Stent system for maintaining smoothness of body cavities

Abstract

A system for maintaining smoothness of a body lumen may include a first endoprosthesis configured to transition from a straightened configuration to a helical configuration defining a plurality of loops; and a second endoprosthesis configured to transition from a radially collapsed configuration toward a radially expanded configuration. The plurality of rings define a passage having an inner diameter. At least a portion of the second endoprosthesis is disposed within the passageway in the radially expanded configuration. The plurality of rings define a passage having an inner diameter. Wherein at least a portion of the second endoprosthesis is disposed within the passageway in the radially expanded configuration.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application Serial No. 63 / 418,812, filed on October 24, 2022, the disclosure of which is incorporated herein by reference. Technical Field

[0003] The present invention relates to medical devices and methods for manufacturing and / or using medical devices. More particularly, the present invention relates to an improved design of a stent system for maintaining the patency of a body cavity at a bifurcation. Background Art

[0004] One currently known treatment for relieving biliary obstruction in the biliary tree is to place a covered endoprosthesis or stent within a restricted body cavity (e.g., bile duct, pancreatic duct, etc.) such as caused by stenosis. For example, it may be necessary to open the body cavity (e.g., bile duct, pancreatic duct, etc.) to allow bile and stone-related debris to pass through to relieve acute pain symptoms. Additionally, the biliary tree has several branches, bifurcations, and / or adjacent cavities. Placing a covered endoprosthesis or stent across the opening of a bifurcation and / or adjacent branch or cavity to treat a stenosed or blocked body cavity may cause additional blockage of currently open or unrestricted cavities, which may be undesirable. There is a current need to provide alternative endoprostheses or stents, as well as alternative methods for manufacturing and using endoprostheses or stents. Summary of the Invention

[0005] In one example, a system for maintaining the patency of a body cavity can include a first endoprosthesis having a lumen extending from a first end to a second end, wherein the first endoprosthesis is configured to transition from a straightened configuration to a helical configuration defining a plurality of loops; and a second endoprosthesis configured to transition from a radially collapsed configuration towards a radially expanded configuration. The plurality of loops can define a passageway having an inner diameter. At least a portion of the second endoprosthesis can be disposed within the passageway in a radially expanded configuration.

[0006] Additionally or alternatively for any of the examples described herein, when the second endoprosthesis is disposed within the passageway in a radially expanded configuration, at least a portion of the second endoprosthesis extends away from the passageway.

[0007] Additionally or alternatively for any of the examples described herein, at least a portion of the first endoprosthesis extends away from the plurality of loops.

[0008] Additionally or alternatively for any of the examples described herein, when the second endoprosthesis is disposed within the passageway in a radially expanded configuration, a first end portion of the first endoprosthesis extends transversely away from the second endoprosthesis relative to a central longitudinal axis of the second endoprosthesis.

[0009] Additionally or alternatively for any example described herein, when the second implant is disposed in the passageway in a radially expanded configuration, the second end portion of the first implant extends away from the second implant generally parallel to the central longitudinal axis of the second implant.

[0010] Additionally or alternatively for any example described herein, the first implant is formed of a polymeric material.

[0011] Additionally or alternatively for any example described herein, a system for maintaining patency of a body cavity can include a first implant having a lumen extending from a first end to a second end, wherein the first implant is configured to transition from a straightened configuration to a helical configuration defining a plurality of loops; and a second implant configured to transition from a radially collapsed configuration to a radially expanded configuration. The plurality of loops can define a passageway having an inner diameter. The second implant can be configured to be disposed within the passageway. The second implant can have an outer diameter in the radially expanded configuration. The outer diameter of the second implant can be within 20% of the inner diameter of the passageway.

[0012] Additionally or alternatively for any example described herein, the plurality of loops define an outer diameter between about 6 French and about 12 French.

[0013] Additionally or alternatively for any example described herein, the first implant is self-biased toward the helical configuration.

[0014] Additionally or alternatively for any example described herein, the second implant is self-biased toward the radially expanded configuration.

[0015] Additionally or alternatively for any example described herein, the second implant includes a polymeric covering extending along at least a portion of its length.

[0016] Additionally or alternatively for any example described herein, the first implant includes a corrugated section disposed between the first end and the plurality of loops.

[0017] Additionally or alternatively for any example described herein, the first implant includes one or more drainage holes extending through the sidewall of the first implant.

[0018] Additionally or alternatively for any example described herein, the first implant includes one or more anti-migration elements extending radially outward therefrom.

[0019] Additionally or alternatively to any of the examples described herein, a method of maintaining the patency of a body cavity can include advancing a first implantable prosthesis in a straightened configuration into a first body cavity, deploying the first implantable prosthesis in a helical configuration defining a plurality of loops within the first body cavity, advancing a second implantable prosthesis in a radially collapsed configuration into the first body cavity, and transitioning the second implantable prosthesis to a radially expanded configuration within the plurality of loops.

[0020] Additionally or alternatively to any of the examples described herein, advancing the first implantable prosthesis in a straightened configuration into the first body cavity includes positioning a first end portion of the first implantable prosthesis in a second body cavity adjacent to the first body cavity.

[0021] Additionally or alternatively to any of the examples described herein, when the second implantable prosthesis is disposed in a radially expanded configuration within the plurality of loops, a first end portion of the first implantable prosthesis extends transversely away from the second implantable prosthesis relative to a central longitudinal axis of the second implantable prosthesis.

[0022] Additionally or alternatively to any of the examples described herein, when unconstrained, the first implantable prosthesis is self-biased toward the helical configuration.

[0023] Additionally or alternatively to any of the examples described herein, when the first implantable prosthesis is advanced into the first body cavity, the first implantable prosthesis is constrained in the straightened configuration by a guide wire.

[0024] Additionally or alternatively to any of the examples described herein, when the first implantable prosthesis is advanced into the first body cavity, the first implantable prosthesis is constrained in the straightened configuration by a delivery sheath.

[0025] The foregoing summary of some embodiments, aspects, and / or examples is not intended to describe every disclosed embodiment or every implementation of the present invention. The following drawings and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present invention can be more fully understood by considering the following detailed description in conjunction with the accompanying drawings, in which:

[0027] Figures 1 to 4 Selected aspects of a stent system for maintaining the patency of a body cavity and a method of using the stent system are shown;

[0028] Figure 5 Shown is Figures 1 to 4 selected aspects of a stent of the stent system;

[0029] Figure 6 Shown is Figure 5 selected aspects of an alternative configuration of the stent; and

[0030] Figure 7 Selected aspects of a stent system for maintaining the patency of a body cavity are shown.

[0031] While aspects of the present invention are amenable to various modifications and alternative forms, specific details thereof have been shown by way of example in the drawings and will be described in more detail. However, it should be understood that the present invention is not intended to limit the aspects of the present invention to the particular embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0032] The following description should be read with reference to the drawings, which are not necessarily drawn to scale, in which like reference numerals in several views indicate like elements. The detailed description and the drawings are intended to illustrate, not limit, the present invention. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of the present invention. The detailed description and the drawings illustrate example embodiments of the present invention.

[0033] For the terms defined below, unless a different definition is given in the claims of this specification or elsewhere, these definitions shall apply.

