Device for anastomosing cut blood vessel

Abstract

An apparatus for anastomosing a cut blood vessel includes a first ring. The first ring has an inner surface defining a lumen configured to selectively receive a first vessel end of a cut vessel. The second ring has an inner surface defining a lumen configured to selectively receive a second vessel end of the cut vessel. The closure mechanism has a first engagement portion engaged to the first ring and a second engagement portion engaged to the second ring. A biasing member of the closure mechanism is configured to urge the first and second rings toward each other after the first and second vessel ends are received into the first and second rings to anastomose the cut vessel.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 390,549, filed on July 19, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present application relates to apparatus and methods for anastomosing cut blood vessels. Background Art

[0003] Microsurgical blood vessel connection (called anastomosis) can be performed using classic suturing techniques (which can take up to two hours or more per vessel due to the complexity of placing multiple tiny microsutures in the vessel) or, in the case of veins, using a vein coupler device. A vein coupler device can include two separate plastic rings. Each plastic ring has a metal spike extending longitudinally. During a vein anastomosis, a medical professional rolls the edge of the cut end of the vein onto the spikes. Using forceps or other devices, the edge of the cut end of the vein is pressed onto the spikes. The plastic rings are then engaged to a delivery device that compresses the spike of one of the plastic rings into a receiving hole on the other plastic ring.

[0004] Arteries can be much less distensible, less compliant, and thicker than veins. Arteries also have different wall characteristics than veins. Therefore, a venous coupler device designed for coupling veins may not be appropriate when used for arterial anastomosis. Summary of the invention

[0005] In one aspect, alone or in combination with any other aspect, an apparatus for anastomosing a cut blood vessel includes a first ring. The first ring has an inner surface defining an inner lumen configured to selectively receive a first blood vessel end of a cut blood vessel. The second ring has an inner surface defining an inner lumen configured to selectively receive a second blood vessel end of a cut blood vessel. A closure mechanism has a first engagement portion engaged to the first ring and a second engagement portion engaged to the second ring. A biasing member of the closure mechanism is configured to push the first ring and the second ring toward each other to anastomosing the cut blood vessel after the first blood vessel end and the second blood vessel end are received into the first ring and the second ring.

[0006] In one aspect, alone or in combination with any other aspect, a method for anastomosing a cut blood vessel includes providing the apparatus. A closing mechanism is manipulated to an open state. With the closing mechanism in the open state, a first ring is positioned on a first vessel end of a cut blood vessel such that the first vessel end is at least partially located within an inner cavity and is surrounded by an inner surface of the first ring. With the closing mechanism in the open state, a second ring is positioned on a second vessel end of a cut blood vessel such that the second vessel end is at least partially located within an inner cavity and is surrounded by an inner surface of the second ring. With the first ring and the second ring positioned on the first vessel end and the second vessel end, the closing mechanism is manipulated to a closed state to push the first ring and the second ring toward each other and engage the first vessel end and the second vessel end with each other to anastomose the cut blood vessel.

[0007] In one aspect, alone or in combination with any other aspect, a system for anastomosing a cut blood vessel includes the apparatus and an applicator for selectively engaging a first actuating portion and a second actuating portion of a closure mechanism and selectively manipulating the first actuating portion and the second actuating portion to move the closure mechanism between an open state and a closed state. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The foregoing and other features of the present application will become apparent to those skilled in the art to which the present application relates by reading the following description with reference to the accompanying drawings, in which: Figure 1 is a side view of an anastomotic coupler device according to an aspect of the present invention, comprising the device in a first state; Figure 2 for Figure 1 a top view of the illustrated aspect, including the device in a first state; Figure 3 for Figure 1 a top view of the illustrated aspect, including the device in a second state; Figure 4 for Figure 1 a rear perspective view of a portion of the illustrated aspect; Figure 5 for Figure 1 a perspective view of an example configuration of elements of the illustrated aspects; Figure 6 for Figure 1 a perspective view of an example configuration of elements of the illustrated aspects; Figure 7 is a perspective view of an applicator according to one aspect of the present invention; and Figure 8 for Figure 1 Cross-sectional views of example configurations of apparatus of the illustrated aspects, including the apparatus in an example use environment. DETAILED DESCRIPTION

[0009] Unless defined otherwise, 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 application belongs.

[0010] As used herein, the term "user" may be used interchangeably to refer to an individual who prepares, assists with, and / or performs a procedure.

[0011] As used herein, unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" may also include the plural forms. It should also be understood that the terms "include" and / or "comprise" used herein may specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0012] As used herein, the phrase "at least one of X and Y" may be interpreted to include X, Y, or a combination of X and Y. For example, if an element is described as having at least one of X and Y, the element may include X, Y, or a combination of X and Y at a particular time, the selection of which may change over time. In contrast, the phrase "at least one of X" may be interpreted to include one or more Xs.

