STENT DESIGN FOR TRANSLUMINAL APPLICATION

Apparatuses, and systems are described for stent designs for transluminal application. The stent may include a stent body having a diameter and a length in a deployed configuration. The stent may include a helical wrapping pattern that is at least partially covered with a material. The helical wrapping pattern may be configured to reduce a foreshortening of the stent body upon deployment from an undeployed configuration to the deployed configuration to less than ten percent of a length of the stent body in the undeployed configuration. In some cases, the stent may include a first anchoring member coupled with a distal portion of the stent body and a second anchoring member coupled with a proximal portion of the stent body. The first and second anchoring members may be configured to increase a diameter of the stent.

BACKGROUND

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

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

SUMMARY

The stent designs for transluminal application may include a stent body having a first diameter and a first length in a deployed configuration and including a helical wrapping pattern that is at least partially covered with a first material. In some case, the helical wrapping pattern may be configured to reduce a foreshortening of the stent body upon deployment from an undeployed configuration to the deployed configuration to less than ten percent of a length of the stent body in the undeployed configuration. The stent may further include a first anchoring member coupled with a distal portion of the stent body and configured to increase a diameter of the distal portion of the stent body to a second diameter greater than the first diameter. In some examples, the stent may include a second anchoring member coupled with a proximal portion of the stent body and configured to increase a diameter of the proximal portion of the stent body to the second diameter greater than the first diameter.

A stent may be described. The stent may include a stent body having a first diameter in a deployed configuration, a first length in the deployed configuration, and comprising a helical wrapping pattern that is at least partially covered with a first material, wherein the helical wrapping pattern is configured to reduce a foreshortening of the stent body upon deployment from an undeployed configuration to the deployed configuration to less than ten percent of a length of the stent body in the undeployed configuration, a first anchoring member coupled with a distal portion of the stent body and configured to increase a diameter of the distal portion of the stent body to a second diameter greater than the first diameter, and a second anchoring member coupled with a proximal portion of the stent body and configured to increase a diameter of the proximal portion of the stent body to the second diameter greater than the first diameter.

In some cases, the first anchoring member comprises a first flared portion coupled with a distal end of the stent body and spaced around a circumference of the distal end of the stent body, and wherein the second anchoring member comprises a second flared portion coupled with a proximal end of the stent body and spaced around a circumference of the proximal end of the stent body. In some cases, a length the first anchoring member is different than a length of the second anchoring member. In some cases, a length the first anchoring member is the same as a length of the second anchoring member.

In some cases, the first material is disposed onto an entire portion of the stent body, the first anchoring member, and the second anchoring member. In some cases, the helical wrapping pattern comprises a single wire frame. In some cases, the first material comprises a plurality of drainage holes disposed within the second anchoring member and the proximal portion of the stent body. The stent may further include one or more markers disposed around the stent body, the first anchoring member, and the second anchoring member. In some cases, the helical wrapping pattern comprises more than one wire frame. In some cases, the helical wrapping pattern comprises a laser cut frame.

In some cases, the stent body further comprises a braided wrapping pattern coupled with a distal end of the helical wrapping pattern, wherein the braided wrapping pattern comprises a braided frame. In some cases, the helical wrapping pattern comprises a single wire frame. In some cases, the first anchoring member comprises a flared portion coupled with the distal end of the stent body and spaced around a circumference of the distal end of the stent body, wherein the first anchoring member comprises the braided wrapping pattern. In some cases, the braided wrapping pattern is uncovered from the first material.

In some cases, the helical wrapping pattern comprises a first wire frame around a first portion of a circumference of the stent body and a second wire frame around a second portion of the circumference of the stent body, wherein the first wire frame and the second wire frame are connected across the length of the stent body. In some cases, the first anchoring member comprises a fast fin that protrudes from the distal portion of the stent body and extends in a proximal direction or a distal direction, and wherein the second anchoring member comprises a second fin that protrudes from the proximal portion of the stent body and extends in the proximal direction or the distal direction. In some cases, the first material is disposed onto an entire portion of the stent body, the first anchoring member, and the second anchoring member.

Certain embodiments of the present disclosure may include some, all, or none of the above advantages or features. One or more other technical advantages or features may be readily apparent to those skilled in the art from the figures, descriptions, and claims included herein. Moreover, while specific advantages or features have been enumerated above, various embodiments may include all, some, or none of the enumerated advantages or features.

DETAILED DESCRIPTION

The present disclosure is generally directed to stent designs for transluminal application. In certain procedures described herein, to place a stent within a body lumen, the luminal wall is pierced, and a stent delivery system is advanced through the hole (i.e., access site or access hole) and positioned at the target site to bypass an obstruction. The stent is then deployed from the stent delivery system. If the stent is not accurately and precisely deployed, the stent may be unable to form a bridge between two body lumens and therefore, may be unable to bypass the obstruction. For example, if the distal portion of the stent is deployed short of (e.g., below) the access hole, the stent may be unable to connect the two body lumens and unable to form an alternate route to bypass the obstruction. In some cases, inaccurate deployment may result in fluid from the lumen leaking out into the surrounding tissue and organs, which may potentially cause serious discomfort or other medical complications.

To address these concerns and other deficiencies, the stent placed within the body lumen may be an example of a non-foreshortening stent. For example, the stent may include a helical wrapping pattern that may be configured to reduce a foreshortening of the stent body upon deployment from the undeployed configuration to the deployed configuration to less than ten percent of a length of the stent body in the undeployed configuration. In such cases, the stent may remain in place during retraction of the outer sheath and deployment of the distal portion as the outer sheath continues to be retracted proximally. The non-foreshortening stent may enable accurate deployment by positioning the stent within the body lumen and maintaining the position of the stent within the body lumen before and after deploying the stent.

In some cases, the stent may include a stent body having a first diameter and a first length in a deployed configuration. The stent may include the helical wrapping pattern that is at least partially covered with a material. In some cases, the stent may include at least two anchoring members coupled with a distal portion and a proximal portion, respectively, of the stent body. For example, the stent may include a first anchoring member coupled with a distal portion of the stent body and configured to increase a diameter of the distal portion of the stent body to a second diameter greater than the first diameter. The stent may further include a second anchoring member coupled with a proximal portion of the stent body and configured to increase a diameter of the proximal portion of the stent body to the second diameter greater than the first diameter. Each of the anchoring members may be configured to anchor the distal portion and proximal portion of the stent within the respective body lumens such that the stent remains in a fixed position.

