Anastomosis device

Abstract

To provide an implantable medical device for connecting tissue layers, for example connecting a gallbladder and a portion of a gastrointestinal tract, to create an anastomosis.SOLUTION: An implantable medical device 200 is provided, including: a tubular structure having a plurality of apposition portions 202 and 204, a central region 206, and a covering material. The implantable medical device is endoscopically deployable and may include open cells or undulating edges that facilitate secure connection between tissue structures.SELECTED DRAWING: Figure 2A

Description

Technical Field

[0001] The present disclosure generally relates to implantable medical devices, and more particularly to implantable devices for connecting tissue layers to form an anastomosis. A method of implanting an anastomosis device within a patient is also provided.

Background Art

[0002] An anastomosis is a surgical connection between two tissue structures such as blood vessels or the intestine. For example, in the context of coronary artery bypass grafting, the graft vessel is anastomosed to the native coronary artery so that blood can flow through the graft vessel.

[0003] Anastomoses can be formed in a variety of ways including, but not limited to, end-to-end anastomoses, end-to-side anastomoses, and side-to-side anastomoses. Suturing is often used to form such anastomoses.

Summary of the Invention

[0004] One aspect of the present invention relates to a transplantable medical device for forming an anastomosis comprising a tubular structure including at least one elongate member forming a framework of interconnected struts. The tubular structure includes (1) a central portion defining a longitudinal axis and including a plurality of central cells defined by the elongate member, (2) 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 (3) 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 a wavy portion of the elongate member and are open to the central portion at a second end. In at least one exemplary embodiment, the elongate member forms (1) a first pattern extending longitudinally along the central portion, (2) one of the plurality of first flange cells, (3) a second pattern extending longitudinally along the central portion on the side opposite the first pattern, and (4) one 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 cells are open to longitudinally adjacent central cells and closed to circumferentially adjacent central cells. In a further embodiment, each of the plurality of second flange cells is open to one or more of the plurality of central cells.

[0005] A second aspect of the present invention relates to a transplantable medical device for forming an anastomosis. The device includes a tubular structure including at least one elongate member forming a framework of interconnected struts. The tubular structure includes (1) a central portion having a plurality of body cells defined by the elongate member, (2) a first juxtaposed portion at a first end of the central portion, the first juxtaposed portion having a plurality of first flange cells defined by the elongate member, and (3) a second juxtaposed portion at a second end of the central portion, the second juxtaposed portion having a plurality of second flange cells defined by the elongate member. The elongate member may be formed such that (1) the elongate member forms a first pattern traversing the central portion along a longitudinal axis, (2) the elongate member defines one of the plurality of first flange cells, (3) the elongate member forms a second pattern traversing the central portion along a longitudinal axis on the side opposite the first pattern, and (4) the elongate member defines one of the plurality of second flange cells. In at least one embodiment, each of the successive flange cells of the plurality of first and second flange cells may be out of phase with the one immediately preceding the plurality of first and second flange cells. Additionally, the body cells may be open to longitudinally adjacent body cells and closed to circumferentially adjacent body cells. In some embodiments, each of the plurality of first flange cells may be open to the body portion and each of the plurality of second flange cells may be open to the body portion.

[0006] A third aspect of the invention relates to a method of implanting an anastomosis device within a patient, comprising: (1) guiding a delivery sheath including the anastomosis device to a target site within the patient; and (2) deploying the anastomosis device from the delivery sheath such that at least one layer of tissue is positioned between a first juxtaposed portion and a second juxtaposed portion. The anastomosis device includes a tubular structure including at least one elongate member forming a framework of interconnected struts. The tubular structure includes the following (1) to (3): (1) a central portion including a plurality of body cells defined by the elongate member; (2) a first juxtaposed portion having a plurality of first flange cells defined by the elongate member at a first end of the central portion, such that the plurality of first flange cells are open to the central portion; and (3) a second juxtaposed portion having a plurality of second flange cells defined by the elongate member at a second end of the central portion, such that the plurality of second flange cells are open to the central portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with the description, serve to explain the principles of the disclosure.

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[0039] One of ordinary skill in the art will readily appreciate that various aspects of the present disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, they should not be construed as limiting.

[0040] The present disclosure relates to implantable devices for connecting tissue layers to avoid, for example, duct obstruction or organ obstruction, such as by creating a direct flow path between tissue structures (e.g., connecting the gallbladder to a portion of the gastrointestinal tract) to facilitate the flow of substances between them. The devices described herein can be placed or delivered endoscopically via a catheter and can include a self-expanding juxtaposition mechanism that facilitates a secure connection between those tissue structures (such a connection may also be referred to herein as a "shunt", "communication passage", "shunt passage", or "tunnel"). Such design features simplify the implantation and reduce the likelihood of complications. In some embodiments, the devices provided herein are configured to be removable after implantation. As an example, the device is implanted and remains in place until the gallbladder and / or its accessory ducts are freed from obstruction, after which the device is removed. In another example, the device is left implanted until the body grows a tissue anastomosis around the device, after which the device is removed. In other embodiments, the device is permanently implanted by ingrowth of tissue into and / or around the device and the device is not removed. The devices described herein can provide an alternative treatment for patients who are not suitable candidates for other types of treatment (e.g., cholecystectomy) and / or to avoid known complications of other types of treatment (e.g., external biliary fistula formation).

[0041] The present disclosure refers to an anastomosis device in an exemplary form. That is, it should be understood that the concepts of the present invention disclosed in this document are also applicable to other types of devices. For example, the present disclosure also provides, in some embodiments, implantable devices that can be used to occlude tissue structures, organs, body ducts, blood vessels, GI tracts, etc. For example, in some embodiments, septal defects can be occluded using those devices provided herein. In other embodiments, the blood vessels or GI tracts of a patient can be occluded using those devices provided herein. In some such embodiments, the device does not include a tunnel or central bore therethrough. Rather, in some embodiments, a coating seals the device to inhibit, regulate, or substantially prevent substances from flowing through the device.

[0042] Referring to FIG. 1, shown is an exemplary anastomosis device 40, according to some embodiments provided herein, that can be implanted in a patient to form a fluid connection between two organs, spaces, tissue structures, ducts, etc., and combinations thereof. For example, in the illustrated embodiment, the anastomosis device 40 connects the gallbladder 10 (defining the internal gallbladder space 12) to the intestine 20 (defining the internal intestinal space 22). Thus, the anastomosis device 40 functions as a fluid shunt device between the internal gallbladder space 12 and the internal intestinal space 22. Such an embodiment can provide a beneficial treatment for the patient, for example, when a flow obstruction exists in the native anatomical duct connecting the internal gallbladder space 12 and the internal intestinal space 22. For example, in some cases, the patient may have one or more gallstones that cause obstruction of the patient's cystic duct 14 and / or common bile duct 16. In such a case, the anastomosis device 40 can provide a fluid flow path such that bile from the gallbladder 10 can flow to the intestine 20. In the absence of the anastomosis device 40, cholecystitis (inflammation of the gallbladder 10) can occur when the outflow of bile from the gallbladder 10 is blocked.

[0043] The anastomosis device provided herein can be used in some aspects for reducing or preventing cholecystitis as described above, but it should be understood that the anastomosis device provided herein can also be used in many other types of embodiments within a patient. For example, the anastomosis device provided herein can be used in connection with various tissue structures and organs such as, but not limited to, the stomach, colon, small intestine, pancreas, blood vessels, bladder, kidney, ducts, etc.

[0044] Generally, some embodiments of the anastomosis device provided herein (of which anastomosis device 40 is one example) include a first tissue juxtaposition portion 42a, a second tissue juxtaposition portion 42b, and a central portion 44 therebetween. The central portion 44 defines a lumen 46 that extends longitudinally from a first end of the anastomosis device 40 to a second end of the device 40. The lumen 46 functions as a connection (e.g., a shunt passage) between the internal gallbladder space 12 and the internal intestinal space 22 such that the internal gallbladder space 12 is in fluid communication with the internal intestinal space 22 via the anastomosis device 40.

[0045] Referring to FIGS. 2A - 2E, an exemplary anastomosis device 200 is shown that includes a framework made up of one or more elongate elements that define a first juxtaposition portion 202, a second juxtaposition portion 204, and a central portion 206. In some embodiments, the anastomosis device 200 can be a type of stent device that, in a broad sense, can refer to a device that includes a framework of elongate elements, including, but not limited to, anastomosis devices. The central portion 206 is disposed between and interconnects the first juxtaposition portion 202 and the second juxtaposition portion 204. A covering material (not shown in FIGS. 2A - 2E) can be disposed over at least a portion of the framework. Such a covering material (e.g., the covering material described below) can also simply be referred to herein as a covering material.

[0046] In some embodiments, the central portion 206 defines a lumen 207 that extends between the first juxtaposed portion 202 and the second juxtaposed portion 204. The first juxtaposed portion 202 and the second juxtaposed portion 204 may form flanges that extend substantially radially outward from both sides of the central portion 206. In some embodiments, the lumen 207 provides an anastomosis passage or tunnel through which biological material or biological fluid can pass. The anastomosis device 200 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 200 naturally exhibits when no external force acts on the anastomosis device 200. It should be understood that when the anastomosis device 200 is implanted in a patient, the configuration of the device 200 may be somewhat different from that shown due to external forces derived from the biological structure of that patient acting on the device 200.

[0047] In some embodiments, the first juxtaposed portion 202, the second juxtaposed portion 204, and the central portion 206 are formed from one or more elongate elements made of materials such as, but not limited to, spring wire (e.g., L605 steel or stainless steel), shape memory alloy wire (e.g., nitinol or nitinol alloy), superelastic alloy wire (e.g., nitinol or nitinol alloy), other suitable types of elongate elements or wires, or combinations thereof. In some embodiments, the first juxtaposed portion 202, the second juxtaposed portion 204, and the central portion 206 are formed from a precursor material that is cut to create a framework made of elongate elements. In some such embodiments, the precursor material is a tubular material or a sheet material. In some embodiments, various types of elongate elements are used at various positions of the first juxtaposed portion 202, the second juxtaposed portion 204, and / or the central portion 206. In some embodiments, the elongate elements of the first juxtaposed portion 202, the second juxtaposed portion 204, and / or the central portion 206 (or portions thereof) may be composed of a polymeric material.

