Artificial graft for anastomotic coupling

Abstract

An artificial graft for anastomotic coupling is provided. The artificial graft includes a tubular body forming a lumen and one or more joining features operable to couple with a joining feature coupled with a tubular structure. When the joining feature is coupled with the joining feature of the tubular structure, the lumen is in fluid communication with a lumen of the tubular structure.

Description

ARTIFICIAL GRAFT FOR ANASTOMOTIC COUPLINGCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 589,737, filed in the U.S. Patent and Trademark Office on October 12, 2023, which is incorporated herein by reference in its entirety for all purposes.FIELD

[0002] The present disclosure relates generally to an artificial graft for anastomotic coupling tubular structures.BACKGROUND

[0003] An anastomosis is a connection between two luminal structures. Commonly, these connections can occur with blood vessels (for example, vascular anastomosis), or tubular gastrointestinal structures (for example, intestines, stomach, esophagus). Conventional techniques allow the anastomosis to be completed between two ends (referred to as end-to-end anastomosis), or between the end of one structure and the side of another structure (referred to as end-to-side anastomosis). Procedures requiring these anastomoses are carried out thousands of times per day, globally. Likewise, multiple surgical specialties rely upon the creation of reliable, unobstructed anastomoses for successful treatment of their respective patients.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Implementations of the present technology will now be described, by way of example only, with reference to the attached figures, wherein:

[0005] FIG. 1 A illustrates a perspective view of an artificial graft for anastomotic coupling;

[0006] FIG. 1 B illustrates a side view of the artificial graft of FIG. 1 A;

[0007] FIG. 2A illustrates the artificial graft coupling with a first tubular structure;

[0008] FIG. 2B illustrates the artificial graft coupling with the first tubular structure;

[0009] FIG. 2C illustrates the artificial graft coupling with both a first tubular structure and a second tubular structure;

[0010] FIG. 3A illustrates an artificial graft with at least two branched portions;

[0011] FIG. 3B illustrates the artificial graft of FIG. 3A coupling with tubular structures;

[0012] FIG. 4A illustrates a branched connector artificial graft;

[0013] FIG. 4B illustrates the branched connector artificial graft of FIG. 4A coupled with tubular structures;

[0014] FIG. 5A illustrates an artificial graft with a graft joining feature that has an angled end;

[0015] FIG. 5B illustrates the artificial graft of FIG. 5A coupled with a tubular structure;

[0016] FIG. 6 illustrates the artificial graft coupled to a side of a tubular structure;

[0017] FIG. 7 illustrates the artificial graft with a joining feature that has an angled end coupled with a side of a tubular structure;

[0018] FIG. 8A illustrates an artificial graft with a tapered diameter;

[0019] FIG. 8B illustrates a side view of the artificial graft of FIG. 8A;

[0020] FIG. 8C illustrates the artificial graft of FIGS. 8A and 8B coupled with tubular structures;

[0021] FIG. 9 illustrates a cartridge;

[0022] FIG. 10A illustrates the cartridge coupling a structure joining feature with a tubular structure;

[0023] FIG. 10B illustrates the cartridge coupling a graft joining feature with a artificial graft;

[0024] FIG. 11 illustrates a male joining feature; and

[0025] FIG. 12 illustrates a female joining feature.DETAILED DESCRIPTION

[0026] It will be appreciated that for simplicity and clarity of illustration, where appropriate, reference numerals have been repeated among the different figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thorough understanding of the examples described herein. However, it will be understood by those of ordinary skill in the art that the examples described herein can be practiced without these specific details. In other instances, methods, procedures and components have not been described in detail so as not to obscure the related relevant feature being described. Also, the descriptionis not to be considered as limiting the scope of the examples described herein. The drawings are not necessarily to scale and the proportions of certain parts may be exaggerated to better illustrate details and features of the present disclosure.

[0027] The original technique for vascular suture anastomoses was created by Alexis Carrel between 1901-1910. This pioneering work resulted in Carrel receiving the Nobel Prize in 1912. Despite 100 years of surgical evolution and innovation since that discovery, the majority of vascular anastomoses to this day still employ suture techniques similar to Carrel’s initial description in the early 1900s. In the 1970s, gastrointestinal stapling devices were introduced, which quickly replaced primary suture techniques for bowel anastomoses. However, most surgeons still employ circumferential suture techniques in the serosal layer overlying the stapled anastomosis for added support. Although generally successful, these techniques can take long periods of time, often require additional surgical expertise, and if not performed correctly, may result in leakage (blood, stool contents, gastric contents, lymphatic fluid), constriction, stenosis, and / or obstruction at the anastomotic site. In the case of vascular anastomoses, stenosis and / or obstruction can result in catastrophic complications such as heart attack, stroke, peripheral limb ischemia, amputation, death, and reconstructive failure and soft-tissue loss. For example, in the setting of gastrointestinal anastomoses, these complications can result in extraluminal leak of gastrointestinal contents, infection, sepsis, obstruction, and death.

[0028] Referring now to FIGS. 1A and 1 B, an artificial graft 100 for anastomotic coupling is provided. As illustrated in FIGS. 2A-3B, 4B, 5B, 6, 7, and 8C, the artificial graft 100 is provided to create a fluid connection between one or more tubular structures 12. For example, the artificial graft 100 can be operable to create a fluid connection between adjacent tubular structures 12, a plurality of branched tubular structures 12, other artificial grafts 100, and / or other devices to be in fluid communication with the first tubular structure 12. The tubular structure 12 can include blood vessels, grafts, prostheses, gastrointestinal structures, esophagus, lymphatics, and / or any other suitable channels of the body or the operation for which the tubular structure is created. In some examples, the tubular structure 12 can include a device structure that is operable to receive fluid from and / or provide fluid to the tubular structure 12, and the artificial graft 100 can be operable to connect the tubular structures 12. The tubular structure 12 forms a lumen 14 through which matter can bepassed, for example blood, food, fluids, and / or cells. The artificial graft 100 also includes a lumen 106 that is formed from walls 103 of the artificial graft 100. Accordingly, when the artificial graft 100 is coupled with the tubular structure 12, the lumen 106 of the artificial graft 100 is operable to be in fluid communication with the lumen 13 of the tubular structure 12 so that the matter can pass through the artificial graft 100 and through the tubular structure 12 without leaking or obstruction.

