Rotatable stent delivery device for covering puncture sites

Abstract

Methods, apparatus, and systems are described for an expandable stent delivery device for covering a puncture site. The method may include delivering a stent delivery system through the puncture site, wherein the stent delivery system includes a positioning member having a first portion, the first portion being rotatable relative to a second portion, and wherein the stent is releasably coupled to the first portion of the positioning member. In some cases, the method may further include withdrawing an external restraining member from the stent to deploy a proximal portion of the stent within a body lumen; and rotating the proximal portion of the stent away from the puncture site by proximally withdrawing the positioning member and returning it through the puncture site. The method may further include covering the puncture site with the proximal portion of the stent when the proximal portion is fully deployed from the external restraining member.

Description

Background Art

[0001] Diseases and conditions of the gallbladder, pancreas, and bile duct (i.e., the pancreaticobiliary system) are associated with significant morbidity, mortality, and impaired quality of life. Obstructions, tumors, injuries, leaks, inflammation, infections, and pathological changes may occur in these structures, which may ultimately lead to symptoms such as biliary colic, cholecystitis, choledocholithiasis, cholelithiasis, pancreatitis, pancreatic duct stone formation, and chronic abdominal pain. Diseases of the pancreaticobiliary system may also be associated with nutritional imbalances (such as malnutrition, obesity, and high cholesterol).

[0002] To treat a bile duct obstruction, clinicians can perform a stent delivery procedure to place a stent across the obstruction. Typically, a stent delivery procedure involves placing an endoscope into the gastrointestinal tract and accessing the bile duct via a catheter. A guidewire can then be deployed through the catheter and advanced into the bile duct. Once the guidewire is in place, a stent or other therapeutic device can be advanced over the guidewire into the bile duct. After the stent is placed in the bile duct, the clinician can remove the stent delivery system. Summary of the Invention

[0003] The described features generally relate to improved methods, systems, and apparatus for a rotatable stent delivery device for covering a puncture site. The method may include delivering a stent delivery system through a puncture site in a wall of a body lumen; withdrawing an external constraining member from the stent to deploy a proximal portion of the stent within the body lumen; rotating the proximal portion of the stent away from the puncture site by proximally withdrawing the positioning member and extending it backward through the puncture site; and covering the puncture site with the proximal portion of the stent when the proximal portion is fully deployed from the external constraining member. The system for delivering the stent to the body lumen may include a stent; a stent delivery device configured to deliver the stent through a puncture site; and an outer sheath configured to constrain the stent in a collapsed configuration. The system may further include a positioning member configured to rotate the proximal portion of the stent away from the puncture site by proximally withdrawing the positioning member and extending it backward through the puncture site.

[0004] A method for delivering a stent into a body lumen is described. The method may include delivering a stent delivery system through a puncture site in a wall of the body lumen, wherein the stent delivery system includes a positioning member having a first portion that is rotatable relative to a second portion, and wherein the stent is releasably coupled to the first portion of the positioning member; withdrawing an external constraining member from the stent to deploy a proximal portion of the stent within the body lumen; rotating the proximal portion of the stent away from the puncture site by proximally withdrawing the positioning member and back through the puncture site; and covering the puncture site with the proximal portion of the stent upon full deployment of the proximal portion from the external constraining member.

[0005] The method may further include retracting the stent toward the puncture site so that the proximal portion of the stent at least partially covers the puncture site. In some instances, the proximal portion can be rotated away from the puncture site so that the positioning member prevents the proximal portion of the stent from becoming lodged between the wall of the body lumen and the positioning member when the stent is retracted. The method may further include removing a primary constraining member from the stent so that the distal portion of the stent is deployed within the body lumen; and expanding the stent within the body lumen. In some instances, the primary constraining member releasably couples the stent to the first portion of the positioning member.

[0006] In some instances, rotating the proximal portion of the stent away from the puncture site can include rotating the first portion of the positioning member and maintaining the second portion of the positioning member in a fixed position. In some instances, the first portion includes one or more bearings disposed around the second portion. In some instances, the first portion and the second portion are coupled by a rotational coupling. In some instances, the stent is at least partially positioned around the positioning member such that the second portion of the positioning member is external to the stent along the proximal portion of the stent and the first portion of the positioning member is internal to the stent along the proximal portion of the stent.

[0007] The method can further include aligning a portion of the external constraining member distal to the puncture site. In some instances, the proximal portion of the stent is aligned 180 degrees from the portion of the external constraining member. In some instances, the portion of the external constraining member comprises an extruded ribbon, one or more wires, splines abutted by one or more laser cuts, or a combination thereof. The method can further include removing the stent delivery system through the puncture site after expanding the stent.

[0008] A system for delivering a stent into a body lumen is described. The system may include a stent, a stent delivery device configured to deliver the stent through a puncture site in a wall of the body lumen, an outer sheath configured to constrain the stent in a collapsed configuration, and a positioning member configured to rotate a proximal portion of the stent away from the puncture site by withdrawing the positioning member proximally and back through the puncture site.

[0009] In some examples, the positioning member includes a first portion that is rotatable relative to a second portion. In some examples, the first portion includes one or more bearings disposed about the second portion. In some examples, the second portion is a tubular member configured to be advanced within the body lumen through the puncture site. The system may further include one or more spacers disposed between the one or more bearings, wherein the one or more spacers are configured to maintain a fixed position relative to the second portion.

[0010] IIn some instances, the stent is positioned to the positioning member such that the first portion of the positioning member is interior of the stent along a distal portion of the stent and the second portion of the positioning member is exterior of the stent along the distal portion of the stent. The system may further include a primary constraining member configured to releasably couple the stent to the positioning member. IIn some instances, the primary constraining member is positioned above the first portion of the positioning member. The first portion and the second portion are coupled by a rotational coupling. IIn some instances, the rotational coupling is positioned at the proximal portion of the stent, wherein the proximal portion of the stent is deployed. IIn some instances, the first portion is a first tubular member and the second portion is a second tubular member, wherein the first tubular member and the second tubular member are configured to be advanced within the body lumen through the puncture site.

[0011] In some examples, the positioning member is positioned between an outer surface of the outer sheath and an inner surface of the outer sheath, wherein the positioning member is configured to rotate the proximal portion of the stent away from the puncture site prior to removal of the outer sheath, such that the proximal portion of the stent covers the puncture site after the outer sheath is withdrawn from the body lumen through the puncture site. In some examples, the positioning member comprises splines abutted by one or more laser cuts. In some examples, the one or more laser cuts are configured to surround the proximal end of the outer sheath. In some examples, the one or more laser cuts comprise a helical arrangement at the distal end of the outer sheath and a longitudinal arrangement at the proximal end of the outer sheath. In some examples, the positioning member comprises an extruded strip along the longitudinal axis of the distal end of the outer sheath. In some examples, the positioning member comprises one or more wires oriented along the longitudinal axis of the outer sheath. In some examples, the proximal portion of the stent is positioned 180 degrees from the positioning member.

[0012] Certain embodiments of the present disclosure may include some, all, or none of the advantages and features described above. One or more additional technical advantages or features will become apparent to those skilled in the art from the drawings, description, and claims included herein. Furthermore, while specific advantages and features have been enumerated above, various embodiments may include all, some, or none of the enumerated advantages or features.

[0013] Further scope of applicability of the described methods and systems will become apparent from the following detailed description, claims, and drawings. The detailed description and specific examples are given by way of illustration only, since various changes and modifications within the spirit and scope of the description will become apparent to those skilled in the art. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In the drawings, similar components or features may have the same reference number. Additionally, components of the same type may be distinguished by following the reference number with a dash and a second reference number that distinguishes the similar components. If only the first reference number is used in the specification, the description applies to any of the similar components having the same first reference number, regardless of the second reference number.

[0015] Figure 1 An exploded view of a system for providing access to a body lumen in accordance with aspects of the present disclosure is presented.

[0016] Figure 2A Stent delivery systems according to aspects of the present disclosure are presented.

[0017] Figure 2B Stent delivery systems according to aspects of the present disclosure are presented.

[0018] Figure 2C Stent delivery systems according to aspects of the present disclosure are presented.

[0019] Figure 2D

[0014] A stent delivery system within a body lumen according to aspects of the present disclosure is presented.

[0020] Figure 2E A stent delivery system is shown with the outer sheath removed in accordance with aspects of the present disclosure.

[0021] Figure 2F A stent delivery system is shown with the flange portion of the stent deployed according to aspects of the present disclosure.

[0022] Figure 2G A delivery system is presented in which a stent is retracted toward a puncture site in accordance with aspects of the present disclosure.

[0023] Figure 2H A stent delivery system is shown with a stent fully deployed according to aspects of the present disclosure.

[0024] Figure 3A A stent delivery system with tethered filaments around the stent according to aspects of the present disclosure is presented.

[0025] Figure 3B A stent delivery system is presented in which a stent is retracted toward a puncture site in accordance with aspects of the present disclosure.

[0026] Figure 3C A stent delivery system is shown with a stent fully deployed according to aspects of the present disclosure.

[0027] Figure 4A A stent delivery system having one or more filaments tethered around a stent according to aspects of the present disclosure is presented.

[0028] Figure 4B A stent delivery system is shown in which a stent is retracted toward a puncture hole according to aspects of the present disclosure.

[0029] Figure 4C A stent delivery system is shown with a stent fully deployed according to aspects of the present disclosure.

[0030] Figure 5A A stent delivery system having a wire frame surrounding the stent according to aspects of the present disclosure is presented.

[0031] Figure 5B A stent delivery system is presented in which a stent is retracted toward a puncture site in accordance with aspects of the present disclosure.

[0032] Figure 5C A stent delivery system is shown with a stent fully deployed according to aspects of the present disclosure.

[0033] Figure 6A A stent delivery system with a splittable sheath according to aspects of the present disclosure is presented.

[0034] Figure 6B A stent delivery system is presented in which a stent is retracted toward a puncture site in accordance with aspects of the present disclosure.

[0035] Figure 6C A stent delivery system is shown with a stent fully deployed according to aspects of the present disclosure.

[0036] Figure 7A A stent delivery system having a coupling ring according to aspects of the present disclosure is presented.

[0037] Figure 7B A stent delivery system is presented in which a stent is retracted toward a puncture site in accordance with aspects of the present disclosure.

[0038] Figure 7C A stent delivery system is shown with a stent fully deployed according to aspects of the present disclosure.

[0039] Figure 8 An exploded view of a system for providing access to a body lumen via an inner pusher is shown in accordance with aspects of the present disclosure.

[0040] Figure 9A A stent delivery system is shown with the outer sheath removed in accordance with aspects of the present disclosure.

[0041] Figure 9B A stent delivery system is presented with a proximal portion of a stent compressed in a body lumen according to aspects of the present disclosure.

[0042] Figure 9C A stent delivery system is shown with a stent fully deployed according to aspects of the present disclosure.

[0043] Figure 10A A stent delivery system having a coupler according to aspects of the present disclosure is presented.

[0044] Figure 10B A stent delivery system is shown with a stent and coupler retracted toward a puncture site according to aspects of the present disclosure.

[0045] Figure 10C A stent delivery system is shown with a stent fully deployed according to aspects of the present disclosure.

[0046] Figure 11 A stent delivery system having a positioning member according to aspects of the present disclosure is presented.

[0047] Figure 12A -C shows a stent delivery system with a stent positioned on a positioning member according to aspects of the present disclosure.

[0048] Figure 13 A stent delivery system having a laser-cut outer sheath according to aspects of the present disclosure is presented.

[0049] Figure 14

[0014] A stent delivery system with a crash extrusion outer sheath according to aspects of the present disclosure is presented.

[0050] Figure 15 A stent delivery system with a wired outer sheath according to aspects of the present disclosure is presented.

[0051] Figure 16 An exploded view of a system for providing access to a body lumen within the pancreatic system is presented in accordance with aspects of the present disclosure.

[0052] Figure 17-19 A flow chart of a method according to aspects of the present disclosure is presented. DETAILED DESCRIPTION

[0053] The present disclosure generally relates to delivering stents in body lumens and covering the puncture site through which the stent is delivered. In certain procedures described herein, in order to place the stent in the body lumen, the lumen wall is punctured, and the stent delivery system is advanced through the hole (i.e., the puncture site or puncture hole) and positioned at the target site (e.g., across an obstruction). The stent is then deployed from the stent delivery system, and the stent delivery system is withdrawn from the lumen through the same hole. If the hole is not covered, the fluid from the lumen may leak into the surrounding tissues and organs, potentially causing severe discomfort or other medical complications.

