Stent system

Abstract

The stent system may include a stent including a first leg having a first end fixedly attached to a distal end of the body portion and extending distally from the distal end of the body portion in a deployed configuration, and a second leg having a first end fixedly attached to the distal end of the body portion and extending distally from the distal end of the body portion in a deployed configuration. The second leg may extend proximally from the distal end of the body portion in a delivery configuration. The stent system may include a bifurcated delivery sheath and two guidewires for simultaneously delivering the two stents. The method of treating a body lumen may include delivering a contrast agent including an antigas agent while implanting a stent in the body lumen.

Description

Technical Field

[0001] The present disclosure relates to medical devices and methods of manufacturing and / or using medical devices. More particularly, the present disclosure relates to an improved design of an endoprosthesis or stent.

Background Art

[0002] Currently available braided or woven self-expanding stents can exhibit significant longitudinal flexibility due to their design and the length of the device. This can be advantageous, particularly for the purpose of device delivery in more tortuous anatomical regions, and can also be advantageous for reducing post-delivery lumen straightening, which is typically considered to cause less trauma to the target lumen. Uncoated metallic endoprostheses or stents may be left in place for chronic conditions but are generally not removable. Plastic endoprostheses or stents are prone to occlusion, which may require repeated procedures (one or more times), and sometimes cannot open the stenosis that initially caused the occlusion of the affected body lumen (e.g., bile duct, pancreatic duct, etc.). In addition, the biliary system has several branches, bifurcations, and / or adjacent lumens. Placing an endoprosthesis or stent within or across a bifurcation can present additional and / or different challenges. Conventionally, placing an endoprosthesis or stent in a bifurcation may require several steps, introduction, removal, and / or replacement of devices and instruments, connection and / or disconnection by a fluid management device, etc. In some cases, air bubbles can be introduced into the surgical instruments, tools, and / or the body lumen during the procedure. Air bubbles are undesirable because they can obscure the physician's view and / or pose a risk to the patient. There is still a need to provide alternative endoprosthesis or stent systems, as well as alternative methods for manufacturing and using endoprosthesis or stent systems.

Summary of the Invention

[0003] In one example, the stent system may comprise a stent configured to transition between a delivery configuration and a deployed configuration. The stent has a body portion with a proximal end and a distal end, and a first end fixedly attached to the distal end of the body portion and a second end opposite the first end. In the deployed configuration, the stent has a first leg extending distally from the distal end of the body portion, and a second leg having a first end fixedly attached to the distal end of the body portion and a second end opposite the first end, and extending distally from the distal end of the body portion in the deployed configuration. In the delivery configuration, the second leg extends proximally from the distal end of the body portion.

[0004] Additionally or alternatively to the examples described herein, in the delivery configuration, the second leg is inverted within the body portion such that the second leg extends proximally from the distal end of the body portion within the body portion.

[0005] Additionally or alternatively to the examples described herein, the stent system may comprise an elongate shaft having a lumen extending therethrough. The stent may be disposed within the lumen in the delivery configuration. The stent may be configured to transition from the delivery configuration to the deployed configuration when the stent is disposed outside the lumen.

[0006] Additionally or alternatively to the examples described herein, the stent system may comprise a first mandrel slidably disposed within the lumen and a second mandrel slidably disposed within the lumen alongside the first mandrel. The first mandrel is at least partially disposed within the first leg, and the second mandrel is at least partially disposed within the second leg.

[0007] Additionally or alternatively to the examples described herein, a first guide wire is slidably disposed within a first lumen extending through the first mandrel. Additionally or alternatively to the examples described herein, a second guide wire is slidably disposed within a second lumen extending through the second mandrel.

[0008] Additionally or alternatively to the examples described herein, the second mandrel is configured to move the stent from a delivery configuration to a deployed configuration. Additionally or alternatively to the examples described herein, the second mandrel includes a distally facing shoulder configured to engage the second end of the second leg in the delivery configuration such that advancement of the second mandrel distally causes the second leg to turn inside out and the stent to transition toward the deployed configuration.

[0009] Additionally or alternatively to the examples described herein, the distal portion of the first mandrel has a D-shaped cross-section with a first flat side, and the distal portion of the second mandrel has a D-shaped cross-section with a second flat side, and the first flat side faces the second flat side within the lumen of the elongate shaft.

[0010] Additionally or alternatively to the examples described herein, the first leg is tapered radially inwardly from the first end toward the second end. Additionally or alternatively to the examples described herein, the second leg is tapered radially inwardly from the first end toward the second end.

[0011] Additionally or alternatively to the examples described herein, the stent system may comprise a body portion having a proximal end and a distal end, a first leg having a first end fixedly attached to the distal end of the body portion and a second end opposite the first end, a second leg having a first end fixedly attached to the distal end of the body portion and a second end opposite the first end, a delivery sheath including the first and second legs, a first mandrel slidably disposed within the first leg of the delivery sheath, a second mandrel slidably disposed within the second leg of the delivery sheath, a first guide wire slidably disposed within the first mandrel, and a second guide wire slidably disposed within the second mandrel.

[0012] Additionally or alternatively to the examples described herein, the delivery sheath includes a first lumen extending from the proximal end of the body portion to the second end of the first leg, and a second lumen extending from the proximal end of the body portion to the second end of the second leg.

[0013] Additionally or alternatively to the examples described herein, the first lumen has a D-shaped cross-section with a first flat side, and the second lumen has a D-shaped cross-section with a second flat side.

[0014] Additionally or alternatively to the examples described herein, the first lumen and the second lumen share a common wall that defines both the first flat side and the second flat side.

[0015] Additionally or alternatively to the examples described herein, the first leg has a flat side, and the second leg has a flat side that faces the flat side of the first leg. Additionally or alternatively to the examples described herein, the stent system may include an elongate shaft having a lumen extending therethrough. The delivery sheath may be disposed within the lumen of the elongate shaft and may be axially slidable relative to the elongate shaft. When the first leg and the second leg are disposed within the lumen of the elongate shaft, the flat side of the first leg fits matingly with the flat side of the second leg.

[0016] Additionally or alternatively to the examples described herein, the stent system may include a first stent that can be disposed within the first leg distal to the first mandrel, and a second stent that can be disposed within the second leg distal to the second mandrel. The first mandrel is configured to push the first stent out of the first leg via axial movement of the first mandrel relative to the first leg. The second mandrel is configured to push the second stent out of the second leg via axial movement of the second mandrel relative to the second leg.

[0017] Additionally or alternatively to the examples described herein, the second end of the first leg and the second end of the second leg are offset from each other laterally with respect to the longitudinal axis of the body portion.

