US20040249400A1 - Anastomosis device - Google Patents

Abstract

An anastomosis device may include a central region, and at least one projection connected to the distal end of the central region, where at least one projection is foldable in at least the proximal direction. An anastomosis device may include a central region, and an inner flange connected to the distal end of the central region, the inner flange deployable from a first position to an expanded position, where the inner flange includes at least one substantially triangular inner flange element.

Description

• This application is a continuation of U.S. patent application Ser. No. 09/664,588, filed on Sep. 18, 2000, which in turn is a divisional of U.S. Pat. No. 6,428,550, issued on Aug. 6, 2002, all of which are incorporated by reference in their entirety.[0001]
BACKGROUND
• 1. Field of the Invention[0002]
• The invention relates to an anastomosis device for forming a sutureless connection between two blood vessels.[0003]
• 2. Brief Description of the Related Art[0004]
• Vascular anastomosis is a procedure by which two blood vessels within a patient are surgically joined together. Vascular anastomosis is performed during treatment of a variety of conditions including coronary artery disease, diseases of the great and peripheral vessels, organ transplantation, and trauma. In coronary artery disease (CAD) an occlusion or stenosis in a coronary artery interferes with blood flow to the heart muscle. Treatment of CAD involves the grafting of a vessel in the form of a prosthesis or harvested artery or vein to reroute blood flow around the occlusion and restore adequate blood flow to the heart muscle. This treatment is known as coronary artery bypass grafting (CABG).[0005]
• In the conventional CABG, a large incision is made in the chest and the sternum is sawed in half to allow access to the heart. In addition, a heart-lung machine is used to circulate the patient's blood so that the heart can be stopped and the anastomosis can be performed. In order to minimize the trauma to the patient induced by conventional CABG, less invasive techniques have been developed in which the surgery is performed through small incisions in the patients chest with the aid of visualizing scopes. Less invasive CABG can be performed on a beating or stopped heart and thus may avoid the need for cardiopulmonary bypass.[0006]
• In both conventional and less invasive CABG procedures, the surgeon has to suture one end of the graft vessel to the coronary artery and the other end of the graft vessel to a blood supplying vein or artery, such as the aorta. The suturing process is a time consuming and difficult procedure requiring a high level of surgical skill. In order to perform the suturing of the graft to the coronary artery and the blood supplying artery the surgeon must have relatively unobstructed access to the anastomosis sites within the patient. In the less invasive surgical approaches, some of the major anastomosis sites cannot be easily reached by the surgeon because of their location. This makes suturing either difficult or impossible without opening up the chest cavity.[0007]
• An additional problem with CABG is the formation of thrombi and atherosclerotic lesions at and around the grafted artery, which can result in the reoccurrence of ischemia. Thrombi and atherosclerotic lesions may be caused by the configuration of the sutured anastomosis site. For example, an abrupt edge at the anastomosis site may cause more calcification than a more gradual transition. However, the preferred gradual transition is difficult to achieve with conventional suturing methods.[0008]
• Accordingly, it would be desirable to provide a sutureless vascular anastomosis device which easily connects a graft to a target vessel. It would also be desirable to provide a sutureless anastomosis device which is formed of one piece and is secured to the target vessel in a single step.[0009]
SUMMARY OF THE INVENTION
• The present invention relates to an anastomosis device for connecting an end of a graft vessel to a target vessel. The anastomosis includes a first linkage formed of a plurality of struts and a plurality of axial members. The first linkage is expandable from a first configuration in which the first linkage is a substantially cylindrical shape to a second configuration in which the first linkage includes a first radially extending flange. A substantially cylindrical central connecting portion extends from the first linkage. A second linkage is configured to form a second radially extending flange spaced from the first radially extending flange.[0010]
• In accordance with an additional aspect of the present invention, an anastomosis device for connecting an end of a graft vessel to a target vessel includes an expandable device formed from a plurality of struts and deformable from a first configuration in which the device is substantially tubular to a second configuration in which the device includes a first radial flange and a second radial flange spaced from the first radial flange a distance sufficient to accommodate a wall of a blood vessel. A first end of the expandable device includes a first linkage which changes from a substantially tubular configuration to a radially extending configuration to form the first flange upon radial expansion of the first end by an expander positioned in a center of the expandable device. A second end of the expandable device includes a second linkage which is configured to form the second radial flange upon deployment of the device.[0011]
