Implantable medical device with visual indicator

Abstract

An 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 dilation surface. The one or more visual indicators are positioned relative to the inner expansion surface such that the one or more visual indicators are endoscopically visible from within or adjacent to the implantable stent.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 325,772, filed on March 31, 2022, which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to implantable medical devices. More particularly, the present disclosure relates to implantable medical devices including a visual indicator that shows the relative orientation of the implantable medical device after implantation. Background Art

[0004] For a variety of different purposes, a variety of implantable medical devices are implanted in the human body. The relative position of some implantable medical devices when they are implanted in the body structure is unknown. The body structure may include the inside of an organ, such as a body cavity or a part of a body cavity, such as the esophagus, trachea, colon, bile duct, blood vessels, etc. In some cases, the implantable medical device may be bilaterally symmetrical, or symmetrical up and down, or symmetrical front and back. However, in some cases, it may be necessary to understand the relative orientation of the implantable medical device. For example, the relative rotational orientation of the implantable medical device around its axis relative to the body structure may be of interest. For example, it may be desirable to indicate the relative orientation of the implantable medical device relative to the sagittal plane, coronal plane and / or transverse plane of the human body. In some cases, it may be desirable to orient the implantable medical device relative to the vertical upward position (e.g., a more optimal direction), or to orient a part of the implantable medical device in a vertical downward position (e.g., a suboptimal direction), or it may be an indication relative to the vertical intermediate position. There is still a need for the implantable medical device to include a visually identifiable method to determine the relative orientation of the implantable medical device after implantation. Summary of the invention

[0005] The present disclosure provides designs, materials, methods of manufacture, and alternative uses of medical devices. As an example, an implantable stent includes an elongated body extending from a distal region to a proximal region, the elongated body including one or more filaments woven together to form the elongated body, the elongated body defining an outer surface of the stent and an inner surface of the stent. One or more visual indicators are positioned relative to the inner surface of the stent so that the one or more visual indicators are endoscopically visible from a position within or adjacent to the implantable stent.

[0006] Alternatively or additionally, the distal region or the proximal region may include a flared end into which the stent inner surface extends, and the one or more visual indicators are positioned within the flared end relative to the stent inner surface.

[0007] Alternatively or in addition, the one or more visual indicators may include two or more visual indicators that are equally spaced circumferentially on the inner surface of the stent, each of the two or more visual indicators being visually distinguishable from indicators at other locations.

[0008] Alternatively or additionally, at least some of the two or more visual indicators may comprise objects fixed relative to the inner surface of the support.

[0009] Alternatively or in addition, the implantable stent may further include a polymer coating on at least a portion of the elongated body.

[0010] Alternatively or additionally, at least some of the two or more visual indicators may comprise a color change introduced into the polymer coating.

[0011] Alternatively or additionally, at least one of the two or more visual indicators may comprise a radiopaque material.

[0012] As another example, an implantable medical device is adapted for endoscopic deployment. The implantable medical device includes an elongated body extending from a distal region to a proximal region, at least one of the distal region and the proximal region including an expansion region defining an inner expansion surface. Two or more visual indicators are fixed relative to the inner expansion surface, each of the two or more visual indicators being positioned to be visible endoscopically.

[0013] Alternatively or in addition, each of the two or more visual indicators may be visually distinguishable from the other of the two or more visual indicators.

[0014] Alternatively or additionally, the color of each of the two or more visual indicators is different from the color of any other of the two or more visual indicators.

[0015] Alternatively or additionally, the implantable medical device may include three visual indicators equally spaced apart on the inner expansion surface.

[0016] Alternatively or additionally, the implantable medical device may include four visual indicators equally spaced apart on the inner expansion surface.

[0017] Alternatively or additionally, at least some of the two or more visual indicators may comprise objects that are fixed relative to the inner expansion surface.

[0018] Alternatively or additionally, the implantable medical device may further include a polymer coating on at least a portion of the elongated body.

[0019] Alternatively or additionally, at least some of the two or more visual indicators may comprise a color change introduced into the polymer coating.

[0020] Alternatively or additionally, at least one of the two or more visual indicators may comprise a radiopaque material.