[0018] Additionally or alternatively to the examples described herein, the stent system may comprise a elongate shaft configured to access a body lumen of a patient and having a lumen extending therethrough, a delivery device slidably disposed within the lumen and configured to deliver a stent to the body lumen, and a source of contrast agent in fluid communication with the elongate shaft for delivery to the body lumen. The contrast agent may include an anti-gas agent.

[0019] Additionally or alternatively to the examples described herein, a method of treating a body lumen may include accessing the body lumen of a patient using an elongate shaft having a lumen extending therethrough, inserting into the lumen of the elongate shaft a delivery device configured to deliver a stent to the body lumen, and supplying a contrast agent including an anti-gas agent while implanting the stent within the body lumen.

[0020] The above summary of some embodiments, aspects and / or examples is not intended to describe every disclosed embodiment or all implementations of the present disclosure. The following drawings and detailed description (mode for carrying out the invention) illustrate these embodiments in more detail.

Brief Description of the Drawings

[0021] The present disclosure can be more fully understood in consideration of the following detailed description in connection with the accompanying drawings.

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DETAILED DESCRIPTION OF THE INVENTION

[0022] Aspects of the present disclosure can have various modifications and alternative forms, and specific ones of them will be shown by way of example in the drawings and described in detail below. However, it should be understood that the intention is not to limit the aspects of the present disclosure to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternative forms within the spirit and scope of the present disclosure.

[0023] The following description should be read with reference to the drawings which are not necessarily to scale, in which like reference numerals indicate like elements throughout several views. The detailed description and the drawings are intended to illustrate rather than limit the present disclosure. Those skilled in the art will understand that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and the drawings illustrate embodiments of the present disclosure.

[0024] For the terms defined below, these definitions shall apply unless otherwise defined in the claims or elsewhere in this specification. In this specification, all numerical values are assumed to be modified by the term "about", whether or not explicitly indicated. The term "about" in the context of numerical values generally refers to a range of numbers that a person skilled in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" can include numbers rounded to the nearest significant digit. Other uses of the term "about" (in contexts other than numerical values) can be assumed to have their ordinary customary definitions as understood from and consistent with the context of this specification, unless otherwise specified.

[0025] The recitation of numerical ranges by endpoints includes all numbers within that range including the endpoints (e.g., 1 - 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Disclosed are some preferred dimensions, ranges and / or values relating to various components, features and / or specifications. Those skilled in the art inspired by the present disclosure will understand that the desired dimensions, ranges and / or values may deviate from those explicitly disclosed.

[0026] As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. The term "or" as used in this specification and the appended claims is generally employed in a sense that includes "and / or" unless the context clearly dictates otherwise. It should be noted that for ease of understanding, some features of the present disclosure may be described in the singular even if they are plural or occur repeatedly within the disclosed embodiments. Each instance of a feature may, unless otherwise explicitly stated, include and / or be included in the singular disclosure. For simplicity and clarity, not all elements of the present disclosure are necessarily shown in each figure or discussed in detail below. However, it will be understood that the following discussion may be equally applicable to any and / or all of the components that exist in more than one, unless otherwise explicitly stated. Further, for clarity, not all instances of some elements or features may be shown in each figure.

[0027] Relative terms such as "proximal", "distal", "advancing", "retreating", and variations thereof can generally be considered with respect to the positioning, orientation, and / or movement of various elements relative to the user / operator / pilot of the device, where "proximal" and "retreating" indicate or refer to being closer to or towards the user, and "distal" and "advancing" indicate or refer to being farther from or away from the user. Optionally, the terms "proximal" and "distal" may be arbitrarily assigned to facilitate understanding of the present disclosure, and in such cases, it will be readily apparent to those skilled in the art. Other relative terms such as "upstream", "downstream", "inflow", and "outflow" refer to the direction of fluid flow within a body lumen, blood vessel, etc., or within the device. Still other relative terms such as "axial", "circumferential", "longitudinal", "lateral", "radial", and / or variations thereof generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0028] The term "range" can be understood to mean the minimum measured value of the dimension being described or specified, if there is a "minimum" preceding the range or dimension so understood, or, if the range or dimension is not specified as "minimum", the maximum measured value of the dimension being described or specified. For example, an "outer range" can be understood to mean the outer dimension, a "radial range" can be understood to mean the radial dimension, a "longitudinal range" can be understood to mean the longitudinal dimension, etc. A given "range" may vary from case to case (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be apparent to those skilled in the art from the context of each individual use. Generally, a given "range" can be considered the maximum dimension that can be measured according to the intended use, and a "minimum range" can be considered the minimum dimension that can be measured according to the intended use. In some cases, a given "range" may generally be measured diagonally within a plane and / or cross-section, but may be measured differently (but not limited to, obliquely, radially, circumferentially (e.g., along an arc), etc.) as is apparent from the particular context.

[0029] The terms "monolithic" and "integral" generally refer to one or more elements made of or consisting of a single structure or basic unit / element. Monolithic and / or integral elements are to exclude structures and / or features made by assembling or otherwise joining a plurality of separate structures or elements.

[0030] Note that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments can include a particular feature, structure, or characteristic, but not all embodiments necessarily include that particular feature, structure, or characteristic. Further, such language does not necessarily refer to the same embodiment. Further, when a particular feature, structure, or measurement is described in relation to one embodiment, unless specifically stated otherwise, that particular feature, structure, or characteristic can be practiced in relation to other embodiments, whether or not explicitly described, within the knowledge of one of ordinary skill in the art. That is, the various individual elements described below are assumed to be combinable or arrangeable with each other to form other additional embodiments or to capture and / or augment the described embodiments, as would be understood by one of ordinary skill in the art, even if not explicitly shown in a particular combination.

[0031] For purposes of clarity, throughout the specification and claims, numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used to name and / or identify various described and / or claimed features for a particular identification. This numerical nomenclature is not intended to be limiting and should be understood to be merely exemplary. In some embodiments, for the sake of brevity and clarity, it may be changed and deviate from the numerical nomenclature used previously. That is, a feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc., or may be completely omitted, and / or a different feature may be referred to as a "first" element. The meaning and / or designation in each case will be apparent to those skilled in the art.

[0032] The figures show selected components and / or arrangements of an endoprosthesis or a stent system. It should be noted that in any given figure, some features of the endoprosthesis or stent system may not be shown or may be shown schematically for the sake of simplicity of explanation. Additional details regarding some of the components of the endoprosthesis or stent system may be shown in more detail in other figures. Note that for ease of understanding, some features of the present disclosure may be described in the singular even though they may be plural or occur repeatedly within the disclosed embodiments. Each instance of a feature may, unless explicitly stated otherwise, include and / or be included in a singular disclosure. For example, references to "filament", "cell" or other features may refer equally to all instances and amounts other than those of the said features. Thus, it will be understood that the following considerations may apply equally to any and / or all of the components present in plurality within the endoprosthesis or stent system, unless explicitly stated otherwise. Further, for the sake of clarity, not all instances of some elements or features may be shown in each figure.