[0034] All numerical values herein are assumed to be modified by the term "about" whether or not explicitly indicated. In the context of numerical values, the term "about" 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 instances, the term "about" may include numbers that round to the nearest significant figure. Unless otherwise specified, the term "about" (e.g., in contexts other than numerical values) may be assumed to have its ordinary and customary definition as understood in the context of this specification and consistent therewith.

[0035] Reference to a numerical range represented by endpoints includes all values within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0036] While some suitable dimensions, ranges, and / or values have been disclosed with respect to various components, characteristics, and / or specifications, those skilled in the art to which the present invention pertains will understand that desired dimensions, ranges, and / or values can be derived from those explicitly disclosed.

[0037] 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. As used in this specification and the appended claims, the term "or" is generally employed in its inclusive sense of "and / or" unless the context clearly dictates otherwise. It should be noted that, for ease of understanding, some features of the present invention may be described in the singular, even though those features may be plural or repetitive in the disclosed embodiments. Each instance of a feature may include and / or incorporate the singular disclosure unless explicitly stated to the contrary. For simplicity and clarity, not all elements of the present invention will necessarily be shown in each figure or discussed in detail hereinafter. However, it should be understood that, unless explicitly stated to the contrary, the following discussion may equally apply to any and / or all of the components where there is more than one.

[0038] Relative terms such as "proximal", "distal", "advance", "retract", and their variants are generally considered with respect to the positioning, orientation, and / or operation of various elements relative to the user / operator / handler of the device, where "proximal" and "retract" indicate or refer to closer to or toward the user and "distal" and "advance" indicate or refer to farther from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned to facilitate understanding of the present invention, and such cases will be apparent to those skilled in the art. Other relative terms such as "upstream", "downstream", "inflow", and "outflow" refer to the direction of fluid flow in a cavity, such as a body cavity, within a blood vessel, or within a device. Other relative terms such as "axial", "circumferential", "longitudinal", "lateral", "radial", etc. and / or their variants generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0039] The term "range" can be understood to mean the maximum measurement of a specified or identified dimension according to the intended use, unless the range or dimension being discussed is preceded by "minimum" or is identified as "minimum", in which case "minimum" can be understood to represent the minimum measurement of a specified or identified dimension according to the intended use. For example, "outer range" can be understood to represent an outer dimension, "radial range" can be understood to represent a radial dimension, "longitudinal range" can be understood to represent a longitudinal dimension, etc. Each instance of "range" can be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.), and will be apparent to those skilled in the art based on the context in which it is used alone. In some cases, a "range" can generally be measured orthogonally in a plane and / or cross-section, but as will be apparent depending on the specific context, it can also be measured differently, such as but not limited to, at an angle, radially, circumferentially (e.g., along an arc), etc.

[0040] The terms "integral" and "unitary" shall generally refer to one or more elements made or composed of a single structure or basic unit / component. Integral and / or unitary elements shall exclude structures and / or features made by assembling or otherwise combining multiple discrete structures or elements.

[0041] It should be noted that references to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include certain features, structures, or characteristics, but each embodiment may not necessarily include that particular feature, structure, or characteristic. Moreover, these phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is within the knowledge of those skilled in the art to use the particular feature, structure, or characteristic in connection with other embodiments, whether explicitly described or not, unless explicitly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, may still be considered combinable or arrangeable with each other to form other additional embodiments, or to supplement and / or enrich the described embodiments, as would be understood by a person of ordinary skill in the art.

[0042] For clarity, a certain identificatory numeral nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the numeral nomenclature is not intended to be restrictive and is merely exemplary. In some embodiments, for the sake of brevity and clarity, the previously used numeral nomenclature may be changed and departed from. 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 omitted altogether, and / or different features may be referred to as the "first" element. The meaning and / or name in each case will be apparent to the person skilled in the art.

[0043] The figures illustrate selected components and / or arrangements of the system. It should be noted that, for simplicity, in any given figure, some features of the system may not be shown or may not be shown schematically. Additional details regarding some of the components of the system may be shown in greater detail in other figures. It should be noted that, for ease of understanding, certain features of the present invention may be described in the singular, even though those features may be plural or recurring in the disclosed embodiments. Each instance of a feature may include and / or incorporate the singular disclosure, unless explicitly stated to the contrary. Thus, it should be understood that, unless explicitly stated to the contrary, the following discussion may equally apply to any and / or all of more than one component present within the system. Additionally, for clarity, in each figure, all instances of some elements or features may not be shown.

[0044] Figure 1Shows selected features of a first body cavity 10 and a second body cavity 20 (e.g., a branch cavity) adjacent to the first body cavity 10. In some examples, the first body cavity 10 and the second body cavity 20 may converge at a bifurcation 12. In other words, the second body cavity 20 may bifurcate or diverge from the first body cavity 10 at the bifurcation 12, or the first body cavity 10 may bifurcate or diverge from the second body cavity 20 at the bifurcation 12. Thus, the first body cavity 10 and the second body cavity 20 may meet or join at the bifurcation 12. As Figure 1 shown, the first body cavity 10 may include a stenosis 14 (e.g., an occlusion) disposed along an inner surface of the wall of the first body cavity 10. As Figure 1 shown, for example, the stenosis 14 may be located upstream of the bifurcation 12. However, in other cases, the stenosis 14 may be located downstream of the bifurcation 12. Placing a covered endoprosthesis or stent within the stenosis 14 formed in the first body cavity 10 may cause partial or complete occlusion of the second body cavity 20 due to the covered endoprosthesis or stent spanning the bifurcation 12. Thus, fluid flowing out of the second body cavity 20 may be prevented from flowing downstream into the first body cavity 10. When treating the first body cavity 10, it may be necessary to maintain the patency of the second body cavity 20 to allow fluid to flow from the second body cavity 20 into the first body cavity 10.

[0045] A method of using the system disclosed herein to maintain the patency of a body cavity may include advancing a guidewire 90 into the first body cavity 10. In some embodiments, the method may further include advancing the guidewire 90 from the first body cavity 10 upstream of the bifurcation 12 into the second body cavity 20. The method may include advancing a first endoprosthesis 100 in a straightened configuration over the guidewire 90 into the first body cavity 10, as Figure 1 shown. It should be understood that the term "endoprosthesis" as used herein may be used interchangeably with the term "stent" herein. In some embodiments, when the first endoprosthesis 100 is advanced through the first body cavity 10 and into the second body cavity 20, the first endoprosthesis 100 may be constrained in a straightened configuration by the guidewire 90. In some alternative embodiments, when the first endoprosthesis 100 is advanced through the first body cavity 10 and into the second body cavity 20, the first endoprosthesis 100 may be constrained in a straightened configuration by a delivery sheath (not shown) surrounding the first endoprosthesis 100. Other configurations including combinations thereof are also contemplated.

[0046] In some embodiments, advancing the first endoprosthesis 100 in a straightened configuration through the first body cavity 10 downstream of the bifurcation 14 and into the second body cavity 20 may include positioning a first end portion 110 of the first endoprosthesis 100 in the second body cavity 20, such as upstream of the bifurcation 12, where a second end portion 112 of the first endoprosthesis 100 remains in the first body cavity 10, such as downstream of the bifurcation 12, as Figure 1 shown.

