Abstract:
A device for connecting two tubular vessels together in a side-by-side or tangential manner is disclosed. The device has an annulus and at least one series of fingers connected to and extending away from the annulus. In the preferred embodiment there are two sets of fingers connected to and extending away from the annulus in opposite directions. Each finger is preferably biased into an arcuate shape. In use, a deployment apparatus is used to constrain the fingers of the device to be in a relatively planar configuration. The deployment apparatus containing the device is placed between and in contact with the two tubular vessels so that one tubular vessel is above the device and one tubular vessel is below the device and so that the fingers of the device come into contact with the tissue of the vessels. As the fingers penetrate the vessels the constraint on the fingers is removed so that the fingers can assume their biased arcuate shape. In this way, the fingers penetrate and grasp the tissue of the vessels so that the device grasps the vessels and pulls the vessels toward each other.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of, and incorporates in by reference in its entirety, U.S. Provisional Application Ser. No. 60/613,434 filed Sep. 27, 2004. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates generally to methods and devices for surgically joining separate pieces of tissue to one another, and more particularly to surgically joining a tubular graft of tissue to a separate piece of tissue. 
     2. Related Art 
     In performing bypass surgery, it is a known practice to repair a clogged or an otherwise damaged segment of tubular tissue, for example a coronary artery, by attaching a healthy section of artery, for example, a mammary artery, to the tubular tissue below the clog or damaged segment so that blood flows from the healthy section of artery into the tubular tissue below the clogged or damaged segment. In addition, it is also known to bypass a clogged or damaged section of artery (e.g., a coronary artery) by forming a graft made of a section of vein harvested from elsewhere (e.g., a Saphenous vein harvested from the thigh) extending from the aorta to a section of the clogged or damaged artery beyond the clog or damage. The resulting graft is known as a Coronary Artery Bypass Graft (CABG—pronounced “cabbage”) and the procedure to form the graft is known as a CABG procedure. 
     While performing the procedures mentioned above, a surgeon ordinarily will perform a sternectomy, a procedure to open the patient&#39;s chest to provide access to the patients heart. Thereafter, the patient is typically put on a bypass system that performs the function of the patient&#39;s own heart and lungs as well as cools and warms the patient&#39;s blood. As the patient is put on the bypass system, the patient&#39;s heart is stopped or “arrested” so that the surgeon may perform the CABG procedure. 
     It is important that each end of the CABG graft is well attached to the aorta or coronary artery, respectively. This is necessary in order to provide a leak-proof anastomosis and also to allow the tissue to heal together into a strong, leak-proof connection. This connection is generally done by the surgeon making numerous stitches of suture (typically 6-8 on each end of the graft) between the vessel and the tissue that the graft is being joined to. In some cases, the surgeon must replace sutures that do not create a leak-proof anastomosis between the pieces of tissue. After the CABG procedure is complete, the patient is taken off the bypass system, the patient&#39;s heart allowed to restart and the patient&#39;s chest closed. 
     The entire procedure is ordinarily quite exhausting and requires a long time to complete the procedure, generally ranging between 2 to 6 hours or more. Statistically, 3-7% of patients that are put on a bypass system experience some form of neurological complications. The longer the patient is on the bypass system, the more likely he or she is to experience such complications. It typically takes a surgeon between 6-12 minutes to attach each end of the graft to the aorta and coronary artery, respectively. Much of the surgeon&#39;s time is spent making certain that the segments of tissue are joined together in a leak-proof anastomosis. Generally, this requires the surgeon to make numerous stitches of suture between the segments of tissue being joined to one another, and in some cases replacing sutures that do not create a leak-proof anastomosis between the pieces of tissue. 
     Though using sutures to join segments of tissue to one another in open heart surgery, or other forms of surgery, has proven successful, not only does it require a longer than desirable amount of time in surgery, there is also a danger of the suture becoming damaged. Damage to a portion of the suture may occur in many ways, such as through inadvertent grasping or clamping by a surgical instrument or through nicking a suture with the needle as an adjacent suture is installed. Ordinarily, a damaged piece of suture has a substantially reduced tensile strength and thus may ultimately fail to maintain the pieces of tissue joined to one another. 
     SUMMARY OF THE INVENTION 
     A device for connecting two tubular vessels together in a side-by-side or tangential manner is disclosed. The device has an annulus and at least one series of fingers connected to and extending away from the annulus. In the preferred embodiment there are two sets of fingers connected to and extending away from the annulus in opposite directions. Each finger is preferably biased into an arcuate shape. 
     In use, a deployment apparatus is used to constrain the fingers of the device to be in a relatively planar configuration. The deployment apparatus containing the device is placed between and in contact with the two tubular vessels so that one tubular vessel is above the device and one tubular vessel is below the device and so that the fingers of the device come into contact with the tissue of the vessels. As the fingers penetrate the vessels the constraint on the fingers is removed so that the fingers can assume their biased arcuate shape. In this way, the fingers penetrate and grasp the tissue of the vessels so that the device grasps the vessels and pulls the vessels toward each other. After the device is deployed in the tissue of the vessels so that the fingers enter into and grasp the tissue, a cutting surface cuts the tissue between the fingers thereby forming an opening from one vessel through the device to the other vessel. 