[0054] In some cases, the proximal portion of the stent can be deployed distally of the puncture. In that case, the delivery system can be retracted, thereby pulling the proximal portion of the stent at least partially above the puncture. The stent can be retracted by pulling the guidewire lumen to cover at least a portion of the puncture. In other examples, the stent can be retracted toward the puncture by pulling a coupling ring attached to the stent. In some cases, the proximal and distal portions of the stent can be constrained to the guidewire lumen by a constraining member. The constraining member can be a filament tied around the stent, a wire wrapped around the stent, a wire frame partially wrapped around the stent, a split sheath, or some combination of these elements. In some examples, the remaining distal portion of the stent can be deployed by pulling the constraining member in the proximal direction to fully expand the stent within the body lumen.

[0055] In some examples, the proximal portion of the stent can be constrained to the guidewire lumen by a constraining member before the proximal portion of the stent is pulled behind the puncture hole. After the proximal portion of the stent at least partially covers the puncture hole, the proximal portion of the stent can be deployed by pulling the constraining member in a proximal direction, thereby releasing the constraining member from around the proximal portion of the stent.

[0056] In other examples, the distal portion of the stent can be deployed distally of the puncture hole. After the stent is placed in the body lumen, the outer sheath can be retracted to deploy the distal portion of the stent in the body lumen. The outer sheath can be retracted toward the puncture hole while the proximal portion of the stent is held within the outer sheath. In order to deploy the proximal portion of the stent in the body lumen, an internal pusher can be advanced through the outer sheath to push the proximal portion of the stent from the outer sheath. In the body lumen, the proximal portion of the stent can be compressed against the deployed distal portion of the stent. In that case, after the proximal portion of the stent has completely exited the outer sheath, the proximal portion of the stent can expand in the proximal direction by rebounding backward. The proximal portion of the stent can at least partially cover the puncture site when expanded in the body lumen.

[0057] In some instances, before the stent is retracted to the puncture hole, the proximal portion of the stent can be repositioned to cover the puncture hole. For example, the proximal portion of the stent can be initially positioned to the puncture site when it is deployed so that the proximal portion can get stuck on the wall or puncture hole of the body lumen when the proximal portion is retracted. In order to prevent this problem, the proximal portion of the stent can be repositioned in the body lumen so that the proximal portion of the stent is rotated away from the puncture hole. The proximal portion of the stent can be rotated away from the puncture hole by attaching the stent to one or more positioning members placed along the guidewire lumen. When the guidewire lumen is retracted to the puncture hole, the positioning member can rotate around the guidewire lumen, thereby rotating the stent attached to the positioning member. In some cases, the fixed portion of the guidewire lumen can be attached to the rotatable portion of the guidewire lumen via a coupler. In that case, the stent can be attached to the rotatable portion of the guidewire lumen so that when the stent is retracted to the puncture hole, the rotatable portion of the guidewire lumen rotates the proximal portion of the stent away from the puncture hole.

[0058] In some cases, the proximal portion of the stent can be repositioned in the body lumen by including one or more positioning members in the outer sheath. For example, the outer sheath can include an extruded strip, one or more wires, or a spline adjacent to one or more laser incisions. The proximal portion of the stent can be positioned 180 degrees with the portion of the outer sheath that includes the positioning members. The hardness of the positioning member can be higher than the portion of the outer sheath that does not have the positioning member. For example, the portion with the positioning member can be aligned to the smaller curvature of the bile duct (for example, the path with the least resistance in the bend will be adopted). If the proximal portion of the stent is positioned relative to the positioning member, the proximal portion of the stent can expand along the outer radius of curvature of the bile duct after the outer sheath is retracted.

[0059] Embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. As used herein, the term "clinician" refers to a physician, surgeon, nurse, or any other care provider and may include support personnel. The term "proximal" will refer to the portion of the device or its components that is closer to the clinician, and the term "distal" will refer to the portion of the device or its components that is farther from the clinician.

[0060] Figure 1 An exploded view of a system 100 for providing access to a body lumen and delivering a stent according to various aspects of the present disclosure is shown. The system 100 generally comprises an outer sheath 105, a lumen member 130, a guidewire lumen 150, a stent 170, and a guidewire 180. The system 100 can be provided as a single component, a selectively combined component, or all provided together as a kit of parts. Before the outer sheath hub 125 abuts the proximal end of the handle assembly, the outer sheath 105 can be inserted into the handle assembly (not shown). Once assembled, the outer sheath 105 extends through the handle assembly to reach the target body lumen.

[0061] For example, during the lumen entry and stent delivery procedure, the outer sheath 105 can enter the target lumen by piercing the lumen wall. In some instances, a sharpening probe can be used in combination with the outer sheath 105 to facilitate piercing the lumen wall. For example, the sharpening probe can be advanced through the outer sheath 105 until the sharpening probe protrudes from the outer sheath 105 and pierces the tissue. Once the outer sheath 105 has entered the lumen, the guidewire 180 can be advanced through the outer sheath 105 and into the lumen. After the guidewire 180 is correctly placed inside the body lumen, the guidewire lumen 150 can be advanced over the guidewire 180 and into the body lumen. The guidewire lumen 150 can be operably coupled to the expandable stent 170. In this way, the guidewire lumen 150 and the stent 170 can be advanced over the guidewire 180 and into the body lumen. The guidewire lumen 150 can be retracted proximally to position the stent 170 to cover the puncture site of the body lumen. As discussed in more detail below, the stent 170 may be attached to the guidewire lumen 150 via a primary constraining member 175 .

[0062] For example, the system 100 can be used to access and provide treatment to one or more body lumens within the gastrointestinal system or the pancreaticobiliary system. It will be appreciated that the system 100 can also be used to provide access to or provide treatment to other organs or luminal systems within the body (e.g., the arterial system, the bronchial system, the urinary system, or any other luminal system) where maneuverability and accuracy are desired.

[0063] In some examples described herein, the handle assembly is coupled to an endoscope, and the outer sheath 105 is guided via endoscopic ultrasound (EUS) to provide access to one or more body lumens or organs associated with the pancreaticobiliary system for the purpose of providing treatment. For example, the system 100 can be configured to provide access to at least the common bile duct to facilitate subsequent procedures to treat stenotic areas or obstructions within the bile duct, including palliative drainage procedures. According to various embodiments, the system 100 can be used to perform an endoscopic ultrasound-guided biliary drainage (EUS-BD) procedure. In particular embodiments, the palliative drainage procedure can be performed in an antegrade manner in conjunction with access to the system 100.

[0064] The outer sheath 105 of the system 100 has an elongated tubular body extending from its proximal end 115 to its distal end 120 and an interior lumen 110. Typically, the outer sheath 105 is configured to enter a body lumen (e.g., by piercing the lumen wall) and provide a conduit through which one or more devices (e.g., a guidewire 180) can be passed to facilitate subsequent treatment of the body lumen or an associated organ. As described with reference to several embodiments, the outer sheath 105 can include features that facilitate the directionally controlled delivery of the guidewire 180 within the body lumen for subsequent delivery of a stent 170, a biopsy device, a drug delivery element, or any number of other therapeutic or diagnostic devices.

[0065] The lumen member 130 is generally an elongated, tubular member having a proximal end 135 and a distal end 140 and is sized to be advanced through the interior lumen 110 of the outer sheath 105. The lumen member 130 may also include a hub 145 coupled to the proximal end 135 of the lumen member 130 to facilitate longitudinal manipulation of the lumen member 130 relative to the outer sheath 105. In certain embodiments, the lumen member 130 includes one or more interior lumens extending from the proximal end 135 to the distal end 140. As described below, the lumen member 130 is configured to accommodate a guidewire lumen 150 and one or more tethers associated with the main constraining member 175. In some cases, the lumen member 130 is configured to accommodate the guidewire lumen 150, and the one or more tethers are positioned between the outer surface of the lumen member 130 and the inner surface of the outer sheath 105.

[0066] The guidewire lumen 150 is generally an elongated, tubular member having a proximal end 155 and a distal end 160, and is sized to be slidably advanced through the interior lumen of the lumen member 130 and positioned over the guidewire 180. The guidewire lumen 150 may also include a hub 165 coupled to the proximal end 155 of the guidewire lumen 150 to facilitate longitudinal or rotational manipulation of the guidewire lumen 150 relative to the outer sheath 105. In certain embodiments, the distal end 160 of the guidewire lumen 150 includes a tip or a raised portion. In some cases, the distal end 160 may include an ablation element coupled to the tip or the raised portion. As described below, the stent 170 may be coupled to the guidewire lumen 150. For example, the stent 170 may be in a side saddle configuration, wherein the guidewire lumen 150 does not extend through the lumen of the stent 170, but rather wherein the guidewire lumen 150 is positioned outside of the stent 170. In some examples, stent 170 can be concentric with guidewire lumen 150. As such, guidewire lumen 150 can extend through the lumen of stent 170. Stent 170 can be coupled to guidewire lumen 150 in a saddle configuration or a combination of concentric configurations (e.g., partially saddle and partially concentric).

[0067] As discussed in more detail below, stent 170 can be releasably coupled to guidewire lumen 150 via primary constraining member 175. In some examples, primary constraining member 175 can be an example of a filament tethered around stent 170, a wire wrapped around stent 170, a wire frame at least partially wrapped around stent 170, a splittable sheath, or a combination thereof.

[0068] The guidewire 180 is generally a flexible, elongated member configured to be slidably advanced through the interior lumen of the guidewire lumen 150. The size and stiffness of the guidewire 180 may be uniform along its entire length, or alternatively it may include sections of varying stiffness.

[0069] Figure 2AA stent delivery system 200 according to various aspects of the present disclosure is shown. The stent delivery system 200 can be configured to place a stent 170-a within a body lumen 205 to restore luminal flow across a stenotic area or obstruction within the body lumen 205. The stent delivery system 200 can be sized or otherwise adapted to place the stent 170-a within any body lumen 205, such as those associated with the pancreaticobiliary system, the arterial system, the bronchial system, the urinary system, or any other luminal system that may require stent therapy. The stent delivery system 200 can generally include an outer sheath 105, a guidewire lumen 150, and a guidewire 180, which can be a reference to a device that is configured to deliver a stent 170-a to a patient. Figure 1 Examples of corresponding components are described. The guidewire 180 can be part of the stent delivery system 200 or can be a separate component. The stent delivery system 200 can be provided as separate components, selectively combined components, or all together as a kit of parts.

[0070] The guidewire lumen 150 can be a tubular structure that is sized to deploy the stent 170-a within the body lumen 205. The guidewire lumen 150 can be passed through a working channel of an endoscope and into the body, for example, as shown in FIG. Figure 1 As will be appreciated, the guidewire lumen 150 can be made from any number of biocompatible materials or combinations of materials suitable for medical sheaths, catheters, and the like.

[0071] Typically, the stent 170-a is a frame or scaffolding structure sized to be placed within a body lumen 205 and configured to provide structural support to the inner surface of the body lumen 205. The stent 170-a can be used to restore patency across a stenotic or obstructed area within the body lumen 205 due to inflammation, tumors, plaque accumulation, or any other obstructive feature. Although reference is made herein to the pancreaticobiliary system, it should be understood that the stents described herein can be used in any body lumen 205. In addition, as discussed in more detail below, the stent 170-a can be positioned around the guidewire lumen 150. In this way, the stent 170-a can be positioned above the puncture site 210 by retracting the guidewire lumen 150.

[0072] Stent 170-a can be made from any number of materials, combinations of materials, and configurations. In some instances, stent 170-a is a self-expanding stent. Stent 170-a can be a braided stent made from multiple wires joined together in a cross-hatched configuration. However, it should be understood that stent 170-a can be made from other stent configurations or combinations of stent configurations. In other instances, stent 170-a is a laser-cut stent formed from a single metal tube with areas cut away to increase flexibility. In still other instances, stent 170-a is a wire-shaped stent formed from one or more helically wound wires. It will be understood that different stent configurations can exhibit specific properties that can impart certain properties to a certain configuration that are advantageous for a particular application, such as radial expansion force, flexibility, reduced anterior shrinkage, or resistance to migration.

