Esophageal stent including an inner liner

Abstract

To design a stent including both a covered portion, a non-covered portion and a tubular liner.SOLUTION: An expandable medical device comprises a tubular scaffold and a liner. The tubular scaffold includes an inner surface, an outer surface, a first end region, a second end region, a medial region positioned between the first end region and the second end region, and a lumen extending from the first end region to the second end region. The liner is disposed within the lumen of the tubular scaffold. The plurality of first portion of the liner are secured to and directly abut on a plurality of first regions of the inner surface of the tubular scaffold, thereby preventing tissue ingrowth. The plurality of second regions of the inner surface do not directly abut on the liner thereby defining a tissue ingrowth region between the inner surface of the tubular scaffold and an outer surface of the liner.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present disclosure relates to medical devices, methods for manufacturing medical devices, and uses thereof. More particularly, the present disclosure relates to stents that include an inner member, such as an inner liner, and methods for manufacturing and using such stents. [Background technology]

[0002] Implantable medical devices (e.g., expandable stents) may be designed to provide a pathway for digestive matter, blood, or other fluids to flow after a medical procedure. Additionally, some implantable medical devices may implement features useful for fistula repair, bypass surgery, and / or anastomosis repair. These medical devices may include radially or self-expanding stents that may be implanted transluminally via an endoscope. Some stents may also be implanted in various body lumens, such as the esophagus, gastrointestinal tract (including the intestines, stomach, and colon), tracheobronchial tree, urinary tract, biliary tract, and vascular system.

[0003] In some cases, it may be desirable to design a stent that has sufficient radial strength to maintain its position within a body lumen while also functioning as a passageway for food or other digestive materials. However, the compressibility and flexibility characteristics that aid in stent positioning can also lead to a tendency for the stent to migrate from its original deployed position. For example, a stent designed for placement in the esophagus or gastrointestinal tract may have a tendency to migrate due to peristalsis (i.e., the involuntary contraction and relaxation of the muscles of the esophagus, intestine, and colon that push the contents of the tract). In addition, the generally moist and inherently smooth environment of the esophagus, intestine, and colon further contributes to the tendency of stents to migrate when deployed within them. One method for reducing stent migration may involve exposing the bare metal portion of the stent to the tissue of the body lumen. A stent scaffold may provide a structure that promotes tissue ingrowth into its gaps or openings (e.g., the stent structure may promote a hyperplastic response). Tissue ingrowth can secure the stent in place and reduce the risk of stent migration.

[0004] Furthermore, while it is important to design a stent that reduces the degree to which the stent migrates within a body lumen, it is also important to design a stent that can be easily removed and / or repositioned from the body lumen after deployment. Also, stents that include bare (i.e., uncovered) portions designed to promote tissue ingrowth (e.g., to reduce stent migration, as described above) may be more difficult to remove after tissue secures the stent to the body lumen. One method for reducing the force required to remove a stent from a body lumen may include creating a physical barrier between the body lumen and the outer surface of the stent by covering a portion of the stent (e.g., reducing the surface area of ​​the stent that can be secured by tissue ingrowth). However, covered stents may be more susceptible to migration than bare stents (as described above).

[0005] Furthermore, in addition to designing a stent that is both well-secured and easily removable from a body lumen, it may be desirable to design the stent with features that assist in the passage of digestible material through the body lumen. For example, in some cases, it may be desirable to design a stent with an inner liner (e.g., a cavity) that allows food or other digestive matter to flow through. Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, in some cases, it may be desirable to design a stent that includes both covered and uncovered (e.g., bare) portions, and a tubular liner. Examples of medical devices that include covered and uncovered portions and an inner liner are disclosed herein. [Means for solving the problem]

[0007] The present disclosure provides alternative designs, materials, manufacturing methods, and uses for medical devices. An exemplary expandable medical device includes a tubular scaffold. The scaffold includes an inner surface, an outer surface, and a cavity extending therein. The expandable medical device also includes a liner disposed within the cavity of the tubular scaffold. Further, the liner is radially spaced from the intermediate region of the tubular scaffold to define a tissue ingrowth region along the intermediate region. Additionally, the liner extending along the tissue ingrowth region is configured to limit the amount of tissue ingrowth along the intermediate region of the scaffold.

[0008] Alternatively or additionally to any of the above embodiments, the liner is configured to limit the amount of tissue ingrowth into the intermediate region of the tubular scaffold due to a hyperplastic response. Alternatively or additionally to any of the above embodiments, the tissue ingrowth region is formed between the inner surface of the tubular scaffold and the outwardly facing surface of the liner.

[0009] Alternatively or additionally to any of the above embodiments, the portion of the liner extending along the tissue ingrowth region is configured to deflect radially inward from the inner surface of the tubular scaffold.

[0010] Alternatively or additionally to any of the above embodiments, the intermediate portion of the tubular scaffold includes a first inner diameter and the diameter of the liner along the tissue ingrowth region includes a second inner diameter, the second inner diameter being greater than 25% of the diameter of the first inner diameter.

[0011] Alternatively or additionally to any of the above embodiments, the liner is designed to maintain a passageway therethrough. Alternatively or additionally to any of the above embodiments, the liner is fixedly attached to at least a portion of the inner surface of the tubular scaffold.

[0012] Alternatively or additionally to any of the above embodiments, the tissue ingrowth region extends circumferentially around the inner surface of the tubular scaffold. Alternatively or additionally to any of the above embodiments, the liner is disposed along a portion of the outer surface of the tubular scaffold.

[0013] Alternatively or additionally to any of the above embodiments, the liner extends continuously along an inner surface of the tubular scaffold, along end portions of the tubular scaffold, and along a portion of an outer surface of the tubular scaffold.

[0014] Alternatively or additionally to any of the above embodiments, the liner is circumferentially attached to the tubular scaffold at a first location and a second location, and a tissue ingrowth region is defined between the first location and the second location.

[0015] Alternatively or additionally to any of the above embodiments, the intermediate region is devoid of a liner so that tissue is allowed to grow through the interstices of the stent along the intermediate region. Another esophageal stent includes an expandable tubular scaffold, the scaffold including an inner surface, an outer surface, and a cavity extending therein. The stent also includes a liner disposed within the cavity of the tubular scaffold. The liner extends continuously within the cavity of the tubular scaffold. The liner is radially spaced from a middle region of the tubular scaffold to define a tissue ingrowth region along the middle region. The liner is configured to maintain a passageway therethrough for a substance to flow.

[0016] Alternatively or additionally to any of the above embodiments, the liner is configured to limit the amount of tissue ingrowth into the intermediate region of the tubular scaffold due to a hyperplastic response. Alternatively or additionally to any of the above embodiments, the tissue ingrowth region is formed between the inner surface of the tubular scaffold and the outwardly facing surface of the liner.

[0017] Alternatively or additionally to any of the above embodiments, the portion of the liner extending along the tissue ingrowth region is configured to deflect radially inward from the inner surface of the tubular scaffold.

[0018] Alternatively or additionally to any of the above embodiments, the intermediate portion of the tubular scaffold includes a first inner diameter and the diameter of the liner along the tissue ingrowth region includes a second inner diameter, the second inner diameter being greater than 25% of the diameter of the first inner diameter.

[0019] Alternatively or additionally to any of the above embodiments, the liner is disposed along a portion of the outer surface of the tubular scaffold. Another esophageal stent includes an expandable tubular scaffold having a cavity extending therein. The scaffold includes a first end portion, a second end portion, and an intermediate portion disposed between the first and second end portions. The stent also includes a liner extending continuously within the cavity of the scaffold. The liner is circumferentially attached along the first and second end portions. A tissue ingrowth region is defined along the intermediate portion of the scaffold. The liner is radially spaced from the intermediate region to define the tissue ingrowth region along the intermediate region of the tubular scaffold. The liner is configured to maintain a passageway therethrough for the flow of a substance.

