Anastomosis device

Abstract

To provide implantable devices for connecting tissue layers to create an anastomosis.SOLUTION: Implantable medical devices for connecting tissue layers, such as for connecting a gallbladder and a portion of a gastrointestinal tract, to create an anastomosis, include a tubular structure having a plurality of apposition portions, a central region, and a covering material. Methods of using the devices include endoscopic deployment, and the devices may include self-expanding frameworks that facilitate a secure connection between the tissue structures.SELECTED DRAWING: Figure 2

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. Methods of using such implantable medical devices are also disclosed.

Background Art

[0002] An anastomosis is an intersecting 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 anastomosis, end-to-side anastomosis, and side-to-side anastomosis. Suturing is often used to form such anastomoses.

Summary of the Invention

Means for Solving the Problems

[0004] One aspect of the present invention relates to a medical device comprising: (1) an expandable frame having a first end, a second end, and an intermediate portion between the first end and the second end; (2) a first juxtaposition portion comprising a plurality of first juxtaposition members, each of which extends toward the intermediate portion; and (3) a second juxtaposition portion comprising a plurality of second juxtaposition members, each of which extends toward the intermediate portion. Each first portion of the first juxtaposition member may be oriented at a first angle with respect to the surface of the intermediate portion, and each second portion of the first juxtaposition member may be oriented at a second angle with respect to the surface of the intermediate portion. In a preferred embodiment, the first angle is acute and smaller than the second angle. Furthermore, each first portion of the second juxtaposition member may be oriented at a third angle with respect to the surface of the intermediate portion, and each second portion of the second juxtaposition member may be oriented at a fourth angle with respect to the surface of the intermediate portion. In a preferred embodiment, the third angle is acute and smaller than the fourth angle. In some embodiments, at least one of the first juxtaposed members is longer than one or more of the other first juxtaposed members. At least one of the first juxtaposed members may be longer than at least one of the second juxtaposed members. In one or more embodiments, all of the first juxtaposed members are longer than all of the second juxtaposed members. The first juxtaposed members may or may not be aligned with the second juxtaposed members with respect to their axes. In another embodiment, one or more of the first juxtaposed members may overlap one or more of the second juxtaposed members in the longitudinal direction. The covering material may be positioned on at least a portion of the frame.

[0005] A second aspect of the present invention relates to a medical device comprising a frame including (1) a first juxtaposition portion including one or more first flange members configured to contact a first tissue surface and apply a juxtaposition force to the first tissue surface, (2) a second juxtaposition portion including one or more second flange members configured to contact a second tissue surface and apply a juxtaposition force to the second tissue surface, and (3) a central portion having a first end and a second end, the central portion defining a longitudinal axis, the central portion being positioned between the first and second juxtaposition portions and defining the central portion that interconnects the juxtaposition portions. In a preferred embodiment, at least one of the first flange members and at least one of the second flange members include a curved portion and a downward portion extending longitudinally toward the central portion. At least one of the curved portions of the first flange member extends longitudinally beyond the first end, and at least one of the curved portions of the second flange member extends longitudinally beyond the second end. In at least one embodiment, at least one of the first flange members or at least one of the second flange members further includes a horizontal portion extending from the descending portion. The curved portion may extend from the first or second end of the central portion. The descending portion may be a straight descending portion. Furthermore, the central portion may be configured to expand and contract longitudinally to maintain contact between the first and second juxtaposed portions and the first and second juxtaposed portions, respectively, with a series of juxtaposed thicknesses.

[0006] A third aspect of the present invention relates to a method for implanting an anastomotic device in a patient, comprising: (1) positioning a delivery sheath containing the anastomotic device at a target location in the patient; and (2) positioning the anastomotic device out of the delivery sheath such that at least one layer of tissue is between a first and second juxtaposition portion of the device. The anastomotic device comprises (1) an expandable frame having a first end, a second end, and an intermediate portion between the first and second ends; (2) a first juxtaposition portion comprising a plurality of first juxtaposition members, each of which extends toward the intermediate portion; and (3) a second juxtaposition portion comprising a plurality of second juxtaposition members extending toward the intermediate portion. The first portion of each of the first juxtaposition members may be oriented in a direction at a first angle with respect to the surface of the intermediate portion, and the second portion of each of the first juxtaposition members may be oriented in a direction at a second angle with respect to the surface of the intermediate portion. In a preferred embodiment, the first angle is acute and smaller than the second angle. Furthermore, each first portion of the second juxtaposed member may face a third angle with respect to the surface of the intermediate portion, and each second portion of the second juxtaposed member may face a fourth angle with respect to the surface of the intermediate portion. In a preferred embodiment, the third angle is acute and smaller than the fourth angle. In at least one preferred embodiment, the tips of the plurality of first juxtaposed members or the plurality of second juxtaposed members are positioned away from the tissue. In another preferred embodiment, two layers of tissue are located between the first and second juxtaposed portions. [Brief explanation of the drawing]

[0007] The accompanying drawings are included to enhance the understanding of this disclosure, are incorporated herein and constitute part of this specification, illustrate embodiments of this disclosure, and are useful together with this specification in explaining the principles of this disclosure.

[0008] [Figure 1] This is a cross-sectional fluoroscopic view of an anastomotic device, which, according to several embodiments, is implanted in a patient and functions as a shunt between the patient's gallbladder and intestines. [Figure 2] This is a fluoroscopic view of an anastomotic device, which is an example of one of several embodiments. [Figure 3]This is a perspective view of an example of juxtaposed members according to several embodiments. [Figure 4] Same as above [Figure 5] Same as above [Figure 6] Same as above [Figure 7] Figures 3-6 are graphs showing the relationship between force and displacement for each of the juxtaposed members. [Figure 8] This is a schematic diagram of an anastomotic device, which is another example according to several embodiments. [Figure 9] This is a schematic diagram of an example of a juxtaposed member according to several embodiments. [Figure 10] This is a fluoroscopic view of yet another example of an anastomotic device according to several embodiments. [Figure 11] Figure 10 is an end view of the anastomosis device. [Figure 12] This is an alternative embodiment of the anastomotic device shown in Figure 10. [Figure 13] This is a side view of the central portion of another anastomotic device, which includes an expansion member according to several embodiments. [Modes for carrying out the invention]

[0009] Those skilled in the art will readily understand that various aspects of this disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to actual size and may be exaggerated to illustrate various aspects of this disclosure, and in that respect should not be construed as limiting.

