Repositionable and removable stent

Abstract

The present disclosure provides an illustrative endoluminal implant having an elongate tubular member and a repositionable and removable stent. The elongate tubular member has a stent and a retrieval suture interwoven with the stent. The retrieval suture includes a first suture ferrule extending about the stent circumference and adjacent to the suture retrieval ferrule, and a second suture ferrule extending about the stent circumference and spaced longitudinally from the first suture ferrule. The first suture ferrule and the second suture ferrule are coupled via one or more interconnection segments. At least one of the first suture loop or the second suture loop has an arc length less than 270 DEG of the stent circumference.

Description

[0001] This application is a divisional application of the Chinese application with application date of September 17, 2019, application number 201980076964.5, and invention name “Repositionable and Removable Stent”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 735,651, filed on September 24, 2018, the entire disclosure of which is incorporated herein by reference. Technical Field

[0004] The present disclosure generally relates to methods and devices for repositioning and / or removing stents or implants. More specifically, the present disclosure relates to structures for collapsing repositionable and / or removable stents or implants. Background Art

[0005] Implantable stents are devices placed in tubular body structures (such as blood vessels, esophagus, trachea, bile duct, colon, small intestine, stomach or body cavity) to provide support and keep the structure open. These devices are manufactured by any of a variety of different manufacturing methods and used in accordance with any of a variety of methods. With respect to known medical devices, delivery systems and methods, each has certain advantages and disadvantages. There is a continuing need for providing alternative medical devices and delivery / retrieval devices and alternative methods for making and using medical devices and delivery / retrieval devices. Summary of the invention

[0006] The present disclosure relates to several alternative designs, materials, methods of making medical device structures and their related uses, such as stents for preventing leakage after anastomosis and / or for the treatment of various gastrointestinal, digestive or other diseases.

[0007] In a first example, the implant may include an elongated tubular member. The elongated tubular member may include a stent having a proximal region, a distal region, and a circumference. A retrieval suture is interwoven with the stent. The retrieval suture may include: a first suture loop extending circumferentially around the stent and adjacent to a suture retrieval loop, and a second suture loop extending circumferentially around the stent and longitudinally spaced from the first suture loop. The first suture loop and the second suture loop may be coupled via one or more interconnecting segments. At least one of the first suture loop or the second suture loop may have an arc length of 270° or less of the stent circumference.

[0008] Alternatively or in addition to any of the above examples, in another example, the first suture collar and the second suture collar can each have an arc length of 270° or less of the circumference of the stent.

[0009] Alternatively or in addition to any of the above examples, in another example, at least one of the first suture ferrule or the second suture ferrule can have an arc length of 180° or less of the circumference of the stent.

[0010] Alternatively or in addition to any of the above examples, in another example, the first suture collar and the second suture collar can each have an arc length of 180° or less of the circumference of the stent.

[0011] Alternatively or in addition to any of the above examples, in another example, the first suture loop can be a discontinuous loop comprising two or more circumferential segments of retrieval suture separated by one or more interconnected longitudinal segments.

[0012] Alternatively or in addition to any of the above examples, in another example, the retrieval suture can be a single unitary structure.

[0013] Alternatively or in addition to any of the above examples, in another example, a stent can include a first outer diameter adjacent to a proximal region, and a second, smaller outer diameter adjacent to a distal region.

[0014] Alternatively or in addition to any of the above examples, in another example, the first suture loop can be located adjacent to the proximal region and the second suture loop can be located adjacent to the distal region.

[0015] Alternatively or in addition to any of the above examples, in another example, the force applied to the retrieval suture loop can be used to partially collapse the stent adjacent to the second suture loop.

[0016] Alternatively or in addition to any of the above examples, in another example, once the outer diameter of the stent adjacent to the second suture loop is at least partially collapsed, the force applied to the retrieval suture loop can be used to collapse the stent adjacent to the first suture loop.

[0017] Alternatively or in addition to any of the above examples, in another example, the retrieval suture can further include a third suture ferrule extending circumferentially around the stent and longitudinally spaced from the second suture ferrule, the second suture ferrule and the third suture ferrule being coupled via one or more interconnecting segments.

[0018] Alternatively or in addition to any of the above examples, in another example, the elongated tubular member can further include a flexible sleeve extending distally from the distal end region of the stent.

[0019] Alternatively or in addition to any of the above examples, in another instance, the retrieval suture may further include a third suture loop extending around the circumference of the flexible sleeve and longitudinally spaced from the second suture loop, the second suture loop and the third suture loop being coupled via one or more interconnecting segments.

[0020] Alternatively or in addition to any of the above examples, in another example, the force applied to the retrieval suture loop can be used to partially collapse the flexible sleeve adjacent to the third suture loop.

[0021] Alternatively or in addition to any of the above examples, in another example, once the outer diameter of the flexible sleeve adjacent to the third suture loop is at least partially collapsed, the force applied to the retrieval suture loop can be used to sequentially collapse the stent adjacent to the second suture loop and then collapse the stent adjacent to the first suture loop.

[0022] In another example, the implant may include an elongated tubular member. The elongated tubular member may include a stent having a proximal end and a distal end and a retrieval suture interwoven with the stent. The retrieval suture may include: a first segment extending circumferentially between a first circumferential position and a second circumferential position, a second segment extending longitudinally between a second circumferential position and a third circumferential position, a third segment extending circumferentially between a third circumferential position and a fourth circumferential position, a fourth segment extending longitudinally between a fourth circumferential position and a fifth circumferential position, and a fifth segment extending circumferentially between a fifth circumferential position and a sixth circumferential position. The first, second, fifth, and sixth circumferential positions may be at a first longitudinal distance away from the proximal end of the stent, and the third and fourth circumferential positions may be at a second longitudinal distance away from the proximal end of the stent different from the first longitudinal distance. The first segment and the fifth segment may jointly form a discontinuous first suture loop and the third segment may form a second suture loop. At least one of the first suture loop or the second suture loop may have an arc length of 270° or less of the stent circumference.

[0023] Alternatively or in addition to any of the above examples, in another example, at least one of the first suture ferrule or the second suture ferrule can have an arc length of 180° or less of the circumference of the stent.

[0024] Alternatively or in addition to any of the above examples, in another example, the retrieval suture can be a single unitary structure.

[0025] In another example, the implant may include an elongated tubular member. The elongated tubular member may include a stent having a proximal region and a distal region; the stent includes: a first outer diameter adjacent to the proximal region and a second smaller outer diameter adjacent to the distal region, a flexible sleeve extending distally from the distal region of the stent, and a retrieval suture interwoven with the stent; the retrieval suture includes a first suture loop extending around the circumference of the stent and adjacent to the suture retrieval loop, a second suture loop extending around the circumference of the stent and longitudinally spaced from the first suture loop, and a third suture loop extending around the circumference of the flexible sleeve and longitudinally spaced from the second suture loop, the first suture loop being coupled to the second suture loop via one or more interconnecting segments and the second suture loop being coupled to the third suture loop via one or more interconnecting segments. At least one of the first, second, or third suture loops may have an arc length of 270° or less of the circumference of the stent.

[0026] Alternatively or in addition to any of the above examples, in another example, at least one of the first, second, or third suture ferrules can have an arc length of 180° or less of the circumference of the stent.

[0027] Alternatively or in addition to any of the above examples, in another example, the retrieval suture can be a single unitary structure.

[0028] Alternatively or in addition to any of the above examples, in another example, the first sewing loop and the second sewing loop can each be comprised of discrete segments.

[0029] The above summary of exemplary embodiments is not intended to describe each disclosed embodiment or every example of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The present invention may be more fully understood based on the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0031] Figure 1 is a side view of an illustrative implant with a retrieval suture in a first configuration;

[0032] Figure 2 is in the first stowed configuration Figure 1 A side view of an illustrative implant;

[0033] Figure 3 is in the second stowed configuration Figure 1 A side view of an illustrative implant;

[0034] Figure 4 is a side view of another illustrative implant with a retrieval suture in a first configuration;

[0035] Figure 5is in the first stowed configuration Figure 4 A side view of an illustrative implant;

[0036] Figure 6 is in the second stowed configuration Figure 4 A side view of an illustrative implant;

[0037] Fig. 7A is a side view of another illustrative implant with a retrieval suture in a first configuration;

[0038] Figure 7B yes Fig. 7A apical view of an illustrative implant;

[0039] Fig. 8A is in the first stowed configuration Fig. 7A A side view of an illustrative implant;

[0040] Figure 8B yes Fig. 8A apical view of an illustrative implant;

[0041] Fig. 9 is a side view of another illustrative implant with a retrieval suture in a first configuration;

[0042] Fig.10 is a side view of another illustrative implant with a retrieval suture in a first configuration;

[0043] Fig.11 is a side view of another illustrative implant with a retrieval suture in a first configuration; and

[0044] Fig.12 is a side view of another illustrative implant with a retrieval suture in a first configuration.

[0045] Although the present invention may have various modifications and alternative forms, the details thereof have been disclosed by way of example in the accompanying drawings and will be described in detail. However, it should be understood that it is not intended to limit the various aspects of the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0046] For the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0047] All numerical values ​​herein are assumed to be modified by the term "about", whether or not explicitly indicated. The term "about" generally refers to a range of numbers that one skilled in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" may be an indication of a number that includes being rounded to the nearest significant figure.

[0048] 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).

[0049] Although some suitable sizes, ranges, and / or values ​​pertaining to various components, features and / or specifications are disclosed, those skilled in the art, in light of this disclosure, will appreciate that the desired sizes, ranges, and / or values ​​may deviate from the explicitly disclosed sizes, ranges, and / or values.

[0050] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise.

[0051] For purposes of this disclosure, "proximal" refers to the end that is closer to an operator of the device during use, while "distal" refers to the end that is farther from an operator of the device during use.

[0052] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are marked with the same numbers. The detailed description and the drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the present disclosure. The illustrative embodiments depicted are exemplary only. Selected features of any illustrative embodiment may be incorporated into another embodiment unless explicitly stated to the contrary.

[0053] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc., in this specification indicate that the described embodiments may include a particular feature, structure, or characteristic, but each embodiment may not necessarily include the particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in conjunction with one embodiment, it should be understood that such feature, structure, or characteristic may also be used in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary.

[0054] Gastric outlet obstruction (GOO) is the clinical and pathophysiological result of any disease process that produces a mechanical obstacle to gastric emptying. The presence of GOO can be classified as a condition that affects the antrum and pylorus, thereby causing pyloric dysfunction, or a condition of the distal duodenum that limits outgoing flow. Clinical conditions such as peptic ulcer disease (PUD), pyloric stenosis, and gastric polyps represent the causes of the former, while pancreatic cancer, ampullary cancer, duodenal cancer, and bile duct cancer represent the causes of the latter. In some cases, GOO can be treated directly by stenting the position using a gastrointestinal (GI) self-expanding stent. However, stenting across the pyloric valve can place the pylorus in a continuous open position. However, this can lead to gastric leakage into the duodenum. Alternative stent designs are desired, allowing immediate obstruction to be opened while allowing natural pyloric function to be maintained.

[0055] Figure 1 A side view of an illustrative intraluminal implant or stent 10 is shown. In some cases, the stent 10 can be composed of an elongated tubular stent framework 12. Although the stent 10 is described as being generally tubular, it is contemplated that the stent 10 can take any desired cross-sectional shape. The stent 10 can have a first or proximal end 14, a second or distal end 16, and an intermediate region 18 disposed between the first end 14 and the second end 16. The stent 10 can include an inner cavity 20 extending from a first opening adjacent to the first end 14 to a second opening adjacent to the second end 16 to allow passage of food, fluids, etc.

[0056] The stent 10 can be expanded from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration. In some cases, the stent 10 can be deployed to a configuration between the collapsed configuration and the fully expanded configuration. The stent 10 can be configured to extend across a stenosis and apply radially outward pressure to the stenosis in the lumen to open the lumen and allow passage of food, fluids, air, etc.

[0057] The stent framework 12 can have a braided structure made of a plurality of filaments. In some embodiments, the stent framework 12 can be braided from a single filament. In other embodiments, the stent framework 12 can be braided from a plurality of filaments, such as in the BRAVE® manufactured and distributed by Boston Scientific Corporation. and In another embodiment, the stent framework 12 can be knitted, such as ULTRAFLEX manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 12 may be of the knotted type, such as PRECISION COLONIC manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 12 may be laser cut, such as the EPIC manufactured by Boston Scientific Corporation. TM Bracket.

[0058] It is contemplated that the stent 10 may be made of a number of different materials, such as but not limited to metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that the stent 10 can expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that the stent 10 can be relatively easily removed. For example, the stent 10 may be composed of alloys, such as but not limited to nitinol and Based on the selected materials used for manufacturing, the stent 10 can be self-expanding (i.e., configured to automatically expand radially when not constrained). In some embodiments, fibers can be used to make the stent 10, which can be composite fibers, for example, having a shell made of nitinol with a platinum core. It is also conceivable that the stent 10 can be composed of polymers, including but not limited to polyethylene terephthalate (PET). In some embodiments, the stent 10 can be self-expanding, although in other embodiments, the stent 10 can be expanded using an expansion device (such as, but not limited to, a balloon inserted into the lumen 20 of the stent 10). The term "self-expanding" as used herein refers to the tendency of the stent to return to a preset diameter when not constrained by an external biasing force (such as, but not limited to, a delivery catheter or sheath). The stent 10 may include a one-way valve (such as an elastic slit valve or a duckbill valve) located inside its lumen 20 to prevent reverse flow of gastrointestinal fluids.

[0059] In some cases, in the radially expanded configuration, the stent 10 may include a first end region 22 near the proximal end 14 and a second end region 24 near the second end 16. In some embodiments, the first end region 22 and the second end region 24 may include a retaining feature or an anti-displacement flare region having an enlarged diameter relative to the middle portion 18 (not explicitly shown in the second end region 24). The anti-displacement flare region, which may be located adjacent to the first end 14 and the second end 16 of the stent 10, may be configured to engage with the interior of the wall of the esophagus, stomach or other body cavity. In some embodiments, the retaining feature or flare region may have a diameter greater than the cylindrical middle region 18 of the stent 10 to prevent the stent 10 from being displaced once it is placed in the esophagus, stomach, or other body cavity. It is conceivable that the transition from the cross-sectional area of ​​the middle region 18 to the retaining feature or flare region may be gradual, inclined or occur in a sudden step manner, as desired. In other embodiments, the stent 10 may have a consistent diameter from the proximal end 14 to the distal end 16.

[0060] It is contemplated that stent 10 may be made of a number of different materials, such as, but not limited to, metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that stent 10 can expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that stent 10 can also be relatively easily removed. For example, stent 10 may be composed of alloys, such as, but not limited to, nitinol and Based on the selected materials used for manufacturing, the stent 10 can be self-expanding or require an external force to expand the stent 10. In some embodiments, composite filaments can be used to make the stent 10, which may include, for example, a shell or covering made of nitinol and a core composed of platinum or other non-radiopaque materials. It is also conceivable that the stent 10 can be composed of polymers, including but not limited to: polyethylene terephthalate (PET). In some cases, the filaments of the stent 10 or its parts can be bioabsorbable or biodegradable, while in other cases the filaments of the stent 10 or its parts can be biostable.

[0061] The implant 10 may be completely, substantially, or partially covered with a polymeric covering, such as a coating (not explicitly shown). The covering may be disposed on the inner and / or outer surfaces of the implant 10 as desired. When so disposed, the polymeric covering may reduce or preclude tissue ingrowth and / or reduce food impaction.