[0020] Alternatively or additionally to any of the above embodiments, the portion of the liner extending along the tissue ingrowth region is configured to deflect radially inward from the inner surface of the tubular scaffold.

[0021] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure, which embodiments are more particularly exemplify in the following figures and detailed description.

[0022] The present disclosure may be more fully understood in consideration of the following detailed description in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0023] [Figure 1] 1 illustrates an exemplary stent. [Figure 2] 2 is a cross-sectional view of the stent of FIG. 1 including a liner taken along line 2-2 of FIG. [Figure 3] 3 is a cross-sectional view of the stent of FIG. 1 taken along line 3-3 of FIG. [Figure 4] 4 is a cross-sectional view of the stent of FIG. 1 taken along line 4-4 of FIG. [Figure 5] 2 is a cross-sectional view of the stent of FIG. 1 including a liner. [Figure 6A]10 is a cross-sectional view of another exemplary stent including a liner and a covered portion. [Figure 6B] 10 is a cross-sectional view of another exemplary stent including a liner and a covered portion. [Figure 7A] 10 is a cross-sectional view of another exemplary stent including a liner and a covered portion. [Figure 7B] 10 is a cross-sectional view of another exemplary stent including a liner and a covered portion. [Figure 8A] 1 is a plan view of another exemplary stent including a liner and a covered portion. [Figure 8B] 1 is a plan view of another exemplary stent including a liner. [Figure 8C] 1 is a cross-sectional view of another exemplary stent. [Figure 9] 1A-1C illustrate an exemplary stent including fixation members. [Figure 10] 1A-1C illustrate an exemplary stent including fixation members. [Figure 11] 1A-1C illustrate an exemplary stent including fixation members. [Figure 12] 1A-1C illustrate an exemplary stent including fixation members. [Figure 13] 1A-1C illustrate an exemplary stent including fixation members. [Figure 14] 1A-1C illustrate an exemplary stent including fixation members. [Figure 15A] 1A-1C illustrate an exemplary stent including a retrieval member. [Figure 15B] 1A-1C illustrate an exemplary stent including a retrieval member. [Figure 16] 1 illustrates an exemplary stent positioned in a body lumen. [Figure 17] 1 illustrates an exemplary stent positioned in a body lumen. [Figure 18] 1 illustrates an exemplary stent positioned in a body lumen. [Figure 19] 1A-1C illustrate an exemplary method for deploying an exemplary stent in the esophagus. [Figure 20] 1A-1C illustrate an exemplary method for deploying an exemplary stent in the esophagus. [Figure 21] 1A-1C illustrate an exemplary method for deploying an exemplary stent in the esophagus. [Figure 22] 1A-1C illustrate an exemplary method for deploying an exemplary stent in the esophagus. DETAILED DESCRIPTION OF THE INVENTION

[0024] While the present disclosure is susceptible to various modifications and alternative forms, specific forms thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that it is not intended to limit the disclosure to the particular embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0025] These definitions shall be applied for the following defined terms, unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​herein are assumed to be modified by the term "about," whether expressly stated or not. In general, the term "about" refers to a range of numbers that one of ordinary skill 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 are rounded to the nearest significant figure.

[0026] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0027] It should be noted that references herein to "embodiments," "some embodiments," "other embodiments," etc., indicate that the described embodiments may include one or more particular features, structures, and / or characteristics. However, such descriptions do not necessarily imply that all embodiments include the particular feature, structure, and / or characteristic. Furthermore, when a particular feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated otherwise.

[0028] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure.

[0029] As mentioned above, in some cases, it may be designed to provide a pathway for digestive matter, blood, or other fluids to flow after a medical procedure. Additionally, some implantable medical devices may implement features useful for fistula repair, bypass surgery, and / or anastomosis repair. These medical devices may include radial or self-expanding stents that may be implanted transluminally via an endoscope. Furthermore, some stents may be implanted in various lumens, such as the esophagus, gastrointestinal tract (including the intestine, stomach, and colon), tracheobronchial tree, urinary tract, biliary tract, and vascular system.

[0030] In some cases, it may be desirable to design a stent that has sufficient radial strength to maintain its position within a body lumen while also functioning as a passageway for food or other digestive materials. However, the compressibility and flexibility characteristics that aid in stent positioning can also lead to a tendency for the stent to migrate from its original deployed position. For example, a stent designed for placement in the esophagus or gastrointestinal tract may have a tendency to migrate due to peristalsis (i.e., the involuntary contraction and relaxation of the muscles of the esophagus, intestine, and colon that push the contents of the tract). In addition, the generally moist and inherently smooth environment of the esophagus, intestine, and colon further contributes to the tendency of a stent to migrate when deployed therein. One method for reducing stent migration may involve exposing the bare metal portion of the stent to the tissue of the body lumen. Stent scaffolds can provide a structure that promotes tissue ingrowth (e.g., hyperplasia) into gaps or openings in the structure. Tissue ingrowth can anchor the stent in place and reduce the risk of stent migration.

[0031] Furthermore, while it is important to design a stent that reduces the degree to which the stent migrates within a body lumen, it is also important to design a stent that can be easily removed and / or repositioned from the body lumen after deployment. Also, stents that include bare (i.e., uncovered) portions designed to promote tissue ingrowth (e.g., to reduce stent migration, as described above) may be more difficult to remove after tissue secures the stent to the body lumen. One method for reducing the force required to remove a stent from a body lumen may include creating a physical barrier between the body lumen and the outer surface of the stent by covering a portion of the stent (e.g., reducing the surface area of ​​the stent that can be secured by tissue ingrowth). However, covered stents may be more susceptible to migration than bare stents (as described above).

[0032] Furthermore, in addition to designing a stent that is well-secured and can be easily removed from the body lumen, it may be desirable to design the stent with features that assist in the passage of digestible material through the body lumen. For example, in some cases, it may be desirable to design a stent with an inner liner (e.g., a lumen) that allows food or other digestive material to flow through.

[0033] Thus, in some cases, it may be desirable to design a stent that includes both covered and uncovered (e.g., bare) portions, and a tubular liner. Examples of medical devices that include covered and uncovered portions and an inner liner are disclosed herein.

[0034] 1 illustrates an exemplary stent 10. Stent 10 may have a first end 21, a second end 23, and a cavity extending therein. When placed in a body lumen (e.g., the esophagus), first or proximal end 21 may be defined as the end of stent 10 closest to the patient's mouth, and second or distal end 23 may be defined as the end of stent 10 closest to the patient's stomach.

[0035] Additionally, stent 10 can include one or more stent strut members 12 that form a tubular scaffold. Stent strut members 12 can extend helically, longitudinally, circumferentially, or in other manners along stent 10. While FIG. 1 shows stent strut members 12 extending along the entire length of stent 10, in other examples, stent strut members 12 can extend along only a portion of stent 10.

[0036] 1 illustrates that exemplary stent 10 includes a first flared end region 14 proximate first end 21 of stent 10 and / or a second flared region 16 proximate second end 23. In some cases, first flared region 14 and second flared region 16 may be defined as an increase in the outer diameter, inner diameter, or both the outer and inner diameters along one or both of first end 21 and / or second end 23 of stent 10. Furthermore, FIG. 1 illustrates that stent 10 includes an intermediate region 18 disposed between first flared region 14 and second flared region 16.

