Stent with an occlusion prevention system

Abstract

An exemplary stent includes an elongated tubular member comprising at least one strut forming a tubular wall having a plurality of cells extending through the thickness of the tubular wall. The elongated tubular member may be configured to move between a radially folded form and a radially expanded form. A coating is disposed on the elongated tubular member and traverses at least a portion of the plurality of cells. One or more magnetic members may be disposed on or within the coating.

Description

Technical Field

[0001] The present disclosure relates to medical devices, methods for manufacturing medical devices, and methods of using them. More specifically, the present disclosure relates to an anti-occlusion stent for embedding in a body lumen and related methods.

Background Art

[0002] Implantable stents are devices that are placed in body lumens such as the esophagus, digestive tract (including the intestine, stomach, and colon), bronchioles, urinary tract, bile duct, vascular system, etc., to support the body lumen and maintain the body lumen in an open state. These stents can be manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Each of the known stents, delivery systems, and methods has specific advantages and disadvantages. For example, some stents can become occluded. Occlusion events can be related to a combination of local factors such as insufficient stenosis resolution and irregular bile properties (but not limited to these), and / or stent design such as coating adhesiveness and / or interaction between the wire and bile (but not limited to these). Thus, there is a continuing need to provide alternative stent designs that increase the effectiveness of the stent during the treatment period while providing an opportunity for preventive intervention to delay occlusion events or potential causes of occlusion without the need for repeated interventions.

Summary of the Invention

[0003] The present disclosure provides alternatives to designs, materials, manufacturing methods, and methods of use for medical devices. Exemplary medical devices can include stents. In one example, the stent may comprise an elongated tubular member having at least one strut forming a tubular wall having a plurality of cells extending through the thickness of the tubular wall, and configured to move between a radially folded form and a radially expanded form; a coating disposed on the elongated tubular member and traversing at least a portion of the plurality of cells; and one or more magnetic members disposed on or within the coating.

[0004] In other examples, either as an alternative or in addition to any of the above examples, the coating may include an inner layer and an outer layer. In an alternative or additional example to any of the above examples, one or more magnetic members may be placed between the inner and outer layers of the coating.

[0005] In an alternative or additional example to any of the above examples, one or more magnetic members may be individual elements located within at least a portion of a plurality of cells. In an alternative or additional example to any of the above examples, one or more magnetic members may be elongated strips extending over at least one strut.

[0006] In an alternative or additional example to any of the above, one or more magnetic members may be arranged at intervals along the length of the elongated tubular member. In an alternative or additional example to any of the above, one or more magnetic members may be arranged at intervals along the circumference of a long, tubular member.

[0007] In an alternative or additional example to any of the above examples, the coating may form pockets within at least some of the cells. In an alternative or additional example to any of the above, the coating may extend from the proximal end to the distal end of a long, tubular member.

[0008] In an alternative or additional example to any of the above, the coating may cover a shorter area than the entire length of the tubular member. In an alternative or additional example to any of the above examples, at least one of the magnetic members may be positioned adjacent to the uncoated region of the elongated tubular member.

[0009] In an alternative or additional example to any of the above examples, one or more magnetic members may include a silicone substrate and a magnetic material. In alternative or additional examples to any of the above, the magnetic material may include carbonyl iron.

[0010] In an alternative or additional example to any of the above examples, one or more magnetic members may be configured to move radially inward and / or radially outward in response to an applied magnetic field.

[0011] In an alternative or additional example to any of the above examples, the applied magnetic field may be a pulsed magnetic field or an alternating magnetic field. In another example, the stent may comprise an elongated tubular member having at least one strut forming a tubular wall having a plurality of cells extending through the thickness of the tubular wall, and configured to move between a radially folded form and a radially expanded form; a coating disposed on the elongated tubular member and traversing at least a portion of the plurality of cells; and a plurality of magnetic members embedded in the coating, the plurality of magnetic members comprising a silicone substrate and carbonyl iron. In response to an applied magnetic field, one or more magnetic members may be configured to move radially inward and / or radially outward with respect to at least one strut.

[0012] In another example, a method for preventing stent occlusion may include the step of delivering the stent to a target location within the body. The stent may comprise an elongated tubular member having at least one strut forming a tubular wall having a plurality of cells extending through the thickness of the tubular wall, and configured to move between a radially folded form and a radially expanded form; a coating disposed on the elongated tubular member and traversing at least a portion of the plurality of cells; and one or more magnetic members disposed on or within the coating. The method may further include the steps of locating a console configured to supply a magnetic field outside the body and adjacent to the target location; and periodically activating the magnetic field. In response to the application of the magnetic field, one or more magnetic members may be configured to move radially inward and / or radially outward relative to at least one strut.

[0013] In an alternative or additional example to any of the above examples, the magnetic field may be a pulsed magnetic field. In an alternative or additional example to any of the above examples, the magnetic field may be an alternating magnetic field.

[0014] In an alternative or additional example to any of the above, the console may be configured to be removably fixed around the main body. The above summaries of some embodiments are not intended to describe each of the embodiments or any implementations disclosed in this disclosure. The following drawings and detailed description illustrate these embodiments in more detail. [Brief explanation of the drawing]

[0015] This disclosure can be better understood by considering the following detailed description of various embodiments in relation to the attached drawings. [Figure 1] This is a side view of an exemplary intraluminal implant or stent. [Figure 2A] Figure 1 is a partial perspective view of an exemplary stent. [Figure 2B] Partial side view of an exemplary stent of FIG. 1 [Figure 3] Schematic cross-sectional view of an exemplary stent along line 3-3 of FIG. 2B [Figure 4A] Side view of an exemplary stent in which magnetic members are arranged in different regular or irregular arrays [Figure 4B] Side view of an exemplary stent in which magnetic members are arranged in different regular or irregular arrays [Figure 4C] Side view of an exemplary stent in which magnetic members are arranged in different regular or irregular arrays [Figure 4D] Side view of an exemplary stent in which magnetic members are arranged in different regular or irregular arrays[[ID=1,7]] [Figure 4E] Side view of an exemplary stent in which magnetic members are arranged in different regular or irregular arrays [Figure 4F] Side view of an exemplary stent in which magnetic members are arranged in different regular or irregular arrays [Figure 4G] Side view of an exemplary stent in which magnetic members are arranged in different regular or irregular arrays [Figure 4H] Side view of an exemplary stent in which magnetic members are arranged in different regular or irregular arrays [Figure 5A] Partial side view of an exemplary stent including magnetic members before magnetization [Figure 5B] Partial side view of an exemplary stent of FIG. 5A including magnetic members after magnetization [Figure 6] Schematic view of an exemplary stent placed in the biliary system [Figure 7] Schematic view of an exemplary arrangement of a console for generating a magnetic field with respect to a patient's body [Figure 8] Perspective view of an exemplary console system [Figure 9A] Partial cross-sectional view of a stent when a magnetic field is selectively applied [Figure 9B]This is a partial cross-sectional view of a stent when a magnetic field is selectively applied. [Figure 9C] This is a partial cross-sectional view of a stent when a magnetic field is selectively applied. [Figure 10] Another illustrative side view of an intraluminal implant or stent. [Modes for carrying out the invention]

[0016] This disclosure is suitable for various modifications and alternative forms, the details of which are illustrated as examples in the drawings and will be described in detail thereafter. However, it should be understood that the intent is not to limit the aspects of this disclosure to the specific embodiments described. Rather, the intent is to cover all modifications, equivalents, and alternatives that fall within the scope of this disclosure.