[0048] Suitable materials for the elongate elements of the devices provided herein include a variety of metallic materials, including alloys that exhibit shape memory properties, elastic properties, and superelastic properties. Shape memory refers to the ability of a material to return to the shape it first remembered after being heated above a critical temperature and plastically deformed. Elasticity is the ability of a material to be deformed when loaded and return, or substantially return, to its original shape when the load is removed. Most metals elastically deform up to a maximum of slightly distorted. Superelasticity refers to the ability of a material to be deformed to a much greater extent when loaded than a normal elastic alloy, but without permanently deforming. For example, the superelastic materials included in the frames of some anastomosis device embodiments provided herein can withstand significant bending and then return, or substantially return, to the original shape of the frame without deforming thereafter. In some embodiments, suitable elastic materials include various stainless steels, alloys such as cobalt-chromium alloys (e.g., ELGILOY™, MP35N, L605), platinum / tungsten alloys, etc., that have been subjected to physical, chemical, and / or other treatments to provide high spring reactivity. Embodiments of shape memory superelastic alloys include ternary shape memory alloys such as NiTi alloys, NiTiPt, NiTiCo, NiTiCr, or other shape memory alloys such as copper-based shape memory alloys. Other materials can combine both shape memory alloys and elastic alloys, such as in a drone field tube where the outer layer is composed of nitinol and the inner core is a radiopaque material such as platinum or tantalum. In such a configuration, the outer layer provides superelastic properties and the inner core remains elastic due to its lower bending stress.

[0049] In some embodiments, the elongate elements used to construct the devices provided herein can be treated in various ways to increase the radiopacity of those devices for improved X-ray imaging. In some embodiments, those devices are at least partially of a drone-fill type NiTi that includes different materials such as materials with increased radiopacity in the core. In some embodiments, those devices include a radiopaque coating or plating on at least a portion of a first juxtaposed portion, a second juxtaposed portion, and a central portion. In some embodiments, one or more radiopaque markers are attached to those devices. In some embodiments, the elongate elements and / or other portions of the devices provided herein can also be seen by ultrasound.

[0050] In some embodiments, the first juxtaposed portion 202, the second juxtaposed portion 204, and the central portion 206 comprise a framework of interconnected elongate elements configured by cutting a tube. In one such embodiment, a tube of a metallic material (e.g., nitinol, stainless steel, cobalt, etc.) is laser cut and then expanded and shaped into a desired configuration. In some such embodiments, the metallic material may be shape memory such that the material is set to a desired configuration and naturally assumes the desired configuration. In some embodiments, a shape memory material such as nitinol can assume a desired configuration when exposed to body temperature.

[0051] As described in more detail below, in some embodiments, the coating material can be disposed on or around some portions of, or on or around all of, the first juxtaposed portion 202, the second juxtaposed portion 204, and / or the central portion 206. In some embodiments, some portions of the first juxtaposed portion 202, the second juxtaposed portion 204, and / or the central portion 206 may be without the coating material. In some embodiments, the coating material is not included in the anastomosis device 200.

[0052] The first juxtaposition portion 202 and the second juxtaposition portion 204 each include a plurality of struts 208. In some embodiments, each strut 208 of the first juxtaposition portion 202 and the second juxtaposition portion 204 is configured to form a flange in the general sense of contacting the tissue surface. More specifically, the first juxtaposition portion 202 and the second juxtaposition portion 204 are configured to engage one or more layers of tissue therebetween and apply a juxtaposition force to the tissue surface. The juxtaposition force provided by the first juxtaposition portion 202 and the second juxtaposition portion 204 makes it easier to fix the instrument 200 to the tissue and can provide a movement resistance such that the instrument 200 reliably remains at the target site of the patient as desired.

[0053] In some embodiments, the material and configuration of the anastomosis instrument 200 (and other anastomosis instruments provided herein) allow it to be elastically compressed, folded, and / or shrunk to be confined within the lumen for transcatheter delivery or endoscopic / thoracoscopic delivery, resulting in a low-profile delivery configuration, and once the instrument is placed at the desired target site in the body and deployed from its lumen, it can self-expand to its operative size and operative configuration. For example, the anastomosis instrument 200 can be configured in a contracted delivery configuration in which the plurality of struts are radially compressed and extend substantially parallel to the axis of the central portion 206, and the central portion 206 is also compressed and shortened. By using such materials and structures, the instrument 200 can also have, for example, beneficial fatigue resistance and elastic properties.

[0054] After deployment, the plurality of struts 208 can extend radially from the central portion 206 and take a shape that applies a desired level of juxtaposition pressure to the tissue. In some embodiments, the plurality of struts 208 extend from the central portion 206 such that the nominal measurement of the angle between the strut 208 and the longitudinal axis of the instrument 200 is about 100°, or about 90°, or about 80°, or about 70°, or about 60°, or about 50°, or about 40°, or about 30°, or about 20°, or about 10°, etc.

[0055] Referring to FIGS. 2A-2E, in some embodiments of the anastomosis instrument 200 (and in some embodiments of other anastomosis instruments provided herein), the plurality of struts 208 are interconnected by a connecting member 210. The connecting member 210 is shown in a deployed configuration in which the connecting member 210 is arranged in a series of waveforms. Here, each wave has a peak 214 extending in the direction of the central portion 206 and a peak 215 extending in a direction away from the central portion 206. In some embodiments, the struts 208 may be connected to the connecting member 210 at the peak 214. In other embodiments, the struts 208 may not be connected to the connecting member 210 at the peak 215.

[0056] In some embodiments, the connecting member 210 causes the juxtaposed portions 202 and 204 to have a more rigid structure by providing support to and stabilizing the struts 208. In such some embodiments, the juxtaposed portions 202 and 204 exhibit a higher level of juxtaposition pressure and can maintain the integrity such that the juxtaposed portions 202 and 204 can conform to the anatomical shape of the tissue. In addition, the sealing ability of the juxtaposed portions 202 and 204 is enhanced. In some embodiments, the stability and support provided by the connecting member 210 improve the juxtaposition force on, for example, the gallbladder and improve the juxtaposition force on portions of the gastrointestinal tract.

[0057] In some embodiments, the connecting members 210 combine to form circumferential rings 216 and 218 that extend circumferentially around the outer circumferences of the respective first juxtaposed portions 202 and second juxtaposed portions 204. The circumferential rings 216 and 218 may have a shape that undulates circumferentially around the edges of the first juxtaposed portion 202 and the second juxtaposed portion 204. In some embodiments, the circumferential rings 216 and 218 may have a shape that undulates axially, as seen in FIG. 2A. In some embodiments, the circumferential rings 216 and 218 may have a shape that undulates radially, as seen in FIG. 2C. In some embodiments, the circumferential rings 216 and 218 may have a shape that undulates in both the axial and radial directions. In some embodiments, the circumferential rings 216 and 218 may have a sinusoidal shape that undulates around the edge of one or both of the first juxtaposed portion 202 and the second juxtaposed portion 204. By forming one or both of the circumferential rings 216 and 218 with a sinusoidal, serpentine, or wavy shape, the surface area contacting tissue between the first juxtaposed portion 202 and the second juxtaposed portion 204 can be increased, thereby reducing the force applied to individual predetermined positions of the tissue.

[0058] The central portion 206 may include a series of body portion struts 220, each strut extending longitudinally to form the central body portion 206 of the anastomosis instrument 200. The body portion struts 220 define body portion cells 222 of the central portion 206 and separate each body portion cell 222 from circumferentially adjacent body portion cells 222. In some embodiments, each of the body portion struts 220 may include a plurality of axially extending portions 224 interconnected with a plurality of inclined portions 226. This allows the body portion struts 220 to form a relatively robust central portion 206 without the need to interconnect the body portion struts 220 across the body portion cells 222 at several positions along the length direction of the body portion struts 220.

[0059] The struts 208 of juxtaposed portions 202 and 204 may define a flange cell 228 between the struts 208. The flange cell 228 may be an open cell and there are no struts separating the flange cell 228 from the central portion 206. As shown in FIGS. 2B, 2D, and 2E, the flange cell 228 is closed at the distal most end of the flange cell 228 by a connecting member 210 and is opened at the central most end of the flange cell 228 such that the flange cell 228 opens into the body portion cell 222.

[0060] FIGS. 2D and 2E show the anastomosis instrument 200 in a partially formed configuration prior to forming the anastomosis instrument 200 in the shape shown in FIGS. 2A, 2B, and 2C. As shown in FIGS. 2D and 2E, the anastomosis instrument 200 may have a substantially cylindrical shape in a partially formed configuration where the struts 208 extend substantially parallel to the body portion struts 220. The anastomosis instrument 200 takes on the shape shown in, for example, FIG. 10 (below) in the manufacturing process and is capable of being converted from the pre - formation configuration shown in FIGS. 2D and 2E to the final configuration shown in FIGS. 2A, 2B, and 2C.

[0061] In some embodiments, the anastomosis instrument 200 can be formed such that the elongate member forms a first pattern that crosses the central portion 206 along the longitudinal axis, the elongate member defines a first flange cell 228 of one of the first juxtaposed portions 202, the elongate member forms a second pattern that crosses the central portion 206 along the longitudinal axis on the opposite side of the first pattern, the elongate member defines a second opposing flange cell 228, and the elongate member repeats such undulating steps to form additional patterns of the central portion 206 and the flange cells 228 of the anastomosis instrument 200.

[0062] In some embodiments, the anastomosis instrument 200 can be formed such that the elongate member defines the flange cells 228 of the first juxtaposed portion 202, the elongate member crosses the central portion 206, the elongate member defines the flange cells 228 of the second juxtaposed portion 204, the elongate member crosses the central portion 206, and then the elongate member repeats this pattern to form additional flange cells 228 of the anastomosis instrument 200 and cross the central portion 206 therebetween. In some embodiments, each of the continuous patterns and each of the continuous flange cells 228 may be out of phase with the immediately preceding one.

[0063] Figures 2A - 2C show the central portion 206 in a deployed or expanded configuration. In some embodiments, as described above, the central portion 206 can include various shape memory materials and superelastic alloys. Thus, the central portion 206 can be configured to self - expand and assume a deployed configuration. In some embodiments, the central portion 206 is balloon - expandable in the deployed configuration. Alternatively, an auxiliary expanding force can be applied to the self - expandable device by the inflation of a balloon. The diameter of the central portion 206 can be made to any size as needed to suit the intended use of the anastomosis device 200 and / or the delivery system. For example, in its low - profile delivery configuration, the anastomosis device 200 can be disposed within a delivery sheath having an outer diameter of about 15 French (5 mm). However, in some embodiments, a sheath smaller or larger than 15 French can be used. For example, in some embodiments, sheaths having outer diameters of 6 French, 7 French, 8 French, 9 French, 10 French, 11 French, 12 French, 13 French, 14 French, 16 French, 17 French, 18 French, 19 French, 20 French, and outer diameters greater than 20 French can be used. When the anastomosis device 200 is configured in an expanded delivery configuration as shown, the diameter of the central portion 206 increases to the deployed diameter. In some examples, the deployed outer diameter of the central portion 206 is configured to at least partially secure the device 200 through an interference fit where the central portion 206 has an interference fit with a tissue opening. Additionally, when the central portion 206 and the tissue opening have an interference fit relationship, leakage outside the device can be reduced or minimized. In such cases, leakage of the contents, conduits, and other types of tissue structures of the organ into which the anastomosis device 200 can be deployed can be substantially prevented. For example, when the anastomosis device 200 is used between the gallbladder and the gastrointestinal tract (see, for example, FIG. 1), leakage into the abdominal cavity is substantially prevented.

