Device for anastomosing severed blood vessels

Abstract

A device for anastomosing severed blood vessels is provided. The device includes a first ring having an inner surface defining a lumen configured to selectively receive a first vascular end of a severed blood vessel. A second ring having an inner surface defining a lumen configured to selectively receive a second vascular end of a severed blood vessel. The closure mechanism includes a first joint portion joined to the first ring and a second joint portion joined to the second ring. A biasing member of the closure mechanism is configured to compress the first ring and the second ring together after the first and second vascular ends are received in the first and second rings, thereby anastomosis of the severed blood vessels.

Description

Detailed Description of the Invention

[0001] (Related Applications) This application claims priority to U.S. provisional application number 63 / 390,549, filed July 19, 2022, the entirety of which is incorporated herein by reference. [Technical Field]

[0002] The present invention relates to a device and method for anastomosing severed blood vessels. [Background technology]

[0003] Microsurgical vascular connections, called anastomoses, can be performed using traditional suturing techniques, which can take two or more hours per vessel due to the complexity of placing multiple tiny microsutures within the vessel, or, in the case of veins, using a venous connector device. A venous connector device can include two separate plastic rings, each with a longitudinally extending metal needle. During venous anastomosis, a medical professional winds the edge of the cut end of the vein onto the needle. Using tweezers or another device, the edge of the cut end of the vein is pressed downward onto the needle. The plastic rings are then connected to a delivery device, which pushes the needle of one plastic ring into the receiving hole in the other plastic ring. Summary of the Invention [Problem to be solved by the invention]

[0004] Arteries are much less distensible, much less compliant, and thicker than veins. Arteries also have different vessel wall properties than veins. Therefore, designing a venous connector device to connect veins may not be sufficient for use in arterial anastomosis. [Means for solving the problem]

[0005] In one aspect, alone or in combination with any other aspect, a device for anastomosing severed blood vessels includes a first ring. The first ring has an inner surface defining a lumen configured to selectively receive a first vascular end of the severed blood vessel. A second ring has an inner surface defining a lumen configured to selectively receive a second vascular end of the severed blood vessel. The closure mechanism includes a first joint portion joined to the first ring and a second joint portion joined to the second ring. A biasing member of the closure mechanism is configured to compress the first ring and the second ring together after the first vascular end and the second vascular end are received in the first and second rings, thereby anastomosing the severed blood vessels.

[0006] In one aspect, alone or in combination with any other aspect, a method for anastomosis of severed blood vessels includes providing the device; manipulating a closure mechanism to an open position; positioning a first ring on a first vascular end of the severed blood vessel such that, when the closure mechanism is in the open position, the first vascular end is at least partially within the lumen and surrounded by the inner surface of the first ring; and positioning a second ring on a second vascular end of the severed blood vessel such that, when the closure mechanism is in the open position, the second vascular end is at least partially within the lumen and surrounded by the inner surface of the second ring. When the first and second rings are located at the first and second vascular ends, manipulating the closure mechanism to a closed position compresses the first and second rings together and joins the first and second vascular ends together, thereby anastomotically connecting the severed blood vessels.

[0007] In one aspect, alone or in combination with any other aspect, a system for anastomosing a severed blood vessel includes the device and an applicator selectively coupled to a first actuator portion and a second actuator portion of the closure mechanism and for transitioning the closure mechanism between an open state and a closed state by selectively operating the first actuator portion and the second actuator portion.

[0008] These and other features of the present invention will become apparent to those skilled in the art to which this disclosure pertains upon reading the following description in conjunction with the drawings. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a side view of an anastomotic coupler device according to one embodiment of the present invention, including the device in a first state. [Figure 2] 2 is a plan view of the embodiment shown in FIG. 1, with the device in a first state. [Figure 3] 2 is a plan view of the embodiment shown in FIG. 1, with the device in a second state. [Figure 4] FIG. 2 is a rear perspective view of a portion of the embodiment shown in FIG. 1. [Figure 5] 2 is a perspective view of an exemplary configuration of the element of the embodiment shown in FIG. 1. [Figure 6] 2 is a perspective view of an exemplary configuration of the element of the embodiment shown in FIG. 1. [Figure 7] 1 is a perspective view of an applicator according to one aspect of the present invention. [Figure 8] 2 is a cross-sectional view of an exemplary configuration of the device of the embodiment shown in FIG. 1, including the device in an exemplary environment of use. DETAILED DESCRIPTION OF THE INVENTION

[0010] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0011] As used herein, the term "user" is used interchangeably and refers to an individual who prepares, assists, and / or executes a process.

[0012] As used herein, the singular forms "a," "one," and "the" can include the plural unless the context clearly dictates otherwise. Furthermore, as used herein, the term "comprising" can specify the presence of stated features, steps, operations, elements, and / or components, but does not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0013] As used herein, the phrase "at least one of X and Y" can be interpreted as a combination that includes X, Y, or X and Y. For example, if an element is described as having at least one of X and Y, the element can include X, Y, or a combination of X and Y at a particular time, and the selection of X, Y, or X and Y can change over time. Conversely, the phrase "at least one of X" can be interpreted as including one or more Xs.

