lumen and distal advancement of the guidewire terminates delivery of the electrosurgical energy to the electrocautery electrode. Rotation of the stent deployment mechanism moves the outer sheath from the extended position to the retracted position to deploy the stent subsequent to distal advancement of the guidewire and subsequent to termination of delivery of the electrosurgical energy to the electrocautery electrode.

[0020] In an aspect of the present disclosure, the system also includes a switch disposed on the handle assembly and configured to be actuated to control delivery of the electrosurgical energy to the distal cutting element.

[0021] In another aspect of the present disclosure, the system also includes an electrical fuse disposed within the handle assembly and configured to limit a number of applications of the electrosurgical energy via the electrocautery electrode.

[0022] In still another aspect of the present disclosure, the stent deployment mechanism is coupled to the outer sheath by a pull wire, wherein actuation of the stent deployment mechanism retracts the pull wire around a pulley disposed within the handle assembly to move the outer sheath to the retracted position.

[0023] In yet another aspect of the present disclosure, the system also includes a connector pin removably coupled to the handle assembly and configured to electrically couple the electrocautery electrode to an electrosurgical energy source . The connector pin is movable from a locking configuration wherein the connector pin is engaged with the pulley to prevent retraction of the pull wire to an unlocked configuration wherein the connector pin is removed from engagement with the pulley to permit retraction of the pull wire.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Aspects of the disclosure are described herein with reference to the accompanying drawings, wherein:

[0025] FIG. 1 illustrates a system for providing access to a body lumen, in accordance with aspects of the present disclosure;

[0026] FIG. 2 illustrates a system for providing access to a body lumen, in accordance with aspects of the present disclosure;

[0027] FIG. 3A illustrates a side view of a system for providing access to a body lumen in a fist configuration with portions removed to show internal components of the system, in accordance with aspects of the present disclosure;

[0028] FIG. 3B shows portions of the system of FIG. 3A illustrating the system in the first configuration, in accordance with aspects of the present disclosure;

[0029] FIG. 3C illustrates the system of FIG. 3 A in a second configuration with portions removed to show internal components of the system, in accordance with aspects of the present disclosure;

[0030] FIG. 3D shows portions of the system of FIG. 3C illustrating the system in the second configuration, in accordance with aspects of the present disclosure;

[0031] FIG. 4 illustrates a side view of a system for providing access to a body lumen with portions removed to show internal components of the system, in accordance with another aspect of the present disclosure;

[0032] FIG. 5 illustrates a side view of a system for providing access to a body lumen with portions removed to show internal components of the system, in accordance with yet another aspect of the present disclosure; and

[0033] FIG. 6 illustrates a system for providing access to a body lumen with portions removed to show internal components of the system, in accordance with still another aspect of the present disclosure.DETAILED DESCRIPTION

[0034] Embodiments of the disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the drawings. The aspects may be combined in any manner consistent with the functionality of the apparatus and / or method disclosed herein. As used herein, the term “clinician” refers to a doctor, a clinician, a nurse, or any other care provider and may include support personnel. Throughout this description, the term “proximal” will refer to the portion of the device or component thereof that is closer to the clinician and the term “distal” will refer to the portion of the device or component thereof that is farther from the clinician. As used herein, the term “exemplary” does not necessarily mean “preferred” and may simply refer to an example unless the context clearly indicates otherwise.

[0035] Terms including “generally,” “about,” “substantially,” and the like, as utilized herein, are meant to encompass variations, e.g., manufacturing tolerances, material tolerances, use and environmental tolerances, measurement variations, design variations, and / or other variations, up to and including plus or minus 10 percent. Additionally, in the drawings and in the description that follows, terms such as front, rear, upper, lower, top, bottom, and similar directional terms are used simply for convenience of description and are not intended to limit the disclosure. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail.

[0036] Traditionally, access to a duct is achieved by placement of a guidewire through a delivery cannula or sphincterotome. In this case, the guidewire is in place prior to a stent delivery catheter and the stent delivery catheter is advanced over the wire into the duct. Currently, in cases where this traditional access method cannot be achieved (e.g., due to a blockage, altered anatomy, etc.), devices exist that allow a physician to punch through tissue walls (e.g., via a needle and / or via an electrocautery electrode) to directly access a duct with the stent delivery catheter. However, in this scenario, no guidewire is previously placed in the duct. After ductal access is achieved, it is safe practice to advance a guidewire into the duct so that access is not lost and so that the stent delivery catheter is guided in the correct direction and not dragging against the back wall of the duct. One method for ensuring the physician will advance a guidewire prior to stent deployment is to build the guidewire into the stent delivery catheter and link the guidewire advancement mechanism and the stent deployment mechanism, whereby the stent deployment mechanism cannot be used unless the guidewire advancement mechanism has been used to distally advance the guidewire. With this in mind, the presentdisclosure provides various embodiments of systems including a stent delivery catheter generally including a stent deployment mechanism (e.g., a thumbwheel), a guidewire advancement mechanism for deploying a guidewire from the stent delivery catheter, and an electrocautery tip for accessing a lumen of a duct by applying electrosurgical energy (e.g., radiofrequency energy) to a wall of the duct to “punch” the stent delivery catheter through the wall. Embodiments of the present disclosure also include mechanisms to ensure that application of electrosurgical energy to the electrocautery tip is terminated prior to distal advancement of the guidewire and / or prior to deployment of the stent.

[0037] FIG. 1 illustrates a system 100 for providing access to a body lumen (e.g., a duct) and delivering a stent in accordance with aspects of the present disclosure. The system 100 generally includes an outer sheath 105, an isolation sheath 110, a proximal marker 115, an anchoring component 120, an electrocautery tip 125, an inner tubular member 130, a stent 150, and a guidewire 145. The system 100 can be provided as individual components, selectively combined components, or all together as a kit of components. The electrocautery tip 125 is coupled with a distal end 140 of the inner tubular member 130 and includes a coiled electrode wire 165 that extends radially around a circumference of a distal end of the electrocautery tip 125. The electrode wire 165 is configured to receive electrosurgical (e.g., radiofrequency) energy for creating an access site in a wall of the body lumen.

