Patent Description:
The present disclosure relates generally to methods and apparatuses for various digestive ailments. More particularly, the disclosure relates to different configurations and methods of manufacture and use of a stent.

Implantable stents are devices that are placed in a body structure, such as a blood vessel, esophagus, trachea, biliary tract, colon, intestine, stomach or body cavity, to provide support and to maintain the structure open. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices, delivery systems, and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices and delivery devices as well as alternative methods for manufacturing and using medical devices and delivery devices.

<CIT> disclose a deployment device for deploying an expandable endoluminal prosthesis within a body vessel may include an elongate member extending longitudinally along at least a portion of a length of the deployment device. The deployment device may include at least one engagement member coupled to the elongate member and extending outwardly from the elongate member. The deployment device may include a circumferential trigger wire extending at least partially circumferentially around the elongate member and removably received between the engagement member and the elongate member. The circumferential trigger wire may be manipulatable from a distal end of the deployment device, whereby the circumferential trigger wire is removable from between the engagement member and the elongate member.

This disclosure is directed to several alternative designs, materials, and methods of manufacturing medical device structures and assemblies, for preventing leaks after an anastomosis surgery and/or treating various gastro-intestinal, digestive, or other ailments.

In a first example, a delivery system for delivering an implant to a body lumen may comprise an outer tubular member defining a lumen and having a proximal end region and a distal end region. An inner tubular member defining a lumen and having a proximal end region and a distal end region may be slidably disposed within the lumen of the outer tubular member. The inner tubular member may have at least one opening positioned in a side wall adjacent to the distal end region, the at least one opening extending from an outer surface to an inner surface of the inner tubular member. An expandable implant may be disposed about the outer surface of the inner tubular member adjacent the distal end region of the inner tubular member, the implant comprising at least a first rigid portion and a first flexible portion. A thread including a distal portion may be wrapped around the first flexible portion of the implant and may be configured to maintain the first flexible portion in a collapsed configuration. The distal end region of the outer tubular member may be disposed over the first rigid portion of the implant and may be configured to maintain the first rigid portion in a radially collapsed configuration.

Alternatively or additionally to any of the examples above, in another example, a distal end of the thread may be positioned adjacent to a proximal end region of the first flexible portion and the thread may be wrapped from the proximal end region to a distal end region of the first flexible portion.

Alternatively or additionally to any of the examples above, in another example, a distal end of the thread may be positioned adjacent to a distal end region of the first flexible portion and the thread may be wrapped from the distal end region to a proximal end region of the first flexible portion.

Alternatively or additionally to any of the examples above, in another example, a proximal portion of the thread may extend into the lumen of the inner tubular member through the at least one opening and extends proximally to a proximal end configured to remain outside the proximal end region of the inner tubular member.

Alternatively or additionally to any of the examples above, in another example, the system may further comprise a pulling member coupled to the proximal end of the thread.

Alternatively or additionally to any of the examples above, in another example, the distal portion of the thread wrapped around the first flexible portion of the implant may include a plurality of releasable knots.

Alternatively or additionally to any of the examples above, in another example, the first rigid portion may comprise a self-expanding stent.

Alternatively or additionally to any of the examples above, in another example, the first flexible portion may comprise a flexible membrane.

Alternatively or additionally to any of the examples above, in another example, the implant may further comprise a second rigid portion and a second flexible portion.

Alternatively or additionally to any of the examples above, in another example, the first flexible portion may be positioned between the first rigid portion and the second rigid portion and a proximal end region of the second flexible portion may be coupled to a distal end region of the second rigid portion.

Alternatively or additionally to any of the examples above, in another example, the at least one opening may comprise a first proximal opening, a second opening, a third opening, and a fourth distal opening, the second and third openings positioned between the first and fourth openings.

Alternatively or additionally to any of the examples above, in another example, the distal portion of the thread may be configured to be woven in and out of the first, second, third and/or fourth openings such that the distal portion of the thread is selectively wrapped around the first and second flexible portions.

Alternatively or additionally to any of the examples above, in another example, a distal end of the thread may be positioned adjacent to a proximal end region of the first flexible portion and the thread may be wrapped from the proximal end region to a distal end region of the first flexible portion, enter the lumen of the inner tubular member through the second opening, exit the lumen of the inner tubular member through the third opening, is wrapped from a proximal end region to a distal end region of the second flexible portion, and re-enters the lumen of the inner tubular member through the fourth opening.

Alternatively or additionally to any of the examples above, in another example, a distal end of the thread may be positioned adjacent to a distal end region of the second flexible portion and the thread may be wrapped from the distal end region to a proximal end region of the second flexible portion, enter the lumen of the inner tubular member through the third opening, exit the lumen of the inner tubular member through the second opening, is wrapped from a distal end region to a proximal end region of the first flexible portion, and re-enters the lumen of the inner tubular member through the first opening.

Alternatively or additionally to any of the examples above, in another example, the second rigid portion may comprise a stent and the second flexible portion may comprise a flexible membrane.

In another example, a delivery system for delivering an implant to a body lumen may comprise an outer tubular member defining a lumen and having a proximal end region and a distal end region and an inner tubular member defining a lumen and having a proximal end region and a distal end region. The inner tubular member may be slidably disposed within the lumen of the outer tubular member and have at least one opening positioned in a side wall adjacent to the distal end region. The at least one opening may extend from an outer surface to an inner surface of the inner tubular member. An expandable implant may be disposed about the outer surface of the inner tubular member adjacent the distal end region of the inner tubular member. The implant may comprise at least a first rigid portion and a first flexible portion. A thread including a distal portion may be wrapped around the first flexible portion of the implant and may be configured to maintain the first flexible portion in a collapsed configuration. The distal end region of the outer tubular member may be disposed over the first rigid portion of the implant and may be configured to maintain the first rigid portion in a radially collapsed configuration.

In another example, a delivery system for delivering an implant to a body lumen may comprise an outer tubular member defining a lumen and having a proximal end region and a distal end region and an inner tubular member defining a lumen and having a proximal end region and a distal end region. The inner tubular member may be slidably disposed within the lumen of the outer tubular member and may have a first proximal opening, a second opening distal to the first opening, a third opening distal to the second opening, and a fourth opening distal to the third opening, the first, second, third, and fourth openings positioned in a side wall adjacent to the distal end region and extending from an outer surface to an inner surface of the inner tubular member. An expandable implant may be disposed about the outer surface of the inner tubular member adjacent the distal end region of the inner tubular member. The implant may comprise a first rigid portion, a first flexible portion, a second rigid portion, and a second flexible portion. A thread including a distal portion may be wrapped around the first flexible portion and the second flexible portion of the implant and may be configured to maintain the first and second flexible portions in a radially collapsed configuration. The distal end region of the outer tubular member may be disposed over the first rigid portion and the second rigid portion of the implant and may be configured to maintain the first and second rigid portions in a radially collapsed configuration.

Alternatively or additionally to any of the examples above, in another example, the distal portion of the thread may be configured to be woven in and out of the first, second, third and/or fourth openings such that the distal portion of thread is selectively wrapped around the first and second flexible portions.

Alternatively or additionally to any of the examples above, in another example, a distal end of the thread may be positioned adjacent to a proximal end region of the first flexible portion and the thread may be wrapped from the proximal end region to a distal end region of the first flexible portion, enters the lumen of the inner tubular member through the second opening, exits the lumen of the inner tubular member through the third opening, is wrapped from a proximal end region to a distal end region of the second flexible portion, and re-enters the lumen of the inner tubular member through the fourth opening.

Alternatively or additionally to any of the examples above, in another example, a distal end of the thread may be positioned adjacent to a distal end region of the second flexible portion and the thread may be wrapped from the distal end region to a proximal end region of the second flexible portion, enters the lumen of the inner tubular member through the third opening, exits the lumen of the inner tubular member through the second opening, is wrapped from a distal end region to a proximal end region of the first flexible portion, and re-enters the lumen of the inner tubular member through the first opening.

Alternatively or additionally to any of the examples above, in another example, a proximal portion of the thread may extend into the lumen of the inner tubular member through at least one of the first, second, third, or fourth openings and may extend proximally to a proximal end configured to remain outside the proximal end region of the inner tubular member.

Alternatively or additionally to any of the examples above, in another example, the distal portion of the thread may be wrapped around the first and/or second flexible portions of the implant includes a plurality of releasable knots.

In another example, a method (not part of the invention) for delivering an implant to a body lumen may comprise advancing a delivery system to a target location in a body lumen. The delivery system may comprise an outer tubular member defining a lumen and having a proximal end region and a distal end region, an inner tubular member defining a lumen and having a proximal end region and a distal end region, the inner tubular member may be slidably disposed within the lumen of the outer tubular member and have at least one opening positioned in a side wall adjacent to the distal end region, the at least one opening may extend from an outer surface to an inner surface of the inner tubular member, an expandable implant may be disposed about the outer surface of the inner tubular member adjacent the distal end region of the inner tubular member, the implant may comprise at least a first rigid portion and a first flexible portion, and a thread including a distal portion wrapped around the first flexible portion of the implant and configured to maintain the first flexible portion in a collapsed configuration. The distal end region of the outer tubular member may be disposed over the first rigid portion of the implant and is configured to maintain the first rigid portion in a radially collapsed configuration. The method may further comprise applying a pulling force to a proximal portion of the thread to unravel the thread wrapped around the first flexible portion and proximally retracting the outer tubular member relative to the inner tubular member to deploy the first rigid portion of the expandable implant from the outer tubular member.

Alternatively or additionally to any of the examples above, in another example, the distal portion of the thread may be wrapped about the first flexible portion such that the first flexible portion expands from the collapsed configuration to an expanded configuration in a distal to proximal direction as the thread is unraveled.