[0062] Implant 10 may also include a suture 26 for retrieval. This suture 26 may include a suture loop 28 for retrieval, which may be configured to be grasped by forceps or other tools during a clinical procedure for stent removal and / or repositioning. In some cases, the suture loop 28 for retrieval may be formed by tying a knot 30 between a first end 32 and a second end 34 of the suture or by combining the first end 32 with the second end 34 (e.g., thermal bonding, adhesive, etc.). In other embodiments, the suture loop 28 for retrieval may be formed at the first end 32 or the second end 34 of the suture 26 for retrieval. In this case, the ends 32, 34 that are separated from the suture loop 28 may be connected to the opposite ends 32, 34 of the stent 10 or the suture 26 for retrieval, although this is not necessary.

[0063] Sutures 26 may be interlaced with stent frame 12 at intervals along the length of implant 10 to form a plurality of suture loops 36a, 36b (collectively referred to as 36). Although the illustrative implant 10 is illustrated and described as having two suture loops 36, it is conceivable that implant 10 may include more than two suture loops 36 as desired. For example, implant 10 may include three, four, five, or more suture loops 36. It is conceivable that suture loops 36 may be positioned at regular or uniform intervals throughout the length of implant 10. However, in other embodiments, suture loops 36 may be positioned at eccentric or uneven intervals along the length of implant 10 as desired. It is conceivable that suture loops 36 may be positioned to facilitate retrieval, repositioning, and / or reshaping of stent 10. For example, in a stent 10 having two or more flared or enlarged areas, such as in the SUTURE ... In the stent, a first retrieval suture loop 36a may be located adjacent to the first flared portion and a second retrieval suture loop 36b may be located adjacent to the second flared portion.

[0064] In some embodiments, one, two or more, or all of the suture loops 36 may extend completely around the circumference of the stent frame 12 (e.g., 360°). In other embodiments, one, two or more, or all of the suture loops 36 may extend around the circumference of the stent frame 12 or have an arc length of less than 360°. In some embodiments, one or more of the suture loops 36 may extend or have an arc length of 350° or less, 300° or less, 270° or less, 225° or less, 180° or less, 135° or less, etc. In other embodiments, one, two or more, or all of the suture loops may extend greater than 360° around the circumference of the stent frame 12.

[0065] The suture loop 36 may be formed from a single integral suture 26. It is contemplated that the suture 26 may be interwoven with the stent framework 12 so that the suture loop 36 may be constrained in a predetermined sequential order. In some cases, the proximal ring 36a may not extend in a continuous ring. Instead, the proximal ring 36a may be broken into portions by longitudinally extending interconnecting segments 46, 58 extending between the proximal ring 36a and the distal ring 36b.

[0066] Suture 26 can be interwoven with stent frame 12 by making one of the ends 32, 34 start at a first circumferential position 40 to penetrate around the proximal end 14 of implant 10 and move (e.g., travel) in a first direction. In this illustrative example, suture 26 is described as initially traveling in a clockwise direction. However, a reverse configuration in which suture is initially traveled in a counterclockwise direction is also conceivable. Suture 26 can be traveled around half of the circumference of implant 10 so that a first section 44 of suture 26 extends between a first circumferential position 40 and a second circumferential position 42. The first and second circumferential positions 40, 42 can be located at similar longitudinal distances (e.g., in a direction extending substantially parallel to the longitudinal axis 50 of implant 10) from the first end 14 of implant 10. In some cases, the suture 26 can be passed so that it is interwoven with the stent frame 12, so that a portion of the suture 26 is inside the lumen 20 of the implant 10 and a portion of the suture 26 is positioned along the outer surface of the implant 10 (e.g., so that it will contact the vascular cavity when the implant 10 is deployed inside the body). At the second circumferential position 42, the suture 26 can be passed along the length of the implant 10 in a direction toward the second end 16, so that the second longitudinally extending interconnected segment 46 of the suture 26 extends in a substantially straight direction along the length of the implant 10. The length of the second segment 46 of the suture 26 can vary based on the use. For example, some implants 10 may include radially extending spines 52 configured to engage with body tissue. The second segment 46 can be configured to extend along a length equal to or greater than the length of the implant 10 including the radially extending spines 52. This is just an example. Other features of the implant 10 (such as, but not limited to, the length of the implant 10) can be used to determine the length of the second segment 46 of the suture 26.

[0067] The second section 46 of the suture 26 may extend from the second circumferential position 42 to the third circumferential position 48. The second circumferential position and the third circumferential position 48 may be at similar radial points around the circumference of the implant 10, but spaced a certain distance along its length. At the third circumferential position 48, the third section 54 of the suture 26 may radially travel around the circumference of the implant 10 in a second direction (e.g., counterclockwise) opposite to the first direction. The third section 54 may extend between the third circumferential position 48 and the fourth circumferential position 56 to form a suture loop 36b. In some embodiments, the third circumferential position 48 and the fourth circumferential position 56 may be at substantially the same radial point around the circumference of the implant 10, so that the suture loop 36b extends around the circumference of the implant 10 substantially or completely 360°. In other embodiments, the third circumferential position 48 and the fourth circumferential position 56 may be radially spaced from each other by, for example, 1° or less, 5° or less, 10° or less, 20° or less, etc.

[0068] At the fourth circumferential position 56, the suture 26 can be threaded along the length of the implant 10 in a direction toward the first end 14 so that the fourth longitudinally extending interconnected segment 58 of the suture 26 extends along the length of the implant 10 in a direction parallel to the longitudinal axis 50. The length of the fourth segment 58 of the suture 26 can be substantially the same length as the second segment 46 of the suture 26. The fourth segment 58 of the suture 26 can extend between the fourth circumferential position 56 and the fifth circumferential position 60. In some cases, the second segment and / or the fourth segment 46, 58 of the suture may not be interwoven with the stent body 12, but instead extend along the inner or outer surface of the stent body 12. In some embodiments, the first, second, and fifth circumferential positions 40, 42, 60 can be located at similar longitudinal distances away from the first end 14 of the implant 10 (e.g., in a direction extending substantially parallel to the longitudinal axis 50 of the implant 10).

[0069] From the fifth circumferential position 60, the suture 26 may be passed through the stent body 12 in a first direction (e.g., away from the first segment 44) to form a fifth segment 62 of the suture 26. The fifth segment 62 of the suture 26 may be passed through the stent body 12 to the sixth circumferential position 64 and / or until it reaches the first circumferential position 40 (e.g., the starting point) to form the proximal loop 36a. As described above, the proximal suture loop 36a may be composed of discontinuous or disconnected segments 44, 62. In some embodiments, the fifth segment 62 stops interlacing with the stent body 12 before the suture 26 reaches the first circumferential position 40. For example, the first circumferential position 40 may be radially spaced from the sixth circumferential position 64 by, for example, 1° or less, 5° or less, 10° or less, 20° or less, etc. The first end 32 of the suture 26 may extend from the first circumferential position 40, and the second end 34 of the suture 26 may extend from the sixth circumferential position 64. The ends 32, 34 of the suture 26 may be tied to form a knot 30, glued, and then the knot 30 cured.

[0070] It is contemplated that in embodiments where it is desired that the suture 26 include a suture loop 36 extending around less than the entire circumference, the suture 26 may initially be threaded around half of the desired final arc length. For example, as will be described in more detail herein, if the completed suture loop 36 is to extend about 180° around the circumference of the implant 10, the suture 26 may initially be threaded about 90° in the circumference before being threaded down the length of the implant 10.

[0071] To collapse the implant 10, the retrieval suture ferrule 28 or the first suture ferrule 36a may be pulled or driven in a proximal direction in the absence of the retrieval suture ferrule 28. It is contemplated that the direction of actuation required to actuate the suture 26 (e.g., proximal or distal) may depend on the direction in which the suture 26 is interwoven with the stent frame 12. When the retrieval suture ferrule 28 or the first suture ferrule 36a is actuated in the absence of the retrieval suture ferrule 28, the suture ferrule 36 begins to constrain or reduce the diameter of the implant 10, such as Figure 2 As shown in Figure 2 A side view of an illustrative implant 10 is shown during actuation of the suture 26. The distal or second suture collar 36b may be constrained first, causing the intermediate portion 18 of the stent body 12 to collapse or decrease in diameter before the first end 14. Continued actuation of the retrieval suture collar 28 may cause the diameter of the first end 14 of the implant 10 to also decrease, as shown in FIG. Figure 3 . It is conceivable that the proximal or first suture loop 36a may not be actuated until slack is removed from the preceding longitudinally extending suture loop 36b and the suture connecting links 46, 58 are tightened to apply force to the next suture loop 36a. However, this is not required. In some cases, the connecting links 46, 58 may have a certain length so that the suture loops 36 simultaneously (or approximately simultaneously) constrain the implant 10 along their lengths.

[0072] Figure 4 A side view of another illustrative intracavitary implant 100 is shown, and the implant 100 includes multiple zones (including a first or proximal zone 102 and a second or distal zone 104). Although the illustrative implant 100 is illustrated and described as having two zones 102, 104, it is conceivable that the implant 100 may include any number of desired zones, such as but not limited to: one, two, three, four, or more. In addition, the zones 102, 104 may be any combination of desired structures and materials. In some cases, the implant 100 may include features (e.g., anti-displacement flaring, fixed spikes, sutures, etc.) to prevent the implant 100 from being displaced and / or offset to the distal / proximal side once the implant 100 is positioned in the body cavity and expanded. The implant 100 may include an inner chamber 106 that extends completely through the length of the implant 10, such as extending from the proximal end 108 of the first zone 102 to the distal end 114 of the second zone 104.

[0073] In some cases, the first region 102 may take the form of a stent 116 that includes an elongated tubular stent framework 118 defining an inner lumen. The stent 116 may be completely, substantially, or partially covered with a polymeric covering, such as a coating (not explicitly shown). The covering may be disposed on the inner and / or outer surfaces of the stent 116 as desired. When so disposed, the polymeric covering may reduce or preclude tissue ingrowth and / or reduce food impaction through the gaps of the stent 116 into the inner lumen. It is contemplated that an area of ​​hyperplasia may be formed away from the outer edge or a portion of the uncovered surface, which will form a seal. The stent 116 may include regions of varying diameters. For example, the stent 116 may include a flared (e.g., enlarged relative to the rest of the stent 116) proximal region 120 that tapers radially inwardly to a constant diameter distal region 122. Although not explicitly shown, if desired, the stent 116 may include regions of increased diameter (e.g., in the distal direction). The stent framework 118 is expandable between a radially collapsed delivery configuration and a radially expanded deployed configuration that can secure the implant 100 at a desired location in a body lumen.

[0074] The stent framework 118 can have a braided structure made of several filaments. In some embodiments, the stent framework 118 can be knitted from a single filament, such as in the ULTRAFLEX® manufactured and distributed by Boston Scientific Corporation. TM In other embodiments, the stent framework 118 may be braided from a plurality of filaments, such as in the TEFLON® manufactured and distributed by Boston Scientific Corporation. and In yet another embodiment, the stent framework 118 may be of the knotted type, such as the PRECISION COLONIC manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 118 may be laser cut, such as the EPIC manufactured by Boston Scientific Corporation. TM Stents. It is contemplated that the stent frames 118 may be formed to have the same structure as one another or to have different structures than one another.

[0075] It is contemplated that the stent frame 118 may be made of a number of different materials, such as, but not limited to, metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that the stent 116 can expand to a certain shape when precisely positioned within the body. The material of the stent frame 118 may be the same or different, as desired. In some cases, the material may be selected so that the stent 116 can also be relatively easy to remove. For example, the stent frame 118 may be composed of alloys, such as, but not limited to, nitinol and Based on the selected materials used for manufacture, the stent 116 can be self-expanding (i.e., configured to automatically expand radially when not constrained). In some embodiments, fibers can be used to make the stent framework 118, which can be composite fibers, for example, having a shell made of nitinol with a platinum core. It is also conceivable that the stent framework 118 can be composed of polymers, including but not limited to polyethylene terephthalate (PET). In some embodiments, the stent 116 can be self-expanding, although in other embodiments, the stent 116 can be expanded using an expansion device (such as, but not limited to, a balloon inserted inside the lumen 106 of the implant 100). The term "self-expanding" as used herein refers to the tendency of the stent to return to a preset diameter when not constrained by an external biasing force (such as, but not limited to, a delivery catheter or sheath).

[0076] The stent 116 may include a one-way valve (eg, an elastic slit valve or a duckbill valve) within its lumen 106 to prevent reverse flow of fluid or other materials (eg, gastrointestinal fluids).

[0077] In some cases, the second region 104 can take the form of a flexible sleeve 124. The flexible sleeve 124 can extend between a proximal end 112 adjacent to the distal end 110 of the stent 116 and a distal end 114 extending distally from the stent 116. For example, the sleeve 124 can be connected, attached, or fixed to a distal region 122 of the first or stent 116 adjacent to the proximal region 112 of the sleeve 124. In some cases, the sleeve 124 can overlap a portion or all of the stent 116. In some cases, the sleeve 124 can be free of any structural components that tend to keep the lumen 106 through the sleeve 124 open, thereby allowing the sleeve 124 to collapse inwardly upon itself and thereby close the lumen 106 when subjected to an external force (such as, but not limited to, a pyloric valve). In some embodiments, sleeve 124 can extend along partly, substantially, or all of the implant 100 length and cover all other parts (outer surface and / or inner surface) of implant 100, including support 116. In other words, although regions 102, 104 have been described as support 116 or sleeve 124, each region can include one or both structures in a framework structure and a flexible sleeve structure. Sleeve 124 can be fixed to support 116 using adhesives or other methods known in the art, including but not limited to thermal methods, mechanical methods, etc.

[0078] The sleeve 124 may have an elongated tubular shape that defines an inner cavity. The stent 116 and the flexible sleeve 124 inner cavity may be fluidly connected to form the inner cavity 106 of the implant 100. It is conceivable that one or more regions 102, 104 of the implant 100 may include more than one inner cavity, as desired. The sleeve 124 may be a flexible film that is easily collapsed on itself. For example, the sleeve 124 may be configured to collapse on itself under the radial force applied by the natural valve or sphincter when the implant 100 is deployed in a body cavity with a natural valve or sphincter. However, the sleeve 124 may be provided with radial supports to keep it in an expanded configuration. Some examples and discussions of illustrative supports can be found in co-pending patent application No. 62 / 419,707, entitled "Deployable Sleeves and Related Methods", filed on November 9, 2016, the disclosure of which is incorporated herein by reference.

[0079] The sleeve 124 may include one or more of the following polymer materials: polyethylene, polypropylene, polystyrene, polyester, bioabsorbable plastic (e.g., polylactic acid), polycarbonate, polyvinyl chloride, polyacrylate, acrylate, polysulfone, polyetheretherketone, thermoplastic elastomer, thermosetting elastomer (e.g., silicone), polyparaxylene (parylene), fluoropolymers (e.g., polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), vinylidene fluoride-hexafluoropropylene copolymer (PVDFHFP)), bioplastics (e.g., cellulose acetate). Additionally or alternatively, the sleeve 124 may include one or more of the following: polyurethane and its copolymers, ethylene-vinyl acetate copolymers, polyethylene terephthalate (PET), polyolefins, cellulosics, polyamides, acrylonitrile-butadiene-styrene copolymers, styrene-isoprene-butadiene (SIBS) block copolymers, acrylic resins, polylactide-co-glycolide copolymers, tetrahydrofuran, block polyetheramide resins (PEBAX), poly(gamma-caprolactone), poly(gamma-hydroxybutyrate), polydioxanone, poly(gamma-ethyl glutamate), polyiminocarbonates, polyorthoesters, and / or polyanhydrides. Blends of the above polymers may also be used, such as, but not limited to, those manufactured by AdvanSource Biomaterails, Inc., headquartered in Wilmington, Massachusetts. This is a class of biodurable thermoplastic polyurethanes based on aromatic polycarbonates.

