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 an inner lumen. The inner lumen is configured to receive a first vascular end of a severed blood vessel. The inner surface of the first ring has at least one needle configured to penetrate the first vascular end and secure the first ring to the first vascular end. A second ring has an inner surface defining an inner lumen, the inner lumen being configured to receive a second vascular end of the severed blood vessel. The inner surface of the second ring has at least one needle configured to penetrate the second vascular end and secure the second ring to the second vascular end. After being secured to the first and second vascular ends, the first and second rings are configured to be coupled and directly joined to each other to anastomose the severed blood vessels.

Description

Detailed Description of the Invention

[0001] (Related Applications) This application claims priority to U.S. provisional application number 63 / 049,270, filed July 8, 2020, the entirety of which is incorporated herein by reference. [Technical field]

[0002] The present disclosure relates to devices and methods for anastomosing severed blood vessels. [Background technology]

[0003] Microsurgical vascular connections, called anastomosis, can be performed using traditional suturing techniques, which can take 30 minutes or 2 hours or longer per vessel due to the complexity of placing multiple tiny micro-sutures in the vessel, or, in the case of veins, can be performed using a venous connector device. The venous connector device can include two separate plastic rings, each with a metal needle extending longitudinally. During venous anastomosis, the 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, a device is provided for anastomosis of severed blood vessels. The device includes a first ring having first and second ring surfaces spaced apart longitudinally and an inner surface extending longitudinally between the first and second ring surfaces. The inner surface defines an inner lumen, the inner lumen configured to receive a first vascular end of the severed blood vessel. The inner surface has at least one needle extending away from the inner surface into the inner lumen. The at least one needle of the first ring is configured to penetrate a vascular wall of the first vascular end and secure the first ring to the first vascular end. The second ring has first and second ring surfaces spaced apart longitudinally and an inner surface extending longitudinally between the first and second ring surfaces. The inner surface defines an inner lumen, the inner lumen configured to receive a second vascular end of the severed blood vessel. The inner surface has at least one needle extending away from the inner surface into the inner lumen. At least one needle of the second ring is configured to penetrate a vessel wall of the second vessel end and secure the second ring to the second vessel end, and the first and second rings are configured to be coupled and directly joined to each other after being secured to the first and second vessel ends to anastomose the severed vessels.

[0006] In one aspect, alone or in combination with any other aspect, there is provided a method of anastomosis of severed blood vessels, the method comprising: providing an apparatus; positioning a first ring at a first blood vessel end of the severed blood vessel such that the first blood vessel end is located in an inner lumen and surrounded by an inner surface of the first ring; securing the first ring to the first blood vessel end by piercing a blood vessel wall of the first blood vessel end with at least one needle extending away from the inner surface of the first ring; positioning a second ring at a second blood vessel end of the severed blood vessel such that the second blood vessel end is located in an inner lumen and surrounded by an inner surface of the second ring; securing the second ring to the second blood vessel end by piercing a blood vessel wall of the second blood vessel end with at least one needle extending away from the inner surface of the second ring; connecting the first and second rings to anastomose the severed blood vessels when the first and second rings are secured to the first and second blood vessel ends.

[0007] In one aspect, alone or in combination with any other aspect, there is provided a device for anastomosis of severed blood vessels, the device including a first ring having first and second ring surfaces spaced apart longitudinally and an inner surface extending longitudinally between the first and second ring surfaces. The inner surface defines an inner lumen, the inner lumen configured to receive a first vascular end of the severed blood vessel. The first ring includes an annular central recess between the inner surface and the first ring surface. The annular recess is defined by longitudinally extending recess sidewalls and a laterally extending recess bottom surface. The recess bottom surface includes at least one needle extending longitudinally away from the recess bottom surface. The at least one needle is configured to penetrate a vascular wall of the first vascular end. The second ring has first and second ring surfaces spaced apart longitudinally and an inner surface extending longitudinally between the first and second ring surfaces. The inner surface defines an inner lumen configured to receive a second vascular end of a severed blood vessel. The second ring includes an annular central recess between the inner surface and the first ring surface. The annular recess is defined by longitudinally extending recess sidewalls and a laterally extending recess bottom surface. The recess bottom surface includes at least one needle extending longitudinally away from the recess bottom surface. The at least one needle is configured to penetrate a blood vessel wall of the second blood vessel end. The first and second rings are configured to be coupled to anastomose the severed blood vessel after being secured to the first and second blood vessel ends.

