Abstract:
In accordance with the present invention there is provided a needle and suture assembly for attaching one piece of tissue to another piece of tissue. The assembly includes a helical needle having proximal and distal ends, a strain relief element having a greater flexibility than a flexibility of the needle attached to the proximal end of the needle, and a suture attached to the strain relief element.

Description:
FIELD OF THE INVENTION 
     The present invention relates, in general, to devices and methods that facilitate the anastomosis of hollow organs of the body. More particularly, it relates to vascular anastomosis devices incorporating sutures for joining a graft blood vessel to a target blood vessel such as the aorta or coronary artery. 
     BACKGROUND OF THE INVENTION 
     Surgically forming a passage between lumens of two normally distinct organs is a critical part of many surgical procedures. In a coronary artery bypass graft (CABG) procedure, the surgeon uses a graft vessel harvested from the patient to connect a blood supply vessel such as the aorta to the diseased coronary artery on the heart. An anastomosis is made on both the distal and proximal ends of the graft vessel. Surgeons typically use the saphenous vein of the leg or the radial artery of the arm or both, in multiple bypass cases. In an alternative procedure, the internal mammary artery (IMA) is used as a graft vessel. In this procedure the IMA is temporarily clamped, severed at a location allowing enough length to be redirected towards the heart, dissected from the chest wall and arterial side branches, and then the distal end (pedicle) is sutured to the left anterior descending coronary artery (LAD) to improve or restore blood flow to the left ventricle of the heart. 
     For the grafting procedures mentioned above, the surgeon performs an end-to-side type of vascular anastomosis. That is, the surgeon attaches the open end of the graft vessel to the side of the target vessel. However, surgeons also perform other types of anastomoses. Surgeons commonly use an end-to-end type of anastomosis for joining together larger hollow organs such as bowel, and for some heart bypass procedures where the arterial flow is completely occluded by the stenosis in the diseased artery. 
     Some surgeons choose to complete al the proximal anastomoses to the aorta before commencing the distal anastomoses to the coronary arteries. In contrast, others choose to complete the distal anastomoses first. Regardless of the order, when undertaking a distal anastomosis to the coronary artery, it is important to atraumatically hold the vessel graft steady and adjacent the coronary artery, with a minimum of visual and surgical obstruction by instruments in the narrow operative field. 
     Currently surgeons perform each vascular anastomosis by hand suturing with a tiny, curved needle and very fine suture filament. Such a suturing method, however, is very time consuming and requires several minutes per anastomosis, even for an experienced surgeon. In some cases the blood flow in the newly joined vessels may be poor, and the surgeon must remove the stitches and repeat the suturing procedure. In surgical procedures involving multiple bypass grafts, the total time required for suturing is very substantial, putting the patient at risk and increasing the cost of the surgical procedure. 
     In a preferred type of suturing method for the anastomosis of blood vessels, the surgeon passes a needle through the wall of the first vessel (such as the coronary artery) from the inside to the outside, and then passes it from the outside to the inside of the second vessel (such as the graft vessel), so that when the suture is drawn tight, the inside walls of the vessels come together, intima-to-intima. This is to ensure that the vessels heal together properly with a smooth layer of endothelial cells formed on the inside of the anastomosis. The surgeon typically places a single stitch in this manner at each of the heel and toe locations of the anastomosis, and then makes a running stitch on each half of the anastomosis between the heel and toe. 
     For the standard CABG procedure, the surgeon accesses the heart through a median sternotomy in which the rib cage is split longitudinally on the midline of the chest, and the left and right rib cages are spread apart. In recent years, surgeons have been using other means of access to the heart to reduce the size of the surgical wound created. In a surgical procedure known as a MIDCAB (Minimally Invasive Direct Coronary Artery Bypass), the surgeon accesses the heart by using a small, left thoracotomy (incision between the ribs on the left chest) directly above the heart. In this procedure, the surgical opening and visibility of the heart are significantly reduced, and hand suturing is more difficult than when using a median sternotomy. Other new developments in the surgical procedures have made conventional suturing even more difficult. For example, some surgeons now perform bypass surgery on beating hearts to avoid the complications associated with using a heart lung bypass machine. 
     The literature contains disclosures of a number of devices for augmentation of the suturing techniques. These devices attempt with varying degrees of success to reduce the difficulty in repeatedly passing a needle and thread through the vascular walls. Examples include the following: U.S. Pat. No. 5,571,090 issued to Sherts on Nov. 5, 1996; U.S. Pat. No. 4,803,984 issued to Narayanan on Feb. 14, 1989; and U.S. Pat. No. 5,545,148 issued to Wurster on Aug. 13, 1996. However, these devices have a number of disadvantages. In Sherts and Narayanan, the individual stitches must be made one at a time and therefore the procedure is still tedious and time consuming. The working ends of the Wurster and Sherts devices appear to obstruct the view of the needle tip so precise placement of the stitch might be difficult in some situations. 
     When suturing tiny blood vessels together, the surgeon must minimize manipulation of the graft and the target vessels to prevent damaging them. This ensures that the vessels heal together properly and a smooth passage between them is created. Usually in a conventional bypass procedure the surgeon applies a surgical clamp upstream (proximal) to the anastomotic location on the coronary artery to stop blood flow there. Applying surgical clamps may injure the artery and compromise the long term viability of the vessel to maintain blood flow. Applying surgical clamps may also dislodge plaque adhered on the intima of the lumen of the diseased vessel, creating emboli that could migrate into the systemic circulation and seriously injure or kill the patient. 
     An example of a device which simplifies the anastomosis procedure for the physician is shown in U.S. Pat. No. 6,015,416 issued to Stefanchik et al on Jan. 18, 2000 (hereinafter Stefanchik), which is hereby incorporated herein by reference. Stefanchik discloses a handheld, surgical device that addresses the aforementioned considerations. The device in Stefanchik facilitates a sutured anastomosis of very small hollow organs such as blood vessels while maintaining blood flow in the vessels. The device in Stefanchik comprises a first member having a first prong for entering a first vessel and a second prong for entering the wall of a second vessel. The device further comprises a second member having a plow for incising at least one of the vessels so as to create a passageway between the vessels. A frame is provided for coupling the first member and the second member together in operational engagement. The second member further includes a plurality of needle paths on either side of the plow for guiding a pair of helical needles with attached sutures through the walls of the vessels on either side of the passageway. The device also includes a means for driving the helical needles so as to attach the vessels together. The device in Stefanchik requires minimal manipulation of the blood vessels and joins the vessels together intima-to-intima. The device in Stefanchik may be used during traditional, open cardiac procedures (CABG) as well as in minimally invasive procedures such as MIDCAB procedures. 