[0080] In more detail, implant 100 may have a generally cylindrical shape, although this is not necessary, it is generally flexible, and the size is appropriately designed to be convenient to be accommodated inside the digestive tract. It is conceivable that implants of various shapes, sizes and designs can be constructed based on the size and geometry of the cavity in which implant 100 has been placed. In various examples, implant 100 may have a length of 3 to 102 inches, 3 to 6 inches, 0.5 to 116 feet (0.15 to 6.1 meters), between 3 to 5 feet (0.9 to 1.5 meters), or between about 2 to 4 feet (0.6 to 1.2 meters). However, in some cases, implant 100 may have a length less than 0.5 feet (0.15 meters) or greater than 116 feet (6.1 meters).

[0081] Once implanted in the patient, the stent 116 can apply radial outward forces to help secure the implant 100 to the body cavity. The implant 100 can be located in the antrum-pylorus-duodenum, esophagus, gastroesophageal junction (GEJ) region (e.g., at or near the cardia, where the sleeve extends into the esophagus; or at or near the pylorus, where the sleeve extends through the stomach or other parts of the gastrointestinal system). The implant 100 can be positioned so that the stent 116 is located at the stomach outlet, where the sleeve 124 bridges the pylorus. The flared structure of the stent 116 can secure the implant 100 with the stomach and serve as an anti-displacement mechanism for the implant 10. For example, the large outer diameter of the proximal end 108 of the stent 116 can engage with the stomach outlet to prevent or limit the movement of the implant 100.

[0082] Implant 100 may also include suture 126 for retrieval. This suture 126 may include suture loop 128 for retrieval, which is configured to be grasped by forceps or other tools during clinical procedures for bracket removal and or repositioning. In some cases, suture loop 128 for retrieval may be formed by tying a knot 130 between a first end 132 and a second end 134 of suture, or by combining (e.g., thermal bonding, adhesive, etc.) the first end 132 and the second end 134 of suture for retrieval. In other embodiments, suture loop 128 for retrieval may be formed at the first end 132 or the second end 134 of suture 126 for retrieval. In this case, the end 132,134 that gets rid of suture loop 128 for retrieval may be connected to the opposite end 132,134 of bracket 100 or retrieval suture 126, although this is not necessary.

[0083] Suture 126 can be interlaced with stent frame 118 along the length of implant 100 at various intervals to form a plurality of suture loops 136a, 136b, 136c (collectively referred to as 136). Although the illustrative implant 100 is illustrated and described as having three suture loops 136, it is conceivable that implant 100 may include less than or more than three suture loops 136 as needed. For example, implant 100 may include two, three, four, five, or more suture loops 136. It is conceivable that suture loops 136 may be regularly or evenly spaced throughout the length of implant 100. However, in other embodiments, suture loops 136 may be positioned along the length of implant 100 at eccentric or uneven intervals as needed. In some embodiments, one, two or more, or all of suture loops 136 may extend completely around the circumference (e.g., 360°) of stent frame 118. In other embodiments, one, two or more, or all of the suture loops 136 may extend less than 360° around the circumference of the stent framework 118. In some embodiments, one or more of the suture loops 136 may extend up to 350° or less, 300° or less, 270° or less, 225° or less, 180° or less, 135° or less, etc. In other embodiments, one, two or more, or all of the suture loops may extend greater than 360° around the circumference of the stent framework 118.

[0084] The suture loop 136 may be composed of a single integral suture 126. It is contemplated that the suture 126 may be interwoven with the stent framework 118 so that the suture loop 136 may be constrained in a predetermined sequential order. In some cases, the proximal ring 136a and / or the intermediate ring 136b may not extend in a continuous ring. Instead, the proximal ring 136a and / or the intermediate ring 136b may be broken into portions by longitudinally extending interconnecting links or segments 146, 70 extending between the proximal ring 136a and the intermediate ring 136b and longitudinally extending interconnecting links or segments 154, 162 extending between the intermediate ring 136b and the distal ring 136b.

[0085] By making one of the ends 132,134 start at the first circumferential position 138 to travel around the proximal end 108 of the implant 100 and move (e.g., travel) in the first direction, the suture 126 can be interwoven with the stent framework 118. In this illustrative example, the suture 126 is described as initially traveling in a clockwise direction. However, a reverse configuration in which the suture is initially traveled in a counterclockwise direction is also conceivable. The suture 126 can be traveled around about half of the circumference of the implant 100 so that the first section 140 of the suture 126 extends between the first circumferential position 138 and the second circumferential position 142. The first and second circumferential positions 138,142 can be located at a longitudinal distance similar to the first end 108 of the implant 100 (e.g., in a direction extending roughly parallel to the longitudinal axis 144 of the implant 100). In some cases, the suture 126 can be routed so that it is intertwined with the stent framework 118, such that a portion of the suture 126 is within the inner cavity 106 of the implant 100 and a portion of the suture 126 is positioned along the outer surface of the implant 100 (e.g., so that it will contact the vascular lumen when the implant 100 is deployed within the body).

[0086] At the second circumferential position 142, the suture 126 can be passed along the length of the implant 100 in the direction toward the distal end 110, so that the second longitudinally extending interconnected section 146 of the suture 126 extends in a generally straight direction along the length of the implant 100. The length of the second section 146 of the suture 126 can vary based on the purpose. For example, some implants 100 may include radially extending spines (not explicitly shown) configured to engage with body tissue. The second section 146 can be configured to extend along a length equal to or greater than the length of the implant 100 including the radially extending spines. This is just an example. Other features of the implant 100 (such as, but not limited to: the length of the implant 100 and / or the length of the stent 116) can be used to determine the length of the second section 146 of the suture 126.

[0087] The second section 146 of the suture 126 may extend from the second circumferential position 142 to the third circumferential position 148. The second circumferential position 142 and the third circumferential position 148 may be at similar radial points around the circumference of the implant 100, but spaced a certain distance along its length. At the third circumferential position 148, the third section 150 of the suture 126 may be threaded in a radial direction around the circumference of the implant 100 in a second direction (e.g., counterclockwise) opposite to the first direction. The suture 126 may be threaded about half of the circumference of the implant 100 so that the third section 150 of the suture 126 extends between the third circumferential position 148 and the fourth circumferential position 152 to form a section of the intermediate suture loop 136b. In some embodiments, the third circumferential position 148 and the fourth circumferential position 152 may be located at a similar longitudinal distance away from the first end 108 of the implant 100 (e.g., in a direction extending generally parallel to the longitudinal axis 144 of the implant 100).

[0088] At the fourth circumferential position 152, the suture 126 can be passed along the length of the implant 100 in a direction toward the distal end 114 of the sleeve 124, so that the fourth longitudinally extending interconnected segment 154 of the suture 126 extends in a generally straight direction along the length of the implant 100. The length of the fourth segment 154 of the suture 126 can vary based on the application. In some cases, the fourth segment 154 can extend to the distal end 114 of the sleeve 124, although this is not necessary. In other embodiments, the fourth segment 154 can extend to a point proximal to the distal end 114 of the sleeve 124. The fourth segment 152 of the suture 126 can extend between the fourth circumferential position 152 and the fifth circumferential position 156. The fourth circumferential position 152 and the fifth circumferential position 156 can be at similar radial points around the circumference of the implant 100, but spaced a certain distance along its length.

[0089] At the fifth circumferential position 156, the fifth segment 158 ​​of the suture 126 travels in a radial direction around the circumference of the implant 10 in a first direction (e.g., the same direction as the first segment 140). The fifth segment 158 ​​may extend between the fifth circumferential position 156 and the sixth circumferential position 160 to form a distal suture loop 136c. In some embodiments, the fifth circumferential position 156 and the sixth circumferential position 160 may be at substantially the same radial point around the circumference of the implant 100, so that the distal suture loop 136c extends around the circumference of the implant 100 substantially or completely 360°. In other embodiments, the fifth circumferential position 156 and the sixth circumferential position 160 may be radially spaced from each other by, for example, 1° or less, 5° or less, 10° or less, 20° or less, etc.

[0090] At the sixth circumferential position 160, the suture 126 can be threaded along the length of the implant 100 in a direction toward the first end 108 such that a sixth longitudinally extending interconnected segment 162 of the suture 126 extends along the length of the implant 100 in a linear direction that is generally parallel to the longitudinal axis 144. The length of the sixth segment 162 of the suture 126 can be substantially the same length as the fourth segment 154 of the suture 126. The sixth segment 162 of the suture 126 can extend between the sixth circumferential position 160 and the seventh circumferential position 164. In some cases, the fourth and / or sixth segments 154, 162 of the suture 126 may not be interwoven with the stent body 118 and / or the flexible sleeve 124, but rather extend along the inner or outer surface of the stent body 118 and / or the flexible sleeve 124.

[0091] At the seventh circumferential position 164, the seventh segment 166 of the suture 126 can be threaded in a radial direction around the circumference of the implant 100 in a second direction (e.g., counterclockwise) opposite to the first direction. The suture 126 can be threaded around approximately half of the circumference of the implant 100 so that the seventh segment 166 of the suture 126 extends between the seventh circumferential position 164 and the eighth circumferential position 168 to form another portion of the intermediate suture loop 136b. Together, the third segment 150 and the seventh segment 166 of the suture 126 can form the intermediate suture loop 136b. In some embodiments, the seventh circumferential position 164 and the eighth circumferential position 168 can be located at a similar longitudinal distance away from the first end 108 of the implant 100 (e.g., in a direction extending generally parallel to the longitudinal axis 144 of the implant 100). It is also contemplated that the seventh and eighth circumferential positions 164, 168 may be located at a longitudinal distance away from the first end 108 of the implant 100 similar to the third and fourth circumferential positions 148, 152. In some embodiments, the seventh circumferential position 164 and the eighth circumferential position 168 may be at substantially the same radial point around the circumference of the implant 100, such that the intermediate suture loop 136b extends substantially or fully 360° around the circumference of the implant 100. In other embodiments, the seventh circumferential position 164 and the eighth circumferential position 168 may be radially spaced from each other by, for example, 1° or less, 5° or less, 10° or less, 20° or less, etc.

[0092] At the eighth circumferential position 168, the suture 126 can be threaded along the length of the implant 100 in a direction toward the first end 108 such that an eighth longitudinally extending interconnected segment 170 of the suture 126 extends along the length of the implant 100 in a linear direction that is generally parallel to the longitudinal axis 144. The length of the eighth segment 170 of the suture 126 can be substantially the same length as the second segment 146 of the suture 126. The eighth segment 170 of the suture 126 can extend between the eighth circumferential position 168 and the ninth circumferential position 172. In some cases, the second and / or eighth segments 146, 170 of the suture 126 may not be interwoven with the stent body 118 and / or the flexible sleeve 124, but rather extend along the inner or outer surface of the stent body 118 and / or the flexible sleeve 124.

[0093] At the ninth circumferential position 172, the ninth segment 174 of the suture 126 may be threaded in a radial direction around the circumference of the implant 100 in a first direction (e.g., clockwise). The suture 126 may be threaded around approximately half of the circumference of the implant 100 such that the ninth segment 172 of the suture 126 extends between the ninth circumferential position 172 and the tenth circumferential position 176 to form another portion of the proximal suture loop 136a. Together, the first segment 140 and the ninth segment 174 of the suture 126 may form the proximal suture loop 136a. In some embodiments, the ninth circumferential position 172 and the tenth circumferential position 176 may be located at a similar longitudinal distance away from the first end 108 of the implant 100 (e.g., in a direction extending generally parallel to the longitudinal axis 144 of the implant 100). It is also contemplated that the ninth and tenth circumferential positions 172, 176 may be located at a longitudinal distance from the first end 108 of the implant 100 similar to the first and second circumferential positions 138, 142. In some embodiments, the ninth circumferential position 172 and the tenth circumferential position 176 may be at substantially the same radial point around the circumference of the implant 100, such that the proximal suture loop 136a extends substantially or completely 360° around the circumference of the implant 100. In other embodiments, the ninth circumferential position 172 and the tenth circumferential position 176 may be radially spaced from each other by, for example, 1° or less, 5° or less, 10° or less, 20° or less, etc. The first end 132 of the suture 126 may extend from the first circumferential position 138, and the second end 134 of the suture 126 may extend from the tenth circumferential position 176. The ends 132, 134 of the suture 126 may be tied to form the knot 130, glued, and then the knot 130 is cured.

[0094] It is contemplated that in embodiments where it is desired that the suture 126 include a suture loop 136 extending around less than the entire circumference, the suture 126 may be initially threaded for half of the desired final arc length. For example, as will be described in greater detail herein, if the completed suture loop 136 extends about 180° around the circumference of the implant 100, the suture 126 may be initially threaded about 90° around the circumference before being threaded down the length of the implant 100.

[0095] In order to collapse the implant 100, the retrieval suture ferrule 128 or the first suture ferrule 136a is pulled or otherwise actuated in the proximal direction in the absence of the retrieval suture ferrule 128. It is contemplated that the direction of actuation required to actuate the suture 126 (e.g., proximal or distal) may depend on the direction in which the suture 126 is interwoven with the stent frame 118. When the retrieval suture ferrule 128 or the first suture ferrule 136a is actuated in the absence of the retrieval suture ferrule 128, the suture ferrule 136 begins to constrain or reduce the diameter of the implant 100, such as Figure 5 As shown in Figure 5 A side view of an illustrative implant 100 is shown during actuation of the suture 126. The distal suture collar 136c can be constrained first, causing the distal end 114 of the cannula 124 to collapse or decrease in diameter prior to the first end 108. Continued actuation of the retrieval suture collar 128 can cause the diameter of the first end 108 of the implant 100 to also decrease, as shown in FIG. Figure 6 . It is conceivable that the middle suture ring 136b may not be actuated until the slack is removed from the longitudinally extending suture ring 136c in front and the suture connecting links 154, 162 are tightened to apply force to the next suture ring 136b. Similarly, it is conceivable that the proximal suture ring 136a may not be actuated until the slack is removed from the longitudinally extending suture ring 136b in front and the suture connecting links 146, 170 are tightened to apply force to the next suture ring 136a. This configuration allows the sleeve 124 to be withdrawn into the support 116 for removal. However, this is not necessary. In some cases, the connecting links 154, 162 and the connecting links 146, 170 may have a certain length so that the suture ring 136 simultaneously (or approximately simultaneously) constrains the implant 100 along its length.

[0096] Fig. 7A A side view of another illustrative endoluminal implant or stent 200 is shown. Figure 7B yes Fig. 7A200. In some cases, the stent 200 can be comprised of an elongated tubular stent framework 202. Although the stent 200 is described as being generally tubular, it is contemplated that the stent 200 can take on any desired cross-sectional shape. The stent 200 can have a first or proximal end 204, a second or distal end 206, and an intermediate region 208 disposed between the first end 204 and the second end 206. The stent 200 can include a lumen 210 extending from a first opening adjacent to the first end 204 to a second opening adjacent to the second end 206 to allow passage of food, fluids, and the like.

[0097] Stent 200 can be expanded from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration. In some cases, stent 200 can be deployed to a configuration between the collapsed configuration and the fully expanded configuration. Stent 200 can be configured to extend across a stenosis and apply radially outward pressure to the stenosis in the lumen to open the lumen and allow passage of food, fluids, air, etc.

