An anastomotic coupler is provided. A ring can include a plurality of receiving portions. A fixation device includes a cartridge. The cartridge includes a plurality of fasteners. Upon actuation of the fixation device, the fasteners puncture the tubular structure. The fasteners are received by the receiving portions such that the tubular structure is coupled with the ring.

FIELD

The present disclosure relates generally to an anastomotic coupler. In at least one example, the present disclosure relates to a surgical system and method to utilize an anastomotic coupler to connect two tubular structures such as vessels, esophagus, intestine, lymphatic structure, and/or graft material.

BACKGROUND

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.

DETAILED DESCRIPTION

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 extra-luminal leak of gastrointestinal contents, infection, sepsis, obstruction, and death.

With the understood importance of reliable, open anastomoses, alternatives to sutures and staples have been used. An example of a vascular anastomotic coupler is described, for instance, in U.S. Patent Pub. No. 2015/0088172 A1 (the '172 Publication). This coupler has two circular ends with spikes or pins. The vessel is brought through the ring and the vessel wall is everted, or rolled over, the pins for securement as shown inFIGS. 2A and 2Bof the '172 Publication. This is completed on each vessel end, and the two rings are then brought together with the spikes/pins being forced into the opposite ring to join the ends together as shown inFIG. 1Cof the '172 Publication. However, because of the potential for micro-motion of the vessels and size mismatch due to the anastomotic coupler of the '172 Publication, blood leakage may happen, and/or one of the pins may tear through the vessel wall creating a leak and/or site for platelet aggregation and thrombosis (blood clot formation). Likewise, with the anastomotic coupler of the '172 Publication, for thicker walled, less elastic vessels, particularly arteries, everting vessel edges can be quite difficult and may result in trauma to the vessel wall (intima) and/or stenosis at the anastomosis, both of which can create platelet aggregation, turbid flow, and/or thrombosis with subsequent obstruction of flow. Additionally, the technique of the '172 Publication requires additional specialized equipment (surgical microscope, high-powered loupe magnification) to use. For gastrointestinal stapled anastomoses, many procedures are performed either side-to-side which is not a natural pathway for intestinal smooth muscle propulsion of stool contents (for example, non-longitudinal flow along the length of the intestine), or end-to-end, which requires a separate, remote full-thickness bowel access incision for deployment, thereby creating a secondary weak point for potential leak, or adhesion formation.

Referring now toFIG. 1, an anastomotic coupler10is provided. The anastomotic coupler10is provided to create a connection between adjacent tubular structures12. The tubular structure12can 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 structure12is created. The tubular structure12forms a lumen14through which matter can be passed, for example blood, food, fluids, and/or cells.

The anastomotic coupler10includes a ring300forming an aperture302. The ring300is operable to receive a tubular structure12through the aperture302. While the ring300as illustrated inFIG. 1has a substantially circular shape, the ring300can have any suitable shape such as rectangular, triangular, octagonal, hexagonal, and/or oval. Additionally, the ring300as illustrated inFIG. 1is a singular solid piece, in some examples, for ease of application or manufacturing purposes, the ring300can include two semi-circular or arc-type pieces that are joined together around the tubular structure12.

The size of the lumen302of the ring300can vary based on the application and the size of the tubular structure12. For example, the diameter of the lumen302can 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 ring300, and the range of diameters for the tubular structure12, the appropriate ring300can be selected by measuring the internal diameter of the tubular structure12. 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 structure12and the ring300, 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.

Referring also toFIG. 2, the anastomotic coupler10also includes a fixation device100. The fixation device100is operable to couple the tubular structure12with the ring300. The fixation device100can include a housing102and a cartridge200. The cartridge200includes a plurality of fasteners206(as shown inFIGS. 5-10B). The fasteners206are operable to puncture the tubular structure12and be partially received in the ring300to couple the tubular structure12with the ring300. In at least one example, the cartridge200can be removably coupled with the housing102. Accordingly, the cartridge200may be replaceable to allow multiple uses of the fixation device100. In some examples, the cartridge200may not be removable such that the fixation device100is provided for a one-time use. The fixation device100can include a pusher rod150operable to actuate the fixation device100to drive the fasteners206from the cartridge200. Upon actuation of the fixation device100, the pusher rod150can translate along a longitudinal axis.