     An object, feature or advantage of this invention, in one or more embodiments of the invention, is to provide an apparatus and method of deployment that provides a secure and reliable side anastomosis between a tubular duct and a wall of a vessel. 
     Another object, feature or advantage of this invention, in one or more embodiments of the invention, is to provide an apparatus and method of deployment that establishes a quick biocompatible bond between mating tissues. 
     Another object, feature or advantage of this invention, in one or more embodiments of the invention, is to provide an apparatus and method of deployment that imparts a biasing force to maintain connected tissues in abutting contact with one another. 
     Another object, feature or advantage of this invention, in one or more embodiments of the invention, is to provide an apparatus and method of deployment that readily penetrates tissue without damaging the tissue. 
     Another object, feature or advantage of this invention, in one or more embodiments of the invention, is to provide an apparatus and method of deployment that provides a quick and reliable mechanism in which to attach separate tissues to one another. 
     Another object, feature or advantage of this invention, in one or more embodiments of the invention, is to provide an apparatus and method of deployment that is of relatively simple design and is economical in manufacture and assembly and is efficient in use. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other objects, features and advantages of this invention will become apparent from the following detailed description of the preferred embodiments and best mode, appended claims and accompanying drawings in which: 
         FIG. 1  is a broken away perspective view showing a fastener apparatus constructed according to one presently preferred embodiment of the invention attaching the tubular graft to the heart wall providing a blood flow path between the tubular graft and the artery underlying the heart wall; 
         FIG. 2  is a perspective view of the fastener apparatus of  FIG. 1  in a preformed state of construction; 
         FIG. 3  is a perspective view of the fastener apparatus of  FIG. 1  in first and a second configuration. 
         FIG. 4  is a cross-sectional view of the apparatus maintained between a pair of plates with a sharpening tool forming bevels on a first set of fingers of the apparatus; 
         FIG. 5  is a cross-sectional view of the apparatus maintained between another pair of plates with a sharpening tool forming bevels on a second set of fingers of the apparatus; 
         FIG. 6  is a plan view of an annulus of a fastener apparatus constructed according to another embodiment of the invention shown in a preformed state of construction; 
         FIG. 7  is a plan view of the annulus of  FIG. 6  in a heat set form and shown in an unbiased state; 
         FIG. 8  is a plan view of the annulus of  FIG. 6  in a closed or under-tension state; 
         FIG. 9  is an exploded perspective view of the annulus of  FIG. 7  with a plurality of fingers arranged to be received in a corresponding number of openings in the annulus; 
         FIGS. 10A-10G  are schematic side views of a deployment apparatus shown joining a tubular duct to a vessel; 
         FIG. 11  is a perspective view of a deployment apparatus with a tubular duct received thereon overlying another tubular duct within a vessel; 
         FIG. 12  is a perspective view of the deployment apparatus of  FIG. 11  showing the fastener apparatus loaded therein and a receptacle of the deployment apparatus with a cutter shown in retracted and extended positions; 
         FIG. 13  is a view similar to  FIG. 12  with the cutter removed and showing the fastener apparatus in an initially loaded position and a deployed position; 
         FIG. 14  is an enlarged perspective view of a portion of a heart showing a point of attachment of a tagging suture to a tubular duct within the heart; 
         FIG. 15  is a view similar to  FIG. 14  showing the tagging suture received through the deployment apparatus and attached to a tubular duct graft; 
         FIG. 16  is a view similar to  FIG. 15  showing the graft of  FIG. 15  received on the receptacle of the deployment apparatus; 
         FIG. 17  is a view similar to  FIG. 16  showing the deployment apparatus disposed in position to initiate attachment of the graft to the tubular duct underlying the heart wall; 
         FIG. 18  is a view similar to  FIG. 17  showing the fastener apparatus being deployed to form an anastomosis between the graft and the tubular duct underlying the heart wall; 
         FIG. 19  is a view similar to  FIG. 18  showing the cutter being moved from its extended position toward its retracted position to form and opening between the graft and the tubular duct within the heart; 
         FIG. 20  is a perspective view of the graft shown attached to the heart wall with an end of the graft sutured closed; 
         FIG. 21  is an enlarged partial cross-sectional view of the deployment apparatus overlying in a heart wall in abutting contact therewith with the fastener apparatus shown in its non-deployed configuration; 
         FIG. 22  is a view similar to  FIG. 21  with the fastener apparatus shown in a partially deployed configuration; 
         FIG. 23  is a view similar to  FIG. 22  with the fastener apparatus shown in a more advanced state of deployment; 
