Sutureless anastomosis systems and methods

Abstract

Disclosed herein are anastomosis systems and couplers thereof. In an example, an anastomosis system configured to suturelessly coupled a first vessel and a second vessel includes a coupler comprising an axial body and a plurality of adhesion apertures disposed along a length of the axial body. The first vessel is configured to extend through a lumen of the axial body, wherein the coupler is configured to secure the first vessel thereto via biocompatible adhesive filling the adhesion apertures, optionally configured to form stud-like structures extending through the adhesive apertures upon solidification of the adhesive.

Description

SUTURELESS ANASTOMOSIS SYSTEMS AND METHODSFIELD

[0001] The present invention relates to anastomosis systems and methods for connecting bodily vessels.BACKGROUND

[0002] Traditional methods of connecting bodily vessels (e.g., blood vessels, lymphatic vessels, etc.), such as suturing, can be time-consuming and technically demanding. These methods often require high precision and skill, posing challenges during complex surgeries, and also necessitate the use of special high-cost equipment such as high-magnification, high- end microscopes and costly ultrathin sutures. Moreover, sutured anastomoses can be prone to complications such as leaks, infections, and thrombosis. Therefore, there is a need for a more efficient, reliable, and less technically demanding method for anastomosis between bodily vessels.SUMMARY

[0003] The present disclosure provides a solution to the challenges of traditional suturing by introducing a sutureless anastomosis system and method. At least some of the disclosed systems employ external couplers to securely connect bodily vessels, such as blood vessels and lymphatic vessels, ensuring a tight connection that facilitates fluid flow between them. The disclosed systems can be suitable for connecting a variety of bodily tubes, including arteries, veins, and lymphatic vessels, enabling both same-type (e.g., vein-to-vein) and cross-type (e.g., lymphovenous) connections. The systems can allow for various configurations of vessel connections, including end-to-end, side-to-end, end-to-side, and side-to-side.

[0004] Following the establishment of a fluid connection between at least two vessels, evaluating the acute and preferably chronic patency of this connection becomes critically important. Several methods exist for evaluating patency, particularly in small vessels such as lymphatic ones, including Lymphoscintigraphy, Indocyanine Green (ICG) Lymphography, Magnetic Resonance Lymphangiography (MRL), Computed Tomography Lymphangiography (CTL), Ultra-high frequency ultrasound, Lymphatic Vessel Cannulation and Dye Injection, Near-Infrared Fluorescence Imaging, Lymphangiography, Bioimpedance Spectroscopy (BIS), and Photoplethysmography. However, many of these technologies are cumbersome, invasive,or insufficiently sensitive for evaluating the patency of specific vessels. Therefore, there is a need for improved technology to evaluate vessel anastomosis patency.

[0005] Anastomosis of vessels is particularly challenging, especially when involving small and delicate vessels, such as lymphatic vessels that are used in lymphovenous bypass which may have diameters ranging from about 0.3 to 1.0 mm. This specialized field of surgery, known as super microsurgery, requires the use of high magnification microscopes and ultra-thin sutures (11-0 or even 12-0), necessitating a highly skilled and experienced surgical team. The minute size of these vessels makes their handling, positioning, and suturing extremely difficult.

[0006] This solution disclosed herein aims to simplify the handling of such vessels by securing them to the internal surface of a coupler, the coupler itself being significantly larger and easier to manage than the vessel itself. This coupler includes securing means on its outer surface that fix the target vessel in place to form a sutureless anastomosis. As an alternative, it can be connected to a second coupler secured to the target vessel, with the two couplers then joined through an integrated mechanical mechanism to ensure a precise and secure connection.

[0007] An anastomosis system can comprise a coupler that includes an axial body extending from a first axial end portion to a terminal end portion, the axial body defining a lumen. The system is configured to suturelessly couple a first vessel and a second vessel such that fluid communication is formed therebetween.

[0008] In some examples, the coupler comprises a plurality of adhesion apertures disposed along a length of the axial body and radially extending between an outer surface of the axial body and an inner surface of the axial body.

[0009] In some examples, the coupler is configured to secure the first vessel extending through the lumen to the axial body via biocompatible adhesive filling at least partially the adhesion apertures.

[0010] In some examples, the adhesion apertures are configured to facilitate formation of studlike structures extending through the adhesive apertures upon solidification of the adhesive applied to fill the adhesion apertures.

[0011] In some examples, each of the adhesion apertures has an area within a range of 104mm2to 0.2 mm2, inclusive.

[0012] In some examples, the adhesion apertures occupy between 2% and 20% of a total surface area of the axial body.

[0013] In some examples, wherein the adhesion apertures are arranged non-circumferentially over the axial body.

[0014] In some examples, the adhesion apertures are distributed in a spiral pattern along a longitudinal axis of the axial body.

[0015] In some examples, the coupler further comprises inner anchors extending radially inwards from the inner surface of the axial body and configured to engage with the first vessel.

[0016] In some examples, the coupler further comprises one or more tissue-growth promoting openings radially extending between the outer surface and the inner surface and configured to promote tissue growth therethrough.

[0017] In some examples, the one or more tissue-growth promoting openings occupy between 1% and 10% of the total surface area of the axial body.

[0018] In some examples, each of the one or more tissue-growth promoting openings defines a textured perimeter.

[0019] In some examples, a terminal edge of the terminal end portion defines a staged geometry.

[0020] In some examples, the axial body further comprises an axial slot extending longitudinally from the first end portion to the terminal portion, the slot having a width configured to allow insertion of the first vessel, in a non-expanded state of the first vessel, therethrough into the lumen.

[0021] In some examples, the coupler further comprises one or more outer anchors extending outwardly from the axial body at an angle in a range of 1° to 60°, and configured to engage the second vessel.

[0022] In some examples, the one or more outer anchors comprise barbs.

[0023] In some examples, the anastomosis system further comprises a delivery tube configured to extend around the coupler.

[0024] In some examples, the one or more outer anchors are configured to assume a compressed configuration when retained inside the delivery tube, and to spring outwardly when exposed from the delivery tube.

[0025] In some examples, there is provided a push tool that can be either part of the anastomosis system, or provided as a separate tool which is not necessarily included in the anastomosis system.

[0026] In some examples, the push tool comprises an engagement portion, a handle, and a shaft extending between the engagement portion and the handle.

[0027] In some examples, the engagement portion can be configured to slide over a portion of the first vessel extending proximally from the coupler.

[0028] In some examples, the engagement portion can be configured to engage with the first axial end portion of the coupler such that when the push tool is distally pushed, the engagement portion pushes the coupler therewith.

[0029] In some examples, the engagement portion is configured to be axially moved through the delivery tube.

[0030] In some examples, the engagement portion comprises a gap.

[0031] In some examples, the push tool further comprises an elbow defined along the shaft and configured to offset the handle from the first vessel secured to the coupler.

[0032] In some examples, there is provided an expansion device that can be either part of the anastomosis system, or provided as a separate device which is not necessarily included in the anastomosis system.

[0033] In some examples, the expansion device is configured to expand an end portion of a vessel.

[0034] In some examples, the expansion device comprises a shaft, and an expandable portion extending from a distal end of the shaft.

[0035] In some examples, the expandable portion comprises a plurality of outwardly biased struts.

[0036] In some examples, the expansion device further comprises a delivery catheter disposed over the shaft and axially movable relative thereto.

[0037] In some examples, the expandable portion is configured to move between a compacted configuration when residing inside the delivery catheter and an expanded configuration in which the struts extend outwardly and farther away from each other when exposed from the delivery catheter.

[0038] In some examples, the plurality of struts circumferentially span across between 150° and 270°, inclusive.

[0039] In some examples, the coupler is a first coupler, and the system further comprises a second coupler.

[0040] In some examples, the second coupler comprises an axial body extending from a first axial end portion to a second end portion and defining a lumen.

[0041] In some examples, the second coupler comprises a plurality of adhesion apertures disposed along a length of the axial body of the second coupler.

[0042] In some examples, the second coupler is configured to secure the second vessel extending through the lumen of its axial body via biocompatible adhesive filling the adhesionapertures of the second coupler, optionally forming stud-like structures extending through the adhesive apertures of the second coupler upon solidification of the adhesive.

[0043] In some examples, the axial body of the second coupler further comprises an axial slot having a width configured to allow insertion of the second vessel, in a non-expanded state of the second vessel, therethrough into the lumen of the axial body of the second coupler.

[0044] In some examples, the anastomosis system further comprises a locking member configured to move between an unlocked state and a locked state.

[0045] In some examples, the locking member comprises a support body axially slidable, in the unlocked state, over one of the first coupler or the second coupler.

[0046] In some examples, the locking member further comprises a grip portion axially extending from the support body and configured to extend towards and lock against the other one of the second coupler or the first coupler, thereby moving the grip portion to the locked state configured to couple the first coupler and the second coupler to each other.

[0047] In some examples, the system is configured to form, in the locked state, fluid communication between a first vessel secured to the first coupler and a second vessel secured to the second coupler.

[0048] In some examples, the second adaptor further comprises a side arm extending from a side opening of the axial body of the second adaptor, wherein the first adaptor is configured to be coupled to the side arm.

[0049] In some examples, the terminal end portion of the first adaptor defines a curved terminal edge matching the curvature of an edge surrounding the side opening of the second adaptor.

[0050] In some examples, the first adaptor further comprises one or more axial locking protrusions, and the side arm further comprises one or more arm slots configured to receive the one or more locking protrusions.

[0051] In some examples, there is provided a dilator that can be either part of the anastomosis system, or provided as a separate device which is not necessarily included in the anastomosis system.

[0052] In some examples, the dilator is configured to extend through a side opening of the second vessel into a lumen of the second vessel, and comprises a tapering surface at a distal end portion thereof.

[0053] In some examples, the dilator further comprises a marker configured to indicate a position of the dilator during insertion of the second vessel into the lumen of the axial body of the second coupler.

[0054] In some examples, a proximal end portion of the dilator further comprises a connector interface configured to be couple an inflator thereto.

[0055] In some examples, there is provided an adhesive dispenser that can be either part of the anastomosis system, or provided as a separate dispenser which is not necessarily included in the anastomosis system.

[0056] In some examples, the adhesive dispenser comprises a container configured to contain biocompatible adhesive, wherein the container extends from a container top to a bottom portion.

[0057] In some examples, the adhesive dispenser further comprises an elongated applicator configured to extend into the container through an entry opening formed at the container top.

[0058] In some examples, a diameter of the entry opening is larger than a diameter of the applicator by 0.01 to 0.2 mm.

[0059] In some examples, the container top comprises an entry cap defining the entry opening.

[0060] In some examples, the entry cap is funnel-shaped.

[0061] In some examples, the system further comprises a holder comprising a holder body, a shaft extending distally from the holder body, and a loop at a distal end of the shaft, wherein the shaft is configured to enable placement of coupler thereover.

[0062] In some examples, the holder further comprises a sleeve configured to be disposed over the coupler when the coupler is positioned over the shaft.

[0063] In some examples, an anastomosis comprises one or more of the components recited in Examples 1-55 below.

[0064] A method of forming an anastomosis between a first vessel and a second vessel can comprise decreasing pressure within the first vessel.

[0065] In some examples, the method further comprises inserting the first vessel into a lumen of an axial body of a coupler.

[0066] In some examples, the method further comprises expanding the first vessel to bring an outer surface of the first vessel into contact with an inner surface of the axial body.

[0067] In some examples, the method further comprises applying biocompatible adhesive to a plurality of adhesion apertures formed along a length of the axial body, thereby securing the first vessel to the axial body of the coupler.

[0068] In some examples, the securing the first vessel to the axial body comprises forming stud-like structures extending through the adhesion apertures upon solidification of the adhesive.

[0069] In some examples, each of the adhesion apertures has an area within a range of 104mm2to 0.2 mm2, inclusive.

[0070] In some examples, the first vessel is a lymphatic vessel.

[0071] In some examples, the second vessel is a vein.

[0072] In some examples, the decreasing pressure within the first vessel comprises clamping the first vessel at offset regions of the first vessel.

[0073] In some examples, the method further comprises trimming the first vessel.

[0074] In some examples, the trimming comprises forming an extended portion of the first vessel terminating at a cut edge that is axially offset from a terminal edge of a terminal end portion of the axial body.

[0075] In some examples, a length of the extended portion is in a range of 1 to 10 times the diameter of the first vessel in an expanded state of the first vessel.

[0076] In some examples, the method further comprises inserting the extended portion of the first vessel into the second vessel.

[0077] In some examples, the method further comprises

[0078] In some examples, the inverting the extended portion over the terminal end portion, and adhering it to the terminal end portion.

[0079] In some examples, the expanding the first vessel comprises inserting an expandable portion of an expansion device into a lumen of the first vessel.

[0080] In some examples, the expanding the first vessel further comprises moving the expandable portion from a compacted configuration to an expanded configuration thereof.

[0081] In some examples, the inserting the expandable portion comprises maintaining the expandable portion inside a delivery catheter, and wherein the moving the expandable portion to the expanded configuration comprises exposing the expandable portion out of the delivery catheter.

[0082] In some examples, the expandable portion comprises at least one wire configured to form a plurality of coils in the expanded configuration.

[0083] In some examples, the expandable portion comprises a plurality of outwardly biased struts arranged to circumferentially span 360° around a central axis of the expandable portion.

[0084] In some examples, the expandable portion comprises an inflatable balloon, wherein the moving the expandable portion to the expanded configuration comprises injecting inflation fluid into the balloon via an inflation tube of the expansion device.

[0085] In some examples, the expanding the first vessel comprises placing the coupler inside a chamber defined by a canister of a vessel expansion system.

[0086] In some examples, the expanding the first vessel further comprises maintaining offset regions of the first vessel, extending through the lumen of the axial body of the coupler, clamped by end portions of the canister.

[0087] In some examples, the expanding the first vessel further comprises applying vacuum to the chamber via a tube connected to a port extending through the canister.

[0088] In some examples, the placing the coupler inside a chamber comprises supporting the coupler by one or more supports extending from the canister into the chamber.

[0089] In some examples, the canister comprises a first segment and a second segment configured to be detachably coupled to each other.

[0090] In some examples, the applying the adhesive to the plurality of adhesion apertures comprises dispensing the adhesive over an outer surface of the axial body in a manner configured to fill the adhesive apertures with the adhesive.

[0091] In some examples, the applying the adhesive to the plurality of adhesion apertures comprises dispensing the adhesive over an inner surface of the axial body in a manner configured to fill the adhesive apertures with the adhesive when the first vessel is expanded against the inner surface of the axial body.

[0092] In some examples, the applying the adhesive to the plurality of adhesion apertures comprises dispensing the adhesive over an outer surface of the first vessel in a manner configured to fill the adhesive apertures with the adhesive when the first vessel is expanded against the axial body.

[0093] In some examples, the inserting the first vessel into the lumen of the axial body comprises passing the first vessel through an axial slot extending along a length of the axial body.

[0094] In some examples, the inserting the first vessel into the lumen of the axial body comprises axially drawing the first vessel into and past the lumen of the axial body, in a direction oriented from a first axial end portion to a second axial end portion of the axial body.

[0095] In some examples, the drawing comprises attaching a pull member to an end portion of the first vessel.

[0096] In some examples, the pull member comprises a wire.

[0097] In some examples, the applying the adhesive to the plurality of adhesion apertures comprises inserting an elongated applicator through an entry opening at a top of a container into the container of an adhesion dispensing apparatus, such that a distal portion of the applicator is dipped in adhesive contained within the container.

[0098] In some examples, the applying the adhesive to the plurality of adhesion apertures further comprises extracting the applicator out of the container.

[0099] In some examples, the applying the adhesive to the plurality of adhesion apertures further comprises applying the adhesive coated over the distal portion of the applicator to the axial body.

[0100] In some examples, the entry opening is larger than a diameter of the applicator by 0.01 to 0.2 mm.

[0101] In some examples, the container top comprises an entry cap defining the entry opening.

[0102] In some examples, the entry cap is funnel-shaped.

[0103] In some examples, the applying the adhesive to the plurality of adhesion apertures comprises placing the coupler and the first vessel extending therethrough inside a chamber of a housing of an adhesive application system, wherein the applicator comprises two flanged portions radially extending outwards from axial end portions of its axial body, such that an enclosed cavity is formed between the axial body, the housing, and the housing, wherein the enclosed cavity is in fluid communication with the plurality of adhesive openings

[0104] In some examples, the applying the adhesive to the plurality of adhesion apertures further comprises introducing the adhesive into the enclosed cavity via a tube coupled to a coupler extending through the housing, wherein the coupler is in fluid communication with the cavity.

[0105] In some examples, the introducing the adhesive into the enclosed cavity is performed after the expanding the first vessel.

[0106] In some examples, the method further comprises curing the adhesive to form an adhesive cast around the axial body.

[0107] In some examples, the axial body further comprises one or more tissue-growth promoting openings radially extending between the outer surface and the inner surface and configured to promote tissue growth therethrough.

[0108] In some examples, the method further comprises securing the second vessel to the coupler, thereby forming the anastomosis creating fluid communication between the first vessel and the second vessel.

[0109] In some examples, the portion of the second vessel which is secured to the coupler extends around an outer side of the coupler.

[0110] In some examples, the securing the second vessel to the coupler comprises engaging the second vessel by one or more outer anchors extending angularly outwards from the axial body of the coupler.

[0111] In some examples, the securing the second vessel to the coupler comprises extending the coupler, while maintaining the one or more outer anchors in a compacted configuration thereof, into a lumen of the second vessel

[0112] In some examples, the securing the second vessel to the coupler further comprises moving the one or more outer anchors to a free expanded configuration thereof.

[0113] In some examples, the maintaining the one or more outer anchors in the compacted configuration comprises maintaining the one or more anchors inside a delivery tube, and the moving the one or more outer anchors to the expanded configuration comprises exposing the one or more anchors out of the delivery tube.

[0114] In some examples, the anastomosis formed by the coupler is an end-to-side anastomosis, wherein the method further comprises forming a side opening in the second vessel, and wherein the extending the coupler into the lumen of the second vessel comprises extending the coupler through the side opening of the second vessel.

[0115] In some examples, the engaging the second vessel by the one or more outer anchors comprises, after the moving the one or more outer anchors to the expanded configuration, pulling the anchor to bring tips of the outer anchors into contact with the second vessel.

[0116] In some examples, the anastomosis formed by the coupler is an end-to-end anastomosis.

[0117] In some examples, the exposing the one or more outer anchors out of the delivery tube comprises distally sliding an engagement portion of a push tool, over portion of the first vessel extending proximally from a first axial end portion of the axial body, until the engagement portion contacts the first axial end portion.

[0118] In some examples, the exposing the one or more outer anchors out of the delivery tube further comprises applying continuous push force on the push tool, thereby distally pushing the axial body of the one or more outer anchors are exposed out of the delivery tube.

[0119] In some examples, the method further comprises, before the extending the coupler into the lumen of the second vessel, expanding an end portion of the second vessel.