[0033] The following disclosure describes aspects of a stent system. For the sake of clarity and / or brevity, the term "stent" is used herein, and the term "stent" is intended to include, but not be limited to, other similar specialized terms such as "intraluminal prosthesis", and / or to encompass. The present disclosure also refers to the treatment of body lumens, particularly body lumens having bifurcations and / or adjacent bifurcations. For the sake of brevity, the term "body lumen" includes, but is not limited to, specific body lumens such as bile ducts, hepatic ducts, cystic ducts, common bile ducts, pancreatic ducts, bronchi, etc. This system is also contemplated for use in other body lumens.

[0034] Figure 1 shows a stent 100 including an expandable framework. The stent 100 and / or the expandable framework can be configured to transition between a radially contracted delivery configuration and a radially expanded deployed configuration. The delivery configuration can be a configuration in which the stent 100 is axially extended and / or radially reduced or compressed as compared to the deployed configuration. The deployed configuration can be a configuration in which the stent 100 is axially shortened and / or radially expanded as compared to the delivery configuration. In at least some embodiments, the stent 100 and / or the expandable framework can be self-expandable. For example, the stent 100 and / or the expandable framework can be formed from a shape memory material such as nitinol. In some embodiments, the stent 100 and / or the expandable framework can be mechanically expandable. For example, the stent 100 and / or the expandable framework can be expandable using an inflatable balloon, using an actuating member, or using other suitable means. During delivery to the treatment site, the stent 100 and / or the expandable framework can be disposed within the lumen of an elongate shaft (e.g., FIG. 3) in the delivery configuration. When released from the lumen of the elongate shaft, the stent 100 and / or the expandable framework can transition, and / or be transitioned, from the delivery configuration to the deployed configuration.

[0035] An expandable framework may include and / or be formed of a plurality of cells. In some embodiments, the expandable framework may include the stent 100 and / or one or more filaments woven to form the expandable framework. In at least some embodiments, one or more filaments may form and / or define a plurality of cells. In some embodiments, the expandable framework may be braided, knitted, or woven from one or more filaments. In some embodiments, the one or more filaments may be wires, threads, strands, etc. In some embodiments, adjacent filaments of the one or more filaments may define cells (i.e., openings or gaps) that penetrate the wall of the expandable framework. Alternatively, in some embodiments, the expandable framework may be a monolithic structure formed from a cylindrical tubular member, such as a single cylindrical laser-cut nickel-titanium (e.g., nitinol) tubular member, and the remaining (e.g., unremoved) portion of the tubular member forms the stent 100 and / or the expandable framework with cells (i.e., openings or gaps) defined therein.

[0036] In some embodiments, the stent 100 and / or the expandable framework may have sufficient flexibility to allow the stent and / or the expandable framework to invert and / or bend upon itself in the delivery configuration. Accordingly, at least a portion of the stent 100 and / or the expandable framework may be invertible in the delivery configuration.

[0037] In some embodiments, the stent 100 and / or the expandable framework may include a body portion 110 having a proximal end 112 and a distal end 114. In some embodiments, the stent 100 and / or the expandable framework may be a bifurcated stent including a first leg 120 and a second leg 130 extending from the body portion 110. For example, the first leg 120 may have a first end 122 fixedly attached to the distal end 114 of the body portion 110 and a second end 124 opposite the first end 122. The first leg 120 may extend distally from the distal end 114 of the body portion 110 in the deployed configuration. In at least some embodiments, the first leg 120 may extend distally from the distal end 114 of the body portion 110 in the delivery configuration. The second leg 130 may have a first end 132 fixedly attached to the distal end 114 of the body portion 110 and a second end 134 opposite the first end 132. The second leg 130 may extend distally from the distal end 114 of the body portion 110 in the deployed configuration. In at least some embodiments, the second leg 130 may extend proximally from the distal end 114 of the body portion 110 in the delivery configuration. In some embodiments, as can be seen from FIG. 2, the second leg 130 may be reversible within the body portion 110 and / or may be reversed within the body portion 110 such that the second leg 130 extends proximally into the body portion 110 from the distal end 114 of the body portion 110 in the delivery configuration.

[0038] In some alternative embodiments, the first leg 120 may extend proximally from the distal end 114 of the body portion 110 in the delivery configuration. In some embodiments, the first leg 120 may be reversible within the body portion 110 and / or may be reversed within the body portion 110 such that the first leg 120 extends proximally into the body portion 110 from the distal end 114 of the body portion 110 in the delivery configuration.

[0039] In some alternative embodiments, both the first leg 120 and the second leg 130 may extend proximally from the distal end 114 of the body portion 110 in the delivery configuration. In some embodiments, both the first leg 120 and the second leg 130 may be reversible and / or both may be reversed within the body portion 110 such that both extend proximally into the body portion 110 from the distal end 114 of the body portion 110 in the delivery configuration.

[0040] In some embodiments, the expandable framework, the body portion 110, the first leg 120, and / or the second leg 130 may be substantially tubular and / or may include and / or define at least one lumen extending axially therethrough. For example, the first leg 120 may include a lumen extending through the first leg 120, and the second leg 130 may include a lumen extending through the second leg 130. The lumen of the first leg 120 may converge with the lumen of the second leg 130 at the distal end 114 of the body portion 110 such that the lumens of the first leg 120 and the second leg 130 merge with the lumen of the body portion 110 at the distal end 114 of the body portion 110. In some embodiments, the expandable framework may have an axial length in the range of about 25 millimeters to about 250 millimeters, about 40 millimeters to about 225 millimeters, about 60 millimeters to about 200 millimeters, about 80 millimeters to about 175 millimeters, about 100 millimeters to about 150 millimeters, or another suitable range. In some embodiments, the expandable framework may have a radially outer dimension or radial extent in the range of about 3 millimeters to about 30 millimeters, about 5 millimeters to about 25 millimeters, about 6 millimeters to about 20 millimeters, about 8 millimeters to about 15 millimeters, or another suitable range. In some embodiments, the first leg 120 may have a first radially outer dimension, the second leg 130 may have a second radially outer dimension, and the body portion 110 may have a third radially outer dimension that is greater than the first radially outer dimension and / or the second radially outer dimension. Other configurations are contemplated. Some suitable but non-limiting materials for the stent 100, the expandable framework, and / or its components or elements, such as metallic materials and / or polymeric materials, are described below.