[0017] The following definitions of terms shall apply unless otherwise given in the claims or elsewhere in this specification. All figures, whether explicitly stated or not, are assumed in this specification to be modified by the term “approximately.” The term “approximately” generally refers to a range of figures that a person skilled in the art would consider equivalent to (i.e., having the same function or result as) the stated value. In many cases, the term “approximately” may be used to indicate a figure rounded to the nearest significant figure.

[0018] Numerical ranges indicated by endpoints include all numbers within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). While several appropriate dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, a person skilled in the art inspired by this disclosure will understand that desired dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0019] Where used herein and in the appended claims, the singular forms “a,” “an,” and “the” include multiple references unless otherwise explicitly indicated herein. Where used herein and in the appended claims, the term “or” is generally adopted in its meaning including “and / or” unless otherwise explicitly indicated herein.

[0020] The following detailed description should be read with reference to the drawings, where similar elements are numbered identically in different drawings. The detailed description and drawings are not necessarily to scale and illustrate exemplary embodiments, and are not intended to limit the scope of this disclosure. The illustrated exemplary embodiments are intended for illustrative purposes only. Selected features of any exemplary embodiment may be incorporated into additional embodiments unless otherwise expressly stated.

[0021] In some cases, it may be desirable to provide an intraluminal implant or stent that can provide patency of the lumen within the patient's pancreaticobiliary system. The relatively narrow bile ducts consist of a series of branches connecting the liver, gallbladder, and pancreas to the duodenal space via papillae for the transport of bile and related enzymes for many metabolic functions, most commonly for the body's ability to digest and absorb fats and vitamins D and K. However, among other etiologies, obstruction can occur within the pancreaticobiliary system due to tumor-associated luminal strictures, stricture formation, infection, or stone and sludge formation. Endoscopic retrograde cholangiopancreatography (ERCP) is used to diagnose and treat these luminal strictures, regardless of whether the disease is malignant or benign. Generally, fully covered self-expanding metal stents (SEMS) can be used so that the radial force of the stent provides a scaffold for the stricture. However, obstruction can occur within the stent after placement. Obstructive events may be a combination of local factors, including, but not limited to, insufficient stenosis resolution and / or irregular bile characteristics. Obstruction may also be related to stent design components, including, but not limited to, coating adhesion and / or interaction between the stent wire and bile (both of which cause resistance and retention of bile over time). Due to the remoteness of the deployed SEMS, the ability to diagnose and intervene in potential obstructive events is limited, and typically, intervention can only resolve the obstructive event when it manifests as a worsening of the patient's symptoms (e.g., jaundice, abdominal pain). Obstruction can result in certain device families being unfairly undervalued or certain brands being avoided, due to increased procedural costs resulting from re-intervention and stent replacement, patient discomfort despite the stent device itself functioning effectively as a scaffold, vascular delays, and / or historical or anecdotal knowledge of obstructive or suggestive obstructive events.This disclosure is directed toward alternative stent designs that offer opportunities for preventive or anticipatory interventions to delay occlusive events or potential causes of occlusion without repeated surgical interventions, and that enhance the effectiveness of stents during the treatment period. Although this disclosure is described in relation to the pancreaticobiliary system, the devices, systems, and / or methods described herein may be used for stents or intraluminal implants placed in other parts of the body, for example, but not limited to, body tissues, body organs, vascular lumens, non-vascular lumens and combinations thereof (for example, but not limited to, coronary or peripheral vascular systems, trachea, bronchi, colon, small intestine, esophagus, bile ducts, urinary tract, prostate, brain, stomach, etc.).

[0022] Figure 1 illustrates, but is not limited to, an exemplary intraluminal implant 10 such as a stent. In some examples, the stent 10 may be formed from an elongated tubular member 12. Although the stent 10 is described as substantially tubular, it is intended that the stent 10 may take any desired cross-sectional shape. The stent 10 may have a first end, i.e., a proximal end 14, a second end, i.e., a distal end 16, and an intermediate region 18 located between the first end 14 and the second end 16. The stent 10 may include a lumen 32 extending from a first opening adjacent to the first end 14 to a second opening adjacent to the second end 16, thereby allowing the passage of food, fluids, etc.

[0023] The stent 10 may be expandable from a first radially folded form (not specified) to a second radially expanded form. In some examples, the stent 10 may be deployed to a form between the folded form and the fully expanded form. The stent 10 may extend across the constriction and be configured to apply radially outward pressure to the constriction within the lumen to open the lumen and allow the passage of material.

[0024] In some embodiments, the proximal end 14 of the stent 10 may include a plurality of loops 38. The plurality of loops 38 may be configured to receive a retrieval tether or suture (not explicitly shown) that is woven through the plurality of loops 38 or passes through one or more of the plurality of loops 38 in a different manner. The retrieval suture may be used to fold and retrieve the stent 10 as needed. For example, the retrieval suture can be pulled like a drawstring to radially contract the proximal end 14 of the stent 10, making it easier to remove the stent 10 from the body lumen.