[0010] The present invention relates to implantable devices for connecting tissue layers to avoid, for example, conduit occlusion or organ occlusion by creating an anastomosis that facilitates the flow of substances between tissue structures by creating a direct channel between them (for example, connecting the gallbladder and a portion of the gastrointestinal tract). The devices described herein may be placed or delivered endoscopically via a catheter and may include a self-expanding juxtaposition mechanism that facilitates secure connection between the tissue structures (such connections may be referred to herein as “shunts,” “communication channels,” “shunt channels,” or “tunnels”). Such designs simplify 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 remains implanted until the body grows tissue anastomoses around it, after which the device is removed. In other embodiments, the device is permanently implanted by tissue grafting into and / or around the device, and the device is not removed. The devices described herein may 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 bile fistula creation).

[0011] This document refers to anastomotic devices of exemplary form. That is, it should be understood that the concepts of the present invention disclosed herein are applicable to other types of devices. For example, in some embodiments, this document also provides implantable devices that can be used to occlude tissue structures, organs, body conduits, blood vessels, GI canals, etc. For example, in some embodiments, the devices provided herein can be used to occlude septal defects. In some embodiments, the devices provided herein can be used to occlude a patient's blood vessels or GI canals. In some such embodiments, the device does not include a tunnel through which it passes. Rather, in some embodiments, a covering material seals the device to restrict, regulate, or substantially prevent the flow of material through it.

[0012] Referring to Figure 1, an anastomotic device 40, which is an example of one or more provided herein, can be implanted in a patient to form a fluid connection between two organs, spaces, tissue structures, conduits, etc., and combinations thereof. For example, in the illustrated embodiment, the anastomotic device 40 connects the gallbladder 10 (defining the internal gallbladder space 12) to the intestine 20 (defining the internal intestinal space 22). Thus, the anastomotic 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 is located within a natural anatomical conduit 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 causing obstruction of the patient's cystic duct 14 and / or common bile duct 16. In such cases, the anastomotic device 40 can provide a fluid channel so that bile from the gallbladder 10 can flow into the intestine 20. If the anastomotic device 40 is not present, the outflow of bile from the gallbladder 10 may be blocked, which could lead to cholecystitis (inflammation of the gallbladder 10).

[0013] While the anastomotic devices provided herein may be used in several embodiments to alleviate or prevent cholecystitis as described above, it should be understood that the anastomotic devices provided herein may also be used in many other types of embodiments within a patient. For example, the anastomotic devices provided herein may be used in connection with various body tissue structures and organs, including, but not limited to, the stomach, colon, small intestine, pancreas, blood vessels, bladder, kidneys, ducts, and so on.

[0014] In general, several embodiments of the anastomotic device provided herein (of which the anastomotic device 40 is one example) include a first tissue juxtaposition section 42a, a second tissue juxtaposition section 42b, and a central section 44 between the first tissue juxtaposition section 42a and the second tissue juxtaposition section 42b. The central section 44 defines a lumen 46 that extends longitudinally from the first end of the anastomotic device 40 to the 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 so that the internal gallbladder space 12 is in fluid communication with the internal intestinal space 22 through the anastomotic device 40.

[0015] Referring to Figure 2, an example of an anastomotic device 500 is shown, which includes a framework made of one or more elongated elements 501 defining a first juxtaposition section 502, a second juxtaposition section 504, and a central section 506. The central section 506 is positioned between the first juxtaposition section 502 and the second juxtaposition section 504 and interconnects them. In some embodiments, the central section 506 is basically cylindrical (although other shapes have been considered and are thought to be within the scope of the present invention).

[0016] In some embodiments, the covering material 512 is positioned on at least a portion of the anastomosis device 500. As will be further described below, the covering material 512 may be positioned on some portion or all of the first juxtaposition section 502, the second juxtaposition section 504, and / or the central section 506. In some embodiments, there are portions of the first juxtaposition section 502, the second juxtaposition section 504, and / or the central section 506 that may remain without the covering material 512.

[0017] In some embodiments, the central portion 506 defines a lumen 507 that extends between the first juxtaposed portion 502 and the second juxtaposed portion 504. In some embodiments, the lumen 507 provides an anastomosis passage or tunnel through which biological material and / or biological fluid can pass. The instrument 500 is shown in an expanded configuration. The expanded configuration is the configuration that the instrument 500 naturally exhibits when there is no external force acting on the instrument 500. It should be understood that when the anastomosis device 500 is implanted in a patient, the configuration of the instrument 500 may be somewhat different from that shown due to external forces derived from the patient's biological structure acting on the instrument 500.

[0018] The anastomosis device 500 is shown in a deployed configuration or an expanded configuration. In some embodiments, the framework of the anastomosis device 500 can be made from various shape memory metallic materials and superelastic alloys as further described below. Thus, in some embodiments, the central portion 506 (and / or the juxtaposed portions 502 and 504) can be configured to self-expand to the deployed configuration. In some embodiments, the central portion 506 is balloon-expandable to the deployed configuration, or an auxiliary expansion force can be applied to the self-expanding instrument by balloon inflation. The diameter of the central portion 506 can be of any desired size to conform to the intended use of the anastomosis device 500 and / or the delivery system.

[0019] When the anastomosis device 500 is configured in its expanded deployment configuration as shown, the diameter of the central portion 506 increases to the deployed diameter. The diameter of the central portion 506 can be of any desired dimension to conform to the intended use of the anastomosis device 500 and / or the delivery system. In some embodiments, the deployed outer diameter of the central portion 506 is configured to at least partially secure the instrument 500 via an interference fit with the tissue opening in which the central portion 506 is located. Note that when the central portion 506 and the tissue opening have an interference fit relationship, leakage beside the instrument can be reduced or minimized. In such cases, leakage of the contents of the organ, conduit, and other types of tissue structures in which the anastomosis device 500 can be placed can be substantially prevented. For example, when using the anastomosis device 500 between the gallbladder and the GI tract (see, e.g., FIG. 1), leakage into the abdominal cavity can be substantially prevented.

[0020] In some embodiments, the deployed outer diameter of the central portion 506 is slightly smaller than the diameter of the tissue opening where the central portion 506 is located, and the juxtaposed portions 502 and 504 press against the tissue to provide movement resistance. In some embodiments, the fully expanded diameter of the central portion 506 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 506 is within a range between about 20 mm and about 30 mm, or between about 15 mm and about 25 mm, or between about 10 mm and about 20 mm, or between about 5 mm and about 15 mm, or between about 4 mm and about 8 mm, etc.

