Abstract:
The present invention is a combination anastomosis device that both sutures and seals connections between two native body tubes and a graft—better proof against leaks than prior art of suturing alone or as some propose, by sealing. The invention is also a combination of supporting devices and methods that allow the anastomoses to be performed in seconds rather than the minutes required by present art, causing no more collateral bodily damage than percutaneous entry, requiring no time on a cardiac bypass system, either no heart stoppage or less than a minute thus potentially increasing the population who can tolerate coronary bypass as an out-patient procedure. The tract of application is not limited to coronary but includes vascular, urinary, pulmonary, alimentary, cerebral-spinal or other mammalian tract. May be manufactured of biodegradeable or biocompatible material and graft may be harvested or synthetic.

Description:
BACKGROUND OF THE INVENTION 
   Wounds of battle created a need for surgeons. The point of body entry was the choice of battle, not the surgeon. The devices were the knife, saw, clamp, needle and thread. The methods and skills for using the tools were not much different than those of the ship&#39;s carpenter or sailmaker. The term “surgery” made no distinction between collateral damage and damage necessary to effect the desired bodily change and that remains essentially true today. Skill with new devices, methods and pharmaceuticals have improved, making elective surgery feasible. 
   A substantial percentage of elective surgical procedures involve joining or anastomizing tubes that are not joined naturally. This is because there are a large number of tubes carrying essential body fluids for circulation and excretion and they often suffer physiological damage. Such sites in tubes are frequently by-passed with another tube extracted from the body or made of artificial material. A few examples illustrate the variety, e.g., urethras for gastrointestinal disorders, blocked arteries, shunts for dialysis, cerebral spinal shunts and bypasses of scarred fallopian tubes. 
   In common medical usage the term “anastomosis” is used for joining or grafting two tubular body parts that are conduits for a fluid. The term is derived from the Greek, referring to opening a mouth, originally referring to the mouths of river branches but used by early anatomists for branching tubular body parts including blood vessels and nerves. The terms “side-to-side” and “end-to-side” are used to distinguish between anastomoses that directly join the cut sides of two tubes and those where the transected end of a tube, called a graft is joined to the artificial opening in the side of another tube. The graft is generally described as a body portion with a first end, a second end and a lumen therebetween. The term “lumen” refers to the inside of the tube where some substance flows. Body tubes are also called conduits or vessels. Since conduits can be troughs and vessels can be objects floating through conduits the term “tube” is used here. 
   Disease in coronary arteries is the leading cause of premature death in industrialized societies. This makes the importance of anastomizing tubes in a coronary bypass so great that surgical methods involving extreme collateral trauma and risk to the patient are justified. In coronary artery bypass graft CABG, surgeons cut, crack and saw their way through the chest to get their hands in place for making anastomoses, which are the necessary to connect coronary arteries distal to the point of narrowing to a blood supply from the aorta. MIDCABG procedures are endoscopic and involve less collateral damage but still represent a severe strain on patients and have replaced CABG procedures in only a small percentage of cases. CABG will remain the gold standard until more compelling alternatives than MIDCABG are found. Anastomoses of coronary arteries are challenging because they are tiny, friable, intolerant of injury and moving with each beat of the heart. The manual skills for sewing extremely small sutures in tiny frail tubes are well perfected by those who perform CABG surgeries but each anastomosis represents a chance for error or stress beyond what the patient can tolerate. To enable these anastomosis to be done at all the heart must be stopped and circulation placed on an artificial bypass machine so the surgeon does not have the added complications of a moving target in a bloody field. This represents further collateral damage. The risk in heart stoppage is always high, but goes up sharply if time on bypass machine lasts longer than an hour. Suturing by hand takes about ten minutes at each site and in a triple bypass operation six sites require an hour. Sometimes the suturing is inadvertently loose, allowing fluid to leak which can cause acute or chronic loss of blood pressure and possible scarring which results in another blockage. In addition to the threat of leakage, fluid mechanics are such that introducing a stream into a tube at a substantially different angle or velocity of flow than is normal for the tube can cause damage. There is a constant search for improved devices and methods for making anastomoses to reduce the possibility of leakage and time on bypass machine. 
   This search for alternatives has led in two directions, the first to improve the CABG procedure, the second to eliminate it. The first centers on devices inserted in tubes during MIDCABG or CABG procedures to accomplish anastomoses faster and better than suturing thus reducing or eliminating time on the bypass machine, duration of heart stoppage and leakage. There are metal devices and those that look like plumbing fixtures to make anastomoses faster and/or better. The only ones of relevance to the present invention are those that use seals as they can be advanced intraluminally after percutaneous entry. The alternatives for eliminating MIDCABG and CABG procedures involve use of devices and methods originally developed for percutaneous coronary intervention (PCI). 
   Three inventions involving seals but intended for use in CABG and MIDCABG procedures are summarized here. One device by Akin, Conston, et al in US Patent Application 2001/0044631, consists of two flexible sheets of material of any shape connected around the circumference of an opening near their center, deployed through openings in side-by-side lumens and held by fluid pressure in each tube. It is claimed this seal is more fluid-tight and more quickly installed by the surgeon&#39;s hands than is suturing. Their tests conducted on swine tend to bear this out. However, in the event that a seal alone is not so leak-proof as hoped, the claims include an embodiment where adhesive is used for a tighter seal. An associated device, described as a surgical dispenser, is used to hold the compressed flexible sheet as it is manually inserted through the side of body tubes. Akin, Conston, et al in US Patent Application 2003/0088256 A1, describe a similar seal partially held in place by fluid pressure but aided by various configurations of support members deployed inside each lumen and in the opening between them. Again adhesives are included in one embodiment. This device is manually inserted through the side of tubes though an end-to-side version is mentioned with a figure but it is not included in their claims. In a third invention, Spence, et al, in US Patent Application 2004/0097992 A1, claims a device of two flexible vessel attaching segments called “double cuffs,” connected around the opening between them and placed in the lumens of side-by-side tubes where fluid pressure temporarily holds them in place. With this device there is no doubt regarding the temporary nature of this seal because an oval of malleable studded metal segments surrounds the opening in each tube and is attached to the flexible seal. These clamps are pressed through the opening and into the metal oval opposite to accomplish a permanent connection. In these three devices it has not been proven that they are more leak-proof than manually applied sutures but, at the very least they suggest the value of seals. Further it is evident that these devices can be emplaced in less time than the approximately ten minutes it takes to manually suture an anastomosis. Though they appear to have certain advantages over manual suturing, they are limited to CABG and MIDCABG operations. 
   In the present invention an end-to-side seal is used, temporarily held in place in one tube by fluid pressure, but made permanent by sutures drawing it against the lumen. As a permanent seal it represents one of two methods used to make the anastomosis leak proof. The other is non-manual suturing of the same anastomosis. This combination of seal and suture in the present invention must be better proof against leaks than suture alone or seal alone. Because it requires only seconds to emplace, it provides the advantages of no time on bypass machine and either no heart stoppage or less than a minute. In addition the present invention includes a combination of devices for conducting the necessary operations intraluminally after percutaneous entry thus avoiding all the collateral damage of CABG and MIDCABG procedures. 
   Long catheters and fluoroscopic devices make it possible to select a point of entry far from the targeted coronary artery. This is called a percutaneous method in the sense that only skin is broken. The site for entry is chosen where there are no interposing body parts between the skin and the tube. Originally the devices and methods introduced at sites in the groin or arm were for the purpose of advancing and inflating a balloon at a narrowing in a coronary artery. Later a stent device was added, now a chemical eluting stent is used to inhibit growth. Each device was an improved invention for intervening at a narrowed, or otherwise damaged, arterial site. The successive devices were invented and patented while the general method continued to be called Percutaneous Coronary Intervention (PCI) and it&#39;s practitioners, interventionists. These methods essentially avoid all collateral damage. Catheters were not originally intended to be used for surgical entry to the body. However with appropriate devices and methods they can be. Several inventions, including the present one do so. This represents the ultimate reversal of entry to the surgical field which was originally determined by battle. It also represents a clear distinction between collateral and necessary damage in surgery. 
   An example of percutaneous and intraluminal entry to the surgical field is found in an invention by Makower in US 2004/0073238, Device, System and Method for Interstitial Transvascular Intervention. It describes an invention for percutaneous entry, intraluminal advancement to a desired location, opening of an artificial port to another blood vessel or organ, tumor or other anatomical structure so that one or more operative devices can be advanced to perform the desired procedure. Several inventions share this object and method, including the present one. Indeed this description represents the longer highway to the surgical field that is the new alternative to the direct road created by battle damage or surgical bulldozing. If each of the highways had been patented by the early anatomist who discovered it, said patents would have lapsed centuries ago. It remains to be seen what devices are devised to travel this road and for what objects. The need for tracking devices is common to catheter-based systems, e.g. fluoroscopic, and those that leave the highways of natural body tracts to venture outside the tracts are likely to need even better tracking devices. Makower describes active and passive orientation detection by means configured of any of a known set of materials that would allow for the radiographic, fluoroscopic magnetic, sonographic or electromagnetic detection of the location of devices in the body. Use of these various known forms of energy for localization is obvious. Two of Makower&#39;s objects make it clear how his invention is different from the present one. One object is the use of a coronary vein running parallel to the coronary artery as a bypass conduit while terminating the vein&#39;s original purpose as a vein. He terms the tiny space between tubes as interstitial, while transluminal refers to going across the parallel tube lumens. The means of joining is side-to-side. The present invention utilizes the CABG method of a harvested vein graft to bypass the occlusion with its proximal end starting at the aorta and distal end at the coronary artery with both anastomoses end-to-side. Though the overall object of revascularization is the same and both inventions use catheters to advance on similar highways with localization by the usual sources of energy before and after leaving the highway, the intermediate objects, devices and methods for achieving them are quite different. A second object of Makower&#39;s device is transmyocardial revascularization which involves evacuating a channel of tissue between vein and left ventricle. This seems as promising as his other method though both may have their own disadvantages. Regardless of potential advantages and disadvantages, these methods for revascularization are quite different from the method of this invention and certain others that involve a graft between aorta and coronary artery. Makower claims applicability to tracts in the mammalian body other than vascular and that the vascular tract is merely a conduit to other fields of surgery. The present invention and others based on percutaneous entry and transluminal advancement of devices make similar claims about generality. 