[0013] It should be understood that when an element is referred to as being "on another element," "attached to another element," "coupled to another element," "contacting another element," etc., it may be directly on, attached to, coupled to, or in contact with the other element, or intervening elements may also be present. In contrast, when an element is referred to as being "directly in contact with" another element, for example, there are no intervening elements.

[0014] For ease of description, spatially relative terms such as "above" may be used herein to describe the relationship of an element or feature to other elements or features shown in the figures. It should be understood that in addition to the orientation shown in the figures, spatially relative terms may also include different orientations of the device in use or operation. For example, if the device in the figure is inverted, an element described as "above other elements or features" will be oriented "below the other elements or features."

[0015] It should be understood that although the terms "first", "second", etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another element. Therefore, without departing from the teachings of this application, the "first" element discussed below may also be referred to as the "second" element. Unless otherwise specifically stated, the order of operations (or steps) is not limited to the order given in the claims or drawings.

[0016] The present invention comprises, consists of, or consists essentially of the following features in any combination.

[0017] The devices according to aspects of the present application solve the following problems of the anastomotic coupler devices of the prior art: when the anastomotic coupler devices are used for arterial anastomosis, they may be inappropriate because their design is based only on the characteristics of veins. The wall of the artery is not like the wall of the vein. Veins are thinner than arteries, more able to expand, and more easily flipped over the edge of the anastomotic coupler device than arteries. The flipped artery and vein help to achieve intima-to-intima engagement during the anastomosis, which helps to prevent the generation of unwanted thrombi (failure of coagulation of the vascular connection) during the anastomosis. The problems of the anastomotic coupler devices of the prior art are overcome by designing the devices according to aspects of the present invention for arterial use.

[0018] The device disclosed herein also reduces the cost of arterial anastomosis by reducing the time required to complete the anastomosis. Because the anastomotic coupler devices of the prior art are not suitable for arterial anastomosis, medical professionals can only use multiple tiny microsuturing devices, which take an average of 30-60 minutes per anastomosis, and may take up to 120 minutes or more in complex cases. Using the device of the present application for arterial anastomosis can reduce the average anastomosis time from 30-60 minutes to about 5 minutes. Therefore, the device of the present invention can reduce the cost of surgery by reducing the operating room time for arterial anastomosis.

[0019] Figure 1-3 An example anastomotic coupler device 100 designed in accordance with the teachings of the present application is depicted. The device 100 includes a closure mechanism 102 having a first ring 104 and a second ring 106 selectively engaged thereto. The closure mechanism 102 includes a first wing 108 and a second wing 110. Figure 4 As shown, the first wing 108 includes a base plate 412 having opposite first and second longitudinal ends 414, 416 and opposite first and second lateral ends 418, 420 extending longitudinally between the first and second longitudinal ends 414, 416. The term "longitudinal" is used herein to refer to Figure 4 A substantially vertical orientation in the direction shown, and Figure 4 The term "lateral" is used herein to refer to a direction substantially perpendicular to the "longitudinal" direction and ... Figure 4 The substrate 412 further includes a first lateral surface 422 and a second lateral surface 424 that are opposite. The term "lateral" is used herein to refer to a direction that is substantially perpendicular to the "longitudinal" and "lateral" directions and is substantially perpendicular to the "longitudinal" and "lateral" directions. Figure 4 It is represented by "TR".

[0020] The first connection protrusion 426 and the second connection protrusion 428 extend from the second lateral surface 424, although the first connection protrusion 426 and the second connection protrusion 428 can extend from any other portion of the base plate 412. The first connection protrusion 426 and the second connection protrusion 428 are also laterally spaced apart from each other on the second lateral surface 424. For example, the first connection protrusion 426 can be located adjacent to the first lateral end 418, and the second connection protrusion 428 can be located adjacent to the second lateral end 420. Each of the first connection protrusion 426 and the second connection protrusion 428 can include an opening 430 extending laterally therethrough. Although the first wing 108 is shown as having two connection protrusions 426, 428, the first wing 108 can have any desired number of connection protrusions.

[0021] Figure 4 The engagement portion 432 is shown connected to the first longitudinal end 414 of the base plate 412 (e.g., extends from the first longitudinal end 414), although the engagement portion 432 can be connected to any other portion of the base plate 412. The engagement portion 432 is configured to selectively receive the first ring 104 and selectively maintain the first ring 104 engaged therewith. Figure 4 In the example configuration shown, the engagement portion 432 includes a first arcuate engagement arm 434 and a second arcuate engagement arm 436 that form a split ring 438. Figure 1-3 As shown, the split ring 438 selectively extends around the first ring 104. Thus, the split ring 438 can be configured such that the first ring 104 is selectively maintained in / engaged with the split ring 438 via a press fit or a friction engagement.