     A shortcoming of the device in Stefanchik is the conventional type of attachment between the suture filament and the helical needle. The suture filament used is a size 7-0 propylene monofilament, and is swaged directly to the stainless steel needle without any kind of strain relieving interface. As each helical needle rotates through the vessel walls, the suture filament twists and pulls at the needle attachment and risk of suture filament breakage is significant. What is needed is a stress relieving interface at the needle-suture attachment. 
     Although stress relieving interfaces are widely used in the electronics industry for attachment of connectors to wires or cords, the novel application of stress relieving interfaces to surgical needle-suture attachments has not been available prior to the present invention. Several references are available describing inventions for controlled suture release so that the needles may be pulled off the suture by applying forces in relatively uniform and consistent ranges. Examples of controlled release sutures are the following: U.S. Pat. No. 4,124,027 issued to Boss on Nov. 7, 1978; U.S. Pat. No. 5,089,010 issued to Korthoff on Feb. 18, 1992; and U.S. Pat. No. 5,403,345 issued to Spingler on Apr. 4, 1995. However, these inventions and the others cited in the references are designed specifically for lowering the force required to separate the needle from the suture. There are no references that describe devices or methods for preventing suture breakage at the suture-needle attachment when the suture is highly stressed due to twisting and pulling at the needle attachment. 
     A second shortcoming of the device disclosed in Stefanchik is poor visibility of one of the two hollow organs being joined together. Stefanchik describes placement of a first prong for entering a wall of a first hollow organ (for example, a graft vessel) and a second prong for entering the wall of a second hollow organ (for example, a coronary vessel on the heart). The second prong is attached to an implement, which obstructs the view of the second hollow organ while the second prong is placed into the wall of the second hollow organ. What is needed is a means for retracting the implement apart from the second prong so that the operator has improved visibility of the second hollow organ during placement of the second prong into the wall of the second hollow organ. 
     A third shortcoming of the device disclosed in Stefanchik is the ease of removing the two needles from the implement after the stitches are made to join the two hollow organs together, and for drawing the two sutures through the two hollow organs to provide enough free length of suture for tying a knot to complete the anastomosis. For the device in Stefanchik, it is necessary to use a surgical grasping tool to grasp each needle, release it from the implement, and pull directly on the needle to draw suture through the two hollow organs. Since the needles are very small and partially obstructed by the implement, it may be difficult for the operator to easily grasp the needle in this manner, especially during an endoscopic surgical procedure. What is needed is a needle receiver for each needle within the element, so that at the end of the actuation of the device in Stefanchik, the needle receiver may be grasped easily by a surgical grasping tool and withdrawn from the implement of the device while pulling the suture attached to the needle to provide a sufficient length of suture for knot tying. 
     For the device in Stefanchik, it is necessary that the implement be temporarily attached to a bodily organ, such as the heart, during the operational sequence of the device and that the drive unit for driving the implement be handheld by an operator during the procedure. Another desirable refinement to the device in Stefanchik would be to use a commercially available, sheathed cable particularly adapted for transmitting rotational and translational force from a drive unit to the implement of the device. By using a commercially available, sheathed cable, the cost to manufacture the surgical device could be reduced. Improving efficiency of force transfer would allow smoother and easier operation of the surgical device. 
     SUMMARY OF THE INVENTION 
     In accordance with the present invention there is provided a needle and suture assembly for attaching one piece of tissue to another piece of tissue. The assembly includes a helical needle having proximal and distal ends, a strain relief element having a greater flexibility than a flexibility of the needle attached to the proximal end of the needle, and a suture attached to the strain relief element. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which: 
     FIG. 1 is an isometric view of the present invention, a surgical device  10 ; 
     FIG. 2 is an isometric view of a head assembly  100  and a handle  500  of surgical device  10  shown in FIG. 1; 
     FIG. 3 is an exploded isometric view of head assembly  100  and handle  500  shown in FIG. 2; 
     FIG. 4 is a side view of a drive unit  600  shown in FIG. 1, with a portion of drive unit shell  610  removed to reveal the internal components; 
     FIG. 5 is a side view in partial section of a left drive cable  608 , which operationally engages with drive unit  600  shown in FIG. 1; 
     FIG. 6 is an isometric view of left drive cable  608  shown in FIG. 5; 
     FIG. 7 is an exploded isometric view of head assembly  100  shown in FIG. 1; 
     FIG. 8 is an exploded isometric view of a right roller assembly  170 , which is part of head assembly  100  shown in FIG. 7; 
     FIG. 9 is an exploded isometric view of right roller assembly  170  shown in FIG. 8, with a right leaf spring  190  and a right spring plate  192  shown in closer alignment with a right roller  196 ; 
     FIG. 10 is an isometric view of right roller assembly  170  shown with a plow  290  and a left helical needle  261 ; 
     FIG. 11 is an exploded isometric view of a right tissue holder  330 , which is part of head assembly  100  shown in FIG. 7; 
     FIG. 12 is an isometric view of right tissue holder  330 , right roller assembly  170 , and a right frame  146  shown in alignment prior to assembly; 
     FIG. 13 is an isometric view of right tissue holder  330 , right roller assembly  170 , and right head frame  146  shown assembled; 
     FIG. 14 is a cross-sectional view of head assembly  100  taken through line  14 — 14  in FIG. 2; 
     FIG. 15 is an exploded isometric view of an upper pin assembly  430 , which is part of head assembly  100  shown in FIG. 7; 
     FIG. 16 is an isometric view of assembled, upper pin assembly  430  shown in FIG. 15; 
     FIG. 17 is an exploded isometric view of a lower pin assembly  460 ; 
     FIG. 18 is an isometric view of assembled, lower pin assembly  460  shown in FIG. 17; 
     FIG. 19 is a side sectional view of head assembly  100  taken at line  19 — 19  in FIG. 14, showing an upper tissue pin  360  inserted into a first vessel  702 , and a lower tissue pin  440  inserted into a second vessel  704 , and with lower pin assembly  460  spaced apart from head assembly  100 ; 
     FIG. 20 is the same view as shown in FIG. 19, but with lower pin assembly  460  spaced near head assembly  100 ; 
     FIG. 21 is the same view as FIG. 20, but with an upper pin assembly  430  adjusted so that first vessel  702  is approximately parallel and close to second vessel  704 ; 