[0041] In some embodiments, the first radial outer dimension of the first leg portion 120 may be tapered radially inwardly from the first end 122 of the first leg portion 120 toward and / or to the second end 124 of the first leg portion 120 in the delivery configuration and / or the deployed configuration. In some embodiments, the second radial outer dimension of the second leg portion 130 may be tapered radially inwardly from the first end 132 of the second leg portion 130 toward and / or to the second end 134 of the second leg portion 130 in the delivery configuration and / or the deployed configuration. In some embodiments, the first leg portion 120 may be tapered radially inwardly from the first end 122 of the first leg portion 120 toward and / or to the second end 124 of the first leg portion 120 in the delivery configuration and / or the deployed configuration, and the second leg portion 130 may be tapered radially inwardly from the first end 132 of the second leg portion 130 toward and / or to the second end 134 of the second leg portion 130. In some embodiments, the third radial outer dimension of the body portion 110 may be substantially constant from the proximal end 112 to the distal end 114 in the delivery configuration and / or the deployed configuration. In some embodiments, the body portion 110 may be tapered radially inwardly from the proximal end 112 of the body portion 110 toward and / or to the distal end 114 of the body portion 110 in the delivery configuration and / or the deployed configuration. Other configurations are contemplated.

[0042] In at least some embodiments, the stent 100 and / or the expandable framework may be disposed within a body lumen extending through a stenosis to maintain and / or re - establish patency of the body lumen. In some embodiments, the stent 100 and / or the expandable framework may be configured to expand at least a portion of the body lumen in the deployed configuration. For example, the stent 100 and / or the expandable framework may be configured to exert a radially outward force against the wall of the body lumen and / or a stenosis formed within the body lumen.

[0043] In some embodiments, the stent 100 and / or the expandable framework may include a flare portion proximate to the proximal end 112 of the body portion 110. The flare portion may extend from the proximal end 112 toward the distal end 114. In some embodiments, the flare portion may have a substantially constant outer diameter along the length of the flare portion. Other configurations are contemplated including, but not limited to, a constant taper along the flare portion. In some embodiments, the outer diameter of the flare portion may be greater than the third radially outer dimension of the body portion 110.

[0044] In some embodiments, the stent 100 may include a polymeric cover (not shown) disposed on and / or covering at least a portion of the expandable framework (e.g., the body portion 110, the first leg 120, the second leg 130, etc.). In some embodiments, the polymeric cover may be disposed on and / or along the outer surface of the expandable framework. In some embodiments, the expandable framework may be embedded in the polymeric cover. In some embodiments, the polymeric cover may be fixedly or releasably secured, joined, or otherwise attached to the expandable framework. In some embodiments, the polymeric cover may be impermeable to fluids, debris, medical instruments, etc. In some embodiments, one or more portions of the expandable framework may be without the polymeric cover. Some suitable but non-limiting materials for the polymeric cover are described below.

[0045] In some embodiments, to assist in positioning the stent 100 within a body lumen, the stent 100 may include at least one radiopaque marker disposed on and / or along the expandable framework. Some suitable but non-limiting materials for the at least one radiopaque marker are described below.

[0046] When in use, when the stent 100 is disposed within the body lumen in the deployed configuration of the stent 100 and / or an expandable framework, a polymer cover disposed on and / or covering the expandable framework can form a barrier, such as a sealing interface, between the lumen of the stent 100 and / or expandable framework and the wall of the body lumen disposed radially outside of the polymer cover. The polymer cover can isolate the lumen of the stent 100 and / or expandable framework from the wall of the body lumen. The polymer cover can prevent the ingrowth of tissue into the lumen of the stent 100 and / or expandable framework, thereby enabling and / or assisting in the removal of the stent 100 and / or expandable framework from the body lumen.

[0047] In some alternative embodiments and / or uses, the implantation of the stent 100 can be permanent and / or not intended to be removed. In some such embodiments and / or uses, at least a portion of the expandable framework can promote the ingrowth of tissue, such that the polymer cover may not be provided to prevent movement of the stent 100 within the body lumen.

[0048] Figures 3-9 illustrate aspects of a stent system for use within a body lumen 10. As can be seen from Figure 3, the body lumen 10 can include a first branched lumen 20 and a second branched lumen 30 that are fluidly connected to the body lumen 10 at a Y-junction. In some embodiments, the first branched lumen 20 and the second branched lumen 30 can form and / or define a bifurcation of the body lumen 10.

[0049] The stent system may include a stent 100 shown by an imaginary line. In some embodiments, the stent system may include an elongate shaft 200 having a lumen extending therein. The stent 100 may be disposable and / or may be disposed within the lumen in a delivery configuration as shown in FIG. 3. The stent 100 may be configured to transition from the delivery configuration to the deployed configuration when the stent 100 is disposed outside the lumen of the elongate shaft 200 and / or when the stent 100 is no longer constrained by the elongate shaft 200.

[0050] The stent system may further include a first mandrel 210 slidably disposed within the lumen of the elongate shaft 200. The stent system may further include a second mandrel 220 slidably disposed within the lumen of the elongate shaft 200 alongside the first mandrel 210. In some embodiments, the first mandrel 210 and / or the second mandrel 220 may extend proximally to the proximal end of the elongate shaft 200 so as to be operable by a user. In some alternative embodiments, the first mandrel 210 and / or the second mandrel 220 may extend to an actuation mechanism disposed proximate to the proximal end of the elongate shaft 200, the actuation mechanism being configured to axially move the first mandrel 210 and / or the second mandrel 220 relative to the elongate shaft 200.

[0051] The first mandrel 210 is at least partially disposed within the body portion 110 and may extend into the first leg portion 120 of the stent 100 in the delivery configuration. The second mandrel 220 is at least partially disposed within the body portion 110 (e.g., alongside the first mandrel 210) and may extend into the second leg portion 130 of the stent 100 in the delivery configuration. In at least some embodiments, the second mandrel 220 may be at least partially disposed within the second leg portion 130 of the stent 100 when the second leg portion 130 is inverted within the body portion 110 of the stent 100. In some embodiments, the first mandrel 210 may be at least partially disposed within the first leg portion 120 of the stent 100 when the first leg portion 120 is inverted within the body portion 110 of the stent 100. In some embodiments, the first mandrel 210 may extend distal to the first leg portion 120 of the stent 100. In some embodiments, the second mandrel 220 may extend distal to the second leg portion 130 of the stent 100.