[0047] The method may include deploying a first endoprosthesis 100 into a helical configuration, where a first end portion 110 of the first endoprosthesis 100 is within a second body cavity 20, such as upstream of a bifurcation 12, and a second end portion 112 of the first endoprosthesis 100 is within a first body cavity 10, such as downstream of the bifurcation 12. Thus, when deployed into the helical configuration, an intermediate portion of the first endoprosthesis 100 may be located at the bifurcation 12. When deployed into the helical configuration, the intermediate portion of the first endoprosthesis 100 may define a plurality of helical loops 130, as Figure 2 shown. As Figure 2 shown, the first endoprosthesis 100 may be deployed at the bifurcation, where the plurality of helical loops 130 are positioned within the first body cavity 10 proximal (e.g., downstream) of the bifurcation 12, and a first end region 110 of the endoprosthesis 100 is within the second body cavity 10 distal (e.g., upstream) of the bifurcation 12. In the deployed helical configuration, a radially outer extent of the helical loops 130 may contact and / or radially outwardly compress an inner surface of the first body cavity 10. The first endoprosthesis 100 may be configured to automatically transition from a straightened configuration (where the helical loops 130 are straightened or elongated) when constrained by a guidewire 90 (or an outer sheath, if present) to the helical configuration when unconstrained (e.g., Figure 2 , Figure 5 ). In at least some embodiments, the first endoprosthesis 100 may be self-biased toward the helical configuration when unconstrained.

[0048] Briefly turning to Figure 5 , which more particularly illustrates selected aspects of the first endoprosthesis 100, the first endoprosthesis 100 may have a lumen 102 extending from a first end 104 to a second end 106. In some embodiments, during use, the first end 104 may be the distal end of the first endoprosthesis 100 and the second end 106 may be the proximal end of the first endoprosthesis 100, although this is not required.

[0049] In some embodiments, at least a portion of the first endoprosthesis 100 may extend away from the plurality of helical loops 130 in a helical configuration. In some embodiments, the first end portion 110 may extend away from the plurality of helical loops 130 in a helical configuration. In some embodiments, the first end portion 110 may extend from the plurality of helical loops 130 to the first end 104 of the first endoprosthesis 100. In some embodiments, the second end portion 112 may extend away from the plurality of helical loops 130 in a helical configuration. In some embodiments, the second end portion 112 may extend from the plurality of helical loops 130 to the second end 106 of the first endoprosthesis 100.

[0050] In some embodiments, the first implantable prosthesis 100 may include one or more anti-migration elements 120. In some embodiments, the one or more anti-migration elements 120 may be formed integrally and / or monolithically with the first implantable prosthesis 100. In some embodiments, the one or more anti-migration elements 120 may be configured to be positioned substantially flush with the outer surface of the first implantable prosthesis 100 in a straightened configuration (e.g., when the first implantable prosthesis 100 is constrained in a straightened configuration) and / or during advancement and / or delivery into the first body cavity 10, as Figure 1 shown.

[0051] In some embodiments, the one or more anti-migration elements 120 may be configured to extend radially outward from the first implantable prosthesis 100 in a helical configuration and / or when unconstrained, as Figure 2 and Figure 5 shown. In some embodiments, the one or more anti-migration elements 120 may be disposed within the first end portion 110 and / or the second end portion 112. In some embodiments, one (or more) of the one or more anti-migration elements 120 may be disposed within the first end portion 110, and one (or more) of the one or more anti-migration elements 120 may be disposed within the second end portion 112. In some embodiments, the one or more anti-migration elements 120 may be disposed only within the first end portion 110. In some embodiments, the one or more anti-migration elements 120 may be disposed only within the second end portion 112. In some embodiments, the one or more anti-migration elements 120 may be self-biased to extend radially outward from the first implantable prosthesis 100 in a helical configuration. In some embodiments, the first implantable prosthesis 100 may include means configured to bias the one or more anti-migration elements 120 to extend radially outward from the first implantable prosthesis 100 in a helical configuration. Other configurations are also contemplated. The one or more anti-migration elements 120 may be configured to engage the inner surface of the body cavity in which the first implantable prosthesis 100 is disposed (e.g., the one or more anti-migration elements 120 may be configured to engage the inner surface of the first body cavity 10 and / or the second body cavity 20). In some cases, the anti-migration element 120 may be a barb extending from the tubular wall of the first implantable prosthesis. In other embodiments, the anti-migration element 120 may be a pigtail or a helical anchor located in the first end portion 110 and / or the second end portion 112.

[0052] Referring again to Figure 5 , in some embodiments, the first implantable prosthesis 100 may include one or more drainage ports 140 that extend through the sidewall of the first implantable prosthesis 100. The one or more drainage ports 140 may be in fluid communication with the cavity 102. The one or more drainage ports 140 may be disposed along the first end portion 110, the second end portion 112, and / or the plurality of helical rings 130. Although inFigure 5 is shown as being disposed along the first end portion 110 and the second end portion 112, but in some embodiments, one or more drainage ports 140 may be disposed only along the first end portion 110, only along the second end portion 112, and / or only along the plurality of helical loops 130. In some embodiments, one or more drainage ports 140 may be disposed along substantially the entire length of the first implant 100 or along any portion thereof.

[0053] In some embodiments, the plurality of helical loops 130 define a passageway 150 having an inner diameter 132. In some embodiments, the plurality of helical loops 130 may circumferentially extend around the passageway 150 and / or the longitudinal axis of the passageway 150. In at least some embodiments, the plurality of helical loops 130 may helically extend around the passageway 150 and / or the longitudinal axis of the passageway 150 in a helical configuration.

[0054] The passageway 150 may be outlined by the inner extent of the plurality of helical loops 130 defined by the outer surface of the tubular wall of the first implant 100. The plurality of helical loops 130 may define an outer diameter 134 and / or the outermost extent defined by the outer surface of the tubular wall of the first implant 100. In some embodiments, the outer diameter and / or the outermost extent of the plurality of helical loops 130 may be between about 6 French (Fr) and about 15 Fr (e.g., between about 2 millimeters and about 5 millimeters). In some embodiments, the outer diameter and / or the outermost extent of the plurality of helical loops 130 may be between about 6 Fr and about 12 Fr (e.g., between about 2 millimeters and about 4 millimeters). In some embodiments, the outer diameter and / or the outermost extent of the plurality of helical loops 130 may be about 6 Fr (e.g., about 2 millimeters), about 7 Fr (e.g., about 2.33 millimeters), about 8 Fr (e.g., about 2.67 millimeters), about 9 Fr (e.g., about 3 mm), about 10 Fr (e.g., about 3.33 mm), about 11 Fr (e.g., about 3.67 millimeters), about 12 Fr (e.g., about 4 millimeters), about 13 Fr (e.g., about 4.33 millimeters), about 14 Fr (e.g., about 4.67 millimeters), about 15 Fr (e.g., about 5 millimeters), etc.

[0055] In some embodiments, the elongate tube of the first implant 100 may have a first overall length in a straightened configuration of about 40 millimeters to about 300 millimeters, about 50 millimeters to about 275 millimeters, about 60 millimeters to about 250 millimeters, about 80 millimeters to about 225 millimeters, about 100 millimeters to about 200 millimeters, about 110 millimeters to about 175 millimeters, or another suitable range.