[0073] The individual wires or frames of stent 170-a can be made of any number of metallic materials, including but not limited to titanium, nitinol, or stainless steel. It should be understood that other metallic materials or non-metallic materials can be used to construct stent 170-a that provide suitable flexibility, rigidity, and biocompatibility. Stent 170-a can include a polymer or fabric sleeve covering some or all of the surfaces of stent 170-a. Such a sleeve can protect the inner surface of the body lumen 205 from damage by the bare metal of stent 170-a and can prevent tissue ingrowth. In some instances, stent 170-a is a drug eluting stent.

[0074] Still refer to Figure 2A To place the stent delivery system 200 within the body lumen 205, a puncture site 210 is formed through the wall 215 of the body lumen 205, and the guidewire 180 is then advanced through the puncture site 210 and into the body lumen 205. Once the guidewire 180 is in place, the guidewire lumen 150 is advanced distally (as indicated by arrow 220), over the guidewire 180, through the puncture site 210, and into the body lumen 205.

[0075] In some cases, stent 170-a can be partially positioned around guidewire lumen 150. For example, guidewire lumen 150 can be external to stent 170-a along a proximal portion 230 of stent 170-a, and guidewire lumen 150 can be internal to stent 170-a along a distal portion 235 of stent 170-a. This configuration can be referred to as a partial side saddle configuration.

[0076] Figure 2B A stent delivery system 200 according to various aspects of the present disclosure is shown. The stent delivery system 200 can be configured to place a stent 170-b within a body lumen 205 to restore luminal flow across a stenotic area or obstruction within the body lumen 205 and can generally include reference Figure 2AParts described.

[0077] exist Figure 2B In the illustrated example, the stent 170-b can be positioned completely around the guidewire lumen 150. For example, the stent 170-b can be positioned completely around the guidewire lumen 150 such that the guidewire lumen 150 is external to the stent 170-b along the proximal portion 230 and the distal portion 235 of the stent 170-b. This configuration can be referred to as a full side saddle configuration, in which the guidewire lumen 150 does not extend through the lumen of the stent 170-b.

[0078] Figure 2C A stent delivery system 200 according to aspects of the present disclosure is shown. The stent delivery system 200 can be configured to place a stent 170-c within a body lumen 205 to restore luminal flow across a stenotic area or obstruction within the body lumen 205 and can generally include reference Figure 2A Parts described.

[0079] exist Figure 2C In the illustrated example, the stent 170-c can be positioned completely around the guidewire lumen 150. In that case, the guidewire lumen 150 can be within the interior of the stent 170-c along the proximal portion 230 and distal portion 235 of the stent 170-c. This configuration can be referred to as a concentric configuration, in which the stent 170-c can be concentric with the guidewire lumen 150 and extend through the lumen of the stent 170-c.

[0080] Figure 2D Shown is a stent delivery system 200 located within a body lumen 205 according to various aspects of the present disclosure. Once located in the body lumen 205, the outer sheath 105, guidewire lumen 150, and lumen member (not shown) can be advanced distally, as indicated by arrow 225. For example, the outer sheath 105 can be advanced distally by pushing the outer sheath hub 125 in a distal direction, and the guidewire lumen 150 can be advanced distally by pushing the hub 165 in a distal direction. In some cases, the outer sheath 105 and guidewire lumen 150 can be advanced distally so that the outer sheath 105 and guidewire lumen 150 extend through the nipple and into the duodenum. The outer sheath 105 can be placed around the guidewire lumen 150. In this way, a stent 170-a can be placed between the inner surface of the guidewire lumen 150 and the outer sheath 105. In some cases, the puncture site 210 may not be covered by the stent 170-a.

[0081] Figure 2EThe stent delivery system 200 is shown with the outer sheath 105 removed, in accordance with various aspects of the present disclosure. As the outer sheath 105 is withdrawn proximally (as indicated by arrow 240), the luminal member (not shown) can remain stationary and the stent 170-a can be exposed within the body lumen 205. The outer sheath 105 can be withdrawn proximally by pulling the outer sheath hub 125 in a proximal direction. In some instances, if repositioning is desired, the outer sheath 105 can be re-advanced distally to cover the stent 170-a. Once the stent 170-a has reached the desired anatomical position within the body lumen 205, the outer sheath 105 can be retracted.

[0082] As discussed in more detail below, stent 170-a can be releasably coupled to guidewire lumen 150 via a primary constraining member 175. In some examples described in more detail below, primary constraining member 175 can be an example of a filament tethered around stent 170-a, a wire wrapped around stent 170-a, a wire frame at least partially wrapped around stent 170-a, a splittable sheath, or a combination thereof.

[0083] Figure 2F The stent delivery system 200 is shown with the flange portion 245 of the stent 170-a deployed, according to aspects of the present disclosure. When the outer sheath 105 is withdrawn proximally (as indicated by arrow 240), the stent 170-a can be exposed within the body lumen 205. In some cases, the stent 170-a can be advanced such that at least a portion of the stent 170-a extends through the papilla and into the duodenum. When the outer sheath 105 is removed through the puncture site 210, the distal portion 235 of the stent 170-a expands to expose the flange portion 245.

[0084] When the stent 170-a is pulled in the proximal direction, the flange portion 245 of the stent 170-a contacts the nipple. In that case, the flange portion 245 prevents the stent 170-a from further retracting in the proximal direction. The clinician may be able to feel the resistance of the flange portion 245 against the nipple and, therefore, may infer the position of the stent 170-a. Additionally or alternatively, the flange portion 245 may be observed to collapse when pulled against the nipple under fluoroscopy or similar imaging techniques, thereby inferring the position of the stent 170-a. In some cases, the stent 170-a may be repositioned within the body lumen 205 based on a distance measurement determined by pulling the stent 170-a until the flange portion 245 contacts the nipple. For example, if the flange portion 245 of the stent 170-a contacts the nipple and the measured distance indicates that the puncture site 210 may be exposed to the body lumen 205 without the stent 170-a covering the puncture site 210, the stent 170-a may be repositioned. The measured distance may include the measured distance between the proximal portion 230 of the stent 170-a and the puncture site 210.

[0085] Figure 2G 1. The stent delivery system 200 is shown with a stent 170-a retracted toward a puncture site 210 according to aspects of the present disclosure. Once the outer sheath 105 has been removed through the puncture site 210, the stent 170-a can be pulled in a proximal direction toward the puncture site 210, as indicated by arrow 250. For example, the stent 170-a can be pulled toward the puncture site 210 until the proximal portion 230 of the stent 170-a at least partially covers the puncture site 210. As discussed in more detail below, the stent 170-a can be retracted toward the puncture site 210 by pulling the guidewire lumen 150 in a proximal direction. For example, the stent 170-a can be pulled toward the puncture site 210 by pulling the hub 165 of the guidewire lumen 150 in a proximal direction. In some cases, stent 170-a can be pulled toward puncture site 210 by pulling hub 165 of guidewire lumen 150, lumen members, and outer sheath hub 125 of outer sheath 105. Additionally, stent 170-a can be repositioned within body lumen 205 to at least partially cover puncture site 210.

[0086] Figure 2HA stent delivery system 200 is shown with a stent 170-a fully deployed according to aspects of the present disclosure. To deploy the stent 170-a within a body lumen 205, the primary constraining member can be released. As discussed in more detail below, the stent 170-a can be deployed by pulling the primary constraining member in a proximal direction, pulling one or more tethers coupled to the primary constraining member, or both. In the case of a self-expanding stent, the stent 170-a expands to contact the inner surface of the body lumen 205. Once the stent 170-a is expanded within the body lumen 205, the guidewire lumen 150 and guidewire 180 are withdrawn through the puncture site 210. In some cases, the guidewire lumen 150 and guidewire 180 can extend through a hole in the wall of the stent 170-a. In such cases, the guidewire lumen 150 and guidewire 180 can be withdrawn through the hole in the wall of the stent 170-a.

[0087] Figure 3A A stent delivery system 300 is shown with a filament tied around a stent 170-a according to various aspects of the present disclosure. When the outer sheath 105 is removed from the puncture site 210, the stent 170-a can be exposed within the body lumen 205. For example, the outer sheath 105 can be removed from the puncture site 210 by withdrawing the outer sheath 105 through the outer sheath hub 125. In some cases, the stent 170-a can be partially positioned around the guidewire lumen 150. This configuration can be referred to as a partial side saddle configuration.

[0088] The stent 170-a can be releasably coupled to the guidewire lumen 150 by the main constraining member 305. In some instances, the main constraining member 305 can be an example of a filament tied around the stent 170-a. For example, the main constraining member 305 can include a single wrap tied around the stent 170-a at the proximal portion 230. The tether 310 can be attached to the main constraining member 305 and extend through the puncture site 210. In some cases, the tether 310 can be an extension of the main constraining member 305 (e.g., comprising the same material as the main constraining member 305 and seamlessly connected to the main constraining member 305). In other instances, the tether 310 can be attached to the main constraining member 305.

[0089] The primary constraining member 305 can be knotted around the proximal portion 230 of the stent 170-a at various distances from the proximal end of the stent 170-a. For example, the distance between the knot of the primary constraining member 305 and the proximal end of the stent 170-a can be in the range of 0 to 40 mm. In some examples, the distance between the knot of the primary constraining member 305 and the proximal end of the stent 170-a can be in the range of 15 to 30 mm. The distance between the knot of the primary constraining member 305 and the distal end of the lumen member 130 can be in the range of 0 to 40 mm. In some examples, the distance between the knot of the primary constraining member 305 and the distal end of the lumen member 130 can be in the range of 20 to 30 mm.

[0090] In some cases, the guidewire lumen 150 can be located outside of the stent 170-a along the proximal portion 230 of the stent 170-a (e.g., proximal to the knot), and the guidewire lumen 150 can be located inside the stent 170-a along the distal portion 235 of the stent 170-a (e.g., distal to the knot). That is, the stent 170-a can be positioned on the guidewire lumen 150 in a partial side saddle configuration. In some cases, the knot can be positioned along the proximal portion 230 of the stent 170-a or along the distal portion 235 of the stent 170-a. In some cases, once the outer sheath 105 is proximally withdrawn to expose the stent 170-a, the proximal portion 230 of the stent 170-a can be expanded. That is, the proximal portion 230 of the stent 170-a can be free from the primary constraining member 305. In such cases, the expanded state of the proximal portion 230 of the stent 170-a can be referred to as a cuff.

[0091] The primary constraining member 305 can be knotted around the stent 170-a and the guidewire lumen 150 so that the primary constraining member 305 is releasable when pulled in the proximal direction. For example, the primary constraining member 305 can include a loop anchored to the guidewire lumen 150 so that the tension of the primary constraining member 305 is directed along the longitudinal axis of the stent 170-a. Once the primary constraining member 305 is knotted, the primary constraining member 305 can be routed proximally into the first lumen of the lumen member 130. In some cases, the guidewire lumen 150 can be routed through the second lumen of the lumen member 130.

[0092] The main restraining member 305 can be made of a single filament material or a multi-filament material. Exemplary materials of the main restraining member 305 include, but are not limited to, polyamide, polyester, polypropylene, polyvinylidene fluoride, or derivatives thereof. The outer diameter of the filament material can be in the range of 0.05 to 0.025 inches. In some instances, the outer diameter of the filament material is in the range of 0.012 to 0.020 inches. The tensile strength of the main restraining member 305 (e.g., tether 310) can be greater than 8 pounds of force. In some instances, the tensile strength of the main restraining member 305 (e.g., tether 310) can be greater than 10 pounds of force.

[0093] In some instances, the primary constraining member 305 can include a wire wrapped around the stent 170-a. For example, the primary constraining member 305 can be a nitinol or other superelastic wire filament. In this case, the single filament can be a single filament wrap or a double filament wrap for constraining the stent 170-a to the guidewire lumen 150 at a center point. The diameter of the nitinol filament can be in the range of 0.0050 to 0.020 inches. In some instances, the diameter of the nitinol filament can be in the range of 0.0070 to 0.014 inches. The nitinol filament can be coated with a lubricating material such as polytetrafluoroethylene (PTFE), parylene-N, or MDX silicon.