[0025] The stent 10 may have a woven structure made from a number of filaments or struts 36 that form a tubular wall. In some embodiments, the stent 10 is knitted or braided from single filaments or struts, each of which is woven together and defines an opening cell 46 that extends across the thickness of the tubular wall of the stent 10. In other embodiments, the stent 10 may be braided so that a plurality of filaments or struts are woven together to define an opening cell 46 that extends circumferentially along the length of the tubular wall of the stent 10. Each opening cell 46 may define an opening (for example, across the thickness of the tubular wall) from the outer surface of the tubular wall to the inner surface of the tubular wall, without containing any filaments or struts 36. Some exemplary stents containing braided filaments include the WallFlex®, WALLSTENT®, and Polyflex® stents, manufactured and sold by Boston Scientific, Corporation. In another embodiment, stent 10 may be a woven type, such as the Ultraflex® stent, manufactured by Boston Scientific, Corporation. In yet another embodiment, stent 10 may be a knotted type, such as the Precision Colonic® stent, manufactured by Boston Scientific, Corporation. In yet another embodiment, stent 10 may be a laser-cut tubular member, such as the EPIC® stent, manufactured by Boston Scientific, Corporation. The laser-cut tubular members may have open-cell geometry and / or closed-cell geometry, including one or more interconnected, integrated filaments or struts defining opening cells 46 therein, the opening cells 46 may extend circumferentially along the longitudinal direction of the tubular wall. Each opening cell 46 may define an opening (e.g., across the thickness of the tubular wall) from the outer surface of the tubular wall to the inner surface of the tubular wall, without including interconnected, integrated filaments or struts.In some examples, the inner and / or outer surfaces of the tubular wall of the stent 10 may be entirely, substantially, or partially coated with a polymer coating or coating 40, as described in more detail herein. The coating or coating 40 may extend over and / or occlude one or more cells 46 defined by struts or filaments 36. In some examples, the stent 10 may be a self-expanding stent (SES), but this is not required.

[0026] In some examples, in a radially extended configuration, the stent 10 may include a first end region 20 adjacent to the proximal end 14 and a second end region 22 adjacent to the second end 16. In some embodiments, the first end region 20 and the second end region 22 may include retaining or anti-movement flared regions 24, 26 having a diameter enlarged relative to the intermediate portion 18. The anti-movement flared regions 24, 26, which may be positioned adjacent to the first end 14 and the second end 16 of the stent 10, may be configured to engage with the inner portion of the body lumen wall. In some embodiments, the retaining or flared regions 24, 26 may have a larger diameter than the cylindrical intermediate region 18 of the stent 10 to prevent it from moving after it has been placed in the body lumen. The transition portions 28 and 30 from the cross-sectional area of ​​the intermediate region 18 to the holding function portion or the flared regions 24 and 26 are intended to be gradual, inclined, or steeply stepped, as desired.

[0027] In some embodiments, the first anti-movement flare region 24 may have a first outer diameter, and the second anti-movement flare region 26 may have a second outer diameter. In some examples, the first and second outer diameters may be substantially the same, while in other examples, the first and second outer diameters may be different. In some embodiments, the stent 10 may include only one of the anti-movement flare regions 24, 26, or neither. For example, the first end region 20 may include an anti-movement flare 24, and the second end region 22 may have an outer diameter similar to that of the intermediate region 18. It is further intended that the second end region 22 may include an anti-movement flare 26, and the first end region 20 may have an outer diameter similar to that of the intermediate region 18. In some embodiments, the stent 10 may have a uniform outer diameter from the first end 14 to the second end 16. It is intended that the outer diameter of the stent 10 may be modified to suit the desired application.

[0028] The elongated tubular members of the stent 10 may be made from a variety of materials, including but not limited to metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that the stent 10 can expand to a desired shape when precisely positioned within the body. In some examples, the material may be selected so that the stent 10 can be removed relatively easily. For example, the elongated tubular members of the stent 10 may be formed from alloys such as (but not limited to) nitinol and Elgiloy®. Depending on the material selected for construction, the stent 10 may be self-expanding or may require external force to expand. In some embodiments, a composite filament may be used to fabricate the stent 10, which may include, for example, an outer shell or cladding layer made from nitinol and a core formed from platinum or other radiopaque material. It is further intended that the elongated tubular members of the stent 10 may be formed from a polymer such as polyethylene terephthalate (PET) (but not limited to PET). In some examples, the filaments or parts thereof of the stent 10 may be bioabsorbable or biodegradable, and in other examples, the filaments or parts thereof of the stent 10 may be biostable.

[0029] Figure 2A shows a partial perspective view of the exemplary stent 10 of Figure 1, and Figure 2B shows a partial side view of the exemplary stent 10 of Figure 1. As described above, the inner and / or outer surfaces of the tubular wall of the stent 10 may be entirely, substantially, or partially coated with a polymer coating or coating 40. The coating 40 may be silicone, polyurethane, or other flexible polymer material. The coating 40 may be applied such that there is excess material or pockets 44 of material extending between the struts 36. For example, instead of extending tautly throughout and coplanar with the struts 36, the coating 40 may slacken and extend radially inward from the struts 36 by a radial distance or height 42, forming a void. However, in some examples, the coating 40 may be taut throughout and extend coplanar with the struts 36. Figures 2A and 2B show the pocket 44 extending radially inward, but the pocket 44 is intended to extend radially outward from the strut 36 over a radial distance or height. In some examples, the pocket 44 may have a substantially truncated conical shape with four flat, converging (e.g., inclined) side walls 48a, 48b, 48c, and 48d and a flat bottom or base wall 48e. Although the pocket 44 is generally shown having a rhomboid cross-section similar to the diamond shape of the cell 46 formed by the strut 36, the pocket 44 can take any desired shape. For example, in some examples, the pocket 44 may have a base wall 48e that has a substantially arcuate shape, such as a substantially spherical shape with a spherical concave radially outward-facing surface and a spherical convex radially inward-facing surface. The pocket 44 may form a gap 50 between its radially outward surface (e.g., the base surface) and the periphery of the tubular wall of the stent 10 formed by the strut 36. If the pocket 44 extends radially outward from the tubular wall of the stent 10, the gap 50 may be located radially outward from the tubular wall of the stent 10.

[0030] In some examples, the pockets 44 may be formed using a mandrel and / or a mold. For example, the mandrel may be formed to have projections or recesses of the desired size and shape for the pockets 44. The struts 36 may be wrapped around the mandrel, braided, woven, or otherwise positioned with the cells of the tubular walls aligned with the projections or recesses. For example, a sleeve made of silicone or other polymer material may be placed on the mandrel and struts 36. The sleeve may be heated or otherwise molded to the shape of the mandrel to form a coated stent 10 containing the pockets 44 between the struts 36. Alternatively, the polymer material may be sprayed or dipped onto the mandrel and struts 36 so that the polymer material flows over the projections of the mandrel and / or into the recesses. The coating 40 is intended to be flexible enough to allow the pockets 44 to be inverted to a desired configuration, so that either a pocket 44 extending radially inward or a pocket 44 extending radially outward can be formed using either a protrusion or a recess.