[0098] The stent framework 202 can have a braided structure made of a plurality of filaments. In some embodiments, the stent framework 202 can be braided from a single filament. In other embodiments, the stent framework 202 can be braided from a plurality of filaments, such as in the . and In another embodiment, the stent framework 202 can be knitted, such as ULTRAFLEX manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 202 may be of a knotted type, such as PRECISION COLONIC manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 202 may be laser cut, such as the EPIC manufactured by Boston Scientific Corporation. TM Bracket.

[0099] It is contemplated that stent 200 may be made of a number of different materials, such as but not limited to metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that stent 200 can expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that stent 200 can also be relatively easily removed. For example, stent 200 may be made of alloys, such as but not limited to nitinol and Based on the selected materials used for manufacturing, the stent 200 can be self-expanding (i.e., configured to automatically expand radially when not constrained). In some embodiments, fibers can be used to make the stent 200, which can be composite fibers, such as having a shell made of nitinol with a platinum core. It is also conceivable that the stent 200 can be made of a polymer, including but not limited to polyethylene terephthalate (PET). In some embodiments, the stent 200 can be self-expanding, although in other embodiments, the stent 200 can be expanded using an expansion device (such as, but not limited to, a balloon inserted into the lumen 210 of the stent 200). As used herein, the term "self-expanding" refers to the tendency of the stent to return to a preset diameter when not constrained by an external biasing force (such as, but not limited to, a delivery catheter or sheath). The stent 200 may include a one-way valve (such as an elastic slit valve or a duckbill valve) located inside its lumen 210 to prevent reverse flow of gastrointestinal fluids.

[0100] In some cases, in the radially expanded configuration, the stent 200 may include a first end region 212 near the proximal end 204 and a second end region 214 near the second end 206. In some embodiments, the first end region 212 and the second end region 214 may include a retention feature or anti-displacement flare region (not explicitly shown) having an enlarged diameter relative to the middle portion 208. The anti-displacement flare region, which may be located adjacent to the first end 204 and the second end 206 of the stent 200, may be configured to engage with the interior of the wall of the esophagus, stomach, or other body cavity. In some embodiments, these retention features or flare regions may have a diameter greater than the cylindrical middle region 208 of the stent 200 to prevent the stent 200 from being displaced once it is placed in the esophagus, stomach, or other body cavity. It is contemplated that the transition from the cross-sectional area of ​​the middle region 208 to the retention features or flare regions occurs gradually, obliquely, or in an abrupt step manner, as desired. In other embodiments, the stent 200 may have a consistent diameter from the proximal end 204 to the distal end 206, such as Fig. 7A as shown in .

[0101] It is contemplated that stent 200 may be made of a number of different materials, such as but not limited to metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that stent 200 can expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that stent 200 can also be relatively easily removed. For example, stent 200 may be composed of alloys, such as but not limited to nitinol and Based on the selected materials used for manufacturing, the stent 200 can be self-expanding or require an external force to expand the stent 200. In some embodiments, composite filaments can be used to make the stent 200, which composite material can include, for example, a shell or covering made of nitinol and a core composed of platinum or other non-radiopaque materials. It is also conceivable that the stent 200 can be composed of polymers, including but not limited to: polyethylene terephthalate (PET). In some cases, the filaments of the stent 200 or its parts can be bioabsorbable or biodegradable, although in other cases the filaments of the stent 200 or its parts can be biostable.

[0102] The implant 200 may be completely, substantially, or partially covered with a polymeric covering, such as a coating (not explicitly shown). The covering may be disposed on the inner and / or outer surfaces of the implant 200 as desired. When so disposed, the polymeric covering may reduce or preclude tissue ingrowth and / or reduce food impaction.

[0103] Implant 200 may also include suture 216 for retrieval. Suture 216 may include suture loop 218 for retrieval, which may be configured to be gripped by forceps or other tools during clinical procedures for stent removal and or repositioning. In some cases, suture loop 218 may be formed by tying a knot 220 between first end 222 and second end 224 of suture or combining the two (e.g., thermal bonding, adhesive, etc.). In other embodiments, suture loop 218 may be formed at first end 222 or second end 224 of suture 216 for retrieval. In this case, the end 2222, 224 of suture loop 218 for retrieval may be connected to opposite ends 222, 224 of stent 200 or suture 216 for retrieval, although this is not necessary.

[0104] Suture 216 can be interlaced with stent framework 202 at various intervals along the length of implant 200 to form a plurality of suture loops 226a, 226b (collectively referred to as 226). Although illustrative implant 200 is illustrated and described as having two suture loops 226, it is conceivable that implant 200 may include more than two suture loops 226 as needed. For example, implant 200 may include three, four, five or more suture loops 226. It is conceivable that suture loops 226 can be positioned along the entire length of implant 200 at regular or uniform intervals. However, in other embodiments, suture loops 226 can be positioned along the length of implant 200 at eccentric or uneven intervals as needed. In some embodiments, one, two or more, or all of suture loops 226 can extend less than the entire circumference of stent framework 202 or less than 360° of the circumference. In this illustrative embodiment, the suture loops 226 may extend around the circumference of the stent frame 202 or have an arc length of 180° or approximately half of the circumference of the stent frame 202. In other embodiments, one, two, or more, or all of the suture loops 226 may extend around the circumference of the stent frame 202 or have an arc length of less than 360° of the circumference of the stent frame 202. In some embodiments, one or more of the suture loops 226 may extend around the circumference of the stent frame 202 up to 350° or less, 300° or less, 270° or less, 225° or less, 180° or less, or 135° or less. In other embodiments, one, two, or more, or all of the suture loops may extend about 360° or more than 360° around the circumference of the stent frame 202, as desired. It is also contemplated that all of the suture loops 226 need not have the same arc length. For example, a first suture loop may extend about 180° and a second suture loop may extend about 270°. This is just one example. It is contemplated that the size and shape of each suture loop 226 may be selected to customize the constraint of the stent 200. For example, if the barbs or projections 260 are disposed on one side of the stent 200, it is desirable to constrain the side of the stent 200 having the barbs or projections 260 so that the barbs or projections 260 are separated from the lumen wall of the body lumen before the stent 200 is removed or repositioned. In some cases, the barbs or projections 260 may be located only around a portion of the circumference of the stent 200, leaving the remaining circumference of the stent 200 free of any barbs or projections. For example, the barbs or projections 260 may be located only around 270° or less, 225° or less, 180° or less, or 135° or less of the circumference of the stent 200. Thus, the suture loop 226 may extend around a portion of the circumference of the stent 200 that includes the barbs or projections 260 while not extending around the remaining circumference of the stent 200 that is devoid of barbs or projections.

[0105] In this illustrative embodiment, stent 200 can have a first circumferential region 211 of the circumference of stent 200 that is directly manipulated by suture 216 and a second circumferential region 213 of the circumference of stent 200 that is not directly manipulated by suture 216. First circumferential region 211 of the circumference of stent 200 can correspond to a portion of the circumference of stent 200 having barbs or protrusions 260, while second circumferential region 213 of the circumference of stent 200 can correspond to a portion of the circumference of stent 200 without any barbs or protrusions. When stent 200 is in an unconstrained configuration (e.g., as Fig. 7A and Figure 7B ), the first circumferential zone 211 may have a first arc length and the second circumferential zone 213 may have a second arc length. When the suture loop 226 extends about 180° around the circumference, the arc lengths of the first and second circumferential zones 211, 213 may be substantially equal, although this is not required. It should be understood that the arc lengths of the first and second circumferential zones 211, 213 correspond to the circumferential distance of the suture loop 226 extending around the circumference of the stent 200.

[0106] The suture loop 226 may be comprised of a single integral suture 216. It is contemplated that the suture 216 may be interwoven with the stent framework 202 such that the suture loop 226 may be constrained in a predetermined sequential order. In some instances, the proximal ring 226a may not extend in a continuous loop. Rather, the proximal ring 226a may be broken into portions by longitudinally extending interconnecting segments 46, 58 extending between the proximal ring 226a and the distal ring 226b.

[0107] Suture 216 can be interwoven with stent frame 202 by making one of the ends 222, 224 start at the first circumferential position 230 to travel around the proximal end 204 of implant 200 and move (e.g., travel) in the first direction. In this illustrative example, suture 216 is described as initially traveling in a clockwise direction. However, a reverse configuration in which suture is initially traveled in a counterclockwise direction is also conceivable. Suture 216 can be traveled around a quarter (or about 90 °) of the circumference of implant 200 so that the first section 232 of suture 216 extends between the first circumferential position 230 and the second circumferential position 234. The first and second circumferential positions 230, 234 can be located at a similar longitudinal distance away from the first end 204 of implant 200 (e.g., in a direction extending roughly parallel to the longitudinal axis 228 of implant 200). In some cases, the suture 216 can be passed so that it is interwoven with the stent framework 202, so that a portion of the suture 216 is located inside the lumen 210 of the implant 200 and a portion of the suture 216 is located along the outer surface of the implant 200 (e.g., so that it will contact the vascular lumen when the implant 200 is deployed inside the body). At the second circumferential position 234, the suture 216 can be passed along the length of the implant 200 in a direction toward the second end 206, so that the second longitudinally extending interconnected segment 236 of the suture 216 extends in a generally straight direction along the length of the implant 200. The length of the second segment 236 of the suture 216 can vary based on the use. For example, some implants 200 may include radially extending barbs or projections 260 configured to engage with body tissue. The second segment 236 can be configured to extend along a length equal to or greater than the length of the implant 200 including the radially extending barbs or projections 260. This is just an example. Other characteristics of the implant 200 , such as, but not limited to, the length of the implant 200 , may be used to determine the length of the second segment 236 of the suture 216 .

[0108] The second section 236 of the suture 216 may extend from the second circumferential position 234 to the third circumferential position 238. The second circumferential position and the third circumferential position 238 may be at similar radial points around the circumference of the implant 200 but spaced a certain distance along its length. At the third circumferential position 238, the third section 240 of the suture 216 may radially travel around the circumference of the implant 200 in a second direction (e.g., counterclockwise) opposite to the first direction. The third section 240 may extend between the third circumferential position 238 and the fourth circumferential position 242 to form the suture loop 226b. The arc length of the third section 240 may be less than 360° of the circumference. In some cases, the arc length of the third section 240 may be within the range of 350° or less, 300° or less, 270° or less, 225° or less, 180° or less, 135° or less, etc. of the circumference. The third circumferential position 238 and the fourth circumferential position 242 may be radially spaced from each other by, for example, 10° or more, 60° or more, 90° or more, 135° or more, 180° or more, 225° or more, etc.

[0109] At the fourth circumferential position 242, the suture 216 may be threaded along the length of the implant 200 in a direction toward the first end 204, such that the fourth longitudinally extending interconnected segment 244 of the suture 216 extends along the length of the implant 200 in a direction parallel to the longitudinal axis 228. The length of the fourth segment 244 of the suture 216 may be substantially the same length as the second segment 236 of the suture 216. The fourth segment 244 of the suture 216 may extend between the fourth circumferential position 242 and the fifth circumferential position 246. In some cases, the second and / or fourth segments 236, 244 of the suture 216 may not be interwoven with the stent body 202, but rather extend along the inner or outer surface of the stent body 202. In some embodiments, the first, second, and fifth circumferential positions 230, 234, 246 may be located at similar longitudinal distances away from the first end 204 of the implant 200 (e.g., in a direction extending substantially parallel to the longitudinal axis 228 of the implant 200).

[0110] From the fifth circumferential position 246, the suture 216 can be threaded through the stent body 202 in a first direction (e.g., away from the first segment 232) to form a fifth segment 248 of the suture 216. The fifth segment 248 of the suture 216 can be threaded through the stent body 202 to a sixth circumferential position 250 and / or until it reaches the first circumferential position 230 (e.g., a starting point) to form a proximal loop 226a. As described above, the proximal suture loop 226a can be composed of discontinuous or disconnected segments 232, 248. In some embodiments, the fifth segment 248 stops interlacing with the stent body 202 before the suture 216 reaches the first circumferential position 230. For example, the first circumferential position 230 can be radially spaced from the sixth circumferential position 250 by, for example, 1° or less, 5° or less, 10° or less, 20° or less, etc. The first end 222 of the suture 216 can extend from the first circumferential location 230 and the second end 224 of the suture 216 can extend from the sixth circumferential location 250. The ends 222, 224 of the suture 216 can be tied to form the knot 220, glued, and then the knot 220 cured.

[0111] It is contemplated that in embodiments where it is desired that the suture 216 include a suture loop 226 extending around less than the entire circumference, as shown in the figures, the suture 216 can be initially threaded about half the length of the desired final arc length. For example, if the completed suture loop 226 is to extend about 180° around the circumference of the implant 200, the suture 216 can be initially threaded about 90° around the circumference before threading down the length of the implant 200, as shown and described.

[0112] To collapse the implant 200, the retrieval suture ferrule 218 or the first suture ferrule 226 can be pulled or actuated in the proximal direction in the absence of the retrieval suture ferrule 218. It is contemplated that the direction of actuation required to actuate the suture 216 (e.g., distal or distal) can depend on the direction in which the suture 216 is interwoven with the stent frame 202. When the retrieval suture ferrule 218 or the first suture ferrule 226a is actuated in the absence of the retrieval suture ferrule 218, the suture ferrule 226 begins to constrain or reduce the diameter of the implant 200, as shown in FIG. Fig. 8A As shown in Fig. 8A A side view of an illustrative implant 200 is shown during actuation of suture 216. When suture loop 226 is located on one side of implant 200 (e.g., circumferential region 211), the implant 200 adjacent to suture loop 226 may be more significantly or to a greater extent constrained or gathered. The distal or second suture loop 226b may be constrained first, thereby causing the distal end 206 of the stent body 202 to gather or reduce in diameter before the first end 204. Continued actuation of the retrieval suture loop 218 may cause the diameter of the first end 204 of the implant 200 to also decrease, as shown in FIG. Fig. 8A . It is conceivable that the distal or first suture loop 226a may not be actuated until slack is removed from the preceding longitudinally extending suture loop 226b and the suture connecting links 236, 244 are tightened to apply force to the next suture loop 226a. However, this is not required. In some cases, the connecting links 236, 244 may have a certain length so that the suture loops 226 simultaneously (or approximately simultaneously) constrain the implant 200 along their lengths.

[0113] It is contemplated that the orientation of the suture loop 226 may preferentially collapse the first circumferential region 211 of the stent 200 including the barbs or protrusions 260. This may result in a shortened arc length of the first circumferential region 211 when the circumferential region 211 is collapsed (relative to the unconstrained configuration), such as Figure 8B As shown in Figure 8B Shows Fig. 8A . The constraint and shortening of the arc length of the first circumferential region 211 can separate the barbs or protrusions 260 from the lumen wall of the body lumen to facilitate the removal of the stent 200 from the body lumen and / or facilitate the repositioning of the stent 200 in the body lumen. In some cases, the constraint of the first circumferential region 211 can cause partial deformation and / or constraint of the second circumferential region 213. In some cases, the second circumferential region 213 can take on a more elliptical shape when the first circumferential region 211 is constrained, such as Figure 8B In some cases, the arc length of the second circumferential region 211 may remain substantially constant, may be slightly increased, or may be slightly decreased relative to the unconstrained configuration.

[0114] Fig. 9 A side view of an illustrative intraluminal implant or stent 300 is shown. In some cases, the stent 300 can be comprised of an elongated tubular stent framework 302. Although the stent 300 is described as being generally tubular, it is contemplated that the stent 300 can take on any desired cross-sectional shape. The stent 300 can have a first or proximal end 304, a second or distal end 306, and an intermediate region 308 disposed between the first end 304 and the second end 306. The stent 300 can include an inner cavity 310 extending from a first opening adjacent to the first end 304 to a second opening adjacent to the second end 306 to allow passage of food, fluids, etc.