[0022] Back to Figure 4 , the actuation portion 440 is connected to the second longitudinal end 416 of the base plate 412 (e.g., extends from the second longitudinal end 416), although the actuation portion 440 can be connected to any other portion of the base plate 412. The actuation portion 440 can include a substantially flat gripping surface 442 to facilitate easy engagement and manipulation of the first wing 108 by a user with fingers and / or tools during use of the device 100. The gripping surface 442 can be connected to the second longitudinal end 416 via a curved portion 444. Thus, the actuation portion 440 can be formed by bending a portion of the first wing 108 away from the first lateral surface 422 in a lateral direction, although the actuation portion 440 can be formed in any other desired manner. Although the curved portion 444 is shown as having a substantially smooth curve forming a curved surface, the curved portion 444 can have a sharper curve forming a more acute surface.

[0023] At least one of the substrate 412, the first connecting protrusion 426, the second connecting protrusion 428, the joining portion 432 and the actuating portion 440 can be integrally molded with at least one other of the substrate 412, the first connecting protrusion 426, the second connecting protrusion 428, the joining portion 432 and the actuating portion 440 as a single integral piece, or can be separated from and subsequently connected to at least one other of the substrate 412, the first connecting protrusion 426, the second connecting protrusion 428, the joining portion 432 and the actuating portion 440 to form a single integral piece.

[0024] like Figure 1-3 As shown, the structure of the second wing 110 can generally mirror the structure of the first wing 108. Thus, the second wing 110 includes a base plate 412, first and second connection protrusions 426, 428, an engagement portion 432, and an actuation portion 440. However, the lateral distance between the first and second connection protrusions 426, 428 of the second wing 110 can be at least slightly different than the lateral distance between the first and second connection protrusions 426, 428 of the first wing 108, such that when the first and second wings 108, 110 are joined together, the openings 430 can all be laterally aligned on a single laterally extending pivot axis PA.

[0025] like Figure 1-3 As shown, the first wing 108 and the second wing 110 are joined together and maintained together via fasteners 146. Figure 2 As shown, the fastener 146 has a shaft 248 received in the aligned openings 430. At the opposite end of the shaft 248, the fastener has an enlarged portion 250 that is too large to pass through the aligned openings 430. Each of the enlarged portions 250 can be permanently fixed to the shaft 248, such as by being integrally formed with the shaft 248 as a single, unitary piece, or each of the enlarged portions 250 can be removable from the shaft 248, such as by being threaded or otherwise connected to the shaft 248 so as to be removable from the shaft 248. If it is desired to permanently or non-removably couple the first wing 108 to the second wing 110, the fastener 146 can be a rivet, or if it is desired to selectively couple the first wing 108 to the second wing 110 (e.g., for replacement of at least one of the first wing 108 and the second wing 110), the fastener 146 can be a bolt with a removable attachment nut.

[0026] The shaft 248 of the fastener 148 provides a laterally oriented axle or axis for pivotal movement of the first wing 108 and the second wing 110 relative to each other. Thus, the second wing 110 is coupled to the first wing 108 so that the first wing 108 and the second wing 110 can pivot relative to each other about the pivot axis PA defined by the shaft 248.

[0027] When the first wing 108 and the second wing 110 are coupled together, selective manipulation of at least one of the actuation portions 440 causes the closure mechanism 102 to open ( Figure 1-2 ) state and closed ( Figure 3 ) states. In the closed state, the actuating portions 440 are spaced apart from each other, while the engaging portions 432 are adjacent to each other. In the open state, the actuating portions 440 are adjacent to and / or engaged with each other, while the engaging portions 432 are pivoted away from each other about the pivot axis PA.

[0028] The closing mechanism 102 can be urged to the closed state by the biasing member 252. The user can apply a force to the actuating portions 440 to push the actuating portions 440 toward each other against the urging of the biasing member 252, thereby moving the closing mechanism 102 to the open state. When the actuating elements 440 are urged toward each other, the engaging portions 432 pivot away from each other. After the applied force is removed, the biasing member 252 pushes the actuating elements 440 away from each other, thereby pushing the engaging portions 432 toward each other.

[0029] exist Figure 2 In the example configuration shown, the biasing member 252 is a torsion spring formed of a non-magnetic material or a paramagnetic material (such as, but not limited to, titanium). In particular, the torsion spring biasing member 252 has a first spring end 254 in contact with the base plate 412 of the first wing 108, a second spring end 256 in contact with the base plate 412 of the second wing 110, and a spring body portion 258 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 can be any other type of spring or biasing feature formed of any suitable material and is configured to bias the closure mechanism 102 to one of an open state and a closed state by using a spring force, an elastic material, elastic deformation, one or more shape memory materials, any other force or mechanical property, or any combination thereof.

[0030] Although the engagement portions 432 are shown as being in the form of split rings 438, either or both of the engagement portions 432 may alternatively or additionally be / include any mechanism that provides a snap-fit ​​engagement, a press-fit engagement, a magnetic engagement, an adhesive engagement, a friction engagement, a screw and nut engagement, a hook and loop engagement, any other suitable engagement, or any combination thereof, between the closure mechanism 102 and the first ring 104 and the second ring 106.