   There is a need for devices and methods that achieve revascularization by the method of coronary bypass proven in millions of CABG procedures but with percutaneous entry, intraluminal advancement, cutting tubes for optimal joining of epithelial layers, clamping, delivery of graft, leak-proof anastomosis done without manual manipulation and quickly enough to avoid bypass machine circulation entirely, with little or no heart stoppage and without the trauma and risk of collateral damage. Fulfillment of this need for patients who cannot tolerate more invasive surgical procedures but can tolerate excisional intraluminal surgery would represent a benefit to a far larger population than the 500,000 or so who now tolerate CABG procedures each year. 
   Two inventions are described below that involve percutaneous entry, transluminal advancement of devices, cutting openings, clamping openings, tracking devices energized by various but obvious alternative forms of electro, magnetic, mechanical energy, snaring guidewires to lead from aorta to artery and use of wire mesh and stents to make anastomoses with the aid of balloons. These inventions and the present invention use the bypass graft common to CABG as a means of illustrating their preferred embodiments but claim greater generality. The present invention does not leave wire or stents in the body but can utilize biocompatible material if there is no desire to use biodegradable material which is absorbed after the anastomosis heals. 
   Goldsteen, et al in Medical Grafting Methods and Apparatus, US Patent Application 2004/0116946 A1, and LaFontaine, et al in System and Methods for Percutaneous Coronary Artery, US Patent Application 2003/0195457 make claims that are similar, including some that are similar to the present invention. Both the inventions cited describe a method of connecting the aorta and coronary artery target site by a single continuous guidewire. Both use a snare method to accomplish this but Goldsteen describes a device placed in the coronary artery to deflect the guidewire through the wall. Both snare this wire by a loop of guidewire pushed through the wall of the aorta and substitute one continuous wire for the snared pair. Goldsteen utilizes endoscopic fiber optic light to illuminate and view the snare. Both advance a guiding catheter to an exit site in the aorta. Both advance a sharpened guidewire or stylet through the catheter to cut through the aorta wall. Goldsteen enlarges this opening by twisting a threaded conical tip hoping that this may facilitate transfer of macerated, loosened tissues into a larger proximal catheter. Successively larger catheters are twisted and pushed though the opening until the largest, the guiding catheter is pushed through. This guiding catheter has a pair of annular balloons that are inflated on either side of the opening to clamp it. It appears from the figures that the inflation lumens for these balloons are coincident with the catheter wall and if so, that would need correction or explanation. There is no requirement to stop the heart. LaFontaine has one embodiment where the heart is stopped and another where it is not while he utilizes a vacuum device to isolate and stop blood flow before cutting through the aortic wall. No indication is provided about the size of cut but after it is made the everted graft mounted on a coupler is pushed (bare) through the opening where it is reverted to outside out as it travels though the pericardium on the wire between aorta and artery. Several electro, magnetic, mechanical devises in addition to radiopaque markers for tracking and locating the graft end are described. Goldsteen utilizes radiopaque markers and orthogonal fluorescent screens to track and display location of an artificial graft conduit as it moves mounted on the outside of a catheter through the pericardium on the guidewire. The artificial conduit is a stent-like wire mesh with interstices filled with artificial graft material. Then one of several versions of a threaded or barbed tip cuts or grinds its way through the artery wall. The artificial graft is advanced through the opening and its wire ends spring radially inside the artery lumen. In case these do not make good contact a balloon is inflated in the opening to adjust them. This process is repeated at the opening in the aortic wall with rings of barbs on either side of the wall. If it is desired to use a natural graft instead of the artificial one, it is placed inside the artificial graft for delivery and attached after the artificial graft is attached namely to the tube walls by rings of barbs pushed on either side of each wall by balloons. In an alternative embodiment the natural graft is not preceded by the artificial graft. LaFontaine cuts an opening of unspecified dimensions in the artery wall and the reverted graft is pushed inside the artery coaxial with the artery. It might be noted that coaxial alignment leaves the epithelial layers of the graft and tube separate by the full thickness of the graft. Regardless of this, a short cylinder of wire mesh is placed either inside or outside the graft end which is expanded by a balloon to the diameter of the artery. If this is insufficient to keep it in place an alternative embodiment provides a short cylinder of adhesive to hold it. The graft is attached to the aorta in a similar manner. He describes variously shaped wire mesh, stent-like devices and balloons to push them into place to keep the graft attached to artery and aorta. 
   The present invention utilizes a combination seal and suture grafting device of biodegradable or biocompatible material that is not dependent on wire and glue to hold graft and tube together. It also provides that the intimal layers of graft and tube are in good contact for sure and fast growth—certainly better than is possible with coaxial contact or gross manipulations with balloons and wire mesh. This is accomplished on the graft preoperatively by a cutting template so its ends are cut to the proper angle for intimal contact with the intima of the tubes it joins. This is maintained by cutting instruments that cut openings of the correct size in tubes so as to expose their intimal linings for proper joining of graft and tube. There is no maceration of delicate tubes involved in any cutting and no irritation by repeated driving of metal barbs though their frail walls. Stiff sutures are driven through the walls in a more delicate manner than provided even by manual suturing as no needle precedes the tiny sutures. The suturing of graft is also completed preoperatively so that only the final stitching to the tubes takes place during the operation. This requires only seconds and no heart stoppage. The sole reason for possibly stopping the heart would be to hold the graft against the heart without it bouncing away and this for no more than a minute. The dual balloon clamps of the present invention do not require heart stoppage as a vacuum device might. The present invention&#39;s annular balloons clamp on either side of the aortic wall at a distance from the opening so as not to squeeze the end of open tissue in a way that later impairs the union of its intimal layer with the intimal layer of the graft. The graft in the present invention is transported inside a catheter delivery tube where it is protected from inadvertent injury during transport and it does not suffer the double insult of eversion and reversion. The present invention does not involve placing a continuous guidewire from artery to aorta as other means appear less damaging. The present invention provides two techniques for manipulating the obvious electro, magnetic, energy sources for tracking the graft and delivery tube, a delay line between electromagnetic transmitter-receivers and a variation of the century-old Wheatstone&#39;s bridge network for detecting tiny differences in electrical signal strength. 
   The devices, pharmaceuticals and methods for accomplishing PCI are described in numerous publications, e.g., The Interventional Cardiac Catheterization Handbook by Morton J. Kern, second edition, 2004, Mosby, Elsevier Inc. To the extent appropriate, devices, methods, pharmaceuticals and general knowledge from such sources as describe that state of the art are applicable to the present devices and methods in various application situations. Of course things that are appropriate vary with the application. For instance heparin, nitroglycerin and certain other pharmaceuticals, appropriate in a homeostatic application would not be appropriate in an application to fallopian tubes or colon. However catheters would be common to all applications. 
   SUMMARY OF THE INVENTION 
   The present invention provides a double-seal device for making leak-proof anastomoses that connect the lumens of two native body tubes through a graft. The purpose is to make anastomoses more secure than can be achieved by suturing alone or sealing alone. A combination of devices and methods support this device in achieving five other objects. First, only seconds are required to make each anastomosis rather than the minutes required for manual suturing; second, no more collateral body damage than percutaneous entry; third, little or no heart stoppage required for coronary bypass operations and no time on bypass circulation machine; fourth, applicable to any vascular, urinary, pulmonary, alimentary, cerebral-spinal or other mammalian tracts and, fifth, the possibility of increasing the population that can tolerate a needed procedure, especially if reduced to an out-patient basis. The sealing graft core and sutures are manufactured of biodegradable materials absorbed by the body after the graft is complete, unless the option of the graft being a foreign body is exercised, wherein the devices are made of non-bioresorbing material. In any case the graft device is coated with appropriate growth supporting biochemical and/or endothelial cells as well as other pharmaceuticals. The first native tube is the site of percutaneous entry or, in some tracts, entry is through a natural body opening. After initial natural or percutaneous entry and intraluminal travel, the first opening to the field of surgery is cut from inside to outside the first tube, thus percutaneous intraluminal excisional surgery (PIES). 
   The devices and methods which constitute the preferred embodiment of the present invention are summarized as follows. A clamping catheter with a cutting balloon is advanced transluminally from the point of entry to the site of the anastomosis in the first tube. After cutting and clamping the wall opening at this site an explorer guidewire is advanced through the opening with one or more of five forms of devices for locating the target on the second tube. When located, the tip of the guidewire is screwed in as an anchor. 
   A delivery catheter slidingly fitted inside the clamping catheter is advanced on the explorer guidewire to the anchored target site. It contains a previously prepared length of graft attached to graft cores at each end by hollow sutures, posts and a circular suture. The brims of the distal and proximal graft cores are slightly compressed to enter the delivery tube. The delivery catheter also contains a catheter with a rodding balloon on its end fitted inside the graft core. The delivery catheter is capped by a holding balloon on which is mounted a cutting device. This makes a slit on the longitudinal axis of the second tube. The delivery tube is immediately pushed through the opening far enough that the brim of the graft core and holding balloon are in the lumen and the stem is in the opening. To remove the graft core from the delivery tube, the rodding balloon is partially inflated to engage the base of the graft core stem. The holding balloon is pulled back and the rodding balloon advanced sufficiently to grip the graft core while the delivery catheter is withdrawn. This allows the brim to expand in the lumen of the second tube and the wall of the second tube to close around the stem of the graft core. This forms a seal as pressure inside the lumen presses the graft core brim against the wall of the lumen which has the same shape as the brim. The key on the distal end of the rodding balloon is in a keyway inside the stem which aligns each rod with the proper stiff suture. The rodding balloon is fully inflated to bring the rods in line with the stiff sutures each is assigned to drive. The stiff suture that must travel the longest distance to enter the brim is in contact with the rod that will drive it first and therefore farthest and the stiff suture with the shortest distance to travel is placed in contact last. This may be accomplished by rods of different length or by stiff sutures at different distances from the base of the graft core. Either way, the rods are advanced through the hollow cones of the hollow sutures in which the stiff sutures are lodged. With the holding balloon pulling the brim of the graft core against the lumen wall, the rodding balloon is advanced, driving the sharp ends of the stiff sutures through the wall of the second tube and into the brim. Barbs prevent the stiff sutures from backing up from this position. 
