STENT HAVING MULTIPLE KNIT PATTERNS - Patent application

Abstract

The stent includes an elongate tubular member formed from at least one filament, the elongate tubular member including a first segment and a second segment, where the first segment has the at least one filament woven in a first knitting pattern that provides the first segment with a first performance characteristic, and where the second segment has the at least one filament woven in a second knitting pattern that provides the second segment with a second performance characteristic different from the first performance characteristic. Either the first knitting pattern or the second knitting pattern includes a plurality of anti-migration loops extending radially outward from the elongate tubular member.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices and methods for making and using medical devices. More particularly, the present disclosure is directed to stents for implantation within a body lumen and associated methods. [Background technology]

[0002] Implantable medical devices (e.g., expandable stents) can be designed to treat various medical conditions within the body. For example, some expandable stents may be designed to expand and support a body lumen and / or provide a fluid pathway for digested material, blood, or other fluids to flow therethrough after a medical procedure. Some medical devices may include expandable or self-expanding stents that can be implanted transluminally via various medical device delivery systems. These stents can be implanted in various body lumens, such as coronary or peripheral arteries, esophageal tract, gastrointestinal tract (including intestine, stomach, and colon), tracheobronchial tract, urinary tract, biliary tract, vasculature, etc.

[0003] In some instances, it may be desirable to design a stent to include sufficient flexibility while maintaining sufficient radial force to open a body lumen at the treatment site. However, in some stents, the compressibility and flexibility properties that aid in stent delivery may also result in the stent having a tendency to migrate from its original deployed position. For example, a stent designed to be placed in the esophageal 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 lubricating environment of the esophagus, intestine, colon, etc. further contributes to the tendency of a stent to migrate when deployed therein. Summary of the Invention [Problem to be solved by the invention]

[0004] Thus, in some instances, it may be desirable to design a stent with anti-migration features to reduce the tendency of the stent to migrate. Disclosed herein are several examples of medical devices that include anti-migration features. [Means for solving the problem]

[0005] The present disclosure provides design, material, manufacturing methods, and use alternatives for medical devices. As an example, a stent includes an elongate tubular member expandable from a reduced diameter configuration to an expanded diameter configuration, the elongate tubular member including at least one filament, the elongate tubular member including a first segment and a second segment, the first segment having at least one filament woven in a first knitting pattern that provides the first segment with a first performance characteristic, and the second segment having at least one filament woven in a second knitting pattern that provides the second segment with a second performance characteristic different from the first performance characteristic. Either the first knitting pattern or the second knitting pattern includes an anti-migration portion.

[0006] Additionally or alternatively, the anti-migration portion may include a plurality of anti-migration loops formed from at least one filament, and when the plurality of anti-migration loops are included as part of the first knitting pattern, the first segment may be adapted such that in response to the stent being placed under axial tension, the plurality of anti-migration loops retract into the first knitting pattern.

[0007] Additionally or alternatively, the anti-migration portion may include a plurality of anti-migration loops formed from at least one filament, and when the plurality of anti-migration loops are included as part of the second knitting pattern, the second segment may be adapted to retain the plurality of anti-migration loops in response to the stent being placed under axial tension.

[0008] Additionally or alternatively, the first segment may include a first plurality of rows in which the filaments are woven in a first knitting pattern, the first plurality of rows extending circumferentially about the longitudinal axis of the elongated tubular member.

[0009] Additionally or alternatively, at least some of the rows of the first plurality of rows may include a plurality of twisted knit stitches having an intermediate step portion extending between adjacent twisted knit stitches.

[0010] Additionally or alternatively, the second segment may include a second plurality of rows in which the filaments may be woven in a second knitting pattern, the second plurality of rows extending circumferentially about the longitudinal axis of the elongated tubular member.

[0011] Additionally or alternatively, at least some of the rows of the second plurality of rows may include a plurality of stitches, each of which may include a loop that passes around a corresponding loop in the previous row without twisting.

[0012] Additionally or alternatively, the elongate tubular member may further include a third segment in which at least one filament may be woven in the same knitting pattern as the first knitting pattern or the second knitting pattern.

[0013] Additionally or alternatively, the first segment may be disposed between the second and third knitted segments, and the filaments may be woven in a second knit pattern within the third segment.

[0014] Additionally or alternatively, the second segment may be disposed between the first knitted segment and a third knitted segment, and the filaments may be woven in the first knit pattern within the third segment.

[0015] Additionally or alternatively, the movement prevention portion may include a flared end. As another example, a stent includes an elongate tubular member expandable from a reduced diameter configuration to an expanded diameter configuration, the elongate tubular member including at least one filament, the elongate tubular member including a first segment having the at least one filament woven in a first knitting pattern and a second segment having the at least one filament woven in a second knitting pattern. A plurality of anti-migration loops are formed from the at least one filament in the first segment. The first knitting pattern is adapted to allow elongation of the first segment when the elongate tubular member is under axial tension, thereby allowing the plurality of anti-migration loops to retract within the first knitting pattern. The second knitting pattern is adapted to limit elongation of the second segment when the elongate tubular member is under axial tension.