[0056] In at least some embodiments, the first endoprosthesis 100 may be formed of a polymeric material. For example, the first endoprosthesis 100 may be formed of a polymeric tubular member extending from a first end 104 to a second end 106 of the first endoprosthesis 100. The polymeric tubular member may maintain a constant diameter as the first endoprosthesis 100 transitions between a straightened configuration and a helical configuration. In other words, the polymeric tubular member may be a polymeric tube that does not expand significantly radially when the first endoprosthesis 100 transitions between a straightened configuration and a helical configuration, thereby maintaining a constant diameter of the polymeric tubular member. The polymeric tubular member may form (e.g., thermally set) helical loops 130 that, when unconstrained, lie along the inner region of the polymeric tubular member. When the polymeric tubular member is elongated and thus straightened, the helical loops 130 may disappear to provide a straightened configuration for delivery to the bifurcation 12. Some suitable but non-limiting examples of materials for the first endoprosthesis 100 are described herein.

[0057] Turning now to Figure 3 , once the first endoprosthesis 100 has been delivered and expanded into a helical configuration across the bifurcation 12, the method may then include advancing a guidewire 190 into the first body lumen 10. The method may also include advancing the guidewire 190 into and / or through the plurality of helical loops 130 and / or through the passageway 150 of the first endoprosthesis 100 after deploying the first endoprosthesis into a helical configuration. The method may also include advancing a second endoprosthesis 200 over the guidewire 190 in a radially collapsed configuration into the first body lumen 10. Thus, the second endoprosthesis 200 may be placed within the helical loops 130 in a radially constrained or collapsed configuration such that the helical loops 130 surround the radially constrained or collapsed second endoprosthesis 200, wherein the second endoprosthesis 200 extends from a portion of the first body lumen 10 proximal (e.g., downstream) of the bifurcation 12 to a portion of the first body lumen 10 distal (e.g., upstream) of the bifurcation 12. The second endoprosthesis 200 may be positioned such that a distal region of the second endoprosthesis 200 may extend across the stenosis 14 (in the first body lumen 10 upstream of the bifurcation 12) in a radially constrained or collapsed configuration while a proximal region of the second endoprosthesis 200 passes through the helical loops 130 of the first endoprosthesis 100 in the first body lumen 10 downstream of the bifurcation 12.

[0058] The second endoprosthesis 200 may be configured to transition from a radially collapsed configuration towards a radially expanded configuration ( Figure 4)Transformation. In at least some embodiments, the second implant 200 can be self-biased towards a radially expanded configuration. In some embodiments, the second implant 200 can be formed of a superelastic and / or shape memory material, such as Nitinol. In some embodiments, when the second implant 200 is advanced into the first body cavity 10, the second implant 200 can be constrained in a radially collapsed configuration by the properties of the shape memory material. In some embodiments, when the second implant 200 is advanced into the first body cavity 10, the second implant 200 can be constrained in a radially collapsed configuration by a delivery sheath 210 surrounding the second implant 200, as Figure 3 shown. Other configurations including combinations thereof are also contemplated.

[0059] The second implant 200 can include an expandable frame that extends axially from a first end (which can be considered the proximal end in some cases) to a second end (which can be considered the distal end in some cases) along a central longitudinal axis of the second implant 200 and / or the expandable frame. In at least some embodiments, the second implant 200 and / or the expandable frame can be self-expandable when unconstrained. In some embodiments, the second implant 200 and / or the expandable frame can be mechanically expandable. For example, the second implant 200 and / or the expandable frame can be expanded using an inflatable balloon, an actuating member, or other suitable means.

[0060] The expandable frame can include and / or be formed with a plurality of compartments. In some embodiments, the expandable frame can include and / or be formed by one or more filaments that are intertwined about a central longitudinal axis of the second implant 200 and / or the expandable frame. In at least some embodiments, the one or more filaments can form and / or define a plurality of compartments. In some embodiments, the expandable frame can be woven, knitted, or woven from one or more filaments. In some embodiments, the one or more filaments can be wires, threads, strands, etc. In some embodiments, adjacent filaments among the one or more filaments can define compartments (i.e., openings or voids) through the walls of the expandable frame. Alternatively, in some embodiments, the expandable frame can be a monolithic structure formed from a cylindrical tubular member, such as a single cylindrical laser-cut Nitinol (e.g., Nitinol) tubular member, where the remaining (e.g., unremoved) portions of the tubular member form struts and / or frames having compartments (i.e., openings or voids) defined therebetween.

[0061] The second implant 200 and / or the expandable frame can be substantially tubular and / or can include and / or define a lumen that extends axially along a central longitudinal axis of the second implant 200 and / or the expandable frame from a first end through it to a second end. In some embodiments, the second implant 200 and / or the expandable frame can have an axial length in the range of about 20 millimeters to about 200 millimeters, about 30 millimeters to about 175 millimeters, about 40 millimeters to about 150 millimeters, about 50 millimeters to about 125 millimeters, about 75 millimeters to about 100 millimeters, or another suitable range. In some embodiments, the second implant 200 and / or the expandable frame can have an outer diameter in the range of about 0.5 millimeters to about 5 millimeters, about 0.75 millimeters to about 4.5 millimeters, about 1 millimeter to about 4 millimeters, about 1.5 millimeters to about 3.5 millimeters, or another suitable range. In some embodiments, the second implant 200 and / or the expandable frame can have an outer diameter in the range of about 4 millimeters to about 28 millimeters, about 4 millimeters to about 14 millimeters, about 14 millimeters to about 28 millimeters, and / or subsets thereof. Other configurations are also contemplated. Some suitable but non-limiting materials for the second implant 200, the expandable frame, and / or its components or elements are described below, e.g., metallic materials and / or polymeric materials.

[0062] In some embodiments, the first total length of the elongated tube of the first implant 100 in a straightened configuration can be related to the axial length of the second implant 200. As shown and / or discussed herein, at least portions of the first end portion 110 and the second end portion 112 of the first implant 100 can extend proximally and distally of the second implant 200, respectively. In some embodiments, the first total length of the first implant 100 in a straightened configuration can be approximately the axial length of the second implant 200 plus (the circumference of the second implant 200 multiplied by the number of helical turns in the plurality of helical turns 130) plus the lengths of the first end portion 110 and the second end portion 112 of the first implant 100 that extend away from the respective ends of the second implant 200.

[0063] The approximate total length of the elongated tube of the first implant 100 in a helical configuration will be less than the first total length. In one non-limiting example, the axial length of the second implant 200 can be about 100 millimeters, and the outer diameter of the second implant 200 can be about 10 millimeters. One example of the first implant 100 that can be associated with and / or used in conjunction with the above example of the second implant 200 can have a first total length of about 300 millimeters in a straightened configuration and an approximate total length of about 120 millimeters in a helical configuration. Other configurations and / or examples are also contemplated.

[0064] In some embodiments, the expandable frame may include a first flared portion adjacent to the first end of the expandable frame. The first flared portion may extend from the first end toward the second end. In some embodiments, the expandable frame may include a second flared portion adjacent to the second end of the expandable frame. The second flared portion may extend from the second end toward the first end. In at least some embodiments, the second flared portion may be longitudinally and / or axially spaced from the first flared portion by a body portion. In some embodiments, the first flared portion and / or the second flared portion may be configured to apply a radially outward force on the wall of the first body cavity 10 to prevent the second implant 200 from migrating within the first body cavity 10.