[0038] During a luminal access and stent delivery procedure, the electrocautery tip 125 may access the target body lumen by piercing a wall of the body lumen via the electrode wire 165, for example, to deliver a stent 150. In general, a stent 150 is a frame or scaffolding structure sized for placement within a body lumen and configured to provide structural support to the inner surface of the body lumen. A stent 150 may be used to restore patency across narrowed or blocked areas within the body lumen due to inflammation, tumors, plaque buildup, or any other obstructive feature. Although references to the pancreaticobiliary system are provided herein, it should be appreciated that the stents described herein may be used in any body lumen.

[0039] The stent 150 may be made from any number of materials, combinations of materials, and constructions. In some examples, the stent 150 is a self-expanding stent. The stent 150 may be a wire-form stent formed by one or more helically wrapped wires. However, it should be appreciated that the stent 150 may be made from other stent constructions or combinations of stent constructions. In other examples, the stent 150 is a laser-cut stent formed from a single metallic tube with regions cut away for increased flexibility. In yet otherexamples, the stent 150 is a braided stent made from a plurality of wires joined together in a cross-hatch configuration. In some examples, the stent 150 may be a combination ofthe braided stent and the wire-form stent.

[0040] It may be appreciated that the different stent constructions may exhibit particular characteristics such as radial expansive force, flexibility, reduced foreshortening, or migration resistance that may render a certain construction advantageous for a particular use. For example, the helical wrapping pattern of the stent 150 may be configured to reduce a foreshortening of the stent body upon deployment from an undeployed configuration to the deployed configuration to less than ten percent of a length of the stent body in the undeployed configuration. In such cases, the stent 150 may be an example of a non-foreshortening stent.

[0041] The individual wires or frame of the stent 150 may be made from any number of metallic materials including, but not limited to, titanium, nitinol, or stainless steel. It should be appreciated that other metallic or non-metallic materials may be used to construct the stent 150 that provides suitable flexibility, stiffness, and biocompatibility. The stent 150 may include a polymeric or fabric sleeve (e.g., first material) that covers some or all of the surface of the stent 150. Such a sleeve may protect the inner surface of the body lumen from the bare metal of the stent 150 and may prevent tissue ingrowth. For example, the stent 150 may include a helical wrapping pattern that is at least partially covered with a first material. In some examples, the stent 150 is a drug -eluting stent.

[0042] The outer sheath 105 of the system 100 has an elongate tubular body and an internal lumen extending from its proximal end to the distal end. In general, the outer sheath 105 may be configured to access a body lumen and to provide a conduit through which one or more devices (e.g., guidewire 145) may pass to facilitate subsequent treatment of the body lumen or associated organs. The outer sheath 105 may include features that facilitate the direction- controlled delivery of the guidewire 145 within the body lumen for subsequent delivery of a stent 150, a biopsy device, a medicinal delivery element, or any number of other treatment or diagnostic devices.

[0043] The outer sheath 105 may be disposed coaxially along at least a portion of the inner tubular member 130 such that the stent 150 is disposed between the inner tubular member 130 and the outer sheath 105 while the stent 150 is in an undeployed configuration. The undeployed configuration may be an example of a stent 150 constrained within the outer sheath 105, an unexpanded configuration of the stent 150, or both. In some cases, the outer sheath 105 may include a braided extrusion in which a braided, distal section of the outer sheath 105 is fusedwith a braided, proximal section of the outer sheath 105. In some examples, the outer sheath 105 may include a coiled extrusion in which a coiled, distal section of the outer sheath 105 is fused with a coiled, proximal section of the outer sheath 105. In some cases, the outer sheath 105 may include a constant diameter along the length of the outer sheath 105.

[0044] In some examples, the outer sheath 105 may include a lubrication coating disposed within an inner surface of the outer sheath 105. The lubrication coating may be made from a variety of materials, including but not limited to silicone. In such cases, the lubrication coating may reduce deployment forces by at least thirty percent to ensure accurate placement of the stent 150 within the body lumen. In some cases, the lubrication coating of the outer sheath 105 may reduce the friction between the outer sheath 105 and the stent 150 as the outer sheath 105 is retracted over the stent 150. The isolation sheath 110 may be configured to receive the outer sheath 105 as the outer sheath 105 is retracted. The isolation sheath 110 may include a lubrication coating disposed within an inner surface of the isolation sheath 110.

[0045] The inner tubular member 130 is generally an elongate, tubular member with a proximal end 135 and a distal end 140 and is dimensioned to be advanced through the internal lumen of the outer sheath 105. The inner tubular member 130 may be configured to advance through an access site in a wall of the body lumen. In certain embodiments, the inner tubular member 130 includes one or more internal lumens extending from the proximal end 135 to the distal end 140 to house a power wire coupled with the electrode wire 165 of the electrocautery tip 125 in one internal lumen and the guidewire 145 in another internal lumen. The inner tubular member 130 may extend from a proximal end of the electrocautery tip 125 to a luer at the handle end and provide a passageway for the guidewire 145. As described below, the inner tubular member 130 is configured to house the guidewire 145. The inner tubular member 130 may be made of a number of materials, but not limited to polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE), polyimide, or both.