[0021] The length of the central portion 506 can be made any desired dimension to conform to the purpose of use of the stapler 500 and / or the delivery system. For example, in one preferred embodiment, the central portion 506 is about 13.5 mm in length and about 15 mm in diameter. In some embodiments, the length of the central portion 506 can be within a range between about 5 mm and about 10 mm, or between about 8 mm and about 13 mm, or between about 11 mm and about 16 mm, or between about 14 mm and about 19 mm, or between about 17 mm and about 22 mm, or may be longer than 22 mm.

[0022] In some embodiments, the stapler 500 has a framework including one or more elongated elements 501. In some embodiments, one or more of those elongated elements 501 are wound to form the framework configuration. In some embodiments, a single elongated element 501 is wound to form the framework of the stapler 500. In some embodiments, two or more elongated elements 510 are wound together to form the framework of the stapler 500.

[0023] In some embodiments, the framework of the first juxtaposition section 502, the second juxtaposition section 504, and the central section 506 is formed from one or more elongated elements 501 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 elongated elements or wires, or combinations thereof. In some embodiments, the first juxtaposition section 502, the second juxtaposition section 504, and the central section 506 are formed from a precursor material that is cut to produce a framework made of elongated elements 501. In some such embodiments, the precursor material is a single precursor material. In some embodiments, one or more elongated elements 501 are wound together to form the framework. In some embodiments, different types of elongated elements 501 are used at different positions in the first juxtaposition section 502, the second juxtaposition section 504, and / or the central section 506. In some embodiments, the elongated elements 501 of the first juxtaposed section 502, the second juxtaposed section 504, and / or the central section 506 (or parts thereof) may be made of polymer material.

[0024] Suitable materials for the elongated elements 501 of the anastomotic device 500 and / or other instruments provided herein include a variety of metallic materials, including alloys exhibiting shape memory, elastic, and superelastic properties. Shape memory refers to the ability of a material to return to its original shape after being heated above its critical temperature and undergoing plastic deformation. Elasticity is the ability of a material to deform under load and return to its original shape when the load is removed. Most metals deform elastically to a maximum of slight distortion. Superelasticity refers to the ability of a material to deform under load to a much greater extent than ordinary elastic alloys, but without making this deformation permanent. For example, the superelastic materials included in the frames of some anastomotic device embodiments provided herein can withstand a considerable degree of bending and then return to the original shape of the frame without deformation, or substantially return to it. In some embodiments, suitable elastic materials include various stainless steels, cobalt-chromium alloys (e.g., ELGILOY®, MP35N, L605), and platinum / tungsten alloys, which have been subjected to physical, chemical, and 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 a drone-filled tube in which the outer layer is composed of nitinol and the inner core is made of a radiopaque material such as platinum or tantalum. In this configuration, the outer layer provides superelastic properties, while the inner core remains elastic for lower bending stresses.

[0025] In some embodiments, the elongated elements 501 used to constitute the anastomotic device 500 and / or the device provided herein may be treated in various ways to increase the radiopaqueness of the device for improved radiographic contrast. In some embodiments, the device is a drone-fill type NiTi containing different materials, such as a material with increased radiopaqueness in the nucleus, most in part. In some embodiments, the device includes a radiopaque coating or plating on at least a portion of the first juxtaposition section, the second juxtaposition section, and the central section. In some embodiments, one or more radiopaque markers are attached to the device. In some embodiments, the elongated elements and / or other parts of the device provided herein may also be visible by ultrasound and may include portions with increased echobrightness.

[0026] In some embodiments, the material and construction of the anastomotic device 500 (and other anastomotic device embodiments provided herein) allow the device to be elastically compressed, folded, and / or folded into a low-profile delivery configuration to encapsulate it within a lumen for transcatheter delivery or endoscopic / thoracoscopic delivery, and allow the device to self-expand to working size and configuration once positioned at a desired target site in the body and positioned out of its lumen. For example, in its low-profile delivery configuration, the anastomotic device 500 may be positioned within a delivery sheath having an outer diameter of approximately 15 French (5 mm). However, in some embodiments, sheaths 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 larger than 20 French can be used. While the anastomotic device 500 is configured as a contraction-delivery structure, in some embodiments, a framework made of one or more elongated elements 501 is compressed radially such that the elongated elements 501 are pushed and stretched substantially parallel to the axis of the central portion 506, and the diameter of the central portion 506 is crushed and reduced.

[0027] The anastomotic device 500 also includes a covering material 512 (which may also be referred to herein as “covering”). In some embodiments, the covering material 512 is positioned over (or over) at least some portion of the first juxtaposition section 502, the second juxtaposition section 504, and the central section 506. In some embodiments, some portion of the first juxtaposition section 502, the second juxtaposition section 504, and / or the central section 506 is not covered by the covering material 512.

[0028] In some embodiments, the covering material 512 is generally impermeable to liquids. That is, in some embodiments, the covering material 512 is made of a material that inhibits or reduces the passage of blood, bile, and / or other bodily fluids and biomolecules through the covering material 512 itself. In some embodiments, the covering material 512 has a material composition and structure that inhibits or prevents tissue endografting and / or endothelialization or epithelialization within the covering material 512. Some such embodiments configured to inhibit or prevent tissue endografting and / or endothelialization can be made more easily removed from the patient in the future if it is desired to do so. In some embodiments, the covering material 512 or a portion thereof has a microporous structure that provides a tissue endograft scaffold suitable for the durable sealing and / or auxiliary fixation force of the anastomosis device 500.

[0029] In some embodiments, the coating 512 comprises a fluoropolymer such as stretched polytetrafluoroethylene (ePTFE) polymer, polyvinylidene fluoride (PVDF), or PVDA. In some embodiments, the coating 512 comprises polyester, silicone, urethane, biocompatible polymer, polyethylene terephthalate (e.g., Dacron®), bioabsorbable material, copolymer, or a combination thereof. In some embodiments, the coating 512 comprises a bioabsorbable fabric. In other embodiments, the bioabsorbable material may provide resistance to migration by promoting adhesion between the instrument 500 and the tissue until the bioabsorbable material is absorbed.