[0065] In some embodiments, the delivery sheath 210 may be an elongate catheter or other tubular shaft adapted to deliver an implant and / or known in the art for delivering an implant. The second implant 200 may be disposed in the lumen of the delivery sheath 210 in a radially constrained or collapsed configuration. In the radially constrained or collapsed configuration, the expandable frame may be substantially straight and / or fully elongated. The second implant 200 may be deployed from the delivery sheath 210 using one or more known techniques, such as withdrawing the delivery sheath 210 proximally from the second implant 200 to expel the second implant 200 from the delivery sheath 210. Other techniques may be used to deploy the second implant 200 from the delivery sheath 210, which are well known but not described for the sake of brevity.

[0066] The method may include transitioning the second implant 200 to a radially expanded configuration within the plurality of rings 130 and / or passageways 150, as Figure 4 shown. In some embodiments, transitioning the second implant 200 to a radially expanded configuration may include withdrawing and / or retracting the delivery sheath 210 relative to the second implant 200 to expose the second implant 200 within the first body cavity 10 and / or within the plurality of rings 130 and / or passageways 150, thereby allowing the second implant 200 to radially expand.

[0067] In at least some embodiments, the second implant 200 and / or the expandable frame may be deployed within a stenotic body cavity to maintain and / or restore patency of the body cavity. In some embodiments, the second implant 200 and / or the expandable frame may be configured to expand at least a portion of the body cavity in a radially expanded configuration. For example, the second implant 200 and / or the expandable frame may be configured to apply a radially outward force on the wall of the body cavity and / or against a stenosis that has formed therein.

[0068] In some embodiments, at least a portion of the second implant 200 may be disposed in a radially expanded configuration within the plurality of rings 130 and / or the passageways 150. In some embodiments, when the second implant 200 is disposed in a radially expanded configuration within the plurality of rings 130 and / or the passageways 150, at least a portion of the second implant 200 may extend away from the plurality of rings 130 and / or the passageways 150.

[0069] In some embodiments, the second implant 200 and / or the expandable frame may be configured to engage the plurality of rings 130 and / or the passageways 150 in a radially expanded configuration. In the radially expanded configuration, the second implant 200 and / or the expandable frame may be configured to apply a radially outward force on the first implant 100 and / or the plurality of rings 130 in a helical configuration such that the first implant 100 and / or the plurality of rings 130 engage with and / or against the wall of the first body cavity 10. In some instances, portions of the second implant 200 extending between adjacent rings 130 may extend radially outward and contact the wall of the first body cavity 10.

[0070] In some embodiments, the second implant 200 may be configured to expand at least a portion of the first body cavity 10 in a radially expanded configuration. For example, the second implant 200 may be configured to apply a radially outward force on the wall of the first body cavity 10 and / or on the stenosis 14 in a radially expanded configuration. In some embodiments, the second implant 200 and / or the expandable frame may be configured to extend across an opening into an adjacent body cavity (e.g., the second body cavity 20). In other words, the second implant 200 may be configured to extend across the bifurcation 12 such that a first end region of the second implant 200 is placed in the first body cavity 10 upstream of the bifurcation 12 (and across the stenosis 14, for example), and a second end region of the second implant 200 is placed in the first body cavity 10 downstream of the bifurcation 12.

[0071] In some embodiments, when the second implant 200 is disposed in a radially expanded configuration within the plurality of rings 130 and / or the passageways 150, a first end portion 110 of the first implant 100 may extend laterally away from the second implant 200 relative to a central longitudinal axis of the second implant 200. In some embodiments, when the second implant 200 is disposed in a radially expanded configuration within the plurality of rings 130 and / or the passageways 150 (which may be located in the first body cavity 20 downstream of the bifurcation 12), the first end portion 110 of the first implant 100 may extend away from the second implant 200 into the second body cavity 20.

[0072] In some embodiments, when the second implant 200 is disposed in a radially expanded configuration within the plurality of rings 130 and / or the passageways 150 (which may be located in the first body cavity 20 downstream of the bifurcation 12), the second end portion 112 of the first implant 100 may extend away from the second implant 200 generally parallel to the central longitudinal axis of the second implant 200. In some embodiments, when the second implant 200 is disposed in a radially expanded configuration within the plurality of rings 130 and / or the passageways 150, the second end portion 112 of the first implant 100 may extend away from the second implant 200 within the first body cavity 10.

[0073] In some embodiments, the second implant 200 may have an outer diameter and / or an outer extent in the radially expanded configuration. In some embodiments, the outer diameter and / or the outer extent of the second implant 200 may be within about 20% of the inner diameter 132 of the passageway 150. In some embodiments, the outer diameter and / or the outer extent of the second implant 200 may be within about 15% of the inner diameter 132 of the passageway 150. In some embodiments, the outer diameter and / or the outer extent of the second implant 200 may be within about 10% of the inner diameter 132 of the passageway 150. In some embodiments, the outer diameter and / or the outer extent of the second implant 200 may be within about 5% of the inner diameter 132 of the passageway 150. In some embodiments, the outer diameter and / or the outer extent of the second implant 200 may be substantially equal to the inner diameter 132 of the passageway 150.

[0074] In some embodiments, a portion of the second implant 200 that extends between adjacent rings of the plurality of rings 130 (when radially expanded within the plurality of rings 130 of the first implant 100) may have a second outer diameter and / or a second outer extent that is greater than the outer diameter and / or the outer extent of the second implant 200 disposed within the passageway 150 and / or the plurality of rings 130, such that the portion of the second implant 200 extends radially outwardly between the adjacent rings 130.

[0075] In some embodiments, the second implant 200 and / or the expandable frame may include a polymeric cover 220 disposed on at least a portion of its length, above it and / or extending therealong. In some embodiments, the polymeric cover 220 may be disposed on and / or along the first flared portion, the second flared portion, and / or the body portion extending therebetween. In some embodiments, the polymeric cover 220 may be disposed on and / or along the outer surface of the expandable frame. In some embodiments, at least a portion of the expandable frame may be embedded in the polymeric cover 220. In some embodiments, the polymeric cover 220 may be fixedly or releasably secured, adhered to, or otherwise attached to the expandable frame. In some embodiments, the polymeric cover 220 may be impermeable to fluids, debris, medical devices, etc. Some suitable but non-limiting materials for the polymeric cover 220 are described below.

[0076] In some embodiments, the polymeric cover 220 may extend along the entire length and / or circumference of the second implant 200 and / or the expandable frame. In some embodiments, the polymeric cover 220 may extend along a portion of the length of the second implant 200 and / or the expandable frame. In some embodiments, the polymeric cover 220 may be discontinuous. In some embodiments, in the radially expanded configuration, the polymeric cover 220 may extend discontinuously between the first end (e.g., proximal end) and the second end (e.g., distal end) of the second implant 200 and / or the expandable frame. In some embodiments, in the radially expanded configuration, the polymeric cover 220 may extend continuously from the first end (e.g., proximal end) to the second end (e.g., distal end) of the second implant 200 and / or the expandable frame. Other configurations are also contemplated.

[0077] After the second implant 200 is deployed within the plurality of rings 130 and / or passageways 150, the second implant 200 and the polymeric cover 220 (if present) may cooperate with the first implant 100 to define a helical fluid path around the second implant 200 (e.g., outside thereof) in the lower portion from the second body cavity 20 to the first body cavity 10. In at least some embodiments, the first implant 100 may create a gap 30 between the outer surface of the second implant 200 and the wall of the first body cavity 10, wherein the gap 30 may define a helical fluid path around the outer surface of the second implant 200.