         FIG. 24  is a view similar to  FIG. 23  with fastener apparatus shown in a more advanced state of deployment; 
         FIG. 25  is a view similar to  FIG. 24  with fastener apparatus shown in a more advanced state of deployment; 
         FIG. 26  is a view similar to  FIG. 25  with the cutting mechanism shown in an initial cutting position; 
         FIG. 27  is a view similar to  FIG. 26  with the cutting mechanism shown in a final cutting position; 
         FIG. 28  is an enlarged cross-sectional view showing the fastener apparatus fully deployed to form an anastomosis between a side wall of the tubular duct and the heart wall to provide blood flow between the tubular graft and an artery underlying the heart wall; 
         FIG. 29  is a broken away perspective view showing a fastener apparatus constructed according to another presently preferred embodiment of the invention attaching a tubular duct to a heart wall providing a blood flow path between the tubular duct and an artery underlying the heart wall; 
         FIG. 30  is a perspective view of the fastener apparatus of  FIG. 29  in a preformed state of construction; 
         FIG. 31  is a perspective schematic view of the fastener apparatus of  FIG. 29  shown in a biased state and being received within a receptacle of an alternate embodiment of a deployment apparatus for disposal within the tubular duct; 
         FIG. 32  is an enlarged cross sectional view of the fastener apparatus received within the deployment apparatus of  FIG. 31   
         FIG. 33  is a schematic view of another embodiment of an annulus for a fastener apparatus according to another embodiment of the invention; 
         FIG. 34  is a schematic view of another embodiment of an annulus for a fastener apparatus according to another embodiment of the invention; 
         FIG. 35  is a bottom view of a fastener apparatus constructed according to another embodiment of the invention; 
         FIG. 36  is a partial top view of the fastener apparatus of  FIG. 35 ; and 
         FIG. 37  is a schematic perspective view of yet another embodiment of a fastener apparatus constructed according to another embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring to  FIG. 1 , an apparatus, referred to hereafter as a fastener  10 , is shown making a generally tangential anastomosis between two pieces of tissue, represented here as a wall  11  of a generally tubular duct  12 , for example and without limitation, a graft of an artery or vein, and a wall  14  of a vessel  16 , for example and without limitation, a wall forming a coronary artery. The anastomosis established by the fastener  10  provides a sutureless connection between a wall  11  of the tubular duct  12  and the wall  14  of a vessel  16 , thereby facilitating making a tangential connection between the duct  12  and the vessel  16 . Desirably, the fastener  10  biases the tubular duct  12  and the wall  14  of the vessel  16  toward one another, thereby establishing a leakproof attachment between the tubular duct  12  and the vessel  16 . Additionally, the continual bias imparted by the fastener  10  between the tubular duct  12  and the wall  14  of the vessel  16  facilitates the formation of a biological bond between the tubular duct  12  and the vessel  16  as the patent heals after the CABG procedure. 
     Referring to  FIGS. 1-3 , the fastener  10  has an annulus  18  with a perpendicular axis  20  and a longitudinal axis  22 . The annulus  18  has a flange  19  with a first set of fingers  24  and a second set of fingers  26 . Fingers  24 ,  26  extend away from the annulus  18 . In the preformed state of construction shown in  FIG. 2 , the fingers  24 ,  26  extend radially inward from the annulus  18 . However, as shown in the 1 st  configuration of  FIG. 3 , fingers  24 ,  26  are biased to extend away from annulus  18  generally in opposite directions from the annulus  18  and in a relatively planar fashion, prior to the fingers  24 ,  26  taking on a generally arcuate, curved, or hook shaped configuration. Further, as shown in the 2 nd  configuration of  FIG. 3 , the first set of fingers  24  are biased to extend generally axially from the annulus  18  in one direction to a 180 degree bend extending generally radially outwardly from the perpendicular axis  20 , thereafter, leading to free ends  28 . In addition, as shown in the 2 nd  configuration of  FIG. 3 , the second set of fingers  26  are biased to extend generally axially from the annulus  18  in another direction generally opposite the direction of the first set of fingers  24  to a 180 degree bend extending generally radially outwardly from the perpendicular axis  20 , thereafter, leading to free ends  30 . 
     In a relaxed condition shown in the 2 nd  configuration of  FIG. 3 , the annulus  18  generally remains generally oval in form, while also in a relaxed condition, the bends in the respective sets of fingers  24 ,  26 , define the generally arcuate, or curved portions of the fastener  10  that define a generally C-shaped fastener in axial cross-section. It should be recognized that the fingers  24 ,  26 , and annulus  18  may be formed having different geometries than described above, for example, instead of the fingers  24 ,  26  having a continuous arcuate shape in their relaxed configuration, fingers  24 ,  26  may have a plurality of stepped linear sections defining the generally hook shaped configuration. 