[0030] In some embodiments, the coating 512 (or a portion thereof) is modified by one or more chemical or physical treatments that improve one or more properties of the material 512. For example, in some embodiments, a hydrophilic coating may be used on the coating 512 to improve the wettability and echo semipermeability of the material 512. In some embodiments, the coating 512 or a portion thereof may be modified with a chemical moiety that promotes one or more of the following: endothelial cell adhesion, endothelial cell migration, endothelial cell proliferation, and thrombosis resistance or thrombosis promotion. In some embodiments, the coating 512 or a portion thereof may be modified to withstand biofouling. In some embodiments, the coating 512 or a portion thereof may be modified with one or more covalently bound active pharmaceutical ingredients (e.g., heparin, antibiotics, etc.) or saturated with one or more active pharmaceutical ingredients. These active pharmaceutical ingredients can be released in situ to promote healing, reduce tissue inflammation, reduce or suppress infection, and promote various other therapeutic treatments and outcomes. In some embodiments, the active pharmaceutical ingredient may be, but is not limited to, a corticosteroid, a human growth factor, an antimitotic agent, an antithrombotic agent, a stem cell material, or dexamethasone sodium phosphate. In some embodiments, the drug is delivered to the target site separately from the covering material 512 to promote tissue healing or tissue growth.

[0031] The covering material 512 is covered and treated before or after it is attached to or positioned around the framework of the anastomotic device 500. One side, both sides, or portions thereof of the covering material 512 may be covered. In some embodiments, a particular covering and / or treatment is applied to the covering material 512 located on a portion of the anastomotic device 500, while other coverings and / or treatments are applied to the material 512 located on other portions of the anastomotic device 500. In some embodiments, a combination of multiple coverings and / or treatments is applied to the covering material 512 or portions thereof. In some embodiments, certain portions of the covering material 512 are left uncovered and / or treated. In some embodiments, the device 500 is covered, fully or partially, to promote or inhibit biological responses such as endothelial cell adhesion, endothelial cell migration, endothelial cell proliferation, and thrombosis resistance or thrombosis promotion.

[0032] In some embodiments, a first portion of the covering material 512 is formed from a first material, and a second portion of the covering material 512 is formed from a second material different from the first material. In some embodiments, the covering material 512 is composed of multiple layers of material, which may be the same material or different materials. In some embodiments, the covering material 512 has one or more radiopaque markers attached to the covering material to improve in vivo radiographic contrast of the anastomosis device 500, or has one or more echo-bright areas to improve ultrasound visibility.

[0033] In some embodiments, one or more portions of the covering material 512 are attached to the frame of the fixture 500, such as the central portion 506 and / or the juxtaposed portions 502 and 504. Such attachment can be achieved by various techniques, but are not limited to, sewing the covering material 512 to the frame of the fixture 500, bonding the covering material 512 to the frame of the fixture 500, laminating multiple layers of the covering material 512 using fasteners or latches to surround elongated portions of the fixture 500, or laminating multiple layers of the covering material through openings within the frame of the fixture 500. In some embodiments, the covering material 512 is attached to the frame of the fixture 500 at a series of separate locations to enhance the flexibility of the frame. In some embodiments, the covering material 512 is loosely attached to the frame of the fixture 500. It should be understood that the covering material 512 may be attached to the frame using other techniques or a combination of the techniques described herein.

[0034] In some embodiments, the framework of the apparatus 500 (or a part thereof) is coated with a binder (e.g., fluorinated ethylene propylene or other suitable adhesive) to facilitate the adhesion of the covering material 512 to the framework. Such adhesive may be applied to the framework by contact coating, powder coating, dipping, spray coating, or any other suitable method.

[0035] The covering material 512 can adapt to changes in the length and / or diameter of the central portion 506 in various ways. In the first example, the covering material 512 may be elastic so that it stretches to accommodate changes in the length and / or diameter of the instrument 500. In the second example, the covering material may include a material that is loose in the low-profile delivery configuration and becomes less loose or completely loose when the instrument 500 is in an expanded configuration. In the third example, the covering material 512 may include folded portions (e.g., pleats) that are folded in the low-profile configuration and become less folded or completely unfolded when the instrument 500 is in an expanded configuration. In some embodiments, a combination of such techniques and / or other techniques may be used so that the covering material 512 can adapt to changes in the length and / or diameter of the central portion 506.

[0036] One or more elongated elements 501 of the central section 506 can be configured in various ways to define a generally cylindrical framework. In the embodiment shown in Figure 2, the elongated elements 501 of the central section 506 are wound circumferentially around the central section 506. In addition to the circumferential winding, the elongated elements 501 may exhibit other winding trajectories, such as the wavy or meandering trajectories shown (e.g., approximately sinusoidal trajectories) and other trajectories. In the illustrated embodiment, the winding trajectories of the elongated elements 501 in the central section 506 have 8 vertices per perimeter and a vertex distance of approximately 3.5 mm. In some embodiments, the elongated elements 501 of the central section 506 may be manufactured to have more or fewer vertices per perimeter as desired to suit a particular application, and may have a vertex distance longer or shorter than 3.5 mm. For example, in some embodiments, the elongated elements 501 of the central portion 506 may be manufactured to have 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, or more than 16 vertices per perimeter. In some embodiments, the elongated elements 501 of the central portion 506 may be manufactured to have vertex distances within the range of approximately 1 mm to approximately 2 mm, or approximately 2 mm to approximately 3 mm, or approximately 3 mm to approximately 4 mm, or approximately 4 mm to approximately 5 mm, or approximately 5 mm to approximately 6 mm, or approximately 6 mm to approximately 7 mm, or longer than 7 mm.

[0037] In some embodiments, the juxtaposed sections 502 and 504 each include one or more flange members 502a and 504a. Such flange members (e.g., flange members 502a and 504a) may also be called “fins,” “petals,” or “finger.” The flange members 502a and 504a are configured to contact the tissue and exert juxtaposed pressure on that tissue. The illustrated embodiments include four flange members 502a and four flange members 504a, but other quantities of flange members 502a and 504a may be included. For example, in some embodiments, one, two, three, five, six, seven, eight, or more than eight flange members 502a and / or 504a may be included. In some embodiments, an unequal number of flange members 502a and flange members 504a may be included.

[0038] The flange members 502a and 504a can be configured to be predictable when in contact with the tissue and to exert a desired juxtaposition force. For example, the material, diameter, and other properties of the slender elements can be selected to obtain the desired juxtaposition force. The slender elements (e.g., nitinol slender elements) can be manufactured to have a specific diameter as desired. Slender elements made of other suitable materials and having a larger or smaller diameter can be selected as desired. The shape of the flange members 502a and 504a can also influence the juxtaposition force they exert. That is, geometric aspects of the flange members 502a and / or 504a, such as but not limited to length, width, radius, angle, arc (etc.), can be selected to obtain the desired juxtaposition force.