     FIG. 22 is the same view as FIG. 21, but with a plow blade  298  shown advanced through first vessel  702  and second vessel  704 ; 
     FIG. 23 is the same view as FIG. 22, but with a left helical needle  261  shown rotated through a portion of first vessel  702  and second vessel  704 , and with a left suture  281  trailing to create a plurality of left suture stitches  708 ; 
     FIG. 24 is a sectional view of head assembly  100  taken at line  24 — 24  in FIG. 23; 
     FIG. 25 is the same view as FIG. 23, but with helical needle  261  fully advanced and ready for removal from head assembly  100 ; 
     FIG. 26 is a top view of head assembly  100  for when left helical needle  261  is in a start position; 
     FIG. 27 is a top view of head assembly  100  and is shown with a surgical tool  800  removing a left needle receiver  333  containing left helical needle  261 ; 
     FIG. 28 is a top view of head assembly  100  with a right head frame  146  and a left head frame  147  shown in an open position for removing head assembly  100  from first vessel  702  and second vessel  704 ; 
     FIG. 29 is a top view of first vessel  702  joined to second vessel  704  by a plurality of right suture stitches  706  and plurality of left suture stitches  708 ; 
     FIG. 30 is the same view as FIG. 29, but with a proximal knot  712  and a distal knot  710  partially tied; 
     FIG. 31 is a side sectional view of a portion of a prior art needle  670  shown attached in a conventional manner to a prior art suture  672 ; and 
     FIG. 32 is a side sectional view of a portion of left helical needle  261  of the present invention shown attached to left suture  281 , and assembled with a stress relieving element  674 . 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In the following detailed description of the present invention, the applicants provide a description of how the invention is used to create a modified end-to-side anastomosis between two blood vessels. The present invention may also be used to create conventional end-to-side, side-to-side and end-to-end anastomoses, and is not limited to only blood vessels, but may be used also for joining other types of hollow organs. 
     Referring now to the drawings wherein like numerals indicate the same element throughout the views, there is shown in FIG. 1 a preferred embodiment of the present invention, a surgical device  10 . Device  10  generally comprises a handle  500 , a head assembly or member  100 , shown in a first position, and a drive unit  600 . Head assembly  100  is operationally connected to handle  500  by a block assembly  132 , which slides along a right rail  490  and a left rail  491  affixed to handle  500 . A lower pin assembly  460 , or arm, is attached to right rail  490  and left rail  491 . Handle  500  includes a first actuator  506  and a second actuator  562 . Drive unit  600  operationally connects to head assembly  100  by a right drive cable, or flexible rotatable member,  606  and a left drive cable, or flexible rotatable member,  608 . Drive unit  600  includes a third actuator  602  and a fourth actuator  604 , which is rotatable only in one direction. 
     FIG. 2 is an isometric view of head assembly  100  in the first position and handle  500 . When an operator completely depresses first actuator  506  on handle  500 , head assembly  100  laterally moves to a second position closer to lower pin assembly  460  and member  100  and locks into place. When an operator depresses second actuator  562  on handle  500 , head assembly  100  returns to the first position. Head assembly  100 , block assembly  132 , and lower pin assembly  460  also comprise what is referred to as a working portion  20  of the present invention. 
     FIG. 3 contains an exploded isometric view of the components of handle  500 , and includes head assembly  100  and lower pin assembly  460  separated from handle  500 . Right rail  490  and left rail  491  fixedly attach to a right rail hole  468  and a left rail hole  467 , respectively, of lower pin assembly  460 . Left rail  491  slidably passes through a left block hole  110  of block assembly  132  and into a left collar hole  578  of a collar  570 . A left collar screw  584  screws into collar  570  and attaches left rail  491  to collar  570 . Similarly, right rail  490  slidably assembles into block assembly  132  and fixedly attaches to a right collar hole  576  of collar  570  by a right collar screw  582 . Handle  500  further includes a rod  536  for moving head assembly  100  up and down. A return spring  544  assembles over rod  536  and bears against a flange  538  as shown in a phantom view of return spring  544 . Return spring  544  also pushes against a spring ledge  550  in a second handle half  504 , thus tending to urge rod  536  in the proximal (upward) direction. Rod distal end  532  passes through a collar opening  580  and pivotally attaches to head assembly  100  by insertion of a block pin  109  through a block hole  108  and a rod hole  534  of rod  536  (pivot assembly). A wedge element  522  is pivotally attached to a bushing  530  connected to rod  536  by a wedge pin  526  inserted through a bushing hole  528  and a wedge hole  524 . When an operator presses a first surface  518  of first actuator  506 , wedge element  522  is pushed in the distal (downward) direction to move head assembly  100  closer to lower pin assembly  460 . First actuator  506  includes a first axle  508  for pivoting in a first axle recess  512  in second handle half  504 . First actuator  506  also includes a first stop post  510  that limits the travel of first actuator  506  by hitting a first stop recess  514  in first handle half  504 . Rod  536  reciprocates longitudinally in a lower bearing surface  529 , a middle bearing surface  554 , and a upper bearing surface  548  of second handle half  504 . The proximal end of rod  536  is adapted with a hook  542  for engaging with a latch  546  in second handle half  504  so that head assembly  100  may be held in the second position when first actuator  506  has been fully depressed. Rod  536  is released by depressing second actuator  562  having a latch release arm  564  that disengages latch  546  from hook  542 , thus allowing head assembly  100  to return to the first position. A first handle half  502  attaches to second handle half  504  by any one of numerous fastening means well known in the art, and a handle fastener hole  560  is provided in the proximal end of second handle half  504 . A first and a second distal end half,  552  and  554 , of first and second handle halves,  502  and  504 , are held together within collar opening  580  and to block assembly  132  by a collar pin  574  passing through a collar pin hole  572  of collar  570 , and engaging with a collar pin slot  503  in first handle half  502 . When handle  500  is fully assembled, first actuator  506  protrudes through a first actuator opening  516  of first handle half  502 , and second actuator  562  protrudes through a second actuator opening  566  of first handle half  502 . 
     As will be apparent to those skilled in the art, all of the components of handle  500  may be constructed of materials and using methods so that it would be practical for handle  500  to be either single patient use disposable or reusable after sterilization in a steam autoclave such as used in hospitals. 