[0016] Additionally or alternatively, the first segment, which includes the multiple anti-migration loops, may be flared. Additionally or alternatively, the second segment may be flared.

[0017] Additionally or alternatively, the stent may further include one or more additional segments in addition to the first segment and the second segment, and in each of the one or more additional segments, at least one filament may be braided in a braid pattern that corresponds to either the first braid pattern or the second braid pattern.

[0018] Additionally or alternatively, the stent may further include a third segment, the second segment may be disposed between the first segment and the third segment, and one or more filaments may be woven in the first knitting pattern within the third segment, and the third segment may include a plurality of anti-migration loops formed from at least one filament.

[0019] In another example, a stent includes an elongate tubular member expandable from a reduced diameter configuration to an expanded diameter configuration, the elongate tubular member including at least one filament, the elongate tubular member including a first segment having the at least one filament woven in a first knitting pattern and a second segment having the at least one filament woven in a second knitting pattern. A plurality of anti-migration loops are formed in the second segment from the at least one filament. The first knitting pattern is adapted to allow elongation of the first segment when the elongate tubular member is under axial tension, and the second knitting pattern is adapted to limit elongation of the second segment when the elongate tubular member is under tension, thereby retaining the plurality of anti-migration loops.

[0020] Additionally or alternatively, the first segment may be flared. Additionally or alternatively, the second segment may be flared. Additionally or alternatively, the stent may further include a third segment in which one or more filaments may be woven into a second knitting pattern, and the third segment may include a plurality of anti-migration loops formed from at least one filament.

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

[0022] The present invention may be more fully understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings. [Brief description of the drawings]

[0023] [Figure 1] 1 is a schematic diagram of an illustrative stent. [Diagram 2] 2 is a side view of a first illustrative knitting pattern that may be used in forming the stent of FIG. 1; [Diagram 3]2 is a side view of a second illustrative knitting pattern that may be used in forming the stent of FIG. 1. [Figure 4] 4 is an enlarged side view of a portion of the illustrative stent of FIG. 1, including both the first illustrative knitting pattern of FIG. 2 and the second illustrative knitting pattern of FIG. 3. [Diagram 5] 1 is a schematic side view of an illustrative stent shown in a deployed configuration. [Figure 6] 6 is a schematic side view of the illustrative stent of FIG. 5 shown in a constrained configuration. [Figure 7] 1 is a schematic side view of an illustrative stent shown in a deployed configuration. [Figure 8] 8 is a schematic side view of the illustrative stent of FIG. 7 shown in a constrained configuration. [Figure 9] 1 is a schematic side view of an illustrative stent shown in a deployed configuration. [Figure 10] 1 is a schematic side view of an illustrative stent shown in a deployed configuration. [Figure 11] 11 is a schematic side view of the illustrative stent of FIG. 9 or the illustrative stent of FIG. 10 shown in a constrained configuration. [Figure 12] 1 is a schematic end view of an illustrative stent in a relaxed configuration. [Figure 13] 13 is a schematic end view of the illustrative stent of FIG. 12 shown in a restrained configuration. [Figure 14] 1 is a schematic side view of an illustrative stent shown in a deployed configuration. [Figure 15] 1 is a schematic side view of an illustrative stent shown in a deployed configuration. [Figure 16] 16 is a schematic side view of the illustrative stent of FIG. 14 or the illustrative stent of FIG. 15 shown in a constrained configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0025] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​are assumed to be modified herein by the term "about," whether or not expressly indicated. The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (i.e., 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 (eg, 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] 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 invention.

[0028] In some instances, it may be desirable to provide an intraluminal implant or stent that can deliver luminal patency to patients with esophageal strictures or other pathologies. Such stents may sometimes be used in patients experiencing dysphagia due to esophageal cancer. Esophageal stents may allow patients to maintain nutrition via oral intake during cancer treatment or palliative periods. Some stents have a woven or knitted configuration to provide good radial strength with minimal foreshortening, which may be desirable in esophageal and tracheal-bronchial applications, as well as some post-bariatric applications. Although the embodiments disclosed herein are discussed with reference to esophageal stents, it is contemplated that the stents described herein may be used and sized for use in other locations, such as, but not limited to, body tissues, body organs, vascular lumens, non-vascular lumens, and combinations thereof, such as, but not limited to, the coronary or peripheral vasculature, trachea, bronchi, colon, small intestine, biliary tract, urinary tract, prostate, brain, stomach, etc.

[0029] FIG. 1 is a schematic diagram of an illustrative intraluminal implant 10, such as, but not limited to, a stent. In some examples, the stent 10 may take the form of an elongated tubular member including a first section 12 and a second section 14. Although the stent 10 is described as generally tubular, it is contemplated that the stent 10 may take any cross-sectional shape desired. The stent 10 may have a first or proximal end 16, a second or distal end 18, and an intermediate region 20 disposed between the first and second ends 16, 18. The stent 10 may include a lumen 22 that extends from a first opening adjacent the first end 16 to a second opening adjacent the second end 18, allowing food, fluids, and the like to pass therethrough.