[0120] In some examples, the expanding the end portion of the second vessel comprises advancing an expandable portion of an expansion device into the distal portion of the second vessel, wherein the expandable portion comprises a plurality of outwardly biased struts which are maintained inside a delivery catheter to keep them in a compacted configuration.

[0121] In some examples, the expanding the end portion of the second vessel further comprises exposing the expandable portion out of the delivery catheter, thereby allowing the struts to spring radially outwards and away from each other.

[0122] In some examples, the plurality of struts circumferentially span across between 150° and 270°, inclusive.

[0123] In some examples, the extending the coupler into the lumen of the second vessel comprises extending the coupler through a portion that is not covered by the struts of the expansion device.

[0124] In some examples, the coupler is a first coupler, and the system further comprises a second coupler.

[0125] In some examples, the method further comprises securing the second vessel to the second coupler.

[0126] In some examples, the method further comprises suturelessly coupling the second coupler to the first coupler, thereby forming the anastomosis that creates fluid communication between the first vessel and the second vessel.

[0127] In some examples, the securing the second vessel to the second coupler comprises decreasing pressure within the second vessel.

[0128] In some examples, the securing the second vessel to the second coupler further comprises inserting the second vessel into a lumen of an axial body of the second coupler.

[0129] In some examples, the securing the second vessel to the second coupler further comprises expanding the second vessel to bring an outer surface of the second vessel into contact with an inner surface of the axial body of the second coupler.

[0130] In some examples, the securing the second vessel to the second coupler further comprises applying biocompatible adhesive to a plurality of adhesion apertures formed along a length of the axial body of the second coupler.

[0131] In some examples, the securing the second vessel to the axial body of the second coupler comprises forming stud-like structures extending through its adhesion apertures upon solidification of the adhesive

[0132] In some examples, the inserting the second vessel into the lumen of the axial body of the second coupler comprises passing the second vessel through an axial slot extending along a length of the axial body of the second coupler.

[0133] In some examples, the method further comprises trimming the second vessel.

[0134] In some examples, the coupling the second coupler to the first coupler forms an end-to- end anastomosis.

[0135] In some examples, wherein the coupling the second coupler to the first coupler comprises approximating terminal end portions of the first vessel and the second vessel to each other.

[0136] In some examples, wherein the coupling the second coupler to the first coupler further comprises locking the first coupler and the second coupler to each other by utilizing a locking member that includes a support body and a grip portions axially extending from the support body.

[0137] In some examples, the grip portion comprises one or more grip arms having inner protrusions, wherein the utilizing the locking member comprises sliding the support body over the axial body of the first coupler until the one or more inner protrusions snap into one or more corresponding retention cavities of the second coupler.

[0138] In some examples, the sliding the support body comprises moving the support body into contact with a stopper extending radially outwards from the axial body of the first coupler.

[0139] In some examples, the utilizing the locking member comprises sliding the support body over the axial body of the second coupler until a protrusion extending radially outwards from the axial body of the second coupler is positioned inside an engagement recess defined by the locking member.

[0140] In some examples, the sliding the support body comprises moving the support body into contact with a stopper extending radially outwards from the axial body of the second coupler.

[0141] In some examples, the second coupler comprises a side arm extending from a side opening of the axial body, wherein the coupling the second coupler to the first coupler forms an end-to-side anastomosis.

[0142] In some examples, the method further comprises forming a side opening in the second vessel.

[0143] In some examples, the forming the side opening in the second vessel is performed prior to the insertion of the second vessel into the lumen of the axial body of the second coupler.

[0144] In some examples, the method further comprises extending a guidewire through the side opening of the second vessel into the lumen of the second vessel.

[0145] In some examples, the method further comprises advancing a dilator over the guidewire, extending through a passage lumen of the dilator, into the lumen of the second vessel, wherein the dilator defined a tapering surface on a distal end portion thereof.

[0146] In some examples, the method further comprises, before the insertion of the second vessel into the lumen of the axial body of the second coupler, retracting the dilator to a position marked by a marker of the dilator.

[0147] In some examples, the insertion of the vessel into the lumen of the axial body of the second coupler comprises aligning the side opening of the second coupler with the side opening of the second vessel.

[0148] In some examples, the method further comprises re-advancing the dilator into the lumen of the second vessel.

[0149] In some examples, the expanding the second vessel comprises extracting the guidewire out of the passage lumen.

[0150] In some examples, the expanding the second vessel further comprises coupling an inflator containing inflation fluid to a connector interface at a proximal end portion of the dilator.

[0151] In some examples, the expanding the second vessel further comprises introducing the inflation fluid, via the passage lumen of the dilator, into the lumen of the second vessel.

[0152] In some examples, the method further comprises removing the dilator from second vessel.

[0153] In some examples, the coupling the second coupler to the first coupler comprises insertion of the first coupler into the side arm.

[0154] In some examples, the inserting the first coupler into the side arm comprises inserting one or more axial locking protrusions extending radially outwards from the axial body of the first coupler into corresponding one or more arm slots formed along the side arm.

[0155] In some examples, at least one of the locking protrusions is wider than the corresponding arm slot into which it is configured to extend.

[0156] In some examples, the inserting one or more axial locking protrusions into the one or more arm slots comprises aligning one or more locking grooves of the one or more locking protrusions with one or more arm grooves of the side arm.

[0157] In some examples, the coupling the second coupler to the first coupler further comprises placing at least one O-ring in the one or more locking grooves and the one or more arm grooves aligned therewith.

[0158] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0159] Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.In the Figures:

[0160] Figs. 1A-1F illustrate optional stages of an exemplary method for axially drawing a vessel through a coupler and securing the vessel thereto.

[0161] Fig. 2 shows an exemplary attachment configuration of a pull member to a vessel.

[0162] Figs. 3A-3C illustrate various examples of adhesion apertures of a coupler.

[0163] Figs. 4A-4D illustrate various examples of adhesion apertures comprising interior extensions.

[0164] Figs. 5A-5D illustrate various examples of inner anchors of a coupler.

[0165] Fig. 5E illustrates exemplary inner grooves of a coupler.

[0166] Fig. 6A is a side view of an axial body of a coupler having various examples of inner anchors cut from its wall material, in an as-cut configuration.

[0167] Fig. 6B is a front view of the axial body of Fig. 6A.

[0168] Fig. 7A shows the inner anchors of Fig. 6A in an inwardly-bent configuration.

[0169] Fig. 7B is a front view of the axial body of Fig. 7A.

[0170] Fig. 8A is a perspective view of an exemplary coupler comprising outer anchors, in an unbent configuration of the outer anchors.

[0171] Fig. 8B is a perspective view of an exemplary coupler defining a staged terminal edge.

[0172] Fig. 9 is a cross-sectional view of a coupler comprising outer anchors, in an outwardly- bent configuration thereof.

[0173] Fig. 10 shows a vessel secured to the inner surface of an anchor having outer anchors.

[0174] Figs. 11 A- 11C illustrate optional stages of an exemplary method for utilizing an expansion device configured to expand an end portion of a second vessel.

[0175] Fig. 12 shows a coupler equipped with outer anchors, forming an end-to-side anastomosis.

[0176] Fig. 13 illustrates a push tool.

[0177] Figs. 14A-14B show optional stages of an exemplary method for forming an end-to- end anastomosis utilizing a delivery tube and push tool of Fig. 13.

[0178] Fig. 15 shows an exemplary adhesive dispenser.

[0179] Fig. 16 is a perspective view of an exemplary coupler that includes an axial slot.

[0180] Fig. 17 shows an exemplary first coupler that includes axial locking protrusions.

[0181] Fig. 18 shows an exemplary second coupler that includes a side arm.

[0182] Figs. 19A-19F illustrate optional stages of an exemplary method for securing a vessel to a coupler that includes an axial slot.

[0183] Figs. 20A-20C illustrate optional stages of an exemplary method for securing a second vessel to a second coupler that includes a side-arm.

[0184] Figs. 21A-21C illustrate optional stages of an exemplary method for coupling a first anchor of the type shown in Fig. 17 to a second anchor of the type shown in Fig. 18.

[0185] Fig. 22 shows a cross-sectional view of a terminal end portion of a coupler that defines an inner funnel-shaped portion.

[0186] Fig. 23 shows a terminal end portion of a coupler that defines a curved terminal edge.

[0187] Fig. 24 shows a terminal end portion of a coupler that defines an angled terminal edge.

[0188] Fig. 25A shows a terminal end portion of a coupler that defines a tapering outer surface.

[0189] Figs. 25B-25C show optional stages of an exemplary method for inverting an extended portion of a vessel over a terminal end portion of a coupler.

[0190] Fig. 26 shows an exemplary expansion device comprising a helically-shaped wire.

[0191] Fig. 27 shows an exemplary expansion device comprising a plurality of outwardly- biased struts.

[0192] Fig. 28 shows an exemplary expansion device comprising an inflatable balloon mounted on an inflation tube.

[0193] Figs. 29A-29B show an exemplary vessel expansion system and optional stages of an exemplary method for utilization thereof.

[0194] Figs. 3OA-3OB show optional stages of an exemplary method for utilizing an adhesive application system.

[0195] Figs. 31A-31I illustrate optional stages of an exemplary method for forming a side-to- side anastomosis using a locking member configured to mate with a retention groove.

[0196] Fig. 32A shows a holder and a coupler disposed over a shaft thereof.

[0197] Figs. 32B-32D show optional stages of an exemplary method for utilization of the holder of Fig. 32A for placement of the coupler over a target vessel.DETAILED DESCRIPTION

[0198] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0199] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0200] All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.

[0201] As used in this application and in the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the terms "have" or "includes" means "comprises". Further, the terms "coupled", "connected", and "attached", as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0202] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as "inner", "outer", "upper", "lower", "inside", "outside", "top", "bottom", "interior", "exterior", "left", right", and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" part can become a "lower" part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0203] The term "plurality" or "plural" when used together with an element means two or more of the element. Directions and other relative references (for example, inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0204] The terms "longitudinal" and "axial" are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0205] The terms "axial direction", "radial direction", and "circumferential direction" have been used herein to describe the arrangement and assembly of components relative to the geometry of the frame of the prosthetic valve, or the geometry of an inflatable balloon that can be used to expand a prosthetic valve. Such terms have been used for convenient description, but the disclosed examples are not strictly limited to the description. In particular, where a component or action is described relative to a particular direction, directions parallel to the specified direction as well as minor deviations therefrom are included. Thus, a description of a component extending along an axial direction of the frame does not require the component to be aligned with a center of the frame; rather, the component can extend substantially along a direction parallel to a central axis of the frame.

[0206] As used herein, the terms "integrally formed" and "unitary" refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other.

[0207] As used herein, operations that occur "simultaneously" or "concurrently" occur generally at the same time as one another, although delays in the occurrence of operation relative to the other due to, for example, spacing between components, are expressly within the scope of the above terms, absent specific contrary language.

[0208] As used herein, terms such as "first", "second", and the like are intended to serve as respective labels of distinct components, steps, etc. and are not intended to connote or imply aspecific sequence or priority. For example, unless otherwise stated, a step of performing a second action and / or of forming a second component may be performed prior to a step of performing a first action and / or of forming a first component.

[0209] As used herein, the term "substantially" means the listed value and / or property and any value and / or property that is at least 75% of the listed value and / or property. Equivalently, the term "substantially" means the listed value and / or property and any value and / or property that differs from the listed value and / or property by at most 25%. For example, "at least substantially parallel" refers to directions that are fully parallel, and to directions that diverge by up to 22.5 degrees.

[0210] In the present disclosure, a reference numeral that includes an alphabetic label (for example, "a", "b", "c", etc.) is to be understood as labeling a particular example of the structure or component corresponding to the reference numeral. Accordingly, it is to be understood that components sharing like names and / or like reference numerals (for example, with different alphabetic labels or without alphabetic labels) may share any properties and / or characteristics as disclosed herein even when certain such components are not specifically described and / or addressed herein.

[0211] Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and systems may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.

[0212] The anastomosis of small and particularly capillary tubes is challenging, especially for vessels in the lymphatic system. Lymphatic vessels have a diameter of about 0.1 mm to 1 mm, with very thin walls and minimal smooth muscle. The lymph flow in these vessels is slow, peristaltic and under low pressure, making it difficult to handle, maneuver, and suture them. This disclosure addresses these challenges by providing a system that fixes the outer surface of the vessel to a coupler, making it mechanically more accessible for coupling.

[0213] The terms "conductor" and “vessel”, as used herein, are interchangeable and refer to a structure that may include a lumen. Examples of such conductors or vessel include, but are not limited to, lymphatic vessels, blood vessels, and airway structures (such as the trachea, bronchus, and bronchioles). Other examples include gastrointestinal structures (such as theesophagus, small intestine, or large intestine), urinary system tubes that transport urine, and reproductive system structures, such as spermatic ducts. Additionally, the conductor may be a structure or organ that does not contain a lumen, such as nerves.

[0214] The connection may be established between a body structure or organ and itself, between different body structures or organs, or between a body structure or organ and an artificial structure. Examples of artificial structures include grafts, artificial vessels, or nerve conductors. In some embodiments, the connection may be made to a structure or organ obtained from a human donor or a xenogeneic (non-human) donor.

[0215] While a connection between a lymphatic vessel and a vein is used as an example, this technology may also be applied as a sutureless anastomosis to connect various bodily vessels, including, but not limited to, arteries, arterioles, capillaries, veins, venules, lymphatic vessels, gastrointestinal vessels, bile duct vessels, airway tubes such as bronchi and bronchioles, ureteric vessels, renal vessels, reproductive vessels, nerve vessels, muscular vessels, splenic vessels, hepatic vessels, pancreatic vessels, thyroid vessels, adrenal vessels, intestinal vessels, mesenteric vessels, ovarian vessels, testicular vessels, and lymph nodes and vessels. This comprehensive list covers a wide range of bodily systems and their respective vessels where this technology could potentially be applied.

[0216] Disclosed herein are systems and / or couplers thereof configured to connect at least two vessels to each other such that at least one of the vessels is connected to at least one corresponding coupled in a sutureless manner. The term “sutureless”, as used herein, refers to securement of at least one vessel to a corresponding coupler without suturing the vessel to the coupler. This can be accomplished, for example, by sutureless securement of the vessel to the corresponding coupler. The coupling technology disclosed can be used to connect two or more vessels in various configurations, such as end-to-side, side-to-end, end-to-end, and side-to-side.

[0217] In some examples, two vessels can be secured to two corresponding coupler, wherein at least one of the vessels is attached to the corresponding couper in a sutureless manner, with the two couplers attached to each other by a suitable mechanical coupling mechanism to form the anastomosis. In some examples, two vessels can be coupled to the same coupler. In some examples, two vessels can be coupled in a sutureless manner to the coupler. In some examples, one of the two vessels can be suturelessly coupled to the coupler, while the other one of the two vessels can be optionally sutured to the coupler.

[0218] Figs. 1A-1F illustrate optional stages of an exemplary method for securing a first vessel 10 to a coupler 102 of a sutureless anastomosis system 100. The first vessel 10 can be, for example, a lymphatic vessel, configured to be suturelessly coupled a second vessel which canbe, for example, a vein, though any other types of vessels or conductors can be implemented as first and / or second vessels.

[0219] The coupler 102 comprises an axial body 108 extending between first and second open- ended axial end portions 112a and 112b, respectively. The axial body 108 defines a lumen 110 and can be, in some examples, substantially cylindrical in shape. The coupler 102 has a wall thickness defined between an inner surface 106 facing the lumen 110 and an opposite outer surface 104 (inner and outer surface indicated, for example, in Figs. 5A-7B). In some examples, the wall thickness of the axial body 108 is within a range of about 0.02 mm to about 1.0 mm. In some examples, the wall thickness of the axial body 108 is within a range of about 0.04 mm to about 0.1 mm. In some examples, the length of the axial body 108, defined between the axial end portions 112a and 112b, can be greater than the diameter of its lumen 110. In some examples, the length of the axial body 108 can be in a range of about 0.5 mm to about 50 mm. In some examples, the length of the axial body 108 can be in a range of about 1.5 mm to about 10 mm. In some examples, the length of the axial body 108 can designed as a function of the diameter of the target vessel 10. For instance, the length of the axial body 108 can be, in some examples, about 3 to 10 times the diameter of the target vessel 10.

[0220] A first vessel 10 can be secured to the inner surface 106 of the axial body 108 by the use of a biocompatible adhesive, optionally combined with additional mechanical attachment elements, such as hooks, barbs, sutures and the like. In some examples, the diameter of the lumen 110 in which the first vessel 10 is to be situated, is within a range of about 80% to about 200% of the outer diameter of the first vessel 10. In some examples, the diameter of the lumen 110 is within a range of about 95% to about 125%, inclusive, of the outer diameter of the first vessel 10.

[0221] In some examples, a first vessel 10 is configured to extend through the axial body 108 and terminate at, or in close proximity to (for example, by extending to a short distance from), a second axial end portion 112b, in which case the second axial end portion 112b can be referred to as a terminal end portion 114 defining a terminal edge 116.

[0222] Coupler 102 is made of a biocompatible material. In some examples, coupler 102 can be made of metal, such as stainless steel (e.g., stainless steel 304 or 316), nickel titanium alloy, cobalt chromium, or any combination thereof. Additional metals the coupler can be made from include, but are not limited to: Titanium, Platinum-gold alloy, Tantalum, Gold, Platinum, Silver, Magnesium Alloys, Copper Alloys, Niobium, Palladium, Iron-based Alloys, or any combination thereof.

[0223] In other examples, coupler 102 can be made from a polymeric material such as, but not limited to: PEEK (poly etheretherketone), polyimide, polyamide, polyethylene, ultra-high molecular weight polyethylene (UHMWPE), polypropylene, polyurethane, silicone, PTFE (polytetrafluoroethylene), ETFE (ethylene tetrafluoroethylene), other perfluorinated polymers, Poly etheretherketone (PEEK) with Carbon Fiber Reinforcement, Polylactic Acid (PLA), Polyglycolic Acid (PGA), Polycaprolactone (PCL), Polycarbonate, Polysulfone (PSU), Poly vinylidene Fluoride (PVDF), Thermoplastic Polyurethane (TPU), Ethylene Vinyl Acetate (EVA), Polyhydroxyalkanoates (PHA), Chitosan, Collagen-Based Polymers, Hyaluronic Acid- Based Polymers, Acrylate Polymers (e.g., PMMA), or any other biocompatible polymer.

[0224] In yet further examples, coupler 102 can be made from ceramic or glass materials such as, but not limited to: hydroxyapatite (Caio(PO4)e(OH)2), tricalcium phosphate (Cas(PO4)2), zirconium dioxide (ZrCE), alumina (AECE), silica (SiCE), bioactive glass (e.g., SiC -CaO-P2Ch system), magnesium phosphate (Mgs(PO4)2), borosilicate glass (SiCE BiCE), phosphate glass (P20s-based), silicate glass (SiCE-based, with CaO and Na2O for bioactivity), lithium disilicate glass (LESEOs), calcium-aluminosilicate glass (CaO- AECE-SiCE), or any other biocompatible ceramic or glass material.