• In accordance with another aspect of the present invention, a method of performing anastomosis includes the steps of providing a one-piece tubular anastomosis device; everting an end of a graft vessel around the anastomosis device; puncturing a target vessel with a trocar; inserting the tubular anastomosis device with everted graft vessel into the puncture in the target vessel; radially expanding the tubular anastomosis device with an expander to cause portion of the tube to fold outward forming a first annular flange; and forming a second annular flange on the anastomosis device to trap a wall of the target vessel between the first and second annular flanges and seal the graft vessel to the target vessel.[0012]
• In accordance with a further aspect of the present invention, an anastomosis device deployment system includes a handle, a holder tube attached to the handle, and an expander positioned within the holder and slidable with respect to the holder to a position at which the expander is positioned within the anastomosis device to radially expand the anastomosis device. The holder tube has a distal end configured to hold the anastomosis device with an attached graft vessel.[0013]
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention will now be described in greater detail with reference to the preferred embodiments illustrated in the accompanying drawings, in which like elements bear like reference numerals, and wherein:[0014]
• FIG. 1 is a perspective view of a first embodiment of an anastomosis device in a configuration prior to use with a graft vessel everted over the device;[0015]
• FIG. 2 is a perspective view of the anastomosis device of FIG. 1 in a deployed configuration;[0016]
• FIG. 3 is a perspective view of a second embodiment of an anastomosis device in a configuration prior to use with a graft vessel everted over the device;[0017]
• FIG. 4 is a perspective view of the anastomosis device of FIG. 3 in a deployed configuration;[0018]
• FIG. 5 is a perspective view of a third embodiment of an anastomosis device in a configuration prior to use with a graft vessel everted over the device;[0019]
• FIG. 6 is a perspective view of the anastomosis device of FIG. 5 in a deployed configuration;[0020]
• FIG. 7 is a perspective view of a fourth embodiment of an anastomosis device in a configuration prior to use with a graft vessel everted over the device;[0021]
• FIG. 8 is a perspective view of the anastomosis device of FIG. 7 in a deployed configuration;[0022]
• FIG. 9 is a perspective view of a fifth embodiment of an anastomosis device in a configuration prior to use with a graft vessel everted over the device;[0023]
• FIG. 10 is a perspective view of the anastomosis device of FIG. 9 with a bottom flange in a deployed configuration;[0024]
• FIG. 11 is a perspective view of the anastomosis device of FIG. 9 with a bottom flange and a top flange both in deployed configurations;[0025]
• FIG. 12 is a side view of a portion of a sixth embodiment of an anastomosis device which has been laid flat for ease of illustration;[0026]
• FIG. 13 is a side view of a portion of a seventh embodiment of an anastomosis device which has been laid flat for ease of illustration;[0027]
• FIG. 14 is a perspective view of an anastomosis device deployment system;[0028]
• FIG. 14A is an enlarged perspective view of the distal end of the anastomosis device deployment system of FIG. 14 with an anastomosis device prior to deployment;[0029]
• FIG. 15 is a side cross sectional view of the anastomosis device deployment system puncturing the target vessel to advance the anastomosis device into the target vessel wall;[0030]
• FIG. 16 is a side cross sectional view of the anastomosis device deployment system advancing the anastomosis device into the target vessel wall;[0031]
• FIG. 17 is a side cross sectional view of the anastomosis device deployment system with an expanded first annular flange;[0032]
• FIG. 18 is a side cross sectional view of the anastomosis device deployment system expanding a second annular flange;[0033]
• FIG. 19 is a schematic side cross-sectional view of a deployment tool taken along line A-A of FIG. 14, the deployment tool is shown during a vessel puncturing step;[0034]
• FIG. 20 is a schematic side cross-sectional view of the deployment tool of FIG. 19 shown during an anastomosis device insertion step;[0035]
• FIG. 21 is a schematic side cross-sectional view of the deployment tool of FIG. 19 shown during an anastomosis device expansion step;[0036]
• FIG. 22 is a schematic side cross-sectional view of the deployment tool of FIG. 19 shown after the anastomosis device has been fully deployed;[0037]
• FIG. 23 is a perspective view of a eighth embodiment of an anastomosis device in a configuration prior to use;[0038]
• FIG. 23A is a side view of a portion of the anastomosis device of FIG. 23 prior to folding a tab of the device inward;[0039]
• FIG. 24 is a perspective view of the anastomosis device of FIG. 23 in a deployed configuration;[0040]
• FIG. 25 is a side view of a portion of a ninth embodiment of an anastomosis device which has been laid flat for ease of illustration;[0041]
• FIG. 26 is a side view of a portion of a tenth embodiment of an anastomosis device which has been laid flat for ease of illustration;[0042]
• FIG. 27 is a side view of a portion of an eleventh embodiment of an anastomosis device which has been laid flat for ease of illustration;[0043]