[0030] Stent 10 may be expandable from a first reduced diameter configuration (not explicitly shown) to a second expanded diameter configuration. In some cases, stent 10 may be deployed to a configuration between a collapsed configuration and an expanded configuration, i.e., stent 10 may be deployed with a deployed diameter that is larger than the diameter of stent 10, or a particular portion thereof, while in its collapsed configuration, but smaller than the diameter of stent 10, or a particular portion thereof, while in its fully expanded configuration. In some cases, the anatomical structure into which stent 10 is deployed may affect its deployed configuration. For example, if the anatomical structure into which stent 10 is deployed has a diameter smaller than the diameter of stent 10, or a particular portion thereof, when fully expanded, stent 10 may have a deployed diameter that is intermediate between the diameter of its collapsed configuration and the diameter of its fully expanded configuration.

[0031] Stent 10 may be formed from one or more or multiple interwoven filaments. For example, stent 10 may have a braided structure made from one or more filaments interwoven with one another. In some cases, stent 10 may have a braided structure formed by braiding a single filament that extends the entire length of the stent. In some cases, stent 10 may be braided from one or more filaments braided together using two or more different braid patterns. For example, first section 12 may be formed by braiding one or more filaments together in a first braid pattern, and second section 14 may be formed by braiding one or more filaments together in a second braid pattern that is different from the first braid pattern. The same filament may be used throughout both the first braid pattern in first section 12 and the second braid pattern in second section 14, or different filaments may be used throughout each of the first braid pattern in first section 12 and the second braid pattern in second section 14. As described below, each of the first and second knitting patterns, and optionally any other knitting patterns used in forming stent 10, may provide unique properties to particular portions of stent 10 formed using those particular knitting patterns.

[0032] In some cases, the filaments of stent 10 may be formed from a monofilament, while in other cases, stent 10 may be formed from two, three, or more filaments that are wound, braided, or woven together prior to braiding stent 10. In some instances, the inner and / or outer surfaces of stent 10 may be entirely, substantially, or partially covered with a polymeric covering or coating. The covering or coating may span the open spaces formed by the filaments that are braided together. The covering or coating may help, for example, to reduce food impaction and / or tumor or tissue ingrowth.

[0033] It will be appreciated that in many cases, performance requirements for a stent, such as stent 10, may be in conflict. For example, strength versus flexibility is a common conflict when designing medical devices such as stents. Building a stent that stays in place and does not move may conflict with the desire that the stent may be able to move or even be removed. Forming stent 10 with multiple sections, such as first section 12 and second section 14, that may have different knitting patterns and therefore different performance characteristics, may help provide the best of both worlds, so to speak. As will be described below, the knitting patterns disclosed herein may be used to form various sections or portions of stent 10 to provide stent 10 with a desired combination of properties.

[0034] It is contemplated that the filaments of the stent 10 may be made from a number of different materials, such as, but not limited to, metals, metal alloys, shape memory alloys, and / or polymers, as desired, to allow the stent 10 to expand into a shape once it is correctly positioned within the anatomy. In some instances, the material may be selected to also allow the stent 10 to be relatively easily removed. For example, the stent 10 may be formed from alloys, such as, but not limited to, Nitinol and Elgiloy®. Depending on the material selected for the construction of the stent 10, the stent 10 may be self-expanding (i.e., configured to automatically expand in diameter when unconstrained). In some instances, the stent 10 may not be self-expanding and therefore may not regain its fully expanded configuration without the assistance of an expansion device, such as, but not limited to, an inflatable balloon positioned within the lumen 22. As used herein, the term "self-expanding" refers to the tendency of the stent 10 to return to a preprogrammed diameter when not restrained by an external biasing force, e.g., a delivery catheter or sheath. Although not shown, stent 10 may include a one-way valve, such as, for example, an elastomeric slit valve or duckbill valve, disposed within lumen 20 to prevent the reflux of gastrointestinal fluids.

[0035] In some examples, in the expanded configuration, the stent 10 may include a first end region 24 proximate the first end 16 and a second end region 26 proximate the second end 18. In some cases, the first end region 24 and the second end region 28 may include a retention feature or anti-migration flared region (not explicitly shown) having an enlarged diameter relative to the intermediate region 20. The anti-migration flared region, which may be disposed adjacent the first end 16 and / or the second end 18, may be configured to engage an interior portion of the wall of the esophagus or other body lumen. In some cases, the retention feature or flared region may have a larger diameter than the intermediate region 20 of the stent 10 to prevent the stent 10 from migrating after being placed in the esophagus or other body lumen. In some examples, the transition from its cross-sectional area of ​​the intermediate region 20 to the retention feature or flared region may be gradual, sloped, or occur in an abrupt stepwise manner, as desired.