[0094] Figure 3B A stent delivery system 300 is shown with a stent 170-a retracted toward a puncture site 210 according to aspects of the present disclosure. Once the outer sheath 105 has been removed through the puncture site 210, the stent 170-a can be pulled proximally toward the puncture site 210, as indicated by arrow 250. For example, the stent 170-a can be pulled toward the puncture site 210 until the proximal portion 230 of the stent 170-a at least partially covers the puncture site 210. The proximal portion 230 of the stent 170-a can be tied so that the primary restraining member 305 prevents the proximal portion 230 from becoming caught on the wall 215 of the body lumen when the stent 170-a is retracted. The stent 170-a can be retracted toward the puncture site 210 by pulling the guidewire lumen 150 proximally. For example, the stent 170-a can be retracted by pulling the hub 165 of the guidewire lumen 150. As discussed in more detail below, the stent 170 - a may be repositioned within the body lumen 205 to at least partially cover the puncture site 210 .

[0095] Figure 3CA stent delivery system 300 is shown with a stent 170-a fully deployed according to aspects of the present disclosure. To deploy the stent 170-a within the body lumen 205, the primary constraining member can be released. The stent 170-a can be deployed by pulling the primary constraining member in a proximal direction. For example, the stent 170-a can be deployed by pulling a tether coupled to the primary constraining member. In that case, the knot can be untied to deploy the stent 170-a. In some cases, the tension of the primary constraining member can be directed along the longitudinal axis of the stent 170-a so that the loop anchored to the guidewire lumen 150 can be loosened. In the case of a self-expanding stent, the stent 170-a expands to contact the inner surface of the body lumen 205. Once the stent 170-a is expanded within the body lumen 205, the guidewire lumen 150, guidewire 180, primary constraining member, and tether are withdrawn through the puncture site 210.

[0096] Figure 4A A stent delivery system 400 is shown with one or more knots tied around a stent 170-a according to aspects of the present disclosure. When the outer sheath 105 is removed from the puncture site 210, the stent 170-a can be exposed within the body lumen 205. The stent 170-a can be positioned around the guidewire lumen 150 in a partial side saddle configuration.

[0097] The stent 170-a can be releasably coupled to the guidewire lumen 150 by a primary constraining member 405. In some instances, the primary constraining member 405 can be an example of one or more knots tied around the stent 170-a. For example, the primary constraining member 405 can include one or more wraps tied around the stent 170-a at spaced intervals along the distal portion 235 of the stent 170-a. In that case, the stent 170-a can be constrained to the guidewire lumen 150 by a series of peripheral wraps, wraps, suture knots, or a combination thereof. In other instances, the primary constraining member 405 can include one or more wraps tied around the stent 170-a at spaced intervals from the distal portion 235 to the proximal portion 230 of the stent 170-a.

[0098] In some examples, the primary constraining member 405 can include a filament wrap wrapped around the proximal portion 230 of the stent 170-a. The filament wrap can be an example of a single wrap, a wrap, or a suture knot. In that case, the proximal portion 230 of the stent 170-a can be tied so that the primary constraining member 405 prevents the proximal portion 230 from getting stuck on the wall 215 of the body lumen 205 when the stent 170-a is retracted. In some cases, once the outer sheath 105 is withdrawn proximally to expose the stent 170-a, the proximal portion 230 of the stent 170-a can be expanded. That is, the proximal portion 230 of the stent 170-a can be freed from the primary constraining member 405.

[0099] The main restraining member 405 can be tied at intervals around the support 170-a and the guidewire lumen 150 so that the main restraining member 405 is releasable when pulled in the proximal direction. For example, the main restraining member 405 can comprise a tension force that is anchored to the guidewire lumen 150 so that one or more rings along the longitudinal axis of the support 170-a guide the main restraining member 405. In that case, the main restraining member 405 can comprise other suture rings, plastics or metal parts for generating a central pulling point. The central pulling point can be anchored to the guidewire lumen 150 at a position between one or more knots along the distal portion 235 of the support 170-a and a single wrapper that is in the proximal portion 230 of the support 170-a.

[0100] The primary restraining member 405 may be made of a monofilament material or a multifilament material. Exemplary materials for the primary restraining member 405 include, but are not limited to, polyamide, polyester, polypropylene, polyvinylidene fluoride, or derivatives thereof.

[0101] Tether 410 can be attached to primary constraining member 405 and extend through puncture site 210. In some instances, tether 410 can be an extension of primary constraining member 405 (e.g., comprising the same material as primary constraining member 405 and seamlessly connected to primary constraining member 405). In other instances, tether 410 can be attached to primary constraining member 405. In some instances, one or more tethers 410 can be attached to primary constraining member 405. For example, a first tether can be coupled to distal portion 235 of stent 170-a, and a second tether can be coupled to proximal portion 230 of stent 170-a. As discussed in more detail below, the first and second tethers can be pulled separately to release proximal portion 230 and distal portion 235 of stent 170-a at different times.

[0102] Stent delivery system 400 can include proximal markers 415 and distal markers 420. Proximal markers 415 and distal markers 420 can be positioned around guidewire lumen 150. For example, proximal marker 415 can be positioned at the proximal edge of stent 170-a, and distal marker 420 can be positioned at the distal edge of stent 170-a. Prior to deploying stent 170-a, proximal markers 415 and distal markers 420 can assist a clinician in stent placement under fluoroscopy.

[0103] The stent delivery system 400 can include a stent anchor 425. In a constrained state (e.g., before the outer sheath 105 is removed), the distal portion 235 of the stent 170-a can be constrained between the stent anchor 425 and the outer sheath 105. In some cases, the stent anchor 425 can route the tether 410 along the distal portion 235 of the stent 170-a. The stent anchor 425 can include a compressible polymer material configured to adhesively bond to the guidewire lumen 150. In some cases, the stent anchor 425 can be configured to provide a pulling center angle for the tether 410. In other examples, the stent anchor 425 can be a strip of the stent 170-a when the tether 410 is pulled in the proximal direction.

[0104] Once the primary constraining member 405 is tied, it can be routed proximally into the first lumen of the lumen member 130. In some cases, the guidewire lumen 150 can be routed through the second lumen of the lumen member 130. In some instances, the multi-lumen member can comprise a three-lumen extrusion. In that case, one or more filaments of the primary constraining member 405 can be routed through the first and third lumens of the lumen member 130. For example, the first filament of the primary constraining member 405 can be tied around the proximal portion 230 (e.g., the proximal cuff portion) of the stent 170-a and routed through the first lumen of the lumen member 130, and the second filament of the primary constraining member 405 can be tied around the distal portion 235 (e.g., the distal protective sheath portion) of the stent 170-a and routed through the third lumen of the multi-lumen member.

[0105] Figure 4B A stent delivery system 400 is shown with a stent 170-a retracted toward a puncture site 210 according to aspects of the present disclosure. Once the outer sheath 105 has been removed through the puncture site 210, the stent 170-a can be pulled in a proximal direction toward the puncture site 210, as indicated by arrow 250. For example, the stent 170-a can be pulled toward the puncture site 210 until the proximal portion 230 of the stent 170-a at least partially covers the puncture site 210. The stent 170-a can be retracted toward the puncture site 210 by pulling the guidewire lumen 150 in a proximal direction. For example, the stent 170-a can be pulled toward the puncture site 210 by pulling the hub 165 of the guidewire lumen 150. The proximal portion 230 of the stent 170-a can be tied so that the primary restraining member 1250 prevents the proximal portion 230 from becoming caught on the wall 215 of the body lumen when the stent 170-a is retracted.

[0106] In some cases, the proximal portion 230 of the stent 170-a can be deployed before the stent 170-a is retracted toward the puncture site 210. For example, one or more tethers 410 can be coupled to the primary constraining member 405. For example, a first tether 410 can be coupled to the proximal portion 230 of the stent 170-a. In that case, the proximal portion 230 of the stent 170-a can be deployed by pulling the first tether 410 in a proximal direction. The stent 170-a can then be retracted toward the puncture site 210 by pulling the guidewire lumen 150 in a proximal direction. In addition, the stent 170-a can be repositioned within the body lumen 205 to at least partially cover the puncture site 210.

[0107] Figure 4C A stent delivery system 400 is shown with a stent 170-a fully deployed according to aspects of the present disclosure. To deploy the stent 170-a within the body lumen 205, the primary constraining member can be released. The stent 170-a can be deployed by pulling the primary constraining member in a proximal direction. For example, the stent 170-a can be deployed by pulling one or more tethers coupled to the primary constraining member in a proximal direction. In that case, one or more knots can be untied to deploy the stent 170-a. For example, a first tether can be coupled to the proximal portion 230 of the stent 170-a and configured to deploy the proximal portion 230 of the stent 170-a. In other examples, a second tether can be coupled to the distal portion 235 of the stent 170-a. In that case, the distal portion 235 of the stent 170-a can be deployed by pulling the second tether in a proximal direction.

[0108] In some cases, the tension of the primary constraining member can be directed along the longitudinal axis of stent 170-a so that one or more rings anchored to guidewire lumen 150 can be loosened. In the case of a self-expanding stent, stent 170-a expands to contact the inner surface of body lumen 205. Once stent 170-a is expanded within body lumen 205, guidewire lumen 150, guidewire 180, primary constraining member, and one or more tethers are withdrawn through puncture site 210.

[0109] Figure 5A A stent delivery system 500 is shown with a wire frame around a stent 170-a according to aspects of the present disclosure. When the outer sheath 105 is removed from the puncture site 210, the stent 170-a can be exposed within the body lumen 205. The stent 170-a can be positioned around the guidewire lumen 150 in a partial side saddle configuration.

[0110] The stent 170-a can be releasably coupled to the guidewire lumen 150 by a primary constraining member 505. In some instances, the primary constraining member 505 can be an example of a wire frame around the stent 170-a. The primary constraining member 505 can be at least partially wrapped around the stent 170-a. For example, the primary constraining member 505 can be formed by heat-setting a nitinol wire around a mandrel to form a series of S-shaped rings or C-shaped rings. The nitinol wire can be coated with a lubricating material (such as PTF, parylene-N, or silicone) to reduce the stent deployment force.

[0111] In some cases, the width of a single S-ring or C-ring can be in the range of 0.0050 to 0.0400 inches. In some instances, the width of a single S-ring or C-ring can be in the range of 0.0100 to 0.0175 inches. The outer diameter of the primary constraining member 505 can be in the range of 0.004 to 0.015 inches. In some instances, the outer diameter of the primary constraining member 505 can be in the range of 0.007 to 0.010 inches.

[0112] The primary constraining member 505 can extend from the distal portion 235 of the stent 170-a to the proximal portion 230 of the stent 170-a and be parallel to the longitudinal axis of the guidewire lumen 150. For example, the primary constraining member 505 can be formed by wrapping an S-shaped ring or a C-shaped ring around the distal portion 235 of the stent 170-a. A continuous S-shaped ring or C-shaped ring can be wrapped from the distal portion 235 to the proximal portion 230 of the stent 170-a.

[0113] The tether 510 can be attached to the primary restraint member 505 and extend through the puncture site 210. In some cases, the tether 510 can be an extension of the primary restraint member 505 (e.g., comprising the same material as the primary restraint member 505 and seamlessly connected to the primary restraint member 505). For example, the tether 510 can be a longitudinal wire comprising nitinol. In other examples, the tether 510 can be attached to the primary restraint member 505. For example, the tether 510 can be attached to the distal end of the primary restraint member 505 and extend in a proximal direction from the distal end of the primary restraint member 505 and into the outer sheath 105.

[0114] In some cases, the primary constraining member 505 can be routed proximally into the first lumen of the lumen member 130. In some cases, the guidewire lumen 150 can be routed through the second lumen of the lumen member 130. In some instances, the lumen member 130 can include a grooved first lumen. In that case, the first lumen can be open toward the outer surface of the lumen member 130 to reduce friction when the tether 510 is retracted to deploy the stent 170-a.