[0039] In some embodiments, the flange members 502a and 504a may be configured to have an offset orientation between the ends of the anastomosis device 500. That is, the axis of one or more of the individual flange members 502a may be offset from the axis of one or more of the individual flange members 504a (e.g., they may be inclined or not aligned in a straight line). In some such embodiments, some or all of the flange members 502a and 504a may be configured to intersect each other (e.g., they may overlap each other in an intervening arrangement). In some such embodiments, some or all of the flange members 502a and 504a may be offset from each other but do not intersect each other. However, in some embodiments, the axis of one or more of the individual flange members 502a may be aligned substantially in a straight line (e.g., substantially parallel) with the axis of one or more of the individual flange members 504a. In some such embodiments, some or all of the flange members 502a and 504a may be configured to be adjacent to each other. In some such embodiments, some or all of the flange members 502a and 504a may be aligned in a straight line with each other, but not adjacent to each other.

[0040] In some embodiments, one or more of the flange members 502a and / or 504a may have a different configuration compared to one or more of the other flange members 502a and / or 504a. For example, flange member 502a may protrude further toward the central portion 506 than flange member 504a (or vice versa). Alternatively, one or more of the flange members 502a or 504a may each protrude further toward the central portion 506 than the other flange members 502a or 504a.

[0041] In some embodiments, one or more of the flange members 502a and / or 504a may have two or more portions having different curvatures (radii). For example, in the illustrated embodiment, at least some of the flange members 502a and / or 504a extend from the central portion 506 at a first radius, then straighten to become a generally linear portion, then bend at a second radius, and then the flange members 502a and / or 504a end thereafter. In some embodiments, the first radius is not the same as the second radius. In some embodiments, their first and second radii bend in opposite directions.

[0042] In some embodiments, the radii 558 of the flange members 502a and 504a protrude beyond the central portion 506 of the device. Therefore, the force applied by the flange members 502a and 504a can push certain tissues inward at the radius 558, potentially forming an anastomosis that is longer, stronger, or less prone to leakage. In some embodiments, the radius of curvature 558 is determined by the allowable strain of the nitinol material when it is introduced into the delivery system (e.g., sheath). For example, in some embodiments, a strain of approximately 6.4% may occur. However, other strain levels less than or greater than approximately 6.4% are used in some embodiments.

[0043] In some embodiments, including multiple flange members 502a and 504a may tend to reduce the likelihood of causing tissue ischemia. In some embodiments, the individual flange members 502a are configured to be different from each other, and / or the individual flange members 504a are configured to be different from each other. In some embodiments, the flange members 502a and 504a may remain separated from each other (as shown), or in some embodiments, the flange members 502a and 504a may be interconnected by, for example, a covering material 512. In some embodiments, the flange members 502a and 504a may face each other or not, may intersect each other, and may have various shapes (e.g., length, width, angle, radius, outer shape, etc.). All combinations of such designs can be combined to produce anastomotic devices with a wide variety of configurations. In some embodiments, one or both of the flange members 502a and 504a protrude from the central portion 506 in the axial direction and take a shape that achieves a specific desired juxtaposition pressure on the tissue.

[0044] In some embodiments, one or more of the external shape of the flange members, the number of flange members, the size of the slender elements, and the tissue thickness are selectable factors to achieve a specific force profile with respect to displacement. For example, referring to Figures 3-6, various example flange member designs 510, 520, 530, and 540 are shown. The free ends shown in Figures 3-6 are when flange member designs 510, 520, 530, and 540 extend from the instrument body (e.g., anastomotic device 500). The force-to-displacement curves for each are shown in Figure 7.

[0045] An example flange member 510 includes an acutely angled downward region 511 extending from the central end (not shown) and a substantially horizontal region 513 extending away from the instrument. An example flange member 520 includes a moderately acutely angled downward region 514 connected to the instrument and an inclined region 515 extending away from the instrument. An example flange member 520 includes a linear downward region 522 extending away from the instrument. An example flange member 530 includes a gradually inclined bending region 532 extending away from the instrument. In some embodiments, one or more regions of the flange members extend longitudinally toward the central portion of the instrument to which those flange members are part (for example, toward the central portion 506 of the anastomosis device 500).

[0046] The force-to-displacement profiles of specific flange members (e.g., flange members 510, 520, 530, and 540) may be advantageous for achieving desired juxtaposition pressure and / or other performance characteristics. For example, referring to Figure 7, the force-to-displacement graphs show the juxtaposition forces that can be applied by each flange member 510 (510f), 520 (520f), 530 (530f), and 540 (540f). The force-to-displacement profile of flange member 510 may include a straight, steep slope, as shown by 510f. The curve 510f may be particularly advantageous when the juxtaposed organs are not in immediate proximity. Its straight, rapidly increasing force resists the separation of those organs. In some embodiments, the force-to-displacement profile of flange member 520 may include a straight, gentle slope that abruptly changes to a straight, steep slope (520f). Curve 520f may be particularly beneficial for generating large juxtaposition forces during the initial healing phase while anastomosis is forming. During this period, the tissue may thicken and become inflamed by utilizing the steep, linear profile of 520f. As tissue inflammation and the resulting tissue thickening decrease, the slack portion of curve 520f is utilized to help avoid tissue necrosis. The force-to-displacement profile of flange member 530 results in a gentle, linear slope (530f). Curve 530f defines a gradual, linear increase in force with respect to displacement and may be particularly useful for tissues considered brittle and easily penetrated. In other embodiments, the force-to-displacement profile of flange member 540 may include a continuously increasing slope (540f). Such variations of flange members (and other variations are also intended within the scope of this disclosure) may be selected for specific applications as desired. For example, the force-to-displacement curve achieved by flange member 540 rises smoothly and its design allows for contact over a wide area across a wide range of displacements, which may be advantageous for specific applications.

[0047] Figures 8 and 9 illustrate another example of an anastomotic device 1200. The anastomotic device 1200 is an example of a variation of the anastomotic device 500 described above. In particular, the anastomotic device 1200 has first and second juxtaposed sections 1202 and 1204 which are designed differently from the first and second juxtaposed sections 502 and 504 of the anastomotic device 500. As will be further described below, one or more juxtaposed members 1208 and 1210 constituting the first and second juxtaposed sections 1202 and 1204 may be configured to provide desired functional characteristics in several embodiments.