[0036] In some examples, the first anti-migration flared region may have a first outer diameter and the second anti-migration flared region may have a second outer diameter. In some examples, the first and second outer diameters may be substantially the same, while in other examples, the first and second outer diameters may be different. In some cases, the stent 10 may include only one anti-migration flared region or none at all. For example, the first end region 24 may include an anti-migration flare and the second end region 26 may have a similar outer diameter as the mid-region 20. It is further contemplated that the second end region 26 may include an anti-migration flare and the first end region 24 may have a similar outer diameter as the mid-region 20. In some embodiments, the stent 10 may have a uniform outer diameter from the first end 16 to the second end 18. In some embodiments, the outer diameter of the mid-region 20 may be within the range of 15 to 25 millimeters in the fully expanded configuration. The outer diameter of the anti-migration flare may be in the range of 20 to 30 millimeters in a fully expanded configuration. It is contemplated that the outer diameter of the stent 10 may be varied to suit a desired application.

[0037] In some cases, composite filaments may be used to fabricate the stent 10, which may include, for example, an outer shell or cladding made from Nitinol and a core formed from platinum or other radiopaque material. It is further contemplated that the stent 10 may be formed from a polymer, including, but not limited to, polyethylene terephthalate (PET). In some instances, the filaments or portions thereof of the stent 10 may be bioabsorbable or biodegradable, and in other instances, the filaments or portions thereof of the stent 10 may be biostable.

[0038] FIG. 2 is a side view of a first illustrative knitting pattern 30 that may be used in forming a portion of the stent 10. In some cases, for example, the first knitting pattern 30 may be used in knitting the first section 12. The first knitting pattern 30 is formed by knitting filaments 32 row by row, with each row extending circumferentially around the stent 10. As shown, the first knitting pattern includes a plurality of rows 34, individually labeled as 34a, 34b, 34c, 34d, 34e, and 34f, that extend circumferentially around the stent 10. The stent 10 may be considered to have a longitudinal axis 36. The stent 10 may include any number of rows 34 desired. For example, the number of rows 34 may be selected to achieve a desired length of the stent 10, or at least a desired length of the first portion 12. The first knitting pattern 30 may be considered to include a plurality of twisted knit stitches.

[0039] The top or first row 34a may be non-fixed and active. In some examples, the first row 34a may include a plurality of loops 38, individually labeled as 38a, 38b, 38c. The loops 38 may each include a loop portion 40, individually labeled as 40a, 40b, 40c. The loops 38 may each include an overlapping base portion 42, individually labeled as 42a, 42b, 42c. The overlapping base portion 42 is understood to be the portion of the loop 38 where one segment of the filament 32 overlaps or crosses over a second segment of the filament 32, the segments of the filament forming the loop portion 40 extending therebetween. Adjacent loops 38 may be interconnected by step sections 44, individually labeled as 44a, 44b. For example, the first step section 44a may extend between the base portion 42a of the first loop 38a and the second base portion 42b of the second loop 38b.

[0040] The next row 34b may be suspended from the loops 38 of the first row 34a. For example, the second row 34b may include a plurality of loops 46, individually labeled as 46a, 46b, 46c. Each loop 46 includes a loop portion 48, individually labeled as 48a, 48b, 48c, and a base portion 50, individually labeled as 50a, 50b, 50c. Adjacent loops 46 may be interconnected by step sections 52, individually labeled as 52a, 52b. When the stent 10, or at least the first section 12, is braided, the loop portion 48 may be wrapped around the base portion 42 of the preceding row 34a. Thus, each loop 46 of a given row may be wrapped around the base portion 42 of a loop 38 of the preceding row.

[0041] It is contemplated that a single row 34 may be formed at a time. For example, row 34 may be formed consecutively with the next row, e.g., row 34b, being formed after the previous row, e.g., row 34a, has formed a complete turn around the stent 10. Although not explicitly shown, the loops 38 of the first row 34a may be wrapped around a section of the filament 32 that is free of loops. As described herein, the loops 46 of the second row 34b may be wrapped around the base portion 42 of the loops 38 of the previous row 34a. For example, the filament 32 may be braided to extend from the first step section 52a, wrap around the base portion 42a of the previous row 34a, cross over itself to form the base section 50b, and continue into the next step section 52b.

[0042] The first knitting pattern 30 provides certain performance characteristics to the stent 10, or at least the first section 12 formed using the first knitting pattern 30. In some cases, the first knitting pattern 30 provides the stent 10, or at least the first section 12, with good radial strength and axial flexibility. The first knitting pattern 30 provides the stent 10, or at least the first section 12, with the ability to easily lengthen in response to the stent 10 being placed under tension. Loops such as loop 38 and loop 46, respectively, lengthen as corresponding stages 44 and 52 shorten. If the first knitting pattern 30 includes one or more anti-migration loops that are easily formed when the first knitting pattern 30 is knitted, applying a tensile force to the stent 10 elongates the first section 12 and pulls out the anti-migration loops. This means that stent 10, in addition to or instead of including one or more flared retention regions, can include anti-migration loops, further allowing for easy repositioning or even removal of stent 10 by simply applying a tensile force to first section 12, thereby stretching stent 10 and pulling out the anti-migration loops. Further details regarding first knit pattern 30 can be found in U.S. Patent Application Publication No. 2019 / 0307586, which is incorporated herein by reference.

