Patent Description:
An anastomosis is a surgical connection between two tissue structures, such as blood vessels or intestines. For example, in the context of coronary artery bypass graft surgery, a graft vessel is anastomosed to a native coronary artery so that blood can flow through the graft vessel.

Anastomoses can be created in various manners including, but not limited to: end-to-end, end-to-side, and side-to-side anastomoses. Often, suturing is used to create such anastomoses.

<CIT> describes an expandable stent with an end portion adapted to be located at a bifurcation or ostium within a patient's vasculature. The device includes a flared stent with a single flaring portion and a main portion connected thereto. The main portion includes a plurality of bands of cells spaced apart axially from one another, adjacent bands of cells being intermittently connected to one another. <CIT> discloses method and apparatus for connecting two anatomical passageways, comprising; a) a first engagement member which is engageable with the first anatomical structure, b) a second engagement member which is engageable with the second anatomical structure, and c) a connecting portion which extends or traverses between the first and second engagement members.

Document <CIT> discloses an anastomosis device according to the preamble of claim <NUM>.

The invention is in accordance with claim <NUM>. Selected further features are recited in the dependent claims.

Disclosed herein is an implantable medical device for creating an anastomosis that includes a tubular structure that includes at least one elongate member forming a framework of interconnected struts. The tubular structure includes (<NUM>) a central portion defining a longitudinal axis, the central portion including a plurality of central portion cells defined by the elongate member, (<NUM>) a first apposition portion at a first end of the central portion, the first apposition portion including a plurality of first flange cells defined by the elongate member, and (<NUM>) a second apposition portion at a second end of the central portion, the second apposition portion including a plurality of second flange cells defined by the elongate member. At least some of the second flange cells are closed at a first end by an undulating portion of the elongate member and opened at a second end to the central portion. In at least one exemplary embodiment, the elongate member forms (<NUM>) a first pattern extending longitudinally along the central portion, (<NUM>) a first flange cell of the plurality of first flange cells, (<NUM>) a second pattern extending longitudinally along the central portion and opposing the first pattern, and (<NUM>) a second flange cell of the plurality of second flange cells. In some embodiments a single elongate member forms the central portion, the first apposition portion, and the second apposition portion. In other embodiments, the central portion cells are open to longitudinally-adjacent central portion cells and are closed to circumferentially-adjacent central portion cells. In further embodiments, each of the plurality of second flange cells is open to one or more of the central portion cells of the plurality of central portion cells. Also disclosed is an implantable medical device for creating an anastomosis. The device includes a tubular structure including at least one elongate member forming a framework of interconnected struts. The tubular structure includes (<NUM>) a central portion having a plurality of body cells defined by the elongate member, (<NUM>) a first apposition portion at a first end of the central portion having a plurality of first flange cells defined by the elongate member, and (<NUM>) a second apposition portion at a second end of the central portion having a plurality of second flange cells defined by the elongate member. The elongate member may be formed such that (<NUM>) the elongate member forms a first pattern traversing the central portion along a longitudinal axis, (<NUM>) the elongate member defines a first flange cell of the first plurality of flange cells, (<NUM>) the elongate member traverses the central portion along the longitudinal axis in a second pattern opposing the first pattern, and (<NUM>) the elongate member defines a second flange cell of the second plurality of flange cells. In at least one embodiment, each successive flange cell of the first and second plurality of flange cells is out of phase with directly preceding flange cells of the first and second plurality of flange cells. Additionally, the body cells may be open to longitudinally-adjacent body cells and may be closed to circumferentially-adjacent body cells. In some embodiments, each of the plurality of first flange cells may be open to the body and each of the plurality of second flange cells may be open to the body.

Also disclosed herein is a method of implanting an anastomosis device in a patient (not according to the claims) that includes (<NUM>) navigating a delivery sheath containing the anastomosis device to a target location within the patient and (<NUM>) deploying the anastomosis device from the delivery sheath such that at least one layer of tissue is between the first apposition portion and the second apposition portion. The anastomosis device includes a tubular structure that includes at least one elongate member forming a framework of interconnected struts. The tubular structure includes (<NUM>) a central portion that includes a plurality of body cells defined by the elongate member, (<NUM>) a first apposition portion at a first end of the central portion having a plurality of first flange cells defined by the elongate member such that the plurality of first flange cells are open to the central portion, and (<NUM>) a second apposition portion at a second end of the central portion that includes a plurality of second flange cells defined by the elongate member such that the plurality of second flange cells are open to the central portion.

The invention is defined in the claims. Any subject-matter that is disclosed herein, but which is not defined in the claims, does not form part of the invention. Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.

The present disclosure is directed to implantable devices for connecting tissue layers, for example, to circumvent a conduit or organ blockage, such as by creating a direct passage between tissue structures (e.g. connecting a gallbladder and a portion of a gastrointestinal tract) to create an anastomosis that facilitates material flow therebetween. The devices described herein are endoscopically deployable or deliverable via a catheter and may include self-expanding apposition mechanisms that facilitate a secure connection between the tissue structures (such a connection may also be referred to herein as a "shunt," "passageway," "shunt passageway," or "tunnel"). Such design features simplify implantation and reduce the likelihood of complications. In some embodiments, the devices provided herein are configured to be removable after implantation. As one example, the device is implanted and remains in place until the gallbladder and/or its associated ducts are cleared of blockages, after which the device is removed. In another example, the device remains implanted until the body grows a tissue-anastomosis around the device, and then the device is removed. In other embodiments, tissue ingrowth into and/or around the device permanently implants the device, and the device is not removed. The devices described herein can provide alternative treatments for patients who are not suitable candidates for other types of treatments (e.g., gallbladder removal surgery) and/or to avoid known complications of other types of treatments (e.g., external biliary drainage).

This disclosure refers to anastomosis devices in an exemplary fashion. That is, it should be understood that the inventive concepts disclosed in this disclosure can also be applied to other types of devices. For example, this disclosure also provides implantable devices that, in some embodiments, can be used for occluding tissue structures, organs, body conduits, blood vessels, the GI tract, and the like. For example, some devices disclosed herein can be used to occlude septal defects. Some devices disclosed herein can be used to occlude a patient's vasculature or GI tract. devices, the device does not include a tunnel or central aperture through the device. Rather, a covering material seals the device to inhibit, modulate, or substantially prevent material from flowing through the device.

Referring to <FIG>, an exemplary anastomosis device <NUM> in accordance with some embodiments provided herein that can be implanted in a patient to create a fluidic connection between two organs, spaces, tissue structures, conduits, and the like, and combinations thereof is shown. For example, in the depicted implementation the anastomosis device <NUM> is connecting a gallbladder <NUM> (that defines an internal gallbladder space <NUM>) with an intestine <NUM> (that defines an internal intestinal space <NUM>). Hence, the anastomosis device <NUM> is acting as a fluidic shunt device between the internal gallbladder space <NUM> and the internal intestinal space <NUM>. Such an implementation may provide a beneficial treatment to the patient when, for example, a flow blockage exists in the native anatomical conduits connecting the internal gallbladder space <NUM> and the internal intestinal space <NUM>. For example, in some instances the patient may have one or more gallstones that cause a blockage of the patient's cystic duct <NUM> and/or common bile duct <NUM>. In such a case, the anastomosis device <NUM> can provide a fluidic passageway such that bile from the gallbladder <NUM> can flow into the intestine <NUM>. If not for the anastomosis device <NUM>, when bile is blocked from flowing out of the gallbladder <NUM> cholecystitis (inflammation of the gallbladder <NUM>) may result.

While the anastomosis devices provided herein can be used in some implementations to relieve or prevent cholecystitis as described above, it should be understood that the anastomosis devices provided herein can also be used in many other types of implementations within a patient. For example, the anastomosis devices provided herein can be used in conjunction with various body tissue structures and organs such as, but not limited to, stomachs, colons, small intestines, pancreases, blood vessels, bladders, kidneys, conduits, and the like.

In general, some embodiments of the anastomosis devices provided herein (of which anastomosis device <NUM> is one type of example), include a first tissue apposition portion 42a, a second tissue apposition portion 42b, and a central portion <NUM> therebetween. The central portion <NUM> defines a lumen <NUM> that extends longitudinally from a first end of the anastomosis device <NUM> to a second end of the device <NUM>. The lumen <NUM> acts as a connection (e.g., a shunt passageway) between the internal gallbladder space <NUM> and the internal intestinal space <NUM>, such that the internal gallbladder space <NUM> is in fluid communication with the internal intestinal space <NUM> via the anastomosis device <NUM>.

Referring to <FIG>, an exemplary anastomosis device <NUM> that includes a framework of elongate elements that define a first apposition portion <NUM>, a second apposition portion <NUM>, and a central portion <NUM> is depicted. In some embodiments, the anastomosis device <NUM> can be a type of stent device, which can refer broadly to devices that include a framework of elongate elements and include devices such as, but not limited to, anastomosis devices. The central portion <NUM> is disposed between and interconnects the first apposition portion <NUM> and the second apposition portion <NUM>. A covering material (not shown in <FIG>) can be disposed on at least some portions of the framework. Such covering materials (e.g., covering material and others described below) may also be referred to herein merely as a covering.

The central portion <NUM> can form a body that defines a lumen <NUM> that extends between the first apposition portion <NUM> and the second apposition portion <NUM>. The first and second apposition portions <NUM> and <NUM> can form flanges extending substantially radially outward from opposite ends of the central portion <NUM>. The lumen <NUM> provides an anastomosis passageway or tunnel through which biological materials or fluids can pass. The device <NUM> is shown in an expanded configuration (also referred to herein as a deployed configuration). The expanded or deployed configuration is the configuration that the device <NUM> naturally exhibits in the absence of external forces acting upon the device <NUM>. It should be understood that when the anastomosis device <NUM> is implanted in a patient, the configuration of the device <NUM> may be somewhat different than shown because of the external forces from the patient's anatomy that are exerted on the device <NUM>.

The first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM> are formed of elongate elements such as spring wire (e.g., L605 steel or stainless steels), shape memory alloy wire (e.g., nitinol or nitinol alloys), super-elastic alloy wire (e.g., nitinol or nitinol alloys), or other suitable types of elongate elements or wires, or combinations thereof. The first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM> can be formed from the same piece of precursor material that is cut to create the framework of elongate elements. In some examples, the precursor material is a tubular material or a sheet material. Different types of elongate elements can be used at different locations of the first apposition portion <NUM>, the second apposition portion <NUM>, and/or the central portion <NUM>. The elongate elements of the first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM> (or portions thereof) may be constructed of polymeric materials.

