Esophageal stent including an inner liner - Patent application

Abstract

Designing a stent that includes both a covered portion, an uncovered portion, and a tubular liner. The expandable medical device includes a tubular scaffold and a liner. The tubular scaffold includes 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. The liner is disposed within the cavity of the tubular scaffold. A plurality of first portions of the liner are secured to and directly abut the plurality of first regions of the inner surface of the tubular scaffold, thereby inhibiting tissue ingrowth, and a plurality of second regions of the inner surface are not directly abutted by the liner, thereby defining tissue ingrowth regions between the inner surface of the tubular scaffold and the outer surface of the liner.

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 path for digestive, blood, or other fluids to flow following a medical procedure. Additionally, some implantable medical devices may implement features that aid in 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 own position within the body lumen, while also having the ability to act as a passageway through which food or other digestive material can flow. However, some stents may have a tendency to migrate from their original deployed position due to the compressibility and flexibility properties that aid in the positioning of the stent. For example, a stent designed to be placed 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 essentially smooth environment of the esophagus, intestine, colon, etc. further contributes to the tendency of the stent to migrate when deployed therein. One method to reduce stent migration may include exposing the bare metal portion of the stent to the tissue of the body lumen. The 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 may anchor 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 the 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, a stent that includes 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, a covered stent may be more susceptible to migration than a bare stent (as described above).

[0005] Furthermore, in addition to designing a stent that is both adequately anchored and easily removable from the body lumen, it may be desirable to design a stent with features that aid 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 digestible material 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 of 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, a tissue ingrowth region is formed between an inner surface of the tubular scaffold and an outwardly facing surface of the liner.

[0009] Alternatively or additionally to any of the above embodiments, the portion of the liner that extends 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, an intermediate portion of the tubular scaffold includes a first inner diameter and a 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 affixed 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 an 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 such that tissue is permitted to grow through the interstices of the stent along the intermediate region. Another esophageal stent includes an expandable tubular 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 the intermediate region of the tubular scaffold to define a tissue ingrowth region along the intermediate 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, a tissue ingrowth region is formed between an inner surface of the tubular scaffold and an outwardly facing surface of the liner.

[0017] Alternatively or additionally to any of the above embodiments, the portion of the liner that extends 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, an intermediate portion of the tubular scaffold includes a first inner diameter and a 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 an 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 end portion and the second end portion. The stent also includes a liner extending continuously within the cavity of the scaffold. The liner is circumferentially attached along the first end portion and the second end portion. A tissue ingrowth region is defined along the intermediate portion of the scaffold. The liner is radially spaced from the intermediate region to define a tissue ingrowth region along the intermediate region of the tubular scaffold. The liner is configured to maintain a passageway through the liner for the flow of a substance.

[0020] Alternatively or additionally to any of the above embodiments, the portion of the liner that extends 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 illustrated in the figures and detailed description that follow.

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

[0023] [Figure 1] 1 illustrates an exemplary stent. [Diagram 2] 2 is a cross-sectional view of the stent of FIG. 1 including a liner taken along line 2-2 of FIG. [Diagram 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. [Diagram 5] 2 is a cross-sectional view of the stent of FIG. 1 including a liner. [Figure 6A]4 is a cross-sectional view of another exemplary stent including a liner and a covered portion. [Figure 6B] 4 is a cross-sectional view of another exemplary stent including a liner and a covered portion. [Figure 7A] 4 is a cross-sectional view of another exemplary stent including a liner and a covered portion. [Figure 7B] 4 is a cross-sectional view of another exemplary stent including a liner and a covered portion. [Figure 8A] 4 is a plan view of another exemplary stent including a liner and a covered portion. [Figure 8B] 4 is a plan view of another exemplary stent including a liner. [Figure 8C] 3 is a cross-sectional view of another exemplary stent. [Figure 9] 1 illustrates an exemplary stent including fixation members. [Figure 10] 1 illustrates an exemplary stent including fixation members. [Figure 11] 1 illustrates an exemplary stent including fixation members. [Figure 12] 1 illustrates an exemplary stent including fixation members. [Figure 13] 1 illustrates an exemplary stent including fixation members. [Figure 14] 1 illustrates an exemplary stent including fixation members. [Figure 15A] 1 illustrates an exemplary stent including a retrieval member. [Figure 15B] 1 illustrates an exemplary stent including a retrieval member. [Figure 16] 1 illustrates an exemplary stent disposed in a body lumen. [Figure 17] 1 illustrates an exemplary stent disposed in a body lumen. [Figure 18] 1 illustrates an exemplary stent disposed 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 PREFERRED EMBODIMENTS