[0008] In one aspect, alone or in combination with any other aspect, there is provided a method of anastomosis of severed blood vessels, the method comprising: providing an apparatus; positioning a first ring on a first vessel end of the severed blood vessel such that the first vessel end is in the inner lumen and surrounded by the inner surface of the first ring; everting an edge of the first vessel end into the central recess of the first ring; piercing the vessel wall of the first vessel end with at least one needle extending away from the bottom surface of the recess of the first ring to secure the first ring to the edge of the first vessel end; positioning a second ring on a second vessel end of the severed blood vessel such that the second vessel end is in the inner lumen and surrounded by the inner surface of the second ring; everting an edge of the second vessel end into the central recess of the second ring; piercing the vessel wall of the second vessel end with at least one needle extending away from the bottom surface of the recess of the second ring to secure the second ring to the edge of the second vessel end. When the first and second rings are secured to the first and second vessel ends, the first and second rings are joined to anastomose the severed vessels. These and other features of the present disclosure will become apparent to those skilled in the art to which the present disclosure pertains upon reading the following description in light of the accompanying drawings. [Brief description of the drawings]

[0009] [Figure 1] 1 is a cross-sectional view of an anastomotic connector device according to one aspect of the present invention, including the device in an exemplary environment of use. [Diagram 2] FIG. 2 is a perspective view of the element in the embodiment of FIG. [Diagram 3] FIG. 2 is a perspective view of the element in the embodiment of FIG. [Figure 4] 2 is a cross-sectional view of an exemplary structure of the element in the embodiment of FIG. 1. [Diagram 5] 2 is a perspective view of an exemplary structure of the element in the embodiment of FIG. 1. [Figure 6] FIG. 1 is a side view of an anastomotic connector device according to one aspect of the present invention, including the device in an exemplary environment of use. [Figure 7] FIG. 7 is a perspective view of the element in the embodiment of FIG. 6. [Figure 8] FIG. 7 is a perspective view of the element in the embodiment of FIG. 6. [Figure 9] 7 is a cross-sectional view of a portion of the embodiment of FIG. 6, including the device in an exemplary environment of use. [Figure 10] FIG. 1 is a side view of an element that can be used in combination with the device. [Figure 11] 2 is a cross-sectional view of an exemplary structure of the element in the embodiment of FIG. 1. [Figure 12] 2 is a cross-sectional view of an exemplary structure of the element in the embodiment of FIG. 1. [Figure 13] 2 is a cross-sectional view of an exemplary structure of the element in the embodiment of FIG. 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[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 disclosure 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", "an" and "the" can include the plural unless the context clearly indicates 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 including 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," "in contact with," 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 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 ease 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 include different orientations in the 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" the 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 called a "second" element without departing from the teachings of the present disclosure. Unless otherwise indicated, the order of operations (or steps) is not otherwise limited to the order shown in the claims or figures.

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

[0018] The device according to the aspect of the present disclosure can solve the problems of the anastomotic coupler devices in the prior art. The design of the anastomotic coupler devices in the prior art may not be sufficient when used for arterial anastomosis because the design is based only on the characteristics of the vein. The arterial wall is different from the venous wall. Compared to the artery, the vein is thinner, more expandable, and more prone to everting at the edge of the anastomotic coupler device. The everted artery and vein contribute to achieving intima-to-intima junction during anastomosis, which contributes to eliminating the occurrence of undesirable thrombus formation (blood clotting failure of the vascular connection) during anastomosis. The device according to the aspect of the present disclosure solves the problems of the anastomotic coupler devices in the prior art by being designed for use in arteries.