[0043] In some applications, the stent 10 may be placed in the anatomy in a location where the stent 10 may undergo significant peristaltic movement. In such situations, the flexibility enabled by the first knitting pattern 30 may allow the stent 10 to bend and flex in response to the underlying pressure waves without the stent 10 migrating within the anatomy. In some applications, it may be desirable to provide the stent 10 with other properties, such as, but not limited to, anti-migration loops that are not easily pulled out in response to tensile forces.

[0044] FIG. 3 is a side view of a second illustrative knitting pattern 60 that may be used in forming a portion of the stent 10. In some cases, for example, the second knitting pattern 60 may be used in knitting the second section 14. The second knitting pattern 60 is formed by knitting the filaments 32 row by row, with each row extending circumferentially around the stent 10. As shown, the second knitting pattern includes a plurality of rows 62, individually labeled as 62a, 62b, 62c, 62d, 62e, and 62f, that extend circumferentially around the stent 10. The stent 10 may be considered to have a longitudinal axis 36. The stent 10 may include any number of rows 62 as desired. For example, the number of rows 62 may be selected to achieve a desired length of the stent 10, or at least a desired length of the second section 14.

[0045] The top or first row 62a may be non-fixed and active. In some examples, the first row 62a may include a number of open loops 64, individually labeled 64a, 64b, 64c. Each open loop 64 is joined to an adjacent open loop 64 via a step 66, individually labeled 66a and 66b. The next row, row 62b, includes a number of open loops 68, individually labeled 68a, 68b, 68c. Each open loop 68 is joined to an adjacent open loop 68 via a step 70, individually labeled 70a and 70b. The next row, row 62c, includes a number of open loops 72, individually labeled 72a, 72b, 72c. Each open loop 72 is joined to an adjacent loop 72 via a step 74, individually labeled 74a and 74b. An open loop is one in which the base of the loop is not twisted (ie, does not contain segments where the filaments form a loop that crosses over one another).

[0046] In forming the second knitting pattern 60, the filaments 32 (the lengths of filaments 32 forming the first knitting pattern 30) form a first row of a plurality of open loops 64 having steps 66 extending between adjacent open loops 64. In the next succeeding circumferential row, the open loops 68 extend around the open bases of the open loops 64 of the previous row, and steps 70 extend between adjacent open loops 68. In the next succeeding circumferential row, the open loops 72 extend around the open bases of the open loops 68 of the previous row. This pattern continues with each successive circumferential row until enough rows 62 have been completed such that the stent 10, or at least the second section 14, achieves the desired length.

[0047] The second knitting pattern 60 provides certain performance characteristics to the stent 10, or at least the second section 14 formed using the second knitting pattern 60. For example, the second knitting pattern 60 does not easily collapse or become radially constrained when removed or repositioned. This is because the connected loops must share a single stage in order to stretch. Each loop is in competition, thus negating the ability of the second knitting pattern 60 to stretch, or at least substantially stretch. As a result, if the second section 14 includes anti-migration loops, the anti-migration loops will not be pulled out in response to applying a tensile force to the stent 10.

[0048] Because the first knitting pattern 30 and the second knitting pattern 60 have different performance characteristics, including how they respond to an applied tensile strength and what that means for any anti-migration loops formed in either the first knitting pattern 30 or the second knitting pattern 60, there may be advantages to using both the first knitting pattern 30 and the second knitting pattern 60 within the same stent 10.

[0049] FIG. 4 shows an illustrative composite knit pattern 80 including a first segment 82, a second segment 84, and a third segment 86 formed together from a single filament 32. As used herein, the term "segment" is intended to refer to a tubular section of a stent having a longitudinal length. A stent is formed from a plurality of segments (i.e., tubular sections) that extend end-to-end along the length of the stent. Thus, in the illustrated example, the stent includes a second segment 84 that is longitudinally disposed between the first segment 82 and the third segment 86. As shown, the second segment 84 uses the first knit pattern 30, and the first segment 82 and the third segment 86 both use the second knit pattern 60. Because the first knitting pattern 30 and the second knitting pattern 60 are both knitted from the same single filament 32, it is possible to mix and match the first knitting pattern 30 and the second knitting pattern 60 within the stent 10 as desired (e.g., in adjacent tubular segments) to provide the stent 10 with appropriate properties.

[0050] In some cases, a stent formed using the composite knitting pattern 80 may include only a relatively small second segment 84 using the first knitting pattern 30, while the first segment 82 and the third segment 86, both using the second knitting pattern 60, may extend to opposite ends of the stent. This provides a stent having two large segments that are less flexible and less responsive to applied tensile forces and one small segment that is more flexible and more responsive to applied tensile forces. It will be understood that the composite knitting pattern 80 shown in FIG. 4 is merely exemplary, as any number of combinations of the first knitting pattern 30 and the second knitting pattern 60 may be combined within a single stent depending on the desired properties. It will also be understood that additional knitting patterns not expressly described herein may be combined with the first knitting pattern 30 and the second knitting pattern 60 in any number of combinations, for example.