[0024] While the 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 specific embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the 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 embodiment may include one or more particular features, structures, and / or characteristics. However, such a description does not necessarily mean 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 path for digestive matter, blood, or other fluids to flow after a medical procedure. Additionally, some implantable medical devices may implement features that aid in 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. Additionally, 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 the body lumen, while also having the ability to act as a passageway through which food or other digestive material can flow. However, some stents may have a tendency to migrate from their original deployed position due to the compressibility and flexibility properties that aid in the positioning of the stent. For example, a stent designed to be placed 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, colon, etc. further contributes to the tendency of the stent to migrate when deployed therein. One method to reduce stent migration may include exposing the bare metal portion of the stent to the tissue of the body lumen. The stent scaffold may provide a structure that promotes tissue ingrowth (e.g., hyperplastic response) into gaps or openings in the structure. The tissue ingrowth may 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 the 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, a stent that includes 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, a covered stent may be more susceptible to migration than a bare stent (as described above).

[0032] Furthermore, in addition to designing a stent that is both adequately anchored and easily removable from the body lumen, it may be desirable to design a stent with features that aid 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), the first or proximal end 21 may be defined as the end of stent 10 closest to the patient's mouth, and the second or distal end 23 may be defined as the end of stent 10 closest to the patient's stomach.

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

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

[0037] However, while FIG. 1 illustrates stent 10 including both first flare region 14 and second flare region 16, it is contemplated that stent 10 may only include 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 a 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 a central longitudinal axis of stent 10).

[0038] In some cases, the stent 10 may be a self-expanding stent, or the stent 10 may be a balloon expandable stent. Examples of self-expanding stents may include stents having one or more struts 12 that combine to form a rigid and / or semi-rigid stent structure. For example, the stent struts 12 may be wires or filaments that are braided, wrapped, entangled, interwoven, woven, knitted, or looped (e.g., in a bobbinette fashion), etc., to form the stent structure. For example, the exemplary stents disclosed herein may resemble braided stents, although this is not intended to limit the possible stent configurations. Rather, the stent shown in the figures may be a stent that is braided, braided, wrapped, entangled, interwoven, woven, knitted, or looped (e.g., in a bobbinette fashion), etc., to form the stent structure. Alternatively, the 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 remaining portions of the tubular member forming the 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 may be constructed from a variety of materials. For example, the stents 10 (e.g., self-expanding or balloon-expandable) may be constructed from metals (e.g., Nitinol, Elgiloy, etc.). In other examples, the stents 10 may be constructed from polymeric materials (e.g., PET). In yet other examples, the stents 10 may be constructed from a combination of metallic and polymeric materials. Additionally, the stents 10 may 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 an inner and / or outer surface of the tubular scaffolding of the stent 10. For example, FIG. 1 shows the exemplary stent 10 including an outer layer 22 (shown in FIG. 1 as a dot pattern) disposed along a portion of the outer 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] In addition, the exemplary stent 10 may include one or more layers disposed against and / or adjacent to an inner 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 layer 20 and the outer layer 22 extend outwardly and inwardly, 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 layer 20 and the outer layer 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 layer 22 and / or the inner layer 20. For example, some portions of the stent 10 may include filaments 12 sandwiched between the outer layer 22 and the inner layer 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. Although Figure 2 shows tapered portions that taper radially outward toward the ends of stent 10, it is envisioned 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 surface of the end portion 27, the tapered portion 25, and the intermediate portion 18. For purposes of explanation herein, the inner layer 20 may be interchangeably referred to as a liner, a coating, and / or a cover. 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. Moreover, the liner 20 may extend continuously (e.g., uninterrupted) from the first end 21 to the second end 23 along the cavity of the stent 10.

[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 an outer surface of one or more of end portions 27.

[0046] In some cases (as shown in FIG. 2), the outer layer 22 may be a continuous extension of the inner layer 20. For example, FIG. 2 shows the inner layer 20 extending along the inner surface 24 of the end portion 27, such that the inner layer 20 "wraps" the end 28 of the end portion 27 and then extends along the outer surface of the end portion 27. Note that in this example, what was described above as the outer layer 22 can define a portion of the inner layer 20 that "wraps" the end 28 of the tubular scaffolding of the stent 10 and also extends along the outer surface of the end portion 27. Additionally, both the inner layer 20 and the portion of the inner layer 20 that wraps around the end 28 of the scaffolding 10 to form the outer layer 22 may together sandwich the filament 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 in 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 the inner layer 20 may be fixedly affixed to the inner surfaces of the end portions 27 and / or tapered regions 25. In other words, Figure 2 illustrates that the inner layer 20 may be adhered (e.g., attached, secured, etc.) to the inner surfaces of the strut members 12 that define the end portions 27 and / or tapered regions 25 of the stent 10.