[0021] As another example, an implantable stent includes an elongated body extending from a distal region to a proximal region, the elongated body including one or more filaments woven together to form the elongated body, the elongated body movable between a collapsed configuration for delivery and an expanded configuration for deployment, the elongated body including a constant diameter main section and a flared end section, the flared end section including an inner expansion surface and an outer expansion surface. A plurality of visual indicators are fixed relative to the inner expansion surface so that each of the plurality of visual indicators is endoscopically visible.

[0022] Alternatively or in addition, the plurality of visual indicators may include three visual indicators equally spaced apart on the inner surface of the bracket, each of the three visual indicators having a unique color relative to the other two visual indicators.

[0023] Alternatively or in addition, the plurality of visual indicators may include four visual indicators equally spaced apart on the inner surface of the bracket, each of the four visual indicators having a unique color relative to the other three visual indicators.

[0024] Alternatively or additionally, at least some of the plurality of visual indicators may include a pigment added to a portion of the polymer coating disposed on the elongated body.

[0025] 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present invention may be more fully understood by considering the following detailed description of various embodiments of the present invention in conjunction with the accompanying drawings, in which:

[0027] Figure 1 A schematic diagram of an exemplary implantable medical device implanted within the pyloric sphincter of a patient's stomach together with an endoscopically deployed visualization device providing visualization of the exemplary implantable medical device;

[0028] Figure 2 for Figure 1 A perspective view of an exemplary implantable medical device;

[0029] Figure 3 for Figure 1 An end view of an exemplary implantable medical device including a total of four visual indicators;

[0030] Figure 4 is a side view of an exemplary implantable medical device;

[0031] Figure 4 A is Figure 4 An enlarged view of a portion of an exemplary implantable medical device;

[0032] Figure 5 For along Figure 4 a cross-sectional view taken along the center line 5-5;

[0033] Figure 6 is a schematic end view of an exemplary implantable medical device including a total of four visual indicators;

[0034] Figure 7 is a schematic end view of an exemplary implantable medical device including a total of three visual indicators;

[0035] Figure 8 is a schematic end view of an exemplary implantable medical device including a total of four visual indicators; and

[0036] Fig. 9 is a schematic end view of an exemplary implantable medical device including a total of three visual indicators.

[0037] Although the present disclosure may be modified into various modifications and alternatives, the details thereof have been shown in the drawings by way of example and will be described in detail. However, it should be understood that it is not intended to limit the present disclosure to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and alternative forms that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0038] With respect to the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0039] All numerical values ​​are assumed to be modified by the term "about" herein, whether or not explicitly indicated. The term "about" generally refers to a numerical range that one skilled in the art would consider equivalent to the stated value (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure.

[0040] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0041] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise.

[0042] The following detailed description should be read with reference to the drawings, in which similar elements in different drawings are labeled the same. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0043] Figure 1 Schematic diagram of an exemplary implantable medical device 10 (shown as a stent) that has been implanted within a pyloric sphincter 12 of a patient's stomach 14. Figure 2 1 is a perspective view of an exemplary implantable medical device 10. The stomach 14 is shown as partially removed to visualize the implantable medical device 10 and the pyloric sphincter 12. It should be understood that the pyloric sphincter 12 acts as a one-way valve, thereby allowing partially digested food to pass from the patient's stomach 14 to their duodenum 16 for further digestion. In some cases, the pyloric sphincter 12 itself may not be sufficient to perform this function, or at least not be sufficient to perform this function adequately. For example, a variety of medical conditions can lead to the loss of this function. Other medical conditions may be exacerbated or even caused by the pyloric sphincter 12 that loses its function.

[0044] Thus, the patient's medical condition may suggest implantation of the implantable medical device 10. In this regard, the implantable medical device 10 may have an overall shape that is conducive to implantation into the pyloric sphincter 12, including a proximal region 18 and a distal region 20. The proximal region 18 includes an anchoring flange or ring 22, an inflow region 24, and a tapered region 26. The distal region 20 includes an anchoring flange or ring 28, an outflow region 30, and a tapered region 32. The intermediate region 34 connects the tapered region 26 of the proximal region 18 to the tapered region 32 of the distal region 20. It should be understood that partially digested food moving through the stomach 14 will enter the inflow region 24 and be guided into and through the tapered region 26, through the intermediate region 34, into and through the tapered region 32, and leave the outflow region 30. Thus, implantable medical device 10 is configured to limit the rate at which partially digested food exits stomach 14 into small intestine 16 and may limit backflow from small intestine 16 into stomach 14 .