Alternatively or additionally to any of the examples above, in another example, the distal portion of the thread may be wrapped about the first flexible portion such that the first flexible portion expands from the collapsed configuration to an expanded configuration in a proximal to distal direction as the thread is unraveled.

Alternatively or additionally to any of the examples above, in another example, upon proximally retracting the outer tubular member the first rigid portion may expand from the radially collapsed configuration to a radially expanded configuration.

The above summary of exemplary embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure.

The invention may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:.

While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention.

In many instances, the terms "about" may be indicative as including numbers that are rounded to the nearest significant figure.

Although some suitable dimensions, ranges, and/or values pertaining to various components, features and/or specifications are disclosed, one of the skill in the art, incited by the present disclosure, would understand desired dimensions, ranges and/or values may deviate from those expressly disclosed.

For purposes of this disclosure, "proximal" refers to the end closer to the device operator during use, and "distal" refers to the end further from the device operator during use.

It is noted that references in the specification to "an embodiment", "some embodiments", "other embodiments", etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Further, when a particular feature, structure, or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, or characteristic may also be used connection with other embodiments whether or not explicitly described unless cleared stated to the contrary.

As self-expanding stent systems evolve, their usage with attached polymeric sleeves may be considered for numerous applications such as, but not limited to, the treatment of gastroesophageal reflux disease (GERD), obesity and/or diabetes treatments (e.g., to reduce the absorption of nutrients), and/or to protect against post bariatric surgery leaks or other damage. In other examples, sleeves may be deployed in a patient's colon to protect a damaged area. In a variety of contexts, sleeves may be made of a material that lacks rigidity and support, making them difficult to deploy within the desired body lumen. For example, the sleeve material may kink or bunch during attempted deployment. Alternative delivery systems, which may include various deployment options, are desired to accommodate delivery of a more rigid stent structure and a more flexible sleeve structure.

<FIG> illustrates a side view of an illustrative implant <NUM> including a first portion <NUM> and a second portion <NUM>. In some cases, the first portion <NUM> may take the form of a stent <NUM> including an elongated tubular stent frame <NUM>. The stent <NUM> may be may be entirely, substantially or partially, covered with a polymeric covering, such as a coating (not explicitly shown). The covering may be disposed on an inner surface and/or outer surface of the stent <NUM>, as desired. When so provided a polymeric covering may reduce or eliminate tissue ingrowth and/or reduce food impaction. The stent <NUM> may include regions of differing diameters. For example, the stent <NUM> may include a flared (e.g., enlarged relative to other portions of the stent <NUM>) proximal end region <NUM>. While not explicitly shown, the distal end region <NUM> of the stent <NUM> may also include a flared end region. The stent frame <NUM> may be expandable between a radially collapsed delivery configuration and a radially expanded deployed configuration. The expanded configuration may secure the implant <NUM> at the desired location in a body lumen. In some cases, the implant <NUM> may include features (e.g., anti-migration flares, fixation spikes, sutures, etc.) to prevent distal/proximal displacement and/or migration of the implant <NUM>, once the implant <NUM> is positioned and expanded in the body lumen.

The stent frame <NUM> may have a woven structure, fabricated from a number of filaments. In some embodiments, the stent frame <NUM> may be braided with one filament. In other embodiments, the stent frame <NUM> may be braided with several filaments, as is found, for example, in the WallFlex®, WALLSTENT®, and Polyflex® stents, made and distributed by Boston Scientific. In another embodiment, the stent frame <NUM> may be knitted, such as the Ultraflex™ stents made by Boston Scientific. In yet another embodiment, the stent frame <NUM> may be of a knotted type, such the Precision Colonic™ stents made by Boston Scientific Scimed, Inc. In still another embodiment, the stent frame <NUM> may be laser cut, such as the EPIC™ stents made by Boston Scientific.

It is contemplated that the stent frame <NUM> can be made from a number of different materials such as, but not limited to, metals, metal alloys, shape memory alloys and/or polymers, as desired, enabling the stent <NUM> to be expanded into shape when accurately positioned within the body. In some instances, the material may be selected to enable the stent <NUM> to be removed with relative ease as well. For example, the stent frame <NUM> can be formed from alloys such as, but not limited to, nitinol and Elgiloy®. Depending the on material selected for construction, the stent <NUM> may be self-expanding (i.e., configured to automatically radially expand when unconstrained). In some embodiments, fibers may be used to make the stent frame <NUM>, which may be composite fibers, for example, having an outer shell made of nitinol having a platinum core. It is further contemplated the stent frame <NUM> may be formed from polymers including, but not limited to, polyethylene terephthalate (PET). In some embodiments, the stent <NUM> may be self-expanding while in other embodiments, the stent <NUM> may be expand by an expansion device (such as, but not limited to a balloon inserted within the lumen <NUM> of the stent <NUM>). As used herein the term "self-expanding" refers to the tendency of the stent to return to a preprogrammed diameter when unrestrained from an external biasing force (for example, but not limited to a delivery catheter or sheath). The stent <NUM> may include a one-way valve, such as an elastomeric slit valve or duck bill valve, positioned within the lumen <NUM> thereof to prevent retrograde flow of gastrointestinal fluids.

In some cases, the second portion <NUM> may take the form of a flexible sleeve <NUM>. The sleeve <NUM> may include a membrane <NUM> and a support <NUM>. A lumen <NUM> may extend the length of the sleeve <NUM> and be in fluid communication with the lumen <NUM> of the stent <NUM>. The sleeve <NUM> may be connected, affixed, or secured to the distal end region <NUM> of the stent <NUM> adjacent to a proximal end region <NUM> of the sleeve <NUM>. In some cases, the sleeve <NUM> may extend into a lumen <NUM> of the stent <NUM>, as shown in <FIG>, although this is not required. In other embodiments, the sleeve <NUM> may extend partially, substantially, or all of a length of the implant <NUM> and cover all other portions (exterior surface and/or interior surface) of the implant <NUM>, including the stent <NUM>. The membrane <NUM> may couple the sleeve <NUM> to the stent <NUM>. In some cases, the membrane <NUM> may be secured by an adhesive or other methods known in the art, including by not limited to thermal methods, mechanical methods, etc..

The sleeve <NUM> may extend from the distal end region <NUM> of the stent <NUM> and may have an elongated, tubular shape with an interior lumen <NUM>. In one example, the membrane <NUM> defines only one interior lumen. However, other embodiments including more than one lumen are contemplated. In an expanded configuration, the sleeve <NUM> may be substantially cylindrical. Absent the support <NUM>, the membrane <NUM> may be a flexible, thin membrane that readily collapses on itself. However the support <NUM> may provide rigidity and structure to sleeve <NUM>. Some examples and discussion of illustrative supports <NUM> may be found in co-pending Patent Application Number <CIT>, titled DEPLOYABLE SLEEVES AND RELATED METHODS. Generally, the support <NUM> may be a helically wound element configured to assume an expanded configuration either upon the release of a biasing force or upon application of a force thereto. In various examples, the support <NUM> may include different materials that provide different levels of rigidity. Rigidity may be varied through material selection, pitch, etc. It is further contemplated that the rigidity may vary along the length of the sleeve <NUM>, as desired. The support <NUM> may extend along a perimeter of the sleeve <NUM>. The support <NUM> may be positioned between two or more layers of material that form the membrane <NUM> (e.g., an interior layer and an exterior layer), or otherwise embedded into the material that forms the membrane <NUM>. In other examples, support <NUM> may extend along the perimeter of sleeve <NUM> by being positioned proximate to the membrane <NUM>, either interior to or exterior to the membrane <NUM>.

The membrane <NUM> may include one or more of the following polymer materials: polyethylene, polypropylene, polystyrene, polyester, biosorbable plastics (e.g., polylactic acid), polycarbonate, polyvinyl chloride, polyacrylate, acrylate, polysulfone, polyetheretherketone, thermoplastic elastomers, thermoset elastomers (e. silicone), poly-p-xylylene (parylene), flouropolymers (e.g., polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), poly(vinylidene fluoride-co-hexafluoropropylene) (PVDFHFP)), bioplastics (e.g., cellulose acetate). The sleeve may additionally or alternatively include one or more of: polyurethane and its copolymers, ethylene vinyl-acetate, polyethylene terephthalate (PET), polyolefins, cellulosics, polyamides, acrylonitrile butadiene styrene copolymers, styrene isoprene butadiene (SIBS) block copolymers, acrylics, poly(glycolide-lactide) copolymer, Tecothane, PEBAX, poly(y-caprolactone), poly(y-hydroxybutyrate), polydioxanone, poly(y-ethyl glutamate), polyiminocarbonates, poly(ortho ester), and/or polyanhydrides. Blends of the above polymers may also be employed.

In further detail, the implant <NUM> may be generally cylindrical in shape, although this is not required, substantially flexible, and sized appropriately for a convenient accommodation within the digestive tract. It is contemplated that various shapes, sizes and designs of the implant may be constructed depending on the size and geometry of the cavities where the implant <NUM> has to be placed. In various examples, the implant may have a length between <NUM>-<NUM> inches, <NUM>-<NUM> inches, <NUM>-<NUM> feet (<NUM>-<NUM> meters), between <NUM>-<NUM> feet (. <NUM>-<NUM> meters), or about <NUM>-<NUM> feet (<NUM>-<NUM> meters). However, the implant <NUM> may have a length of less than <NUM> feet (<NUM> meters) or greater than <NUM> feet (<NUM> meters).

