Abstract:
A delivery system for an anastomosis connector, comprising: a body including a handle for applying force; a capsule adapted to interlock with said body and for carrying a connector, wherein said force is transferred by said interlocking to deploy said connector; and an extension, adapted to be connected between said body and said capsule, thereby extending a reach of said delivery system.

Description:
RELATED APPLICATIONS  
         [0001]    The present application is related to the following PCT publication and applications and is a continuation-in-part thereof: PCT/IL01/00600, PCT/IL01/00266, WO 01/41624, PCT/IL01/00074, WO 01/41623, WO 00/56226 and WO 00/56228 the disclosures of which are incorporated herein by reference.  
         FIELD OF THE INVENTION  
         [0002]    The present invention relates generally to the field of creating anastomotic connections, especially between blood vessels.  
         BACKGROUND OF THE INVENTION  
         [0003]    Several types of methods of connecting a graft to a blood vessel have been previously suggested, including, for example creating an anastomotic connection using a single connector and creating a connection using a plurality of surgical clips. In a side to end connection, an incision or a hole is usually formed in the side vessel and the end of the end vessel attached to the incision or hole.  
           [0004]    After the anastomotic connection is completed, one or both of the blood vessels may change in diameter, for example, a saphaneous vein naturally increases in diameter, due to the increase pressure inside the vein. In addition, forces acting on the side blood vessel may extend any incision or hole formed in the vessel, potentially causing a leakage of blood.  
         SUMMARY OF THE INVENTION  
         [0005]    An aspect of some embodiments of the invention relates to an anastomotic connector, a set of clips for forming an anastomotic connection and/or an anastomosis delivery system, having a special design, for example a reinforcement and/or a motion limiter, at parts that correspond to high tension portions of the anastomotic connection, to prevent damage to a target blood vessel. Thus, in one embodiment of the invention, some clips are more loosely coupled (if at all coupled) than other clips.  
           [0006]    In an exemplary embodiment of the invention, the anastomotic connection is characterized by including a plurality of tissue attachment points, for example spikes of a connector or individual clips, which attachment points can move relative to each other, for example, expand. In an exemplary embodiment of the invention, pairs of attachment points that are at ends of an incision are coupled together to reduce their relative motion. In the example of clips, a double, angled, clip is optionally provided for the incision ends.  
           [0007]    In an alternative embodiment of the invention, each tissue attachment point is defined by an apertured segment and the apertured segments are not substantially distorted when the connector as a whole is distorted, for example to increase in radius.  
           [0008]    An aspect of some embodiments of the invention relates to an anastomotic connection adapted to conform to blood vessel geometry and/or allow changes in blood vessel diameter. In an exemplary embodiment of the invention, the connector comprises a ring that interconnects a plurality of substantially independent clip elements. A virtual ring is defined by the clamp points of the clips (when closed). In an exemplary embodiment of the invention, the virtual ring and the ring are not congruent rings. Optionally, the rings are offset in the plane of the ring and/or along a direction perpendicular to the plane of the ring. Alternatively or additionally, the rings have different diameters. Alternatively or additionally, the ring has a different degree of obliqueness and/or orientation than the virtual ring.  
           [0009]    In an exemplary embodiment of the invention, the differences in ring geometries cause the clips to be twisted relative to the ring. Alternatively or additionally, each clip can move separately, so that the clamp points define a non-planar ring that better conforms to the side blood vessel geometry. Alternatively or additionally, if the blood vessels change in geometry, the degree of twisting of each clip can change. In an exemplary embodiment of the invention the clips are designed to have a preferential twist direction, thus encouraging a desired blood vessel conformance. In some embodiments of the invention, the interconnection ring provided a minimum degree of flexibility while still imposing an flexible limitation on the relative positions and/or orientations of the clip elements. Optionally, the ring is thin or twist joints interconnect the clips and the ring, to allow the twisting.  
           [0010]    In an exemplary embodiment of the invention, the clips are interconnected by straight segment. Alternatively, the clips are interconnected by bent segments, which allow radial expansion and/or support twisting.  