[0064] In some embodiments, the deployed outer diameter of the central portion 206 is slightly smaller than the diameter of the tissue opening where the central portion 206 is located, and the juxtaposed portions 202 and 204 press against the tissue to provide a movement resistance. In some embodiments, the fully expanded diameter of the central portion 206 is about 30 mm, or about 25 mm, or about 20 mm, or about 15 mm, or about 12 mm, or about 10 mm, or about 8 mm, or about 6 mm, or about 4 mm, etc.

[0065] In some embodiments, one or more portions of the anastomosis device 200 include a coating material. To more clearly illustrate the framework of the anastomosis device 200, FIGS. 2A-2E show the anastomosis device 200 without the coating material. In some embodiments, the coating material is disposed on (or over) at least some portions of the first juxtaposed portion 202, the second juxtaposed portion 204, and the central portion 206. In some embodiments, some portions of the first juxtaposed portion 202, the second juxtaposed portion 204, and / or the central portion 206 are not covered by the coating material.

[0066] In some embodiments, the coating material is generally liquid-impermeable. That is, in some embodiments, the coating material is made of a material that suppresses or reduces the passage of blood, bile, and / or other body fluids and biological substances through the coating material itself. In some embodiments, the coating material has a material composition and configuration that suppresses or prevents in-growth of tissue and / or endothelialization or epithelialization into the coating material. Some such embodiments configured to suppress or prevent in-growth of tissue and / or endothelialization can be more easily removed from the patient at a future date if desired. In some embodiments, the coating material or a portion thereof has a microporous structure that provides an in-growth scaffold suitable for a durable seal and / or auxiliary fixing force of the anastomosis device 200.

[0067] In some embodiments, the coating material includes fluoropolymers such as expanded polytetrafluoroethylene (ePTFE) polymer or polyvinylidene fluoride (PVDF). In some embodiments, the coating material includes polyester, silicone, urethane, other biocompatible polymers, polyethylene terephthalate (e.g., Dacron®), bioabsorbable materials, copolymers, or combinations thereof. In some embodiments, the coating material includes a bioabsorbable woven fabric. In some other embodiments, the bioabsorbable material may provide migration resistance by promoting adhesion between the instrument 200 and the tissue until the bioabsorbable material is absorbed.

[0068] In some embodiments, the coating material (or a portion thereof) is modified by one or more chemical or physical treatments that improve one or more properties of the material. For example, in some embodiments, a hydrophilic coating is used on the coating material to improve the wettability and echo semi-permeability of the material. In some embodiments, the coating material or a portion thereof is modified with a chemical moiety that promotes one or more of endothelial cell adhesion, endothelial cell migration, endothelial cell proliferation, and thrombus resistance or thrombus promotion. In some embodiments, the coating material or a portion thereof is modified to resist biofouling. In some embodiments, the coating material or a portion thereof is modified with one or more covalently attached prodrugs (e.g., heparin, antibiotics, etc.) or saturated with one or more prodrugs. Those prodrugs can be released in situ to promote healing, reduce tissue inflammation, reduce or suppress infections, and promote various other therapeutic treatments and outcomes. In some embodiments, the prodrug is a corticosteroid, a human growth factor, an anti-mitotic agent, an anti-thrombotic agent, a stem cell material, or dexamethasone sodium phosphate. In some embodiments, a drug is delivered to the target site separately from the coating material to promote tissue healing or tissue growth.

[0069] Coating and treatment are applied to the covering material before or after the covering material is attached onto the framework of the anastomosis device 200. Note that 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 located at a certain part of the anastomosis device 200, and other coatings and / or treatments are applied to that material located at other parts of the anastomosis device 200. In some embodiments, a combination of multiple coatings and / or treatments is applied to all or part of the covering material. In some embodiments, a certain part of the covering material remains uncoated and / or untreated. In some embodiments, the device 200 is fully or partially coated to promote or interfere with biological reactions such as, but not limited to, endothelial cell adhesion, endothelial cell migration, endothelial cell proliferation, and thrombus resistance or thrombus promotion.

[0070] In some embodiments, a first portion of the covering material is formed from a first material, and a second portion of the covering material is formed from a second material different from the first material. In some embodiments, the covering material includes multiple layers of materials, which may be the same material or different materials. In some embodiments, the covering material has one or more radiopaque markers attached thereto to improve in vivo X-ray imaging of the anastomosis device 200, or has a portion with one or more echo brightness regions to improve ultrasonic visibility.

[0071] In some embodiments, one or more portions of the covering material are attached to the framework of the instrument 200, such as the central portion 206 and / or the juxtaposed portions 202 and 204. The attachment can be accomplished by various techniques including, but not limited to, sewing the covering material to the framework of the instrument 200, adhering the covering material to the framework of the instrument 200, laminating using clasps or returns of multiple layers of the covering material to surround portions of the elongated members of the instrument 200, laminating multiple layers of the covering material through openings within the framework of the instrument 200, and the like. In some embodiments, the covering material is attached to the framework of the instrument 200 at a series of discrete locations to increase the flexibility of the framework. In some embodiments, the covering material is loosely attached to the framework of the instrument 200. It should be understood that the covering material can be attached to the framework of the instrument 200 using other techniques or combinations of techniques described herein.

[0072] In some embodiments, the framework of the instrument 200 (or a portion thereof) is coated with a binder (such as fluorinated ethylene propylene or other suitable adhesive) to facilitate attachment of the covering material to the framework. Such an adhesive can be applied to the framework using contact coating, powder coating, dip coating, spray coating, or any other suitable method.

[0073] In some embodiments, the covering material can accommodate changes in the length and / or diameter of the central portion 206 in various ways. In a first example, the covering material can be elastic such that the covering material stretches to accept changes in the length and / or diameter of the instrument 200. In a second example, the covering material can include a material that is slack in a low-profile delivery configuration and less slack or no slack when the instrument 200 is in an expanded configuration. In a third example, the covering material can include folded portions (e.g., pleats) that are folded in a low-profile configuration and have less folding or are fully unfolded when the instrument 200 is in an expanded configuration. In other embodiments, the axial adjustment member does not include a covering material. In some embodiments, combinations of such techniques and / or other techniques can be used such that the covering material can accommodate changes in the length and / or diameter of the central portion 206.

[0074] FIG. 3A is a flat pattern of an anastomosis instrument 300 according to some exemplary embodiments. In some embodiments, the anastomosis instrument 300 can be similar to the anastomosis instrument 200 described above. For example, the anastomosis instrument 300 includes a framework of elongated elements that define a first juxtaposed portion 302, a second juxtaposed portion 304, and a central portion 306. The central portion 306 is disposed between and interconnects the first juxtaposed portion 302 and the second juxtaposed portion 304. In some embodiments, the anastomosis instrument 300 is formed from a tubular material that is cut (e.g., laser cut) and shaped into a preferred shape. Other materials and manufacturing techniques are also contemplated. The covering material described above (not shown in FIG. 3A) can be disposed over at least some (or all) of the framework of the anastomosis instrument 300.

[0075] FIG. 3A shows an anastomosis device 300 with a flat pattern for clarity purposes. However, the anastomosis device 300 may be formed in a tubular shape where the central portion 306 forms a substantially cylindrical structure and the first juxtaposed portion 302 and the second juxtaposed portion 304 extend outward from both ends of the central portion 306. In some embodiments, the central portion 306 may form a tubular body portion that defines a lumen extending between the first juxtaposed portion 302 and the second juxtaposed portion 304. The first juxtaposed portion 302 and the second juxtaposed portion 304 may form flanges that extend substantially radially outward from both ends of the central portion 306. In some examples, the lumen defined by the central portion 306 provides an anastomosis passage or tunnel through which biological materials or liquids can pass. When implanting the anastomosis device 300 into a patient, it should be understood that due to the different external forces applied to the device 300 by the patient's anatomical structure, the configuration of the device 300 may be somewhat different from the illustrated configuration.

[0076] In some embodiments, the connecting members 310 combine to form circumferential rings 316 and 318 that extend circumferentially around the outer circumferences of the radial directions of the respective first juxtaposed portion 302 and the second juxtaposed portion 304. The circumferential rings 316 and 318 may have a shape that undulates circumferentially around the edges of the first juxtaposed portion 302 and the second juxtaposed portion 304. In some embodiments, the circumferential rings 316 and 318 may have a shape that undulates sinusoidally around the edges of one or both of the first juxtaposed portion 302 and the second juxtaposed portion 304. By forming one or both of the circumferential rings 316 and 318 in a sinusoidal, serpentine, or other undulating shape, the surface area in contact with the tissue between the first juxtaposed portion 302 and the second juxtaposed portion 304 can be improved, thereby reducing the force applied to individual predetermined positions of the tissue. By forming one or both of the circumferential rings 316 and 318 in a sinusoidal, serpentine, or other undulating shape, it becomes possible to easily crush the first juxtaposed portion 302 and the second juxtaposed portion 304 (deployment by a low profile) while maintaining other desired characteristics.

[0077] The central portion 306 can include a series of body portion struts 320, each strut extending axially to form the central body portion of the anastomosis device 300. The body portion struts 320 define body portion cells 322 of the central portion 306 and separate each body portion cell 322 from circumferentially adjacent body portion cells 322. In some embodiments, each of the body portion struts 320 can include a plurality of axially extending portions 324 interconnected with a plurality of inclined portions 326. This allows the body portion struts 320 to form a relatively resilient central portion 306 without the need to interconnect the body portion struts 320 across the body portion cells 322 at several locations along the length of the body portion struts 320.

[0078] The struts 308 of the juxtaposed portions 302 and 304 can define flange cells 328 between the struts 308. In some embodiments, the flange cells 328 can be open cells (there are no struts separating the flange cells 328 from the central portion 306). In some embodiments, the flange cells 328 are closed at the distal most ends of the flange cells 328 by connection members 310 and are open at the central most ends of the flange cells 328 such that the flange cells 328 open into the body portion cells 322. The inclined portions 326 can partially separate axially adjacent body portion cells 322, but a gap can be provided such that each body portion cell 322 opens into axially adjacent body portion cells 322.

[0079] FIG. 3B is an enlarged view of a single flange cell 328 of the anastomosis device 300 in the deployed configuration. FIG. 3C is an enlarged view of a single flange cell 328 of the anastomosis device 300 in the collapsed configuration. The anastomosis device 300 can be elastically collapsed, folded, and / or shrunk into a low profile delivery configuration for containment within a lumen for transcatheter delivery or endoscopic / thoracoscopic delivery (flange cell 328 in the collapsed configuration shown in FIG. 3C). In some embodiments, the anastomosis device is capable of self-expanding into an operative size and operative configuration once placed at a desired target site within the body (upon deployment from the delivery lumen) (e.g., flange cell 328 in the deployed configuration shown in FIG. 3B).

[0080] FIG. 3D is an enlarged view of the body cell 322 of the anastomosis device 300 in the deployed configuration. FIG. 3E is an enlarged view of the body cell 322 of the anastomosis device 300 in the crushed configuration.