[0029] The artificial graft 100 includes a tubular body 102 with a lumen 106 and one or more joining features 104 (e.g., graft joining features 104) forming an aperture 1040. In some examples, the tubular body 102 of the artificial graft 100 can be integral with the joining feature(s) 104. In at least one example, the graft joining feature 104 is operable to be coupled with the artificial graft 100. The graft joining feature 104 is operable to couple with a corresponding structure joining feature 21 that is coupled to a tubular structure 12 such that the tubular structure 12 is coupled with the artificial graft 100, for example as described below in FIGS. 9-12. When the tubular structure 12 is coupled with the artificial graft 100, the material can flow between the lumen 14 of the tubular structure 12 and the lumen 106 of the artificial graft 100.

[0030] In at least one example, the graft joining feature 104 can be provided to the medical practitioner (e.g., doctor, nurse, technician, etc.) already coupled with the tubular body 102 of the artificial graft 100. Accordingly, the practitioner does not need to perform the additional step to couple the graft joining feature 104 with the tubular body 102 of the artificial graft 100, leading to ease of use and ensuring that the artificial graft 100 is ready for use. This can also lessen the opportunity for leakage and / or problems during the anastomosis procedure or afterwards. While the graft joining feature 104 as illustrated in FIGS. 1A-1 B has a substantially circular shape, the graft joining feature 104 can have any suitable shape such as rectangular, triangular, octagonal, hexagonal, and / or oval. Additionally, the graft joining feature 104 as illustrated in FIGS. 1 A and 1 B is a singular solid piece, in some examples, for ease of application or manufacturing purposes, the graft joining feature 104 can include two or more semi-circular or arc-type pieces that are joined together around tubular body 102 of the artificial graft 100. The artificial graft 100 can be coupled with the graft joining feature 104 by any suitable mechanism such as sutures, cartridges, staples, tacks, adhesion, compression, stitching, etc. without deviating from the scope of the disclosure.

[0031] The size of the lumen 1040, 106 of the graft joining feature 104 and the artificial graft 100 can vary based on the application and the size of the artificial graft 100 and corresponding tubular structure 12 to be coupled with the artificial graft 100. For example, the diameter of the lumen 14 of the tubular structure 12 can range from about 0.5 millimeters (mm) (for example for lymphatic connections) to about 60 millimeters (for example for gastrointestinal connections). Due to the range of diameters for the tubular structure 12, and the corresponding range of diameters for the artificial graft 100, the appropriate graft joining feature 104 can be selected by measuring the internal diameter of the tubular structure 12 and / or the artificial graft 100. This can be accomplished, for example, with an intraluminal measurement guide / device.

[0032] If there is a significant size mismatch (1 mm or greater) between the tubular structure 12 and the opposing tubular structure 12, then an artificial graft 100 with a tubular body 102 with a corresponding male and female end can be used to allow for gradual transition in size in any direction to accommodate the size difference. For example, a cylindric tube can be provided that tapers in size such that one end is 1 mm-2 mm larger / smaller than the other end, which would enable a connection of a 1 mm vessel to a 2.5 mm-3.5 mm vessel during microsurgical procedures without problem and vice versa. For example, FIGS. 8A, 8B, and 8C illustrate an artificial graft 100 with tubular body 102 that has a tapered diameter. This taper can include a plurality of diameters, a plurality of lengths, plurality of branches, etc. As shown in FIGS. 8A and 8B, the tubular body 102 of the artificial graft 100 can have a first end 800 that has a diameter 800D that is greater than a diameter 802D of an opposing second end 802 of the tubular body 102. Accordingly, as shown in FIG, 8C, the artificial graft 100 can connect a first tubular structure 50 that has a lumen 14 having a larger diameter with a second tubular structure 51 that has a lumen 14 having a smaller diameter than the lumen 14 of the first tubular structure 50.

[0033] The prosthetic vascular artificial graft 100 can have the external graft joining feature 104 integrated / included into at least one of the ends 200, 202 that is compatible with, and ean be joined or coupled to, a structure joining feature 20 secured separately to the end, or side, of a tubular structure 12 such as a native blood vessel or prosthetic. For example, as illustrated in FIGS. 2A, 2B, 2C, 3B, 4B, 5B, 6, 7, and 8C, the artificial graft 100 is coupled with one or more tubular structures 12.

[0034] The artificial graft 100, and corresponding graft joining feature 104 can be of a plurality of lengths and a plurality of inner diameters, and can have one lumen 106, or can have one or more branches, with each lumen 106 or branch having a plurality of angles, lengths and / or diameters, that can also be connected to tubular structure 12 such as a native blood vessel or prosthetic using a compatible structure joining feature 20 and / or coupling mechanism.

[0035] For example, FIGS. 1A-4B illustrate artificial grafts 100 with graft joining features 104 and tubular bodies 102 that are operable to couple with tubular structures 12 along the path of the tubular structure 12. In some examples, as illustrated in FIGS. 5A, 5B, and 7, the graft joining feature 104 can be configured to extend at an angle 704 from the tubular structure 12. Accordingly, the tubular body 102 of the artificial graft 100, and / or the tubular structure 12 does not bend and potentially form a kink that can affect the flow of the material through the lumens 14, 106. Accordingly, the medical practitioner can choose the artificial graft 100 that fits the desired purpose and configuration.

[0036] In some examples, as illustrated in FIGS. 6 and 7, the graft joining feature 100 can be operable to be coupled with a side 13 of the tubular structure 12 via the structure joining feature 20 coupled to the side 13 of the tubular structure for an end- to-side anastomosis. In some examples, as illustrated in FIG. 6, the artificial graft 100 can be coupled with the structure joining feature 20 that extends substantially perpendicularly (e.g., the angle 600A can be about 90 degrees) from the side wall 13 of the tubular structure 12. In some examples, as illustrated in FIG. 7, the artificial graft 100 can be coupled with the structure joining feature 20 that extends at an angle 704 (e.g., the angle 704 can be less than 90 degrees) from the side wall 13 of the tubular structure 12.

