IMPLANTABLE MEDICAL DEVICE HAVING VISUAL INDICATOR - Patent application

Abstract

The implantable medical device includes an elongate body extending from a distal region to a proximal region, where at least one of the distal region and the proximal region includes a flared region defining an inner flared surface, and the one or more visual indicators are positioned relative to the inner flared surface such that the one or more visual indicators are endoscopically viewable from within or adjacent to the implantable stent.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to implantable medical devices. More particularly, the present disclosure is directed to implantable medical devices that include a visual indicator that indicates the relative orientation of the implantable medical device upon implantation. [Background technology]

[0002] A variety of implantable medical devices are implanted within the human body for a variety of different purposes. Some implantable medical devices are agnostic as to the relative position at which the implantable medical device is implanted within an internal body structure. The internal body structure may include, for example, the interior of an organ or a portion of a body lumen, such as the esophagus, trachea, colon, bile duct, vasculature, etc. In some cases, the implantable medical device may be bilaterally symmetrical, or top-bottom symmetrical, or front-to-back symmetrical. In some cases, however, it may be desirable to know the relative orientation of the implantable medical device. For example, the relative rotational orientation of the implantable medical device about its axis relative to the internal body structure may be of interest. For example, an indication of the relative orientation of the implantable medical device relative to sagittal, coronal, and / or transverse planes through the human body may be desirable. In some cases, an indication of the orientation of the implantable medical device relative to a vertically upward position (i.e., superior orientation), or which portion of the implantable medical device is oriented in a vertically downward position (i.e., inferior orientation), or perhaps an intermediate position relative to the vertical, may be desirable. There remains a need for an implantable medical device that includes a visually perceptible method for determining the relative orientation of the implantable medical device upon implantation. Summary of the Invention

[0003] The present disclosure provides design, material, manufacturing, and use alternatives for medical devices. As an example, an implantable stent includes an elongate body extending from a distal region to a proximal region, the elongate body including one or more filaments woven together to form the elongate body, the elongate body defining an outer stent surface and an inner stent surface. One or more visual indicators are positioned relative to the inner stent surface such that the one or more visual indicators are endoscopically viewable from within or proximate to the implantable stent.

[0004] Alternatively, or in addition, the distal or proximal region may include a flared end, the inner stent surface extending into the flared end, and the one or more visual indicators positioned relative to the inner stent surface in the flared end.

[0005] Alternatively, or in addition, the one or more visual indicators may include two or more visual indicators equally spaced circumferentially on the inner stent surface, each of the two or more visual indicators being visually distinguishable from the other position indicators.

[0006] Alternatively, or additionally, at least some of the two or more visual indicators may include objects fixed relative to the inner stent surface. Alternatively, or in addition, the implantable stent may further include a polymeric coating over at least a portion of the elongate body.

[0007] Alternatively, or additionally, at least some of the two or more visual indicators may include a color change induced in the polymer coating. Alternatively, or in addition, at least one of the one or more visual indicators may include a radiopaque material.

[0008] As another example, an implantable medical device is adapted to be deployed with an endoscope. The implantable medical device includes an elongate body extending from a distal region to a proximal region, at least one of the distal region and the proximal region including a flared region defining an inner flared surface. Two or more visual indicators are secured relative to the inner flared surface, each of the two or more visual indicators positioned to be viewable with an endoscope.

[0009] Alternatively or additionally, each of the two or more visual indicators may be visually distinguishable from others of the two or more visual indicators. Alternatively or additionally, each of the two or more visual indicators may include a color that is different from the color of any other of the two or more visual indicators.

[0010] Alternatively, or in addition, the implantable medical device may include three visual indicators equally spaced on the inner flared surface. Alternatively, or in addition, the implantable medical device may include four visual indicators equally spaced on the inner flared surface.

[0011] Alternatively, or additionally, at least some of the two or more visual indicators may include objects fixed relative to the inner flared surface. Alternatively, or in addition, the implantable medical device may further include a polymeric coating covering at least a portion of the elongate body.

[0012] Alternatively, or additionally, at least some of the two or more visual indicators may include a color change induced in the polymer coating. Alternatively, or in addition, at least one of the two or more visual indicators may include a radiopaque material.

[0013] As another example, an implantable stent includes an elongate body extending from a distal region to a proximal region, the elongate body including one or more filaments woven together to form the elongate body, the elongate body movable between a collapsed configuration for delivery and an expanded configuration for deployment, the elongate body including a main segment of constant diameter and a flared end segment, the flared end segment including an inner flared surface and an outer flared surface, and a plurality of visual indicators secured relative to the inner flared surface such that each of the plurality of visual indicators is viewable with an endoscope.