Upon retraction of the outer sheath, the stent releases from within the outer sheath and expands into a deployed configuration within the body lumen. For example, the distal portion including the first anchoring member may deploy from the outer sheath into a deployed configuration within the first body lumen. In such cases, the first anchoring member of the stent may accurately and precisely deploy in the first body lumen, thereby enabling the stent to be able to form a bridge between two body lumens and bypass the obstruction. For example, the distal portion of the stent (e.g., the first anchoring member) may deploy in the first body lumen and anchor itself within the first body lumen.

In some cases, the proximal portion including the second anchoring member may precisely deploy within the second body lumen and allow the stent to bridge between two body lumens upon expansion. The outer sheath may be withdrawn past a distal end of a marker to expand the proximal portion of the stent. In such cases, the second anchoring member of the stent may expand from within the outer sheath such that upon fully exiting the outer sheath, the proximal portion (e.g., the second anchoring member) expands to a deployed configuration within the second body lumen. The second anchoring member may enable the stent to anchor itself within the second body lumen. The deployed configuration may be an example of the stent fully exiting the outer sheath and expanding between the first body lumen and the second body lumen, thereby providing an alternative route to bypass the obstruction.

Embodiments of the present disclosure are now described in detail with reference to the drawings. As used herein, the term “clinician” refers to a doctor, surgeon, nurse, or any other care provider and may include support personnel. The term “proximal” will refer to the portion of the device or component thereof that is closer to the clinician and the term “distal” will refer to the portion of the device or component thereof that is farther from the clinician.

FIG.1illustrates a system100for providing access to a body lumen and delivering a stent in accordance with aspects of the present disclosure. The system100generally includes an outer sheath105, an isolation sheath110, a marker115, an anchoring component120, an electrocautery tip125, an inner tubular member130, a stent150, and a guidewire145. The system100can be provided as individual components, selectively combined components, or all together as a kit of components.

During a luminal access and stent150delivery procedure, the electrocautery tip125may access the target body lumen by piercing a wall of the body lumen, for example, to deliver a stent150. In general, a stent150is a frame or scaffolding structure sized for placement within a body lumen and configured to provide structural support to the inner surface of the body lumen. A stent150may be used to restore patency across narrowed or blocked areas within the body lumen due to inflammation, tumors, plaque buildup, or any other obstructive feature. Although references to the pancreaticobiliary system are provided herein, it should be appreciated that the stents described herein may be used in any body lumen. Furthermore, as discussed in more detail below, the stent150may be disposed around the inner tubular member130.

The stent150may be made from any number of materials, combinations of materials, and constructions. In some examples, the stent150is a self-expanding stent. The stent150may be a wire-form stent formed by one or more helically wrapped wires. However, it should be appreciated that the stent150may be made from other stent constructions or combinations of stent constructions. In other examples, the stent150is a laser-cut stent formed from a single metallic tube with regions cut away for increased flexibility. In yet other examples, the stent150is a braided stent made from a plurality of wires joined together in a cross-hatch configuration. In some examples, the stent150may be a combination of the braided stent and the wire-form stent.

It may be appreciated that the different stent constructions may exhibit particular characteristics such as radial expansive force, flexibility, reduced foreshortening, or migration resistance that may render a certain construction advantageous for a particular use. For example, the helical wrapping pattern of the stent150may be configured to reduce a foreshortening of the stent body upon deployment from an undeployed configuration to the deployed configuration to less than ten percent of a length of the stent body in the undeployed configuration. In such cases, the stent150may be an example of a non-foreshortening stent.

The individual wires or frame of the stent150may be made from any number of metallic materials including, but not limited to, titanium, nitinol, or stainless steel. It should be appreciated that other metallic or non-metallic materials may be used to construct the stent150that provides suitable flexibility, stiffness, and biocompatibility. The stent150may include a polymeric or fabric sleeve (e.g., first material) that covers some or all of the surface of the stent150. Such a sleeve may protect the inner surface of the body lumen from the bare metal of the stent150and may prevent tissue ingrowth. For example, the stent150may include a helical wrapping pattern that is at least partially covered with a first material. In some examples, the stent150is a drug-eluting stent.

The outer sheath105of the system100has an elongate tubular body and an internal lumen extending from its proximal end to the distal end. In general, the outer sheath105may be configured to access a body lumen and to provide a conduit through which one or more devices (e.g., a guidewire145) may pass to facilitate subsequent treatment of the body lumen or associate organs. The outer sheath105may include features that facilitate the direction-controlled delivery of a guidewire145within the body lumen for subsequent delivery of a stent150, a biopsy device, a medicinal delivery element, or any number of other treatment or diagnostic devices.

The outer sheath105may be disposed coaxially along at least a portion of the inner tubular member130such that the stent150is disposed between the inner tubular member130and the outer sheath105while the stent150is in an undeployed configuration. The undeployed configuration may be an example of a stent150constrained within the outer sheath105, an unexpanded configuration of the stent150, or both.

In some examples, the outer sheath105may include a lubrication coating disposed within an inner surface of the outer sheath105. The lubrication coating may be made from a variety of materials, including but not limited to silicone. In such cases, the lubrication coating may reduce deployment forces by at least thirty percent to ensure accurate placement of the stent150within the body lumen. In some cases, the lubrication coating of the outer sheath105may reduce the friction between the outer sheath105and the stent150as the outer sheath105is retracted over the stent150. The isolation sheath110may be configured to receive the outer sheath105as the outer sheath105is retracted.

The inner tubular member130is generally an elongate, tubular member with a proximal end135and distal end140and is dimensioned to be advanced through the internal lumen of the outer sheath105. The inner tubular member130may be configured to advance through an access site in a wall of the body lumen. The inner tubular member130may be coupled with an anchoring component120at the distal end140of the inner tubular member130. In certain embodiments, the distal end140of the inner tubular member130includes a tip or bulged portion (e.g., anchoring component120).

The stent150may be coupled to the inner tubular member130and the anchoring component120. For example, the stent150may be concentric with the inner tubular member130and the anchoring component120. As such, the inner tubular member130may extend through the lumen of the stent150. For example, the stent150may be disposed coaxially onto the inner tubular member130. The stent150may be positioned between the outer sheath105and the inner tubular member130at the proximal end135of the inner tubular member130.