     The first set of fingers  24  are moveable or bendable between a first, extended or biased, generally linear or at least partially flattened configuration ( FIG. 21 ) and a second, retracted or unbiased, at least partially arcuate, hook shaped, curled or otherwise nonlinear configuration ( FIGS. 1 and 28 ) extending at least in part generally radially outwardly from the perpendicular axis  20  to penetrate the tissue, in use. The second set of fingers  26  are moveable or bendable between a first, extended or biased, generally linear or at least partially flattened configuration and a second, retracted or unbiased, at least partially arcuate, hook shaped, curled or otherwise nonlinear configuration ( FIGS. 1 and 28 ) extending at least in part generally radially outwardly from the perpendicular axis  20  to penetrate the tissue, in use. 
     The first set of fingers  24  have an inner surface  32  and an outer surface  34  ( FIG. 28 ) terminating at the free ends  28  that preferably define a point to facilitating piercing the tubular duct  12  and vessel  16 , for example. As best shown in  FIG. 21 , when the first set of fingers  24  are in their biased and generally flattened configuration (as will be explained hereafter), the inner surfaces  32  face generally away from one another along the perpendicular axis  20  and the outer surfaces  34  face generally toward one another along the perpendicular axis  20 . Desirably, the first set of fingers  24  each have a bevel  36 , such that when in their biased configuration, the bevels  36  extend from each free end  32  generally toward the inner surfaces  32  and the perpendicular axis  20 . The bevels  36  help to form a sharpened end  32  to allow the end  32  to more easily penetrate the tissue of a vessel. 
     The second set of fingers  26  have an inner surface  38  and an outer surface  40  terminating at the free ends  30  that preferably define a point to facilitating piercing the tubular duct  12  and vessel  16 , for example. When the second set of fingers  26  are in their biased configuration as shown in  FIG. 21 , he inner surfaces  38  face generally away from each other along the perpendicular axis  20  and the outer surfaces  40  face generally toward each other along the perpendicular axis  20  and the inner surfaces  38  face generally away from the perpendicular axis  20 . Desirably, the second set of fingers  26  each have a bevel  42  extending from each free end  30  generally toward the inner surfaces  38  and the perpendicular axis  20 . The bevels  42  help to form a sharpened end  30  to allow the end  30  to more easily penetrate the tissue of a vessel. 
     The first and second sets of fingers  24 ,  26  are generally constructed in a symmetrical relation to each other such that they are axially aligned with one another about the circumference of the annulus  18 , though they could be staggered relative to one another, if desired in the intended application. The fingers  24 ,  26  are constructed of a resiliently springy material having a shape memory so that they automatically return toward their unbiased, generally arcuate or hook shaped configuration when the force displacing or extending the fingers  24 ,  26  to their biased position (as for example as shown in  FIG. 21 ) is removed. Desirably, shape memory alloys are used in constructing the fastener  10 , thereby giving the first and second sets of fingers  24 ,  26  their resiliently springy properties. Some exemplary materials include, without limitation, nitinol, MP35N, tantalum, tungsten, platinum, 304 stainless steel, and other stainless steels, as desired for the intended application. While those materials listed are generally consider the preferred materials for the fingers  24 ,  26 , any material that has a shape memory and that is biocompatible may be used including, without limitation, plastics and ceramics. 
     The fastener  10  is desirably fabricated from a thin, flat sheet of material, for example, from one of the materials listed above or having the functional characteristics mentioned above. The thickness of the material used to construct the fastener  10  depends greatly on the physical properties of the material including the elasticity of the material. As shown in  FIG. 2 , in fastener  10 &#39;s initial construction, the first and second sets of finger  24 ,  26  extend radially inwardly from an annulus  18 . Thereafter, fingers  24 ,  26  are heat formed into their final shape (i.e., the shape having the bias to form the arcuate “C” shape configuration described above), as is discussed hereafter in more detail. 
     Desirably, when the fingers  24 ,  26  are in their biased, first positions, the material chosen remains in an elastic state of deformation, thereby biasing the fingers  24 ,  26  to return to their second, relaxed positions. Using 304 stainless steel, one of the materials listed above, a thickness of about 0.0001″-0.0150″ is generally preferred, though it should be understood that the thickness may vary according to the material used as will be well understood in the art. 
     As best shown in  FIG. 2 , the first step in the construction of the fastener  10  is to produce a generally flat annular pattern (generally referred to by the reference number  10 ) from a sheet of material, wherein the pattern has the first and second sets of fingers  24 ,  26  extending radially inwardly toward one another. Desirably, the pattern has diametrically opposite loops  21  extending radially outwardly from the annulus  18 . The loops  21  act at least in part as spring joints to facilitate returning the apparatus  10  to its unbiased form upon deployment of the fastener  10  as will be described hereafter. The method of manufacture of the fastener  10  may incorporate a variety of construction methods, for example and without limitation, photo-chemical etching, laser cutting, die punching, electric discharge machining (EDM), and other methods of construction, as desired and as well understood by those skilled in the art. It should be understood that the first and second sets of fingers  24 ,  26  may be constructed having different lengths from one another. 