[0037] The graft joining feature 104 can be integrated / included / coupled to the artificial graft 100 through a plurality of suitable manufacturing processes including one or more of the following: fastening, snapping, clamping, stenting, tacking, pinning, loop and hook, weaving, sewing, adhesive, stitching, anchoring, compression, stapling, clipping, stent, ring, tacks, magnet, adhesive, and / or pins, etc. In some examples, the artificial graft 100 may be configured to be coupled with one or more graft joining features 104. For example, as illustrated in FIGS. 3A-4B, an artificial graft 100 with a plurality of branches 301 , 302, 303 may not have the joining feature(s) 104coupled or integrated thereon until a medical practitioner couples the joining feature(s) 104 in preparation of anastomosis. In some examples, the artificial graft 100 with the plurality of branches 301 , 302, 303 may have the joining features 104 already coupled or integrated thereon such that the practitioner does not have the complete the additional step.

[0038] As illustrated in FIGS. 3A-3B and 4A-4B, the artificial graft 100 can include one or more branches 301 , 302, 303. As shown in FIGS. 3A-4B, the artificial graft 100 can include two branches 302, 303 that branch off a first branch 301. In some examples, one branch 303 may have a lumen 3030 that extends substantially along the same path as the lumen 3010 of the first branch 301 while a second branch 302 may have a lumen 3020 that extends at an angle 300A from the path of the lumen 3010 of the first branch 301 . In some examples, both the second branch 302 and third branch 303 may branch off of the first branch 301 at an angle. In some examples, any one of the second branch and / or third branch 303 may form a second angle (e.g., angle 302A). The first branch 301 may be coupled with a first graft joining feature 351 operable to be coupled with a first tubular structure 50. Each of the branches 302, 303 can be coupled with a second graft joining feature 352, 353 such that each branch 302, 303 can be coupled with additional tubular structures 51 , 52. The second graft joining feature(s) 352, 353 can be operable to be coupled with an additional structure joining feature 20 of the additional tubular structures 51 , 52. While FIGS. 3A-4B illustrate two branches 302, 303, in some examples, the artificial graft 100 can include a tubular body 102 with any suitable number of branches at any desirable angle without deviating from the scope of the disclosure. Additionally, any of the branches 302, 303 may have any suitable shape, taper, diameter, etc. as desirable for the purpose of the anastomosis procedure.

[0039] The graft joining feature 104 and / or the structure joining feature 20 can be of any suitable geometric shape forming a central lumen / opening 1040 that allows passage of unobstructed, sealed and leak-proof, fluid to flow through lumen 106, and could include, but not be limited to, a ring, a cylinder, and / or any geometric shape including an angled shape that has a plurality of angles (see for example FIGS. 5A, 5B, and 7).

[0040] Coupling the graft joining feature 104 of the artificial graft 100 with the structure joining feature 20 of the tubular structure 12 can occur through a plurality ofmechanisms including, but not limited to, snap, hook, clamp, loop, magnet, adhesive, suture, clip, compression, pin, staple, and / or tacking. Examples of the joining features 104, 20 are discussed in further detail below in regard to FIGS. 10A-12.

[0041] In at least one example, as illustrated in FIGS. 1A-8C, the artificial graft can include graft joining features 104 integrated / included in each / all ends / branches of the artificial graft 100, such that the graft joining features 104 are compatible with and can couple directly to structure joining features 20 coupled to tubular structures 12 such as native vessels and / or prosthetics and allowing a quick joining. The graft diameters, lengths, branches, and / or branch angles can vary without deviating from the scope of the disclosure.

[0042] In at least one example, the artificial graft 100 can include a coating of the artificial graft 100 (e.g., within the walls 103 along the lumen 106) with any suitable surface coating that provides benefit such as reducing the risk of platelet adhesion and thrombosis, and / or provides antimicrobial coverage and / or supports endothelial cell attachment to maintain an unobstructed, sealed and leak proof flow.

[0043] In at least one example, the artificial graft 100 can allow for inclusion or integration of a biosensor that could detect and transmit data to an external device that provides diagnostic information regarding the flow of the fluid, including but not limited to pressure, oxygen saturation, flow velocity, presence of flow, presence of thrombosis, or any other suitable vascular / blood flow parameter measurement.

[0044] The artificial graft 100 is operable to permit unobstructed, and leak-proof flow / passage of fluid / blood to travel through the artificial graft 100 from a proximal tubular structure 12 (e.g., native vessel and / or prosthetic) into the distal tubular structure 12.

[0045] In practice, for example in vascular surgery, the vascular surgeon can measure the inner diameter of the tubular structure 12 (e.g., native structure and / or prosthetic) and secure a compatible structure joining feature 20 to the proximal tubular structure 12. The surgeon can then measure the inner diameter of the distal tubular structure 12 as well. Similarly, a compatible graft joining feature 104 for the distal end of the artificial graft 100 can be coupled to the distal tubular structure 12. Based on this information, the surgeon can select the corresponding artificial graft 100 with integrated and / or included joining feature 104 and couple it to the proximal tubular structure 12 and corresponding structure joining feature 20. The surgeon can thentunnel the artificial graft 100 to the desired location and length near the distal target tubular structure 12, and couple the artificial graft 100 with the distal tubular structure 12, allowing unobstructed bypass flow from the proximal tubular structure 12 to the distal tubular structure 12 through the artificial graft 100.

[0046] In at least one example, the distal end of the artificial graft 100 may have an integrated or included joining feature 104. In some examples, the distal end of the artificial graft 100 can be coupled to a corresponding external joining feature 104 by the surgeon or technician.

[0047] In at least one example, the artificial graft 100 and / or the graft joining feature 104 can be constructed of any suitable biomaterial compatible with tissue and blood, including but not limited to Dacron, PTFE, biologic tissue, synthetic materials, plastics, metals, etc.