The anchoring component120may extend through the lumen of the stent150at a distal portion160of the stent150. In such cases, the stent150may be positioned between the outer sheath105and the anchoring component120at the distal end140of the inner tubular member130. For example, the distal portion160of the stent150may be disposed coaxially along the anchoring component120such that the distal portion160of the stent150is disposed between the anchoring component120and the outer sheath105while the stent150is in the undeployed configuration.

The anchoring component120may be made from a variety of materials, including but not limited to silicone. The anchoring component120may be disposed at a distal end140of the inner tubular member130and configured to retain a distal portion160of the stent150in place along the inner tubular member130as the outer sheath105is retracted proximally to deploy the stent150. Upon retraction of the outer sheath105, the stent150may release from the anchoring component120and expand into a deployed configuration within the body lumen. The deployed configuration may be an example of an unconstrained configuration, an expanded configuration, or both. The anchoring component120may be an example of a bump, an increased diameter component of the inner tubular member130, a hook, or a combination thereof. In such cases, the anchoring component120may be configured to keep the distal portion160of the stent150stationary as the outer sheath105is retracted.

The system100may further include a marker115. The marker115may be an example of a proximal marker that is disposed around the inner tubular member130and positioned such that a proximal end of the stent150abuts against the marker115while the stent150is in the undeployed configuration. The marker115may be configured to indicate a location of the proximal end of the stent150within the system100. The marker115may be configured to retain a proximal portion155of the stent150in place along the inner tubular member130as the outer sheath105is retracted proximally to deploy the stent150. In some cases, the marker115may be coupled with the inner tubular member130such that the marker115remains stationary as the outer sheath105is retracted. In other examples, the marker115is slidably disposed onto the inner tubular member130such that the marker115is a moving marker as the outer sheath105is retracted back to deploy the stent150.

The marker115includes generally an elongate, tubular member and is configured to house the inner tubular member130. In some cases, the marker115may be tapered such that a distal end of the marker115may extend underneath the proximal portion155of the stent150. For example, the marker115may be an example of a proximal anchoring component such that the marker115may be configured to compress the proximal portion155of the stent150between the marker115and the outer sheath105.

The electrocautery tip125may be an example of a distal cutting element coupled with the distal end140of the inner tubular member130and configured to create the access site in the wall of the body lumen. The electrocautery tip125may include a coiled electrode wire that extends radially around a circumference of a distal end of the electrocautery tip125, a single electrode wire that extends longitudinally and in a proximal direction from a distal end of the electrocautery tip125, a single, spiral electrode wire that extends around a distal end of the electrocautery tip125, or an electrode tube. In some case, the electrocautery tip125may include a tapered cover disposed around the electrocautery tip125. The outer sheath105may at least partially overlap the tapered cover.

The guidewire145is generally a flexible elongate member configured to slidably advance through the internal lumen of the inner tubular member130. In such cases, the guidewire145may be disposed within the inner tubular member130. The guidewire145may be uniform in size and stiffness along its entire length, or alternatively, may include sections of differing stiffness.

FIG.2illustrates a stent200with flared portions in accordance with aspects of the present disclosure. The stent200may be configured to restore luminal flow across narrowed areas or blockages within a body lumen, as described with reference toFIG.1. The stent200may be sized or otherwise adapted to be placed within any body lumen, 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 treatment. In some cases, the stent200may be placed within the body lumen by a stent delivery system, as described with reference toFIG.1. The stent200may be an example of stent150as described with reference toFIG.1.

The stent200may be categorized as having a proximal portion155-a, which may, for example, be placed within a duodenum, and a distal portion160-awhich may, for example, be placed within a biliary duct. The stent200may include a stent body205that has a diameter245and a length240in a deployed configuration. The stent body205may extend between the distal portion160-aand the proximal portion155-a. The stent body205may include a distal end260and a proximal end265. In such cases, the stent body205may extend between the distal end260and the proximal end265. The stent body205may be an example of a mid-body portion of the stent200that includes a narrow region between a first flared portion210and a second flared portion215.

The stent200may include a first anchoring member (e.g., first flared portion210) coupled with a distal end260of the stent body205. The first flared portion210may be configured to increase a diameter of the distal portion160-aof the stent body205to a second diameter255greater than the first diameter245. In such cases, the diameter255of the first flared portion210may be greater than a diameter245of the stent body205in the deployed configuration. The first flared portion210may be coupled with a distal end260of the stent body205and spaced around a circumference of the distal end260of the stent body205.

The stent200may include a second anchoring member (e.g., a second flared portion215) coupled with a proximal portion155-aof the stent body205. The second flared portion215may be configured to increase a diameter of the proximal portion155-aof the stent body205to a second diameter255greater than the first diameter245. In such cases, the diameter255of the second flared portion215may be greater than a diameter245of the stent body205in the deployed configuration. The second flared portion215may be coupled with a proximal end265of the stent body205and spaced around a circumference of the proximal end265of the stent body205.

In some cases, a length250of the first flared portion210may be greater than a length270of the second flared portion215. In other examples, the length250of the first flared portion210may be equal to a length270of the second flared portion215. For example, the first flared portion210may have a length250ranging from 3 mm to 15 mm. The second flared portion215may have a length270ranging from 3 mm to 15 mm. In some examples, the length270of the second flared portion215may be shorter than the length250of the first flared portion210. The diameter255of the first flared portion210may be the same as the diameter of the second flared portion215. In some cases, the diameter255of the first flared portion210may be different than the diameter of the second flared portion215. The first flared portion210and the second flared portion215may include the helical wrapping pattern220.

The first flared portion210and second flared portion215may respectively bridge each end of the stent200(e.g., the proximal end265and the distal end260) to the stent body205. For example, the first flared portion210may bridge the stent body205with the distal end260of the stent200. The second flared portion215may bridge the stent body205with the proximal end265of the stent200. In some cases, the transition between the narrower diameter245of the stent body205and the wider diameters255of the first flared portion210and the second flared portion215may be gradual or steep. The first flared portion210and the second flared portion215may enable the stent200to resist migration within the body lumen by expanding from a undeployed configuration to a deployed configuration, as described with reference toFIG.6. The stent body205may bridge the two body lumens, and the first flared portion210and the second flared portion215may act as anti-migration tool to prevent the stent200from moving further into either body lumen. Using the first flared portion210and the second flared portion215as an anti-migration tool may be less invasive to the body tissue compared to other anti-migration tools used in stents.