   This completes the distal anastomosis with both sutures and seal in place. The cutting device and holding balloon are deflated and removed but the rodding balloon is left in the delivery tube to be used again with the proximal graft core. The delivery tube is withdrawn, with the proximal graft core and rodding balloon, to the site of the clamping balloons so that the proximal brim is in the lumen of the first tube and the stem in the opening. A proximal holding balloon (a mirror image of the distal holding balloon) is advanced through the clamping catheter to a position of pushing against the brim of the proximal core. The process of aligning the key in the keyway and gripping the graft core is performed before deflating the clamping balloons and withdrawing the clamping catheter from the immediate site. The delivery tube is then removed from the site while the proximal graft core is gripped. The rodding balloon is deflated slightly and advanced sufficiently to clear the longest rod distally from the interior of the stem, then inflated to align the rods with the stiff sutures they are to drive into the brim. The holding balloon is pushed against the brim and the rods are driven to complete the second anastomosis. The graft is now sutured and sealed. The devices are withdrawn and the percutaneous entry closed in the usual manner. 
   The anastomoses can be on different body tubes, e.g., vein and artery for dialysis or at proximal and distal points on the same tube, e.g., loops of the colon. The first tube may have branches with different names, any one of which can be the second tube, e.g., the aorta having branches called the left, right and circumferential coronary arteries. It may be noted that the skin can be one of the tubes, as in an operation for colostomy. 
   The term “first tube” refers here to the first tube entered for delivery of the devices rather than the first tube to receive an anastomosis. The term “second tube” refers to the second tube entered—even if it is a distal part or branch of the same tube with the same or a different anatomical name. To further avoid confusion it is pointed out that with the present devices and methods the second tube entered is the first to receive an anastomosis. 
   The devices and methods revealed here utilize the two transected ends of a graft, and thus do not produce a side-to-side graft. If adjacent tubes are to be joined with the devices and methods revealed here, the graft or grafts can be cut so short that the end-to-end graft functions like a side-to-side anastomosis. It may be noted that commonly, and particularly herein, the third tube is called the graft. So the terms used here for the body parts being joined are first tube, second tube and graft. These terms are generic and exact as well as simple and direct, an advantage in a discussion as abstract as a patent application. 
   The devices are made of collagen or other bioresorbable material that disappears after the graft has healed (become a stoma) or biocompatible material if the graft is to remain in the body as a foreign object. The devices are imbedded with such biochemicals as will support the growth at the sites of the anastomoses. Biochemicals that promote slipperiness may also be used as adhesives. The graft is obtained by customary harvesting means, from the patient or a donor unless a foreign body is selected from one of many non-biological sources. The devices and methods are designed to be used with PCI methods, pharmaceuticals and techniques. 
   More specific details are provided regarding this invention&#39;s devices and methods in application to a coronary bypass because the small sizes of coronary arteries make the sizes of devices critical. It is perceived as important to show that the invention&#39;s devices that must be stacked inside each other will still fit within small coronary arteries—down to a certain limiting size. This is not intended to limit the devices of the invention to this application, but to show details that are critical with respect to any body tubes of such small size. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  shows two tubes joined by a graft, visually the same product of the present invention and prior art. 
       FIG. 2   a  shows the preparation bench on which the graft is prepared prior to the operation. 
       FIG. 2   b  shows a cross-section of graft mounted on a cutting sleeve used to prepare the graft. 
       FIG. 3   a  shows a graft core with stem and brim. 
       FIG. 3   b  shows a view of the graft core with two hollow sutures inside the stem and posts snapped on their ends with a segment of circular suture between said posts. 
       FIG. 3   c  shows the relationship of hollow and stiff sutures with posts and a segment of the circular suture. 
       FIG. 3   d  shows a graft core with posts, hollow sutures and circular suture ring on the preparation bench with the graft coming out of the delivery tube ready to be mounted on the stem. 
       FIG. 4   a  shows the device for snapping together posts and hollow sutures. 
       FIG. 4   b  shows the compression tweeze device for compressing the brim of the graft core and pushing it into the delivery tube. 
       FIG. 4   c  shows the cross-section of a prepared graft sutured on the stem of a graft core at the 6 and 12 o&#39;clock positions by hollow sutures and posts. Angle of intersection and tangential angles are equal in this position. 
       FIG. 4   d  shows the same elements as shown in  FIG. 4   c  at the 3 and 9 o&#39;clock positions, noting how hollow sutures must point stiff sutures back toward the stem&#39;s longitudinal axis to intersect the brim from this position. 
       FIG. 4   e  shows the same elements as  FIG. 4   c  but at the 4 and 10 o&#39;clock positions. 
       FIG. 4   f  shows a rodding balloon with rods pointed distally and proximally. 
       FIG. 5   a  shows circular excision device with conical dart. 
       FIG. 5   b  shows a cylindrical cutting arm device. 
       FIG. 5   c  shows a cylindrical cutting arm device mounted in a catheter. 
       FIG. 5   d  shows a tracked slitting device with three views of blade mounted on cart as it is at successive positions along the track. 
       FIG. 5   e  shows a circular push-blade cutting device. 
       FIG. 5   f  shows a deflated tubular push-blade cutting device mounted on a holding balloon. 
       FIG. 5   g  shows an inflated tubular cutting device with blade exposed and mounted on a holding balloon. 
       FIG. 5   h  shows a tubular push-blade device deflated, folded and ready for withdrawal. 
       FIG. 6   a  shows the end of a clamping catheter with deflated clamping balloons and a dual channel made by a double wall. 
       FIG. 6   b  shows the clamping balloons inflated with radiopaque markers. 
       FIG. 6   c  shows a cross-sectional view of one semi-inflated clamping balloon. 
       FIG. 6   d  shows a cross-sectional view of a deflated clamping balloon. 
       FIG. 7  shows the explorer guidewire with screw tip and radiopaque longitudinal marker. 
       FIG. 8  shows the target guidewire with longitudinal radiopaque marker. 
       FIG. 9   a  shows the explorer guidewire with transmitting tip and target guidewire with a receiver tip. 
       FIG. 9   b  shows a transmitter on the tip of the explorer guidewire and a delay line to a second transmitter proximal to the longitudinal marker and a target guidewire with two receivers and delay line between them. 
       FIG. 9   c  shows two transmitters on the target guidewire and four receivers on the delivery tube. 
       FIG. 9   d  shows two transmitters mounted in the target guidewire surrounded by 4 receivers on the distal opening of the delivery tube. 
       FIG. 10   a  shows a holding balloon with embedded tubular cutting device and explorer guidewire. 
       FIG. 10   b  shows the inflated tubular push-blade with blade exposed. 
       FIG. 10   c  shows a deflated rodding balloon close to entering the stem of the graft core. 
       FIG. 10   d  shows a view of the inflated rodding entering the graft core with key and keyway aligned. 
       FIG. 11   a  shows the relationship of a cross-section of graft and wall of second tube with graft core, posts, hollow sutures and stiff sutures in a completed anastomosis. 
       FIG. 11   b  shows the same anastomosis as shown in  FIG. 10   a  from a different view. 
       FIG. 12   a  shows a graft core and plane erected at 90 degrees to the tangent to the stem at the point of erection thus forming the tangential angle between stem and brim at that point. 
       FIG. 12   b  shows the same erected plane tangent to another point on the stem and the tangential angle at that point. 
       FIG. 12   c  shows the plane and tangential angle at another point on the stem. 
       FIG. 12   d  shows the plane and tangential angle with cross-sections of two different grafts of different thicknesses which illustrates the longer distance the stiff suture must travel for greater thicknesses of graft and also how the stiff suture must be pointed back toward the target point on the brim for obtuse angles. 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     FIG. 1  shows the product of the present invention that is visually the same as that of prior art; the sides of a mammalian first tube  1  and second tube  2  connected by the transected ends of a graft  3 . The transected ends of said graft are also identified  4 ,  5 . The present invention has additional features that are not part of prior art, including a doubly sealed graft, no more collateral damage to the body than percutaneous entry, suturing accomplished in as many seconds as manual suturing requires minutes, no need to stop the heart more than for a few seconds in coronary bypass applications and potential for a larger population who can tolerate a procedure that may be virtually out-patient. 
   The innermost endothelial linings of two tubes, called intima, should be in contact all along their circumference for a graft to grow properly. The prior art leaves this to the surgeon&#39;s eye-hand coordination skill and a scissors. Many patent applications ignore the need or even thwart it in some ways. But in the preferred embodiment of this patent application means of accomplishing this intimal contact are provided without the surgeon&#39;s manual suturing skills, the imprecision of a scissors snip, the maceration of tissue, inadvertent or intentional separation of intimal layers. This process starts with graft  3  being prepared prior to the operation. 
     FIG. 2   a  shows a device called a preparation bench  6  for preparing graft  3  prior to the operation. Cutting sleeve  7  is mounted on support bracket  8 . The support bracket is movable along a measured slot  9  with measurement marks  17 . This provides the means for accurately cutting the graft to the correct length. One cutting sleeve provides the means of making the transected end  5  of graft  3  the correct circumference and shape. The other cutting sleeve is for the other end  4  of said graft  3  and the second tube  2 . The two shapes are based on the shape of the junction between said graft and first tube and said graft and second tube (usually different). The junction of the end of one cylinder (e.g., graft  3 ) and the side of another cylinder (e.g., either tube  1  or  2 ) is a complex three dimensional oval curve that is a function of their relative sizes and the angle at which they are joined. Along the center of the bench is the delivery tube  10  on a rest  11 . A graft core  12  is shown mounted on the other support bracket. Graft core  12  is placed there after both graft ends are cut and shaped. Then one sleeve is removed and replaced by graft core  12 . The cutting sleeve and graft cores are the same dimensions and so fit on the same supports. The end of the graft is taken from the cutting sleeve and placed on the graft core and sutured there. The graft  3  with graft cores  12  sutured to each end, will be encapsulated inside the delivery tube  10  as the final step accomplished on the bench  6 . The graft cores  12  will be slightly compressed as they are pushed into the ends of the delivery tube  10 . So the graft  3  must be placed in the delivery tube while its ends are free of these graft cores  12 . The details of the graft cores will be shown and discussed after the preparation process with the cutting sleeve  7  is finished. 