Suitable materials for the elongate elements of the devices provided herein include a variety of metallic materials including alloys exhibiting, shape memory, elastic and super-elastic characteristics. Shape memory refers to the ability of a material to revert to an originally memorized shape after plastic deformation by heating above a critical temperature. Elasticity is the ability of a material to deform under load and return or substantially return to its original shape when the load is released. Most metals will deform elastically up to a small amount of strain. Super-elasticity refers to the ability of a material to deform under strain to much larger degree than typical elastic alloys, without having this deformation become permanent. For example, the super-elastic materials included in the frames of some anastomosis device embodiments provided herein are able to withstand a significant amount of bending and flexing and then return or substantially return to the frame's original form without deformation. In some embodiments, suitable elastic materials include various stainless steels which have been physically, chemically, and otherwise treated to produce a high springiness, metal alloys such as cobalt chrome alloys (e.g., ELGILOYTM, MP35N, L605), platinum/tungsten alloys. Embodiments of shape memory and super-elastic alloys include the NiTi alloys, ternary shape memory alloys such as NiTiPt, NiTiCo, NiTiCr, or other shape memory alloys such as copper-based shape memory alloys. Additional materials could combine both shape memory and elastic alloys such as a drawn filled tube where the outer layer is constructed of nitinol and the inner core is a radiopaque material such as platinum or tantalum. In such a construct, the outer layer provides the super-elastic properties and the inner core remains elastic due to lower bending stresses.

In some embodiments, the elongate elements used to construct the devices provided herein can be treated in various ways to increase the radiopacity of the devices for enhanced radiographic visualization. In some embodiments, the devices are at least partially a drawn-filled type of NiTi containing a different material at the core, such as a material with enhanced radiopacity. In some embodiments, the devices include a radiopaque cladding or plating on at least portions of the first apposition portion, the second apposition portion, and the central portion. In some embodiments, one or more radiopaque markers are attached to the devices. In some embodiments, the elongate elements and/or other portions of the devices provided herein are also visible via ultrasound.

In some embodiments, the first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM>, comprise a framework of interconnected elongate elements that is constructed by cutting a tube. In one such embodiment, a tube of metallic material (e.g., nitinol, stainless steel, cobalt, etc.) is laser cut, and then the tube is expanded and shaped into the desired configuration. In some such embodiments, the metallic material is shape-set in the desired configuration so that the material receives a shape-memory whereby the material will naturally strive to attain the desired configuration. In some embodiments, shape memory materials such as nitinol may strive to attain the desired configuration when exposed to body temperature.

As described in more detail below, in some embodiments a covering material can be disposed on or around some portions, or on or around all of the first apposition portion <NUM>, the second apposition portion <NUM>, and/or the central portion <NUM>. In some embodiments, portions of the first apposition portion <NUM>, the second apposition portion <NUM>, and/or the central portion <NUM> can remain free of the covering material. In some embodiments, no covering material is included on the anastomosis device <NUM>.

The first apposition portion <NUM> and the second apposition portion <NUM> each include a plurality of struts <NUM>. The struts <NUM> of each of the first and second apposition portions <NUM> and <NUM> may be configured to form, in a general sense, flanges that contact tissue surfaces. More particularly, the first apposition portion <NUM> and the second apposition portion <NUM> are configured to engage one or more layers of tissue therebetween, and to provide apposition forces against the tissue surfaces. The apposition forces provided by the first and second apposition portions <NUM> and <NUM> can facilitate fixation of the device <NUM> to the tissue and provide migration resistance such that the device <NUM> can reliably remain positioned at a target site in a patient as desired.

In some embodiments, the materials and configuration of the anastomosis device <NUM> (and the other anastomosis device embodiments provided herein) allow the devices to be elastically crushed, folded, and/or collapsed into a low-profile delivery configuration for containment within a lumen for transcatheter or endoscopic/thorascopic delivery, and to self-expand to an operative size and configuration once positioned at a desired target site within a body and deployed from the lumen. For example, the anastomosis device <NUM> can be configured in a collapsed delivery configuration in which the plurality of struts <NUM> are radially compressed such that they are forced to extend substantially parallel to the axis of the central portion <NUM>, and in which the diameter of the central portion <NUM> is also crushed to become smaller. Due to the use of such materials and structure, the device <NUM> may also exhibit, for example, beneficial fatigue resistance and elastic properties.

After deployment, the plurality of struts <NUM> extend from the central portion <NUM> at a radial orientation and geometry to exert a desired level of apposition pressure on the tissue. In some embodiments, the plurality of struts <NUM> extend from the central portion <NUM> such that the nominal measure of the angle between the struts <NUM> and the longitudinal axis of the device <NUM> is about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, and the like.

Still referring to <FIG>, in some embodiments of the anastomosis device <NUM> (and in some embodiments of the other anastomosis devices provided herein) the plurality of struts <NUM> are interconnected by connecting members <NUM>. The connecting members <NUM> are shown in deployed configurations in which the connecting members <NUM> are arranged in a series of undulations-each having a vertex <NUM> extending towards the central portion <NUM> and a vertex <NUM> extending away from the central portion <NUM>. In some embodiments, the struts <NUM> can connect to the connecting members <NUM> at the vertex <NUM>. In other embodiments, the struts <NUM> can connect to the connecting members <NUM> at the vertex <NUM>.

The connecting members <NUM> may serve to support and stabilize the struts <NUM> to thereby cause the apposition portions <NUM> and <NUM> to have a more rigid construct. In some examples, the apposition portions <NUM> and <NUM> can exert a greater level of apposition pressure while maintain a compliancy by which the apposition portions <NUM> and <NUM> can conform to the anatomical topography of the tissue. In addition, the sealing capabilities of the apposition portions <NUM> and <NUM> may be enhanced. The stability and support provided by the connecting member <NUM> may serve to increase the apposition force provided against the gallbladder or provided against the portion of the gastrointestinal tract, for example.

The connecting members <NUM> combine to form circumferential rings <NUM> and <NUM> extending circumferentially around a radially-outer circumference of each of the first and second apposition portions <NUM> and <NUM>, respectively. The circumferential rings <NUM> and <NUM> can have a shape that is wavy or that undulates circumferentially around edges of the first and second apposition portions <NUM> and <NUM>. The circumferential rings <NUM> and <NUM> can have a shape that undulates in an axial direction, as can be seen in <FIG>. The circumferential rings <NUM> and <NUM> can have a shape that undulates in a radial direction, as can be seen in <FIG>. The circumferential rings <NUM> and <NUM> can have a shape that undulates in both axial and radial directions. The circumferential rings <NUM> and <NUM> can undulate sinusoidally around the edges of one or both of the first and second apposition portions <NUM> and <NUM>. Forming one or both of the circumferential rings <NUM> and <NUM> with a sinusoidal, serpentine, or otherwise undulating shape can increase an amount of surface area of contact between the first and second apposition portions <NUM> and <NUM> and tissue, thus reducing force at a given location on that tissue.

The central portion <NUM> can include a series of body struts <NUM>, each extending longitudinally and forming the central body <NUM> of the anastomosis device <NUM>. The body struts <NUM> define body cells <NUM> of the central portion <NUM> and separate the respective body cells <NUM> from circumferentially-adjacent body cells <NUM>. In some embodiments, each of the body struts <NUM> can include a plurality of axially-extending portions <NUM> interconnected with a plurality of angled portions <NUM>. This can allow the body struts <NUM> to create a relatively strong central portion <NUM> without necessarily interconnecting the body struts <NUM> across the body cells <NUM> at several locations along the length of the body struts <NUM>.

The struts <NUM> of the apposition portions <NUM> and <NUM> can define flange cells <NUM> between the struts <NUM>. The flange cells <NUM> can be open cells, with no strut separating the flange cells <NUM> from the central portion <NUM>. As shown in <FIG>, <FIG>, the flange cells <NUM> are closed at a distal-most end of the flange cells <NUM> by connecting members <NUM> and are open at a center-most end of the flange cells <NUM>, such that the flange cells <NUM> are open to the body cells <NUM>.

<FIG> show the anastomosis device <NUM> in a partially-formed configuration, prior to forming the anastomosis device <NUM> in the shape illustrated in <FIG>, <FIG>. As shown in <FIG>, the anastomosis device <NUM> can have a substantially cylindrical shape in the partially-formed configuration, with the struts <NUM> extending substantially parallel to the body struts <NUM>. The anastomosis device <NUM> can be shaped in a manufacturing process, such as, for example, that described with respect to <FIG> (below), to transform the anastomosis device <NUM> from the pre-formed configuration shown in <FIG> to the final configuration shown in <FIG>, <FIG>.

The anastomosis device <NUM> can be formed in a manner such that an elongate member forms a first pattern traversing the central portion <NUM> along a longitudinal axis, the elongate member defines a first flange cell <NUM> of the first apposition portion <NUM>, the elongate member traverses the central portion <NUM> along the longitudinal axis in a second pattern opposing the first pattern, the elongate member defines a second opposing flange cell <NUM>, and the elongate member then repeats those winding steps to form additional patterns of the central portion <NUM> and flanges cells <NUM> of the anastomosis device <NUM>.

The anastomosis device <NUM> can be formed in a manner such that the elongate member defines a flange cell <NUM> of the first apposition portion <NUM>, the elongate member traverses the central portion <NUM>, the elongate member defines a flange cell <NUM> of the second apposition portion <NUM>, the elongate member traverses the central portion <NUM>, and thereafter the elongate member repeats the pattern to form additional flange cells while traversing the central portion <NUM> in between. Each successive pattern and each successive flange cell <NUM> can be out of phase with those directly preceding.