[0031] Each of the first ring 104 and the second ring 106 can be any desired ring configured to selectively receive a portion of a blood vessel. Figure 1-3As shown, each of the first ring 104 and the second ring 106 can generally include a first ring surface 160 and a second ring surface 162 facing each other, an inner surface 164 and an outer surface 166 extending transversely from the first ring surface 160 to the second ring surface 162, and an inner cavity 168 defined by the inner surface 164. The inner surface 164 of the first ring 104 and the second ring 106 may include a tissue engagement feature 270 for securing the first ring 104 and the second ring 106 to a blood vessel. The tissue engagement feature 270 may include, but is not limited to, one or more spikes, barbs, protrusions, textured areas, adhesives, or any combination thereof.

[0032] The engagement portions 432 of the first wing 108 and the second wing 110 are each configured to selectively receive a respective one of the first ring 104 and the second ring 106, although the device 100 may be configured such that the first ring 104 and the second ring 106 are permanently fixed to their respective engagement portions 432. In particular, as Figure 1-3 As shown, each split ring 438 of the closure mechanism 102 contacts and extends around the outer surface 166 of a corresponding one of the first ring 104 and the second ring 106. Figure 1-2 As shown, when the closure mechanism 102 is in the open state, the first ring surfaces 160 of the first ring 104 and the second ring 106 are configured to be spaced apart from each other. Figure 3 As shown, when the closure mechanism 102 is in the closed state, the first ring surfaces 160 of the first ring 104 and the second ring 106 are configured to be adjacent to and / or engaged with each other.

[0033] International Application No. PCT / US2021 / 035754, filed on June 3, 2021 by Higdon et al., and entitled “DEVICE FOR ANASTASMATTING A CURVED VEGETARIAN” (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 receive a portion of a blood vessel and having the same general ring structure as described above. Thus, each of the first ring 104 and the second ring 106 can be any of the rings in the “’754 Application” or can be a modified version thereof. Thus, in Figure 5 In the example configuration shown, the diameter of the first ring 104 tapers inwardly from the first ring surface 160 to the second ring surface 162. The first ring surface 160 and the second ring surface 162 face in laterally opposite directions. The inward taper of the first ring 104 shapes the first ring 104 into a funnel, a groove, or a truncated 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 an inner cavity 168 defined by the inner surface 164. As shown in FIG. Figure 5As shown, corresponding to the shape of the first ring 104, the inner cavity 168 may be substantially shaped as a funnel, a groove, or a truncated cone.

[0034] The first ring 104 has an annular central recess 572 between the inner surface 164 and the first ring surface 160. The central recess 572 is defined by recess sidewalls 574 extending substantially laterally from the first ring surface 160 and a recess floor 576 extending substantially perpendicularly from the inner surface 164.

[0035] A plurality of tissue engagement features 270 in the form of spikes extend from at least one of the inner surface 164 of the first ring 104 and the recess floor 576. For example, a first set of spikes 270a may extend from the inner surface 164 into the lumen 168 at an angle of approximately 45-60 degrees relative to the inner surface 164. A second set of spikes 270b may extend substantially perpendicularly from the recess floor 576. Thus, the second set of spikes 270b extend in a transverse direction. The first ring 104 may also include a plurality of posts 578 extending substantially perpendicularly and transversely from the first ring surface 160.

[0036] like Figure 6 As shown, the structure of the second ring 106 can generally mirror the structure of the first ring 104. Thus, the second ring includes a first ring surface 160 and a second ring surface 162 facing each other, an inner surface 164 and an outer surface 166 extending transversely from the first ring surface 160 to the second ring surface 162, an inner cavity 168, and a central recess 572 defined by a recess sidewall 574 and a recess floor 576. The second ring 106 and the corresponding inner cavity 168 of the second ring 106 are also shaped as a funnel, a groove, or a truncated cone. The second ring 106 includes a first set of spikes 270a, which can extend from the inner surface 164 to the inner cavity 168 at an angle of approximately 45-60 degrees relative to the inner surface 164. The second ring 106 also includes a second set of spikes 270b, which can extend substantially perpendicularly from the recess floor 576. However, unlike the first ring 104 , the first ring surface 160 of the second ring 106 may include a plurality of receiver recesses 580 configured to receive the plurality of posts 578 when the first ring 104 and the second ring 106 are engaged together.

[0037] As an alternative, 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 receiver 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 receiver recess 580.

[0038] Each of the first set of spikes 270a, the second set of spikes 270b, and / or the posts 578 may be made of the same material as the first and second rings 104, 106. In such a configuration, each of the first set of spikes 270a, the second set of spikes 270b, and / or the posts 578 may be integrally or unitarily formed as a single piece with the first and second rings 104, 106, or may be formed separately from and joined to the first and second rings 104, 106. Alternatively, each of the first set of spikes 270a, the second set of spikes 270b, and / or the posts 578 may be made of a material different from the material used to form the first and second rings 104, 106. In such a configuration, each of the first set of spikes 270a, the second set of spikes 270b, and / or the posts 578 may be formed separately from and joined to the first and second rings 104, 106. Each of the first set of spikes 270a, the second set of spikes 270b and / or the posts 578 may be formed separately from and joined to the first ring 104 and the second ring 106 by bonding, sealing, adhering, press fitting, insert molding, injection molding, by any other suitable direct or indirect attachment or coupling means, or by any combination thereof.