[0031] Referring further to Figure 3, which shows a schematic cross-sectional view of an exemplary stent 10 along line 3-3 in Figure 2B, the pocket 44 may further include a magnetic member 52, thereby the stent 10 including at least one or more magnetic members 52. In some examples, the magnetic member 52 may be fixed to the coating, such as within the pocket 44, while the magnetic member 52 is spaced apart from the struts 36 of the stent 10 and / or does not directly contact the struts 36 of the stent 10. In other words, in some examples, the magnetic member 52 may be placed in a cell 46 between adjacent filaments or struts 36 of the stent 10 without directly contacting the filaments or struts 36 that form the scaffold structure of the stent 10. In some embodiments, the magnetic member 52 may be sealed between the inner layer 40a and the outer layer 40b of the coating 40. However, this is not mandatory. In some cases, the magnetic member 52 may be located on the inner surface of the inner layer 40a or on the outer surface of the outer layer 40b of the coating 40. As described above, in some examples, the inner and / or outer surfaces of the scaffold structure of the stent 10 may be entirely, substantially, or partially covered by a polymer coating or layer 40. For example, the coating or covering 40 may extend across the opening cells 46 of the scaffold structure to prevent the intrusion and growth of tissue into the lumen of the stent 10. However, in some embodiments, one or both of the polymer coatings 40a and 40b may be omitted. For example, in some embodiments, the stent 10 may include only an outer polymer coating 40b on the outer surface of the scaffold structure. In other embodiments, the stent 10 may include only an inner polymer coating 40a on the inner surface of the scaffold structure. In some examples, the inner layer 40a and the outer layer 40b may be formed as a single, integrated structure. In other embodiments, the inner layer 40a and the outer layer 40b may be formed as separate layers. The inner layer 40a and the outer layer 40b may be formed from the same material or different materials, as desired. The inner layer 40a and / or outer layer 40b are intended to be applied in such a way that the elasticity of the coating 40 allows for localized movement of the magnetic member 52.The inner layer 40a and / or outer layer 40b may traverse or be positioned within openings or gaps 46 defined between adjacent stent filaments or struts 36 of the scaffold structure. Since the inner layer 40a and outer layer 40b extend outward and inward, respectively, it will be understood that they may contact each other and / or form an interface region within the space (e.g., opening, cell, gap) 46 within the wall of the scaffold structure of the stent 10. For example, the detail view in Figure 3 shows that both the inner layer 40a and outer layer 40b may extend into openings 46 defined between adjacent stent struts 36, forming an interface region. Furthermore, the inner layer 40a and outer layer 40b may extend further between adjacent filaments or struts 36, thereby filling any space between adjacent filament or strut members 36 and thus preventing the intrusion and growth of tissue into the lumen of the stent 10.

[0032] The magnetic members 52 can be arranged in several different patterns such that they extend along the length and / or circumference of the stent 10. In some examples, each opening 46 may contain a magnetic member 52, as shown in Figures 2A and 2B. However, this is not required. Figures 4A to 4H show exemplary side views of the stent 10 with the magnetic members 52 arranged in different regular or irregular arrangements. One or more magnetic members 52 can be spaced apart along the length and / or circumference of the stent 10. As shown in Figure 4A, some openings 46 may not have a magnetic member 52 or may not contain one. Figure 4A shows magnetic members 52 distributed generally uniformly along the length of the stent 10, but this is not required. In another example, as shown in Figure 4B, the magnetic members 52 can be arranged as one or more longitudinal arrangements. The longitudinal arrangement may be evenly or eccentrically spaced along the circumference of the stent 10, and may be spaced over the entire circumference of the stent 10 or over a shorter area. Furthermore, the stent 10 may include, as necessary, only a single arrangement of magnetic members 52 or two or more arrangements. The longitudinal arrangement may extend over the entire length of the stent 10 or over a shorter area, as necessary. The longitudinal arrangement does not need to extend continuously along the length of the stent 10. For example, the arrangement may include gaps or spaces within the arrangement.

[0033] Furthermore, in some embodiments, the magnetic members 52 are not limited to being located within the opening 46. For example, the magnetic members 52 may be located above and / or below one or more struts 36. In another example, as shown in Figure 4C, the magnetic members 52 may be located as one or more longitudinally extending magnetic members 52. The longitudinally extending magnetic members 52 may be located evenly or eccentrically along the circumference of the stent 10, and may be located over the entire circumference of the stent 10 or over a shorter period. Furthermore, the stent 10 may optionally include only a single longitudinally extending magnetic member 52 or two or more longitudinally extending magnetic members 52. The longitudinally extending magnetic members 52 may optionally extend over the entire length of the stent 10 or over a shorter period. The longitudinally extending magnetic members 52 do not need to extend continuously along the length of the stent 10. For example, a magnetic member 52 extending in the longitudinal direction may contain gaps or spaces within the magnetic member 52.

[0034] In another example, as shown in Figure 4D, the magnetic members 52 may be arranged as one or more circumferential arrangements. The circumferential arrangement may be spaced evenly or eccentrically along the length of the stent 10, and may be spaced over the entire length of the stent 10 or a shorter range. Furthermore, the stent 10 may include only a single arrangement of magnetic members 52 or two or more arrangements, as needed. The circumferential arrangement may extend around the entire circumference of the stent 10, or over a shorter range, as desired. The circumferential arrangement does not need to extend continuously along the circumference of the stent 10. For example, the circumferential arrangement may include gaps or spaces within the arrangement. In another example, as shown in Figure 4E, the magnetic members 52 may be arranged as one or more circumferentially extending magnetic members 52. The circumferentially extending magnetic members 52 may be evenly or eccentrically spaced along the length of the stent 10, and may be spaced over the entire length of the stent 10 or a shorter range. Furthermore, the stent 10 may optionally include only a single circumferentially extending magnetic member 52, or two or more circumferentially extending magnetic members 52. The circumferentially extending magnetic members 52 may optionally extend around the entire circumference of the stent 10, or over a shorter range. The circumferentially extending magnetic members 52 do not need to extend continuously along the circumference of the stent 10. For example, the circumferentially extending magnetic members 52 may include gaps or spaces within the magnetic members 52.

