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

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.

Document <CIT> relates to a rapid vascular anastomosis device used for a surgical operation. The rapid vascular anastomosis device comprises a pair of annulus-shaped anastomosis rings, a plurality of axially through holes distributed circumferentially are formed in the two ends faces of each anastomosis ring, and a plurality of axial thrusting needles are circumferentially distributed on one end face of each anastomosis ring; the number, spacing and diameters of the thrusting needles on one anastomosis ring are matched with the number, spacing and diameters of the through holes in the other anastomosis ring, and therefore the pair of anastomosis rings can be combined with each other by means of matching between the thrusting needles and the through holes; the ends of the thrusting needles are provided with barbs, so that the ends of the thrusting needles cannot retreat after penetrating through the through holes.

Document <CIT> discloses an assembly for joining two vessel segments of a patient comprising a coupler formed of adjoining coupler halves, and a cuff having a large diameter portion and a small diameter portion. Each of the coupler halves includes an aperture for receiving an end of one of the vessel segments. One of the coupler halves comprises a connector element sized and shaped for connection to the other coupler half. The vessel segments are alignable in the respective coupler halves such that a path for fluid flow is formed therebetween upon connection of the coupler halves. The large diameter portion of the cuff is positioned over at least a portion of the coupler, and the small diameter portion of the cuff is positioned over one of the vessel segments. The cuff further includes a probe positioned at the small diameter portion. The probe is positioned within the cuff in a manner such that a signal is receivable therein corresponding to fluid flow through the vessel segment.

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

Certain optional features of the invention are defined in the dependent claims. According to the present disclosure, there is provided an anastomotic coupler and a system having the features of the respective independent claims. The dependent claims relate to preferred embodiments.

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 description is 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.

The original technique for vascular suture anastomoses was created by Alexis Carrel between <NUM>-<NUM>. This pioneering work resulted in Carrel receiving the Nobel Prize in <NUM>. Despite <NUM> 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 <NUM>. In the <NUM>, 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 <CIT> (the '<NUM> 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 in FIGS. 2A and 2B of the ` <NUM> 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 in FIG. 1C of the ` <NUM> Publication. However, because of the potential for micro-motion of the vessels and size mismatch due to the anastomotic coupler of the '<NUM> 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 '<NUM> 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 ` <NUM> 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 to <FIG>, an anastomotic coupler <NUM> is provided. The anastomotic coupler <NUM> is provided to create a connection between adjacent tubular structures <NUM>. The tubular structure <NUM> 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 <NUM> is created. The tubular structure <NUM> forms a lumen <NUM> through which matter can be passed, for example blood, food, fluids, and/or cells.

The anastomotic coupler <NUM> includes a ring <NUM> forming an aperture <NUM>. The ring <NUM> is operable to receive a tubular structure <NUM> through the aperture <NUM>. While the ring <NUM> as illustrated in <FIG> has a substantially circular shape, the ring <NUM> can have any suitable shape such as rectangular, triangular, octagonal, hexagonal, and/or oval. Additionally, the ring <NUM> as illustrated in <FIG> is a singular solid piece, in some examples, for ease of application or manufacturing purposes, the ring <NUM> can include two semi-circular or arc-type pieces that are joined together around the tubular structure <NUM>.

The size of the lumen <NUM> of the ring <NUM> can vary based on the application and the size of the tubular structure <NUM>. For example, the diameter of the lumen <NUM> can range from about <NUM> millimeters (mm) (for example for lymphatic connections) to about <NUM> millimeters (for example for gastrointestinal connections). Due to the range of diameters for the ring <NUM>, and the range of diameters for the tubular structure <NUM>, the appropriate ring <NUM> can be selected by measuring the internal diameter of the tubular structure <NUM>. This can be accomplished, for example, with an intraluminal measurement guide/device. If there is a significant size mismatch (<NUM> or greater) between the tubular structure <NUM> and the ring <NUM>, 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 <NUM>-<NUM> larger/smaller than the other end, which would enable a connection of a <NUM> vessel to a <NUM>-<NUM> vessel during microsurgical procedures without problem and vice versa.