[0039] It is contemplated that the first ring surface 160 may include any desired number of posts 578 and receiver recesses 580 only on a portion of the first ring surface 160 opposite the biasing member 252, rather than including multiple posts 578 and receiver recesses 580 extending circumferentially on the first ring surface 160 of the first and second rings 104, 106.

[0040] It is also contemplated that a loop locking mechanism may be provided on at least one of the first loop 104 and the second loop 106 for selectively maintaining the closure mechanism 102 in a closed state. The loop locking mechanism may be a clip closure, a latch closure, a ratchet element, an interlocking element, an adhesive, a hook and loop fastener, a magnetic fastener, a snap fastener, a hook and eye fastener, a rope eye fastener, any other suitable mechanism or technology, or any combination thereof, for selectively maintaining the closure mechanism 102 in a closed state. The loop locking mechanism may be located on one or more surfaces of at least one of the first loop 104 and the second loop 106. The loop locking mechanism may be located on at least one of the first loop 104 and the second loop 106 opposite the biasing member 252. If a loop locking mechanism is provided, the post 578 and the receiver recess 580 may be omitted from the first loop 104 and the second loop 106. One of ordinary skill in the art will readily be able to provide a suitable loop locking mechanism for a particular use environment.

[0041] The anastomotic coupler device 100 described above may be part of a system 182 for anastomosing a cut blood vessel, the system also including an applicator 784 ( Figure 7 ), for selectively engaging an actuating portion 440 of the closing mechanism 102, and selectively manipulating the actuating portion 440 to move the closing mechanism 102 between an open state and a closed state.

[0042] like Figure 7 As shown, the applicator 784 includes a first elongated member 786 and a second elongated member 788 connected to each other so that they can selectively pivot relative to each other. The first elongated 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 actuation portion 440 of the first wing 108. The arm 792 can have a first bend 796 (e.g., a 45 degree bend) adjacent to the handle 790 and a second bend 798 (e.g., a 45 degree bend) adjacent to the jaw 794. The second elongated 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 actuation portion 440 of the second wing 110. The arm of the second elongated member 788 may have a first bend 796 (eg, a 45 degree bend) adjacent the handle 790 and a second bend 798 (eg, a 45 degree bend) adjacent the jaw 794 .

[0043] The handle 790 can be selectively manipulated to move the closure mechanism 102 between the open state and the closed state. For example, when the closure mechanism 102 is in the closed state, the jaws 794 can be engaged to the actuation portion 440. The handle 790 can then be pivoted toward each other, which in turn pivots the jaws 794 toward each other. The pivoted jaws 794 push the actuation portion 440 toward each other against the biasing member 252 to 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 where the closure mechanism 102 is maintained in the open state. For example, the locking mechanism 7100 may include a latch arm 7100a (shown here as being located on the first elongated member 786) that is rotatably located on one of the first elongated member 786 and the second elongated member 788 and a protrusion 7100b (shown here as being located on the second elongated member 788) that is fixedly located on one of the first elongated member 786 and the second elongated member 788. Thus, the latch arm 7100a may be rotated to engage with the protrusion 7100b to lock the applicator 784 in a position where the closing mechanism 102 is held in the open state. When the user desires to manipulate the closing mechanism 102 back to the closed state, the user may simply unlock the applicator 784 through the locking mechanism 7100 and then pivot the handle 790 away from each other. The pivoted handle 790 correspondingly pivots the jaws 794 away from each other, thereby allowing the biasing member 252 to return the closing element 102 to the closed state.

[0044] Although the applicator 784 is described as functioning by the jaws 794 pivoting toward each other when the handles 790 pivot toward each other, the applicator 784 may also be configured such that the jaws 794 pivot toward each other when the handles 790 pivot away from each other. One of ordinary skill in the art can readily design the operational details of an appropriate applicator for a particular use environment based on the teachings described and illustrated herein.

