Abstract:
An anastomosis delivery system for delivering a connector having at least one backwards spike having a bent tip, comprising: a hollow guide sheath; and a hollow, axially slotted section, fitting within said sheath, said section having a flared configuration and an unflared configuration and wherein said axially slotted section is adapted to contain at least a part of said connector and to limit axial motion of said connector when said section is in its unflared configuration.

Description:
RELATED APPLICATIONS  
       [0001]    This application is related to PCT publications and applications WO99/62415, WO00/56226, WO00/56227, PCT/IL00/00611, WO00/56228, PCT/IL00/00609 and PCT/IL01/00074, all of which designate the US, the disclosures of which are incorporated herein by reference. This application also claims the benefit under 119 (e) of 60/254,689, the disclosure of which is incorporated herein by reference. This application is also related to an application titled “GRAFT AND CONNECTOR DELIVERY”, filed on even date by same applicant in the Israel receiving office of the PCT, the disclosure of which is incorporated herein by reference. 
     
    
     
         [0002]    The present invention relates to performing anastomotic connections, for example, via a vascular system.  
         BACKGROUND OF THE INVENTION  
         [0003]    Bypass procedures, in which a clogged vessel, for example in the heart, is bypassed by an unclogged conduit, are well known in the art. Recently, the desirability of performing this procedure using a vascular approach, has come to prominence, at least because the surgical wound is less traumatic to the patient. This procedure is known as a transvascular procedure.  
           [0004]    In a transvascular procedure, however, there is a danger that the various tools and devices, which are provided through a catheter, will be damaged by or damage the catheter and/or be deployed incorrectly.  
           [0005]    A competing method is operating through a small hole in the chest, a mini-thoractomy. However, this method cannot generally be used where there are more than two vessels to bypass, as is often the case.  
         SUMMARY OF THE INVENTION  
         [0006]    An aspect of some embodiments of the invention relates to protecting a delivery catheter and tools being delivered via the catheter during a bypass procedure. In an exemplary embodiment of the invention, a protective sheath is provided for enclosing a punch, prior to and/or after the punch transfixes the tissue to be punched. Alternatively or additionally, a same or different protective sheath is provided for enclosing and, optionally assisting in deployment, of an anastomotic connector.  
           [0007]    Alternatively, in an exemplary embodiment of the invention, an outer cutting tube of a punch is used as the protective sheath for the punch.  
           [0008]    Optionally, the sheath is more rigid at its distal end, where it protects the tool.  
           [0009]    Optionally, the sheath is shaped to aim the tools to be perpendicular (or at any other desired angle) to the wall of the blood vessel from which the procedure is performed, for example, an aorta  
           [0010]    An aspect of some embodiments of the invention relates to a guide for deployment of an anastomotic device. In an exemplary embodiment of the invention, the guide comprises a plurality of receptacles for maintaining bent back spikes of an anastomotic connector in a radially compressed and/or pulled back position. In an exemplary embodiment of the invention, the tips of the spikes are bent, even if the body of the spike is straightened for delivery. Optionally, the guide prevents the connector from pulling itself out prematurely, for example, if front spikes of the connector engage nearby tissue. Optionally, the guide also restrins front spikes of the connector. In some embodiments, the receptacle comprises an inner lip in the guide, possibly allowing the connector some axial motion, until the back spikes hit the lip. This allows the front spikes of the connector to exit and engage nearby tissue, without pulling the whole connector out of the guide. Alternatively, the receptacle comprises holes for holding the tips of the spikes. Optionally, the receptacle comprises a capsule that is closed at one end. In an exemplary embodiment of the invention, the spikes comprise 3, 4, 5, 6 or a greater or fewer number of spikes.  
           [0011]    In an exemplary embodiment of the invention, the guide includes a flaring out section distal of the receptacles.  
           [0012]    Only when the guide exits a hole in an aorta, the flaring out portion spreads out, freeing the back spikes to engage the aorta A similar mechanism may be used for entering a blood vessel, for example a coronary vessel, in which the flaring out occurs inside the free volume of the vessel, freeing back and/or front spikes of the connector. In an exemplary embodiment of the invention, the flaring out portion comprises a tube with axial splits. Possibly, a balloon or other expanding device is used to force the flaring. Alternatively, the tube may be pre-stressed to flare out when released.  
           [0013]    Alternatively, the bent part of the spike is held between two elements such as tubes and/or elongate members. In one exemplary embodiment of the invention, the two elements define at their tip a receptacle for the bent spike tips (e.g., perpendicular to the guide axis). Alternatively, the two elements hold the spike by radial pressure. Optionally, at least one of the elements includes a slot or window for receiving the bent portion of the back spike.  
           [0014]    In an exemplary embodiment of the invention, the guide comprises a capsule with one closed end. Optionally, the connector is held by inserting an inner mandrel (or object, such as a bead) between the backward spikes.  
           [0015]    An aspect of some embodiments of the invention is an anti-dislodgement mechanism for a catheter tip that is inserted into (and/or out of) a hollow organ, for example a blood vessel, through an entry hole. In an exemplary embodiment of the invention, the catheter, at least at its tip, includes two layers connected at their tips, namely an inner tube and an outer, axially slit tube. When the inner tube is retracted concurrently with maintaining the outer tube in place, the slit portion of the outer tube flares out to have a diameter greater than that of the entry hole, for example, twice or three times the radius, so that the catheter cannot be retracted.  
           [0016]    An aspect of some embodiments of the invention relates to a guided punch. In an exemplary embodiment of the invention, a hole is punched in a vessel, for example an aorta, by penetrating the aorta with a thin guide wire and then advancing the punch over the guide wire. Optionally, an intermediate thickness tube is advanced into the hole formed by the guide wire, prior to advancing the punch. Optionally, the intermediate tube has a blunt end and is used to enclose the tip of the guide wire and prevent inadvertent puncturing of other body tissues. Optionally, the guide wire is retracted after it is used to penetrate the aorta, so that only the less sharp objects (e.g., the punch tip) are extended. The punch may be, for example, a rotating cutting punch or a axially moving punch.  
           [0017]    An aspect of some embodiments of the invention relates to a rotating punch mechanism. In an exemplary embodiment of the invention, the punch comprises a central guide portion and a surrounding outer cutting tube. An inner diameter of the cutting tube defines the diameter of the cut. In an exemplary embodiment of the invention, the central guide portion, for example, a thin guide-wire like portion, is inserted into the target tissue to be punched Possibly, the central guide portion includes a stop to prevent over-penetration of the guide portion. The cutting tube is then pushed against the target tissue and rotated around the guide portion to cut out a section of the tissue. Optionally, the outer tube is coupled to the central guide, so that it is advanced with it. Alternatively or additionally, the outer tube is elastically urged against the target tissue. Alternatively or additionally, the outer tube is manually advanced.  