The central portion <NUM> is shown in a deployed or expanded configuration in <FIG>. The central portion <NUM>, as described above, can include a variety of metallic shape memory materials and super-elastic alloys. Thus, the central portion <NUM> can be configured to self-expand to the deployed configuration. The central portion <NUM> can be balloon expandable into the deployed configuration. Alternatively, supplemental expansion forces can be applied to a self-expandable device by balloon dilation. The diameter of the central portion <NUM> can be made in any size as desired in order to suit the intended use and/or delivery system of the anastomosis device <NUM>. For example, in the low-profile delivery configuration the anastomosis device <NUM> can be disposed within a delivery sheath that has about a <NUM> Fr. (<NUM>) outer diameter. However, in some embodiments, sheaths that are smaller or larger than <NUM> (<NUM> Fr. ) can be used. For example, sheaths that have outer diameters of <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), and larger than <NUM> (<NUM> Fr. ), can be used. When the anastomosis device <NUM> is configured in its expanded deployed configuration as shown, the diameter of the central portion <NUM> increases to a deployed diameter. In some implementations, the deployed outer diameter of the central portion <NUM> is configured to at least partially anchor the device <NUM> via an interference fit with the tissue aperture in which the central portion <NUM> resides. Additionally, when the central portion <NUM> and the tissue aperture have an interference fit relationship, para-device leakage may be reduced or minimized. In such a case, leakage of the contents of the organs, conduits, and other types of tissue structures in which the anastomosis device <NUM> may be deployed can be substantially prevented. For example, when the anastomosis device <NUM> is used between a gallbladder and GI tract (e.g., refer to <FIG>), leakage into the abdominal cavity can be substantially prevented.

The deployed outer diameter of the central portion <NUM> may be slightly less than the diameter of the tissue aperture in which the central portion <NUM> resides, and the apposition portions <NUM> and <NUM> compress the tissue to provide the migration resistance. The fully expanded diameter of the central portion <NUM> may be about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, and the like.

One or more portions of the anastomosis device <NUM> can include covering material. For enhanced visualization of the framework of the anastomosis device <NUM>, the anastomosis device <NUM> is shown in <FIG> without a covering material. In some examples, a covering material is disposed on at least some portions (or on all) of the first apposition portion <NUM>, the second apposition portion <NUM>, and/or the central portion <NUM>. In some examples, some portions of the first apposition portion <NUM>, the second apposition portion <NUM>, and/or the central portion <NUM> are not covered by the covering material.

In some embodiments of the claimed invention, the covering material is generally fluid impermeable. That is, in some embodiments the covering material is made of a material that inhibits or reduces passage of blood, bile and/or other bodily fluids and materials through the covering material itself. In some embodiments, the covering material has a material composition and configuration that inhibits or prevents tissue ingrowth and/or endothelialization or epithelialization into the covering material. Some such embodiments that are configured to inhibit or prevent tissue ingrowth and/or endothelialization can be more readily removed from the patient at a future date if so desired. In some embodiments, the covering material, or portions thereof, has a microporous structure that provides a tissue ingrowth scaffold for durable sealing and/or supplemental anchoring strength of the anastomosis device <NUM>.

In some embodiments, the covering material comprises a fluoropolymer, such as an expanded polytetrafluoroethylene (ePTFE) polymer, or polyvinylidene fluoride (PVDF). In some embodiments, the covering material comprises a polyester, a silicone, a urethane, another biocompatible polymer, polyethylene terephthalate (e.g., Dacron®), bioabsorbable materials, copolymers, or combinations thereof. In some embodiments, the covering material comprises a bioabsorbable web. In some other embodiments, the bioabsorbable material may also provide an anti-migration feature by promoting attachment between the device <NUM> and tissue until the bioabsorbable material is absorbed.

In some embodiments, the covering material (or portions thereof) is modified by one or more chemical or physical processes that enhance one or more properties of the material. For example, in some embodiments, a hydrophilic coating is applied to the covering material to improve the wettability and echo translucency of the material. In some embodiments, the covering material, or portions thereof, is modified with chemical moieties that facilitate one or more of endothelial cell attachment, endothelial cell migration, endothelial cell proliferation, and resistance to or promotion of thrombosis. In some embodiments, the covering material, or portions thereof, is modified to resist biofouling. In some embodiments, the covering material, or portions thereof, is modified with one or more covalently attached drug substances (e.g., heparin, antibiotics, and the like) or impregnated with the one or more drug substances. The drug substances can be released in situ to promote healing, reduce tissue inflammation, reduce or inhibit infections, and to promote various other therapeutic treatments and outcomes. In some embodiments, the drug substance is a corticosteroid, a human growth factor, an anti-mitotic agent, an antithrombotic agent, a stem cell material, or dexamethasone sodium phosphate, to name some embodiments. In some embodiments, a pharmacological agent is delivered separately from the covering material to the target site to promote tissue healing or tissue growth.

Coatings and treatments may be applied to the covering material before or after the covering material is joined or disposed on the framework of the anastomosis device <NUM>. Additionally, one or both sides of the covering material, or portions thereof, may be coated. In some embodiments, certain coatings and/or treatments are applied to the covering material(s) located on some portions of the anastomosis device <NUM>, and other coatings and/or treatments are applied to the material(s) located on other portions of the anastomosis device <NUM>. In some embodiments, a combination of multiple coatings and/or treatments are applied to the covering material, or portions thereof. In some embodiments, certain portions of the covering material are left uncoated and/or untreated. In some embodiments, the device <NUM> is fully or partially coated to facilitate or frustrate a biological reaction, such as, but not limited to, endothelial cell attachment, endothelial cell migration, endothelial cell proliferation, and resistance to or promotion of thrombosis.

In some embodiments, a first portion of the covering material is formed of a first material and a second portion of the covering material is formed of a second material that is different than the first material. In some embodiments, the covering material includes multiple layers of materials, which may be the same or different materials. In some embodiments, portions of the covering material have one or more radiopaque markers attached thereto to enhance in vivo radiographic visualization of the anastomosis device <NUM>, or one or more echogenic areas to enhance ultrasonic visibility.

In some embodiments, one or more portions of the covering material are attached to the framework of the device <NUM>, such as the central portion <NUM> and/or the apposition portions <NUM> and <NUM>. The attachment can be accomplished by a variety of techniques such as, but not limited to, stitching the covering material to the framework of the device <NUM>, adhering the covering material to the framework of the device <NUM>, laminating multiple layers of the covering material to encompass portions of the elongate members of the device <NUM>, using clips or barbs, or laminating multiple layers of the covering material together through openings in the framework of the device <NUM>. In some embodiments, the covering material is attached to the framework of the device <NUM> at a series of discrete locations thereby facilitating the flexibility of the framework. In some embodiments, the covering material is loosely attached to the framework of the device <NUM>. It is to be appreciated that the covering material may be attached to the framework of the device <NUM> using other techniques or combinations of techniques described herein.

In some embodiments, the framework of the device <NUM> (or portions thereof) is coated with a bonding agent (e.g., fluorinated ethylene propylene or other suitable adhesive) to facilitate attachment of the covering material to the framework. Such adhesives may be applied to the framework using contact coating, powder coating, dip coating, spray coating, or any other appropriate means.

The covering material can adapt to changes in the length and/or diameter of the central portion <NUM> in a variety of manners. In a first example, the covering material can be elastic such that the covering material can stretch to accommodate changes in the length and/or diameter of the device <NUM>. In a second example, the covering material can include slackened material in the low-profile delivery configuration that becomes less slackened or totally unslackened when the device <NUM> is in the expanded configuration. In a third example, the covering material can include folded portions (e.g., pleats) that are folded in the low-profile configuration and less folded or totally unfolded when the device <NUM> is in the expanded configuration. In other embodiments, an axial adjustment member of a device in accordance with claim <NUM> is free of covering material. In some embodiments, combinations of such techniques, and/or other techniques can be used whereby the covering material can adapt to changes in the length and/or diameter of the central portion <NUM>.

<FIG> is a flat pattern of an anastomosis device <NUM>. The anastomosis device <NUM> can be similar to the anastomosis device <NUM> described above. For example, the anastomosis device <NUM> includes a framework of elongate elements that defines a first apposition portion <NUM>, a second apposition portion <NUM>, and a central portion <NUM>. The central portion <NUM> is disposed between and interconnects the first apposition portion <NUM> and the second apposition portion <NUM>. In some examples, the anastomosis device <NUM> is formed from a tubular material that is cut (e.g., laser cut) and shape-set to a preferred form. Other materials and fabrication techniques are also envisioned. A covering material as described above (not shown in <FIG>) can be disposed on at least some portions (or all) of the framework of the anastomosis device <NUM>.

The anastomosis device <NUM> is shown in <FIG> as a flat pattern for clarity. However, the anastomosis device <NUM> can be formed into a tubular shape, with the central portion <NUM> forming a substantially cylindrical structure, and with the first and second apposition portions <NUM> and <NUM> extending outward from opposing ends of the central portion <NUM>. In some examples, the central portion <NUM> can form a tubular body that defines a lumen that extends between the first apposition portion <NUM> and the second apposition portion <NUM>. The first and second apposition portions <NUM> and <NUM> can form flanges extending substantially radially outward from opposite ends of the central portion <NUM>. In some implementations, the lumen defined by the central portion <NUM> provides an anastomosis passageway or tunnel through which biological materials and liquids can pass. It should be understood that when the anastomosis device <NUM> is implanted in a patient, the configuration of the device <NUM> may be somewhat different than shown because of the external forces from the patient's anatomy that are exerted on the device <NUM>.

In some examples, the connecting members <NUM> combine to form circumferential rings <NUM> and <NUM> extending substantially circumferentially around a radially-outer circumference of each of the first and second apposition portions <NUM> and <NUM>, respectively. The circumferential rings <NUM> and <NUM> can have a shape that is wavy or that undulates circumferentially around the outer edges of the first and second apposition portions <NUM> and <NUM>. In some examples, the circumferential rings <NUM> and <NUM> can undulate sinusoidally around the edges of one or both of the first and second apposition portions <NUM> and <NUM>. Forming one or both of the circumferential rings <NUM> and <NUM> with a sinusoidal, serpentine, or otherwise undulating shape can increase an amount of surface area of contact between the first and second apposition portions <NUM> and <NUM> and tissue, thus reducing force at a given location on that tissue. Forming one or both of the circumferential rings <NUM> and <NUM> with a sinusoidal, serpentine, or otherwise undulating shape can also help facilitate crushability (for deployment via a low-profile) of the first and second apposition portions <NUM> and <NUM> while maintaining other desirable properties.