     To facilitate bonding between tissue and the fastener  10  as part of the healing process after the fastener  10  is placed, both sides of the flat annual pattern, particularly the inner surfaces  32 ,  38  and the outer surfaces  34 ,  40  are preferably provided with a surface texture or roughed generally having a surface finish of about 30-60 RMS using a process such as chemical etching, or mead-blasting, for example. By creating a roughed surface, the tissue is better able to bond to the fastener  10 . Alternately, the fastener  10  may be coated either at the first stage of construction or later with a material to facilitate or strengthen tissue growth or minimize infections or a combination of these. 
     As shown in  FIG. 4 , desirably, while the fastener  10  is in its initially constructed flat configuration, the bevels  36  are formed on the first set of fingers  24 . While forming the bevels  36  on the first set of fingers  24 , the flat annual pattern is placed between a pair of generally flat dies or plates  44 ,  46 . Each plate  44 ,  46  has a through hole  48 ,  50 , respectively, sized to allow the first set of fingers  24  to extend radially inwardly into the through holes  48 ,  50  upon concentrically aligning the through holes  48 ,  50  and the first set of fingers  24  with one another along the axis  20 . The plate  44  has a counter bore  52  to allow the first set of fingers  24  to deflect during the formation of the bevels  36 . 
     In forming the bevels  36  on the first set of fingers  24 , the fastener  10  is maintained between the plates  44 ,  46  so that a sharpening tool, for example and without limitation, a honing rod  54 , can be passed in one direction, represented by arrow A, through the through holes  48 ,  50  of the plates  44 ,  46  to engage the free ends  28  of the first set of fingers  24 . Accordingly, as the honing rod  54  engages the first set of fingers  24 , the fingers deflect generally in the direction of arrow A, into the counter bore  52 . As such, material is removed from the first set of fingers  24  to form the bevels  36 . It should be recognized that the honing rod  54 , in addition to being passed axially through the through holes  48 ,  50  of the plates  44 ,  46 , can be rotated about the axis  20  in the direction of arrows B to facilitate forming a uniform bevel  36  on each of the first set of fingers  24 . 
     As shown in  FIG. 5 , desirably, while the fastener  10  is in its initially constructed flat configuration, the bevels  42  are formed on the second set of fingers  26 . While forming the bevels  42  on the second set of fingers  26 , the flat annual pattern is placed between a pair of generally flat dies or plates  56 ,  58 . Each plate  56 ,  58  has an outer diameter  60 ,  62 , respectively, sized to allow the second set of fingers  26  to extend radially outwardly therefrom upon concentrically aligning the outer diameters  60 ,  62  and the second set of fingers  26  with one another along the axis  20 , with the fastener  10  maintained between the plates  56 ,  58 . The plate  56  has a recessed surface  64  to allow the second set of fingers  26  to deflect during the formation of the bevels  42 . 
     In forming the bevels  42  on the second set of fingers  26 , the fastener  10  is maintained between the plates  56 ,  58  so that a sharpening tool, for example and without limitation, a honing cylinder  66 , can be passed in one direction, represented by arrows C, generally in the same direction as arrow A in which the honing rod  54  is passed, to engage the free ends  30  of the second set of fingers  26 . The honing cylinder  66  has a bore  68  greater in diameter than the outer diameters  60 ,  62  of the plates  56 ,  58  and less than the outer diameter of the second set of fingers  26 . Accordingly, as the honing cylinder  66  passes over the second set of fingers  26 , the bore  68  engages the free ends  30  of the second set of fingers  26  to deflect the fingers  26  generally in the direction of arrow C, toward the recessed surface  64 . As such, material is removed from the second set of fingers  26  and the bevels  42  are formed. 
     The flat annular pattern, as shown in  FIG. 2 , is then elastically deformed to provide the finished, unbiased shaped of the fastener  10 , as best shown in  FIGS. 1 and 3  by preferably bending or deforming alternate fingers upwardly and downwardly, respectively, to form the first and second sets of fingers  24 ,  26 , and to form the radially outwardly extending flange  19 . The deformed pattern is maintained in the desired finish shape by subjecting the elastically deformed pattern to a controlled heat treatment process. During the heat treatment process, the deformed pattern is raised to the critical temperature of the material, for example, about 932° F. for nitinol, between about 800-1200° F. for MP35N, and is then quenched, preferably in water, to retain the pattern in conformity with the outer surfaces of the dies. Upon finishing the heat treatment process, the first set of fingers  24  are shaped to their unbiased, generally arcuate configuration extending at least partially generally radially outwardly from the perpendicular axis  20 , while the second set of fingers  26  are shaped to their unbiased, generally arcuate configuration extending at least partially generally radially outwardly from the perpendicular axis  20 . 