           [0018]    Optionally, the cutting tube advances as it rotates, for example, on a screw. Optionally, he advance is limited to a fixed amount, for example, to be less or somewhat more than the thickness of the punched vessel, for example, between 3 mm and 9 mm for an aorta.  
           [0019]    An aspect of some embodiments of the invention relates to an anastomosis connector having a plurality of non-penetrating spikes, each of which is formed by the meeting, at an angle, of two arms. Optionally, the plurality of spikes is merged into a single unit In an exemplary embodiment of the invention, the connector comprises a cylindrical or ring body  5  having, at one end thereof, a plurality of non-penetrating spikes. In an exemplary embodiment of the invention, the spikes are merged into an undulating curve, curved areas of which act as the spike parts in contact with vascular tissue. In an exemplary embodiment of the invention, the curve serves to apply pressure to a wall of a blood vessel (e.g., an aorta), that is perpendicular to the central axis of the connector. Optionally, the spikes are designed to bend (e.g., by locally weakening the connector) or are pre-bent at at least two locations. One bend location causes part of the curve to lie perpendicular to the cylinder axis. A second bend location causes the rest of the curve to lie at a sharp angle to the cylinder axis. In an exemplary embodiment of the invention, the spikes are curved in the bending plane so that they can better apply pressure to a perpendicular blood vessel wall.  
           [0020]    In an exemplary embodiment of the invention, the curve defines areas of higher curvature, which areas twist when the spikes are deployed. Alternatively, a torsion bar is provided at points of high twisting. Alternatively or additionally, two or more torsion bars and/or torsion joints are provided in series. In one example, a spike is bent 180° by providing two torsion bars or joints, one for each bend. In an exemplary embodiment of the invention, each torsion area is defined by two arms that define the ends of the bar. In an exemplary embodiment of the invention, the spike comprises two arms that meet a torsion bar and two more arms extend from the torsion bar, and meet at a second torsion bar. One or more arms extending from the second bar define the tip of the spike (or another torsion bar). Alternatively, a torsion bar or area is defined between two arms that meet at an angle or at a slight offset (e.g., with the twist area being defined in the offset).  
           [0021]    An aspect of some embodiments of the invention relates to loading of an anastomosis connector into a delivery system used for a vascular approach. In one example, the delivery system comprises a tube that encloses at least part of the connector. In an exemplary embodiment of the invention, the connector has a set of forward pointing spikes and a set of backwards pointing spikes and the connector is mounted by bending back the backwards set of spikes and restraining the backwards spikes in the delivery system. Optionally, however, the bent tips of the backwards spikes remain bent. The forward spikes are optionally not bent backwards, for example being restrained by the delivery system or sticking out of the delivery system.  
           [0022]    In an exemplary embodiment of the invention, the backwards spikes are bent back by enclosing each spike in a flexible tube and pulling the tubes through the delivery system. Alternatively, the spikes are bent back with a tool that bends the spikes back to fit into tube of the delivery system.  
           [0023]    In an exemplary embodiment of the invention, the connector is held, in the delivery system, between an inner and an outer tube. In an exemplary embodiment of the invention, the connector is held using a pre-defined bend in the backwards spikes of the connector. In an exemplary embodiment of the invention, the inner and outer tube define a step that engages the bent tip of the spikes. Alternatively or additionally, the inner tube defines a slot that receives the bend area itself.  
           [0024]    An aspect of some embodiments of the invention relates to the injection of contrast material during a bypass procedure. In an exemplary embodiment of the invention, a catheter is provided in an aorta or other large vessel and then exits the vessel to perform a bypass. In an exemplary embodiment of the invention, the catheter comprises a sheath, optionally bent to lay perpendicular to the aorta, and an inner punch mechanism. Optionally, the punch mechanism includes an inner sheath. Optionally, the punch mechanism is replaced by a graft delivery system. In an exemplary embodiment of the invention, injection of contrast material is used to determine that the catheter is near the aorta wall. In an exemplary embodiment of the invention, the catheter is aimed so that when it exits the aorta, it will enter fatty tissue rather than cardiac tissue. Imaging may be, for example, using X-ray fluoroscopy, CT or open MRI.  
           [0025]    Alternatively or additionally, contrast material is injected outside the aorta In an exemplary embodiment of the invention, the thickness of the aorta is measured by imaging the area and measuring the distance between different areas with contrast material. Alternatively or additionally, the external contrast material is used as a landmark for determining how far to advance the punch, graft and/or a connector on the graft. Alternatively or additionally, contrast material is injected into the graft, from the aorta, to detect leaks.  
           [0026]    In an exemplary embodiment of the invention, the catheter system includes multiple ports for contrast material (e.g., in the catheter handle), including: in the sheath (outside of the punch), in the punch and optionally in the inner sheath of the punch. Optionally, one or more dedicated contrast material channels are provide din the catheter, for example, as separate tubes.  
           [0027]    An aspect of some embodiments of the invention relates to utilizing the venous coronary system for providing arterial blood to the heart. In an exemplary embodiment of the invention, the coronary sinus is blocked and the coronary sinus and/or one of the veins leading to it are connected, possibly via a bypass conduit, to the arterial system, for example to the aorta or to a mammary artery. It is expected that the veins will provide blood to the heart, possibly becoming more artery-like as time goes on. Optionally, one of the veins is disconnected from the coronary sinus and connected, possibly via a bypass conduit, to the vena cava or another part of the venous system, to provide drainage from the coronary vascular system.  
           [0028]    There is thus provided in accordance with an exemplary embodiment of the invention, an anastomosis delivery system for delivering a connector having at least one backwards spike having a bent tip, comprising:  
           [0029]    a hollow guide sheath; and  
           [0030]    a hollow, axially slotted section, fitting within said sheath, said section having a flared configuration and an unflared configuration and wherein said axially slotted section is adapted to contain at least a part of said connector and to limit axial motion of said connector when said section is in its unflared configuration. Optionally, axially moving said section selectively advances said spike. Alternatively or additionally, axially moving said section selectively retracts said spike.  
           [0031]    In an exemplary embodiment of the invention, said slotted section maintains said bent tip in a bent configuration.  