[0081] The framework of the anastomosis device 300 can be formed using any of the materials and techniques described herein. For example, in some embodiments, the framework of the anastomosis device 300 can be formed from a precursor material that is cut to create the framework. In some such embodiments, the precursor material is a single piece of precursor material such as, but not limited to, a tubular material or a sheet-like material. In some embodiments, the framework of the anastomosis device 300 is formed as a wire-wound structure of a single wire or multiple wires that form the structure of the first juxtaposed portion 302, the second juxtaposed portion 304, and the central portion 306 to create the opening structures of the body cell 322 and the flange cell 328, and the wavy shapes of the direction rings 316 and 318. In some embodiments, the wire-wound structure is advantageous for facilitating the functions of the opening structures of the body cell 322 and the flange cell 328, and the wavy shapes of the direction rings 316 and 318.

[0082] In some embodiments, the anastomosis device 300 can be wound (or laser cut) such that the elongate member forms (i) a first pattern that crosses the central portion 306 along the longitudinal axis, (ii) one first flange cell 328 of the first juxtaposed portion 302, (iii) a second pattern that crosses the central portion 306 along the longitudinal axis on the opposite side of the first pattern, (iv) a second opposing flange cell 328, etc. The elongate member can repeat such a pattern of the central portion 306 and the flange cell 328 to construct a complete anastomosis device 300.

[0083] In some embodiments, the anastomosis device 300 may be wound (or laser cut) such that the elongate member defines the flange cells 328 of the first juxtaposed portion 302, the elongate member crosses the central portion 306, the elongate member defines the flange cells 328 of the second juxtaposed portion 304, the elongate member crosses the central portion 306, and then the elongate member repeats this pattern to form additional flange cells 328 of the anastomosis device 300 and cross the central portion 306 therebetween. In some such embodiments, each of the continuous patterns and each of the continuous flange cells are symmetric with the previous ones.

[0084] FIG. 4A is a flat pattern of an anastomosis device 400 according to some exemplary embodiments. In some embodiments, the anastomosis device 400 may be similar to the anastomosis devices 200 and 300 described above. For example, in some embodiments, the anastomosis device 400 includes a framework of elongate elements that define a first juxtaposed portion 402, a second juxtaposed portion 404, and a central portion 406. The central portion 406 is disposed between the first juxtaposed portion 402 and the second juxtaposed portion 404 and interconnects them. The coating material (not shown in FIG. 4A) described above may be disposed on at least some (or all) of the portions of the framework of the anastomosis device 400.

[0085] FIG. 4A shows the anastomosis device 400 in a flat pattern for clarity purposes. However, the anastomosis device 400 may be formed in a tubular shape where the central portion 406 forms a substantially cylindrical structure and the first juxtaposed portion 402 and the second juxtaposed portion 404 extend outwardly from both ends of the central portion 406. In some embodiments, the central portion 406 may form a tubular body portion that defines a lumen extending between the first juxtaposed portion 402 and the second juxtaposed portion 404. The first juxtaposed portion 402 and the second juxtaposed portion 404 may form flanges that extend substantially radially outward from both ends of the central portion 406. In some examples, the lumen defined by the central portion 406 provides an anastomosis passage or tunnel through which biological materials or liquids can pass. It should be understood that when the anastomosis device 400 is implanted in a patient, the configuration of the device 400 may vary somewhat from the illustrated configuration due to the different external forces applied to the device 400 by the patient's anatomy.

[0086] In some embodiments, the connecting members 410 combine to form circumferential rings 416 and 418 that each extend circumferentially around the outer circumference of the respective first juxtaposed portion 402 and second juxtaposed portion 404. The circumferential rings 416 and 418 may have a shape that undulates circumferentially around the edges of the first juxtaposed portion 402 and second juxtaposed portion 404. In some embodiments, the circumferential rings 416 and 418 may have a wavy shape as shown in FIG. 4. In some embodiments, the circumferential rings 416 and 418 may have a sinusoidally undulating shape around the edge of one or both of the first juxtaposed portion 402 and second juxtaposed portion 404. By forming one or both of the circumferential rings 416 and 418 with a sinusoidal, serpentine, or other wavy shape, in some examples, the surface area contacting tissue between the first juxtaposed portion 402 and the second juxtaposed portion 404 can be improved, thereby reducing the force applied to individual predetermined positions of the tissue. By forming one or both of the circumferential rings 416 and 418 with a sinusoidal, serpentine, or other wavy shape, the first juxtaposed portion 402 and the second juxtaposed portion 404 can be easily crushed while maintaining other desired properties.

[0087] The central portion 406 may include a series of body portion struts 420, each of which extends substantially axially to form the central body portion of the anastomosis instrument 400. The body portion struts 420 define body portion cells 422 of the central portion 406 and separate each body portion cell 422 from circumferentially adjacent body portion cells 22. In some embodiments, each of the body portion struts 420 may include a plurality of axially extending portions 424 interconnected with a plurality of inclined portions 426. This allows the body portion struts 420 to form a relatively robust central portion 406 without the need to interconnect the body portion struts 420 across the body portion cells 422 at several locations along the length direction of the body portion struts 420.

[0088] In some embodiments, the struts 408 of juxtaposed portions 402 and 404 may define a flange cell 428 between the struts 408. In some embodiments, the flange cell 428 may be an open cell and there may be no struts separating the flange cell 428 from the central portion 406. The flange cell 428 is closed at the distal most end of the flange cell 428 by a connecting member 410 and is open at the central most end of the flange cell 428 such that the flange cell 428 opens into the body cell 422. As shown in FIG. 4, the flange cell 428 of the first juxtaposed portion 402 is aligned with and opens into the body cell 422, and the flange cell 428 of the second juxtaposed portion 404 is aligned with the body strut 42, but is in an oblique position with respect to the body cell 422.

[0089] In some embodiments, the inclined portion 426 may partially separate longitudinally adjacent body cells 422, but a gap may be provided such that each of the body cells 422 opens into a longitudinally adjacent body cell 422.

[0090] In some embodiments, the anastomosis device 400 may be wound (or laser cut) such that the elongate member forms (i) a first pattern that crosses the central portion 406 along the longitudinal axis, (ii) one first flange cell 428 of the first juxtaposed portion 402, (iii) a second pattern that crosses the central portion 406 along the longitudinal axis on the side opposite the first pattern, (iv) a second opposing flange cell 428, and the like. The elongate member can repeat such a pattern to form the central portion 406 and the flange cells 428 of the anastomosis device 400.

[0091] In other embodiments, the anastomosis instrument 400 may be wound (or laser cut) such that the elongate member defines the flange cells 428 of the first juxtaposed portion 402, the elongate member crosses the central portion 406, the elongate member defines the flange cells 428 of the second juxtaposed portion 404, the elongate member crosses the central portion 406, and then the elongate member repeats this pattern to form additional flange cells and cross the central portion 406 therebetween. In some embodiments, each of the continuous patterns and each of the continuous flange cells 428 are out of phase with the previous ones. In some embodiments, each of the continuous patterns and each of the continuous flange cells 428 are in phase with the previous ones.

[0092] FIG. 5 is a flat pattern of an anastomosis instrument 500 according to some exemplary embodiments. In some embodiments, the anastomosis instrument 500 may be similar to the anastomosis instruments 200, 300, 400 described above. For example, in some embodiments, the anastomosis instrument 500 includes a framework of elongate elements that define a first juxtaposed portion 502, a second juxtaposed portion 504, and a central portion 506. The central portion 506 is disposed between the first juxtaposed portion 502 and the second juxtaposed portion 504 and interconnects them. The coating material (not shown in FIG. 5) described above may be disposed on at least some (or all) of the framework.

[0093] FIG. 5 shows the anastomosis instrument 500 in a flat pattern for clarity purposes. However, the anastomosis instrument 500 may be formed in a tubular shape in which the central portion 506 forms a substantially cylindrical structure and the first juxtaposed portion 502 and the second juxtaposed portion 504 extend outwardly from both ends of the central portion 506. In some embodiments, the central portion 506 may form a tubular body portion that defines a lumen extending between the first juxtaposed portion 502 and the second juxtaposed portion 504. The first juxtaposed portion 502 and the second juxtaposed portion 504 may form flanges that extend substantially radially outward from both ends of the central portion 506. In some examples, the lumen defined by the central portion 506 provides an anastomosis passage or tunnel through which biological materials or liquids can pass. It should be understood that when the anastomosis instrument 500 is implanted in a patient, the configuration of the instrument 500 may vary somewhat from the illustrated configuration due to the external forces applied to the instrument 500 by the patient's anatomy.

[0094] In some embodiments, the connecting members 510 combine to form circumferential rings 516 and 518 that each extend circumferentially around the outer circumference of the respective first juxtaposed portion 502 and second juxtaposed portion 504. The circumferential rings 516 and 518 may have a shape that undulates circumferentially around the edges of the first juxtaposed portion 502 and the second juxtaposed portion 504. In some embodiments, the circumferential rings 516 and 518 may have a wavy shape, as seen in FIG. 5. In some such embodiments, the circumferential rings 516 and 518 may have a shape that undulates sinusoidally around the edge of one or both of the first juxtaposed portion 502 and the second juxtaposed portion 504. By forming one or both of the circumferential rings 516 and 518 in a sinusoidal, serpentine, or wavy shape, in some examples, the surface area contacting tissue between the first juxtaposed portion 502 and the second juxtaposed portion 504 can be improved, thereby reducing the force applied to individual predetermined positions of the tissue. By forming one or both of the circumferential rings 516 and 518 in a sinusoidal, serpentine, or other wavy shape, the first juxtaposed portion 502 and the second juxtaposed portion 504 can be easily crushed (low-profile delivery configuration) while maintaining other desired characteristics.

[0095] The central portion 506 may include a series of body portion struts 520, each strut extending axially to form the central body portion of the anastomosis instrument 500. In some embodiments, the body portion struts 520 define body portion cells 522 of the central portion 506 and separate each body portion cell 522 from circumferentially adjacent body portion cells 522. In some embodiments, each of the body portion struts 520 may include a plurality of axially extending portions 524 interconnected with a plurality of inclined portions 526. This allows the body portion struts 520 to form a relatively robust central portion 506 without the need to interconnect the body portion struts 520 at several locations along the length direction of the body portion struts 520. The struts 508 of the first juxtaposed portion 502 and the second juxtaposed portion 504 define flange cells 528 between the struts 508.

[0096] As shown in FIG. 5, in some embodiments, each column of the body portion cells 522 is aligned at one end with the flange cell 528 and opens at the other end. In some embodiments, the body portion cells 522 may be axially aligned with a gap 530 that extends between adjacent struts 508 of one or both of the first juxtaposed portion 502 and the second juxtaposed portion 504, and opens to the gap 530. The inclined portion 526 partially separates the axially adjacent body portion cells 522, but a gap can be provided such that each body portion cell 522 opens to the axially adjacent body portion cell 522.