[0115] Figure 5BA stent delivery system 500 is shown with a stent 170-a retracted toward a puncture site 210 according to aspects of the present disclosure. Once the outer sheath 105 has been removed through the puncture site 210, the stent 170-a can be pulled in a proximal direction toward the puncture site 210, as indicated by arrow 250. For example, the stent 170-a can be pulled toward the puncture site 210 until the proximal portion 230 of the stent 170-a at least partially covers the puncture site 210. The stent 170-a can be retracted toward the puncture site 210 by pulling the guidewire lumen 150 in a proximal direction. For example, the stent 170-a can be retracted toward the puncture site 210 by pulling the hub 165 of the guidewire lumen 150. Furthermore, the stent 170-a can be repositioned within the body lumen 205 to at least partially cover the puncture site 210.

[0116] Figure 5C A stent delivery system 500 is shown with a stent 170-a fully deployed according to aspects of the present disclosure. To deploy the stent 170-a within the body lumen 205, the primary constraining member can be released. The stent 170-a can be deployed by pulling the primary constraining member in a proximal direction. For example, the stent 170-a can be deployed by pulling a tether coupled to the primary constraining member. The tether attached to the distal end of the primary constraining member can be configured to deploy the stent 170-a from a distal direction to a proximal direction. For example, this deployment mechanism can allow a clinician to stop distal stent deployment and reposition the stent 170-a relative to the puncture site 210.

[0117] In some cases, the primary constraining member can be configured to deploy stent 170-a from a proximal to a distal direction. In that case, the proximal portion of the primary constraining member can extend into outer sheath 105. That is, after outer sheath 105 is retracted in the proximal direction, the proximal end of the primary constraining member can be unwound. In other examples, a tether can be attached and extend from a proximal loop of the primary constraining member. In that case, when the tether is pulled in the proximal direction, the proximal portion of the primary constraining member unwinds to release stent 170-a from the proximal direction to the distal direction.

[0118] In the case of a self-expanding stent, stent 170-a expands to contact the inner surface of body lumen 205. Once stent 170-a is expanded within body lumen 205, guidewire lumen 150, guidewire 180, primary constraining member, and tether are withdrawn through puncture site 210.

[0119] Figure 6AA stent delivery system 600 with a splittable sheath according to various aspects of the present disclosure is shown. When the outer sheath 105 is removed from the puncture site 210, the stent 170-a can be enclosed within the body lumen 205. In some cases, the stent 170-b can be partially positioned around the guidewire lumen 150 so that the guidewire lumen 150 is outside the stent 170-b along the proximal portion 230 and distal portion 235 of the stent 170-b, which can be referred to as a side saddle configuration. That is, in the side saddle configuration, the guidewire lumen 150 does not extend through the lumen of the stent 170-b. In some cases, the guidewire lumen 150 can include a distal tip 605.

[0120] The stent 170-b can be releasably coupled to the guidewire lumen 150 by a primary constraining member. In some instances, the primary constraining member can be an instance of a split sheath 610. The split sheath 610 can refer to a partially tubular portion between the inner surface of the outer sheath 105 and the outer surface of the stent 170-b. That is, the split sheath 610 itself may not be completely tubular. In some cases, the split sheath 610 can be hard enough to resist the radial expansion force of the stent 170-b within the split sheath 610. The split sheath 610 can be made of a variety of materials such as thermoplastic elastomers. Exemplary thermoplastic elastomer materials include, but are not limited to, polyether block amide (PEBA). For example, the split sheath 610 can include a copolymer material having thermoplastic characteristics and elastomeric characteristics.

[0121] Split sheath 610 may include longitudinal elements 615. Longitudinal elements 615 may be oriented along the longitudinal axis of the tubular body of split sheath 610. Longitudinal elements 615 may be adhered to split sheath 610 to form the tubular body of split sheath 610. Longitudinal elements 615 may be made from a variety of materials, such as polymers. Exemplary polymer-based materials include, but are not limited to, high-density polyethylene (HDPE). For example, longitudinal elements 615 may be composed of a material characterized by unbranched, linear polyethylene polymer chains. In that case, split sheath 610 may be made from various materials, such as thermoplastic elastomers. Exemplary thermoplastic elastomer materials include, but are not limited to, polyether block amide (PEBA). For example, split sheath 610 may include a copolymer material having both thermoplastic and elastomeric characteristics. In some examples, longitudinal elements 615 may be perforations along the longitudinal axis of split sheath 610. In other examples, longitudinal elements 615 may be ropes or wires.

[0122] To prevent the splittable sheath 610 from prematurely splitting, the distal end of the splittable sheath 610 can include a braided reinforcement heat-fused around the splittable sheath 610. For example, the braided reinforcement can be coupled to a portion of the splittable sheath 610, and the braided reinforcement can include a partial tubular body having a channel aligned with the longitudinal elements 615. The braided reinforcement can be made of a braided frame structure. For example, the braided reinforcement can be made of a braided tube having a channel cut along its longitudinal direction. In some examples, the braided reinforcement can be made of multiple wires joined together in a cross-hatched configuration.

[0123] In some cases, the proximal portion 230 of the stent 170-b can be deployed before the distal tip 605 is retracted. In some instances, the outer sheath 105 can be positioned at the proximal end of the stent delivery system 600. The splittable sheath 610 can include an open pocket 620 (e.g., a slit) at the proximal end of the splittable sheath 610 where the stent 170-b can be partially deployed. For example, the open pocket 620 can be configured to accommodate the stent 170-b when the outer sheath 105 is positioned at the proximal end of the stent delivery system 600 and to deploy the stent 170-a when the outer sheath 105 is pulled from the proximal end of the stent delivery system 600 and through the puncture site 210.

[0124] Figure 6B The stent delivery system 600 is shown with the stent 170-b retracted toward the puncture site 210 according to aspects of the present disclosure. Once the outer sheath 105 has been removed through the puncture site 210, the stent 170-b can be pulled in a proximal direction toward the puncture site 210, as indicated by arrow 250. For example, the stent 170-b can be pulled toward the puncture site 210 until the proximal portion 230 of the stent 170-b at least partially covers the puncture site 210. The stent 170-b can be retracted toward the puncture site 210 by pulling the splittable sheath 610 in a proximal direction, as indicated by arrow 250. Additionally, the stent 170-a can be repositioned within the body lumen 205 to at least partially cover the puncture site 210.

[0125] To fully deploy stent 170-b, distal tip 605 of guidewire lumen 150 can be configured to facilitate tearing of splittable sheath 610 along longitudinal elements 615. For example, the outer diameter of distal tip 605 can be larger than the inner diameter of splittable sheath 610. Thus, as distal tip 605 is pulled proximally through splittable sheath 610, distal tip 605 can stretch splittable sheath 610 and cause it to tear along longitudinal elements 615. When splittable sheath 610 tears, stent 170-b can begin to deploy from splittable sheath 610 and into body lumen 205. Because stent 170-b is positioned in a side-saddle configuration between the inner surface of splittable sheath 610 and guidewire lumen 150, stent 170-b is pushed from the distal end of splittable sheath 610 as distal tip 605 is withdrawn proximally.

[0126] When the outer sheath 105 is retracted in the proximal direction, the proximal portion 230 of the stent 170-a can be deployed through the open pocket 620 of the splittable sheath 610. That is, the stent 170-b can cover at least a portion of the puncture site 210 in the body lumen 205. To provide support for the open pocket 620, the open pocket 620 of the splittable sheath 610 can be reinforced with one or more axial wires. For example, the one or more axial wires can be positioned within the splittable sheath 610 and oriented 180 degrees relative to the open pocket 620. The one or more axial wires can be made of any number of metallic materials, including, but not limited to, nitinol or stainless steel.

[0127] Figure 6C A stent delivery system 600 is shown with a stent 170-b fully deployed according to various aspects of the present disclosure. To deploy the stent 170-b within a body lumen 205, the primary constraining member can release the stent 170-b from the constrained configuration. The stent 170-b can be deployed by withdrawing the distal tip of the guidewire lumen 150 in a proximal direction. In that case, the distal tip can tear the primary constraining member along the longitudinal elements, thereby deploying the stent 170-b within the body lumen 205. Once the stent 170-b is expanded within the body lumen 205, the guidewire lumen 150, the guidewire 180, and the primary constraining member are withdrawn through the puncture site 210. In the case of a self-expanding stent, the stent 170-b expands to contact the inner surface of the body lumen 205.

[0128] Figure 7AA stent delivery system 700 having a coupling ring 705 according to aspects of the present disclosure is shown. When the outer sheath 105 is removed from the puncture site 210, the stent 170-a can be exposed within the body lumen 205. The stent 170-a can be positioned around the guidewire lumen 150 in a partial side saddle configuration. In some cases, the stent 170 can be positioned around the guidewire lumen 150 in a concentric configuration. To deploy the stent 170-a within the body lumen 205, the outer sheath 105 can be removed. In the case of a self-expanding stent, the stent 170-a expands to contact the inner surface of the body lumen 205.

[0129] Stent delivery system 700 may include a coupling ring 705. Coupling ring 705 may be releasably coupled to stent 170-a. In some cases, coupling ring 705 may comprise an eyelet or ring that is attached to stent 170-a. Coupling ring 705 may be circular or oval. In some instances, coupling ring 705 may comprise a stainless steel material that can be welded between the filaments of stent 170-a. For example, coupling ring 705 may be attached to the struts or braided wires of stent 170-a. In some instances, coupling ring 705 may be shaped as a split ring. In such cases, a "split ring" may be attached to coupling ring 705 welded to stent 170-a. The split ring may be configured so that the ends of the split ring can be split and detached from coupling ring 705. Coupling ring 705 may be attached to stent 170-a at a distance of one-quarter or one-third of the length of stent 170-a from the proximal end of proximal portion 230.

[0130] The stent delivery system 700 may also include a tether 710. The tether 710 may be coupled to the coupling ring 705. In the case of a split ring, the tether 710 may be laser welded to the split ring. In some instances, the tether 710 may be inserted through an eyelet of the coupling ring 705 and extended proximally through the outer sheath 105. In some instances, the tether 710 may be routed proximally into the first lumen of the lumen member 130. In some instances, the guidewire lumen 150 may be routed through the second lumen of the lumen member 130.

[0131] Figure 7B The stent delivery system 700 according to aspects of the present disclosure is shown with the stent 170-a retracted toward the puncture site 210. Once the outer sheath 105 is removed through the puncture site 210, the guidewire lumen 150 can be removed through the puncture site 210, and the stent 170-a can be pulled in a proximal direction toward the puncture site 210, as indicated by arrow 250. For example, the stent 170-a can be pulled toward the puncture site 210 until the proximal portion 230 of the stent 170-a at least partially covers the puncture site 210.

[0132] Stent 170-a can be retracted toward puncture site 210 by pulling tether 710 in a proximal direction. Once a predetermined force is exceeded, tether 710 can be detached from coupling ring 705. In some examples, tether 710 can be withdrawn from an eyelet of coupling ring 705 through which tether 710 was inserted. In other examples, coupling ring 705 can be separated and opened to detach tether 710 from coupling ring 705. In addition, stent 170-a can be repositioned within body lumen 205 to at least partially cover puncture site 210.

[0133] Figure 7C The stent delivery system 700 is shown with the stent 170-a fully deployed according to aspects of the present disclosure. Once the stent 170-a is expanded within the body lumen 205, the guidewire lumen 150, the guidewire 180, the tether coupled to the main constraining member, and the tether coupled to the coupling ring are withdrawn through the puncture site 210.

[0134] Figure 8 Shown is an exploded view of a system 800 for providing an approach to enter a body lumen by an inner pusher according to various aspects of the present disclosure. System 800 generally comprises an outer sheath 805, an inner pusher 830, a guidewire lumen 850, a stent 870, and a guidewire 875. System 800 can be provided as a separate component, a selectively combined component, or all provided as a kit of components together. Before the outer sheath handle 825 abuts against the proximal end of the handle assembly, the outer sheath 805 can be inserted into the handle assembly (not shown). Once assembled, the outer sheath 805 just extends through the handle assembly to arrive at the target body lumen.