[0052] As can be seen from FIG. 3, the distal portion of the first mandrel 210 may have a D-shaped cross-section having a first flat side 212, and the distal portion of the second mandrel 220 may have a D-shaped cross-section having a second flat side 222. The first flat side 212 may face the second flat side 222 within the lumen of the elongate shaft 200 and / or when both the distal portion of the first mandrel 210 and the distal portion of the second mandrel 220 are disposed within the lumen of the elongate shaft 200. In some embodiments, the first flat side 212 may extend along substantially the entire length of the first mandrel 210. In some embodiments, the first flat side 212 may extend proximally from the distal end of the first mandrel 210 to an intermediate portion of the first mandrel 210, and the first flat side 212 may flare outwardly from the central axis of the first mandrel 210 until the first flat side 212 terminates at and / or substantially disappears at the outer surface of the first mandrel 210 proximal to the stent 100. In some embodiments, the second flat side 222 may extend along substantially the entire length of the second mandrel 220. In some embodiments, the second flat side 222 may extend proximally from the distal end of the second mandrel 220 to an intermediate portion of the second mandrel 220, and the second flat side 222 may flare outwardly from the central axis of the second mandrel 220 until the second flat side 222 terminates at and / or effectively disappears at the outer surface of the second mandrel 220 proximal to the stent 100. The first flat side 212 on the distal portion of the first mandrel 210 and the second flat side 222 on the distal portion of the second mandrel 220 may allow the first mandrel 210 and the second mandrel 220 to occupy less combined space within the lumen of the elongate shaft 200 proximal to the distal end of the elongate shaft 200. Thus, the lumen of the elongate shaft 200 can accommodate the stent 100 therein within any increase in size and / or without a distally flared end on the elongate shaft 200.

[0053] In some embodiments, the first leg 120 of the stent 100 may conform to the outer shape and / or outer profile of the distal portion of the first mandrel 210. In some embodiments, the first leg 120 may be configured to extend around the distal portion of the first mandrel 210 and / or may be configured to take a shape similar to that of the first mandrel 210 (e.g., a D-shaped cross-section). In some embodiments, the second leg 130 of the stent 100 may conform to the outer shape and / or outer profile of the distal portion of the second mandrel 220. In some embodiments, the second leg 130 may be configured to extend around the distal portion of the second mandrel 220 and / or may be configured to take a shape similar to that of the second mandrel 220 (e.g., a D-shaped cross-section).

[0054] In some embodiments, the stent system may include a first guide wire 230 slidably disposed within a first lumen extending within the first mandrel 210. The first mandrel 210 may be configured to slide along the first guide wire 230 within the body lumen 10 and / or to follow over the first guide wire 230. In some embodiments, the first guide wire 230 may extend out of the first lumen of the first mandrel 210 and be advanced into the first branch lumen 20. Thereafter, the first mandrel 210 and the elongate shaft 200 (and the stent 100 disposed therein) may be advanced and / or followed over the first guide wire 230 and into the first branch lumen 20 as shown in FIG. 4.

[0055] Returning temporarily to FIG. 3, in some embodiments, the stent system may include a second guide wire 240 slidably disposed within a second lumen extending within the second mandrel 220. The second guide wire 240 may be held and / or maintained at a substantially fixed position within the second lumen of the second mandrel 220 until the physician is ready to use the second guide wire 240.

[0056] After the first mandrel 210 and the elongate shaft 200 are advanced into the first branch lumen 20, as can be seen from FIG. 5, the first mandrel 210 can be held in a fixed position when the elongate shaft 200 (with the second mandrel 220 disposed therein) is withdrawn proximally to expose the first leg 120 of the stent 100 into the first branch lumen 20. In some embodiments, the first mandrel 210 can include a distally facing shoulder configured to engage the proximal end 112 of the body portion 110 of the stent 100. The distally facing shoulder of the first mandrel 210 can be configured to prevent proximal movement of the stent 100 relative to the first mandrel 210 and / or to push the stent 100 out of the lumen of the elongate shaft 200 when the elongate shaft 200 is moved proximally and / or withdrawn relative to the first mandrel 210. In some embodiments, the first leg 120 of the stent 100 can begin to radially expand toward a deployed configuration after the first leg 120 is exposed from the lumen of the elongate shaft 200.

[0057] Next, as shown in FIG. 6, the second guide wire 240 can be extended from the second lumen of the second mandrel 220 and advanced into the second branch lumen 30. Thereafter, as shown in FIGS. 7 and 8, the second mandrel 220 is advanced and / or tracked within the second branch lumen 30 over the second guide wire 240 such that the second leg 130 of the stent 100 can be turned inside out within the second branch lumen 30. The second mandrel 220 can be configured to transition the stent 100 from the delivery configuration toward the deployed configuration by turning inside out the second leg 130 of the stent 100. In some embodiments, the second mandrel 220 can include a distally facing shoulder 228 along the distal portion of the second mandrel 220. The distally facing shoulder 228 of the second mandrel 220 can be configured to engage the second end 134 of the second leg 130 of the stent 100 in the delivery configuration such that distal advancement of the second mandrel 220 relative to the body portion 110 of the stent 100 turns the second leg 130 inside out and transitions the stent 100 toward the deployed configuration. Thus, when the second mandrel 220 is advanced distally relative to the body portion 110 of the stent 100 and / or the elongate shaft 200, the distally facing shoulder 228 distally extrudes the inverted second leg 130 from inside the body portion 110 of the stent 100 into the second branch lumen 30, thereby turning inside out the second leg 130.

[0058] As can be seen from FIG. 8, the distal portion of the second mandrel 220 having a D-shaped cross-section can include a first portion and a second portion disposed proximal to the first portion. The distally facing shoulder 228 can be disposed at the distal end of the second portion and / or the proximal end of the first portion. The second portion can have a larger cross-sectional area than the first portion to facilitate engagement of the distally facing shoulder 228 with the proximal end 112 of the body portion 110 of the stent 100.

[0059] Next, the elongate shaft 200 can be moved proximally relative to the stent 100 and / or withdrawn so that the stent 100 is completely released and can transition to a fully expanded configuration. In some embodiments, at least the first mandrel 210 can be held in place as the elongate shaft 200 is moved proximally and / or withdrawn relative to the stent 100 to prevent the stent 100 from translating proximally with the elongate shaft 200. In some embodiments, the second mandrel 220 can include a second distally facing surface configured to engage the proximal end 112 of the body portion 110 of the stent 100, similar to the distally facing surface of the first mandrel 210 that faces distally.

[0060] After the stent 100 has radially expanded and engaged the walls of the body lumen 10, the first branch lumen 20, and the second branch lumen 30, as shown in FIG. 9, the first mandrel 210, the second mandrel 220, the first guide wire 230, and the second guide wire 240 can be retracted into the lumen of the elongate shaft 200. Thereafter, the elongate shaft 200 (and the components disposed therein) can be withdrawn from and / or removed from the body lumen 10 to leave the stent 100 in place at the bifurcation.