[0014] When an element is referred to as being "on," "attached to," "connected to," "contacting," or the like, it should be understood that the element may be directly attached to, connected to, or in contact with the other element, or that intermediate elements may be present. Conversely, when an element is referred to as being, for example, "directly in contact with" another element, no intermediate elements are present.

[0015] For convenience of description, relative spatial terms, such as "above," may be used herein to describe the relationship of one element or feature illustrated in the figures to another or multiple elements or features. It should be understood that, in addition to the orientation depicted in the figures, the relative spatial terms may also encompass different orientations in use or operation of the device. For example, if the device in the figures were inverted, an element that is "above" another element or feature would be described as being oriented "below" that other element or feature.

[0016] It should be understood that although the terms "first," "second," etc. are used herein to describe various elements, these elements should not be limited to these terms. These terms are used to distinguish one element from another. Thus, a "first" element described below may be referred to as a "second" element without departing from the teachings of the present invention. Unless otherwise specified, the order of operations (or steps) is not limited to the order shown in the claims or drawings.

[0017] The present invention comprises or consists essentially of the following features in any combination:

[0018] Devices according to aspects of the present invention can solve the problems of prior art anastomotic coupler devices. Because the design of prior art anastomotic coupler devices is based solely on the characteristics of veins, prior art anastomotic coupler devices may be insufficient when used in arterial anastomosis. Arterial walls are different from venous walls. Compared to arteries, veins are thinner, more distensible, and more prone to everting at the edges of an anastomotic coupler device. Everted arteries and veins contribute to achieving intima-to-intima junctions during anastomosis, which helps eliminate undesirable thrombus formation (blood clotting failure of the vascular connection) during anastomosis. Devices according to aspects of the present invention solve the problems of prior art anastomotic coupler devices by being designed for arterial use.

[0019] The devices disclosed herein reduce the cost of arterial anastomosis by shortening the time it takes to complete an anastomosis. Prior art anastomosis connector devices, when used for arterial anastomosis, are insufficient, forcing medical professionals to use multiple tiny microsutures, with each anastomosis taking an average of 30-60 minutes, and in more complex cases, 120 minutes or more. Performing arterial anastomosis using the device of the present invention can reduce the average anastomosis time from 30-60 minutes to approximately 5 minutes. Thus, the device of the present invention reduces surgical costs by shortening the surgical time for arterial anastomosis.

[0020] 1-3 depict an exemplary anastomotic coupler device 100 designed from the teachings of the present invention. The device 100 includes a closure mechanism 102, which includes a first ring 104 and a second ring 106 selectively joined together. The closure mechanism 102 includes a first wing 108 and a second wing 110. As shown in FIG. 4, the first wing 108 includes a base 412 having opposing first and second longitudinal ends 414 and 416, and opposing first and second transverse ends 418 and 420 extending longitudinally between the first and second longitudinal ends 414 and 416. The term "longitudinal" is used herein to refer to a substantially vertical direction, which is the direction shown in FIG. 4, and is represented by "LO" in FIG. 4. The term "transverse" is used herein to refer to a direction substantially perpendicular to the "longitudinal" direction, and is represented by "LA" in FIG. 4. The substrate 412 further includes opposing first and second transverse surfaces 422, 424. The term "transverse" is used herein to refer to a direction substantially perpendicular to the "machine" and "horizontal" directions, and is represented in Figure 4 by "TR".

[0021] A first connecting protrusion 426 and a second connecting protrusion 428 extend from the second transverse surface 424. The first connecting protrusion 426 and the second connecting protrusion 428 may extend from any other portion of the substrate 412. The first connecting protrusion 426 and the second connecting protrusion 428 are laterally spaced apart from one another along the second transverse surface 424. For example, the first connecting protrusion 426 may be located near the first transverse end 418, and the second connecting protrusion 428 may be located near the second transverse end 420. Each of the first connecting protrusion 426 and the second connecting protrusion 428 may include an opening 430 extending laterally therethrough. While the first wing 108 is shown having two connecting protrusions 426, 428, it may have any desired number of connecting protrusions.

[0022] The joint 432 shown in FIG. 4 is connected to (e.g., extending from) the first longitudinal end 414 of the substrate 412. The joint 432 may be connected to any other portion of the substrate 412. The joint 432 is configured to selectively receive the first ring 104 and selectively maintain a joint with the first ring 104. In the exemplary configuration shown in FIG. 4, the joint 432 includes a first arcuate joint arm 434 and a second arcuate joint arm 436 that form a split ring 438. As shown in FIGS. 1-3, the split ring 438 extends to selectively surround the first ring 104. Thus, the split ring 438 may be configured such that the first ring 104 is selectively held and joined to the split ring 438 by a press fit or a friction fit.