The central portion <NUM> can include a series of body struts <NUM>, each extending substantially axially and forming the central body of the anastomosis device <NUM>. The body struts <NUM> define body cells <NUM> of the central portion <NUM> and separate the respective body cells <NUM> from circumferentially-adjacent body cells <NUM>. Each of the body struts <NUM> can include a plurality of axially-extending portions <NUM> interconnected with a plurality of angled portions <NUM>. This can allow the body struts <NUM> to create a relatively strong central portion <NUM> without necessarily interconnecting the body struts <NUM> across the body cells <NUM> at several locations along the length of the body struts <NUM>.

The struts <NUM> of the apposition portions <NUM> and <NUM> can define flange cells <NUM> between the struts <NUM>. In some examples, the flange cells <NUM> are open cells (with no strut separating the flange cells <NUM> from the central portion <NUM>). In some examples, the flange cells <NUM> are closed at a distal-most end of the flange cells <NUM> by connecting members <NUM> and are open at a center-most end of the flange cells <NUM>, such that the flange cells <NUM> are open to the body cells <NUM>. The angled portions <NUM> can partially separate axially-adjacent body cells <NUM> but leave gaps such that each body cells <NUM> is open to each axially-adjacent body cell <NUM>.

<FIG> is an enlarged view of a single flange cell <NUM> of the anastomosis device <NUM> in a deployed configuration. <FIG> is an enlarged view of a single flange cell <NUM> of the anastomosis device <NUM> in a crushed configuration. The anastomosis device <NUM> can be elastically crushed, folded, and/or collapsed into a low-profile delivery configuration (with the flange cell <NUM> in the crushed configuration illustrated in <FIG>) for containment within a lumen for transcatheter or endoscopic/thorascopic delivery lumen. In some examples, the anastomosis device self-expands (upon deployment from the delivery lumen) to an operative size and configuration once positioned at a desired target site within a body (e.g., the flange cell <NUM> expands to the deployed configuration as illustrated in <FIG>).

<FIG> is an enlarged view of the body cell <NUM> of the anastomosis device <NUM> in a deployed configuration. <FIG> is an enlarged view of the body cell <NUM> of the anastomosis device <NUM> in a crushed configuration.

The frame of the anastomosis device <NUM> can be formed using any of the materials and techniques described herein. For example, the frame of the anastomosis device <NUM> can be formed from a precursor material that is cut to create the framework. In some such examples, the precursor material is a single piece of precursor material such as, but not limited to, a tubular material or a sheet material. The frame of the anastomosis device <NUM> can be formed as a wire-wound structure of a single wire or a plurality of wires that form the structures of the first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM>, so as to create the open structures of the body cells <NUM> and the flange cells <NUM> as well as the undulating shape of the circumferential rings <NUM> and <NUM>. A wire-wound structure may advantageously facilitate functionality of the open structures of the body cells <NUM> and the flange cells <NUM> as well as the undulating shape of the circumferential rings <NUM> and <NUM>.

The anastomosis device <NUM> can be wire-wound (or laser cut) in a manner such that an elongate member forms (i) a first pattern traversing the central portion <NUM> along a longitudinal axis, (ii) a first flange cell <NUM> of the first apposition portion <NUM>, (iii) a second pattern traversing the central portion <NUM> along the longitudinal axis opposing the first pattern, (iv) a second opposing flange cell <NUM>, and so on. The elongate member can be formed to repeat those patterns of the central portion <NUM> and flanges cells <NUM> to construct a complete anastomosis device <NUM>.

The anastomosis device <NUM> can be wire-wound (or laser cut) in a manner such that the elongate member defines a flange cell <NUM> of the first apposition portion <NUM>, the elongate member traverses the central portion <NUM>, the elongate member defines a flange cell <NUM> of the second apposition portion <NUM>, the elongate member traverses the central portion <NUM>, and thereafter the elongate member repeats the pattern to form additional flange cells while traversing the central portion <NUM> in between. In some such embodiments, each successive pattern and flange cell are symmetric to those proceeding.

<FIG> is a flat pattern of an anastomosis device <NUM>. The anastomosis device <NUM> can be similar to the anastomosis devices <NUM> and <NUM> described above. For example, the anastomosis device <NUM> can include a framework of elongate elements that defines a first apposition portion <NUM>, a second apposition portion <NUM>, and a central portion <NUM>. The central portion <NUM> is disposed between and interconnects the first apposition portion <NUM> and the second apposition portion <NUM>. A covering material as described above (not shown in <FIG>) can be disposed on at least some portions (or all) of the framework.

The anastomosis device <NUM> is shown in <FIG> as a flat pattern for clarity. However, the anastomosis device <NUM> can be formed into a tubular form, with the central portion <NUM> forming a substantially cylindrical structure, and with the first and second apposition portions <NUM> and <NUM> extending outward from opposing ends of the central portion <NUM>. The central portion <NUM> can form a tubular body that defines a lumen that extends between the first apposition portion <NUM> and the second apposition portion <NUM>. The first and second apposition portions <NUM> and <NUM> can form flanges extending substantially radially outward from opposite ends of the central portion <NUM>. In some implementations, the lumen defined by the central portion <NUM> provides an anastomosis passageway or tunnel through which biological materials can pass. It should be understood that when the anastomosis device <NUM> is implanted in a patient, the configuration of the device <NUM> may be somewhat different than shown because of the external forces from the patient's anatomy that are exerted on the device <NUM>.

The connecting members <NUM> can combine to form circumferential rings <NUM> and <NUM> extending substantially circumferentially around a radially-outer circumference of each of the first and second apposition portions <NUM> and <NUM>, respectively. The circumferential rings <NUM> and <NUM> can have a shape that is wavy or that undulates circumferentially around edges of the first and second apposition portions <NUM> and <NUM>. The circumferential rings <NUM> and <NUM> can have a shape that undulates, as can be seen in <FIG>. The circumferential rings <NUM> and <NUM> can undulate sinusoidally along the edges of one or both of the first and second apposition portions <NUM> and <NUM>. Forming one or both of the circumferential rings <NUM> and <NUM> with a sinusoidal, serpentine, or otherwise undulating shape can, in some implementations, increase an amount of surface area of contact between the first and second apposition portions <NUM> and <NUM> and tissue, thus reducing the force at a given location on that tissue. Forming one or both of the circumferential rings <NUM> and <NUM> with a sinusoidal, serpentine, or otherwise undulating shape can also help facilitate crushability of the first and second apposition portions <NUM> and <NUM> while maintaining other desirable properties.

The central portion <NUM> can include a series of body struts <NUM>, each body strut extending substantially axially and forming the central body of the anastomosis device <NUM>. The body struts <NUM> define body cells <NUM> of the central portion <NUM> and separate the respective body cells <NUM> from circumferentially-adjacent body cells <NUM>. In some embodiments, each of the body struts <NUM> may include a plurality of axially-extending portions <NUM> interconnected with a plurality of angled portions <NUM>. Such a configuration can allow the body struts <NUM> to create a relatively strong central portion <NUM> without necessarily interconnecting the body struts <NUM> at several locations along the length of the body struts <NUM>.

The struts <NUM> of the apposition portions <NUM> and <NUM> can define flange cells <NUM> between the struts <NUM>. In some such embodiments, the flange cells <NUM> can be open cells, with no strut separating the flange cells <NUM> from the central portion <NUM>. The flange cells <NUM> can be closed at a distal-most end of the flange cells <NUM> by connecting members <NUM> and can be open at a center-most end of the flange cells <NUM>, such that the flange cells <NUM> can be open to the body cells <NUM>. As illustrated in <FIG>, the flange cells <NUM> of the first apposition portion <NUM> are aligned with the body cells <NUM> and open to the body cells <NUM>, and the flange cells <NUM> of the second apposition portion <NUM> are aligned with the body struts <NUM> but are askew of the body cells <NUM>.

In some embodiments, the angled portions <NUM> can partially separate longitudinally-adjacent body cells <NUM> but leave gaps such that each of the body cells <NUM> is open to each longitudinally-adjacent body cell <NUM>.

The anastomosis device <NUM> can be wire-wound (or laser cut) in a manner such that an elongate member forms (i) a first pattern traversing the central portion <NUM> along a longitudinal axis, (ii) a first flange cell <NUM> of the first apposition portion <NUM>, (iii) a second pattern traversing the central portion <NUM> along the longitudinal axis opposing the first pattern, (iv) a second opposing flange cell <NUM>, and so on. The elongate member can repeat those patterns to form all of the central portion <NUM> and flanges cells <NUM> of the anastomosis device <NUM>.

The anastomosis device <NUM> can be wire-wound (or laser cut) in a manner such that the elongate member defines a flange cell <NUM> of the first apposition portion <NUM>, the elongate member traverses the central portion <NUM>, the elongate member defines a flange cell <NUM> of the second apposition portion <NUM>, the elongate member traverses the central portion <NUM>, and thereafter the elongate member repeats the pattern to form additional flange cells while traversing the central portion <NUM> in between. Each successive pattern and each successive flange cell <NUM> can be out of phase with those proceeding. In some embodiments, each successive pattern and each successive flange cell <NUM> can be in phase with those proceeding.

<FIG> is a flat pattern of an anastomosis device <NUM>. The anastomosis device <NUM> can be similar to the anastomosis devices <NUM>, <NUM>, and <NUM> described above. For example, the anastomosis device <NUM> includes a framework of elongate elements that defines a first apposition portion <NUM>, a second apposition portion <NUM>, and a central portion <NUM>. The central portion <NUM> is disposed between and interconnects the first apposition portion <NUM> and the second apposition portion <NUM>. A covering material as described above (not shown in <FIG>) can be disposed on at least some portions (or on all portions) of the framework.

The connecting members <NUM> combine to form circumferential rings <NUM> and <NUM> extending substantially circumferentially around a radially-outer circumference of each of the first and second apposition portions <NUM> and <NUM>, respectively. The circumferential rings <NUM> and <NUM> can have a shape that is wavy or that undulates circumferentially around edges of the first and second apposition portions <NUM> and <NUM>. The circumferential rings <NUM> and <NUM> can have a shape that undulates, as shown in <FIG>. Tthe circumferential rings <NUM> and <NUM> can undulate sinusoidally along the edges of one or both of the first and second apposition portions <NUM> and <NUM>. Forming one or both of the circumferential rings <NUM> and <NUM> with a sinusoidal, serpentine, or otherwise undulating shape may, in some implementations, increase an amount of surface area of contact between the first and second apposition portions <NUM> and <NUM> and tissue, thus reducing force at a given location on that tissue. Forming one or both of the circumferential rings <NUM> and <NUM> with a sinusoidal, serpentine, or otherwise undulating shape can also help facilitate crushability to a low-profile delivery configuration of the first and second apposition portions <NUM> and <NUM> while maintaining other desirable properties.