[0048] In some embodiments, the framework of the instrument 1200 or any part thereof may comprise elongated elements such as 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 wire, or combinations thereof. In the illustrated embodiment of the instrument 1200, its framework includes elongated elements formed, for example, by winding. In some embodiments, various types of wire are used at various positions of the instrument 1200. Alternatively, the instrument 1200 or any part thereof may be formed from the same precursor material, which is cut to create the elongated element framework structure as desired. In some embodiments, the instrument 1200 or any part thereof may be composed of polymeric material. The instrument 1200 is shown with a covering material as described above. It should be understood that the anastomotic device 1200 may be constructed using any of the materials and techniques described herein in relation to any other anastomotic devices described herein.

[0049] The central portion 1206 of the instrument may be configured to have suitable radial strength by, for example, varying the sinusoidal amplitude, angle, number of vertices per step, number of steps, wire diameter of the elongated element, and selecting (or not selecting) a covering material. For anastomotic applications, the radial strength of the central portion 1206 may be designed to resist circumferential loading from surrounding tissue. Thus, in some embodiments, the radial strength of the central portion 1206 is configured to facilitate remodeling of the tissue outside the central portion 1206 to approximate the size of the outer diameter of the central portion 1206. When the anastomotic device 1200 (and other anastomotic devices provided herein) is implanted to form an anastomosis, the radial strength of the central portion 1206 provides resistance to hoop forces applied by the surrounding tissue. Thus, an anastomotic device having strong radial strength in the central portion (e.g., central portion 1206) substantially maintains an open lumen of the desired dimensions. In addition, instruments with strong radial strength can advantageously function as a scaffold for tissue growth around the instrument.

[0050] In some embodiments, the material and configuration of the anastomotic device 1200 allow the device 1200 to be elastically compressed, folded, and / or folded into a low-profile configuration for sealing within a lumen for transcatheter delivery or endoscopic / thoracoscopic delivery, and allow the device to self-expand to working size and configuration once positioned at a desired target site in the body and out of its lumen.

[0051] The first juxtaposition portion 1202 and the second juxtaposition portion 1204 are configured to interlock with one or more layers of tissue between them and to apply a juxtaposition force to those tissue surfaces. The juxtaposition force applied by the first and second juxtaposition portions 1202 and 1204 promotes the fixation of the instrument 1200 to the tissue and provides resistance to movement so that the instrument 1200 remains securely positioned at the target site in the patient as desired.

[0052] Each of the first juxtaposition section 1202 and the second juxtaposition section 1204 includes one or more juxtaposition members 1208 and 1210, respectively. The anastomosis device 1200 may be configured in a contracted low-profile delivery configuration in which the juxtaposition members 1208 and 1210 are radially compressed so that they extend substantially parallel to the longitudinal axis of the device. In the deployed or extended configuration, the juxtaposition members 1208 and 1210 protrude outward from the central section 1206.

[0053] In some embodiments, at least one of the juxtaposed members 1208 and / or 1210 is oriented to have a first angle 1216 with respect to the central portion 1206 and a second angle 1214 with respect to the central portion 1206 (as shown in Figure 9). In other words, in some embodiments, at least one of the juxtaposed members 1208 and / or 1210 is non-planar. In the illustrated embodiments, the juxtaposed member 1210 is oriented to have a first angle 1216 with respect to the central portion 1206, and the juxtaposed member 1210 is also oriented to have a second angle 1214 with respect to the central portion 1206. In some embodiments, the first angle 1216 is obtuse. For example, in some embodiments, angle 1216 is acute, for example, less than about 90°, or less than about 75°, or less than about 60°, or less than about 45°, or less than about 30°, or less than about 25°, or less than about 20°, or less than about 15°, or less than about 10°, or less than about 5°. In some embodiments, angle 1216 is between about 15° and about 20°, or between about 10° and about 30°, or between about 5° and about 45°.

[0054] In some embodiments, the angle 1216 is relatively obtuse, and the juxtaposition member 1210 extends toward the central portion 1206, so that a portion of the juxtaposition member 1210 is therefore positioned relatively close to the access position (i.e., the incision position where the anastomotic device 1200 is placed). Thus, this configuration promotes effective and sustainable juxtaposition of tissues.

[0055] In some embodiments, the second angle 1214 is a larger angle than the first angle 1216. For example, in some embodiments, the angle 1214 is greater than about 90°, less than about 45°, less than about 25°, less than about 20°, less than about 15°, less than about 10°, or less than about 5°. In some embodiments, the angle 1214 is between about 30° and about 40°, or between about 20° and about 45°, or between about 30° and about 50°, or between about 40° and about 60°, or between about 50° and about 70°, or between about 60° and about 80°, or between about 70° and about 90°. In some embodiments, the second angle 1214 is larger than the first angle 1216 so that part of the juxtaposed members is positioned further away from the access position. On the one hand, the obtuse first angle 1216 generates a juxtaposition force near the access position through tissue contact, while the larger second angle 1214 allows tissue contact away from the access position, providing a resistance to movement to maintain the instrument 1200 in the correct position. Also, in some embodiments, the larger second angle 1214 allows the ends of the juxtaposition members 1208 and / or 1210 not to be in contact with the tissue in place. In some such embodiments, having fins positioned away from the juxtaposed tissue can delay or avoid the possibility of tissue overgrowth on the fins. By delaying or avoiding tissue overgrowth, the instrument can be easily removed when / when needed. In some embodiments, a single juxtaposition member of this design may provide the benefits associated with having a double-length juxtaposition member.

[0056] In some embodiments, the juxtaposed members 1208 and 1210 are aligned with respect to their axes such that their positions coincide with each other longitudinally around the outer edge of the central portion 1206. In some embodiments, the juxtaposed members 1208 and 1210 are offset from each other's axes such that their positions do not coincide with each other longitudinally around the outer edge of the central portion 1206. In some such embodiments, one or more of the juxtaposed members 1208 of the first juxtaposed portion 1202 overlap longitudinally with one or more of the juxtaposed members 1210 of the second juxtaposed portion 1204, as shown in Figures 8 and 9 (e.g., intersecting in an intervening arrangement). In some embodiments, some or all of the juxtaposed members 1208 and 1210 may be offset from each other, or they may be aligned in a straight line with each other, while not intersecting each other. In some embodiments, some or all of the juxtaposed members 1208 and 1210 may be aligned in a straight line with respect to each other and adjacent to each other.