• FIG. 28 is a side view of an eleventh embodiment of an anastomosis device which has been laid flat for ease of illustration; and[0044]
• FIG. 29 is a top view of the anastomosis device of FIG. 28 with a flange deployed.[0045]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The present invention relates to an anastomosis device and method for connecting a graft vessel to a target vessel without the use of conventional sutures. The anastomosis device according to the present invention can be deployed with a deployment system which greatly increases the speed with which anastomosis can be performed over prior art suturing methods. In addition, the anastomosis device provides a smooth transition between the graft vessel and the target vessel. The devices according to the present invention are particularly designed for use in connecting graft vessels to blood delivery or target vessels. Suturing a graft vessel to a target vessel is difficult with conventional techniques, particularly in minimally invasive procedures where space may be limited. However, with an anastomosis device and deployment system of the present invention, anastomosis can be performed efficiently and effectively in tight spaces.[0046]
• FIG. 1 illustrates an[0047]anastomosis device10 according to a first embodiment of the present invention. Theanastomosis device10 includes a plurality ofaxial members12 and a plurality ofstruts14 interconnecting the axial members. Theaxial members12 and struts14 form afirst linkage16 at a first end of the device and asecond linkage18 at a second end of the device. The first andsecond linkages16,18 form first andsecond flanges20,22 when theanastomosis device10 is deployed as illustrated in FIG. 2. The deployedflanges20,22 may be annular ring shaped or conical in shape. The first andsecond linkages16,18 are connected by a central connectingportion24.
• In use, a[0048]graft vessel30 is inserted through a center of thetubular anastomosis device10 and is everted over thefirst linkage16 at the first end of the device. The first end of the device may puncture part way or all the way through the graft vessel wall to hold thegraft vessel30 on the device. Anopening34 is formed in thetarget vessel32 to receive thegraft vessel30 andanastomosis device10. Once theanastomosis device10 witheverted graft vessel30 are inserted through theopening34 in thetarget vessel32, the first andsecond flanges20,22 are formed as shown in FIG. 2 to secure the graft vessel to the target vessel by trapping the wall of the target vessel between the two flanges. Theanastomosis device10 forms a smooth transition between thetarget vessel32 and thegraft vessel30 which helps to prevent thrombi formation.
• The first and[0049]second flanges20,22 are formed by radial expansion of theanastomosis device10 as follows. The first andsecond linkages16,18 are each made up of a plurality ofaxial members12 and struts14. Thestruts14 are arranged in a plurality-of diamond shapes with adjacent diamond shapes connected to each other to form a continuous ring of diamond shapes around the device. Oneaxial member12 extends through a center of each of the diamond shapes formed by thestruts14. A reducedthickness section26 or hinge in each of theaxial members12 provides a location for concentration of bending of the axial members. When an expansion member such as a tapered rod or an inflatable balloon is inserted into thetubular anastomosis device10 and used to radially expand the device, each of the diamond shaped linkages ofstruts14 are elongated in a circumferential direction causing a top and bottom of each of the diamond shapes to move closer together. As the top and bottom of the diamond shapes move closer together, theaxial members12 bend along the reducedthickness sections26 folding the ends of the device outward to form the first andsecond flanges20,22. Once the first andsecond flanges20,22 have been formed, the wall of thetarget vessel32 is trapped between the flanges and theeverted graft vessel30 is secured to the target vessel.
• In the[0050]anastomosis device10 shown in FIGS. 1 and 2, thestruts14 may be straight or curved members having constant or varying thicknesses. In addition, theaxial members12 may have the reducedthickness sections26 positioned at a center of each of the diamond shapes or off center inside the diamond shapes. The positioning and size of the reducedthickness sections26 will determine the location of theflanges20,22 and an angle the flanges make with an axis of the device when fully deployed. A final angle between theflanges20,22 and longitudinal axis of thedevice10 is about 40-100 degrees, preferably about 50-90 degrees.
• FIG. 3 illustrates a second embodiment of a[0051]tubular anastomosis device40 formed of a plurality ofstruts42 interconnected in a diamond pattern. A first end of the device includes a plurality ofinterior diamonds44 positioned within the diamonds formed by the plurality ofstruts42. When the device is deployed, as illustrated in FIG. 4, theinterior diamonds44 fold outward to form a firstannular flange46. A second end of thedevice40 includes a plurality ofpull tabs48 each having a T-shapedend50 to be received in a corresponding slot in a deployment device. The deployment device holds theanastomosis device40 during positioning and deployment of thefirst flange46. Once the firstannular flange46 has been formed, thepull tabs48 are folded radially outward and downward in the direction of the arrows B to form a second annular flange (not shown). Although thepull tabs48 have been illustrated with T-shaped ends, the pull tabs may have other configurations such as loops which engage hooks of a deployment device.