[0045] like Figure 8 As shown, in use, the closing mechanism 102 is manipulated to an open state against the push of the biasing member 252. The closing mechanism 102 can be manipulated to an open state in the manner described above, either directly by a user or indirectly via the handle 790 of the applicator 784. If provided, the locking mechanism 7100 can be actuated to lock the applicator 784 in a position where the closing mechanism 102 is maintained in an open state. The first ring 104 is then positioned on a first vessel end 8102 of a cut blood vessel 8104 of the patient such that the first vessel end 8102 engages the inner surface 164. The blood vessel 8104 can be any tube that carries a fluid, such as, but not limited to, an artery, a vein, an arteriole, a capillary, a venule, and / or the intestine. For example, the blood vessel 8104 is Figure 8164. When the first vessel end 8102 engages the inner surface 164, the first set of spikes 270a protrude into the vessel wall 8106 to maintain the first vessel end 8102 engaged with the first ring 104. An instrument such as the rubber microplunger of the '754 application can be used to gently ensure that the first set of spikes 270a penetrate into the vessel wall 8106. Due to its 45-60 degree extension, the first set of spikes 270a protrude into the outer layer (adventitia) 8108 and the middle layer (media) 8110 of the vessel wall 8106 without protruding into the innermost layer (intima) 8112. Therefore, the first set of spikes 270a protrude into the vessel wall 8106 without disrupting the inner lining (i.e., the innermost layer 8112) of the vessel 8104.

[0046] Then, the edge 8114 of the first vessel end 8102 is flipped over the central recess 572 of the first ring 104. When the edge 8114 of the first vessel end 8102 is flipped over the central recess 572, the second set of spikes 270b penetrate into the vessel wall 8106 to secure the first ring 104 to the edge 8114. The instrument / micro plunger can be used to gently push the second set of spikes 270b to penetrate into the vessel wall 8106. Similarly, like the first set of spikes 270a, the second set of spikes 270a can be configured so that they penetrate the vessel wall 8106 without damaging the inner lining membrane (i.e., the innermost layer 8112) of the vessel 8104.

[0047] Before or after the first ring 104 is secured to the first vessel end 8102, but when the closure mechanism 102 is in the open state, the second ring 106 is secured to the second vessel end 8116 of the cut vessel 8104 in a manner similar to that described above. It should be understood that Figure 8 The first ring 104 and the second ring 106 of the illustrated anastomotic coupler device 100 have an inwardly tapered inner surface 164. The inward taper of the inner surface 164, combined with the angled extension of the first set of spikes 270a relative to the inwardly tapered inner surface 164, helps orient the first set of spikes 270a to a desired position for penetrating the first and second vessel ends 8102, 8116. Thus, the inward taper of the inner surface 164, combined with the angled extension of the first set of spikes 270a relative to the inwardly tapered inner surface 164, helps prevent the first and second vessel ends 8102, 8116 from undesirably disengaging from the first and second rings 104, 106.

[0048] Although the first and second rings 104 , 106 are described as being coupled to the closure mechanism 102 prior to being secured to their respective vessel ends 8102 , 8116 , the first and second rings 104 , 106 may be secured to their respective vessel ends 8102 , 8116 prior to being coupled to their respective engagement portions 432 .

[0049] With the first and second rings 104, 106 secured to their respective vessel ends 8102, 8116, the applicator 784 (when provided) can be unlocked via the locking mechanism 7100. Once unlocked, the handle 790 can be manipulated in the manner described above to allow the biasing member 252 to return the closure mechanism 102 to the closed state. The first and second rings 104, 106 are engaged together such that when the biasing member 252 pushes the closure mechanism 102 to the closed state, the first surfaces 160 of the first and second rings 104, 106 abut against each other. When the first and second rings 104, 106 are engaged together, the inverted portions 8114 of the first and second vessel ends 8102, 8116 contact each other. This end-to-end contact of the first and second vessel ends 8102, 8116 can enable a successful anastomosis and help prevent the formation of thrombi.

[0050] Where the post 578 and the receiver recess 580 are provided, the post 578 of the first ring 104 may be received in the receiver recess 580 of the second ring 106 when the first ring 104 and the second ring 106 are engaged together. This post-depression engagement helps secure the first ring 104 and the second ring 106 together, thereby helping to maintain the closure mechanism 102 in a closed state. At least one of the post 578 and / or the receiver recess 580 may have a locking feature (e.g., a protrusion or a barb) to help prevent the post 578 from undesirably disengaging from the receiver recess 580. For example, as Figure 8 As shown in the example configuration of , the post 578 can be substantially arrow-shaped and have at least one annular protrusion 8118 that is configured to selectively contact a complementary surface 8120 in the receiver recess 580 to selectively prevent the post 578 from undesirably disengaging from the receiver recess 580. However, the urging force provided by the biasing member 252 can be adapted to solely hold the first ring 104 and the second ring 106 together and prevent the closure mechanism 102 from undesirably moving to the open state. In this case, the post 578 and the receiver recess 580 can be omitted from the first ring 104 and the second ring 106.

[0051] Once the first and second rings 104, 106 are secured together, the engagement between the posts 578 and the receiver recesses 580 also helps prevent one of the first and second vessel ends 8102, 8116 from rotating laterally and / or longitudinally relative to the other of the first and second vessel ends 8102, 8116. If the anastomosed first and second vessel ends 8102, 8116 rotate relative to each other, at least one of the first and second vessel ends 8102, 8116, and the vessel 8104 as a whole may tighten or kink, which may result in delayed vascular thrombosis. However, the engagement between the posts 578 and the receiver recesses 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 second rings 104, 106, which in turn helps prevent one of the first and second vessel ends 8102, 8116 from rotating laterally and / or longitudinally relative to the other of the first and second rings 104, 106. Thus, a medical professional can rotate each of the first vessel end 8102 and the second vessel end 8116 to a desired orientation and then anastomose the first vessel end 8102 and the second vessel end 8116 by inserting the post 578 into the receiver recess 580 to prevent the first vessel end 8102 and the second vessel end 8116 from rotating laterally and / or longitudinally relative to each other.