The fixation device100includes stop104to receive the tubular structure12. In at least one example, the stop104can be formed as a portion of the cartridge200to ensure alignment with the cartridge200. In some examples, the stop104can be formed as a portion of the housing102. The stop104extends radially from the housing104such that a free end of the tubular structure abuts the stop104. As illustrated inFIG. 3, the housing102receives the free end of the tubular structure12such that the cartridge200is inserted into the lumen14of the tubular structure. When correctly positioned, the free end of the tubular structure12abuts the stop104. The stop104ensures the placement and alignment of the ring300, the cartridge200, and the free end of the tubular structure12. The alignment of the ring300, the cartridge200, and the free end of the tubular structure12is critical to ensure adequate connection between the tubular structure12and another tubular structure12.

As illustrated inFIG. 4, after the tubular structure12is received by the fixation device100and abuts the stop104, the ring300can be positioned to abut the stop such that the ring300is aligned with the free end of the tubular structure12.

The stop104can include a plurality of alignment components106which correspond with alignment components304of the ring300. Accordingly, when the ring300is aligned and/or correctly positioned, the alignment components106of the stop104are aligned with the alignment components304of the ring300. In some examples, the alignment components106,304can include one or more alignment markers108,304. The alignment markers108,304can be shaped, for example as triangles. Accordingly, to align the ring300, the tips of the triangles for the alignment markers108,304can point towards one another. In some examples, the alignment components106,304can include one or more alignment pins110and corresponding alignment receivers308. When the ring300is aligned, the alignment pins100can be received by the alignment receivers308. While the figures illustrate the alignment pins100being disposed on the fixation device100and the alignment receivers308being disposed on the ring300, in some examples, the alignment pins100may be disposed on the ring300and the alignment receivers can be disposed on the fixation device100.

FIG. 5illustrates a cross-sectional view of the tubular structure12, the ring300, and the cartridge200aligned. In addition to ensuring the ring300aligns with the free end of the tubular structure12, the ring300is aligned with the cartridge200. When the ring300is properly aligned with the cartridge200, a plurality of receiving portions310of the ring300are aligned with the plurality of fasteners206of the cartridge200.

As illustrated inFIG. 6, the tack600can include a puncturing portion602which is operable to puncture the tubular structure12. An abutment surface603abuts against a surface of the corresponding receiving portion310of the ring300. A body604spans the thickness of the wall of the tubular structure12, and an end606includes an abutment surface608which abuts against the inner surface of the tubular structure12. The abutment surfaces603,608prevent the fastener206from being removed from the tubular structure12and the ring300.

As illustrated inFIG. 7, the tack700can include a puncturing portion702which is operable to puncture the tubular structure12. The exemplary tack700does not include as long of a puncturing portion702as the puncturing portion602as illustrated inFIG. 6. An abutment surface703abuts against a surface of the corresponding receiving portion310of the ring300. A body704spans the thickness of the wall of the tubular structure12, and an end706includes an abutment surface708which abuts against the inner surface of the tubular structure12. The abutment surfaces703,708prevent the fastener206from being removed from the tubular structure12and the ring300.

As illustrated inFIG. 8, the staple800can include two puncturing portions802which are operable to puncture through the tubular structure12and be received in the corresponding receiving portion310of the ring300. A body804spans between the puncturing portions802and is operable to abut the inner surface of the tubular structure12to prevent the fastener206from being removed from the tubular structure12. In at least one example, the puncturing portions802may be operable to bend or deform when received in the receiving portion310to prevent the puncturing portions802from being removed from the ring300, ensuring coupling of the tubular structure12with the ring300.

Referring toFIGS. 5 and 9, the cartridge200can include a plurality of drivers204corresponding with the plurality of fasteners206. Upon actuation of the fixation device100, the drivers204activate to push the corresponding fasteners206radially outward from the cartridge200. The drivers204may include rods which abut the fasteners206and towards the center of the body202of the cartridge200. In some examples, the drivers204may be spring loaded.