• In use, the[0052]graft vessel30 is inserted through a center of thetubular anastomosis device40 and everted over the first end of the device as shown in FIG. 3. Anopening34 is formed in thetarget vessel32 and theanastomosis device40 with the evertedgraft vessel30 are inserted through theopening34 in the target vessel. An expander is then advanced axially through theanastomosis device40 to radially expand the device and cause the deployment of the firstannular flange46. During advancement of the expander, thedevice40 is held in place by the deployment device which is connected to the T-shaped ends50 of thepull tabs48. After deployment of the firstannular flange46 the expander is removed and thepull tabs48 are disconnected from the deployment device and folded outward in the direction of the arrows B in FIG. 4 to form the second annular flange. The wall of thetarget vessel32 is trapped between the first and second annular flanges.
• In the embodiment of FIGS. 3 and 4, the[0053]interior diamonds44 which form the firstannular flange46 each include top and bottom reducedthickness connection members54 which connect theinterior diamonds44 to thestruts42. Each of theinterior diamonds44 also include aU-shaped web member56 and two reducedthickness portions58 located at opposite sides of the interior diamonds. As thedevice40 is radially expanded, the diamond shapes formed by thestruts42 become more elongated in a circumferential direction, shortening the height of each of these diamond shapes. As the height of the diamond shapes formed by thestruts42 decreases, theinterior diamonds44 are folded outward into the configuration illustrated in FIG. 4. When thedevice40 is fully expanded and the firstannular flange46 is fully formed, the diamonds which originally surrounded theinterior diamonds44 are completely extended and thestruts42 which originally formed the diamonds are parallel or substantially parallel. Theinterior diamonds44 are each folded in half at the reducedthickness portions58 or hinges.
• FIGS. 5 and 6 illustrate a third embodiment of a[0054]tubular anastomosis device60 having a plurality ofstruts62,interior diamonds64, and a plurality ofpull tabs68. Theanastomosis device60 of FIGS. 5 and 6 differs from theanastomosis device40 of FIGS. 3 and 4 in the arrangement of theinterior diamonds64. Theinterior diamonds64, as illustrated in FIG. 5, are connected to the surroundingstruts62 by threeconnection members70. Theconnection members70 are located at opposite sides of each of theinterior diamonds64 and at the bottom of the interior diamonds. A top-corner72 of each of theinterior diamonds64 is not connected to the struts and folds inward upon expansion of the device.
• With this embodiment of FIGS. 5 and 6, as an expander is inserted axially through the[0055]anastomosis device60, thetop corners72 of each of theinterior diamonds64 fold inwardly while a bottom edge of the device folds outwardly to form the firstannular flange66. The expander may also push on the inwardly foldedtop corners72 of theinterior diamonds64 to further bend thefirst flange66 outward. Thedevice60 also includes a plurality of pointed ends74 which puncture the evertedgraft vessel30 and help to retain the graft vessel on theanastomosis device60.
• In use, the[0056]anastomosis device60 is provided with agraft vessel30 which is inserted through a center of the device and everted over the pointed ends74 andinterior diamonds64 of the device. Theanastomosis device60 andeverted graft vessel30 are then inserted in theopening34 in thetarget vessel32 and the firstannular flange66 is deployed by expansion of the device with an axially movable expander. After formation of the firstannular flange66, thepull tabs68 are folded downward and outward in the direction of the arrows B illustrated in FIG. 6 to form the second annular flange and trap the wall of the target vessel between the first and second annular flanges.
• An alternative embodiment of an[0057]anastomosis device80 illustrated in FIGS. 7 and 8 includes two rows of diamond-shapedmembers82 which fold outward to form the first and secondannular flanges84,86. Each of the diamond-shapedmembers82 is connected to M-shapedstruts88 at one end and to V-shapedstruts90 at an opposite end. The diamond-shapedmembers82 are connected only at the top end and bottom end. A central connectingportion92 of thedevice80 includes a plurality of large diamond-shapedsupport members94. As an expander is inserted into thedevice80, the device expands from a configuration illustrated in FIG. 7 to the configuration illustrated in FIG. 8 in which the first and secondannular flanges84,86 have been formed. During expansion, the M-shapedstruts88 and the V-shapedstruts90 are extended to straight or substantially straight members and the largediamond support members94 move away from one another. The diamond-shapedmembers82 each fold in half atreduced thickness portions96 as in the embodiment illustrated in FIGS. 3 and 4.