[0045] It should be understood that the anchoring ring 22 is configured to fit the proximal portion of the pyloric sphincter 12, while the anchoring ring 28 is configured to fit the distal portion of the pyloric sphincter 12. The anchoring rings 22 and 28, together with the tapered regions 26 and 32, are used to both conform to the natural anatomy of the pyloric sphincter 12 and anchor the implantable medical device 10 relative to the pyloric sphincter 12. The anchoring rings 22 and 28 may be sized to assist in holding the implantable medical device 10 in place, thereby resisting the natural peristaltic movement of the stomach 14.

[0046] In some cases, as shown, the implantable medical device 10 may include a tubular skeleton formed by a braided structure, which is formed by braiding one or more or more filaments together. The braided structure can be formed by braiding one or more filaments extending in a first spiral direction and one or more filaments extending in a second spiral direction different from the first spiral direction. Each of the filaments extending in the first spiral direction can extend continuously through the inflow region 24, anchoring flange or ring 22 and tapered region 26 of the proximal region 18, and the tapered region 32, anchoring flange or ring 28 and outflow region 30 of the distal region 20. Similarly, each of the filaments extending in the second spiral direction can extend continuously through the inflow region 24, anchoring flange or ring 22 and tapered region 26 of the proximal region 18, and the tapered region 32, anchoring flange or ring 28 and outflow region 30 of the distal region 20. The tubular framework may include cells or gaps formed between adjacent filaments extending approximately parallel in a first helical direction, which intersect adjacent filaments extending approximately parallel in a second helical direction. At least some of the filaments may be metal filaments. For example, at least some of the filaments may be polymer filaments. The implantable medical device 10 may include, for example, a polymer covering or coating disposed on the braided structure. Individual filaments may be encapsulated in a polymer covering or coating, particularly when the polymer covering or coating is applied by dip coating.

[0047] In some cases, the implantable medical device 10 may not be used to replace the function of the pyloric sphincter 12, but may be used to block the flow of materials through a body passage (such as the pyloric sphincter 12). For example, treatments for various medical conditions such as obesity, diabetes, or duodenal ulcers may involve bypassing the duodenum or limiting the flow of materials through the duodenum. In some cases, the implantable medical device 10 can be used to inhibit or obstruct the passage of materials (fluids, chyme, etc.) from the stomach 14 through the pyloric sphincter 12 to the duodenum 16. Additional details about the possible uses of the implantable medical device 10 and its construction can be found, for example, in U.S. Provisional Patent Application Serial No. 63 / 307,764, entitled "Device, System, and Method for Blocking Anatomical Passages," filed on February 8, 2022, and U.S. Provisional Patent Application Serial No. 63 / 307,771, entitled "Device, System, and Method for Preventing Migration, and Implantation Methods Thereof," filed on February 8, 2022, which are incorporated herein by reference.

[0048] like Figure 1As seen, an endoscope 36 including a visualization tool 38 (disposed at a distal end 40 of the endoscope 36) has been extended through the esophagus into the stomach 14 and adjacent the implantable medical device 10. Thus, after the implantable medical device 10 has been implanted, the visualization tool 38, which may represent, for example, a lens or camera, or the end of a fiber optic cable capable of bringing light back to a sensor or camera, is able to visualize a portion of the implantable medical device 10. Once the implantable medical device 10 is implanted, it should be understood that only some portions of the implantable medical device 10 are visible from an endoscopic perspective because the exterior portions of the implantable medical device 10 that face and / or contact the tissue are obstructed by the tissue and, therefore, cannot be easily visualized. In some cases, the visualization tool 38 is able to see an interior surface or an inner surface or an end surface within the proximal region 18 of the implantable medical device 10, such as surface 42 (see FIG. 4 ). Figure 2 ). Visualization tool 38 is also able to see a portion of inflow region 24 and the interior of tapered region 26. Thus, it is possible to visually ascertain orientation, such as, but not limited to, the rotational orientation of implantable medical device 10 relative to the patient's anatomy.