[0037] However, while FIG. 1 depicts stent 10 including both first flare region 14 and second flare region 16, it is contemplated that stent 10 may include only one flare region. For example, it is contemplated that stent 10 may include only flare region 14 or only flare region 16. It is further contemplated that all or a portion of first flare region 14 and / or second flare region 16 may flare outward (e.g., away from the central longitudinal axis of stent 10). Alternatively, it is further contemplated that all or a portion of first flare region 14 and / or second flare region 16 may flare inward (e.g., toward the central longitudinal axis of stent 10).

[0038] In some cases, stent 10 may be a self-expanding stent, or stent 10 may be a balloon-expandable stent. Examples of self-expanding stents may include stents having one or more struts 12 combined to form a rigid and / or semi-rigid stent structure. For example, stent struts 12 may be wire or filaments that are braided, wrapped, entangled, interwoven, woven, knitted, or looped (e.g., in a bobbinette fashion) to form the stent structure. For example, exemplary stents disclosed herein may resemble braided stents, although this is not intended to limit the possible stent configurations. Rather, the stents shown in the figures may be braided, braided, wrapped, entangled, interwoven, woven, or looped (e.g., in a bobbinette fashion) to form the stent structure. Alternatively, stent 10 may be a unitary structure formed from a cylindrical tubular member, such as a single cylindrical tubular laser-cut nitinol tubular member, with the remainder of the tubular member forming stent struts 12. Openings or gaps in the wall of the stent 10 may be defined between adjacent stent struts 12 .

[0039] The example stents 10 disclosed herein can be constructed from a variety of materials. For example, the stents 10 (e.g., self-expanding or balloon-expandable) can be constructed from metals (e.g., Nitinol, Elgiloy, etc.). In other examples, the stents 10 can be constructed from polymeric materials (e.g., PET). In yet other examples, the stents 10 can be constructed from a combination of metallic and polymeric materials. Additionally, the stents 10 can include bioabsorbable and / or biodegradable materials.

[0040] In some cases, the exemplary stent 10 may include one or more layers disposed against and / or adjacent to the interior and / or exterior surfaces of the tubular scaffolding of the stent 10. For example, FIG. 1 shows the exemplary stent 10 including an outer layer 22 (shown as a dot pattern in FIG. 1 ) disposed along a portion of the exterior surface of the stent 10 (e.g., along the first flared portion 14 and / or the second flared portion 16 of the stent 10). In some cases, the outer layer 22 may be an elastomeric or non-elastomeric material. For example, the outer layer 22 may be a polymeric material such as silicone or polyurethane.

[0041] Additionally, the exemplary stent 10 may include one or more layers disposed against and / or adjacent to the interior surface of the stent 10. Although not shown in FIG. 1 (but shown in FIG. 2), the stent 10 may include an inner layer 20 disposed within a cavity of the stent 10. In some cases, the inner layer 20 may be an elastomeric or non-elastomeric material. For example, the inner layer 20 may be a polymeric material such as silicone, polyurethane, UE, PVDF, Chronoflex®, or a similar biocompatible polymer formulation.

[0042] It will be appreciated that as the inner and outer layers 20 and 22 extend outward and inward, respectively, they may contact and / or form interface areas at spaces (e.g., openings, cells, gaps) in the wall of the tubular scaffold of the stent 10. Additionally, the inner and outer layers 20 and 22 may extend further between adjacent struts 12, thereby filling any spaces between adjacent strut members 12 of the tubular scaffold. The stent 10 may include areas where one or more filaments 12 are surrounded, wrapped, and / or covered by the outer and / or inner layers 22 and / or 20. For example, portions of the stent 10 may include filaments 12 sandwiched between the outer and inner layers 22 and 20.

[0043] Figure 2 shows a cross-section of an exemplary stent 10 taken along line 2-2 in Figure 1. Figure 2 illustrates that first flaring region 14 and / or second flaring region 16 can include tapered portions 25 and end portions 27. While Figure 2 shows the tapered portions tapering radially outward toward the ends of stent 10, it is contemplated that one or more of tapered portions 25 can alternatively taper radially inward.

[0044] FIG. 2 further illustrates the inner layer 20 extending along all or a portion of the inner surface 24 of the stent 10. For example, FIG. 2 illustrates the inner layer 20 extending along the inner surfaces of the end portions 27, the tapered portion 25, and the intermediate portion 18. For purposes of description herein, the inner layer 20 may be interchangeably referred to as a liner, a coating, and / or a covering. The liner 20 may extend circumferentially along the cavity of the stent member 10. In other words, it will be understood that the liner 20 may be defined as an annular layer that extends continuously along the cavity of the stent member 10. Furthermore, the liner 20 may extend continuously (e.g., uninterrupted) along the cavity of the stent 10 from the first end 21 to the second end 23.

[0045] 2 illustrates that stent 10 can include an outer layer 22 disposed along an outer surface 26 of stent 10. For example, in some cases, stent 10 can include an outer layer 22 disposed along the outer surface of one or more of end portions 27.

[0046] In some cases (as shown in FIG. 2), outer layer 22 may be a continuous extension of inner layer 20. For example, FIG. 2 shows inner layer 20 extending along inner surface 24 of end portion 27, such that inner layer 20 "wraps" end 28 of end portion 27 and then extends along the outer surface of end portion 27. Note that in this example, what was described above as outer layer 22 can define a portion of inner layer 20 that "wraps" end 28 of tubular scaffolding of stent 10 and also extends along the outer surface of end portion 27. Furthermore, both inner layer 20 and the portion of inner layer 20 that wraps end 28 of scaffolding 10 to form outer layer 22 may together sandwich filaments 12 therebetween. Additionally, although FIG. 2 shows the inner layer 20 wrapped around (e.g., extending continuously around) both end portions 27 of the stent 10 of FIG. 2, it is contemplated that the inner layer 20 may wrap around only one end portion 27 of the stent member 10.

[0047] Figure 2 illustrates that inner layer 20 may be fixedly attached to the inner surfaces of end portions 27 and / or tapered regions 25. In other words, Figure 2 illustrates that inner layer 20 may be bonded (e.g., attached, secured, etc.) to the inner surfaces of strut members 12 that define end portions 27 and / or tapered regions 25 of stent 10.

[0048] Additionally, Figure 2 illustrates that in some instances, a portion of the inner layer 20 can be spaced apart (e.g., spaced radially inward) from the inner surface 24 of the stent 10 to provide a gap or space therebetween. In particular, Figure 2 illustrates that the portion of the inner layer 20 extending along the intermediate portion 18 of the stent member 10 can be detached from the intermediate portion 28 of the tubular scaffolding of the stent 10 and spaced radially inward from the inner surface 24 of the tubular scaffolding of the stent 10. For example, Figure 2 illustrates that the liner 20 can be attached (e.g., circumferentially) at first attachment point 30 and second attachment point 32, with the portion of the length of the liner 20 between attachment points 30 / 32 remaining unattached (i.e., not directly attached) to the tubular scaffolding of the intermediate portion 18 of the stent 10. 2 illustrates that the inner layer 20 can be unattached to the inner surface 24 of the tubular scaffold (i.e., struts 12) of the stent 10 along the portion of the stent 10 between the first attachment point 30 and the second attachment point 32. Note that the portion of the stent 10 shown in FIG. 2 where the inner layer 20 is unattached to the inner surface 24 of the struts 12 of the stent 10 can correspond to the intermediate portion 18 of the stent 10 described above. In other words, in some instances, the inner layer 20 can be unattached and thus extend radially inward from the inner surface 24 of the tubular scaffold (i.e., struts 12) along the intermediate portion 18 of the stent 10.