[0115] The stent 300 can be expanded from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration. In some cases, the stent 300 can be deployed to a configuration between the collapsed configuration and the fully expanded configuration. The stent 300 can be configured to extend across a stenosis and apply radially outward pressure to the stenosis in the lumen to open the lumen and allow passage of food, fluids, air, etc.

[0116] The stent frame 302 can have a braided structure made of a plurality of filaments. In some embodiments, the stent frame 302 can be braided from one filament. In other embodiments, the stent frame 302 can be braided from a plurality of filaments, such as in the BRAVE® manufactured and distributed by Boston Scientific Corporation. and In another embodiment, the stent framework 302 can be knitted, such as ULTRAFLEX manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 302 may be of the knotted type, such as PRECISION COLONIC manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 302 may be laser cut, such as the EPIC manufactured by Boston Scientific Corporation. TM Bracket.

[0117] It is contemplated that stent 300 may be made of a number of different materials, as desired. For example, but not limited to, metals, metal alloys, shape memory alloys, and / or polymers, so that stent 300 can expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that stent 300 can also be relatively easily removed. For example, stent 300 may be made of alloys, such as, but not limited to, nitinol and Based on the selected materials used for manufacturing, the stent 300 can be self-expanding (i.e., configured to automatically expand radially when not constrained). In some embodiments, fibers can be used to make the stent 300, which can be composite fibers, such as having a shell made of nitinol with a platinum core. It is also conceivable that the stent 300 can be composed of polymers, including but not limited to polyethylene terephthalate (PET). In some embodiments, the stent 300 can be self-expanding, while in other embodiments, the stent 300 can be expanded using an expansion device (such as, but not limited to, a balloon inserted into the lumen 310 of the stent 300). As used herein, the term "self-expanding" refers to the tendency of the stent to return to a preset diameter when not constrained by an external biasing force (such as, but not limited to, a delivery catheter or sheath). The stent 300 may include a one-way valve (such as an elastic slit valve or a duckbill valve) located inside its lumen 310 to prevent reverse flow of gastrointestinal fluids.

[0118] In some cases, in the radially expanded configuration, the stent 300 may include a first end region 312 near the proximal end 304 and a second end region 314 near the second end 306. In some embodiments, the first end region 312 and the second end region 314 may include a retention feature or an anti-displacement flare region having an enlarged diameter relative to the middle portion 308 (not explicitly shown in the second end region 314). The anti-displacement flare region (which may be located adjacent to the first end 304 and the second end 306 of the stent 300) may be configured to engage with the interior of the wall of the esophagus, stomach or other body cavity. In some embodiments, the retention feature or flare region may have a diameter greater than the cylindrical middle region 308 of the stent 300 to prevent the stent 300 from being displaced once it is placed in the esophagus, stomach, or other body cavity. It is conceivable that the transition from the cross-sectional area of ​​the middle region 308 to the retention feature or flare region may be gradual, inclined or occur in an abrupt step manner, as desired. In other embodiments, the stent 300 can have a consistent diameter from the proximal end 304 to the distal end 306 .

[0119] It is contemplated that stent 300 may be made of a number of different materials, such as, but not limited to, metals, metal alloys, shape memory alloys, and / or polymers, as desired, to enable stent 300 to expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that stent 300 can also be relatively easily removed. For example, stent 300 may be composed of alloys, such as, but not limited to, nitinol and Based on the selected materials used for manufacturing, the stent 300 can be self-expanding or require an external force to expand the stent 300. In some embodiments, composite filaments can be used to make the stent 300, which may include, for example, a shell or covering made of nitinol and a core composed of platinum or other non-radiopaque materials. It is also conceivable that the stent 300 can be composed of polymers, including but not limited to: polyethylene terephthalate (PET). In some cases, the filaments of the stent 300 or its parts can be bioabsorbable or biodegradable, while in other cases the filaments of the stent 300 or its parts can be biostable.

[0120] The implant 300 may be completely, substantially, or partially covered with a polymeric covering, such as a coating (not explicitly shown). The covering may be disposed on the inner and / or outer surfaces of the implant 300 as desired. When so disposed, the polymeric covering may reduce or preclude tissue ingrowth and / or reduce food impaction.

[0121] The implant 300 may also include a retrieval suture 316. The retrieval suture 316 may be composed of a first suture bundle 318a and a second suture bundle 318b (collectively referred to as 318). The suture bundles 318a, 318b may be a single bundle that has been folded over on itself, such as Fig. 9 319 in the figure. It is conceivable that, in this case, before the suture 316 is retrieved and interwoven with the implant 300, the suture 316 can be folded in half on itself. In other embodiments, the bundle of sutures 318a, 318b separates the bundles extending side by side. Although the suture 316 is described as having two bundles of sutures 318, it is conceivable that the suture 316 can be retrieved as required and can include less than two bundles or more than two bundles. Wherein the first end 320a, 320b of the suture bundle 318 can be limited to retrieve the free end of the suture 316 while the free end 322a, 322b of each bundle 318a, 318b can be formed. The first end 320a, 320b (collectively referred to as 320) of each wire bundle 318a, 318b can be tied with the second end 322a, 322b (collectively referred to as 322) of each wire bundle 318a, 318b to form a knot 324. In some cases, the knot 324 can be a slipknot, or other knots that allow the first end 320 or the second end 322 to be grasped and actuated by forceps or other tools during a clinical procedure for stent removal and or repositioning. It is contemplated that the use of a slipknot 324 can reduce or eliminate the breakage of the retrieval suture 316 during the removal or repositioning of the implant.

[0122] The retrieval suture 316 may be interlaced with the stent frame 302 at intervals along the length of the implant 300 to form a plurality of suture loops 326a, 326b (collectively referred to as 326). Although the illustrative implant 300 is illustrated and described as having two suture loops 326, it is conceivable that the implant 300 may include more than two suture loops 326 as needed. For example, the implant 300 may include three, four, five, or more suture loops 326. It is conceivable that the suture loops 326 may be positioned at regular or uniform intervals throughout the total length of the implant. However, in other embodiments, the suture loops 326 may be positioned at eccentric or uneven intervals along the length of the implant 300 as needed. It is conceivable that the suture loops 326 may be positioned to facilitate the retrieval, repositioning, and / or reshaping of the stent 300. For example, in a stent 300 having two or more flared or enlarged areas (such as the SURFACE® manufactured and distributed by Boston Scientific Corporation), the suture loops 326 may be positioned to facilitate the retrieval, repositioning, and / or reshaping of the stent 300. In the embodiment of the present invention, the first retrieval suture loop 326a can be located adjacent to the first flared portion and the second retrieval suture loop 326b can be located adjacent to the second flared portion.

[0123] In some embodiments, one, two or more, or all of the suture loops 326 may extend completely around the circumference of the stent framework 302 (e.g., 360°). In other embodiments, one, two or more, or all of the suture loops 326 may extend less than 360° around the circumference of the stent framework 302. In some embodiments, one or more of the suture loops 326 may extend 350° or less, 300° or less, 270° or less, 225° or less, 180° or less, 135° or less, etc. In other embodiments, one, two or more, or all of the suture loops may extend greater than 360° around the circumference of the stent framework 302.

[0124] As described above, the suture loop 326 can be composed of two or more suture bundles 318. It is contemplated that the suture bundles 318 can be interwoven with the stent frame 302 so that the suture loop 326 can be constrained in a predetermined sequential order. In some cases, the proximal ring 326a may not extend in a continuous ring. Instead, the proximal ring 326a can be broken into portions by longitudinally extending interconnecting segments 336, 344 extending between the proximal ring 326a and the distal ring 326b.

[0125] Suture bundle 318 can be interwoven with stent frame 302 by making one end of end 320,322 start at first circumferential position 328 around proximal end 304 of implant 300 and move (for example, pass) in first direction.In this illustrative example, suture 316 is described as initially passing in clockwise direction.However, the reverse configuration in which suture initially passes in counterclockwise direction is also conceivable.Suture 316 can be passed around about half of the circumference of implant 300, so that first section 330 of suture 316 extends between first circumferential position 328 and second circumferential position 332.First and second circumferential positions 328,332 can be located at similar longitudinal distance away from first end 304 of implant 300 (for example, in the direction extending to axis 334 roughly parallel to implant 300). In some cases, the suture 316 can be passed through so that it is interwoven with the stent framework 302, so that a portion of the suture 316 is located inside the lumen 310 and a portion of the suture 316 is located along the outer surface of the implant 300 (e.g., so that it will contact the vascular cavity when the implant 300 is deployed inside the body). At the second circumferential position 332, the suture 316 can be passed along the length of the implant 300 in the direction toward the second end 306, so that the second longitudinally extending interconnected segment 336 of the suture 316 extends along the length of the implant 300 in a generally straight direction. The length of the second segment 336 of the suture 316 can vary based on the purpose. For example, some implants 300 may include radially extending spines (not explicitly shown) configured to engage with body tissue. The second segment 336 can be configured to extend along a length equal to or greater than the length of the implant 300 including the radially extending spines. This is just an example. Other characteristics of the implant 300 , such as, but not limited to, the length of the implant 300 , may be used to determine the length of the second segment 336 of the suture 316 .

[0126] The second section 336 of suture 316 can extend from the second circumferential position 332 to the third circumferential position 338. The second circumferential position 332 and the third circumferential position 338 can be at similar radial points around the circumference of implant 300, but spaced a certain distance along its length. At the third circumferential position 338, the third section 340 of suture 316 can radially travel around the circumference of the implant in a second direction (e.g., counterclockwise) opposite to the first direction. The third section 340 can extend between the third circumferential position 338 and the fourth circumferential position 342 to form a suture loop 326b. In some embodiments, the third circumferential position 338 and the fourth circumferential position 342 can be substantially at the same radial point around the circumference of the implant 300, so that the suture loop 326b extends around the circumference of the implant 300 substantially or completely 360°. In other embodiments, the third circumferential location 338 and the fourth circumferential location 342 may be radially spaced from each other by, for example, 1° or less, 5° or less, 10° or less, 20° or less, etc.

[0127] At the fourth circumferential position 342, the suture 316 can be threaded along the length of the implant 300 in a direction toward the first end 304 so that the fourth longitudinally extending interconnected segment 344 of the suture 316 extends along the length of the implant 300 in a direction relative to the longitudinal axis 334. The length of the fourth segment 344 of the suture 316 can be substantially the same length as the second segment 336 of the suture 316. The fourth segment 344 of the suture 316 can extend between the fourth circumferential position 342 and the fifth circumferential position 346. In some cases, the second and / or fourth segments 336, 344 of the suture may not be interwoven with the stent body 302, but instead extend along the inner or outer surface of the stent body 302. In some embodiments, the first, second, and fifth circumferential positions 328, 332, 346 can be located at similar longitudinal distances away from the first end 304 of the implant 300 (e.g., in a direction extending substantially parallel to the longitudinal axis 334 of the implant 300).

[0128] From the fifth circumferential position 346, the suture 316 can be threaded through the stent body 302 in a first direction (e.g., away from the first segment 330) to form a fifth segment 348 of the suture 316. The fifth segment 348 of the suture 316 can be threaded through the stent body 302 to a sixth circumferential position 350 and / or until it reaches the first circumferential position 328 (e.g., a starting point) to form a proximal loop 326a. As described above, the proximal suture loop 326a can be composed of discontinuous or disconnected segments 330, 48. In some embodiments, the fifth segment 348 stops interlacing with the stent body 302 before the suture 316 reaches the first circumferential position 328. For example, the first circumferential position 328 can be radially spaced from the sixth circumferential position 350 by, for example, 1° or less, 5° or less, 10° or less, 20° or less, etc. In the illustrated example, the second end 322 of the suture bundle 318 may extend from a first circumferential location 328 and the first end 320 of the suture bundle 318 may extend from a sixth circumferential location 350. The ends 320, 322 of the suture 316 may be tied to form a slipknot 324 as described above.

[0129] In order to collapse the implant 300, the ends 320, 322 of one of the suture bundles 318 may be pulled or actuated in the proximal direction. It is contemplated that the direction of actuation required to actuate the suture 316 (e.g., proximal or distal) may depend on the direction in which the suture 316 is interwoven with the stent frame 302. When the first end 320 or the second end 322 is actuated, the suture collar 326 begins to constrain or reduce the diameter of the implant 300 (not explicitly shown). The distal or second suture collar 326b may be constrained first, thereby causing the middle portion 308 of the stent body 302 to collapse or reduce in diameter before the first end 304. The continued actuation of the suture bundle 318 may cause the diameter of the first end 304 of the implant 300 to also be reduced (not explicitly shown). It is conceivable that the proximal or first suture loop 326a may not be actuated until slack is removed from the front longitudinally extending suture loop 326b and the suture connecting links 336, 344 are tightened to apply force to the next suture loop 326a. However, this is not necessary. In some cases, the connecting links 336, 344 may have a certain length so that each suture loop 326 simultaneously (or approximately simultaneously) constrains the implant 300 along its length.

[0130] Fig.10A side view of an illustrative intraluminal implant or stent 400 is shown. In some cases, the stent 400 can be composed of an elongated tubular stent framework 402. Although the stent 400 is described as being generally tubular, it is contemplated that the stent 400 can take any desired cross-sectional shape. The stent 400 can have a first or proximal end 404, a second or distal end 406, and an intermediate region 408 disposed between the first end 404 and the second end 406. The stent 400 can include an inner cavity 410 extending from a first opening adjacent to the first end 404 to a second opening adjacent to the second end 406 to allow passage of food, fluids, etc.

[0131] The stent 400 can be expanded from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration. In some cases, the stent 400 can be deployed to a configuration between the collapsed configuration and the fully expanded configuration. The stent 400 can be configured to extend across a stenosis and apply radially outward pressure to the stenosis in the lumen to open the lumen and allow passage of food, fluids, air, etc.

[0132] The stent framework 402 can have a braided structure made of a plurality of filaments. In some embodiments, the stent framework 402 can be braided from a single filament. In other embodiments, the stent framework 402 can be braided from a plurality of filaments, such as in the . and In another embodiment, the stent framework 402 can be knitted, such as ULTRAFLEX manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 402 may be of the knotted type, such as PRECISION COLONIC manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 402 may be laser cut, such as the EPIC manufactured by Boston Scientific Corporation. TM Bracket.

[0133] It is contemplated that stent 400 may be made of a number of different materials, such as but not limited to metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that stent 400 can expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that stent 400 can also be relatively easily removed. For example, stent 400 may be made of alloys, such as but not limited to nitinol and Based on the selected materials used for manufacturing, the stent 400 can be self-expanding (i.e., configured to automatically expand radially when not constrained). In some embodiments, fibers can be used to make the stent 400, which can be composite fibers, such as having a shell made of nitinol with a platinum core. It is also conceivable that the stent 400 can be composed of polymers, including but not limited to polyethylene terephthalate (PET). In some embodiments, the stent 400 can be self-expanding, while in other embodiments, the stent 400 can be expanded using an expansion device (such as, but not limited to, a balloon inserted into the lumen 410 of the stent 400). As used herein, the term "self-expanding" refers to the tendency of the stent to return to a preset diameter when not constrained by an external biasing force (such as, but not limited to, a delivery catheter or cannula). The stent 400 may include a one-way valve (such as an elastic slit valve or a duckbill valve) located inside its lumen 410 to prevent reverse flow of gastrointestinal fluids.