[0035] In another example, as shown in Figure 4F, the magnetic members 52 may be arranged as one or more helical arrangements. The helical arrangements may be spaced evenly or eccentrically along the length of the stent 10, and may be spaced or extend over the entire length and / or circumference of the stent 10 or a shorter range. Furthermore, the stent 10 may include only a single arrangement of magnetic members 52 or two or more arrangements, as necessary. The helical arrangements do not need to extend continuously along the length and / or circumference of the stent 10. For example, the helical arrangements may include gaps or spaces within the arrangement. In another example, as shown in Figure 4G, the magnetic members 52 may be arranged as one or more helical arrangements of magnetic members 52. The spirally extending magnetic members 52 may be evenly or eccentrically spaced along the length of the stent 10, and may be spaced or extend over the entire length and / or circumference of the stent 10 or over a shorter area. Furthermore, the stent 10 may, as desired, include only a single spirally extending magnetic member 52 or two or more spirally extending magnetic members 52. The spirally extending magnetic members 52 do not need to extend continuously along the length and / or circumference of the stent 10. For example, the spirally extending magnetic members 52 may include gaps or spaces within the magnetic members 52.

[0036] As shown in Figure 4H, the magnetic members 52 may be clustered at the proximal end 14 and / or distal end 16 of the stent 10, while the intermediate region 18 is intended to be free of magnetic members 52. In yet another example, the intermediate region 18 may contain magnetic members 52, while the proximal end 14 and / or distal end 16 of the stent 10 are free of magnetic members 52. These are just some examples of possible arrangements of the magnetic members 52. It should be understood that the magnetic members 52 may be arranged in any regular or irregular arrangement as desired. Figures 4A to 4H generally show the magnetic members 52 as individual elements within the opening 46 between the struts 36 or as elongated strips, but in some cases the magnetic members 52 may be incorporated into the entire coating 40 or a selected area thereof. The stent 10 may further include magnetic members 52 as any combination of separate elements within the opening 46, elongated strips extending over at least one strut 36, and / or elongated strips incorporated into the entirety or a region of the coating 40.

[0037] The magnetic member 52 may be a colloid, such as a silicone substrate mixed with a predetermined amount of ferromagnetic material or other magnetic material, but is not limited to these. In some examples, the ferromagnetic material may be carbonyl iron powder. Other ferromagnetic materials include, but are not limited to, iron, cobalt nickel, rare earth metals, and / or alloys or compounds thereof. It is intended that other types of magnetic materials, such as ferrimagnets, may also be used, but is not limited to these. The colloid may be mixed using a standard mixing process. Carbonyl iron powder is available with fillers of various lengths and densities that can be added to the silicone substrate to adjust the magnetic properties of the magnetic member 52. The colloidal coating may be applied via dip coating, spray coating, or manually in sleeve form.

[0038] In one example, an inner layer 40a or a base layer (e.g., a silicone layer) may be formed on the strut 36. A colloid containing a ferromagnetic material or other ferromagnetic components may then be dropped or added to specific locations. The colloid may adhere to the base layer. Then, if desired or necessary, an outer layer 40b may be optionally applied over the inner layer 40a and the colloid to encapsulate the colloid. In such an example, the inner layer 40a and / or the outer layer 40b may be immersed or sprayed as in each case. Alternatively, the inner layer 40a and / or the outer layer 40b and / or the colloid may be formed as a sleeve and applied to the stent 10 in sleeve form.

[0039] Various coating techniques allow the magnetic member 52 to be applied to very specific areas of the stent 10 in any desired pattern to achieve the desired effect. Furthermore, it is intended that the mechanical properties of the stent 10 can be adjusted or customized by using coating materials (e.g., various silicones, but not limited to these) having different or variable mechanical properties to achieve the desired effect. In one exemplary example, a silicone with higher elasticity and higher flexibility may be used for a stent adapted for use in more meandering areas of the body. This is just one example.

[0040] In general, when a magnetic field is applied, the magnetic members 52 may move radially outward or radially inward relative to the stent framework (e.g., struts 36). The movement of each magnetic member 52 may be localized within the cell space 46 if the magnetic members 52 are provided as separate elements within the opening 46. For example, the magnetic members 52 may move radially inward and / or radially outward, but not circumferentially and / or longitudinally.

[0041] The magnetic member 52 may be selectively exposed to a magnetic field to move the coating 40 of the stent 10. For example, a local magnetic field may be generated by a custom-made or made-to-order mobile console configured to be positioned outside the patient. The console may generate an alternating magnetic field that generates oscillating attractive and repulsive forces on the magnetic member 52 embedded in the coating 40 of the stent 10. As the magnetic field oscillates, the magnetic member 52 may move or oscillate, causing the coating 40 to move or oscillate. This can facilitate the movement of bile, gallstones, food, or other bodily fluids or debris through the stent 10 and may help prevent occlusive events.

[0042] Figure 5A shows a partial side view of an exemplary stent 10 including the magnetic member 52 before magnetization, and Figure 5B shows a partial side view of the exemplary stent 10 of Figure 5A including the magnetic member 52 after magnetization. As shown in Figures 5A and 5B, the magnetic member 52 is applied to a specific region of the stent 10. For example, the magnetic member 52 does not cover the entire stent 10 or extend across the entire stent 10. When magnetization is applied, localized movement of the magnetic member 52 may occur. For example, in the illustrated example, magnetization causes the magnetic member 52 and the coating 40 to move radially outward from the plane of the strut 36, while keeping each magnetic member 52 within a specific cell region 46. In the absence of magnetization, the elasticity of the coating 40 is intended to allow the coating 40 to return to a form in which the coating 40 is generally in the plane of the strut 36. Alternatively or additionally, due to the elasticity of the coating 40, the coating 40 may extend radially inward within the lumen 32 of the stent 10, at least temporarily. If the struts 36 of the stent 10 are formed from or contain a magnetic material, the struts 36 are intended to be able to move in response to an applied magnetic field. Struts 36 formed from a polymer material are intended to be unaffected by an applied magnetic field.

[0043] Figure 6 shows a schematic diagram of an exemplary stent 10 placed in the biliary system. In the illustrated example, the stent 10 is placed in the bile duct 100 and is positioned across the stricture 102. The distal end 16 of the stent 10 passes through a papillary mass 104 and extends into the duodenum 108 through the duodenal wall 106. The stent 10 may be placed in the biliary system by endoscopic retrograde cholangiopancreatography (ERCP). For example, the stent 10 may be guided to the bile duct site and subsequently deployed as shown in Figure 6. The patient may be discharged with the stent 10 in place. For subsequent maintenance of the stent 10 after a certain period (e.g., to prevent occlusion of the stent lumen 32), the patient may be guided through non-invasive treatment options. For example, the stent 10 may be periodically exposed to a magnetic field to move the magnetic member 52 and coating 40, thereby removing or preventing occlusion within the lumen 32 of the stent 10. The interval between magnetic field applications is intended to vary depending on, among other factors, whether the patient is symptomatic (e.g., showing signs of occlusion). In some cases, the interval between magnetic field applications may range from minutes, hours, days, weeks, or months. It is further intended that the magnetic field may be applied in outpatient facilities, phased treatment facilities, or as a home care option under appropriate guidance. Applying a magnetic field to the stent 10 may be a less invasive and less costly intervention compared to surgical correction of the occlusion.