   The length of the bench  6  as shown is somewhat shorter than the typical size in an application in order that both ends can be seen clearly in one figure. The bench must be securely fastened to a stable table for use. 
     FIG. 2   b  shows a detailed view of a cutting sleeve  7  of the correct diameter mounted on the support bracket  8 . The basis for selecting the correct outside diameter for the sleeve  7  is the estimated diameter of the smaller of the two tubes  1 ,  2  less (about) twice the thickness of the wall of the graft. One end of graft  3  is drawn up to mark  13 . Graft  3  is shown only in cross-section as a white space at the top and bottom of the sleeve so the elements of the sleeve can be viewed. To make the ends of said graft the same diameter as the cutting sleeve, a cut is made with a scalpel on the longitudinal axis of the graft from mark  13  to the sleeve&#39;s base  14 . This cut is where the white cross-section of the graft is shown on top of the sleeve. Folding the cut sides of the graft together, another (almost parallel) cut is made such that the two sides come together evenly. This is done so the end of the graft will fit snugly (without pulling) around the cutting sleeve  7 . If the part harvested as a graft is a vein, the direction of flow in its lumen must be in the same direction as in its previous location. Thus veins are reversed bringing their smaller diameter to join the (larger) first tube and larger diameter to the second (smaller) tube. Slitting the graft during preparation allows the circumference of the two graft cores to be the same—the same size as the stems which are the same diameter. The size of the opening in the first tube must be the same size as the opening made in the second tube and that circumference must be the same as that of the stem(s). Problems regarding fluid flow are thereby minimized. 
   The guiding groove  15  is a template for inserting a scalpel and guiding it along the groove. Said groove  15  is in the shape made by the end-to-side intersection of two cylinders at the angle the user intends to use in the application. The internal angle of said groove is continuously varying along its sinuous path. It guides the scalpel to cut an acute bevel on the graft. This bevel is cut back from the innermost layer of the graft to the outermost layer in order to expose the inner layer without outer layers overlaying it. This acute angle varies for every point on the junction and is one-half the tangential angle between graft and tube at that point. This tangential angle may be determined by erecting a plane at a right angle to the tangent at a given point on the junction. This plane will intersect graft and tube to display the angle between them. The miter angle between graft and tube is one half the tangential angle. It provides half the space for the graft end and half for the wall of the open tube. In this way the intimal layers of graft and tube are exposed to each other around the circumference of the anastomoses. This is best described in the context of graft cores  12 . It is sufficient to point out here that the shape and angles imposed by this guide are more complex than can readily be made free-hand with scalpel or scissors. 
   Short hypodermic needles  16  are pushed by a lever through holes and on through the graft  3 . A vacuum may be introduced through the needles in situations where greater precision is desired. With or without vacuum, the preparer anticipates and coordinates this action with use of a sponge for pressing graft  3  gently against the needles  16  as they emerge and pass through the graft  3 . The needles deposit a small amount of marker dye so the locations on the graft  3  will be apparent when it is mounted on the graft core  12 . The number of hollow needles  16  varies with the application, but for convenience the number twelve will be used here with the understanding that the term “or whatever number” will not be used over and over in this description each time it is appropriate, but is intended as generally applied. The spacing of the needles can also be varied. For instance there may be two close together and then a larger space to the next one, etc. Again, only for convenience of discussion these twelve will be placed at the twelve “clock” positions. 
   At the other end of the bench the other end of tube  3  is on a cutting sleeve  7  that has a groove based on the junction between that end of the graft and the tube to which it will be joined. At this step the graft is measured for the exact length desired. The supporting bracket  8  for said cutting sleeve  7  is mounted in a slot  9  where it can be moved back and forth and locked in place at the measurement mark  17  that reads the distance between the guiding grooves  15  on the two sleeves. This end of the graft is drawn so it is without kinks but not tight and placed on the other cutting sleeve, as the preparer sets the desired length on measurement mark  17  of slot  9 . It is the distance between the sites chosen for anastomosis on the first and second tubes and must not be too long or the graft will form kinks that inhibit flow, or so short that the graft  3  will not reach or be somewhat stretched between the selected sites. The desired sites and length are determined by ultrasound or other devices prior to preparation. The scale on the slot  9  provides that the desired length is the length actually cut. When the cutting process is completed on the second sleeve, one cutting sleeve  7  is removed from its mounting bracket and a graft core  12  put on that support bracket  8 . Since all devices are sized to work together the graft core has the same inside diameter as the cutting sleeve and fits on the support bracket in the same position. 
     FIG. 3   a  shows graft core  12 . The core consists of a stem  18  and a brim  19 . The junction  20  between the two is a complex curve created by the intersection of two cylinders and matches the size and shape of the guiding groove  15  on the cutting sleeve  7 . The angle  21  at which the longitudinal axis of the stem  18  intersects the longitudinal axis of the brim  19  may be at any angle. In certain application situations, e.g., CABG, surgeons prefer angles between thirty and forty-five degrees (plus or minus). Each possible angle of intersection  21  produces a different complex curve for the junction  20  and a different set of tangential angles between the stem and brim at each point around the junction. However, it is cumbersome to show figures with several angles  21  and a set of tangential angles for each. So this patent application will use forty-five degrees and mean any number, plus or minus from that. And the tangential angles at the representative clock positions will be used as illustrative of all such angles. In some few cases ninety degrees will be used for illustrative purposes. Each application situation has tubes of characteristic dimensions, but the relationship of the dimensions of the suite of devices in the preferred embodiment of this invention remain (approximately) the same. 
   The outside surface  22  of the brim  19  has the curvature and dimensions of the lumen of the tube into which it is to be placed in intimate contact and thus create a seal. The lumens of body tubes have deviations from being perfect cylinders for various reasons. And the brim may deviate from a perfectly smooth surface if it is found advantageous to place a small trench and bump to catch stiff sutures that enter the brim at a very oblique angle. Whether this ‘imperfection’ in the surface would promote a blood clot is not known but probably not as the stiff suture in the trench might create sufficient surface tension to keep fluid from entering the trench. So, while perfection is not possible, certain rules-of-thumb are followed to make the fit as good as practicable. For instance, in the case of a lumen of 3.5 millimeters (its diameter) the curve of the outside surface  22  of brim  19  has a radius of 1.75 millimeters. The rule-of thumb for the thickness of the brim is about ten percent of the diameter of the lumen of the smaller of tubes  1  and  2 . Thus the brim which is to be placed in the smaller lumen of 3.5 mm would have a thickness of about 0.35 mm. That thickness makes the radius of curvature of the inside surface  23  of the brim (about) 1.05 mm. That is 1.75 mm minus two times the 0.35 mm. thickness, i.e., 1.75−0.7=1.05. The stem  13  has an outside surface  24  radius about equal to the inside surface  23  radius of the brim  19  and a thickness about the same as that of the brim (0.35 mm in this example). In addition the brim is flexible and thus adjusts its shape to that of the lumen for a seal that is at least temporarily a good one. When sutures enter the brim and draw it into tighter contact with the lumen the resulting flexible seal is better than can be achieved by pressure from the fluid alone (as with other patent applications) and the sutures add the second seal that is the only seal under prior art. 
   The outside surface  22  radius of the brim  19  of graft core  12 , to be placed in the larger lumen of the first tube will have the curvature of the radius of that lumen. But the stem  18  of that graft core  12  will be the same size as the stem  18  of graft core  12  for the (usually smaller) second tube. The thickness of the stem  18  and the brim  19  is the same or similar for the distal and proximal graft cores. If the lumen of the first tube  1  is several times the diameter of the second tube  2 , the radius of curvature of that brim is fairly flat with respect to the curvature of the brim that is lodged in the smaller lumen. This would be the case in a situation where the second tube is a corollary artery and the first tube the ascending aorta. The exact sizes of the two tubes to be joined will vary by application situation but the size relationships noted here should be considered as useful rules-of-thumb for sizing a package or kit of coordinately sized devices for a given application situation. 
     FIG. 3   b  shows another view of the graft core  12 . In this view the base of said graft core is shown as open so two of the (nominally) twelve hollow sutures  25  inside the stem can be seen. In this figure the hollow sutures  25  start at the base of the graft core and make a forty-five degree turn to come out of the stem radially at a certain angle and distance from the junction  20  of brim and stem. This distance is a function of both the tangential angle between the stem and brim and the thickness of the graft. The angle at which the hollow suture exits the stem can be any acute angle, but 45 degrees and 30 degrees are used as examples. The thickness of the graft affects how far the lip of the brim should be extruded beyond the stem as well as the length of the stem. These relationships are described in a later paragraph along with illustrative tangential angles between brim and stem. 
   These tangential angles are determiners of how far each stiff suture must be driven to enter the brim, along with the thickness of the graft. The perpendicular distance between the surface of the stem and the end of the hollow suture  25  is slightly more than the thickness of the graft so the hollow suture end will extend slightly beyond the graft. The two hollow sutures shown here represent the (nominally) twelve that are located at the clock positions. The 6 o&#39;clock position is in the “heel” and the 12 o&#39;clock position the “toe” position, using the “foot’ terms common in the context of CABG procedures. Each hollow suture  25  will be placed in one of the dye-marked holes cut in the graft by hypodermic needles  16 . The ends of the hollow sutures that come out of the surface of graft  3  are all at the same distance from the junction  20 . There is a post  26  for each hollow suture. The length of the post depends on the thickness of the graft and the acuteness of the tangential angle between brim and stem at the point on the junction where the post is placed to meet its corresponding hollow suture. The opening at the end of each hollow suture  27  is oriented toward the brim. The exact orientation is a function of the angle between brim and stem. 