Once implanted in a patient, the stent <NUM> may exert a radially outward force to help secure the implant <NUM> to the body lumen. The implant <NUM> may be positioned in the esophagus, the gastro-esophageal junction (GEJ) region, or at or near the pylorus with the sleeve <NUM> extending through the stomach or other portions of the gastro-intestinal system. In another example, the stent <NUM> may be positioned in the patient's intestine. In some examples, the implant <NUM> does not include the stent <NUM>. Instead, the sleeve <NUM> may be secured directly to the patient's tissue using sutures or any other suitable attachment mechanism.

<FIG> is a side view of an illustrative delivery system <NUM> for delivering an implant having both a rigid portion and a flexible portion, such as the implant <NUM> described herein, to a target region. The delivery system <NUM> may include an outer or exterior elongate shaft or tubular member <NUM> and an inner elongate shaft or tubular member <NUM>. The inner tubular member <NUM> may be slidably disposed within a lumen of the outer tubular member <NUM>. The outer tubular member <NUM> may extend proximally from a distal end region <NUM> to a proximal end region <NUM> configured to remain outside of a patient's body. A first hub or handle <NUM> may be coupled to the proximal end region <NUM> of the outer tubular member <NUM>. The inner tubular member <NUM> may extend proximally from a distal end region <NUM> to a proximal end region <NUM> configured to remain outside of a patient's body. A second hub or handle <NUM> may be coupled to the proximal end region <NUM> of the inner tubular member <NUM>. The inner tubular member <NUM> may further include a distal tip <NUM> positioned adjacent to the distal end region <NUM>. The distal tip <NUM> may be configured to be atraumatic.

The outer tubular member <NUM> may include a lumen <NUM> extending from the distal end region <NUM> to the proximal end region <NUM>. The lumen <NUM> may also extend through the first handle <NUM>. The lumen <NUM> of the outer shaft <NUM> and the first handle <NUM> may be configured to slidably receive the inner shaft <NUM>. The inner tubular member <NUM> may include a lumen <NUM> extending from the distal end region <NUM> to the proximal end region <NUM>. The lumen <NUM> of the inner tubular shaft <NUM> may also extend through the second handle <NUM>. The lumen <NUM> of the inner shaft <NUM> may be configured to receive a thread, pull-wire and/or guidewire, as desired.

The implant <NUM> may be disposed around a portion of the inner tubular member <NUM> at or adjacent to the distal end region <NUM> thereof. When the implant <NUM> is disposed over the inner tubular member <NUM>, in a delivery configuration, the stent portion <NUM> may be restrained in a collapsed reduced diameter or delivery configuration by the outer tubular member <NUM> surrounding the stent portion <NUM>. The distal end region <NUM> of the outer tubular member <NUM> may be positioned such that the outer tubular member <NUM> surrounds and covers the length of stent <NUM> during delivery. The outer tubular member <NUM> may have sufficient hoop strength to retain the stent <NUM> in its reduced diameter state.

The sleeve <NUM> may be held in a radially collapsed configuration through the use of a thread <NUM> (e.g., filament or wire). The thread <NUM> may be any thin flexible element capable of being wrapped and unwrapped about the sleeve <NUM>. A distal portion of the thread <NUM> may be wound or wrapped about the sleeve <NUM> while a proximal portion of the thread <NUM> may extend proximally through the lumen <NUM> to a point outside the delivery device <NUM>. The thread <NUM> may be wound about an outer surface of the sleeve <NUM> to apply a biasing force to the sleeve <NUM> which maintains the sleeve <NUM> in a collapsed or reduced diameter configuration. In some embodiments, a distal end <NUM> of the thread <NUM> may be positioned adjacent to the proximal end region <NUM> of the sleeve <NUM>. In other embodiments, the distal end <NUM> of the thread <NUM> may be positioned adjacent to the distal end region <NUM> of the sleeve <NUM> as described in more detail with respect to <FIG> and <FIG>. It is contemplated that the position of the distal end <NUM> of the thread <NUM> may determine which portion of the sleeve <NUM> (e.g., proximal or distal) is expanded first. In some cases, the thread <NUM> may be wound such that the clinician may have the option of selecting which portion of the sleeve <NUM> is deployed first.

The thread <NUM> may be wrapped around the sleeve <NUM> in a generally helical manner, although this is not required. The spacing of adjacent windings <NUM> of the thread <NUM> may be uniform or variable as desired. In other words the pitch of the windings <NUM> may be the same, varied, or combinations thereof, as desired. In some cases, the thread <NUM> may include a plurality of knots <NUM> similar in form and function to those used in knitting or crocheting, which allow the thread <NUM> to be releasably secured about the sleeve <NUM>. The knots <NUM> may generally maintain the thread <NUM> in a desired configuration while still allowing the thread <NUM> to be unraveled or removed as desired. In some cases, the thread <NUM> may not include knots <NUM>.

The thread <NUM> may extend through a skive, slot, or other opening <NUM> in a side wall of the inner tubular member <NUM> and into the lumen <NUM> of the inner tubular member <NUM>. The opening <NUM> may extend from an outer surface to an inner surface of the inner tubular member <NUM> to allow the thread <NUM> (or other components, as desired) to extend between the exterior of the inner tubular member <NUM> and the interior thereof. The thread <NUM> may extend proximally through the lumen <NUM> and exit proximally at the second handle <NUM>. The proximal end <NUM> of the thread <NUM> is configured to remain outside of the inner tubular member <NUM> and may be coupled to or otherwise affixed to a pull member <NUM> or other actuation mechanism. The pull member <NUM>, such as a pull ring, a pull tab, or the like, may facilitate actuation of thread <NUM>; however a pull member <NUM> or other actuation mechanism may not be present or required.

<FIG> illustrate a method of delivering the illustrative implant <NUM> to a body lumen using the delivery device <NUM> of <FIG>. <FIG> illustrates a close up side view of a distal portion of the delivery device <NUM> with the implant <NUM> in a collapsed or delivery configuration. The delivery device <NUM> may be advanced through the gastrointestinal tract transorally or transrectally, as desired. The delivery device <NUM> may be advanced with or without the use of a guidewire. Once the implant <NUM> is positioned adjacent to the target region, the restraining forces maintaining the stent <NUM> and the sleeve <NUM> in the radially collapsed configuration may be removed either in series (one after the other) or simultaneously (e.g., together) to deploy the implant <NUM>.

In some cases, the sleeve <NUM> may be deployed prior to the stent <NUM>. Once the implant <NUM> is adjacent to the desired location, a proximal or pulling force <NUM> may be applied to the proximal end <NUM> of the thread <NUM>, as shown in <FIG>. In some cases, the pulling force <NUM> may be applied by placing a finger inside of the pull member <NUM> and pulling away from the handle <NUM>. As the member <NUM> is pulled or actuated, the thread <NUM> begins to unravel. In the embodiments shown in <FIG>, the thread <NUM> is wrapped or wound such that the thread <NUM> disposed over the distal portion <NUM> of the sleeve <NUM> is removed or unraveled first. Still referring to <FIG>, as the biasing force of the thread <NUM> is released as the thread <NUM> is unraveled, the sleeve <NUM> begins to radially expand into its unbiased or deployed configuration. As the thread <NUM> is pulled, the portion of the thread <NUM> previously wound around the sleeve <NUM> unravels and enters the lumen <NUM> through the opening <NUM>. The thread <NUM> then moves proximally through the lumen <NUM>. Continued unraveling of the thread <NUM> will cause more of the length of the sleeve <NUM> to be released, as shown in <FIG>. Proximal actuation of the proximal end <NUM> of the thread <NUM> may continue until the distal end <NUM> of the thread <NUM> has been completely unraveled, as shown in <FIG>. It is contemplated that the clinician may continue to pull the thread <NUM> until the distal end <NUM> has been completely removed from the lumen <NUM> and the device <NUM> although this is not required.

Once the sleeve <NUM> has been partially or fully deployed, the stent <NUM> may be released. It should be noted that it is not necessarily required to deploy the sleeve <NUM> first. In some cases, it may be desirable to deploy the stent <NUM> portion first, followed by deployment of the sleeve <NUM> by unraveling the thread <NUM> as discussed above. The stent <NUM> may be released by actuating the first handle <NUM> proximally relative to the second handle <NUM>, e.g., by pulling the first handle <NUM> (see, for example, <FIG>) proximally while maintaining the second handle <NUM> in a fixed position. Thus, the outer tubular shaft <NUM> may be retracted proximally relative to the inner tubular shaft <NUM>. In other words, the outer tubular shaft <NUM> may be proximally retracted while the inner tubular shaft <NUM> is held stationary. As shown in <FIG>, as the outer tubular shaft <NUM> is retracted proximally to uncover the stent <NUM>, the biasing force is removed from the exterior of the stent <NUM> and the stent <NUM> assumes its radially expanded, unbiased, deployed configuration. Once the outer tubular member <NUM> no longer covers the proximal end <NUM> of the stent <NUM>, the implant <NUM> may assume its fully deployed configuration, as shown in <FIG>. The delivery device <NUM> may then be removed from the body lumen.

<FIG> illustrate another method of delivering the implant <NUM> to a body lumen. The structure of the delivery device <NUM> may be substantially the same as described above with respect to <FIG>. However, the thread <NUM> may be wound in a different direction such that the sleeve <NUM> is deployed proximally to distally (as opposed to distally to proximally, as shown in <FIG>).