     FIG. 4 is a side view of drive unit or needle driver  600  with a portion of a drive unit shell  610  removed to reveal the internal components. Third actuator  602  has a first extension  613  for engaging a first connector  612 , which is fixedly attached to right shaft  649  of right drive cable  606 . Third actuator  602  has a second extension  615  for engaging a second connector  614 , which is fixedly attached to left shaft  650  of left drive cable  608 . An operator may slide third actuator  602  in either longitudinal direction in a translation slot  617  of drive unit shell  610 . When an operator slides third actuator  602  in a proximal direction (left), first and second shafts,  649  and  650 , translate in the distal (left) direction. When an operator slides actuator  602  in a proximal direction, first and second shafts,  649  and  650 , translate in a proximal (right) direction. 
     Still referring to FIG. 4, fourth actuator  604  of drive unit  600  is rotatably attached to a main gear  620 , which meshes with a first shaft gear  618 , which in turn meshes with a second shaft gear  619 . When an operator rotates fourth actuator  604  in a clockwise direction, first shaft gear  618  rotates in a counter clockwise direction, and second shaft gear  619  rotates in a clockwise direction. As a consequence, right shaft  649  rotates in a counter clockwise direction, and left shaft  650  rotates in a clockwise direction. To simplify operation of drive unit  600 , a one way rotation mechanism is preferably included, although not shown in FIG. 4, in drive unit  600  to allow rotation of rotation knob  604  to occur only in the clockwise direction. Such a one way rotation mechanism is disclosed in related patent U.S. Pat. No. 6,015,416. A first shaft drive end  622  has a non-circular cross section and fits slideably into first shaft gear  618 , so that right shaft  649  may be rotatably driven by first shaft gear  618 , yet be free to translate longitudinally. A second shaft drive end  624  also has a non-circular cross section and fits slideably into second shaft gear  619 , so that left shaft  650  may be rotatably driven by second shaft gear  619 , yet be free to translate longitudinally. 
     Those skilled in the art will recognize that drive unit  600  may be made of materials and using methods so that drive unit  600  may be either single patient use disposable or sterilizable in hospitals for multiple patient use. 
     FIG. 5 is a side sectional view of the distal portion of left drive cable  608 . The distal portion of right drive cable  606  is identical to that of left drive cable  608 . Left shaft  650  is attached to a left drive connector  652  having a drive connector bore  658 . An inner spring  655 , preferably in compression, made of spring wire surrounds left shaft  650  and is covered by a sheath  654 , preferably in tension, made of a wire mesh or braided wire. Inner spring  655  and sheath  654  are attached to a ferrule  660  having a pair of ferrule indentations  656  for retention in head assembly  100  (see FIG.  19 ). Right and left drive cables,  606  and  608 , are flexible but have minimal shape memory and do not elongate when tensioned during usage. Preferably, drive cables  606  and  608  have the ability to transmit rotation and/or translation without kinking or elongation. A particularly suitable sheathed cable for right and left drive cables,  606  and  608 , is a flexible camera cable for a remote shutter actuator, available from Brandess-Kalp Aetna Group, 701 Corporate Woods Parkway, Vernon Hills, N.J. 60061. 
     FIG. 6 is an isometric view of the distal portion of left drive cable  608  shown in FIG.  5 . In this view it can be seen that connector bore  658  is non-circular so that left drive cable  608  can transmit a rotational force from drive unit  600  to head assembly  100  shown in FIG. 3. A pushing surface  661  on left drive connector  652  permits left drive cable  608  to transmit a translational force from drive unit  600  in the distal direction to head assembly  100 . Right drive cable  606  (see FIG. 4) is configured similarly also to transmit rotational and translational forces from drive unit  600  to head assembly  100 . 
     FIG. 7 is an exploded, isometric view of several components of the working end (tissue contacting portion) of the present invention and generally includes head assembly  100  and block assembly  132 . Head assembly  100  further includes an upper pin assembly  430 , a right tissue holder  330  having a right needle receiver  339 , a left tissue holder  331  having a left needle receiver  333 , a right roller assembly  170 , a left roller assembly  171 , a plow  290 , a right frame  146 , and a left frame  147 . Right roller assembly  170  further includes a right roller housing  172 , a right leaf spring  190 , a right roller plate  192 , a right roller  196  (having a plurality of annular rings disposed thereon), a right needle guide  220  and right helical needle  260  having a right suture  280  attached to it. Left roller assembly  171  further includes a left roller housing  173 , a left leaf spring  191 , a left roller plate  193 , a left roller  197  (having a plurality of annular rings disposed thereon), a left needle guide  221 , and a left helical needle  261  having a left suture  281  attached to it. Right and left sutures,  280  and  281 , are preferably made from a polypropylene monofilament, size 7-0 (0.003 in.), as is typically used for sewing together blood vessels for a coronary artery bypass graft procedure. The above assembly being one example of a means for two hollow organs about a passageway therebetween. The remaining components shown in FIG. 7 are preferably made from stainless steel using numerous well-known manufacturing techniques including injection molding of stainless steel. 
     Still referring to FIG. 7, block assembly  132  includes a block  102  generally for mounting head assembly  100  to handle  500  as shown in FIG.  3 . Block  102  has a support wall  114  having a support face  116  configured for aligning and supporting left and right frames,  147  and  146 , of head assembly  100 . A right frame ledge  152  on a right turret  148  of right frame  146  fits closely onto a support face edge  117  of support face  116 . A left turret  149  of left frame  147  also fits closely onto support face edge  117 . Support face  116  has a right roller hole  118 , which provides access for right drive cable  606  (not shown) to connect to right roller  196 . A left roller hole  119  similarly provides access for left drive cable  608  (not shown) to connect to left roller  197 . Support face  116  has a smaller, central hole  122  for left and right sutures,  280  and  281 , to exit head assembly  100 . An assembly pin hole  124  in support face  116  retains a clamp pin  128 . 