[0225] It is to be understood that in some examples, coupler 102 can comprise a combination of two or more of the materials described above, optionally tailored to achieve desired material properties such as strength, flexibility, and / or biocompatibility.

[0226] A first vessel 10 defines an inner surface 16 surrounding a lumen 12, and an opposite outer surface 14 (indicated, for example, in Fig. 19E). In some examples, biocompatible adhesive 570, such as biocompatible glue, can be applied to the inner surface 106. The adhesive 570 can be optionally applied over the entire inner surface 106, or over only a portion of the inner surface 106. Additionally or alternatively, biocompatible adhesive 570 can be applied to an outer surface of the first vessel 10.

[0227] Various exemplary implementations for anastomosis systems, couplers, and / or components thereof, can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any device, system or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any device, system or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations.

[0228] For example, the coupler 102ashown in Figs. 1A-1F can be structurally and functionally similar to any example of coupler 102 described herein, except that the axial body 108aof coupler 102adefines a plurality of adhesion apertures 120 radially extending through its wall thickness. Adhesion apertures 120 are configured to enable passage of biocompatible adhesive 570 applied to the coupler 102ato pass therethrough, to secure the outer surface 14 of the first vessel 10 to the axial body 108a. Advantageously, adhesive 570 applied to the coupler 102a, optionally from the outer surface 104, is passed through the adhesion apertures 120 and solidifies therein in a manner that forms stud-like structures that extend radially through the apertures 120 to better affix the first vessel 10 to the coupler 102a.

[0229] The adhesion apertures 120 can be of various shapes, such as circular, elliptical, triangular, square, rectangular, slot-shaped, or any other geometric form suitable for the intended purpose. In some examples, adhesion apertures 120 can further define interior extensions, as will be described in greater detail below with respect to Figs. 4A-4D.

[0230] In some examples, a combination of two or more different aperture shapes or sizes may be utilized to optimize coupling or adhesive application. In some examples, adhesion apertures 120 may have a substantially radial conical profile defining a larger diameter at the outer surface 104 of coupler 102 relative to the diameter at the inner surface 106. Advantageously, such a conical configuration can enhance the retention and stability of the studs formed from solidifies adhesive, by providing a tapered contact area.

[0231] In some examples, each adhesion aperture 120 can have an area ranging from about 104mm2to about 0.2 mm2, thereby advantageously enabling precise control over the bonding surface area and the application of adhesive. The number of adhesion apertures 120 on axial body 108amay occupy, in some examples, from about 0.5% to 10%. The number of adhesion apertures 120 on axial body 108amay occupy, in some examples, from about 10% to 50%. The number of adhesion apertures 120 on axial body 108amay occupy, in some examples, from 50% and up to 90% of its total surface area. The number of adhesion apertures 120 on axial body 108amay occupy, in some examples, from about 2% to 20%, thereby ensuring extensive and uniform distribution of adhesive or securing material. The size of each adhesion aperture 120 can be influenced by the viscosity of the adhesive 570, designed to be large enough to allow the adhesive 570 applied to the outer surface 104aof coupler 102ato penetrate and reach the outer surface 14 of first vessel 10.

[0232] For example, for a cylindrical coupler having a diameter of 0.9 mm (i.e., radius R = 0.45 mm) and a length 1 = 3 mm, the total cylindrical surface area will be (2K X R X 1) = 2K X 0.45 x 3 = 8.48 mm2. The area of a circular aperture having a diameter of 0.2 mm (i.e., radiusr = 0.1 mm), the aperture area will be (n x r2) = (u x 0.12) = 0.0314 mm2. Assuming that the coupler includes 10 apertures, resulting in a total area occupied by the apertures of 0.314 mm2, the apertures occupy 3.7% of the total surface area of the coupler in such an example. Variation of aperture diameter, coupler length and diameter, and the total number of apertures per coupler, results in a range of about 2% to about 20%, inclusive, of the area occupied by the apertures, for couplers that can be utilized for formation of anastomosis between veins and veins or between veins and lymphatic vessels.

[0233] Compared to alternative adhesion option by which adhesive is applied along a full circumference of the first vessel 10, inclusion of adhesion apertures 120 through which adhesive 570 is applied, particularly at appropriate dimensions and spatial arrangements of the apertures 120, pose a significant advantage by limiting the area of the outer surface 14 of first vessel 10 that receives the adhesive application, as excessive glue material may cause the vessel 10 to lose flexibility or experience shrinkage due to chemical, mechanical, or thermal effects and increase the biocompatibility risk associated with using a glue on lymphatic or blood vessels. To mitigate such risks, adhesion apertures 120 may be arranged non-circumferentially over the axial body 108ato avoid creating radial stresses on vessel 10, which could lead to shrinkage or reduced flexibility of the vessel. For instance, adhesion apertures 120 may be distributed, in some examples, in a spiral pattern along a longitudinal axis Cx of the axial body 108, or in a longitudinal manner extending parallel to axis Cx or angularly relative to axis Cx. Any of the spiral and / or longitudinal adhesion apertures can extend over part of the length of the coupler, or, in some example, along the entire length of the coupler between the two axial end portions 112a and 112b.

[0234] It is to be understood that various examples of adhesion apertures are shown throughout the figures to be arranged circumferentially merely of ease of illustration, and that the adhesion apertures of any exemplary coupler disclosed herein can be arranged non-circumferentially. The term “arranged non-circumferentially” means that the adhesion apertures 120 are arranged along less than 360° at any specific axial position of the axial body 108,

[0235] In some examples, coupler 102 may include, in addition to or as an alternative to adhesion apertures 120, at least one tissue-growth promoting opening 148 (indicated, for example, in Fig. 8A) extending through the wall thickness of the axial body 108, configured to promote tissue ingrowth (or overgrowth) therethrough after device implantation. These tissuegrowth promoting openings 148 can advantageously promote long-term fixation of vessel 10 to the coupler 102, compensating for potential weakening of glue fixation over time. In some examples, the total open area defines by tissue-growth promoting openings 148, through whichtissue ingrowth or overgrowth may occur, is in a range of about 1% to about 10% of the outer surface area of the axial body 108.

[0236] In some examples, each of the tissue-growth promoting openings 148 is larger in size than any of the adhesion apertures 120. The tissue-growth promoting openings 148 may have various geometric shapes, such as round, square, elliptical, slit-like, or other configurations that can support tissue ingrowth and enhance integration between the outer surface 14 of vessel 10 and the surrounding tissues or organs (for example, tissue walls or organs that may surround the coupler 102 after implantation), tissue-growth promoting openings 148 may extend along the longitudinal direction, circumferential axis, or a combination of both directions.

[0237] In some examples, the density of tissue-growth promoting openings 148 may vary along the longitudinal axis Cx, allowing for customizable adhesion strength across the surface. For instance, in some examples, the density of tissue-growth promoting openings 148 may be higher near one or both axial end portions 112 to increase surface bonding at critical points of attachment. In other examples, the density of tissue-growth promoting openings 148 may be concentrated in a central portion of the axial body 108 to optimize adhesive distribution or structural integrity. The variation in density of openings 148 can be tailored to meet desired mechanical or functional requirements of the resulting vessel and anchor assembly.

[0238] In some examples, as shown in Fig. 1A, a pull member 530 can be initially coupled to an end portion 20 of the first vessel 10. In some examples, pull member 530 can comprise a suture or an elongated wire, such as a polymeric or metallic wire. For example, pull member 530 can optionally comprise a suture wire of sizes 6-0, 7-0, 8-0, 9-0, or 10-0. Pull member 530 includes an attachment portion 532 at which it is attached to the end portion 20 of vessel 10. The attachment portion 532 may be, in various examples, threaded, tied, sutured, glued, clipped, staples, or otherwise secured to the end portion 20 of vessel 10. In the example illustrated in Fig. 1A, a suture tie 534 around end portion 20 is used for securement.

[0239] In some examples, the flow of bodily fluids to vessel 10 may be restricted prior to and / or during stages of the procedure for securing the vessel 10 to coupler 102, reducing the pressure inside the vessel 10 and causing it to shrink in diameter. This reduced diameter can facilitate the passage of vessel 10 through the lumen of coupler 102.

[0240] As shown in Fig. 1A, the pull member 530 is extended through the lumen 110 of the axial body 108, after which it can be pulled to pull the vessel 10 therewith into and through the lumen 110 of coupler 102, causing the end portion 20 of vessel 10 to move from the first axial end portion 112a towards and past the second axial end portion 112b, drawing the vessel 10 into and through the lumen 110, as shown in Fig. IB.

[0241] Once the vessel 10 is extended through the lumen 110 of coupler 102, adhesive 570 can be applied over the adhesion apertures 120 and / or outer surface 104 to fill the adhesion apertures 120, as shown in Fig. 1C. Adhesive 570 can be applied to some or all of the adhesion apertures 120 and / or to part or the entirety of outer surface 104. Various methods can be implemented for dispensing the adhesive 570, including, but not limited to: utilization of syringes 5801and needles, glue pens, micro-tip bottles, brush applicators 58011, dropper bottles, dispensing guns, automated dispensers, toothpicks / fine tools, thin wire (which can be metallic or polymeric), glue dots, and / or capillary tubes.

[0242] In some examples, the biocompatible adhesive 570 can comprise a relatively low- viscosity glue, such as ethyl cyanoacrylate. This type of glue can effectively fill adhesion apertures 120 and other vacant spaces, ensuring proper interaction with the outer surface 14 of vessel 10. In other examples, the biocompatible adhesive 570 can comprise a higher-viscosity glue, such as 2-butyl cyanoacrylate or 2-octyl cyanoacrylate. These glues are less likely to spread beyond their application site, more likely to remain in their applied position, and less likely to penetrate the wall of vessel 10, thereby reducing the potential impact on the fluid flowing through its lumen 12 and minimizing the risk of vessel occlusion.

[0243] Fig. ID illustrates a subsequent optional step of expanding (e.g., inflating) the first vessel 10. In some examples, first vessel 10 can be inflated by a syringe 490 utilized to fill the vessel 10 with an appropriate fluid, such as liquid (e.g., saline) or gas (e.g., nitrogen or carbon dioxide). In some examples, first vessel 10 can be expanded by applying a vacuum around the vessel 10. In some examples, first vessel 10 can be expanded by restoring the flow of bodily fluid (e.g., blood or lymphatic fluid) to the vessel 10, allowing it to re-fill naturally. Expansion or re-filling of vessel 10 increases its diameter, pushing its outer surface 14 against the inner surface 106 of coupler 102. Such expansion may improve the interaction between the applied adhesive in apertures 120 and vessel 10, leading to fixation of the vessel 10 in its patent configuration within the coupler 102.

[0244] In alternative implementations, expansion or re-filling of vessel 10 may occur prior to adhesive 570 application, after vessel 10 has been positioned within the lumen 110 of coupler 102. This ensures that the vessel 10 is in its expanded state within the coupler 102 before the adhesive 570 is applied. In such a case, the applied adhesive will immediately interact with the outer surface 14 of the vessel 10.

[0245] After vessel 10 is securely fixed to coupler 102, the end portion 20 of vessel 10 can be optionally trimmed to a desired length, as illustrated in Fig. IE for example. Trimming can be performed by any appropriate cutting tool 544, such as a blade (e.g., scalpel), scissors or micro-scissors, an RF cutting tool, diathermy devices, lasers, ultrasonic knives, or any other appropriate dissecting instrument as is known in the art. In some examples, the first vessel 10 is cut at the level of the second axial end portion 112b. In some examples, the first vessel 10 is cut at a position axially offset from the second axial end portion 112b, resulting in the creation of an extended portion 22 having a length defined between the second axial end portion 112b and the cut edge 24 of the vessel 10.

[0246] Extended portion 22 may be of importance in certain scenarios, such as when inserted into a second vessel 30 (e.g., vein), as shown for example in Figs. 11A-11C. This extended portion 22 can advantageously ensure that body fluids flowing from the first vessel 10 into a second vessel 30 predominantly contact bodily tissues, thereby minimizing contact with foreign materials like the coupler 102. Such minimized interaction serves to reduce the risk of anastomosis occlusion due to thrombus formation or protein deposition, which can occur from prolonged contact with foreign materials.

[0247] In some instances, extended portion 22 may be optionally inverted over the second axial end portion 112b of the axial body 108, as illustrated in Fig. IF. Such inversion can further reduce potential interaction of body fluids with the coupler 102, as the area most prone to interaction is covered with bodily tissue.

[0248] Fig. 2 shows another manner by which a pull member 530 can be initially coupled to an end portion 20 of the first vessel 10, as an alternative, for example, to the suture tie 534 shown in Fig. 1A. In some examples, an attachment portion 532 of the suture wire 530 can be passed through the tissue material of the end portion 20 of vessel 10. This can be done by using a needle attached to an end of suture 530, which may be cut after the suture wire 530 has passed through the tissue material of the end portion 20, allowing a free end of suture wire 530 to be extended through the lumen 110 of coupler 102, as shown in Fig. 2.

[0249] In some instances, a pull member 530 can be passed through the lumen 110 of coupler 102 prior to being attached to the end portion 20 of vessel 10. Alternatively, the pull member 530 can be attached to the end portion 20 of vessel 10 prior to being extended through the lumen 110 of coupler 102.

[0250] Figs. 3A-3C illustrate various examples of adhesion apertures 120, configured to be filled with adhesive material 570 that can form, once solidified therein, stud-like structures to increase interaction with the axial body 108 of coupler 102. Fig. 3A illustrates exemplary adhesion apertures 1201' which can be implemented as through-holes defining uniform diameters between the outer surface 104 and the inner surface 106. It is to be understood that the adhesion apertures can have circular or non-circular cross-sectional areas. For example, across-sectional area of an adhesion apertures 120 can be circular, elliptic, rectangular, triangular, star-shaped, or have any other shape. Any reference herein to a diameter of any type of adhesion aperture 120 can refer, when having a non-circular shape, to an equivalent diameter of an equivalent circular cross-sectional having the same cross-sectional area.

[0251] Fig. 3B illustrates exemplary adhesion apertures 120 that define two diameters, such as exemplary adhesion apertures 120’2shown to have a portion with a larger diameter closer to the inner surface 106 and a portion with a smaller diameter closer to the outer surface 104, as well as exemplary adhesion apertures 12O’3shown to have a portion with a smaller diameter closer to the inner surface 106 and a portion with a larger diameter closer to the outer surface 104. It is to be understood that two types of exemplary adhesion apertures 120i2and 120i3are shown together in Fig. 5B for illustrative purpose only, and that any axial body 108 disclosed herein to include adhesion apertures 120 can have all of the adhesion apertures 120 defining the same size and / or profile, or any combination of two or more sizes or profiles of adhesion apertures 120. Fig. 3C shows another example of adhesion apertures 120’4having a profile that tapers from the outer surface 104 to the inner surface 106.

[0252] In some examples, any adhesion aperture 120 disclosed herein can further include interior extensions 119 extending across at least part of the surface area defined by the perimeter of the adhesion aperture 120. Figs. 4A-4D show several examples of adhesion apertures 120 equipped with differently shaped interior extensions 119. Fig. 4A shows an adhesion aperture 120’ comprising an exemplary interior extension 119)5shaped as a cross-bar extending diametrically across the aperture 120' and dividing it into two sub-spaces. Fig. 4B shows an adhesion aperture 120’6comprising an exemplary plus-shaped interior extension 119)6dividing the aperture 120’6into four sub-spaces. Fig. 4C shows an adhesion aperture 12O’7comprising an exemplary interior extension 119)6extending diametrically across the aperture 120’7and comprising a central widened portion, illustrated to be circularly shaped with a diameter smaller than that of the aperture’s perimeter, dividing the aperture 12O’7into two archshaped sub-spaces. Fig. 4D shows an adhesion aperture 120’8comprising an exemplary interior extension 119jSthat can be similar to the interior extension 119^7, except that the interior extension 119jXis connected to one side of the aperture’s perimeter and is not connected to the opposite side, thus forming a sub-space within aperture 120,xwhich is not divided but rather narrowed to a C-shaped configuration. Advantageously, designs of adhesion apertures 120 that include interior extension 119 can enhance retention force of the adhesive material’s stud-like structures to the coupler 102 due to the increased effecting locking area.

[0253] In some examples, an interior extension 119 is attached to the perimeter of the corresponding aperture 120 at more than one point of attachment, such as two diametrically opposing points of attachment as shown in Figs. 4A and 4C, or four points of attachment as shown in Fig. 4B, dividing the corresponding aperture to two or more sub-spaces. In some examples, an interior extension 119 extends from the perimeter of the corresponding aperture 120 at a single point of attachment, as shown in Fig. 4D, thus not dividing the aperture 120 but rather optionally changing the shape and size of the resulting sub-space. It is to be understood that any other number of attachment points is contemplated. While exemplified in Figs. 4A-4C for a circularly-shaped aperture 120, it is to be understood that an interior extension 119 can be included in any other shape of an aperture. Moreover, while the central widened portions is shown in Figs. 4C and 4D to resemble in shape (e.g., circular shape) the aperture’s perimeter, it is to be understood that any other shape of an interior extension 119 can be implemented.

[0254] In some examples, the axial body 108 can further include additional features configured to improve the strength of this coupling of the vessel 10 to the axial body 108. In some examples, the axial body 108 can comprise inner anchors 118 extending radially inwards, such as past the inner surface 106, to engage with the outer surface 14 of the vessel 10. Figs. 5D-5G illustrate various examples of inner anchors 118. While the axial bodies 108 are shown to include inner anchors 118 without showing adhesion apertures 120, it is to be understood that this is shown by way of illustration and not limitation, and that in some examples, axial body 108 includes both adhesion apertures 120 and inner anchors 118.

[0255] Figs. 5 A illustrates exemplary inner anchors 11811implemented as barbs projecting from the inner surface 106 into the lumen 110. The inner anchors 11811can be oriented at an angle relative to the longitudinal axis Cx, with their tips configured to be oriented opposite to the flow direction of fluid flowing through the first vessel 10 when coupled to the coupler 102, thus improving coupling due to the resulting fluid drag force. In alternative examples, the inner anchors 11811can extend perpendicularly to the longitudinal axis Cx. In some examples, the length of the inner anchors 11811can be in a range of about 10% to about 60% of a tissue wall thickness of the vessel 10 configured to be engaged thereby. In some examples, the length of the inner anchors 11811can be in a range of about 90% to about 300% of the wall thickness of the axial body 108. In some examples, the length of the inner anchors 11811can be in a range of about 120% to about 200% of a wall thickness of the axial body 108.

[0256] Figs. 5B and 5C illustrate exemplary inner anchors 11812and 11813implemented as hooks and double-head hooks, respectively. Inner anchors 11812and 11813can be angled orperpendicular relative to the longitudinal axis Cx, and can be dimensioned according to any of the examples described herein with respect to inner anchors 118.