           [0011]    In an exemplary embodiment of the invention, an anastomotic connector comprises a plurality of clips and a plurality of tissue pullers that pull vascular tissue into the clip.  
           [0012]    In another exemplary embodiment of the invention, the connector is a base-plate type connector in which the base plate is flexible to allow conformance of base plate to the side blood vessel.  
           [0013]    In an exemplary embodiment of the invention, the individual clips or portions of the base plate, even if apertured, do not substantially distort when the connector as a whole is distorted.  
           [0014]    An aspect of some embodiments of the invention relates to a ring anastomotic connector in which a resilient ring interconnects a plurality of independently-patent tissue holders, for example clips or hook tips each of which can clamp together two blood vessel walls, against force. In an exemplary embodiment of the invention, the ring defines a desired anastomosis radius. The ring may be resiliently or plastically deformed to support a greater radius if the blood vessel expands. Alternatively or additionally, the ring may resiliently urge the radius towards a certain size. Different resiliency values may be used for different blood vessels, in which different post-bypass behaviors are expected. In some embodiments of the invention, a similar design is used for hole closure devices, for example to allow for distortion of the blood vessel.  
           [0015]    An aspect of some embodiments of the invention relates to clips including an aperture for the passage of one or two tissue pullers. The clips may include one or more spikes to engage blood vessel tissue. Optionally, the aperture also accommodates a clip holder for holding the clip during tissue pulling.  
           [0016]    Alternatively or additionally, the aperture is used to hold the clip in place during deployment or for guiding a clip deforming element.  
           [0017]    An aspect of some embodiments of the invention relates to a puller-pair geometry, in which two pullers, each designated for a different blood vessel are arranged to be coaxial. In an exemplary embodiment of the invention, one puller fits along a slot defined in the other puller.  
           [0018]    In an alternative embodiment of the invention, an anastomotic connector comprises an apertured base, through which a plurality of hooked pullers extend. Optionally, each aperture has associated therewith one or more tabs that cooperates with a geometry of the puller to prevent disengagement of the puller once the puller is retracted through the aperture.  
           [0019]    An aspect of some embodiments of the invention relates to a base-plate type anastomosis connector that allows sutures to be added to correct defects in an anastomosis. In an exemplary embodiment of the invention, the base plate is apertured and/or is sparse (i.e., does not fill space), to allow room for insertion of a needle therethrough. Alternatively or additionally, the base plate is made of a piercable material. Optionally, the base plate is flexible to allow distortion of the base plate and/or anastomotic connection during stitching.  
           [0020]    An aspect of some embodiments of the invention, relates to the design of a puller engagement element. In an exemplary embodiment of the invention, the element includes a tab that prevents disengagement of the puller once the puller is retracted. In an exemplary embodiment of the invention, the tab has curved tab geometry, to allow a greater length of a tab in a limited space. The length, coupled with a sufficient tab thickness and/or metallurgical treatment, optionally provide sufficient strength, resilience and/or range of motion to the tab. One, two or more tabs may be provided.  
           [0021]    An aspect of some embodiments of the invention relates to a puller engagement element that includes a bar, which bar is engaged by a hook tip of the pullers. In an exemplary embodiment of the invention, the aperture is defined as a pair of openings separated by a short segment, such as a bar. The puller extends through one opening and, when retracted, the tip of the hook of the puller extends into the other opening.  
           [0022]    An aspect of some embodiments of the invention relates to a method of holding a base part of an anastomotic connector during deployment. In an exemplary embodiment of the invention, at least two hinged tabs hold the base portion against a delivery system. When the base portion is to be released, the tabs are released and allowed to rotate, so they do not block the motion of the base plate. In an exemplary embodiment of the invention, the tabs are held at an outer section thereof and prevented from rotation by an element that hooks an aperture nearer an inner section thereof. The tabs are released by retracting the element so that it pulls through the aperture and releases it.  