[0014] Alternatively, or in addition, the multiple visual indicators may include three visual indicators equally spaced on the inner stent surface, each of the three visual indicators being a unique color relative to the other two visual indicators.

[0015] Alternatively or additionally, the plurality of visual indicators may include four visual indicators equally spaced on the inner stent surface, each of the four visual indicators being a unique color relative to the other three visual indicators.

[0016] Alternatively, or in addition, at least some of the plurality of visual indicators may include a pigment added to a portion of a polymeric coating disposed on the elongate body. The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments.

[0017] A more complete understanding of the present invention can be obtained from the following detailed description of various embodiments of the invention in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0018] [Figure 1]1 is a schematic diagram of an exemplary implantable medical device implanted within the pyloric sphincter of a patient's stomach and a visualization device deployed with an endoscope to provide visualization of the exemplary implantable medical device. [Diagram 2] 2 is a perspective view of the exemplary implantable medical device of FIG. 1. [Diagram 3] 2 is an end view of the exemplary implantable medical device of FIG. 1 including a total of four visual indicators. [Figure 4] 1 is a side view of an exemplary implantable medical device. [Figure 4A] 5 is an enlarged view of a portion of the exemplary implantable medical device of FIG. 4. [Diagram 5] 5 is a cross-sectional view taken along line 5-5 of FIG. 4. [Figure 6] 1 is a schematic end view of an exemplary implantable medical device including a total of four visual indicators. [Figure 7] 1 is a schematic end view of an exemplary implantable medical device including a total of three visual indicators. [Figure 8] 1 is a schematic end view of an exemplary implantable medical device including a total of four visual indicators. [Figure 9] 1 is a schematic end view of an exemplary implantable medical device including a total of three visual indicators. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] While the present disclosure is amenable to various modifications and alternative forms, details of which have been shown by way of example in the drawings and will be described in detail. It is to be understood, however, that the invention is not intended to limit the disclosure to the particular embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0020] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. In this specification, all numerical values, whether expressly stated or not, are assumed to be modified by the term "about." The term "about" generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" can include numbers that are rounded to the nearest significant figure.

[0021] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0022] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0023] FIG. 1 is a schematic diagram of an exemplary implantable medical device 10, shown as a stent, implanted within a pyloric sphincter 12 of a patient's stomach 14. FIG. 2 is a perspective view of the implantable medical device 10. The stomach 14 is shown partially cut away to visualize the implantable medical device 10 and the pyloric sphincter 12. It will be appreciated that the pyloric sphincter 12 functions as a one-way valve, passing partially digested food from the patient's stomach 14 to the duodenum 16 for further digestion. In some cases, the pyloric sphincter 12 itself may not be adequate to perform this function, or at least to perform this function adequately. Various medical conditions may contribute to the loss of this function, for example. The loss of function of the pyloric sphincter 12 may worsen or even cause other medical conditions.

[0024] Accordingly, the patient's medical condition may suggest the implantation of an implantable medical device 10. In this regard, the implantable medical device 10 may have an overall shape that facilitates implantation into the pyloric sphincter 12, including a proximal region 18 and a distal region 20. The proximal region 18 includes a fixation flange or ring 22, an inflow region 24, and a tapered region 26. The distal region 20 includes a fixation flange or ring 28, an outflow region 30, and a tapered region 32. An intermediate region 34 joins the tapered region 26 of the proximal region 18 to the tapered region 32 of the distal region 20. It will be appreciated that partially digested food traveling through the stomach 14 enters the inflow region 24, is guided through and passes into the tapered region 26, passes through the intermediate region 34, is guided through and passes into the tapered region 32, and exits the outflow region 30. As a result, implantable medical device 10 can be configured to limit the rate at which partially digested food leaves stomach 14 and enters small intestine 16 , thereby limiting reflux from small intestine 16 back into stomach 14 .

[0025] It will be appreciated that fixation ring 22 is configured to fit against a proximal portion of pyloric sphincter 12 and fixation ring 28 is configured to fit against a distal portion of pyloric sphincter 12. Together, fixation ring 22, 28, along with tapered region 26 and tapered region 32, conform to the natural anatomy of pyloric sphincter 12 and serve to anchor implantable medical device 10 relative to pyloric sphincter 12. Fixation ring 22, 28 may be sized to resist the natural peristaltic movement of stomach 14 to help hold implantable medical device 10 in place.