     FIG. 3   c  shows the size relationship of the stiff suture  27  to the hollow suture  25 . The post  26 , when pressed and snapped on the end of the hollow suture  25  (as shown) holds it in place and is the second side of the suture holding the graft to the stem  18 . One segment of the circular suture  29  is shown attached to the post. A hollow cone  28  flares from the base of each hollow suture  25 . The stiff suture is shown outside the hollow suture here, but in practice it is located inside the hollow suture. One segment of circular suture  29  which connects all posts in a ring is shown. When a metal rod (not shown in this figure) of the same diameter as the stiff suture  27  is introduced into the hollow cone  28  at the base of the graft core it rests against the stiff suture  27 . Pushing the rod while holding the graft core  12  drives the stiff suture out the end of the hollow suture through the wall of tube  1  or  2  and into the brim  19 . The stiff suture  27  is barbed so it will not retract once driven forward. The barbs are lodged in the brim  19  and in the hollow suture  25 . The length of the driving rods is such that they drive the stiff sutures the correct distance for entering the brim. These operations are introduced at this point to aid in describing the graft core  12 . There is work with the graft core on the preparation bench  6  before the stiff sutures  27  are driven during the operation. 
     FIG. 3   d  shows one end of the preparation bench  6  with a graft core  12  mounted in place of the cutting sleeve. The preparer normally places the end of the graft directly on the graft core after said sleeve is removed from the support arm  8 . For purposes of illustrating what the end  4  looks like it has been allowed to hang out of the delivery tube  13  with the slit showing. The preparer utilizes the flexibility in circumference provided by the slit to wrap the end  4  around the stem  18  of the graft core  12  where the (nominally) twelve hollow sutures  25  are sticking out. The slit enables the preparer to slip one hollow suture  25  at a time through the dye-marked openings in the graft  3  as its end  4  is wrapped around the stem  18 . The hollow sutures  25  are shown emerging from the stem  18  and the posts  26  coming from the junction with rings on their ends for snapping on the hollow sutures and the circular suture  29  tying together the ends of the posts. At the time of manufacture the posts are connected in the circular suture  29  except for one or more open link(s). The open link(s) allows the circular suture to be pushed away from interfering with the manipulation of hollow sutures and posts. 
   After the ring on each post has been snapped on its hollow suture by a snapper device shown in  FIG. 4   a , the open link of the circular suture is snapped together. This makes the circular suture the circumference and the posts spokes going back to the junction  20 . The purpose of the circular suture is to stabilize the location of each hollow suture and to prevent the individual hollow sutures from being forced backward when the stiff sutures are driven forward from their ends. As the stiff sutures all push through the wall of the tube being anastomized to the graft, there is considerable back pressure on the ends of the hollow sutures from which the stiff sutures issue. This circular suture  29  will not increase in circumference and so tends to prevent the hollow sutures from backing up. The hollow sutures and posts are manufactured so the exit point of each hollow suture is pointed at the outer circumference of the brim. At certain clock positions this is straight out, at others there is an inward bend. This makes the stiff sutures inside the hollow sutures pointed at their target on the brim. 
     FIG. 4   c  shows a cross-section of graft  3  mounted on the stem  18  by hollow sutures  25  and posts  26 . The angle of intersection of the longitudinal axes of stem  18  and brim  19  is 45 degrees as seen in the angle at the bottom of the figure (the 6 o&#39;clock position). The complement of 45 degrees is 135 degrees, as seen between the stem and brim at the top of the figure (the 12 o&#39;clock position). At the 6 and 12 o&#39;clock positions the tangential angles are the same as the angles of intersection. One half of the tangential angles is the miter angle. The end of the graft is cut to this angle by the guide on the cutting sleeve and is shown cut to that miter angle in the figure. The miter angle is also the angle of the post, as likewise seen in the figure. The miter angle leaves an equal amount of space for the wall of the tube as it folds around the brim and therefore an (approximately) equal amount of wall tissue for the stiff suture to cut through on the way to the brim. The hollow suture is shown emerging from the stem at an angle of 45 degrees. This angle could be some other value but 45 degrees allows a proper “bite” of graft tissue to be caught in the triangle between hollow suture, post and stem. The graft is thus sutured to the stem during the preoperation preparation. All that remains to complete the suturing is pushing the stiff sutures inside the hollow sutures through the wall of the tube and into the brim.  FIG. 4   d  shows a cross-section of the graft on the stem at the 3 and 9 o&#39;clock positions. At these positions the angle of intersection and tangential angles are different. The tangential angle between stem and brim is about 167 degrees at these positions. The miter angle is half the tangential or about 84 degrees and the graft is shown as cut to that angle by the guide on the cutting sleeve. The post emerges from the junction at that angle and the hollow suture shown emerging at 45 degrees. The angle at which the stiff suture must emerge from the hollow suture is also about 84 degrees back toward the longitudinal axis of the stem. This is in order to intersect the brim.  FIG. 4   e  shows the 4 and 10 o&#39;clock positions for the same elements. In this case the hollow sutures point the stiff sutures approximately in line with the longitudinal axis of the stem. 
   The process is repeated on the other end  5  of graft  3 . The slits in the ends  4 ,  5  of the graft  3  are now sutured together by hand. When this is accomplished graft  3  is sutured to a graft core  12  on each end. After the graft cores are sutured to each end of the graft the preparation on the bench is finished by using a compression tool  30  shown in  FIG. 4   b  to compress the brim and push it inside the delivery tube (still on its rest on the bench). When this is accomplished on both ends, the delivery tube is connected to a delivery catheter of the same diameter and of an appropriate length for conducting the operation. 
   The graft core is fabricated from biodegradable or biocompatible material. Biodegradable if the stoma is to be physiologic. Biocompatible if the graft core and graft are to remain in the body permanently. Suitable biodegradable substances are certain collagens, sugars, hydrogels, lactides and other material known to have a certain period for absorption by the body (resorbtion). Biocompatible materials include certain polymers, elastomers and silicones. The sutures of the graft core may be of the same or similar material, but of different characteristics. The hollow sutures are bonded inside the body of the stem ending at the base of the stem and may be made of a slightly harder material than the stem to facilitate the smooth forward movement of the stiff sutures inside them, but not so hard that the barbs on the stiff sutures will not engage. The stiff sutures are made of a still harder and stiffer form of the same biodegradable material as they must puncture the brim as well as the walls of the first and second tubes. The material for stiff sutures must bend sufficiently as to bulge slightly if the tube in which the graft core is lodged moves with the beat of the heart. The entire core, brim and stem will move with the beat but the brim may be affected first and thus the need for a slight bending of the stiff suture until the stem follows. The ends of stiff suture must retain a sharp edge to reduce friction as they are driven through the walls and brim. Since the brim is compressed when placed in the delivery tube, the brim must be manufactured of pliable material that will return to its original shape after this deformation. The brim is also soft enough to allow puncture by the stiff sutures. Chemicals for stimulating growth of the grafts are imbedded in the junction between brim and stem at manufacture. Chemicals to make the openings in walls slip over the brim in the desired direction may also be applied. 
   Applications where the graft core and graft are to remain in the body permanently are bonded together. They may be made of the same or different material at the factory. In any case, the hollow sutures are made of a harder inert material than the graft core, and the stiff sutures of an even stiffer material. An epoxy glue of the type that bonds when the A and B parts are mixed may be used to make a long-lasting bond between stiff sutures and the brim. Part A is in the brim and part B on the stiff sutures. The thin layers of A and B mix as the stiff sutures move through the brim. The stiff sutures must be of a material flexible enough to resist breaking from a plurality of heart beats if they are flexed for years of such beating. 
     FIG. 4   f  shows a rodding balloon  31 . Its twelve rods  32  are exposed in the distal and proximal directions so that it can be used for pushing the stiff sutures  27  in the distal graft core  12  through the second body and then without having to remove the rodding balloon, its proximal rods are used to pull against the stiff sutures  27  in the proximal graft core  12  driving them through the first body part. The rodding catheter  33  to which the rodding balloon is attached is also shown. The key  34  is also shown as it is attached to the distal end of the catheter. This key is small but can be seen in this view. The function of the key will be discussed in the context of the figure which shows the matching keyway inside the stem of the graft core—where it is almost hidden from view. When the rodding balloon  31  is advanced, the rods  32  push the stiff sutures  27  from the base of the core stem to the point where it turns at forty-five degrees (for instance) to emerge from the stem. This action moves the stiff sutures  27  into the brim. The stiff sutures have barbs on their surface to keep them in the position to which they are advanced. These are embedded in the brim and in the hollow sutures from the point where they turn to emerge from the stem. If the bond of stiff suture and brim is not strong enough a small amount of appropriate glue may be added at the place where the stiff suture enters the brim. This action with the rodding balloon is performed later, when the brim is inside the lumen of the second tube. The purpose in introducing the rodding balloon now is to show how the stiff sutures are driven. More details regarding the rodding balloon and the graft core  12  will be shown when the brim is in the lumen of the second tube  2  and the stem in the artificial opening slit in the wall of the second tube. A less preferred embodiment of the rodding balloon is to utilize two, a distal and a proximal, with rods facing in only one direction. This alternative embodiment is sufficiently obvious as not to need an illustration. The advantage of combining rods in both directions is that one rodding balloon need not be withdrawn for the other to be advanced. If there are application situations where the anastomosis with the first tube  1  is much larger than with the second  2 , one rodding balloon  31  may not be capable of changing diameter to the extent necessary. Then distal and proximal rodding balloons of different sizes would be required. 
   Cutting devices are needed to exit the first tube and enter the second tube. There are a variety of conditions in which the tubes of the body exist. It may be expected that cutting devices of various types will be needed for this diversity of conditions. To accommodate this, five alternative embodiments of the invention provide five cutting devices. Each is designed for use in certain conditions that would be encountered in an application situation. Variations on these five are obvious. 