[0048] In addition, Figure 2 illustrates that in some instances, a portion of the inner layer 20 may be spaced (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 a portion of the inner layer 20 extending along the intermediate portion 18 of the stent member 10 may be removed 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 may be attached (e.g., circumferentially) at first attachment point 30 and second attachment point 32, and a portion of the length of the liner 20 between attachment points 30 / 32 may remain 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 illustrated 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 to be placed 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 and inherently smooth environment of the body lumen). Thus, one method to reduce 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. The tissue ingrowth may secure the stent in place and reduce the risk of stent migration.

[0050] It can thus 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 and 22 attached thereto and spanning the gaps in the tubular scaffold to prevent tissue ingrowth along their respective faces and the gaps therebetween.

[0051] However, it will be appreciated 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 midsection 18 of the stent 10). In other words, FIG. 2 shows a "tissue ingrowth region" 36 defined along the midsection 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 in FIG. 2 as "D1." The distance "D1" may be about 0.5 mm to 10 mm, or about 1 mm to 6 mm, or about 1.5 mm to 4 mm, or about 2 mm.

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

[0053] Further, it will be appreciated that in some cases, the liner 20 may be constructed from an elastic material. Thus, 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 does not flex relative to the stent 10.

[0054] Although the liner 20 may include elastic elements that allow it to flex radially inward from the inner surface 24 of the tubular scaffold 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 retain a passageway 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 may 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 scaffold of the stent 10 along the intermediate region 18 is shown as "D4". Additionally, in FIG. 2, the inner diameter of the inner liner 20 along the intermediate region 18 is shown as "D2". Diameter "D4" may be about 10 mm to 30 mm, or about 15 mm to 25 mm, or about 20 mm, as the case may be. Furthermore, diameter "D2" may be about 10 mm to 30 mm, or about 15 mm to 25 mm, or about 18 mm, as the case may be. Additionally, in some cases, it may be desirable to design the 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 cavity 40 remains 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, it may be desirable to control the amount of tissue ingrowth that occurs along the stent 10 because the amount of tissue ingrowth may directly correspond to the force required to remove the stent 10 from a body lumen. 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 shown as "D3". Diameter "D3" can be equal to or greater than diameter "D2". Diameter "D3" can be about 15 mm to 35 mm, or about 20 mm to 30 mm, or about 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 cone-shaped funnel. Additionally, as shown in FIG. 2, stent 10 can taper inwardly toward a central longitudinal axis of stent 10 along flaring portion 14 and outwardly away from the central longitudinal axis of stent 10 along flaring portion 16.

[0058] FIG. 3 illustrates a cross section taken along line 3-3 of FIG. 2. As discussed above, this cross section is taken through end portion 27 of flare 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 attached directly 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] FIG. 4 illustrates a cross section taken along line 4-4 of FIG. 2. As discussed above, this cross section is taken through the intermediate portion 18 of the stent 10. As shown in FIG. 4, the inner layer 20 of the stent 10 can be spaced away (i.e., radially inward) from the filaments 12 of the stent 10 along the intermediate portion 18. Further, FIG. 4 illustrates a tissue ingrowth region 36 extending between the inner surface 24 of the filaments 12 of the stent 10 and the outwardly facing surface 38 of the inner member 20. In addition, FIG. 4 illustrates that the tissue ingrowth region 36 extends circumferentially around 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 the inner layer 20 and the outer layer 22 are fixedly attached (e.g., directly secured) to the end portion 27 and / or tapered portion 25, other configurations are contemplated. For example, FIG. 5 illustrates an exemplary stent member 110. The stent 110 may be similar in form and function to the stent 10 described above. For example, the stent 110 may include a liner 120 disposed within a cavity of the tubular scaffold of the stent 110. Additionally, as shown in FIG. 5, the liner 120 may be circumferentially attached along the inner surface 124 of the stent 110 at attachment points 130 and / or attachment points 132. The attachment points 130 / 132 may be located at opposing end regions of the stent 110, such as opposing flared end regions of the 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 illustrated with respect to distance from the end 128 of the stent member 110. For example, attachment points 130 / 132 are illustrated as a distance "W" from the end 128 (as measured along the exterior surface 126 of the stent 110). In other examples, attachment points 130 / 132 may be located at distances illustrated as "X," "Y," and "Z" (as measured longitudinally from the end 128 of the stent 110). Distance "Z" may be understood to be an equivalent attachment location 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. Further, 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 100.