[0049] As discussed above, stents designed for placement in a body lumen (e.g., the esophagus or gastrointestinal tract) may have a tendency to migrate (due to peristalsis and / or the generally moist, inherently smooth environment of the body lumen). Therefore, one method for reducing stent migration may include exposing areas that promote tissue ingrowth, such as uncovered and / or bare metal portions of the stent, to the tissue of the body lumen. An uncovered or bare stent scaffold may provide a structure that promotes tissue ingrowth into its gaps or openings. Tissue ingrowth may secure the stent in place and reduce the risk of stent migration.

[0050] It will therefore be appreciated that the portions of the stent 10 described above, including inner and / or outer layers attached to (e.g., covering) the struts or filaments 12 of the stent, may act to prevent tissue growth into the gaps or openings therein. For example, the struts or filaments 12 of the tapered regions 25 and end portions 27 of the stent 10 may include inner and / or outer layers 20, 22 attached thereto and spanning the gaps in the tubular scaffold, preventing tissue ingrowth along their respective surfaces and the gaps therebetween.

[0051] However, it will be understood that tissue may be permitted to grow around, between, within, etc., those filaments 12 of the stent 10 to which the inner layer 20 is not attached (e.g., in the portion of the inner layer 20 extending along the intermediate portion 18 of the stent 10). In other words, FIG. 2 shows a "tissue ingrowth region" 36 defined along the intermediate region 18 of the stent 10. The detailed view of FIG. 2 shows that the tissue ingrowth region 36 may extend radially inward from the inner surface 24 of the stent member 10 to the outer surface 38 of the inner liner 20. The distance from the inner surface 24 of the stent member 10 to the outer surface 38 of the inner liner may be shown as "D1" in FIG. 2. The distance "D1" may be between about 0.5 mm and 10 mm, or between about 1 mm and 6 mm, or between about 1.5 mm and 4 mm, or about 2 mm.

[0052] 2 further illustrates that tissue ingrowth region 36 may be defined as the space between inner surface 24 of the tubular scaffold of stent 10 and outer surface 38 of liner 20 extending between attachment points 30 / 32. Tissue ingrowth region 36 may be disposed between attachment points 30 / 32. Thus, tissue ingrowth region 36 may be defined as the space between inner surface 24 of the tubular wall defined by struts or filaments 12 of stent 10 between circumferential attachment points 30 / 32 and outer surface 38 of the wall of inner layer 20. Furthermore, tissue ingrowth region 36 may be defined as extending circumferentially within the cavity of tubular scaffold of stent 10. In other words, it will be appreciated that tissue ingrowth region 36 may be defined as the annular space extending continuously along the cavity of the tubular scaffold formed radially inward of the stent wall by struts or filaments of stent 10.

[0053] It will be further understood that, in some cases, the liner 20 may be constructed from an elastic material. Accordingly, a liner 20 including an elastic material component may be able to stretch radially inward. For example, as tissue grows through the interstices of the stent member 10, it may push radially inward against the outer surface 38 of the inner layer 20. Correspondingly, the inner layer 20 may flex, stretch, etc. radially inward in response to an inward force (e.g., tissue ingrowth) acting thereon. In particular, the space D1 between the inner surface 24 of the stent 10 and the outer surface 38 of the liner 20 may increase as the liner 20 flexes radially inward. In other embodiments, the liner 20 may be inelastic and therefore not flex relative to the stent 10.

[0054] Although the liner 20 can include elastic elements that allow it to flex radially inward from the inner surface 24 of the tubular scaffolding of the stent 10, in some cases it may be desirable to limit the amount of flexing of the inner layer 20. For example, FIG. 2 shows that the inner layer 20 extends therein and defines a cavity 40. The cavity 40 may be designed to allow food and / or other digestible material to flow therethrough. Thus, in some cases it may be desirable to design the inner layer 20 to maintain a passage defined by the cavity 40 to allow food and / or other digestible material to flow through the stent 10 when implanted in a body lumen. In other words, in some cases it may be desirable to prevent the cavity 40 from closing radially inward on itself. In some cases, the inner layer 20 may include reinforcing filaments (e.g., fibers) embedded in the material of the inner layer 20 that can be tensioned after a threshold amount of elongation of the material of the inner layer 20 to prevent further elongation of the inner layer 20. In some cases, the reinforcing filaments may be arranged in the inner layer 20 longitudinally, circumferentially, helically, randomly, or in other manners.

[0055] In FIG. 2, the inner diameter of the tubular scaffolding of stent 10 along intermediate region 18 is shown as "D4." Additionally, in FIG. 2, the inner diameter of inner liner 20 along intermediate region 18 is shown as "D2." Diameter "D4" may, in some cases, be about 10 mm to 30 mm, or about 15 mm to 25 mm, or about 20 mm. Furthermore, diameter "D2" may, in some cases, be about 10 mm to 30 mm, or about 15 mm to 25 mm, or about 18 mm. Additionally, in some cases, it may be desirable to design inner liner 20 such that diameter "D2" is equal to or greater than a given percentage of diameter "D4." For example, in some cases, diameter "D2" may be 10% or more of "D4", or 25% or more of "D4", or 50% or more of "D4", or 60% or more of "D4", or 75% or more of "D4", or in some cases, "D2" may be between 10-20% of "D4", or "D2" may be between 20-30% of "D4", or "D2" may be between 30-40% of "D4", or "D2" may be between 40-50% of "D4", or "D2" may be between 50-75% of "D4", or "D2" may be between 75-90% of "D4".

[0056] It will be appreciated that limiting the amount of deflection of the inner liner 20 not only ensures that the cavities 40 remain open, but can also limit the amount of tissue ingrowth that occurs along the stent 10. For example, by limiting the degree to which the liner 20 can deflect radially inward along the intermediate region 18, the amount of tissue ingrowth that occurs along the intermediate region 18 can be controlled. As discussed above, the amount of tissue ingrowth can directly correspond to the force required to remove the stent 10 from a body lumen, and therefore it may be desirable to control the amount of tissue ingrowth that occurs along the stent 10. In other words, the stent 10 can be customized to have a given removal force by limiting the amount of elasticity of the liner 20 (e.g., thereby limiting the amount of radially inward deflection).

[0057] As can be seen from FIG. 2 , end portion 27 can include an inner diameter, designated as “D3.” Diameter “D3” can be equal to or greater than diameter “D2.” Diameter “D3” can be approximately 15 mm to 35 mm, or approximately 20 mm to 30 mm, or approximately 25 mm, as the case may be. In other words, inner layer 20 can be generally shaped to taper longitudinally from end portion 27 closest to first end 21 to intermediate portion 18. For example, tapered portion 25 can somewhat resemble a conical funnel. Furthermore, as shown in FIG. 2 , stent 10 can taper inward toward a central longitudinal axis of stent 10 along flaring portion 14 and outward away from the central longitudinal axis of stent 10 along flaring portion 16.

[0058] FIG. 3 shows a cross-section taken along line 3-3 in FIG. 2. As discussed above, this cross-section is taken through end portion 27 of flared region 14. As shown in FIG. 3, filaments 12 of stent 10 defining end portion 27 may be sandwiched between inner layer 20 and outer layer 22. In other words, FIG. 3 illustrates that filaments 12 in some portions of stent 10 (e.g., along flare region 14 and / or flare region 16) may have both inner layer 20 and outer layer 22 directly attached thereto. In other words, along some portions of stent 10 (e.g., along flare region 14 and / or flare region 16), there may not be a space between filaments 12 and both inner layer 20 and outer layer 22.