<FIG> illustrates a close up side view of a distal portion of the delivery device <NUM> with the implant <NUM> in a radially collapsed or delivery configuration. The implant <NUM> may be disposed around a portion of the inner tubular member <NUM> at or adjacent to the distal end region <NUM> thereof. When the implant <NUM> is disposed over the inner tubular member <NUM>, in a delivery configuration, the stent portion <NUM> may be restrained in a collapsed reduced diameter or delivery configuration by the outer tubular member <NUM> surrounding the stent portion <NUM>. The distal end region <NUM> of the outer tubular member <NUM> may be positioned such that the outer tubular member <NUM> surrounds and covers the length of stent <NUM> during delivery. The outer tubular member <NUM> may have sufficient hoop strength to retain the stent <NUM> in its reduced diameter state.

The sleeve <NUM> may be held in a radially collapsed configuration through the use of a thread <NUM> (e.g., filament or wire). The thread <NUM> may be wound about an outer surface of the sleeve <NUM> to apply a biasing force to the sleeve which maintains it in a collapsed or reduced diameter configuration. In some embodiments, a distal end <NUM> of the thread <NUM> may be positioned adjacent to the distal end region <NUM> of the sleeve <NUM>. The thread <NUM> may be wrapped around the sleeve <NUM> in a generally helical manner, although this is not required. The spacing of adjacent windings <NUM> of the thread <NUM> may be uniform or variable as desired. In other words the pitch of the windings <NUM> may be the same, varied, or combinations thereof, as desired. In some cases, the thread <NUM> may include a plurality of knots <NUM> similar in form and function to those used in knitting or crocheting, which allow the thread <NUM> to be releasably secured about the sleeve <NUM>. The knots <NUM> may generally maintain the thread <NUM> in a desired configuration while still allowing the thread <NUM> to be unraveled or removed as desired. In some cases, the thread <NUM> may not include knots <NUM>.

The thread <NUM> may extend through an opening <NUM> and into the lumen <NUM> of the inner tubular member <NUM>. The opening <NUM> may extend from an outer surface to an inner surface of the inner tubular member <NUM> to allow the thread (or other components, as desired) to extend between the exterior of the inner tubular member <NUM> and the interior thereof. The thread <NUM> may extend proximally through the lumen <NUM> and exit proximally at the second handle <NUM>. The proximal end <NUM> of the thread <NUM> may be coupled to or otherwise affixed to a pull member <NUM> or other actuation mechanism. The pull member <NUM>, such as a pull ring, a pull tab, or the like, may facilitate actuation of thread <NUM>; however a pull member <NUM> or other actuation mechanism may not be present or required.

The delivery device <NUM> may be advanced through the gastrointestinal tract transorally or transrectally, as desired. The delivery device <NUM> may be advanced with or without the use of a guidewire. Once the implant <NUM> is positioned adjacent to the target region, the restraining forces maintaining the stent <NUM> and the sleeve <NUM> in the radially collapsed configuration may be removed either in series (one after the other) or simultaneously (e.g., together) to deploy the implant <NUM>.

In some cases, the stent <NUM> may be deployed prior to the sleeve <NUM>. Once the implant is positioned adjacent to the desired location, the stent <NUM> may be released. The stent <NUM> may be released by actuating the first handle <NUM> proximally relative to the second handle <NUM>, e.g., by pulling the first handle <NUM> (see, for example, <FIG>) proximally while maintaining the second handle <NUM> in a fixed position. Thus, the outer tubular shaft <NUM> may be retracted proximally relative to the inner tubular shaft <NUM>. In other words, the outer tubular shaft <NUM> may be proximally retracted while the inner tubular shaft <NUM> is held stationary. As shown in <FIG>, as the outer tubular shaft <NUM> is retracted proximally to uncover the stent <NUM>, the biasing force is removed from the exterior of the stent <NUM> and the stent <NUM> assumes its radially expanded, unbiased, deployed configuration. While <FIG> illustrates the stent <NUM> in a partially deployed configuration, the stent <NUM> may be fully deployed prior to deploying the sleeve <NUM>.

Still referring to <FIG>, once the stent <NUM> has been partially or fully deployed, deployment of the sleeve <NUM> may begin. A proximal or pulling force <NUM> may be applied to the proximal end <NUM> of the thread <NUM>. In some cases, the pulling force <NUM> may be applied by placing a finger inside of the pull member <NUM> and pulling away from the handle <NUM>. As the member <NUM> is pulled or actuated, the thread <NUM> begins to unravel. In the embodiments shown in <FIG>, the thread <NUM> is wrapped or wound such that the thread <NUM> disposed over the proximal portion <NUM> of the sleeve <NUM> is removed or unraveled first. As the biasing force of the thread <NUM> is released as the thread <NUM> is unraveled, the sleeve <NUM> begins to radially expand into its unbiased or deployed configuration. As the thread <NUM> is pulled, the portion of the thread <NUM> previously wound around the sleeve <NUM> unravels and enters the lumen <NUM> through the opening <NUM>. The thread <NUM> then moves proximally through the lumen <NUM>. Continued unraveling of the thread <NUM> will cause more of the length of the sleeve <NUM> to be released. Proximal actuation of the proximal end <NUM> of the thread <NUM> may continue until the distal end <NUM> of the thread <NUM> has been completely unraveled. It is contemplated that the clinician may continue to pull the thread <NUM> until the distal end <NUM> has been completely removed from the lumen <NUM> and the device <NUM> although this is not required. Once the outer tubular member <NUM> no longer covers the proximal end <NUM> of the stent <NUM> and the thread <NUM> has been removed, the implant <NUM> may assume its fully deployed configuration, as shown in <FIG>. The delivery device <NUM> may then be removed from the body lumen.

While the opening <NUM> is illustrated as distal to the sleeve <NUM>, it is contemplated that the opening <NUM> may be positioned in other locations as desired. In one example, the opening <NUM> in the inner tubular member <NUM> may be positioned adjacent to the stent <NUM>. In other words, the opening <NUM> may be positioned underneath the stent <NUM> when the implant <NUM> is radially collapsed around the inner tubular member <NUM> in the delivery configuration. It is contemplated that the thread <NUM> may be threaded through the stent frame <NUM> and over the sleeve <NUM>. In another example, the opening <NUM> may be placed in a sliding arrangement to allow for the opening of a knot, such as knot <NUM>, at a proximal or a distal point on the sleeve <NUM>. Such an arrangement may allow for a decision on release direction of the sleeve <NUM> (e.g., proximal to distal release or distal to proximal release) at the time of implantation, as will be described in more detail with respect to <FIG>.

In yet another embodiment the inner tubular shaft <NUM> may include a proximal opening and a distal opening (or more than two openings) for allowing the thread <NUM> to enter and/or exit the lumen <NUM> of the inner tubular member <NUM> at different locations. In some cases, the thread <NUM> may extend distally through the lumen <NUM>, exit through one of the two or more openings, wind around the sleeve <NUM>, re-enter the lumen <NUM> through another (different) of the two or more openings, and extend distally through the lumen <NUM>. In such an instance, both free ends of the thread <NUM> may be actuatable at the proximal end of the delivery device <NUM>. For example, proximal pulling of one end of the thread <NUM> may result in proximal to distal deployment of the sleeve <NUM> while proximal pulling of the other end of the thread <NUM> may result in distal to proximal deployment of the sleeve <NUM>. It is contemplated that the ends of the thread <NUM> may be identified with a marking to indicate which direction the sleeve <NUM> would be deployed upon actuation of the respective end of the thread <NUM>.

<FIG> illustrates a side view of another illustrative implant <NUM> including a plurality of rigid and flexible portions. In the illustrated embodiment, the implant <NUM> may include a first stent portion <NUM>, a first sleeve portion <NUM>, a second stent portion <NUM>, and a second sleeve portion <NUM>. Thus, the sleeve portions <NUM> may alternate with the stent portions along a length of the implant <NUM>. However, it is contemplated that the implant <NUM> may include any number of rigid and flexible regions desired. It is further contemplated that the rigid and flexible portions may be arranged in any order and/or pattern desired.

In some cases, the first stent portion <NUM> may include an elongated tubular stent frame <NUM>. The stent <NUM> may be may be entirely, substantially or partially, covered with a polymeric covering, such as a coating (not explicitly shown). The covering may be disposed on an inner surface and/or outer surface of the stent <NUM>, as desired. When so provided a polymeric covering may reduce or eliminate tissue ingrowth and/or reduce food impaction. The stent <NUM> may include regions of differing diameters. For example, the stent <NUM> may include a flared (e.g., enlarged relative to other portions of the stent <NUM>) proximal end region <NUM>. While not explicitly shown, the distal end region <NUM> of the stent <NUM> may also include a flared end region. The stent frame <NUM> may be radially expandable between a radially collapsed delivery configuration and a radially expanded configuration. The expanded configuration may secure the implant <NUM> at the desired location in a body lumen.

The second first stent portion <NUM> may include an elongated tubular stent frame <NUM>. The stent <NUM> may be may be entirely, substantially or partially, covered with a polymeric covering or coating (not explicitly shown). The coating may be disposed on an inner surface and/or outer surface of the stent <NUM>, as desired. When so provided a polymeric covering, such as a coating, may reduce or eliminate tissue ingrowth and/or reduce food impaction. The stent <NUM> may include regions of differing diameters. For example, while not explicitly shown the stent <NUM> may include a flared (e.g., enlarged relative to other portions of the stent <NUM>) proximal end region <NUM> and/ or a flared distal end region <NUM>. The stent frame <NUM> may be radially expandable between a radially collapsed delivery configuration and a radially expanded configuration. The expanded configuration may secure the implant <NUM> at the desired location in a body lumen. In some cases, the implant <NUM> may include features (e.g., anti-migration flares, fixation spikes, sutures, etc.) to prevent distal/proximal displacement and/or migration of the implant <NUM>, once the implant <NUM> is positioned and expanded in the body lumen.