[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 create 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 than the distance of the attachment points 130 / 132.

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

[0066] 6A-8B show exemplary stents that may be similar in form and function to the stent designs disclosed above. For example, each of the stents shown 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 shown 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 shown in FIGS. 6A-8B may further include an additional outer layer (which may be formed separately or in conjunction with the outer layer and / or inner layer disposed in the flared end region) disposed along the outer surface of the 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 scaffold 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 illustrate the outer layer 223 extending circumferentially along the outer surface 226 of the stent 210) and may be disposed 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 illustrated in FIG. 6A, the individual outer layers 223 may be longitudinally spaced apart from one another. It will be appreciated that the configuration of the outer layer 223 creates one or more tissue ingrowth regions 236 (similar in function to those described above) along an intermediate region of the stent 210. The tissue ingrowth regions 236 may be circumferentially uncovered portions of the tubular scaffolding of the stent 210. The inner layer 220 may be positioned radially inward of the 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 inwardly) 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 inwardly from the inner surface 224 of the tubular stent 210 without being attached thereto, while other portions of the inner layer 220 are attached to the inner surface 224 of the stent 210. The space created by the inner layer 220 extending radially inwardly of 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 scaffold 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 can 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 permitted.

[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 scaffold 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 scaffold of the stent 410. FIG. 8A illustrates that the outer layer 423 may be arranged 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 layer 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 scaffold 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 illustrates 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 420. 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 the entire (or a portion) 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 illustrates an exemplary cross-section of the exemplary stent 410 shown in Figure 8B taken 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. Additionally, 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 may create one or more tissue ingrowth regions 436.

[0074] Exemplary stents disclosed herein may include one or more fixation members designed to prevent the tubular member from shifting relative to the body lumen in which the stent is implanted. For example, some stents disclosed herein may include anti-migration elements. Anti-migration elements may include hooks, barbs, posts, flares, hoops, fins, quills, or tines, and 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 illustrates a stent 510 including one or more fixation members 542. The one or more fixation members 542 may be disposed on and extend radially outwardly away from the outer surface 526 of the stent 510 and may be configured to contact an inner surface of a body lumen. For example, in at least some examples disclosed herein, the fixation members 542 may include protrusions extending radially outwardly away from the outer surface of the stent 510 to engage and / or penetrate a 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, or the like.

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

[0078] It is contemplated that the securing members 542 may include 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 an extension of the shaded portion of the stent 510. In addition, 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 that the securing members 542 positioned in the flared regions 514 and 516 point 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 stents disclosed herein and the interior surface of a body lumen are contemplated in Figures 10-14. The exemplary stents of Figures 10-14 may be similar in form and function to other stent designs disclosed herein.

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

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

[0082] 12 shows a stent 810 including fixation members 842, which may include one or more loop-shaped protrusions that extend 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 projections 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 fixing member 1042, which may include both a laterally extending loop-shaped portion 1042 and a loop-shaped portion pointing away from end 1021 of the stent 1010 (e.g., toward end 1023).

[0084] It will be appreciated that any of the above fixation members may be configured to prevent longitudinal shifting or migration of the stent relative to the inner surface of the body lumen when the stent is positioned adjacent to a 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 shifting or migration of the stent relative to the body lumen.

[0085] 15 illustrates an exemplary stent 1110 configured for removal of the 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 the 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] As shown in FIG. 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 the uncovered portion of the tubular scaffold of the stent 1110 adjacent to the outer layer 1122. To remove the stent member 1110, the clinician can grab a portion of the sutures 1150 from near the outer surface of the stent 1110. Grasping and pulling the suture 1150 can clamp a portion of the stent 1110, 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 can include a longer dependent portion (not shown) configured to be easily grasped by a removal device.