[0023] Returning to FIG. 4 , actuator portion 440 is connected to second longitudinal end 416 of substrate 412 (e.g., extending from second longitudinal end 416). Actuator portion 440 may be connected to any other portion of substrate 412. Actuator portion 440 may include a generally flat gripping surface 442 for a user to easily engage and manipulate first wing 108 with fingers and / or tools during use of device 100. Gripping surface 442 may be connected to second longitudinal end 416 via curved portion 444. Thus, actuator portion 440 may be formed by bending a portion of first wing 108 laterally, away from first lateral surface 422, although actuator portion 444 may be formed in any other desired manner. While curved portion 444 is shown having a generally smooth curvature forming a curved surface, curved portion 444 may have a sharper curvature forming a more acute surface.

[0024] At least one of the substrate 412, the first connecting protrusion 426, the second connecting protrusion 428, the joint portion 432 and the actuator portion 440 may be integrally molded with at least one other of the substrate 412, the first connecting protrusion 426, the second connecting protrusion 428, the joint portion 432 and the actuator portion 440 to form a single integral member, or may be formed separately from at least one other of the substrate 412, the first connecting protrusion 426, the second connecting protrusion 428, the joint portion 432 and the actuator portion 440 and then connected and molded at a later stage.

[0025] 1-3 , the structure of the second wing 110 may essentially mirror the structure of the first wing 108. Accordingly, the second wing 110 includes a substrate 412, a first connecting protrusion 426 and a second connecting protrusion 428, a joint portion 432, and an actuator portion 440. However, the lateral distance between the first connecting protrusion 426 and the second connecting protrusion 428 of the second wing 110 may be at least slightly different from the lateral distance between the first connecting protrusion 426 and the second connecting protrusion 428 of the first wing 108. In this manner, when the first wing 108 is joined to the second wing 110, the openings 430 can all be laterally aligned on a single laterally extending pivot axis PA.

[0026] As shown in FIGS. 1-3 , the first wing 108 and the second wing 110 are joined and maintained joined together via fasteners 146. As shown in FIG. 2 , the fasteners 146 have a shaft 248 received in aligned openings 430. At the opposite end of the shaft 248, the fasteners have enlarged portions 250 that are too large to pass through the aligned openings 430. Each enlarged portion 250 can be permanently secured to the shaft 248, such as by forming a single, integral member therewith. Alternatively, each enlarged portion 250 can be detachable from the shaft 248, such as by being threadedly or otherwise connectable to and detachable from the shaft 248. If it is desired to permanently or non-movably connect the first wing 108 to the second wing 110, the fasteners 146 can be rivets. Alternatively, if it is desired to selectively connect the first wing 109 to the second wing 110 (e.g., to interchange at least one of the first wing 108 and the second wing 110), the fastener 146 may be a bolt with a removable nut.

[0027] The axis 248 of the fastener 148 provides a transversely oriented shaft or axis for pivoting of the first and second wings 108, 110 relative to one another. The second wing 110 is thus joined to the first wing 108. In this manner, the first wing 108 and the second wing 110 are pivotable relative to one another about a pivot axis PA defined by the axis 248.

[0028] When the first wing 108 and the second wing 110 are coupled, selective manipulation of at least one actuator portion 440 selectively transitions the closure mechanism 102 between an open (FIGS. 1-2) state and a closed (FIG. 3) state. In the closed state, the actuator portions 440 are spaced apart, but the joint portions 432 are adjacent to each other. In the open state, the actuator portions 440 are adjacent and / or joined to each other, and the joint portions 432 are pivoted apart about the pivot axis PA.

[0029] The closing mechanism 102 may be urged to the closed state by the biasing member 252. A user can apply force to the actuator members 440 to press the actuator members 440 together against the bias of the biasing member 252, thereby transitioning the closing mechanism 102 to the open state. When the actuator members 440 are pressed together, the joints 432 pivot away from each other. After the applied force is removed, the biasing member 252 moves the actuator members 440 apart, bringing the joints 432 closer together.

[0030] 2, the biasing member 252 is a torsion spring made of a non-magnetic or paramagnetic material (e.g., but not limited to, titanium). In particular, the torsion spring biasing member 252 has a first spring end 254 that contacts the substrate 412 of the first wing 108, a second spring end 256 that contacts the substrate 412 of the second wing 110, and a spring body portion 258 that is wound around the shaft 248 of the fastener 146 between the first spring end 254 and the second spring end 256. However, the biasing member 252 may be any other type of spring or biasing feature formed of any suitable material and configured to transition the closure mechanism 102 between one of the open and closed states using a spring force, a resilient material, elastic deformation, one or more shape memory materials, any other force or mechanical property, or any combination thereof.

[0031] Although the joints 432 are shown in the form of split rings 438, one or two of the joints 432 may alternatively or additionally include any mechanism that provides locking engagement, press fit engagement, magnetic engagement, adhesive, frictional engagement, screw and nut engagement, hook ring engagement, other suitable engagement, or any combination thereof, between the closure mechanism 102 and the first and second rings 104, 106.

[0032] Each of the first ring 104 and the second ring 106 may be any desired ring configured to selectively receive a portion of a blood vessel. Generally, as shown in FIGS. 1-3 , each of the first ring 104 and the second ring 106 may include opposing first and second ring surfaces 160, 162, inner and outer surfaces 164 extending laterally from the first ring surface 160 to the second ring surface 162, and a lumen 168 defined by the inner surfaces 164. The inner surfaces 164 of the first and second rings 104, 106 may include tissue interfacing features 270 for securing the first and second rings 104, 106 to the blood vessel. The tissue interfacing features 270 may include, but are not limited to, one or more spikes, hooks, protrusions, textured regions, adhesives, or any combination thereof.