The pusher rod150, as illustrated inFIG. 5, is tapered from a front portion154with a smaller diameter D1to a rear portion152with a larger diameter D2which is greater than the smaller diameter D1. The drivers204may abut the fasteners206on one end while extending into the cartridge200so that the opposing end of the fasteners206abut the pusher rod150.

Referring toFIGS. 10A and 10B, the fixation device100is actuated. Actuation of the fixation device100can include translating the pusher rod150along the longitudinal axis through the cartridge200from the front portion154towards the rear portion152. The pusher rod150, increasing in thickness, then activates the drivers204to drive the fasteners206radially outward from the cartridge200, through the tubular structure12, and into the receiving portions310of the ring300. Once the ring300is coupled with the tubular structure12, the fixation device100can be removed from the tubular structure12. The ring300is then affixed or secured to the end of the tubular structure12, maintaining the structure of the lumen of the tubular structure12.

The fixation device100, the ring300, and/or the fasteners206can 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 device100, the ring300, and/or the fasteners206can 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).

The above process of coupling the ring300with the tubular structure12can be repeated for a second tubular structure12with a second ring300. For example,FIG. 11illustrates an exemplary male ring350, andFIG. 12illustrates an exemplary corresponding female ring350. Similar to the ring300discussed above, the male ring350and the female ring360each include an aperture302operable to receive a tubular structure12, receiving portions310operable to receive the fasteners206, and alignment portions304,308. The male ring350includes a mating portion352, and the female ring360includes a corresponding mating portion362. The mating portion352is operable to couple with the mating portion362to couple the male ring350and the female ring360with one another. As illustrated inFIGS. 11 and 12, the mating portion352of the male ring350extends from the ring350and is operable to be received by the mating portion362of the female ring360. In some examples, the rings300can 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 rings300are securely coupled with one another.

As illustrated inFIG. 13, when the rings350,360are coupled with one another, the lumens14of the two tubular structures20,22are aligned in fluid communication with one another. In at least one example, the rings350,360can create a seal to prevent fluid leakage. Accordingly, the anastomotic coupler10provides a more reliable, faster, more secure anastomotic coupling device to create a sealed, leak-proof, open connection between the ends of the tubular structures20,22and 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.

As illustrated inFIG. 14, a cap1400can be provided over the two rings350,360. The cap1400can assist in ensuring the connection between the rings350,360, as well as protecting the rings350,360from external damage. As illustrated inFIG. 15, the cap1400can include a recess1402which is operable to receive the two rings350,360. An opening1404can be formed such that the cap1400can be deformed to snap over the two rings350,360.

Referring toFIG. 16, a flowchart is presented in accordance with an example embodiment. The method1600is provided by way of example, as there are a variety of ways to carry out the method. The method1600described below can be carried out using the configurations illustrated inFIG. 1-15, for example, and various elements of these figures are referenced in explaining example method1600. Each block shown inFIG. 16represents one or more processes, methods or subroutines, carried out in the example method600. Furthermore, the illustrated order of blocks is illustrative only and the order of the blocks can change according to the present disclosure. Additional blocks may be added or fewer blocks may be utilized, without departing from this disclosure. The example method1600can begin at block1602.

At block1602, a first tubular structure is received in an aperture of a first ring.

At block1604, a fixation device receives the first tubular structure such that a first cartridge is inserted into a lumen of the first tubular structure.

At block1606, the first ring is aligned with the first cartridge such that a plurality of receiving portions of the first ring are aligned with a plurality of fasteners of the first cartridge.