[0057] Referring to Figures 10-12, an anastomotic device 1300 is shown having a central section 1306, a first juxtaposition section 1302, and a second juxtaposition section 1304 which are interchangeable with any other central sections described herein. In some embodiments, the framework of the device 1300 or any part thereof may comprise one or more elongated elements such as 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 wire, or combinations thereof (as described above with respect to the elongated element 501).

[0058] In the illustrated embodiment of the instrument 1300, the framework consists of a single elongated element formed, for example, by winding and shaping. In some embodiments, various types of elongated elements are used at various positions on the instrument 1300. Alternatively, the anastomotic device 1300 (or a part thereof) may be formed from the same precursor material that is cut and stretched to create the elongated element framework structure as desired. In some embodiments, the instrument 1300 (or a part thereof) may be made of a polymer material. It should be understood that the anastomotic device 1300 may be constructed using any of the materials and techniques described herein with respect to any other anastomotic devices described herein.

[0059] In some embodiments, the framework of the central portion 1306 may be configured such that the central portion 1306 is extendable in the longitudinal direction. For example, in the illustrated embodiment of the anastomotic device 1300, the framework of the central portion 1306 includes a meandering portion that allows for longitudinal expansion and contraction (like a spring). Thus, the longitudinal length of the central portion 1306 is self-adjustable based on the load force in the body. This feature may be advantageous, for example, in maintaining juxtaposition when tissue thickness changes during the healing process (e.g., in at least some cases of acute cholecystitis). It should be understood that this feature may be incorporated into any of the aforementioned embodiments of the device described herein.

[0060] The apparatus 1300 may include a coating material 1312. In some embodiments, the coating material 1312 is made of an elastic material that may have a high percentage of recovery strain (e.g., a recovery strain of about 100% per unit length). Some embodiments of such a coating material may include, but are not limited to, pure silicone, urethane material, or other materials that are absorbed into or laminated with other materials, including fluoropolymers such as ePTFE. In some embodiments, the coating material 1312 is as described herein (e.g., similar to or identical to coating material 512).

[0061] The first juxtaposition portion 1302 and the second juxtaposition portion 1304 are configured to interlock one or more layers of tissue between them and to apply a juxtaposition force to their tissue surfaces. The juxtaposition force applied by the first and second juxtaposition portions 1302 and 1304 promotes the adhesion of the instrument 1300 to its tissue and provides displacement resistance so that the instrument 1300 remains securely positioned at the target site in the patient as desired.

[0062] The first juxtaposition section 1302 and the second juxtaposition section 1304 each include one or more juxtaposition members 1302a or 1302a' and 1304a or 1304a' (also referred to herein as fixing members, fins, flanges, petals, etc.). In some embodiments, the juxtaposition members 1302a and 1304a are exposed slender elements (without covering material). In some embodiments, the juxtaposition members 1302a' and 1304a' have covering material 1312 positioned over at least some area of ​​their slender elements.

[0063] In some embodiments, one or more of the juxtaposed members 1302a or 1302a' and / or 1304a or 1304a' have a different configuration (e.g., shape, length, width, external shape, etc.) from one or more other juxtaposed members 1302a or 1302a' and / or 1304a or 1304a'.

[0064] In some embodiments, the material of the anastomotic device 1300 allows the device 1300 to be elastically compressed, folded, and / or folded into a low-profile configuration to contain it within a lumen for transcatheter or endoscopic / thoracoscopic delivery, and allows the device to self-expand to working size and configuration once it is positioned at a desired target site in the body and out of its lumen. For example, the anastomotic device 1300 may be configured in a contracted delivery configuration in which the framework is compressed to a low profile such that the juxtaposed members 1302a or 1302a' and 1304a or 1304a' extend substantially parallel to the longitudinal axis of the device 1300. In the deployed or expanded configuration, the juxtaposed members 1302a or 1302a' and 1304a or 1304a' extend outward from the central portion 1306.

[0065] In some embodiments, the lengths of some of the juxtaposed members 1302a or 1302a' and 1304a or 1304a' differ in order to apply both sufficient juxtaposition force near the access location or outer edge of the access hole where access is performed, and movement resistance farther away from there. For example, in some embodiments, one or more of the juxtaposed members 1302a or 1302a' are longer than one or more of the juxtaposed members 1304a or 1304a'. In some embodiments, the juxtaposed members 1302a or 1302a' and / or 1304a or 1304a' have different lengths and are alternately swapped or arranged in a pattern on the outer edge of the first juxtaposed section 1302 and / or the second juxtaposed section 1304. In some embodiments, the juxtaposed members 1302a or 1302a' and / or 1304a or 1304a' within each juxtaposed section 1102 and / or 1104 are of uniform length.

[0066] In some embodiments, the juxtaposition members 1302a or 1302a' and / or 1304a or 1304a' have lengths selected at least partially based on the size of the tissue structure into which the instrument 1300 is to be implanted. For example, if the first tissue structure generally includes a smaller shape than the second tissue structure, it may be advantageous for the juxtaposition members 1302a or 1302a' to have different lengths than the juxtaposition members 1304a or 1304a'. In this example, it may be beneficial to have shorter juxtaposition members for the portion that penetrates into smaller tissue structures, while longer juxtaposition members may be more suitable for larger tissue structures. In some such embodiments, shorter juxtaposition members fit more snugly into smaller tissue structures to ensure sufficient tissue contact required by the anastomosis device, while longer juxtaposition members provide resistance to movement that helps hold the instrument in place. In some embodiments, such short and long juxtaposed members 1302a or 1302a' and / or 1304a or 1304a' are staggered, nested, or separated around the outer edges of a particular juxtaposed section 1302 and / or 1304.

[0067] The anastomotic device 1300 (and other embodiments sharing the design features of the anastomotic device 1300) may offer the following advantages: Having juxtaposition members 1302a or 1302a' and / or 1304a or 1304a' of different lengths allows for juxtaposition at various target tissue locations. Having one or more such specific juxtaposition zones minimizes or eliminates leakage of fluid or other contents passing through the lumen of the device. Discrete juxtaposition members 1302a or 1302a' and / or 1304a or 1304a' that move independently of each other may provide favorable juxtaposition member alignment for non-planar tissue shapes. Better alignment can minimize tissue damage, especially when used in diseased tissue beds. The flexible discrete design of the juxtaposed members 1302a or 1302a' and / or 1304a or 1304a' facilitates the removal of the instrument 1300 by folding the juxtaposed members 1302a or 1302a' and / or 1304a or 1304a' parallel to the lumen of the instrument 1300. This flexibility of the juxtaposed members 1302a or 1302a' and / or 1304a or 1304a' may help minimize tissue damage when removing the anastomotic device 1300.