[0051] 5-16 provide illustrative, but non-limiting examples of combining the first and second knitting patterns 30, 60 in various ways, along with various options for the first and / or second knitting patterns 30, 60 to include anti-migration loops. It is understood that in each embodiment, each segment formed by the first knitting pattern 30 and each segment formed by the second knitting pattern 60 may be formed of a single filament 32 woven into the respective knitting pattern. Thus, the filament 32 forming the first and second knitting patterns 30, 60 may extend the entire length of the stent. In FIGS. 5-16, the first knitting pattern 30 is represented by a standard line thickness, and the second knitting pattern 60 is represented by a thicker line thickness.

[0052] FIG. 5 is a schematic diagram of an illustrative stent 90 segment including a first segment 92 using the second knitting pattern 60, a second segment 94 using the first knitting pattern 30, and a third segment 96 using the second knitting pattern 60. Thus, in the illustrated example, the stent 90 includes a second segment 94 disposed longitudinally between the first segment 92 and the third segment 96. In some ways, the stent 90 can be considered as an example using the composite knitting pattern 80 shown in FIG. 4. The second segment 94 includes a plurality of anti-migration loops 98 formed from the filaments 32. It will be appreciated that the anti-migration loops 98 can be readily formed during knitting of the stent 90 and / or can be formed thereafter. For example, a mandrel, such as an adjustable mandrel having an adjustable configuration, can be used to radially displace the filaments 32 outward from adjacent loops of the first knitting pattern 30 to form the filaments into the anti-migration loops. An anti-migration loop may be a section of filament 32 that extends radially outward away from an adjacent portion of first knit pattern 30. For example, anti-migration loop 98 may be formed by extending a selected step portion of filament 32 that extends between adjacent loop portions radially outward beyond the adjacent portion of first knit pattern 30. Further details regarding forming anti-migration loops may be found in U.S. Patent Application Publication No. 2019 / 0029850, which is incorporated herein by reference.

[0053] FIG. 6 shows the stent 90 after an axial tensile force has been applied to the stent 90. As can be seen, the first segment 92 and the third segment 96, both of which use the second knitting pattern 60, have lengthened somewhat in the longitudinal direction. However, the anti-migration loops 98 that were present in the second segment 94 can be seen to have been pulled out and essentially disappeared. In other words, the axial force on the stent 90 causes the anti-migration loops 98 to be pulled into the knitting pattern 30, thus causing the anti-migration loops 98 to retract. Thus, the stent 90 enjoys the properties of both the second knitting pattern 60 as well as the first knitting pattern 30. The anti-migration loops 98 help secure the stent 90 in place, but when the stent 90 is grasped to retrieve it, the stent 90 lengthens somewhat in the longitudinal direction, allowing the second segment 94 to retract the anti-migration loops 98 into the first knitting pattern 30. This means that the stent 90 can be easily removed without damage to the surrounding tissue that may occur if the anti-migration loops 98 are still engaged within the tissue. The use of a stent, such as stent 90, may be beneficial for the treatment of conditions where the stent may benefit from the presence of an anti-migration loop, such as anti-migration loop 98, but where device removal would be sensitive to the continued presence of anti-migration loop 98. One example would be bariatric surgery leak treatment. By placing anti-migration loop 98 within second segment 94 representing first knitting pattern 30, this problem is avoided.

[0054] FIG. 7 is a schematic diagram of a portion of an illustrative stent 100 including a first segment 102 using the first knitting pattern 30, a second segment 104 using the second knitting pattern 60, and a third segment 106 using the first knitting pattern 30. Thus, in the illustrated example, the stent 100 includes a second segment 104 disposed longitudinally between the first segment 102 and the third segment 106. In some respects, the stent 100 may be considered an inverse example of the stent 90. The second segment 104 includes a plurality of anti-migration loops 108 formed from the filaments 32. It will be appreciated that the anti-migration loops 108 may be readily formed during knitting of the stent 100 and / or may be formed thereafter. For example, a mandrel, such as an adjustable mandrel having an adjustable configuration, may be used to radially displace the filaments 32 outwardly from adjacent loops of the second knitting pattern 60 to form the filaments into the anti-migration loops. An anti-migration loop may be a section of the filament 32 that extends radially outward away from an adjacent portion of the second knitting pattern 60. For example, the anti-migration loop 108 may be formed by extending a selected step portion of the filament 32 that extends between adjacent loop portions radially outward beyond the adjacent portion of the second knitting pattern 60.