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

[0020] 1-3 depict an exemplary anastomotic coupler device 100 designed from the teachings of the present disclosure. The anastomotic coupler device 100 includes a first ring 102 and a second ring 104. The first ring 102 has a diameter that gradually tapers inward from a first ring surface 106 to a second ring surface 108. The first ring surface 106 and the second ring surface 108 face in opposite longitudinal directions. The term "longitudinal" is used herein to refer to a generally vertical direction in the orientation of FIG. 1 and is indicated by "LO" in FIG. 1. The first ring 102 gradually tapers inward to shape the first ring 102 into a funnel, groove, or truncated cone. An inner surface 110 and an outer surface 112 of the first ring 102 extend in a longitudinal direction from the first ring surface 106 to the second ring surface 108. The first ring 102 has an inner lumen 114 defined by the inner surface 110. As shown in FIG. 1, depending on the shape of the first ring 102, the inner lumen 114 may be shaped generally as a funnel, a groove, or a frustum of a cone.

[0021] The first ring 102 has an annular central recess 116 between the inner surface 110 and the first ring surface 106. The central recess 116 is defined by a recess sidewall 118 extending generally longitudinally from the first ring surface 106 and a recess bottom 120 extending generally laterally from the inner surface 110. The term "lateral" is used herein to refer to a direction generally perpendicular to the "longitudinal" direction, which is designated as horizontal in the orientation of Figure 1 and is designated "LA" in Figure 1.

[0022] As shown in FIGS. 1-3, the plurality of needles 122, 124 extend away (e.g., directly away) from at least one of the inner surface 110 and the recess bottom surface 120 of the first ring 102. For example, the first group of needles 122 extend away from the inner surface 110 at an angle (e.g., but not limited to, about 1-90 degrees, and preferably about 45-60 degrees) to the inner surface 110 and enter the inner lumen 114. The second group of needles 124 extend away (e.g., directly away) from the recess bottom surface 120 generally perpendicularly. Thus, the second group of needles 124 extend in a longitudinal direction. The first ring 102 further includes a plurality of posts 126 that extend away (e.g., directly away) from the first ring surface 106 generally perpendicularly and longitudinally.

[0023] The second ring 104 is generally a mirror image of the first ring 102. Thus, the second ring 104 includes opposing first and second ring surfaces 128 and 130, inner and outer surfaces 132 and 134 extending longitudinally from the first ring surface 128 to the second ring surface 130, an inner lumen 136, and a central recess 138 defined by recess sidewalls 140 and a recess bottom surface 142. The second ring 104 and the corresponding inner lumen 136 of the second ring 104 are also shaped as a funnel, groove, or frustum. The second ring 102 includes a first group of needles 144 that extend at an angle (e.g., about 1-90 degrees, but not limited thereto, and more preferably about 45-60 degrees) relative to the inner surface 132 and enter the inner lumen 136 away from (e.g., directly away from) the inner surface 132. The second ring 104 further includes a second group of needles 146 that may extend generally perpendicularly away (e.g., directly away) from the recess bottom surface 142. However, unlike the first ring 102, the first ring surface 128 of the second ring 104 includes a plurality of receiving recesses 148 that are configured to receive the plurality of posts 126 when the first ring 102 and the second ring 104 are coupled together.

[0024] As shown in FIG. 1, in use, the first ring 102 is positioned over a first vessel end 150 of a severed blood vessel 152, thereby joining the first vessel end 150 to the inner surface 110. The blood vessel may be any fluid-carrying tube, such as, but not limited to, an artery, a vein, an arteriole, a capillary, a venule, a bronchi, a bronchiole, and an intestine. For example, the blood vessel 152 shown in FIG. 1 is an artery. As the first vessel end 150 joins the inner surface 110, the first group of needles 122 penetrate into the vessel wall 154 to keep the first vessel end 150 joined to the first ring 102. An instrument 1080, such as a rubber mini-column stopper 1080 (see FIG. 10), may be used to gently push the first group of needles 122 into the vessel wall 154. Because of their extended angles, the first group of needles 122 are able to penetrate the outer layer (adventitia) 156 and the middle layer (media) 158 of the vessel wall 154, but not the innermost layer (intima) 160. Alternatively, the first group of needles 122 are able to penetrate the outer layer 156 of the vessel wall 154, but not the middle layer 158 and the innermost layer 160. In either case, the first group of needles 122 penetrate the vessel wall 154 but do not breach the lining of the vessel 152.