[0134] In some cases, in the radially expanded configuration, the stent 400 may include a first end region 412 near the proximal end 404 and a second end region 414 near the second end 406. In some embodiments, the first end region 412 and the second end region 414 may include a retention feature or an anti-displacement flare region (not explicitly shown at the second end region 414) having an enlarged diameter relative to the middle portion 408. These anti-displacement flare regions, which may be located adjacent to the first end 404 and the second end 406 of the stent 400, may be configured to engage with the interior of the wall of the esophagus, stomach, or other body cavity. In some embodiments, these retention features or flare regions may have a diameter greater than the cylindrical middle region 408 of the stent 400 to prevent the stent 400 from being displaced once it is placed in the esophagus, stomach, or other body cavity. It is conceivable that the transition from the cross-sectional area of ​​the middle region 408 to the retention feature or flare region may be gradual, inclined, or occur in a sudden step manner, as desired. In other embodiments, the stent 400 can have a consistent diameter from the proximal end 404 to the distal end 406 .

[0135] It is contemplated that stent 400 may be made of a number of different materials, such as but not limited to metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that stent 400 can expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that stent 400 can also be relatively easily removed. For example, stent 400 may be made of alloys, such as but not limited to nitinol and Based on the selected materials used for manufacturing, the stent 400 can be self-expanding or require an external force to expand the stent 400. In some embodiments, composite filaments can be used to make the stent 400, which may include, for example, a shell or covering made of nitinol and a core composed of platinum or other non-radiopaque materials. It is also conceivable that the stent 400 can be composed of polymers, including but not limited to: polyethylene terephthalate (PET). In some cases, the filaments of the stent 400 or its parts can be bioabsorbable or biodegradable, while in other cases the filaments of the stent 400 or its parts can be biostable.

[0136] The implant 400 may be completely, substantially, or partially covered with a polymeric covering, such as a coating (not explicitly shown). The covering may be disposed on the inner and / or outer surfaces of the implant 400 as desired. When so disposed, the polymeric covering may reduce or preclude tissue ingrowth and / or reduce food impaction.

[0137] Implant 400 may also include sutures 416. The sutures 416 may be interlaced with the stent framework 402 at intervals along the length of the implant 400 to form a plurality of suture loops 418a, 418b, 418c (collectively referred to as 418). Although the illustrative implant 400 is illustrated and described as having three suture loops 418, it is conceivable that the implant 400 may include less than three or more than three suture loops 418 as required. For example, the implant 400 may include two, four, five, or more suture loops 418. It is conceivable that the suture loops 418 may be positioned at regular or uniform intervals over the full length of the entire implant 400. However, in other embodiments, the suture loops 418 may be positioned at eccentric or uneven intervals along the length of the implant 400 as required. It is conceivable that the suture loops 418 may be positioned to facilitate the retrieval, repositioning, and / or reshaping of the stent 400. For example, in a stent 400 having two or more flared or enlarged regions (such as the 400 manufactured and distributed by Boston Scientific Corporation), In the embodiment of the present invention, the first suture loop 418a can be located adjacent to the first flared portion and the second suture loop 418b can be located adjacent to the second flared portion.

[0138] In some embodiments, the implant 400 may include: a first plurality of rings 424a, 424b, 424c (collectively referred to as 424) adjacent to the proximal end 404 of the implant; a second plurality of rings 426a, 426b, 426c (collectively referred to as 426) adjacent to the middle region 408 of the implant 400; and a third plurality of rings 428a, 428b, 428c (collectively referred to as 428) adjacent to the distal end 406 of the implant 400. The positioning of the rings 424, 426, 428 is not limited to the configuration described and illustrated. Rather, the positioning of the rings 424, 426, 428 may depend on the desired location and number of suture loops 418. For example, in some cases, a plurality of rings 424, 426, 428 may be located at each location where a suture loop 418 is desired. However, this is not necessary. In some cases, a suture loop 418 may be provided in the absence of a ring. In addition, although each group of multiple rings 424,426,428 is illustrated as including three rings, it is contemplated that each group of multiple rings 424,426,428 may have fewer than three or more than three rings as desired. In addition, each group of multiple rings 424,426,428 need not each have the same number of rings.

[0139] Each ring 424a, 424b, 424c of the first plurality of rings 424 may be located at a similar longitudinal distance (e.g., in a direction extending substantially parallel to the longitudinal axis 430 of the implant 400). The rings 424 may be positioned at consistent intervals around the circumference of the stent 400. For example, when three rings 424 are provided, the rings 424 may be separated by approximately 120°. However, as desired, the rings 424 may be eccentric or have uneven intervals. In some cases, the rings 424 may not be positioned around the entire circumference of the stent frame 402. For example, if the suture collar 418 extends around the stent 400 to less than the entire circumference or less than 360°, the rings 424 may be positioned to overlap the portion of the circumference extending with the suture collar 418.

[0140] Each ring 426a, 426b, 426c of the second plurality of rings 426 may be located at a similar longitudinal distance (e.g., in a direction extending substantially parallel to the longitudinal axis 430 of the implant 400). The rings 426 may be positioned at consistent intervals around the circumference of the stent 400. For example, when three rings 426 are provided, each ring 426 may be separated by approximately 120°. However, as desired, the rings 426 may be eccentric or have uneven intervals. In some cases, the rings 426 may not be positioned around the entire circumference of the stent frame 402. For example, if the suture loop 418 extends around the stent 400 to less than the entire circumference or less than 360°, the rings 426 may be positioned to overlap the portion of the circumference extending with the suture loop 418.

[0141] Each ring 428a, 428b, 428c of the third plurality of rings 428 may be located at a similar longitudinal distance (e.g., in a direction extending substantially parallel to the longitudinal axis 430 of the implant 400). The rings 428 may be positioned at consistent intervals around the circumference of the stent 400. For example, when three rings 428 are provided, each ring 428 may be separated by approximately 120°. However, as desired, each ring 428 may be eccentric or have uneven intervals. In some cases, the rings 428 may not be positioned around the entire circumference of the stent frame 402. For example, if the suture collar 418 extends around the stent 400 to less than the entire circumference or less than 360°, the rings 428 may be positioned to overlap the portion of the circumference extending with the suture collar 418.

[0142] In some embodiments, one, two or more, or all of the suture loops 418 may extend completely around the circumference of the stent framework 402 (e.g., 360°). In other embodiments, one, two or more, or all of the suture loops 418 may extend less than 360° around the circumference of the stent framework 402. In some embodiments, one or more of the suture loops 418 may extend 350° or less, 300° or less, 270° or less, 225° or less, 180° or less, 135° or less, etc. In other embodiments, one, two or more, or all of the suture loops may extend greater than 360° around the circumference of the stent framework 402.

[0143] As described above, the suture loop 418 can be formed from the retrieval suture 416. It is contemplated that the suture 416 can be threaded through or through the openings of the rings 424, 426, 428 instead of or in addition to interweaving the suture 418 with the stent frame 402. It is contemplated that threading the suture 416 through the rings 424, 426, 428 instead of the stent frame 402 or by using these rings to at least partially reduce the length of the suture 416 interwoven with the stent frame 402 reduces the force required to actuate the suture 416 by reducing the frictional forces exerted on the suture 416.

[0144] It is contemplated that the rings 424, 426, 428 may be fixedly attached to the stent frame 402 when the suture 416 is passed only through the openings of the rings 424, 426, 428. This may allow movement of the rings 424, 426, 428 to be transferred to the stent frame 402. In some cases, the first plurality of rings 424 and the third plurality of rings 428 (e.g., the rings located adjacent to the proximal end 404 and the distal end 406) may be fixedly coupled to the stent frame 402 while the second plurality of rings 426 may be removably coupled to the stent frame 402. This is merely an example. The rings 424, 426, 428 may be fixedly or removably coupled in any desired configuration. In addition, some of the rings of each group of multiple rings may be fixedly coupled while other rings of the same group of multiple rings may be removably coupled to the stent frame 402. It is contemplated that when the rings 424 , 426 , 428 are removably coupled to the stent frame 402 , the suture 416 may at least partially interweave with the stent frame 402 proximate the movable rings 424 , 426 , 428 such that movement of the suture 416 is translated to the stent frame 402 .

[0145] Suture 416 can have a first end 420 coupled to a first ring 424a of the first plurality of rings 424 and a second end 422 coupled to a first ring 428a of the third plurality of rings 428. Suture 416 can be interwoven with rings 424, 426, 428 and / or stent frame 402 in any number of ways. In one example, first end 420 of suture 416 can be coupled to first ring 424a of the first plurality of rings 424. Second end 422 of suture 416 can be threaded through an opening in second ring 424b and then through an opening in third ring 424c. Suture 416 is then threaded through the opening in first ring 424a to form first suture loop 418a. Although suture 416 is described as being threaded in a clockwise direction, a reverse configuration is also contemplated. As described above, the first plurality of rings 424 can be fixedly coupled to the stent frame 402 such that the sutures 416 need not be interwoven with the stent frame 402 in order to manipulate the stent frame 402 adjacent to the first plurality of rings 424 .

[0146] Once the suture 416 passes through the opening in the first ring 424a, the suture 416 can be directed toward the first ring 426a of the second plurality of rings 426. In some cases, the second plurality of rings 426 can be circumferentially offset from the first plurality of rings 424. In such cases, the longitudinally extending segment 432 of the suture 416 extending between the first plurality of rings 424 and the second plurality of rings 426 can extend at a non-orthogonal angle relative to a plane formed by the second plurality of rings 426. In some cases, the longitudinally extending segment 432 can include a ring instead of or in addition to the rings 424, 426, 428 at the suture loop 418.

[0147] The second end 422 of the suture 416 may be passed through the opening in the first ring 426a. The suture 416 may then be directed to and passed through the opening in the third ring 426c (e.g., in the opposite direction of the first suture loop 418a, although this is not required). The suture 416 may then be directed from the third ring 426c to and passed through the second ring 426b. The suture 416 may then be passed through the opening in the first ring 426a to form the second suture loop 418b. When the second plurality of rings 426 are not fixedly coupled to the stent frame 402, the suture 416 may be at least partially interwoven with the stent frame between the first ring 426a and the third ring 426c, between the third ring 426c and the second ring 426b, and / or between the second ring 426b and the first ring 426a.

[0148] Once the suture 416 has been passed through the opening in the first ring 426a to form the sewing loop 418b, the suture 416 can be directed toward the first ring 428a of the third plurality of rings 428. In some cases, the third plurality of rings 428 can be circumferentially offset from the second plurality of rings 426. In such cases, the longitudinally extending segment 434 of the suture 416 extending between the second plurality of rings 426 and the third plurality of rings 428 can extend at a non-orthogonal angle relative to a plane formed by the third plurality of rings 428. In some cases, the longitudinally extending segment 434 can include a ring instead of or in addition to the rings 424, 426, 428 at the sewing loop 418.

[0149] The second end 422 of the suture 416 can be passed through the opening in the first ring 428a. The suture 416 can then be directed to and passed through the opening on the second ring 426b (e.g., in the opposite direction of the second suture loop 418b, although this is not required). The suture 416 can then be directed from the second ring 428b to and passed through the third ring 428c. The suture 416 can then pass through and be coupled to the first ring 428a to form the third suture loop 418c. As described above, the third plurality of rings 428 can be fixedly coupled to the stent frame 402 so that the suture 416 does not need to be interwoven with the stent frame 402 to manipulate the stent frame 402 adjacent to the third plurality of rings 428.

[0150] In order to make implant 400 close, reposition, or change shape, suture 416 can be grasped at any position between first end 420 and second end 422 or at any loop 424,426,428 and pulled or actuated in the proximal direction. In some cases, suture 416 can be provided with extra length or slack to allow suture 416 to be grasped more easily. In some cases, the extra length can be most obvious in longitudinal extension section 432,434. In other embodiments, suture 416 can be actuated in the distal direction. It is conceivable that the direction of actuation required for actuating suture 416 (e.g., proximal or distal) can depend on the direction in which suture 416 is interwoven with stent frame 402. When suture 416 is actuated, suture collar 418 begins to constrain or reduce the diameter of implant 400 (not explicitly shown). The suture collar 418,418b,418c that first constrains can depend on the position of grasping suture 416. For example, the suture loop 418 closest to the grasping position may constrain first. Continued actuation of the suture 416 may cause the suture loop 418 to move away from the grasping position to constrain or reduce in diameter.

[0151] Fig.11 A side view of an illustrative intraluminal implant or stent 500 is shown. In some cases, the stent 500 can be composed of an elongated tubular stent framework 502. Although the stent 500 is described as being generally tubular, it is contemplated that the stent 500 can take any cross-sectional shape desired. The stent 500 can have a first or proximal end 504, a second or distal end 506, and an intermediate region 508 disposed between the first end 504 and the second end 506. The stent 500 can include an inner cavity 510 extending from a first opening adjacent to the first end 504 to a second opening adjacent to the second end 506 to allow passage of food, fluids, etc.

[0152] Stent 500 can be expanded from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration. In some cases, stent 500 can be deployed to a configuration between the collapsed configuration and the fully expanded configuration. Stent 500 can be configured to extend across a stenosis and apply radially outward pressure to the stenosis in the lumen to open the lumen and allow passage of food, fluids, air, etc.

[0153] The stent frame 502 can have a braided structure made of a plurality of filaments. In some embodiments, the stent frame 502 can be braided from a single filament. In other embodiments, the stent frame 502 can be braided from a plurality of filaments, such as in the BRAVE® manufactured and distributed by Boston Scientific Corporation. and In another embodiment, the stent framework 502 can be knitted, such as ULTRAFLEX manufactured by Boston Scientific Corporation. TMIn yet another embodiment, the stent framework 502 may be of the knotted type, such as PRECISION COLONIC manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 502 may be laser cut, such as the EPIC manufactured by Boston Scientific Corporation. TM Bracket.

[0154] It is contemplated that stent 500 may be made of a number of different materials, such as but not limited to metals, metal alloys, shape memory alloys, and / or polymers, as desired, to enable stent 500 to expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that stent 500 can also be relatively easily removed. For example, stent 500 may be composed of alloys, such as but not limited to nitinol and Based on the selected materials used for manufacturing, the stent 500 can be self-expanding (i.e., configured to automatically expand radially when not constrained). In some embodiments, fibers can be used to make the stent 500, which can be composite fibers, such as having a shell made of nitinol with a platinum core. It is also conceivable that the stent 500 can be composed of polymers, including but not limited to polyethylene terephthalate (PET). In some embodiments, the stent 500 can be self-expanding, while in other embodiments the stent 500 can be expanded using an expansion device (such as but not limited to a balloon inserted into the lumen 510 of the stent 500). As used herein, the term "self-expanding" refers to the tendency of the stent to return to a preset diameter when not constrained by an external biasing force (such as but not limited to a delivery catheter or cannula). The stent 500 may include a one-way valve (such as an elastic slit valve or a duckbill valve) located inside its lumen 510 to prevent reverse flow of gastrointestinal fluids.

[0155] In some cases, in the radially expanded configuration, the stent 500 may include a first end region 512 near the proximal end 504 and a second end region 514 near the second end 506. In some embodiments, the first end region 512 and the second end region 514 may include a retaining feature or an anti-displacement flare region (not explicitly shown in the second end region 514) having an enlarged diameter relative to the middle portion 508. The anti-displacement flare region (which may be located adjacent to the first end 504 and the second end 506 of the stent 500) may be configured to engage with the interior of the wall of the esophagus, stomach or other body cavity. In some embodiments, the retaining feature or flare region may have a diameter greater than the cylindrical middle region 508 of the stent 500 to prevent the stent 500 from being displaced once it is placed in the esophagus, stomach or other body cavity. It is conceivable that the transition from the cross-sectional area of ​​the middle region 508 to the retaining feature or flare region may be gradual, inclined or occur in a sudden step manner as desired. In other embodiments, the stent 500 may have a consistent diameter from the proximal end 504 to the distal end 506.