[0052] After being manipulated to the closed position, the user may manipulate the closure mechanism 102 back to the open position 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 / reflow of the first and second vessel ends 8102, 8116. Thus, the closure mechanism 102 provides a relatively easy mechanism for moving the first and second rings 104, 106 (and the respective first and second vessel ends 8102, 8116) into and out of engagement with each other as desired.

[0053] Each of the closure mechanism, the first ring 102, the second ring 104, the tissue engaging feature 270 (e.g., the first set of spikes 270a and / or the second set of spikes 270b), the post 578, and / or the applicator 784 can be at least partially formed from silicone, rubber, polyvinyl chloride, polyethylene, polypropylene, nylon, stainless steel, titanium, any other metal, any other plastic, any other biocompatible material, or any combination thereof.

[0054] Although aspects of the present application have been particularly shown and described with reference to the above exemplary aspects, a person of ordinary skill in the art will appreciate that various additional aspects may be considered. For example, the specific method of using the device as described above is merely illustrative; a person of ordinary skill in the art may readily determine any number of tools, sequences of steps, or other means / options for placing the device or its components as described above in a substantially similar position as shown and described herein. Any of the structures and components described may be integrally formed as a single mass or piece, or composed of separate subcomponents, wherein any of these configurations involve any suitable stock or custom parts and / or any suitable material or combination of materials; however, the selected materials should be biocompatible for a variety of uses. Any of the structures and components described may be disposable or reusable, as required by a particular use environment. Any component may be provided with a user-perceivable indicia to indicate the material, configuration, at least one size, etc. associated with the component, which user-perceivable indicia may assist a user in selecting a component for a particular use environment from a series of similar components. The term "substantially" is used herein to denote a quality that is largely (but not necessarily entirely) of a specified quality - a "substantially" quality recognizes that some relatively minor non-mass items may be included. Although certain components described herein are shown as having specific geometric shapes, all structures of the present application may have any suitable shape, size, configuration, relative relationship, cross-sectional area, or any other physical characteristic required for a particular application. Any structure or feature described with reference to one aspect or configuration may be provided alone or in combination with other structures or features in any other aspect or configuration, as it is impractical to describe each of the aspects and configurations discussed herein as having all the options discussed with respect to all other aspects and configurations. A device or method incorporating any of these features should be understood to fall within the scope of the present application as determined based on the following claims and any equivalents thereof.

[0055] Other aspects, objects and advantages can be obtained from a study of the drawings, the application and the appended claims.

Claims

1. A device for anastomosing a cut blood vessel, comprising: a first ring having an inner surface defining a lumen configured to selectively receive a first vessel end of the cut blood vessel; a second ring having an inner surface defining a lumen configured to selectively receive a second vessel end of the cut vessel; and A closure mechanism having a first engagement portion engaged to the first ring and a second engagement portion engaged to the second ring, wherein a biasing member of the closure mechanism is configured to push the first ring and the second ring toward each other to anastomose the cut blood vessel after the first blood vessel end and the second blood vessel end are received into the first ring and the second ring.

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

3. The device according to claim 2, wherein: The closing mechanism has a first actuating portion connected to the first engaging portion and a second actuating portion connected to the second engaging portion, wherein selective manipulation of at least one of the first actuating portion and the second actuating portion causes the closing mechanism to selectively move between the closed state and the open state.

4. A system for anastomosing a cut blood vessel, comprising: The device according to claim 3; and An applicator for selectively engaging the first and second actuation portions of the closure mechanism and selectively manipulating the first and second actuation portions to move the closure mechanism between the open state and the closed state.

5. The system according to claim 4, wherein: The applicator has a locking mechanism for selectively locking the applicator in a position where the closure mechanism is maintained in the open state.

6. The system according to claim 4, wherein: The applicator comprises: a first handle, a first arm extending from the first handle, and a first jaw at an end of the first handle, the first jaw for selectively engaging the first actuation portion; and A second handle, a second arm extending from the second handle, and a second jaw located at one end of the second handle, the second jaw being used to selectively engage the second actuating portion, the first handle and the second handle being capable of being selectively manipulated to move the closing mechanism between the open state and the closed state.

7. The system according to claim 6, wherein: The first arm has a first bend adjacent the first handle and a second bend adjacent the first jaw, and The second arm has a first bend adjacent the second handle and a second bend adjacent the second jaw.