• FIGS. 9-11 illustrate a further alternative embodiment of an[0058]anastomosis device100 according to the present invention. Thedevice100 includes a plurality ofaxial members102 having reducedthickness portions104. Each of theaxial members102 is positioned within a multi-sidedexpandable linkage106. A central connectingportion108 connects theexpandable linkage106 to a plurality ofpull tabs110. Each of thepull tabs110 has a T-shapedend112 which is received in a corresponding slot in a deployment device to hold theanastomosis device100 during insertion and expansion. However, other pull tab shapes may also be used. As an expander is inserted axially into theanastomosis device100, thelinkage106 expands causing theaxial members102 to fold along the reducedthickness portions104 and extend radially outward forming a firstradial flange114, as illustrated in FIG. 10. The firstradial flange114 may be configured to extend at an acute angle from an axis ofanastomosis device100 or may be folded to form an angle of up to 90 degrees or greater. The angle between the axis of anastomosis device and the lower portion of theaxial members102 after the firstradial flange114 has been deployed is preferably between about 40 and 100 degrees. After the first radial flange has been deployed, thepull tabs110 are disengaged from the deployment device and folded outwards in the direction of the arrows B to form a secondradial flange116 as illustrated in FIG. 11. To disengage and fold thepull tabs110 outwards, the deployment device is moved distally with respect to the anastomosis device. The first and secondradial flanges114,116 trap a wall of thetarget vessel32 between the flanges and thus secure the evertedgraft vessel30 to the target vessel.
• FIGS. 12 and 13 illustrate alternative embodiments of the[0059]device100 of FIGS. 9 through 11. The expandabletubular anastomosis device120 of FIG. 12 has been cut and laid flat for ease of illustration. Thedevice120 includes a plurality ofaxial members122 havinghinges124 in the form of U-shaped grooves. Theaxial members122 are each mounted at opposite ends in anexpandable linkage126. Theexpandable linkage126 is at one end of thedevice120 while an opposite end of the device includes aplurality pull tabs130. Thepull tabs130 andlinkage126 are connected by a central connectingportion128. Each of thepull tabs130 has a T-shapedend132, ashoulder134, and atriangular slot136. Extending from an end of each of thepull tabs130 opposite the T-shaped ends132 is atab lock138.
• In use, the[0060]anastomosis device120 of FIG. 12 is used in a manner substantially similar to that of the device shown in FIGS. 9-11. In particular, thedevice120 is attached to an deployment tool by the T-shaped ends132 of thepull tabs130. A graft vessel is extended through the center of thetubular device120 and everted around the end of the device opposite thepull tabs130. An expander is advanced axially into the device to expand theexpandable linkage126 and cause the lower portion of each of theaxial members122 below thehinges124 to bend outward to form a first flange. The material in the center of each of the U-shaped cuts which form thehinges124 serves as a backstop to prevent the flange from bending or rolling due to radial compressive forces applied to the flange by the stretched graft vessel. In contrast, with the narrowed section hinge shown in FIG. 1 the bend at the hinge tends to roll away from the desired hinge point due to compressive forces applied by the graft vessel. Thebackstop hinge124 prevents rolling of the bend along theaxial member122.
• After formation of the first flange with the expander, the expander is withdrawn. During this withdrawal of the expander, an annular groove on an exterior surface of the expander engages the tab locks[0061]138 causing thepull tabs130 to bend outwardly to form the second flange. Alternatively, the tab locks138 may be caught on a leading edge of the expander. As thepull tabs130 bend outwardly, the T-shaped ends132 of the pull tabs disengage from the deployment device. According to one embodiment of the invention, the second flange is formed by a first bend in thepull tabs130 at a location between thetriangular slot136 and thelock tab138 and a second bend in the pull tab at theshoulder134. These two bends in thepull tabs130 allow the anastomosis device to accommodate target vessels with different wall thicknesses. Each of the two bends preferably forms an angle of about 20-70 degrees.
• FIG. 13 illustrates a further embodiment of a[0062]tubular anastomosis device120′ which corresponds substantially to the device shown in FIG. 12. However, FIG. 13 illustrates several different variations ofhinges124′ for theaxial members122′. In particular, thehinges124′ may be formed in any of the different manners illustrated in FIG. 13 by removing material from theaxial members122′ to cause bending at the desired location. These hinges124′ may include openings of various shapes and/or cut away portions on the sides of theaxial members122′. The different hinge configurations have been shown in one device only for purposes of illustration.
• FIGS. 14-18 illustrate a[0063]deployment system150 and sequence of deploying ananastomosis device120 such as the device shown in FIG. 12 with the deployment system. In FIGS. 14-16 thegraft vessel30 has been eliminated for purposes of clarity. As shown in FIGS. 14-18, thedeployment system150 includes a hollow outer trocar152 (not shown in FIG. 14), aholder tube154 positioned inside the trocar, and anexpander tube156 slidable inside the holder tube. As can be seen in the detail of FIG. 14A, theanastomosis device120 is attached to a distal end of theholder tube154 by inserting the T-shaped ends112 of each of thepull tabs110 inslots158 around the circumference of the holder tube. Thetrocar152,holder tube154, andexpander tube156 are all sidable with respect to one another during operation of the device. Adevice handle160 is provided for moving the tubes with respect to one another will be described in further detail below with respect to FIGS. 19-22.