[0044] Figure 7 shows a schematic diagram of an exemplary arrangement of a console 200 for generating a magnetic field on the body of patient 202. The console 200 is positioned outside of patient 202, adjacent to the desired treatment area. In Figure 7, the console 200 is positioned adjacent to the biliary system. The console 200 is intended to be positioned at any location on patient 202, including, but not limited to, the anterior, posterior, left, or right side, in order to achieve the desired treatment.

[0045] Figure 8 shows a perspective view of an exemplary console system 204. The console system 204 may be portable and / or wearable so that a user can apply a magnetic field in a clinical setting, at home, or while going about their daily activities. The console system 204 may include a main body 206 defining a pocket or recess 208. The pocket 208 may be sized and molded to receive the console 200. One or more straps 210a, 210b may extend from the main body 206. One or more straps 210a, 210b may be secured around the body of a patient 202 so that the patient 202 can operate the console 200 hands-free. The length of the straps 210a, 210b may be adjustable to accommodate different body parts and / or different body types. Each of the straps 210a, 210b may include fastening mechanisms 212a, 212b adjacent to its free ends 214a, 214b. The fastening mechanisms 212a, 212b may be releasably coupled to one another so as to allow the straps 210a, 210b to be releasably secured around the patient 202. Some exemplary fastening mechanisms 212a, 212b may include, but are not limited to, hook-and-loop fasteners, snap mechanisms, buttons, zippers, etc. Upon activation, the console 200 generates a local magnetic field that can attract and / or repel the magnetic member 52 within the stent 10. In some embodiments, the console 200 can generate an alternating magnetic field that can periodically generate oscillating attractive and repulsive forces on the magnetic member 52 embedded in the coating 40 of the stent 10, thereby moving the coating 40 radially outward and radially inward, thereby promoting the continued movement of the sludge material. The frequency of the oscillations is intended to be tuned to achieve the desired effect. In another example, a periodic field transitioning from pulsed attraction to neutrality may be applied. In this case, the magnetic member 52 does not necessarily need to be magnetically charged in its own embodiment.Alternatively, the magnetic field can attract the magnetic member 52 in the coating 40 toward a supply source applied via the console 200, and when the supply source is removed, the magnetic member 52 bounces back to its original position due to the elasticity of the coating 40, causing the magnetic member 52 and / or the coating 40 to temporarily overshoot and protrude into the lumen 32 of the stent 10, thus causing confusion in the coating 40 and promoting the continued movement of the sludge material.

[0046] The vibration frequency of the magnetic field, whether alternating or pulsed, can be controlled and adjusted via the console 200. For example, the frequency may be increased for more vigorous movement of the coating 40 of the stent 10, or decreased for gentler movement of the coating 40 of the stent 10. In some examples, increasing the frequency may increase the radial distance over which the coating 40 of the stent 10 is displaced. As described above, the movement or vibration of the coating 40 of the stent 10, though not limited to these, may facilitate the continued movement of internal materials such as sludge, bile, and lithotripsy debris through the lumen 32 of the stent 10, thereby preventing or minimizing stagnation and occlusion. Furthermore, the movement of the coating 40 may inhibit the adhesion of occlusive precursor materials such as biofilms to the surface of the stent 10. If sludge, bile, lithotripsy debris, biofilms, etc., are left undispersed, it is thought that this could lead to premature occlusion or other malfunctions of the stent 10.

[0047] In some embodiments, the magnetic field can be selectively applied along the length of the stent 10. Figures 9A to 9C show partial cross-sectional views of the stent 10 when the magnetic field is selectively applied. In Figure 9A, the stent 10 is in its initial state with no magnetic field applied. As shown, the inner layer 40a of the coating, the outer layer 40b of the coating, and the magnetic members 52 are either coplanar or substantially parallel to the plane of the strut 36. In Figure 9B, a magnetic field is applied to the first region 60 of the stent 10, but the magnetic field applied to the second region 62 of the stent 10 is zero or no magnetic field is applied. In the presence of the applied magnetic field, the magnetic members 52 in the first region 60 are attracted radially outward from their initial configuration, as shown in Figure 9B, while the magnetic members 52 in the second region 62 remain stationary. In Figure 9C, the magnetic field is removed from the first region 60 and applied to the second region 62. When the magnetic field is removed from the first region 60, the elasticity of the inner layer 40a and outer layer 40b causes the coating 40 and magnetic member 52 to bounce or move radially inward within the lumen 32 of the stent 10, at least temporarily, as shown in Figure 9C. Furthermore, the magnetic member 52 in the second region 62 is attracted radially outward from its initial form. When the magnetic field is removed from the second region 62, the magnetic member 52 may move radially inward. Selective activation of the magnetic field across a specific region of the stent 10 may allow the coating of the stent 10 to undulate in a wave-like pattern along its length. Furthermore, it is intended that an alternating magnetic field may be used to generate wave-like motion along the length of the stent 10. However, this is not essential. In some embodiments, the entire stent 10 may be exposed to the magnetic field simultaneously. In yet another embodiment, a magnetic field can be applied to the region of the stent 10 adjacent to the stenosis 102 or another diseased area to cause the stent 10 to pulsate in the stenosis 102, thereby manipulating the stenosis.

[0048] As described above, the magnetic members 52 can be distributed in several different arrangements along the longitudinal and / or circumferential directions of the stent 10. In some examples, the magnetic members may be positioned to suit a particular condition during treatment or the estimated location of a potential obstruction. For example, if an obstruction is predicted to potentially occur higher up in the bile duct (e.g., potentially due to stones, debris, etc.), the magnetic members 52 may be positioned closer to the proximal end 14 of the stent 10. In another example, if an obstruction is predicted to potentially occur lower down on the stent 10 (e.g., potentially due to food obstruction, etc.), the magnetic members 52 may be positioned closer to the distal end 16 of the stent 10 (e.g., closer to the duodenal end).