[0025] The edge 162 of the first vascular end 150 then everts into the central recess 116 of the first ring 102. As the edge 162 of the first vascular end 150 everts into the central recess 116, the second group of needles 124 pierce the vessel wall 154 to secure the first ring 102 to the edge 162 of the first vascular end 150. The mini-column stopper 1080 is used to gently push the second group of needles 124 into the vessel wall 154. Similar to the first group of needles 122, the second group of needles 124 may be configured such that they pierce the vessel wall 154 but do not breach the lining of the vessel 152.

[0026] Either before or after the first ring 102 is secured to the first vessel end 150, the second ring 104 is secured to the second vessel end 164 of the severed vessel 152 in a manner similar to that described above. When the first ring 102 and the second ring 104 are secured to their respective vessel ends 150, 164, the first ring 102 and the second ring 104 are connected together such that the first surfaces 106, 128 of the first ring 102 and the second ring 104 abut one another (e.g., in direct contact or direct joining). When the first ring 102 and the second ring 104 are connected together, the everted portions 162, 166 of the first vessel end 150 and the second vessel end 164 contact one another. Such end-to-end contact of the first vessel end 150 and the second vessel end 164 aids in the success of the anastomosis and helps prevent the development of thrombus formation.

[0027] It should be appreciated that unlike known venous coupler devices, the first ring 102 and the second ring 104 of the anastomotic coupler device 100 have gradually inwardly constricting inner surfaces 110, 132. The gradually inwardly constricting inner surfaces 110, 132 in combination with the first group of needles 122, 144 extending at an angle relative to the gradually inwardly constricting inner surfaces 110, 132 help guide the first group of needles 122, 144 into position for insertion into the first and second vascular ends 150, 164. Thus, the gradually inwardly constricting inner surfaces 110, 132 in combination with the first group of needles 122, 144 extending at an angle relative to the gradually inwardly constricting inner surfaces 110, 132 helps to prevent the first and second vascular ends 150, 164 from inadvertently disengaging from the first and second rings 102, 104.

[0028] When the first ring 102 and the second ring 104 are coupled together, the posts 126 of the first ring 102 are received in the receiving recesses 148 of the second ring 104. The anastomotic coupler device 100 is configured so that the posts 126 do not pierce the vessel wall 154 during use. The post-recess interface helps secure the first ring 102 and the second ring 104 together. At least one of the posts 126 and / or the receiving recesses 148 may have a locking feature (e.g., a barb) to prevent the posts 126 from inadvertently disengaging from the receiving recesses 148. For example, as shown in FIG. 4, at least one post 126 is generally arrow-shaped and has at least one protrusion 468 extending laterally. The protrusion 468 and / or the post 126 may be formed of a resilient material, allowing the protrusion 468 to at least partially flex as desired. The associated receiving recess 148 may have a first portion 470 that has a lateral width that is smaller than the lateral width of a second portion 472 .

[0029] The post 126 may be configured such that when the post 126 is inserted into the receiving recess 148, the protrusion 468 flexes, thereby allowing the post 126 to pass through the first portion 470 of the receiving recess 148. When the post 126 is fully inserted into the receiving recess 148, the protrusion 468 is positioned in the second portion 472 and returns to its pre-deflection state. The interface between the protrusion 468 and the abutment surface 474 of the second portion 472 at least partially prevents the post 126 from accidentally disengaging from the receiving recess 148. However, if a user wishes to remove the post 126 from the receiving recess 148, the user may apply a force that is configured to flex the protrusion 468 and allow the post 126 to pass through the first portion 470 of the receiving recess 140.