[0135] For example, during a lumen access procedure, the outer sheath 805 can enter the target lumen by piercing the lumen wall. In some instances, a sharpening probe can be used in conjunction with the outer sheath 805 to facilitate piercing the lumen wall. For example, the sharpening probe can be advanced through the outer sheath 805 until the sharpening probe protrudes from the outer sheath 805, thereby piercing the tissue. Once the outer sheath 805 has entered the lumen, the guidewire 875 can be advanced through the outer sheath 805 and into the lumen. After the guidewire 875 is correctly placed inside the body lumen, the guidewire lumen 850 can be advanced over the guidewire 875 and into the body lumen. The guidewire lumen 850 can typically be a tubular structure sized to allow the stent 870 to be deployed within the body lumen. In this way, the guidewire lumen 850 and the stent 870 can be advanced over the guidewire 875 and into the body lumen. The guidewire lumen 850 can be retracted to position the stent 870 to cover the puncture site of the body lumen.

[0136] For example, system 800 can be used to access and provide treatment to one or more body lumens within the gastrointestinal system or the pancreaticobiliary system. It will be appreciated that system 800 can also be used to provide access to or provide treatment to other organs or luminal systems within the body (e.g., the arterial system, the bronchial system, the urinary system, or any other luminal system) where maneuverability and accuracy are desired.

[0137] The outer sheath 805 of the system 800 has an elongated tubular body extending from its proximal end 815 to its distal end 820 and an internal lumen 810. Typically, the outer sheath 805 is configured to enter a body lumen (e.g., by piercing the lumen wall) and provide a conduit through which one or more devices (e.g., a guidewire 875) can be passed to facilitate subsequent treatment of the body lumen or an associated organ. As described with reference to several embodiments, the outer sheath 805 can include features that facilitate the directionally controlled delivery of the guidewire 875 within the body lumen for subsequent delivery of a stent 870, a biopsy device, a drug delivery element, or any number of other therapeutic or diagnostic devices.

[0138] The inner pusher 830 is generally an elongated, tubular member having a proximal end 835 and a distal end 840 and is sized to be advanced through the interior lumen 810 of the outer sheath 805. The inner pusher 830 can also include an intermediate handle 845 coupled to the proximal end 835 of the inner pusher 830 to facilitate longitudinal manipulation of the inner pusher 830 relative to the outer sheath 805. In certain embodiments, the inner pusher 830 can abut the proximal portion of the stent 870 when the proximal portion of the stent 870 is constrained within the outer sheath 805. As described below, the inner pusher 830 is configured to advance through the outer sheath 805 and deploy the proximal portion of the stent 870 from the outer sheath 805.

[0139] The guidewire lumen 850 is typically an elongated, tubular member having a proximal end 855 and a distal end 860, and is sized to be slidably advanced through the interior lumen of the inner pusher 830 and positioned over the guidewire 875. The guidewire lumen 850 may also include a proximal handle 865 coupled to the proximal end 855 of the guidewire lumen 850 to facilitate longitudinal or rotational manipulation of the guidewire lumen 850 relative to the outer sheath 805. In certain embodiments, the distal end 860 of the guidewire lumen 850 includes a tip or raised portion. As described below, the stent 870 may be coupled to the guidewire lumen 850. For example, the stent 870 may be in a side saddle configuration, wherein the guidewire lumen 850 does not extend through the lumen of the stent 870. In some instances, the stent 870 may be concentric with the guidewire lumen 850. This configuration may be referred to as a concentric configuration, wherein the guidewire lumen 850 may extend through the lumen of the stent 870. The stent 870 may be coupled to the guidewire lumen 850 in a full side-saddle configuration, a partial side-saddle configuration, or a combination of concentric configurations.

[0140] The guidewire 875 is generally a flexible, elongated member configured to be slidably advanced through the interior lumen 810 of the outer sheath 805. The size and stiffness of the guidewire 875 may be uniform along its entire length, or alternatively it may include sections of varying stiffness.

[0141] Figure 9A A stent delivery system 900 is shown with the outer sheath removed, in accordance with aspects of the present disclosure. When the outer sheath 805 is withdrawn proximally through the puncture site 210, the stent 870 can be exposed within the body lumen 205. For example, the distal portion 910 of the stent 870 can be deployed while the outer sheath 805 is retracted toward the puncture site 210. The distal portion 910 of the stent 870 can then be positioned in a fixed position against a stenosis within the body lumen 205. In some instances, the stent 870 can be completely positioned around the guidewire lumen 850. In that case, the guidewire lumen 850 can be internal to the stent 870 along the proximal portion 905 of the stent 870 and external to the stent 870 along the distal portion 910.

[0142] In some cases, the proximal portion 905 of the stent 870 can remain within the interior of the outer sheath 805. For example, as the outer sheath 805 is retracted toward the puncture site 210, the proximal portion 905 of the stent 870 can remain within the interior surface of the outer sheath 805. The outer sheath 805 can be retracted until the distal end of the outer sheath 805 is aligned (or substantially aligned) with the interior surface of the puncture site 210.

[0143] The stent delivery system can include an inner pusher 830. The inner pusher 830 can extend through the inner surface of the outer sheath 805. In some cases, the inner pusher can be slidably positioned over the guidewire lumen 850. Before the proximal portion 905 of the stent 870 is deployed, the proximal portion 905 of the stent 870 can abut the proximal end of the inner pusher 830 within the outer sheath 805.

[0144] The guidewire lumen 850 can contain a stent anchor 915. The stent anchor 915 can be located 1 to 2 cm distal to the location of the stent 870 outside of the guidewire lumen 850 (e.g., 1 to 2 cm distal to where the proximal portion 905 begins). The stent anchor 915 can be configured to allow a clinician to reconstrain the stent 870 prior to repositioning (i.e., advancing the outer sheath 805 in a distal direction to reconstrain the distal portion 910 of the stent 870).

[0145] In some instances, the guidewire lumen 850 can include a distal tip. The distal tip can taper at the proximal portion and distal portion of the distal tip. In some cases, the distal tip can be configured to facilitate retracting the guidewire lumen 850 concentrically with the guidewire lumen 850 through the stent 870 without displacing the stent 870 after deployment.

[0146] The outer sheath 805 can include a distal marker 920. For example, the distal marker 920 can be positioned around the distal end of the outer sheath 805. For example, the outer sheath 805 can be retracted until the distal marker 920 is proximal to the stent anchor 915. As described in further detail below, once the outer sheath 805 is retracted past the stent anchor 915, the inner pusher 830 can be advanced to push the proximal portion 905 of the stent 870 into the body lumen 205. However, once the outer sheath 805 is retracted past the stent anchor 915, the outer sheath 805 cannot be advanced in the distal direction to reconstrain the distal portion 910 of the stent 870.

[0147] In some cases, the outer sheath 805 can include an inner shield of an etched PTFE liner having a wall thickness in the range of 0.0010 to 0.0020 inches and an outer shield of a polyether block amide (Pebax) material having a wall thickness in the range of 0.0040 to 0.0080 inches. The proximal portion of the outer sheath 805 can also include a braided reinforcement heat-fused between the inner PTFE liner and the outer Pebax shield.

[0148] Figure 9B A stent delivery system 900 is shown in which the proximal portion 905 of a stent 870 is compressed within a body lumen 205 in accordance with various aspects of the present disclosure. Once the outer sheath 805 is retracted toward the puncture site 210, the inner pusher 830 can be advanced in a distal direction (as indicated by arrow 925) to push the proximal portion 905 from the distal end of the outer sheath 805. For example, the intermediate handle 845 can be advanced in a distal direction to advance the inner pusher 830. As the inner pusher 830 advances, the proximal portion 905 of the stent 870 can begin to exit the outer sheath 805 and be compressed against the distal portion 910 of the stent 870. As shown, as the proximal portion 905 is advanced toward the fixed distal portion 910, the stent 870 can compress like an accordion. The inner pusher 830 can be advanced until the proximal portion 905 of the stent 870 is completely withdrawn from the outer sheath 805. In some cases, the inner pusher 830 can be advanced until the distal end of the inner pusher 830 is aligned with the distal end of the outer sheath 805 .

[0149] When the inner pusher 830 is advanced, the outer sheath 805 can remain in a fixed position. That is, while the intermediate handle 845 coupled to the inner pusher 830 can be advanced distally, the outer sheath handle 825 coupled to the outer sheath 805 can be locked in a static position. For example, the outer sheath 805 can be locked to the endoscope via a clamping mechanism or a locking mechanism (e.g., Touhy boost). In some cases, when the inner pusher 830 is advanced in the distal direction, the proximal handle 865 of the guidewire lumen 850 can remain in a locked position.

[0150] Figure 9C A stent delivery system 900 is shown with a stent 870 fully deployed according to various aspects of the present disclosure. To deploy the stent 870 within the body lumen 205, the inner pusher 830 can be advanced until the entire stent 870 is pushed into the body lumen 205. Once the guidewire lumen 850 and the guidewire 875 are withdrawn through the puncture site 210, the stent 870 can be fully deployed so that the proximal portion 905 of the stent 870 can expand to at least partially cover the puncture site 210. In that case, due to the fact that the stent 870 compresses like an accordion, the proximal portion 905 can "spring back" or rebound to cover the puncture site 210. In the case of a self-expanding stent, the stent 870 expands to contact the inner surface of the body lumen 205.

[0151] Figure 10A A stent delivery system 1000 having a coupler 1020 according to aspects of the present disclosure is shown. When the outer sheath 805 is withdrawn proximally, the stent 870 can be exposed within the body lumen 205. In some instances, if repositioning is desired, the outer sheath 805 can be advanced distally to cover the stent 870. Once the stent 870 reaches the desired anatomical position within the body lumen 205, the outer sheath 805 can be retracted.

[0152] In some cases, the stent 870 can be releasably coupled to the guidewire lumen 850 via a primary constraining member 1015. For example, the primary constraining member 1015 can couple the distal portion 1010 of the stent 870 to the distal section of the guidewire lumen 850. In some cases, the primary constraining member 1015 can be tied around the proximal portion 1005 of the stent 870 without coupling the proximal portion 1005 to the guidewire lumen 850. In some instances, the primary constraining member 1015 can be an example of a filament tied around the stent 870, a wire wrapped around the stent 870, a wire frame at least partially wrapped around the stent 870, a splittable sheath, or a combination thereof, as described with reference to Figures 3-5. In some cases, the stent 870 can be partially positioned around the guidewire lumen 850. For example, the guidewire lumen 850 can be exterior to the stent 870 along a proximal portion 1005 of the stent 870 , and the guidewire lumen 850 can be interior to the stent 870 along a distal portion 1010 of the stent 870 .

[0153] The stent delivery system 1000 can include a coupler 1020. The coupler 1020 can couple the distal segment of the guidewire lumen 850 to the proximal segment of the guidewire lumen 850. For example, the guidewire lumen 850 can include separate concentric shaft components (e.g., a distal segment and a proximal segment), wherein the distal segment and the proximal segment of the guidewire lumen 850 can each be coupled to each other via the coupler 1020. In some cases, the coupler 1020 can be located below the proximal portion 1005 of the stent 870. In other examples, the coupler 1020 can be located at a node between the proximal segment of the guidewire lumen 850 and the proximal handle 865 of the guidewire lumen 850.

[0154] Coupler 1020 can be made of a variety of materials, including but not limited to metal, plastic, or both. In some cases, the proximal and distal sections of guidewire lumen 850 can be attached to coupler 1020 by adhesive, welding, or both. The diameter of coupler 1020 can vary depending on the diameter of guidewire lumen 850.

[0155] In some examples, the proximal portion 1005 of the stent 870 can be aligned on the bottom of the guidewire lumen 850 (e.g., facing the puncture site 210). In that case, when the stent 870 is retracted toward the puncture site 210, the proximal portion 1005 of the stent 870 can get stuck on the wall 215 or the puncture site 210. As discussed in more detail below, to prevent the stent 870 from getting stuck on the wall 215 or the puncture site 210, the stent 870 can be rotated to align the proximal portion 1005 of the stent 870 on the top of the guidewire lumen 850 (e.g., facing away from the puncture site 210).