[0033] The joints 432 of the first wing 108 and the second wing 110 are each configured to selectively receive a corresponding one of the first ring 104 and the second ring 106. The device 100 may be configured to permanently secure the first ring 104 and the second ring 106 to their respective joints 432. In particular, as shown in FIGS. 1-3 , each split ring 438 of the closure mechanism 102 contacts and extends around the outer surface 166 of a corresponding one of the first and second rings 104, 106. As shown in FIGS. 1-2 , when the closure mechanism 102 is in an open state, the first ring surfaces 160 of the first and second rings 104, 106 are spaced apart from one another. However, as shown in FIG. 3 , when the closure mechanism 102 is in a closed state, the first ring surfaces 160 of the first and second rings 104, 106 are configured to abut and / or abut one another.

[0034] Higdon et al., filed June 3, 2021, entitled "Device for Anastomosis of Severed Blood Vessels," International Application No. PCT / US2021 / 035754 (hereinafter referred to as the "'754 Application," the subject matter of which is incorporated herein by reference in its entirety), discusses various rings configured to selectively accommodate a portion of a blood vessel and having the same general ring structure as described above. Accordingly, each of the first ring 104 and the second ring 106 may be any of the rings of the '754 Application or modified versions thereof. Thus, in the exemplary configuration shown in FIG. 5 , the diameter of the first ring 104 tapers inwardly from the first ring surface 160 to the second ring surface 162. The first and second ring surfaces 160, 162 face in opposite directions from the lateral direction. The inward contraction of the first ring 104 forms a funnel, groove, or cone. The inner surface 164 and the outer surface 166 of the first ring 104 extend laterally from the first ring surface 160 to the second ring surface 162. The first ring 104 has a lumen 168 defined by the inner surface 164. Depending on the shape of the first ring 104, the lumen 168 may be generally formed as a funnel, a groove, or a cone, as shown in FIG.

[0035] First ring 104 has an annular central recess 572 between inner surface 164 and first ring surface 160. Central recess 572 is defined by recess sidewalls 574 extending generally laterally from first ring surface 160 and a recess bottom 576 extending generally perpendicularly from inner surface 164.

[0036] A plurality of spike-shaped tissue engagement features 270 extend from at least one of the inner surface 164 and the recess bottom surface 576 of the first ring 104. For example, a first group of spikes 270a can extend into the lumen 168 at an angle of approximately 45-60 degrees from the inner surface 164 relative to the inner surface 164. A second group of spikes 270b can extend generally perpendicularly from the recess bottom surface 576. Thus, the second group of spikes 270b extend laterally. The first ring 104 may include a plurality of posts 578 extending generally perpendicularly and laterally from the first ring surface 160.

[0037] As shown in FIG. 6 , the structure of the second ring 106 can essentially mirror the structure of the first ring 104. Accordingly, the second ring includes opposing first and second ring surfaces 160 and 162, inner and outer surfaces 164 and 166 extending laterally from the first ring surface 160 to the second ring surface 162, a lumen 168, and a central recess 572 defined by recess sidewalls 574 and a recess bottom 576. The second ring 106 and its corresponding lumen 168 are also shaped as a funnel, groove, or cone. The second ring 106 includes a first group of spikes 270a that can extend from the inner surface 164 into the lumen 168 at an angle of approximately 45 to 60 degrees relative to the inner surface 164. The second ring 106 further includes a second group of spikes 270b that can extend substantially perpendicularly from the recess bottom 576. However, unlike the first ring 104, the first ring surface 160 of the second ring 106 may include a plurality of receiving recesses 580 configured to receive a plurality of posts 578 when the first ring 104 and the second ring 106 are joined.

[0038] Alternatively, the first ring surface 160 of the second ring 106 may include at least one post 578, and the first ring surface 160 of the first ring 104 may include at least one receiving recess 580 configured to receive the at least one post 578. As another alternative, the first ring surface 160 of each of the first ring 104 and the second ring 106 may include at least one post 578 and at least one receiving recess 580.

[0039] The first group of spikes 270a, the second group of spikes 270b, and / or the posts 578 can be made from the same material as the first and second rings 104, 106, respectively. In such a configuration, the first group of spikes 270a, the second group of spikes 270b, and / or the posts 578 can be integrally formed with or formed as a single piece as a whole with the first and second rings 104, 106, respectively, or can be formed separately from and connected to the first and second rings 104, 106. Alternatively, the first group of spikes 270a, the second group of spikes 270b, and / or the posts 578 can be formed from a different material than the material used to form the first and second rings 104, 106, respectively. In such a configuration, the first group of spikes 270a, the second group of spikes 270b, and / or the posts 578 can be formed separately from and connected to the first and second rings 104, 106, respectively. The first group of spikes 270a, the second group of spikes 270b and / or the posts 578 may each be separately formed and joined to the first and second rings 104, 106 by gluing, sealing, pasting, press-fitting, insert molding, injection molding, any other suitable direct or indirect joining or bonding, or any combination thereof.