[0030] Alternatively, or in addition to the above, the locking feature of the post 126 and the receiving recess 148 that at least partially prevents the post 126 from disengaging from the receiving recess 148 may include designing the size and / or shape of the post 128 and the receiving recess 148 to provide a frictional or interference engagement between the post 126 and the receiving recess 148. As another alternative or supplement, the locking feature may include designing the post 126 and the receiving recess 148 to have at least one of a magnetic and a ferromagnetic material to provide a magnetic interface between the post 126 and the receiving recess 148.

[0031] When the first and second rings 102, 104 are secured together, the interface of the posts 126 and receiving recesses 148 also helps prevent lateral rotation of one of the first and second vessel ends 150, 164 relative to the other of the first and second vessel ends 150, 164. If the anastomosing first and second vessel ends 150, 164 rotate relative to one another, at least one of the first and second vessel ends 150, 164, and the vessel 152 may become pinched together, which may cause delayed vascular thrombosis. However, the interface between the posts 126 and the receiving recess 148 prevents one of the first ring 102 and the second ring 104 from rotating laterally relative to the other of the first ring 102 and the second ring 104, which contributes to preventing one of the first blood vessel end 150 and the second blood vessel end 164 from rotating laterally relative to the other of the first blood vessel end 150 and the second blood vessel end 164. Thus, a user can laterally rotate each of the first blood vessel end 150 and the second blood vessel end 164 to a predetermined orientation and then insert the posts 126 into the receiving recess 148 to anastomose the first blood vessel end 150 and the second blood vessel end 164, thereby preventing the first blood vessel end 150 and the second blood vessel end 164 from rotating laterally relative to each other.

[0032] At least one of the first ring 102 and the second ring 104 may have an orientation feature configured to ensure that the first ring 102 and the second ring 104 are desirably oriented with respect to each other. For example, as shown in FIG. 5, at least one post 126 can be configured to be received in only one correspondingly configured receiving recess 148. In the exemplary structure of FIG. 5, one post 126 (herein designated post 126a) is generally shaped as a rectangular prism, and the other post 126 is generally shaped as a cylinder. Similarly, one receiving recess 148 (herein designated receiving recess 148a) is generally square, and the other receiving recess 148 is generally circular. The post 126a can be inserted only into the rectangular receiving recess 148a. Thus, the first ring 102 and the second ring 104 can abut and join with each other only when the post 126a and the receiving recess 148a align. Such a configuration helps ensure that the first ring 102 and the second ring 104 are oriented as desired before being connected to one another.

[0033] 5, each of the first ring 102 and the second ring 104 may have an orientation indicator 576, 578 located or embedded in the outer surfaces 112, 134 of the first ring 102 and the second ring 104. The first ring 102 and the second ring 104 may be configured such that the orientation indicators 576, 578 align with one another only when the first ring 102 and the second ring 104 are oriented relative to one another as desired.

[0034] 6-9 depict another exemplary anastomotic connector device 100 designed from the teachings of the present disclosure. The anastomotic connector device 100' shown in FIGS. 4-7 is similar to the anastomotic connector device 100 shown in FIGS. 1-3, so that the same or similar features as those described with reference to FIGS. 1-3 bear the same reference numerals and only add the notation "'". The description of the elements and operations similar to those in the anastomotic connector device 100 described in FIGS. 1-3 need not be repeated for the anastomotic connector device 100' shown in FIGS. 6-9, but should be considered as appropriately combined below by reference. It should be noted that the elements shown or described in the exemplary anastomotic connector devices 100, 100' may be shared with the other of the exemplary anastomotic connector devices 100, 100', whether or not they are explicitly stated or illustrated.

[0035] The anastomotic coupler device 100' shown in Figures 6-9 is similar to the anastomotic coupler device 100 shown in Figures 1-3, except that the anastomotic coupler device 100' shown in Figures 6-9 does not include a central recess 116 in the first ring 102' and the second ring 104'. Thus, the first ring 102' and the second ring 104' of the anastomotic coupler device 100' do not include the second group of needles 124. However, it is contemplated that the first ring 102' and the second ring 104' of the anastomotic coupler device 100' are configured to include a central recess 116 and the second group of needles 124.