The stent frames <NUM>, <NUM> may have a woven structure, fabricated from a number of filaments. In some embodiments, the stent frames <NUM>, <NUM> may be braided with one filament. In other embodiments, the stent frames <NUM>, <NUM> may be braided with several filaments, as is found, for example, in the WallFlex®, WALLSTENT®, and Polyflex® stents, made and distributed by Boston Scientific. In another embodiment, the stent frames <NUM>, <NUM> may be knitted, such as the Ultraflex™ stents made by Boston Scientific. In yet another embodiment, the stent frames <NUM>, <NUM> may be of a knotted type, such the Precision Colonic™ stents made by Boston Scientific Scimed, Inc. In still another embodiment, the stent frames <NUM>, <NUM> may be laser cut, such as the EPIC™ stents made by Boston Scientific. It is further contemplated that the stent frames <NUM>, <NUM> may be fabricated in the same manner or different manners to provide differing properties a long a length of the implant <NUM>, as desired.

It is contemplated that the stent frames <NUM>, <NUM> can be made from a number of different materials such as, but not limited to, metals, metal alloys, shape memory alloys and/or polymers, as desired, enabling the stents <NUM>, <NUM> to be expanded into shape when accurately positioned within the body. In some instances, the material may be selected to enable the stents <NUM>, <NUM> to be removed with relative ease as well. For example, the stent frames <NUM>, <NUM> can be formed from alloys such as, but not limited to, nitinol and Elgiloy®. Depending the on material selected for construction, the stents <NUM>, <NUM> may be self-expanding (i.e., configured to automatically radially expand when unconstrained). In some embodiments, fibers may be used to make the stent frames <NUM>, <NUM>, which may be composite fibers, for example, having an outer shell made of nitinol having a platinum core. It is further contemplated the stent frames <NUM>, <NUM> may be formed from polymers including, but not limited to, polyethylene terephthalate (PET). In some embodiments, the stents <NUM>, <NUM> may be self-expanding while in other embodiments, the stents <NUM>, <NUM> may be expand by an expansion device (such as, but not limited to a balloon inserted within the lumen of the stent(s) <NUM>, <NUM>). As used herein the term "self-expanding" refers to the tendency of the stent to return to a preprogrammed diameter when unrestrained from an external biasing force (for example, but not limited to a delivery catheter or sheath). One or both of the stents <NUM>, <NUM> may include a one-way valve, such as an elastomeric slit valve or duck bill valve, positioned within the lumen thereof to prevent retrograde flow of gastrointestinal fluids.

In some cases, the first sleeve <NUM> may include a flexible membrane <NUM>. While not explicitly shown, the sleeve <NUM> may include a support similar in form and function to the support <NUM> described herein with respect to <FIG>. The sleeve <NUM> may be connected, affixed, or secured to the distal end region <NUM> of the first stent <NUM> adjacent to a proximal end region <NUM> of the sleeve <NUM>. The sleeve <NUM> may be connected, affixed, or secured to the proximal end region <NUM> of the second stent <NUM> adjacent to a distal end region <NUM> of the sleeve <NUM>. In some cases, the sleeve <NUM> may extend into a lumen of one or both of the stents <NUM>, <NUM>, although this is not required. In other embodiments, the sleeve <NUM> may extend partially, substantially, or all of a length of the implant <NUM> and cover all other portions (exterior surface and/or interior surface) of the implant <NUM>, including the stents <NUM>, <NUM>. The membrane <NUM> may couple the sleeve <NUM> to one or both of the stents <NUM>, <NUM>. In some cases, the membrane <NUM> may be secured by an adhesive or other methods known in the art, including by not limited to thermal methods, mechanical methods, etc..

In some cases, the second sleeve <NUM> may include a flexible membrane <NUM>. While not explicitly shown, the sleeve <NUM> may include a support similar in form and function to the support <NUM> described herein with respect to <FIG>. The sleeve <NUM> may be connected, affixed, or secured to the distal end region <NUM> of the second stent <NUM> adjacent to a proximal end region <NUM> of the sleeve <NUM>. In some cases, the sleeve <NUM> may extend into a lumen of the stent <NUM>, although this is not required. In other embodiments, the sleeve <NUM> may extend partially, substantially, or all of a length of the implant <NUM> and cover all other portions (exterior surface and/or interior surface) of the implant <NUM>, including the stents <NUM>, <NUM>. The membrane <NUM> may couple the sleeve <NUM> to one or both of the stents <NUM>, <NUM>. In some cases, the membrane <NUM> may be secured by an adhesive or other methods known in the art, including by not limited to thermal methods, mechanical methods, etc..

The sleeves <NUM>, <NUM> may have an elongated, tubular shape with an interior lumen. Lumens of each of the stents <NUM>, <NUM>, and sleeves <NUM>, <NUM> may be fluidly coupled to form a lumen <NUM> extending from the proximal end region <NUM> of the first stent <NUM> to the distal end region <NUM> of the second sleeve <NUM>. In one example, the implant <NUM> defines only one interior lumen. However, other embodiments including more than one lumen are contemplated. In an expanded configuration, the sleeves <NUM>, <NUM> may be substantially cylindrical, although this is not required. Absent a support, the membranes <NUM>, <NUM> may be flexible, thin membranes that readily collapses on themselves. However, if so provided, supports may provide rigidity and structure to sleeves <NUM>, <NUM>. Some examples and discussion of illustrative supports may be found in co-pending Patent Application Number <CIT>, titled DEPLOYABLE SLEEVES AND RELATED METHODS.

The membranes <NUM>, <NUM> may include one or more of the following polymer materials: polyethylene, polypropylene, polystyrene, polyester, biosorbable plastics (e.g., polylactic acid), polycarbonate, polyvinyl chloride, polyacrylate, acrylate, polysulfone, polyetheretherketone, thermoplastic elastomers, thermoset elastomers (e.g., silicone), poly-p-xylylene (parylene), flouropolymers (e.g., polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), poly(vinylidene fluoride-co-hexafluoropropylene) (PVDFHFP)), bioplastics (e.g., cellulose acetate). The sleeve may additionally or alternatively include one or more of: polyurethane and its copolymers, ethylene vinyl-acetate, polyethylene terephthalate (PET), polyolefins, cellulosics, polyamides, acrylonitrile butadiene styrene copolymers, styrene isoprene butadiene (SIBS) block copolymers, acrylics, poly(glycolide-lactide) copolymer, Tecothane, PEBAX, poly(y-caprolactone), poly(y-hydroxybutyrate), polydioxanone, poly(y-ethyl glutamate), polyiminocarbonates, poly(ortho ester), and/or polyanhydrides. Blends of the above polymers may also be employed.

Once implanted in a patient, one or both of the stent <NUM>, <NUM> may exert a radially outward force to help secure the implant <NUM> to the body lumen. The implant <NUM> may be positioned in the esophagus, the gastro-esophageal junction (GEJ) region, or at or near the pylorus with the sleeve(s) <NUM>, <NUM> extending through the stomach or other portions of the gastro-intestinal system. In another example, the implant <NUM> may be positioned in the patient's intestine. In some examples, the implant <NUM> does not include one or both of the stent <NUM>, <NUM>. Instead, the sleeve(s) <NUM>, <NUM> may be secured directly to the patient's tissue using sutures or any other suitable attachment mechanism.

<FIG> is a side view of an illustrative delivery system <NUM> for delivering an implant having both a rigid portion and a flexible portion, such as any of the implants described herein, to a target region. The delivery system <NUM> may include an outer or exterior elongate shaft or tubular member <NUM> and an inner elongate shaft or tubular member <NUM>. The inner tubular member <NUM> may be slidably disposed within a lumen of the outer tubular member <NUM>. The outer tubular member <NUM> may extend proximally from a distal end region <NUM> to a proximal end region <NUM> configured to remain outside of a patient's body. A first hub or handle <NUM> may be coupled to the proximal end region <NUM> of the outer tubular member <NUM>. The inner tubular member <NUM> may extend proximally from a distal end region <NUM> to a proximal end region <NUM> configured to remain outside of a patient's body during an implantation procedure. A second hub or handle <NUM> may be coupled to the proximal end region <NUM> of the inner tubular member <NUM>. The inner tubular member <NUM> may further include a distal tip <NUM> positioned adjacent to the distal end region <NUM>. The distal tip <NUM> may be configured to be atraumatic.

The outer tubular member <NUM> may include a lumen <NUM> extending from the distal end region <NUM> to the proximal end region <NUM>. The lumen <NUM> may also extend through the first handle <NUM>. The lumen <NUM> of the outer shaft <NUM> and the first handle <NUM> may be configured to slidably receive the inner shaft <NUM>. The inner tubular member <NUM> may include a lumen <NUM> extending from the distal end region <NUM> to the proximal end region <NUM>. The lumen <NUM> of the inner tubular shaft <NUM> may extend through the second handle <NUM>. The lumen <NUM> of the inner shaft <NUM> may be configured to receive a thread, pull-wire and/or guidewire, as desired.

The implant <NUM> may be disposed around a portion of the inner tubular member <NUM> at or adjacent to the distal end region <NUM> thereof. When the implant <NUM> is disposed over the inner tubular member <NUM>, in a delivery configuration, the stent portions <NUM>, <NUM> may be restrained in a collapsed reduced diameter or delivery configuration by the outer tubular member <NUM> surrounding the stent portions <NUM>, <NUM>. In some cases, the outer tubular member <NUM> may be configured to extend over the entire length of the implant <NUM>. The distal end region <NUM> of the outer tubular member <NUM> may be positioned such that the outer tubular member <NUM> surrounds and covers at least the length of stent portions <NUM>, <NUM> during delivery. The outer tubular member <NUM> may have sufficient hoop strength to retain the stents <NUM>, <NUM> in their reduced diameter state.