Referring also to <FIG>, the anastomotic coupler <NUM> also includes a fixation device <NUM>. The fixation device <NUM> is operable to couple the tubular structure <NUM> with the ring <NUM>. The fixation device <NUM> can include a housing <NUM> and a cartridge <NUM>. The cartridge <NUM> includes a plurality of fasteners <NUM> (as shown in <FIG>). The fasteners <NUM> are operable to puncture the tubular structure <NUM> and be partially received in the ring <NUM> to couple the tubular structure <NUM> with the ring <NUM>. In at least one example, the cartridge <NUM> can be removably coupled with the housing <NUM>. Accordingly, the cartridge <NUM> may be replaceable to allow multiple uses of the fixation device <NUM>. In some examples, the cartridge <NUM> may not be removable such that the fixation device <NUM> is provided for a one-time use. The fixation device <NUM> can include an actuation mechanism operable to actuate the fixation device <NUM> to drive the fasteners <NUM> from the cartridge <NUM>. As illustrated, in at least one example, the actuation mechanism can include a pusher rod <NUM>. Upon actuation of the fixation device <NUM>, the pusher rod <NUM> can translate along a longitudinal axis upon receiving a force. In some examples, the actuation mechanism can include a manually activated mechanism, a spring activated mechanism, a screw mechanism, and/or any other suitable mechanism to drive the fasteners <NUM> from the cartridge <NUM>. For example, the pusher rod <NUM> may translate along the longitudinal axis upon receiving a manual force from a user physically pushing the pusher rod <NUM>. In another example, the pusher rod <NUM> may translate along the longitudinal axis upon receiving a force from a spring. The spring may be released to push the pusher rod <NUM> upon a user pressing a button or a switch.

The fixation device <NUM> includes stop <NUM> to receive the tubular structure <NUM>. In at least one example, the stop <NUM> can be formed as a portion of the cartridge <NUM> to ensure alignment with the cartridge <NUM>. In some examples, the stop <NUM> can be formed as a portion of the housing <NUM>. The stop <NUM> extends radially from the housing <NUM> such that a free end of the tubular structure abuts the stop <NUM>. As illustrated in <FIG>, the housing <NUM> receives the free end of the tubular structure <NUM> such that the cartridge <NUM> is inserted into the lumen <NUM> of the tubular structure. When correctly positioned, the free end of the tubular structure <NUM> abuts the stop <NUM>. The stop <NUM> ensures the placement and alignment of the ring <NUM>, the cartridge <NUM>, and the free end of the tubular structure <NUM>. The alignment of the ring <NUM>, the cartridge <NUM>, and the free end of the tubular structure <NUM> is critical to ensure adequate connection between the tubular structure <NUM> and another tubular structure <NUM>.

As illustrated in <FIG>, after the tubular structure <NUM> is received by the fixation device <NUM> and abuts the stop <NUM>, the ring <NUM> can be positioned to abut the stop such that the ring <NUM> is aligned with the free end of the tubular structure <NUM>.

The stop <NUM> can include a plurality of alignment components <NUM> which correspond with alignment components <NUM> of the ring <NUM>. Accordingly, when the ring <NUM> is aligned and/or correctly positioned, the alignment components <NUM> of the stop <NUM> are aligned with the alignment components <NUM> of the ring <NUM>. In some examples, the alignment components <NUM>, <NUM> can include one or more alignment markers <NUM>, <NUM>. The alignment markers <NUM>, <NUM> can be shaped, for example as triangles. Accordingly, to align the ring <NUM>, the tips of the triangles for the alignment markers <NUM>, <NUM> can point towards one another. In some examples, the alignment components <NUM>, <NUM> can include one or more alignment pins <NUM> and corresponding alignment receivers <NUM>. When the ring <NUM> is aligned, the alignment pins <NUM> can be received by the alignment receivers <NUM>. While the figures illustrate the alignment pins <NUM> being disposed on the fixation device <NUM> and the alignment receivers <NUM> being disposed on the ring <NUM>, in some examples, the alignment pins <NUM> may be disposed on the ring <NUM> and the alignment receivers can be disposed on the fixation device <NUM>.

<FIG> illustrates a cross-sectional view of the tubular structure <NUM>, the ring <NUM>, and the cartridge <NUM> aligned. In addition to ensuring the ring <NUM> aligns with the free end of the tubular structure <NUM>, the ring <NUM> is aligned with the cartridge <NUM>. When the ring <NUM> is properly aligned with the cartridge <NUM>, a plurality of receiving portions <NUM> of the ring <NUM> are aligned with the plurality of fasteners <NUM> of the cartridge <NUM>.