     FIG. 5   a  shows the embodiment of circular excision device  35  in the inflated state. A relatively large diameter first tube is required to maneuver this device to a position of about ninety degrees with respect to the tube wall. The circular microtome blade  36  excises a disk of tissue. The advantage of a disk is that the endothelial layer is thus equally exposed around the entire circumference. This is not the case with a slit. It is not the case with devices that twist their way through said wall throwing off bits of tissue like a meat grinder. The cruciform conical arrow  38  and its guidewire  39  are manipulated independently of the balloon and pass through a tunnel in the center of the balloon. The balloon is mounted on a catheter advanced through the clamping catheter to the target site of anastomosis. The clamping catheter is maneuvered to about ninety degrees with respect to the wall at the target site. The balloon is inflated causing the circular microtome blade  36  to extend from the distal end of the balloon as shown. The cruciform conical arrow  38  is pushed by its guidewire  39  out of the tunnel running through the balloon and through the wall of tube  1 . The serrated microtome blade  36  is pushed forward cutting a disc of tissue from the wall. Blade  36  has sufficient depth to cut entirely through (the expected) thickness of the first tube wall so there are no tissue connections holding the disc to the wall. The blade is serrated to engage cutting the tissue at an angle. The number of serrations is variable. The four shown are merely for example. The shape of the serrations is such that no twisting of the blade is needed. That is because in many applications, including those in the aorta, twisting the catheter on which the balloon is mounted would be likely to move said catheter away from its location. Radiopaque markers on the blade serrations show on the fluoroscopic equipment when the blade is through the wall. At this point the conical arrow  38  is withdrawn into the balloon tunnel. The balloon is deflated. This returns the blade to a protected position inside the excision balloon  37 . The balloon  37  and conical arrow are withdrawn into the tunnel in the balloon with the tissue disc spitted on the guidewire  39 . The blunt proximal side of the conical arrow  38  keeps it on while it is safely put away in the tunnel. Said device is removed through the clamping catheter outside the body. 
     FIG. 5   b  shows the cylindrical slicing device  40  in two views, inside and outside the cylinder  41  that encases the mechanism. This device is used in situations where the blade arm  42  must operate at (more or less) right angles to the axis of the catheter in which it is advanced. Cutting device  40  requires a situation where there are no body parts in the arc of the blade between the catheter and the tube being cut. The cylinder  41  encasing the microtome blade arm  42  is of a diameter to fit snugly in the catheter through which it is advanced. A radioplaque marker  43  on the distal end of the cylinder is compared to a marker on the end of the delivery tube  10  to advance the cylinder sufficiently to expose the slot  48  in the cylinder through which the blade arm  42  will travel, while leaving a sufficient portion of the cylinder  41  inside the clamping catheter for support. The operator pulls back on the control (not shown and exterior to the mammalian body) which draws the guidewire  44  back between two pulleys  45  embedded in the wall of the cylinder. This deploys the blade arm  42  through its arc. The blade arm is attached at the proximal end to a spring  46  whose other end is connected to a support rod  47 . The support rod  47  is embedded in the cylinder wall opposite the slot  48  where the blade arm emerges when pulled. Once the cut is made the spring returns the blade arm  42  inside the cylinder  41 .  FIG. 5   c  shows this device  43  being advanced forward of the delivery tube  10  to cut a tube  2  with blade arm  42 . 
     FIG. 5   d  shows two views of a tracked slitter  49 . This form of cutting device has the advantage of not needing to be deflated after cutting. Said device may be advanced into the lumen immediately as the blade is hidden at the end of the track. It&#39;s track  50  is shown here as a cylinder with a slot above, except at its end. The track  50  could be of a different shape. The important characteristic of said track is that it is slidably engaged with a moving element  52  so as not to wobble or twist as it is drawn through the tunnel  51 . The moving element  52  is shown at three locations along the track, beginning, middle and end. Said moving element  52  is shown above the track so as not to obscure it from view. The moving element  52  has a slot in it to accommodate the swivel blade  53  when it rises. The swivel blade is pivotally mounted on axle  54  that turns in the body of the moving element  52 . The swivel blade&#39;s original position in the track is lying fiat in the tunnel, blade up. When the blade is pulled by a guidewire  55  (not shown in its entirety as its path is obvious as it extends above the slot in the track and it would obscure many things if shown) attached to a pin  56  extending from the side of the blade, the swivel blade rises to the erect position (center image). The blade is held there by a bar  57  across the moving element. Continued pull on the guidewire  55  drags the erect blade  53  along the length of the track. The track can be any length. The blade may be any length. The blade cuts as it moves. When it is a little more than blade&#39;s length from the end of the track, a lever  58  attached to the top of the track engages the bar  57  and pushes it down. Bar  57  drops, and without it to hold the blade erect, the blade  53  drops as well. The blade descends into the track tunnel, blade down. The pulling guidewire  55  leads to a pulley  59 . The pulling guidewire turns back 180 degrees on said pulley  59 . Said guidewire leads to another pulley  60  near the midpoint of the track (not visible in figure) where it turns ninety degrees on that pulley and exits at the midpoint of the track. Said guidewire then continues in the delivery tube and back to the operator. Continued pulling on this guidewire pulls the moving element through a hinged bar  61  into a receptacle  62  where the cylinder  50  is covered. The hinged bar is spring-loaded and closes behind the moving element. Pushing back on the pulling guidewire  55  does not open the door or free the moving element from the receptacle. A push on the guidewire  55  releases the latch that holds the two halves of the track together. This causes the track to unlock from its straight position and bend at the middle. The hinge  63  on its upper side swings so the two halves of the track fold against each other. Now pulling on the pulling guidewire  55  draws the folded track back through the delivery catheter. The folded track occupies only a small space and so can be withdrawn through a small opening. The tracked slitter may be removed with the holding balloon on which it is mounted or drawn through the center opening in the holding balloon. 
     FIG. 5   e  shows a circular push-blade balloon  64 . It is an alternative to the circular excision device. It does not require a ninety degree (square) approach to the wall to be cut. However it cannot be used at an angle much more acute than that. It has the advantage of moving forward with the catheter behind it also moving forward. It may be used with the first or second tube, so long as the second tube is large enough that the blade does not endanger the side opposite the cut. Either way it may save some seconds in moving the catheter forward after cutting. This may be of primary importance in some situations. It consists of a non-compliant body  65 , a compliant extender  66  which exposes the microtome blade  67  when inflated. When the balloon is semi-deflated the blade folds into the extender  66  and the extender folds back into the body  65  of the balloon. 
     FIG. 5   f  shows the deflated tubular push-blade balloon  68  as it is normally mounted, on a holding balloon  69 .  FIG. 5   g  shows the tubular push-blade balloon  68  inflated to extend the blade. The tubular push-blade balloon  68  has the advantage of saving seconds in certain situations. Its disadvantage is when the second tube is small, the blade may be pushed forward too far and cut into the other side. If used with a small second tube the push-blade balloon must be deflated immediately after cutting to protect the opposite wall of the second tube from injury caused by an exposed blade. The holding balloon  69  is of the same shape as the brim which it holds and the same radius as the inside surface of the brim being held. The holding balloon has its own inflation lumen and guidewire (not shown).  FIG. 5   h  shows the tubular push-blade deflated and folded ready to be withdrawn through the center opening in the holding balloon. In some situations the tubular push-blade balloon will not be folded and withdrawn before the holding balloon is also folded and withdrawn. 
   Equipment common to PCI catheter labs are fluoroscopic devices for viewing tissue, radiopaque markers and contrast emitted from catheters. The screens on fluoroscopes often show the target from different directions allowing the Interventionist to combine images in a mental three-dimensional view. These devices help thread a guiding catheter through the branches of the femoral artery into the ascending aorta, and then position the catheter at a right angle with respect to the ostium or entry point to the targeted coronary artery. These devices and other localizing equipment are appropriate for use in the present state-of-the-art applications, examples of which have been cited, as well as with the present suite of devices and methods. 
     FIG. 6   a  shows the distal end of the clamping catheter  70  with two rings of clamping balloons  71  and  72  in their deflated state, around the clamping catheter  70 . The clamping catheter is of the appropriate length and diameter (greater than that of the delivery tube) for use in the application situation. The opening in the first tube is cut to fit the circumference of the stem of the graft core, not that of the larger clamping catheter. Thus pushing the clamping catheter through the smaller opening forces the wall to a larger circumference. When the clamp is removed the wall will return to the original unstretched size of the opening made for the stem. The clamping catheter  70  is made in sizes and shapes that duplicate those of guiding and diagnostic catheters and is advanced through a sheath using the same methods and skills as normally used in PCI procedures. The shapes have names such as Judkins, Amplatz, Arani, etc. These are designed for maneuvering in the femoral artery, aorta and coronary arteries. Application situations other than these served by present state of the PCI art will undoubtedly require other shapes and sizes. The preferred embodiment of the devices and methods of the invention disclosed here include such shapes for the clamping catheter as are in common use in PCI situations but do not include such shapes and sizes as may be required for all application situations. Whatever shape and size is selected, the clamping catheter is advanced through a natural or percutaneous entry to the site of anastomosis in first tube. 
   In  FIG. 6   a  it may also be seen that the clamping catheter has a double wall  73  with a divider  74  between the halves of the crescent-shaped conduit made by the double wall. It should be noted that any conduits for carrying the liquid that inflates the clamping balloons must take up space either inside or outside the wall of a single wall catheter. That is, they cannot be coincident with the catheter wall. Because of the need to inflate the balloons quickly, this non-tubular conduit is designed to carry a larger volume than would two tubes that increase the diameter of the clamping catheter as much as does the double wall. An additional volume of fluid flows in the “wings’ of the crescent. One half of this crescent-shaped conduit has an entry port to the distal balloon  71  and the other half an entry port to the proximal balloon  72 . Neither port can be seen in this view. The end of the clamping catheter is open in this diagram in order to view what is inside. 
     FIG. 6   b  shows the distal clamping balloon  71  and proximal balloon  72  in their inflated state. Radiopaque markers  75  are on the balloons and on the distal end of the clamping catheter  70  for use in determining their location by fluoroscopic means. After the wall of the first tube has been cut, probably by a circular excision balloon, it must be immediately clamped. The proximal clamping balloon  72  may be inflated prior to cutting but the distal balloon must remain deflated in order to fit through the opening cut. The size of the Opening will be smaller than the circumference of the clamping catheter in order to fit the stem of the proximal graft core that will later be lodged in the opening. The wall of the first tube  1  goes between them but is not shown in order for the balloons to be seen. 
     FIG. 6   c  shows a cross-sectional view of one inflated clamping balloon. The curved member  76  is made of compliant material while the straight portions  77  are made of non-compliant material. The clamping balloons are not simply unshaped balloons but specially shaped so that they do not touch the opening directly but create a ring of pressure at some distance from the opening in the wall. The compliant material bulges around the balloon&#39;s circumference to squeeze the wall in proportion to the amount of inflation pressure. The pressure is adjusted to achieve the minimum balloon pressure that will control bleeding from the open cut and loss of fluid from the lumen of first tube. Once this is achieved the clamping catheter is ready to perform its role as a guiding catheter for all devices advanced through it. The cutting device is withdrawn. 