[0049] To more easily ascertain the relative rotational orientation of the implantable medical device 10 after implantation, such as, but not limited to, implantation within the pyloric sphincter 12, the implantable medical device 10 includes visual indicators that are disposed relative to the proximal region 18 of the implantable medical device 10. The implantable medical device 10 may include one, two, three, four, or more visual indicators that are each visible to a viewing device, such as a visualization tool 38 of an endoscope 36, that is positioned proximal to the implantable medical device 10, wherein the visualization tool 38 is able to see an end view of the implantable medical device 10, the end view including end surfaces and / or interior surfaces visible from the open end of the implantable medical device 10; or extending through a lumen within the implantable medical device 10, wherein the visualization tool 38 of the endoscope 36 is able to see the interior surface of the implantable medical device 10. For example, the implantable medical device 10 may include one visual indicator such that viewing the proximal region 18 allows visualization of the one visual indicator relative to the remainder of the implantable medical device 10. This allows for a determination that the one visual indicator is at or near top dead center (ie, the 12 o'clock position), for example, relative to the remainder of the proximal region 18 .

[0050] Having two or more visual indicators, particularly where each of the two or more visual indicators is visually distinct, can aid in determining the relative orientation of the implantable medical device 10, particularly where the two or more visual indicators are visible but the rest of the implantable medical device 10 is not readily visible. For example, if two visual indicators are disposed along opposite sides of the surface 42, 180 degrees apart, thereby defining a line bisecting the surface 42, then the relative rotational orientation of the implantable medical device 10 may be visually determined by positioning the two visual indicators and determining their relative rotational positions with respect to the visualization tool 38 of the endoscope 36. For example, one visual indicator may have a relative position of 70 degrees (relative to a particular reference frame provided by the visualization tool 38), while another visual indicator may have a relative position of 160 degrees with respect to the same reference frame. By knowing that the two visual indicators are fixed relative to the implantable medical device 10, the relative orientation of the implantable medical device 10 relative to the body structure in which it is implanted can be determined by the visualization tool 38 of the endoscope 36.

[0051] No matter how many visual indicators are included, in some cases, each of these visual indicators (if more than one) is visually distinguishable from each other. In some cases, each visual indicator is of a different color. In some cases, each visual indicator is of a different size. In some cases, each visual indicator is of a different shape. Combinations of different colors, different sizes and / or different shapes are also envisioned. For example, it should be understood that a group of two or more visual indicators may include multiple distinguishing features. For example, a first visual indicator may be round and yellow, while another visual indicator may be square and red. The first visual indicator may be small and diamond-shaped. The second visual indicator may be large and diamond-shaped. These are just examples. The visual indicator may be formed in situ on the implantable medical device 10. In some cases, the visual indicator may be formed separately and then fixed in situ on the implantable medical device 10.

[0052] In some cases, one or more of the visual indicators may be formed of a radiopaque material and then secured to the implantable medical device 10. Forming at least one of the visual indicators of a radiopaque material may aid in locating the position of the implantable medical device 10 during the invisible imaging mode. Examples of radiopaque materials include, but are not limited to, barium sulfate, bismuth compounds, and tungsten.

[0053] Figure 3 FIG. 1 is an end view of the proximal region 18 of the implantable medical device 10. Figure 3As seen, the implantable medical device 10 includes a total of four visual indicators 44, each labeled 44a, 44b, 44c and 44d. As shown, each of the four visual indicators occupies one unit of the braided structure forming the implantable medical device 10. Looking at visual indicator 44d, for example, visual indicator 44d occupies a unit 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 unit. For example, in some cases, each of the visual indicators 44 may occupy four units or gaps of the stent skeleton into a 2×2 grid. In some cases, each of the visual indicators 44 may be of different sizes to more easily distinguish visually between a specific visual indicator 44 and other visual indicators 44.

[0054] In some cases, each of the visual indicators 44 may be a unique color to more easily distinguish between 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, assume that the visual indicator 44a is white, the visual indicator 44b is blue, the visual indicator 44c is yellow, and the visual indicator 44d is red. As another example, assume that the visual indicator 44a is green, the visual indicator 44b is orange, the visual indicator 44c is purple, and the visual indicator 44d is yellow. Other colors may also be used depending on the wavelength of light that the visualization tool 38 is most receptive to.