[0048] In at least one example, an anastomotic kit can be provided for a medical practitioner for anastomosis. The anastomotic kit can include the artificial graft 100 and one or more joining features 20 for the tubular structures 12. In at least one example, the kit can include one or more cartridges 2900 that correspond with the joining feature(s) 20 for the tubular structures 12. The joining features 20 can correspond with the joining features of the artificial graft 100. Accordingly, the joining features 20 of the tubular structures 12 are easily coupled with the joining features 104 of the artificial graft 100. The effort to ensure that the components for anastomosis as in conventional practices is therefore reduced or removed. The one or more cartridges 2900 can be operable to couple the tubular structure 12 with the joining feature 20 (e.g., joining ring 3100, 3200 as shown in FIGS. 11 and 12). Accordingly, once the tubular structure 12 is coupled with the joining ring 3100, 3200, the artificial graft 100 simply couples with the proximal and distal tubular structures 12 via the joining features 1000 for anastomosis.

[0049] In at least one example, the anastomotic kit can include a fixation device operable to actuate the cartridge to couple with the joining ring 3100, 3200 for the tubular structure 12. The fixation device can be operable to couple the tubular structure 12 with the joining feature 20. While the disclosure may discuss joining ring 3100, 3200 as the structure joining feature 20, other mechanisms for joining feature 20 can be utilized without deviating from the scope of the disclosure.

[0050] The cartridge 2900 can include a plurality of fasteners (as shown in FIGS. 9, 10A, and 10B). The fasteners 2920 are operable to puncture the tubular structure 12 and be partially received in the joining ring 1000 to couple the tubular structure 12 with the ring 1000.

[0051] In some examples, such as when the practitioner needs to couple the joining feature 104 with the tubular body 102 of the artificial graft 100, a similar mechanism with the cartridge 2900 can be included and utilized to couple the joining feature 104 with the tubular body 102. The joining features 1000 can be utilized for either the tubular structure 12 and / or the artificial graft 100, and either the male ring 3100 (as shown in FIG. 11) or the female ring 3200 (as shown in FIG. 12) can be utilized for the tubular structure 12 and the artificial graft 100, so long as the other of the tubular structure 12 and the artificial graft 100 has the corresponding joining feature 1000.

[0052] The fixation device, the ring 1000, and / or the fasteners 2920 can be made from mechanically suitable materials that are approved, and have sufficient strength, for use in the human or animal body. For example, the following materials, alone or in any combination, can be used: metals, in particular titanium or stainless steel, including the special alloys used for implants and medical instruments, nitinol, carbon materials, including carbon fiber meshes, soft plastic, for example silicone, hard plastic, for example Teflon, ceramic material, and / or bioresorbable material. The fixation device, the ring 1000, and / or the fasteners 2920 can be provided entirely or partially with a coating and / or structure that prevents or at least reduces the adherence of blood constituents. Such a coating can be composed of a material that smooths the surface. In at least one example, the coating can also contain anti-thrombotic medicaments (e.g. heparin).

[0053] In at least one example, as illustrated in FIGS. 1 1 and 12, the joining features 1000 can include a male ring 3100 and a corresponding female ring 3200. the male ring 3100 and the female ring 3200 each include an aperture 3104, 3204 operable to receive a tubular structure 12, one or more receiving portions (e.g., walls 3110, 3210) operable to receive the fasteners 2920. The male ring 3100 includes a mating portion 3108, and the female ring 3200 includes a corresponding mating portion 3282, 3208. The mating portion 3108 is operable to couple with the mating portion 3282, 3208 to couple the male ring 3100 and the female ring 3200 with oneanother. As illustrated in FIGS. 10A, 10B, and 12, the mating portion 3108 of the male ring 3100 can extend from the female ring 3200 and can be operable to be received by the mating portion 3282, 3208 of the female ring 3200. In some examples, the rings 1000 can be coupled with one another by, for example, fastening, snapping, clamping, stenting, tacking, pinning, loop and hook, adhesive, and / or other connecting method so long as the rings 1000 are securely coupled with one another.

[0054] In at least one example, the artificial graft 100 can include a male ring 3100 while the tubular structure 12 is coupled with a corresponding female ring 3200. In some examples, the artificial graft 100 can include a female ring 3200 while the tubular structure 12 is coupled with a corresponding male ring 3100.

[0055] When the rings 1000 are coupled with one another, the lumens 14, 106 of the tubular structure 12 and the artificial graft 100 are aligned in fluid communication with one another. In at least one example, the rings 1000 can create a seal to prevent fluid leakage. Accordingly, the artificial graft 100 provides a more reliable, faster, more secure anastomotic coupling device to create a sealed, leak-proof, open connection between the ends of the tubular structure(s) 12 with the ends of the artificial graft 100 and allow for “stented” unobstructed flow of luminal contents through the connection / anastomosis (e.g. blood, lymph, fluid, stool contents, gastric contents, etc.). This connection can be strong enough to withstand tension, traction, and high flow pressure, which may occur with distal obstruction.

[0056] FIG. 9 illustrates an example of a cartridge 2900 that is operable to couple the ring 1000 with the tubular structure 12 and / or the artificial graft 100. Other configurations and mechanisms can be utilized to couple the ring 1000 with the tubular structure 12 and / or the artificial graft 100, such as adhesion, tacks, staples, etc.

[0057] FIG. 9 illustrates the cartridge 2900 with the fasteners 2920 extended at an angle 2920A from the axial surface 2904 of the body 2901 .