• As shown in FIG. 15, initially, the[0064]holder tube154,expander tube156, and theanastomosis device120 are positioned within thetrocar152 for insertion. Thetrocar152 has a hollow generally conical tip with a plurality ofaxial slots162 which allow the conical tip to be spread apart so that theanastomosis device120 can slide through the opened trocar. Thetrocar152, acting as a tissue retractor and guide, is inserted through the wall of thetarget vessel32 forming anopening34. As shown in FIG. 16, theanastomosis device120 is then advanced into or through thetarget vessel wall32 with theholder tube154. The advancing of theholder tube154 causes the distal end of thetrocar152 to be forced to spread apart. Once theanastomosis device120 is in position and thetrocar152 has been withdrawn, the first annular flange is deployed by advancing theexpander tube156 into the anastomosis device. The advancing of theexpander tube156 increases the diameter of theanastomosis device120 causing the first flange to fold outward from the device. This expanding of the first flange may be performed inside the vessel and then thedevice120 may be drawn back until the flange abuts an interior of thetarget vessel wall32.
• As shown in FIG. 18, after the first flange has been deployed, the[0065]expander tube156 is withdrawn forming the second flange. As theexpander tube156 is withdrawn, theanastomosis device120 drops into aradial groove157 on an exterior of the expander tube due to the elasticity of the device. Theradial groove157 holds theanastomosis device120 stationary on the expander tube. Theholder tube154 is then moved forward disengaging the anastomosisdevice pull tabs130 from theslots158 in the holder tube. Theshoulders134, shown most clearly in FIGS. 15 and 16, engage a tapered distal end of theholder tube154 causing thepull tabs130 to be released from theslots158. As theholder tube154 is moved further forward, the holder tube causes the second flange to be deployed. The edges of theradial groove157 are preferably beveled so that theanastomosis device120 will be able to be removed from theexpander tube156 after the anastomosis device is completely deployed.
• One alternative embodiment of the[0066]holder tube154 employs a plurality of flexible fingers which receive thepull tabs130 of theanastomosis device120. According to this embodiment eachpull tab130 is received by an independent finger of theholder tube154. To deploy the second or outer flange of theanastomosis device120, the flexible fingers flex outward bending thepull tabs130 outward.
• FIGS. 19-22 illustrate the operation of the[0067]handle160 to move thetrocar152, theholder tube154, and theexpander tube156 with respect to one another to deploy theanastomosis device120 according to the present invention. Thehandle160 includes agrip170 and atrigger172 pivotally mounted to the grip at apivot174. Thetrigger172 includes afinger loop176 and threecontoured cam slots178,180,182 corresponding to thetrocar152,holder tube154, andexpander tube156, respectively. Each of these tubes has a fitting184 at a distal end thereof. Apin186 connected to each of thefittings184 slides in a corresponding one of thecam slots178,180,182. A fourth cam slot and tube may be added to control deployment of the second flange.
• The[0068]handle160 is shown in FIG. 18 in an insertion position in which thetrocar152 extends beyond theholder tube154 and theexpander tube156 for puncturing of thetarget vessel wall32. As thetrigger172 is rotated from the position illustrated in FIG. 19 to the successive positions illustrated in FIGS. 20-22, thepins186 slide in thecam slots178,180,182 to move thetrocar152,holder tube154 andexpander tube156.
• FIG. 20 shows the[0069]handle160 with thetrigger172 rotated approximately 30 degrees from the position of FIG. 19. This rotation moves theholder tube154 andexpander tube156 forward into the wall of thetarget vessel32 spreading thetrocar152. Theanastomosis device120 is now in position for deployment. FIG. 21 shows thetrigger172 rotated approximately 45 degrees with respect to the position of FIG. 19 and thecam slot182 has caused theexpander tube156 to be advanced within theholder tube154 to deploy the first flange. Thetrocar152 has also been withdrawn.
• FIG. 22 shows the[0070]handle160 with thetrigger172 pivoted approximately 60 degrees with respect to the position shown in FIG. 19. As shown in FIG. 22, theexpander tube156 has been withdrawn to pull the first flange against thevessel wall32 and theholder tube154 is moved forward to deploy the second flange and disengage theholder tube154 from theanastomosis device120.
• The[0071]handle160 also includes afirst channel188 and asecond channel190 in thegrip170 through which the graft vessel (not shown) may be guided. Thegrip170 also includes acavity192 for protecting an opposite end of the graft vessel from the attachment end.