[0156] It is contemplated that stent 500 may be made of a number of different materials, such as but not limited to metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that stent 500 can expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that stent 500 can also be relatively easily removed. For example, stent 500 may be composed of alloys, such as but not limited to nitinol and Based on the selected materials used for manufacturing, the stent 500 can be self-expanding or require an external force to expand the stent 500. In some embodiments, composite filaments can be used to make the stent 500, which may include, for example, a shell or covering made of nitinol and a core composed of platinum or other non-radiopaque materials. It is also conceivable that the stent 500 can be composed of polymers, including but not limited to: polyethylene terephthalate (PET). In some cases, the filaments of the stent 500 or its parts can be bioabsorbable or biodegradable, although in other cases, the filaments of the stent 500 or its parts can be biostable.

[0157] The implant 500 may be completely, substantially, or partially covered with a polymeric covering, such as a coating (not explicitly shown). The covering may be disposed on the inner and / or outer surfaces of the implant 500 as desired. When so disposed, the polymeric covering may reduce or preclude tissue ingrowth and / or reduce food impaction.

[0158] Implant 500 may also include suture 516. This suture 516 may be formed as a part of stent framework 502. For example, suture 516 may be woven, knitted, or included in stent framework 502 during manufacture of stent 500. In other words, one or more filaments of stent framework 502 may be replaced by suture 516. Suture 516 may be made of a material having different mechanical properties from the remaining stent framework 502. For example, suture 516 may be more elastic than the remaining stent framework 502. Suture 516 may be formed with stent framework 502 so that it has some extra length or slack. This may allow suture 516 to sag or protrude into the lumen 510 of the stent, thereby allowing suture 516 to be more visible to a doctor.

[0159] In order to make implant 500 close, reposition, or change the shape, suture 516 can be grasped at any position between first end 504 and second end 506 of stent 500 and pulled or actuated in the proximal direction. In other embodiments, suture 516 can be actuated in the distal direction. It is conceivable that the direction of actuation required for actuating suture 516 (e.g., proximal or distal direction) can depend on the direction of suture 516 wound or knitted with stent frame 502. When suture 516 is actuated, suture 516 can shrink stent frame 502 axially and circumferentially to begin to constrain or reduce the diameter of implant 500 (not explicitly shown). The part of stent frame 502 constrained first can depend on where suture 516 is grasped. For example, stent frame 502 closest to the grasping position can be constrained first. The continuous actuation of suture 516 can cause stent frame 502 to be away from the grasping position to constrain or reduce the diameter.

[0160] Fig.11 A side view of an illustrative intraluminal implant or stent 600 is shown. In some cases, the stent 600 can be composed of an elongated tubular stent framework 602. Although the stent 600 is described as being generally tubular, it is contemplated that the stent 600 can take any desired cross-sectional shape. The stent 600 can have a first or proximal end 604, a second or distal end 606, and an intermediate region 608 disposed between the first end 604 and the second end 606. The stent 600 can include an inner cavity 610 extending from a first opening adjacent to the first end 604 to a second opening adjacent to the second end 606 to allow passage of food, fluids, etc.

[0161] Stent 600 can be expanded from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration. In some cases, stent 600 can be deployed to a configuration between the collapsed configuration and the fully expanded configuration. Stent 600 can be configured to extend across a stenosis and apply radially outward pressure to the stenosis in the lumen to open the lumen and allow passage of food, fluids, air, etc.

[0162] The stent frame 602 can have a braided structure made of a plurality of filaments. In some embodiments, the stent frame 602 can be braided from a single filament. In other embodiments, the stent frame 602 can be braided from a plurality of filaments, such as in the BRAVE® manufactured and distributed by Boston Scientific Corporation. and In another embodiment, the stent framework 602 can be knitted, such as ULTRAFLEX manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 602 may be of a knotted type, such as PRECISION COLONIC manufactured by Boston Scientific Corporation. TM In yet another embodiment, the stent framework 602 may be laser cut, such as the EPIC manufactured by Boston Scientific Corporation. TM Bracket.

[0163] It is contemplated that stent 600 may be made of a number of different materials, such as but not limited to metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that stent 600 can expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that stent 600 can also be relatively easily removed. For example, stent 600 may be composed of alloys, such as but not limited to nitinol and Based on the selected materials used for manufacturing, the stent 600 can be self-expanding (i.e., configured to automatically expand radially when not constrained). In some embodiments, fibers can be used to make the stent 600, which can be composite fibers, such as having a shell made of nitinol with a platinum core. It is also conceivable that the stent 600 can be composed of polymers, including but not limited to polyethylene terephthalate (PET). In some embodiments, the stent 600 can be self-expanding, while in other embodiments, the stent 600 can be expanded using an expansion device (such as, but not limited to, a balloon inserted into the lumen 610 of the stent 600). As used herein, the term "self-expanding" refers to the tendency of the stent to return to a preset diameter when not constrained by an external biasing force (such as, but not limited to, a delivery catheter or cannula). The stent 600 may include a one-way valve (such as an elastic slit valve or a duckbill valve) located inside its lumen 610 to prevent reverse flow of gastrointestinal fluids.

[0164] In some cases, in the radially expanded configuration, the stent 600 may include a first end region 612 near the proximal end 604 and a second end region 614 near the second end 606. In some embodiments, the first end region 612 and the second end region 614 may include a retaining feature or an anti-displacement flare region (not explicitly shown in the second end region 614) having an enlarged diameter relative to the middle portion 608. These anti-displacement flare regions, which may be located adjacent to the first end 604 and the second end 606 of the stent 600, may be configured to engage with the interior of the wall of the esophagus, stomach, or other body cavity. In some embodiments, the retaining feature or flare region may have a diameter greater than the cylindrical middle region 608 of the stent 600 to prevent the stent 600 from being displaced once it is placed in the esophagus, stomach, or other body cavity. It is conceivable that, as desired, the transition from the cross-sectional area of ​​the middle region 608 to the retaining feature or flare region may be gradual, inclined, or occur in a sudden step manner. In other embodiments, the stent 600 may have a consistent diameter from the proximal end 604 to the distal end 606.

[0165] It is contemplated that stent 600 may be made of a number of different materials, such as but not limited to metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that stent 600 can expand to a certain shape when precisely positioned within the body. In some cases, the material may be selected so that stent 600 can also be relatively easily removed. For example, stent 600 may be composed of alloys, such as but not limited to nitinol and Based on the selected materials used for manufacturing, the stent 600 can be self-expanding or require an external force to expand the stent 600. In some embodiments, composite filaments can be used to make the stent 600, which may include, for example, a shell or covering made of nitinol and a core composed of platinum or other non-radiopaque materials. It is also conceivable that the stent 600 can be composed of polymers, including but not limited to polyethylene terephthalate (PET). In some cases, the filaments of the stent 600 or its parts can be bioabsorbable or biodegradable, while in other cases the filaments of the stent 600 or its parts can be biostable.

[0166] The implant 600 may be completely, substantially, or partially covered with a polymeric covering, such as a coating (not explicitly shown). The covering may be disposed on the inner and / or outer surfaces of the implant 600 as desired. When so disposed, the polymeric covering may reduce or preclude tissue ingrowth and / or reduce food impaction.

[0167] Implant 600 may also include suture 616 for retrieval. This suture 616 may include suture loop 618 for retrieval, which may be configured to be gripped by forceps or other tools during the removal and or repositioning clinical procedures for support. In some cases, suture loop 618 for retrieval may be formed by tying a knot 620 between a first end 622 and a second end 624 of suture or by combining (e.g., thermal bonding, adhesive, etc.) between a first end 622 and a second end 624 of suture for retrieval. In other embodiments, suture loop 618 for retrieval may be formed at a first end 622 or a second end 624 of suture 616 for retrieval. In this case, the end 622,624 of suture loop 618 for retrieval may be connected to support 600 or the opposite end 622,624 of suture 616 for retrieval, although this is not necessary.

[0168] Suture 616 can be interlaced with stent frame 602 along the length of implant 600 at various intervals to form a plurality of suture loops 626a, 626b (collectively referred to as 626). Although the illustrative implant 600 is disclosed and described as having two suture loops 626, it is conceivable that implant 600 may include more than two suture loops 626 as needed. For example, implant 600 may include three, four, five, or more suture loops 626. It is conceivable that suture loops 626 can be positioned at regular or uniform intervals throughout the length of implant 600. However, in other embodiments, suture loops 626 can be positioned along the length of implant 600 at eccentric or uneven intervals as needed. It is conceivable that suture loops 626 can be positioned to facilitate the retrieval, repositioning, and / or reshaping of stent 600. For example, in a stent 600 having two or more flared or enlarged areas, such as in the SUTURE 626 manufactured and distributed by Boston Scientific Corporation, the SUTURE 626 may be positioned to facilitate the retrieval, repositioning, and / or reshaping of stent 600. For example, in a stent 600 having two or more flared or enlarged areas, such as in the SUTURE 626 manufactured and distributed by Boston Scientific Corporation, the SUTURE 626 may be positioned to facilitate the retrieval, repositioning, and / or reshaping of stent 600. In the stent, a first retrieval suture loop 626a can be located adjacent to the first flared portion and a second retrieval suture loop 626b can be located adjacent to the second flared portion.

[0169] In some embodiments, one, two or more, or all of the suture loops 626 may extend completely around the circumference of the stent frame 602 (e.g., 360°). In other embodiments, one, two or more, or all of the suture loops 626 may extend less than 360° around the circumference of the stent frame 602. In some embodiments, one or more of the suture loops 626 may extend 330° or less, 300° or less, 270° or less, 225° or less, 180° or less, 135° or less, etc. In other embodiments, one, two or more, or all of the suture loops may extend greater than 360° around the circumference of the stent frame 602. In other embodiments, the suture loops 626 may be positioned such that the rings 626a, 626b individually extend less than 360° around the circumference of the stent frame 602 but collectively extend about 360° around the circumference, such as Fig.11 as shown in .

[0170] The suture loop 626 may be composed of a single integral suture 616. It is contemplated that the suture 616 may be interwoven with the stent framework 602 so that the segments of the suture loop 626 may be constrained in a predetermined sequential order. In some cases, the proximal ring 626a and / or the distal ring 626b may not extend in a continuous ring. Instead, the proximal ring 626a and / or the distal ring 626b may be broken into portions by longitudinally extending interconnecting segments 638, 644, 652, 660, 670, 678 extending between the proximal ring 626a and the distal ring 626b.

[0171] Suture 616 can be interwoven with stent frame 602 by making one end in end 2622,624 start at first circumferential position 628 around proximal end 604 of implant 600 and move (for example, walk) in first direction.In this illustrative example, suture 616 is described as initially walking in clockwise direction.However, the reverse configuration in which suture initially walks in counterclockwise direction is also conceivable.Suture 616 can be made to walk around about one sixth (for example, 60 °) of the circumference of implant 600, so that first section 630 of suture 616 extends between first circumferential position 628 and second circumferential position 632.First and second circumferential positions 628,632 can be located at similar longitudinal distance away from first end 604 of implant 600 (for example, in the direction extending in parallel to longitudinal axis 634 of implant 600). In some cases, the suture 616 can be passed through so that it is interwoven with the stent framework 602, so that a portion of the suture 616 is located inside the lumen 610 of the implant 600 and a portion of the suture 616 is located along the outer surface of the implant 600 (e.g., so that it will contact the vascular cavity when the implant 600 is deployed inside the body). At the second circumferential position 632, the suture 616 can be passed along the length of the implant 600 in the direction toward the second end 606, so that the second longitudinally extending interconnected segment 638 of the suture 616 extends along the length of the implant 600 in a generally straight direction. The length of the second segment 638 of the suture 616 can vary based on the use. For example, some implants 600 may include radially extending spines (not explicitly shown) configured to engage with body tissue. The second segment 638 can be configured to extend along a length equal to or greater than the length of the implant 600 including the radially extending spines. This is just an example. Other characteristics of the implant 600 , such as, but not limited to, the length of the implant 600 , may be used to determine the length of the second segment 638 of the suture 616 .

[0172] The second segment 638 of the suture 616 can extend from the second circumferential position 632 to a third circumferential position 638. The second circumferential position and the third circumferential position 638 can be at similar radial points around the circumference of the implant 600, but spaced a certain distance along its length. At the third circumferential position 638, the third segment 640 of the suture 616 can be threaded radially around the circumference of the implant 600 in a first direction (e.g., clockwise). The third segment 640 can extend between the third circumferential position 638 and the fourth circumferential position 642 up to about one-sixth (e.g., 60°) of the circumference of the implant 600 to form a portion of the suture loop 626b.

[0173] At the fourth circumferential position 642, the suture 616 can be threaded along the length of the implant 600 in a direction toward the first end 604 so that the fourth longitudinally extending interconnected segment 644 of the suture 616 extends along the length of the implant 600 in a direction parallel to the longitudinal axis 634. The length of the fourth segment 644 of the suture 616 can be substantially the same length as the second segment 638 of the suture 616. The fourth segment 644 of the suture 616 can extend between the fourth circumferential position 642 and the fifth circumferential position 646. In some cases, the second and / or fourth segments 638, 644 of the suture may not be interwoven with the stent body 602, but instead extend along the inner or outer surface of the stent framework 602. In some embodiments, the first, second, and fifth circumferential positions 628, 632, 646 can be located at similar longitudinal distances away from the first end 604 of the implant 600 (e.g., in a direction extending substantially parallel to the longitudinal axis 634 of the implant 600).

[0174] From the fifth circumferential position 646, the suture 616 can be threaded through the stent body 602 in a first direction (e.g., away from the first segment 630) to form a fifth segment 648 of the suture 616. The fifth segment 648 of the suture 616 can be threaded through the stent framework 602 to a sixth circumferential position 650. The suture 616 can be threaded around approximately one-sixth (e.g., 60°) of the circumference of the implant 600 to form a portion of the proximal ring 626a.

[0175] At the sixth circumferential position 650, the suture 616 can be routed along the length of the implant 600 in a direction toward the second end 606 such that a sixth longitudinally extending interconnected segment 652 of the suture 616 extends in a generally straight direction along the length of the implant 600. The length of the sixth segment 652 of the suture 616 can be substantially the same length as the second segment 654 and / or the fourth segment 644 of the suture 616.

[0176] The sixth segment 652 of the suture 616 can extend from the sixth circumferential position 650 to the seventh circumferential position 654. The sixth circumferential position 650 and the seventh circumferential position 654 can be at similar radial points around the circumference of the implant 600, but spaced a distance apart along its length. At the seventh circumferential position 654, the seventh segment 656 of the suture 616 can be radially threaded in a first direction (e.g., clockwise) around the circumference of the implant 600. The seventh segment 656 can extend between the seventh circumferential position 654 and the eighth circumferential position 658 up to about one-sixth (e.g., 60°) of the circumference of the implant 600 to form a portion of the suture loop 626b.

[0177] At the eighth circumferential position 658, the suture 616 can be threaded along the length of the implant 600 in a direction toward the first end 604 such that an eighth longitudinally extending interconnected segment 660 of the suture 616 extends along the length of the implant 600 in a direction parallel to the longitudinal axis 634. The length of the eighth segment 660 of the suture 616 can be substantially the same length as the second, fourth, and sixth segments 636, 644, 652 of the suture 616. The eighth segment 660 of the suture 616 can extend between the eighth circumferential position 658 and a ninth circumferential position 662.