[0059] Figure 4 shows a cross-section taken along line 4-4 in Figure 2. As mentioned above, this cross-section is taken through the intermediate portion 18 of the stent 10. As shown in Figure 4, the inner layer 20 of the stent 10 can be spaced away from (i.e., radially inward of) the filaments 12 of the stent 10 along the intermediate portion 18. Furthermore, Figure 4 shows a tissue ingrowth region 36 extending between the inner surface 24 of the filaments 12 of the stent 10 and the outward-facing surface 38 of the inner member 20. In addition, Figure 4 shows that the tissue ingrowth region 36 extends circumferentially about the longitudinal axis of the stent 10, radially outward of the liner 20 and radially inward of the filaments 12 of the tubular scaffold.

[0060] While the above description discloses examples in which inner layer 20 and outer layer 22 are fixedly attached (e.g., directly secured) to end portion 27 and / or tapered portion 25, other configurations are also contemplated. For example, FIG. 5 illustrates an exemplary stent member 110. Stent 110 may be similar in form and function to stent 10 described above. For example, stent 110 may include a liner 120 disposed within a cavity of the tubular scaffolding of stent 110. Furthermore, as shown in FIG. 5, liner 120 may be circumferentially attached along inner surface 124 of stent 110 at attachment points 130 and / or 132. Attachment points 130 / 132 may be located at opposing end regions of stent 110, such as opposing flared end regions of stent 110.

[0061] However, FIG. 5 illustrates that different attachment point locations 130 / 132 are contemplated along the stent member 110. For simplicity, contemplated exemplary locations of attachment point locations 130 / 132 are shown in terms of distance from the edge 128 of the stent member 110. For example, attachment points 130 / 132 are shown as distance "W" from the edge 128 (as measured along the outer surface 126 of the stent 110). In other examples, attachment points 130 / 132 may be located at distances indicated as "X," "Y," and "Z" (as measured longitudinally from the edge 128 of the stent 110). Distance "Z" may be understood to be an attachment location equivalent to attachment points 30 / 32 along the stent 110 described above. Additionally, in some examples, distance "W" may be approximately 25% of distance "Z," distance "X" may be approximately 50% of distance "Z," and distance "Y" may be approximately 75% of distance "Z."

[0062] Additionally, it is envisioned that the liner 120 may not be attached along the inner surface 124 of the stent 110. For example, the attachment points 130 / 132 may be located at the ends of the stent 110. Furthermore, in instances where the attachment points 130 / 132 are located at the ends 128, the liner 120 may cover and / or encase the ends 128 of the stent 110.

[0063] 5, different attachment points 130 / 132 along the stent 110 may correspond to different sized tissue ingrowth regions 136 (described above as tissue ingrowth regions 36 of the stent 10). For example, the tissue ingrowth section 136 defined by attachment points 130 / 132 positioned a distance "W" from the end 128 may be larger than the tissue ingrowth region 136 defined by attachment points 130 / 132 positioned a distance "Y" from the end 128. It can be appreciated that a larger tissue ingrowth region may produce a stent 100 with increased removal forces, for the reasons described above.

[0064] Additionally, the outer layer 122 may extend any desired distance from the end 128 of the stent 110 along the outer surface of the tubular scaffold defined by the filaments or struts 112. For example, the outer layer 122 may extend a distance designated as "W," "X," "Y," or "Z" from the end 128. The distance that the outer layer 122 extends from the end 128 of the stent 110 may be the same or different from the distance of the attachment points 130 / 132.

[0065] While the above description of stent 10 and stent 110 shows various attachment locations along stent 10, it is envisioned that liner 20 may be attached anywhere along the inner surface 24 and / or outer surface of stent member 10. Different attachment locations may result in the stent having different performance characteristics (e.g., different removal forces, different anti-migration characteristics). Note that the attachment distances shown in FIG. 5 are equally applicable to attachment points 132 at opposite ends of stent 110 and / or to outer layers 122 at opposite ends of stent 110.

[0066] 6A-8B illustrate exemplary stents that may be similar in form and function to the stent designs disclosed above. For example, each of the stents illustrated in FIGS. 6A-8B may include an inner liner disposed within a cavity of the tubular scaffold of the stent (e.g., as shown in FIG. 2). Additionally, each of the stents illustrated in FIGS. 6A-8B may also include an outer layer as described above (e.g., as shown in FIG. 1) extending along at least a portion of the flared end region of the tubular scaffold. However, the stents illustrated in FIGS. 6A-8B may further include an additional outer layer (which may be formed separately or in conjunction with the outer and / or inner layers disposed in the flared end region) disposed along the outer surface of an intermediate portion of the stent, leaving the remainder of the tubular scaffold uncovered to promote tissue ingrowth therethrough.

[0067] For example, FIG. 6A illustrates an exemplary stent 210. The exemplary stent 210 may be similar in form and function to the stent designs disclosed above. However, as FIG. 6A illustrates, the stent 210 includes an additional outer layer 223 disposed along an outer surface 226 of the tubular scaffolding of the stent 210. FIG. 6A illustrates the outer layer 223 as a circumferential ring of material, which extends circumferentially along the outer surface 226 of the stent 210 (the dashed lines in FIG. 6A indicate the outer layer 223 extending circumferentially along the outer surface 226 of the stent 210) and may be positioned so as to be spaced apart from one another. In some examples, the outer layers 223 may be oriented to extend laterally across the stent 210. As shown in FIG. 6A, the individual outer layers 223 may be longitudinally spaced apart from one another. It will be appreciated that the configuration of outer layer 223 creates one or more tissue ingrowth regions 236 (similar in function to those described above) along the intermediate region of stent 210. Tissue ingrowth regions 236 may be circumferentially uncovered portions of the tubular scaffolding of stent 210. Inner layer 220 may be positioned radially inward of tissue ingrowth regions 236 to limit the amount of tissue ingrowth permitted.

[0068] Alternatively, some stent examples disclosed herein may be designed such that one or more portions of the inner layer extending along the inner surface of the stent may be spaced apart (i.e., spaced radially inward) from the inner surface of the stent to provide a gap or space therebetween. For example, FIG. 6B (which may be similar in form and function to the stent design disclosed above with respect to FIG. 6A ) illustrates an alternative stent example in which one or more portions of the inner layer 220 extending along the inner surface 224 of the stent 210 may be spaced radially inward from the inner surface 224 of the tubular stent 210 without being attached thereto, while other portions of the inner layer 220 are attached thereto. The space created by the inner layer 220 extending radially inward from the inner surface 224 of the stent 210 may define one or more tissue ingrowth regions 236. The tissue ingrowth regions 236 may extend circumferentially along the inner surface 224 of the stent 210.

[0069] FIG. 7 illustrates another exemplary stent 310. The exemplary stent 310 may be similar in form and function to the stent designs disclosed above. However, as FIG. 7 illustrates, the stent 310 includes an additional outer layer 323 disposed along the outer surface 326 of the tubular scaffolding of the stent 310. FIG. 7 illustrates that the outer layer 323 may be disposed to extend circumferentially along the outer surface 326 of the stent 310 (the dashed lines in FIG. 7 indicate the outer layer 323 extending circumferentially along the outer surface 326 of the stent 310). However, FIG. 7 illustrates that the outer layer 323 may be oriented to extend in a helical configuration along the outer surface 326 of the stent 310. It will be appreciated that the configuration of the outer layer 323 creates one or more tissue ingrowth regions 336 (similar in form and function to those described above) along the stent 310. Tissue ingrowth region 336 can be a circumferentially uncovered portion of the tubular scaffolding of stent 310. Inner layer 320 can be positioned radially inward of tissue ingrowth region 336 to limit the amount of tissue ingrowth allowed.