[0257] Figs. 5D illustrates exemplary inner anchors 11814implemented as bumps extending radially inwards from the inner surface 106. While illustrated in Fig. 5D to have a substantially triangular profile, is it to be understood that bumps 11814can have any other profile, such as rounded, squared, or randomly rough.

[0258] It is to be further understood that a single axial body 108 can be equipped with a single type of inner anchors 118, or any combination of different types of inner anchors 118, such as barbs, hooks, double hooks, and / or bumps.

[0259] In some examples, any of the inner anchors 118 described herein can be made from the same material as the coupler. Alternatively, any of the inner anchors 118 can be made from other materials, including polymers or metals (e.g., stainless steel alloys or nickel-titanium). In some examples, inner anchors 118 may be part of a sleeve (not shown) cut to shape, with inner anchors 118 (e.g., implemented as barbs and the like) deformed to the required angle before sleeve fixation into axial body 108. Such a sleeve can be manufactured from a foil or a tube and shaped using laser cutting, water jet, EDM, or chemical etching, followed by surface treatment if required. The sleeve may be then glued or mechanically secured to the inner surface 106 of the axial body 108.

[0260] In some examples, the axial body 108 can comprise inner grooves 122 along the inner surface 106. surface extending radially inwards, such as past the inner surface 106, configured to improve engagement with the outer surface 14 of the vessel 10. Fig. 5E illustrates exemplary inner grooves 122 that to not penetrate through the whole wall thickness of the axial body 108, meaning that inner grooves 122 are not exposed to the outer surface 104. Two exemplary configuration are shown in Fig. 5E, namely a series of discrete inner grooves 12211or continuous inner grooves 12212that can be connected to adjacent grooves in a periodical fashion. Both types of inner grooves 122 are configured to provide a form of roughness, and may have any cross-sectional profile such as, but not limited to: triangular, square, circular, or continuous. It is to be understood that two types of exemplary inner grooves 12211and 12212are shown together in Fig. 5E for illustrative purpose only, and that any axial body 108 disclosed herein to include inner grooves 122 can have all of the inner grooves 122 of the same or different configurations.

[0261] While the axial body 108 is shown to include inner grooves 122 without showing adhesion apertures 120, it is to be understood that this is shown by way of illustration and not limitation, and that in some examples, axial body 108 includes both adhesion apertures 120and inner grooves 122, wherein the inner grooves 122 can be optionally disposed between the apertures 120 or along other regions of the inner surface 106 that do not include the apertures 120.

[0262] In some examples, inner anchors 118 can be integrally formed with the axial body 108. For example, axial body 108 can formed from a metallic materials, and the inner anchors 118 can formed through laser cutting or chemical etching from the tubular wall material of the axial body 108. Fig. 6A is a side view of an axial body 108 having various examples of inner anchors 118 cut from its wall material. Fig. 6B is a front view of the axial body of Fig. 6A. In some examples, the cutout can form apertures 121 around the inner anchors 118. Inner anchors 118 can have any of a variety of designs, such as inner anchors 11815having a pin-like design, inner anchors 11816having an arrowhead design, inner anchors 11817having a double arrowhead design, and / or inner anchors 11818featuring one or more barbs. It is to be understood that other shapes of inner anchors 118 can be implemented for improving anchoring against a vessel 10.

[0263] As shown in Figs. 6A-6B, the inner anchors 118 can be substantially flush with the inner surface 106 and / or outer surface 104 after cutting. In some examples, any of the inner anchors 118 disclosed throughout the current specification can bend or curve radially inwards towards the lumen 110. Fig. 7A schematically shows a sectional axial view of the axial body 108 of Figs. 6A-6B with the inner anchors 118 bent radially inwards. Fig. 7B is a front view of the axial body of Fig. 7A. In some examples, an axial body 108 with integrally formed inner anchors 118 can be made of a plastically deformable material (e.g., stainless steel or any other appropriate material), such that the inner anchors can be inwardly bent after being cut, and retain their inwardly-bent configuration thereafter.

[0264] In some examples, inner anchors 118 can be angled at an angle in a range of about 1° to about 40°, relative to central axis Cx, wherein the inner anchors 118 can have their tips axially oriented towards the second axial end portion 112b. Such an angle and orientation allows for smooth insertion of vessel 10 into the coupler 102 from the first axial end portion 112a toward the second axial end portion 112b. If vessel 10 dislodges from its fixation to coupler 102 and attempts to move in an opposite direction oriented towards the first axial end portion 112a, the tips of the inner anchors 118 will pin into the vessel 10, securing it firmly in place.

[0265] It is to be understood that various types of exemplary inner anchors 118 are shown together in Figs. 6A-7B for illustrative purpose only, and that any axial body 108 disclosed herein to include inner anchors 118 can have similar or different designs of inner anchors 118.

[0266] In some examples, the apertures 121 formed around inner anchors 118 which are cut from the wall material of the axial body 108 can optionally serve also as adhesion apertures, through which adhesive material can be applied. In some examples, additional adhesion apertures 120 can be defined between integrally formed inner anchors 118 and apertures 121 thereof, or along other regions of the axial body 108 that do not include inner anchors 118 and apertures 121 thereof.

[0267] Fig. 8A is a perspective view of an exemplary coupler 102b, which can be structurally and functionally similar to any example of coupler 102 described herein, except that 102bfurther comprises one or more outer anchors 144. Couplers 102bhaving outer anchors 144 can include additional features and / or design configurations, some of which are described below with respect to exemplary coupler configuration 102blshown in Fig. 8A and exemplary coupler configuration 102b2shown in Fig. 8B. Fig. 9 schematically shows a cross-sectional view of the coupler 102b. Outer anchors 144 can be generally shaped to have any of the shapes disclosed herein for any example of inner anchors 118, such as, but not limited to, spikes 144blas illustrated in Fig. 8A, pin-like designs, arrowhead, double arrowhead 144b2as shown in Fig. 8B , barbs, and the like. In some examples, an outer anchor can terminate with a sharp tip, as shown for example for outer anchor 144blin Fig. 8 A, configured to enable at least partial penetration into the tissue wall of a second vessel 30 disposed thereover. Alternatively, an outer anchor 144 can terminate, in some examples, with a blunt or rounded tip to minimize risk of perforating the outer vessel 30 when such perforation is to be avoided.

[0268] In contrast to the inner anchors 118, the outer anchors 144 are outwardly oriented, away from the outer surface 104, as shown in Figs. 8B and 10. In some examples, the outer anchors 144 can be integrally formed with the axial body 108. For example, axial body 108 can formed from a metallic materials, and the outer anchors 144 can formed through laser cutting or chemical etching from the tubular wall material of the axial body 108.

[0269] The outer anchors 144 can move between a compressed configuration, as shown in Fig. 8A, and an outwardly-biased expanded configuration, as shown for example in Figs. 8B and 9. In some examples, the outer anchors 144 can be substantially flush with the outer surface 104 and / or inner surface 106 after cutting, as shown in Fig. 8A for example, after which they can be outwardly bent as shown in Fig. 9. In some examples, an axial body 108 with integrally formed outer anchors 144 can be made of a plastically deformable material (e.g., stainless steel or any other appropriate material), such that the inner anchors can be inwardly bent after being cut, and retain their inwardly-bent configuration thereafter.

[0270] In some examples, outer anchors 144 can be angled at an angle in a range of about 1° to about 60°. In some examples, outer anchors 144 can be angled at an angle in a range of about 1° to about 40°. In some examples, outer anchors 144 can be angled at an angle in a range of about 10° to about 60°, relative to central axis Cx. In some examples, outer anchors 144 can be angled at an angle in a range of about 10° to about 30°, relative to central axis Cx. The outer anchors 144 can have their tips axially oriented towards the first axial end portion 112a. In some examples, the outer anchors 144 are closer to the second axial end portion 112b than to the first axial end portion 112a. Such angles, positions and orientation enable a second vessel 30 to be slid over the outer anchors 144 (for example, in a direction oriented from the second axial end portion 112b towards the first axial end portion 112a), placing the second vessel 30 (for example, a free end portion thereof), as will be discussed in greater detail, for example, with respect to Figs. 14A-14B below. Any pull-back movement in an opposite direction (e.g., oriented from the first axial end portion 112a toward the second axial end portion 112b) causes outer anchors 144 to engage and lock into the tissue wall of the second vessel 30, preventing its detachment.

[0271] In some examples, coupler 102bincludes at least one series of outer anchors 144 disposed around a circumference of the axial body 108bat the same axial position. At least one series of outer anchors 144 can be, in some examples, located axially closer to the second axial end portion 112b than to the first axial end portion 112a. In some examples, a series of outer anchors 144 can include between three to eight outer anchors 144, which can be equally or unequally spaced from each other along the circumference of the axial body 108b. In some examples, multiple series of outer anchors 144 can be provided, axially spaced from each other (example not explicitly illustrated). Such arrangements of multiple series can advantageously allow for enhanced anchoring, and can potentially enable shorter outer anchors 144 to be used.

[0272] In some examples, the length of an outer barb 144 can be in a range of about 0.1 mm to about 1.5 mm. In some examples, the length of an outer barb 144 can be in a range of about 0.5 mm to about 0.8 mm. In some examples, the width of an outer barb 144 can be in a range of about 0.1 mm to about 1 mm.

[0273] Fig. 10 shows an exemplary coupler 102bwith a first vessel extending through its axial body 108band secured thereto. Exemplary coupler 102bcan include adhesion apertures 120 which can be implemented according to any designs of adhesion apertures 120 disclosed throughout the specification, and can be secured to a first vessel 10 according to any example described with respect to coupler 102aor any other securement methods disclosed throughout the specification.

[0274] In some examples, a single coupler, such as exemplary coupler 102b, can be utilized to secure both a first vessel 10 and a second vessel 30 thereto, without the need to use another coupler. A first vessel 10 can be, for example, a lymphatic vessel, and a second vessel 30 can be a vein, though any other types of vessels or conductors can be implemented as first and / or second vessels. A second vessel 30, shown for example in Figs. 11A-11C, defines an inner surface 36 surrounding a lumen 32, and an opposite outer surface 34.

[0275] In some examples, a method of forming an end-to-end anastomosis by which end portions of first 10 and second 30 vessels are coupled to each other via a coupler 102, includes mounting a second vessel 30 onto coupler 102b, to which a first vessel 10 is already secured (for example, as shown in Fig. 10), by sliding it over the axial body 108busing tweezers or any other pulling and / or stretching tools commonly used by those skilled in the art of microsurgical surgery. In certain cases, an open-ended end portion 42 (indicated, for example, in Figs. 11A- 11C) of second vessel 30 may need to be expanded or stretched to fit over the second axial end portion 112b of coupler 102band outer anchors 144 thereof. In some examples, one or more temporary sutures (not shown) can be threaded through the wall tissue of second vessel 30 near its end portion 42. These temporary sutures can be used to radially stretch the vessel 30 and expand its lumen 32, facilitating placement of the vessel 30 over the second axial end portion 112b of the coupler 102b, after which the temporary sutures can be removed.

[0276] Figs. 11 A- 11C illustrate optional stages of an exemplary method for utilizing an expansion device 430 to facilitate insertion of a coupler 102binto a second vessel 30, as part of a procedure of forming an end-to-end anastomosis for example. As shown in Figs. 1 IB-11C, an expansion device 430 includes a shaft 432 and an expandable portion 436 extending from a distal end 434 of the shaft 432, wherein the expandable portion 436 comprises a plurality of outwardly biased struts 438 extending axially from the shaft distal end 434, and configured to move between a compacted configuration, in which the struts 438 are maintained closed to each other, and an expanded configuration, in which the struts 438 are outwardly biased away from each other, enlarging spacings 440 therebetween. The struts 438 can be formed of a shape memory material, such as nickel titanium alloy (Nitinol) or a shape-memory polymer, preshaped to assume the expanded configuration in a free state thereof. Alternatively, the struts 438 can be formed from stainless steel or other suitable material which can be shaped to assume an outwardly biased configuration in a free state thereof.

[0277] As shown in Fig. 11 A, a delivery catheter 442 can be disposed over the expansion device, having a lumen small enough to maintain the expandable portion 436 of the expansion device 430 in a compacted configuration during delivery. The outer diameter of the deliverycatheter 442 can be dimensioned to enable insertion thereof into the lumen 32 of the second vessel.

[0278] In this compacted configuration, the distal portion 444 of the catheter 442, in which the expandable portion 436 is disposed in a compacted configuration, is inserted through the end portion 42 of the second vessel 30 into lumen 32, as shown in Fig. 11 A. Thereafter, the delivery catheter 442 is retracted, pulling the catheter distal portion 444 out of the lumen 32, while the expansion device 430 remains in position, thereby exposing the expandable portion 436 to allow the struts 438 to spring radially outwards, away from each other, thereby expanding the end portion 42 of the second vessel 30 as shown in Fig. 1 IB.

[0279] An exemplary expansion device 430r, shown in Fig. 11A-11C, includes a plurality of struts 438 that circumferentially span less than 360°. For example, expansion device 430ris shown in Figs. 1 IB-11C to include three struts 438 (though any other number is contemplated), the ends of which span across 180°. In some examples, the plurality of struts 438 span across between about 150° and about 270°. In some examples, the plurality of struts 438 span across between about 170° and about 190°. In some examples, the plurality of struts 438 span across about 180°. This leaves an open or exposed area, in this case an area extending circumferentially over about 180° that does not include struts, through which a coupler 102bcan be inserted, optionally in a diagonal manner as illustrated in Fig. 11C, through the end portion 42 and into the lumen 32 of the second vessel 30.

[0280] The coupler 102bis inserted with the first vessel 10 already coupled thereto, according to any method disclosed herein. As shown in Fig. 11C, during insertion of the coupler 102binto the second vessel 30, the outer anchors 144 are maintained in a compressed configuration (e.g., pressed radially inwards). After the portion of coupler 102bthat includes outer anchors 144 is properly positioned within the end portion 42 of second vessel 30, the expansion device 430 can be pulled out of the vessel 30.

[0281] The coupler 102bsufficiently extends into the lumen 32 of second vessel 30 such that the outer anchors 144 are positioned within the lumen 32, such as within the end portion 42 of the second vessel 30, after which the outer anchors 144 can be allowed to spring outwards to their expanded configuration, anchoring into the second vessel 30. In some examples, coupler 102bcan be pulled to some extent to facilitate engagement (e.g., penetration) of the outer anchors 144 with the inner surface 36 of the second vessel 30.

[0282] While not shown in Fig. 11C, in some examples, a delivery tube, such as a catheter or overtube, which can be similar to delivery tube 250 described in greater detail below with respect to Fig. 14A, can be disposed over the coupler 102band outer anchors 144 thereof. Thedelivery tube 250 defines an inner lumen that closely matches the outer diameter of the axial body 108b, and is smaller than the diameter defined by the outer anchors 144 in their expanded free state, thus maintaining the outer anchors 144 in a compressed configuration during delivery and insertion of the coupler 102binto second vessel 30. Once in position, the delivery tube can be retracted to expose the outer anchors 144 and allow for deployment thereof.

[0283] In some examples, the expanded portion 436ris configured to define, in its compacted configuration, a maximum radial distance between struts 438 thereof, in a range of about 20% to about 100% of the outer diameter of coupler 102. In some examples, the expanded portion 436ris configured to define, in its fully expanded configuration, a maximum distance between struts 438 thereof, in a range of about 100% to about 500% of the outer diameter of coupler 102. In some examples, the outwardly biased struts 438 can be formed from rods, tubes, and the like. In some examples, the outwardly biased struts 438 can be polished or undergo other appropriate surface treatment procedures to reduce friction when being in contact with the inner surface 36 of second vessel 30.

[0284] Fig. 12 shows an exemplary coupler 102bused for forming an end-to-side anastomosis, in which case an end portion of a first vessel 10 is coupled, via coupler 102b, to the second vessel 30 via a side opening 40 formed in the second vessel 30. The first vessel 10 can be attached to an inner surface 106 of the coupler 102, according to any example disclosed herein, and a side opening 40 can be formed in the tissue wall of the second vessel 30, for example in a manner similar to that described in greater detail below with respect to Figs. 20A-20C. For example, the side opening 40 can be created using a scalpel, laser, electrocautery, ultrasonic scalpel, scissors, or any other appropriate tool.

[0285] The coupler 102bcan be delivered, in a compressed configuration of the outer anchors 144, to and through the side opening 40. In some examples, a delivery tube 250 can be used to maintain the outer anchors 144 in a compressed configuration during delivery, and retracted to deploy the anchors 144 in a similar manner to that described above. In some examples, the outer anchors 144 can be kept in a compressed configuration and allowed to expand by alternative mechanisms that omit the delivery tube. For example, the outer anchors 144 can be temporarily restrained during advancement and allowed to naturally return to their expanded configuration after passing through the wall of the second vessel 30.

[0286] The extent of insertion of coupler 102binto the lumen 32 can be such that the outer anchors 144 are positioned entirely within the lumen 32. After deployment of the outer anchors, coupler 102bcan be pulled to some extent to facilitate engagement (e.g., penetration) of theouter anchors 144 with the inner surface 36 of the second vessel 30, around the perimeter of the side opening 40.

[0287] Fig. 13 illustrates a push tool 510 that can be used to expose the portion of coupler 102bthat includes outer anchors 144 out of a delivery tube. The push tool 510 comprises a distal engagement portion 518 sized to slide within a lumen 256 of a delivery tube 250 of the type shown, for example, in Fig. 14A. The engagement portion 518 can be ring-shaped or C-shaped, defining a central opening 520 through which a first vessel 10 can extend. The push tool 510 further includes a shaft 512 extending from the engagement portion 518 to a handle 516 that can be gripped by a user. In some examples, an elbow 514 can be defined along the shaft 512 to radially offset the handle 516 from the first vessel 10 when in use, for convenient handling of the tool 510.

[0288] Figs. 14A-14B show optional stages of an exemplary method for forming a side-to-side anastomosis with coupler 102b, utilizing a delivery tube 250 and push tool 510. As shown in Fig. 14A, the coupler 102b, having the first vessel 10 secured thereto according to any example described herein, can be inserted into a delivery tube 250, which can serve as an overtube, during the delivery and insertion stages into the second vessel 30. The delivery tube 250 can be a relatively thin-walled tube positioned over coupler 102band outer anchors 144 thereof, to protect the second vessel 30 from the outer anchors 144 and maintain the anchors 144 in a compressed configuration during the insertion procedure. Delivery tube 250 can extend from a proximal end 254 to a distal end 252 and define an inner lumen 256 configured to accommodate the coupler 102b.

[0289] The term “proximal”, as used herein, refers to an end of a device, tool or component, which is closer to a user performing an anastomosis procedure.

[0290] The term “distal”, as used herein, refers to an end of a device, tool or component, which is farther from a user performing an anastomosis procedure.