The central portion <NUM> can include a series of body struts <NUM>, each body strut extending substantially axially and forming the central body of the anastomosis device <NUM>. In some examples, the body struts <NUM> define body cells <NUM> of the central portion <NUM> and separate the respective body cells <NUM> from circumferentially-adjacent body cells <NUM>. Each of the body struts <NUM> can include a plurality of axially-extending portions <NUM> interconnected with a plurality of angled portions <NUM>. This can allow the body struts <NUM> to create a relatively strong central portion <NUM> without necessarily interconnecting the body struts <NUM> at several locations along the length of the body struts <NUM>. The struts <NUM> of the apposition portions <NUM> and <NUM> can define flange cells <NUM> between the struts <NUM>.

As illustrated in <FIG>, in some examples each column of body cells <NUM> is aligned with a flange cell <NUM> at one end, and is open at an opposite end. In some embodiments, the body cells <NUM> can be axially aligned with and open to a gap <NUM> extending between adjacent struts <NUM> of one or both of the first and second apposition portions <NUM> and <NUM>. The angled portions <NUM> can partially separate axially-adjacent body cells <NUM> but can leave gaps such that each body cells <NUM> is open to each axially-adjacent body cell <NUM>.

The anastomosis device <NUM> can be formed in a manner such that an elongate member forms (i) a first pattern traversing the central portion <NUM> along a longitudinal axis, (ii) a first flange cell <NUM> of the first apposition portion <NUM>, (iii) a second pattern traversing the central portion <NUM> opposing the first pattern, (iv) a second opposing flange cell <NUM>, and so on. In some examples, the elongate member repeats those patterns to form additional portions of the central portion <NUM> and flanges cells <NUM> to complete the anastomosis device <NUM>.

The anastomosis device <NUM> can be formed in a manner such that the elongate member defines a flange cell <NUM> of the first apposition portion <NUM>, the elongate member traverses the central portion <NUM>, the elongate member defines a flange cell <NUM> of the second apposition portion <NUM>, the elongate member traverses the central portion <NUM>, and thereafter the elongate member repeats the pattern to form additional flange cells while traversing the central portion <NUM> in between. Each successive pattern and each successive flange cell can be out of phase with those directly preceding. In some embodiments, each successive pattern and each successive flange cell can be in phase with those directly preceding.

Referring to <FIG> and <FIG>, the framework <NUM> of another example anastomosis device includes a first apposition portion <NUM>, a second apposition portion <NUM>, and a central portion <NUM>. For enhanced visualization of the framework <NUM>, the framework <NUM> is shown without a covering material, however covering material(s) as described elsewhere herein can be applied. In <FIG>, the framework <NUM> is shown in a low-profile delivery configuration. In <FIG>, the apposition portions <NUM> and <NUM> are shown in their expanded (deployed) configurations, while the central portion <NUM> is still shown in its low-profile configuration. When the framework <NUM> is fully expanded, the central portion <NUM> will become radially enlarged (e.g., refer to <FIG>).

The central portion <NUM> is disposed between the first apposition portion <NUM> and the second apposition portion <NUM>. The central portion <NUM> defines a lumen <NUM> that extends between the first apposition portion <NUM> and the second apposition portion <NUM>. In some examples, the lumen <NUM> provides an anastomosis passageway or tunnel through which biological materials and liquids can pass.

The materials, configurations, and techniques for construction of the framework <NUM> (and for the anastomosis devices that utilize framework <NUM>) can be the same as those described above in reference to the anastomosis device 200The first apposition portion <NUM> and the second apposition portion <NUM> are configured to engage one or more layers of tissue therebetween, and to provide apposition forces against the tissue surfaces. The apposition forces provided by the first and second apposition portions <NUM> and <NUM> can facilitate attachment of the framework <NUM> to the tissue and provide displacement resistance such that the framework <NUM> can reliably remain positioned at a target site in a patient as desired.

The first and second apposition portions <NUM> and <NUM> are formed of elongate elements in the form of struts <NUM>. In some examples, the struts <NUM> are configured to naturally form loops or semi-circles after deployment from a delivery sheath. In some such examples, the deployed apposition portions <NUM> and <NUM> are therefore comprised of a plurality of struts that jointly form toroid-shaped portions that are configured to contact tissue surfaces. In some examples, the deployed apposition portions <NUM> and <NUM> form other shapes such as, but not limited to, flanges, petals, hemispherical, and the like.

In the low-profile delivery configuration, the plurality of struts <NUM> are compressed such that they extend substantially parallel to the central portion <NUM>. The materials of device <NUM> allow the anastomosis devices to be elastically crushed, folded, and/or collapsed into a low-profile configuration for containment within a lumen for transcatheter or endoscopic/thorascopic delivery, and to self-expand to an operative size and configuration once positioned at a desired target site within a body and deployed from the lumen.

The central portion <NUM> includes at least one stent ring <NUM>. As shown, the stent rings <NUM> are aligned with each other along the longitudinal axis of the central portion <NUM>. In some examples, the stent rings <NUM> exhibit a serpentine pattern. It is to be appreciated that suitable patterns for the devices described herein include a variety of shapes and/or patterns. In some embodiments, the stent rings <NUM> are interconnected to each other by at least one strut <NUM> of the apposition portions <NUM> and <NUM>.

The central portion <NUM> is shown in a low-profile configuration. The central portion <NUM>, as discussed above, can include a variety of metallic shape memory materials and super-elastic alloys. Thus, the central portion <NUM> can be configured to self-expand to a deployed configuration. In some examples, the central portion <NUM> is balloon expandable to a deployed configuration. The diameter of the central portion <NUM> can be made in any size as desired in order to suit the intended use and/or delivery system of the anastomosis device. For example, the undeployed or low-profile delivery of the central portion <NUM> can be disposed within a delivery sheath that has about a <NUM> Fr. (<NUM>) outer diameter. However, in some examples, sheaths that are smaller or larger than <NUM> (<NUM> Fr. ) can be used. For example, sheaths that have outer diameters of <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ),, and larger than <NUM> (<NUM> Fr. ), can be used in some embodiments. During deployment, the diameter of the central portion <NUM> adjusts to a deployment diameter. In some examples, the deployed diameter of the central portion <NUM> is configured to at least partially anchor the device <NUM> via an interference fit with a tissue aperture. In other embodiments, a distance between the apposition portions is configured at least partially to anchor the device <NUM>. In some embodiments, the diameter of the central portion <NUM> increases, e.g., to about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, and the like.

Referring to <FIG>, another example anastomosis device <NUM> includes a framework of elongate elements that defines a first apposition portion <NUM>, a second apposition portion <NUM>, and a central portion <NUM>. The central portion <NUM> is disposed between and interconnects the first apposition portion <NUM> and the second apposition portion <NUM>. A covering material <NUM> is disposed on at least some portions of the framework. In some embodiments, the central portion <NUM> defines a lumen <NUM> that extends between the first apposition portion <NUM> and the second apposition portion <NUM>. In some implementations, the lumen <NUM> provides an anastomosis passageway or tunnel through which biological materials or liquids can pass. The device <NUM> is shown in an expanded configuration. The expanded configuration is the configuration that the device <NUM> naturally exhibits in the absence of external forces acting upon the device <NUM>. It should be understood that when the anastomosis device <NUM> is implanted in a patient, the configuration of the device <NUM> may be somewhat different than shown because of the external forces from the patient's anatomy that are exerted on the device <NUM>.

The materials, configurations, and techniques for construction of the anastomosis device <NUM> can be the same as those described above in reference to the anastomosis device <NUM>.

The apposition portions <NUM> and <NUM> of the anastomosis device <NUM> are analogous to the apposition portions <NUM> and <NUM> described above in reference to framework <NUM>. The apposition portions <NUM> and <NUM> naturally configure themselves into the exemplary toriodal shapes shown.

In some examples, the central portion <NUM> is a cellular construction made up of multiple diamond-shaped cells <NUM> that are interconnected by joints <NUM>. In other examples, such cells of the central portion <NUM> may have other shapes. In some examples, open spaces <NUM> are defined by the diamond-shaped cells <NUM>. It should be understood that the depicted configuration of the central portion <NUM> is just one example, and many other types of configurations can be incorporated.

Referring to <FIG>, an anastomosis device <NUM> includes a first apposition portion <NUM>, a second apposition portion <NUM>, and a central portion <NUM>. The device <NUM> is shown with a covering material <NUM> (as per any of the other covering materials described herein, and attached to the device <NUM> in any of the manners described above). In some examples, the covering material <NUM> is attached to device <NUM> to create a single conduit <NUM>. In some examples, the central portion <NUM> is covered independently from the apposition portions <NUM> and/or <NUM> such that cover on the apposition portions are distinct from the covering material <NUM> that creates the central lumen <NUM>. In other examples, the central portion <NUM> is covered (or partially covered), while the apposition portions <NUM> and <NUM> remain free of covering material <NUM>.

The central portion <NUM> is disposed between and interconnects the first apposition portion <NUM> and the second apposition portion <NUM>. In some examples, an additional central end portion <NUM> extends beyond one or both of the apposition portions <NUM> and <NUM>. The central end portion <NUM> can extend from one or both of the apposition portions <NUM> and to any desired length. In some examples, no central end portions <NUM> are included. Having one or both of the central end portion <NUM> can help to facilitate device removal in some examples. For example, an endoscopic grasper can be used to grasp the central end portion <NUM> and remove the device <NUM>.

The central portion <NUM> defines a lumen <NUM> that extends between the first apposition portion <NUM> and the second apposition portion <NUM>. In some embodiments, the lumen <NUM> provides an anastomosis passageway or tunnel through which biological materials or liquids can pass. The device <NUM> is shown in a deployed (expanded) configuration. The expanded or deployed configuration is the configuration that the device <NUM> or a portion thereof naturally exhibits in the absence of external forces acting upon the device <NUM>.