[0070] Alternatively, some stent examples disclosed herein may be designed such that one or more portions of the inner layer extending along the inner surface of the stent may be spaced apart (i.e., spaced radially inward) from the inner surface of the stent to provide a gap or space therebetween. For example, FIG. 7B (which may be similar in form and function to the stent design disclosed above with respect to FIG. 7A ) illustrates an alternative stent example in which one or more of the inner layers 320 extend in a helical direction along and may be attached to the inner surface 324 of the stent 310. It will be appreciated that the helical configuration of the inner layer 320 creates one or more tissue ingrowth regions 336 along the stent 310 (similar in form and function to those described above). The tissue ingrowth regions 336 may be helically oriented, uncovered portions of the tubular scaffolding of the stent 310.

[0071] FIG. 8A illustrates an exemplary stent 410. The exemplary stent 410 may be similar in form and function to the stent designs disclosed above. However, as FIG. 8A shows, the stent 410 includes an additional outer layer 423 disposed along an outer surface 426 of the tubular scaffolding of the stent 410. FIG. 8A illustrates that the outer layer 423 may be disposed to extend longitudinally along the outer surface 426 of the stent 410. As shown in FIG. 8A, the individual outer layers 423 may be circumferentially spaced apart from one another. It will be appreciated that the configuration of the outer layers 423 creates one or more tissue ingrowth regions 436 (similar in function to those described above) along the stent 410. The tissue ingrowth regions 436 may be uncovered portions of the tubular scaffolding of the stent 410. The inner layer 420 may be positioned radially inward of the tissue ingrowth regions 436 to limit the amount of tissue ingrowth permitted.

[0072] Alternatively, some stent examples disclosed herein may be designed such that one or more portions of the inner layer extending along the inner surface of the stent may be spaced apart (i.e., spaced radially inward) from the inner surface of the stent to provide a gap or space therebetween. FIG. 8B shows an alternative stent example (which may be similar in form and function to the stent design disclosed above with respect to FIG. 8A ) having an inner layer 420 spaced apart from the inner surface of the stent 410. As shown in FIGS. 8B and 8C (discussed below), the inner layer 420 may include one or more discrete attachment points 425 along the inner surface of the stent 410, where the inner layer 420 is attached to the inner surface of the stent 410. Note that the discrete attachment points of the inner layer 420 may extend all (or part) of the longitudinal length along the inner surface of the stent 410 (e.g., from the distal end region to the proximal end region).

[0073] Figure 8C shows an exemplary cross-section of the exemplary stent 410 shown in Figure 8B along line 8C-8C. Figure 8C illustrates that one or more portions of the inner layer 420 may be attached along the inner surface of the stent 410. Furthermore, the inner layer 420 may be attached along the inner surface of the stent 410 at one or more discrete attachment points 425. It can be appreciated that the spaces between the discrete attachment points 425 can create one or more tissue ingrowth regions 436.

[0074] Exemplary stents disclosed herein may include one or more fixation features designed to prevent displacement of the tubular member relative to the body lumen in which the stent is implanted. For example, some stents disclosed herein may include anti-migration features. Anti-migration features may include hooks, barbs, posts, flares, hoops, fins, quills, tines, or the like. Anti-migration features may be beneficial in controlling the amount of stent movement during and / or after deployment in a body lumen.

[0075] Figures 9-14 show exemplary stents that may be similar in form and function to the stent designs disclosed above. For example, the stents of Figures 9-14 may be similar in form and function to the stent designs shown in Figures 1 and 2.

[0076] 9 shows a stent 510 including one or more fixation members 542. The one or more fixation members 542 may be disposed on an outer surface 526 of the stent 510 and extend radially outward from the outer surface 526 and may be configured to contact the inner surface of a body lumen. For example, in at least some examples disclosed herein, the fixation members 542 may include protrusions extending radially outward from the outer surface of the stent 510 to engage and / or penetrate the wall of the body lumen. In some examples, the fixation members 542 may include loops, barbs, hooks, points, spikes, spools, ribs, circumferential rims, prongs, tines, etc.

[0077] 9 illustrates that the securing members 542 may be disposed along different portions of the stent 510. For example, FIG. 9 illustrates securing members disposed along both flared region 514 and flared region 516. However, it is contemplated that securing members 542 may be disposed along only one of flared portions 514 / 516. It is further contemplated that securing members 542 may be disposed along any portion of the exterior surface of the stent 510 (including flared portion 514 and / or flared portion 516). For example, FIG. 9 illustrates two rows of securing members disposed along flared portion 514.

[0078] It is contemplated that the securing members 542 may comprise separate components affixed (e.g., welded) to the exterior surface of the stent 510. However, it is also contemplated that the securing members 542 may be integrally formed from the filaments or struts of the stent 510. For example, the securing members 542 may be extensions of the shaded portions of the stent 510. Additionally, it is contemplated that the securing members 542 of the stent 510 may extend away from the stent 510 at various angles, orientations, etc. For example, FIG. 9 shows the securing members 542 positioned in the flared regions 514 and 516 pointing away from the end 521 of the stent 510 (e.g., toward the end 523).

[0079] Other fixation configurations and / or methods designed to prevent migration of the exemplary stent disclosed herein and the interior surface of a body lumen are contemplated in Figures 10-14. The exemplary stent of Figures 10-14 may be similar in form and function to other stent designs disclosed herein.

[0080] 10 shows a stent 610 that includes anchoring members 642, which may resemble posts, quills, or spike-like projections that extend away from the outer surface 626 of the stent 610. Furthermore, the anchoring members 642 point away from the end 621 of the stent 610 (e.g., toward the end 623).

[0081] 11 shows a stent 710 including anchoring members 742, which may include one or more loop shapes and / or posts or spike-like protrusions that extend away from the outer surface 726 of the stent 710. Additionally, the anchoring members 742 point away from the end 721 of the stent 710 (e.g., toward the end 723).

[0082] 12 shows a stent 810 including fixation members 842, which may include one or more loop-shaped protrusions extending away from the outer surface 826 of the stent 810. Additionally, the flared end region of the stent 810 may include some members 842 pointing away from the end 821 of the stent 810 and some members pointing toward the end 823 of the stent 810.

[0083] FIG. 13 shows a stent 910 that includes anchoring members 942 that may resemble loop-shaped protrusions that extend laterally away from the outer surface 926 of the stent 910 . FIG. 14 shows a stent 1010 having a flared end region that includes a fixation member 1042, which may include both a loop-shaped portion 1042 that extends laterally and a loop-shaped portion that points away from end 1021 of the stent 1010 (e.g., toward end 1023).

[0084] It will be appreciated that any of the above-described fixation members may be configured to prevent longitudinal shift or migration of the stent relative to the interior surface of the body lumen when the stent is positioned adjacent to the target site. In some cases, fixation members including loops, barbs, hooks, points, spikes, spools, ribs, etc. may be configured to protrude into and / or penetrate the wall of the body lumen, thereby anchoring the fixation member into the tissue of the body lumen and preventing longitudinal shift or migration of the stent relative to the body lumen.

[0085] 15 shows an exemplary stent 1110 configured for removing an implantable medical device 110 from a body lumen. The stent 1110 may be similar in form and function to other stent designs disclosed herein. As discussed herein, while the medical device 1110 is implanted along a body lumen, tissue ingrowth may occur along the tissue ingrowth region, thereby reducing migration of the implantable medical device 1110 within the body lumen. However, in some instances, it may be necessary to remove the medical device 1110 from the body lumen.

[0086] 15 , the stent 1110 can include sutures 1150 (e.g., filaments) attached to gaps 1152 formed from the filaments 1112 in the flared region 1114 of the stent 1110. In other words, the sutures 1150 can be interwoven between one or more gaps 1152 of the filaments 1112 of the stent 1110. Further, as seen in FIG. 15 , the sutures 1150 are disposed adjacent to the outer layer 1122. In other words, the sutures 1150 can be interwoven through the gaps 1152 of the filaments 1112 circumferentially along an uncovered portion of the tubular scaffolding of the stent 1110 adjacent the outer layer 1122. To remove the stent member 1110, a clinician can grasp a portion of the sutures 1150 from near the outer surface of the stent 1110. Grasping and pulling the suture 1150 can tighten a portion of the stent 1110, causing the stent 1110 to collapse radially inward, thereby releasing it from the body lumen. Additionally, it is contemplated that in at least some instances, the suture 1150 may include a longer, dependent portion (not shown) configured to be easily grasped by a removal device.