[0156] Figure 10BThe stent delivery system 1000 is shown with a stent 870 and a coupler 1020 retracted toward a puncture site 210 according to aspects of the present disclosure. Once the outer sheath 805 is withdrawn through the puncture site 210, the stent 870 can be pulled in a proximal direction toward the puncture site 210, as indicated by arrow 250. The stent 870 can be retracted toward the puncture site 210 by pulling the guidewire lumen 850 in a proximal direction. For example, the stent 870 can be pulled toward the puncture site 210 until the proximal portion 1005 of the stent 870 at least partially covers the puncture site 210. Furthermore, the stent 870 can be repositioned within the body lumen 205 to at least partially cover the puncture site 210. In some cases, the proximal portion 1005 of the stent 870 can be tethered so that the primary constraining member 1015 prevents the proximal portion 1005 from becoming caught on the wall 215 of the body lumen when the stent 870 is retracted.

[0157] In some cases, the stent 870 can be rotated to align the proximal portion 1005 of the stent 870 over the top of the guidewire lumen 850 (e.g., away from the puncture site 210). To rotate the proximal portion 1005 of the stent 870, the proximal section of the guidewire lumen 850 can be rotated via the coupler 1020. For example, by withdrawing the guidewire lumen 850 proximally (e.g., including the coupler 1020) and passing it backward through the puncture site 210, the proximal portion 1005 of the stent 870 can be rotated away from the puncture site 210. In this case, the guidewire lumen 850 can be under tension and configured to align with the inner curve of the body lumen 205. For example, the guidewire lumen 850 can be pulled to the inner curve of the body lumen 205, and the coupler 1020 can rotate the proximal portion 1005 of the stent 870 toward the outer curve of the body lumen 205. In some cases, the proximal section of the guidewire lumen 850 can be rotated away from the puncture site 210 so that the coupler 1020 prevents the proximal portion 1005 of the stent 870 from getting caught on the wall 215 of the body lumen 205 when the stent 870 is retracted. In this case, the distal section of the guidewire lumen 850 can remain in a stationary position while the proximal section of the guidewire lumen 850 rotates.

[0158] Figure 10C The stent delivery system 1000 is shown with a stent 870 fully deployed in accordance with aspects of the present disclosure. To deploy the stent 870 within the body lumen 205, the primary constraining member can be released. In some instances, the stent 870 can be deployed by pulling the primary constraining member in a proximal direction, pulling one or more tethers coupled to the primary constraining member, or both. In the case of a self-expanding stent, the stent 870 expands to contact the inner surface of the body lumen 205. Once the stent 870 is expanded within the body lumen 205, the guidewire lumen 850 and guidewire 875 are withdrawn through the puncture site 210.

[0159] Figure 11 A stent delivery system 1100 with a positioning member according to various aspects of the present disclosure is shown. The positioning member can include extrusions 1105-a, 1105-b, and 1105-c and rotating rings 1110-a and 1110-b. Extrusions 1105-a, 1105-b, and 1105-c and rotating rings 1110-a and 1110-b can be concentrically loaded into the guidewire lumen 850.

[0160] Extrusions 1105-a, 1105-b, and 1105-c can be made of a variety of materials, including but not limited to polyimide. Extrusions 1105-a, 1105-b, and 1105-c can be bonded to guidewire lumen 850 such that rotating rings 1110-a and 1110-b can be separated by a distance equal to or greater than the length of extrusions 1105-a, 1105-b, and 1105-c.

[0161] The rotating rings 1110-a and 1110-b can be made of a variety of materials, including but not limited to stainless steel, polyetheretherketone (PEEK), the polyetherimide product family (i.e., Ultem), other metals, or combinations thereof. The rotating rings 1110-a and 1110-b can be releasably coupled to the guidewire lumen 850 so that the rotating rings 1110-a and 1110-b can freely rotate around the guidewire lumen 850. As described in further detail below, the rotating rings 1110-a and 1110-b can rotate the stent to align the proximal portion of the stent away from the puncture site.

[0162] In some cases, the extrusions 1105-a, 1105-b, and 1105-c can be separated from the rotating rings 1110-a and 1110-b by spacers 1115-a, 1115-b, 1115-c, and 1115-d. For example, the extrusion 1105-a can be separated from the rotating ring 1110-a by spacer 1115-a. The spacers 1115-a, 1115-b, 1115-c, and 1115-d can be made of a variety of materials, including but not limited to nylon.

[0163] In some examples, the proximal retention member 1120 can abut an edge of the extrusion 1105-a and the distal retention member 1125 can abut an edge of the extrusion 1105-c. The proximal retention member 1120 and the distal retention member 1125 can be made of a variety of materials, including but not limited to Pebax. As described in further detail below, the proximal retention member 1120 and the distal retention member 1125 can act as stops for the primary restraining member attached to the stent.

[0164] In some cases, rotating rings 1110 - a and 1110 - b can be instances of a single rotating ring. In other instances, rotating ring 1110 - a can abut proximal retention member 1120 and rotating ring 1110 - b can abut distal retention member 1125 .

[0165] Figure 12A -C shows a stent delivery system 1200 in which a stent is positioned on a positioning member according to aspects of the present disclosure. Figure 10A -C, a positioning member (e.g., comprising extrusions 1105-a, 1105-b, and 1105-c and rotating rings 1110-a and 1110-b) can be used to rotate the proximal portion 1005 of the bracket 870 at the top of the guidewire lumen 850 (e.g., away from the puncture site).

[0166] In some cases, stent 870 can be partially positioned around guidewire lumen 850. For example, guidewire lumen 850 can be external to stent 870 along a proximal portion 1005 of stent 870, and guidewire lumen 850 can be internal to stent 870 along a distal portion 1010 of stent 870. In some cases, stent 870 can be releasably coupled to guidewire lumen 850 via primary constraining members 1015-a and 1015-b. For example, primary constraining member 1015-a can couple distal portion 1010 of stent 870 to rotating ring 1110-a, and primary constraining member 1015-b can couple distal portion 1010 of stent 870 to rotating ring 1110-b. In some instances, the primary restraining members 1015-a and 1015-b can be instances of filaments tied around the stent 870, wires wrapped around the stent 870, wire frames at least partially wrapped around the stent 870, splittable sheaths, or combinations thereof, as described with reference to Figures 3-5.

[0167] As reference Figure 12A As described, the proximal portion 1005 of the stent 870 can be aligned on the bottom of the guidewire lumen 850 (e.g., facing the puncture site). In that case, when the stent 870 is retracted toward the puncture site, the proximal portion 1005 of the stent 870 can be stuck on the wall or puncture site, as shown in reference Figure 10A To prevent stent 870 from getting stuck on a wall or puncture site, stent 870 can be rotated to align the proximal portion 1005 of stent 870 over the top of guidewire lumen 850 (eg, facing away from the puncture site).

[0168] As reference Figure 12BAs described, support 870 can be rotated so that the proximal portion 1005 of support 870 is aligned on the top of guidewire lumen 850 (for example, back to the puncture site). To rotate the proximal portion 1005 of support 870, the distal portion 1010 of support 870 can rotate via rotating rings 1110-a and 1110-b. For example, by extracting guidewire lumen 850 out to the proximal side and making it pass through the puncture site backward, the proximal portion 1005 and distal portion 1010 of support 870 can rotate away from the puncture site. In that case, the distal portion 1010 of the support 870 that is coupled to rotating rings 1110-a and 1110-b respectively by main restraining member 1015-a and 1015-b can rotate. That is, rotating rings 1110-a and 1110-b can rotate relative to guidewire lumen 850.

[0169] As reference Figure 12C As described, the proximal portion 1005 of the stent 870 can be rotated to align the proximal portion 1005 of the stent 870 on the top of the guidewire lumen 850 (e.g., away from the puncture site). In this case, the rotating rings 1110-a and 110-b can prevent the proximal portion 1005 of the stent 870 from getting stuck on the wall of the body lumen 205 when the stent 870 is retracted, as shown in FIG. Figure 10A In this case, the extrusions 1105 - a , 1105 - b , and 1105 - c bonded to the guidewire lumen 850 may remain in a stationary position while the rotating rings 1110 - a and 1110 - b rotate about the guidewire lumen 850 .

[0170] Figure 13 A stent delivery system 1300 having a laser-cut outer sheath 805 according to aspects of the present disclosure is shown. In some cases, the outer sheath 805 can include one or more laser cuts 1310. For example, the laser cuts 1310 can wrap around the outer sheath 805 to form splines 1305. In that case, the laser cuts 1310 can extend around a portion of the circumference of the outer sheath 805 and abut the splines 1305. The splines 1305 can extend from the proximal end of the outer sheath 805 to the distal end of the outer sheath 805. In some cases, the laser cuts 1310 can be imparted to the outer sheath 805 in more than one pattern. For example, the laser cuts 1310 can be cut to form helical splines. In some instances, the helical splines can extend along the distal portion of the outer sheath 805 and the longitudinal splines can extend along the proximal portion of the outer sheath 805.

[0171] In some cases, the stent can be loaded within the outer sheath 805 relative to the laser cut 1310. For example, to align the stent in a body lumen so that the proximal portion of the stent is oriented away from the inner wall of the body lumen, the proximal portion of the stent can be positioned 180 degrees from the splines 1305. In some cases, the splines 1305 can include a higher stiffness than the stiffness imparted to the laser cut 1310 in the outer sheath 805. For example, the splines 1305 can be aligned to the smaller curvature of the tube (e.g., to take the path of least resistance in the bend) and aligned to the inner radius of curvature of the tube. In such cases, the outer sheath 805 can be aligned to the inner radius of curvature of the tube, thereby aligning the stent with the inner radius of curvature of the tube. In some cases, the guidewire lumen can be rotated within the stent.

[0172] If the proximal portion of the stent is positioned opposite the spline 1305, the proximal portion of the stent can expand along the outer radius of curvature of the tube after the outer sheath 805 is retracted. That is, the proximal portion of the stent can be deployed away from the inner wall of the body lumen when the outer sheath 805 is retracted. This can prevent the proximal portion of the stent from getting stuck on the inner wall of the body lumen or the puncture site when the stent is retracted to cover the puncture site. The outer sheath 805 can be made of a variety of metal materials, including but not limited to nitinol.

[0173] Figure 14 A stent delivery system 1400 with a collision extrusion outer sheath according to aspects of the present disclosure is shown. In some cases, the outer sheath 805 can contain a collision extrusion 1405. For example, the collision extrusion 1405 can extend from the distal end of the outer sheath 805 to the proximal end. The collision extrusion 1405 can be positioned between an outer surface 1410 of the outer sheath 805 and an inner surface 1415 of the outer sheath 805. In some examples, the inner surface 1415 of the outer sheath 805 can be an example of a PTFE liner. In other examples, the outer surface 1410 of the outer sheath 805 can be made of a low durometer material. In some cases, the collision extrusion 1405 can be made of a high durometer material. The collision extrusion 1405 can be approximately 1 mm to 3 mm wide.

[0174] In some cases, the stent can be loaded in the outer sheath 805 relative to the collision extrusion 1405. For example, to align the stent in the body lumen so that the proximal portion of the stent is oriented toward the inner wall away from the body lumen, the proximal portion of the stent can be positioned 180 degrees with the collision extrusion 1405. The collision extrusion 1405 can include a stiffness higher than the stiffness of the portion of the outer sheath 805 that does not have the collision extrusion 1405. For example, the collision extrusion 1405 can be aligned to the smaller curvature of the tube (for example, the path of least resistance in the bend will be adopted) and aligned to the inner radius of curvature of the tube. In such cases, the outer sheath 805 can be aligned to the inner radius of curvature of the tube, thereby aligning the stent with the inner radius of curvature of the tube. In some cases, the guidewire lumen can rotate within the stent.

[0175] If the proximal portion of the stent is positioned opposite the collision extrusion 1405, the proximal portion of the stent can expand along the outer radius of curvature of the tube after the outer sheath 805 is retracted. For example, the outer sheath 805 can be retracted to deploy the stent, and the proximal portion of the stent can be deployed away from the inner wall of the body lumen. This can prevent the proximal portion of the stent from getting stuck on the inner wall of the body lumen or the puncture site when the stent is retracted to cover the puncture site.