[0036] Anastomotic coupler device 100' also differs from anastomotic coupler device 100 in that first ring 102' and second ring 104' are shaped as a semi-octagon or trapezoid, rather than a funnel, groove, or frustum. Thus, as shown in FIGURE 9, inner lumen 114' of first ring 102' corresponds to the shape of first ring 102' and is semi-octagonal or trapezoidal. Although not shown, inner lumen 136' of second ring is also semi-octagonal or trapezoidal.

[0037] The anastomotic coupler device 100' may be used in the anastomosis process in a manner similar to that described above. Accordingly, for the sake of brevity, the description of use above will not be repeated, but is incorporated mutatis mutandis. As described above, during the anastomosis process, an instrument 1080 (e.g., rubber mini-column stopper 1080) may be used to gently ensure that needles 122, 122', 144, 144', 124, 124', 146, 146' penetrate the vessel wall 154. FIG. 10 depicts an exemplary rubber mini-column stopper 1080 including a handle portion 1082 and a rubber tip portion 1084.

[0038] The first group of needles 122, 122', 144, 144', the second group of needles 124, 124', 146, 146' and / or the posts 126, 126' may be manufactured from the same material as the first and second rings 102, 102', 104, 104', respectively. In such a construction, the first group of needles 122, 122', 144, 144', the second group of needles 124, 124', 146, 146' and / or the posts 126, 126' may be integrally or entirely formed as a single piece with the first and second rings 102, 102', 104, 104', respectively, or may be formed separately from and connected to the first and second rings 102, 102', 104, 104'. Alternatively, the first group of needles 122, 122', 144, 144', the second group of needles 124, 124', 146, 146' and / or the posts 126, 126' may be manufactured from a material different than the material used to form the first ring 102, 102', 104, 104', respectively. In such a construction, the first group of needles 122, 122', 144, 144', the second group of needles 124, 124', 146, 146' and / or the posts 126, 126' may be formed separately from and coupled to the first and second rings 102, 102', 104, 104', respectively. The first group of needles 122, 122', 144, 144', the second group of needles 124, 124', 146, 146' and / or the posts 126, 126' may be formed separately from the first and second rings 102, 102', 104, 104', respectively, and connected thereto by adhering, sealing, bonding, press fitting, insert molding, over molding, any other suitable direct or indirect mounting or connecting device or combination thereof.

[0039] FIG. 11 illustrates an exemplary structure, in which the first group of needles 122, the second group of needles 124, and the posts 126 may each be formed separately from the first ring 102 and then connected to the first ring. The second ring 104 is not shown in FIG. 11, but the following description may be applied to connect the first and second groups of needles 144, 146 to the second ring 104. As shown in FIG. 11, the first group of needles 122 may be disposed in a first material layer 1186. The first group of needles 122 may be formed as a single member integral with the first material layer 1186, or may be formed separately from the first material layer 1186 and then connected to the first material layer. When the first group of needles 122 is located in the first material layer 1186, the first material layer 1186 may be connected to the inner surface 110 of the first ring 102. In such a construction, the first layer of material 1186 helps to define the inner lumen 114 and may contact the vessel wall 154 in use.

[0040] The second group of needles 124 may be provided in the second layer of material 1188. The second group of needles 124 may be formed integrally with the second layer of material 1188 as a single piece, or may be formed separately from the second layer of material 1188 and connected thereto. When the second group of needles 124 are located in the second layer of material 1188, the second layer of material 1188 may be connected to the recess bottom surface 120 of the first ring 102. In such a structure, the second layer of material 1188 helps to define the inner lumen 114 and may contact the vessel wall 154 in use. Because the recess bottom surface 120 may be annular, the second layer of material 1188 may be annular to abut the annular recess bottom surface 120.

[0041] The posts 126 may be disposed in a third layer of material 1190. The posts 126 may be formed integrally with the third layer of material 1190 as a single piece, or may be formed separately from and connected to the third layer of material 1190. When the posts 126 are located in the third layer of material 1190, the third layer of material 1190 may be connected to the first ring surface 106 of the first ring 102. Because the first ring surface 106 of the first ring 102 may be annular, the third layer of material 1190 may be annular to abut the annular first ring surface 106.