[0087] FIG. 15B further illustrates the exemplary stent 1110 described above with respect to FIG. 15A. However, as shown in FIG. 15B, sutures 1150 may be positioned adjacent end portions 1128 of the stent 1110. Similar to what was described above with respect to FIG. 15A, the sutures 1150 may be interwoven through the outer layer 1122 and / or interstices 1152 of the filaments 1112. Additionally, the sutures 1150 may extend circumferentially along the tubular scaffolding of the stent 1110. To remove the stent member 1110, a clinician can grasp a portion of the sutures 1150 from near the outer surface of the stent 1110. By grasping and pulling the sutures 1150, a portion of the stent 1110 can be clamped, causing the stent 1110 to collapse radially inward, thereby releasing it from the body lumen. Additionally, it is envisioned that in at least some instances, the suture 1150 may include a longer, dependent portion (not shown) configured to be easily grasped by a removal device.

[0088] In some cases, it may be desirable to attach and / or couple a secondary treatment device to one or more of the exemplary stent designs disclosed herein. For example, in some cases, it may be desirable to deploy a stent into a body lumen, wait for a hyperplastic response to occur (e.g., tissue ingrowth occurs) so that the tissue ingrowth secures the stent to the body lumen, and then deploy and / or attach a secondary treatment device to the stent. As shown below, various secondary treatment devices can be envisioned for attachment to the exemplary stents. In some instances, the secondary treatment device can be similar in shape and function to the stent designs disclosed herein. However, in other cases, the treatment device can differ from the stents described herein (e.g., include various different attachment mechanisms, geometries, etc.).

[0089] 16-18 illustrate an exemplary stent experiencing a tissue hyperplasia response in an exemplary body lumen. FIG. 16 illustrates an exemplary stent 10 deployed in body lumen 11. As shown, after initial deployment in body lumen 11, as the expandable scaffolding of stent 10 expands to an expanded state in body lumen 11, end portions 27 of first flaring region 14 and first flaring region 16 can exert a radially outward force against the inner surface of body lumen 11. This radially outward force exerted against the inner surface of body lumen 11 can provide temporary resistance to migration of stent 10 within body lumen 11.

[0090] Additionally, end portion 27 of stent 10 may contact tissue on the interior surface of body lumen 11. This contact of end portion 27 with tissue on the interior surface of body lumen 11 may provide a seal that narrows the passage of food or other substances through cavity 40 of stent 10. For example, as food or other substances travel down the esophagus, flared portion 14 / 16 of stent 10 may prevent the food from traveling along the outside of stent 10 and along the interior surface of body lumen 11. Rather, flared portion 14 / 16 is designed to provide a circumferential seal around the interior surface of body lumen 11 so that food can be routed through cavity 40 of stent 10. As discussed above, inner layer 20 of stent 10 may create a passageway (e.g., cavity 40) through which food and other substances can pass (without leaking out to the exterior surface of stent 10).

[0091] Figure 17 shows tissue 13 extending through stent filaments 12 along intermediate region 18 of stent member 10 radially inward of the uncovered portion of the tubular scaffolding of stent 10. Figure 17 further shows that tissue 13 is growing into tissue ingrowth region 36 toward liner 20 (as indicated by the arrows in Figure 17). Thus, tissue can grow through the interstices of the tubular scaffolding of stent 10 and around struts or filaments 12 of the tubular scaffolding of stent 10 throughout the uncovered portion of intermediate region 18.

[0092] Figure 18 shows that tissue 13 has grown radially inward from the wall of the exemplary body lumen 11 to a location where it radially inwardly contacts inner layer 20. However, as shown in Figure 18, inner layer 20 has reached a point where it no longer flexes radially inward, thus preventing tissue 13 from further collapsing cavity 40 of stent member 10 (as indicated by the double arrow in Figure 18).

[0093] 19-22 illustrate an exemplary methodology for deploying an exemplary stent (or any other device disclosed herein) in a body lumen (e.g., the esophagus). While the following figures describe the exemplary stent 10 as being deployed in the esophagus, it is envisioned that this methodology may be used to deploy the stent 10 (or any other device disclosed herein) in any other body lumen. For purposes of illustration, the stent 10 described in the following methodology may be similar in form and function to the stent 10 of FIGS. 1 and 2 described above.

[0094] 19 illustrates an exemplary first step in deploying stent 10 within esophagus 56. Specifically, first end portion 51 of delivery device 50 may be advanced through esophagus 56 such that first end portion 51 can be positioned within stomach 54.

[0095] 20 illustrates an exemplary second step in deploying stent 10 within esophagus 56. Specifically, FIG. 20 illustrates that a clinician can first deploy second or distal flaring portion 16 of stent 10 within stomach 54. It can be appreciated that stomach 54 may provide sufficient open space for flaring portion 16 of stent 10 to fully expand. In other words, flaring portion 16 is allowed to expand to its full radial extent before being placed within esophagus 56.

[0096] 21 illustrates an exemplary third step in deploying stent 10 within esophagus 56. Specifically, FIG. 21 illustrates the clinician retracting both stent 10 and delivery device 50 proximally from the stomach into esophagus 56, causing flaring portion 16 to be deployed and radially expanded from delivery device 50. It will be appreciated that as flaring portion 16 of stent 10 is retracted from stomach 54 into esophagus 56, flaring portion 16 may contract from a fully expanded configuration (while within stomach 54) to a partially contracted configuration (while within esophagus 56). The step of initially deploying flaring portion 16 of stent 10 into stomach 54 provides the advantage of having flaring portion 16 to exert maximum radially outward force against the wall of esophagus 56 when retracted.

[0097] FIG. 22 illustrates an exemplary fourth step in deploying stent 10 within esophagus 56. Specifically, FIG. 22 illustrates that delivery device 50 (not shown in FIG. 22) has been fully retracted, thereby deploying both intermediate portion 18 and first flaring portion 14 of stent 10 into esophagus 56. As described above, both first flaring portion 14 and second flaring portion 16 may be deployed such that they create a seal along the inner surface of esophagus 56. In some cases, intermediate portion 18 of stent 10 may be spaced from the inner surface of esophagus 56, while in other cases, intermediate portion 18 may contact the inner surface of esophagus 56. After deployment of stent 10, a hyperplastic response may occur, as described in connection with FIGS. 16-18 above, allowing tissue to grow into and / or through the tubular scaffold along the uncovered intermediate portion 18 of stent 10.

[0098] Materials that may be used in the various components of stent 10 (and / or other stents disclosed herein) and the various medical devices disclosed herein may include materials generally associated with medical devices. For simplicity, the following description will refer to stent 10 and other components of stent 10. However, this is not intended to be limiting to the devices and methods described herein, and the description may apply to other similar medical devices disclosed herein.

[0099] Stent 10 and other components of stent 10 may be made from metals, alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials. Some examples of suitable polymers are polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (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 (e.g., EMS AmericanThe sheath may include materials such as GRILAMID® (available from Grion), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinyl chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, and polymer / metal composites thereof. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6 percent LCP.

[0100] Some examples of suitable metals and alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; mild steel; 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 INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®; other HASTELLOY® alloys; nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKELVAC® 400, and NICORROS® 400); nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®); nickel-molybdenum alloys (e.g., 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-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®); platinum-rich stainless steel; titanium; combinations thereof, etc.; or any other suitable material.