At block1608, the fixation device is actuated such that the plurality of fasteners puncture the first tubular structure radially outward from the lumen. The cartridge can include a plurality of drivers corresponding with the plurality of fasteners. Upon actuation of the fixation device, the drivers activate to push the corresponding fasteners radially outward from the cartridge. In at least one example, the fixation device can include a pusher rod. The pusher rod can be tapered from a front portion with a smaller diameter to rear portion with a larger diameter. Upon actuation of the fixation device, the pusher rod can translate along a longitudinal axis to activate the drivers. In at least one example, to activate the drivers, the pusher rod translates along the longitudinal axis and passes through the cartridge from the front portion to the rear portion such that the pusher rod abuts and pushes the drivers and the corresponding fasteners radially outward from the cartridge.

At block1610, the first tubular structure is coupled with the first ring by the receiving portions receiving the plurality of fasteners.

In at least one example, a second tubular structure can be received in an aperture of a second ring. A fixation device can receive the second tubular structure such that a second cartridge is inserted into a lumen of the second tubular structure. In at least one example, the fixation device may be the same fixation device that was utilized for the first ring. In some examples, the fixation device may be the same fixation device utilized for the first ring with a second cartridge that replaced the first cartridge. In some examples, the fixation device may be a second fixation device. The second ring can be aligned with the second cartridge such that a plurality of receiving portions of the second ring are aligned with a plurality of fasteners of the second cartridge. The fixation device can be actuated such that the plurality of fasteners puncture the second tubular structure radially outward from the lumen. The second tubular structure can be coupled with the second ring by the receiving portions receiving the plurality of fasteners.

The first ring can be aligned with the second ring such that the lumen of the first tubular structure and the lumen of the second tubular structure are aligned in fluid communication with one another. The first ring can be coupled with the second ring to join the first tubular structure with the second tubular structure, providing a continuous passage between the first tubular structure and the second tubular structure. In at least one example, a cap can be positioned about the first and the second ring to ensure the connection between the first ring and the second ring.

FIGS. 17A-17Eillustrate examples of an anastomotic coupler10which is operable to couple an end of a tubular structure12with a side of a tubular structure12. Elements described in the system ofFIGS. 17A-18that have similar or the same name and/or the same reference numbers as elements in the disclosure forFIGS. 1-16may have the same features as discussed above. While the discussion below forFIGS. 17A-17Emay highlight some differences in features, the disclosure for the system ofFIGS. 17A-18are not limited to those and may also include any and/or all of the features as discussed above.

FIG. 17Aillustrates alignment and positioning of a fixation device100and a ring300on a tubular structure12. The fixation device100and the ring300are positioned such that the ring300can be coupled to the tubular structure12where an aperture302of the ring300can be aligned with a hole1300formed in a wall13of the tubular structure12. In other words, the tubular structure12has a hole1300formed in a side wall13. In at least one example, a cutting mechanism (not shown) can be operable to cut the hole1300in the wall13of the tubular structure12. In some examples, the cutting mechanism can be a separate component operable to cut a precise hole1300in the wall13of the tubular structure12. In some examples, the cutting mechanism can be part of the fixation device1700such that only one component is needed in the fixation device1700to cut a hole1300and couple the ring300to the tubular structure12. The cutting mechanism can create a symmetrical, controllable-sized opening in the side wall13of the tubular structure12.

In at least one example, the fixation device1700can be similar to fixation device100as discussed herein. In some examples, fixation device1700may be modified to couple the ring1702to the wall13of the tubular structure12to align with the hole1300in the wall13instead of coupling the ring1702to the tubular structure12in line with the lumen14of the tubular structure. In at least one example, the fixation device1700can include a stop which extends radially from the housing102such that the wall13of the tubular structure12abuts the stop. Accordingly, the fixation device1700provides guidance to the user for when the fixation device1700is in a desired position. In some examples, the stop can include a plurality of alignment components corresponding with alignment components of the ring1702. As such, when the ring1702is aligned, the alignment components of the stop are aligned with the alignment components of the ring1702.

As illustrated inFIGS. 17A and 17B, a cartridge1710can be disposed within the lumen14of the tubular structure12. The cartridge1710, similar to cartridge300, includes a plurality of fasteners260(for example shown in17C-17E) operable to be received in corresponding plurality of receiving portions310in the ring300. The ring1702, as illustrated inFIGS. 17A-17Ehas a cylindrical shape. However, in other examples, the ring1702can have any suitable shape such that the ring1702can be aligned with the hole1300and prevent leakage between the tubular structure12and the ring1702. The ring1702, in some examples, may include a sealing component operable to abut against the wall13of the tubular structure12to prevent leakage of fluid.