           [0023]    An aspect of some embodiments of the invention relates to an anastomotic connector having long pullers, which pullers are distorted to assist in mounting a graft on the connector. In an exemplary embodiment of the invention, the pullers include recurved tips, that curve back 180°. In an exemplary embodiment of the invention, the pullers are bent out and then back, so that the tips point radially out at about 90° to the axis of the connector. The graft is mounted, for example, by pulling its lip over the tips. In an exemplary embodiment of the invention, after the graft is mounted, the pullers are released to straighten. Alternatively or additionally, the extra length of the pullers is compensated for by an extra long retraction, during deployment.  
           [0024]    An aspect of some embodiments of the invention relates to an extension mechanism for an anastomosis delivery and/or hole punching system. In an exemplary embodiment of the invention, a same system can be used for open chest, for keyhole and/or for endoscopic surgery. In an exemplary embodiment of the invention, the delivery system includes at least one axial rod (which may be hollow) that is advanced, retracted and/or rotated to effect the operation of the system. In an exemplary embodiment of the invention, the rod(s) is formed from two parts that interlock to provide the required coupling. To extend the delivery system, the two parts are disconnected and an extension piece having matching interlock mechanism inserted. Thus, for example, an anastomosis delivery system in which the pullers are retracted into a base part has the pullers coupled to an initial rod and an extension rod coupled to the initial rod. The pulling and sequencing mechanism is optionally located in the delivery system handle.  
           [0025]    In an exemplary embodiment of the invention, an anastomosis delivery mechanism is provided as a modular capsule that can be attached to the delivery system and/or an extension. Optionally, a same drive mechanism is provided for punching and for anastomosis delivery, so that a same device can be used for both, except that a punching capsule is replaced by a delivery capsule. Both capsules, for example, may be activated by retraction and/or rotation of the rod.  
           [0026]    Optionally, the capsule includes a lever, for example a rotating lever, for advancing and/or retracting the pullers, at least as part of an insertion process. In an exemplary embodiment of the invention, the lever locks in at least one and optionally two puller positions. Such a lever may also be supplied as a separate control in a non-capsule embodiment of the invention.  
           [0027]    Optionally, the extension is flexible, rather than rigid as in other embodiments. Optionally, a channel for a camera and/or light source is provided in the extension, for assisting endoscopic surgery.  
           [0028]    In an exemplary embodiment of the invention, the delivery system is a split system in which retraction of the rod causes the system to split and release a delivered blood vessel. In an exemplary embodiment of the invention, the end of the delivery system is coupled to the extension piece in a manner that keeps the two connected even when splitting is performed, for example, via the rod interlock or by providing an interlock between the bodies of the end and the extension.  
           [0029]    An aspect of some embodiments of the invention relates to an anastomosis delivery system including at least one hinge and/or distortable portion, for use along non-straight path.  
           [0030]    In an exemplary embodiment of the invention, the delivery system includes a flexible cable for transferring force (retracting force) from the delivery system handle to the connector. In one embodiment of the invention, the delivery system is hinged, for example in one, two, three or more dimensions. In another embodiments of the invention, the delivery system is flexible over its entire length, like a goose-neck.  
           [0031]    An aspect of some embodiments of the invention relates to a side cutter for a blood vessel. In an exemplary embodiment of the invention, the side cutter includes an L shaped element having a sharpened tip. The tip is poked into a blood vessel and one arm of the L inserted into the blood vessel following the tip. The L element is optionally rotated so that its arm is parallel to the vessel axis. The L element is then retracted relative to a base, providing cutting action by an optional sharpened inner lip on the L and/or shearing action against the base. The base is optionally sharpened. The base may be provided on one sides of the L element or it may sandwich the L element. Optionally, the cutting arm of the L is parallel to the base, alternatively, the arm may be inclined towards the base or away from the base, relative to the axis of the cutter. In an exemplary embodiment of the invention, the cutting arm is flexible and twisted in towards the plane of the base.  