[0291] In some examples, the delivery tube 250 can further define a tapering end portion 258 that tapers to a smaller diameter at its distal end 252. The tapering end portion 258 can be stretchable or expandable, for example by being formed of a stretchable material that can be circumferentially stretched when the coupler 102bis pushed therethrough, or by having one or more flaps which are biased towards each other and can be pushed radially outwards to expand the distal opening when the coupler 102bis pushed therethrough. A tapering end portion 258 can facilitate easier insertion into the second vessel 30.

[0292] As further shown in Fig. 14A, the engagement portion 518 of the push tool 510 can be disposed over the portion of the first vessel 10 extending proximally from the coupler 102b,and slid in the distal direction towards the first axial end portion 112a of the coupler 102b. In some examples, the engagement portion 518 defines a gap or slot 522 through which the first vessel 10 can be inserted into the central opening 520 of the engagement portion 518.

[0293] As mentioned above, the engagement portion 518 is sized to have a diameter smaller than that of lumen 256 of delivery tube 250 to allow it to slide through delivery tube 250, while the diameter of the central opening 520 is larger than the outer diameter of the first vessel 10 to allow the first vessel 10 to extend therethrough, The diameter of the engagement portion 518 also closely matches that diameter of the axial body 108b, configured to contact the first axial end portion 112a when pushed thereagainst, as shown in Fig. 14A.

[0294] In some examples, the push tool 510 can be used to provide a counterforce against the first axial end portion 112a to maintain the coupler 102bin position while the delivery tube 250 is proximally pulled, or the push tool 510 can be pushed against the first axial end portion 112a while the delivery tube 250 is proximally pulled, thereby exposing the outer anchors 144 out of the delivery tube 250, after which both the delivery tube 250 and push tool 510 can be retrieved as shown in Fig. 14B. Once exposed, the outer anchors 144 can be configured to spring radially outwards and engage the inner surface 36 of the second vessel 30, securing it in place.

[0295] In some examples, the outer anchors 144 are configured to penetrate through the entire wall thickness of the second vessel 30, as shown for outer anchor 144’ in Fig. 14B. Alternatively, the outer anchors 144 can be configured to engage with the vessel wall without fully penetrating it, as shown for outer anchor 144” in Fig. 14B. It is to be understood that penetrating and non-penetrating outer anchors 144’ and 144” are shown in Fig. 14B in combination for illustrative purpose only, and that a coupler 102bcan have all of its outer anchors 144’ configured to penetrate into the tissue wall, all of its outer anchors configured to engage in a non-fully penetrating manner, or a combination of both.

[0296] While illustrated in Figs. 14A-14B for use in a method of forming an end-to-end anastomosis, it is to be understood that a push tool 510 can be similarly used to expose the outer anchors 144 of a coupler 102bout of a delivery tube 250 in a procedure for forming an end-to-side anastomosis, such as that described above with respect to Fig. 12.

[0297] A coupler 102bis configured to secure a first vessel 10 to an inner surface 106 thereof, while extending at least partially into a lumen 32 of a second vessel 30 secured to outer anchors 144 thereof. As mentioned above, the extended portion 22 and / or edge 24 of the first vessel 10 can at or close to the second axial end portion 112b, serving as the terminal end portion 114 of the coupler 102b. The flow of fluid through the two interconnected vessels 30 and 10 can be,in some examples, in a direction oriented from the first axial end portion 112a towards the second axial end portion 112b, which advantageously ensures that the flowing fluid encounters minimal disturbance as it flows from an internal smaller-sized first vessel 10 to a larger-sized second vessel 30.

[0298] In some examples, the terminal edge 116 of the coupler 102 can be internally chamfered, as shown for example in Fig. 8A. In other examples, the terminal edge 116 can be rounded or externally chamfered (examples not illustrated). In some examples, the first axial end portion 112a can be rounded, internally chamfered, or externally chamfered (examples not illustrated). Advantageously, adding one or more chamfers or rounded corners over one or both axial end portions 112 can facilitate easier insertion of a first vessel 10 into the coupler 102, or allow for a second vessel 30 to more easily slide over the coupler’s outer surface 104.

[0299] Coupler 102bis shown in Figs. 8A and 8B to include at least two types of apertures, namely a plurality of adhesion apertures 120 through which an adhesive can be applied and / or form stud-like structures upon solidification thereof, and a plurality of tissue-growth promoting openings 148, which can serve for tissue adhesion between the first vessel 10, which is attached to the inner surface 106 of coupler 102b, and the second vessel 30 placed around the outer surface 104 of the coupler 102band / or other tissue (e.g., native tissues) surrounding the 102b. The design (e.g., shape and dimensions) of the tissue-growth promoting openings 148 can be adapted to optimize tissue attachment. For example, any tissue-growth promoting opening 148 may have a larger diameter (or a larger area) than any of the adhesion apertures 120. In some examples, the tissue-growth promoting openings 148 and may have textured or otherwise nonsmooth perimeters, configured to promote tissue adhesion. While adhesive material extending through adhesion apertures 120 can provide adequate immediate and short-term attachment to the vessel 10 to the coupler 102, the inclusion of additional tissue-growth promoting openings 148 can be of importance for the longer-term chronic period, during which the glue's fixation strength may weaken.

[0300] In some examples, any of the inner surface 106 and / or outer surface 104 can be textured or roughened to enhance adhesive bonding during gluing and / or to promote subsequent biological integration with the vessel. Texturing or roughening of the surface can be achieved by etching, sand blasting, or any other suitable technique known in the art. Alternatively, any of the inner surface 106 and / or outer surface 104 can be smooth to facilitate threading of vessel 10 into the coupler lumen or to ease the advancement of vessel 30 over the outer surface of the coupler. Smoothening of a surface can be achieved mechanically, chemically, through electropolishing, or by any other suitable technique known in the art.

[0301] In some examples, coupler 102bcan further include one or more inner anchors 118, such as inner anchors 11819illustrated for example in Fig. 8 A, to improve securement of the first vessel 10 to coupler 102b. A series of inner anchors 11819(shown in an as-cut configuration in Fig. 8A, after which they can be shaped to be angularly oriented radially inwards) can be disposed next to the outer anchors 144, optionally oriented in an opposite direction and arranged in a staggering configuration, such that the inner anchors 11819can be circumferentially disposed between the outer anchors 144. In some examples, as further shown in Fig. 8A, the outer anchors 144 and the inner anchors 11819can extend from opposite edges of corresponding cutouts or apertures 121 formed therearound. In some examples (not illustrated), inner anchors 11819can be provide next to the first axial end portion 112a, in addition to, or instead of, the inner anchors 11819shown in Fig. 8 A next to the terminal end portion 114. In alternative configuration, as shown for example in Fig. 8B, coupler 102bcan be devoid of inner anchors 11819. It is to be understood that inner anchors 118 are illustrated in Fig. 8A by way of illustration and not limitation, and that inclusion of inner anchors in any exemplary coupler disclosed herein is merely optional. Likewise, any exemplary coupler illustrated without inner anchors, can be optionally provided with inner anchors 118.

[0302] The design of coupler 102blin Fig. 8A is shown to form larger-sized around outer anchors 144bland inner anchors 11819. In some examples, the larger-sized apertures 121 can serve as larger-sized adhesion apertures 120 through which adhesive material can extend. In alternative examples, these larger-sized apertures 121 can serve, as mentioned above, as tissuegrowth promoting openings 148. For example, interaction between the anchors 144 and 118 and the vessels 30 and 10 may cause minor tissue damage, which could stimulate tissue growth and support the body’s natural healing process. Positioning an aperture 148 for tissue adhesion, at or proximate to the terminal end portion 114, where vessels 30 and 10 interact and are potentially influenced by proliferation or inflammation mechanisms triggered by stretching or injury, can advantageously further enhance the rate and likelihood of tissue adhesion between these vessels.

[0303] In some examples, as shown for coupler 102blin Fig. 8A, the terminal edge 116 can be continuously circular. In some examples, as shown for coupler 102b2in Fig. 8B, the terminal edge 116 can be non-circular but rather have a staged geometry that defines axially-extending peak regions and axially-recessed through regions or cutouts therebetween. Such a staged geometry of the terminal edge 116 may reduce the amount of foreign coupler material extending into the lumen 32 of the second vessel 30. This can be of benefit since foreign material protruding into the lumen 32 of the second vessel 30 (e.g., into venous circulationwhen the second vessel is a vein) may increase risk of thrombosis due to potential flow disturbances and low flow velocities.

[0304] It is to be understood that features such as chamfered edges of staged edges are shown in Figs. 8A-8B as part of exemplary couplers 102bbay way of illustration and not limitation, and that such features can be either omitted from any exemplary coupler 102bor can be implemented as part of any other exemplary coupler disclosed herein.

[0305] As mentioned above, various types of dispensers or applicators 580 can be employed to apply adhesive 570. Fig. 15 shows an exemplary adhesive dispenser 586 that can be used to apply adhesive 570 for securing a vessel 10 to a coupler 102. Adhesive dispenser 586 comprises an elongated applicator 588 and a container 592. The container 592 is configured to contain adhesive material 570 therein, and extends from a container top 595 to a container bottom 594 that can be, in some examples, conical in shape (for example, the container 592 can be generally shaped as an Eppendorf-like tube). The container includes an entry cap 596 at the container top 595, the entry cap 596 defining an entry opening 598 through which the applicator 588 can extend.

[0306] The applicator 588 can be provided, in some examples, in the form of a wire, a rod, a tube, and the like. The applicator can be optionally made of metal, (e.g., stainless steel, nitinol, titanium, gold, or platinum) or polymer (e.g., perfluoro polymers, polypropylene, polyethylene, PEEK, or polyimide). The applicator can be optionally made of glass or ceramic, including, but not limited to: borosilicate glass, fused silica, aluminosilicate glass, quartz, aluminum oxide (alumina), zirconium oxide (zirconia), silicon carbide, silicon nitride, or any combination thereof, depending on the desired mechanical, thermal, or biocompatibility properties. In some examples, the diameter of the applicator can be in a range of about 0.03 mm to about 0.5 mm. In some examples, the diameter of the applicator can be in a range of about 0.05 mm to about 0.25 mm.

[0307] The applicator 588 includes a distal portion or tip 590, such that when the application is inserted through the entry opening 598 into container 592, its tip 590 is dipped in the adhesive material 570. The applicator 588 is then withdrawn from the container 592 and its coated tip 590 is used to apply adhesive 570 at the desired site.

[0308] Conventional dipping of applicators into an adhesive 570 can result, in some cases, in a non-uniform layer of adhesive 570 surrounding the applicator. Advantageously, the proposed adhesive dispenser 586 provides a mechanism for removing excess adhesive 570 to better control the adhesion process. The size of the entry opening 598 corresponds to the diameter of the applicator 588 (for example, being slightly larger in diameter than the applicator), whereinthe difference between the diameters of the entry opening 598 and the applicator 588 is designed to achieve a desired amount of adhesive 570 coating the applicator 588. When the applicator is withdrawn from the container 592, it passes through the entry cap 596 such that excess adhesive is wiped off.

[0309] In some examples, the entry cap 596 can be funnel-shaped, as illustrated, to facilitate easier insertion of the applicator 588. In some examples, the entry cap 596 can be made of a different material from the rest of the container 592. In various examples, the entry cap 596 can be flexible and formed from an elastic material, or can be rigid. In some examples, the diameter of the entry opening 598 can substantially match the diameter of the applicator 588. In some examples, the diameter of the entry opening 598 can be larger than the diameter of the applicator 588 by about 0.01 - 0.2 mm.

[0310] In some embodiments, excess adhesive at the tip of the applicator may additionally or alternatively be removed or redistributed by directing a gas stream — such as air or nitrogen — along the longitudinal axis of the applicator 588. This axial gas flow can exert a shear or drag force on the adhesive, thereby removing excess material and promoting a more uniform distribution of the adhesive layer on the applicator tip 590.

[0311] Fig. 16 is a perspective view of an exemplary coupler 102c, which can be structurally and functionally similar to any example of coupler 102bdescribed herein, except that the body portion 108cof coupler 102cfurther includes an axial slot 124 extending longitudinally along its length, configured to allow placement of a first vessel 10 into the lumen 110. In such implementations, the internal pressure of vessel 10 can be reduced, decreasing its outer diameter to facilitate easy insertion into the lumen 110 through the slot 124. In some examples, the axial slot 124 can be relatively narrow, potentially slit-like, defining a width that can generally correspond to twice the thickness of a first vessel 10.

[0312] This design enables insertion of a first vessel 10, which can be a small-sized vessel in the case of a lymphatic vessel for example, into the coupler 102cwithout prior dissection of the vessel 10. This approach may simplify the procedure, as blood and lymphatic vessels often shorten when dissected, making securement to the coupler more difficult. To facilitate insertion, the first vessel 10 can first be clamped at end portion thereof to reduce internal pressure and decrease its profile, as will be described in greater detail, for example, with respect to Figs. 19A-19F. This allows for easier insertion of the collapsed vessel 10 through the axial slot 124 in the coupler. After insertion, the vessel may be reinflated by removing the clamp(s) or using other inflation methods described throughout the current disclosure. Adhesive 570 canthen be applied to secure the vessel in place, and the vessel can be dissected at the desired location, potentially leaving a short protrusion proximal to the coupler.

[0313] In some examples, a coupler 102 to which a first vessel 10 is secured can be a first coupler 102 of a system 100 that further includes a second coupler 160 to which a second vessel 30 is to be secured. The first coupler 102, having first vessel 10 secured thereto, and the second coupler 160, having second vessel 30 secured thereto, are configured to be coupled to each other in a sutureless manner, thus forming a sutureless connection between the first vessel 10 and the second vessel 30, such that their respective lumens 12 and 32 are in fluid communication. A second coupler 160 of a system 100 can be generally structured according to any of the examples described throughout the current disclosure for the first coupler 102.

[0314] When a first coupler 102 is coupled to a second coupler 160, the terminal end portion 114 is closer to the second coupler 160 than the first axial end portion 112a, wherein the first vessel 10 can continuously extend out of and away from the first axial end portion 112a.

[0315] Figs. 17 and 18 show examples of a first coupler 102 and a second coupler 160, respectively, of an anastomosis system 100. Any second coupler 160 disclosed herein comprises an axial body 166 extending between first and second open-ended axial end portions 170a and 170b, respectively. The axial body 166 defines a lumen 168 and can be, in some examples, substantially cylindrical in shape. The second coupler has a wall thickness defined between an inner surface 164 facing the lumen 168 and an opposite outer surface 162. In some examples, the length of the axial body 166, defined between the axial end portions 180a and 170b, can be greater than the diameter of its lumen 168.

[0316] The axial body 166, outer surface 162, inner surface 164, and axial end portions 170 of any second coupler 160 disclosed herein can be implemented according to any example described throughout the current disclosure for axial body 108, outer surface 104, inner surface 106, and axial end portions 112 of a first coupler 102. Moreover, any second coupler 160 disclosed herein can be formed from any of the materials disclosed herein for a first coupler 102. The first coupler 102 and the second coupler 160 can comprise similar or different materials.

[0317] A second vessel 30 can be secured to the inner surface 164 of the axial body 166 by the use of a biocompatible adhesive and / or mechanical attachment elements, such as hooks, barbs, sutures and the like. In some examples, the diameter of the lumen 168 in which the second vessel 30 is to be situated, is within a range of about 80% to about 200% of the outer diameter of the second vessel 30. In some examples, the diameter of the lumen 168 is within a range of about 95% to about 125%, inclusive, of the outer diameter of the second vessel 30.

[0318] In some examples, any of the inner surface 106 of first coupler 102 and / or the inner surface 164 of second coupler 160 can be fully or partially coated with one or more substances configured to improve biocompatibility and / or enhance adhesion between the inner surface of the corresponding coupler and the outer surface of the vessel placed therein. Examples of such coatings can include, but are not limited to: hydroxyapatite, heparin, hydrophilic, antimicrobial, drug-eluting coatings, and any combination thereof.

[0319] In some examples, any of the outer surface 104 of first coupler 102 and / or the outer surface 162 of second coupler 160 can comprise rough finishing, grooves, coatings, or other treatments which can be configured to either enhance tissue ingrowth, enhance integration, and / or facilitate coupling with the counterpart coupler.

[0320] Figs. 17 and 18 show an exemplary first coupler 102dand an exemplary second coupler 160d, respectively, of an anastomosis system 100dthat can be utilized to form an end-to-side connection of a first vessel (e.g., lymphatic vessel) to a second vessel (e.g., vein), though it is to be understood that exemplary first coupler 102aand second coupler 160aand features associated therewith are not limited to such a configuration, and that other types of vessels, other types of connections, and other arrangements may be used.

[0321] An exemplary first coupler 102dshown in Fig. 17 can be structurally and functionally similar to any example of first coupler 102 described herein, except that first coupler 102dfurther includes one or more axial locking protrusions 140, configured to assist in coupling the first coupler 102dto the second coupler 160din a manner that will be described in greater detail below. In some examples, first coupler 102dcan include an axial slot 124 extending longitudinally along its length, which can be configured according to any examples described herein for axial slot 124 with respect, for example, to Fig. 16.

[0322] An exemplary second coupler 160dshown in Fig. 18 can be structurally and functionally similar to any example of second coupler 160 described herein, except that the second coupler 160dis configured as a T-coupler that includes a side arm 174 extending sideways from the axial body 166d. The axial body 166dcan define a side opening 172 from which the side arm 174 extends to an open-ended arm end portion 178, such that an arm lumen 176 defined by the side arm 174 is in fluid communication with the lumen 168 of the axial body 166d.

[0323] While the side arm 174 is shown in Fig. 18 to extend perpendicularly to the axial body 166d, it is to be understood that the side arm 174 can optionally extend at any other angle relative to the axial body 166d. In some examples, an angle defined between the side arm 174 and the axial body 166dcan be approximately equal to 90° (for example, within a range of±10% from a 90° angle). In some examples, an angle defined between the side arm 174 and the axial body 166dcan be in a range of 20° to 80°, inclusive. In some examples, an angle defined between the side arm 174 and the axial body 166dcan be in a range of 30° to 60°, inclusive.

[0324] In some examples, a second coupler 160dcan include an axial slot 184 extending longitudinally along its length, configured to allow placement of a treated vessel into the lumen 168. In such implementations, the vessel's internal pressure can be reduced, decreasing its outer diameter to facilitate easy insertion into the lumen 168 through the slot 184. In some examples, the axial slot 184 can be relatively narrow, potentially slit-like, defining a width that can generally correspond to twice the thickness of a second vessel 30.

[0325] While illustrated and described together, it is to be understood that in some examples, a second coupler 160 can be provided with an axial slot 184 but without a side arm 174, and that in some examples, a second coupler 160 can be provided with a side arm 174 but without an axial slot 184. When both an axial slot 184 and a side arm 174 are provided, the slot 184 can be on a side of the axial body 166dthat is opposite to the side arm 174, as illustrated for example in Fig. 18, or at any other circumferential position of the axial body 166d, without intersecting with the side arm 174 itself.