[0058] As illustrated in FIG. 9, the cartridge 2900 can include a body 2901 which is operable to be received in a tubular structure 12. The body 2901 can have an outer radial surface 2902 and an axial surface 2904. As will be shown below, the outer radial surface 2902 can be operable to abut against and be substantially parallel to a wall 13 of the tubular structure 12 and / or a wall 103 of the artificial graft 100. In at least one example, the outer radial surface 2902 can be substantially perpendicular to the radial direction away from the center of the cartridge 2900. In at least one example, the outerradial surface 2902 can extend substantially parallel to the longitudinal axis X-X. The axial surface 2904 can extend at an angle from the outer radial surface 2902. In at least one example, the axial surface 2904 can extend substantially perpendicular to the longitudinal axis X-X. In at least one example, the axial surface 2904 can extend substantially parallel to the radial direction away from the center of the cartridge 2900. In at least one example, when the outer radial surface 2902 is abutting the wall 13 of the tubular structure 12, the axial surface 2904 can extend at an angle in relation to the wall 13 of the tubular structure 12.

[0059] The body 2901 of the cartridge 2900 can form a body lumen 2906 to permit fluid to flow across the body 2901 . When the cartridge 2900 is positioned within the tubular structure 12, fluid can flow through the lumen 14 of the tubular structure 12 (or, in some examples, the lumen 106 of the artificial graft 100) as well as through the body lumen 2906 of the cartridge 2900. Accordingly, the cartridge 2900, when positioned in the tubular structure 12, does not obstruct the flow of the fluid through the tubular structure 12 and / or the artificial graft 100.

[0060] The cartridge 2900 can also include a support 2940 and one or more columns 2930 that extend between the body 2901 (for example the axial surface 2904) and the support 2940. As illustrated in FIG. 9, the cartridge 2900 can include three columns 2930. In some examples, the cartridge 2900 can include one, two, or more than three columns without deviating from the scope of the disclosure.

[0061] In at least one example, the support 2940 has substantially the same shape and / or size as the body 2901 . The support 2940 can have a support outer radial surface 2942 and a support axial surface 2944. In at least one example, the support axial surface 2944 can substantially face the axial surface 2904. The support outer radial surface 2942 can be operable to abut against and be substantially parallel to a wall 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100. In at least one example, the support outer radial surface 2942 can be substantially perpendicular to the radial direction away from the center of the cartridge 2900. In at least one example, the support outer radial surface 2942 can extend substantially parallel to the longitudinal axis X-X. The support axial surface 2944 can extend at an angle from the support outer radial surface 2942. In at least one example, the support axial surface 2944 can extend substantially perpendicular to the longitudinal axis X-X. In at least one example, the support axial surface 2944 can extend substantiallyparallel to the radial direction away from the center of the cartridge 2900. In at least one example, when the support outer radial surface 2942 is abutting the wall 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100, the support axial surface 2944 can extend at an angle in relation to the wall 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100.

[0062] The support 2940 of the cartridge 2900 can form a support lumen 2946 to permit fluid to flow across the support 2940. The support lumen 2946 can be in fluid communication with the body lumen 2906 such that fluid can flow across the entire cartridge 2900. When the cartridge 2900 is positioned within the tubular structure 12, fluid can flow through the lumen 14 of the tubular structure 12 and / or the wall 103 of the artificial graft 100 as well as through the body lumen 2906 and the support lumen 2946 of the cartridge 2900. Accordingly, the cartridge 2900, when positioned in the tubular structure 12 and / or the artificial graft 100, does not obstruct the flow of the fluid through the tubular structure 12 and / or the artificial graft 100. The support 2940 can provide additional support to the tubular structure 12 and / or the artificial graft 100 in addition to the body 2901 .

[0063] One or more fasteners 2920, 2920 extend from the axial surface 2904 at an angle from the longitudinal axis X-X. In at least one example, the cartridge 2900 can be deployed in the tubular structure 12 with the fasteners 2920 already deployed. In at least one example, the fasteners 2920 2920 extending at an angle 2920A can abut against and then at least partially puncture the walls 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100. In some examples, the tubular structure 12 and / or the artificial graft 100 can be pulled and / or pushed against the fasteners 2920 so that the fasteners 2920 at least partially puncture the walls 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100. The fasteners 2920 can extend from the axial surface 2904 at any suitable angle in relation to the longitudinal axis X-X. For example, the fasteners 2920 can extend at an angle 2920A between 1 degree and 90 degrees in relation to the longitudinal axis X-X, but other angles may be suitable without deviating from the scope of the disclosure. In at least one example, the fasteners 2920 can extend at an angle 2920A between about 30 degrees and about 60 degrees. In some examples, the angle 2920A can be between about 40 degrees and about 50 degrees. In some examples, the angle 2920A can be between about 45 degrees. As will be discussed further below, the angle 2920A of the fasteners2920 can importantly correspond with the taper of the walls of the rings 1000 to create a seal, provide the desired tensile strength, and sufficiently couple with the tubular structure 12 and / or the wall 103 of the artificial graft 100. The fasteners 2920 can be operable to puncture the wall 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100. As the fasteners 2920 extend from the axial surface 2904 at an angle from the longitudinal axis X-X, the fasteners 2920 also extend at an angle in relation to the wall 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100 when the cartridge 2900 is positioned in the tubular structure 12 and / or the artificial graft 100. Accordingly, the fasteners 2920 being at an angle in relation to the wall 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100 allow for the fasteners 2920 to puncture through the wall 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100, coupling the cartridge 2900 to the tubular structure 12 and / or the artificial graft 100.

[0064] As illustrated in FIG. 9, an end 2922 of the fasteners 2920 can be barbed to include a barb. In some examples, the end 2922 of the fasteners 2920 can be barbed to include two barbs extending in opposite directions. In some examples, the end 2622 of each of the fasteners 2920 can be substantially linear. In some examples, the end 2922 of the fasteners 2920 can be bent. The ends 2922 of the fasteners 2920 can all be the same or different. For example, the fasteners 2920 can each have an end 2922 that is barbed, linear, curved, bent, and / or hooked. The fasteners 2920 can each have an end 2922 that has other shapes and configurations without deviating from the scope of the disclosure so long as the fasteners 2920 can puncture the wall 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100 and maintain coupling with the wall 13, 103.

[0065] While FIG. 9 illustrates a cartridge 2900 with three fasteners 2920, one, two, four, or more fasteners 2920 can be provided without deviating from the scope of the disclosure. While FIG. 9 illustrates a cartridge 2900 with fasteners 2920 all having the same lengths, in some examples, the lengths of the fasteners 2920 can vary.