In some examples, the position of the receiving portions310in the ring1702may be adjusted to better receive the plurality of fasteners260and provide a stronger coupling between the ring1702and the tubular structure12. For example, as illustrated inFIGS. 17A-17E, the receiving portions310may be disposed towards the bottom of the ring1702so that the receiving portions310are adjacent to the tubular structure12.

Similarly, in some examples, the position of the fasteners260in the cartridge1710may be adjusted towards the top to be adjacent to the wall13of the tubular structure12. Accordingly, the distance between the fasteners260in the cartridge1710and the receiving portions310can be smaller to minimize the chance of error in coupling the ring1702with the tubular structure12.

As illustrated inFIG. 17A-17C, the ring1702can be positioned opposite the cartridge1710in relation to the wall13of the tubular structure12. The ring1702can be positioned external of the tubular structure12so that the ring1702does not cause any obstruction in the lumen14of the tubular structure12. The cartridge1710, as illustrated inFIGS. 17A-17C, can be positioned inside the lumen14of the tubular structure12to push the fasteners260across the wall13of the tubular structure12into the receiving portions310of the ring1702. In some examples, the cartridge1710may also be positioned external of the tubular structure12, so long as the fasteners260can couple the ring1702with the tubular structure12.

As illustrated inFIG. 17C, the fixation device1700can be actuated so that the plurality of fasteners260puncture the tubular structure12and are received by the receiving portions310. Accordingly, the tubular structure12can be coupled with the ring1702. In at least one example, as illustrated inFIG. 17C, the fixation device1700can include a pusher rod150. Upon actuation of the fixation device1700, the pusher rod150can translate along a longitudinal axis to activate drivers to push the corresponding fasteners260from the cartridge1710. In some examples, the fixation device1700can have any suitable mechanism to activate the drivers to push the fasteners260from the cartridge1710.

As illustrated inFIG. 17D, after the ring1702is coupled with the tubular structure12, the fixation device1700, along with the cartridge1710, can be removed. The ring1702remains coupled with the tubular structure12such that the aperture302of the ring1702is aligned with the hole1300in the wall13of the tubular structure12.

As illustrated inFIG. 17E, the ring1702is operable to be coupled with a second tubular structure22such that a lumen14of the second tubular structure22is in fluid communication with the lumen14of the tubular structure20via the hole1300formed in the wall13of the tubular structure20. The side ring1702is operable to be coupled with the first tubular structure20such that the aperture302of the side ring1702is aligned with the hole1300formed in the wall13of the first tubular structure12. The end ring1704, similar to the rings350,360as illustrated inFIGS. 1-14, is operable to be coupled with a second tubular structure22such that the aperture302of the end ring1704is in line with the lumen14of the second tubular structure22. The side ring1702is operable to be coupled with the end ring1704such that the lumen14of the second tubular structure22is in fluid communication with the lumen14of the first tubular structure20via the hole1300formed in the wall13of the first tubular structure20. Accordingly, an end-to-side anastomosis is achieved. In some examples, the side ring1702and the end ring1704create a seal to prevent fluid leakage. The seal can be achieved by any suitable mechanism.

As illustrated inFIG. 17E, fluid may flow through the lumen14of the first tubular structure20while some fluid may flow into and through the lumen14of the second tubular structure22. In some examples, fluid from the second tubular structure22may flow into the first tubular structure20.

The aforementioned side-to-end anastomotic coupler50and system provides users with a better, more reliable alternative to the conventional techniques. The only technique conventionally practiced for side-to-end anastomosis is through hand-sewn suture techniques. Hand-sewn suture techniques are labor intensive and prone to failure. Similarly, the process of creating the side opening in the tubular structure is conventionally completed in an uncontrolled fashion using a scalpel or scissors to haphazardly cut the side of the structure, which can result in an asymmetric opening of variable size.