[0097] In some embodiments, the anastomosis device 500 can be formed such that the elongate member forms (i) a first pattern that crosses the central portion 506 along the longitudinal axis, (ii) one first flange cell 528 of the first juxtaposed portion 502, (iii) a second pattern that crosses the central portion 506 along the longitudinal axis on the opposite side of the first pattern, (iv) a second opposing flange cell 528, etc. In some embodiments, the elongate member repeats such a pattern to form additional portions of the central portion 506 and the flange cells 528, completing the anastomosis device 500.

[0098] In other embodiments, the anastomosis device 500 can be formed such that the elongate member defines the flange cell 528 of the first juxtaposed portion 502, the elongate member crosses the central portion 506, the elongate member defines the flange cell 528 of the second juxtaposed portion 504, the elongate member crosses the central portion 506, and then the elongate member repeats this pattern to form additional flange cells and cross the central portion 506 therebetween. In some embodiments, each of the continuous patterns and each of the continuous flange cells are out of phase with the immediately preceding one. In some embodiments, each of the continuous patterns and each of the continuous flange cells are in phase with the immediately preceding one.

[0099] Referring to FIGS. 6A and 6B, an exemplary anastomosis device framework 600 is shown that includes a first juxtaposed portion 602, a second juxtaposed portion 604, and a central portion 606. For purposes of clarity in showing the framework 600, the framework 600 is shown without a covering material, although any covering material described herein can be attached. In FIG. 6A, the framework 600 is shown in a low-profile delivery configuration. In FIG. 6B, the juxtaposed portions 602 and 604 are shown in an expanded (deployed) configuration, and the central portion 606 is shown in a low-profile configuration. When the framework 600 is fully expanded, the central portion 60 expands radially (see, e.g., FIGS. 7A-C).

[0100] The central portion 606 is disposed between the first juxtaposed portion 602 and the second juxtaposed portion 604. The central portion 606 defines a lumen 607 that extends between the first juxtaposed portion 602 and the second juxtaposed portion 604. In some embodiments, the lumen 607 provides an anastomosis passage or tunnel through which a biological material or biological fluid can pass.

[0101] The materials, construction, and techniques for constructing the framework 600 (and the anastomosis device that utilizes the framework 600) are similar to those described for the anastomosis device 200. The first juxtaposed portion 602 and the second juxtaposed portion 604 are configured to engage one or more layers of tissue therebetween and apply a juxtaposing force to the tissue surface. The juxtaposing force applied by the first and second juxtaposed portions 602 and 604 facilitates securing the framework 600 to the tissue and can provide a resistance to movement such that the framework 600 remains securely at a target site within the patient as desired.

[0102] The first juxtaposed portion 602 and the second juxtaposed portion 604 are formed from elongate elements in the form of struts 608. In some embodiments, the struts 608 are configured to naturally form loops or semi-circles after deployment from a delivery sheath. Thus, in some such embodiments, the deployed juxtaposed portions 602 and 604 are configured to contact the tissue surface and are composed of a plurality of struts that combine to form an annular-shaped portion. In some embodiments, the deployed juxtaposed portions 602 and 604 form other shapes, including but not limited to, flange-shaped, petal-shaped, hemispherical, etc.

[0103] In a low-profile delivery configuration, the plurality of struts 608 are compressed so as to extend substantially parallel to the central portion 606. The material of the instrument 600 can be elastically crushed, folded, and / or shrunk into a low-profile delivery configuration to confine the anastomosis instrument within a lumen for trans-catheter delivery or endoscopic / thoracoscopic delivery, and once deployed from the lumen at a desired target site within the body, self-expand to assume an operative size and operative configuration.

[0104] The central portion 606 includes at least one stent ring 616. As shown, the stent rings 616 are aligned with each other along the longitudinal axis of the central portion 606. In some embodiments, the stent rings 616 exhibit a serpentine pattern. It should be understood that suitable patterns for the instruments described herein include a variety of shapes and / or patterns. In some embodiments, the stent rings 616 are interconnected with each other by at least one strut 608 of the juxtaposed portion 602 and the juxtaposed portion 604.

[0105] The central portion 606 is shown in a low-profile configuration. In some embodiments, as described above, the central portion 606 can include various shape memory materials and superelastic alloys. Thus, the central portion 606 can be configured to self-expand and assume a deployed configuration. In some embodiments, the central portion 606 is balloon-expandable to a deployed configuration. The diameter of the central portion 606 can be made any size as needed to suit the intended use of the anastomosis device and / or the delivery system. For example, the undeployed or low-profile delivery configuration of the central portion 606 can be disposed within a delivery sheath having an outer diameter of about 15 French (5 mm). However, in some embodiments, a sheath smaller or larger than 15 French can be used. For example, sheaths having outer diameters of 6 French, 7 French, 8 French, 9 French, 10 French, 11 French, 12 French, 13 French, 14 French, 16 French, 17 French, 18 French, 19 French, 20 French, and greater than 20 French can be used. In some embodiments, during deployment, the diameter of the central portion 606 is adjusted to a deployed diameter. In some examples, the deployed outer diameter of the central portion 606 is configured to at least partially secure the device 600 via an interference fit having a tissue aperture. In other embodiments, the distance between juxtaposed portions is configured to at least partially secure the device 600. In some embodiments, the diameter of the central portion 606 expands to, for example, about 30 mm, or about 25 mm, or about 20 mm, or about 15 mm, or about 12 mm, or about 10 mm, or about 8 mm, or about 6 mm, or about 4 mm, etc.

[0106] Referring to FIGS. 7A-7C, another exemplary anastomosis device 700 includes a framework of an elongate element that defines a first juxtaposed portion 702, a second juxtaposed portion 704, and a central portion 706. The central portion 706 is disposed between the first juxtaposed portion 702 and the second juxtaposed portion 704 and interconnects them. A covering material 712 is disposed on at least some portions of the framework. In some embodiments, the central portion 706 defines a lumen 707 that extends between the first juxtaposed portion 702 and the second juxtaposed portion 704. In some examples, the lumen 707 provides an anastomosis passage or tunnel through which biological materials or liquids can pass. The device 700 is shown in an expanded configuration. The expanded configuration is the configuration that the device 700 naturally exhibits when no external force is applied to the device 700. When transplanting the anastomosis device 700 into a patient, it should be understood that the configuration of the device 700 may vary to some extent from the illustrated configuration because the external force applied to the device 700 depends on the patient's anatomical structure.

[0107] The materials, configuration, and techniques for constructing the anastomosis device 700 are the same as those described for the anastomosis device 200.

[0108] The first juxtaposed portion 702 and the second juxtaposed portion 704 of the anastomosis device 700 are similar to the juxtaposed portion 602 and the juxtaposed portion 604 described for the framework 600. As shown, the juxtaposed portion 702 and the juxtaposed portion 704 together form, for example, an annular shape.

[0109] In some embodiments, the central portion 706 comprises a plurality of diamond-shaped cells 716 interconnected by joints 714. In other exemplary embodiments, the cells of such a central portion 706 may have other shapes. In some embodiments, an opening space 710 is defined by the diamond-shaped cells 716. It should be understood that the illustrated configuration of the central portion 706 is an example and that many other arbitrary types of configurations can also be incorporated.

[0110] Referring to FIGS. 8A and 8B, the anastomosis instrument 800 includes a first juxtaposed portion 802, a second juxtaposed portion 804, and a central portion 806. The instrument 800 is shown with a covering material 112 (any other covering material described herein may be applied to the instrument 800 in any manner described herein). In some embodiments, the covering material 112 is applied to the instrument 800 to create a single conduit 807. In some embodiments, the central portion 806 is covered independently of the juxtaposed portion 802 and / or the juxtaposed portion 804, and the covering material applied to these juxtaposed portions is distinguishable from the covering material 112 that forms the central lumen 807. In other embodiments, the central portion 806 is covered (or partially covered), but the juxtaposed portion 802 and the juxtaposed portion 804 are not provided with the covering material 112.

[0111] The central portion 806 is disposed between the first juxtaposed portion 802 and the second juxtaposed portion 804 and interconnects them. In some embodiments, an additional central end portion 813 extends beyond one or both of the juxtaposed portion 802 and the juxtaposed portion 804. The central end portion 813 can extend to a desired length beyond one or both of the juxtaposed portion 802. In some embodiments, the central end portion 813 is not included. Having the central end portion 813 at one or both ends may facilitate removal of the instrument. For example, the central end portion 813 can be grasped using an endoscope gripper to remove the device 800.

[0112] The central portion 806 defines a lumen 807 that extends between the first juxtaposed portion 802 and the second juxtaposed portion 804. In some examples, the lumen 807 provides an anastomosis passage or tunnel through which biological materials or liquids can pass. The instrument 800 is shown in a deployed (expanded) configuration. The expanded configuration or deployed configuration is the configuration that the instrument 800 or a portion thereof naturally exhibits when no external force is applied to the instrument 800.

[0113] In some embodiments, the first juxtaposed portion 802, the second juxtaposed portion 804, and the central portion 806 may include a spring wire (e.g., L605 steel or stainless steel), a shape memory alloy wire (e.g., nitinol or nitinol alloy), a superelastic alloy wire (e.g., nitinol or nitinol alloy), other suitable types of elongated elements or wires, or combinations thereof. In some such embodiments, the first juxtaposed portion 802, the second juxtaposed portion 804, and the central portion 806 may be formed from the same piece of precursor material that is cut to create the desired wire structure. For example, in some such embodiments, the precursor material is a tube (e.g., nitinol tube) that is laser cut to form the desired wire structure. In some embodiments, various types of wires are used at various positions of the first juxtaposed portion 802, the second juxtaposed portion 804, and / or the central portion 806. In other embodiments, the first juxtaposed portion 802, the second juxtaposed portion 804, and / or the central portion 806 or portions thereof may be composed of a polymeric material.

[0114] The first juxtaposed portion 802 and the second juxtaposed portion 804 are configured to engage one or more layers of tissue therebetween and apply a juxtaposing force to the tissue surface. The juxtaposing force applied by the first and second juxtaposed portions 802 and 804 facilitates fixing the instrument 800 to the tissue and can provide a resistance to movement such that the instrument 800 remains securely at the target site of the patient as desired. In the illustrated embodiment, each of the first juxtaposed portion 802 and the second juxtaposed portion 804 includes a series of overlapping petal-shaped portions 809. The petal-shaped portions 809 are configured to form a disk in the general sense of contacting the tissue surface as a whole. These disks illustrated in embodiment 800 are perpendicular to the central portion 806, although the disks of the first juxtaposed portion 802 and the second juxtaposed portion 804 can be formed at angles other than right angles to facilitate juxtaposition to various tissue thicknesses and tissue shapes. The disks of the first juxtaposed portion 802 and the second juxtaposed portion 804 facilitate juxtaposition to diseased tissue (e.g., gangrene) with minimal force by increasing the contact surface area with the tissue and dispersing the juxtaposing pressure.