     FIG. 7 also shows a clamp  137  of block assembly  132  having a clamp opening  135 , which fits over right and left turrets,  148  and  149 , of right and left frames,  146  and  147 . Clamp  137  comprises a right clamp element  142  and a left clamp element  144  attached to a clamp spring  140 , preferably by welding, so that right and left clamp elements,  142  and  144 , are normally sprung apart in an open position. Right turret  148  is attached, preferably by welding, to right clamp element  142 . Left turret  149  is attached, preferably by welding, to left clamp element  144 . When clamp  137  is normally sprung apart, right frame  146  and left frame  147  are sprung apart in a vee-shaped configuration as shown in FIG. 28. A right clamp element hole  138  in right clamp element  142  aligns with a left clamp element hole (not visible) in left clamp element  144  when clamp  137  is in a closed position as shown in FIG.  7 . Clamp pin  128  assembles through a clamp spring hole  136 , right clamp element hole  138 , the hidden left clamp element hole in left clamp element  144 , and pin assembly hole  124  in block  102 , to hold clamp  137  in the closed position. When clamp  137  is held in a closed position, right frame  146  and left frame  147  are held together as shown in FIG.  27 . 
     Clamp  137  in FIG. 7 also includes a U-shaped, retainer wire  130  for insertion into a pair of shaft retention holes  112  (only one shaft retention hole  112  is visible) in block  102 . Right and left drive cables,  606  and  608 , (not shown in FIG. 7) are retained in block  102  by retainer wire  130 . 
     Turning briefly to FIG. 19, a side sectional view of head assembly  100  reveals left drive cable  608  retained in block  102  by retainer wire  130  engaging with ferrule indentation  656  of ferrule  660  of left drive cable  608 . Left shaft  650  is shown attached to left shaft connector  652 , which is operationally engaged on a left drive post  203  of left roller  197  (partial view) for rotation and translation. Although not visible in FIG. 19, right drive cable  606  is attached in a similar manner to right roller  196  and block  102 . 
     Now referring to FIGS. 8 and 9, in the exploded isometric views, right roller assembly  170  is shown in alignment with plow  290  and left helical needle  261 . The following description for the right roller assembly  170  is also descriptive of the left roller assembly, except that left helical needle  261  is driven in the opposite rotational direction of right helical needle  260  in order to counteract the forces during operation within head assembly  100 . The primary function of right roller assembly  170  is to align and rotate helical needle  260  in the counter clockwise direction (looking proximal to distal) to drive helical needle  260  through tissue. Each rotation of helical needle  260  constitutes a stitch in the tissue, thus a running stitch may be made by multiple rotations of helical needle  260 . Right helical needle  260  comprises a plurality of helical coils  264  and a tip  262  for penetration of tissue. In the free state, helical needle  260  appears circular when viewed from an end. When head assembly  100  is clamped onto tissue, helical needle  260  appears slightly elliptical when viewed from the end because the needle is held tightly between right roller  196  and plow  290  so that the needle may be driven by rotation of right roller  196 . Right roller  196  comprises a plurality of annular grooves  198  spaced evenly apart. A right drive post  202  extends from the proximal end of right roller  196  for operational engagement with right drive cable  606  (not shown). Right drive post  202  has a non-circular cross section for rotational engagement, and a tapered tip  204  for easy assembly. Right needle guide  220  has a plurality of ribs  222  spaced evenly apart approximately the same distance as the helical coils  264  on right helical needle  260 . Each individual helical coil  264  projects between two adjacent ribs  222  so as to contact the inside of the corresponding one of a plurality of annular grooves  198  in right roller  196 . Right roller  196  is forcibly held against helical needle  260  by leaf spring  190  sandwiched between right roller housing  172  and right roller plate  192 , which bears against right roller  196 . FIG. 8 shows the free state of right leaf spring  190 , and FIG. 9 shows the assembled, compressed state of right leaf spring  190 . A shank  200  on right roller  196  rotates in a half-bushing  188  on right roller housing  172 . A roller end  206  is retained against the inside of a retaining arm  224  of right needle guide  220 . Retaining arm  224  inserts into a retention slot  180  and a retention hole  182  of right roller housing  172 . Right needle guide  220  further includes a guide ramp  226  and guide slot  227 , which are instrumental in moving the upper pin assembly  430  (see FIG. 7) during operation as will be described. Similarly, right needle guide  220  includes a lower guide ramp  242  and a lower guide slot  244 , which are instrumental in holding the lower pin assembly  460  (see FIG. 3) during operation, as will be described later. 
     FIG. 10 is an isometric view of right roller assembly  170  containing right helical needle  260  in a start position, plow  290 , and left helical needle  261 , also in a start position. Plow  290 , which is a means for incising at least one of the hollow organs so as to create a passageway therebetween, includes a plurality of left plow grooves  292  spaced evenly apart about the same distance as ribs  222  on right needle guide  220 . A plurality of left helical coils  263  are positioned in a like plurality of left plow grooves  292 . Similarly, a plurality of right helical coils  264  are positioned in a like plurality of right plow grooves (not visible). A plow blade  298  on the distal end of plow  290  is adapted to cut and separate tissue as plow  290  is translated longitudinally in the distal direction. Plow  290  includes a carriage  312  having a right wing  306  and a left wing  304 . When an operator actuates third actuator  602  (see FIG. 4) to translate right and left drive cables,  606  and  608 , in the distal direction, right cable pushing surface  660  (see FIG. 6) of right drive cable  606  pushes against carriage edge  291  of right wing  306  of carriage  312 . Similarly, a left cable pushing surface (not shown) pushes against carriage edge  291  of left wing  304 . A right housing lip  178  assembles into a right wing notch  310  of carriage  312 . A left housing lip (not shown) assembles into a left wing notch  308 . When carriage  312  is pushed by right and left drive cables,  606  and  608 , carriage  312  of plow  290  in turn pushes right roller assembly  170  and left roller assembly  171  (FIG. 7) in the distal direction. This moves right roller housing  172  (FIG. 7) and left roller housing  173  (FIG. 7) from an initial position to an operational position for joining the hollow organs together. 