[0042] The first ring 102, 102', the second ring 104, 104', the first group of needles 122, 122', 144, 144', the second group of needles 124, 124', 146, 146', the posts 126, 126', the device 1080, the first layer of material 1186, the second layer of material 1188 and / or the third layer of material 1190 may each be at least partially formed from silicone, rubber, polyvinyl chloride, polyethylene, polypropylene, nylon, stainless steel, titanium, any other metal, any other biocompatible material, or any combination thereof.

[0043] Although the rings 102, 104 have been described as being shaped as a funnel, groove, truncated cone, or semi-octagon, the rings 102, 104 may have any desired shape. For example, as shown in FIG. 12, the outer surfaces 112, 134 of the rings 102, 104 may be shaped as a cylinder, such that the outer diameter of the rings 102, 104 does not generally taper inwardly or outwardly from the first ring surface 106, 128 to the second ring surface 108, 130, but the inner diameter defined by the inner surfaces 110, 132 of the rings 102, 104 tapers inwardly from the first ring surface 106, 128 to the second ring surface 108, 130. The inner lumens 114, 136 of the rings 102, 104 shown in FIG. 12 thereby tapers inwardly from the first ring surface 106, 128 to the second ring surface 108, 130. Alternatively, as shown in Figure 13, the first ring 102 and the second ring 104 may be formed into a ring or cylinder having continuous outer and inner diameters (i.e., diameters that do not gradually narrow inwardly or outwardly from generally the first ring surfaces 106, 128 to the second ring surfaces 108, 130). This results in the inner lumens 114, 136 of the rings 102, 104 shown in Figure 13 being generally cylindrically formed.

[0044] In short, and in other words, the present invention is described as having an aspect that can include the following contents.

[0045] (1) For example, it may be shaped into a funnel, a groove, a truncated cone, a half-octagon, or a cylindrical ring.

[0046] (2) The needle may be angled at approximately 45-60 degrees relative to the inner lumen of the ring so as to penetrate into the outer layer of the vessel wall and hold the vessel end of the severed vessel without disrupting the innermost layer of the vessel wall.

[0047] (3) a central annular recess between the inner surface of the ring and the first ring surface, into which a portion of the vessel end can evert;

[0048] (4) The multiple needles extend vertically from the bottom surface of the central recess so as to pierce and hold the everted portion of the end of the blood vessel.

[0049] (5) The posts in the first ring are received in the receiving recesses in the second ring to secure the first and second rings together and prevent the first and second rings from rotating laterally relative to one another.

[0050] Although aspects of the present disclosure have been specifically shown and described with reference to the above exemplary embodiments, various additional aspects can be envisioned 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 easily determine any number of tools, step sequences, or other means / options for placing the device or parts thereof in a position generally similar to that shown herein. Any of the structures and members may be formed entirely into a single whole or member, or may be composed of a single sub-member, any of these structures relating to any suitable off-the-shelf or customized parts 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 members may be disposable or reusable, as desired for a particular use environment, for example. Any of the members may be provided with user-perceptible markings to indicate the material, structure, at least one dimension, etc. of the part, and the user-perceptible markings may potentially help the user select a part from an array of similar parts to identify the use environment. The "predetermined" state may be determined any time before the manipulated structure actually reaches the state, and the "predetermined" occurs at the latest before the structure reaches the predetermined state. The term "approximately" is used herein to indicate a quality, which is to a large extent but entirely a given quality. The "approximately" quality may include relatively few non-quality items. Although some elements described herein are shown to have a particular geometric shape, all structures of the present disclosure 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, either alone or in combination with other structures or features, and it is not practical for each aspect and structure described herein to have all the options described in relation to all other aspects and structures. Apparatuses and methods combining any of these features should be understood to be within the scope of the present disclosure as determined based on the appended claims and their equivalents.