[0066] As illustrated in FIG. 9, the cartridge 2900 can include three columns 2930. In some examples, the cartridge 2900 can include one, two, or more than three columns without deviating from the scope of the disclosure. In at least one example, the cartridge 2900 can include a beveled surface for the support. In at least one example, the beveled surface can be opposite the support axial surface in relation tothe support radial surface. The beveled surface can assist in inserting the cartridge 2900 into the tubular structure.

[0067] FIG. 10A illustrates the cartridge 2900 deployed in the tubular structure 12 and coupled with a male ring 1000, 3100. FIG. 10B illustrates the cartridge 2900 deployed in the artificial graft 100 and coupled with a male ring 1000, 3100. FIG. 11 illustrates the male ring 3100. FIG. 11 illustrates an example of the male ring 3100 that can be utilized to be coupled with the tubular structure 12 and / or the artificial graft 100. In some examples, the male ring 3100 can be included or integral with the artificial graft 100. In such an example, the male ring 3100 may or may not include all of the features illustrated or disclosed herein, but does include mating components 3108 to be operable to couple with the female ring 3200.

[0068] The male ring 3100 includes a body 3102 that forms an aperture 3104. The male ring 310 is operable to receive a tubular structure 12 through the aperture 3104. While the male ring 3100 as illustrated in FIG. 11 has a substantially circular shape, the male ring 3100 can have any suitable shape such as rectangular, triangular, octagonal, hexagonal, and / or oval. Additionally, the male ring 3100 as illustrated in FIG. 11 is a singular solid piece, in some examples, for ease of application or manufacturing purposes, the male ring 3100 can include two or more semi-circular or arc-type pieces that are joined together around the tubular structure 12 and / or the artificial graft 100.

[0069] The male ring 3100 can include a front end 3120 and a rear end 3122 opposite the front end 3120. The front end 3120 can be operable to be inserted into and / or received by a female ring 3200 (as illustrated in FIG. 12). The male ring 3100 can include a projection 3106 that extends from the body 3102. In at least one example, the projection 3106 extends around the entire circumference of the body 312. In at least one example, the projection 3106 can have a radius 3106R about 0.1 millimeters.

[0070] The size of the male ring 3100 and the lumen 3104 of the male ring 3100 can vary based on the application and the size of the tubular structure 12. For example, the diameter of the lumen 3104 can range from about 0.5 millimeters (mm) (for example for lymphatic connections) to about 60 millimeters (for example for gastrointestinal connections). Due to the range of diameters for the male ring 3100, and the range of diameters for the tubular structure 12 and / or the artificial graft 100,the appropriate male ring 3100 can be selected by measuring the internal diameter of the tubular structure 12 and / or the artificial graft 100. This can be accomplished, for example, with an intraluminal measurement guide / device. If there is a significant size mismatch (1 mm or greater) between the tubular structure 12 and / or the artificial graft 100 and the male ring 3100, then a short, cylindrical tube connector with a corresponding male and female end can be used to allow for gradual transition in size in any direction to accommodate the size difference. For example, a cylindric tube can be provided that tapers in size such that one end is 1 mm-2 mm larger / smaller than the other end, which would enable a connection of a 1 mm vessel to a 2.5 mm-3.5 mm vessel during microsurgical procedures without problem and vice versa.

[0071] The male ring 3100 can include a male receiving portion 3108 formed as a portion of the lumen 3104. In at least one example, the male receiving portion 3108 can be formed adjacent to the front end 3120 of the body 3102. The male receiving portion 318 can be in the form of a notch or a recess. The male receiving portion 318 can have a width 3108W between about 0.3 millimeters and about 1.0 millimeters. In some examples, the width 3108W can be between about 0.4 millimeters and about 0.7 millimeters. In some examples, the width 3108W can be about 0.5 millimeters. The lumen 3104, as illustrated in FIG. 11 can have walls 3110 that taper at an angle such that a diameter of the lumen 3104 decreases from a front diameter 3140D at the end of the male receiving portion 3108 near the front end 3120 of the body 3102 to a rear diameter 3142D at the rear end 3122 of the body 3102.

[0072] The walls 3110 of the lumen 3104 can taper at an angle 3110A between about 2 degrees and about 8 degrees. In some examples, the walls 3110 can taper at an angle 3110A between about 3 degrees and about 6 degrees. In some examples, the walls 131 can taper at an angle 3110A between about 4 degrees and about 5 degrees. In some examples, the walls 131 can taper at an angle 31 10A about 4.46 degrees. The taper can create a seal with the tubular structure 12 and / or the artificial graft 100 and provide tensile strength.

[0073] In at least one example, the walls 3110 are operable to compress the fasteners 2920 extending from the tubular structure 12 against the external side of the walls 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100. For example, the fasteners 2920 can at least partially puncture the walls 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100 at the angle 2920A of thefasteners 2920 (for example, about 45 degrees). The male ring 3100 can be slid along the tubular structure 12 and / or the artificial graft 100 to be positioned over the cartridge 2900 such that the walls 3110 of the male ring 3100 abut against and compress the fasteners 2920. The angle 3110A of the walls 3110 of the male ring 3100 corresponding to the angle 2920A of the fasteners 2900 can provide desired coupling of the cartridge 2900 and the male ring 3100 with the tubular structure 12 and / or the artificial graft 100 as well as the desired tensile strength. In at least one example, the fasteners 2920 may not puncture the walls 3110 of the male ring 3100. In some examples, the fasteners 2920 may puncture the walls 3110 of the male ring 3100.

[0074] The annulus 14 of the tubular structure 12 can be aligned and / or in fluid communication with the annulus 3104 of the male ring 3100 such that fluid can flow between the annulus 14 of the tubular structure 12 and the annulus 3104 of the male ring 3100.