[0046] The inner tubular member 130 may be coupled with an anchoring component 120 at the distal end 140 of the inner tubular member 130. In certain embodiments, the distal end 140 of the inner tubular member 130 includes a tip or bulged portion (e.g., anchoring component 120). The stent 150 may be coupled to the inner tubular member 130 and the anchoring component 120. For example, the stent 150 may be concentric with the inner tubular member 130 and the anchoring component 120. As such, the inner tubular member 130 may extend through the lumen of the stent 150. For example, the stent 150 may be disposed coaxially onto the inner tubular member 130. The stent 150 may be positioned between theouter sheath 105 and the inner tubular member 130 at the proximal end 135 of the inner tubular member 130.

[0047] The anchoring component 120 may extend through the lumen of the stent 150 at a distal portion 160 of the stent 150. In such cases, the stent 150 may be positioned between the outer sheath 105 and the anchoring component 120 at the distal end 140 of the inner tubular member 130. For example, the distal portion 160 of the stent 150 may be disposed coaxially along the anchoring component 120 such that the distal portion 160 of the stent 150 is disposed between the anchoring component 120 and the outer sheath 105 while the stent 150 is in the undeployed configuration.

[0048] The anchoring component 120 may be made from a variety of materials, including but not limited to silicone. The anchoring component 120 may be disposed at a distal end 140 of the inner tubular member 130 and configured to retain a distal portion 160 of the stent 150 in place along the inner tubular member 130 as the outer sheath 105 is retracted proximally to deploy the stent 150. As described below in further detail, upon retraction of the outer sheath 105, the stent 150 may release from the anchoring component 120 and expand into a deployed configuration within the body lumen. The deployed configuration may be an example of an unconstrained configuration, an expanded configuration, or both.

[0049] The anchoring component 120 may be an example of a bump, an increased diameter component of the inner tubular member 130, a hook, or a combination thereof. In such cases, the anchoring component 120 may be configured to keep the distal portion 160 of the stent 150 stationary as the outer sheath 105 is retracted. In some examples, the anchoring component 120 may be 8 mm in length or 4 cm in length for a stent 150 that is 8-10 cm in length. In some cases, the inner tubular member 130 may include a single anchoring component 120 or more than one anchoring component 120. For example, the inner tubular member 130 may include at least three anchoring components 120 made of polyether block amide (PEBA) and positioned along the inner tubular member 130. The anchoring components 120 may extend 1 cm higher from the outer surface of the inner tubular member 130.

[0050] The system 100 may further include a proximal marker 115. The proximal marker 115 may be an example of a proximal marker that is disposed around the inner tubular member 130 and positioned such that a proximal end of the stent 150 abuts against the proximal marker 115 while the stent 150 is in the undeployed configuration. The proximal marker 115 may be configured to indicate a location of the proximal end of the stent 150 within the system 100. The proximal marker 115 may be configured to retain a proximal portion 155 of the stent 150in place along the inner tubular member 130 as the outer sheath 105 is retracted proximally to deploy the stent 150. In some cases, the proximal marker 115 may be coupled with the inner tubular member 130 such that the proximal marker 115 remains stationary as the outer sheath 105 is retracted.

[0051] The proximal marker 115 generally includes an elongate, tubular member and is configured to house the inner tubular member 130. In some cases, the proximal marker 115 may be tapered such that a distal end of the proximal marker 115 may extend underneath the proximal portion 155 of the stent 150. For example, the proximal marker 115 may be an example of a proximal anchoring component such that the proximal marker 115 may be configured to compress the proximal portion 155 of the stent 150 between the proximal marker 115 and the outer sheath 105.

[0052] In aspects of the present disclosure, the electrocautery tip 125 may include a coiled electrode wire (e.g., electrode wire 165) that extends radially around a circumference of a distal end of the electrocautery tip 125, a single electrode wire that extends longitudinally and in a proximal direction from a distal end of the electrocautery tip 125, a single, spiral electrode wire that extends around a distal end of the electrocautery tip 125, or an electrode tube. In some cases, the electrocautery tip 125 may include a tapered cover disposed around the electrocautery tip 125. The outer sheath 105 may at least partially overlap the tapered cover. The tapered cover may be made from a variety of materials, including but not limited to silicone or other flexible materials. In some cases, the outer diameter of the electrocautery tip 125 may be equal to the inner diameter of the outer sheath 105. In other examples, the outer diameter of the electrocautery tip 125 may be greater than the inner diameter of the outer sheath 105.

[0053] The guidewire 145 is generally a flexible elongate member configured to slidably advance through the internal lumen of the inner tubular member 130. In such cases, the guidewire 145 may be disposed within the inner tubular member 130. The guidewire 145 may be uniform in size and stiffness along its entire length, or alternatively, may include sections of differing stiffness.

[0054] FIG. 2 illustrates a system 200 for providing access to a body lumen in accordance with aspects of the present disclosure. The system 200 generally includes the outer sheath 105, the isolation sheath 110, the proximal marker 115, the anchoring component 120 (not shown), the electrocautery tip 125, the inner tubular member 130 (not shown), and the stent 150, which may be examples of the corresponding components described with reference to FIG. 1. The system 200 may also include a thumbwheel 205, a locking pin 210, a guidewire lumen 220,and a connector port 225. The system 200 can be provided as individual components, selectively combined components, or all together as a kit of components.

[0055] The thumbwheel 205 may be coupled with a proximal end 215 of the outer sheath 105 and configured to retract the outer sheath 105 proximally. In some cases, the outer sheath 105 may be bonded (e.g., attached) to the thumbwheel 205 via a cable and a carriage (e.g., a plastic component). For example, the outer sheath 105 may be coupled with the handle assembly 230 via the carriage at the proximal end 215 of the outer sheath 105. The actuation of the thumbwheel 205 may retract the outer sheath 105 to deploy the stent 150. As described below, the outer sheath 105 may be retracted into the stationary isolation sheath 110.

[0056] The locking pin 210 may be configured to prevent deployment when the device is inserted into the scope. For example, features of the locking pin 210 may engage into the carriage to prevent accidental deployment. To begin actuation of the thumbwheel 205, the locking pin 210 may be removed from the handle assembly 230. In such cases, the device may be deployed based on removing the locking pin 210 and actuating the thumbwheel 205.