[0040] It is contemplated that the first ring surface 160 may include any desired number of pillars 578 and accommodating recesses 580, rather than including a plurality of pillars 578 and accommodating recesses 580 extending circumferentially on the first ring surface 160 of the first ring 104 and the second ring 106 only in the portion of the first ring surface 60 facing the biasing member 252.

[0041] It is also contemplated that at least one of the first ring 104 and the second ring 106 may be provided with a ring locking mechanism for selectively holding the closure mechanism 102 in a closed state. The ring locking mechanism may be a clip closure member, a latch closure member, a ratchet member, an interlocking member, an adhesive, a hook-and-ring fastener, a magnetic fastener, a snap, a hook-and-eye fastener, a rope-and-eye fastener, or any other suitable mechanism or technique, or any combination thereof, for selectively holding the closure mechanism 102 in a closed state. The ring locking mechanism may be disposed on a surface of at least one of the first ring 104 and the second ring 106. The ring locking mechanism may be located on at least one of the first ring 104 and the second ring 106 opposite the biasing member 252. If a ring locking mechanism is provided, the post 578 and the receiving recess 580 may be omitted from the first ring 104 and the second ring 106. One skilled in the art would readily be able to provide a ring locking mechanism appropriate for a particular use environment.

[0042] The anastomotic coupler device 100 described above may be part of a system 182 for anastomotically severing blood vessels. The system further includes an applicator 784 (FIG. 7) for selectively engaging the actuator portion 440 of the closure mechanism 102 and selectively manipulating the actuator portion 440 to transition the closure mechanism 102 between the open and closed states.

[0043] 7, the applicator 784 includes a first elongate member 786 and a second elongate member 788 connected to each other so as to be selectively pivotable relative to each other. The first elongate member 786 includes a handle 790, an arm 792 extending from the handle 790, and a jaw 794 located at one end of the handle 790 for selectively engaging the actuator portion 440 of the first wing 108. The arm 792 may have a first curved portion 796 (e.g., a 45-degree curve) adjacent the handle 790 and a second curved portion 798 (e.g., a 45-degree curve) adjacent the jaw 794. The second elongate member 788 similarly includes a handle 790, an arm 792 extending from the handle 790, and a jaw 794 located at one end of the handle 790 for selectively engaging the actuator portion 440 of the second wing 110. The arm of the second elongate member 788 may have a first curved portion 796 (eg, a 45 degree curve) adjacent the handle 790 and a second curved portion 798 (eg, a 45 degree curve) adjacent the jaw 794 .

[0044] The handles 790 can be selectively manipulated to transition the closure mechanism 102 between an open state and a closed state. For example, when the closure mechanism 102 is in the closed state, the jaws 794 can be mated to the actuator portions 440. The handles 790 can then pivot toward each other, and the jaws 794 can pivot toward each other in response. The pivoting jaws 794 abut against the biasing member 252 to urge the actuator portions 440 toward each other and manipulate the closure mechanism 102 to the open state. If desired, the locking mechanism 7100 of the applicator 784 can then be actuated to lock the applicator 784 in a position that holds the closure mechanism 102 in the open state. For example, the locking mechanism 7100 may include a latch arm 7100a (shown here attached to the first elongate member 786) rotatably attached to one of the first and second elongate members 786, 788, and a protrusion 7100b (shown here attached to the second elongate member 788) fixedly attached to one of the first and third elongate members 786, 788. The latch arm 7100a can thus rotate until it engages the protrusion 7100b to lock the applicator 784 in a position that holds the closure mechanism 102 open. When a user desires to operate the closure mechanism 102 back to the closed state, the user can simply unlock the actuator 784 via the locking mechanism 7100 and then pivot the handles 790 away from each other. In response, the pivoting handles 790 move the jaws 794 apart, allowing the biasing member 252 to return the closure mechanism 102 to the closed state.

[0045] Although applicator 784 has been described as functioning by pivoting jaws 794 relative to one another when handles 790 are pivoted toward one another, applicator 784 may also be configured such that jaws 794 pivot relative to one another when handles 790 are pivoted away from one another. Those skilled in the art, following the teachings described and illustrated herein, can readily design appropriate applicator operating details for a particular use environment.

[0046] As shown in FIG. 8 , during use, the closure mechanism 102 is operated to an open position against the thrust of the biasing member 252. The closure mechanism 102 can be operated directly by a user, as described above, or indirectly via the handle 790 of the actuator 784. If provided, the locking mechanism 7100 can be actuated to lock the applicator 784 in a position in which the closure mechanism 102 is held open. The first ring 104 is then positioned over a first vascular end 8102 of a severed blood vessel 8104 of the patient, such that the first vascular end 8102 is joined to the inner surface 164. The blood vessel 8104 may be any fluid-carrying vessel, such as, but not limited to, an artery, a vein, a small artery, a capillary, a small venule, and / or the intestine. For example, the blood vessel 8104 is shown in FIG. 8 as an artery. When the first vascular end portion 8102 is joined to the inner surface 164, the first group of spikes 270a protrudes into the vascular wall 8106 to hold the first vascular end portion 8102 joined to the first ring 104. An instrument such as the rubber microplunger of the '754 application can be used to ensure that the first group of spikes 270a lightly penetrates the vascular wall 8106. Due to their 45-60 degree extension, the first group of spikes 270a protrude into the outer layer (tunica adventitia) 8108 and middle layer (tunica media) 8110 of the vascular wall 8106, but not into the innermost layer (tunica intima) 8112. Thus, the first group of spikes 270a protrudes into the vascular wall 8106 without disrupting the inner lining (i.e., the innermost layer 8112) of the blood vessel 8104.