The stent200may include a helical wrapping pattern220that may be at least partially covered with a cover material225. The helical wrapping pattern220may be configured to reduce a foreshortening of the stent body205upon deployment from an undeployed configuration to the deployed configuration to less than ten percent of a length240of the stent body205in the undeployed configuration. In such cases, the length240of the stent body205may be maintained before deployment and after deployment to ensure accurate and precise placement with the body lumen. The stent200may be an example of a non-foreshortening stent.

The helical wrapping pattern220may include a single wire. The single wire of the helical wrapping pattern220may be made from any number of metallic materials including, but not limited to, titanium, nitinol, or stainless steel. It should be appreciated that other metallic or non-metallic materials may be used to construct the stent200that provide suitable flexibility, stiffness, and biocompatibility. The single wire may be helically wrapped around the stent200such that the helical wrapping pattern220extends from the proximal portion155-aand to the distal portion160-a. In some cases, using the single wire may improve the structural stability of the stent200as compared to a multi-wire stent. In some cases, the helical wrapping pattern220may enable the stent200to evenly withstand pressure across the entire body of the stent200. The helical wrapping pattern220may define at least two diameters of the stent200(e.g., diameter255of the first flared portion210and diameter245of the stent body205). In some cases, the diameter245of the stent body205may range from 5 mm to 10 mm. The diameter255of the first flared portion210may range from 8 mm to 14 mm.

In some examples, the cover material225may fully cover the stent200. For example, the cover material225may cover an entire portion of the stent body205, the first flared portion210, and the second flared portion215. In some examples, the cover material225may at least partially cover the stent body205, the first flared portion210, the second flared portion215, or a combination thereof. The cover material225may cover the helical wrapping pattern220to protect the body lumen from the metallic contact of the single wire of the helical wrapping pattern220. In such cases, the cover material225may be more biocompatible with the body lumen than the metal of the single wire of the helical wrapping pattern220. The cover material225may be made from any number of materials including, but not limited to, expanded polytetrafluoroethylene-fluoroethylene-propylene (ePTFE-FEP), a plastic material, or silicone. In some cases, the cover material225may include one or more layers. For example, the cover material225may include layers of ePTFE which may include pores and layers of FEP which may enable the stent200to be impermeable to certain pressure levels. In some cases, the cover material225may be selected to be thin enough to achieve a smaller profile of the constrained diameter245of the stent body205. For example, the smaller profile of the stent body205may enable a more efficient stent delivery.

In some examples, the cover material225may include cut-out drainage holes, such as the drainage holes230. In some cases, the drainage holes230may enable fluid drainage into the body lumen, which may increase the efficiency of the stent200. In some cases, the drainage holes230may enable drainage across a duct where stent placement may be desired. In some cases, the placement of the drainage holes230at the distal portion160-aof the stent200may enable bile drainage while also preventing food or other debris from traveling up the lumen of the stent200, thereby causing an occlusion. In some cases, the drainage holes230may be disposed within the second flared portion215and the proximal portion155-aof the stent body205. In such cases, the drainage holes230may be interspersed around the circumference of the stent200near the proximal end265. In some cases, one or more drainage holes230may be laser cut into the cover material225. In some cases, the drainage holes230may be a triangular shape and located at each point of the helical wrapping pattern220of the single wire. In some cases, the drainage holes230may be disposed within the proximal portion155-a, the stent body205, the distal portion160-a, or a combination thereof.

The stent200may include marker bands235. The marker bands235may be placed at each section of the stent200. For example, the marker bands235may be disposed around the stent body205, the first flared portion210, and the second flared portion215. The marker bands235may aid in stent placement, as described with reference toFIGS.1and6. In some cases, the marker bands235may be made from any number of metallic materials including, but not limited to, gold. In such cases, the marker bands235may enable visual differentiation from the cover material225as well as the gold material of the marker bands235being more biocompatible with the body lumen than other metals.

The stent200may be made from any number of materials, combinations of materials, and constructions. In some examples, the stent200may be a laser-cut stent formed from a single metallic tube with regions cut way for increased flexibility. For example, the helical wrapping pattern220may include a laser cut frame. In some examples, the stent200may be a wire-formed stent formed by one or more helically wrapped wires, as described with reference toFIG.3. It may be appreciated that the different stent constructions may exhibit particular characteristics such as radial expansive force, flexibility, reduced foreshortening, or migration resistance that may render a certain construction advantageous for a particular use.

FIG.3illustrates a stent300with more than one wire frame305in accordance with aspects of the present disclosure. The stent300may be configured to restore luminal flow across narrowed areas or blockages within a body lumen, as described with reference toFIGS.1and2. The stent300may be sized or otherwise adapted to be placed within any body lumen, 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 treatment. In some cases, the stent300may be placed within the body lumen by a stent delivery system, as described with reference toFIG.1. The stent300may be an example of stent150as described with reference toFIG.1.

The stem300may be categorized as having a proximal portion155-b, which may, for example, be placed within a duodenum, and a distal portion160-bwhich may, for example, be placed within a biliary duct. The stent300may include a stent body205-bthat has a diameter245-aand a length240-ain a deployed configuration. The stent body205-amay extend between the distal portion160-band the proximal portion155-b. The stent body205-amay include a distal end260-aand a proximal end265-a. In such cases, the stent body205-amay extend between the distal end260-aand the proximal end265-a. The stent body205-amay be an example of a mid-body portion of the stent300that includes a narrow region between a first flared portion210-aand a second flared portion215-a.

The stent30) may include a first anchoring member (e.g., first flared portion210-a) coupled with a distal end260-aof the stent body205-a. The first flared portion210-amay be configured to increase a diameter of the distal portion160-bof the stent body205-ato a second diameter255-agreater than the first diameter245-a. In such cases, the diameter255-aof the first flared portion210-amay be greater than a diameter245-aof the stent body205-ain the deployed configuration. The first flared portion210-amay be coupled with a distal end260-aof the stent body205-aand spaced around a circumference of the distal end260-aof the stent body205-a.

The stent300may include a second anchoring member (e.g., a second flared portion215-a) coupled with a proximal portion155-bof the stent body205-a. The second flared portion215-amay be configured to increase a diameter of the proximal portion155-bof the stent body205-ato a second diameter255-agreater than the first diameter245-a. In such cases, the diameter255-aof the second flared portion215-amay be greater than a diameter245-aof the stent body205-ain the deployed configuration. The second flared portion215-amay be coupled with a proximal end265-aof the stent body205-aand spaced around a circumference of the proximal end265-aof the stent body205-a.