The sleeves <NUM>, <NUM> may be held in a radially collapsed configuration through the use of a thread <NUM> (e.g., filament or wire). The thread <NUM> may be any thin flexible element capable of being wrapped and unwrapped about the sleeves <NUM>, <NUM>. The thread <NUM> may be wound about an outer surface of the sleeves <NUM>, <NUM> to apply a biasing force to the sleeves <NUM>, <NUM> which maintains the sleeves <NUM>, <NUM> in a collapsed or reduced diameter configuration. In some embodiments, a distal end <NUM> of the thread <NUM> may be positioned adjacent to the proximal end region <NUM> of the first sleeve <NUM>. In other embodiments, the distal end <NUM> of the thread <NUM> may be positioned adjacent to the distal end region <NUM> of the second sleeve <NUM> as described in more detail with respect to <FIG>. It is contemplated that the position of the distal end <NUM> of the thread <NUM> may determine which portion of the sleeve <NUM> (e.g., proximal or distal) is expanded first and/or which sleeve <NUM>, <NUM> is deployed first. In some cases, the thread <NUM> may wound such that the clinician may have the option of selecting which portion of the sleeves <NUM>, <NUM> and/or which sleeve <NUM>, <NUM> is deployed first.

The thread <NUM> may be wrapped around the sleeves <NUM>, <NUM> in a generally helical manner, although this is not required. The spacing of adjacent windings <NUM> of the thread <NUM> may be uniform or variable as desired. In other words the pitch of the windings <NUM> may be the same, varied, or combinations thereof, as desired. In some cases, the thread <NUM> may include a plurality of knots <NUM> similar in form and function to those used in knitting or crocheting, which allow the thread <NUM> to be releasably secured about the sleeves <NUM>, <NUM>. The knots <NUM> may generally maintain the thread <NUM> in a desired configuration while still allowing the thread to be unraveled or removed as desired. In some cases, the thread <NUM> may not include knots <NUM>.

The thread <NUM> may extend through one or more skives, slots, or other openings <NUM>, <NUM>, <NUM>, <NUM> to enter and exit the lumen <NUM> of the inner tubular member <NUM>, as desired, as will be described in more detail with reference to <FIG>. The openings <NUM>, <NUM>, <NUM>, <NUM> may extend from an outer surface to an inner surface of the inner tubular member <NUM> to allow the thread <NUM> (or other components, as desired) to extend between the exterior of the inner tubular member <NUM> and the interior thereof. The openings <NUM>, <NUM>, <NUM>, <NUM> may be spaced along a length of the inner tubular member <NUM>. The openings <NUM>, <NUM>, <NUM>, <NUM> may be positioned in line with one another (e.g., sharing a common axis). It is contemplated that the thread <NUM> may be woven in and out of the slots or openings <NUM>, <NUM>, <NUM>, <NUM> to be selectively wrapped around the sleeves <NUM>, <NUM> of the implant <NUM> while leaving an outer surface of the stents <NUM>, <NUM> generally or substantially free from the thread <NUM>. Thus, the thread <NUM> may be positioned radially inward of the stents <NUM>, <NUM>. For example, the thread <NUM> may pass through the stents <NUM>, <NUM> to enter and/or exit an opening <NUM>, <NUM>, <NUM>, <NUM> but may not be disposed about the stents <NUM>, <NUM> (e.g., radially outward of the stents <NUM>, <NUM>) in a manner or extent sufficient to maintain the stent <NUM>, <NUM> in a collapsed configuration absent the outer tubular member <NUM>. The thread <NUM> may extend proximally through the lumen <NUM> and exit proximally at the second handle <NUM>. The proximal end <NUM> of the thread <NUM> may be coupled to or otherwise affixed to a pull member <NUM> or other actuation mechanism. The pull member <NUM>, such as a pull ring, a pull tab, or the like, may facilitate actuation of thread <NUM>; however a pull member <NUM> or other actuation mechanism may not be present or required.

<FIG> illustrates a close up side view of a distal portion of the delivery device <NUM> with the implant <NUM> in a radially collapsed or delivery configuration. The delivery device <NUM> may be advanced through the gastrointestinal tract transorally or transrectally, as desired. The delivery device <NUM> may be advanced with or without the use of a guidewire. Once the implant <NUM> is positioned adjacent to the target region, the restraining forces maintaining the stents <NUM>, <NUM> and the sleeves <NUM>, <NUM> in the radially collapsed configuration may be removed either in series (one after the other) or simultaneously (e.g., together) to deploy the implant <NUM>.

As can be seen in more detail in <FIG>, the thread <NUM> may extend distally from its proximal end <NUM> through the lumen <NUM> of the inner tubular member <NUM>. The thread <NUM> may exit the lumen <NUM> through the distal-most opening, or fourth opening, <NUM>. The thread <NUM> may then wind around the second sleeve <NUM> in a proximal direction (e.g. from distal to proximal). The thread <NUM> may re-enter the lumen <NUM> through a third opening <NUM> (e.g., proximal to the fourth opening <NUM>). In some cases, the third opening <NUM> may be positioned beneath (radially inward of) the second stent <NUM>. In such an instance, the thread <NUM> may pass between portions of the stent frame <NUM> and into the lumen <NUM>. The thread <NUM> may extend proximally within the lumen <NUM> and exit the lumen <NUM> through a second opening <NUM> (e.g., proximal to the third opening <NUM>). The thread <NUM> may then wind around the first sleeve <NUM> in a proximal direction (e.g. from distal to proximal). A distal end <NUM> of the thread <NUM> may be positioned adjacent to the proximal end region <NUM> of the first sleeve <NUM>. While the first and second sleeves <NUM>, <NUM> are illustrated as two separate and distinct elements, it is contemplated that the first and second sleeves <NUM>, <NUM> may be formed from a single unitary membrane that extend along the second stent <NUM> and/or the first stent <NUM>, as desired.

In an implant having a plurality of sections <NUM>, <NUM>, <NUM>, <NUM>, it may be desirable to deploy the rigid stent portions <NUM>, <NUM> first, followed by the flexible sleeve portions <NUM>, <NUM>. The stents <NUM>, <NUM> may be deployed by actuating the first handle <NUM> proximally relative to the second handle <NUM>, e.g., by pulling the first handle <NUM> (see, for example, <FIG>) proximally while maintaining the second handle <NUM> in a fixed position. Thus, the outer tubular shaft <NUM> may be retracted proximally relative to the inner tubular shaft <NUM>. In other words, the outer tubular shaft <NUM> may be proximally retracted while the inner tubular shaft <NUM> is held stationary. As the outer tubular shaft <NUM> is retracted proximally to uncover the stents <NUM>, <NUM>, the biasing force is removed from the exterior of the stents <NUM>, <NUM> and the stents <NUM>, <NUM> assume their radially expanded, unbiased, deployed configuration while the sleeves <NUM>, <NUM> remain in the collapsed configuration under the biasing force of the thread <NUM>. Once the stents <NUM>, <NUM> have been deployed, the sleeves <NUM>, <NUM> may be deployed.

A proximal or pulling force may be applied to the proximal end <NUM> of the thread <NUM>. In some cases, the pulling force may be applied by placing a finger inside of the pull member <NUM> and pulling away from the handle <NUM>. As the member <NUM> is pulled or actuated, the thread <NUM> begins to uncoil or unravel. In the embodiment shown in <FIG>, the thread <NUM> is wrapped or wound such that the thread <NUM> disposed over the distal portion <NUM> of the second sleeve <NUM> is removed or unraveled first. As the biasing force of the thread <NUM> is released, the second sleeve <NUM> begins to expand into its unbiased or deployed configuration in a distal to proximal direction. As the thread <NUM> is pulled, the portion of the thread <NUM> previously wound around the second sleeve <NUM> unravels and enters the lumen <NUM> through the fourth opening <NUM>. The thread <NUM> then moves proximally through the lumen <NUM>. Continued unraveling of the thread <NUM> will cause more of the length of the second sleeve <NUM> to be released, followed by the first sleeve <NUM> (in a distal to proximal direction). Proximal actuation of the proximal end <NUM> of the thread <NUM> may continue until the distal end <NUM> of the thread <NUM> has been completely unraveled and both the first and second sleeves <NUM>, <NUM> are deployed. It is contemplated that the clinician may continue to pull the thread <NUM> until the distal end <NUM> has been completely removed from the lumen <NUM> and the device <NUM> although this is not required. The entire delivery device <NUM> may then be removed from the body lumen.

<FIG> illustrates another close up side view of a distal portion of the delivery device <NUM> with the implant <NUM> in a radially collapsed or delivery configuration. The delivery device <NUM> may be advanced through the gastrointestinal tract transorally or transrectally, as desired. The delivery device <NUM> may be advanced with or without the use of a guidewire. Once the implant <NUM> is positioned adjacent to the target region, the restraining forces maintaining the stents <NUM>, <NUM> and the sleeves <NUM>, <NUM> in the radially collapsed configuration may be removed either in series (one after the other) or simultaneously (e.g., together) to deploy the implant <NUM>.