[0047] The edge 8114 of the first vascular end portion 8102 then everts into the central recess 572 of the first ring 104. When the edge 8114 of the first vascular end portion 8102 everts into the central recess 572, the second group of spikes 270b penetrates into the vessel wall 8106, securing the first ring 104 to the edge 8114. An instrument / microplunger can be used to gently press the second group of spikes 270b into the vessel wall 8106. Similarly, the second group of spikes 270a, like the first group of spikes 270a, can be configured to penetrate the vessel wall 8106 without disrupting the inner lining (i.e., the innermost layer 8112) of the blood vessel 8104.

[0048] The second ring 106 is secured to the second vascular end 8116 of the severed vessel 8104 in a similar manner when the closure mechanism 102 is in the open position, but before or after the first ring 104 is secured to the first vascular end 8102. It should be appreciated that the first and second rings 104, 106 of the anastomotic coupler device 100 shown in FIG. 8 have an inwardly tapered inner surface 164. The inward constriction of the inner surface 164, combined with the extension of the first group of spikes 270a at an angle relative to the inwardly tapering inner surface 164, helps to orient the first group of spikes 270a in an ideal position for piercing the first and second vascular ends 8102, 8116. Thus, the inward narrowing of the inner surface 164, combined with the extension of the first group of spikes 270a at an angle to the inward narrowing inner surface 164, helps to prevent the first and second vascular ends 8102, 8116 from undesirably disengaging from the first and second rings 104, 106.

[0049] Although the first and second rings 104, 106 have been described as being connected to the closure mechanism 102 before being secured to the respective vascular ends 8102, 8116, the first and second rings 104, 106 may also be secured to the respective vascular ends 810, 8116 before being connected to the respective joints 432.

[0050] When the first and second rings 104, 106 are secured to the respective vascular ends 8102, 8116, the applicator 784 (if provided) can be unlocked by the locking mechanism 7100. Once unlocked, the handle 790 can be manipulated as described above to allow the biasing member 252 to return the closure mechanism 102 to the closed state. When the biasing member 252 urges the closure mechanism 102 to the closed state, the first and second rings 104, 106 are brought together such that the first surfaces 160 of the first and second rings 104, 106 abut one another. When the first and second rings 104, 106 are brought together, the everted portions 8114 of the first and second vascular ends 8102, 8116 contact one another. Such end-to-end contact of the first and second vascular ends 8102, 8116 can help to ensure a successful anastomosis and prevent thrombus formation.

[0051] When the post 578 and receiving recess 580 are provided, the post 578 of the first ring 104 may be received in the receiving recess 580 of the second ring 106 when the first and second rings 104, 106 are joined. This post-depression joining helps secure the first and second rings 104, 106 together, thereby helping to maintain the closure mechanism 102 in a closed state. At least one of the post 578 and / or receiving recess 580 may have a locking feature (e.g., a protrusion or hook) that helps prevent the post 578 from undesired disengagement from the receiving recess 580. For example, as shown in the exemplary configuration of FIG. 8 , the post 578 may be generally arrow-shaped and may have at least one annular protrusion 8118 configured to selectively contact a complementary surface 8120 within the receiving recess 580 to selectively prevent the post 578 from undesired disengagement from the receiving recess 580. However, the thrust provided by the biasing member 252 may be adapted to hold the first and second rings 104, 106 together and prevent the closure mechanism 102 from undesirably transitioning to the open state. In this case, the posts 578 and the receiving recesses 580 may be omitted from the first ring 104 and the second ring 106.

[0052] When the first and second rings 104, 106 are secured together, the interface between the posts 578 and the receiving recesses 580 also helps prevent lateral and / or longitudinal rotation of one of the first and second vessel ends 8102, 8116 relative to the other of the first and second vessel ends 810, 8116. If the anastomosed first and second vessel ends 8102, 8116 were to rotate relative to one another, at least one of the first vessel end 812, the second vessel end 8116, and the vessel 8104 could become generally constricted or twisted, potentially causing delayed vascular thrombosis. However, the interface between the post 578 and the receiving recess 580 prevents one of the first and second rings 104, 106 from rotating laterally and / or longitudinally relative to the other of the first and third rings 104, 106, which in turn helps prevent one of the first and second vascular ends 8102, 8116 from rotating laterally and / or longitudinally relative to the other of the first and second vascular ends 810, 8116. Thus, a medical professional can rotate each of the first and second vascular ends 8102, 8116 in a desired direction and then insert the post 578 into the receiving recess 580, thereby bringing the first and second vascular ends 810, 8116 together and preventing the first and second vascular ends 810, 8116 from rotating laterally and / or longitudinally relative to each other.