In some cases, a length250-aof the first flared portion210-amay be equal to a length270-aof the second flared portion215-a. The diameter255-aof the first flared portion210-amay be the same as the diameter of the second flared portion215-a. In some cases, the diameter255-aof the first flared portion210-amay be different than the diameter of the second flared portion215-a. The first flared portion210-aand the second flared portion215-amay include the helical wrapping pattern220-a.

The first flared portion210-aand second flared portion215-amay respectively bridge each end of the stent300(e.g., the proximal end265-aand the distal end260-a) to the stent body205-a. For example, the first flared portion210-amay bridge the stent body205-awith the distal end260-aof the stent200-a. The second flared portion215-amay bridge the stent body205-awith the proximal end265-aof the stent200-a. In some cases, the transition between the narrower diameter245-aof the stent body205-aand the wider diameters255-aof the first flared portion210-aand the second flared portion215-amay be gradual or steep. The first flared portion210-aand the second flared portion215-amay enable the stent300to resist migration within the body lumen by expanding from a undeployed configuration to an deployed configuration, as described with reference toFIG.6. The stent body205-amay bridge the two body lumens, and the first flared portion210-aand the second flared portion215-amay act as anti-migration tool to prevent the stent200from moving further into either body lumen. Using the first flared portion210-aand the second flared portion215-aas an anti-migration tool may be less invasive to the body tissue compared to other anti-migration tools used in stents.

The helical wrapping pattern220-amay include more than one wire frame305. For example, the helical wrapping pattern220-amay include wire frame305-a,305-b, and305-c. The series of wire frames305may extend along the entire length of the stent300. In some cases, the wire frames305may be welded together at one or more points along the stent body205-a. In some cases, each of the wire frames305may be separate from each other wire frame305. For example, wire frame305-amay be a separate wire from wire frame305-b, and wire frame305-bmay be separate from wire frame305-c. In some cases, more than one wire frame305may be grouped together to form a sub-unit of wire frames305. In such cases, stent300may include more than one sub-unit of wire frames305. In some examples, the first flared portion210-amay include a wire frame305-c, the stent body205-amay include at least a wire frame305-b, and the second flared portion215-bmay include a wire frame305-a. In such cases, the stent300may include three sub-units of wire frames305. In some cases, the wire frame305-bof the stent body205-amay be disconnected from wire frame305-aand wire frame305-c. In such cases, the wire frames305-a,305-b, and305-cmay be connected via the cover material225-a.

The wire frames305of the helical wrapping pattern220-amay be made from any number of metallic materials including, but not limited to, titanium, nitinol, or stainless steel. It should be appreciated that other metallic or non-metallic materials may be used to construct the stent300that provide suitable flexibility, stiffness, and biocompatibility. The wire frames305may be wrapped around the stent300such that the helical wrapping pattern220-aextends from the proximal portion155-band to the distal portion160-b. The wire frames305may define at least two diameters of the stent300(e.g., diameter255-aof the first flared portion210-aand diameter245-aof the stent body205-a).

In some cases, the wire frames305may each include different diameters (e.g., thickness) of the wires. For example, the wire frame305-balong the stent body205-amay include a diameter different than the wire frame305-cand wire frame305-aat the first flared portion210-aand the second flared portion215-a, respectively. In some cases, the wire frames305-aand305-c(e.g., the wire frames305located at each end of the stent300) may include a diameter larger than the diameter of the wire frame305-bof the stent body205-a.

In some examples, the cover material225-amay fully cover the stent300. For example, the cover material225-amay cover an entire portion of the stent body205-a, the first flared portion210-a, and the second flared portion215-a. In some examples, the cover material225-amay at least partially cover the stent body205-a, the first flared portion210-a, the second flared portion215-a, or a combination thereof. The cover material225-amay cover the helical wrapping pattern220-ato protect the body lumen from the metallic contact of the more than one wire frames305of the helical wrapping pattern220-a. In such cases, the cover material225-amay be more biocompatible with the body lumen than the metal of the more than one wire frame305of the helical wrapping pattern220-a.

The cover material225-amay be made from any number of materials including, but not limited to, expanded polytetrafluoroethylene-fluoroethylene-propylene (ePTFE-FEP), a plastic material, or silicone. In some cases, the cover material225-amay be selected to be thin enough to achieve a smaller profile of the constrained diameter245-aof the stent body205-a. For example, the smaller profile of the stent body205-amay enable a more efficient stent delivery. In some cases, the cover material225-amay provide the connective material between adjacent wire frames305. For example, the overall structure of the stent300may be provided by the combination of the wire frames305and the cover material225-a. In some cases, the stent300may include drainage holes.

The stent300may be made from any number of materials, combinations of materials, and constructions. It may be appreciated that the different stent constructions may exhibit particular characteristics such as radial expansive force, flexibility, reduced foreshortening, or migration resistance that may render a certain construction advantageous for a particular use.

FIG.4illustrates a stent400with anchoring fins in accordance with aspects of the present disclosure. The stent400may be configured to restore luminal flow across narrowed areas or blockages within a body lumen, as described with reference toFIGS.1-3. The stent400may be sized or otherwise adapted to be placed within any body lumen, 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 treatment. In some cases, the stent400may be placed within the body lumen by a stent delivery system, as described with reference toFIG.1. The stent400may be an example of stent150as described with reference toFIG.1.

The stent400may be categorized as having a proximal portion155c, which may, for example, be placed within a duodenum, and a distal portion160-cwhich may, for example, be placed within a biliary duct. The stent400may include a stent body205-bthat has a diameter245-band a length240-bin a deployed configuration. The stent body205-bmay extend between the distal portion160-cand the proximal portion155-c.

The stent400may include a first anchoring member (e.g., first fin420) coupled with a distal portion160-cof the stent400. The first fin420may protrude from the distal portion160-cof the stent body205-band extend in a distal direction. In some cases, the first fin420may extend in a proximal direction. The first fin420may be configured to increase a diameter of the distal portion160-cof the stent body205-bto a second diameter255-bgreater than the first diameter245-b. In such cases, the diameter255-bof the first fin420may be greater than a diameter245-bof the stent body205-bin the deployed configuration.