           [0032]    In an exemplary embodiment of the invention, said slotted section includes at least one receptacle for engaging said bent tip. Optionally, said receptacle comprises an inner lip of said section, adapted for catching said tip. Alternatively or additionally, said receptacle comprises a hole in said section, for engaging said tip.  
           [0033]    In an exemplary embodiment of the invention, said section comprises a second, inner tube and wherein said inner tube and said slotted section define between them a receptacle for a bent section of at least one bent spike of connector. Optionally, said receptacle is a space between tips of said slotted section and said inner tube.  
           [0034]    In an exemplary embodiment of the invention, said receptacle is an opening in said inner tube. Alternatively or additionally, said slotted section and said inner tube grip between them a part of said connector.  
           [0035]    In an exemplary embodiment of the invention, said slotted section comprises a capsule closed at one end.  
           [0036]    There is also provided in accordance with an exemplary embodiment of the invention, an anastomosis delivery system for delivering a connector having at least one backwards spike having a bent tip, comprising:  
           [0037]    a hollow guide sheath;  
           [0038]    an apertured inner tube fitting within said sheath; and  
           [0039]    a plurality of spike locking elements disposed between said guide sheath and said apertured inner tube, wherein said spike locking elements, when extended, are adapted to grip a part of said anastomosis connector between said inner tube and said locking elements and wherein said apertures are each adapted to receive a said bent tip of said anastomosis connector.  
           [0040]    There is also provided in accordance with an exemplary embodiment of the invention, an anastomosis delivery system for delivering a connector having at least one backwards spike having a bent tip, comprising:  
           [0041]    a hollow guide sheath;  
           [0042]    a cylindrical capsule having one open end an one closed end; and  
           [0043]    an anastomosis connector held in said capsule. Optionally, the system comprises a stopper arranged between a plurality of said backwards spikes and urging said spikes towards said capsule  
           [0044]    There is also provided in accordance with an exemplary embodiment of the invention, a method of mounting an anastomosis connector having a plurality of bent backwards spikes including bent tips, into a delivery tube, comprising:  
           [0045]    bending back said spikes to point backwards along an axial direction of said connector, away from a graft mounted on said connector;  
           [0046]    maintaining said tips in a bent configuration; and  
           [0047]    inserting said spikes into a receptacle of said delivery tube, which receptacle maintains said tips in a bent configuration.  
           [0048]    Optionally, bending back comprises:  
           [0049]    mounting a thin flexible tube on each of said spikes;  
           [0050]    threading said tube through a plurality of tip holding apertures in said receptacle; and  
           [0051]    retracting said tubes to bend said spikes and pull them into said receptacle. Optionally, the method comprises:  
           [0052]    locking said connector in place; and  
           [0053]    retracting said tubes to remove them from said spikes.  
           [0054]    Additionally, bending back comprises:  
           [0055]    pushing back each spike, using a jig, into said receptacle; and  
           [0056]    locking said spike tip in said receptacle.  
           [0057]    There is also provided in accordance with an exemplary embodiment of the invention, a guided punch, comprising:  
           [0058]    a sharp, extendible guide wire; and  
           [0059]    a hollow punch mechanism adapted to ride on the guide wire, wherein said guide wire is adapted to extend from said punch. Optionally, said guide wire has a limited extension distance of less than 3 cm. Optionally, said distance is shorter than 1 cm. Optionally, said distance is greater than 0.3 cm.  
           [0060]    In an exemplary embodiment of the invention, said punch comprises a hollow tube adapted to fit between said punch mechanism and said guide wire.  
           [0061]    In an exemplary embodiment of the invention, said punch is a rotating punch  
           [0062]    In an exemplary embodiment of the invention, said punch is an axially moving punch.  
           [0063]    In an exemplary embodiment of the invention, said punch is adapted for injection of contrast material inside of said hollow of said punch mechanism.  
           [0064]    There is also provided in accordance with an exemplary embodiment of the invention, a rotating punch, comprising:  
           [0065]    a sharp, central guide wire; and  
           [0066]    a rotating outer tube having a vascular cutting edge defined by a lip of said tube. Optionally, said outer tube advances as it is rotated. Optionally, said advancing is limited to less than 3 cm. Optionally, said advancing is limited to less than 1 cm.  
           [0067]    In an exemplary embodiment of the invention, said punch is adapted for a particular target vessel, by matching said advancing limitation to the target vessel.  
           [0068]    In an exemplary embodiment of the invention, said cutting edge is smooth. Alternatively, said cutting edge is serrated.  
           [0069]    In an exemplary embodiment of the invention, said guide wire is smooth. Alternatively, said guide wire is adapted to engage vascular tissue it is inserted into.  
           [0070]    In an exemplary embodiment of the invention, the punch comprises a hollow tube adapted to be brought over said guide wire and within said rotating outer tube. Optionally, said punch is adapted for injection of contrast material inside of said hollow tube.  
           [0071]    In an exemplary embodiment of the invention, said punch is adapted for injection of contrast material between said spike and said outer tube.  
           [0072]    In an exemplary embodiment of the invention, said outer tube is bent at a right angle, such that positioning perpendicular to a vessel wall is assisted. Alternatively or additionally, said outer tube has an increasing outer diameter, away from said cutting edge.  
           [0073]    In an exemplary embodiment of the invention, the punch comprises a balloon distal from said cutting edge, said balloon, when inflated, having an outer diameter slightly greater than a diameter of said outer tube and about the inner diameter of a sheath associated with said punch.  
           [0074]    There is also provided in accordance with an exemplary embodiment of the invention, an advancing rotating punch, comprising:  
           [0075]    a sharp, central guide wire; and  
           [0076]    a rotating outer tube adapted to cut a target vessel which advances relative to said wire when it rotates.  
           [0077]    There is also provided in accordance with an exemplary embodiment of the invention, a catheter system, comprising:  
           [0078]    an outside sheath having an inner volume;  
           [0079]    a first contrast injection port communicating with the inner volume of said sheath;  
           [0080]    at least one inner mechanism conveyed by said sheath and having an inner volume; and  
           [0081]    a second contrast injection port communicating with the inner volume of said inner mechanism. Optionally, said at least one inner mechanism comprises two switchable inner mechanisms. Alternatively or additionally, said at least one inner mechanism comprises an inner tube and said system comprises a third contrast injection port associated with said inner tube. Alternatively or additionally, said sheath is bent to facilitate perpendicular positioning of a tip of said sheath against an inner wall of a target blood vessel. Optionally, inner mechanism is bent to match said bend in said sheath. Alternatively or additionally, said system comprises a straight guide wire adapted to fit in said sheath and maintain said sheath straight when said sheath is guided to a target area.  