[0049] It is further anticipated that removal of the stent 10 after a predetermined period of placement may be difficult. For example, adhesive buildup between the outer coating 40b of the stent 10 and the lumen wall and / or between residual bile and the surrounding lumen wall may hinder the removal of the stent 10. Adhesive buildup may be exacerbated by the radial force of the struts 36 of the stent 10 and / or the presence of pores in the coating 40 that allow for tissue intrusion and growth. Routine exposure to a controlled magnetic field generated by the magnetic source 200 is intended to cause the coating 40, including the magnetic members 52, to vibrate, move, and oscillate, as described herein, thereby influencing and promoting the temporary separation of the stent 10 from the surrounding lumen and the breakdown of the temporary adhesive bond. This may allow the stent 10 to be maintained in a weaker bond state, making removal easier. Repeated exposure to a magnetic field at predetermined intervals may prevent or minimize the long-term implantation of the stent 10 in the lumen wall, thereby improving its removeability. Similarly, localized movement of the coating 40 and magnetic member 52 may separate tissue intrusion growth from pores in the coating 40, potentially allowing for easier stent removal. Thus, if the stent 10 is to be removed after the implantation period, a pre-intervention magnetic field exposure program is intended to facilitate easier stent removal. In yet another example, the magnetic field may be strategically applied to allow for remote removal of the stent 10 while it is passing through natural blood vessels, without the need to insert additional medical devices into the body.

[0050] Furthermore, by incorporating a coating 40 containing a magnetic member 52 into a partially coated (PC) stent, efficient removal of the stent 10 may be possible, even when the partially coated stent is designed for tissue penetration and growth. Typically, partially coated stents may require prior argon plasma coagulation (APC), overtube techniques (OT), and / or stent-in-stent (SIS) techniques if removal is necessary, all of which can increase the overall cost and / or complexity of the procedure. Figure 10 shows a side view of another exemplary intraluminal implant 300, including but not limited to a stent. The stent 300 may be similar in shape and function to the stent 10 described herein. In some cases, the stent 300 may be formed from an elongated tubular member 302. Although the stent 300 is described as substantially tubular, it is intended that the stent 300 may take any desired cross-sectional shape. The stent 300 may have a first end, i.e., a proximal end 304, a second end, i.e., a distal end 306, and an intermediate region 308 located between the first end 304 and the second end 306. The stent 300 may include a lumen 310 extending from a first opening adjacent to the first end 304 to a second opening adjacent to the second end 306, thereby allowing the passage of food, fluids, etc.

[0051] The stent 300 may be expandable from a first radially folded form (not explicitly shown) to a second radially expanded form. In some examples, the stent 300 may be deployed to a form between the folded form and the fully expanded form. The stent 300 may be configured to extend across the constriction and apply radially outward pressure to the constriction within the lumen, thereby opening the lumen and allowing the passage of material.

[0052] In some embodiments, the proximal end 304 of the stent 300 may include a plurality of loops 312. The loops 312 may be configured to receive a retrieval tether or suture (not explicitly shown) which is woven through the plurality of loops 312 or which passes through one or more of the plurality of loops 312 in a different manner. The retrieval suture may be used to fold and retrieve the stent 300 as needed. For example, the retrieval suture can be pulled like a drawstring to radially contract the proximal end 304 of the stent 300, making it easier to remove the stent 300 from the body lumen.

[0053] The stent 300 may have a woven structure made from a number of filaments or struts 314 forming a tubular wall. In some embodiments, the stent 300 may be knitted or braided from single filaments or struts, each of which is woven together and defines an opening cell 316 extending over the thickness of the tubular wall of the stent 300. In other embodiments, the stent 300 may be braided so that a plurality of filaments or struts are woven together to define an opening cell 316 extending circumferentially along the length of the tubular wall of the stent 300. Each opening cell 316 may define an opening (e.g., across the thickness of the tubular wall) from the outer surface of the tubular wall to the inner surface of the tubular wall, without containing filaments or struts 314. In yet another embodiment, the stent 300 may be knitted. In yet another embodiment, the stent 300 may be knotted. In yet another embodiment, the stent 300 may be a laser-cut tubular member. Laser-cut tubular members may have open-cell geometry and / or closed-cell geometry, including one or more interconnected, integrated filaments or struts defining opening cells 316 between them, the opening cells 316 may extend circumferentially along the length of the tubular wall. Each opening cell 316 may define an opening (e.g., across the thickness of the tubular wall) from the outer surface of the tubular wall to the inner surface of the tubular wall, without including interconnected, integrated filaments or struts. In some examples, the inner and / or outer surfaces of the tubular wall of the stent 300 may be partially covered by a polymer coating or coating 318. The coating or coating 318 may extend over one or more cells 316 defined by struts or filaments 314 and / or occlude the cells 316. The coating 318 may consist of two or more layers and may be similar in shape and function to the coating 40 described herein. In some cases, the stent 300 may be a self-expanding stent (SES), but this is not mandatory.

[0054] The coating 318 may partially cover the open cells 316 while leaving some cells 316 or circumferential regions 320a, 320b uncoated. The uncoated regions 320a, 320b may allow tissue invasion and growth in selected areas of the stent 300. In the illustrated embodiment, the stent 300 includes two regions 320a, 320b that are largely or mostly uncoated. The first region 320a may be located close to the proximal end 304 and longitudinally spaced from the proximal end 304, and the second region 320b may be located close to the distal end 306 and longitudinally spaced from the distal end 306. This is just one example. The predominantly uncoated regions 320a and 320b are intended to begin at the proximal end 304 or the distal end 306, respectively, or to extend to the proximal end 304 or the distal end 306. Other configurations of the predominantly uncoated regions 320a and 320b may be used as desired. In some examples, the stent 300 may include only a single uncoated region or may include two or more uncoated regions.

[0055] In some examples, in a radially extended configuration, the stent 300 may include a first end region 322 adjacent to the proximal end 304 and a second end region 324 adjacent to the second end 306. In some embodiments, the first end region 322 and the second end region 324 may include retaining or anti-movement flared regions 326, 328 having a diameter enlarged relative to the intermediate portion 308. The anti-movement flared regions 326, 328, which may be positioned adjacent to the first end 304 and the second end 306 of the stent 300, may be configured to engage with the inner portion of the body lumen wall. In some embodiments, the retaining or flared regions 326, 328 may have a larger diameter than the cylindrical intermediate region 308 of the stent 300 to prevent it from moving after it has been placed in the body lumen. The transitions 330 and 332 from the cross-sectional area of ​​the intermediate region 308 to the holding function portion or the flared regions 326 and 328 are intended to be gradual, inclined, or abruptly stepped, as desired.