[0053] After being operated to the closed state, the user can re-operate the closure mechanism 102 to the open state for any reason, such as to inspect the first and second vessel ends 8102, 8116 within the first and second rings 104, 106, to inspect the orientation of the first and second vessel ends 8102, 8116, or the orientation of the first and second rings 104, 106, or to assess the ejection / reflux of the first and second vessel ends 8102, 8116. Thus, the closure mechanism 102 provides a relatively easy mechanism for coupling and uncoupling the first and second rings 104, 106 (and the corresponding first and second vessel ends 8102, 8116) to one another as needed.

[0054] Each of the closure mechanism, first ring 102, second ring 104, tissue engagement feature 270 (e.g., first group of spikes 270a and / or second group of spikes 270b), posts 578 and / or applicator 784 may be formed at least in part from silicone resin, rubber, polyvinyl chloride, polyethylene, polypropylene, nylon, stainless steel, titanium, any other metal, any other biocompatible material, or any combination thereof.

[0055] While aspects of the present invention have been specifically shown and described with reference to the above exemplary embodiments, various additional aspects are contemplated, as will be understood by those skilled in the art. For example, the specific method for using the device described above is exemplary. Those skilled in the art can readily determine any number of tools, step sequences, or other means / options for placing the device or its components in positions generally similar to those shown herein. Any of the structures and components may be formed entirely into a single whole or unitary component, or may be composed of individual subcomponents, and any of these structures may involve any suitable off-the-shelf or customized component and / or any suitable material or combination of materials. However, the selected material should be biocompatible for many use applications. Any of the structures and components may be disposable or reusable, as desired for a particular use environment, for example. Any component may have user-perceptible markings to indicate the component's material, structure, at least one dimension, etc., potentially aiding the user in selecting a component from an array of similar components for specific use environments. The term "approximately" is used herein to indicate a quality, which is a given quality to a large extent but completely. "Approximately" quality may include relatively few non-quality items. While some elements described herein are shown as having specific geometric shapes, all structures of the present invention may have any suitable shape, size, configuration, relative relationship, cross-sectional area, or any other physical characteristic desired for a particular application. Any structure or feature described with reference to one aspect or structure may be provided in any other aspect or structure, alone or in combination with other structures or features, and it may not be practical to include every aspect and structure described herein with all the options described in relation to every other aspect and structure. Apparatuses and methods combining any of these features should be understood to be within the scope of the present invention, as determined by the appended claims and their equivalents.

[0056] Other aspects, objects and advantages can be obtained from a study of the drawings, the disclosure and the appended claimed protection.

Claims

1. 1. A device for anastomosing severed blood vessels, comprising: a first ring having an inner surface defining a lumen configured to selectively receive a first vessel end of the severed blood vessel; a second ring having an inner surface defining a lumen configured to selectively receive a second vessel end of the severed blood vessel; a closure mechanism having a first joint joined to the first ring and a second joint joined to the second ring; a biasing member of the closure mechanism configured to anastomose the severed blood vessels by pressing the first ring and the second ring together after the first blood vessel end and the second blood vessel end are accommodated in the first ring and the second ring.

2. 2. The device of claim 1, wherein the closure mechanism has a closed state and an open state, wherein in the closed state, the first ring and the second ring are adjacent to each other, and in the open state, the first ring and the second ring are spaced apart against the bias of the biasing member.

3. the closing mechanism includes a first actuator unit connected to the first joint and a second actuator unit connected to the second joint; The device of claim 2 , wherein selective manipulation of at least one of the first actuator element and the second actuator element selectively transitions the closure mechanism between the closed state and the open state.

4. 1. A system for anastomosing severed blood vessels, comprising: An apparatus according to claim 3; an applicator selectively coupled to the first actuator portion and the second actuator portion of the closure mechanism, and for transitioning the closure mechanism between the open state and the closed state by selectively operating the first actuator portion and the second actuator portion.

5. The system of claim 4 , wherein the applicator includes a locking mechanism that selectively locks the applicator in a position in which the closure mechanism is held open.

6. The applicator comprises: a first handle; a first arm extending from the first handle; and a first jaw located at one end of the first handle for selectively connecting to the first actuator portion; a second handle; a second arm extending from the second handle; and a second jaw located at one end of the second handle for selectively connecting to the second actuator portion; The system of claim 4 , wherein the first handle and the second handle are selectively operable to transition the closure mechanism between the open state and the closed state.

7. the first arm includes a first curved portion adjacent the first handle and a second curved portion adjacent the first jaw; The system of claim 6 , wherein the second arm comprises a first curved portion adjacent the second handle and a second curved portion adjacent the second jaw.