[0057] In some cases, the isolation sheath 110 may stabilize the device against the scope channel and isolate friction that the catheter may experience otherwise in tortuosity. In such cases, the system 200 may enable accurate deployment of the stent 150 through the system 200 (e.g., including at least the isolation sheath 110 and the outer sheath 105) to ensure stability of the catheter against the scope. In some cases, the isolation sheath 110 may include two different diameters along the length of the isolation sheath 110 to customize interaction with the scope channel.

[0058] The isolation sheath 110 may be made of a material such as high-density polyethylene (HDPE). The isolation sheath 110 may be in contact with the inner diameter of the working channel of the endoscope, thereby inducing friction between the isolation sheath 110 and working channel. As the thumbwheel is actuated and the outer sheath 105 is retracted, the friction between the isolation sheath 110 and the working channel may be greater than the friction between the isolation sheath 110 and the outer sheath 105 such that the isolation sheath 110 remains stationary as the outer sheath 105 is retracted. In such cases, the isolation sheath 110 may be configured as a barrier between the outer sheath 105 and the working channel, thereby reducing the overall friction on the system 200.

[0059] The outer sheath 105 may be inserted into the handle assembly 230, and once assembled, the outer sheath 105 extends through the handle assembly 230 to the target body lumen. In some cases, a power wire may be connected to the electrode wire 165 of theelectrocautery tip 125 and may be laminated on the inner lumen member by a polyester heat shrink. In such cases, the power wire may extend through the handle assembly 230 and through the connector port 225. The electrode wire 165 of the electrocautery tip 125 may be connected through the connector port 225 in the handle assembly 230. In some cases, the electrode wire 165 may connect to a radiofrequency (RF) generator.

[0060] The guidewire lumen 220 may generally be a tubular structure that is sized to deploy the stent 150 within the body lumen. The guidewire lumen 220 may access the human body through the working channel of an endoscope, for example. As will be appreciated, the guidewire lumen 220 may be made from any number of biocompatible materials or combinations of materials suitable for medical sheaths, catheters, and the like.

[0061] Referring now to FIGS. 3A-3D, an embodiment of a system 300 is illustrated, similar to system 200 described above. Accordingly, system 300 will only be described to the extent believed necessary in elucidating its differences from system 200. System 300 generally includes a thumbwheel 305, a locking pin 310, a guidewire lumen 320, a connector port 325, a handle assembly 330, a guidewire advancement mechanism 335, an interference sleeve 340, a guidewire 345, and a pulley 350. The advancement mechanism 335 and the interference sleeve 340 are coupled to the guidewire 345, with the guidewire advancement mechanism 335 proximally spaced from the interference sleeve 340. The thumbwheel 305 is also coupled to the outer sheath 105 (not shown) via a pull wire 315 such that rotation of the thumbwheel 305 in a particular rotational direction (e.g., counter clockwise) causes the pull wire 315 to retract around the pulley 350 toward the thumbwheel 405 to, in turn, retract the outer sheath 105 and deploy the stent 150 (not shown). The system 300 can be provided as individual components, selectively combined components, or all together as a kit of components.

[0062] System 300 includes functionality for ensuring that the guidewire 345 is advanced distally from the handle assembly 330 prior to retraction of the outer sheath 105 to deploy the stent 150. For example, FIG. 3A illustrates the guide wire 345 retracted within the handle assembly 330 (e.g., in a retracted position), the locking pin 310 in locked engagement with the thumbwheel 305 (see FIG. 3B), and the interference sleeve 340 engaged with the locking pin 310 such that the locking pin 310 is prevented from being retracted away from the thumbwheel 305. With the locking pin 310 in locked engagement with thumbwheel 305 as shown in FIG. 3 A, the thumbwheel 305 cannot be rotated to cause retraction of the outer sheath 105 to deploy the stent 150 until the locking pin 310 is disengaged from the thumbwheel 305. The locking pin 310 cannot be disengaged from the thumbwheel 305 until the guidewire 345 is advanceddistally (e.g., into an advanced position) via distal advancement of the advancement mechanism 335 to move the interference sleeve 340 out of engagement with the locking pin 310, as shown in FIG. 3C. This order of operations required by the structural components of system 300 ensures that the guidewire 345 is advanced distally (e.g., to an advanced position) prior to deployment of the stent 150. In embodiments of the present disclosure, the advancement mechanism 335 may be a slider configured to slide the guidewire 345 along a longitudinal axis of the handle assembly 330 to move the interference sleeve 340 into and out of engagement with the locking pin 310.

[0063] With the interference sleeve 340 moved out of engagement with the locking pin 310, as shown in FIG. 3C, the locking pin 310 is free to be retracted away from the thumbwheel 305 and ultimately removed from the handle assembly 330 to enable rotation of the thumbwheel 305. As shown in FIG. 3D, the locking pin 310 may include a recess or notch 312 that is configured to receive the interference sleeve 340 and the guidewire 345. When the interference sleeve 345 is received within the notch 312 (FIG. 3B), the locking pin 310 is prevented from being retracted away from the thumbwheel 305. When the interference sleeve 340 is moved distally past the notch 312 of the locking pin 310 such that only the guidewire 345 is received within the notch 312 (FIG. 3D), the locking pin 310 is free to be retracted away from the thumbwheel 305 to disengage the locking pin 310 from the thumbwheel 305. Once the locking pin 310 is disengaged from the thumbwheel, or otherwise removed from the handle assembly 330, the thumbwheel 305 is free to rotate to retract the outer sheath 105 via the pull wire 315 and deploy the stent 150.