The fasteners <NUM> can be any suitable fastener <NUM> to couple the ring <NUM> with the tubular structure <NUM> and prevent movement between the ring <NUM> and the tubular structure <NUM>. For example, the fasteners <NUM> can include, but are not limited to, tacks <NUM>, <NUM> (as shown in <FIG>), staples <NUM> (as shown in <FIG>), pins, adhesive, internal ring, internal mesh, wire, clamp, coil, and/or suture. Other suitable mechanisms to couple the ring <NUM> with the tubular structure <NUM> can be utilized without deviating from the scope of the present disclosure.

As illustrated in <FIG>, the tack <NUM> can include a puncturing portion <NUM> which is operable to puncture the tubular structure <NUM>. An abutment surface <NUM> abuts against a surface of the corresponding receiving portion <NUM> of the ring <NUM>. A body <NUM> spans the thickness of the wall of the tubular structure <NUM>, and an end <NUM> includes an abutment surface <NUM> which abuts against the inner surface of the tubular structure <NUM>. The abutment surfaces <NUM>, <NUM> prevent the fastener <NUM> from being removed from the tubular structure <NUM> and the ring <NUM>.

As illustrated in <FIG>, the tack <NUM> can include a puncturing portion <NUM> which is operable to puncture the tubular structure <NUM>. The exemplary tack <NUM> does not include as long of a puncturing portion <NUM> as the puncturing portion <NUM> as illustrated in <FIG>. An abutment surface <NUM> abuts against a surface of the corresponding receiving portion <NUM> of the ring <NUM>. A body <NUM> spans the thickness of the wall of the tubular structure <NUM>, and an end <NUM> includes an abutment surface <NUM> which abuts against the inner surface of the tubular structure <NUM>. The abutment surfaces <NUM>, <NUM> prevent the fastener <NUM> from being removed from the tubular structure <NUM> and the ring <NUM>.

As illustrated in <FIG>, the staple <NUM> can include two puncturing portions <NUM> which are operable to puncture through the tubular structure <NUM> and be received in the corresponding receiving portion <NUM> of the ring <NUM>. A body <NUM> spans between the puncturing portions <NUM> and is operable to abut the inner surface of the tubular structure <NUM> to prevent the fastener <NUM> from being removed from the tubular structure <NUM>. In at least one example, the puncturing portions <NUM> may be operable to bend or deform when received in the receiving portion <NUM> to prevent the puncturing portions <NUM> from being removed from the ring <NUM>, ensuring coupling of the tubular structure <NUM> with the ring <NUM>.

Referring to <FIG> and <FIG>, the cartridge <NUM> can include a plurality of drivers <NUM> corresponding with the plurality of fasteners <NUM>. Upon actuation of the fixation device <NUM>, the drivers <NUM> activate to push the corresponding fasteners <NUM> radially outward from the cartridge <NUM>. The drivers <NUM> may include rods which abut the fasteners <NUM> and towards the center of the body <NUM> of the cartridge <NUM>. In some examples, the drivers <NUM> may be spring loaded.

The pusher rod <NUM>, as illustrated in <FIG>, is tapered from a front portion <NUM> with a smaller diameter D1 to a rear portion <NUM> with a larger diameter D2 which is greater than the smaller diameter D1. The drivers <NUM> may abut the fasteners <NUM> on one end while extending into the cartridge <NUM> so that the opposing end of the fasteners <NUM> abut the pusher rod <NUM>.

Referring to <FIG> and <FIG>, the fixation device <NUM> is actuated. Actuation of the fixation device <NUM> can include translating the pusher rod <NUM> along the longitudinal axis through the cartridge <NUM> from the front portion <NUM> towards the rear portion <NUM>. The pusher rod <NUM>, increasing in thickness, then activates the drivers <NUM> to drive the fasteners <NUM> radially outward from the cartridge <NUM>, through the tubular structure <NUM>, and into the receiving portions <NUM> of the ring <NUM>. Once the ring <NUM> is coupled with the tubular structure <NUM>, the fixation device <NUM> can be removed from the tubular structure <NUM>. The ring <NUM> is then affixed or secured to the end of the tubular structure <NUM>, maintaining the structure of the lumen of the tubular structure <NUM>.

The fixation device <NUM>, the ring <NUM>, and/or the fasteners <NUM> 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. Other materials may be used without deviating from the scope of the present disclosure so long as the material is biocompatible and have sufficient strength and durability. The fixation device <NUM>, the ring <NUM>, and/or the fasteners <NUM> 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).