           [0082]    In an exemplary embodiment of the invention, said at least one inner mechanism comprises a punch. Optionally, said system comprises an inner tube having a diameter that varies, along its length between a diameter of said punch and an inner diameter of said sheath.  
           [0083]    In an exemplary embodiment of the invention, said system comprises balloon distal of said punch and having a diameter that varies between a diameter of said punch and an inner diameter of said sheath.  
           [0084]    There is also provided in accordance with an exemplary embodiment of the invention, an anastomotic connector, comprising:  
           [0085]    a cylinder-like body, and  
           [0086]    at least one set of spikes, coupled to said body by twisting joints. Optionally, said spikes are adapted not to penetrate tissue which the spikes contact. Optionally, said twisting joints comprise at least one torsion bar. Alternatively or additionally, said twisting joints comprise at least one bend area. Alternatively or additionally, said set of spikes are bent. Optionally, said set of spikes are bent at two different locations along the spikes. Alternatively or additionally, each spike comprises two arms that meet at a tip of the spike and are each attached to a different part of said connector. Optionally, each arm is attached to a base extension of said connector, by a twisting joint. Optionally, said arms and said base extensions define a continuous curve.  
           [0087]    There is thus provided in accordance with an exemplary embodiment of the invention, a fixating guide sheath for insertion into a blood vessel, comprising:  
           [0088]    an inner tube; and  
           [0089]    an outer tube, slotted near an end thereof, wherein said inner tube is retracted relative to said outer tube, said slotted outer tube flares out to prevent further retraction of said sheath. Optionally, said sheath is bent near said end. 
       
    
    
     BRIEF DESCRIPTION OF TEE DRAWINGS  
       [0090]    Non-limiting embodiments of the invention will be described with reference to the following description of exemplary embodiments, in conjunction with the figures. The figures are generally not shown to scale and any measurements are only meant to be exemplary and not necessarily limiting. In the figures, identical structures, elements or parts which appear in more than one figure are preferably labeled with a same or similar number in all the figures in which they appear, in which:  
         [0091]    FIGS.  1 - 15  illustrate a process of performing a proximal transvascular anastomosis, in accordance with an exemplary embodiment of the invention;  
         [0092]    [0092]FIG. 16 illustrates a capsule for guiding the delivery of an anastomosis connector, in accordance with an exemplary embodiment of the invention;  
         [0093]    [0093]FIG. 17 illustrates an alternative catheter delivery system, including a separate protective sheath, in accordance with an exemplary embodiment of the invention;  
         [0094]    FIGS.  18 - 22  illustrate a guided punch, in accordance with an exemplary embodiment of the invention;  
         [0095]    [0095]FIGS. 23A and 23B illustrate an anti-dislodgment mechanism for a catheter, in accordance with an exemplary embodiment of the invention;  
         [0096]    [0096]FIG. 24A illustrates a rotating and cutting out punch mechanism, in accordance with an exemplary embodiment of the invention;  
         [0097]    FIGS.  24 B- 24 D show an exemplary rotating punch, in accordance with an exemplary embodiment of the invention;  
         [0098]    FIGS.  24 E- 24 F show an alternative rotating punch, in accordance with an exemplary embodiment of the invention;  
         [0099]    [0099]FIG. 25 illustrates a device delivery guide, as an alternative to the capsule shown in FIG. 16, in accordance with an exemplary embodiment of the invention;  
         [0100]    [0100]FIG. 26 is an exploded view of the guide system of FIG. 25;  
         [0101]    FIGS.  27 A- 27 C illustrate two exemplary anastomosis connectors, in accordance with an exemplary embodiment of the invention;  
         [0102]    FIGS.  28 A- 28 B illustrate a method of mounting a connector, such as the connector of FIG. 27, into a delivery system, in accordance with an exemplary embodiment of the invention;  
         [0103]    FIGS.  29 A- 29 D show a method of mounting a connector, in accordance with an alternative exemplary embodiment of the invention; and  
         [0104]    FIGS.  30 A- 30 C show details of the process of attaching the connector of FIG. 27 to an aorta, in accordance with an exemplary embodiment of the invention 
     
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS  
       [0105]    In a transvascular procedure at least part of the procedure is performed via a catheter. In one example, the provision of a graft and/or its attachment to a source artery are performed via a catheter. The other side of the anastomosis, for example, may be performed via the same or a different catheter and via a same or different vessel or it may be performed using a more invasive technique, such as open surgery or (mini-) thoractomy. In an exemplary embodiment of the invention, the transvascular technique is used to provide grafts for multiple bypass operations, with one or more mini-thoractomy openings being used to attach the grafts to target coronary vessels.  
         [0106]    Although the following description focuses on the heart, the following devices and/or procedures may be used for other organs and bypass procedures as well, as appropriate.  
         [0107]    FIGS.  1 - 15  illustrate a process of performing a proximal transvascular anastomosis, in accordance with an exemplary embodiment of the invention. In this process, a catheter is brought against the inside of an aortic wall, a hole is punched out of an aorta, the catheter is advanced into the punched out hole, an anastomosis connector mounted on a graft is positioned in the hole and then the catheter is retracted and the connector is deployed.  
         [0108]    In an exemplary embodiment of the invention, catheter  100  is a J-tip catheter. Optionally, a rigid stylet is used for insertion and/or navigation of the catheter.  
         [0109]    [0109]FIG. 1 shows a guiding catheter  100 , being brought against an inside wall of an aorta  102  at a location  104  thereof. A punch mechanism provided inside catheter  100  includes a needle punch  106  having a punch area  112  adapted to receive tissue to be punched out and an outer punch tube  108  which cooperates with needle punch  106  to cut off the received tissue. Optionally, a balloon  110  is provided proximal of needle punch  106 . Its use, and that of an alternative mechanism, will be described below. Catheter  100  may include a hemostat valve, to prevent blood leakage.  
         [0110]    As shown in FIG. 1, during feeding of the punch mechanism, outer tube  108  is optionally brought forward (or needle punch  106  kept retracted relative to the outer tube) over the tip of needle punch  106 , to prevent the tip from inadvertently engaging catheter  100 , aorta  102  and/or other nearby tissues or devices.  