[0055] FIG. 8 shows the stent 100 after an axial tensile force has been applied to the stent 100. As can be seen, the first segment 102 and the third segment 106, both of which use the first knitting pattern 30, are elongated in the longitudinal direction. However, the second segment 104, which includes the anti-migration loops 108, remains almost the same as seen in FIG. 7. The use of a stent such as the stent 100 is beneficial in locations where the stent undergoes substantial movement within the anatomy, such as peristalsis. The stent 100 can withstand pressure waves by allowing the segments of the stent including the first knitting pattern 30 to elongate axially while maintaining the radially extending anti-migration loops 108 even when the stent 100 is constrained. The stent 100 can be useful in highly motile areas, such as esophageal strictures. The ability of the stent 100 to remain intact while undergoing continued peristaltic movement and even to deform slightly through partial stretching can help prevent migration, risk of perforation, and potential stent end stenosis. The rigid anti-migration loops 108 formed within the second knitting pattern 60 counteract any tendency to migrate.

[0056] In some cases, the stent may include multiple regions formed with the first knitting pattern 30, each of the multiple regions including an anti-migration loop. Figure 9 is a schematic diagram of a portion of a stent 110 including a first segment 112 using the second knitting pattern 60, a second segment 114 using the first knitting pattern 30, a third segment 116 using the second knitting pattern 60, a fourth segment 118 using the first knitting pattern 30, and a fifth segment 120 using the second knitting pattern 60. Thus, in the illustrated example, the stent 110 includes the second segment 114 longitudinally disposed between the first segment 112 and the third segment 116, the fourth segment 118 longitudinally disposed between the third segment 116 and the fifth segment 120, and the third segment 116 longitudinally disposed between the second segment 114 and the fourth segment 118. The second segment 114 includes a plurality of anti-migration loops 122 that extend radially outward and face toward the center of the stent 110. The fourth segment 118 includes a plurality of anti-migration loops 124 that also extend radially outward and face toward the center of the stent 110, with the anti-migration loops 122 in the second segment 114 facing in the opposite direction as the anti-migration loops 124 in the fourth segment 118.

[0057] 10 is a schematic diagram of segments of an illustrative stent 110a including a first segment 112 using the second knitting pattern 60, a second segment 114 using the first knitting pattern 30, a third segment 116 using the second knitting pattern 60, a fourth segment 118 using the first knitting pattern 30, and a fifth segment 120 using the second knitting pattern 60. The second segment 114 includes a plurality of anti-migration loops 122a extending radially outward and oriented in a direction away from the center of the stent 110. The fourth segment 118 includes a plurality of anti-migration loops 124a extending radially outward and oriented in a direction away from the center of the stent 110, with the anti-migration loops 122a in the second segment 114 facing in an opposite direction to the anti-migration loops 124a in the fourth segment 118.

[0058] It will be understood that because stents 110 and 110a have their anti-migration loops 122, 122a and 124, 124a formed in the portions of stents 110, 110a that use the first knitting pattern 30, FIG. 11 may be considered to represent either stent 110 or stent 110a in its restrained configuration with an axial tensile force applied to stent 110, 110a.

[0059] 12 is a schematic end view of an illustrative stent 130 in which every other loop on a cross section is formed from an alternating knit pattern. For example, the stent 130 may include some anti-migration loops 132 formed as part of the first knit pattern 30 and some anti-migration loops 134 formed as part of the second knit pattern 60. The anti-migration loops 132 and anti-migration loops 134 may be provided in any desired arrangement and / or location along the length and / or around the circumference of the stent 130. For example, the anti-migration loops 132 may alternate with the anti-migration loops 134, for example, around the circumference of the stent 130. In some instances, the anti-migration loops 132 may alternate with the anti-migration loops 134, for example, in a single row, consecutive rows, or adjacent segments of the stent 130. Each row may have the same pattern of alternating anti-migration loops 132 and anti-migration loops 134, for example. In some cases, the pattern may vary from row to row, as desired. For example, in some instances, a single row of a stent may include a portion having a first knitting pattern 30 and a portion having a second knitting pattern 60. Such a row may include one or more anti-migration loops 132 formed in the first knitting pattern 30 and / or one or more anti-migration loops 134 formed in the second knitting pattern 60. In some cases, the anti-migration loops 132 and / or anti-migration loops 134 in a particular row may be circumferentially aligned or circumferentially offset from the anti-migration loops 132 and / or anti-migration loops 134 in another row, for example.

[0060] 13, when the stent 130 is axially stretched, the anti-migration loops 132 that are part of the first knitting pattern 30 retract into the first knitting pattern 30 during axial stretching of the stent 130, while the anti-migration loops 134 that are part of the second knitting pattern 60 do not retract into the second knitting pattern 60 during axial stretching. The resulting configuration with half anti-migration loops may be easier to migrate or remove from the anatomy.

[0061] 14 is a schematic side view of an illustrative stent 140. The illustrative stent 140 includes a first segment 142 using the first knitting pattern 30 and a second segment 144 using the second knitting pattern 60. In the illustrated example, the second segment 144 is disposed longitudinally adjacent to the first segment 142. The first segment 142 is flared and thus has a larger diameter than the second segment 144. It will be appreciated that application of an axial tensile force to the stent 140 reduces the diameter of the flared first segment 142 and stretches it longitudinally, essentially removing the flare and facilitating repositioning or even removal of the stent 140.