The first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM> can comprise a spring wire (e.g., L605 steel or stainless steels), shape memory alloy wire (e.g., nitinol or nitinol alloys), super-elastic alloy wire (e.g., nitinol or nitinol alloys), other suitable types of wires, or combinations thereof. In some such examples, the first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM> can be formed from the same piece of precursor material that is cut to create the wire structure as desired. For example, the precursor material may be a tube (e.g., a nitinol tube) that is laser cut to form the desired wire structure. In some examples, different types of wires are used at different locations of the first apposition portion <NUM>, the second apposition portion <NUM>, and/or the central portion <NUM>. In other examples, the first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM> or portions thereof may be constructed of polymeric materials.

The first apposition portion <NUM> and the second apposition portion <NUM> are configured to engage one or more layers of tissue therebetween, and to provide apposition forces against the tissue surfaces. The apposition forces provided by the first and second apposition portions <NUM> and <NUM> can facilitate fixation of the device <NUM> to the tissue and provide displacement resistance such that the device <NUM> can reliably remain positioned at a target site in a patient as desired. In the depicted example, each of the first and second apposition portions <NUM> and <NUM> comprise a series of overlapping petals <NUM> that are collectively configured to form, in a general sense, discs that contact tissue surfaces. Although the discs shown in the depicted example <NUM> are perpendicular to the central portion <NUM>, the discs of first and second apposition portions <NUM> and <NUM> can be formed at non-orthogonal angles to facilitate apposition of varying tissue thicknesses and tissue topographies. The discs of first and second apposition portions <NUM> and <NUM> distribute the apposition pressure to a large tissue contact surface area, thereby facilitating apposition of diseased tissue (e.g. gangrenous) with minimal force.

In some examples, the first apposition portion <NUM> and the second apposition portion <NUM> each include a plurality of struts <NUM> that generally form a series of petals <NUM> having an S-shaped bend. These bends can affect the available apposition force and improve the ease of manufacturing. For example, during some manufacturing processes of device <NUM>, the device pattern is cut from a cylindrical tube and the proximal end of the cut tube is compressed towards the distal end of the cut tube. Including an S-shaped bend in the device can be advantageous during this process. In other examples, increasing the number of the petals <NUM>, the amount of overlap, and/or the thickness of the struts <NUM> can increase the available apposition force. In some examples, the first apposition portion <NUM> and/or the second apposition portion <NUM> can be formed in different manners (other than the series of petals <NUM> having an S-shaped bend). For example, the first apposition portion <NUM> and/or the second apposition portion <NUM> can be formed as loops that approximate radial spokes, and the like.

The number of petals <NUM> and the percentage of overlap of adjacent petals <NUM> can be selected to tailor the apposition force and area as desired. In some examples, each strut <NUM> is connected to one rhombus shaped cell on either end of the struts <NUM>. In some such examples, the diameter of the first and second apposition portions <NUM> and <NUM> are determined by the length of the struts <NUM> that connects the cells and the angle of twist during manufacturing process. The S-shaped struts <NUM> establish a preferential bending location that can affect the shape of the petal <NUM> during shape setting process. The S-shaped struts <NUM> can provide flexibility in design by not having to attach an entire length of frame to graft material and/or not having to use an elastomer material for graft. The S-shaped struts <NUM> can permit attachment of relatively thin and flexible material for a relatively small device profile. The S-shaped struts <NUM> can enable collapsibility of the first and second apposition portions <NUM> and <NUM>, and ultimately improve the ability of the device <NUM> to be loaded within a sheath, and deployed via an endoscope working channel.

When the anastomosis device is configured in its low-profile delivery configuration, the plurality of struts <NUM> are compressed such that they extend substantially parallel to the longitudinal axis of the central portion <NUM>. In some embodiments, the materials of device <NUM> allow the anastomosis devices to be elastically crushed, folded, and/or collapsed into a low-profile configuration for containment within a lumen for transcatheter or endoscopic/thorascopic delivery, and to self-expand to an operative size and configuration once positioned at a desired target site within a body and deployed from the lumen. In addition, the device <NUM> may exhibit, for example, beneficial fatigue resistance and elastic properties.

The central portion <NUM> includes at least one stent ring <NUM>. As shown, the stent ring <NUM> includes a series of interconnected cells <NUM>. During radial expansion, the cell <NUM> expands in the circumferential direction and collapses in the longitudinal direction. The radial strength of the central portion <NUM> can be increased by varying the geometry of the stent ring, varying the tube thickness of the initial tubular construct, or selecting a stronger material. It should be clear that suitable patterns for the devices described herein include a variety of different shapes and/or patterns. In some embodiments, the stent rings <NUM> are interconnected to each other by at least one bridge member <NUM>.

The central portion <NUM> is shown in an expanded or deployed configuration. The central portion <NUM>, as discussed above, can include a variety of metallic shape memory materials and super-elastic alloys. Thus, the central portion <NUM> can be configured to self-expand to a deployed configuration. In some examples, the central portion <NUM> is balloon expandable to a deployed configuration. The diameter of the central portion <NUM> can be made in any size as desired in order to suit the intended use and/or delivery system of the anastomosis device. For example, the undeployed or low-profile delivery of the central portion <NUM> can be disposed within a delivery sheath that has about a <NUM> Fr. (<NUM>) outer diameter. However, sheaths that are smaller or larger than <NUM> (<NUM> Fr. ) can be used. For example, sheaths that have outer diameters of <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), and larger than <NUM> (<NUM> Fr. ), can be used. The device <NUM> can be longitudinally stretched to reduce the first and second apposition portions <NUM> and <NUM> to a smaller diameter. The size of the first and second apposition portions <NUM> and <NUM> can be reduced to at least as small as central portion <NUM> of the device <NUM>. This reduction in size of the first and second apposition portions <NUM> and <NUM> enables crushing/crimping of the device <NUM> on to a catheter for endoscopic delivery, for example.

During deployment, the diameter of the central portion <NUM> expands to a larger diameter. In some embodiments, the deployed diameter of the central portion <NUM> is configured to at least partially anchor the device <NUM> via an interference fit with the tissue aperture. In some embodiments, the diameter of the central portion <NUM> increases, e.g., to about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, and the like.

A distance between the apposition portions can be configured at least partially to anchor the device <NUM>. In some examples, the distance between the apposition portions is less than <NUM>, e.g., less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM>, and so forth. The distance between the flange member <NUM> and the flange member design can be tailored accommodate tissue conditions pre and post drainage. For example, the flanges <NUM> can be sufficiently flexible and the distance between the flanges sized so as to avoid pressure necrosis on the thicker tissue.

Referring to <FIG>, an anastomosis device <NUM> includes a first apposition portion <NUM>, a second apposition portion <NUM>, and a central portion <NUM> is illustrated. For simplicity, the device <NUM> is shown without a covering material; however, in some embodiments the covering material(s) described elsewhere herein can be applied to portions of or all or the frame material. The central portion <NUM> is disposed between the first apposition portion <NUM> and the second apposition portion <NUM>. In some examples, the central portion <NUM> defines a lumen <NUM> that extends between the first apposition portion <NUM> and the second apposition portion <NUM>. In some embodiments, the lumen <NUM> provides an anastomosis passageway or tunnel through which biological materials or liquids can pass. While in the depicted example the central portion <NUM> includes a single row of cells, in some examples two, three, four, five, or more than five rows of cells are included. The device <NUM> is show in a deployed configuration. In some examples, the expanded or deployed configuration is the configuration that the device <NUM> or a portion thereof naturally exhibits in the absence of external forces acting upon the device <NUM>.

The first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM> can comprise a spring wire (e.g., L605 steel or stainless steels), shape memory alloy wire (e.g., nitinol or nitinol alloys), super-elastic alloy wire (e.g., nitinol or nitinol alloys), other suitable types of wire, or combinations thereof. In some such examples, the first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM> can be formed from the same piece of precursor material that is cut to create the wire structure as desired. For example, in some such examples the precursor material is a tube (e.g., a nitinol tube) that is laser cut to form the desired wire structure. In some examples, different types of wires are used at different locations of the first apposition portion <NUM>, the second apposition portion <NUM>, and/or the central portion <NUM>. The first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM> or portions thereof may be constructed of polymeric materials.

The first apposition portion <NUM> and the second apposition portion <NUM> are configured to engage one or more layers of tissue therebetween, and to provide apposition forces against the tissue surfaces. The apposition forces provided by the first and second apposition portions <NUM> and <NUM> can facilitate attachment of the device <NUM> to the tissue and provide displacement resistance such that the device <NUM> can reliably remain positioned at a target site in a patient as desired. In some examples, each of the first and second apposition portions <NUM> and <NUM> are configured to form, in a general sense, discs that contact tissue surfaces.

The first apposition portion <NUM> and the second apposition portion <NUM> each include a plurality of struts <NUM>. The anastomosis device <NUM> can be configured in a collapsed delivery configuration in which the plurality of struts <NUM> is compressed such that they extend substantially parallel to the central portion <NUM>. The device <NUM> may exhibit, for example, beneficial fatigue resistance and elastic properties. The materials of the device <NUM> may allow the anastomosis devices to be elastically crushed, folded, and/or collapsed into a low-profile configuration for containment within a lumen for transcatheter or endoscopic/thorascopic delivery, and to self-expand to an operative size and configuration once positioned at a desired target site within a body and deployed from the lumen.

During deployment, the plurality of struts <NUM> protrude from the central portion <NUM> at an axial orientation and shape to achieve specific apposing pressures on the tissue. In some examples, the plurality of struts <NUM> protrude from the central portion <NUM> such the exposed face of the apposition portions <NUM> and <NUM> is substantially perpendicular to the longitudinal axis of the device <NUM>.

Still referring to <FIG>, in the depicted example the plurality of struts <NUM> are interconnected by a connecting member <NUM>. The connecting member <NUM> is shown in a deployed configuration in which the connecting member <NUM> is arranged in a series of undulations each having a vertex <NUM> extending away from the central portion <NUM>. When the anastomosis device <NUM> is configured in its low-profile delivery configuration, the measure of the angle at the vertex <NUM> between adjacent the struts <NUM> is less than the measure of the measure of the angle at the vertex <NUM> between adjacent the struts <NUM> when the anastomosis device <NUM> is configured in its deployed expanded configuration as shown. In some examples, the measure of the angle at the vertex <NUM> between adjacent the struts <NUM> decrease when the anastomosis device is configured in its low-profile delivery configuration. For example, the measure of the angle can be is less than <NUM>°, e.g., less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, and so forth. In some examples, the measure of the angle at the vertex <NUM> between adjacent the struts <NUM> decrease when the anastomosis device is configured in its low-profile delivery configuration. For example, the angle can be less than <NUM>°, e.g., less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, less than <NUM>°, and so forth. The stability and support provided by the connecting member <NUM> serves to increase the apposition force provided against the gallbladder or provided against the portion of the gastrointestinal tract.