[0326] A first coupler 102 and a second coupler 160 of any of the examples disclosed herein are configured to be suturelessly coupled to each other in a manner that forms fluid communication between their respective lumens 110 and 168. As mentioned above, a first vessel 10 is configured to be secured to a first coupler 102, and a second vessel 30 is configured to be secured to a second coupler 160, such that when the first coupler 102 and the second coupler 160 are coupled to each other, fluid communication between the first vessel 10 and the second vessel 30 is established.

[0327] In some examples, a first coupler 102, such as first coupler 102d, is configured to be suturelessly coupled to a side arm 174 of the second coupler 160d. In some examples, the side arm 174 defines one or more arm slots 180, such as the two arms slots 180 illustrated in Fig. 18. The first coupler 102dis shown in Fig. 17 to include complementary axial locking protrusions 140 configured to mate with the arm slots 180. For example, a first coupler 102dcan be inserted into the side arm 174 such that the axial locking protrusions 140 slide into, or otherwise engage with, the arm slots 180.

[0328] While two diametrically opposing axial locking protrusions 140 and two diametrically opposing arm slots 180 are illustrated, it is to be understood that any other number is contemplated. In some examples, engagement between axial locking protrusions 140 and armslots 180 can assist in alignment and positioning of the first coupler 102drelative to the second coupler 160d. Additionally or alternatively, engagement between axial locking protrusions 140 and arm slots 180 can be configured to lock the first coupler 102dagainst the second coupler 160d.

[0329] In some examples, the width of each of the axial locking protrusions 140 is slightly greater than the width of a corresponding arm slot 180, such that when the axial locking protrusion 140 is forcibly inserted into the arm slot 180, frictional engagement between the two locks the first coupler 102dwith the second coupler 160d.

[0330] Each axial locking protrusion 140 can axially extend from a trailing end 146a to a leading end 146b, wherein the leading end 146b is closer to the terminal end portion 114. In some examples, the leading end 146b can be rounded to facilitate easier insertion into the corresponding arm slot 180.

[0331] In some examples, each axial locking protrusion 140 further comprises one or more locking grooves 142, and the side arm 174 can further define one or more arm grooves 190, such that when the axial locking protrusion 140 are inserted into the arm slot 180, the locking grooves 142 are aligned with the arm grooves 190, together forming continuous grooves into which O-rings or other ring-like members can be inserted to lock the first coupler 102dwith the second coupler 160d.

[0332] In some examples, the side arm 174 can optionally include a guide rail 182 protruding inwards towards arm lumen 176. When a second coupler 160dequipped with a side arm 174 having a guide rail 182 is used in combination with a first coupler 102ddefining an axial slot 124, the slot 124 of the first coupler 102dcan slide over the guide rail 182 to facilitate insertion of the first coupler 102dinto the side arm 174.

[0333] It is to be understood that exemplary first coupler 102dand second coupler 160dare shown to include full-matter walls in Figs. 17 and 18 by way of illustration and not limitation, and that any of the first coupler 102dand second coupler 160dcan have a plurality of adhesion apertures 120 extending through their wall thicknesses according to any examples described herein with respect to implementations of adhesion apertures 120, allowing for advantageous securement of vessels 10 and 30 against the inner surfaces 106 and 164 of couplers 102dand 160d, respectively, by application of adhesive 570 that can fill such adhesion apertures 120 and form stud-like structure upon solidification thereof, for improved securement. Moreover, any of the first coupler 102dand second coupler 160dcan further include inner anchors 118 and / or tissue-growth promoting openings 148 according to any examples described throughout the current disclosure.

[0334] Figs. 19A-19F illustrate optional stages of an exemplary method for securing a first vessel 10 to a coupler that includes an axial slot 124. While securement of a first vessel 10 to an exemplary first coupler 102dis illustrated in Figs. 19A-19F, it is to be understood that this is shown by way of illustration only, and that steps of the method described herein with respect to Figs. 19A-19F can be similarly implemented to secure a first vessel 10 to an exemplary coupler 102c, or to secure a second vessel 30 to a second coupler 160, such as to the axial body 166dof the second coupler 160d, mutatis mutandis.

[0335] In some examples, biocompatible adhesive 570, such as biocompatible glue, can be applied to the inner surface 106. The adhesive 570 can be optionally applied over the entire inner surface 106 as shown in Fig. 19A, or over only a portion of the inner surface 106 as shown in Fig. 19B. Additionally or alternatively, biocompatible adhesive 570 can be applied to an outer surface of the first vessel 10.

[0336] Various types of applicators or dispensers 580 (including, for example, adhesive dispenser 586) can be utilized for that end, such as, but not limited to: pneumatic dispensers, hydrolytic dispensers, ultrasonic dispensers, syringes, or swabs. Applicators or dispensers 580 can be used to apply the adhesive 570 evenly across the entire area of the inner surface 106 or locally at one or more regions of the inner surface 106. In some examples, the axial body 108 of first coupler 102 can define inner grooves 122 designed to direct and distribute the adhesive material 570 evenly over the inner surface 106.

[0337] As shown in Fig. 19C, the first vessel 10 can be clamped on two offset regions 18 thereof which are axially offset from the axial end portions 112 of the first coupler 102, optionally by using clamping members 540 such as forceps-like clamps as illustrated for example in Fig. 19C, or any other clamping tools, temporary sutures, and the like. Clamping reduces vessel filling, resulting in decreased pressure and a smaller cross-sectional profile. The first vessel 10 can be then inserted in this state into coupler 102 through axial slot 124, as illustrated in Fig. 19C.

[0338] Once situated in coupler 102, the first vessel 10 can be expanded to bring its outer surface 14 into contact with the inner surface 106 of the coupler 102. In some examples, expansion of the first vessel 10 can be achieved by releasing the clamping members 540 (or temporary sutures), thereby allowing the lumen 12 of the first vessel 10 to refill and return to its physiological pressure. In some examples, expansion of the first vessel 10 can be achieved by injecting fluid (e.g., saline or any other appropriate inflation fluid) into the first vessel 10 to pressurize it, optionally to a pressure higher than physiological levels. This can be achieved, for example, utilizing an inflator, such as a syringe 490 with needle 492 as shown in Fig. 19D.Additional methods and tools for expanding the vessel will be described below, for example with respect to Figs. 26-28.

[0339] As shown in the cross-sectional view of Fig. 19E, once the first vessel 10 is expanded and brought into contact with the inner surface 106, securement between the two can be achieved. For example, this contact between the surfaces of the first vessel 10 and first coupler 102 can allow the adhesive to secure one to the other.

[0340] As mentioned above, while not illustrated in Fig. 19A-19F, any coupler disclosed herein can advantageously include adhesion apertures 120. When adhesion apertures 120 are included, adhesive can be further applied from the outer side of the coupler and fill the adhesion apertures 120 after expansion of the vessel 10 as shown in Fig. 19E. This can be optionally performed instead of, or in addition to, application of adhesive to the inner surface 106 as shown in Fig. 19A and 19B. In some examples, adhesive 570 applied over the inner surface 106 of coupler 102 and / or over the outer surface 14 of vessel 10 can flow into the adhesion apertures 120 and fill the apertures 120 upon expansion of the vessel 10, resulting in similarly formed stud-like structures upon solidification of the adhesive 570.

[0341] Fig. 19F illustrated a subsequent optional step of cutting the first vessel 10 at the level of, or proximate to, the terminal end portion 114 of the coupler 102. This can be accomplished by using a cutting tool 544, such as a scalpel, a blade, scissors, RF cutting device, or any appropriate cutting tool.

[0342] Figs. 20A-20C illustrate optional stages of an exemplary method for securing a second vessel 30 to a second coupler 160 that includes a side arm 174, such as exemplary T-shaped second coupler 160d. As shown in Fig. 20A, the second vessel 30 can be clamped on offset regions 38 thereof, which are positions that are axially offset from the axial end portions 170 of the second coupler 160 when the second coupler 160 is disposed over the second vessel 30. This can be optionally accomplished by mechanical clamping members 540 as shown in Fig. 20A, or by other methods such as suture ligation, balloons, or any other clamping tools, configured to significantly reduce pressure and flow in second vessel 30.

[0343] Subsequently, a side opening 40 is formed at a desired position between the offset regions 38, as shown in Fig. 20A. The side opening 40 can be created using a scalpel, laser, electrocautery, ultrasonic scalpel, scissors, or any other appropriate tool.

[0344] Once the side opening 40 is formed, a dilator 460 can be inserted into the second vessel 30 through the side opening 40, as shown in Fig. 20B. In some examples, a guidewire 476 can be initially passed through opening 40, over which the dilator 460 can be advanced into thesecond vessel 30, though it is to be understood that utilization of a guidewire 476 is merely optional.

[0345] Dilator 460 extends from a proximal end portion 462 to a to a distal end portion 466, and can define a tapering surface 468 extending to a narrower tip 470 at the distal end portion 466. When used in combination with a guidewire 476, the dilator 460 can further define a passage lumen 472 which can serve as a guidewire passage lumen extending along its length, through which the guidewire 476 can extend.

[0346] After insertion of dilator 460 into second vessel 30, the second vessel 30 should be inserted into the second coupler 160d. However, if dilator 460 is left fully extended into lumen 32 of the second vessel 30, a wider axial slot 184 may be required to allow for insertion of the vessel 30 into the lumen 168 of second coupler 160d. In some examples, dilator 460 can further include a marker 474 to indicate a position to which the dilator 460 should be retracted to enable insertion of second vessel 30 into the second coupler 160d, as shown in Fig. 20C. By partially retracting dilator 460 to a positioned marked by marker 474, as shown in Fig. 20C, the side arm 174 of second coupler 160dcan be properly aligned with side opening 40 of second vessel 30, allowing for easier insertion of second vessel 30 through axial slot 184.

[0347] The second vessel 30 is then inserted into the lumen 168 of second coupler 160d, such that the side opening 40 of the second vessel 30 is aligned with the side opening 172 of the second coupler 160d. The dilator can be then advanced through the side arm 174 into the lumen 32 of the second vessel 30, optionally over guidewire 476 which can be advanced a-priori into the lumen 32. Once properly position, the second vessel 30 can be expanded such that its outer surface 34 comes into contact with the inner surface 164 of the axial body 166, wherein adhesive 570 is used to secure the second vessel 30 to the axial body 166 of second coupler 160din this state.

[0348] In some examples, expansion of the second vessel 30 can be accomplished by utilization of an inflator, such as a syringe 490 with needle 492 penetrating through the wall of vessel 30 at a position offset from an axial end portion 170 of the coupler 160, the syringe 490 utilized to fill the vessel 30 with an appropriate fluid, such as liquid (e.g., saline) or gas (e.g., nitrogen or carbon dioxide).

[0349] In some examples, the passage lumen 472 can be utilized to inflate the second vessel 30. For example, the guidewire 476, if used, can be withdrawn from the dilator 460, and inflation fluid can be delivered through the lumen 472 into vessel 30. In some examples, a connector 464, such as a Luer connector of a stopcock, can optionally be provided on the proximal end portion 462 of dilator 460. An inflator (e.g., a syringe-like inflator) can be thencoupled to connector 464 and utilized to eject inflation fluid, though passage lumen 472 of dilator 460, into the lumen 32 of second vessel 30. Additional methods and tools for expanding the vessel will be described below, for example with respect to Figs. 26-28.

[0350] In some examples, adhesive 570 can be applied to the inner surface 164 of second coupler 160dprior to insertion of second vessel 30 into lumen 168. In some examples, adhesive 570 can be applied over the outer surface 34 of the second vessel 30 prior to insertion thereof into the lumen 168 of second coupler 160d. In some examples, the axial body 166 of second coupler 160dis provided with adhesion aperture 120. In some examples, when provided with adhesion aperture 120, adhesive 570 can be applied from the outer side of the axial body 166 after expansion of the second vessel 30.

[0351] Figs. 21A-21C illustrate optional stages of an exemplary method for coupling a first coupler 102dto a second coupler 160d, together forming an assembled anastomosis system 100d. A second vessel 30 secured to a second coupler 160dneeds to have a side opening 40 thereof aligned with a side opening 172 of the second coupler 160dto facilitate fluid connection between the lumen 176 of the side arm 174 and the lumen 32 of the second vessel 30. In some examples, the side opening 40 can be formed prior to insertion of the second vessel 30 into second coupler 160d, for example in a manner that can be similar to that described above with respect to Fig. 20A. Alternatively, the vessel 30 can be first inserted into the second coupler 160d, and the side opening 40 in vessel 30 can be formed once already residing inside second coupler 160d. For example, side opening 40 can be formed by insertion of a perforation tool through the side arm 174, such as, but not limited to: a hypodermic needle, micro-cannula, scalpel, cutting laser beam (e.g., Nd, CO2 lasers), electrocautery, radiofrequency ablation, a cryoprobe, rotational atherectomy, ultrasonic scalpel which can be optionally based on High- Intensity Focused Ultrasound (HIFU), or micro-scissors. In some examples, a perforation tool can be integrated into a catheter, a dilator (e.g., dilator 460 or any other type of dilator), or a handle, to enable easier access of the perforation tool through the side arm 174 to the vessel 30.

[0352] Once the second vessel 30 is secured to the second coupler 160dwith a side opening 40 thereof aligned with the side opening 172 of the second coupler 160d, the first coupler 102d, having the first vessel 10 already secured thereto, is inserted into the side arm 174 with the terminal end portion 114 oriented towards the side opening 172, as shown in Fig. 21 A, until both couplers 102dand 160dare locked against each other. Locking can be optionally accomplished by utilization of axial locking protrusions 140 inserted into arm slots 180, asshown for example in the zoomed-in view of Fig. 21C, and / or optional O-rings or other ringlockers placed in locking grooves 142 and arm grooves 190, as described above.

[0353] As mentioned above, an extended portion 22 of the first vessel 10 can extend, in some examples, past the terminal edge 116 of the first coupler 102. In some examples, the length of the extended portion 22, defined between the terminal edge 116 of the first coupler 102 and the cut edge 24 of the first vessel 10, can be in a range of between 1 to 10 times the diameter of the first vessel 10. For example, an extended portion 22 can have a length of about 0.5 mm to about 5 mm extending past the terminal edge 116 for a first vessel (e.g. a lymphatic vessel) having a diameter of about 0.5 mm.

[0354] Fig. 2 IB shows an example of an assembled system 100dwith an extended portion 22 of the first vessel 10 extending past the terminal edge 116 of the first coupler 102d, wherein coupling of the first coupler 102dto the second coupler 160dcan be performed such that the extended portion 22 is first threaded in a telescopic fashion into the lumen 32 of the second vessel 30, directed in a desired orientation within the lumen 32. In some cases, a guidewire (such as guidewire 476) may be initially advanced from the side arm 174 into the lumen 32 and oriented towards a desired axial end portion 170a or 170b (which can be generally opposite to the direction of flow through second vessel 30), allowing the extended portion 22 of first vessel 10, along with the first coupler 102dsecured to the first vessel 10, to be guided thereover, after which the couplers 102dand 160dcan be locked against each other as described above and / or shown in Fig. 21C. Such a configuration of an extended portion 22 extending into the second vessel 30 can advantageously minimize the risk of anastomosis failure by ensuring that no foreign materials interfere with the flow of body fluids between vessels 10 and 30.

[0355] In some examples, the side arm 174 can be a detachable component that can be decoupled from the axial body 166 of the second coupler 160dprior to formation of the side opening 40, to allow for easier access to the side opening 172 of second coupler 160d, and can be connected to the axial body 166 after formation of the side opening 40.

[0356] In some examples, a second coupler 160 can be devoid of a side arm, while including a side opening 172 formed on the axial body 166, and the first coupler 102 can be configured to connect to the second coupler 160 such that the axial body 108 of the first coupler 102 is aligned with the side opening 172 of the second coupler 160. Such a design can simplify access for creating side opening 40. Any of the methods described herein for forming an anastomosis using a T-shaped second coupler 160dcan be similarly implemented for formation of an anastomosis that includes a second coupler 160 having a side opening 172 without a side arm, mutatis mutandis.

[0357] While some types of first couplers and second couplers are disclosed herein to include an axial slot, it is to be understood that in some examples, any of the first couplers or second couplers can alternatively include at least one parting line extending along the length of their axial bodies (for example, between the axial end portions), the parting line configured to form a longitudinal separation or at least an opening. Such a separation may serve as an alternative to the axial slot for inserting a corresponding vessel into the coupler, and in some examples, may even allow doing so without clamping the vessel or otherwise decreasing pressure within the vessel. Such a longitudinal separation line can define at least two longitudinal parts of the coupler which can be disassembled and / or re-assembled and locked to each other by any locking means, such as, but not limited to: snaps, screws, pins, glue, or any other means known to those skilled in the art of part coupling.

[0358] Various configuration can be adapted to a terminal end of a first coupler 102 or a second coupler 160 of any type disclosed herein. Fig. 22 shows a cross-sectional view of a terminal end portion 114eof an exemplary first coupler 102e. First coupler 102ecan be structurally and functionally similar to any example of coupler 102 described herein, except that the terminal end portion 114edefines an inner funnel-shaped portion 117. The majority of the axial body 108ecan have a relatively uniform inner diameter DB, which expands at the terminal end portion 114eto a larger diameter DT at the terminal edge 116e. An inner funnel-shaped portion 117 can be of benefit, in some examples, for improved coupling of the first coupler 102eto a second coupler 160. In some examples, a length LF of the funnel-shaped portion 117 can be, in some examples, in a range of about 0.2 mm to about 5 mm. In some examples, the length LF can be in a range of about 0.5 mm to about 2 mm.

[0359] Fig. 23 shows a terminal end portion 114fof an exemplary first coupler 102f. First coupler 102fcan be structurally and functionally similar to any example of coupler 102 described herein, except that the terminal end portion 114fdefines a curved terminal edge 116f. The curved terminal edge 116fcan be implemented on a first coupler similar to any example described herein for first coupler 102d, configured to be coupled to a second coupler 160d, in which case the curvature of terminal edge 116fcan match the curvature of the edge surrounding the side opening 172 of second coupler 160d.

[0360] Fig. 24 shows a terminal end portion 114gof an exemplary first coupler 102g. First coupler 102gcan be structurally and functionally similar to any example of coupler 102 described herein, except that the terminal end portion 114gdefines an angled terminal edge 116g. As mentioned above, while the side arm 174 is illustrated in Fig. 18 to be perpendicular to the axial body 166 of exemplary second coupler 160d, in alternative configuration, the sidearm 174 can extend at other angles relative to the axial body 166. In such examples, an angle of the terminal edge 116gof first coupler 102g, which may be otherwise similar to any example described herein with respect to first coupler 102d, can be designed to match a similar angle defined between a non-perpendicular side arm 174 and the respective axial body 166 from which it extends.

[0361] Figs. 25A-25C illustrate cross-sectional views of a distal portion of a terminal end portion 114hof an exemplary first coupler 102h, and optional stages of an exemplary method for inverting an extended portion 22 of a first vessel 10 secured thereto. First coupler 102hcan be structurally and functionally similar to any example of coupler 102 described herein, except that the terminal end portion 114hdefines a tapering outer surface 104. The majority of the axial body 108hcan have a relatively uniform outer diameter and / or thickness, tapering to a smaller outer diameter at the terminal edge 116h, as shown in Fig. 25 A. The angle of tapering can be, in some examples, in a range of about 1° to about 75°. In some examples, the angle of tapering can be in a range of about 10° to about 30°.