[0064] In embodiments of the present disclosure, the system 300 may include a second locking pin (not shown) that serves to interrupt electrical continuity between the electrode wire 165 of the electrocautery tip 125 and an electrosurgical energy source (not shown). In this scenario, the clinician would be required to remove the second locking pin before activating energy delivery to the electrode wire 165 of the electrocautery tip 125. Requiring the clinician to remove the second locking pin to enable energy delivery serves to ensure that it is indeed the clinician’s intention to cauterize tissue using the electrode wire 165 of the electrocautery tip 125.

[0065] Referring now to FIG. 4, an embodiment of a system 400 is illustrated, similar to system 200 described above. Accordingly, system 400 will only be described to the extent believed necessary in elucidating its differences from system 200. System 400 generally includes a thumbwheel 405, a pulley 410, a guidewire lumen 420, a connector port 425, ahandle assembly 430, and a guidewire 445. The thumbwheel 405 is operably coupled to the guidewire 445 such that rotation of the thumbwheel 405 in a particular rotational direction (e.g., counter clockwise) causes distal advancement of the guidewire 445. The thumbwheel 405 is also coupled to the outer sheath 105 (not shown) via a pull wire 415 such that rotation of the thumbwheel 405 in a particular rotational direction (e.g., counter clockwise) causes the pull wire 415 to retract around the pulley 410 toward the thumbwheel 405 to, in turn, retract the outer sheath 105 and deploy the stent 150 (not shown). The system 400 can be provided as individual components, selectively combined components, or all together as a kit of components.

[0066] In order to ensure that the guidewire 445 is advanced prior to deployment of the stent 150, the system 400 is configured such that rotation of the thumbwheel 405 advances the guidewire 445 distally before causing retraction of the outer sheath 105 to deploy the stent 150. With this purpose in mind, the pull wire 415 is provided with an adequate amount of slack such that rotation of the thumbwheel 405 initially causes only the guidewire 445 to advance distally a set distance (e.g., about 5cm) until the slack is removed from the pull wire 415 via continued rotation of the thumbwheel 405. Once the slack in the pull wire 415 is removed, continued rotation of the thumbwheel 405 causes the pull wire 415 to retract around the pulley 410 toward the thumbwheel 405 to, in turn, retract the outer sheath 105 to deploy the stent 150.

[0067] Referring now to FIG. 5, an embodiment of a system 500 is illustrated, similar to system 200 described above. Accordingly, system 500 will only be described to the extent believed necessary in elucidating its differences from system 200. System 500 generally includes a thumbwheel 505, a pulley 510, a guidewire lumen 520, a connector port 525, a handle assembly 530, and a guidewire 545. The thumbwheel 505 is operably coupled to the guidewire 545 such that rotation of the thumbwheel 505 in a particular rotational direction (e.g., counter clockwise) causes distal advancement of the guidewire 545. The thumbwheel 505 is also coupled to the outer sheath 105 (not shown) via a pull wire 515 such that rotation of the thumbwheel 505 in a particular rotational direction (e.g., counter clockwise) causes the pull wire 515 to retract around the pulley 510 toward the thumbwheel 505 to, in turn, retract the outer sheath 105 and deploy the stent 150 (not shown). An electrical lead 555 extends proximally from the electrode wire 165 of the electrocautery tip 125 through the handle assembly 530 and the connector port 525 to ultimately electrically couple the electrode wire 165 of the electrocautery tip 125 with an electrosurgical energy source. The system 500 can beprovided as individual components, selectively combined components, or all together as a kit of components.

[0068] The system 500 includes an electrocautery switch 550 electrically coupled between the electrode wire 165 of the electrocautery tip 125 (not shown) and an electrosurgical energy source (e.g., RF generator). The electrocautery switch 550 may be disposed within the guidewire lumen 520 such that the guidewire 545 is configured to advance through the guidewire lumen 520 into engagement with the switch 550 to terminate delivery of energy to the electrode wire 165 of the electrocautery tip 125. In this way, energy is no longer provided to the electrode wire 165 of the electrocautery tip 125 prior to advancement of the guidewire 545 into a body lumen. For example, the switch 550 may initially be in a closed configuration to complete a circuit between the electrode wire 165 of the electrocautery tip 125 and an electrosurgical energy source. Distal advancement of the guidewire 545 caused by rotation of the thumbwheel 505 serves to advance the guidewire 545 distally into engagement with the switch 550 such that the switch 550 is caused to move from the closed configuration to an open configuration (or vice versa) to interrupt electrical continuity through the electrical lead 555, thereby terminating energy delivery to the electrode wire 165 of the electrocautery tip 125. It is also contemplated that movement of the switch 550 from the open configuration to the closed configuration may serve to terminate energy delivery to the electrode wire 165 of the electrocautery tip 125. For example, closing of the switch 550 may serve to communicate a signal to an electrosurgical energy source to terminate energy delivery.

[0069] In embodiments of the present disclosure, the switch 550 may be embodied as a conductive element (not shown) disposed on the guidewire 545. The electrical lead 555 may include a switch (not shown) that controls delivery of energy through the electrical lead 555 to the electrode wire 165 of the electrocautery tip 125. In this scenario, when the guidewire 545 is in a retracted position, electrical continuity through the electrical lead 555 is maintained to allow for delivery of energy to the electrode wire 165 of the electrocautery tip 125. As the guidewire 545 advances distally, the switch 550 of the guidewire 545 interacts with the switch of the electrical lead 555 to cause the switch of the electrical lead 555 to open, thereby interrupting electrical continuity through the electrical lead 555 to terminate energy delivery to the electrode wire 165 of the electrocautery tip 125. In this way, delivery of energy to the electrode wire 165 of the electrocautery tip 125 is terminated prior to advancement of the guidewire 545 into a body lumen. In embodiments of the present disclosure, the electrical lead 555 may also serve as a pull wire that is configured to deflect the electrocautery tip 125 (notshown) for steering the outer sheath 105 (not shown) through a body lumen. In aspects of the present disclosure, energy may be delivered to the electrode wire 165 via the electrical lead 555 in response to the guidewire 545 being advanced from a retracted position to an advanced position that is a predetermined distance from the retracted position. Once the guidewire 545 is advanced the predetermined distance to the advanced position, energy delivery to the electrode wire 165 is terminated. In this way, the electrode wire is inactive while the guidewire 545 is further advanced into the body lumen. Retracting the guidewire 545 proximally a predetermined distance (e.g., to the advanced position, to the retracted position, or to a position between the advanced position and the retracted position) may serve to re-enable energy delivery to the electrode wire 165.