[0115] In some embodiments, the first juxtaposed portion 802 and the second juxtaposed portion 804 each include a plurality of struts 808 that form a series of petal-like portions 809 having generally S-shaped bending portions. These bending portions may affect the available juxtaposing force or improve manufacturability. For example, in the manufacturing process of the instrument 800, the pattern of the instrument is cut from a cylindrical tube, and the proximal end of the cut tube is compressed toward the distal end of the cut tube. Including an S-shaped bending portion in the instrument can be advantageous in the process. In other embodiments, the available juxtaposing force can be enhanced by increasing the number of petal-like portions 809, the overlapping portions, and / or the thickness of the struts 808. In some embodiments, the first juxtaposed portion 802 and / or the second juxtaposed portion 804 may be formed in a different (different from a series of petal-like portions having S-shaped bending portions) manner. For example, in some embodiments, the first juxtaposed portion 802 and / or the second juxtaposed portion 804 may be formed as a loop that spokes substantially radially, such as a spoke.

[0116] The number of petal-like portions 809 and the ratio of the overlapping portions between adjacent petal-like portions 809 can be selected to adjust the desired juxtaposing force and area. In some embodiments, one end of any of the struts 808 is connected to one rhombus-shaped cell. In some such embodiments, the diameters of the first juxtaposed portion 802 and the second juxtaposed portion 804 are determined by the length of the struts 808 connecting the cells and the twisting angle in the manufacturing process. The S-shaped struts 808 establish preferred bending positions that may affect the shape of the petal-like portions 809 during the shaping process. In some embodiments, the S-shaped struts 808 can provide flexibility in the design by eliminating the need to attach the entire framework length to the graft material and / or the need to use an elastomeric material for the graft. In some embodiments, the S-shaped struts 808 can enable the combination of relatively thin and flexible materials in the shape of relatively small instruments. In some embodiments, the S-shaped struts 808 can enable the shrinkability of the first juxtaposed portion 802 and the second juxtaposed portion 804 and ultimately improve the ability of the instrument 800 to be stored within a sheath and deployed through an endoscopic working channel.

[0117] When the anastomosis device is configured in a low-profile delivery configuration, the plurality of struts 808 are compressed so as to extend substantially parallel to the longitudinal axis of the central portion 806. In some embodiments, the material of the anastomosis device 800 is elastically crushed, folded, and / or shrunk to confine the device within a lumen for transcatheter delivery or endoscopic / thoracoscopic delivery, enabling a low-profile delivery configuration, and once the device is placed at a desired target site within the body and deployed from its lumen, it self-expands to an operative size and operative configuration. Additionally, the device 800 can exhibit, for example, beneficial fatigue resistance and elastic properties.

[0118] The central portion 806 includes at least one stent ring 816. As shown, the stent ring 816 includes a series of interconnected cells 810. During radial expansion, the cells 810 expand circumferentially and contract longitudinally. The radial force of the central portion 806 can be increased by changing the shape of the stent ring, changing the wall thickness of the tubular structure, or selecting a stronger material. It is clear that various different shapes and / or patterns are included as suitable patterns for the devices described herein. In some embodiments, the stent rings 816 are interconnected to each other by at least one bridge member 812.

[0119] The central portion 806 is shown in an expanded configuration or a deployed configuration. In some embodiments, as described above, the central portion 806 can include various metallic shape memory materials and superelastic alloys. Thus, the central portion 806 can be configured to self-expand and take on a deployed configuration. In some embodiments, the central portion 806 is self-expandable to a deployed configuration. In some embodiments, the central portion 806 is balloon-expandable to a deployed configuration. The diameter of the central portion 806 can be made any size as needed to suit the intended use of the anastomosis device and / or the delivery system. For example, the undeployed or low-profile delivery configuration of the central portion 806 can be disposed within a delivery sheath having an outer diameter of about 15 French (5 mm). However, in some embodiments, a sheath smaller than 15 French or larger than 15 French can be used. For example, sheaths having outer diameters of 6 French, 7 French, 8 French, 9 French, 10 French, 11 French, 12 French, 13 French, 14 French, 16 French, 17 French, 18 French, 19 French, 20 French, and larger than 20 French can be used. In some embodiments, the instrument 800 can be longitudinally stretched to make the first juxtaposed portion 802 and the second juxtaposed portion 804 of a smaller diameter. The sizes of the first juxtaposed portion 802 and the second juxtaposed portion 804 can be made at least as small as the central portion 806 of the instrument 800. By making the sizes of the first juxtaposed portion 802 and the second juxtaposed portion 804 smaller, for example, it enables crimping of the instrument 800 against a catheter for endoscopic delivery.

[0120] During deployment, the diameter of the central portion 806 expands to a larger diameter. In some examples, the deployed outer diameter of the central portion 806 is configured to at least partially secure the instrument 800 via an interference fit having a tissue aperture. In some embodiments, the diameter of the central portion 806 expands to, for example, about 30 mm, or about 25 mm, or about 20 mm, or about 15 mm, or about 12 mm, or about 10 mm, or about 8 mm, or about 6 mm, or about 4 mm, etc.

[0121] In other embodiments, the distance between the juxtaposed portions is configured to at least partially secure the instrument 800. In some embodiments, the distance between the juxtaposed portions is less than 5 mm, such as less than 4 mm, less than 3 mm, less than 2 mm, less than 1 mm, etc. In some embodiments, the distance between the flange members 809 and the design of the flange members can be adjusted according to the state of the tissue before and after drainage. For example, the flange 809 is sufficiently flexible to avoid compressive necrosis of thick tissue, and the same is true for the size of the flange and the distance between the flanges.

[0122] Referring to FIGS. 9A-9E, a anastomosis instrument 900 including a first juxtaposed portion 902, a second juxtaposed portion 904, and a central portion 906 is shown. For clarity purposes, the instrument 900 is shown without a covering material, but in some embodiments any of the covering materials described herein can be attached to some or all of the framework material. The central portion 906 is disposed between the first juxtaposed portion 902 and the second juxtaposed portion 904. In some embodiments, the central portion can form a tubular body portion that defines a lumen 907 extending between the first juxtaposed portion 902 and the second juxtaposed portion 904. In some embodiments, the lumen 907 provides an anastomosis passage or tunnel through which biological materials or liquids can pass. In the illustrated embodiment, the central portion 906 includes a single row of cells, but in some embodiments two, three, four, five, or more than five rows of cells are included. The instrument 900 is shown in a deployed configuration. In some embodiments, the expanded configuration or deployed configuration is the configuration that the instrument 900 or a portion thereof naturally exhibits when no external force acts on the instrument 900.

[0123] In some embodiments, the first juxtaposed portion 902, the second juxtaposed portion 904, and the central portion 906 may include a spring wire (e.g., L605 steel or stainless steel), a shape memory alloy wire (e.g., nitinol or a nitinol alloy), a superelastic alloy wire (e.g., nitinol or a nitinol alloy), other suitable types of wires, or combinations thereof. In some such embodiments, the first juxtaposed portion 902, the second juxtaposed portion 904, and the central portion 906 may be formed from the same piece of precursor material that is cut to create the desired wire structure. In some such embodiments, the first juxtaposed portion 902, the second juxtaposed portion 904, and the central portion 906 may be formed from the same piece of precursor material that is cut to create the desired wire structure. For example, in some such embodiments, the precursor material is a tube (e.g., a nitinol tube) that is laser cut to form the desired wire structure. In some embodiments, various types of wires are used at various locations of the first juxtaposed portion 902, the second juxtaposed portion 904, and / or the central portion 906. In some embodiments, the first juxtaposed portion 902, the second juxtaposed portion 904, and / or the central portion 906 or portions thereof may be composed of a polymeric material.

[0124] The first juxtaposed portion 902 and the second juxtaposed portion 904 are configured to engage one or more layers of tissue therebetween and apply a juxtaposing force to the tissue surface. The juxtaposing force applied by the first and second juxtaposed portions 902 and 904 facilitates fixing the instrument 900 to the tissue and can provide a resistance to movement such that the instrument 900 remains securely at the target site of the patient as desired. In some embodiments, each of the first juxtaposed portion 902 and the second juxtaposed portion 904 is configured to form a disk in the general sense of contacting the tissue surface.

[0125] The first juxtaposition portion 902 and the second juxtaposition portion 904 each include a plurality of struts 908. The anastomosis instrument 900 can be configured in a collapsed delivery configuration in which the plurality of struts 908 are radially compressed and extend substantially parallel to the axis of the central portion 906. The instrument 900 can have, for example, beneficial fatigue resistance and elastic properties. In some embodiments, the material of the instrument 900 allows it to be elastically crushed, folded, and / or collapsed into a low-profile delivery configuration for percatheter delivery or for containment within the lumen for endoscopic / thoracoscopic delivery, and once the instrument is placed at a desired target site within the body and deployed from its lumen, it self-expands to its operative size and operative configuration.

[0126] During deployment, the plurality of struts 908 can project axially from the central portion 906 and assume a shape that provides a specific level of juxtaposition pressure to the tissue. In some embodiments, the plurality of struts 908 project from the central portion 906 such that the exposed surfaces of the first juxtaposition portion 902 and the second juxtaposition portion 904 are substantially perpendicular to the longitudinal axis of the instrument 900.

[0127] Referring to FIGS. 9A-9E, in the illustrated embodiment, the plurality of struts 908 are interconnected by a connecting member 910. The connecting member 910 is shown in a deployed configuration arranged in a series of waveforms having vertices 918, each of the connecting members 910 extending in a direction away from the central portion 906. The measured angle between adjacent struts 908 at the vertex 918 when the anastomosis device 900 is configured in a low-profile delivery configuration is less than the measured angle between adjacent struts 908 at the vertex 918 when the anastomosis device 900 is configured in the illustrated deployed or expanded configuration. In some embodiments, as the anastomosis device is configured in a low-profile delivery configuration, the measured angle between adjacent struts 908 at the vertex 918 decreases. For example, the measured value of this angle is less than 100°, such as less than 90°, less than 80°, less than 70°, less than 60°, less than 50°, less than 40°, less than 30°, less than 20°, less than 10°, etc. In some embodiments, as the anastomosis device is configured in a low-profile delivery configuration, the measured angle between adjacent struts 908 at the vertex 918 decreases. For example, this angle is less than 100°, such as less than 90°, less than 80°, less than 70°, less than 60°, less than 50°, less than 40°, less than 30°, less than 20°, less than 10°, etc. The stability and support provided by the connecting member 910 improve the juxtaposition force on the gallbladder and the juxtaposition force on the portion of the gastrointestinal tract.

[0128] When the anastomosis device is configured in a low-profile delivery configuration, the cells 914 expand longitudinally (as shown in FIG. 9E), and as the struts 908 are compressed toward the longitudinal axis, the distance between adjacent vertices 918 decreases. During deployment, the cells 914 expand radially (as shown in FIG. 9D), and the distance between the struts 908 increases. In some embodiments, as adjacent vertices 918 are compressed together, the vertices 918 extend in a direction away from the central portion 906.

[0129] As described above, the connecting member 910 can include various metallic shape memory materials and superelastic alloys. Thus, the connecting member 910 can be configured to self-expand and assume an expanded or deployed configuration, for example, to include a predetermined angle at the apex 918. The connecting member 910 typically operates from a closed state (substantially aligned state) to an open state position that can be about 90-100°, although in some configurations it can be less than or greater than 90-100°.