[0061] FIG. 10 shows a selected aspect of a stent system comprising a delivery sheath 300, the delivery sheath 300 including a body portion 310 having a proximal end 312 and a distal end 314, a first leg 320 having a first end 322 fixedly attached to the distal end 314 of the body portion 310 and a second end 324 opposite the first end 322, and a second leg 330 having a first end 332 fixedly attached to the distal end 314 of the body portion 310 and a second end 334 opposite the first end 332. In some embodiments, the delivery sheath 300 can be considered and / or referred to as a split sheath or a branched sheath.

[0062] In some embodiments, the second end 324 of the first leg 320 and the second end 334 of the second leg 330 may be offset and spaced apart from the longitudinal axis of the body portion 310 and / or offset laterally away from each other. In some embodiments, the second end 324 of the first leg 320 and the second end 334 of the second leg 330 may be self - biased and spaced apart from the longitudinal axis of the body portion 310 and / or self - biased to be laterally away from each other. Other configurations are contemplated.

[0063] In some embodiments, the delivery sheath 300 may include a first mandrel 340 slidably disposed within the first leg 320 of the delivery sheath 300. In some embodiments, the first mandrel 340 may be slidably disposed within the first leg 320 of the delivery sheath 300 and the body portion 310 of the delivery sheath 300. In some embodiments, the delivery sheath 300 may include a second mandrel 350 slidably disposed within the second leg 330 of the delivery sheath 300. In some embodiments, the second mandrel 350 may be slidably disposed within the second leg 330 of the delivery sheath 300 and the body portion 310 of the delivery sheath 300.

[0064] In some embodiments, the delivery sheath 300 may include a first guide wire 360 slidably disposed within the first mandrel 340 and / or the first leg 320 of the delivery sheath 300. In some embodiments, the first guide wire 360 may be slidably disposed within the first mandrel 340 and the first leg 320 and / or the body portion 310 of the delivery sheath 300. In some embodiments, the delivery sheath 300 may include a second guide wire 370 slidably disposed within the second mandrel 350 and / or the second leg 330 of the delivery sheath 300. In some embodiments, the second guide wire 370 may be slidably disposed within the second mandrel 350 and the second leg 330 and / or the body portion 310 of the delivery sheath 300.

[0065] In some embodiments, the delivery sheath 300 may include a first lumen 302 extending from the proximal end 312 of the body portion 310 to the second end 324 of the first leg 320, and a second lumen 304 extending from the proximal end 312 of the body portion 310 to the second end 334 of the second leg 330. In some embodiments, the first lumen 302 has a D-shaped cross-section with a first flat side. In some embodiments, the second lumen 304 has a D-shaped cross-section with a second flat side.

[0066] In some embodiments, the first mandrel 340 has a D-shaped cross-section with a first flat side 342. In some embodiments, the second mandrel 350 has a D-shaped cross-section with a second flat side 352. In some embodiments, the first flat side 342 of the first mandrel 340 may face the second flat side 352 of the second mandrel 350. In some embodiments, the first flat side 342 of the first mandrel 340 may face and / or be aligned with the first flat side of the first lumen 302. In some embodiments, the first flat side 342 of the first mandrel 340 and the first flat side of the first lumen 302 prevent relative rotation of the first mandrel 340 within the first lumen 302 while allowing axial movement and / or sliding of the first mandrel 340 within the first lumen 302. In some embodiments, the second flat side 352 of the second mandrel 350 may face and / or be aligned with the second flat side of the second lumen 304. In some embodiments, the second flat side 352 of the second mandrel 350 and the second flat side of the second lumen 304 prevent relative rotation of the second mandrel 350 within the second lumen 304 while allowing axial movement and / or sliding of the second mandrel 350 within the second lumen 304. In some embodiments, at least a portion of the first lumen 302 and at least a portion of the second lumen 304 share a common wall that defines both the first flat side and the second flat side, as can be seen from FIG. 10A. In some embodiments, at least a portion of the first lumen 302 and at least a portion of the second lumen 304 share a common wall that defines both the first flat side and the second flat side within the body portion 310 of the delivery sheath 300. For clarity, the first guide wire 360 and the second guide wire 370 are not shown in FIG. 10A.

[0067] Returning to FIG. 10, the first leg 320 of the delivery sheath 300 may include a flat side surface 326, and the second leg 330 of the delivery sheath 300 may include a flat side surface 336 that faces the flat side surface 326 of the first leg 320. The flat side surface 326 of the first leg 320 and the flat side surface 336 of the second leg 330 may be complementary and / or may be configured to matingly engage with each other when the first leg 320 and the second leg 330 are constrained within the lumen to reduce the overall cross-section of the lumen required to accommodate the delivery sheath 300.

[0068] In some embodiments, the stent system may include a first stent 380 that may be disposed within the first leg 320 distal to the first mandrel 340 and / or within the first lumen 302. The first mandrel 340 may include a first distal surface configured to engage the first stent 380. The first mandrel 340 may be configured to extrude the first stent 380 from the first leg 320 and / or the first lumen 302 via axial movement of the first mandrel 340 relative to the first leg 320. In one example, the delivery sheath 300 may be held substantially in place while the first mandrel 340 is advanced distally within the first lumen 302 and / or the first leg 320. In another example, the first mandrel 340 may be held substantially in place while the delivery sheath 300 is retracted proximally over the first mandrel 340. Other examples including combinations thereof are also contemplated.

[0069] In some embodiments, the stent system may include a second stent 390 that can be disposed within a second leg 330 distal to the second mandrel 350. The second mandrel 350 may include a second distal surface configured to engage the second stent 390. The second mandrel 350 may be configured to extrude the second stent 390 from the second leg 330 and / or the second lumen 304 via an axial movement of the second mandrel 350 relative to the second leg 330. In one example, the delivery sheath 300 may be held substantially in place while the second mandrel 350 is advanced distally within the second lumen 304 and / or the second leg 330. In another example, the second mandrel 350 may be held substantially in place while the delivery sheath 300 is retracted proximally over the second mandrel 350. Other examples including combinations thereof are also contemplated.