[0070] In embodiments of the present disclosure, an indicator 560 may be disposed on the handle assembly 530 that serves to indicate whether or not the guidewire 545 has been advanced. In aspects of the present disclosure, the indicator 560 may be a sticker label that changes color to indicate the status of the guidewire 545. For example, the indicator 560 may initially be the color red and when the guidewire 545 is advanced the indicator 560 changes to the color green. In aspects of the present disclosure, the indicator 560 may be a visual indicator and include one or more light emitting diodes (LEDs) that illuminate a particular color (e.g., green or red) to indicate the status of the guidewire 545. For example, the indicator 560 may illuminate the color green when the guidewire 545 is retracted and illuminate the color red when the guidewire 545 is advanced distally. In this scenario, the color red may be illuminated by the indicator 560 upon the guidewire 545 being advanced a particular threshold distance. In embodiments of the present disclosure, the indicator 560 may be an audio or haptic indicator. For example, the indicator 560 may include a buzzer configured to vibrate such that the clinician holding the handle assembly 530 feels vibration caused by the buzzer. Additionally or alternatively, the indicator 560 may be configured to broadcast a sound (e.g., a beep, a tone, or the like) based on whether the guidewire 545 is retracted or advanced distally.

[0071] In embodiments of the present disclosure, the connector port 525 may include structure configured to be engaged with the pulley 510 within the handle assembly 530 to prevent rotation of the pulley 510 until the connector port 525 is disengaged from the pulley 510 or otherwise disconnected from the handle assembly 530. Disengagement of the connector port 525 from the pulley 510 enables rotation of the pulley 510 to facilitate retraction of the outer sheath 105 to deploy the stent 150. In this scenario, the clinician may be required to disconnect the connector port 525 from the handle assembly 530 to terminate energy deliveryto the electrocautery tip before the pull wire 515 can be retracted to cause retraction of the outer sleeve 105 to deploy the stent. The above-noted order of operations serves to ensure that energy delivery to the electrode wire 165 of the electrocautery tip 125 is terminated prior to deployment of the stent 150.

[0072] Referring now to FIG. 6, an embodiment of a system 600 is illustrated, similar to system 200 described above. Accordingly, system 600 will only be described to the extent believed necessary in elucidating its differences from system 200. System 600 generally includes a thumbwheel 605, a pulley 610, a guidewire lumen 620, a connector port 625, a handle assembly 630, and a guidewire 645. The thumbwheel 605 is operably coupled to the guidewire 645 such that rotation of the thumbwheel 605 in a particular rotational direction (e.g., counter clockwise) causes distal advancement of the guidewire 645. The thumbwheel 605 is also coupled to the outer sheath 105 (not shown) via a pull wire 615 such that rotation of the thumbwheel 605 in a particular rotational direction (e.g., counter clockwise) causes the pull wire 615 to retract around the pulley 610 toward the thumbwheel 605 to, in turn, retract the outer sheath 105 and deploy the stent 150 (not shown). An electrical lead 655 extends proximally from the electrode wire 165 of the electrocautery tip 125 (not shown) through the handle assembly 630 and the connector port 625 to ultimately electrically couple the electrode wire 165 of the electrocautery tip 125 with an electrosurgical energy source. In embodiments of the present disclosure, the electrical lead 655 may also serve as a pull wire that is configured to deflect the electrocautery tip 125 (not shown) for steering the outer sheath 105 (not shown) through a body lumen. The system 600 can be provided as individual components, selectively combined components, or all together as a kit of components.

[0073] The system 600 includes one or more electrical fuses 650 disposed within the handle assembly 630 and electrically coupled to the electrical lead 655. The one or more fuses 650 are configured to limit the number of energy applications to the electrode wire 165 of the electrocautery tip 125 as a safety precaution. For example, the one or more fuses 650 may limit the number of energy applications to the electrode wire 165 of the electrocautery tip 125 to one or two applications. In this way, the clinician is able to access a body lumen using the electrode wire 165 of the electrocautery tip 125 while ensuring that energy delivery is terminated prior to the guidewire 645 being advanced into the body lumen.

[0074] In embodiments of the present disclosure, the system 600 may include an electrocautery switch 660 disposed on the handle assembly 630 and configured to be actuated by the clinician to control delivery of electrosurgical energy to the electrode wire 165 of theelectrocautery tip 125. In some existing systems, energy delivery may typically be controlled by a footswitch coupled to an electrosurgical energy source. The clinician taps the footswitch with their foot to cause delivery of or terminate delivery of energy from an electrosurgical energy source to an electrode such as the electrode wire 165 of the electrocautery tip 125 of the present disclosure. It is contemplated by the present disclosure, that the electrocautery switch 660 may either operate as a standalone switch to autonomously control energy delivery. It is also contemplated by the present disclosure that the electrocautery switch 660 operates in conjunction with a footswitch (not shown) to control energy delivery. For example, the clinician may in aspects of the present disclosure be required to actuate (e.g., hold down) the electrocautery switch 660 simultaneously with the footswitch to cause energy delivery to the electrode wire 165 of the electrocautery tip 125. Requiring the use of both the footswitch and the electrocautery switch 660 to cause energy delivery serves to operate as a level of confirmation that the clinician’ s intent is indeed to cauterize tissue using the electrode wire 165 of the electrocautery tip 125.