[0051] 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 and a second ring are included. The first ring has first and second ring surfaces spaced apart longitudinally and an inner surface extending longitudinally between the first and second ring surfaces, the inner surface of the first ring defining an inner lumen configured to receive a first vascular end of the severed blood vessel, the first ring including an annular central recess between the inner surface and the first ring surface, the annular central recess of the first ring defined by longitudinally extending recess sidewalls and a laterally extending recess bottom surface, the inner surface of one ring has at least one inner surface needle extending away from the inner surface into the inner lumen, the at least one inner surface needle of the first ring configured to penetrate a vessel wall of the first vessel end and secure the first ring to the first vessel end; the recess bottom surface of the first ring includes at least one bottom needle extending longitudinally away from the recess bottom surface, the at least one bottom needle of the first ring is used to penetrate an everted portion of the first vessel end; the second ring has first and second ring surfaces spaced apart longitudinally and an inner surface extending longitudinally between the first and second ring surfaces, the inner surface of the second ring defining an inner lumen configured to receive a second vascular end of the severed blood vessel, the second ring including an annular central recess between the inner surface and the first ring surface, the annular central recess of the second ring being defined by longitudinally extending recess sidewalls and a laterally extending recess bottom surface, the inner surface of the second ring having at least one inner surface needle extending away from the inner surface into the inner lumen, the at least one inner surface needle of the second ring configured to penetrate a vessel wall of the second vascular end and secure the second ring to the second vascular end, the recess bottom surface of the second ring including at least one bottom needle extending longitudinally from the recess bottom surface, the at least one bottom needle of the second ring being used to penetrate an everted portion of the second vascular end, 13. A device for anastomosing severed blood vessels, wherein the first ring and the second ring are configured to be coupled and directly joined to each other after being secured to the first blood vessel end and the second blood vessel end to anastomose the severed blood vessels.

2. 2. The device of claim 1, wherein the at least one needle of the first ring extends at an angle between forty-five (45) and sixty (60) degrees relative to the inner surface of the first ring, and the at least one needle of the second ring extends at an angle between forty-five (45) and sixty (60) degrees relative to the inner surface of the second ring.

3. 2. The device of claim 1, wherein the 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 coupled to one another.

4. 4. The apparatus of claim 3, wherein a portion of the at least one post is configured to interface with a portion of the corresponding receiving recess to at least partially prevent the at least one post from disengaging from the corresponding receiving recess.

5. 4. The apparatus of claim 3, wherein the at least one post is at least partially prevented from rotating relative to one another when the at least one post is received in the corresponding receiving recess.

6. 4. The device of claim 3, wherein the first ring includes a plurality of posts and the second ring includes a plurality of receiving recesses for receiving the plurality of posts, and at least one of the posts is configured to be received in only one correspondingly configured receiving recess.

7. the first ring includes an outer surface extending longitudinally between the first ring surface and the second ring surface, the outer surface of the first ring having an orientation indicator; and 2. The apparatus of claim 1, wherein the second ring includes an outer surface extending longitudinally between the first ring surface and the second ring surface, the outer surface of the second ring having an orientation indicator, the orientation indicators of the first ring and the second ring configured to align with one another when the first ring and the second ring are coupled to one another.

8. the first ring has a first layer of material formed separately from the first ring and coupled to the inner surface of the first ring, the at least one inner surface needle extending away from the inner surface of the first ring being provided in the first layer of material, the first ring has a second layer of material formed separately from the first ring and coupled to the bottom surface of the recess of the first ring, the at least one bottom surface needle extending away from the bottom surface of the recess of the first ring being provided in the second layer of material, and 2. The apparatus of claim 1, wherein the second ring has a first layer of material formed separately from the second ring and coupled to the inner surface of the second ring, the at least one inner surface needle extending away from the inner surface of the second ring being provided in the first layer of material, the second ring has a second layer of material formed separately from the second ring and coupled to the bottom surface of the recess of the second ring, and the at least one bottom surface needle extending away from the bottom surface of the recess of the second ring being provided in the second layer of material.

9. the inner lumen of the first ring gradually contracts inwardly from the first ring surface to the second ring surface of the first ring; and 2. The device of claim 1, wherein the inner lumen of the second ring gradually constricts inwardly from the first ring surface to the second ring surface of the second ring.

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