The stent400may include a second anchoring member (e.g., second fin415) coupled with a proximal portion155-cof the stent400. The second fin415may protrude from the proximal portion155-cof the stent body205-band extend in a proximal direction. In some cases, the second fin415may extend in a distal direction. The second fin415may be configured to increase a diameter of the proximal portion155-cof the stent body205-bto a second diameter255-bgreater than the first diameter245-b. In such cases, the diameter255-bof the second fin415may be greater than a diameter245-bof the stent body205-bin the deployed configuration. In some cases, a distance that the second fin415extends from the surface of the stent body205-bmay be different than a distance that the first fin420extends from the surface of the stent body205-b. In some examples, the distance that the second fin415extends from the surface of the stent body205-bmay be the same as a distance that the first fin420extends from the surface of the stent body205-b.

The first fin420and the second fin415may enable the stent400to resist migration within the body lumen by expanding from a undeployed configuration to an deployed configuration, as described with reference toFIG.6. The stent body205-bmay bridge the two body lumens, and the first fin420and the second fin415may act as anti-migration tool to prevent the stent400from moving further into either body lumen. Using the first fin420and the second fin415as an anti-migration tool may be less invasive to the body tissue compared to other anti-migration tools used in stents. In some cases, compared with the anchoring members as described with referenceFIGS.2and3, the first fin420and the second fin415may allow for a smaller constrained profile of the stent400when the stent400is loaded in the delivery system, as described with reference toFIG.1.

The stent400may include a helical wrapping pattern220-bthat may be at least partially covered with a cover material225-b. The helical wrapping pattern220-bmay be configured to reduce a foreshortening of the stent body205-bupon deployment from an undeployed configuration to the deployed configuration to less than ten percent of a length240-bof the stent body205-bin the undeployed configuration. In such cases, the length240-bof the stent body205-bmay be maintained before deployment and after deployment to ensure accurate and precise placement with the body lumen. The stent400may be an example of a non-foreshortening sten.

The helical wrapping pattern220-bmay include first wire frames405and second wire frames410. The first wire frames405may include at least first wire frames405-a,405-b,405-c, and405-d. The first wire frames405may wrap around a first portion425of the circumference of the stent body205-b. For example, the first portion425of the circumference of the stent body205-bmay include a top half (e.g., hemisphere) of the stent body205-bthat extends from a midpoint on a first side of the stent body205-b, over the top of the stent body205-b, and to a midpoint on a second side of the stent body205-b. In such case, the first wire frames405include half rings that form half of the circumference of the stent400. In some cases, the first wire frame405-amay include the second fin415, and the first wire frame405-dmay include the first fin420.

The first fin420may be formed by bending and/or shape setting a crown of the helical wrapping pattern220-b. For example, a crown (e.g., point) of the first wire frame405-dmay be bent out of a plane of the stent body205-bsuch that the angle of the first fin420may range from 30 degrees to 55 degrees relative to the plane parallel to a central axis of the stent body205-b. In some examples, the second fin415may be formed by bending and/or shape setting a crown of the helical wrapping pattern220-b. For example, a crown (e.g., point) of the first wire frame405-amay be bent out of a plane of the stent body205-bsuch that the angle of the second fin415may range from 30 degrees to 55 degrees relative to the plane parallel to a central axis of the stent body205-b.

The second wire frames410may include at least second wire frames410-a.410-b,410-c,410-d, and410-e. The second wire frames410may wrap around a second portion430of the circumference of the stent body205-b. For example, the second portion430of the circumference of the stent body205-bmay include a bottom half (e.g., hemisphere) of the stent body205-bthat extends from the midpoint on the first side of the stent body205-b, over the bottom of the stent body205-b, and to the midpoint on the second side of the stent body205-b. In such case, the second wire frames410include half rings that form half of the circumference of the stent400. In some cases, the second wire frames410may include the first fin420and the second fin415. In some examples, the first wire frame405may include the first fin420, and the second wire frame410may include the second fin415, or vice versa.

The first wire frames405and the second wire frames410may be connected across the length240-bof the stent body205-b. For example, the first wire frame405-amay be connected (e.g., welded) to both the second wire frame410-aand the second wire frame410-b. The second wire frame410-bmay be connected to both the first wire frame405-aand the first wire frame405-b. By connecting first wire frames405and second wire frames410in a staggered fashion along the length240-bof the stent body205-b(e.g., in a zig-zag pattern), the stent400may have improved structural integrity while maintaining flexibility. The welding of first wire frames405and second wire frames410may also contribute to increased axial stiffness of the stent400, which may help prevent compression during deployment and thereby improve deployment accuracy.

The first wire frames405and the second wire frames410of the helical wrapping pattern220-bmay be made from any number of metallic materials including, but not limited to, titanium, nitinol, or stainless steel. It should be appreciated that other metallic or non-metallic materials may be used to construct the stent400that provide suitable flexibility, stiffness, and biocompatibility. The first wire frames405and the second wire frames410may be helically wrapped around the stent400such that the helical wrapping pattern220-bextends from the proximal portion155-cand to the distal portion160-c. In some cases, the helical wrapping pattern220-bmay enable the stent400to evenly withstand pressure across the entire body of the stent400.

In some cases, the cover material225-bmay be disposed onto an entire portion of the stent body205-b, a first fin420(e.g., a first anchoring member), and a second fin415(e.g., a second anchoring member). In such cases, the cover material225-bmay fully cover the stent400. The cover material225-bmay cover the helical wrapping pattern220-bto protect the body lumen from the metallic contact of the first wire frames405and the second wire frames410of the helical wrapping pattern220-b. In such cases, the cover material225-bmay be more biocompatible with the body lumen than the metal of the first wire frames405and the second wire frames410of the helical wrapping pattern220-b. The cover material225-bmay be made from any number of materials including, but not limited to, expanded polytetrafluoroethylene-fluoroethylene-propylene (ePTFE-FEP), a plastic material, or silicone. In some cases, the cover material225-bmay be selected to be thin enough to achieve a smaller profile of the constrained diameter245-bof the stent body205-b. For example, the smaller profile of the stent body205-bmay enable a more efficient stent delivery.

The stent400may be made from any number of materials, combinations of materials, and constructions. In some examples, the stent400may be a laser-cut stent formed from a single metallic tube with regions cut away for increased flexibility. For example, the helical wrapping pattern220-bmay include one or more laser-cut frames. In some examples, each of the first wire frames405and each of the second wire frames410may be an example of a laser-cut frame. It may be appreciated that the different stent constructions may exhibit particular characteristics such as radial expansive force, flexibility, reduced foreshortening, or migration resistance that may render a certain construction advantageous for a particular use.