     FIG. 11 is an exploded, isometric view of right tissue holder  330 . Left tissue holder  331  (see FIG. 7) is a mirror image of right tissue holder  330 . Right tissue holder  330  comprises a channel  349 , and the following elements, which are attached to channel  349 , preferably by welding: an right upper spring latch  346 , a right lower spring latch  348 , an right upper tissue clamp  332 , and a right lower tissue clamp  334 . Upper tissue clamp  332  locates into an upper channel recess  350  and has a plurality of upper clamp flutes  354 . Lower tissue clamp  334  locates into a lower channel recess  352  and has a plurality of lower clamp flutes  356 . A wireform connector  336  inserts into channel hole  358  and a right frame hole hidden from view in FIG. 11, and removably attaches channel  349  to right housing  146 . Right tissue holder  330  further comprises right needle receiver  339 , which includes a needle receiver bracket  338  and a needle holder  340 . Needle holder  340  includes a right post  342  and a head  341 , which is attached, preferably by welding, to needle receiver bracket  338 . Right needle receiver  339  is removably retained in right tissue holder  330  by upper spring latch  346  engaging a bracket arm  344  of needle receiver bracket  338 , and lower spring latch  348  engaging a bracket edge  343  of needle receiver bracket  338 , so that post  342  of needle receiver  339  is in the path of right helical needle  260  as shown in FIGS. 12 and 13. 
     FIG. 12 shows the alignment for assembly of right tissue holder  330  and right roller assembly  170  to right frame  146 . (Left tissue holder  331  and left roller assembly  171  assemble to left frame  147  in the identical manner.) A housing rail  174  on right roller housing  172  slides into a frame slot  151  of right frame  146 , permitting right roller housing  170  to move freely along shelf  156  of right frame  146 . In FIG. 13, right roller housing  170  is positioned in the initial position, which is the most proximal position, and retained in right frame  146  by attaching right tissue holder  330  to right frame  146  by wireform  336  into elongated hole  150 , channel hole  358 , and the hole hidden from view on right frame  146 . Right frame  146  includes an upper tissue pin slot  160  and a lower tissue pin slot  158 , which helps retain upper pin assembly  430  to right frame  146 . 
     FIG. 14 is a cross sectional view, taken along line  14 — 14  of FIG. 2, of head assembly  100 . Right frame  146  and left frame  147  are shown held together in the closed position. Plow  290  is shown in the center and is engaged with right helical needle  260  and left helical needle  261 . Right and left helical needles,  260  and  261 , are shown to be out of phase. That is, right helical needle  260  is slightly more distal in the longitudinal direction than left helical needle  261 . The right and left roller assemblies,  170  and  171  (see FIG.  10 ), are offset longitudinally by half the distance between ribs  222  on needle guide  220 , and anvil  290  is configured to match this offset, so that stitches created on the right side of the hollow organs joined together are not directly opposed by stitches on the left side. Also shown in cross section in FIG. 14 are the following: right and left roller housings,  172  and  173 ; right and left leaf springs,  190  and  191 , right and left roller plates,  192  and  193 ; right and left rollers,  196  and  197 ; and right and left needle guides,  220  and  221 . Right turret  148  of right frame  146  and left turret  149  of left frame  147  are shown together as they would be held by clamp  147  (not shown) as described for FIG.  7 . 
     FIG. 15 is an exploded isometric view of upper pin assembly  430 , which comprises an upper tissue pin  360 , a spring plate  400 , a guide plate  420 , and a tissue holder  380 , all of which are preferably made of a stainless steel. Upper tissue pin  360  includes a pin platform  368  at its distal end having a right flange  366 , a left flange  365 , a right ridge  405 , a left ridge  406 , and a central flat  367 . Upper tissue pin  360  further includes a plurality of upper pin slots  361  on a middle region  359 , an insertion region  362 , a pin tip or distal end  363 , and an upper pin channel  364  running longitudinally through the entire length of upper tissue pin  360 . Spring plate  400  includes a bridge  404 , a right and a left spring stop,  403  and  401 , extending from one side of bridge  404 , and a spring arm  402  extending from the same side of bridge  404  and between right and left spring stops,  403  and  401 . Spring arm  402  is attached, preferably by welding, to flat  367  of platform  368  of tissue pin  360 , and is spring biased to be in a normally up position as shown in FIG.  19 . Right and left spring stops,  403  and  401 , hit upon right and left ridges,  405  and  406 , to limit the upper position of tissue pin  360 . Tissue holder  380  comprises a holder arm  381  and a cuff  382 . Holder arm  381  attaches, preferably by welding, to spring arm  402 . Cuff  382  assists in holding the open end of one of the hollow organs to be anastomosed during the sequence of operation, as will be described later. Guide plate  420  comprises a guide plate extension  424 , which is attached, preferably by welding, to bridge  404  of spring plate  400 . Guide plate  420  further comprises a cut-out  422  to provide clearance for tissue pin  360  to move to the up position. FIG. 16 is an isometric view of the assembled upper tissue pin  430 , shown as the tissue pin  360  would be oriented when in a down position. 
     FIG. 17 is an isometric view of lower pin assembly  460 , which comprises a lower tissue pin  440 , a pin support  466 , right rail  490 , and left rail  491 , all of which are preferably made from stainless steel. Right rail  490  inserts into right rail hole  468  and is preferably welded together. Left rail  491  inserts into left rail hole  467  and is also preferably welded together. Pin support  466  includes a support arm  462  having a support arm ramp  469  and a support extension  464 . Lower pin  440  comprises a lower pin base or proximal end  449 , which is attached, preferably by welding, to support extension  464 . A right finger  447  and a left finger  448  extend from the sides of lower pin base  449 . Lower pin  440  further comprises a plurality of lower pin slots  443  on a lower pin middle region  441 , an lower pin insertion region  444 , a lower pin tip or distal end  445 , and a lower pin channel  446  extending through the length of lower pin  440 . FIG. 18 is an isometric view of the lower pin assembly  460  shown in FIG.  17 . 