         [0111]    In an exemplary embodiment of the invention, catheter  100  includes a bend, to support correct angular orientation to the aorta wall. Optionally, the punch includes a matching bend. In an exemplary embodiment of the invention, the catheter is inserted in a straight manner and when a guide wire or stylet is removed from the catheter, it reverts to its bent orientation. Contrast material may also be injected before the stylet is removed, to allow the position of catheter  100  to be determined. In an exemplary embodiment of the invention, the catheter is oriented in a direction that ensures that there is no critical and/or sensitive tissue right outside the aorta, where it might be damaged by the bypass procedure.  
         [0112]    In an exemplary embodiment of the invention, contrast material (e.g., x-ray, CT, MRI or ultrasound contrast material) is injected through catheter  100  to ensure that its tip contacts the wall if the catheter is close enough to the wall, the profile of the wall and of the catheter are expected to show up in the image. It should be noted that due to the fast flow in the aorta, it may be desirable to time the imaging to the provision of the contrast.  
         [0113]    In FIG. 2, needle punch  106  is brought up against location  104  and outer tube  108  is retracted.  
         [0114]    In FIG. 3, needle punch  106  is advanced through aorta  102 , so that the wall of the aorta is received in punch area  112 . Optionally, this penetration is sensed (manually) or seen, for example by injecting contrast material into catheter  100  and viewing the relative location of punch  106  and the wall.  
         [0115]    As described below, punch  106  may comprise a sharp tip that once inserted is replaced by or covered by an over tube that is less sharp. In an exemplary embodiment of the invention, contrast material is injected out of the aorta through the punch or through the sheath, to ensure the punch is outside the aorta. Alternatively or additionally, contrast material is injected between the sheath and the punch. Comparing the two sets of injections allows a determination of the thickness of the aorta wall.  
         [0116]    In FIG. 4, outer tube  108  is advanced through aorta  102  and past punch area  112 , where it cuts out the received portion of the aorta. Optionally, outer tube  108  is advanced past the tip of needle punch  106 , to protect tissue outside the blood vessel (or inside, for inward punching) from being damaged by the tip. In an inward punching embodiment, it is the blood vessel wall, away from the punch location that is protected. Optionally, the motions of needle punch.  106  and outer tube  108  are coupled so that a user needs to operate only a single control. In one example, the advance of needle punch  106  a certain distance (e.g., through the aorta), releases a spring loaded mechanism that advances outer tube  108  past the tip of needle punch  106 . Alternatively, a less automatic mechanisms may be used, for example one in which stops are provided in the controls, so that manual motion of the needle punch and/or the outer sleeve is stopped by the stop when a desired relative position is achieved. Alternatively or additionally, suitable markings for the different tubes are provided in the part of the delivery system outside the body. In one example, the handle of catheter  100  and/or the proximal end of outer tube  108  are transparent or slotted, so the relative locations of the needle punch tube (its proximal end) and/or the outer tube, can be seen. Such mechanisms may optionally be used for the methods shown in the other figures.  
         [0117]    In FIG. 5, balloon  110  is positioned to be inside the hole in the aorta. This is an optional procedure, used to assist in inserting the catheter  100  into the hole in the aorta. Balloon  110  may be fixed to needle punch  106 . Alternatively, it may be conveyed over the length of the proximal part of needle punch  106 .  
         [0118]    In FIG. 6, outer tube  108  is retracted, leaving balloon  110  in contact with the aorta, sealing the hole in the aorta.  
         [0119]    In FIG. 7, balloon  110  is inflated, expanding the opening in the aorta to be slight less, the same or even greater than the diameter of catheter  100 . Optionally, the tip of outer tube  108  is not sharp, at least not on its inside edge. This may prevent the balloon from being damaged by the edge of tube  108 .  
         [0120]    In FIG. 8, catheter  100  is advanced through the opening in aorta  102 . Optionally, balloon  110  is inflated to engage catheter  100 , so the two are advanced as one. Alternatively, catheter  100  is advanced over balloon  110 .  
         [0121]    In FIG. 9, balloon  110  is deflated.  
         [0122]    In FIG. 10, needle punch  106  is retracted with balloon  110 , leaving catheter  100  transfixing the aorta  
         [0123]    [0123]FIG. 11 shows a second stage of the anastomosis process in which a graft  122  (e.g., a vein, harvested artery or other graft type) is attached to aorta  102  at location  104 . A guide wire  120  is optionally used for conveying graft  122  through catheter  100  and/or for navigation to the target vessel (not shown) various methods may be used for navigation, including, without limitation, X-ray fluoroscopy, ultrasound and MRI. Optionally, catheter  100  and/or other parts of the delivery system and/or portions thereof are made radio-opaque (or ultrasound reflecting) to assist in imaging the procedure.  
         [0124]    Optionally, the contrast material that was previously injected outside the aorta is used as a reference for determining how far to advance the graft and/or connectors.  
         [0125]    In an exemplary embodiment of the invention, graft  122  is provided attached to a connector  124 . However, in other embodiments, the connector or the graft may be provided separate. In an exemplary embodiment of the invention, connector  124  is restrained in a delivery capsule  126 , optionally using a holder  128 .  
         [0126]    In FIG. 11, capsule  126  is positioned so that the connector is inside the hole in aorta  102 .  
         [0127]    In FIG. 12, catheter  100  is retracted, leaving capsule  126  engaged by aorta  102 . Possibly, this engagement is strong enough to prevent some or all leaks out of aorta  102 .  
         [0128]    In FIG. 13, connector  124  is advanced relative to capsule  126 , for example by advancing guide wire  120 , which may be coupled to holder  128 . A plurality of forward spikes  130  of connector  124  are thus freed from capsule  126  Optionally, capsule  126  is retracted alternatively or additionally to the advancement of connector  124 .  
         [0129]    In FIG. 14, capsule  126  is retracted with connector  124 , so that spikes  130  are pulled into the wall of aorta  102 .  
         [0130]    In FIG. 15, capsule  126  is further retracted, without connector  124 , so that a plurality of backward spikes  132  of connector  124  are freed to engage aorta  102 . The connection between aorta  102  and graft  122  is now complete. The other end of graft  122  may be connected to a target vessel in various manners, including by applying the same process in an opposite direction at the target vessel or through a mini-thoracic or keyhole opening.  
         [0131]    Optionally, contrast material is injected into the graft and/or in the aorta near the graft. Such an injection allows to detect leaks from the connection or from the graft and/or to view the placement of all the connector legs relative to the aorta wall.  