[0101] In at least some embodiments, portions or all of the stent 10 and other components may be doped with, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be a material capable of producing a relatively bright image on a fluoroscopy screen or other imaging technique during a medical procedure. This relatively bright image assists the user of the stent 10 in determining its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may be incorporated into the design of the guidewire 10 to achieve the same results.

[0102] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to stent 10. For example, stent 10 and other components or portions thereof may be made of a material that does not substantially distort images or create substantial artifacts (i.e., gaps in the images). Additionally, stent 10 and other components or portions thereof may be made of a material 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 ELGILOY®, PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), and nitinol, among others.

[0103] It will be understood that this disclosure is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, the use of any of the features of one illustrative embodiment in other embodiments. The scope of the disclosure is, of course, defined by the language in which the appended claims are expressed.

[0104] The technical ideas included in the present disclosure are described below. (Appendix 1) a tubular scaffold including an inner surface, an outer surface, a first end region, a second end region, an intermediate region located between the first end region and the second end region, and a cavity extending between the first end region and the second end region; a liner disposed within the cavity of the tubular scaffold; a plurality of first portions of the liner secured to and directly abutting a plurality of first regions of the interior surface of the tubular scaffold, thereby inhibiting tissue ingrowth; a plurality of second regions of the inner surface free from direct abutment against the liner, thereby defining tissue ingrowth regions between the inner surface of the tubular scaffold and the outer surface of the liner.

[0105] (Appendix 2) 10. The medical device of claim 1, wherein the liner extends at least along the entire intermediate region of the tubular scaffold.

[0106] (Appendix 3) a first end of the liner forming an outer layer along a portion of the outer surface along the first end region of the tubular scaffold; 10. The medical device of claim 1, wherein the second end of the liner forms an outer layer along a portion of the outer surface along the second end region of the tubular scaffold.

[0107] (Appendix 4) the liner is circumferentially attached to the inner surface of the first end region of the tubular scaffold; 10. The medical device of claim 1, wherein the liner is circumferentially attached to the inner surface of the second end region of the tubular scaffold.

[0108] (Appendix 5) the plurality of first portions of the liner extend helically along and are secured to the inner surface of the tubular scaffold; 2. The medical device of claim 1, wherein the tissue ingrowth region is defined between a plurality of spaced apart helical turns in the liner.

[0109] (Appendix 6) 6. The medical device of claim 5, wherein the plurality of helical turns of the liner extend along only the intermediate region of the tubular scaffold.

[0110] (Appendix 7) 10. The medical device of claim 1, wherein the plurality of first portions of the liner secured to the interior surface of the tubular scaffold include a plurality of spaced apart, discrete attachment points.

[0111] (Appendix 8) 8. The medical device of claim 7, wherein regions of the liner between the plurality of spaced-apart discrete attachment points are spaced from the interior surface of the tubular scaffold and form the tissue ingrowth regions.

[0112] (Appendix 9) 9. The medical device of claim 8, wherein the plurality of spaced apart discrete attachment points extend longitudinally along the tubular scaffold.

[0113] (Appendix 10) 10. The medical device of claim 9, wherein the plurality of spaced apart discrete attachment points extend longitudinally along the entire intermediate region of the tubular scaffold.

[0114] (Appendix 11) 10. The medical device of claim 9, wherein the plurality of spaced apart discrete attachment points comprises four longitudinal attachment points circumferentially spaced along the inner surface of the tubular scaffold.

[0115] (Appendix 12) the tubular scaffold includes a plurality of gaps extending from the outer surface of the tubular scaffold to the inner surface of the tubular scaffold; 10. The medical device of claim 1, wherein the medical device does not have any outer covering radially outward of the intermediate region of the tubular scaffold to allow tissue to grow through the plurality of gaps in the tubular scaffold along the intermediate region.

[0116] (Appendix 13) 10. The medical device of claim 1, wherein the plurality of second portions of the liner are radially spaced from the inner surface of the tubular scaffold and define the tissue ingrowth region.

[0117] (Appendix 14) 14. The medical device of claim 13, wherein the woven ingrowth region extends circumferentially along the inner surface of the tubular scaffold.

[0118] (Appendix 15) 15. The medical device of claim 14, wherein the tissue ingrowth region comprises at least two circumferential tissue ingrowth regions spaced longitudinally along the intermediate region of the tubular scaffold.

Claims

1. a tubular scaffold defining a cavity therethrough; a liner extending within and continuously around the cavity to define a flow path through the cavity; the scaffold having a tissue ingrowth region spaced from the liner to allow tissue ingrowth into the tissue ingrowth region of the tubular scaffold between the scaffold and the liner; The medical device, wherein the liner is configured to prevent tissue growth into the scaffold.

2. A tubular scaffold defining a cavity therethrough; a liner extending within and continuously around the cavity to define a flow path through the cavity; the scaffold having a tissue ingrowth region spaced from the liner to allow tissue ingrowth into the tissue ingrowth region of the tubular scaffold between the scaffold and the liner; The medical device, wherein the liner is spaced radially inward from a tissue ingrowth region of the scaffold.

3. A tubular scaffold defining a cavity therethrough; a liner extending within and continuously around the cavity to define a flow path through the cavity; the scaffold having a tissue ingrowth region spaced from the liner to allow tissue ingrowth into the tissue ingrowth region of the tubular scaffold between the scaffold and the liner; A medical device, wherein the tissue ingrowth region of the scaffold extends circumferentially around an inner surface of the scaffold.

4. A tubular scaffold defining a cavity therethrough; a liner extending within and continuously around the cavity to define a flow path through the cavity; the scaffold having a tissue ingrowth region spaced from the liner to allow tissue ingrowth into the tissue ingrowth region of the tubular scaffold between the scaffold and the liner; A medical device wherein the liner is formed of a continuous layer of material.

5. A tubular scaffold defining a cavity therethrough; a liner extending within and continuously around the cavity to define a flow path through the cavity; the scaffold having a tissue ingrowth region spaced from the liner to allow tissue ingrowth into the tissue ingrowth region of the tubular scaffold between the scaffold and the liner; 1. A medical device, wherein a portion of the liner extending along the tubular tissue ingrowth region of the scaffold is configured to deflect radially inward from an inner surface of the scaffold.

6. A medical device as described in any one of claims 1 to 5, wherein the liner is configured to maintain a passageway therethrough.

7. A medical device described in any one of claims 1 to 6, wherein a gap is formed in the tissue ingrowth region of the scaffold, and the tissue ingrowth region is devoid of the liner to allow tissue to grow through the gap.

8. A medical device described in any one of claims 1 to 5, wherein the first end or second end of the scaffold is flared.

9. The medical device of claim 8, wherein the tissue ingrowth region of the scaffold is longitudinally spaced from the flared end of the scaffold.

10. A medical device as described in claim 9, wherein each of the first end and second end of the scaffold is flared, and a tissue internal growth region of the scaffold is located between the flared first end and the flared second end.

11. A medical device described in any one of claims 8 to 10, wherein the liner is attached to at least one of the flared first end or second end.

12. The medical device of claim 11, wherein the liner is flared along at least one of the flared first end or second end.

13. A medical device described in any one of claims 1 to 6, wherein a portion of the liner is fixed to the scaffold.

14. A medical device described in any one of claims 1 to 6, wherein a portion of the liner is arranged along a portion of the outer surface of the scaffold.

15. A medical device as described in any one of claims 1 to 6, wherein the liner is configured to limit the amount of tissue ingrowth into the tissue ingrowth region of the tubular scaffold due to a hyperplastic response.

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