[0026] In some cases, as shown, the implantable medical device 10 can include a tubular scaffold formed from a braided structure formed by braiding one or more filaments together. The braided structure can be formed by braiding together one or several filaments extending in a first helical direction and one or several filaments extending in a second helical direction different from the first helical direction. Each of the filaments extending in the first helical direction can extend continuously through the inflow region 24, the fixed flange or ring 22, and the tapered region 26 of the proximal region 18, and the tapered region 32, the fixed flange or ring 28, and the outflow region 30 of the distal region 20. Similarly, each of the filaments extending in the second helical direction can extend continuously through the inflow region 24, the fixed flange or ring 22, and the tapered region 26 of the proximal region 18, and the tapered region 32, the fixed flange or ring 28, and the outflow region 30 of the distal region 20. The tubular scaffold can include cells or interstices formed between adjacent filaments extending generally parallel to a first helical direction that intersect with adjacent filaments extending generally parallel to a second helical direction. At least some of the filaments can be metallic filaments. At least some of the filaments can be, for example, polymeric filaments. The implantable medical device 10 can include, for example, a polymeric covering or coating disposed over the braided structure. Individual filaments can be encapsulated within the polymeric covering or coating, especially if the polymeric covering or coating is applied by dip coating.

[0027] In some cases, the implantable medical device 10 may not be used to replace the function of the pyloric sphincter 12, but instead may be used to occlude the flow of matter through a bodily passageway, such as the pyloric sphincter 12. For example, methods of treating various medical conditions, such as obesity, diabetes, or duodenal ulcers, may include bypassing the duodenum or restricting the flow of matter through the duodenum. In some cases, the implantable medical device 10 may be used to inhibit or block the passage of matter (fluid, chyme, etc.) from the stomach 14 through the pyloric sphincter 12 to the duodenum 16. Further details regarding possible uses and the structure of the implantable medical device 10 can be found, for example, in U.S. Provisional Patent Application No. 63 / 307764, entitled "DEVICES, SYSTEMS, AND METHODS FOR OCCLUDING AN ANATOMICAL PASSAGE," filed on February 8, 2022, and U.S. Provisional Patent Application No. 63 / 307771, entitled "DEVICES, SYSTEMS, AND METHODS RESISTING MIGRATION AND METHOD OF IMPLANTATION THEREOF," filed on February 8, 2022, which are incorporated by reference into this specification.

[0028] As seen in FIG. 1 , an endoscope 36 including a visualization tool 38 located at a distal end 40 of the endoscope 36 extends through the esophagus into the stomach 14 and is in proximity to the implantable medical device 10. The visualization tool 38 can thus take the form of, for example, a lens or camera or the end of a fiber optic cable to return light to a sensor or camera, and can visualize a portion of the implantable medical device 10 after it has been implanted. It will be appreciated that once the implantable medical device 10 is implanted, only a portion of the implantable medical device 10 is visible with the endoscope, as portions of the exterior portion of the implantable medical device 10 that face and / or contact tissue are obscured by tissue and therefore cannot be readily visualized. In some cases, the visualization tool 38 can view an interior or inner surface, such as a surface 42 (see FIG. 2 ) within the proximal region 18, or an end surface of the implantable medical device 10. The visualization tool 38 can also be capable of viewing a portion of the inflow region 24 and the interior of the tapered region 26. Thus, it is possible to visually confirm the orientation, including but not limited to the rotational orientation, of implantable medical device 10 relative to the patient's anatomy.

[0029] The implantable medical device 10 includes a visual indicator disposed relative to a proximal region 18 of the implantable medical device 10 to facilitate ascertaining the relative rotational orientation of the implantable medical device 10 when the implantable medical device 10 is implanted (such as, but not limited to, implantation within the pyloric sphincter 12). The implantable medical device 10 may include one, two, three, four, or more visual indicators. Each of these visual indicators is visible to a viewing device, such as a visualization tool 38 of an endoscope 36. The visualization tool 38 of the endoscope 36 may be disposed proximal to the implantable medical device 10 where the visualization tool 38 of the endoscope 36 can view the implantable medical device 10, including its end face and / or its interior surface visible from its open end, or may extend through a lumen within the implantable medical device 10 where the visualization tool 38 of the endoscope 36 can view the interior surface of the implantable medical device 10. For example, implantable medical device 10 may include a visual indicator such that viewing proximal region 18 allows visualization of the visual indicator relative to the remainder of implantable medical device 10. This allows determination that the visual indicator is at or near a reference position (i.e., the 12 o'clock position), for example, relative to the remainder of proximal region 18.