Referring toFIG. 18, a flowchart is presented in accordance with an example embodiment. The method1800is provided by way of example, as there are a variety of ways to carry out the method. The method1800described below can be carried out using the configurations illustrated inFIG. 1-17E, for example, and various elements of these figures are referenced in explaining example method1800. Each block shown inFIG. 18represents one or more processes, methods or subroutines, carried out in the example method1800. Furthermore, the illustrated order of blocks is illustrative only and the order of the blocks can change according to the present disclosure. Additional blocks may be added or fewer blocks may be utilized, without departing from this disclosure. The example method1800can begin at block1802.

At block1802, a side ring is coupled with a first tubular structure such that an aperture of the side ring is aligned with a hole formed in a wall of the first tubular structure.

At block1804, the side ring is coupled with a second tubular structure such that a lumen of the second tubular structure is in fluid communication with a lumen of the first tubular structure via the hole formed in the wall of the first tubular structure. In at least one example, the second tubular structure can be coupled with an end ring such that an aperture of the end ring is in line with the lumen of the second tubular structure. The side ring can be coupled with the end ring to join the first tubular structure with the second tubular structure. In at least one example, the side ring and the end ring can create a seal to prevent fluid leakage.

FIGS. 19-25Cillustrate examples of an anastomotic coupler10which is operable to couple two tubular structures12with a cartridge200having fasteners206extending therefrom at an angle1902A. Elements described in the system ofFIGS. 19-25Cthat have similar or the same name and/or the same reference numbers as elements in the disclosure forFIGS. 1-18may have the same features and/or functions as discussed above. While the discussion below forFIGS. 19-25Cmay highlight some differences in features, the disclosure for the system ofFIGS. 19-25Care not limited to those and may also include any and/or all of the features as discussed above. Similarly, the examples inFIGS. 1-18may utilize any and/or all of the features as discussed below forFIGS. 19-25C.

FIG. 19illustrates an exemplary cartridge200,1900which includes a body1901and fasteners206,1902extending from the body1901. The body1901, as illustrated inFIG. 19, can be substantially cylindrical. In other examples, the body1901can be in other configurations or shapes such as rectangular, ovoid, or any other suitable shape. In some examples, the body1901can include mesh, braided mesh, stent, and may be a solid ring and/or tube, and/or any combination of mesh, stent, and solid material. The body1901can form a lumen1903which passes through the body1901. The lumen1903is operable to permit fluidic passage across the body1901through the lumen1903. Accordingly, when the cartridge1900is disposed within the tubular structure(s)12, the lumen1903is in fluid communication with the lumen14of the tubular structure(s)12such that fluid can pass through the lumen1903between the tubular structure(s)12.

The fasteners1902extend from the body1901of the cartridge1900at an angle1902A from the body1901. For example, the fasteners1902may extend at an angle1902A that is between about 1 degree and about 89 degrees. The fasteners1902may extend at an angle1902that is greater than 0 degrees and less than 90 degrees. In such an example, the fasteners1902may be deployed by rotating the fasteners1902in relation to the tubular structure12. In some examples, the fasteners1902may extend at an angle1902A of 90 degrees (directly radially outward similar toFIGS. 1-18), and may be actuated by expansion of the body1901of the cartridge200. The fasteners1902are operable to puncture through a wall of one and/or two tubular structure(s)12. In some examples, the fasteners1902can have a hook design.

In at least one example, as illustrated inFIG. 19, the fasteners1902can be coupled to the body1901of the cartridge1900. In some examples, as illustrated inFIGS. 22A-25C, the fasteners1902can be formed as a part of the body1901such that the fasteners1902and the body1901are one unitary piece and/or material.

FIG. 20illustrates a sheath2000operable to cover the fasteners1902. Accordingly, upon insertion of the cartridge1900into the tubular structure12, the fasteners1902are not inadvertently scratching and/or puncturing the tubular structure12.