[0078] In some embodiments, the first implant 100 may be configured to provide drainage internally from the second body cavity 20 to the first body cavity 10 and / or through the lumen 102 of the first implant 100. In some embodiments, the first implant 100 may cooperate with the second implant 200 and the polymeric cover 220, if present, to provide drainage externally from the second body cavity 20 to the first body cavity 10 along and / or using a helical fluid path around the exterior of the second implant 200. In some embodiments, the first implant 100 may be configured to provide drainage internally (e.g., through the lumen 102 of the first implant 100) and externally (e.g., along the exterior of the first implant 100 that forms a gap 30 along the exterior of the second implant 200) from the second body cavity 20 to the first body cavity 10.

[0079] Figure 6 Selected aspects of an alternative configuration of the first implant 100 are shown. In some embodiments, the first implant 100 may include a flexible region, such as a corrugated section 160 disposed between the first end 104 and the plurality of rings 130. The flexible region (e.g., corrugated section 160) may be more flexible than the remainder of the length of the first implant 100, including a portion of the tubular member of the first implant 100 on either side of the flexible region. In some embodiments, the first end portion 110 may include the corrugated section 160. In some embodiments, the corrugated section 160 may divide the first end portion 110 into a first section 162 and a second section 164, with a flexible region (e.g., corrugated section 160) therebetween. In some embodiments, the first section 162 may be disposed proximal to the flexible or corrugated section 160 and / or between the flexible or corrugated section 160 and the plurality of rings 130, and the second section 164 may be disposed distal to the flexible or corrugated section 160 and / or between the flexible or corrugated section 160 and the first end 104.

[0080] In some embodiments, the corrugated segment 160 may resemble an accordion and / or bellows. The corrugated segment 160 may add additional aspects of flexibility and / or bendability to the first end portion 110 of the first implant 100. In some embodiments, the first implant 100 having the corrugated segment 160 may be configured to more easily conform to the irregular nature of tortuous anatomy. In some embodiments, the corrugated segment 160 may be configured to bend and / or deflect the second segment 164 relative to the first segment 162. In other words, the central longitudinal axis of the second segment 164 may extend at a non-parallel angle (e.g., acute, perpendicular, or obtuse) relative to the central longitudinal axis of the first segment 162. In some embodiments, the second segment 164 may bend and / or deflect in a coplanar manner relative to the first segment 162. In some embodiments, the second segment 164 may bend and / or deflect obliquely and / or in a non-coplanar manner relative to the first segment 162. Other configurations are also contemplated.

[0081] In some embodiments, the corrugated segment 160 may be manipulated by a guide wire 90 during delivery of the first implant 100. In some embodiments, the corrugated segment 160 may be steered using one or more mechanisms built into the first implant 100. For example, one or more steering wires may be disposed within and / or may extend along the wall of the first implant 100. Other configurations are also contemplated.

[0082] Figure 7Shows selected aspects of alternative uses and / or configurations of the systems and / or methods disclosed herein for maintaining the patency of a body cavity. In some embodiments, the method can include advancing a guidewire into a first body cavity 10 such that the guidewire extends upstream of the bifurcation 12. The method can include advancing a first endoprosthesis 100 in a straightened configuration on the guidewire into the first body cavity 10 to a position where the first endoprosthesis 100 spans the bifurcation 12, wherein a distal region of the first endoprosthesis 100 is located in the first body cavity 10 upstream of the bifurcation 12 and a proximal region of the first endoprosthesis 100 is located in the first body cavity 10 downstream of the bifurcation 12. In some embodiments, when advancing the first endoprosthesis 100 across the bifurcation 12 through the first body cavity 10, the first endoprosthesis 100 can be constrained in the straightened configuration by the guidewire. In some alternative embodiments, when advancing the first endoprosthesis 100 through the first body cavity 10 and across the bifurcation 12, the first endoprosthesis 100 can be constrained in the straightened configuration by a delivery sheath surrounding the first endoprosthesis 100. Other configurations including combinations thereof are also contemplated. In some embodiments, advancing the first endoprosthesis 100 in a straightened configuration into the first body cavity 10 can include positioning a first end portion 110 of the first endoprosthesis 100 in the first body cavity 10 upstream of the bifurcation 12 and positioning a second end portion 112 of the first endoprosthesis 100 in the first body cavity 10 downstream of the bifurcation 12 such that an intermediate region of the first endoprosthesis 100 spans the bifurcation 12.

[0083] The method can include deploying the first endoprosthesis 100 in a helical configuration defining a plurality of loops 130 in the first body cavity 10, as Figure 7 shown, wherein a first end portion 110 of the first endoprosthesis 100 is in the first body cavity 10 on a first side of the bifurcation 12, such as upstream of the bifurcation 12, and a second end portion 112 of the first endoprosthesis 100 is in the first body cavity 10 on a second side of the bifurcation 12, such as, downstream of the bifurcation 12. Thus, when deployed to the helical configuration, an intermediate portion of the first endoprosthesis 100 can be located at the bifurcation 12. When deployed to the helical configuration, the intermediate portion of the first endoprosthesis 100 can define a plurality of helical loops 130. The first endoprosthesis 100 can be configured to automatically transition from a straightened configuration (wherein the helical loops 130 are straightened or elongated) when constrained by a guidewire 90 (or an outer sheath, if present) to a helical configuration when unconstrained. In at least some embodiments, the first endoprosthesis 100 can be self-biased toward the helical configuration when unconstrained.

[0084] In some embodiments, at least a portion of the first implant 100 may extend away from the plurality of loops 130 of the helical configuration. In some embodiments, the first end portion 110 may extend away from the plurality of loops 130 of the helical configuration. In some embodiments, the first end portion 110 may extend from the plurality of loops 130 to the first end 104 of the first implant 100. In some embodiments, the second end portion 112 may extend away from the plurality of loops 130 of the helical configuration. In some embodiments, the second end portion 112 may extend from the plurality of loops 130 to the second end 106 of the first implant 100.

[0085] Once the first implant 100 has been delivered and expanded into the helical configuration across the bifurcation 12, the method may then include advancing a second guidewire 190 into the first body lumen 10. The method may also include advancing the second guidewire 190 into and / or through the plurality of helical loops 130 and / or through the passageway 150 of the first implant 100 after deploying the first implant into the helical configuration. The method may also include advancing a second implant 200 along the second guidewire in a radially collapsed configuration into the first body lumen 10. Thus, the second implant 200 may be placed within the helical loops 130 in a radially constrained or collapsed configuration such that the helical loops 130 surround the radially constrained or collapsed second implant 200, wherein the second implant 200 extends from a portion of the first body lumen 10 proximal (e.g., downstream) to the bifurcation 12 to a portion of the first body lumen 10 distal (e.g., upstream) to the bifurcation 12. The second implant 200 may be positioned such that a distal region of the second implant 200 may extend distally of the bifurcation 12 in a radially constrained or collapsed configuration while a proximal region of the second implant 200 may extend proximally of the bifurcation 12 in a radially constrained or collapsed configuration.