         [0132]    Two optional fat beads  134  and  136 , that are fixed on guide wire  120 , are shown. They may be used, for example, for radio-opaque imaging based techniques, such as fluoroscopy, to aid in verifying position and/or navigating. Alternatively or additionally, bead  134  may be used to apply force to holder  128  and/or keep it inside capsule  126 . Holder  128  may, in different embodiments, be freely moving, coupled to guide wire  120 , coupled to capsule  126  or riding on guidewire  120 , with a ratchet mechanism that allow one direction of motion only. In an exemplary embodiment of the invention, holder  128  is a disk.  
         [0133]    [0133]FIG. 16 illustrates a capsule  200  for guiding the delivery of an anastomosis connector, in accordance with an exemplary embodiment of the invention. This capsule may be used in place of capsule  126 , in place of holder  128  and/or in addition to one or both of the parts, in different embodiments. As shown capsule  200  is formed of a slotted tube  202 , in which the slots define a plurality of wings  204 , which can swing out radially. Each wing has an inner rim  206  or other means for maintaining a tip of spike  130  in place. In an exemplary embodiment of the invention, capsule  200  releases spikes  130 , when the wings exit (e.g., are pushed out) from capsule  126  and/or from aorta  102  (if there is no capsule).  
         [0134]    [0134]FIG. 17 illustrates an alternative delivery catheter system, including a separate protective sheath  250 , within catheter sheath  100 , in accordance with an exemplary embodiment of the invention. In this embodiment, a separate retractable/advancable sheath  250  is used to protect catheter  100  from punch  106 . Optionally, sheath  250  is also used for guiding connector  124 , as explained below in FIG. 25. The use of a balloon is optional, for example a thickening of the punch outer tube may replace the balloon, as described herein.  
         [0135]    FIGS.  18 - 22  illustrate a guided punch, in accordance with an exemplary embodiment of the invention. The punch comprises a punch tip  400 , which cooperates with a punch base  406 , to remove a section of aorta  102 .  
         [0136]    In an exemplary embodiment of the invention, punch tip  400  is hollow, so that a sharp guide wire  402  can be extended there-through A pilot puncture in aorta  102  is made by wire  402 . It should be noted that punch tip  400  does not then include a very sharp tip, so a protective sheath mechanism may be avoided, in some embodiments of the invention. The degree of extension of guide wire  402  may optionally be limited to the (expected) thickness of the aorta or less, in which case needle punch  400  is preferably brought against aorta  102  before guide wire  402  is extended. Alternatively, the extension is greater than the thickness, to ensure penetration of the aorta, for example, being between 3 mm and 10 mm. As noted above, contrast material may be injected through the sheath, to determine the aorta thickness.  
         [0137]    In FIG. 19, an optional tube  404  is advanced over the guide wire and through the aorta wall. This tube is thicker than the guide wire and may also serve to enclose the sharp tip of guide wire  402 , to prevent inadvertent puncturing of nearby tissue. Alternatively, tube  404  may be an extension of punch tip  400 . Once tube  404  is advanced, guide wire  402  is optionally retracted.  
         [0138]    In FIG. 20, punch tip  400  is advanced over tube  404  (or guide wire  402  or just advanced), to penetrate the aortic wall, so the aortic wall is received between punch base  406  and punch tip  400 .  
         [0139]    In FIG. 21, punch base  406  is advanced through the aortic wall, to punch out the received section. Optionally, base  406  (and optionally punch tip  400  as well) are then further advanced As shown, punch base  406  optionally thickens as it is advanced, so that its final outer diameter is near the inner (and outer) diameter of catheter  100  and the hole in the aortic wall is widened. Alternatively, a balloon may be used. Such a thickening method may be used as an alternative in FIGS.  1 - 15 .  
         [0140]    In FIG. 22, catheter  100  is advanced into the widened hole, as shown in FIG. 1, above.  
         [0141]    A potential advantage of using a guide wire, is that if the needle punch is pushed to far ahead and then retracted out of the aorta wall, the guide wire can maintain the location of the hole formed by the punch, and prevent unnecessary damage of the aorta, caused by reinserting the punch at a second location.  
         [0142]    [0142]FIGS. 23A and 23B illustrate an anti-dislodgment mechanism for a catheter  500 , in accordance with an exemplary embodiment of the invention. Catheter  500  comprises two layers, an inner layer  502  and an outer layer  504 . In an exemplary embodiment of the invention, the separation into two layers is only at the tip of the catheter, with the outer layer  504  transforming into one or more axial cords away from the tip.  
         [0143]    Optionally, catheter  500  is provided through guide catheter  100 . In an exemplary embodiment of the invention, catheter  500  is conveyed through catheter  100 , until its tip passes the opening in the aorta. Catheter  100  may then be retracted, so that the aorta engages catheter  500 . Alternatively, catheter  500  maybe the only guiding catheter and replace catheter  100 .  
         [0144]    In FIG. 23A Catheter  500  is shown extending out of an aorta  102 . However, in other uses, catheter  102  may be extending into a hollow body lumen, for example a blood vessel, a bladder or a digestive organ.  
         [0145]    In FIG. 23B, inner layer  502  is retracted, while outer layer  504  is not, causing outer layer  505  to collapse, optionally about one or more pre-provided hinges  506 , so that the outer diameter of the collapsed portion is significantly greater than the diameter of the opening. Optionally, a plurality of slots is formed in outer layer  504 , to support such collapsing. Alternatively or additionally, to collapsing outside of aorta  102 , the collapsing may take place within the aortic wall, albeit not with a same diameter increase.  
         [0146]    A suitable positioning of hinges and slots (axially separated by a collar of unslotted material) will allow outer layer  504  to form to portions of increased diameter, one inside the aorta and one outside. Alternatively, only a collapsed portion external to the aorta is formed, for example by providing a collar of unslotted material at the tip of catheter  500 .  
         [0147]    Optionally a balloon  508  is temporarily inflated to assist and/or guide the collapsing, by actively widening the diameter of catheter  500 .  
         [0148]    Optionally, a thin membrane or balloon is provided over the tip of catheter  500 , as part of the catheter, to prevent the slotted parts of outer layer  504  from inadvertently engaging any nearby tissue.  
         [0149]    [0149]FIG. 24A illustrates a rotating and cutting out punch mechanism, in accordance with an exemplary embodiment of the invention. The mechanism is provided, for example, in catheter  500  and is used for cutting-out a section from an aorta  102 .  