           [0032]    An aspect of some embodiments of the invention, relates to a device for removing a connector from a blood vessel, for example, after mounting of a graft on the connector or after completing an anastomosis. In an exemplary embodiment of the invention, the connector comprises a ring around one blood vessel (or graft) and a plurality of spikes that extend from the ring (e.g. or through the ring) to penetrate a second blood vessel with sharp tips of the spikes. In an exemplary embodiment of the invention, the device comprises at least one pincer that is adapted to engage a single spike at the ring and then retract the spike relative to the ring. Optionally, the ring serves to straighten the spike as it is retracted. Optionally, the device does not block the motion of a tab part of the ring, which tab part is designed to prevent retraction of the spike under normal conditions. Alternatively, the device includes a protrusion that bends the tab out of the way. Alternatively, the pincer also engages and pulls back the tab.  
           [0033]    There is thus provided in accordance with an exemplary embodiment of the invention, an anastomotic connector comprising:  
           [0034]    a plurality of clip segments; and  
           [0035]    a plurality of twistable resilient segments that interconnect the clip segments. Optionally, said segments are bendable out of a plane defined by said clip segments. Alternatively or additionally, a resilience of said attachment segments is defined to control a diameter changing behavior of said connector.  
           [0036]    Optionally, said clip segments do not penetrate target tissue when the clip closes. Alternatively, said clip segments do penetrate target tissue when the clip closes, but do not transfix said tissue.  
           [0037]    There is also provided in accordance with an exemplary embodiment of the invention, an anastomotic connector comprising:  
           [0038]    a plurality of clip segments each defining a clip contact area at which opposite sides of the clip engage tissue; and  
           [0039]    a plurality of attachment segments that interconnect the clip segments, wherein said attachment segments lie in a first circumference and said contact areas lie in a second circumference and wherein said two circumferences are not the same. Optionally, a resilience of said attachment segments is defined to control a diameter changing behavior of said connector. Alternatively or additionally, said circumferences are not on a same plane.  
           [0040]    There is also provided in accordance with an exemplary embodiment of the invention, an anastomotic connector comprising:  
           [0041]    a plurality of connection segments each defining a contact area between the segment and a target blood vessel; and  
           [0042]    a plurality of attachment segments that interconnect said connection segments and limit relative motion of the connection segments, wherein some of said attachment segments limit relative motion of said connection segments more than the motion of other connection segments is limited. Optionally, said connection segments each comprises an apertured segments through which a puller that engages the target vessel can be advanced and retracted. Alternatively or additionally, the connector comprises a base plate, and said connection segments each comprises an apertured area the base plate. Alternatively or additionally, said connection segments each comprises a clip element. Alternatively or additionally, the connector is designed to limit relative motion to a greater degree for areas of the target vessel that are expected to be under a higher degree of strain. Alternatively or additionally, said connection segments are arranged in the form of an ellipse and relative motion between segments is reduced at narrow ends of the ellipse.  
           [0043]    There is also provided in accordance with an exemplary embodiment of the invention, an anastomosis connector comprising:  
           [0044]    a base plate having a plurality of apertures defined therein; and  
           [0045]    a set of pullers adapted to pass through at least some of said apertures during deployment of said connector,  
           [0046]    wherein said base palate is made spatially sparse enough to allow suturing of an anastomotic connection, using a needle, through the base plate.  
           [0047]    There is also provided in accordance with an exemplary embodiment of the invention, an anastomosis connector comprising:  
           [0048]    a plurality of clip segments, each clip defining an engagement volume in which the clip engages tissue;  
           [0049]    a plurality of attachment segments interconnecting the clip segments; and  
           [0050]    a set of tissue pullers each including at least one tissue engager,  
           [0051]    wherein, said clips define a plurality of apertures adapted for extending said tissue pullers through the apertures such that retracting the pullers carries engaged tissue into said engagement volume of said clips. Optionally, said apertures are adapted for holding the connector using a connector holder. Alternatively or additionally, said tissue pullers comprises pairs of axially elongate pullers, each pair comprising two pullers co-axially disposed with respect to each other. Optionally, one of said pair of connectors is adapted to engage tissue of a target blood vessel and wherein another of said pair of pullers is adapted to engage tissue of a vessel on which said connector is mounted prior to completing said anastomosis. Alternatively or additionally, at least one of said pair of pullers has a tip that is wider than said aperture, such that retracting the puller closes the clip when said clip has a resting point on either side of said aperture.  