[0070] FIG. 11 shows a stent system present within the body lumen 10. As can be seen from FIG. 11, the stent system may include an elongate shaft 400 having a lumen extending therethrough. The delivery sheath 300 may be disposable and / or is disposed within the lumen of the elongate shaft 400 and is axially slidable relative to the elongate shaft 400 and / or within the lumen of the elongate shaft 400. In use, the stent system may be advanced into and / or within the body lumen 10 towards a bifurcation or Y-junction of the body lumen 10. As shown, the first guide wire 360 may be advanced and / or disposed within the first branch lumen 20 and / or the second guide wire 370 may be advanced and / or disposed within the second branch lumen 30. In some embodiments, the first guide wire 360 and the second guide wire 370 may be advanced and / or disposed in sequence. In some embodiments, the first guide wire 360 and the second guide wire 370 may be advanced and / or disposed simultaneously. The stent system enables the placement of both the first guide wire 360 and the second guide wire 370 using a single access point and / or access device, thereby reducing the chance of air bubble entrainment into the patient, the body lumen 10, and / or the stent system (and / or its components). In some embodiments, the first guide wire 360 and the second guide wire 370 may be disposed within the patient after being initially disposed within the first branch lumen 20 and the second branch lumen 30, respectively, and may be used to simultaneously guide and / or follow the first and second mandrels, the first and second legs, etc.

[0071] After the first guide wire 360 is disposed within the first branch lumen 20 and the second guide wire 370 is disposed within the second branch lumen 30, as shown in FIGS. 12-13, the delivery sheath 300 can be advanced distally within the body lumen 10 out of the lumen of the elongate shaft 400 such that the first leg 320 advances over the first guide wire 360 and into the first branch lumen 20 and the second leg 330 advances over the second guide wire 370 and into the second branch lumen 30. The first stent 380 can be disposed within the first leg 320 and the second stent 390 can be disposed within the second leg 330. Thus, the first stent 380 is advanced into the first branch lumen 20 together with the first leg 320, and the second stent 390 is advanced into the second branch lumen 30 together with the second leg 330. When the delivery sheath 300 is advanced distally out of the lumen of the elongate shaft 400, the first leg 320 and the second leg 330 can be displaced apart and / or displaced laterally away from each other such that it is easier for the first leg 320 to follow over the first guide wire 360 and into the first branch lumen 20 and for the second leg 330 to follow over the second guide wire 370 and into the second branch lumen 30. Relative movement and / or axial movement between the elongate shaft 400 and the delivery sheath 300 can be used to control the spreading of the first leg 320 and the second leg 330. For example, as more of the delivery sheath 300 (e.g., the first leg 320 and the second leg 330) is exposed from the elongate shaft 400 and / or advanced distally relative to the elongate shaft 400, the first leg 320 and the second leg 330 can spread further apart laterally.

[0072] Thereafter, while holding the first mandrel 340 and the second mandrel 350 substantially in place, the delivery sheath 300 and / or the elongate shaft 400 are withdrawn proximally relative to the first mandrel 340 and the second mandrel 350, pushing the first stent 380 distally from the first leg 320 and / or the first lumen 302 into the first branch lumen 20 and / or the body lumen 10, and pushing the second stent 390 distally from the second leg 330 and / or the second lumen 304 into the second branch lumen 30 and / or the body lumen 10, where the first stent 380 and the second stent 390 are deployed. In some embodiments, as shown in FIG. 14, the first stent 380 may be partially disposed within the first branch lumen 20 and partially disposed within the body lumen 10, and the second stent 390 may be disposed partially within the second branch lumen 30 and partially within the body lumen 10, alongside the first stent 380. In some embodiments, as can be seen from FIG. 15, the first stent 380 may be disposed entirely within the first branch lumen 20 and the second stent 390 may be disposed entirely within the second branch lumen 30. Other configurations and / or positionings are contemplated.

[0073] The stent system and delivery sheath 300 may be useful for simultaneously deploying the first stent 380 and the second stent 390 across and / or adjacent to the bifurcation in the body lumen 10 at the bifurcation. By introducing all of the necessary elements into a single device or system, the number of exchanges can be reduced and / or the opportunity for introducing air bubbles into the system, patient, body lumen 10, etc. is decreased, thereby improving physician visibility and patient safety.

[0074] FIG. 16 is a block diagram showing a selected embodiment of a stent system configured to reduce air or gas bubbles introduced into a body lumen. In some embodiments, the stent system may include an elongate shaft configured to access a body lumen of a patient. The elongate shaft may have a lumen extending therein. In some embodiments, the elongate shaft may be an endoscope or endoscope device having at least one lumen disposed therein. Other configurations are contemplated. In some embodiments, the stent system may include a delivery device slidably disposed within the lumen of the elongate shaft. The delivery device may be configured to deliver a stent to the body lumen. In some embodiments, the delivery device may be configured to deliver a branched stent to the body lumen and / or a branch of the body lumen. The stent system may include a source of contrast agent in fluid communication with the lumen of the elongate shaft for supplying contrast agent to the body lumen. The contrast agent may be used to assist in the delivery and / or placement of the stent, as is known in the art. In at least some embodiments, the contrast agent may include, but is not limited to, an anti-gas agent such as simethicone. Other anti-gas agents are contemplated.

[0075] In some embodiments, the anti-gas agent may optionally be supplied directly to the body lumen and / or through the elongate shaft and / or the lumen of the elongate shaft to the body lumen. In some embodiments, the anti-gas agent may optionally be supplied directly to the body lumen and / or through the delivery device to the body lumen. In some embodiments, the source of contrast agent may optionally be in fluid communication with the delivery device instead of the lumen of the elongate shaft. In such embodiments, the contrast agent may be supplied to the body lumen by the delivery device instead of the elongate shaft.

[0076] A method of treating a body lumen may include accessing the patient's body lumen using an elongate shaft having a lumen extending therethrough. As described herein, in some embodiments, the elongate shaft can be an endoscope or an endoscopic device. Other configurations and / or devices are contemplated. The method may include inserting into the lumen of the elongate shaft a delivery device, such as, but not limited to, any of the devices described herein. The delivery device can be configured to deliver a stent to the body lumen. In some embodiments, the delivery device can be configured to deliver a branched stent to the body lumen or a bifurcation of the body lumen. In at least some embodiments, the method may further include supplying a contrast agent containing an anti-gas agent into the elongate shaft, the delivery device, and / or the body lumen while implanting the stent into the body lumen. In some embodiments, the method may include supplying a contrast agent containing an anti-gas agent while implanting a branched stent into the body lumen and / or into or within a bifurcation of the body lumen. In some embodiments, the method may include injecting an anti-gas agent into the contrast agent prior to supplying the contrast agent to the body lumen. In some embodiments, the method may include injecting an anti-gas agent into the contrast agent as the contrast agent is supplied to the body lumen. In some embodiments, the anti-gas agent can be admixed with and / or mixed with the contrast agent. In some embodiments, the anti-gas agent can be dissolved in the contrast agent.

[0077] Materials that can be used for the various components of the stent systems and the various elements disclosed herein may generally include those associated with medical devices. For purposes of simplicity, the following description refers to the system. However, this is not intended to limit the devices and methods described herein, as this description can apply to other elements, members, components or devices disclosed herein, such as, but not limited to, an elongate shaft, a mandrel(s), a guidewire(s), a polymeric cover, and / or its elements or components.