     FIGS. 19-28 show various steps of the operational sequence for the present invention. FIG. 19 is a side view of working portion  20  (see FIG. 2) of the present invention, but with left frame  147  and left roller assembly  171  (except for left helical needle  261 ) removed. Head assembly  100  is shown in the first position spaced apart from lower tissue pin assembly  460 . Upper tissue pin  360  is shown in the up position and inclined relative to the longitudinal axis of head assembly  100 . Although not apparent in FIG. 19, head assembly  100  is in the closed position (a top view of head assembly  100  is also shown in the closed position in FIG.  26 ). Right roller housing  172  is in the initial (furthest to the right) position. Left helical needle  261  is shown in the start (furthest to the right) position. A first vessel  702 , also referred to as a first hollow organ, is shown in phantom view positioned onto upper tissue pin  360 . First vessel  702  may, for example, be a harvested vein or artery from the patient. A second vessel  704 , also referred to as a second hollow organ, is shown in phantom view positioned onto lower pin assembly  460 . As disclosed in U.S. Pat. No. 6,015,416, upper and lower tissue pins,  360  and  440 , may be penetrated into the respective vessels after a surgical cutting instrument (not shown) is first used to create a tiny incision in the vessel. Second vessel  704 , which may be a stenosed coronary artery, is shown still attached to an organ  700 , which may be the heart of a surgical patient. Cuff  380  is shown clasping around the posterior side and near an open end  703  of first vessel  702  to help hold open end  703  during the operational sequence. Left drive cable  608  is shown attached to head assembly  100  by retainer wire  130  engaging with ferrule indentations  656 . Left shaft  650 , which translates in the distal direction and then rotates in the counter clockwise direction during the operational sequence, is initially stationary for this step. Left drive connector  652 , attached to left shaft  650 , abuts against carriage edge  291  of plow  290 . Left drive connector  652  is also rotationally attached to left drive post  203  of left roller  197 . Similarly, right drive cable  606  (hidden behind left drive cable  608 ) is operationally engaged with plow  290  and right roller  196  (also hidden). Clamp pin  128  is filly engaged with clamp  137  of block assembly  132  and holding together left and right frames,  146  and  147  (see FIG.  26 ), in the closed position. Left suture  281  is shown trailing behind left needle  261  and exiting through block  102 . Right suture  280  (not shown) trails right needle  260  (hidden in this view) and also exits block  102 . Both sutures,  280  (not shown in FIG. 19) and  281 , extend freely from head assembly  100  during the operational sequence, and are drawn into head assembly  100  as right and left helical needles,  260  (hidden in FIG. 19) and  261 , are advanced and penetrated into first and second vessels,  702  and  704 . 
     FIG. 20 is a similar view as FIG. 19 showing the next step in the operational sequence. Head assembly  100  is lowered into the second position so that lower pin assembly  460  and a portion of second vessel  704  are aligned within head assembly  100 . Lower clamp flutes  356  of lower clamp  334  press against the sides of second vessel  704 . Second vessel  704  is now held directly in the path of right and left helical needles,  260  (hidden) and  261 . Second vessel  704  is normally attached to organ  700 , and is relatively immobile. Therefore, the operator lowers head assembly  100  close to organ  700  by actuation of first actuator  506  (not shown) as described earlier for FIG.  2 . Upper tissue pin  360  and first vessel  702  remain in the up position. First and second helical needles,  260  (hidden) and  261 , remain in the start position. Right roller assembly  170  remains in the initial position. 
     FIG. 21 is a similar view as FIG. 20 showing the next step of the operational sequence. Plow  290  is now shown moved from a proximal position (as shown in FIG. 20) to an intermediate position. Plow blade  298  of plow  290  is immediately proximal to first and second vessels,  702  and  704 . The operator moves plow  290  to the intermediate position by the initial actuation of third actuator  602  (not shown) on drive unit  600  as described for FIG. 4, causing right and left shafts,  649  (hidden) and  650 , to translate in the distal (left) direction. As already described, translation of right and left shafts,  649  and  650 , advances right and left roller assemblies,  170  and  171  (not shown), from the initial position to a middle position, still proximal to first and second vessels,  702  and  704 . As described for FIG. 8, right roller housing  172  has guide ramp  226  and guide slot  227 , and left roller housing  173  (not shown in FIG. 21, see FIG. 7) has a similar ramp and guide slot. As right and left roller housings,  172  and  173  (not shown in FIG. 21) advance to the middle position, right and left flanges,  366  (hidden) and  365 , of upper pin assembly  430  (more clearly depicted in FIG.  15 ), are captured in guide ramp  226  (hidden), then guide slot  227  of right roller housing  172 , and simultaneously in the guide ramp and slot of left roller housing  173 , causing upper pin assembly  430  to move to the down position. Operation of actuator  602  causes the distal ends  363  and  445  adjacent to one another. Consequently, upper tissue pin  360  and first vessel  702  are moved into the down position within head assembly  100  so that first vessel  702  is aligned parallel and tightly against second vessel  704 , and in the path of right and left helical needles,  260  (hidden) and  261 . Upper clamp flutes  354  of upper clamp  332  push against first vessel  702  to hold it in place. Plurality of upper pin slots  361  of upper tissue pin  360  are aligned with plurality of lower pin slots  443  of lower tissue pin  440 , thus becoming guides within the lumens of first and second vessels,  702  and  704 , for first and second helical needles,  260  and  261 . 
     FIG. 22 is a similar view as FIG. 21, showing the next step of the operational sequence. The operator completely actuates third actuator  602  (not shown) on drive unit  600  as described for FIG. 4, thus causing first and second shafts,  649  (hidden) and  650 , to translate further in the distal (left direction). As a result, plow  290  advances to a distal position and plow blade  298  cuts a passageway between first and second vessels,  702  and  704 . As plow  290  advances it pushes right and left roller assemblies,  170  and  171  (not shown), to an operational position alongside of first and second vessels,  702  and  704 . Plow grooves  292  of plow  290  align with upper pin slots  361  of upper tissue pin  360  and lower pin slots  443  of lower tissue pin  440 , to form a path for right and left helical needles,  260  (hidden) and  261 . 
     FIG. 23 is similar view as FIG. 22, showing the next step of the operational sequence. The operator actuates fourth actuator  604  (not shown) to rotate first and second shafts,  649  (hidden) and  650 , in opposite directions as described for FIG.  4 . Right and left helical needles,  260  (hidden) and  261 , rotate and advance within head assembly  100  and through first and second vessels,  702  and  704 , creating a stitch through them with each full rotation. As a plurality of left suture stitches  708  are completed, left helical needle  261  winds onto a left post  345  of left needle receiver  333 . Similarly, right helical needle  260  winds onto right post  342  (hidden) of right needle receiver  330  (hidden), creating a plurality of right suture stitches  706  (hidden in FIG.  23 ). 
     FIG. 24 is a cross-sectional view of head assembly  100  taken along line  24 — 24  of FIG.  23 . Right and left helical needles,  260  and  261 , are penetrated through first and second vessels,  702  and  704 , which are held tightly by right upper tissue clamp  332 , right lower tissue clamp  334 , a left upper tissue clamp  313 , and a left lower tissue clamp  315 . Upper pin channel  364  of upper tissue pin  360  is captured on upper plow rail  296  of plow  290 . Lower pin channel  446  of lower pin  440  is captured on lower plow rail  294  of plow  290 . The severed edges of first and second vessels,  702  and  704 , are partially inverted due to the shape of plow  290 . When right and left sutures,  280  and  281 , are tied together as will be described for FIG. 30, first and second vessels,  702  and  704 , preferably become joined intima-to-intima so that endothelial cells can easily grow over their junction and form a smooth inner lining of the vessels. 