[0030] Having two or more visual indicators can aid in determining the relative orientation of the implantable medical device 10, especially when each of the two or more visual indicators is visually distinguishable, especially when two or more visual indicators are visible but the remainder of the implantable medical device 10 is not easily seen. For example, if two visual indicators are located 180 degrees apart on a line that bisects the surface 42 and are along opposite sides of the surface 42, it is possible to visually confirm the relative rotational orientation of the implantable medical device 10 by locating the two visual indicators and determining their relative rotational positions with the visualization tool 38 of the endoscope 36. For example, one visual indicator can have a relative position of 70 degrees (with respect to a particular frame of reference provided by the visualization tool 38) and the other visual indicator can have a relative position of 160 degrees with respect to the same frame of reference. By knowing where the two visual indicators are fixed relative to the implantable medical device 10, the relative orientation of the implantable medical device 10 with respect to the body structure in which the implantable medical device 10 is implanted can be confirmed with the visualization tool 38 of the endoscope 36.

[0031] Regardless of how many visual indicators are included, in some cases, each of the visual indicators (if more than one) are visually distinguishable from one another. In some cases, each visual indicator is a different color. In some cases, each visual indicator is a different size. In some cases, each visual indicator is a different shape. Combinations of different colors, different sizes, and / or different shapes are also contemplated. For example, it will be understood that a set of two or more visual indicators can include multiple distinguishing features. For example, a first visual indicator can be round and yellow, and another visual indicator can be square and red. A first visual indicator can be small and diamond-shaped. A second visual indicator can be large and diamond-shaped. These are merely examples. The visual indicators can be formed in place on the implantable medical device 10. In some cases, the visual indicators can be formed separately and then secured in place on the implantable medical device 10.

[0032] In some cases, one or more of the visual indicators may be formed from a radiopaque material and then secured to the implantable medical device 10. Having at least one of the visual indicators formed from a radiopaque material can assist in locating the implantable medical device 10 during non-visible imaging modalities. Examples of radiopaque materials include, but are not limited to, barium sulfate, bismuth compounds, and tungsten.

[0033] 3 is an end view of the proximal region 18 of the implantable medical device 10. As seen in FIG. 3, the implantable medical device 10 includes a total of four visual indicators 44, individually labeled as 44a, 44b, 44c, and 44d. As shown, each of the four visual indicators 44 occupies one cell of the braided structure forming the implantable medical device 10. Looking at visual indicator 44d, for example, visual indicator 44d occupies a cell formed by the intersection of filaments 46, 48, 50, and 52. In some cases, at least some of the visual indicators 44 may be larger than one cell. For example, in some cases, each of the visual indicators 44 may occupy four cells or gaps of the stent scaffold in a 2×2 grid. In some cases, each of the visual indicators 44 may be a different size to make it easier to visually distinguish a particular visual indicator 44 from the other visual indicators 44.

[0034] In some cases, each of the visual indicators 44 may be a unique color to more easily identify the visual indicators 44. Some unique colors that may be used include black, white, red, blue, green, yellow, orange, purple, etc. As an illustrative but non-limiting example, for example, visual indicator 44a is white, visual indicator 44b is blue, visual indicator 44c is yellow, and visual indicator 44d is red. As another example, for example, visual indicator 44a is green, visual indicator 44b is orange, visual indicator 44c is purple, and visual indicator 44d is yellow. Other colors may be used as well, depending on the wavelength of light to which visualization tool 38 is most receptive.

[0035] The visual indicators 44 may be formed in any manner. As an example, each of the visual indicators 44 may be formed by adding a specific pigment or other color source to a polymer coating or covering that extends over at least the proximal region 18 of the implantable medical device 10. For example, the specific pigment may be added to a small amount of the polymer that forms the polymer coating or covering. Alternatively, they may be mixed together and then coated onto the polymer coating or covering. In some cases, at least some of the visual indicators 44 may be formed separately and then fixed in place on the surface 42. For example, a colored disk or other shape may be adhesively fixed to the surface 42. If the colored disk is made of metal, the colored disk may be welded or soldered in place on the surface 42, such as by welding or soldering the colored disk to one or more of the metal filaments that form the tubular scaffold of the stent. The visual indicators 44 may be considered to be equally spaced circumferentially around the central longitudinal axis of the implantable device 10.

[0036] In some cases, each visual indicator 44 may be a unique color, a unique shape, and / or a unique size relative to the other visual indicators 44. As an illustrative but non-limiting example, visual indicator 44a may be a circle, visual indicator 44b may be a square, visual indicator 44c may be a triangle, and visual indicator 44d may be a polygon having at least five sides. As another illustrative but non-limiting example, visual indicator 44a may be a circle having a diameter of 1 millimeter (mm), visual indicator 44b may be a circle having a diameter of 2 mm, visual indicator 44c may be a circle having a diameter of 3 mm, and visual indicator 44d may be a circle having a diameter of 4 mm. These are merely examples.