As the fasteners1902extend at an angle1902A from the body1901, the fasteners1902are operable to puncture through the tubular structure12when the cartridge1900is rotated about a longitudinal axis in relation to the tubular structure12. Due to the fasteners1902puncturing the tubular structure12at an angle, the fasteners1902couple the cartridge1900with the tubular structure12so that the fasteners1902are not easily removed. For example, the tubular structure12or the cartridge1900would have to move relative to one another at a specification rotation and distance from one another to de-couple the fasteners1902from the tubular structure1900.

FIGS. 21A-21Cillustrate an example of actuation of the cartridge1900to couple the cartridge1900with a tubular structure12. The anastomotic coupler10, in the example illustrated inFIGS. 21A-21C, can include a fixation device100,2100. The fixation device100,2100can be similar to the fixation device100described above forFIGS. 1-18. A ring300,2102can be provided about the tubular structure12, external the annulus14. The fixation device2100includes a housing102and an actuation mechanism150, for example a pusher rod, a button, a motor, and/or any other suitable mechanism to actuate the cartridge1900. The cartridge1900can be coupled with the fixation device2100. A stop104can be positioned on the housing102adjacent to the cartridge1900. As shown inFIG. 21B, the stop104is operable to abut against the edge of a tubular structure12to ensure accurate positioning of the cartridge1900within the annulus14of the tubular structure12. As illustrated inFIG. 21B, the cartridge1900is inserted into the annulus14of the tubular structure12. In at least one example, the ring2102can abut the stop104to accurately position the ring2102to be aligned with the cartridge1900.

While the examples illustrated inFIGS. 21A-25Cillustrate the cartridge1900being disposed within the annulus14and the ring2102disposed external the tubular structure12, in other examples the cartridge1900can be disposed external the tubular structure12while the ring2102is disposed within the annulus14.

As shown inFIG. 21B, the actuation mechanism150can be actuated, for example pulled away from the housing102, to move the sheath2000to expose the fasteners1902. Other mechanisms to remove the sheath2000to expose the fasteners1902can be utilized, for example pulling a string, cutting apart the sheath2000, or any other suitable mechanism to expose the fasteners1902of the cartridge1900after the cartridge1900has been disposed within the annulus104of the tubular structure102.

As illustrated inFIG. 21C, the actuation mechanism150can be actuated, for example rotated or push a button or any other suitable mechanism, to rotate the cartridge1900and puncture the tubular structure12with the fasteners1902. The fasteners1902are operable to be rotated to engage the tubular structure12, as the fasteners1902extend at the angle1902A from the body1901of the cartridge1900.

In some examples, the cartridge1900can also expand radially to push the body1901of the cartridge1900and subsequently the fasteners1902against the tubular structure12. In some examples, the body1901of the cartridge1900and/or the fasteners1902can expand radially by expansion, rotation, balloon expansion, traction, compression, and/or any other suitable mechanism. By pushing the fasteners1902against the tubular structure12, the fasteners1902may puncture the tubular structure12. In some examples, the cartridge1900and/or the fasteners1902can be rotated after puncturing the tubular structure12to secure the coupling of the cartridge1900with the tubular structure12.

The fasteners1902are then secured by and/or in the ring2102to maintain the position and coupling of the cartridge1900with the tubular structure12. Examples of the mechanism to retain the fasteners1902in the ring2102and/or configurations of the cartridge1900are illustrated inFIGS. 22A-25C.FIGS. 22A-25Cillustrate different mechanisms of utilizing gaskets2200as receiving portions for the fasteners1902.

FIGS. 22A-22Cillustrate an example of a cartridge1900that has one row of fasteners1902and rings300that secure the fasteners1902by compression between two gaskets2200. To secure two tubular structures20,22to the cartridge1900, the two tubular structures20,22may overlay one another over the fasteners1902of the cartridge1900. The fasteners1902may puncture the two tubular structures20,22to secure the cartridge1900against the two tubular structures20,22and align the lumen14of each of the tubular structures20,22and the lumen1903of the cartridge1900. Accordingly, fluid can pass through a tubular structure20, through the cartridge1900, and to the other tubular structure22.