[0362] A tapered terminal end portion 114hcan support easier inversion of an extended portion 22 of a first vessel 10 secured thereto. As shown in Fig. 25B, a first vessel 10, secured to the inner surface 106 of the axial body 108, can be cut to form an extended portion 22 extending from the terminal edge 116hto a cut edge 24 of the first vessel 10. In some examples, the length of the extended portion 22 can be in a range of about 1 to 10 times the outer diameter of the first vessel 10. In some examples, the length of the extended portion 22 can be in a range of about 2 to 4 times the outer diameter of the first vessel 10.

[0363] Subsequently, the extended portion 22 can be optionally inverted around the tapered terminal end portion 114h, as shown in Fig. 25C. In some examples, adhesive 570 can be applied on the outer surface 104 of the tapered terminal end portion 114hand / or on the outer surface 14 of the extended portion 22 prior to inversion, to facilitate adhesion therebetween.

[0364] It is to be understood that an axial slot 124 is illustrated in Figs. 25A-25C by way of illustration and not limitation, and that the first coupler 102hcan be provided either with or without an axial slot 124. It is to be understood that inversion of an extended portion 22 is shown in Figs. 25B-25C over a tapered terminal end portion 114hby way of illustration only, and that in some examples, an extended portion 22 can be inverted over any other example of a terminal end portion 114 that can but does not have to be tapered. While illustrated with respect to inversion of an extended portion 22 of a first vessel 10 around a terminal end portion 114 of a first coupler 102, it is to be understood that a second vessel 30 can be similarly inverted over a terminal end portion of a second coupler 160, mutatis mutandis.

[0365] Various examples disclosed herein for attachment of a vessel to a corresponding coupler, such as a first vessel 10 to a first coupler 102 or a second vessel 30 to a second coupler 160, describe a step of expanding the corresponding vessel to bring it into contact with the inner surface of the corresponding coupler. Various expansion devices can be employed for expanding the vessel, examples of which are disclosed herein.

[0366] Fig. 26 shows a side view of an exemplary expansion device 410 that can be used for expanding a target vessel. Expansion device 410 comprises an expansion portion 416 extending from a distal end 414 of a shaft 412. The expansion portion 416 can be made of one or more wires shaped to form a plurality of coils 418 in a free state thereof. While a single wire is shown in the illustrated example, it is to be understood that a plurality of wires (which can be, for example, wrapped around each other) can be employed, defining a total wire diameter that can be in a range of between about lOp and about 800p . In some examples, the wire (or the plurality of wires) can comprise an elastic or superelastic metal or polymer. In some examples, the wire (or the plurality of wires) can comprise a shape-memory material, such as a nickel-titanium alloy or Poly(isocyanurate-urethane).

[0367] The expansion portion 416 can move between a compacted configuration and an expanded configuration in a free-state thereof. The expansion portion 416 can be kept inside a delivery catheter 420 during delivery, wherein the inner diameter of the delivery catheter 420 is smaller than the diameter of the coils 418 in the expanded configuration, thus maintaining the expansion portion 416 in a compacted configuration inside the catheter 420, such that the expansion portion 416 is either straight in the compacted configuration or defines coils that have a smaller diameter than their free-state expanded configuration.

[0368] The catheter 420 can be advanced into the lumen of the vessel to be expanded, at which point the expansion portion 416 is exposed from the catheter 420, either by pushing the expansion portion 416 out of the distal end 422 of catheter 420, and / or by pulling the catheter 420 relative to the expansion portion 416, thus allowing the expansion portion 416 to self expand, with the coils pushing against the wall of the vessel in which it is positioned to expand the vessel therewith. In some examples, the outer diameter of the coils, in their free state expanded configuration, is designed to be equal to or larger than the inner diameter of the target vessel in its uncompressed mode, by about 5% to 30%.

[0369] Fig. 27 shows a side view of an exemplary expansion device 430qthat can be used for expanding a target vessel. Expansion device 430qand utilization methods thereof can be similar to any examples described above with respect to expansion device 430r, with the exception that the outwardly biased struts 438 of expansion portion 436qare arranged to circumferentiallyspan 360° around a central axis of shaft 432, distributed to expand the entire circumference of the target vessel.

[0370] Fig. 28 shows a side view of an exemplary expansion device 450 that can be used for expanding a target vessel. Expansion device 450 comprises an inflatable balloon 454 mounted on a distal portion of an inflation tube 452 (which can be, in some examples, a balloon catheter). The inflation tube 452 can be fluidly connectable to a fluid source (not shown) comprising inflation fluid for inflating the balloon 454. The term "inflation fluid", as used herein, means a fluid such as liquid (e.g., saline, though other liquids or gas can be used) or gas, used for inflating the balloon 454. The inflation fluid source (not shown) is in fluid communication with a lumen of the inflation tube 452, such that fluid from the fluid source can flow through the inflation tube 452 into balloon 454 to inflate it.

[0371] In use, the balloon 454 can be positioned within a lumen of the target vessel in a deflated state thereof, after which inflation fluid (e.g., saline, water, helium, carbon dioxide, air, and the like) can be delivered from the fluid source (e.g., a syringe or a pump) through the inflation tube 452, and injected into a cavity of the balloon 454 so as to inflate the balloon 454, which in turn dilates the target vessel. When the target vessel is sufficiently expanded, the balloon can be deflated to stop applying radial force on the target vessel and assume a smaller deflated diameter, allowing it to be retrieved from the vessel.

[0372] Figs. 29A-29B show an exemplary vessel expansion system 308 and optional steps of a method for utilizing system 308 for expanding a target vessel. It is to be understood that expansion and securement of a first vessel 10 to a first coupler 102 are illustrated in Fig. 29 A- 29B and described herein by way of example only, and that the system 308 can be similarly utilized for expanding any of a first vessel 10 to a first coupler 102 or a second vessel 30 to a second coupler 160.

[0373] The vessel expansion system 308 comprises a canister 310 that includes a first segment 312 and a second segment 318 that together enclose an inner chamber 324. The chamber 324 is sized to accommodate the coupler 102 and a portion of the target vessel 10 to be secured thereto. The first segment 312 and the second segment 318 can be separated by a parting line that can be optionally aligned with a central axis of the canister 310. When both segments 312 and 318 are assembled together, the canister 310 is configured to isolate the chamber 324 from the external environment, for example by sealing between the segments 312 and 318. In some examples, sealing between segments 312 and 318 can be achieved by a polymeric O-ring placed along the parting line, or by a soft lining of the contact area on at least one of the segments 312 and 318.

[0374] The canister 310 can further include one or more supports configured to support, and optionally align and / or center the coupler 102 within chamber 324. While two supports 316 are shown to extend from first segment 312, and two supports 322 are shown to extend from the second segment 318, with the coupler 102 disposed between and supported by the supports 316 and 322, it is to be understood that any other number of supports is contemplated.

[0375] End portions 314 and 320 of the first segment 312 and the second segment 318, respectively, are configured to clamp over the offset regions 18 of the vessel 10. For example, first end portion 314a of the first segment 312 and the first end portion 320a of the second segment 318 are clamped over the first offset region 18a, while second end portion 314b of the first segment 312 and the second end portion 320b of the second segment 318 are clamped over the second offset region 18b, to reduce the pressure inside the portion of the vessel 10 extending inside the chamber 324 and through coupler 102, between the two offset regions 18, as shown for example in Fig. 29 A.

[0376] In some examples, the end portions 314 and 320 can be formed from a soft material, or can have dimples configured to contact the offset regions 18 of the vessel 10, to allow at least partial crimping of vessel 10, reducing or occluding flow therethrough, while minimizing risk of injuring the vessel 10.

[0377] The system 308 further comprises a port 326 extending through the canister 310, for example through at least one of the segments 312 or 318, to which a tube 328 can be coupled. In some examples, a valve (not shown) is provided on the port 326 or the tube 328. In some examples, vacuum can be applied to the chamber 324 by connecting the tube 328 to a vacuum source, which can be, in some non-limiting examples, a syringe or vacuum pump. The term “vacuum”, as used herein, refers to reduced pressure relative to atmospheric pressure.

[0378] The vessel 10 is shown in Fig. 29A in a collapsed state, wherein adhesive 570 can be already dispensed over the outer surface 14 of the vessel 10 and / or a surface of the coupler 102. While not explicitly illustrated in Fig. 29A-29B, it is to be understood that in some examples, a coupler 102 (or coupler 160) placed inside canister 310 can include adhesion apertures 120.

[0379] After placement of the coupler 102 and collapsed vessel 10 within the chamber 324 of canister 310, the two segments 312 and 318 may be locked against each other using any locking mechanism such as screws, pins, or mechanical compression. In some examples, by compressing the segments 312 and 318 against each other at their parting line, substantial sealing may be achieved to allow at least partial vacuum formation within chamber 324.

[0380] Next, vacuum can be formed in chamber 324 via tube 328, configured to cause the vessel 10 to expand, brining it into contact with the inner surface 106 of coupler 102, as shownin Fig. 29B, with adhesive 570 disposed therebetween serving to secure the two to each other. Vacuum can remain for a period of time required for the adhesive 570 to cure. When provided with adhesion apertures 120, the adhesive material can flow into the adhesion apertures 120 and fill them as the vessel 10 is pressed against coupler 102, allowing stud-like structures to form within the adhesion apertures 120 when the adhesive 570 solidifies. When adhesive 570 is cured, vacuum can be released, and canister 310 can be disassembled, leaving vessel 10 secured to coupler 102. Follow-up procedures, such as cutting the vessel 10 at an edge 24, optionally forming an extended portion 22, which can optionally remain extending from the terminal edge 116 or alternatively can be inverted over the terminal end portion 114, can be performed according to any of the examples described herein.

[0381] Figs. 3OA-3OB show an exemplary adhesive application system 338 and optional steps of a method for utilizing system 338 for securing a vessel to a coupler through which it extends. It is to be understood that expansion and securement of a first vessel 10 to a first coupler 102 are illustrated in Fig. 3OA-3OB and described herein by way of example only, and that the system 338 can be similarly utilized securing any of a first vessel 10 to a first coupler 102 or a second vessel 30 to a second coupler 160.

[0382] The method described herein with respect to Figs. 3OA-3OB employs a casting-like approach, where an exemplary coupler 102kfunctions as the mold core. Coupler 102kcan be structurally and functionally similar to any example of a coupler that comprises adhesion apertures 120, such as any example of coupler 102a, except that coupler 102kfurther comprises flanged portion 136 extending radially outwards at both axial end portion 112. For example, a first flanged portion 136a can be at or proximate to the first axial end portion 112a, and a second flanged portion 136b can be at or proximate to the second axial end portion 112b, wherein the adhesion apertures 120 are disposed along the portion of the axial body 108kextending between the two flanged portions 136. As mentioned, while described herein and illustrated with respect to a first coupler 102k, it is to be understood that a second coupler 160 that includes adhesion apertures can similarly define two flanged portions 136 at axial end portions 170 thereof, and utilized in a similar manner with system 338 as will be described below, to secure a second vessel 30 thereto, mutatis mutandis.

[0383] The system 338 comprises a housing 340 defining a chamber 342, wherein the housing 340 can serve as a mold’s female part, in which the coupler 102kis placed. In some examples, the housing 340 can be substantially cylindrical in shape, matching an optional circular profile of the flanged portions 136. The diameter of chamber 342 can generally match the outer diameter of the flanged portions 136, such that when coupler 102kis placed within the chamber342, an enclosed cavity 344 is formed radially bound between the housing and the outer surface 104 of the axial body 108k, and axially bound between the two flanged portions 136. The cavity 344 is in fluid communication with the plurality of adhesion apertures 120, and is sealed from the remainder of the chamber 342.

[0384] A vessel 10 extends through the housing 340 and through coupler 102k. Initial extension of the vessel 10 through the lumen 110 of coupler 102kcan be performed while the vessel 10 is in a clamped or otherwise non-expanded state thereof. Once properly position to extend through lumen 110 of coupler 102k, the vessel 10 is expanded, optionally according to any of the methods disclosed herein, to bring its outer surface 14 into contact with the inner surface 106 of the axial body 108k, as shown in Fig. 30A.

[0385] The system 308 further comprises a port 346 extending through the housing 340 in fluid communication with the cavity 344, to which a tube 348 can be coupled. In some examples, a valve (not shown) is provided on the port 346 or the tube 348. In some examples, the tube 348 can serve as an adhesive filling tube. For example, the filling tube 348 can be connected to a reservoir of adhesive 570, configured to introduce the adhesive 570 into cavity 344. For example, the filling tube 348 can be coupled to a syringe or a pump configured to eject adhesive material 570 out of tube 348 and port 346 into cavity 344.

[0386] Adhesive 570 is introduced into cavity 344 until it fills the cavity 344 and adhesion apertures 120, at which point further introduction of adhesive 570 can be ceased. Once the adhesive 570 has substantially cured, an adhesive cast 572 is formed between the flanged portions 136, around the outer surface 104, with stud-like structures 574 extending through the adhesion apertures 120 towards the outer surface 14 of the vessel 10.

[0387] The coupler 102kwith the vessel 10 secured thereto by the adhesive cast 572 can then be removed from the housing 340, as shown in Fig. 30B. This can be accomplished, in some examples, by axially sliding the coupler 102kout of housing 340, or by any other suitable removal method.

[0388] In some examples, housing 340 can include a longitudinal slit (not shown) or a parting line that can divide it into two or more sections that can be assembled and disassembled, such that when removal is required, the two sections can be disassembled to facilitate easier removal.

[0389] In some examples, housing 340 can be formed from a material that does not interact with, or adhere to, the adhesive material 570 to allow removal of the coupler 102kwith the adhesive cast 572 therefrom. Housing 340 can comprise, in some examples, any one of: PTFE, other types of perfluoropolymers, polyimides (e.g., Kapton, Vespel), PEEK (Polyether EtherKetone), or any combination thereof. The choice of material can be selected according to the type of adhesive 570 intended for use.

[0390] In some examples, the tube 348 can be a vacuum tube, configured to apply vacuum to the cavity 344 to facilitate expansion of a vessel 10 extending through the lumen 110 of coupler 102k, in a manner that can be similar to any example described above with respect to tube 328 of system 308, mutatis mutandis.

[0391] In some examples, the same tube 348 can be a dual-purpose tube, first connected to a vacuum source and used to apply vacuum to the cavity 344 to facilitate expansion of a vessel 10, after which it can be disconnected to the vacuum source and connected to an adhesive reservoir, utilized to introduce the adhesive 570 into cavity 344 to form an adhesive cast 572.

[0392] In some examples, the port 346 can be a dual-purpose port to which different tubes 348 can be connected. For example, a first tube 348 can be connected on one end to the port 346 and on the other end to a vacuum source, used to apply vacuum to the cavity 344 to facilitate expansion of a vessel 10. Thereafter, the vacuum tube can be disconnected, and a new tube, serving as a filling tube, can be coupled to the port 346 and used to introduce the adhesive 570 into cavity 344 to form an adhesive cast 572.

[0393] In some examples, a coupler 102 (or coupler 160) devoid of flanged portions 136 can be used with system 338. For example, instead of flanged portions formed as part of a coupler, the housing 340 can include supports extending radially inwards, optionally similar to examples of supports 316, 322 of the system 308, as long as they are structured to surround the entire circumference of each of the corresponding axial end portion 112. The axial position of the inwardly-extending supports of a housing 340 in such an example can be designed to align with the terminal end portion 114 of the coupler 102, such that when the coupler is placed within such supports, a similarly sealed cavity 344 is formed. The method can be similarly performed according to any of the examples described above with respect to coupler 102k, mutatis mutandis.

[0394] In some examples, an anastomosis system 100 utilized to form a side-to-side anastomosis, can include a locking member, such as locking member 210 shown in Figs. 31A- 311, configured to couple the first coupler 102 to the second coupler 160. Figs. 31A-31D illustrate optional stages of an exemplary method for assembling components of an exemplary anastomosis system 1001. Anastomosis system 1001includes an exemplary first coupler 1021, an exemplary second coupler 1601, and an exemplary locking member 210.

[0395] First coupler 1021, shown in isolation in Fig. 31 A, can be structurally and functionally similar to any example of first coupler 102 described herein, except that first coupler 1021further comprises a stopper 126 extending radially outwards from the terminal end portion 114, the stopper 126 defining a step 134 at the transition between the outer surface 104 of the axial body 1081and the larger diameter of stopper 126, the step oriented towards the first axial end portion 112a. For example, a stopper 1261is illustrated in Figs. 31A-31D to be formed as a flanged portion extending from the terminal end portion 114.

[0396] A first vessel 10 can be secured to the first coupler 1021according to any of the methods disclosed throughout the current specification. In some examples, adhesive 570 can be applied to the inner surface 106 of the first coupler 1021as illustrated in Fig. 21B, and / or to an outer surface 14 of the first vessel 10. The first vessel 10 is extended through the lumen 110, optionally in a clamped or otherwise non-expanded state thereof, after which the vessel 10 can be expanded to come into contact with the inner surface 106 of the first coupler 1021, as illustrated in Fig. 31C. In some examples, the first coupler 1021can include an axial slot 124 through which the first vessel 10 can be inserted into lumen 110. However, it is to be understood that an axial slot 124 is illustrated with connection to first coupler 1021for illustrative purpose only, and that in some examples, first coupler 1021can be devoid of an axial slot.

[0397] It is to be understood that the axial body 1081of first coupler 1021is shown to be formed of full-matter wall material merely for simplification of illustration, and that in some examples, the axial body 1081of first coupler 1021can further include a plurality of adhesion apertures 120. When a plurality of adhesion apertures 120 are present, application of adhesive on the inner surface 106 as shown in Fig. 3 IB can be optionally skipped, and adhesive 570 can be applied from the outer surface 104 to fill the adhesion apertures 120 after expansion of the first vessel 10, as shown in Fig. 31C.

[0398] An optional subsequent step of the method can include trimming of the portion of the first vessel 10 extending from the terminal end portion 114. In some examples, the first vessel 10 can be trimmed at the level of the terminal edge 116, as illustrated in Fig. 3 ID. Alternatively, an extended portion 22 of the first vessel 10 can be formed after trimming, in which case the extended portion 22 can either remain in an axially-extended configuration, or can be inverted over the terminal end portion 114. Leaving an extended portion 22 that axially extends past the terminal edge 116 allows the extended portion 22 to be inserted into the lumen 32 of the second vessel 30 during formation of an anastomosis, such as a side-to-side anastomosis, which can advantageously prevent or lower the risk of occlusion of the end portion of first vessel 10 that may otherwise occur due foreign matter interaction of the terminal end portion 114 of a coupler 102 with body fluids or tissues.