[0075] The male ring 3100 and / or the cartridge 2900 can be made from mechanically suitable materials that are approved, and have sufficient strength, for use in the human or animal body. For example, the following materials, alone or in any combination, can be used: metals, in particular titanium or stainless steel, including the special alloys used for implants and medical instruments, nitinol, carbon materials, including carbon fiber meshes, soft plastic, for example silicone, hard plastic, for example Teflon, ceramic material, and / or bioresorbable material. The male ring 3100 and / or the fastener 20 can be provided entirely or partially with a coating and / or structure that prevents or at least reduces the adherence of blood constituents. Such a coating can be composed of a material that smooths the surface. In at least one example, the coating can also contain anti-thrombotic medicaments (e.g. heparin).

[0076] FIG. 12 illustrates an example of a female ring 3200. The female ring 3200 includes a body 3202 that forms an aperture 3204. The female ring 320 is operable to receive a tubular structure 12 and / or the artificial graft 100 through the aperture 3204. While the female ring 3200 as illustrated in FIG. 12 has a substantially circular shape, the female ring 3200 can have any suitable shape such as rectangular, triangular, octagonal, hexagonal, and / or oval. Additionally, the female ring 3200 as illustrated in FIG. 12 is a singular solid piece, in some examples, for ease of application or manufacturing purposes, the female ring 3200 can include two semi-circular or arc-type pieces that are joined together around the tubular structure 12 and / or the artificial graft 100.

[0077] The female ring 3200 can include a front end 3220 and a rear end 3222 opposite the front end 3220. The front end 3220 can be operable to be receive a male ring 3100 (as illustrated in FIG. 11 ). FIG. 12 illustrates an example of the female ring 3200 that can be utilized to be coupled with the tubular structure. In some examples, the female ring 3200 can be included or integral with the artificial graft. In such an example, the female ring 3200 may or may not include all of the features illustrated or disclosed herein, but does include mating components 3282, 3208 to be operable to couple with the male ring 3100.

[0078] The size of the female ring 3200 and the lumen 3204 of the female ring 3200 can vary based on the application and the size of the tubular structure 12 and / or the artificial graft. For example, the diameter of the lumen 3204 can range from about 0.5 millimeters (mm) (for example for lymphatic connections) to about 60 millimeters (for example for gastrointestinal connections). Due to the range of diameters for the female ring 3200, and the range of diameters for the tubular structure 12 and / or the artificial graft 100, the appropriate female ring 3200 can be selected by measuring the internal diameter of the tubular structure 12 and / or the artificial graft 100. This can be accomplished, for example, with an intraluminal measurement guide / device. If there is a significant size mismatch (1 mm or greater) between the tubular structure 12 and / or the artificial graft 100 and the female ring 3200, then a short, cylindrical tube connector with a corresponding male and female end can be used to allow for gradual transition in size in any direction to accommodate the size difference. For example, a cylindric tube can be provided that tapers in size such that one end is 1 mm-2 mm larger / smaller than the other end, which would enable a connection of a 1 mm vessel to a 2.5 mm- 3.5 mm vessel during microsurgical procedures without problem and vice versa.

[0079] The female ring 3200 can include a female receiving portion 3240 formed as a portion of the lumen 3204. In at least one example, the female receiving portion 3240 can be formed adjacent to the front end 3220 of the body 3202. The female receiving portion 3240 can be in the form of a notch or a recess. The female receiving portion 3240 can have a lip 3206 that extends into the female receiving portion 3240. As illustrated in FIG. 12, the lip 3206 can correspond with the protrusion 3106 such that when the male ring 3100 is received in the female receiving portion 3240, theprotrusion 3106 extends into and past the lip 3206. Once the protrusion 3106 is inserted past the lip 3206, the abutment between the protrusion 3106 and the lip 3206 couple the male ring 3100 with the female ring 3200. Accordingly, the lip 3206 and the protrusion 3106 provide a snap fit between the male ring 3100 and the female ring 3200.

[0080] The female receiving portion 3240 also includes a recess 3282 that is operable to receive the front end 3120 of the male ring 3100. As illustrated in FIG. 12, an abutment 3208 adjacent to the recess 3282 is operable to be received in the male receiving portion 3108. With the recess 3282 and the abutment 308 corresponding with the front end 3120 and the male receiving portion 3108, the male ring 3100 and the female ring 3200 are aligned and coupled with one another. With the recess 3282 and the abutment 3208 corresponding with the front end 3120 and the male receiving portion 3108, the male ring 3100 and the female ring 3200 are operable to create a seal such that fluid does not leak out of the anastomotic coupler. The male ring 3100 and the female ring 3200 are operable to join together with compression to create a seal and prevent leakage.

[0081] The walls 3210 of the lumen 3204 can taper at an angle 3210A between about 2 degrees and about 8 degrees. In some examples, the walls 3210 can taper at an angle 3210A between about 3 degrees and about 6 degrees. In some examples, the walls 132 can taper at an angle 3210A between about 4 degrees and about 5 degrees. In some examples, the walls 132 can taper at an angle 3210A about 4.46 degrees. The taper can create a seal with the tubular structure 12 and / or the artificial graft 100 and provide tensile strength.

[0082] In at least one example, the walls 3210 are operable to compress the fasteners 2920 extending from the tubular structure 12 and / or the artificial graft 100 against the external side of the walls 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100. For example, the fasteners 2920 can at least partially puncture the walls 13 of the tubular structure 12 and / or the wall 103 of the artificial graft 100 at the angle 2920A of the fasteners 2920 (for example, about 45 degrees). The female ring 3200 can be slid along the tubular structure 12 to be positioned over the cartridge 2900 such that the walls 3210 of the female ring 3200 abut against and compress the fasteners 2920. The angle 3210A of the walls 3210 of the female ring 3200 corresponding to the angle 2920A of the fasteners 2900 can provide desiredcoupling of the cartridge 2900 and the female ring 3200 with the tubular structure 12 and / or the artificial graft 100 as well as the desired tensile strength. In at least one example, the fasteners 2920 may not puncture the walls 3210 of the female ring 3200. In some examples, the fasteners 2920 may puncture the walls 3210 of the female ring 3200.