[0078] In some embodiments, the stent system and / or its components can be made from metals, alloys, polymers (some examples of which are disclosed later), metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials.

[0079] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., other polyester elastomers such as butylene / poly(alkylene ether) phthalate and / or HYTREL® available from DuPont), polyamide (e.g., DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA), e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX high density polyethylene, MARLEX low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon - 12 (EMS AmericanGRILAMID® available from Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyurethane silicone copolymers (e.g., Elast-Eon® from AorTech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, and polymer / metal composites thereof, etc. In some embodiments, the sheath can be mixed with liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.

[0080] Some examples of suitable metals and alloys include stainless steels such as 304V, 304L, 316LV stainless steel; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic Nitinol; nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, HASTELLOY® C276®, other HASTELLOY® alloys such as UNS:N10276), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nickel-molybdenum alloys (e.g., UNS:N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel alloys such as other nickel-tungsten or tungsten alloys; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY®, PHYNOX®); platinum-enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material may be mentioned.

[0081] In some embodiments, in a linear elastic and / or non-superelastic nickel-titanium alloy, nickel ranges from about 50 to about 60 weight percent, and the balance can be essentially titanium. In some embodiments, in the composition, nickel ranges from about 54 to about 57 weight percent. One example of a suitable nickel-titanium alloy is the FHP-NT alloy commercially available from Furukawa Techno-Materials Co., Ltd. in Kanagawa Prefecture, Japan. Other suitable materials can include ULTRANIUM™ available from Neo-Metrics and GUM METAL™ available from Toyota. In some other embodiments, a superelastic alloy, such as superelastic nitinol, can be used to achieve the desired properties.

[0082] In at least some embodiments, some or all of the stent system and / or its components can be doped with a radiopaque material, made from a radiopaque material, or otherwise include a radiopaque material. A radiopaque material is understood to be a material that can produce a relatively bright image on an x-ray fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image helps the user of the system and / or its components to determine its position. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials filled with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils can be incorporated into the design of the system and / or its components to achieve the same result.

[0083] In some embodiments, the systems and / or other elements disclosed herein are provided with a degree of magnetic resonance imaging (MRI) compatibility. For example, the system and / or its components or parts may be made of materials that do not substantially distort the image and do not introduce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they can introduce artifacts in MRI images. The system or a part thereof can also be made of materials that can be imaged by an MRI device. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nitinol, and the like.

[0084] In some embodiments, the systems and / or other elements disclosed herein may include a fabric material disposed on or within the structure. The fabric material may be composed of a biocompatible material such as a polymer material or a biological material adapted to promote ingrowth of tissue. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials such as polyethylene and polypropylene, polyester, polyurethane, and / or mixtures or combinations thereof.

[0085] In some embodiments, the systems and / or other elements disclosed herein may include a textile material and / or be formed from a textile material. Some examples of suitable textile materials may include synthetic fibers that may be flat, shaped, twisted, woven, preshrunk or unshrunk. Synthetic biocompatible threads suitable for use in the present disclosure include, but are not limited to, polyesters including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefin, polyvinyl, polymethyl acetate, polyamide, naphthalene dicarboxylate derivatives, natural silk, and polytetrafluoroethylene. Further, at least one of the synthetic fibers may be a metal thread, or a glass or ceramic thread or fiber. Useful metal threads include threads made of or including stainless steel, platinum, gold, titanium, tantalum or Ni-Co-Cr based alloys. The thread may further include carbon, glass or ceramic fibers. Desirably, the thread is made of a thermoplastic material including, but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The thread may be multifilament, monofilament or of the staple type. The type and denier of the thread selected may be chosen to form a biocompatible and implantable prosthesis, more particularly a vascular structure having the desired properties.

[0086] In some embodiments, the systems and / or other elements disclosed herein may contain a suitable therapeutic agent and / or may be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrorphanylalanine proline arginine chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiotensin, monoclonal antibodies that can inhibit smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilone, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vasocyte growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translation promoters); vasocyte growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, and bifunctional molecules composed of antibodies and cytotoxins); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vascular mechanisms may be mentioned.

[0087] It should be understood that the present disclosure is, in many respects, merely illustrative. Without departing from the scope of the present disclosure, changes may be made in details, particularly in matters of shape, size, and the arrangement of steps. This may include using any of the features of one exemplary embodiment in other embodiments within an appropriate range. The scope of the present disclosure is, of course, defined by the language expressed in the appended claims.

Claims

1. A stent system comprising: An elongate shaft having a lumen extending therein; A first mandrel slidably disposed within the lumen; A second mandrel slidably disposed within the lumen alongside the first mandrel; A stent configured to transition between a delivery configuration and a deployed configuration, the stent comprising: A body portion having a proximal end and a distal end; A first leg having a first end fixedly attached to the distal end of the body portion and a second end opposite the first end, the first leg extending distally from the distal end of the body portion in the deployed configuration; A second leg having a first end fixedly attached to the distal end of the body portion and a second end opposite the first end, the second leg extending distally from the distal end of the body portion in the deployed configuration; Wherein the second leg extends proximally from the distal end of the body portion in the delivery configuration; The stent is configured to be disposed within the lumen in the delivery configuration and to transition from the delivery configuration to the deployed configuration when the stent is disposed outside the lumen; The first mandrel has a D-shaped cross-section with a first flat side, the second mandrel has a D-shaped cross-section with a second flat side, and the first flat side faces the second flat side within the lumen of the elongate shaft; The first flat side and the second flat side are disposed within the stent in the delivery configuration.

2. The stent system according to claim 1, wherein the second leg is inverted within the body portion such that in the delivery configuration, the second leg extends proximally from the distal end of the body portion within the body portion.

3. The stent system according to claim 1 or 2, wherein the first mandrel is at least partially disposed within the first leg and the second mandrel is at least partially disposed within the second leg.

4. The stent system according to claim 1 or 2, wherein the first guide wire is slidably disposed within a first lumen extending within the first mandrel. **Claim 5** The stent system according to claim 4, wherein the second guide wire is slidably disposed within a second lumen extending within the second mandrel. **Claim 6** The stent system according to claim 1 or 2, wherein the second mandrel is configured to move the stent from the delivery configuration toward the deployed configuration. **Claim 7** The stent system according to claim 6, wherein the second mandrel includes a distally facing shoulder configured to engage the second end of the second leg portion in the delivery configuration such that advancement of the second mandrel distally turns the second leg portion inside out and the stent moves toward the deployed configuration.

Images