[0075] While several aspects of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular aspects. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

[0076] The following examples are illustrative of the techniques described herein.

[0077] Example 1. A system for delivering a stent into a body lumen, the system comprising: a handle assembly; a guidewire disposed within a lumen defined through the handle assembly and configured to be advanced from a retracted position to an advanced position for placement within a body lumen; an outer sheath defining a lumen configured to receive the guidewire for placement of the guide wire within the body lumen, the outer sheath configured to be moved from an extended position to a retracted position to deploy a stent within the body lumen; a distal cutting element extending distally from the outer sheath and configured to create an access site in a wall of the body lumen; and a stent deployment mechanism coupled to the handle assembly and configured to cause movement of the outer sheath from the extended position to the retracted position to deploy the stent, wherein movement of the guidewire from the retracted position to the advanced position enables transition of the stent deployment mechanism from a locked configuration wherein actuationof the stent deployment mechanism is prevented to an unlocked configuration wherein actuation of the stent deployment mechanism is permitted to retract the outer sheath and deploy the stent.

[0078] Example 2. The system according to Example 1, wherein the stent deployment mechanism is a thumbwheel extending from the handle assembly and configured to rotate relative to the handle assembly to move the outer sheath to the retracted position.

[0079] Example 3. The system according to Example 2, wherein the thumbwheel is coupled to the outer sheath by a pull wire, and rotation of the thumbwheel retracts the pull wire around a pulley disposed within the handle assembly to move the outer sheath to the retracted position.

[0080] Example 4. The system according to Example 1, further comprising a locking mechanism removably coupled to the handle assembly and configured to engage the stent deployment mechanism to maintain the stent deployment mechanism in the locked configuration, wherein removal of the locking mechanism from engagement with the stent deployment mechanism transitions the stent deployment mechanism to the unlocked configuration.

[0081] Example 5. The system according to Example 4, further comprising an interference sleeve disposed on the guidewire and configured to engage the locking mechanism to prevent disengagement of the locking mechanism from the stent deployment mechanism.

[0082] Example 6. The system according to Example 5, wherein movement of the guidewire from the retracted position to the advanced position disengages the interference sleeve from the locking mechanism to permit disengagement of the locking mechanism from the stent deployment mechanism.

[0083] Example 7. The system according to Example 1, wherein the distal cutting element includes an electrocautery electrode configured to apply electrosurgical energy to the wall of the body lumen.

[0084] Example 8. The system according to Example 1 , further comprising an inner tubular member configured to advance through the access site in the wall of the body lumen, wherein the outer sheath is disposed coaxially along at least a portion of the inner tubular member.

[0085] Example 9. The system according to Example 8, wherein the stent is disposed between the inner tubular member and the outer sheath to maintain the stent in an undeployed configuration.

[0086] Example 10. The system according to Example 8, further comprising an anchoring component disposed at a distal portion of the inner tubular member and configured to retain a distal portion of the stent in place along the inner tubular member as the outer sheath is moved toward the retracted position, wherein upon movement of the outer sheath to the retracted position, the stent releases from the anchoring component and expands into a deployed configuration within the body lumen.

[0087] Example 11. A system for delivering a stent into a body lumen, the system comprising: a handle assembly; a guidewire disposed within a lumen defined through the handle assembly and configured to be advanced distally from the handle assembly for placement through the access site and within the body lumen; an outer sheath defining a lumen configured to receive the guidewire for placement of the guidewire within the body lumen, the outer sheath configured to be moved from an extended position to a retracted position to deploy a stent within the body lumen; a distal cutting element extending distally from the outer sheath and configured to create an access site in a wall of the body lumen; and a stent deployment mechanism coupled to the handle assembly, wherein rotation of the stent deployment mechanism distally advances the guidewire through the access site and into the body lumen, and continued rotation of the stent deployment mechanism relative to the handle assembly moves the outer sheath from the extended position to the retracted position to deploy the stent subsequent to distal advancement of the guidewire.

[0088] Example 12. The system according to Example 11, wherein the distal cutting element is configured to apply electrosurgical energy to tissue to create the access site in the wall of the body lumen, and distal advancement of the guidewire terminates delivery of the electrosurgical energy to the distal cutting element.

[0089] Example 13. The system according to Example 11, wherein the handle assembly includes at least one of a visual indicator, a haptic indicator, or an audible indicator configured to generate an indication based on a position of the guidewire.

[0090] Example 14. The system according to Example 11, wherein the distal cutting element is electrically coupled to an electrosurgical energy source via an electrical lead extending through the handle assembly, and the electrical lead is configured to be manipulated to deflect the distal cutting element.

[0091] Example 15. The system according to Example 11, wherein the stent deployment mechanism is coupled to the outer sheath by a pull wire, wherein the rotation of the stent deployment mechanism to distally advance the guidewire removes slack in the pull wire andthe continued rotation of the stent deployment mechanism retracts the pull wire to move the outer sheath from the extended position to the retracted position to deploy the stent.

[0092] Example 16. A system for delivering a stent into a body lumen, the system comprising: a handle assembly; a guidewire disposed within a lumen defined through the handle assembly and configured to be advanced distally from the handle assembly for placement through the access site and within the body lumen; an outer sheath defining a lumen configured to receive the guidewire for placement of the guidewire within the body lumen, the outer sheath configured to be moved from an extended position to a retracted position to deploy a stent within the body lumen; an electrocautery electrode extending distally from the outer sheath and configured to apply electrosurgical energy to tissue to create an access site through a wall in the body lumen, wherein distal advancement of the guidewire terminates delivery of the electrosurgical energy to the electrocautery electrode; and a stent deployment mechanism coupled to the handle assembly, wherein rotation of the stent deployment mechanism moves the outer sheath from the extended position to the retracted position to deploy the stent subsequent to distal advancement of the guidewire and subsequent to termination of delivery of the electrosurgical energy to the electrocautery electrode.