[0062] FIG. 15 is a schematic side view of an illustrative stent 150 including a first segment 152 using the first knitting pattern 30 and a second segment 154 using the second knitting pattern 60. In the illustrated example, the second segment 154 is disposed longitudinally adjacent to the first segment 152. The first segment 152 is flared and thus has a larger diameter than the second segment 154. The first segment 152 also includes a plurality of anti-migration loops 156. It will be appreciated that applying an axial tensile force to the stent 150 reduces the diameter of the flared first segment 152 and stretches it longitudinally, essentially eliminating the flare and retracting the anti-migration loops 156 back into the first knitting pattern 30 in the first segment 152, thereby making it easier to reposition or even remove the stent 150. This can be seen in FIG.

[0063] It should be understood that the present disclosure is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size, and step organization, without exceeding the scope of the present disclosure. This may include, to the extent appropriate, the use of any of the features of one illustrative embodiment used in another embodiment. The scope of the present invention is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. A stent comprising:

1. An elongate tubular member expandable from a reduced diameter configuration to an expanded diameter configuration, the elongate tubular member comprising at least one filament, the elongate tubular member including a first segment and a second segment, the first segment having the at least one filament woven in a first knit pattern that provides the first segment with a first performance characteristic, and the second segment having the at least one filament woven in a second knit pattern that provides the second segment with a second performance characteristic different from the first performance characteristic, wherein either the first knit pattern or the second knit pattern includes a migration prevention portion. A stent comprising:

2. 2. The stent of claim 1, wherein the anti-migration portion comprises a plurality of anti-migration loops formed from the at least one filament, and when the plurality of anti-migration loops are included as part of the first knitting pattern, the first segment is adapted such that the plurality of anti-migration loops retract into the first knitting pattern in response to the stent being placed under axial tension.

3. 2. The stent of claim 1, wherein the anti-migration portion comprises a plurality of anti-migration loops formed from the at least one filament, and when the plurality of anti-migration loops are included as part of the second knitting pattern, the second segment is adapted to retain the plurality of anti-migration loops in response to the stent being placed under axial tension.

4. The stent of any one of claims 1 to 3, wherein the first segment comprises a first plurality of rows in which the filaments are woven in the first knitting pattern, the first plurality of rows extending circumferentially about a longitudinal axis of the elongated tubular member.

5. The stent of claim 4 , wherein at least some of the rows of the first plurality of rows comprise a plurality of twisted knit stitches having intermediate step portions extending between adjacent twisted knit stitches.

6. The stent of any one of claims 1 to 5, wherein the second segment comprises a second plurality of rows in which the filaments are woven in the second knitting pattern, the second plurality of rows extending circumferentially about a longitudinal axis of the elongated tubular member.

7. The stent of any one of claims 1 to 6, wherein the elongated tubular member further comprises a third segment in which the at least one filament is braided in the same braid pattern as the first braid pattern or the second braid pattern.

8. 8. The stent of claim 7, wherein the first segment is disposed between the second braided segment and the third braided segment, and the filaments are braided in the second braid pattern within the third segment.

9. 8. The stent of claim 7, wherein the second segment is disposed between the first braided segment and the third braided segment, and the filaments are braided in the first braid pattern within the third segment.

10. The stent of any one of claims 1 to 9, wherein the migration prevention portion comprises a flared end.

11. A stent an elongate tubular member expandable from a reduced diameter configuration to an expanded diameter configuration, said elongate tubular member comprising at least one filament, said elongate tubular member including a first segment having said at least one filament woven in a first knitting pattern and a second segment having said at least one filament woven in a second knitting pattern; a plurality of anti-migration loops formed from the at least one filament in the first segment; Equipped with The first knitting pattern is adapted to allow elongation of the first segment when the elongate tubular member is under axial tension, thereby allowing the plurality of anti-migration loops to retract within the first knitting pattern. The second knit pattern is adapted to limit elongation of the second segment when the elongate tubular member is under axial tension. Stent.

12. 12. The stent of claim 11, wherein the first segment including the plurality of anti-migration loops is flared or the second segment is flared.

13. 13. The stent of claim 11 or 12, further comprising a third segment, the second segment being disposed between the first segment and the third segment, the one or more filaments being woven in the first knitting pattern in the third segment, and the third segment including a plurality of anti-migration loops formed from the at least one filament.

14. A stent an elongate tubular member expandable from a reduced diameter configuration to an expanded diameter configuration, said elongate tubular member comprising at least one filament, said elongate tubular member including a first segment having said at least one filament woven in a first knitting pattern and a second segment having said at least one filament woven in a second knitting pattern; a plurality of anti-migration loops formed within the second segment from the at least one filament; and Equipped with The first knit pattern is adapted to permit elongation of the first segment when the elongate tubular member is subjected to axial tension. the second knit pattern is adapted to limit elongation of the second segment when the elongate tubular member is under tension, thereby retaining the plurality of anti-migration loops. Stent.

15. The stent of claim 14 , wherein the first segment or the second segment is flared.

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