           [0052]    There is also provided in accordance with an exemplary embodiment of the invention, an anastomosis connector comprising:  
           [0053]    a base plate defining a plurality of apertures therein; and  
           [0054]    a set of pullers adapted to pass through at least some of said apertures during deployment of said connector, each of said pullers including a tissue engaging tip,  
           [0055]    wherein said apertures are arranged in pairs, one aperture for receiving a puller and one aperture for receiving the tip of the puller when the puller is retracted. Optionally, the connector comprises a bar around which said puller hooks, which bar defines a separation between said pair of apertures.  
           [0056]    There is also provided in accordance with an exemplary embodiment of the invention, an anastomosis connector comprising:  
           [0057]    a base plate defining a plurality of apertures therein; and  
           [0058]    a set of pullers adapted to pass through at least some of said apertures during deployment of said connector,  
           [0059]    wherein said each of said pullers comprises:  
           [0060]    a tip; and  
           [0061]    a tab section adapted to distort out of a plane of said puller when said puller is disconnected adjacent said tab.  
           [0062]    There is also provided in accordance with an exemplary embodiment of the invention, a delivery system for an anastomosis connector, comprising:  
           [0063]    a body; and  
           [0064]    at least one slotted forward plate attached to said body, wherein said plate and said body define therebetween a receptacle for a base plate of an anastomosis connector and wherein said slots match apertures formed in said base plate for extension of tissue engagement spikes therethrough,  
           [0065]    wherein said forward plate is adapted to bend out of the way of axial motion of said base plate, when said connector is deployed. Optionally, said forward plate is mounted on at least one hinge. Alternatively or additionally, said forward plate is divided into at least two coplanar plates. Alternatively or additionally, said forward plate is attached to said body via a distortable attachment.  
           [0066]    There is also provided in accordance with an exemplary embodiment of the invention, a delivery system for an anastomosis connector, comprising:  
           [0067]    a body including a handle for applying force;  
           [0068]    a capsule adapted to interlock with said body and for carrying a connector, wherein said force is transferred by said interlocking to deploy said connector; and  
           [0069]    an extension, adapted to be selectively connected between said body and said capsule, thereby extending a reach of said delivery system. Optionally, said extension is bendable.  
           [0070]    There is also provided in accordance with an exemplary embodiment of the invention, a delivery system for an anastomosis connector, comprising:  
           [0071]    a body including a handle for applying force;  
           [0072]    a connector holder area defined at a distal end of said body and adapted for holding an anastomosis connector, wherein said force is transferred to said area for deploying said connector; and  
           [0073]    a non-limp geometry changing elongate section bridging between said body and said area. Optionally, said elongate section is hinged. Alternatively or additionally, said elongate section is distortable. Alternatively or additionally, the system comprises a flexible cable for transferring said force between said handle and said area.  
           [0074]    In an exemplary embodiment of the invention, said system is adapted for holding and deploying a two part connector comprising a plurality of tissue engaging elements that are retracted by said force during deployment, such that a base ring portion of the connector is engaged by the holder area and a tissue puller portion of the connector is retracted by said force.  
           [0075]    There is also provided in accordance with an exemplary embodiment of the invention, a delivery system for an anastomosis connector, comprising:  
           [0076]    a body including a handle for applying force;  
           [0077]    a connector holder area defined at a distal end of said body and adapted for holding an anastomosis connector, wherein said force is transferred to said area for deploying said connector; and  
           [0078]    a control for selectively advancing a plurality of tissue engaging elements from said connector holder area, said control being separate from said handle for applying force. Optionally, said control comprises a rotating knob. Alternatively or additionally, said control is mounted on a separate capsule element that includes said connector holder area. Alternatively or additionally, said tissue engaging elements form part of a connector. Alternatively or additionally, said tissue engaging elements form part of said delivery system.  