[0176] Figure 15 A stent delivery system 1500 with a wired outer sheath according to aspects of the present disclosure is shown. In some cases, the outer sheath 805 can contain a first wire 1505-a and a second wire 1505-b. For example, the first wire 1505-a and the second wire 1505-b can extend from the distal end of the outer sheath 805 to its proximal end. The first wire 1505-a and the second wire 1505-b can be positioned between an outer surface 1510 of the outer sheath 805 and an inner surface 1515 of the outer sheath 805. In some examples, the inner surface 1515 of the outer sheath 805 can be an example of a PTFE liner. In some cases, a helical braided shield can be positioned over the inner surface 1515 of the outer sheath 805. The outer surface 1510 of the outer sheath 805 can be made of a polymer material. The first wire 1505-a and the second wire 1505-b can be made of a variety of metallic materials, including, but not limited to, stainless steel. In some cases, the first conductive line 1505 - a and the second conductive line 1505 - b can be positioned 180 degrees from each other.

[0177] In some cases, the stent can be loaded within the outer sheath 805 relative to the first and second guidewires 1505-a, 1505-b. For example, to align the stent within a body lumen so that the proximal portion of the stent is oriented away from the inner wall of the body lumen, the proximal portion of the stent can be positioned 90 degrees relative to the first and second guidewires 1505-a, 1505-b. For example, the stent can be deployed outward at a 90-degree angle relative to the first and second guidewires 1505-a, 1505-b. In some cases, the first and second guidewires 1505-a, 1505-b can comprise a stiffness greater than the stiffness of a portion of the outer sheath 805 that does not comprise the first and second guidewires 1505-a, 1505-b. For example, the first and second guidewires 1505-a, 1505-b can be aligned to a smaller curvature of the tube (e.g., to take the path of least resistance in the bend) and to the inner radius of curvature of the tube. In this case, the portion of the outer sheath 805 that does not have the first and second wires 1505 - a , 1505 - b may be aligned with the inner radius of curvature of the tube.

[0178] If the proximal portion of the stent is positioned at 90 degrees to the first guide wire 1505-a and the second guide wire 1505-b, the proximal portion of the stent can expand along the outer radius of curvature of the tube after the outer sheath 805 is retracted. For example, the outer sheath 805 can be retracted and the proximal portion of the stent can be deployed away from the inner wall of the body lumen. This can prevent the proximal portion of the stent from getting stuck on the inner wall of the body lumen or the puncture site when the stent is retracted to cover at least a portion of the puncture site.

[0179] In some cases, the outer sheath 805 may contain a third wire (not shown). In that case, the first wire 1505-a, the second wire 1505-b, and the third wire may be positioned 90 degrees apart around the circumference of the outer sheath 805. The second wire 1505-b may be aligned to the smaller curvature of the tube and to the inner radius of curvature of the tube. The first wire 1505-a and the third wire may be aligned at 90 degrees to the second wire 1505-b. That is, the stent may be deployed outward from between the first wire 1505-a and the third wire (e.g., 180 degrees from the second wire 1505-b). In some cases, the outer sheath 805 may contain a collision extrusion, as shown in reference Figure 14 In that case, the first conductor 1505 - a , the second conductor 1505 - b , and the collision extrusion can be positioned 120 degrees apart around the circumference of the outer jacket 805 .

[0180] refer to Figure 16 , shows a system 1600 for providing access to a body lumen within the pancreatic system according to aspects of the present disclosure. The system 1600 may be a reference Figure 1-1516. The pancreaticobiliary system is an example of a system or component described in any of the figures in the drawings, or includes a function of a system or component. The illustrated portion of the pancreaticobiliary system includes the common bile duct 1605, which drains bile from both the cystic duct 1635 (which drains from the gallbladder 1630) and the common hepatic duct 1640 (which drains from the liver 1645) into the duodenum 1615, where the bile mixes and reacts with digested food. As shown, the common bile duct 1605 joins the pancreatic duct 1620 at the ampulla of Vater 1610 (shown as blocked) before draining into the duodenum 1615 through the major duodenal papilla.

[0181] The clinician can advance an endoscope 1625 (e.g., an EUS endoscope) into the lumen of the patient's duodenum 1615 to a position where the bile duct is visualized (e.g., via endosonography). The clinician can then enter the common bile duct 1605 by advancing a separate access device through the working channel of the endoscope 1625, through the wall of the duodenum 1615 (i.e., transduodenally), and then through the wall of the common bile duct 1605.

[0182] The clinician can then insert a guidewire 875 via a separate access device, allowing the stent delivery system 1650 to be tracked over the guidewire 875. After the stent delivery system 1650 is advanced into the common bile duct 1605, the stent delivery system 1650 can be pulled back to position the stent over the puncture site, as described with reference to Figures 2-9. In some cases, the stent delivery system 1650 can be repositioned to place the stent over the puncture site, as described with reference to Figures 10-15. The stent delivery system 1650 can be a reference to Figure 1-15 Examples of systems or components depicted in any of the figures.

[0183] Figure 17 A flow chart is shown of a method 1700 for a rotatable stent delivery device for covering a puncture site in accordance with aspects of the present disclosure. At block 1705, the method may include delivering a stent delivery system through the puncture site in a wall of a body lumen, wherein the stent delivery system includes a positioning member having a first portion that is rotatable relative to a second portion, and wherein the stent is releasably coupled to the first portion of the positioning member, as described with reference to FIGs. 10-15.

[0184] At block 1710, the method can include withdrawing an outer constraining member from the stent to deploy a proximal portion of the stent within a body lumen, as described with reference to Figures 10-15.

[0185] At block 1715, the method can include rotating the proximal portion of the stent away from the puncture site by withdrawing the positioning member proximally and back through the puncture site, as described with reference to Figures 10-15.

[0186] At block 1720, the method can include covering the puncture site with the proximal portion of the stent upon full deployment of the proximal portion from the external constraining member, as described with reference to Figures 10-15.

[0187] Figure 18 A flow chart is shown of a method 1800 for a rotatable stent delivery device for covering a puncture site in accordance with aspects of the present disclosure. At block 1805, the method may include delivering a stent delivery system through the puncture site in a wall of a body lumen, wherein the stent delivery system includes a positioning member having a first portion that is rotatable relative to a second portion, and wherein the stent is releasably coupled to the first portion of the positioning member, as described with reference to FIGs. 10-15.

[0188] At block 1810 , the method can include withdrawing an outer constraining member from the stent to deploy a proximal portion of the stent within a body lumen, as described with reference to FIGS. 10-15 .

[0189] At block 1815, the method can include rotating the proximal portion of the stent away from the puncture site by withdrawing the positioning member proximally and back through the puncture site, as described with reference to Figures 10-15.

[0190] At block 1820 , the method may include retracting the stent toward the puncture site such that a proximal portion of the stent at least partially covers the puncture site, as described with reference to FIGS. 10-15 .

[0191] At block 1825, the method can include covering the puncture site with the proximal portion of the stent upon full deployment of the proximal portion from the external constraining member, as described with reference to Figures 10-15.

[0192] Figure 19 A flow chart is shown of a method 1900 for a rotatable stent delivery device for covering a puncture site in accordance with aspects of the present disclosure. At block 1905, the method may include delivering a stent delivery system through the puncture site in a wall of a body lumen, wherein the stent delivery system includes a positioning member having a first portion that is rotatable relative to a second portion, and wherein the stent is releasably coupled to the first portion of the positioning member, as described with reference to FIGs. 10-15.

[0193] At block 1910, the method can include withdrawing an outer constraining member from the stent to deploy a proximal portion of the stent within a body lumen, as described with reference to Figures 10-15.

[0194] At block 1915 , the method may include aligning a portion of the outer constraining member away from the puncture site, as described with reference to FIGS. 10-15 .

[0195] At block 1920, the method can include rotating the proximal portion of the stent away from the puncture site by withdrawing the positioning member proximally and back through the puncture site, as described with reference to Figures 10-15.

[0196] At block 1925, the method can include covering the puncture site with the proximal portion of the stent when fully deployed proximally, as described with reference to Figures 10-15.

[0197] It should be noted that these methods describe possible embodiments, and operations and steps can be rearranged or otherwise modified to make other embodiments possible. In some instances, aspects from two or more methods can be combined. For example, aspects of each method in a method can include steps or aspects of other methods, or other steps or technologies described herein.

[0198] The description herein is provided to enable one skilled in the art to make or use the present disclosure. Various modifications of the present disclosure will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other variations without departing from the scope of the present disclosure. Therefore, the present disclosure is not limited to the examples and designs described herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

[0199] Although several embodiments of the present disclosure have been described and illustrated herein, a person of ordinary skill in the art will readily conceive of various other means or structures for performing the functions or obtaining one or more of the results or advantages described herein, and each of such variations or modifications is considered to be within the scope of the present disclosure. More specifically, a person of ordinary skill in the art will readily recognize that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that actual parameters, dimensions, materials, or configurations will depend on the specific application or applications in which the teachings of the present disclosure are used.

[0200] Using only routine experimentation, those skilled in the art will recognize or be able to ascertain many equivalents to the specific embodiments of the disclosure described herein. It should be understood, therefore, that the foregoing embodiments are introduced by way of example only, and that, within the scope of the appended claims and their equivalents, the disclosure may be practiced differently than specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, kit, or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, or methods is included within the scope of the present disclosure if such features, systems, articles, materials, kits, or methods are not mutually inconsistent.

[0201] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0202] Unless expressly indicated to the contrary, as used herein in the specification and in the claims, the indefinite articles "a" and "an" should be understood to mean "at least one." Furthermore, as used herein, including in the claims, "or" used in a series of items (e.g., a series of items preceded by phrases such as "at least one" or "one or more") indicates an inclusive list, so that, for example, at least one of a series of A, B, or C means A or B or C or AB or AC or BC or ABC (i.e., A and B and C).

[0203] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the various appearances of the phrases "in one embodiment" or "in an embodiment" throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

Claims

1. A system for delivering a stent into a body lumen, comprising: Bracket; a stent delivery device configured to deliver the stent via a puncture site in a wall of the body lumen; an outer sheath configured to constrain the stent into a collapsed configuration; as well as a positioning member configured to rotate the proximal portion of the stent away from the puncture site by withdrawing the positioning member proximally and back through the puncture site; The positioning member includes a first portion that is rotatable relative to a second portion. 2 . The system of claim 1 , wherein the first portion includes one or more bearings disposed about the second portion. 3 . The system of claim 1 , wherein the second portion is a tubular member configured to be advanced through the puncture site within the body lumen.

4. The system of claim 1 , further comprising: One or more spacers are positioned between the one or more bearings, wherein the one or more spacers are configured to maintain a fixed position relative to the second portion.

5. The system of claim 1 , wherein the stent is positioned to the positioning member such that the first portion of the positioning member is within the stent along a distal portion of the stent and the second portion of the positioning member is outside the stent along the distal portion of the stent.

6. The system of claim 1, further comprising: A primary restraining member is configured to releasably couple the bracket to the positioning member.

7. The system of claim 6, wherein the primary restraining member is positioned above the first portion of the positioning member.

8. The system of claim 1, wherein the first portion and the second portion are coupled by a rotational coupling.

9. The system of claim 8, wherein the rotational coupling is positioned at the proximal portion of the stent, wherein the proximal portion of the stent is deployed.

10. The system of claim 8, wherein the first portion is a first tubular member and the second portion is a second tubular member, wherein the first tubular member and the second tubular member are configured to be advanced through the puncture site within the body lumen.

11. The system of claim 1 , wherein the positioning member is positioned between an outer surface of the outer sheath and an inner surface of the outer sheath, wherein the positioning member is configured to rotate the proximal portion of the stent away from a puncture site before removing the outer sheath, such that after the outer sheath is withdrawn from the body lumen via the puncture site, the proximal portion of the stent covers the puncture site.

12. The system of claim 11, wherein the locating member comprises splines abutted by one or more laser cuts.

13. The system of claim 12, wherein the one or more laser cuts are configured to surround a distal end of the outer sheath.

14. The system of claim 12, wherein the one or more laser cuts comprise a helical arrangement at the distal end of the outer sheath and a longitudinal arrangement at the proximal end of the outer sheath.

15. The system of claim 11, wherein the positioning member comprises an extruded strip along a longitudinal axis of the distal end of the outer sheath.

16. The system of claim 11, wherein the positioning member comprises one or more wires oriented along a longitudinal axis of the outer sheath.

17. The system of claim 11, wherein the proximal portion of the stent is positioned 180 degrees relative to the positioning member.

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