[0087] 15B further illustrates the exemplary stent 1110 described above with respect to FIG. 15A. However, as shown in FIG. 15B, sutures 1150 may be disposed adjacent end portions 1128 of the stent 1110. Similar to that described above with respect to FIG. 15A, the sutures 1150 may be interwoven through gaps 1152 of the outer layer 1122 and / or filaments 1112. Additionally, the sutures 1150 may extend circumferentially along the tubular scaffold of the stent 1110. To remove the stent member 1110, a clinician may 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 may be clamped, causing the stent 1110 to collapse radially inward, thereby allowing it to be released 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 in a body lumen, wait for a hyperplastic reaction to occur (e.g., tissue ingrowth occurs) so that the tissue ingrowth anchors 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 coupling 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 a body lumen 11. As shown, after initial deployment in the body lumen 11, end portions 27 of first flaring region 14 and end portions 27 of first flaring region 16 can exert a radially outward force against an inner surface of the body lumen 11 as the expandable scaffolding of stent 10 expands to an expanded state in the body lumen 11. This radially outward force exerted against the inner surface of the body lumen 11 can provide a temporary resistance to movement of stent 10 within the body lumen 11.

[0090] Additionally, end portion 27 of stent 10 may contact tissue on the inner surface of body lumen 11. This contact of end portion 27 with tissue on the inner surface of body lumen 11 may provide a seal that narrows the passage of food or other materials through cavity 40 of stent 10. For example, as food or other materials travel down the esophagus, flared portion 14 / 16 of stent 10 may prevent food from traveling along the outside of stent 10 and along the inner surface of body lumen 11. Rather, flared portion 14 / 16 is designed to provide a circumferential seal around the inner surface of body lumen 11 such that food is directed 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 materials may pass (without leaking to the outer surface of stent 10).

[0091] 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. FIG. 17 further shows that tissue 13 has grown into tissue ingrowth region 36 toward liner 20 (as indicated by the arrows in FIG. 17). Thus, tissue may grow through the interstices of the tubular scaffolding of stent 10, throughout the uncovered portion of intermediate region 18, and around struts or filaments 12 of the tubular scaffolding of stent 10.

[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 contacts radially inwardly the inner layer 20. However, as shown in Figure 18, the inner layer 20 has reached a point where it no longer flexes radially inwardly, thus preventing the tissue 13 from further collapsing the cavity 40 of the 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). Although the exemplary stent 10 is described in the following figures as being deployed in the esophagus, it is envisioned that the 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 may first deploy second or distal flaring portion 16 of stent 10 within stomach 54. It can be appreciated that stomach 54 may provide sufficient free area 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 prior to being placed within esophagus 56.

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

[0097] FIG. 22 illustrates an exemplary fourth step in deploying the stent 10 in the esophagus 56. Specifically, FIG. 22 illustrates that the delivery device 50 (not shown in FIG. 22) has been fully retracted, thereby deploying both the middle portion 18 and the first flaring portion 14 of the stent 10 into the esophagus 56. As discussed above, both the first flaring portion 14 and the second flaring portion 16 may be deployed such that they create a seal along the inner surface of the esophagus 56. In some cases, the middle portion 18 of the stent 10 may be spaced from the inner surface of the esophagus 56, while in other cases, the middle portion 18 may contact the inner surface of the esophagus 56. After deployment of the 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 middle portion 18 of the 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 refers 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, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, and the like, 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 copolymers (EVA), silicones, 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 any of the following materials: 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 are stainless steels, such as 304V, 304L, 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, etc.), nickel copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400), nickel cobalt chromium molybdenum alloys (e.g., UNS: R30035, such as MP35-N®), nickel molybdenum alloys (e.g., HASTELLOY® ALLOY®, etc.), nickel copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc. ... 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, and the like; cobalt chromium alloys; cobalt chromium molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®); platinum enriched stainless steels; titanium; combinations thereof, and the like; 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 radiopaque materials. 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 the stent 10. For example, the stent 10 and other components or portions thereof may be made of a material that does not substantially distort an image and does not create substantial artifacts (i.e., gaps in the image). Also, the stent 10 and other components or portions thereof may be made of a material that an MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), and nitinol, among others.