[0037] 3 shows a total of four visual indicators 44, each spaced about 90 degrees circumferentially about the central longitudinal axis of the implantable device 10, although this is not required in all cases. For example, there may be a total of three visual indicators 44, each spaced about 120 degrees circumferentially. In some cases, there may be a total of two visual indicators 44, each spaced about 180 degrees apart. It will be appreciated that the visual indicators 44 may be visible through the visualization tool 38 of the endoscope 36 when the endoscope 36 is positioned such that the visualization tool 38 is either proximal to the proximal region 18 of the implantable medical device 10 or is disposed within the inflow region 24 (shown in FIG. 1 ) of the implantable medical device 10.

[0038] FIG. 4 is a side view of an exemplary intraluminal implant 60, such as, but not limited to, a stent. In some cases, the stent 60 may take the form of an elongated tubular member. Although the stent 60 has been described and illustrated as being generally tubular, it is envisioned that the stent 10 may take any cross-sectional shape desired. The stent 60 may have a first or proximal end 62, a second or distal end 64, and an intermediate region 66 disposed between the first end 62 and the second end 64. The stent 60 may include a lumen 68 that extends from a first opening adjacent the first end 62 to a second opening adjacent the second end 64 to allow food, fluids, and the like to pass therethrough.

[0039] Stent 60 may be expandable from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration. In some cases, stent 60 may be deployed to a configuration between the collapsed and expanded configurations, i.e., stent 60 may be deployed with a deployed diameter that is larger than the diameter of stent 60, or a particular portion thereof, while in its collapsed configuration, but smaller than the diameter of stent 60, or a particular portion thereof, while in its fully expanded configuration. In some cases, the anatomical structure in which stent 60 is deployed may affect its deployed configuration. For example, if the anatomical structure in which stent 60 is deployed has a diameter smaller than the diameter of stent 60, or a particular portion thereof, when fully expanded, stent 60 may have a deployed diameter that is intermediate between the diameter of its collapsed configuration and the diameter of its fully expanded configuration.

[0040] The stent 60 can be formed from a plurality of interwoven filaments forming a tubular scaffold. For example, the tubular scaffold of the stent 60 can have a braided structure made from a plurality of filaments including a first plurality of filaments each extending in a first helical direction and a second plurality of filaments each extending in a second helical direction. As seen in FIG. 4A, the filaments are woven together, for example, such that the filaments pass over the first filaments and then under the second filaments. The tubular scaffold can include cells or gaps formed between adjacent filaments extending generally parallel to the first helical direction that intersect with adjacent filaments extending generally parallel to the second helical direction. It is envisioned that the filament(s) of the stent 60 may be made from a number of different materials, such as, but not limited to, metals, metal alloys, shape memory alloys, and / or polymers, as needed, allowing the stent 60 to expand into a shape when correctly positioned within the anatomy. In some cases, materials may be selected to also allow the stent 60 to be removed relatively easily. For example, the stent 60 may be formed from alloys such as, but not limited to, Nitinol and Elgiloy®.

[0041] Depending on the materials selected for the construction of stent 60, stent 60 may be self-expanding; that is, stent 60 may be configured to automatically radially expand when unconstrained. In some cases, stent 60 may not be self-expanding and therefore may not resume its fully expanded configuration without the assistance of an expansion device, such as, but not limited to, an inflatable balloon disposed within lumen 68. As used herein, the term "self-expanding" refers to the tendency of stent 60 to return to a preprogrammed diameter when unconstrained by an external biasing force, e.g., a delivery catheter or sheath. Although not shown, stent 60 may include a one-way valve, such as an elastomeric slit valve or duckbill valve, disposed within lumen 18, for example, to prevent the backflow of gastrointestinal fluids.

[0042] In some cases, in the radially expanded configuration, the stent 60 can include a first end region 70 proximate the first end 62 and a second end region 72 proximate the second end 64. In some cases, as shown, the first end region 70 and the second end region 72 can include a retention feature or anti-migration flared region having an enlarged outer diameter relative to the outer diameter of the intermediate region 66. The anti-migration flared region can be disposed adjacent the first end 62 and / or the second end 64 and can be configured, for example, to engage an inner portion of the wall of the esophagus or other body lumen. In some cases, the retention feature or flared region can have a larger outer diameter than the intermediate region 66 of the stent 60 to prevent the stent 60 from migrating once positioned within the esophagus or other body lumen. In some cases, the transition from the cross-sectional area of ​​the intermediate region 66 to the retention feature or flared region can occur in a gradual, sloped, or abrupt step-like manner, as desired.