When the anastomosis device is configured in its low-profile delivery configuration, a cell <NUM> expands longitudinally (as shown in <FIG>) and, as the struts <NUM> are compressed towards the longitudinal axis, the distance between the adjacent vertices <NUM> is reduced. During deployment, the cell <NUM> expands radially (as shown in <FIG>), and the distance between the struts <NUM> increases. In some examples, the vertex <NUM> extends away from the central portion <NUM> as the adjacent vertex <NUM> is compressed together.

The connecting member <NUM>, as described above, can comprise a variety of metallic shape memory materials and super-elastic alloys. Thus, the connecting member <NUM> can be configured to self-expand to an expanded deployed configuration, e.g., including a pre-determined angle of the vertex <NUM>. The connecting member <NUM> typically operate from closed (nearly aligned) to open positions that can be around <NUM>-<NUM> degrees between them, but can be made to open less or more than <NUM>-<NUM> degrees in certain configurations.

Referring to <FIG>, an exemplary forming mandrel <NUM> can be used to create some embodiments of the apposition portions of the anastomosis devices provided herein. For example, the forming mandrel <NUM> can be used to create the frame as shown in <FIG>, and <FIG>. The winding mandrel <NUM> can be configured with the dimensional spacing, radii, and angles corresponding to the shape of the device <NUM> as desired. The forming mandrel <NUM> can also be readily modified to create other embodiments of devices having other configurations as desired.

In some embodiments, the mandrel <NUM> includes two identical endplates <NUM> and <NUM>, a shaft <NUM>, a central bore <NUM>, and a collar <NUM>. The endplates <NUM>, <NUM>, are oriented with the shaft <NUM> such that the endplates <NUM>, <NUM> oppose each other. In some embodiments, the endplates <NUM>, <NUM> includes a locking mechanism, such as a setscrew, by which the endplates <NUM>, <NUM> are releasably lockable to the shaft <NUM>. When the individual locking mechanisms are released, the individual endplates <NUM> and/or <NUM> can be axially translated, removed from the shaft <NUM>, and/or rotated in relation to the shaft <NUM> and in relation to each other.

In some embodiments, after the device framework is mounted onto the mandrel <NUM> as described above, the assembly is heated to shape-set the device to its configuration, e.g., a deployed or expanded configuration. In one such non-limiting example, the devise is laser cut from a NiTi tube, and the NiTi tube in an expanded state on the mounting mandrel <NUM> is heated at about <NUM>° C for about <NUM> minutes. In other embodiments, higher or lower temperatures and shorter or longer times are used. The heating process will cause the laser cut NiTi tube to be heat-set into the deployed shape or the memory shape. Accordingly, the laser cut NiTi tube will tend to naturally self-expand to reconfigure itself to the memory shape when deployed from a delivery sheath to a target site within a body. In some embodiments, only a portion of the device is heated to a memory shape. For example, only the apposition portions <NUM> and/or <NUM>, or the struts <NUM> are heated.

In some embodiments, a diameter of the shaft <NUM> is the desired deployed diameter of the central portion <NUM>. To mount the device framework, at least one endplate <NUM> or <NUM> is removed from the shaft <NUM> and the shaft <NUM> is inserted into the lumen of the framework. The removed endplate is re-attached to the shaft <NUM> such that distance between the two endplates <NUM> and <NUM> is approximately equal to the desired length of the central portion <NUM> of the device. This distance causes end regions of the device to press against the endplates <NUM> and <NUM> and causes the struts <NUM> to bend and causes the connecting member <NUM> to extend from the longitudinal axis of the device at an angle of about <NUM>°. The collar <NUM> can be secured around the mounted device framework (as shown) to constrain the framework in the desired configuration until forming is complete.

Referring to <FIG>, an exemplary anastomosis device <NUM> in accordance with claim <NUM> includes a framework of elongate elements that defines a first apposition portion <NUM>, a second apposition portion <NUM>, and a central portion <NUM>. The central portion <NUM> is disposed between and interconnects the first apposition portion <NUM> and the second apposition portion <NUM>. A covering material <NUM> is disposed on at least some portions of the framework. Such a covering material (e.g., covering material <NUM> and others described below) may also be referred to herein merely as a covering.

In some embodiments, the central portion <NUM> defines a lumen <NUM> that extends between the first apposition portion <NUM> and the second apposition portion <NUM>. In some implementations, the lumen <NUM> provides an anastomosis passageway (i.e., a tunnel) through which biological materials or liquids can pass. The device <NUM> is shown in an expanded configuration (also referred to herein as a deployed configuration). The expanded or deployed configuration is the configuration that the device <NUM> naturally exhibits in the absence of external forces acting upon the device <NUM>. In should be understood that when the anastomosis device <NUM> is implanted in a patient, the configuration of the device <NUM> may be somewhat different than shown because of the external forces from the patient's anatomy that are exerted on the device <NUM>.

The framework of anastomosis device <NUM> can be made using any of the materials and techniques as described above in reference to other anastomosis devices. In some embodiments, the first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM>, comprise a framework of interconnected elongate elements that is constructed by cutting a tube or a sheet. In some such embodiments, a tube of metallic material (e.g., nitinol, stainless steel, cobalt, etc.) is laser cut, and then the tube is expanded and shaped into the desired configuration. In some such embodiments, the metallic material is shape-set in the desired configuration so that the material receives a shape-memory whereby the material will naturally strive to attain the desired configuration. In some embodiments, shape memory materials such as nitinol may strive to attain the desired configuration when exposed to body temperature.

In some embodiments, a covering material <NUM> can be disposed on some portions or on all of the first apposition portion <NUM>, the second apposition portion <NUM>, and/or the central portion <NUM>. In some embodiments, portions of the first apposition portion <NUM>, the second apposition portion <NUM>, and/or the central portion <NUM> can remain free of the covering material <NUM>.

The first apposition portion <NUM> and the second apposition portion <NUM> each include a plurality of struts <NUM>. In some embodiments, the struts <NUM> of each of the first and second apposition portions <NUM> and <NUM> are configured to form, in a general sense, discs that contact tissue surfaces. More particularly, the first apposition portion <NUM> and the second apposition portion <NUM> are configured to engage one or more layers of tissue therebetween, and to provide apposition forces against the tissue surfaces. The apposition forces provided by the first and second apposition portions <NUM> and <NUM> can facilitate fixation of the device <NUM> to the tissue and provide migration resistance such that the device <NUM> can reliably remain positioned at a target site in a patient as desired.

In some embodiments, the materials and configuration of the anastomosis device <NUM> (and the other anastomosis device embodiments provided herein) allow the devices to be elastically crushed, folded, and/or collapsed into a low-profile delivery configuration for containment within a lumen for transcatheter or endoscopic/thorascopic delivery, and to self-expand to an operative size and configuration once positioned at a desired target site within a body and deployed from the lumen. For example, the anastomosis device <NUM> can be configured in a collapsed delivery configuration in which the plurality of struts <NUM> are radially compressed such that they are forced to extend substantially parallel to axis of the central portion <NUM>, and in which the diameter of the central portion <NUM> is also crushed to become smaller. Due to the use of such materials and structure, the device <NUM> may also exhibit, for example, beneficial fatigue resistance and elastic properties.

After deployment, the plurality of struts <NUM> extend from the central portion <NUM> at a radial orientation and geometry to exert a desired level of apposition pressure on the tissue. In some embodiments, the plurality of struts <NUM> extend from the central portion <NUM> such that the nominal measure of the angle between the struts <NUM> and the longitudinal axis of the device <NUM> is about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, and the like. In some embodiments, the plurality of struts <NUM> extend from the central portion <NUM> such that the nominal measure of the angle between the struts <NUM> and the longitudinal axis of the device <NUM> is in a range from about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°.

Still referring to <FIG>, in some embodiments of the anastomosis device <NUM> (and in some embodiments of the other anastomosis devices provided herein) the plurality of struts <NUM> are interconnected by connecting members <NUM>. The connecting members <NUM> are shown in deployed configurations in which the connecting members <NUM> are arranged in a series of undulations-each having a vertex <NUM> extending towards the central portion <NUM> and a vertex <NUM> extending away from the central portion <NUM>. In some embodiments, the connecting members <NUM> serve to support and stabilize the struts <NUM> to thereby cause the apposition portions <NUM> and <NUM> to have a more rigid construct. In some such embodiments, the apposition portions <NUM> and <NUM> can exert a greater level of apposition pressure while maintain a compliancy by which the apposition portions <NUM> and <NUM> can conform to the anatomical topography of the tissue. In addition, the sealing capabilities of the apposition portions <NUM> and <NUM> may be enhanced. The stability and support provided by the connecting member <NUM> serves to increase the apposition force provided against the gallbladder or provided against the portion of the gastrointestinal tract.

While in the depicted embodiment the connecting members <NUM> are a series of generally linear segments that are joined to form a chevron between adjacent struts <NUM>, in some embodiments the connecting members <NUM> comprise a continuous wavy or sinusoidal configuration (e.g., a sine wave). For example, in some embodiments the connecting members <NUM> may be linear between the struts <NUM> when the anastomosis device <NUM> is in its deployed configuration. While in the depicted embodiment, the connecting members <NUM> extend from the radial ends of the struts <NUM>, in some embodiments the connecting members <NUM> may be attached to or extend from the struts <NUM> at other locations on the struts <NUM>. In some embodiments, two or more sets of connecting members <NUM> can be included (extending from one or more of the struts <NUM>).

When the anastomosis device <NUM> is configured in its low-profile delivery configuration, the measure of the angle defined by the vertices <NUM> and <NUM> is less than the measure of the angle defined by the vertices <NUM> and <NUM> when the anastomosis device <NUM> is configured in its deployed expanded configuration as shown. Said another way, as the struts <NUM> are compressed towards the device's longitudinal axis, the distance between the adjacent vertices <NUM> and <NUM> is reduced. In some embodiments, each vertex <NUM> extends towards the central portion <NUM> and each vertex <NUM> extends away from the central portion <NUM> when the anastomosis device <NUM> is in the collapsed low-profile delivery configuration.