     Alternatively, as shown in  FIGS. 6-8 , the fastener  10  may be fabricated from separate pieces of selected material, such as from the aforementioned materials, wherein the annulus  18  is fabricated separately from the fingers  24 ,  26 . A plurality of through openings  70  are formed about the circumference of the annulus  18  at predetermined and preferably equally spaced locations from one another. Through openings  70  may be formed by any means well known in the art including, but not limited to, micro-drilling, etching or laser-drilling. 
     The annulus  18  is then preferably heat formed to its intended finish shape ( FIG. 7 ), whereupon the one piece fingers  24 ,  26  are inserted into the through openings  70  a predetermined distance, and preferably to their midpoint. The fingers  24 ,  26  are preferably fixed in the openings by way of a weld joint such as is well understood by those skilled in the art. 
     Upon forming the fastener  10  to its finished configuration, the fastener  10  is preferably subjected to a passivating process to remove any impurities from the surfaces of the fastener  10 . The passivation may be achieved by electropolishing, chemical passivation, or a hybrid technique known as selective abstraction passivation. The electropolishing passivation process utilizes a reducing acid environment in conjunction with a source of DC power. The electropolishing process removes impurities from the surfaces of the fastener  10  to a depth of about 20-30 angstroms, depending on the exposure time of the fastener  10  to the reducing acid environment and DC power. The chemical passivation process can be performed in a variety of manners, for example, pickling, wherein the fastener  10  is immersed in a solution of hydrofluoric acid (HF) and nitric acid (HNO3) for a period of time; chelant passivation (citric acid), and selective abstraction, wherein a specifically formulated abstraction chemistry is used in conjunction with electrolysis. The selective abstraction technique removes only the readily soluble passive film contaminants such as iron, nickel, aluminum (grinding residue), and the like. Upon passivating the surfaces of the fastener material, desirably the fastener  10  is cleaned utilizing a plasma cleaning process. 
     The plasma cleaning process removes all foreign materials remaining on the surfaces of the fastener material. Some of the plasma cleaning mechanisms that may be used includes, for example, induction coupled barrel reactors and capacitance coupled parallel plate reactors. 
     Upon cleaning the surfaces of the fastener  10 , preferably the surfaces are at least partially coated with a bio-adhesive material to facilitate forming a cohesive bond between the fastener  10 , the tubular duct  12  and the vessel  16 . The bio-adhesive materials may include by-products of the patient&#39;s own blood, for example, platelet gel formed from the patient&#39;s blood. Otherwise, biocompatible adhesives including calcium, for example and without limitation, may be used. These same bio-adhesives may also be introduced while attaching the fastener  10  to the tubular duct  12  and the vessel  16 , as discussed in more detail hereafter. As shown generally in  FIGS. 10A-10G , upon coating the fastener  10  with the bio-adhesive, the fastener  10  is generally ready for deployment by an apparatus, referred to hereafter as a deployment tool  72 . 
     As shown in  FIG. 10 , the deployment tool  72  has a main body  74  with a luminary guide, hereafter referred to as a guide member  76 , received on the main body  74  for slidable relative movement therealong between a retracted loading position ( FIG. 10A ) and an extended deploying position ( FIG. 10G ). As shown in  FIGS. 11-13 , to facilitate the slidable movement of the guide member  76 , the body  74  preferably has a lateral slot  78  within one and preferably opposite sidewalls  80  of the body  74  for receipt of guide fingers  82  depending from the guide member  76 . The body  74  has upper and lower walls  84 ,  86  with inclined surfaces  88  preferably having concave surfaces converging toward each other adjacent an end  90  of the body  74 . A longitudinal channel  92  extends through the upper and lower walls  84 ,  86  from the end  90  of the body  74  toward a handle  94  of the body  74 . The channel  92  has sidewalls that define a fastener cavity  96  sized to receive and maintain the fastener  10  in its biased and generally flattened position between the sidewalls by engaging the fingers  24 ,  26  of the fastener  10  until a user is ready to deploy the fastener  10  into the selected tissues, as shown in part in  FIG. 12 . It should be understood that though  FIG. 12  shows the fingers  24 ,  26  still in their biased position for demonstration of the slidable movement of the fastener apparatus  10 , they actually would take on their nonbiased curved configuration in use. A pair of recesses  98  ( FIGS. 21-24 ) extend laterally outwardly from the channel  92 , wherein the recesses  98  are sized to receive the annulus  18  of the fastener  10  to facilitate guided slidable movement of the fastener  10  through the channel  92 . The channel  92  is also sized to allow a portion of the guide member  76  to slide therethrough as the main body  74  of the deployment apparatus  72  is moved axially relative to the guide member  76 . 