[0055] Visual indicator 44 can be formed in any manner. As an example, each of visual indicator 44 can be formed by adding a specific pigment or other color source to a polymer coating or covering extending at least on the proximal region 18 of implantable medical device 10. For example, a specific pigment can be added to a small amount of polymer forming a polymer coating or covering, and can be mixed together and then applied to the polymer coating or covering. In some cases, at least some of visual indicator 44 can be formed separately and then fixed to surface 42 in situ. For example, a colored disc or other shape can be fixed to surface 42 with an adhesive. If the colored disc is metal, it can be welded or brazed to a position on surface 42, such as by welding or brazing the colored disc to one or more of the metal filaments forming the tubular skeleton of the stent. Visual indicator 44 can be considered to be equidistantly spaced around the central longitudinal axis of implantable device 10.

[0056] In some cases, each visual indicator 44 may be a unique color, unique shape, and / or unique size relative to the other visual indicators 44. As an illustrative but non-limiting example, visual indicator 44a may be circular, visual indicator 44b may be square, visual indicator 44c may be triangular, 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 circular with a 1 millimeter (mm) diameter, visual indicator 44b may be circular with a 2 mm diameter, visual indicator 44c may be circular with a 3 mm diameter, and visual indicator 44d may be circular with a 4 mm diameter. These are examples only.

[0057] Although Figure 3 A total of four visual indicators 44 are shown, each circumferentially spaced about 90 degrees around the central longitudinal axis of the implantable device 10, but this is not necessary in all cases. For example, there may be a total of three visual indicators 44, each circumferentially spaced about 120 degrees. In some cases, there may be a total of two visual indicators 44, each spaced about 180 degrees. It should be understood that when the endoscope 36 is positioned so that the visualization tool 38 is proximal to the proximal region 18 of the implantable medical device 10 or is located within the inflow region 24 of the implantable medical device 10 ( Figure 1 As shown), the visual indicator 44 may be visible via the visualization tool 38 of the endoscope 36.

[0058] Figure 4 1 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 is described and shown as being generally tubular, it should be understood that the stent 10 may take any desired cross-sectional shape. 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 extending from a first opening adjacent to the first end 62 to a second opening adjacent to the second end 64 to allow food, fluids, etc. to pass therethrough.

[0059] The stent 60 can be expanded from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration. In some cases, the stent 60 can be deployed to a configuration between the collapsed configuration and the expanded configuration, that is, the stent 60 can be deployed to have a deployment diameter that is larger than the diameter of the stent 60 or a specific portion thereof when it is in its collapsed configuration but smaller than the diameter of the stent 60 or a specific portion thereof when it is in its fully expanded configuration. In some cases, the anatomical structure in which the stent 60 is deployed can affect its deployment configuration. For example, if the anatomical structure in which the stent 60 is to be deployed has a diameter that is smaller than the diameter of the stent 60 or a specific portion thereof when it is fully expanded, then the stent 60 can have a deployment diameter between its collapsed configuration diameter and its fully expanded configuration diameter.

[0060] The stent 60 may be formed of a plurality of interwoven filaments forming a tubular framework. For example, the tubular framework of the stent 60 may have a braided structure made of 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. Figure 4 As seen in A, the filaments are woven together so that, for example, a filament passes over a first filament and then under a second filament. The tubular skeleton may include cells or gaps formed between adjacent filaments extending generally parallel in a first helical direction, which intersect adjacent filaments extending generally parallel in a second helical direction. It is contemplated that the filaments of stent 60 may be made of a variety of different materials as desired, such as but not limited to metals, metal alloys, shape memory alloys, and / or polymers, thereby allowing stent 60 to expand and take shape when accurately positioned within the anatomical structure. In some cases, the material may be selected to also allow stent 60 to be more easily removed. For example, stent 60 may be formed of alloys, such as but not limited to nitinol and

[0061] Depending on the material selected for constructing the stent 60, the stent 60 may be self-expanding, i.e., configured to automatically expand radially when unconstrained. In some cases, the stent 60 may be non-self-expanding and therefore cannot be restored to its fully expanded configuration without the assistance of an expansion device (such as, but not limited to, an inflatable balloon disposed within the lumen 68). As used herein, the term "self-expanding" refers to the tendency of the stent 60 to return to a pre-programmed diameter when not constrained by an external biasing force (e.g., a delivery catheter or sheath). Although not shown, the stent 60 may include a one-way valve, such as an elastic slit valve or a duckbill valve, located within the lumen 18 to, for example, prevent backflow of gastrointestinal fluids.