8. the closing mechanism includes a first wing and a second wing; the first wing has a first substrate, the first bonding portion is connected to a first longitudinal end of the first substrate, and the first actuator portion is connected to a second longitudinal end of the first substrate; the second wing has a second substrate, the second bonding portion is connected to a first longitudinal end of the second substrate, and the second actuator portion is connected to a second longitudinal end of the second substrate; The device of claim 1 , wherein selective manipulation of at least one of the first actuator member and the second actuator member selectively transitions the closure mechanism between the closed state and the open state.

9. the first joint portion includes a first arcuate joint arm and a second arcuate joint arm forming a first split ring for selectively receiving the first ring; 9. The apparatus of claim 8, wherein the second joint comprises a first arcuate joint arm and a second arcuate joint arm forming a second split ring for selectively receiving the second ring.

10. the first actuator portion includes a substantially flat first clamping surface connected to a second longitudinal end of the first substrate via a first curved portion of the first actuator portion; the second actuator portion includes a substantially flat second clamping surface connected to a second longitudinal end of the second substrate via a second curved portion of the second actuator portion; 9. The apparatus of claim 8.

11. the first wing includes a first connecting protrusion and a second connecting protrusion extending from a transverse surface of the first substrate, each of the first connecting protrusion and the second connecting protrusion of the first wing having an opening extending laterally therethrough; the second wing includes a first connecting protrusion and a second connecting protrusion extending from a transverse surface of the second substrate, each of the first connecting protrusion and the second connecting protrusion of the second wing having an opening extending laterally therethrough; 9. The device of claim 8, wherein the closure mechanism comprises a fastener extending through each opening to pivotally connect the first wing and the second wing to one another.

12. the closing mechanism includes a first wing and a second wing; the first wing has the first joint portion and a first actuator portion, the second wing is pivotally connected to the first wing, the second wing having the second joint portion and a second actuator portion; 2. The apparatus of claim 1, wherein selective operation of at least one of the first actuator section and the second actuator section causes at least one of the first wing and the second wing to pivot relative to the other one of the first wing and the second wing.

13. an inner surface of the first ring having at least one spike extending from the inner surface into the lumen, the at least one spike of the first ring configured to extend into a vessel wall of the first vessel end to secure the first ring to the first vessel end; 2. The device of claim 1, wherein an inner surface of the second ring has at least one spike extending from the inner surface into the lumen, the at least one spike of the second ring configured to extend into a vessel wall of the second vessel end to secure the second ring to the second vessel end.

14. 14. The device of claim 13, wherein the at least one spike on the first ring extends at an angle of about forty-five (45) to about sixty (60) degrees relative to the inner surface of the first ring, and the at least one spike on the second ring extends at an angle of about forty-five (45) to about sixty (60) degrees relative to the inner surface of the second ring.

15. 2. The device of claim 1, wherein a first ring surface of the first ring includes at least one post configured to be received in a corresponding receiving recess in the first ring surface of the second ring when the first ring and the second ring are joined together.

16. 16. The device of claim 15, wherein a portion of the at least one post is configured to abut a portion of the corresponding receiving recess, thereby at least partially preventing the at least one post from disengaging from the corresponding receiving recess.

17. The device of claim 1 , wherein the biasing member is a spring.

18. 1. A method for anastomosing severed blood vessels, comprising: Providing an apparatus according to claim 1; operating the closing mechanism to an open state; positioning the first ring over a first vascular end of the severed blood vessel such that the first vascular end is at least partially within the lumen and surrounded by an inner surface of the first ring when the closure mechanism is in the open state; positioning the second ring over a second vascular end of the severed blood vessel such that the second vascular end is at least partially within the lumen and surrounded by an inner surface of the second ring when the closure mechanism is in the open state; and when the first ring and the second ring are located at the first blood vessel end and the second blood vessel end, operating the closure mechanism to a closed state to press the first ring and the second ring together and join the first blood vessel end and the second blood vessel end to each other, thereby anastomosing the severed blood vessel.

19. each of the first ring and the second ring includes at least one spike extending from the inner surface into the lumen; The method comprises: anchoring the first ring to the first vessel end by driving the at least one spike of the first ring into a vessel wall at the first vessel end; 19. The method of claim 18, further comprising: anchoring the second ring to the second vessel end by driving the at least one spike of the second ring into a vessel wall at the second vessel end.

20. the first ring includes an annular central recess located between the inner surface and the first ring surface, the annular recess being defined by recess sidewalls and a recess bottom surface, the recess bottom surface including at least one spike extending longitudinally away from the recess bottom surface; the second ring includes an annular central recess located between the inner surface and a second ring surface, the annular recess being defined by recess sidewalls and a recess bottom surface, the recess bottom surface including at least one spike extending longitudinally away from the recess bottom surface, the second ring surface substantially facing the first ring surface when the closure mechanism is in the closed state; The method comprises: everting an edge of the first vessel end into a central recess of the first ring; piercing the at least one spike extending away from the recessed bottom surface of the first ring into the vessel wall of the first vessel end to secure the first ring to the rim of the first vessel end; everting an edge of the second vascular end into a central recess of the second ring; 19. The method of claim 18, further comprising piercing the at least one spike extending away from the recessed bottom surface of the second ring into the vessel wall of the second vessel end to secure the second ring to the rim of the second vessel end.

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