As illustrated inFIGS. 22B-22C, the two rings2102,2103can be brought together to couple with one another via mating portions352,362(similar toFIGS. 1-18). Upon coupling of the mating portions352,362, gaskets2200for each of the rings2102,2103compress against each other, receiving the fasteners1902between the two gaskets2200. In some examples, the compression of the gaskets2200against the fasteners1902can sufficiently secure the coupling of the rings2102,2103with the cartridge1900. In some examples, after compression of the gaskets2200against the fasteners1902, the fasteners1902, the rings2102,2103, and/or the gaskets2200may be rotated so that the fasteners1902puncture into the gaskets2200. In some examples, the fasteners1902may be received by the gaskets2200or the ring2102,2103. In some examples, the gaskets2200can be made of any biocompatible material including silicone, rubber, and other elastomers, including thermoplastic and/or bioresorbable elastomers. In some examples, the gaskets2200can be made of polyurethane elastomer, polydiene, poly(vinyl) chloride elastomers, and/or any other suitable material.

FIGS. 23A-23Cillustrate an example of utilizing two separate cartridges1900coupled with a corresponding tubular structure20,22, and securing the fasteners1902by compression between the two gaskets2200. As illustrated inFIGS. 23A-23C, each of the cartridges1900can include at least one row of fasteners1902. Each of the fasteners1902have punctured the corresponding tubular structures20,22. The two tubular structures20,22, each with cartridges1900coupled thereto, are brought together so that the lumens14are in fluid communication with one another through the lumens1903of the cartridges1900. Similar toFIGS. 22A-22C, the rings2102,2103are brought together and coupled with one another via mating portions352,362. Upon bringing the rings2102,2103together, gaskets2200for each of the rings2102,2103compress against each other, receiving the fasteners1902for the two cartridges1900between the two gaskets2200. In some examples, the compression of the gaskets2200against the fasteners1902can sufficiently secure the coupling of the rings2102,2103with the cartridges1900. In some examples, after compression of the gaskets2200against the fasteners1902, the fasteners1902, the rings2102,2103, and/or the gaskets2200may be rotated so that the fasteners1902puncture into the gaskets2200. In some examples, the fasteners1902may be received by the gaskets2200or the ring2102,2103.

FIGS. 24A-24Cillustrate an example of the fasteners1902directly puncturing into the gasket2200of the corresponding ring300while puncturing through the tubular structure12. The rings2102,2103are then brought together and coupled with one another via mating portions352,362. WhileFIGS. 24A-24Cillustrate an example similar toFIGS. 23A-23Cwhere two separate cartridges1900are utilized, in some examples, similar toFIGS. 22A-22C, one cartridge1900may be utilized.FIGS. 24A-24Cillustrate the mechanism of the fasteners1902being directly received in and/or puncturing the corresponding gasket2200. This mechanism can be utilized in addition to and/or in place of compressing the fasteners1902with the gaskets2200.

FIGS. 25A-25Cillustrate an example of a cartridge1900that includes two (or more) rows of fasteners1902on one body1901. Accordingly, instead of overlaying the two tubular structures20,22as inFIGS. 22A-22C, each tubular structure20,22may couple with a corresponding row of fasteners1902. In some examples, even with multiple rows of fasteners1902, the tubular structures20,22may still overlap over one or more rows of fasteners1902. The rings2102,2103are brought together and coupled with one another via mating portions352,362. Upon bringing the rings2102,2103together, gaskets2200for each of the rings2102,2103compress against each other, receiving the fasteners1902for the two cartridges1900between the two gaskets2200. In some examples, the compression of the gaskets2200against the fasteners1902can sufficiently secure the coupling of the rings2102,2103with the cartridges1900. In some examples, after compression of the gaskets2200against the fasteners1902, the fasteners1902, the rings2102,2103, and/or the gaskets2200may be rotated so that the fasteners1902puncture into the gaskets2200.

The disclosures shown and described above are only examples. Even though numerous properties and advantages of the present technology have been set forth 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.