[0062] In some cases, in the radially expanded configuration, the stent 60 may include a first end region 70 adjacent to the first end 62 and a second end region 72 adjacent to the second end 74. In some cases, as shown, the first end region 70 and the second end region 72 may include a retention feature or an anti-migration flared region having an increased outer diameter compared to the outer diameter of the middle region 66. The anti-migration flared region (which may be positioned adjacent to the first end 62 and / or the second end 64) may be configured to, for example, engage the inner portion of the wall of the esophagus or other body cavity. In some cases, the retention feature or flared region may have an outer diameter larger than the middle region 66 of the stent 60 to prevent the stent 60 from migrating after being placed in the esophagus or other body cavity. In some cases, the transition portion of the cross section from the middle region 66 to the retention feature or flared region may be gradual, inclined, or appear in a sudden step manner as required.

[0063] 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 outermost diameter and the second outermost diameter may be substantially the same; while in other cases, the first outermost diameter and the second outermost diameter may be different. In some cases, the stent 60 may include only one anti-migration flared region 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 an outer diameter similar to that of the middle region 66. It is also envisioned that the second end region 72 may include an anti-migration flare, and the first end region 70 may have an outer diameter similar to that of the middle 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 middle region 66 may be in the range of 15 mm to 25 mm in the fully expanded configuration. The outer diameter of the anti-migration flare may be in the range of 20 mm to 30 mm in the fully expanded configuration. It is envisioned that the outer diameter of the stent 60 may be changed to suit the desired application.

[0064] 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 the first helical direction. The stent 60 includes an additional filament (not cited) extending in the first helical direction. The first helical direction can be considered to extend from left to right in a clockwise direction, or from proximal to distal. The stent 60 includes, for example, individual filaments 76a, 76b, and 76c, each extending in the second helical direction. The stent 60 includes an additional filament (not cited) extending in the second helical direction. The second helical direction can be considered to extend from left to right in a counterclockwise direction, or from proximal to distal.

[0065] The stent may be implanted in any desired manner. This may include implanting the stent 60 in a blood vessel, esophagus, stomach, trachea, colon, intestine, or other body cavity using a stent delivery device, which, in the case of self-expanding stent 60, may include an elongated shaft with an outer sheath configured to constrain the stent 60 in a collapsed delivery configuration until the outer sheath is withdrawn to allow the stent 60 to resume its expanded deployment configuration. In some cases, the stent 60 may be pushed out of the lumen of the elongated shaft of the stent delivery device to deploy the stent 60. If the stent 60 is non-self-expanding, the stent delivery device may include a balloon and an expandable frame or similar structure to expand the stent 60 from its collapsed delivery configuration to its expanded deployment configuration. In some cases, the stent 60 may be delivered endoscopically.

[0066] Figure 5 For along Figure 4 5-5 of , showing a cross-sectional view of the stent 60. As seen, the stent 60 includes a polymer layer 78 having a plurality of filaments 74, 76 disposed within the polymer layer 78. In some cases, the 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. The stent 60 may include an over-under pattern, wherein each filament 74 extending in the first helical direction alternatively passes over and under the filament 76 extending in the second helical direction, and the filament 76 extending in the second helical direction alternatively passes over and under the filament 74 extending in the first helical direction. Alternatively, the stent 60 may include a two-over-two pattern, or another pattern, as desired.

[0067] As compared to Figures 1 to 3 As discussed with respect to the implantable medical device 10 shown, regardless of how the stent 60 is implanted, once the stent 60 has been implanted, it may be desirable to be able to visualize the position or orientation of the stent 60. Thus, the stent 60 may include visual indicators that are visible from within or near the stent 60 by observing along a central longitudinal axis of the stent 60 after the stent 60 is implanted in a body cavity (such as by endoscopically observing the interior of the stent 60).

[0068] Figure 6 The first or proximal end 62 and the accompanying first end region 70 are shown for an end view of the stent 60 along the central longitudinal axis of the stent 60. It should be understood that the first or proximal end 62 of the stent 60 can be viewed using an endoscope or a scope equipped with a lens or camera (such as a microscope) located in a body cavity in which the stent 60 is implanted. Figure 1 A similar tool to the visualization tool 38 shown is visible endoscopically. Figure 6, the lumen 68 of the stent 60 is visible, surrounded by the inner surface 82 of the flared portion of the stent 60; which is visually visible with the visualization tool of the endoscope. The inner surface 82 corresponds to the inner surface of the anti-migration expansion feature in the first end region 70.