8. The device according to claim 1, wherein: The closing mechanism comprises: a first wing having a first substrate, the first engagement portion being connected to a first longitudinal end of the first substrate, and the first actuation portion being connected to a second longitudinal end of the first substrate, A second wing having a second base plate, the second engagement portion being connected to a first longitudinal end of the second base plate, and a second actuation portion being connected to a second longitudinal end of the second base plate, selective manipulation of at least one of the first actuation portion and the second actuation portion selectively moving the closure mechanism between the closed state and the open state.

9. The device according to claim 8, wherein: The first engagement portion includes a first arcuate engagement arm and a second arcuate engagement arm, the first arcuate engagement arm and the second arcuate engagement arm forming a first split ring for selectively receiving the first ring, and The second engagement portion includes a first arcuate engagement arm and a second arcuate engagement arm, the first arcuate engagement arm and the second arcuate engagement arm forming a second split ring for selectively receiving the second ring.

10. The device according to claim 8, wherein: The first actuation portion includes a substantially planar first clamping surface connected to a second longitudinal end of the first substrate via a first curved portion of the first actuation portion, and The second actuation portion includes a substantially planar second clamping surface connected to a second longitudinal end of the second substrate via a second curved portion of the second actuation portion.

11. The device according to claim 8, wherein: The first wing includes a first connection protrusion and a second connection protrusion extending from a lateral surface of the first substrate, each of the first connection protrusion and the second connection protrusion of the first wing includes an opening extending laterally therethrough, The second wing includes a first connection protrusion and a second connection protrusion extending from a lateral surface of the second substrate, each of the first connection protrusion and the second connection protrusion of the second wing includes an opening extending laterally therethrough, and The closure mechanism includes a fastener extending through each opening to pivotally engage the first wing and the second wing together.

12. The device according to claim 1, wherein: The closing mechanism comprises: a first wing having the first engagement portion and a first actuation portion; and A second wing is pivotally connected to the first wing, the second wing having the second engagement portion and a second actuation portion, selective manipulation of at least one of the first actuation portion and the second actuation portion causing at least one of the first wing and the second wing to pivot relative to the other of the first wing and the second wing.

13. The apparatus according to claim 1, wherein: The inner surface of the first ring has at least one spike extending from the inner surface into the inner cavity, the at least one spike of the first ring being configured to extend into a vessel wall of the first vessel end, thereby securing the first ring to the first vessel end, and The 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 being configured to extend into a vessel wall of the second vessel end and secure the second ring to the second vessel end.

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

15. The apparatus according to claim 1, wherein: The first ring surface of the first ring includes at least one post configured to be received in a corresponding receiver recess on the first ring surface of the second ring when the first ring and the second ring are engaged together.

16. The device according to claim 15, wherein: A portion of the at least one post is configured to engage a portion of the corresponding receiver recess to at least partially prevent the at least one post from disengaging from the corresponding receiver recess.

17. The apparatus according to claim 1, wherein: The biasing member is a spring.

18. A method for anastomosing a cut blood vessel, comprising: Providing an apparatus according to claim 1; manipulating the closing mechanism to an open state; With the closure mechanism in the open state, positioning the first ring on a first vessel end of the cut blood vessel such that the first vessel end is at least partially within the lumen and surrounded by an inner surface of the first ring; With the closure mechanism in the open state, positioning the second ring on a second vessel end of the cut blood vessel such that the second vessel end is at least partially within the lumen and is surrounded by an inner surface of the second ring; and With the first ring and the second ring located on the first blood vessel end and the second blood vessel end, the closing mechanism is manipulated to a closed state to push the first ring and the second ring toward each other and engage the first blood vessel end and the second blood vessel end with each other to anastomose the cut blood vessel.

19. The method according to claim 18, wherein: Each of the first ring and the second ring has at least one spike extending from the inner surface into the inner cavity, the method further comprising: penetrating a vessel wall of the first vessel end with the at least one spike of the first ring to secure the first ring to the first vessel end; and The at least one spike of the second ring is used to penetrate the vessel wall of the second vessel end to secure the second ring to the second vessel end.

20. The method according to claim 18, wherein: The first ring includes an annular central recess between the inner surface and the first ring surface, the annular recess being defined by recess sidewalls and a recess floor, the recess floor including at least one spike extending longitudinally away from the recess floor, and The second ring includes an annular central recess between the inner surface and the second ring surface, the annular recess being defined by recess sidewalls and a recess floor, the recess floor including at least one spike extending longitudinally away from the recess floor, the second ring surface substantially facing the first ring surface when the closure mechanism is in the closed state, The method further comprises: Flipping the edge of the first blood vessel end onto the central concave portion of the first ring; penetrating a vessel wall of the first vessel end with the at least one spike, the at least one spike extending away from a floor of the recess of the first ring, to secure the first ring to an edge of the first vessel end; Flipping the edge of the second blood vessel end over the central recess of the second ring; and The vessel wall of the second vessel end is penetrated with the at least one spike, the at least one spike extending away from the recessed floor of the second ring to secure the second ring to the edge of the second vessel end.

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