[0130] Referring to FIG. 10, the juxtaposition portion of the anastomosis instrument of some embodiments described herein can be created using an exemplary forming mandrel 1000. For example, a framework as shown in FIGS. 9A, 9B, and 9C can be created using the forming mandrel 1000. The winding mandrel 1000 can be configured in a three-dimensional space, radius, and angle that conforms to the shape of the desired instrument 900. The forming mandrel 900 can be readily modified to create other embodiments of instruments having other configurations, if desired.

[0131] In some embodiments, the mandrel 1000 includes two identical end plates 1002 and 1004, a shaft 1008, a central hole 1010, and a collar 1006. The end plates 1002 and 1004 are oriented with respect to the shaft 1008 so as to face each other. In some embodiments, the end plates 1002 and 1004 include a locking mechanism such as a set screw, whereby the end plates 1002 and 1004 can be releasably locked with respect to the shaft 1008. When the individual locking mechanisms are released, the individual end plates 1002 and / or 1004 can be axially moved, removed from the shaft 1008, and / or rotated with respect to the shaft 1008 and each other.

[0132] In some embodiments, after attaching the framework of the device to a mandrel 1000 as described above, the assembly is heated to set the shape of the device into its configuration, e.g., deployed configuration or expanded configuration. In such non-limiting examples, the device is laser cut from a NiTi tube and attached to the mandrel 1000 to heat the NiTi tube in the expanded state at about 470 °C for about 8 minutes. In other embodiments, the temperature may be higher or lower, and the time may be longer or shorter. The laser-cut NiTi tube is heat-set into the deployed shape or the memory shape by the heating process. Thus, when the laser-cut NiTi tube is deployed from the delivery sheath at the target site in the body, it naturally self-expands and is more likely to reconfigure itself into the memory shape. In some embodiments, only a part of the device is heated to the memory shape. For example, only the juxtaposition portions 902 and / or 904, or only the struts 908 are heated.

[0133] In some embodiments, the diameter of the shaft 1008 is the desired diameter in the state where the central portion 906 is deployed. To attach the framework of the device, at least one end plate 1002 or 1004 is removed from the shaft 1008, and the shaft 1008 is inserted into the lumen of the framework. The removed end plate is attached to the shaft 1008 again so that the distance between the two end plates 1002 and 1004 is substantially equal to the desired length of the central portion 906 of the device. Due to this distance, the end regions of the device are pressed against the end plates 1002 and 1004, the struts 908 are bent, and the connecting member 910 extends from the longitudinal axis of the device at an angle of about 90 °. The collar 1004 can be fixed around the attached framework of the device (as shown in the figure), thereby constraining the framework to the desired configuration until the formation is completed.

[0134] Referring to FIGS. 11A-11C, a anastomosis device 100 is shown that includes a framework of an elongate element that defines a first juxtaposition portion 102, a second juxtaposition portion 104, and a central portion 106. The central portion 106 is disposed between the first juxtaposition portion 102 and the second juxtaposition portion 104 and interconnects them. A covering material 112 may be disposed over at least a portion of the framework. Such a covering material (e.g., the covering material 112 or the covering materials described below) may also be simply referred to as a covering material herein.

[0135] In some embodiments, the central portion 106 defines a lumen 107 that extends between the first juxtaposed portion 102 and the second juxtaposed portion 104. In some examples, the lumen 107 provides an anastomotic passage (i.e., a tunnel) through which a biological substance or body fluid can pass. The instrument 100 is shown in an expanded configuration (also referred to herein as a deployed configuration). The expanded or deployed configuration is the configuration that the instrument 100 naturally exhibits when no external force acts on the instrument 100. It should be understood that when the instrument 100 is implanted in a patient, the configuration of the instrument 100 may be somewhat different from that shown due to external forces derived from the biological structure of that patient acting on the instrument 100.

[0136] In some embodiments, the framework of the anastomosis instrument 100 can be formed using any of the materials and techniques described for other anastomosis instruments. In some embodiments, the first juxtaposed portion 102, the second juxtaposed portion 104, and the central portion 106 comprise a framework of interconnected elongate elements formed by cutting a tube or sheet. In one such embodiment, a tube of a metallic material (e.g., nitinol, stainless steel, cobalt, etc.) is laser cut and then expanded and shaped into the desired configuration. In some such embodiments, the metallic material may be shape memory such that it is shaped into the desired configuration and this material naturally assumes the desired configuration. In some embodiments, a shape memory material such as nitinol can assume the desired configuration when exposed to body temperature.

[0137] In some embodiments, the coating material can be disposed over some or all of the first juxtaposed portion 102, the second juxtaposed portion 104, and / or the central portion 106. In some embodiments, some portions of the first juxtaposed portion 102, the second juxtaposed portion 104, and / or the central portion 106 may be without the coating material.

[0138] The first juxtaposition part 102 and the second juxtaposition part 104 each include a plurality of struts 108. In some embodiments, the respective struts 108 of the first juxtaposition part 102 and the second juxtaposition part 104 are configured to form a disk in the general sense of contacting the tissue surface. More specifically, the first juxtaposition part 102 and the second juxtaposition part 104 are configured to engage one or more layers of tissue therebetween and apply a juxtaposing force to the tissue surface. The juxtaposing force applied by the first juxtaposition part 102 and the second juxtaposition part 104 makes it easier to fix the instrument 100 to the tissue and can provide a movement resistance such that the instrument 100 remains securely at the target site of the patient as desired.

[0139] In some embodiments, the material and configuration of the anastomosis instrument 100 (and other anastomosis instruments provided herein) allow it to be elastically crushed, folded, and / or compressed to be confined within a lumen for transcatheter delivery or endoscopic / thoracoscopic delivery to form a low-profile delivery configuration, and once the instrument is placed at a desired target site in the body and deployed from its lumen, it can self-expand to an operative size and operative configuration. For example, the anastomosis instrument 100 can be configured in a contracted delivery configuration in which the plurality of struts 108 are radially compressed and extend substantially parallel to the axis of the central portion 106, and the central portion 106 is also crushed and shortened. By using such materials and structures, the instrument 100 can also have, for example, beneficial fatigue resistance and elastic properties.

[0140] Upon deployment, the plurality of struts 108 can extend radially from the central portion 106 and assume a shape that provides a desired level of juxtaposition pressure to the tissue. In some embodiments, the plurality of struts 108 extend from the central portion 106, and the nominal measurement of the angle between the strut 108 and the longitudinal axis of the instrument 100 is about 100°, or about 90°, or about 80°, or about 70°, or about 60°, or about 50°, or about 40°, or about 30°, or about 20°, or about 10°, etc. In some embodiments, the plurality of struts 108 extend from the central portion 106, and the nominal measurement of the angle between the strut 108 and the longitudinal axis of the instrument 200 is about 80° to about 100°, or about 70° to about 90°, or about 60° to about 80°, or about 50° to about 70°, or about 40° to about 60°, or about 30° to about 50°, or about 20° to about 40°, or about 10° to about 30°.

[0141] Referring to FIGS. 11A - 11C, in some embodiments of the anastomosis instrument 400 (and in some embodiments of other anastomosis instruments provided herein), the plurality of struts 108 are interconnected by a connecting member 110. The connecting member 110 is shown in a deployed configuration where the connecting member 110 is arranged in a series of waveforms. Here, each wave has a peak 114 that extends in the direction of the central portion 106 and a peak 115 that extends in a direction away from the central portion 106. In some embodiments, the connecting member 110 provides support to the struts 108 to stabilize them, such that the juxtaposed portions 102 and 104 assume a more rigid structure. In such some embodiments, the juxtaposed portions 102 and 104 exhibit a higher level of juxtaposition pressure and can maintain the integrity such that the juxtaposed portions 102 and 104 can conform to the anatomical shape of the tissue. Additionally, the sealing ability of the juxtaposed portions 102 and 104 is enhanced. The stability and support provided by the connecting member 110 improve, for example, the juxtaposition force against the gallbladder and the juxtaposition force against portions of the gastrointestinal tract.

[0142] In the illustrated embodiment, the connecting member 110 forms a chevron between adjacent struts 108 where a series of generally linear segments are joined, but in some embodiments the connecting member 110 has a connected wavy or sinusoidal configuration (e.g., a sine wave). For example, in some embodiments the connecting member 110 can be linear between the struts 108 when the anastomosis device 100 is in a deployed configuration. In the illustrated embodiment, the connecting member 110 extends from the radial ends of the struts 108, but in some embodiments the connecting member 110 can be attached to or extend from another portion of the strut 108. In some embodiments, two or more connecting members 110 (extending from one or more struts 108) may be included.

[0143] The measured angle defined by the vertices 114 and 115 when the anastomosis device 100 is configured in a low-profile delivery configuration is less than the measured angle defined by the vertices 114 and 115 when the anastomosis device 100 is configured in the deployed or expanded configuration shown. In other words, the struts 108 are compressed in the direction of the longitudinal axis of the device and the distance between adjacent vertices 114 and 115 is reduced. In some embodiments, when the anastomosis device 100 is in a low-profile delivery configuration, each vertex 114 extends in the direction of the central portion 106 and each vertex 115 extends away from the central portion 106.

[0144] As described above, the connecting member 110 can include a variety of materials including, but not limited to, metallic shape memory materials and superelastic alloys. Thus, the connecting member 110 can self-expand and be configured, for example, such that the measured angles of the vertices 114 and 115 take on a predetermined expanded deployed configuration.

[0145] Referring to FIG. 11D, the central portion 106 includes one or more circumferential stent rings 116 and one or more axial adjustment members 118. For the purpose of clarity, it should be understood that in FIG. 11D, the central portion 106 is shown without the covering material. The axial adjustment member 118 interconnects the stent rings 116. Using this configuration, the central portion 106 is configured to expand or contract axially in response to the tensile force transmitted from the juxtaposed portions 102 and 104 to the central portion 106. Such a force results in a juxtaposition pressure applied to the tissue pressed between the juxtaposed portions 102 and 104. In other words, the axial adjustment member 118 can function as a suspension spring and is adapted to extend or contract axially so that the anastomosis instrument 100 can accommodate various thicknesses of the tissue between the juxtaposed portions 102 and 104. This function is advantageous because, for example, the thickness of the tissue may increase when inflamed and decrease (heal) when returning to normal. In such a case, the anastomosis instrument 100 can automatically adjust according to changes in the tissue thickness during the healing process.

[0146] In the illustrated embodiment, two stent rings 116 are included. In some embodiments, there may be more or fewer than two stent rings 116. In the illustrated embodiment, the stent rings 116 are aligned with each other. That is, the peaks and / or valleys of the individual stent rings 116 are arranged to be axially aligned with the peaks and / or valleys of the other individual stent rings 116. However, such an alignment is not necessary in all embodiments. In the illustrated embodiment, the stent rings 116 exhibit a pattern of peaks and valleys in a sine wave pattern. However, it is clear that the stent rings 116 can have any other suitable shape. For example, in some embodiments, a meandering pattern or a pattern of closed diamond-shaped cells is suitable. The stent rings 116 are interconnected to each other by at least one axial adjustment member 118, and the stent rings 116 are connected to the struts 108 of the juxtaposed portion 102 or the juxtaposed portion 104.