As can be seen in more detail in <FIG>, the thread <NUM> may extend distally from its proximal end <NUM> through the lumen <NUM> of the inner tubular member <NUM>. The thread <NUM> may exit the lumen <NUM> through the proximal-most opening, or first opening, <NUM>. In some cases, the first slot <NUM> may be positioned beneath (radially inward of) the first stent <NUM>. In such an instance, the thread <NUM> may pass between portions of the stent frame <NUM> and out of the lumen <NUM>. The thread <NUM> may then wind around the first sleeve <NUM> in a distal direction (e.g. from proximal to distal). The thread <NUM> may re-enter the lumen <NUM> through a second slot <NUM> (e.g., distal to the first slot <NUM>). In some cases, the second slot <NUM> may be positioned below the second stent <NUM>. In such an instance, the thread <NUM> may pass between portions of the stent frame <NUM> and into the lumen <NUM>. The thread <NUM> may extend distally within the lumen <NUM> and exit the lumen <NUM> through a third opening <NUM> (e.g., distal to the second opening <NUM>). The thread <NUM> may then wind around the second sleeve <NUM> in a distal direction (e.g. from proximal to distal). A distal end <NUM> of the thread <NUM> may be positioned adjacent to the distal end region <NUM> of the second sleeve <NUM>. While the first and second sleeves <NUM>, <NUM> are illustrated as two separate and distinct elements, it is contemplated that the first and second sleeves <NUM>, <NUM> may be formed from a single unitary membrane that extend along the second stent <NUM> and/or the first stent <NUM>, as desired.

A proximal or pulling force may be applied to the proximal end <NUM> of the thread <NUM>. In some cases, the pulling force may be applied by placing a finger inside of the pull member <NUM> and pulling away from the handle <NUM>. As the member <NUM> is pulled or actuated, the thread <NUM> begins to uncoil or unravel. In the embodiment shown in <FIG>, the thread <NUM> is wrapped or wound such that the thread <NUM> disposed over the proximal portion <NUM> of the first sleeve <NUM> is removed or unraveled first. As the biasing force of the thread <NUM> is released, the first sleeve <NUM> begins to expand into its unbiased or deployed configuration in a proximal to distal direction. As the thread <NUM> is pulled, the portion of the thread <NUM> previously wound around the first sleeve <NUM> unravels and enters the lumen <NUM> through the first opening <NUM>. The thread <NUM> then moves proximally through the lumen <NUM>. Continued unraveling of the thread <NUM> will cause more of the length of the first sleeve <NUM> to be released, followed by the second sleeve <NUM> (in a proximal to distal direction). Proximal actuation of the proximal end <NUM> of the thread <NUM> may continue until the distal end <NUM> of the thread <NUM> has been completely unraveled and both the first and second sleeves <NUM>, <NUM> are deployed. It is contemplated that the clinician may continue to pull the thread <NUM> until the distal end <NUM> has been completely removed from the lumen <NUM> and the device <NUM> although this is not required. The entire delivery device <NUM> may then be removed from the body lumen.

During implantation, the stent may be implanted through endoscopic procedures, and therefore, they may be mounted on a delivery device for delivery under direct vision and/or under fluoroscopy. Radiopaque markers positioned on the implant <NUM>, <NUM> or delivery device <NUM>, <NUM>, may enable an operator to ascertain whether the implant <NUM>, <NUM> is in a desirable location, optimal, and safe. Finally, once the stent is positioned, the operator may retract and/or remove, the delivery device.

<FIG> illustrates a distal end region of another illustrative delivery system <NUM> for delivering an implant having both a rigid portion and a flexible portion, such as the implant <NUM> described herein, to a target region. <FIG> is a cross-sectional view of the illustrative delivery system <NUM> taken at line <NUM>-<NUM> of <FIG>. The illustrative delivery system <NUM> may be configured to include a sliding element to allow for a clinician to intraoperatively select a direction of expansion for the flexible portion of the implant (e.g., distal to proximal as described with respect to <FIG> or proximal to distal as described with respect <FIG>).

The delivery system <NUM> may include an outer or exterior elongate shaft or tubular member <NUM> (see, for example, <FIG>) and an inner elongate shaft or tubular member <NUM>. The inner tubular member <NUM> may be slidably disposed within a lumen of the outer tubular member. The outer tubular member may be similar in form and function to the outer tubular member <NUM> described herein. The outer tubular member may extend proximally from a distal end region to a proximal end region configured to remain outside of a patient's body. A first hub or handle, similar in form and function the handle <NUM> described herein, may be coupled to the proximal end region of the outer tubular member. The inner tubular member <NUM> may extend proximally from a distal end region <NUM> to a proximal end region (not explicitly shown) configured to remain outside of a patient's body during an implantation procedure. A second hub or handle, similar in form and function to the second handle <NUM> described herein, may be coupled to the proximal end region of the inner tubular member <NUM>. The inner tubular member <NUM> may further include a distal tip <NUM> positioned adjacent to the distal end region <NUM>. The distal tip <NUM> may be configured to be atraumatic.

The inner tubular member <NUM> may include a lumen <NUM> extending from the distal end region <NUM> to the proximal end region <NUM>. The lumen <NUM> of the inner tubular shaft <NUM> may also extend through the second handle. The lumen <NUM> of the inner shaft <NUM> may be configured to receive a thread, pull-wire and/or guidewire, as desired.

The inner tubular member <NUM> may include a slot <NUM> extending along a portion of the length thereof at or adjacent to the distal portion <NUM>. In some embodiments, the slot <NUM> may have a length similar to a length of the flexible portion of the implant, such as the implant <NUM> described herein, although this is not required. A sliding skive <NUM> may be slidably positioned within the slot <NUM>. The sliding skive <NUM> may be configured to move between first position adjacent the proximal end <NUM> of the slot and a second position (illustrated in phantom) adjacent the distal end <NUM> of the slot <NUM>. In some cases, the sliding skive <NUM> may be positioned at an intermediate location between the proximal end <NUM> and the distal end <NUM>, although this is not required.

The sliding skive <NUM> may be actuated by means of a slider <NUM>, or other actuation mechanism, positioned with the lumen <NUM> of the inner tubular member <NUM>. The slider <NUM> may extend proximally to a point outside of the body such that the sliding skive <NUM> can be moved (e.g., pushed distally or pulled proximally) along the slot <NUM> by the clinician. In some embodiments, the sliding skive <NUM> may include a first protrusion 422a positioned adjacent a proximal end of the sliding skive <NUM> and a second protrusion 422b adjacent the distal end of the sliding skive <NUM>. It is contemplated that the protrusions 422a, 422b may be configured to engage a mating recess 424a, 424b adjacent the proximal end <NUM> and/or the distal end <NUM> of the slot <NUM> to allow the sliding skive <NUM> to be releasably fixed in a desired position. It is contemplated that the protrusions 422a, 422b may be positioned at any surface of the sliding skive <NUM> desired. Similarly, the mating recesses 424a, 424b may be positioned at any location on the inner tubular member <NUM> (e.g., an inner surface and/or outer surface) to receive the protrusions 422a, 422b. Furthermore, the mating structures may be reversed in some instances.

<FIG> illustrates a cross-sectional view (not to scale) of the illustrative delivery device <NUM> taken at line <NUM>-<NUM> of <FIG>. <FIG> illustrates a proximal perspective view of the illustrative sliding skive <NUM>. The sliding skive <NUM> may be sized and shaped to slide longitudinally within the slot <NUM> while including retention features configured to prevent the sliding skive <NUM> from uncoupling from the inner tubular member <NUM>. For example, the sliding skive <NUM> may include a top portion <NUM> configured to move along an outer surface of the inner tubular member <NUM>, an intermediate portion <NUM> configured to within the slot <NUM>, and a bottom portion <NUM> configured to move along an inner surface of the inner tubular member <NUM>. The top and bottom portions <NUM>, <NUM> may have a width dimension greater than a width of the slot <NUM> and/or a width of the intermediate portion <NUM> such that the sliding skive <NUM> is prevented from moving in the radial direction (e.g., disengaging the from the slot <NUM>). A slot or through hole <NUM> may extend from a top surface of the top portion <NUM> to a bottom surface of the bottom portion <NUM>. This may allow a thread (not explicitly shown) to pass from a location exterior to the inner tubular member <NUM> and into the lumen <NUM> thereof. In some cases, the thread may extend into a lumen <NUM> of the slide <NUM>. The lumen <NUM> of the slider <NUM> may be configured to extend proximally from the sliding skive <NUM> to a location external of the patient's body to allow for actuation of the thread as described in more detail herein. It is further contemplated that the surfaces of the sliding skive <NUM> may be turned, smoothed or otherwise rounded to allow a thread to run easily over the surface, as will be described in more detail herein.

<FIG> and <FIG> illustrate the distal portion of the illustrative delivery system <NUM> having an implant <NUM> disposed over a portion of the inner tubular member <NUM> at or adj acent to the distal end region <NUM> thereof. When the implant <NUM> is disposed around the inner tubular member <NUM>, in a delivery configuration, the stent portion <NUM> may be restrained in a radially collapsed reduced diameter or delivery configuration by the outer tubular member <NUM> surrounding the stent portion <NUM>. The distal end region of the outer tubular member <NUM> may be positioned such that the outer tubular member <NUM> surrounds and covers the length of stent <NUM> during delivery. The outer tubular member <NUM> may have sufficient hoop strength to retain the stent <NUM> in its reduced diameter state.

The sleeve <NUM> may be held in a radially collapsed configuration through the use of two or more threads <NUM>, <NUM> (e.g., filaments or wires). The threads <NUM>, <NUM> may be any thin flexible element capable of being wrapped and unwrapped about the sleeve <NUM>. A distal portion of the threads <NUM>, <NUM> may be wound or wrapped about the sleeve <NUM> while a proximal portion of the thread <NUM>, <NUM> may extend proximally through the lumen <NUM> or lumen <NUM> to a point outside the delivery device <NUM>. The threads <NUM>, <NUM> may be wound about an outer surface of the sleeve <NUM> to apply a biasing force to the sleeve <NUM> which maintains it in a collapsed or reduced diameter configuration.