[0056] In some embodiments, the first anti-movement flare region 326 may have a first outer diameter, and the second anti-movement flare region 328 may have a second outer diameter. In some examples, the first and second outer diameters may be substantially the same, while in other examples, the first and second outer diameters may be different. In some embodiments, the stent 300 may include only one of the anti-movement flare regions 326, 328, or neither. For example, the first end region 322 may include an anti-movement flare 326, and the second end region 324 may have an outer diameter similar to that of the intermediate region 308. It is further intended that the second end region 324 may include an anti-movement flare 328, and the first end region 322 may have an outer diameter similar to that of the intermediate region 308. In some embodiments, the stent 300 may have a uniform outer diameter from the first end 304 to the second end 306. The outer diameter of the stent 300 is intended to be modified to suit the desired application.

[0057] The elongated tubular members of the stent 300 may be made from a variety of materials, including but not limited to metals, metal alloys, shape memory alloys, and / or polymers, as desired, so that the stent 300 can expand to a desired shape when precisely positioned within the body. In some examples, the material may be selected so that the stent 300 can be removed relatively easily. For example, the elongated tubular members of the stent 300 may be formed from alloys such as (but not limited to) nitinol and Elgiloy®. Depending on the material selected for construction, the stent 300 may be self-expanding or may require external force to expand. In some embodiments, a composite filament may be used to fabricate the stent 300, which may include, for example, an outer shell or cladding layer made from nitinol and a core formed from platinum or other radiopaque material. It is further intended that the elongated tubular members of the stent 300 may be formed from a polymer such as polyethylene terephthalate (PET) (but not limited to PET). In some examples, the filaments or parts thereof of the stent 300 may be bioabsorbable or biodegradable, and in other examples, the filaments or parts thereof of the stent 300 may be biostable.

[0058] The stent 300 may include one or more magnetic components 334. One or more magnetic components 334 may be similar in shape and function to the magnetic members 52 described herein. For example, the magnetic components 334 may be embedded between the inner and outer layers of the coating 318. However, this is not required. In some cases, the magnetic components 334 may be located on the inner surface of the inner layer or the outer surface of the outer layer of the coating 318. One or more magnetic components 334 may be colloids, such as a silicone substrate mixed with a predetermined amount of ferromagnetic material or other magnetic material, but are not limited to these.

[0059] The magnetic components 334 may be positioned adjacent to or extending within the mostly uncoated regions 320a, 320b. The magnetic components 334 may be arranged in any uniform or non-uniform configuration as desired. In some examples, the magnetic components 334 may be individual elements positioned within the cell 316. In other cases, the magnetic components 334 may be elongated bars or strips. In yet another case, the magnetic components 334 may substantially cover a portion of the stent 300. In some embodiments, an "island" or region of coating 318, including one or more magnetic components 334, may extend within the substantially uncoated regions 320a, 320b. This allows for areas of tissue invasion and growth, while the movement of the magnetic components 334 in response to the applied magnetic field may cause the mostly uncoated regions 320a, 320b to move, thereby facilitating tissue detachment. Stents, delivery systems, and their various components may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, and equivalents, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steel (e.g., 304V, 304L, and 316LV stainless steel); mild steel; nickel-titanium alloys (e.g., linear elastic and / or superelastic nitinol); other nickel alloys (e.g., nickel-chromium-molybdenum alloys, nickel-copper alloys, nickel-cobalt-chromium-molybdenum alloys, nickel-molybdenum alloys, 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; platinum-enriched stainless steel; titanium; combinations thereof, etc.; or any other suitable material.

[0060] Some examples of suitable polymers for stents or delivery systems include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene (ETFE), fluoroethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as HYTREL® available from DuPont), and polyamides (e.g., DURETHAN® or Elf available from Bayer). Available from Atochem: CRISTAMID®, elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., available under trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS American (e.g., GRILAMID® available from Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-β-isobutylene-β-styrene) (e.g., SIBS and / or SIBS)50A) may include polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like.

[0061] In at least some embodiments, part or all of the stent or delivery system may also be doped with, fabricated from, or otherwise incorporate radiopaque material. Radiopaque material is generally understood to be a material (with a thickness greater than 0.005 inches) that is opaque to RF energies in the wavelength range from X-rays to gamma rays. These materials can produce a relatively dark image on a fluoroscopy screen compared to the bright image produced by non-radiopaque materials such as tissue. This relatively bright image helps the user of the stent or delivery system determine its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, and equivalents. Furthermore, other radiopaque marker bands and / or coils may also be incorporated into the design of the stent or delivery system to achieve the same result.

[0062] It should be understood that this disclosure is illustrative in many respects. Modifications may be made in detail, particularly with respect to shape, size, and process arrangement, without departing from the scope of this disclosure. This may include, to an appropriate extent, the use of any feature of one exemplary embodiment in other embodiments. The scope of this disclosure is, of course, defined in the language expressing the appended claims.

Claims

1. It is a stent, An elongated tubular member comprising at least one strut forming a tubular wall, wherein the tubular wall has a plurality of cells extending through the thickness of the tubular wall, and the elongated tubular member is configured to move between a radially folded form and a radially expanded form, A coating is provided on the elongated tubular member and extends across at least a portion of the plurality of cells, A stent comprising one or more magnetic members disposed on or within the coating.

2. The stent according to claim 1, wherein the coating includes an inner layer and an outer layer.

3. The stent according to claim 2, wherein the one or more magnetic members are disposed between the inner layer and the outer layer of the coating.

4. The stent according to any one of claims 1 to 3, wherein the one or more magnetic members are individual elements disposed within at least a portion of the plurality of cells.

5. The stent according to any one of claims 1 to 3, wherein the one or more magnetic members are elongated strips extending over at least one strut.

6. The stent according to any one of claims 1 to 5, wherein the one or more magnetic members are arranged at intervals along the length of the elongated tubular member.

7. The stent according to any one of claims 1 to 6, wherein the one or more magnetic members are arranged at intervals along the circumference of the elongated tubular member.

8. The stent according to any one of claims 1 to 7, wherein the coating forms pockets within at least some of the plurality of cells.

9. The stent according to any one of claims 1 to 8, wherein the coating extends from the proximal end to the distal end of the elongated tubular member.

10. The stent according to any one of claims 1 to 8, wherein the coating covers an area shorter than the entire length of the elongated tubular member.

11. The stent according to claim 10, wherein at least one of the one or more magnetic components is disposed adjacent to an uncoated area of ​​the elongated tubular member.

12. The stent according to any one of claims 1 to 11, wherein the one or more magnetic members include a silicone substrate and a magnetic material.

13. The stent according to claim 12, wherein the magnetic material comprises carbonyl iron.

14. The stent according to any one of claims 1 to 13, wherein one or more magnetic members are configured to move radially inward and / or radially outward in response to an applied magnetic field.

15. The stent according to claim 14, wherein the applied magnetic field is a pulsed magnetic field or an alternating magnetic field.

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