[0068] Referring to Figure 13, another example central section 206 may be included as part of any of the anastomotic devices provided herein. Similar to central sections 506, 1206, and 1306, central section 206 is composed of a framework of one or more elongated elements. While central section 206 without covering is shown to enhance visibility, in some embodiments coverings described in other parts of this specification may be applied to central section 206. In this example, central section 206 is shown in a non-expanding configuration or a low-profile delivery configuration. Once placed in a patient, central section 206 may self-expand or be expanded into an expandable configuration.

[0069] One or more elongated elements of the central section 206 may be constructed from the same type of material and using the same type of technique as described above with respect to the elongated elements of the anastomotic device 500. In some embodiments, the central section 210 is formed from one or more coiled wires. In some embodiments, the central section 206 is formed from a single precursor material that is cut to produce an elongated element framework structure as desired. In some such embodiments, the precursor material is a tube (e.g., a nitinol tube) that is laser-cut to form the desired elongated element framework structure. In some such embodiments, the precursor material is a sheet (e.g., a nitinol sheet) that is laser-cut to form the desired elongated element framework structure. In some embodiments, different types of elongated elements are used in different parts of the central section 206. For example, in some embodiments, the central section 206 or a part thereof may be made of a polymer material.

[0070] The central section 206 includes one or more axial adjustment members 218 extending along the longitudinal axis of the central section 206. The axial adjustment members 218 allow the axial length of the central section 206 (also referred herein as the “longitudinal length”) to expand or contract elastically (as described above with respect to the framework of the central section 1306 of the anastomosis device 1300).

[0071] The central section 206 also includes one or more cells 212. In some embodiments, one or more cells 212 interconnect axial adjustment members 218. The cells 212 enable radial expansion and contraction of the central section 206 and apply radial forces to the instrument to maintain its outer diameter / size while resisting external compressive forces. When the central section 206 expands radially, the cells 212 expand circumferentially and contract longitudinally. The cells 212 are shown having a rhomboid shape, but other shapes may be used. In the illustrated embodiments, pairs of cells 212 are interconnected circumferentially by bridging members 213. However, in some embodiments, a single cell 212 or more than two cells 212 may be included (rather than the pairs shown).

[0072] In some embodiments, cells 212 are separated from adjacent cells 212 along the longitudinal axis of the central portion 206. Therefore, cells 212 connected to the axial adjustment member 218 do not substantially restrict the axial expansion or contraction of the axial adjustment member 218 and / or the central portion 206. In some embodiments, cells 212 provide radial strength to the central portion 206. That is, in some embodiments, cells 212 tend to self-expand into an expanding configuration. Such self-expansion can apply radial forces from the central portion 206 to the tissue in contact with it.

[0073] In some embodiments, the axial length of the central portion 206 is adjusted, for example, by a physician before or during placement to accommodate differences in tissue thickness. In other embodiments, the axial adjustment member 218 self-responds to mechanical forces acting in situ on the placed anastomotic device. For example, the axial adjustment member 218 allows the axial length of the device to dynamically adapt during the healing process (as described above with respect to the central portion 1306).

[0074] The anastomotic devices provided herein can be placed at a target site in a patient using one or more catheters, delivery sheaths, and other suitable instruments and techniques. In some embodiments, the anastomotic devices provided herein can be placed using an endoscopic or laparoscopic approach.

[0075] It should be understood that one or more design features of the anastomotic devices provided herein can be combined with other features of other anastomotic devices provided herein. In practice, hybrid designs can be created by combining various features derived from two or more anastomotic device designs provided herein, and such hybrid designs are within the scope of this disclosure.

[0076] In some such embodiments, the apparatus does not include a tunnel or central opening through which the apparatus passes.

[0077] In some embodiments, the device provided herein may be used to seal or fix a heart valve implant. A heart valve implant allows for unidirectional flow of blood from the heart chambers and typically has a first inlet and a second outlet. The contraction of the heart causes blood to flow through the valve from its inlet to its outlet. The valve assembly within the heart valve implant ensures unidirectional flow between its inlet and outlet ends, opening when blood pressure is higher at the inlet end to allow flow from the inlet to the outlet, and closing when the pressure is higher at the outlet than at the inlet end to prevent flow. In some embodiments, the device includes a tunnel or central opening through which the device passes, along with juxtaposition sections for fixing the valve assembly and an anti-reflux seal. The valve assembly can be mounted within the tunnel or central opening. The juxtaposition sections of the device may be configured to conform well to the shape of the heart chambers or blood vessels and to respond to the heartbeat. In some embodiments, a covering material is configured to prevent flow around the juxtaposition sections while allowing flow through the valve assembly within the tunnel or opening.

[0078] The present invention has been described both in general terms and in relation to specific embodiments. It will be apparent to those skilled in the art that various modifications and changes can be made to these embodiments without departing from the scope of this disclosure. Accordingly, these embodiments include such modifications and changes to the extent that they fall within the scope of the attached claims and their equivalents.

Claims

1. The system comprises two or more separate first flange members configured to contact a first tissue surface and to apply a parallel force to the first tissue surface, wherein the first flange members are formed from a first elongated member, a first parallel portion, The system comprises two or more mutually separated second flange members configured to contact a second structural surface and to apply a parallel force to the second structural surface, the second flange members being formed from a second elongated member, and A central portion having a first end and a second end, and a lumen extending between the first end and the second end, wherein the central portion defines a longitudinal axis, is positioned between the first and second juxtaposed portions, and is formed from a third elongated member, the third elongated member being not connected to the first and second elongated members, the central portion A frame comprising a plurality of elongated members that define, At least one of the first flange members and at least one of the second flange members comprises a curved portion, a downward portion extending in the longitudinal direction of the central portion, and a horizontal portion extending horizontally relative to the downward portion. The frame comprises, A medical device in which the first parallel section, the second parallel section, and the central section are connected by a covering material.

2. The medical device according to claim 1, wherein the descending portion is a straight descending portion.

3. The medical device according to claim 1, wherein the central portion is configured to expand and contract longitudinally to maintain contact between the first and second tissue surfaces of the first and second juxtaposed portions, respectively, over a series of tissue thicknesses.

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