[0086] The second implant 200 may be configured to transition from a radially collapsed configuration to a radially expanded configuration. In at least some embodiments, the second implant 200 may be self-biased toward the radially expanded configuration. In some embodiments, the second implant 200 may be formed of a superelastic and / or shape memory material, such as nitinol. In some embodiments, when the second implant 200 is advanced into the first body lumen 10, the second implant 200 may be constrained in the radially collapsed configuration by the properties of the shape memory material. In some embodiments, when the second implant 200 is advanced into the first body lumen 10, the second implant 200 may be constrained in the radially collapsed configuration by a delivery sheath surrounding the second implant 200. Other configurations including combinations thereof are also contemplated.

[0087] In some embodiments, the delivery sheath may be an elongate catheter or other tubular member adapted to deliver an endoprosthesis and / or known in the art for delivering an endoprosthesis. The second endoprosthesis 200 may be disposed in a radially constrained or collapsed configuration within the lumen of the delivery sheath. In the radially collapsed configuration, the expandable frame may be substantially straight and / or fully elongated. The second endoprosthesis 200 may be deployed from the delivery sheath using one or more known techniques, such as withdrawing the delivery sheath proximally from the second endoprosthesis 200 to discharge the second endoprosthesis 200 from the delivery sheath. Other techniques may be used to deploy the second endoprosthesis 200 from the delivery sheath, which are well known but not described for the sake of brevity.

[0088] The method may include transitioning the second endoprosthesis 200 to a radially expanded configuration within the plurality of rings 130 and / or passages 150, as Figure 7 shown. In some embodiments, transitioning the second endoprosthesis 200 to a radially expanded configuration may include withdrawing and / or retracting the delivery sheath relative to the second endoprosthesis 200 to expose the second endoprosthesis 200 within the first body cavity 10 and / or within the plurality of rings 130 and / or passages 150, thereby allowing the second endoprosthesis 200 to radially expand.

[0089] In at least some embodiments, the second endoprosthesis 200 and / or the expandable frame may be deployed within the narrow first body cavity 10 extending therethrough to maintain and / or reconstruct the patency of the body cavity 10. In some embodiments, the second endoprosthesis 200 and / or the expandable frame may be configured to expand at least a portion of the first body cavity 10 in the radially expanded configuration. For example, the second endoprosthesis 200 and / or the expandable frame may be configured to apply a radially outward force against the wall of the first body cavity 10 and / or against a stenosis already formed therein.

[0090] In some embodiments, at least a portion of the second endoprosthesis 200 may be disposed in a radially expanded configuration within the plurality of rings 130 and / or passages 150. In some embodiments, when the second endoprosthesis 200 is disposed in a radially expanded configuration within the plurality of rings 130 and / or passages 150, at least a portion of the second endoprosthesis 200 may extend away from the plurality of rings 130 and / or passages 150.

[0091] In some embodiments, the second implant 200 may be configured to engage the plurality of rings 130 and / or the passageways 150 in a radially expanded configuration. In the radially expanded configuration, the second implant 200 may be configured to apply a radially outward force on the first implant 100 and / or the plurality of rings 130 in a helical configuration, such that the first implant 100 and / or the plurality of rings 130 engage with and / or against the wall of the first body cavity 10. In some cases, portions of the second implant 200 extending between adjacent rings 130 may extend radially outward and contact the wall of the first body cavity 10.

[0092] In some embodiments, the second implant 200 may be configured to expand at least a portion of the first body cavity 10 in a radially expanded configuration. For example, the second implant 200 may be configured to apply a radially outward force on the wall of the first body cavity 10 in a radially expanded configuration. In some embodiments, the first implant 100 and the second implant 200 may be configured to extend across an opening into an adjacent body cavity (e.g., the second body cavity 20), as Figure 7 shown. In other words, the second implant 200 may be configured to extend across the bifurcation 12 such that a first end region of the second implant 200 is placed in the first body cavity 10 upstream of the bifurcation 12 and a second end region of the second implant 200 is placed in the first body cavity 10 downstream of the bifurcation 12.

[0093] In some embodiments, when the second implant 200 is disposed within the plurality of rings 130 and / or the passageways 150 in a radially expanded configuration, a first end portion 110 of the first implant 100 may extend away from the second implant 200 generally parallel to the central longitudinal axis of the second implant 200. In some embodiments, when the second implant 200 is disposed within the plurality of rings 130 and / or the passageways 150 in a radially expanded configuration, the first end portion 110 of the first implant 100 may extend away from the second implant 200 within the first body cavity 10.

[0094] In some embodiments, when the second implant 200 is disposed within the plurality of rings 130 and / or the passageways 150 in a radially expanded configuration, a second end portion 112 of the first implant 100 may extend away from the second implant 200 generally parallel to the central longitudinal axis of the second implant 200. In some embodiments, when the second implant 200 is disposed within the plurality of rings 130 and / or the passageways 150 in a radially expanded configuration, the second end portion 112 of the first implant 100 may extend away from the second implant 200 within the first body cavity 10.

[0095] In one example, when the second implant 200 is disposed in the plurality of rings 130 and / or passageways 150 in a radially expanded configuration, the first end portion 110 of the first implant 100 may extend within the first body cavity 10 upstream of the second implant 200, and when the second implant 200 is disposed in the plurality of rings 130 and / or passageways 150 in a radially expanded configuration, the second end portion 112 of the first implant 100 may extend within the first body cavity 10 downstream of the second implant 200. In another example, when the second implant 200 is disposed in the plurality of rings 130 and / or passageways 150 in a radially expanded configuration, the first end portion 110 of the first implant 100 may extend within the first body cavity 10 downstream of the second implant 200, and when the second implant 200 is disposed in the plurality of rings 130 and / or passageways 150 in a radially expanded configuration, the second end portion 112 of the first implant 100 may extend within the first body cavity 10 upstream of the second implant 200.

[0096] After the second implant 200 is deployed within the plurality of rings 130 and / or passageways 150, the second implant 200 and the polymeric cap 220 (if present) may cooperate with the first implant 100 to define a helical fluid path around the second implant 200 (e.g., on its exterior) from an upper portion (e.g., upstream portion) of the first body cavity 10 to a lower portion (e.g., downstream portion) of the first body cavity 10 and from the second body cavity 20 to the lower portion (e.g., downstream portion) of the first body cavity 10. In at least some embodiments, the first implant 100 may create a gap 30 between the exterior (e.g., outer surface) of the second implant 200 and the wall of the first body cavity 10, where the gap 30 may define a helical fluid path around the exterior (e.g., outer surface) of the second implant 200. The gap 30 may be fluidly accessible from the second body cavity 20 so as to maintain fluid flow along the helical gap 30 from the second body cavity 20 to the first body cavity 10 when treating the first body cavity 10 with the system.

[0097] In some embodiments, the first implant 100 may cooperate with the second implant 200 and the polymeric cap 220 (if present) to provide drainage from the second body cavity 20 to the first body cavity 10 externally along and / or using a helical fluid path around the exterior of the second implant 200. In some embodiments, the first implant 100 may include a plurality of drainage ports 140 formed along an intermediate portion of the first implant 100. The plurality of drainage ports 140 may be in fluid communication with the lumen 102 of the first implant 100. The intermediate portion of the first implant 100, including the drainage ports 140, may be positioned across the opening into the second body cavity 20. The plurality of drainage ports 140 may permit fluid from the second body cavity 20 to enter and / or flow into the lumen 102 of the first implant 100. Thus, in some embodiments, the first implant 100 may be configured to provide drainage internally from the second body cavity 20 to the first body cavity 10 and / or through the lumen 102 of the first implant 100. In some embodiments, the first implant 100 may be configured to provide drainage internally (e.g., through the lumen 102 of the first implant 100) and externally (e.g., along the exterior of the first implant 100 forming a gap 30 along the exterior of the second implant 200) from the second body cavity 20 to the first body cavity 10.