     As shown in  FIG. 12 , the guide member  76  has an axially extending receptacle  100  sized to receive the tubular duct  12  thereon. The receptacle  100  has a pair of bodies  101 ,  102  spaced laterally from one another to define a cutter channel  104 . Each body  101 ,  102  preferably has upwardly extending flanges  106  with cutter slots  108  extending axially along each flange  106 . The slots  108  carry a cutter  110  via tabs  112  extending laterally outwardly from the cutter  110  for slidable movement within the slots  108 . Preferably, each body  101 ,  102  has a lower concave surface  114  flaring from a bottom of the bodies  101 ,  102  laterally outwardly from one another to provide partially guided support for the fastener apparatus  10  as it is being deployed. 
     The function of cutter  110 , as will be explained in detail hereafter, is to cut tissue. Specifically, the function of cutter  110  is to cut the tissue of the wall  11  of the tubular duct  12  and the wall  14  of a vessel  16  after the fastener  10  is deployed in the tissue of the tubular duct  12  and vessel  16  as shown in  FIG. 25 . Consequently, cutter  110  must have a sharp edge that may cut the tissue of the tubular duct  12  and vessel  16 . In one embodiment of the fastener  10 , the cutter  110  may take the form of a small surgical blade. In another embodiment of the fastener  10  the cutter  110  may take the form of a sharpened surgical wire. Other forms for cutter  110  will occur to those skilled in the art that meet the functional requirements of cutter  110  as explained herein. 
     The guide member  76  has a housing  116  sized for reciprocating movement of an actuator rod  118 . The rod  118  has one end  119  preferably having a notch  120  arranged for attachment to the cutter  110  via a pin  122  to provide pivotal movement of the cutter  110  relative to the rod  118 , and another end arranged for operable attachment to an actuator trigger mechanism. Accordingly, when the trigger mechanism is actuated, such as by being moved from a first retracted position to a second depressed position, the actuator rod  118  slides within the housing  116  toward the trigger, thereby causing the blade  110  to pivot to a cutting position. In addition, to the pivotal movement of the cutter  110 , the cutter  110  is caused to slide within the cutter channel  104  from a free end of the receptacle  100  toward the handle or trigger during a cutting procedure by pulling on the trigger. As such, the cutter  110  moves from an extended initial position to a retracted final position upon making an incision. 
     In deployment, as shown in  FIG. 14 , the surgeon can facilitate locating the fastener apparatus by tagging a point (P) of attachment on the vessel  16  with a suture  124 . As shown in  FIG. 15 , at least one of the ends and shown here as both ends of the suture  124  are fed through at least one of the loops  21  in the fastener apparatus  10  and through the axial channel  92  in the main body  74  of the deployment apparatus  72 . The suture ends are then preferably stitched through the tubular graft  12  adjacent its end. 
     As shown in  FIG. 16 , the graft  12  is then disposed on the receptacle  100  with the suture  124  being received in part between an end of the graft  12  and the deployment apparatus  72 . As shown in  FIGS. 17 and 21 , the deployment apparatus  72 , with graft thereon, is positioned on the vessel  16 , as facilitated by the guided assistance provided by the tagged suture  124 . Thereafter, the fastener apparatus  10  is deployed by preferably pulling the main body  74  to move the guide member  76  to its extended deployed position, as shown in  FIGS. 18 and 22-25 . It should be understood that though  FIG. 18  shows the fingers  24 ,  26  still in their biased position for demonstration of the slidable movement of the fastener apparatus  10 , they generally would take on their nonbiased curved configuration in use to attach themselves to the graft  12  and the underlying tissue vessel  16 . 
     In  FIGS. 22-25 , the fingers  24 ,  26  of the fastener apparatus  10  are shown in progressive states of movement as they take on their unbiased form and are deployed into the tissues being joined. The fingers  24 ,  26  begin to take their unbiased shape upon clearing the confines of the main body  74  of the deployment apparatus  72  as the main body  74  is pulled, and as the receptacle  100  and the graft  12  are slid downwardly along the upper wall  84  of the main body  74  ( FIG. 22 ). At the same time, the underlying tissue vessel  16  slides along the lower wall  86 , thus allowing the lower fingers  26  to penetrate the underlying tissue vessel  16  at the same time and rate as the upper fingers  24  penetrate the graft  12 . In  FIG. 23 , the fingers  24 ,  26  are shown in a partially curled state where they begin to turn back generally toward one another, thereby preferably imparting a bias to pull the graft  12  and the underlying tissue vessel  16  toward one another. 
     As shown in  FIGS. 19 and 26 , the cutter  110  is then pivoted to its cutting position about the pin  122  by depressing the lever or trigger, thereby moving a cutting tip of the cutter  110  into a cutting position. The cutter  110  is then actuated by pulling the actuator rod  118 , thereby causing the cutter  110  to traverse along the receptacle  76  via guided movement facilitated by the cutter slots  108  in the flanges  106  to form an incision through the graft  12  and the underlying tissue vessel  16 , with the cutter  110  extending between the opposite sides of the annulus  18  and through the cutter channel  92  in the main body  74 . Upon completion of the incision, as shown in  FIGS. 27 and 28 , the fastener apparatus  10  is generally free to assume its unbiased state, thereby establishing an opening  126  between the joined graft  12  and underlying tissue vessel  16  to provide blood flow through the opening  126 . As shown in  FIG. 20 , the end of the graft  12  is then closed off, such as by a purse string suture  126 , for example. 