[0069] like Figure 6 As seen, the stent 60 includes a total of four visual indicators 84, each labeled 84a, 84b, 84c, and 84d. As shown, each of the four visual indicators 84 occupies a total of four units (e.g., a 2×2 grid of units) forming the braided structure of the stent 60. Looking at, for example, visual indicator 84d, visual indicator 84d occupies a four-unit area formed by the intersection of filaments 86, 88, 90, and 92. In some cases, at least some of the visual indicators 84 may be larger than the four-unit area. At least some of the visual indicators 84 may be smaller than the four-unit area. In some cases, each of the visual indicators 84 may be of different sizes to more easily distinguish visually between a particular visual indicator 84 and other visual indicators 84. It should be appreciated that once stent 60 has been implanted, visual indicator 84 may remain visible via visualization tool 38 of endoscope 36 by positioning endoscope 36 such that visualization tool 38 is proximal to stent 60, or such that visualization tool 38 partially extends into the flared region of stent 60, near the inner surface 82 of stent 60. Visual indicator 84 is visible by looking down the central longitudinal axis of stent 60 and / or from a position within stent 60; but may not be visible from a position radially outward of stent 60, such that the outer surface of stent 60 may contact tissue.

[0070] In some cases, each of the visual indicators 84 may be a unique color to more easily distinguish between the visual indicators 84. Some unique colors that can be used include black, white, red, blue, green, yellow, orange, purple, etc. As an illustrative but non-limiting example, it is assumed that the visual indicator 84a is white, the visual indicator 84b is blue, the visual indicator 84c is yellow, and the visual indicator 84d is red. As another example, it is assumed that the visual indicator 84a is green, the visual indicator 84b is orange, the visual indicator 84c is purple, and the visual indicator 84d is yellow. According to the wavelength of light that the visualization tool 38 is most easily accepted, other colors can also be used. The visual indicator 84 can be formed in any way. As an example, each of the visual indicators 84 can be formed by adding a specific pigment or other color source to the polymer layer 78 or by adding a colored polymer material applied to the polymer layer 78.

[0071] exist Figure 6In the embodiment, the stent 60 includes a total of four visual indicators 84, which are equally spaced about 90 degrees circumferentially around the central longitudinal axis of the stent 60. In some cases, such as for example Figure 7 As can be seen, stent 60 can include a total of three visual indicators 84, each labeled 84a, 84b, and 84c, which are equally spaced about 120 degrees circumferentially about the central longitudinal axis of stent 60. In some cases, at least some of the visual indicators can be formed separately and then secured in situ to inner surface 82. For example, a colored disk or other shape can be adhesively secured to inner surface 82. If the colored disk is metal, it can be welded or brazed to a location on inner surface 82, such as by welding or brazing the colored disk to one or more of the metal filaments that form the tubular skeleton of stent 60. In some cases, the visual indicators can be seen as equally spaced circumferentially about the central longitudinal axis of stent 60. It should be appreciated that by positioning the endoscope 36 so that the visualization tool 38 is proximal to the stent 60, or so that the visualization tool 38 partially extends into the flared region of the stent 60, near the inner surface 82 of the stent 60, the visual indicator 84 may remain visible via the visualization tool 38 of the endoscope 36. The visual indicator 84 is visible by looking down the central longitudinal axis of the stent 60 and / or from a position within the stent 60; but may not be visible from a position radially outward of the stent 60 because the outer surface of the stent 60 may be in contact with tissue.

[0072] Figure 8 60, a total of four visual indicators 94 are shown, each labeled 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, unique shape and / or unique size relative to other visual indicators 94. As an illustrative but non-limiting example, visual indicator 94a may be circular, visual indicator 94b may be square, visual indicator 94c may be triangular, and visual indicator 94d may be a polygon with at least five sides. As another illustrative but non-limiting example, visual indicator 94a may be a circle with a diameter of 1 millimeter (mm), visual indicator 94b may be a circle with a diameter of 2mm, visual indicator 94c may be a circle with a diameter of 3mm, and visual indicator 94d may be a circle with a diameter of 4mm. These are just examples.