[0043] In some cases, the first anti-migration flared region may have a first outermost diameter and the second anti-migration flared region may have a second outermost diameter. In some cases, the first and second outermost diameters may be substantially the same, while in other cases, the first and second outermost diameters may be different. In some cases, the stent 60 may include only one of the anti-migration flared regions or may not include an anti-migration flared region. For example, the first end region 70 may include an anti-migration flare and the second end region 72 may have a similar outer diameter as the mid-region 66. It is further contemplated that the second end region 72 may include an anti-migration flare and the first end region 70 may have a similar outer diameter as the mid-region 66. In some embodiments, the stent 60 may have a uniform outer diameter from the first end 62 to the second end 64. In some embodiments, the outer diameter of the mid-region 66 may be within a range of 15 to 25 millimeters in a fully expanded configuration. The outer diameter of the anti-migration flare may range from 20 to 30 millimeters in a fully expanded configuration. It is envisioned that the outer diameter of the stent 60 may be varied to suit a desired application.

[0044] In some cases, the stent 60 includes a first plurality of filaments extending in a first helical direction and a second plurality of filaments extending in a second helical direction. The stent 60 includes, for example, individual filaments 74a, 74b, and 74c, each extending in a first helical direction. The stent 60 includes additional filaments (not referenced) extending in a first helical direction. The first helical direction can be considered to extend in a clockwise direction, from left to right or from proximal to distal. The stent 60 includes, for example, individual filaments 76a, 76b, and 76c, each extending in a second helical direction. The stent 60 includes additional filaments (not referenced) extending in a second helical direction. The second helical direction can be considered to extend in a counterclockwise direction, from left to right or from proximal to distal.

[0045] The stent 60 can be implanted in any desired manner. This can include implanting the stent 60 in a blood vessel, esophagus, stomach, trachea, colon, intestine, or other body lumen using a stent delivery device that can include an elongated shaft having an outer sheath configured to restrain the stent 60 in a collapsed delivery configuration until the outer sheath is withdrawn to allow the stent 60 to resume its expanded, deployed configuration. In some cases, the stent 60 can be pushed out of the lumen of the elongated shaft of the stent delivery device to deploy the stent 60. In some cases, the stent 60 can be delivered endoscopically to expand the stent 60 from its collapsed, delivery configuration to its expanded, deployed configuration. In some cases, the stent 60 can be delivered endoscopically.

[0046] FIG. 5 is a cross-sectional view taken along line 5-5 of FIG. 4 showing stent 60. As can be seen, stent 60 includes a polymer layer 78 having a number of filaments 74, 76 disposed within polymer layer 78. In some cases, filaments 74, 76 may be considered to represent filaments 74a, 74b, and 74c extending in a first helical direction and filaments 76a, 76b, and 76c extending in a second helical direction. Stent 60 may include a 1-over-1-under pattern, in which each filament 74 extending in the first helical direction alternately crosses over and under filaments 76 extending in the second helical direction, and each filament 76 extending in the second helical direction alternately crosses over and under filaments 74 extending in the first helical direction. Alternatively, stent 60 may include a 2-over-2-under pattern, or another pattern, as desired.

[0047] 1-3, regardless of how the stent 60 is implanted, it may be desirable to be able to visualize the position or orientation of the stent 60 once the stent 60 is implanted. Thus, the stent 60 may include a visual indicator that can be seen from within or near the stent 60 by viewing the interior of the stent 60 with an endoscope, or by viewing along a central longitudinal axis of the stent 60 after it is implanted within a body lumen.

[0048] 6 is an end view of the stent 60 taken along the central longitudinal axis of the stent 60, showing the first or proximal end 62 and associated first end region 70. It will be appreciated that the first or proximal end 62 of the stent 60 is endoscopically visible using an endoscope or similar tool (such as visualization tool 38 shown in FIG. 1) equipped with a lens or camera disposed within the body lumen in which the stent 60 is implanted. In view of FIG. 6, it can be seen that the lumen 68 of the stent 60 is surrounded by an inner surface 82 of a flared portion of the stent 60 that is visually visible with the endoscopic visualization tool. The inner surface 82 corresponds to the inner surface of a flared anti-migration feature in the first end region 70.