[0178] From the ninth circumferential position 662, the suture 616 can be threaded through the stent body 602 in a first direction (e.g., away from the fifth segment 648) to form a ninth segment 664 of the suture 616. The ninth segment 664 of the suture 616 can be threaded through the stent framework 602 to a tenth circumferential position 668. The suture 616 can be threaded around approximately one-sixth (e.g., 60°) of the circumference of the implant 600 to form a portion of the proximal ring 626a.

[0179] At the tenth circumferential position 668, the suture 616 can be threaded along the length of the implant 600 in a direction toward the second end 606 such that the tenth longitudinally extending interconnected segment 670 of the suture 616 extends in a generally straight direction along the length of the implant 600. The length of the tenth segment 670 of the suture 616 can be substantially the same length as the second, fourth, sixth, and eighth segments 654, 644, 652, 660 of the suture 616.

[0180] The tenth segment 670 of the suture 616 can extend from the tenth circumferential position 668 to the eleventh circumferential position 672. The tenth circumferential position 668 and the eleventh circumferential position 672 can be at similar radial points around the circumference of the implant 600, but spaced a distance apart along its length. At the eleventh circumferential position 672, the eleventh segment 674 of the suture 616 can be threaded radially in a first direction (e.g., clockwise) around the circumference of the implant 600. The eleventh segment 674 can extend between the eleventh circumferential position 672 and the twelfth circumferential position 676 up to about one-sixth (e.g., 60°) of the circumference of the implant 600 to form a portion of the suture loop 626b.

[0181] At the twelfth circumferential position 676, the suture 616 may be threaded along the length of the implant 600 in a direction toward the first end 604 so that the twelfth longitudinally extending interconnected segment 678 of the suture 616 extends along the length of the implant 600 in a direction parallel to the longitudinal axis 634. The length of the twelfth segment 678 of the suture 616 may be substantially the same length as the second, fourth, sixth, eighth, and tenth segments 636, 644, 652, 660, 670 of the suture 616. The twelfth segment 678 of the suture 616 may extend between the twelfth circumferential position 676 and the thirteenth circumferential position 680. The thirteenth circumferential position 680 may be at substantially the same radial position as the first circumferential position 628. However, this is not required. For example, the first circumferential position 628 may be radially spaced from the thirteenth circumferential position 680 by, for example, 1° or less, 5° or less, 10° or less, 20° or less, etc. The first and second ends 620, 622 of the suture 616 may then be tied or secured as described above.

[0182] The proximal suture loop 626a can be comprised of circumferentially discontinuous segments of suture including a first segment 630, a fifth segment 648, and a ninth segment 664. The circumferential points forming each of these segments (e.g., the first, second, fifth, sixth, ninth, and tenth circumferential points 628, 632, 646, 650, 662, 668) can be located at similar longitudinal distances away from the first end 604 of the implant 600 (e.g., in a direction extending generally parallel to the longitudinal axis 634 of the implant 600). The distal suture loop 626b can be comprised of circumferentially discontinuous segments of suture including a third segment 640, a seventh segment 656, and an eleventh segment 674. The circumferential points that make up each of these segments (e.g., the third, fourth, seventh, eighth, eleventh, and twelfth circumferential points 638, 642, 654, 658, 672, 676) may be located at similar longitudinal distances away from the first end 604 of the implant 600 (e.g., in a direction extending generally parallel to the longitudinal axis 634 of the implant 600).

[0183] Although each circumferentially extending segment 630, 640, 648, 656, 664, 674 is described as extending about 60° around the circumference of the stent frame 602, this is not required. If it is desired that each circumferentially extending segment is substantially uniform, the arc length of the circumferentially extending segment may depend on the number of circumferentially extending segments. It is also contemplated that the circumferentially extending segments need not all have the same arc length.

[0184] In order to collapse the implant 600, the retrieval suture ferrule 618 or a portion of the first suture ferrule 626a can be pulled or actuated in the proximal direction in the absence of the retrieval suture ferrule 618. It is conceivable that the direction of actuation required to actuate the suture 616 (e.g., proximal or distal direction) can depend on the direction in which the suture 616 is interwoven with the stent framework 602. When the retrieval suture ferrule 618 or the first suture ferrule 626a is actuated in the absence of the retrieval suture ferrule 618, the suture ferrule 626 begins to constrain or reduce the diameter of the implant 600. The orientation of the suture ferrule 626 can cause the suture ferrule 626 to generate constraints at substantially the same time. However, the opposite sides of the proximal suture ferrule 626a and the distal suture ferrule 626b can be constrained first.

[0185] The material of the various parts (and its variant, system or parts disclosed herein) of implant 10,100,200 and their various elements disclosed herein may include the material generally relevant to medical device.For simple purpose, the following discussion is with reference to implant 10,100,200 (and variant, system or parts disclosed herein). However, this is not intended to limit device and method described herein, because this discussion may be applicable to other elements, member, parts or device disclosed herein.

[0186] The implant 10, 100, 200 can be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, etc., or other suitable materials. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L and 316LV stainless steel; mild steel; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as 625、UNS:N06022 UNS:N10276 Other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, etc.), 400、NICKEL 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, etc.), etc.), nickel-molybdenum alloys (e.g., UNS: N10665, etc.), ALLOY ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (for example, UNS: R30003 such as etc.); platinum-rich stainless steel; titanium; combinations thereof, etc.; or any other suitable material.

[0187] As mentioned herein, within the family of commercially available nickel-titanium or Nitinol alloys is a category designated as "linear elastic" or "non-superelastic", which, despite being chemically similar to conventional shape memory and superelastic varieties, may exhibit unique and useful mechanical properties. Linear elastic and / or non-superelastic Nitinol may be distinguished from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol does not exhibit a distinct "superelastic plateau" or "signal zone" in its stress / strain curve as does superelastic Nitinol. In contrast, in linear elastic and / or non-superelastic Nitinol, as recoverable strain increases, stress continues to increase in a generally linear or slightly but not necessarily completely linear relationship until plastic deformation begins, or at least increases in a more linear relationship than the superelastic plateau and / or sign zone that may be seen with superelastic Nitinol. Therefore, for the purposes of this disclosure, linear elastic and / or non-superelastic Nitinol may also be referred to as "generally" linear elastic and / or non-superelastic Nitinol.

[0188] In some cases, linear elastic and / or non-superelastic Nitinol can also be distinguished from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol can accept strains up to about 2-5% while still being substantially elastic (e.g., before elastic deformation occurs) while superelastic Nitinol can accept strains up to about 8% before elastic deformation occurs. Both of these materials can be distinguished from other linear elastic materials (such as stainless steel) that can accept only about 0.2 to 0.44% strain before elastic deformation occurs (which can also be distinguished based on their composition).

[0189] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not show any martensite / austenite phase transformation detectable over a large temperature range using differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA). For example, in some embodiments, in the linear elastic and / or non-superelastic nickel-titanium alloy, there may be no martensite / austenite phase transformation detectable using DSC and DMTA analysis in the range of about -60 degrees Celsius (°C) to about 120°C. Therefore, over this very wide temperature range, the mechanical bending properties of this material are generally inert to the effects of temperature. In some embodiments, the mechanical bending properties of the linear elastic and / or non-superelastic nickel-titanium alloy at ambient or room temperature are approximately the same as the mechanical properties at body temperature, for example, they do not show superelastic plateaus and / or signature zones. In other words, over a large temperature range, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic properties and / or properties.

[0190] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may contain nickel in the range of about 50 to about 60 weight percent, with the remainder being essentially titanium. In some embodiments, its composition is nickel in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is the FHP-NT alloy purchased from Furukawa Technical Materials Co., Ltd., Kanagawa Prefecture, Japan. Some examples of nickel-titanium alloys are disclosed in U.S. Patents 5,238,004 and 6,508,803, the contents of which are incorporated herein by reference. Other suitable materials may include ULTANIUM TM (available from Neo-Metrics) and GUMMETAL TM (Available from Toyota Corporation.) In some other embodiments, superelastic alloys (eg, superelastic Nitinol) may be used to obtain the desired properties.

[0191] In at least some embodiments, part or all of the implant 10, 100, 200 may also be doped with, manufactured with, or include a radiopaque material. Radiopaque materials are generally understood to be materials that are not transparent (with a thickness of <0.005") to radiofrequency energy in the wavelength range from X-rays to gamma rays. These materials are able to produce a relatively dark image on a fluorescent screen relative to the bright image produced by non-radiopaque materials (such as tissue). This relatively bright image helps the user of the implant 10, 100, 200 determine its position. Examples of radiopaque materials may include, but are not limited to: gold, platinum, palladium, tantalum, tungsten alloys, polymer materials filled with radiopaque fillers, etc. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the implant 10, 100, 200 to achieve the same results.

[0192] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the implant 10, 100, 200. For example, the implant 10, 100, 200, or portions thereof, may be made of a material that does not substantially distort the image and produce noticeable artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may be unsuitable because they may produce artifacts in the MRI image. The implant 10, 100, 200, or portions thereof may also be made of a material that can be imaged by the MRI instrument. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, etc.). etc.) nickel-cobalt-chromium-molybdenum alloy (e.g., UNS: R30035 etc.), Nitinol, etc., and other materials.

[0193] Some examples of suitable polymers for implants 10, 100, 200 may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, such as available from DuPont Corporation), ), polyetherester block copolymers, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARN available from DSM Engineering Plastics, ), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as those available from DuPont ), polyamide (e.g., available from Bayer Or purchased from Elf Atochem ), elastomeric polyamides, polyamide / ether block copolymers, polyether block amides (PEBA, for example, purchased block polyether amide resin), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), High density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., ), polysulfone, nylon, nylon-12 (such as available from EMS American Grilon Company ), perfluoropropyl vinyl ether (PFA), ethylene-vinyl alcohol copolymers, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) triblock copolymers (e.g., SIBS and / or SIBS 50A), polycarbonates, ion cross-linked polymers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer / metal composites, etc.

[0194] It will be appreciated by those skilled in the art that the different embodiments of the implant described herein, their modes of operation, etc. are only representatives of the environment in which the present disclosure operates. Therefore, a variety of alternatively shaped collaborative components of design may also be used as substitutes for the purpose of engaging, manipulating the support and positioning the support at the desired target site, and therefore do not limit the scope of the present disclosure. In addition, the disclosed implant may be fully retractable, extendable, and retractable, thereby allowing its flexible deployment. In particular, the configuration described herein may also be applicable to other medical uses, so a variety of other medical devices may be used together with implantation. These medical devices may include biopsy forceps, shears, lithotripters, dilators, other cautery tools, etc.

[0195] In addition, although implant is usually described as being accompanied by exemplary rigidity and flexible zone, multiple other configuration and arrangement also are conceivable and possible.In addition, operation, device and parts described herein can be applied to other purposes in the same manner, wherein need parts be positioned in wherein need to avoid leakage or other treatment is desired position.Therefore, the disclosed embodiment is applicable to medical treatment and / or non-medical environment.In addition, under the premise of not departing from the scope of disclosed embodiment, during implementation, some aspects of the aforementioned embodiment can be selectively used for collaboration, or are removed.

[0196] Those skilled in the art will recognize that the present invention may be embodied in a variety of forms other than the specific embodiments described and covered herein. Therefore, changes may be made in form and detail without departing from the scope and spirit of the present disclosure as described in the appended claims.

Claims

1. An implant comprising: a stent having a proximal region, a distal region, and a circumference; as well as a retrieval suture interwoven with the stent, the retrieval suture comprising a proximal suture loop extending circumferentially around a proximal end region of the stent, and a distal suture loop extending circumferentially around the stent and longitudinally spaced distally from the proximal suture loop, the proximal and distal suture loops being connected together via three or more longitudinal segments of the retrieval suture; Wherein the proximal suture loop and the distal suture loop are each discontinuous rings comprising three or more circumferential segments of the retrieval suture separated by three or more interconnected longitudinal segments.

2. The implant of claim 1, wherein the three or more circumferential segments of each of the proximal suture collar and the distal suture collar extend together 360° around the circumference of the stent.

3. The implant of claim 2, wherein the three or more circumferential segments of each of the proximal suture loop and the distal suture loop all have a uniform arc length.

4. The implant of claim 2, wherein some of the three or more circumferential segments of each of the proximal suture loop and the distal suture loop have a first arc length, and at least one of the three or more circumferential segments has a second arc length different from the first arc length.

5. The implant of claim 1, wherein the retrieval suture is a single suture.

6. The implant of claim 1, further comprising a pull ring extending proximally from the proximal suture loop, the pull ring being configured for grasping to remove or reposition the stent.

7. The implant of claim 6, wherein the pulling loop is formed by the first end or the second end of the retrieval suture.

8. The implant of claim 1, further comprising at least one intermediate suture collar located between the proximal and distal suture collars.

9. The implant of claim 8, wherein the at least one intermediate suture loop extends circumferentially around an intermediate region between the proximal and distal regions of the stent.

10. The implant of claim 9, wherein the at least one intermediate suture loop is a discontinuous ring comprising two or more circumferential segments of the retrieval suture separated by one or more longitudinal segments connecting the intermediate suture to the proximal and distal suture loops.

11. The implant of claim 1 , wherein the stent comprises a plurality of barbs extending radially outward from at least a portion of the stent.

12. The implant of claim 1, wherein the stent comprises a lumen extending from the proximal region to the distal region, the stent further comprising a one-way valve disposed within the lumen.

13. The implant of claim 1, wherein one or both of the proximal or distal regions have a flared region having a larger diameter than an intermediate region between the proximal and distal regions.

14. An implant comprising: a stent having a proximal region, a distal region, and a circumference; as well as A single retrieval suture interwoven with the stent, the retrieval suture comprising a proximal suture loop extending circumferentially around a proximal region of the stent and comprising three or more discontinuous circumferential segments, and a distal suture loop extending circumferentially around a distal region of the stent and comprising three or more discontinuous circumferential segments, wherein the distal suture loop is longitudinally spaced distally from the proximal suture loop, wherein the three or more discontinuous circumferential segments of the proximal and distal suture loops are connected to each other by a plurality of longitudinal segments of the retrieval suture, wherein the circumferential segments of the proximal suture loop are circumferentially offset from the circumferential segments of the distal suture loop.

15. The implant of claim 14, wherein the three or more discrete circumferential segments of each of the proximal and distal suture loops extend together 360° around the circumference of the stent.

16. The implant of claim 15, wherein the three or more discrete circumferential segments of each of the proximal and distal suture loops all have a uniform arc length.

17. The implant of claim 15, wherein some of the three or more circumferential segments of each of the proximal and distal suture loops have a first arc length, and at least one of the three or more circumferential segments has a second arc length different from the first arc length.

18. The implant of claim 14, further comprising at least one intermediate suture collar located between the proximal and distal suture collars.

19. An implant according to claim 18, wherein the at least one intermediate suture loop is a discontinuous ring, the discontinuous ring comprising two or more circumferential segments of the retrieval suture separated by one or more longitudinal segments, wherein the one or more longitudinal segments connect the intermediate suture to the proximal suture loop and the distal suture loop.

20. An implant comprising: a stent having a proximal region, a distal region, and a circumference; a retrieval suture interwoven with the stent, the retrieval suture comprising a proximal suture loop extending circumferentially around a proximal end region of the stent, and a distal suture loop extending circumferentially around the stent and longitudinally spaced distally from the proximal suture loop, the proximal and distal suture loops being connected together by three or more longitudinal segments of the retrieval suture; and a pull loop extending longitudinally away from at least one of the proximal suture loop and the distal suture loop, the pull loop being formed by a portion of the retrieval suture; Wherein the proximal suture loop and the distal suture loop are each discontinuous rings comprising three or more circumferential segments of the retrieval suture separated by three or more interconnected longitudinal segments.

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