FIG.5illustrates a hybrid stent500in accordance with aspects of the present disclosure. The stent500may be configured to restore luminal flow across narrowed areas or blockages within a body lumen, as described with reference toFIGS.1-4. The stent500may be sized or otherwise adapted to be placed within any body lumen, 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 treatment. In some cases, the stent500may be placed within the body lumen by a stent delivery system, as described with reference toFIG.1. The stent500may be an example of stent150as described with reference toFIG.1.

The stent500may be categorized as having a proximal portion155-d, which may, for example, be placed within a duodenum, and a distal portion160-dwhich may, for example, be placed within a biliary duct. The stent500may include a stent body205-cthat has a diameter245-cand a length240cin a deployed configuration. The stent body205-cmay extend between the distal portion160-dand the proximal portion155-d. The stent body205-cmay include a distal end260-b. The stent body205-cmay be an example of a mid-body portion of the stent500that includes a narrow region as compared to a flared portion510.

The stent500may include a first anchoring member (e.g., flared portion510) coupled with a distal end260-bof the stent body205-c. The flared portion510may be configured to increase a diameter of the distal portion160-dof the stent body205-cto a second diameter255-cgreater than the first diameter245-c. In such cases, the diameter255-cof the flared portion510may be greater than a diameter245-cof the stent body205-cin the deployed configuration. The flared portion510may be coupled with a distal end260-bof the stent body205-band spaced around a circumference of the distal end260-bof the stent body205-c.

The flared portion510and the proximal portion155-dmay respectively bridge each end of the stent500(e.g., the proximal end and the distal end260-b) to the stent body205-c. For example, the flared portion510may bridge the stent body205-cwith the distal end260-bof the stent500. In some cases, the transition between the narrower diameter245-cof the stent body205-cand the wider diameter255-cof the flared portion510may be gradual or steep. The flared portion510may enable the stent50M) to resist migration within the body lumen by expanding from a undeployed configuration to an deployed configuration, as described with reference toFIG.6. The stent body205-cmay bridge the two body lumens, and the flared portion510may act as anti-migration tool to prevent the stent500from moving further into either body lumen. Using the flared portion510as an anti-migration tool may be less invasive to the body tissue compared to other anti-migration tools used in stents.

The stent500may include a helical wrapping pattern220-cthat may be at least partially covered with a cover material225-c. The helical wrapping pattern220-cmay be configured to reduce a foreshortening of the stent body205-cupon deployment from an undeployed configuration to the deployed configuration to less than ten percent of a length240-cof the stent body205-cin the undeployed configuration. In such cases, the length240-cof the stent body205-cmay be maintained before deployment and after deployment to ensure accurate and precise placement with the body lumen. The portion of the stent500with the helical wrapping pattern220-cmay be an example of a non-foreshortening stent.

The helical wrapping pattern220-cmay include a single wire. The single wire of the helical wrapping pattern220-cmay be made from any number of metallic materials including, but not limited to, titanium, nitinol, or stainless steel. It should be appreciated that other metallic or non-metallic materials may be used to construct the stent500that provide suitable flexibility, stiffness, and biocompatibility. The single wire may be helically wrapped around the stent500such that the helical wrapping pattern220-cextends from the proximal portion155-cand to the distal end260-b. In some cases, using the single wire may improve the structural stability of the stent500as compared to a multi-wire stent. In some cases, the helical wrapping pattern220-cmay enable the stent500to evenly withstand pressure across the entire body of the stent500.

In some examples, the cover material225-cmay cover the stent body205-cthat includes the helical wrapping pattern220-c. For example, the cover material225-cmay cover an entire portion of the stent body205-c. In some examples, the cover material225-cmay at least partially cover the stent body205-c. The cover material225-cmay cover the helical wrapping pattern220-cto protect the body lumen from the metallic contact of the single wire of the helical wrapping pattern220-c. In such cases, the cover material225-cmay be more biocompatible with the body lumen than the metal of the single wire of the helical wrapping pattern220-c. The cover material225-cmay be made from any number of materials including, but not limited to, expanded polytetrafluoroethylene-fluoroethylene-propylene (ePTFE-FEP), a plastic material, or silicone. In some cases, the cover material225-cmay be selected to be thin enough to achieve a smaller profile of the constrained diameter245-cof the stent body205-c. For example, the smaller profile of the stent body205-cmay enable a more efficient stent delivery.

The stent500may include a braided wrapping pattern505. The braided wrapping pattern505may be coupled with the distal end260-bof the stent body205-c. In such cases, the braided wrapping pattern505may be located at the distal portion160-dof the stent500. The braided wrapping pattern505may include a braided frame. The braided frame may be made from a plurality of wires joined together in a cross-hatch configuration. The braided frame of the braided wrapping pattern505may be made from any number of metallic materials including, but not limited to, titanium, nitinol, or stainless steel. In some cases, the helical wrapping pattern220-cand the braided wrapping pattern505may be made from the same material or different materials.

The braided wrapping pattern505may be uncovered from the cover material225-c. In some cases, the entire stent500may uncovered by the cover material225-c. The stent500may be categorized as a hybrid design (e.g., including both the helical wrapping pattern220-cand the braided wrapping pattern505). In some examples, the braided wrapping pattern505may be connected to the helical wrapping pattern220-cvia one or more wires looped through the ends of the helical wrapping pattern220-cat the distal end260-b.

The braided wrapping pattern505include the flared portion510. In some examples, the flared portion510of the braided wrapping pattern505may include a 90 degree flare, a 45 degree flare, or a star-shaped flare. In some examples, the braided wrapping pattern505may include one or more fins as additional anti-migration tools, as described with reference toFIG.4.

The stent500may be made from any number of materials, combinations of materials, and constructions. It may be appreciated that the different stent constructions may exhibit particular characteristics such as radial expansive force, flexibility, reduced foreshortening, or migration resistance that may render a certain construction advantageous for a particular use.

FIG.6illustrates a stent delivery system600with the stent150-afully deployed in accordance with aspects of the present disclosure. The stent delivery system600may generally include the stent150-a, which may be examples of the corresponding stents described with reference toFIGS.1through5.

The stent delivery system600may be configured to place a stent150-awithin a first body lumen605to restore luminal flow from a first body lumen605to a second body lumen610, thereby bypassing narrowed areas or blockages within at least the first body lumen605. The stent delivery system600may be sized or otherwise adapted to place a stent within any body lumen, 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 treatment.