[0049] As seen in FIG. 6, the stent 60 includes a total of four visual indicators 84, individually labeled as 84a, 84b, 84c, and 84d. As shown, each of the four visual indicators 84 occupies a total of four cells (e.g., a 2×2 grid of cells) of the braided structure forming the stent 60. Looking at visual indicator 84d, for example, visual indicator 84d occupies a four-cell area formed by the intersections of filaments 86, 88, 90, and 92. In some cases, at least some of the visual indicators 84 may be larger than a four-cell area. At least some of the visual indicators 84 may be smaller than a four-cell area. In some cases, each of the visual indicators 84 may be a different size to make it easier to visually distinguish a particular visual indicator 84 from the other visual indicators 84. It will be appreciated that once the stent 60 is implanted, the visual indicators 84 may remain visible through the visualization tool 38 of the endoscope 36 by positioning the endoscope 36 either so that the visualization tool 38 is proximal to the stent 60 or so that the visualization tool 38 extends partway through the flared region of the stent 60 near the inner surface 82 of the stent 60. The visual indicators 84 may be visible by looking down the central longitudinal axis of the stent 60 and / or from a position within the stent 60, and not from a position radially outward from the stent 60, as the outer surface of the stent 60 may be in contact with tissue.

[0050] In some cases, each of the visual indicators 84 may be a unique color to more easily identify the visual indicators 84. Some unique colors that may be used include black, white, red, blue, green, yellow, orange, purple, and the like. As an illustrative but non-limiting example, for example, visual indicator 84a is white, visual indicator 84b is blue, visual indicator 84c is yellow, and visual indicator 84d is red. As another example, for example, visual indicator 84a is green, visual indicator 84b is orange, visual indicator 84c is purple, and visual indicator 84d is yellow. Other colors may be used as well, depending on the light wavelengths that the visualization tool 38 is most receptive to. The visual indicators 84 may be formed in any manner. As an example, each of the visual indicators 84 may be formed by adding a particular pigment or other color source to the polymer layer 78 or by applying a colored polymer material to the polymer layer 78.

[0051] In FIG. 6, the stent 60 includes a total of four visual indicators 84 that are equally circumferentially spaced about 90 degrees apart about the central longitudinal axis of the stent 60. In some cases, as seen, for example, in FIG. 7, the stent 60 may include a total of three visual indicators 84, individually labeled 84a, 84b, and 84c, that are equally circumferentially spaced about 120 degrees apart about the central longitudinal axis of the stent 60. In some cases, at least some of the visual indicators may be formed separately and then fixed in place on the inner surface 82. For example, a colored disk or other shape may be adhesively fixed to the inner surface 82. If the colored disk is made of metal, the colored disk may be welded or soldered in place on the inner surface 82, such as by welding or soldering the colored disk to one or more of the metal filaments that form the tubular scaffold of the stent 60. In some cases, the visual indicators may be considered to be equally circumferentially spaced about the central longitudinal axis of the stent 60. It will be appreciated that the visual indicators 84 may remain visible through the visualization tool 38 of the endoscope 36 by positioning the endoscope 36 either so that the visualization tool 38 is proximal to the stent 60 or so that the visualization tool 38 extends partway through the flared region of the stent 60 near the inner surface 82 of the stent 60. The visual indicators 84 may be visible by looking down the central longitudinal axis of the stent 60 and / or from positions within the stent 60, but not from positions radially outward from the stent 60, as the outer surface of the stent 60 may be in contact with tissue.

[0052] FIG. 8 is an end view of the stent 60, showing a total of four visual indicators 94, individually labeled as 94a, 94b, 94c, and 94d. As shown, each of the visual indicators 94 is circular. However, in some cases, each visual indicator 94 may be a unique color, a unique shape, and / or a unique size relative to the other visual indicators 94. As an illustrative but non-limiting example, visual indicator 94a may be a circle, visual indicator 94b may be a square, visual indicator 94c may be a triangle, and visual indicator 94d may be a polygon having at least five sides. As another illustrative but non-limiting example, visual indicator 94a may be a circle having a diameter of 1 millimeter (mm), visual indicator 94b may be a circle having a diameter of 2 mm, visual indicator 94c may be a circle having a diameter of 3 mm, and visual indicator 94d may be a circle having a diameter of 4 mm. These are merely examples.

[0053] In FIG. 8, the stent 60 includes a total of four visual indicators 94 that are equally circumferentially spaced about 90 degrees apart about the central longitudinal axis of the stent 60. In some cases, as seen, for example, in FIG. 9, the stent 60 may include a total of three visual indicators 94, individually labeled as 94a, 94b, and 94c, that are equally circumferentially spaced about 120 degrees apart about the central longitudinal axis of the stent 60. In some cases, at least some of the visual indicators may be formed separately and then fixed in place on the inner surface 82. It will be appreciated that the visual indicators 94 may remain visible through the visualization tool 38 of the endoscope 36 by positioning the endoscope 36 either so that the visualization tool 38 is proximal to the stent 60 or so that the visualization tool 38 extends partway through the flared region of the stent 60 near the inner surface 82 of the stent 60. The visual indicator 94 is visible by looking down the central longitudinal axis of the stent 60 and / or from a position within the stent 60, and may not be visible from a position radially outward from the stent 60 because the outer surface of the stent 60 may be in contact with tissue.