     FIG. 6   d  shows a cross-section of the deflated distal clamping balloon  71  in a semi-inflated state and a conceptual diagram of the cross section. The purpose of these diagrams is to show how the compliant  76  segment and the non-compliant straight sections are folded. The support section  77  is made of non-compliant material. It is important not to distort, collapse or injure the intimal layer or the native state of the tissue surrounding the opening or it will not join properly with the end of the graft. The support section keeps the circumference of the interface section a small distance away from the catheter to avoid clamping directly on the open end of tissue resting on the catheter. As pressure is increased in the balloon the support section unfolds in relatively straight surfaces between the fold lines while the compliant material of the interface section bulges out in proportion to the internal pressure. This provides the necessary control of the amount of clamping pressure being applied to the two sides of the wall of the first tube. The pressure must be sufficient to stop bleeding and to seal the opening to prevent leakage of fluid from the first tube without inducing spasms. 
   The circular excision device is most likely to be used to cut the opening at the first tube site. Though others could be used, the figures and words used to describe subsequent methods are consistent with an approach to the wall of the first tube at ninety degrees. No time should be lost in moving the clamping catheter  70  into the opening and inflating the clamping balloons  71 , one on each side of the wall of the first tube to stop bleeding from the excision and to prevent escape of the tube&#39;s fluid through the new opening. The proximal balloon may be inflated before the cut is made so that the clamping catheter may be advanced immediately through the opening and up to the point where the proximal balloon prevents it from advancing further. At this point the distal balloon may be quickly inflated. Radiopaque markers on the clamping catheter and balloons provide another method of ensuring that the distal balloon ring is exterior to the wall and the proximal balloon interior to the wall. 
     FIG. 7  shows the distal end of the explorer guidewire  79 . Said guidewire is steerable by a J-tip bent by the physician to the shape wanted for the situation. The curve allows the wire to be guided in the direction of the bend by rotating the guidewire slightly with a torque tool that slides over the proximal end of the guidewire. The tip also has screw threads  80  on it. This enables the physician to embed it in the second tube when the target area is located. The distal end of the explorer guidewire also has an opaque marker  81  along its length. This allows it to be seen in orthogonal views of the fluoroscopic display. Thus it can be maneuvered in three dimensions. 
   Finding the target area will be more difficult in some application situations. For these a target guidewire  82  can be advanced to the target area through the second tube  2 .  FIG. 8  shows a target guidewire  82  in the second tube  2 , with its longitudinal opaque marker  83  lining up with the marker  81  on the explorer guidewire tip. This makes the longitudinal axes of the two tubes parallel as well as close as seen in the two orthogonal fluoroscopic views. The screw-threaded tip can now be twisted into the second tube at the target area. The delivery tube is advanced immediately to make the slit at the target, so the embedded tip does not have to remain in place for more than a few seconds. Improvements in fluoroscopic devices are in one of the faster growing fields, so orthogonal fluoroscopic images will be available in most well-equipped catheter laboratories. Another device can be used if fluoroscopic images are not adequate. 
     FIG. 9   a  shows the explorer guidewire  79  with its screw tip  80  as a transmitter and the target guidewire  82  with a receiver tip  84 . The RF signal to the transmitter is sent through the wire of the explorer guidewire, thus requiring no added space. The connection from the receiver to a display may require two wires. In this case a dual guidewire would be used as there is adequate space for guidewires in the second tube. Signal strength increases as the distance between transmitter and receiver decreases and the display would show this to guide the transmitter and receiver until only the wall of the second tube separates them. 
   Since it is important for the slit to be aligned precisely on the longitudinal axis of the second tube, two transmitters and receivers in line may be used in more difficult situations. The same RF signal is used for the two transmitters and receivers but a time delay line is placed between the two so they are distinguishable in time. The circuit in the display is sensitive to the strength of signal between the transmitter-receiver pair that send and receive at the same time. Thus when each pair is separated only by the wall of the second tube they are in longitudinal alignment as well as in immediate proximity. 
     FIG. 9   b  shows the locations of the two transmitters  80  and  85 , with a time delay line  86  between them. Also shown are receivers  84  and  87  with the time delay line  88  between them. The opaque markers  81  and  83  are in white rather than black, as used in previous figures.  FIG. 9   c  shows and south (S) and north (N) poles of electomagnet  101  in target guidewire  82 . This is a magnetic alternative to two RF transmitters. The electro-magnet may have sufficient strength to draw the cutting blade toward it and keep the blade in place even with a beating heart. To increase the strength of attraction the blade may be magnetized as a permanent magnet. Care must be taken to mark its poles so they are appropriately aligned opposite the N and S poles in explorer guidewire  79 . 
     FIG. 9   d  shows two transmitters  84  and  87  with delay line  86  between them mounted in the target guidewire  82  surrounded by four receivers  89 ,  90 ,  91  and  92  on the distal opening  93  of the delivery tube  10 . This arrangement of transmitters and receivers is chosen for situations where the explorer guidewire does not provide sufficient accuracy for longitudinal alignment. The four receivers are shown on the delivery tube as it is advanced over the explorer guidewire to the target site. The receiver in the twelve o&#39;clock position  89 , is timed to receive the signal from the distal transmitter and the receiver in the 6 o&#39;clock position  90 , from the proximal transmitter. The receiver  91  in the 3 o&#39;clock position and the receiver in the 6 o&#39;clock position  92  are timed to receive first from one transmitter and then the other. The circuitry of receivers  91  and  92  compares the signal strength from each transmitter to determine when they are equal. They are then equidistant longitudinally. This circuitry also compares signal strength from each side to determine when they are equal to assure lateral equidistance. This circuitry is a variation of the century-old arrangement known as Wheatstone&#39;s bridge. When all comparisons are balanced the four receivers will be accurately positioned outside the graft and in line with its longitudinal axis. This arrangement need be taken only when necessary in a difficult application situation. Physicians who specialize in different application situations will quickly determine which devices and methods are appropriate for them. 
   The delivery tube  10  was advanced to the site of the clamping balloons with the explorer guidewire and remains there until the explorer guidewire has been screwed into the target. The delivery tube is then advanced to the target site. The delivery tube contains the graft with graft cores on each end.  FIG. 10   a  shows a holding balloon  69  with a cutting device embedded that covers the opening in the distal end of delivery tube  10  as it follows along the explorer guidewire  79 . 
     FIG. 10   b  shows the push-blade balloon  68  inflated and ready to cut at the site where the explorer guidewire is screwed in the second tube. The center opening in the holding balloon  69  is for withdrawing the cutting device after use. It also provides the exit notch for the explorer guidewire  79 . When the explorer guidewire  79  was initially advanced toward the target site from the site of the clamping balloon  72  it was through this center opening. 
   When the end of the delivery tube is aligned with the graft at the target site the holding balloon is against and conforming with the outside wall of the second tube. If the cutting device mounted on the holding balloon is a tubular push-blade balloon, it is inflated and the slit made. If the cutting device is a tracked slitter no inflation is necessary, the wire controlling the blade is drawn, the slit is made and the blade sheathed. When a push-blade is used the balloon must be deflated to hide the blade before the delivery tube is advanced. Either cutting device may be withdrawn at this time or may be left in place as the delivery tube is advanced into the lumen of the second tube  2 . Certain forms of cutting devices together with second tubes of small size create a danger to the wall opposite the opening if they are advanced without covering the blade by deflation. The cutting device and holding balloon are deflated and withdrawn outside the body after the anastomosis is made. 
   The length of the slit made is the length of the blade or the length of travel on the track. In either case this is determined by the circumference of the stem of the graft core. The length of the slit must be (approximately) one-half the circumference of the stem as each side of the slit fits around the stem. The circumference of the stem is 3.14 (pi) times the outside diameter of the stem. Thus the correct length of the slit is approximately one-half of 3.14 times the stem diameter. Dividing 3.14 by 2 yields 1.57. The cutting device selected should cut a slit that is about 1.57 times the diameter of the stem. This is just one of the approximate relationships among the dimensions of the devices. 
   A way of ensuring that the size relationships described in a later paragraph are maintained is for the manufacturer to assemble a correctly sized set of all the devices of this suite. The physician selects the correct suite based on the diameters of the first and second tube that are to be joined and the thickness of the graft. The physician has a choice regarding cutting devices and type of device for guiding the delivery tube. But once those sizes are determined prior to the operation, the sizing of the suite of devices is fixed and not a matter of preference. 
   After the slit is made, the delivery tube is immediately advanced through the slit opening and pushed downstream in the lumen of the second tube until it&#39;s heel is also in the lumen. Radiopaque markers on the heel and toe assist the physician in determining when the delivery tube&#39;s heel is inside the lumen. 
   Another catheter, with rodding balloon  31  at its distal end has been advanced through the delivery tube and into the distal graft core.  FIG. 10   c  shows the rodding balloon  31  being advanced toward the base of the graft core  12 . The hollow cones  28  are around the circumference of the base of the stem  18 . Not shown are the stiff sutures  27  inside the stem  18 , but the proximal end of each stiff suture is located at a hollow cone  28 . This is the case with the embodiment illustrated. In an alternative embodiment the stiff sutures may be placed away from the hollow cones in the base by the distance that said stiff sutures travel a shorter distance than the stiff suture(s) that travel(s) the longest distance. In that embodiment the proximal rods would all be of the same length. In the illustrated embodiment, the rods  32  are shown with different lengths. The longest rod is for driving the stiff suture that travels the greatest distance to reach and enter the brim. The longest distance is at the point where the tangential angle is most obtuse, the 3 and 9 o&#39;clock positions. Generally the more obtuse the tangential angle the longer the distance. The thickness of the graft is also a factor in this distance. Generally, the thicker the graft, the longer the distance. However these distances are computed by the manufacturer from tables given in a later paragraph. The differences in length shown are illustrative that there are differences and the ends of the rods form a pattern. The actual differences are computed as the distance of longest travel minus the difference of shortest travel. The longest rod touches its stiff suture(s) first and pushes it some distance before the second longest rods engage their stiff sutures, and so on. The longest rod has been driving its stiff suture(s) most of the distance to the brim when the shortest rod engages its stiff suture(s). The rodding balloon  31  is shown deflated. Since the balloon is deflated, the circumference of the circle the rods lie in is smaller than the circumference of the circle of hollow cones on the base of the stem. When the balloon is partially inflated the rods are still inside the graft core but the lip  94  of the balloon is expanded sufficiently be of a circumference to engage the base of the stem. This is for pushing against the base of the stem while the holding balloon is pulled against the brim to grip the core as the delivery tube is withdrawn. The rods are covered by a shaped cap so they do not catch on the anything. It does not expand when balloon inflates. A keyway  95  is shown on the interior of the stem. The key  34  is also shown attached to the rodding catheter. This key and keyway ensure that the rods engage the stiff sutures for which they were intended. 