The connecting member <NUM>, as described above, can comprise a variety of materials including, but not limited to, metallic shape memory materials and super-elastic alloys. Thus, the connecting members <NUM> can be configured to self-expand to an expanded deployed configuration, e.g., including to a pre-determined angle of the vertices <NUM> and <NUM>.

Referring also to <FIG>, the central portion <NUM> includes one or more circumferential stent rings <NUM> and one or more axial adjustment members <NUM>. It should be understood that for enhanced visibility, the central portion <NUM> is shown in <FIG> without a covering material. The axial adjustment members <NUM> interconnect the stent rings <NUM>. Using this construct, the central portion <NUM> is configured to axially expand or contract in response to tensile forces transferred to the central portion <NUM> from the apposition portions <NUM> and <NUM>. Such forces can be the result of the apposition pressure applied to tissue(s) compressed between the apposition portions <NUM> and <NUM>. Said another way, the axial adjustment members <NUM> can act as suspension springs so that the anastomosis device <NUM> can axially extend or contract to accommodate various thicknesses of tissue between the apposition portions <NUM> and <NUM>. This feature can be advantageous, for example, because tissue may be thicker when it is inflamed, and may become thinner as it returns to normal (heals). In such a case, the anastomosis device <NUM> can automatically adjust in response to varying tissue thicknesses throughout the healing process.

In the depicted embodiment, two stent rings <NUM> are included. In some embodiments, fewer or more than two stent rings <NUM> can be included. In the depicted embodiment, the stent rings <NUM> are aligned with each other. That is, the peaks and/or valleys of each individual stent ring <NUM> is positioned in axial alignment with the peaks and/or valleys of the other individual stent ring <NUM>. However, such alignment is not required in all embodiments. In the depicted embodiment, the stent rings <NUM> exhibit a pattern of peaks and valleys in a sinusoidal-like pattern. However, it should be clear that the stent rings <NUM> can be configured to have any other suitable geometry. For example, a serpentine pattern or a pattern of closed rhombus-shaped cells are suitable in some embodiments. The stent rings <NUM> are interconnected to each other by at least one axial adjustment member <NUM>, and the stent rings <NUM> are connected to the struts <NUM> of the apposition portions <NUM> or <NUM>.

The central portion <NUM> is shown in a deployed or expanded configuration. In some embodiments, the central portion <NUM>, as described above, can comprise a variety of metallic shape memory materials and super-elastic alloys. Thus, the central portion <NUM> can be configured to self-expand to the deployed configuration. In some embodiments, the central portion <NUM> is balloon expandable to the deployed configuration, or supplemental expansion forces can be applied to a self-expandable device by balloon dilation. The diameter of the central portion <NUM> can be made in any size as desired in order to suit the intended use and/or delivery system of the anastomosis device <NUM>. For example, in the low-profile delivery configuration the anastomosis device <NUM> can be disposed within a delivery sheath that has about a <NUM> Fr. (<NUM>) outer diameter. However, in some embodiments, sheaths that are smaller or larger than <NUM> (<NUM> Fr. ) can be used. For example, sheaths that have outer diameters of <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), <NUM> (<NUM> Fr. ), and larger than <NUM> (<NUM> Fr. ) can be used in some embodiments. When the anastomosis device <NUM> is configured in its expanded deployed configuration as shown, the diameter of the central portion <NUM> increases to a deployed diameter. In some implementations, the deployed outer diameter of the central portion <NUM> is configured to at least partially anchor the device <NUM> via an interference fit with the tissue aperture in which the central portion <NUM> resides. However, in some implementations the deployed outer diameter of the central portion <NUM> is slightly less than the diameter of the tissue aperture in which the central portion <NUM> resides, and the apposition portions <NUM> and <NUM> compress the tissue to provide the migration resistance. In some embodiments, the fully expanded diameter of the central portion <NUM> is about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, or about <NUM>, and the like. In some embodiments, the fully expanded diameter of the central portion <NUM> is in a range between about <NUM> to about <NUM>, or about <NUM> to about <NUM>, or about <NUM> to about <NUM>, or about <NUM> to about <NUM>, or about <NUM> to about <NUM>, and the like.

The one or more axial adjustment members <NUM> are disposed within the central portion <NUM> so as to interconnect the stent rings <NUM>. In some embodiments, the axial adjustment members <NUM> are configured in an undulating or horseshoe-like shape (not shown). The undulations of the axial adjustment member <NUM> extend in directions so that the central portion <NUM> can axially extend as a result of axially extending the axial adjustment members <NUM> (e.g., by causing the axial adjustment members <NUM> to become more linear). The undulations of the axial adjustment members <NUM> provide a store of excess material and/or mechanical energy to facilitate the expansion or contraction of the axial length of the device <NUM>.

The length of the central portion <NUM> can be made in any dimension as desired in order to suit the intended use and/or delivery system of the anastomosis device <NUM>. The inclusion of the one or more axial adjustment members <NUM> can allow the anastomosis device <NUM> to be useable over a range of tissue thicknesses, and can advantageously improve contact between the tissues for enhancing anastomosis performance. In some embodiments, the adjacent stent rings <NUM> can be longitudinally separated from each other until the device reaches an axial adjustment limit, e.g., until the axial adjustment members <NUM> appear as a substantially straight line.

In some implementations, the axial length of the device is at least somewhat adjusted before or during deployment, e.g., by a clinician to accommodate particular tissue thicknesses at a target implant site. In other example implementations, the axial adjustment members <NUM> automatically responds to mechanical forces exerted on the deployed device <NUM> in situ. For example, the axial adjustment members <NUM> may permit the axial length of the device <NUM> to dynamically adjust during deployment and/or during the tissue healing process. In one such example implementation in which an anastomosis is created between a gallbladder and a duodenum, the gallbladder (if inflamed) can have an initial wall thickness that later reduces when the inflammation subsides. The axial adjustment members <NUM> can permit the axial length of the device <NUM> to dynamically adjust from the initial thickness to the later thickness as the inflammation of the gallbladder wall subsides.

The anastomosis device <NUM> also includes the covering material <NUM>. The covering material <NUM> can be constructed of any of the materials and using any of the techniques described above in reference to the covering materials of the other anastomosis devices provided herein. In some embodiments, the covering material <NUM> is disposed on at least some portions (or on all) of the first apposition portion <NUM>, the second apposition portion <NUM>, and the central portion <NUM>. In some embodiments, some portions of the first apposition portion <NUM>, the second apposition portion <NUM>, and/or the central portion <NUM> are not covered by the covering material <NUM>.

Referring to <FIG>, another exemplary anastomosis device <NUM> includes a framework of elongate elements that defines a first apposition portion <NUM>, a second apposition portion <NUM>, and a central portion <NUM>. The central portion <NUM> is disposed between and interconnects the first apposition portion <NUM> and the second apposition portion <NUM>. A covering material <NUM> is disposed on at least some portions of the framework. In some embodiments, the central portion <NUM> defines a lumen <NUM> that extends between the first apposition portion <NUM> and the second apposition portion <NUM>. In some implementations, the lumen <NUM> provides an anastomosis passageway or tunnel through which biological materials or liquids can pass. The device <NUM> is shown in an expanded configuration. The expanded configuration is the configuration that the device <NUM> naturally exhibits in the absence of external forces acting upon the device <NUM>.

The materials, configurations, and techniques for construction of the anastomosis device <NUM> can be the same as those described above in reference to the other anastomosis devices provided herein. In some embodiments, the anastomosis device <NUM> does not include elongate elements that interconnect the struts <NUM> (in contrast to the connecting members <NUM> that interconnect the struts <NUM> of the anastomosis device <NUM>).

In some embodiments, the anastomosis device <NUM> can be constructed to have a tailored radial strength by varying design parameters such as the number of cells, tube thickness, cell geometry, covering material, and the like. For example, in anastomosis device applications the central portion <NUM> is designed to have a radial strength that is resistant to circumferential loading from the surrounding tissue. The radial strength of some such anastomosis devices facilitates the remodeling of the tissue external to the lumen, and can cause the tissue to have a lumen size that approximates the lumen size of the device.

In some embodiments, the free ends of one or more of the struts <NUM> include a member <NUM>. In some embodiments, the member <NUM> can include an anchor, barb, protrusion, atraumatic member, and/or a support scaffold for the covering material <NUM>. In some embodiments two or more struts <NUM> includes members <NUM> that have the differing configurations. In some embodiments, each of the struts <NUM> have members <NUM> with the same configuration.

It should be understood that one or more design features of the anastomosis devices provided herein can be combined with other features of other anastomosis devices provided herein. In effect, hybrid designs that combine various features from two or more of the anastomosis device designs provided herein can be created, and are within the scope of this disclosure.

Some of the devices provided herein can be used for sealing or anchoring a heart valve implant. A heart valve implant enables one-way flow of blood from a heart chamber and usually has a first inflow end and a second outflow end. The contractions of the heart cause flow of blood through the valve from the inflow end to the outflow end. Between the inflow and outflow ends, a valve assembly within the heart valve implant provides for one way flow, opening to allow flow from the inflow to the outflow end when the pressure of the blood is higher on the inflow end, and closing to prevent flow when the pressure on the outflow end is higher than the inflow end. In some examples, the device includes a tunnel or central aperture through the device with apposition portions to anchor a valve assembly and seal against backward flow. A valve assembly can be attached in the tunnel or central aperture. The apposition portions of the device can be configured to be highly conformable to the topography of the heart chambers or blood vessels, and compliant with the beating movements of the heart, in some examples, a covering material is configured to allow flow through a valve assembly in the tunnel or aperture while preventing flow around the apposition portions.

Claim 1:
A anastomosis device (<NUM>, <NUM>) framework of elongate elements which define:
a first apposition portion (<NUM>, <NUM>);
a second apposition portion (<NUM>, <NUM>); and
a central portion (<NUM>) disposed between and interconnecting the first apposition portion and the second apposition portion;
characterized in that
the central portion includes two or more circumferential stent rings (<NUM>) and one or more axial adjustment members (<NUM>) being disposed within the central portion (<NUM>) so as to interconnect the stent rings (<NUM>); and the central portion (<NUM>) is configured to axially expand or contract in response to tensile forces transferred to the central portion (<NUM>) from the apposition portions (<NUM>, <NUM>) and (<NUM>, <NUM>).