The illustrated portions of the system include the first body lumen605(e.g., a common bile duct), which drains bile from both the cystic duct (which drains from the gallbladder) and the common hepatic duct (which drains from the liver) into the second body lumen610(e.g., duodenum), where the bile mixes and reacts with digesting food. A clinician may advance an endoscope (e.g., an EUS endoscope) into the lumen of a patient's duodenum (e.g., second body lumen610) to a position in which the bile ducts may be visualized (e.g., via endosonography). The clinician may then access the common bile duct (e.g., first body lumen605) by advancing a separate access device from a working channel of the endoscope, through the wall625of the duodenum (i.e., trans-duodenally), and then through the wall620of the common bile duct.

The stent delivery system600may be configured for choledochoduodenostomy (CDS) and hepaticogastrostomy (HGS) procedures in which the stent150-ais implanted across two tissues layers (e.g., duodenum to common bile duct or stomach to intrahepatic duct). In some cases, the stent delivery system600may be configured for transmittal biliary drainage. In such cases, the stent150-amay bridge between the second body lumen610(e.g., the duodenum) and a portion of the first body lumen605(e.g., the biliary duct) to create a bridge to bypass an obstruction. The obstruction may be an example of a distal malignant biliary obstruction that obstructs drainage. For example, the stent delivery system600may be configured to provide access to at least the common biliary duct to facilitate subsequent procedures to treat narrowed areas or blockages within the bile duct and create a bypass around the narrowed areas or blockages within the bile duct to provide access to the stomach and from the biliary duct via the stent150-a.

The distal portion160-eof the stent150-amay include the first flared portion210-b. In such cases, the first flared portion210-bmay expand within the first body lumen605in direct response to retracting the outer sheath (not shown) past the anchoring component (not shown). As the outer sheath is removed through the access site615, the distal portion160-eof the stent150-aexpands to expose the first flared portion210-b. As the distal portion160-eof the stent150-aexpands, the first flared portion210-bcontacts the wall620of the first body lumen605. The first flared portion210-b(e.g., distal portion160-e) of the stent150-amay be anchored within the first body lumen605such that the distal portion160-eof the stent150-aremains in a fixed position. In that case, the distal portion160-cprevents the stent150-afrom being further withdrawn through the access site615. The clinician may be able to feel the resistance of the first flared portion210-bagainst the first body lumen605and may therefore infer the location of the stent150-a. Additionally or alternatively, the distal portion160-eof the stent150-amay be viewed under fluoroscopy or similar imaging techniques to infer the location of the stent150-a.

The distal portion160-cof the stent150-amay deploy in a same location as compared to a location prior to retracting the outer sheath. In the case of a non-foreshortening stent, the stent150-amay deploy at a same location that the stent150-ais placed within the first body lumen605. Once the outer sheath is retracted, the distal portion160-cof the stent150-amay expand into the first body lumen605and anchor itself to the first body lumen605. In such cases, the anchored distal portion160-cof the stent150-amay maintain the stent in a stationary position as the outer sheath is retracted.

To deploy the stent150-awithin the first body lumen605and second body lumen610, the outer sheath may be retracted past a distal end of the marker (not shown). In the case of a non-foreshortening stent, the stent150-aexpands to contact the inner surface of the first body lumen605and the inner surface of the second body lumen610such that the stent150-aforms a bridge between the first body lumen605and the second body lumen610.

The proximal portion155-cof the stent150-amay expand from within the outer sheath such that upon fully exiting the outer sheath, the proximal portion155-eexpands to a deployed configuration within the second body lumen610. In such cases, the entire portion of the stent150-amay expand such that at least a portion of the stent150-aextends through the first body lumen605and into the second body lumen610.

The outer sheath may be retracted to a second position (e.g., past the distal end of the marker), and the proximal portion155-eof the stent150-amay deploy in a same location as compared to a location prior to retracting the outer sheath. In the case of a non-foreshortening stent, the stent150-amay deploy at a same location that the stent150-ais placed within the second body lumen610. Once the outer sheath is retracted, the proximal portion155-eof the stent150-amay expand into the second body lumen610and anchor itself to the second body lumen610. In such cases, the anchored proximal portion155-eof the stent150-amay maintain the stent150-ain a stationary position.

The proximal portion155-eof the stent150-amay include a second flared portion215-b. In such cases, the second flared portion215-bmay expand within the second body lumen610in direct response to retracting the outer sheath. The proximal portion155-eof the stent150-amay expand to expose the second flared portion215-b. As the proximal portion155-eof the stent150-aexpands, the second flared portion215-bcontacts the wall625of the second body lumen610. The second flared portion215-b(e.g., proximal portion155-e) of the stent150-amay be anchored within the second body lumen610such that the proximal portion155-cof the stent150-aremains in a fixed position.

The first flared portion210-b(e.g., distal portion160-e) of the stent150-amay be anchored within the first body lumen605such that the distal portion160-eof the stent150-aremains in a fixed position. In such cases, the distal portion160-cof the stent150-amay be compressed against the wall620of the first body lumen605after deploying the distal portion160-eof the stent150-afrom the outer sheath. Furthermore, the stent150-amay at least partially cover the access site9615.

The second flared portion215-b(e.g., proximal portion155-e) of the stent150-amay be anchored within the second body lumen610such that the proximal portion155-cof the stent150-aremains in a fixed position. In such cases, the proximal portion155-cof the stent150-amay be compressed against the wall625of the second body lumen610after expanding the proximal portion155-eof the stent150-afrom within the outer sheath. Furthermore, the stent150-amay at least partially cover the access site of the second body lumen610.

It should be noted that these methods describe possible implementation, and that the operations and the steps may be rearranged or otherwise modified such that other implementations are possible. In some examples, aspects from two or more of the methods may be combined. For example, aspects of each of the methods may include steps or aspects of the other methods, or other steps or techniques described herein.

While several embodiments of the present disclosure have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means or structures for performing the functions or obtaining the results or one or more of the advantages described herein, and each of such variations or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, or configurations will depend upon the specific application or applications for which the teachings of the present disclosure is/are used.

Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the disclosure described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the disclosure may be practiced otherwise than as 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, if such features, systems, articles, materials, kits, or methods are not mutually inconsistent, is included within the scope of the present disclosure.

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

The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” Also, as used herein, including in the claims, “or” as used in a list of items (for example, a list of items prefaced by a phrase such as “at least one of” or “one or more”) indicates an inclusive list such that, for example, a list of at least one 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).