• FIG. 23-26 illustrate a further alternative embodiment of the anastomosis device according to the present invention. As shown in FIG. 23, an[0072]anastomosis device200 includes a plurality ofpull tabs202, adiamond linkage204, and a plurality ofneedles206. As shown in the detail of FIG. 23A, each of theneedles206 has atail portion208 which is bent radially inwardly as shown in FIG. 23 prior to use. In this embodiment, the graft vessel is inserted through the center of theanastomosis device200 and everted over theneedles206 as in the previous embodiments. Theneedles206 puncture the graft vessel and securely retain the graft vessel on the anastomosis device. To deploy thedevice200 of FIG. 23, anexpander210 is inserted axially into the device in a direction of the arrow C and engages thetail portions208 of theneedles206 to fold the needles radially outward. Theexpander210 is preferably larger in diameter than an original inner diameter of thedevice200 such that the device is expanded during deployment. This expansion will stretch the opening in thetarget vessel32 providing a better seal between the graft and target vessels. However, it should be understood that an outer diameter of theexpander210 according to this embodiment can be equal to or smaller than an inner diameter of thedevice200 and can bend theneedles206 outward without radially expanding the device.
• FIG. 24 illustrates the[0073]device200 of FIG. 23 in which the expander has been used to radially expand the device and bend theneedles206 outward. Thepull tabs202 are then folded downward to trap the wall of thetarget vessel32 between theneedles206 and the pull tabs.
• FIGS. 25 and 26 illustrate two modified versions of the embodiment of FIG. 23. The variations of FIGS. 24 and 25 each include[0074]pull tabs202,diamond linkages204, and needles206 havingtail portions208 bent inwardly. FIG. 25 and26 also illustratehorns212 which help to retain the graft vessel after eversion.
• A cantilevered end of each of the axial members may be either rounded as shown in FIGS. 12 and 13 or pointed as shown in FIGS. 1, 2,[0075]5 and6. The rounded cantilever ends prevent puncturing of the graft vessel while the pointed cantilever ends puncture through the vessel and prevent the vessel from slipping off of the anastomosis device. The puncturing of the vessel also relieves stresses on the vessel which are created when expanding the first flange. Although the pointed cantilever ends may provide more secure retention of the graft vessel, these pointed ends will provide undesirable metal within the bloodstream.
• FIG. 27 illustrates a modified version of the anastomosis device of FIG. 12 in which the[0076]anastomosis device120″ includes modifiedneedles206′ with saw tooth edges for grasping tissue of the graft vessel. This version of theanastomosis device120″ also includes backstop hinges124 and pulltabs130.
• FIGS. 28 and 29 illustrate an alternative embodiment of an[0077]anastomosis device220. Having the first flange formed from a plurality ofmembers222 which fold out tangentially from a body of the anastomosis device. Thedevice220 includespull tabs224, connected by adiamond linkage226 to themembers222. As thediamond linkage226 is expanded in the manner described above with respect to the earlier embodiments, themembers222 fold outward in a direction which is substantially tangential to a body of the expanding device as shown in FIG. 28. The tangentially foldedmembers222 form the inner flange of thedevice220. Thepull tabs224 are then folded downward to form the outer flange. According to this embodiment of the invention, a second flange may also be formed from a plurality of members which fold out tangentially from a body of the anastomosis device.
• Each of the anastomosis devices described above are preferably single piece devices which are formed by laser cutting or punching from a tube or sheet of material. The devices may be provided in varying sizes to join vessels of different sizes. The linkages, pull tabs, and other elements which have been discussed above with regard to the various embodiments may be used in varying numbers and arrangements.[0078]
• The invention has been described as an anastomosis device which is expanded with an expander. The expander may be a tube, a balloon, or any other known expanding device.[0079]
• Although the invention has been principally discussed with respect to coronary bypass surgery, the anastomosis devices of the present invention may be used in other types of anastomosis procedures. For example, the anastomosis device may be used in femoral-femoral bypass, vascular shunts, subclavian-carotid bypass, organ transplants, and the like.[0080]
• The anastomosis devices may be made of any known material which can be bent and will retain the bent shape such as stainless steel, nickel titanium alloys, and the like. The hinges or pivot joints which have been discussed above in the various embodiments of the present invention are designed to concentrate the bending at a desired location. For example, the hinges may be formed with a reduced thickness or width, or with openings in order to concentrate the bending in the hinges.[0081]
• The dimensions of the anastomosis device of the present invention are determined by the dimensions of the blood vessels to be joined. A distance between the two flanges is designed to accommodate the wall thickness of a target vessel which may vary. The anastomosis devices according to the present invention have been illustrated as cylindrical members. However, the devices may also be shaped into oval shapes, football shapes, or other shapes to accommodate smaller target vessels.[0082]
• While the invention has been described in detail with reference to the preferred embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed, without departing from the present invention.[0083]