[0054] The devices described herein, and various components thereof, may be manufactured according to essentially any suitable manufacturing technique, including molding, casting, machining, and the like, or any other suitable technique. Additionally, the various structures may include materials commonly associated with medical devices, such as metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, and the like, or any other suitable materials. These materials may include transparent or translucent materials to aid in visualization during procedures. Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steels, mild steels, nickel-titanium alloys, such as linear elastic and / or superelastic Nitinol, other nickel alloys, e.g., nickel-chromium-molybdenum alloys (e.g., UNS:N06625, such as INCONEL® 625, UNS:N06022, such as HASTELLOY® C-22®, HASTELLOY® C276®, and the like). (UNS:N10276 such as HASTELLOY® alloys, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY® alloys, other HASTELLOY® alloys, etc.), nickel-cobalt alloys (e.g., UNS:N10276 such as HASTELLOY® alloys, other HASTELLOY® alloys, B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc., cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®), platinum-enriched stainless steels, combinations thereof, etc., or any other suitable material.

[0055] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalates, and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. Atochem's CRISTAMID®), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, available, for example, under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), MARLEX® high density polyethylene, MARLEX® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS American Examples include GRILAMID® available from Grillon, perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like.

[0056] It will be understood that the present disclosure is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. This may include, to the extent appropriate, using any of the features of one exemplary embodiment in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. An implantable stent comprising: The implantable stent comprises an elongate body extending from a distal region to a proximal region, the elongate body including one or more filaments woven together to form the elongate body, the elongate body defining an outer stent surface and an inner stent surface; the implantable stent comprises one or more visual indicators disposed relative to the inner stent surface, the one or more visual indicators positioned such that the one or more visual indicators are endoscopically visible from within or adjacent to the implantable stent. Implantable stents.

2. 2. The implantable stent of claim 1, wherein the distal region or the proximal region includes a flared end, the inner stent surface extends into the flared end, and the one or more visual indicators are positioned relative to the inner stent surface within the flared end.

3. 3. The implantable stent of claim 1 or 2, wherein the one or more visual indicators comprise two or more visual indicators equally spaced circumferentially on the inner stent surface, each of the two or more visual indicators being visually distinguishable from the other position indicators.

4. The implantable stent of claim 3 , wherein at least some of the two or more visual indicators comprise objects secured relative to the inner stent surface.

5. The implantable stent of claim 3 , further comprising a polymeric coating covering at least a portion of the elongate body.

6. The implantable stent of claim 5 , wherein at least some of the two or more visual indicators comprise a color change imparted to the polymeric coating.

7. The implantable stent of any one of claims 1 to 6, wherein at least one of the one or more visual indicators is made of a radiopaque material.

8. 1. An implantable medical device adapted to be deployed with an endoscope, comprising: The implantable medical device comprises an elongate body extending from a distal region to a proximal region, at least one of the distal region and the proximal region including a flared region defining an inner flared surface; the implantable medical device comprising two or more visual indicators secured to the inner flared surface, each of the two or more visual indicators positioned for viewing by an endoscope; Implantable medical devices.

9. The implantable medical device of claim 8 , wherein each of the two or more visual indicators is visually distinguishable from others of the two or more visual indicators.

10. 10. The implantable medical device of claim 8 or 9, wherein each of the two or more visual indicators comprises a color that is different from a color of any other of the two or more visual indicators.

11. The implantable medical device of any one of claims 8 to 10, comprising three or four visual indicators equally spaced on the inner flared surface.

12. 1. An implantable stent comprising: The implantable stent comprises an elongate body extending from a distal region to a proximal region, the elongate body including one or more filaments woven together to form the elongate body, the elongate body movable between a collapsed configuration for delivery and an expanded configuration for deployment, the elongate body including a main segment of constant diameter and a flared end segment, the flared end segment including an inner flared surface and an outer flared surface, The implantable stent includes a plurality of visual indicators, each of the plurality of visual indicators secured to the inner flared surface for viewing by an endoscope. Implantable stents.

13. 13. The implantable stent of claim 12, wherein the plurality of visual indicators includes three visual indicators equally spaced on the inner stent surface, each of the three visual indicators being a unique color relative to the other two visual indicators.

14. 13. The implantable stent of claim 12, wherein the plurality of visual indicators includes four visual indicators equally spaced on the inner stent surface, each of the four visual indicators being a unique color relative to the other three visual indicators.

15. The implantable stent of any one of claims 12 to 14, wherein at least some of the plurality of visual indicators comprise pigments added to a portion of a polymeric coating disposed on the elongate body.

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