[0399] It is to be understood that some parts of the first coupler 1021are not necessarily illustrated to scale, and that dimensions of different regions or components may vary. For example, a stopper 1261can define a smaller outer diameter than that illustrated in Figs. 31A- 3 ID, to enable easier inversion of an extended portion 22 of the first vessel 10 thereover, when such inversion is desired.

[0400] A locking member 210, shown for example in Fig. 3 ID, includes a support body 212 from which a grip portion 236 extends. In some examples, the grip portion 236 can include one or more grip arms 218. The locking member 210 is configured to axially slide over the axial body 108 of the first coupler 102. For example, the locking member 210 can be positioned around a portion of the first vessel 10 extending from the first axial end portion 112a, and can be slid towards the terminal end portion 114. In some examples, the support body 212 can be a ring-like member that defines a central opening through which the first vessel 10 and / or axial body 108 of the first coupler 102 can extend. An exemplary locking member 210 is illustrated with a slot 214 formed along its support body 212, which can be used to position the locking member 210 around the vessel 10 and / or axial body 108. However, it is to be understood that inclusion of a slot 214 is merely optional.

[0401] While two diametrically opposing grip arms 218 are illustrated, it is to be understood that any other number of grip arms 218 is contemplated, including, in some examples, a single grip arm or grip member that can optionally circumscribe the entire circumference around the axial body 108.

[0402] The support body 212 defines an inner step 216, for example formed by a rear wall thereof, oriented towards the step 134 of the first coupler 1021. The grip arms 218 are radially offset from the outer surface 104 of the axial body 1081, and can be configured to slide over the stopper 126 such that when the locking member 210 is slid over the axial body 1081towards the terminal end portion 114, further movement thereof is stopped by contact of the inner step 216 of support body 212 with the step 134 of the stopper 126, with the grip arms 218 extending in this position past the stopper 126.

[0403] Second coupler 1601, shown in isolation in Fig. 3 IE, can be structurally and functionally similar to any example of second coupler 160 described herein, except that second coupler 1601further comprises a retention cavity 188 formed at the outer surface 162 of its axial body 1661. In some examples, a retention cavity 188 can be in the form of a groove or depression that does not extend through the entire wall thickness of axial body 1661, as illustrated in Figs. 3 IE-311. Alternatively, a retention cavity can be in the form of one or more blind holes or through holes (not illustrated).

[0404] A second vessel 30 can be secured to the second coupler 1601according to any of the methods disclosed throughout the current specification. In some examples, adhesive 570 can be applied to the inner surface 164 of the second coupler 1601and / or to an outer surface 34 of the second vessel 30. The second vessel 30 is extended through the lumen 168, optionally in a clamped or otherwise non-expanded state thereof, after which the vessel 30 can be expanded to come into contact with the inner surface 164 of the second coupler 1601, as illustrated in Fig. 3 IF. In some examples, the second coupler 1601can include an axial slot 184 (not shown in Figs. 3 IE-311) through which the second vessel 30 can be inserted into lumen 168. However, it is to be understood that an axial slot 184 is illustrated with connection to second coupler 1601for illustrative purpose only, and that in some examples, second coupler 1601can be devoid of an axial slot.

[0405] It is to be understood that the axial body 1661of second coupler 1601is shown to be formed of full-matter wall material merely for simplification of illustration, and that in some examples, the axial body 1661of second coupler 1601can further include a plurality of adhesion apertures 120. When a plurality of adhesion apertures 120 are present, application of adhesive on the inner surface 164 can be optionally skipped, and adhesive 570 can be applied from the outer surface 162 to fill the adhesion apertures 120 of axial body 1661after expansion of the second vessel 30, as shown in Fig. 3 IF.

[0406] An optional subsequent step of the method can include trimming of the portion of the second vessel 30 extending from a terminal end portion 192, which, like terminal end portion 114, is defined at the second axial end portion 112b when the second vessel 30 terminated at or in some proximity to the terminal edge 194 of the terminal end portion 192. In some examples, the second vessel 30 can be trimmed at the level of the terminal edge 194, as illustrated in Fig. 31G. Alternatively, an extended portion of the first vessel 10 can be formed after trimming, in which case the extended portion of the second vessel 30 can either remain in an axially-extended configuration, or can be inverted over the terminal end portion 192 of the second coupler 160.

[0407] Fig. 31H shows the two couplers 1021and 1601with the corresponding vessel 10 and 30 secured thereto, prior to coupling the couplers to each other. It is to be understood that a first vessel 10 can be secured to a first coupler 102 prior to, simultaneously with, or after securing a second vessel 30 to the second coupler 160.

[0408] To couple the two couplers 1021and 1601to each other, they can be brought into close proximity with each other and facing one another, optionally such that their respective terminal end portions 114 and 192 may contact each other, and sliding the locking member 210 over theaxial body 1081towards the terminal end portion 114, optionally until it is engaged by the stopper 126, preventing further movement thereof. As the locking member 210 is axially slid, the grip arms 218 are moved past the terminal edge 116 of the first coupler 1021and slide around the outer surface 162 of the second coupler 1601until inner protrusions 220 at the ends of the grip arms 218 reach and snap into the retention cavity 188, as shown in Fig. 3 II. In some examples, locking member 210 can be advanced until it is stopped by stopper 126 prior to bringing the two couplers 1021and 1601into close proximity with each other.

[0409] In some examples, the grip arms 218 can be formed as relatively elastic and / or flexible members which are biased radially inwards in the free state, such that upon reaching the retention cavity 188 (e.g., retention groove) they can snap into position and prevent further spontaneous axial movement between the couplers 102 and 160.

[0410] Fig. 32A shows an exemplary system 100mthat includes a coupler 102 and a holder 270 configured to enable storage of the adaptor 102 and / or facilitate placement of the coupler 102 over a target vessel 10. The holder 270 includes a holder body 272 that can be optionally dimensioned and / or shaped to enable being held by a user, a shaft 274 extending distally from the holder body 272, and a loop 276 at a distal end of the shaft 272. During storage or prior to placement of the adaptor 102 over a target vessel, the adaptor 102 can be held in place over the shaft 274. In some examples, the shaft 274 is designed to extend through the lumen 110 of coupler 102 in a manner that can optionally prevent spontaneous displacement of the adaptor 102 relative to shaft 274, yet allow the coupler 102 to axially slide over the shaft 274 under application of manual force. In some examples, the holder 270 further comprises a sleeve 278 that can be disposed over the shaft 274 and / or coupler 102 placed thereon, though it is to be understood that inclusion of a sleeve 278 is merely optional. In some examples, the holder 270 can be provided as a stand-alone tool. In some examples, the holder 270 is provided together with the coupler 102 placed over its shaft 274, together forming the system 100m.

[0411] In some example, the holder body 272 can include an optional marker 280 such as printed indicia, embossing, a separate marker affixed to the body 272 and the like. The marker can include one or more alphanumerical letters, numbers, graphical symbols, and the like. A line of products can include several types and / or sizes of holders 270. The marker can be indicative of the type and / or size of the holder 270. For example, an “M” marker illustrated in Figs. 32A-32D can be indicative of a medium size for a line of products that includes a variety of sizes, such as extra-small (XS), small (S), medium (M), large (L), extra-large (XL) and the like. It is to be understood that the marker 280 is shown in Figs. 32A-32D by way of illustrationand not limitation, and may take the form of any other letter, word, digit, number, icon, or any combination thereof, and that in some examples, a holder 270 can be devoid of such a marker.

[0412] Figs. 32B-32D show optional steps of a method for utilizing system 100mfor placing the coupler 102 over a target vessel. A member 530 in the form of a suture or an elongated wire can be threaded through the loop 276 of the holder 270, with the opposite end(s) of the member 530 attached, at an attachment portion 532, to an end portion 20 of the vessel 10, as shown in Fig. 32B. As mentioned above, inclusion of a sleeve 278 is optional and not mandatory. If a sleeve 278 was included, the sleeve 278 can be removed prior to threading of the member 530 through the loop 276.

[0413] The shaft 274, loop 276 and member 530 together form, in this manner, a continuous guide path or rail along which the coupler 102 can be then slid distally, as shown in Fig. 32C, towards and over the vessel 10. Once properly placed over the vessel 10, as shown in Fig. 32D, the coupler 10 can be attached to the vessel 10 by application of an adhesive 570 and / or any other suitable manner disclosed herein. The end portion 20 of the vessel 10 can be trimmed according to any example described herein, either after attachment of the coupler 102 to the vessel 10 or after placement of the coupler 102 over vessel 10 but prior to attachment.

[0414] While illustrated in Figs. 32A-32D and described herein for use with a coupler 102 configured to be placed over, and coupled to, a first vessel 10, it is to be understood that the holder 270 can be similarly used in combination with second coupler 160, configured for placement over second vessel 30, mutatis mutandis.

[0415] Any of the systems, couplers, etc. herein can be sterilized (for example, with heat, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated assembly, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, Ethylene Oxide (EO) Gas Sterilization, Hydrogen Peroxide (Vaporized Hydrogen Peroxide - VHP) Sterilization, Glutaraldehyde Sterilization, Peracetic Acid Sterilization, Formaldehyde Sterilization, Chlorine Dioxide Sterilization, Ozone (Os) Sterilization, Cidex OPA (Ortho-phthalaldehyde) Sterilization, Alcohol (Isopropyl Alcohol and Ethyl Alcohol).

Claims

CLAIMS1. An anastomosis system comprising: a coupler comprising: an axial body extending from a first axial end portion to a terminal end portion, the axial body defining a lumen; and a plurality of adhesion apertures disposed along a length of the axial body and radially extending between an outer surface of the axial body and an inner surface of the axial body; wherein the system is configured to suturelessly couple a first vessel and a second vessel such that fluid communication is formed therebetween; and wherein the coupler is configured to secure the first vessel extending through the lumen to the axial body via biocompatible adhesive filling at least partially the adhesion apertures.

2. The system of claim 1, wherein the adhesion apertures are configured to facilitate formation of stud-like structures extending through the adhesive apertures upon solidification of the adhesive applied to fill the adhesion apertures.

3. The system of any one of claims 1 - 2, wherein each of the adhesion apertures has an area within a range of 104mm2to 0.2 mm2, inclusive.

4. The system of any one of claims 1 - 3, wherein the adhesion apertures occupy between 2% and 20% of a total surface area of the axial body.

5. The system of any one of claims 1 - 4, wherein the adhesion apertures are arranged non-circumferentially over the axial body.

6. The system of claim 5, wherein the adhesion apertures are distributed in a spiral pattern along a longitudinal axis of the axial body.

7. The system of any one of claims 1 - 6, wherein at least one of the adhesion apertures comprises an interior extension extending from at least one side thereof.

8. The system of any one of claims 1 - 7, wherein the terminal end portion defines a tapering outer surface.

9. The system of any one of claims 1 - 8, wherein the coupler further comprises inner anchors extending radially inwards from the inner surface of the axial body and configured to engage with the first vessel.

10. The system of claim 9, wherein the inner anchors comprise barbs.

11. The system of any one of claims 9 - 10, wherein the inner anchors are angled relative to the inner surface of the axial body.

12. The system of any one of claims 1 - 11, wherein the coupler further comprises one or more tissue-growth promoting openings radially extending between the outer surface and the inner surface and configured to promote tissue growth therethrough.

13. The system of claim 12, wherein the one or more tissue-growth promoting openings occupy between 1% and 10% of the total surface area of the axial body.

14. The system of any one of claims 12 - 13, wherein any of the one or more tissuegrowth promoting openings defines a larger area than any of the adhesion apertures.

15. The system of any one of claims 12 - 14, wherein each of the one or more tissuegrowth promoting openings defines a textured perimeter.

16. The system of any one of claims 1 - 15, wherein a terminal edge of the terminal end portion defines a staged geometry.

17. The system of any one of claims 1 - 16, wherein the axial body further comprises an axial slot extending longitudinally from the first end portion to the terminal portion, the slot having a width configured to allow insertion of the first vessel, in a nonexpanded state of the first vessel, therethrough into the lumen.

18. The system of any one of claims 1 - 17, wherein each of the adhesion apertures defines a larger area at the outer surface than at the inner surface.

19. The system of any one of claims 1 - 18, wherein the coupler further comprises one or more outer anchors extending outwardly from the axial body at an angle in a range of 1° to 60°, and configured to engage the second vessel.

20. The system of claim 19, wherein the one or more outer anchors are closer to the terminal end portion than to the first axial end portion, and are axially oriented towards the first axial end portion.

21. The system of any one of claims 19 - 20, wherein the one or more outer anchors are integrally formed with the axial body.

22. The system of any one of claims 19 - 21, wherein the one or more outer anchors comprise barbs.

23. The system of any one of claims 19 - 22, further comprising a delivery tube configured to extend around the coupler.

24. The system of claim 23, wherein the one or more outer anchors are configured to assume a compressed configuration when retained inside the delivery tube, and to spring outwardly when exposed from the delivery tube.

25. The system of any one of claims 23 - 24, wherein the delivery tube further define a tapering end portion.

26. The system of any one of claims 23 - 25, further comprising a push tool comprising: an engagement portion configured to slide over a portion of the first vessel extending proximally from the coupler, and to engage with the first axial end portion of the coupler such that when the push tool is distally pushed, the engagement portion pushes the coupler therewith; a handle; and a shaft extending between the engagement portion and the handle.

27. The system of claim 26, wherein the engagement portion is configured to be axially moved through the delivery tube.

28. The system of any one of claims 26 - 27, wherein the engagement portion comprises a gap.

29. The system of any one of claims 26 - 28, wherein the push tool further comprises an elbow defined along the shaft and configured to offset the handle from the first vessel secured to the coupler.

30. The system of any one of claims 19 - 29, further comprising an expansion device configured to expand an end portion of the second vessel, the expansion device comprising: a shaft; an expandable portion extending from a distal end of the shaft and comprising a plurality of outwardly biased struts; and a delivery catheter disposed over the shaft and axially movable relative thereto; wherein expandable portion is configured to move between a compacted configuration when residing inside the delivery catheter and an expanded configuration in which the struts extend outwardly and farther away from each other when exposed from the delivery catheter; and wherein the plurality of struts circumferentially span less across less than 360°.

31. The system of claim 30, wherein the plurality of struts circumferentially span across between 150° and 270°, inclusive.

32. The system of any one of claims 1 - 31, wherein the coupler is a first coupler, and wherein the system further comprises a second coupler comprising: an axial body extending from a first axial end portion to a second end portion and defining a lumen; and a plurality of adhesion apertures disposed along a length of the axial body of the second coupler;wherein the second coupler is configured to secure the second vessel extending through the lumen of its axial body via biocompatible adhesive filling the adhesion apertures of the second coupler.

33. The system of claim 32, wherein the axial body of the second coupler further comprises an axial slot having a width configured to allow insertion of the second vessel, in a non-expanded state of the second vessel, therethrough into the lumen of the axial body of the second coupler.

34. The system of any one of claims 32 - 33, further comprising a locking member configured to move between an unlocked state and a locked state, the locking member comprising: a support body axially slidable, in the unlocked state, over one of the first coupler or the second coupler; and a grip portion axially extending from the support body and configured to extend towards and lock against the other one of the second coupler or the first coupler, thereby moving the grip portion to the locked state configured to couple the first coupler and the second coupler to each other; wherein the system is configured to form, in the locked state, fluid communication between a first vessel secured to the first coupler and a second vessel secured to the second coupler.

35. The system of claim 34, wherein the grip portion defines an angled surface at an axial end thereof.

36. The system of any one of claims 32 - 33, wherein the second adaptor further comprises a side arm extending from a side opening of the axial body of the second adaptor, and wherein the first adaptor is configured to be coupled to the side arm.

37. The system of claim 36, wherein the terminal end portion of the first adaptor defines a curved terminal edge matching the curvature of an edge surrounding the side opening of the second adaptor.

38. The system of claim 36, wherein the side arm is angled at a non-perpendicular angle relative to the axial body of the second adaptor, and wherein the terminal end portion of the first adaptor defines an angled terminal edge.

39. The system of any one of claims 36 - 38, wherein the first adaptor further comprises one or more axial locking protrusions, and wherein the side arm further comprises one or more arm slots configured to receive the one or more locking protrusions.

40. The system of claim 39, wherein at least one of the locking protrusions is wider than the corresponding arm slot into which it is configured to extend.

41. The system of any one of claims 39 - 40, wherein each of the one or more locking protrusions further comprises one or more locking grooves, and wherein the side arm further comprises one or more arm grooves configured to align with the one or more locking grooves of the one or more locking protrusions.

42. The system of any one of claims 36 - 41, further comprising a dilator configured to extend through a side opening of the second vessel into a lumen of the second vessel, the dilator comprising a tapering surface at a distal end portion thereof.

43. The system of claim 42, wherein the dilator further comprises a marker configured to indicate a position of the dilator during insertion of the second vessel into the lumen of the axial body of the second coupler.

44. The system of any one of claims 42 - 43, wherein the dilator further comprises a passage lumen.

45. The system of claim 44, wherein the passage lumen is configured to allow extension of a guidewire therethrough.

46. The system of any one of claims 44 - 45, wherein the passage lumen is configured to enable flow of inflation fluid therethrough.

47. The system of claim 46, wherein a proximal end portion of the dilator further comprises a connector interface configured to be couple an inflator thereto.

48. The system of any one of claims 1 - 47, further comprising an expansion device configured to be inserted into a lumen of at least the first vessel and expand the first vessel, the expansion device comprising a shaft and an expandable portion extending from a distal end of the shaft, the expandable portion configured to move between a compacted configuration and an expanded configuration.

49. The system of claim 48, further comprising a delivery catheter through which the shaft is configured to extend and to be axially moved relative thereto, wherein the expandable portion is configured to assume the compacted configuration when residing inside the delivery catheter, and to passively move to its expanded configuration when exposed out of the delivery catheter.

50. The system of claim 49, wherein the expandable portion comprises at least one wire configured to form a plurality of coils in the expanded configuration.

51. The system of claim 49, wherein the expandable portion comprises a plurality of outwardly biased struts arranged to circumferentially span 360° around a central axis of the shaft.

52. The system of claim 48, wherein the shaft is an inflation tube, and wherein the expandable portion is an inflatable balloon.

53. The system of any one of claims 1 - 52, further comprising an adhesive dispenser comprising: a container configured to contain biocompatible adhesive, wherein the container extends from a container top to a bottom portion; and an elongated applicator configured to extend into the container through an entry opening formed at the container top; wherein a diameter of the entry opening is larger than a diameter of the applicator by 0.01 to 0.2 mm.

54. The system of claim 53, wherein the container top comprises an entry cap defining the entry opening.

55. The system of claim 54, wherein the entry cap is funnel-shaped.

56. The system of any one of claims 1 - 55, further comprising a holder comprising: a holder body; a shaft extending distally from the holder body; and a loop at a distal end of the shaft; wherein the shaft is configured to enable placement of coupler thereover.

57. The system of claim 56, further comprising a sleeve configured to be disposed over the coupler when the coupler is positioned over the shaft.

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