     In  FIG. 29 , another fastener apparatus  210  constructed according to another preferred embodiment of the invention is shown making a generally tangential anastomosis between a generally tubular duct  12  and a wall  14  of a vessel  16 . The fastener apparatus  210  has an annulus  218  constructed generally the same as the annulus  18  in the first embodiment, with a first set of fingers  224  extending axially in one direction from the annulus  218 . The fingers  224  are constructed generally the same as the first or second sets of fingers  24 ,  26  in the first embodiment, and thus are not described in further detail. As shown in  FIG. 30 , the fastener apparatus  210  has a generally similar preformed configuration as the fastener apparatus  10  in the previous embodiment, however all of the fingers  224  are formed in the same axial direction, rather than alternating axial directions as in the previous embodiment. The apparatus  210  is shown in  FIG. 30  having eyelets  211  extending laterally from a pair of loops  221  to facilitate threading a tagging suture  124 , otherwise, the construction of the fastener apparatus  210  is the same, and is not discussed further. 
     In deployment, as shown generally in  FIG. 31 , a deployment apparatus  272  has a receptacle  273  sized for receipt within a selected tubular duct or graft  12 . With the fastener apparatus  210  disposed in the receptacle  273  ( FIG. 32 ), the fingers  224  are biased toward a flattened state ( FIG. 31 ), as in the previous embodiment. Upon inserting the tubular duct  12  over the receptacle  273 , and positioning the tubular duct  12  in the intended location of attachment relative to the tissue vessel  16 , the fastener apparatus  210  is deployed generally similarly as in the previous embodiment, however, the annulus  218  is received internally to the graft  12 , while the fingers  224  penetrate through a wall  215  of the graft  12  and into the adjoining tissue vessel  16 . As such, the annulus  218  itself acts to partially bias the graft  12  into abutting contact with the underlying tissue vessel  16  by engaging an internal surface  217  of the graft wall  215 . It should be recognized that the tagging suture  124  may also be used to facilitate attachment of the fastener apparatus  210 , as in the previous embodiment. Because the annulus  218  itself acts to partially bias the graft  12  into abutting contact with the underlying tissue vessel  16 , it may be desirable to may annulus  218  wider than annulus  18  so that there is more surface area on annulus  218  in contact with the tissue vessel  16 . In this way, there is less of a chance that the annulus  218  will cut into the tissue of the tissue vessel  16 . 
     As shown in  FIG. 33 , another embodiment of a fastener apparatus  310  has a discontinuous annulus  318 . One end  312  of the annulus  318  has a generally hook shaped end, while another end  314  has a generally looped end sized for receipt of the hooked end  312 . Otherwise, one or two sets of fingers (not shown) may extend axially from the annulus  318 , as in the previous embodiments. 
     As shown in  FIG. 34 , another embodiment of a fastener apparatus  410  generally similar to the previous embodiment is shown, however, the apparatus  410  has a continuous loop of material forming an annulus  418 . Opposite ends  412 ,  414  of the annulus  418  are preferably twisted to form loops  416  to facilitate guided attachment of the apparatus  410  by a tagging suture  124 , as described above. 
     As shown in  FIGS. 35 and 36 , another presently preferred embodiment of a fastener apparatus  510  has an annulus  518  constructed from a pair of resilient springy wires  512 ,  514 . Each wire  512 ,  514  has ends with one of a loop formation  516  and a hook formation  517 , wherein the loops and hooks are arranged for attachment to an adjoining hook or loop on the opposite wire. It should be recognized that the annulus  518  may have one or two sets of fingers  24 ,  26 , as described above, depending on the nature of the tissue connection. 
     As shown in  FIG. 37 , another presently preferred embodiment of the invention has an annulus  618  similar to the previous embodiment with first and second sets of fingers  624 ,  626  constructed from coiled spring wire. The first and second fingers  624 ,  626  are laterally spaced from one another by a coiled section  612  that defines a through opening  614  preferably sized for a tight fit about the annulus  618 . The coiled section  612  may be defined by a plurality of coils to space the fingers  624 ,  626  laterally from one another, or the coil can be formed by a single coil, thereby locating the first and second fingers  624 ,  626  adjacent one another. As such, the number of first and second fingers  624 ,  626  may be altered or tailored for the specific type of anastomosis being formed. It should be recognized that the gage or diameter of spring wire may be altered, as desired. Otherwise, it should be recognized that the first and second fingers  624 ,  626  can be generally constructed the same as described above. 
     It is to be understood that the embodiments discussed above are exemplary embodiments of the presently preferred constructions, and thus are intended to be illustrative and not limiting. The scope of the invention is defined by the following claims.