[0073] exist Figure 8 In the embodiment, the stent 60 includes a total of four visual indicators 94, which are equally spaced about 90 degrees circumferentially around the central longitudinal axis of the stent 60. In some cases, such as for example Fig. 9As can be seen, stent 60 may include a total of three visual indicators 94, each labeled 94a, 94b, and 94c, which are equally spaced approximately 120 degrees circumferentially about the central longitudinal axis of stent 60. In some cases, at least some of the visual indicators may be formed separately and then affixed in situ to inner surface 82. It should be understood that visual indicators 94 may remain visible via visualization tool 38 of endoscope 36 by positioning endoscope 36 so that visualization tool 38 is proximal to stent 60, or so that visualization tool 38 partially extends into the flared region of stent 60, near inner surface 82 of stent 60. Visual indicators 94 are visible by looking down the central longitudinal axis of stent 60 and / or from a position within stent 60; but may not be visible from a position radially outward of stent 60 because the outer surface of stent 60 may contact tissue.

[0074] The devices described herein and their various components can be manufactured according to substantially any suitable manufacturing technique, including molding, casting, machining, etc., or any other suitable technique. In addition, the various structures can include materials commonly associated with medical devices, such as metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, etc., or any other suitable material. These materials can include transparent or translucent materials to facilitate visualization during surgery. Some examples of suitable metals and metal alloys include stainless steel (such as 304V, 304L, and 316LV stainless steel), mild steel, nickel-titanium alloys (such as linear elastic and / or superelastic nitinol), other nickel alloys (such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625; UNS:N06022, such as UNS:N10276, such as other alloys, etc.)), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ALLOY ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten alloys or tungsten alloys, etc., cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.), platinum-rich stainless steel, combinations thereof, etc., or any other suitable material.

[0075] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available, for example, from DuPont ), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics ), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as those available from DuPont ), polyamide (e.g., available from Bayer AG or available from Elf Atto Chemicals ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name obtained), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), High density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polybutylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as available from EMS American Nylon Resins Company ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. thereof.

[0076] It should be understood that the present disclosure is in many respects illustrative only. Changes may be made in detail without exceeding the scope of the present disclosure, particularly with respect to the arrangement of shapes, sizes, and steps. To an appropriate degree, this may include using any of the features of an example embodiment in other embodiments. Of course, the scope of the present invention is defined in the language of the appended claims.

Claims

1. An implantable stent, comprising: an elongated body extending from the distal region to the proximal region, the elongated body comprising one or more filaments woven together to form the elongated body, the elongated body defining a stent outer surface and a stent inner surface; as well as One or more visual indicators are positioned relative to the inner surface of the stent such that the one or more visual indicators are endoscopically visible from a location within or adjacent to the implanted stent.

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

3. An implantable stent according to claim 1 or 2, wherein the one or more visual indicators include two or more visual indicators circumferentially equidistantly spaced apart on the inner surface of the stent, and each of the two or more visual indicators is visually distinguishable from indicators at other positions.

4. An implantable stent according to claim 3, wherein at least some of the two or more visual indicators include objects fixed relative to the inner surface of the stent.

5. The implantable stent of claim 3, further comprising a polymer coating on at least a portion of the elongated body.

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

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

8. An implantable medical device adapted for endoscopic deployment, the implantable medical device comprising: an elongated 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; and Two or more visual indicators are secured relative to the inner expansion surface, each of the two or more visual indicators being positioned to be endoscopically visible.

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

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

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

12. An implantable stent, comprising: an elongated body extending from a distal region to a proximal region, the elongated body comprising one or more filaments woven together to form the elongated body, the elongated body movable between a collapsed configuration for delivery and an expanded configuration for deployment, the elongated body comprising a constant diameter main section and a flared end section, the flared end section comprising an inner flared surface and an outer flared surface; as well as A plurality of visual indicators are fixed relative to the inner expansion surface such that each of the plurality of visual indicators is endoscopically visible.

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

14. The implantable stent of claim 12, wherein the plurality of visual indicators comprises four visual indicators equally spaced apart on the inner surface of the stent, each of the four visual indicators having 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 a pigment added to a portion of a polymer coating disposed on the elongated body.

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