[0093] Example 17. The system according to Example 16, further comprising a switch disposed on the handle assembly and configured to be actuated to control delivery of the electrosurgical energy to the distal cutting element.

[0094] Example 18. The system according to Example 16, further comprising an electrical fuse disposed within the handle assembly and configured to limit a number of applications of the electrosurgical energy via the electrocautery electrode.

[0095] Example 19. The system according to Example 16, wherein the stent deployment mechanism is coupled to the outer sheath by a pull wire, wherein actuation of the stent deployment mechanism retracts the pull wire around a pulley disposed within the handle assembly to move the outer sheath to the retracted position.

[0096] Example 20. The system according to Example 19, further comprising a connector pin removably coupled to the handle assembly and configured to electrically couple the electrocautery electrode to an electrosurgical energy source, wherein the connector pin is movable from a locking configuration wherein the connector pin is engaged with the pulley to prevent retraction of the pull wire to an unlocked configuration wherein the connector pin is removed from engagement with the pulley to permit retraction of the pull wire.

Claims

WHAT IS CLAIMED IS:

1. A system for delivering a stent into a body lumen, the system comprising: a handle assembly (230); a guidewire (145) disposed within a lumen defined through the handle assembly (230) and configured to be advanced from a retracted position to an advanced position for placement within a body lumen ; an outer sheath (105) defining a lumen configured to receive the guidewire (145) for placement of the guidewire (145) within the body lumen, the outer sheath (105) configured to be moved from an extended position to a retracted position to deploy a stent (150) within the body lumen; a distal cutting element (125) extending distally from the outer sheath (105) and configured to create an access site in a wall of the body lumen; and a stent deployment mechanism (205) coupled to the handle assembly (230) and configured to cause movement of the outer sheath (105) from the extended position to the retracted position to deploy the stent (150), wherein movement of the guidewire (145) from the retracted position to the advanced position enables transition of the stent deployment mechanism (205) from a locked configuration wherein actuation of the stent deployment mechanism (205) is prevented to an unlocked configuration wherein actuation of the stent deployment mechanism (205) is permitted to retract the outer sheath (105) and deploy the stent (150).

2. The system according to claim 1, wherein the stent deployment mechanism (205) is a thumbwheel extending from the handle assembly (230) and configured to rotate relative to the handle assembly (230) to move the outer sheath (105) to the retracted position.

3. The system according to claim 2, wherein the thumbwheel is coupled to the outer sheath (105) by a pull wire (315), and rotation of the thumbwheel retracts the pull wire (315) around a pulley (350, 410, 510, 610) disposed within the handle assembly (230) to move the outer sheath (105) to the retracted position.

4. The system according to claim 1, further comprising a locking mechanism (210) removably coupled to the handle assembly (230) and configured to engage the stent deployment mechanism (205) to maintain the stent deployment mechanism (205) in the lockedconfiguration, wherein removal of the locking mechanism (210) from engagement with the stent deployment mechanism (205) transitions the stent deployment mechanism (205) to the unlocked configuration.

5. The system according to claim 4, further comprising an interference sleeve (340) disposed on the guidewire (145) and configured to engage the locking mechanism (210) to prevent disengagement of the locking mechanism (210) from the stent deployment mechanism (205).

6. The system according to claim 5, wherein movement of the guidewire (145) from the retracted position to the advanced position disengages the interference sleeve (340) from the locking mechanism (210) to permit disengagement of the locking mechanism (210) from the stent deployment mechanism (205).

7. The system according to claim 1, wherein the distal cutting element (125) includes an electrocautery electrode (165) configured to apply electrosurgical energy to the wall of the body lumen.

8. The system according to claim 1, further comprising an inner tubular member (130) configured to advance through the access site in the wall of the body lumen, wherein the outer sheath (105) is disposed coaxially along at least a portion of the inner tubular member (130).

9. The system according to claim 8, wherein the stent (150) is disposed between the inner tubular member (130) and the outer sheath (105) to maintain the stent (150) in an undeployed configuration.

10. The system according to claim 8, further comprising an anchoring component (120) disposed at a distal portion of the inner tubular member (130) and configured to retain a distal portion of the stent (150) in place along the inner tubular member (130) as the outer sheath (105) is moved toward the retracted position, wherein upon movement of the outer sheath (105) to the retracted position, the stent (150) releases from the anchoring component (120) and expands into a deployed configuration within the body lumen.

11. The system according to claim 1 , wherein distal advancement of the guidewire (145) terminates delivery of the electrosurgical energy to the distal cutting element (125).

12. The system according to claim 1, wherein the handle assembly (230) includes at least one of a visual indicator (560), a haptic indicator (560), or an audible indicator (560) configured to generate an indication based on a position of the guidewire (145).

13. The system according to claim 1, wherein the distal cutting element (125) is electrically coupled to an electrosurgical energy source via an electrical lead (555) extending through the handle assembly (230), and the electrical lead (555) is configured to be manipulated to deflect the distal cutting element (125).

14. The system according to claim 1, wherein the stent deployment mechanism (205) is coupled to the outer sheath (105) by a pull wire (415), wherein the rotation of the stent deployment mechanism (205) to distally advance the guidewire (145) removes slack in the pull wire (415) and the continued rotation of the stent deployment mechanism (205) retracts the pull wire (415) to move the outer sheath (105) from the extended position to the retracted position to deploy the stent (150).

15. The system according to claim 1, further comprising a switch (660) disposed on the handle assembly (230) and configured to be actuated to control delivery of the electrosurgical energy to the distal cutting element (125).

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