The above process of coupling the ring <NUM> with the tubular structure <NUM> can be repeated for a second tubular structure <NUM> with a second ring <NUM>. For example, <FIG> illustrates an exemplary male ring <NUM>, and <FIG> illustrates an exemplary corresponding female ring <NUM>. Similar to the ring <NUM> discussed above, the male ring <NUM> and the female ring <NUM> each include an aperture <NUM> operable to receive a tubular structure <NUM>, receiving portions <NUM> operable to receive the fasteners <NUM>, and alignment portions <NUM>, <NUM>. The male ring <NUM> includes a mating portion <NUM>, and the female ring <NUM> includes a corresponding mating portion <NUM>. The mating portion <NUM> is operable to couple with the mating portion <NUM> to couple the male ring <NUM> and the female ring <NUM> with one another. As illustrated in <FIG> and <FIG>, the mating portion <NUM> of the male ring <NUM> extends from the ring <NUM> and is operable to be received by the mating portion <NUM> of the female ring <NUM>. In some examples, the rings <NUM> can be coupled with one another by, for example, fastening, snapping, clamping, tacking, pinning, loop and hook, adhesive, and/or other connecting method so long as the rings <NUM> are securely coupled with one another.

As illustrated in <FIG>, when the rings <NUM>, <NUM> are coupled with one another, the lumens <NUM> of the two tubular structures <NUM>, <NUM> are aligned in fluid communication with one another. In at least one example, the rings <NUM>, <NUM> can create a seal to prevent fluid leakage. Accordingly, the anastomotic coupler <NUM> provides a more reliable, faster, more secure anastomotic coupling device to create a sealed, leak-proof, open connection between the ends of the tubular structures <NUM>, <NUM> 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. In at least one example, the two rings <NUM>, <NUM> may be joined such that the mating portion <NUM> of the male ring <NUM> telescopes a predetermined distance into the mating portion <NUM> of the female ring <NUM> to create a sufficient seal to prevent fluid leakage from the tubular structures <NUM> through the rings <NUM>, <NUM>.

As illustrated in <FIG>, a cap <NUM> can be provided over the two rings <NUM>, <NUM>. The cap <NUM> can assist in ensuring the connection between the rings <NUM>, <NUM>, as well as protecting the rings <NUM>, <NUM> from external damage. As illustrated in <FIG>, the cap <NUM> can include a recess <NUM> which is operable to receive the two rings <NUM>, <NUM>. An opening <NUM> can be formed such that the cap <NUM> can be deformed to snap over the two rings <NUM>, <NUM>.

Referring to <FIG>, a flowchart is presented in accordance with an example embodiment. The method <NUM> is provided by way of example, as there are a variety of ways to carry out the method. The method <NUM> described below can be carried out using the configurations illustrated in <FIG>, for example, and various elements of these figures are referenced in explaining example method <NUM>. Each block shown in <FIG> represents one or more processes, methods or subroutines, carried out in the example method <NUM>. 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 method <NUM> can begin at block <NUM>.

At block <NUM>, a first tubular structure is received in an aperture of a first ring.

At block <NUM>, a fixation device receives the first tubular structure such that a first cartridge is inserted into a lumen of the first tubular structure.

At block <NUM>, 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 block <NUM>, 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 block <NUM>, 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.

Claim 1:
An anastomotic coupler (<NUM>) comprising:
a ring (<NUM>) forming an aperture (<NUM>) operable to receive a tubular structure (<NUM>), the ring (<NUM>) including a plurality of receiving portions (<NUM>);
a fixation device (<NUM>) including a housing (<NUM>) and a cartridge (<NUM>), the cartridge (<NUM>) including a plurality of fasteners (<NUM>), the housing (<NUM>) operable to receive the tubular structure (<NUM>) such that the cartridge (<NUM>) is inserted into a lumen (<NUM>) of the tubular structure (<NUM>),
wherein the ring (<NUM>) is aligned with the cartridge (<NUM>) such that the plurality of receiving portions (<NUM>) are aligned with the plurality of fasteners (<NUM>),
wherein upon actuation of the fixation device (<NUM>), the plurality of fasteners (<NUM>) puncture the tubular structure (<NUM>) radially outward from the lumen (<NUM>) and are received by the receiving portions (<NUM>) such that the tubular structure (<NUM>) is coupled with the ring (<NUM>).