The threads <NUM>, <NUM> may be wound in opposite directions such that the threads <NUM>, <NUM> may be released sequentially to allow for selective release of the sleeve <NUM>. In some embodiments, a distal end <NUM> of a first thread <NUM> may be positioned adjacent to the proximal end region <NUM> of the sleeve <NUM> to allow for distal to proximal release in a manner similar to that described with respect to <FIG>. A distal end <NUM> of a second thread <NUM> may be positioned adjacent to the distal end region <NUM> of the sleeve <NUM> to allow for proximal to distal release in a manner similar to that described with respect <FIG>. The presence of two threads <NUM>, <NUM> may allow the clinician to intraoperatively select which direction he or she desires to release the sleeve <NUM>. The thread <NUM> or <NUM> that is wound in that direction may be removed second (e.g. after removal of the thread wound in the undesired deployment direction) to deploy the sleeve <NUM>.

The threads <NUM>, <NUM> may be wrapped around the sleeve <NUM> in a generally helical manner, although this is not required. The spacing of adjacent windings of the threads <NUM>, <NUM> may be uniform or variable as desired. In other words the pitch of the windings may be the same, varied, or combinations thereof, as desired. In some cases, the threads <NUM>, <NUM> may include a plurality of knots similar in form and function to those used in knitting or crocheting, which allow the threads <NUM>, <NUM> to be releasably secured about the sleeve <NUM>. The knots may generally maintain the threads <NUM>, <NUM> in a desired configuration while still allowing the threads <NUM>, <NUM> to be unraveled or removed as desired. In some cases, the threads <NUM>, <NUM> may not include knots.

The threads <NUM>, <NUM> may extend through the opening <NUM> in the sliding skive <NUM> into the lumen <NUM> of the inner tubular member <NUM> or the lumen <NUM> of the slider <NUM>. The threads <NUM>, <NUM> may extend proximally through the lumen <NUM> and exit proximally at a handle. The proximal ends of the threads <NUM>, <NUM> are configured to remain outside of the inner tubular member <NUM> and may be coupled to or otherwise affixed to a pull member or other actuation mechanism. The pull member may facilitate actuation of threads <NUM>, <NUM>; however a pull member or other actuation mechanism may not be present or required.

The sliding skive <NUM> may be positionable such that it is located nearest the portion of the thread <NUM>, <NUM> that will be released first. This may prevent too much pressure from being applied to the inner tubular member <NUM> during device <NUM> deployment (a phenomenon known of 'bowing' can occur if too much pressure is applied while the knots are being pulled to open and deploy). The sliding arrangement may eliminate or significantly reduce this bowing. For example, in <FIG> the sliding skive <NUM> may be positioned adjacent to the distal end region <NUM> of the slot <NUM>. As described above, the sliding skive <NUM> may be releasably secured through engagement of protrusions and grooves. This arrangement may allow for the release of the first thread <NUM>. As can be seen, the sliding skive <NUM> is positioned nearest to the region <NUM> of the first thread <NUM> which is released from the sleeve <NUM> first (e.g., distal to proximal release). The second thread <NUM> may include some slack (or extra length) to allow for a region <NUM> of the thread <NUM> to pass under the sleeve <NUM> and into the sliding skive <NUM>. Once the first thread <NUM> is released (e.g., in a manner similar to that described with respect to <FIG>), the sliding skive <NUM> may be slid to the proximal end <NUM> of the slot <NUM>. As the second thread <NUM> is still in place, the sleeve <NUM> remains in its radially collapsed configuration. The second thread <NUM> may then be released (e.g., in a manner similar to that described with respect to <FIG>).

Alternatively, the second thread <NUM> may be released prior to the first thread <NUM>. It should be noted that the use of "first" and "second" is not intended to limit the order of release of the threads <NUM>, <NUM> but rather as a means of differentiating between the two threads <NUM>, <NUM>. In <FIG> the sliding skive <NUM> may be positioned adjacent to the proximal end region <NUM> of the slot <NUM>. As described above, the sliding skive <NUM> may be releasably secured through engagement of protrusions and grooves. This arrangement may allow for the release of the second thread <NUM>. As can be seen, the sliding skive <NUM> is positioned nearest to the region <NUM> of the second thread <NUM> which is released from the sleeve <NUM> first (e.g., proximal to distal release). The first thread <NUM> may include some slack (or extra length) to allow for a region <NUM> of the thread <NUM> to pass under the sleeve <NUM> and into the sliding skive <NUM>. Once the second thread <NUM> is released (e.g., in a manner similar to that described with respect to <FIG>), the sliding skive <NUM> may be slid to the distal end <NUM> of the slot <NUM>. As the first thread <NUM> is still in place, the sleeve <NUM> remains in its radially collapsed configuration. The first thread <NUM> may then be released (e.g., in a manner similar to that described with respect to <FIG>).

Alternatively, or additionally, the delivery device <NUM> may be provided with a second sliding skive <NUM>', as shown in <FIG>. A first sliding skive <NUM> may be positioned adjacent the distal end <NUM> of the slot 412and a second sliding skive <NUM>' may be positioned adjacent the proximal end <NUM> of the slot <NUM>. It is contemplated that instead of sliding skives <NUM>, <NUM>', the inner tubular member <NUM> may be provided with two slots (similar in form and function to the slot <NUM> described above). A first slot may be positioned adjacent to the proximal end <NUM> of the sleeve <NUM> and a second slot may be provided adjacent to the distal end <NUM> of the sleeve <NUM>. It is contemplated that a dual sliding skive <NUM>, <NUM>' and/or dual slot arrangement may allow the physician to intraoperatively select the order of release of the threads <NUM>, <NUM> in a manner similar to that described with respect to <FIG> without actuation of the sliding skive <NUM>. The materials that can be used for the various components of implants <NUM>, <NUM> (and/or other medical devices disclosed herein including delivery devices <NUM>, <NUM>, <NUM>) may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to implant <NUM>, <NUM>. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other similar medical devices disclosed herein.

Implant <NUM>, <NUM> may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, <NUM>, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY 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, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear that the super elastic plateau and/or flag region that may be seen with super elastic nitinol.

Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also can be distinguished based on its composition), which may accept only about <NUM> to <NUM> percent strain before plastically deforming.

of Kanagawa, Japan. Some examples of nickel titanium alloys are disclosed in <CIT> and <CIT>. Other suitable materials may include ULTANlUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota).

In at least some embodiments, portions or all of implant <NUM>, <NUM> may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are generally understood to be materials which are opaque to RF energy in the wavelength range spanning x-ray to gamma-ray (at thicknesses of <<NUM>"). These materials are capable of producing a relatively dark image on a fluoroscopy screen relative to the light image that non-radiopaque materials such as tissue produce. This relatively bright image aids the user of implant <NUM>, <NUM> in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of implant <NUM>, <NUM> to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into implant <NUM>, <NUM>. For example, implant <NUM>, <NUM> or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. Implant <NUM>, <NUM> or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.

Some examples of suitable polymers for implant <NUM>, <NUM> may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available 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 (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like.

Those skilled in the art will appreciate that the different embodiments of the implant described here, their mode of operation, etc., are merely representative of the environment in which the present disclosure operates. Accordingly, a variety of alternatively shaped collaborating components may also be used as a substitutive for the purpose of engaging, steering and locating the stent at a desired target site, thus, not limiting the scope of the present disclosure. Further, the disclosed implants may be adequately stretchable, extendable, and retractable, allowing for its flexible deployment. More particularly, the configurations described here may be applicable for other medical applications as well, and accordingly, a variety of other medical devices may be used in combination with the implant. Those medical devices may include biopsy forceps, scissors, lithotripters, dilators, other cautery tools, and the like.

Claim 1:
A delivery system (<NUM>; <NUM>; <NUM>) for delivering an implant (<NUM>; <NUM>) to a body lumen, the system comprising:
an outer tubular member (<NUM>; <NUM>; <NUM>) defining a lumen (<NUM>; <NUM>) and having a proximal end region (<NUM>; <NUM>) and a distal end region (<NUM>; <NUM>);
an inner tubular member (<NUM>; <NUM>; <NUM>) defining a lumen (<NUM>; <NUM>) and having a proximal end region (<NUM>; <NUM>) and a distal end region (<NUM>; <NUM>), the inner tubular member (<NUM>; <NUM>; <NUM>) slidably disposed within the lumen (<NUM>; <NUM>) of the outer tubular member (<NUM>; <NUM>; <NUM>) and having at least one opening (<NUM>; <NUM>, <NUM>, <NUM>, <NUM>; <NUM>) positioned in a side wall adjacent to the distal end region (<NUM>; <NUM>), the at least one opening (<NUM>; <NUM>, <NUM>, <NUM>, <NUM>; <NUM>) extending from an outer surface to an inner surface of the inner tubular member (<NUM>; <NUM>; <NUM>);
an expandable implant (<NUM>; <NUM>) disposed about the outer surface of the inner tubular member (<NUM>; <NUM>; <NUM>) adjacent the distal end region (<NUM>; <NUM>) of the inner tubular member (<NUM>; <NUM>; <NUM>), the implant (<NUM>; <NUM>) comprising at least a first rigid portion (<NUM>) and a first flexible portion (<NUM>, <NUM>); and
a thread (<NUM>; <NUM>; <NUM>, <NUM>) including a distal portion wrapped around the first flexible portion (<NUM>; <NUM>) of the implant and configured to maintain the first flexible portion (<NUM>, <NUM>) in a collapsed configuration;
wherein the distal end region (<NUM>; <NUM>) of the outer tubular member (<NUM>; <NUM>; <NUM>) is disposed over the first rigid portion (<NUM>) of the implant and is configured to maintain the first rigid portion (<NUM>) in a radially collapsed configuration.