Claims (22)

What is claimed is:

1. An anastomosis device, comprising:

a central region, comprising a plurality of struts; and

at least one projection connected to the distal end of said central region, wherein at least one said projection is foldable in at least the proximal direction.

2. The anastomosis device ofclaim 1, wherein at least one said projection includes at least one member extending at least partially along a perimeter of an open area.

3. The anastomosis device ofclaim 1, wherein at least one said projection is substantially trapezoidal.

4. The anastomosis device ofclaim 1, wherein at least one said projection is substantially diamond-shaped.

5. The anastomosis device ofclaim 1, wherein at least one said projection is substantially triangular.

6. The anastomosis device ofclaim 1, wherein said central region is radially expandable along at least part of its length.

7. The anastomosis device ofclaim 1, wherein at least one said projection is made of superelastic material.

8. The anastomosis device ofclaim 8, wherein said superelastic material is nickel-titanium alloy.

9. The anastomosis device ofclaim 1, wherein said struts extend substantially longitudinally.

10. The anastomosis device ofclaim 1, wherein said struts are spaced apart from one another.

11. An anastomosis device, comprising:

a central region; and

an inner flange connected to the distal end of said central region and deployable from a first position to an expanded position, wherein said inner flange includes at least one generally triangular inner flange element.

12. The anastomosis device ofclaim 11, wherein at least one said triangular inner flange element further comprises an axial member connected to and substantially bisecting said triangular inner flange element.

13. The anastomosis device ofclaim 11, wherein at least one said triangular inner flange element is substantially open.

14. The anastomosis device ofclaim 11, further comprising an outer flange connected to the proximal end of said central region and deployable to an expanded position, wherein said outer flange includes at least one outer flange element radially offset from said at least one generally triangular inner flange element.

15. The anastomosis device ofclaim 14, wherein at least one said outer flange element is generally triangular.

16. The anastomosis device ofclaim 11, wherein at least one said triangular outer flange element is substantially open.

17. The anastomosis device ofclaim 11, wherein said central region is radially expandable along at least part of its length.

18. The anastomosis device ofclaim 11, wherein said inner flange is made of superelastic material.

19. The anastomosis device ofclaim 18, wherein said superelastic material is nickel-titanium alloy.

20. An anastomosis device, comprising:

an inner flange and deployable from a first position to an expanded position, wherein said inner flange includes at least one generally triangular inner flange element; and

an outer flange proximal to said inner flange and deployable to an expanded position, wherein said outer flange includes at least one outer flange element.

21. The anastomosis device ofclaim 20, wherein at least one said outer flange element is radially offset from said at least one generally triangular inner flange element.

22. The anastomosis device ofclaim 20, wherein at least one said outer flange element is generally triangular.

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