     FIG. 25 is similar view as FIG. 23, showing the next step in the operational sequence. Left helical needle  261  is completely wound onto left post  345  of left needle receiver  333 . Similarly, right helical needle  260  (hidden) is completely wound onto right post  342  (hidden) of right needle receiver  330  (hidden). Right and left sutures,  260  (hidden) and  281 , now join first and second vessels,  702  and  704 , together loosely, and will be further tightened manually after head assembly  100  is removed. 
     FIG. 26 is a top view of head assembly  100  (shown without first and second vessels,  702  and  704 ) with right frame  146  and left frame  147  held together in the closed position by clamp pin  128  in block assembly  132 . Right and left helical needles,  260  and  261 , are partially visible and are m the start position. Plow  290  is partially visible and is in the proximal position. Right roller assembly  170  and left roller assembly  171 , are partially visible and are in the initial position. 
     FIG. 27 is the same view as FIG. 26, showing head assembly  100  (again without first and second vessels,  702  and  704 ). Left helical needle  261  is completely contained in left needle receiver  333  such as also depicted in FIG.  25 . The operator may use a surgical tool  800  to grasp needle receiver  333  and release it from a left upper spring latch  347  and a left lower spring latch  351  of head assembly  100 . Left suture  281  is simultaneously drawn through head assembly  100  (and vessels,  702  and  704 , if they were contained in head assembly  100 ). Left helical needle  261  and left needle receiver  333  are cut from left suture  281  using a surgical cutting tool such as a scalpel or scissors. The operator must take care to provide enough free length of suture extending from head assembly  100  for tying a knot later. Similarly, right helical needle  260  is removed from head assembly  100  by using surgical tool  800  to grasp needle receiver  330  and release it from right upper spring latch  346  and right lower spring latch  348  of head assembly  100 . Right suture  280  (hidden) is drawn through head assembly  100  (and vessels  702  and  704  if they are contained in head assembly  100 ). Helical needle  260  and right needle receiver  330  are removed by cutting right suture  280  (hidden in FIG. 27) with the surgical cutting tool, again taking care to provide a sufficient length of suture extending from head assembly  100  for knot tying later. 
     FIG. 28 is a top view of head assembly  100  in the open position. (Right and left needle receivers,  330  and  333 , have been removed from head assembly  100  as described for FIG. 27.) The operator manually retracts release pin  128  to allow right frame  146  and left frame  147  to spring apart to the orientation depicted. The operator may next move head assembly  100  in the proximal (upward, as viewed in FIG. 28) direction to remove upper and lower tissue pins,  360  and  440 , from the lumens of first and second vessels,  702  and  704 , respectively. 
     FIG. 29 is a top view of first and second vessels,  702  and  704 , immediately after head assembly  100  has been removed as described for FIG.  28 . First and second vessels,  702  and  704 , are loosely held together by a plurality of right and left suture stitches,  706  and  708 , of right and left sutures,  280  and  281 , respectively. 
     FIG. 30 is a similar view as FIG. 29, showing a partially tied distal knot  710  and a partially tied proximal knot  712  in right and left sutures,  280  and  281 . Distal knot  710  is first tied under first vessel  702  by applying a plurality of conventional, alternating suture throws. Proximal knot  712  is then tied over first vessel  702  by applying a plurality of conventional, alternating suture throws, thus closing open end  703  of first vessel  702 . As proximal knot  712  is drawn together, plurality of right and left suture stitches,  706  and  708 , are tightened to hold first and second vessels,  702  and  704 , tightly together and sealing around the edges of the newly created passageway between them. The unneeded portions of right and left sutures,  280  and  281 , are then trimmed off using a surgical cutting tool and the anastomosis is completed. The operator may also tie the knots in the reverse order, that is, proximal knot  712  may alternatively be tied before tying distal knot  710 . 
     FIG. 31 is a sectional view of a prior art needle  670  conventionally attached to a suture  672 . As is well-known in the art, there are a variety of methods for attaching a surgical needle to a suture. FIG. 31 depicts one method in which needle  670  having a needle hole  675  is crimped directly over suture  672 . When suture  672  is pulled in a direction non-parallel to the longitudinal axis of needle  670 , there is a stress concentration at a corner edge  673  of needle hole  675 . With sufficient force, the strength of suture  672  is exceeded and suture  672  breaks next to corner edge  673 . 
     FIG. 32 is a cross-sectional view of left helical needle  261  of the present invention. A stress relieving element  674  covers left suture  281  inside a left helical needle hole  671  and extending outside hole  671  a short (1-3 mm, for example) distance. Stress relieving element  674  provides an interface between needle  261 , which may be made of, but is not limited to, a stainless steel, and suture  281 , which may be made of, but is not limited to, a polymer or organic material that is much softer than stainless steel. Stress relieving element  674  is preferably a flexible plastic. A suitable material for stress relieving element  674  is a high performance, medical grade, natural colored, polyimide tubing (code 030-I) that is available from MicroLumen, Inc., 7930 Woodland Center Blvd., Tampa, Fla., U.S.A. 33614. The inner diameter of the 030-I polyimide tubing is 0.0031 inches (0.078 mm) and the wall thickness is 0.00040 inches (0.010 mm). When left suture  281  is pulled in a direction non-parallel to the longitudinal axis of needle  261 , stress is not as concentrated at corner edge  677  as for the stress at corner edge  673  of the prior art needle  670  in FIG.  31 . Therefore, the maximum off-axis pulling force that may be applied to suture  281  is much higher than for the prior art needle/suture combination in FIG. 31, everything else being equal. In the present invention, the stress relieving element  674  is particularly useful during the repeated rotations of right and left helical needles,  260  and  261 , through head assembly  100 . Stress relieving element  674 , however, is not limited to use with the present invention, but is generally applicable to many other surgical needle/suture combinations. 
     While the applicant describes in this document a preferred embodiment of the present invention, it will be obvious to those skilled in the art that the applicant provides such an embodiment as an example only. Numerous variations and substitutions will now occur to those skilled in the art without departing from the spirit and scope of the appended claims.