         [0150]    In an exemplary embodiment of the invention, the mechanism comprises an inner pivot section  600  that is inserted into the aorta wall, anchoring in the wall or transfixing the wall. Optionally, pivot section  600  has a sharp tip  601 . Alternatively or additionally, a sharp guide wire  402  (described above) is used to penetrate aorta  102 . Optionally, tip  601  is barbed or inflatable or can be rotated to engage the aortic wall, for example using a threading (not shown). Thus, inadvertent retraction of tip  601  and/or motion of the punch, may be prevented. Optionally, as noted above, tip  601  may be replaced by a thin tube, which may be self flaring, for example as described below. An external cutting tube  602  has a sharp edge  604 . Edge  604  may be smooth. Alternatively, it may be serrated, saw-tipped and/or may have a non-uniform diameter.  
         [0151]    A plurality of threading sections  608  and  610  may couple tube  602  and pivot section  600 . Alternatively, other methods may be used. In an exemplary embodiment of the invention, there is a significant empty space between tip  601  and edge  604 . Tip  601  may be axially movable relative to edge  604 , however, they may have a fixed relative position, for example tip  601  recessed or advanced relative to edge  604 . In an exemplary embodiment of the invention, edge  604  advances towards tip  601 , as it rotates. Such rotation may be used for various types of rotating punches, includes punches with a single cutting spike axially extending from edge  604   
         [0152]    In use, tip  601  is inserted into aorta  102  and tube  602  is rotated around it. An outer tube is optionally advanced into the hole thus formed Tip  601  and/or tube  602  are then retracted.  
         [0153]    FIGS.  24 B- 24 D show an exemplary rotating punch  620 , in accordance with an exemplary embodiment of the invention. Punch  620  comprises a head  622  (one exemplary embodiment of which is described in general in FIG. 24A), an elongate shaft  624 , adapted for passing through a catheter or an endoscope, a handle  626  and a rotatable cam  628 . In an exemplary embodiment of the invention, cam  628  is coupled to tube  602 . Optionally, tip  601  is attached to an external grip  630  for selectively advancing and/or retracting tip  601 .  
         [0154]    [0154]FIG. 24C is a close-up of head  622 , showing an optional (non-rotating or freely rotating) outer sheath  633 , having a narrowing cone  634  terminating at a lip  632 . In an exemplary embodiment of the invention, cone  634  is used to advance sheath  633  into an opening created by cutting edge  604 . Optionally, tube  602  and/or cone  632  are retracted, allowing the use of sheath  633  as a delivery guide. Alternatively, cone  634  is used to widen the punched hole, to assist in advancing the outer sheath (e.g., catheter or endoscope) into the punched hole.  
         [0155]    [0155]FIG. 24D is a cross-sectional view of handle  626 , showing a hollow inner shaft  636  through which a retractable tip  630  is advanced.  
         [0156]    FIGS.  24 E- 24 F show an alternative rotating punch  640 , in accordance with an exemplary embodiment of the invention. A rotating cam  648  is set on a side of a body  646  of punch  640 . A head  642  can be the same head  622  of FIG. 24B.  
         [0157]    [0157]FIG. 24F is a view of the working mechanism of punch  640 , showing the rotation of a shaft  656 , while allowing an inner guide wire  650  to remain stationary and/or be moved axially. An optional safety pin  658  is also shown, for preventing inadvertent rotation of shaft  656 .  
         [0158]    [0158]FIG. 25 illustrates a device delivery guide  700 , as an alternative to the capsule shown in FIG. 16, in accordance with an exemplary embodiments of the invention. In guide  700 , the tips of backward spikes  132  of connector  124  are engaged in a plurality of holes  704 , in a tubular element  700 .  
         [0159]    [0159]FIG. 26 is an exploded view of the guide  700 , showing that a plurality of wings  702  is formed at the end of guide  700 , such that when they flare out, holes  704  release the tips of spikes  132 .  
         [0160]    FIGS.  27 A- 27 C illustrate two exemplary anastomosis connectors, in accordance with an exemplary embodiment of the invention. FIG. 27A shows a connector  800 , in plan view having a body  802  comprised of a plurality of arcs  804  that interconnect adjacent spikes segments  806 . Spike segments  806  extend in one direction (the backwards direction), away from body  802 , to form a plurality of spikes  808 . In the opposite direction, spike segments  806  extend to form bases for a plurality of non-penetrating spikes  810 . In an exemplary embodiment of the invention, each of spike segments  806  splits into two bases  812 , however, this is not required. In an exemplary embodiment of the invention, spikes  810  are formed of two arms  814  that meet at a spike tip  815  and are attached at their other ends to spike bases  812 , of adjacent spike segments  806 . In an exemplary embodiment of the invention, arms  814  and bases  812  define an undulating curve. The exemplary dimensions shown are in mm.  
         [0161]    [0161]FIG. 27B shows an alternative, embodiment, in which the form of the curve is different. Possibly, the form of FIG. 27A allows greater force to be applied by the twisted joints. Alternatively, the joints may be replaced by straight torsion bars. Optionally, the torsion bars are made thinner or weaker than the surrounding connector, to ensure that they twist. Optionally, the form of the curve is adapted to match a bending pattern of the undulating curve, as shown in FIG. 27C.  
         [0162]    [0162]FIG. 27C shows a side cross-sectional view of a single spike segment  806  of connector  800 , showing an exemplary bend configuration of the spikes. Optionally, the sharp bends are achieved by twisting the spikes. In an exemplary embodiment of the invention, the spikes are pre-bent and connector  800  is elastic, super-elastic or shape memory, so that it attempts to return to the geometry shown in FIG. 27C, when delivered. Alternatively, connector  800  is a plastically deformed connector.  
         [0163]    As shown, in an exemplary embodiment of the invention, spike  808  is a penetrating spike that is bent twice 90°. In an exemplary embodiment of the invention, the bending is performed by twisting of the spike, e.g., arms  814  or bases  812 . Spike  810  is a non-penetrating spike mounted on bases  812  (one shown). Base  812  is curved or bent away from segment  806 . Then, base  812  bends (or is twisted) at the point of attachment to arm  814 . Arm  814  is optionally curved so that tip  815  when contacting a vessel wall will tend to bend away from the wall, rather than attempt to penetrate it.  
         [0164]    FIGS.  28 A- 28 B illustrate a method of mounting a connector, such as connector  800 , into a delivery system  900 , in accordance with an exemplary embodiment of the invention. FIG. 28A shows connector  800  mounted in a loading tube  902 . A graft  904  is everted over connector  800  and transfixed by spikes  808 . Spikes  810  are held between the graft and loading tube  902 .  
         [0165]    A thin, flexible tube  906  is mounted on each spike  808  and passed through a slot  910  of an inner window tube  908  of delivery system  900 . An intermediate, locking tube  912  is optionally provided between window tube  908  and an outer tube  914 .  