[0147] Shows the central portion 106 in a deployed or expanded configuration. In some embodiments, as described above, the central portion 106 may include various shape memory materials and superelastic alloys. Thus, the central portion 106 can be configured to self-expand and take on a deployed configuration. In some embodiments, the central portion 106 is balloon-expandable in the deployed configuration or can apply an auxiliary expansion force to an instrument that is self-expandable by balloon inflation. The diameter of the central portion 106 can be made any size as needed to suit the intended use of the anastomosis instrument 100 and / or the delivery system. For example, in its low-profile delivery configuration, the anastomosis instrument 100 can be disposed within a delivery sheath having an outer diameter of about 15 French (5 mm). However, in some embodiments, a sheath smaller or larger than 15 French can be used. For example, sheaths having outer diameters of 6 French, 7 French, 8 French, 9 French, 10 French, 11 French, 12 French, 13 French, 14 French, 16 French, 17 French, 18 French, 19 French, 20 French, and outer diameters greater than 20 French can be used. In some embodiments, when the anastomosis instrument 100 is configured in an expanded deployment configuration as shown, the diameter of the central portion 106 increases to the deployed diameter. In some examples, the deployed outer diameter of the central portion 106 is configured to at least partially secure the instrument 100 through an interference fit where the central portion 106 has an opening in certain tissue. However, in some embodiments, the deployed outer diameter of the central portion 106 is slightly smaller than the diameter of the tissue opening where the central portion 106 is located, and the juxtaposed portions 102 and 104 press against the tissue to provide movement resistance. In some embodiments, the fully expanded diameter of the central portion 106 is about 30 mm, or about 25 mm, or about 20 mm, or about 15 mm, or about 12 mm, or about 10 mm, or about 8 mm, or about 6 mm, or about 4 mm, etc. In some embodiments, the fully expanded diameter of the central portion 106 is in the range of about 20 mm to about 30 mm, or about 15 mm to about 25 mm, or about 10 mm to about 20 mm, or about 5 mm to about 15 mm, or about 4 mm to about 8 mm, etc.

[0148] To interconnect the stent rings 116, one or more axial adjustment members 118 are disposed within the central portion 106. In some embodiments, the axial adjustment member 118 is configured in a wavy or horseshoe shape (not shown). (For example, by making the axial adjustment member 118 more linear), the waveform of the axial adjustment member 118 extends in a direction such that as the axial adjustment member 118 extends axially, the central portion 106 extends axially. The waveform of the axial adjustment member 118 provides for conservation of surplus material and / or energy such that the axial length of the instrument 100 is facilitated to expand or contract.

[0149] The length of the central portion 106 can be made to any dimension as required to suit the intended use of the anastomosis instrument 100 and / or the delivery system. By including one or more axial adjustment members 118, the anastomosis instrument 100 can be used for various tissue thicknesses and tissues, and the contact between tissues can be advantageously improved and the anastomosis performance can be improved. In some embodiments, adjacent stent rings 116 are longitudinally separated from each other until the instrument reaches the axial adjustment limit, for example, until the axial adjustment member 118 appears substantially linear.

[0150] In some examples, the axial length of the instrument is adjusted at least to some extent by the physician before or during deployment to accommodate tissue of a specific thickness at the target implantation site. In other examples, the axial adjustment member 118 automatically responds to such physical forces exerted on the instrument 100 deployed in situ. For example, the axial adjustment member 118 may be enabled to dynamically adjust the axial length of the instrument 100 during deployment and / or during the tissue healing process. In one such example where an anastomosis is created between the gallbladder and the duodenum, the gallbladder (if inflamed) may gradually become thinner from its original wall thickness as the inflammation subsides. The axial adjustment member 118 may be enabled to dynamically adjust the axial length of the instrument 100 to the wall thickness that gradually becomes thinner as the inflammation of the gallbladder wall subsides from the original thickness.

[0151] The anastomosis device 100 includes a covering material 112. The covering material 112 can be composed of any material and can be configured using any technique as described for the covering materials of other anastomosis devices described herein. In some embodiments, the covering material 112 is disposed on (or over the entire) at least some portions of the first juxtaposed portion 102, the second juxtaposed portion 104, and the central portion 106. In some embodiments, some portions of the first juxtaposed portion 102, the second juxtaposed portion 104, and / or the central portion 106 are not covered by the covering material 112.

[0152] Referring to FIG. 12, another exemplary anastomosis device 160 is shown that includes a framework of elongate elements that define a first juxtaposed portion 162, a second juxtaposed portion 164, and a central portion 166. The central portion 166 is disposed between and interconnects the first juxtaposed portion 162 and the second juxtaposed portion 164. A covering material 172 is disposed on at least some portions of the framework. In some embodiments, the central portion 166 defines a lumen 167 that extends between the first juxtaposed portion 162 and the second juxtaposed portion 164. In some examples, the lumen 167 provides an anastomosis passage or tunnel through which biological material or biological fluid can pass. The device 160 is shown in an expanded configuration. The expanded configuration is the configuration that the device 160 naturally exhibits when no external force acts on the device 160.

[0153] The materials, configurations, and techniques for constructing the anastomosis device 160 can be similar to those described for the other anastomosis devices described herein. In some embodiments, the anastomosis device 160 does not include elongate elements that interconnect struts 168 (in contrast to the connecting member 110 that interconnects the struts 108 of the anastomosis device 100).

[0154] In some embodiments, the anastomosis device 160 can adjust the radial force by changing design parameters such as the number of cells, the thickness of the tube, the shape of the cells, the covering material, etc. For example, in the application of the anastomosis device, the central portion 166 is designed to have a radial force that resists the circumferentially applied force from the surrounding tissue. The radial force of some such anastomosis devices can facilitate remodeling of the tissue external to the lumen and cause the lumen size of the tissue to approximate the lumen size of the device.

[0155] In some embodiments, the free ends of one or more struts 168 include a member 170. In some embodiments, the member 170 may include an anchor, spine, protrusion, atraumatic member, and / or support scaffold of the covering material 172. In some embodiments, two or more struts 168 include members 170 having different configurations. In some embodiments, each of the struts 168 has a member 170 of the same configuration.

[0156] It should be understood that one or more design matters of the anastomosis instrument provided herein may be combined with other design matters of other anastomosis instruments provided herein. In fact, various design matters derived from two or more of the anastomosis instrument designs provided herein can be combined to create a hybrid design, and those hybrid designs are within the scope of the present disclosure.

[0157] In some embodiments, the instrument provided herein can be used for sealing or fixing a heart valve implant. The heart valve implant allows only one-way flow of blood from the heart chamber and typically has a first inflow end and a second outflow end. The contraction of the heart causes blood flow through the valve from its inflow end to its outflow end. The valve assembly within the heart valve implant creates only one-way flow between its inflow and outflow ends, and when the blood pressure is high at the inflow end, the valve assembly opens to allow flow from the inflow end to the outflow end, and when the pressure is higher at the outflow end than at the inflow end, the valve assembly closes to prevent flow. In some embodiments, the instrument includes a tunnel or central opening through the instrument with juxtaposed portions for fixing the valve assembly and the backflow prevention seal. The valve assembly can be mounted within the tunnel or central opening. The juxtaposed portions of the instrument can be well-matched to the shape of the heart chamber or blood vessel and configured to accommodate the pulsation of the heart. In some embodiments, the covering material is configured to prevent flow around those juxtaposed portions while allowing flow through the valve assembly within the tunnel or opening.

[0158] The invention of the present application has been described so far both generally and with respect to specific embodiments. It will be apparent to those skilled in the art that various modifications and changes can be made to this embodiment without departing from the scope of the present disclosure. Accordingly, this embodiment is intended to cover those modifications and changes as long as they fall within the scope of the appended claims and their equivalents.

Claims

1. A medical device comprising a fixation structure for fixing an occlusion device within a patient's heart, the fixation structure comprising a tubular structure comprising at least one elongate member forming a framework of interconnected struts, the tubular structure comprising a central portion defining a central tunnel, wherein the occlusion device is fixable to the central portion within the central tunnel; and a first flange extending substantially radially outward from the central portion and comprising a plurality of struts interconnected to define a plurality of first flange cells between the struts, the first flange conforming to the shape of the heart chamber; and a second flange extending substantially radially outward from the central portion and comprising a plurality of second flange cells defined by at least one elongate member, the second flange configured to engage one or more layers of tissue; and the central portion being located between the first flange and the second flange and including a first ring portion of cylindrical shape extending from the first flange, a second ring portion of cylindrical shape extending from the second flange, and a plurality of axial adjustment members interconnecting the first ring portion and the second ring portion such that the first ring portion and the second ring portion are axially adjustable relative to each other, a medical device.

2. The medical device according to claim 1, wherein the plurality of axial adjustment members include at least one elongate member forming a wavy or U-shaped pattern.

3. The medical device according to claim 1 or 2, wherein the first and second ring portions are longitudinally separable from each other until the fixation structure reaches an axial adjustment limit.

4. The medical device according to any one of claims 1 to 3, wherein the plurality of axial adjustment members are circumferentially aligned.

5. The medical device according to any one of claims 1 to 4, wherein the axial length of the fixation structure is dynamically adjustable as part of the deployment of the fixation structure by the axial adjustment members.

6. The medical device according to any one of claims 1 to 5, wherein each of the first and second ring portions includes at least one elongate member forming a wavy pattern.

7. The medical device according to any one of claims 1 to 6, wherein each of the first and second flanges comprises a circumferential ring that undulates substantially sinusoidally along the edges of the first and second flanges.

8. The medical device according to any one of claims 1 to 7, further comprising an occlusion device fixed to the central portion within the central tunnel.

9. A heart valve including a heart valve graft and a fixation structure, wherein the heart valve graft has an inflow end and an outflow end, and the heart valve is operable such that blood can flow through its interior from the inflow end to the outflow end when the pressure is high at the inflow end, and is operable to restrict blood from flowing from the outflow end to the inflow end when the pressure is high at the outflow end; the fixation structure comprises a tubular structure having at least one elongate member forming a framework of interconnected struts, the tubular structure has, a central portion defining a central tunnel, wherein the heart valve graft is fixed to the central portion within the central tunnel; and, a first flange extending substantially radially outward from the central portion and having a plurality of interconnected struts for defining a plurality of first flange cells; and, a second flange extending substantially radially outward from the central portion and having a plurality of second flange cells defined by at least one elongate member; and, the central portion is located between the first flange and the second flange and includes a plurality of axial adjustment members interconnecting a first ring portion and a second ring portion such that the first ring portion and the second ring portion are axially adjustable relative to each other. A heart valve.

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