     FIG. 10   d  shows the rodding balloon  31  inflated, making the twelve metal rods  32 , in the same circumference as the stiff sutures and the stem in which they are located. The rods are seen being introduced to the stiff sutures located within the hollow sutures in the stem of the graft core  12 . The part of the balloon that makes up the protective shells  94  is non-compliant material and thus does not move out with the rods when the balloon is inflated. The rods  32  are in place to push the stiff sutures  27 . The relationship of key  34 , shown in position in  FIG. 4   f  and the keyway  95  shown in position in this figure as well as in detail are important at this point in the method. The keyway  95  and key  34  are used by the physician to determine when the rods are aligned with the hollow cone and when they are aligned on the base between the hollow cones  28 . When the key is all the way counterclockwise in the keyway, the rods are in line with the hollow cones. When the key is turned clockwise to the other stop of the keyway the rods are between the hollow cones, i.e., ready to push against the base of the stem. The first action after introducing the delivery tube into the lumen of the second tube is to grip the graft core while the delivery tube is withdrawn. To do this the physician places the key in the clockwise position where the rods are aligned to the spaces between the hollow cones on the base of the stem. 
   The holding balloon is pulled by its wire while the rodding catheter is pushed, thus gripping the graft core between them. This brim of the graft core is inside the delivery tube and inside the lumen of the second tube. The stem of the graft core is in the delivery tube but extends outside the lumen of the second tube. The delivery tube is withdrawn outside the second tube and the brim  19 , no longer compressed by the delivery tube, expands inside the lumen of the second tube  2 . The brim deploys and is larger in circumference than the opening in the wall. The wall of the second tube  2  closes around the stem of the graft core. 
   The rodding balloon  31  is shifted to the counterclockwise position in the keyway and this brings the rods away from the base of the stem and into the hollow cones where they are in contact with the stiff sutures. To complete the anastomosis the stiff sutures are driven by the rodding balloon through the wall of the second tube and into the brim inside the lumen of the second tube, while the holding balloon is continually drawn proximally to hold the brim against the wall of the second tube. All stiff sutures are driven simultaneously to maintain balance around the circumference. To drive each separately would pull in the direction of each as it was driven. Another advantage of simultaneously driving the stiff sutures is that it requires only seconds to accomplish. Thus the conditions for a good graft are met and the stiff sutures are driven through the wall of the second tube and into the brim now inside the lumen of the graft. This completes the anastomosis of the second tube. 
     FIG. 11   a  shows the graft core  12  with a graft  3  sutured on it (as was shown in  FIG. 4   c  with the addition of a cross section of the wall of the second tube and the stiff suture pushed through said wall and into the brim. The hollow sutures  25  and posts  26  are shown holding the graft to the stem  18  of said graft core. Now the stiff sutures  27  are also shown cutting through the wall of the second tube  2  shown here in cross section. The wall of the second tube surrounds the stem along the junction and the angle of the wall approximates the miter as shown. That is, said wall&#39;s intimal layer pulls back more than the inner intimal layers after a slit is made along the longitudinal axis of the wall except at the 6 and 12 o&#39;clock positions where the pull back is slight. However the pull back of the outer layer generally makes the inner layer closer to the junction creating a bevel of variable acuteness. 
     FIG. 11   b  shows the same elements as  FIG. 11   a  but at the 3 and 9 o&#39;clock positions and with the inside surface of the tube also shown. If the outside surface were shown it would obscure the cross-sectional segment of the tube wall. The ghost of the brim is shown inside the tube. The stiff sutures are shown as having gone through the wall and lodged in the brim inside the lumen. After the anastomosis is thus finished with the second tube by driving the stiff sutures, the holding balloon is deflated and withdrawn with the cutting blade if it has not already been withdrawn. The rodding balloon remains as it will be used again in the anastomosis with the first tube. 
   A holding balloon of the same shape as holding balloon  69  is advanced on a thick guidewire to hold the brim of the proximal graft core in place for the anastomosis with the first tube. The same rodding balloon is used, but with the proximal side of the rods. The key  34  is set in the keyway  95  of the proximal graft core so the rods engage the stem when the rodding balloon is inflated. The clamping balloons on the first tube are deflated and the clamping catheter slightly withdrawn. The radiopaque markers on the delivery tube show when it is in a position where the brim is inside the lumen of the first tube and the stem in the opening. The rods are pulled against the stem of the graft core while the holding balloon is pushed, thus gripping the graft core while the delivery catheter is withdrawn. The key is then moved in the keyway so the rods are aligned with the stiff sutures and they are then driven through the wall of the first tube and into the brim being held in place by the holding balloon. This completes the second anastomosis and all devices are removed after deflation. The operation is finished with the conventional PCI closing procedures. 
   It is evident that there are relationships among the various devices of the present invention, particularly with respect to size. There are also infinities of possible angles and dimensions. For these and other reasons the suite of devices for a given application should be put together by the manufacturer licensed to manufacture and sell the devices when the physician defines the application situation. One of the ways of dealing with infinities of variables is that used with PCI devices such as catheters. Catheters are sized in production according to the French system. One French unit is one-third of a millimeter, three French units are one millimeter, 9 French is three millimeters and so on. The units are normally abbreviated as 1F, 2F, etc. This refers to inside diameters. Thus physicians order catheters by French sizes though there is obviously an infinity of possible sizes between the French sizes. The advantages of following the already established French convention is obvious. This in no way limits the dimensions of the present invention to French sizes. In addition there are relationships among the sizes of devices in the suite as described in this application for patent. The sizes vary with application situation but the relationships of sizes remains fairly constant. Using these relationships, as with using the French system of sizing reduces an infinity of possibilities to a meaningful manageable number. Without limiting the present invention to any particular sizes or relationships the sizes and relationships in Table 1 offer a practical way of managing an infinity of possibilities. 
   Table 1 gives typical sizes of the first tube and thickness of graft in coronary artery bypass application situations. These sizes would be determined prior to the operation and be used to select the proper size graft core and supporting suite of devices. In addition the physician would also determine the length of graft between the sites selected for anastomosis. The method the physician uses to make the measurements will affect the results. For instance a measurement made inside the lumen of the coronary artery will give a different result than a measurement made exterior to the same coronary artery at the same site. By either measurement the thickness of the coronary artery wall would have to be estimated to provide an estimate of the other dimension. Such estimating is expected and device sizes are sufficiently fungible to tolerate estimates. Likewise the relationships of device sizes are more rules-of-thumb than precise formulas. It is in this way that the values are given in Table 1. These, like the French system, give particular sizes, eliminating all in between. They also use particular (approximate) sizes of devices that all have appropriate dimensions for small body tubes. The relationships among the sizes as well as the sizes may be extrapolated to larger sizes. A column of figures in Table 1 represents the approximate sizes to be used together as a suite for one application. A new column of figures can be created by extrapolating from the numbers given in Table 1. 
                                               TABLE 1                           Tube OD   3.6   3   2.4   2.1   1.5           Brim OD   2.8   2.4   2.1   1.5   1.2           Brim ID   2.1   1.8   1.5   1.2   0.9           Stem OD   2.1   1.8   1.5   1.2   0.9           Stem Thick   0.3   0.3   0.15   0.15   0.15           Hollow Sut   0.15   0.125   0.1   0.07   0.05           Stiff Sut   0.07   0.05   0.05   0.035   0.025                        
In Table 1 all entries are in millimeters. The Tube OD is the outside diameter of the smaller tube (usually the second tube) to be joined. Stem thickness is abbreviated Stem Thick and suture as Sut. The preferred embodiment of the present invention includes reasonable consistency in the relationships of sizes of the device in the suite.
 
   Relationships regarding tangential angles, thickness of grafts and distance stiff sutures must travel are dealt with in the following figures.  FIG. 12   a  shows a graft core where the longitudinal axes of stem and brim intersect at 45 degrees, producing an angle of intersection  21  of 45 degrees at the 6 o&#39;clock position and 135 degrees at the 12 o&#39; clock position. A plane  96  at right angles to the tangent at surface of said stem has been erected at the 12 o&#39;clock position. This shows the tangential angle  97  of stem and brim at this position and it is the same as the angle of intersection at this position. It is also the same at the 6 o&#39;clock position. But the angles of intersection are different at all other points on the junction.  FIG. 12   b  shows the graft core rotated to the 2 o&#39;clock position and a plane  96  erected at a right angle to the tangent at that point on the junction to show the tangential angle  97  of about 152 degrees at the 2 o&#39;clock position. Half this angle is about 76 degrees for entry in the groove of cutting sleeve. It is larger than the tangential angle at 12 o&#39;clock.  FIG. 12   c  shows the tangential angle  97  at the 3 o&#39; clock position. It is about 167 degrees and still more obtuse. It is evident that the greater the tangential angle the longer the distance the sutures must travel to reach the brim. 
   However the distance is also a function of the thickness of the graft.  FIG. 12   d  shows a cross section of two grafts  98  and  99  on the same stem. This is for purposes of comparison as two grafts are never so placed in an application. The miter angle  100  is shown. Two hollow sutures and two stiff sutures are shown schematically because numbers on them would obscure their location. Each hollow suture comes out of the stem at 45 degrees toward the point of intersection of the miter flange and their graft. It is evident that the thicker the graft the farther the distance the stiff suture must travel to reach the brim. Without calculating all the possible distances, it is evident that they can be calculated. It is also evident that, like the French system for catheters, some conventions must be used to limit sizes from the infinite number of possibilities. 
   Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.