         [0166]    [0166]FIG. 28B shows the effect of pulling back on all the flexible tubes  906  substantially simultaneously. Graft  904  is pulled out of loading tube  902 . Spikes  810  (released from tube  902 ) are optionally allowed to open and engage the outer lip of tube  914 . Spikes  808  are pulled into slots  810 . In an exemplary embodiment of the invention, locking tube  912  is advanced, locking connector  800  between locking tube  912  and window tube  908 . Further retraction of tubes  906  will thus only cause the removal of tubes  906  from spikes  808  and not further retraction of connector  800 . Connector  800  is then optionally released, by retracting locking tube  912 .  
         [0167]    It should be noted that locking connector  800  and/or the use of holding slot  910  potentially allow connector  800  to be selectively pulled or pushed within outer tube  914 .  
         [0168]    FIGS.  29 A- 29 D show a method of mounting connector  800 , in accordance with an alternative exemplary embodiment of the invention. A graft loader  930  restrains a connector  800 , which transfixes an everted graft  902 . Unlike holder  902  of FIG. 28A, holder  930  includes one or more pins  932 , for folding pikes  808  back into a delivery system  940  (FIG. 29B). In an exemplary embodiment of the invention, holder  930  includes a ring  931  defining a plurality of through channels for a plurality of pins  932 , one for each spike  808 . Alternatively, a single pin is used for all spikes, in series.  
         [0169]    In FIG. 29B, a forward tip  934  of pin  932  advances and bends spike  808  back. In an exemplary embodiment of the invention, delivery system  940  comprises outer tube  914  and an inner tube  942 , having an extending inner lip  944 . Tip  934  pushes spike  808  against inner lip  944 . A plurality of spike holders  946 , having inwards extending fingers  948  are provided to engage the tip of spikes  808 . Optionally, spikes holders  946  comprise sections of a single slotted tube. As shown, fingers  948  are proximal to the end of tube  942 , for example, by advancing tube  942  further than spike holders  946 , out of outer tube  914 .  
         [0170]    In FIG. 29C, holders  946  are advanced, so that the tip of spike  808  is held between finger  948 , inner lip  944  and the front lip of tube  942 . Both holders  946  and tube  942  are optionally retracted, so that pulling hard on connector  800  will not inadvertently dislodge spikes  808 .  
         [0171]    In FIG. 29D, delivery system  940  is retracted relative to graft holder  930 , so that connector  800  and graft  902  are pulled off of holder  930 . Optionally, spikes  810  open and engage tube  914 .  
         [0172]    In an exemplary embodiment of the invention, the graft holder uses a graft conveying element in the shape of a flexible element with a retractable pin at its end. Such an element is described, for example in PCT/IL01/00069, the disclosure of which is incorporated herein by reference.  
         [0173]    FIGS.  30 A- 30 C show details of the process of attaching connector  800  to an aorta  952 , in accordance with an exemplary embodiment of the invention, which does not necessarily require a capsule. In FIG. 30A, a hole has been punched in aorta  952  and a guide sheath  950  inserted in the hole, optionally plugging it. A delivery system including outer tube  914  and a graft  902  is advanced through sheath  950  and past the wall of aorta  952 , optionally along a guide wire  954 .  
         [0174]    In FIG. 30B, guide sheath  950  is retracted out of the opening in the aorta, so that the wall of aorta  952  engages outer tube  914  instead. In addition, outer tube  914  is retracted sufficiently to allow non-penetrating spikes  810  to contact aorta  952 . In other embodiments, penetrating spikes are used. One potential advantage of non-penetrating spikes is that there is less danger of inadvertently damaging tissue or catching on tissue outside the aorta by the spikes.  
         [0175]    Connector  800  is unlocked (in this implementation) by retracting first locking tube  912  and then window tube  908 . The extended spikes  810  prevent retraction of connector  800 .  
         [0176]    In FIG. 30C, outer tube  914  is retracted, freeing spikes  808  to bend and engage aorta  952  opposite spikes  808 , completing the anastomotic connection of graft  902  to aorta  952 .  
         [0177]    In an exemplary embodiment of the invention, the above or other methods of performing a bypass are used to connect a venous system to an arterial system, such that the venous system serves as a conduit for oxygenated blood.  
         [0178]    In an exemplary embodiment of the invention, a graft is connected between the aorta, a mammary artery or other artery to the coronary sinus and/or to one or more of the coronary veins.  
         [0179]    In an embodiment where the connection is to the coronary sinus, the connection between the coronary sinus and the vena cava is sealed, for example, using a suture, an internal suture, a clogging device or any other means of sealing blood vessels known in the art. Optionally, at least one of the coronary veins is disconnected from the coronary sinus and connected to the venous system, to provide some measure of venous drainage.  
         [0180]    In an embodiment where the connection from the aorta is to a coronary vein, the connection of the vein to the coronary sinus is severed.  
         [0181]    The access for performing the bypass procedures may be of any type known in the art, for example, transvascular, thoracic or using open surgery.  
         [0182]    It will be appreciated that the above described methods of providing a tools and bypassing may be varied in many ways, including, changing the order of acts, which acts are performed more often and which less often, the arrangement of the tools, the type and order of tools used and/or the particular timing sequences used. Further, the location of various elements may be switched, without exceeding the sprit of the disclosure. In addition, a multiplicity of various features, both of methods and of devices have been described. It should be appreciated that different features may be combined in different ways. In particular, not all the features shown above in a particular embodiment are necessary in every similar exemplary embodiment of the invention. Further, combinations of features from different embodiments into a single embodiment or a single feature are also considered to be within the scope of some exemplary embodiments of the invention. In addition, some of the features of the invention described herein may be adapted for use with prior art devices, in accordance with other exemplary embodiments of the invention. The particular geometric forms and measurements used to illustrate the invention should not be considered limiting the invention in its broadest aspect to only those forms. Although some limitations are described only as method or apparatus limitations, the scope of the invention also includes apparatus designed to carry out the methods and methods of using the apparatus.  
         [0183]    Also within the scope of the invention are surgical kits, for example, kits that include sets of delivery systems and anastomotic connectors. Optionally, such kits also include instructions for use. Measurements are provided to serve only as exemplary measurements for particular cases, the exact measurements applied will vary depending on the application. When used in the following claims, the terms “comprises”, “comprising”, “includes”, “including” or the like means “including but not limited to”.  
         [0184]    It will be appreciated by a person skilled in the art that the present invention is not limited by what has thus far been described. Rather, the scope of the present invention is limited only by the following claims.