[0098] Materials that may be used for the systems and their various elements disclosed herein may include those commonly associated with medical devices. For simplicity, the following discussion refers to the system. However, this is not intended to limit the devices and methods described herein, as the discussion may apply to other elements, components, parts, or devices disclosed herein, such as, but not limited to, the first implant, the second implant, the expandable frame, the polymeric cap, etc. and / or their elements or parts.

[0099] In some embodiments, the system and / or its components may be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, etc. or other suitable materials.

[0100] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., ), polyether block ester, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether ester (e.g., ), ether or ester-based copolymers (e.g., butylene phthalate / poly(alkylene ether) and / or other polyester elastomers, such as, ), polyamide (e.g., or ) elastomers, polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name commercially available), ethylene-vinyl acetate copolymers (EVA), silicones, polyethylene (PE), high density polyethylene, low density polyethylene, linear low density polyethylene (e.g., ), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as, ), perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, polyurethane silicone copolymers (e.g., or ), biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the system and / or its components can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0101] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; low carbon steels; nickel-titanium alloys such as linear elastic and / or superelastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625, such as 625, UNS:N06022, such as UNS:N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS:N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS:N10665, such as ALLOY ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0102] In at least some embodiments, some or all of the system and / or parts thereof may also be doped with radiopaque materials, made of them, or otherwise include them. Radiopaque materials should be understood as materials that can produce relatively bright images on a fluoroscope or with another imaging technique (e.g., ultrasound, etc.) during a medical procedure. Such relatively bright images help the user of the system to determine its position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the system to achieve the same result.

[0103] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the systems and / or other elements disclosed herein. For example, the system and / or its components or parts may be made of materials that do not substantially distort the image and create a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. The system or parts thereof may also be made of materials that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nitinol, etc.

[0104] In some embodiments, the systems and / or other elements disclosed herein may include a fabric material disposed above or within the structure. The fabric material may be composed of biocompatible materials suitable for promoting in-growth within tissue, such as polymeric materials or biomaterials. In some embodiments, the fabric material may include bioabsorbable materials. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials such as polyethylene, polypropylene, polyester, polyurethane, and / or mixtures or combinations thereof.

[0105] In some examples, the systems and / or other elements disclosed herein may comprise and / or be formed from textile materials. Some examples of suitable textile materials may include synthetic yarns, which may be flat, shaped, twisted, textured, pre-shrunk or non-shrinking. Synthetic biocompatible yarns suitable for the present invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylene, polyethylene, polyurethane, polyolefins, polyethylene, poly(methyl acetate), polyamides, naphthalene dicarboxylic acid derivatives, natural silk and polytetrafluoroethylene. In addition, at least one of the synthetic yarns may be a metal yarn or a glass or ceramic yarn or fiber. Useful metal yarns include those made of or containing stainless steel, platinum, gold, titanium, tantalum or Ni-Co-Cr based alloys. The yarn may also include carbon, glass or ceramic fibers. Desirably, the yarn is made of a thermoplastic material, including but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarn may be of the multifilament, monofilament or staple type. The type and denier of the yarn selected may be chosen in a manner that forms a biocompatible and implantable prosthesis, and particularly a vascular structure having the desired properties.

[0106] In some embodiments, the system and / or other elements disclosed herein may include a suitable therapeutic agent and / or be treated therewith. Some examples of suitable therapeutic agents may include anticoagulants (such as heparin, heparin derivatives, urokinase, and PPack (D-phenylalanyl-prolyl-arginine chloromethyl ketone)); antiproliferatives (such as enoxaparin, angiotensin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalazine); anti-tumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, 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); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translation initiators); vascular cell 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, bifunctional molecules composed of antibodies and cytotoxins); immunosuppressants (such as the mTOR family of drugs, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, pimecrolimus, novolimus, milcimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol-lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0107] It should be understood that the invention is illustrative in many respects. Changes may be made in details, particularly in matters of the shape, size, and arrangement of steps, without exceeding the scope of the invention. To the appropriate extent, this may include using any of the features of one exemplary embodiment in other embodiments. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. A system for maintaining the patency of a body cavity, comprising: A first implantable prosthesis having a lumen extending from a first end to a second end, wherein the first implantable prosthesis is configured to transition from a straightened configuration to a helical configuration defining a plurality of loops; And A second implantable prosthesis configured to transition from a radially collapsed configuration towards a radially expanded configuration; Wherein the plurality of loops define a passageway having an inner diameter; Wherein at least a portion of the second implantable prosthesis is disposed within the passageway in the radially expanded configuration.

2. The system according to claim 1, wherein when the second implantable prosthesis is disposed within the passageway in the radially expanded configuration, at least a portion of the second implantable prosthesis extends away from the passageway.

3. The system according to any one of claims 1 to 2, wherein at least a portion of the first implantable prosthesis extends away from the plurality of loops.

4. The system according to claim 3, wherein when the second implantable prosthesis is disposed within the passageway in the radially expanded configuration, a first end portion of the first implantable prosthesis extends laterally away from the second implantable prosthesis relative to a central longitudinal axis of the second implantable prosthesis.

5. The system according to any one of claims 3 to 4, wherein when the second implantable prosthesis is disposed within the passageway in the radially expanded configuration, a second end portion of the first implantable prosthesis extends away from the second implantable prosthesis substantially parallel to the central longitudinal axis of the second implantable prosthesis.

6. The system according to any one of claims 1 to 5, wherein the second implantable prosthesis has an outer diameter in the radially expanded configuration; Wherein the outer diameter of the second implantable prosthesis is within 20% of the inner diameter of the passageway.

7. The system according to any one of claims 1 to 6, wherein the plurality of loops define an outer diameter between about 6 French and about 12 French.

8. The system according to any one of claims 1 to 7, wherein the first implantable prosthesis is self-biased towards the helical configuration.

9. The system according to any one of claims 1 to 8, wherein the second implantable prosthesis is self-biased towards the radially expanded configuration.

10. The system according to any one of claims 1 to 9, wherein the second implantable prosthesis includes a polymeric covering extending along at least a portion of its length.

11. The system according to any one of claims 1 to 10, wherein the first implantable prosthesis includes a corrugated section disposed between the first end and the plurality of loops.

12. The system according to any one of claims 1 to 11, wherein the first implantable prosthesis includes one or more drainage holes extending through a sidewall of the first implantable prosthesis.

13. The system according to any one of claims 1 to 12, wherein the first implantable prosthesis includes one or more anti-migration elements extending radially outward therefrom.

14. The system according to any one of claims 1 to 13, wherein the first implantable prosthesis is formed of a polymeric material.

15. A method for maintaining the patency of a body cavity, comprising: Advance the first implant in a straightened configuration into the first body cavity; Deploy the first implant in a helical configuration defining a plurality of loops within the first body cavity; Advance the second implant in a radially collapsed configuration into the first body cavity; and Convert the second implant to a radially expanded configuration within the plurality of loops.

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