[0103] It should be understood that the present disclosure is in many respects merely illustrative. Changes may be made in details, particularly in the shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. This may include, to the extent appropriate, the use of any of the features of one exemplary embodiment used in other embodiments. The scope of the present disclosure is, of course, defined by the language in which the appended claims are expressed. The technical ideas contained 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 inner surface of the tubular scaffold, thereby inhibiting tissue ingrowth; the expandable medical device, wherein a plurality of second regions of the inner surface are free of direct abutment against the liner, thereby defining a tissue ingrowth region between the inner surface of the tubular scaffold and an outer surface of the liner. (Appendix 2) 2. The medical device of claim 1, wherein the liner extends at least along the entirety of the intermediate region of the tubular scaffold. (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; 2. 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. (Appendix 4) the liner is circumferentially attached to the inner surface of the first end region of the tubular scaffold; 2. 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. (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 of the liner. (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. (Appendix 7) 2. The medical device of claim 1, wherein the first portions of the liner secured to the inner surface of the tubular scaffold include a plurality of spaced apart discrete attachment points. (Appendix 8) 8. The medical device of claim 7, wherein areas of the liner between the plurality of spaced apart discrete attachment points are spaced from the inner surface of the tubular scaffold forming the tissue ingrowth areas. (Appendix 9) 9. The medical device of claim 8, wherein the plurality of spaced apart discrete attachment points extend longitudinally along the tubular scaffold. (Appendix 10) 10. The medical device of claim 9, wherein the plurality of spaced apart discrete attachment points extend longitudinally along an entirety of the intermediate region of the tubular scaffold. (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. (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; 2. 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 of the tubular scaffold along the intermediate region. (Appendix 13) 2. 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 forming the tissue ingrowth region. (Appendix 14) 14. The medical device of claim 13, wherein the woven ingrowth region extends circumferentially along the inner surface of the tubular scaffold. (Appendix 15) 15. The medical device of claim 14, wherein the tissue ingrowth region includes at least two circumferential tissue ingrowth regions spaced longitudinally along the intermediate region of the tubular scaffold.

Claims

1. a tubular scaffold including a wall having an inner surface and 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; The liner comprises: a plurality of first portions abutting a plurality of first regions of an inner surface of the wall of the tubular scaffold, thereby inhibiting tissue ingrowth into the tubular scaffold; a second portion spaced from a second region of an inner surface of the wall of the tubular scaffold thereby defining a tissue ingrowth region between the second portions of the liner and the second region of an inner surface of the wall of the tubular scaffold.

2. 10. The medical device of claim 1, wherein a plurality of gaps extend from the exterior surface to the interior surface of the wall of the tubular scaffold.

3. 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 along the intermediate region through gaps in the tubular scaffold.

4. 10. The medical device of claim 1, wherein the medical device does not have any outer covering radially outward of the second region of the wall of the tubular scaffold.

5. a tubular scaffold including a tubular wall defining a cavity therethrough and a tubular tissue ingrowth region along a length of the tubular wall and promoting tissue ingrowth; a liner disposed within the cavity of the scaffold and spaced radially inward from the tubular tissue ingrowth region of the scaffold thereby permitting tissue ingrowth along the tubular tissue ingrowth region of the scaffold; The liner is fixedly attached to at least a portion of the scaffold.

6. 6. The medical device of claim 5, wherein the liner is configured to limit an amount of tissue ingrowth into the tissue ingrowth region of the tubular scaffold due to a hyperplastic response.

7. 6. The medical device of claim 5, 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.

8. 6. The medical device of claim 5, wherein a portion of the liner is disposed along a portion of an exterior surface of the scaffold.

9. 6. The medical device of claim 5, wherein the liner is affixed to the scaffold at a first location and a second location longitudinally spaced from the first location, and the tissue ingrowth region is defined between the first location and the second location.

10. 10. The medical device of claim 9, wherein at least one of the first location and the second location is along an inner surface of the scaffold.

11. a tubular scaffold including a tubular wall defining a cavity therethrough and a tubular tissue ingrowth region along a length of the tubular wall and promoting tissue ingrowth; 14. A medical device comprising: a liner formed of a continuous layer of material and disposed within the cavity of the scaffold, the liner fixedly attached to at least a portion of the scaffold and detached from the scaffold along the tubular tissue ingrowth region of the scaffold, thereby permitting tissue ingrowth into the tubular tissue ingrowth region of the scaffold.

12. 12. The medical device of claim 11, wherein the liner extends continuously along an inner surface of the scaffold, along end portions of the scaffold, and along a portion of an outer surface of the scaffold.

13. 12. The medical device of claim 11, wherein the scaffold tissue ingrowth region is formed between and spaced apart from the first and second ends of the scaffold.

14. 12. The medical device of claim 5 or 11, wherein the liner is configured to maintain a passageway therethrough.

15. 12. The medical device of claim 5 or 11, wherein a tissue ingrowth region of the scaffold has gaps formed therein, the tissue ingrowth region being devoid of the liner to allow tissue to grow through the gaps.

16. 12. The medical device of claim 5 or 11, wherein the tissue ingrowth region of the scaffold extends circumferentially around an inner surface of the scaffold.

17. 12. The medical device of claim 5 or 11, wherein the first and second ends of the scaffold are flared.

Images