[0083] The annulus 14 of the tubular structure 12 and / or the annulus 106 of the artificial graft 100 can be aligned and / or in fluid communication with the annulus 3204 of the female ring 3200 such that fluid can flow between the annulus 14 of the tubular structure 12 and / or the annulus 106 of the artificial graft 100 and the annulus 3204 of the female ring 3200.

[0084] The female ring 3200 and / or the cartridge 2900 can be made from mechanically suitable materials that are approved, and have sufficient strength, for use in the human or animal body. For example, the following materials, alone or in any combination, can be used: metals, in particular titanium or stainless steel, including the special alloys used for implants and medical instruments, nitinol, carbon materials, including carbon fiber meshes, soft plastic, for example silicone, hard plastic, for example Teflon, ceramic material, and / or bioresorbable material. The female ring 3200 and / or the fastener 2920 can be provided entirely or partially with a coating and / or structure that prevents or at least reduces the adherence of blood constituents. Such a coating can be composed of a material that smooths the surface. In at least one example, the coating can also contain anti-thrombotic medicaments (e.g. heparin).

[0085] When the rings 3100, 3200 are coupled with one another, the lumens 14, 106 of the tubular structure and the artificial graft 100 are aligned in fluid communication with one another. In at least one example, the rings 3100, 3200 can create a seal to prevent fluid leakage. Accordingly, the artificial graft and / or the anastomotic kit provides a more reliable, faster, more secure anastomotic coupling device to create a sealed, leak-proof, open connection between the tubular structures 12 and the artificial graft 100 and allow for “stented” unobstructed flow of luminal contents through the connection / anastomosis (e.g. blood, lymph, fluid, stool contents, gastric contents, etc.). This connection can be strong enough to withstand tension, traction, and high flow pressure, which may occur with distal obstruction.

[0086] The disclosures shown and described above are only examples. Even though numerous properties and advantages of the present technology have been set deforth in the foregoing description, together with details of the structure and function of the present disclosure, the disclosure is illustrative only, and changes may be made in the detail, especially in matters of shape, size and arrangement of the parts within the principles of the present disclosure to the full extent indicated by the broad general meaning of the terms used in the attached claims. It will therefore be appreciated that the examples described above may be modified within the scope of the appended claims.

Claims

CLAIMS1. An artificial graft for anastomotic coupling, the artificial graft comprising: a tubular body forming a lumen; and a graft joining feature coupled with the tubular body, wherein the graft joining feature is operable to couple with a structure joining feature that is coupled with a tubular structure, wherein when the graft joining feature is coupled with the structure joining feature, the lumen is in fluid communication with a lumen of the tubular structure.

2. The artificial graft of claim 1 , wherein the graft joining feature is operable to couple with the structure joining feature via one or more of the following: snap, hook, clamp, loop, magnet, adhesive, suture, clip, compression, pin, staple, and / or tacking.

3. The artificial graft of claim 1 , wherein the tubular body forms a proximal end and a distal end, wherein the proximal end is operable to be coupled with a first tubular structure and the distal end is operable to be coupled with a second tubular structure.

4. The artificial graft of claim 3, wherein the proximal end and / or the distal end include a corresponding graft joining feature.

5. The artificial graft of claim 1 , wherein the tubular body includes one or more branches.

6. The artificial graft of claim 5, wherein each of the one or more branches is coupled with a second graft joining feature.

7. The artificial graft of claim 6, wherein each of the one or more branches is operable to be coupled with an additional tubular structure, wherein the second graft joining feature is operable to be coupled with an additional structure joining feature of the additional tubular structure.

8. The artificial graft of claim 1 , wherein the graft joining feature is operable to be coupled with a side of the tubular structure via the structure joining feature coupled to the side of the tubular structure for an end-to-side anastomosis.

9. The artificial graft of claim 1 , wherein the graft joining feature is configured to extend at an angle from the tubular structure.

10. An anastomotic kit comprising: an artificial graft including: a tubular body forming a lumen; and one or more graft joining features coupled with the tubular body, wherein each of the one or more graft joining features, one or more structure joining features operable to be coupled with the tubular structure, the one or more structure joining features operable to be coupled with the graft joining feature of the artificial graft, wherein when the one or more graft joining features is coupled with the one or more structure joining features, the lumen is in fluid communication with a lumen of the tubular structure.11 . The anastomotic kit of claim 10, wherein each of the one or more graft joining features is operable to couple with the one or more structure joining features via one or more of the following: fastening, snapping, clamping, stenting, tacking, pinning, loop and hook, clipping, compression, magnet, and / or adhesive.

12. The anastomotic kit of claim 10, wherein the tubular body forms a proximal end and a distal end, wherein the proximal end is operable to be coupled with a first tubular structure and the distal end is operable to be coupled with a second tubular structure.

13. The anastomotic kit of claim 12, wherein the proximal end and / or the distal end include a corresponding graft joining feature of the one or more joining features.

14. The anastomotic kit of claim 12, wherein the one or more structure joining features includes a first structure joining feature operable to be coupled with the first tubular structure and a second structure joining feature operable to be coupled with the second tubular structure, wherein the first structure joining feature is operable to couple with the graft joining feature coupled with the proximal end of the artificial graft, and wherein the second structure joining feature is operable to couple with the graft joining feature coupled with the distal end and the artificial graft.

15. The anastomotic kit of claim 10, wherein the tubular body includes one or more branches.

16. The anastomotic kit of claim 15, wherein each of the one or more branches is coupled with a second graft joining feature.

17. The anastomotic kit of claim 16, wherein each of the one or more branches is operable to be coupled with an additional tubular structure, wherein the second graft joining feature is operable to be coupled with an additional structure joining feature of the additional tubular structure.

18. The anastomotic kit of claim 10, wherein the graft joining feature is operable to be coupled with a side of the tubular structure via the structure joining feature coupled to the side of the tubular structure for an end-to-side anastomosis.

19. The anastomotic kit of claim 10, wherein the graft joining feature is configured to extend at an angle from tubular structure.

20. The anastomotic kit of claim 10, further comprising one or more cartridges operable to couple the one or more structure joining features with the tubular structure.

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