           [0079]    There is also provided in accordance with an exemplary embodiment of the invention, a connector removal device for removing a spike that completes an anastomotic connection in a spike and base type connector, comprising:  
           [0080]    at least one spike engager adapted to engage at least one spike of a deployed connector;  
           [0081]    an axially elongate contra element axially movable relative to said spike engager and adapted to rest against a base portion of said connector while said spike engager retracts said spike away from said base portion by said axial motion. Optionally, said spike engager engages said spike by friction. Optionally, said spike engager comprises a split tube. Alternatively or additionally, said contra element comprises an overtube that fits over said spike engager and wherein said contra element has an inner diameter that clamps said spike engager shut when said engager is within said contra element. Alternatively or additionally, said spike engager engages a plurality of spikes at a time.  
           [0082]    There is also provided in accordance with an exemplary embodiment of the invention, a method of mounting a graft on a generally cylindrical connector having a plurality of axially extending spikes, each with a curved tip at a distal end of the connector, comprising:  
           [0083]    bending each spike such that the spike points inwards towards the axis and the tip points outwards away from the axis;  
           [0084]    bringing a graft to said axis between the inward pointing spikes; and  
           [0085]    mounting the graft on the spike points. Optionally, bringing comprises conveying the graft between the spikes from a proximal end of the connector to the spike tips. Alternatively or additionally, mounting comprises mounting the graft sequentially over the tips. Alternatively or additionally, bending comprises mounting the connector in a jig. Alternatively or additionally, bending comprises bending the spikes outwards and then bending inwards so that the bent part of the spikes define a diameter greater than that of unbent spikes.  
           [0086]    There is also provided in accordance with an exemplary embodiment of the invention, a jig for holding a spiked connector in a configuration in which the spikes bend inwards, comprising;  
           [0087]    a body defining an axial channel for receiving a connector; and  
           [0088]    a plate attached to an end of said body and defining a plurality of trans-axial channels for receiving spikes of said connector, said plate defining a hole in its center for receiving a graft. Optionally, said plate comprises a slotted disk. Alternatively or additionally, the jig comprises at least one rotatable disk underlying said plate for selectively defining slots along which said spikes can be conveyed when twisted. Alternatively or additionally, the jig comprises at least one rotatable slotted disk overlying said plate for selectively aligning slots of said disk with slots of said plate. Optionally, said slots in said disk are arranged so that said selective alignment can be sequential for different ones of said slots of said plate.  
           [0089]    There is also provided in accordance with an exemplary embodiment of the invention, a blood vessel cutter for forming an aperture in a blood vessel, comprising:  
           [0090]    a first section having a cutting face; and  
           [0091]    a second section having a cutting face matching said cutting face of said first section and axially movable relative thereto to provide shearing cutting action,  
           [0092]    wherein, said second section comprises a pointed tip adapted for piercing a blood vessel; and  
           [0093]    wherein said second section is flexible and said pointed tip is twisted towards a plane of said first section, such that when said first section is moved towards said second section, said first section pushes said second section out of its way. Optionally, said cutting face of said second section is sharp. Alternatively or additionally, said cutting faces are not parallel to each other in a plane generally common to the two cutting faces. Alternatively or additionally, said second cutting face is not perpendicular to said axial motion. Alternatively or additionally, said pointed tip points away from said first plane.  
       
    
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0094]    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:  
         [0095]    [0095]FIG. 1 illustrate an anastomosis clip set mounted on a clip deployment system that includes a plurality of pullers, in accordance with an exemplary embodiment of the invention;  
         [0096]    [0096]FIG. 2 illustrates a delivery system for elastic clips, in accordance with an exemplary embodiment of the invention;  
         [0097]    [0097]FIG. 3 illustrates a portion of a delivery system for plastic deforming of clips, in accordance with an exemplary embodiment of the invention;  
         [0098]    [0098]FIG. 4 illustrates an alternative clip system in which clips face inwards rather than axially, in accordance with an exemplary embodiment of the invention;  
         [0099]    [0099]FIG. 5 illustrates an alternative clip design, in accordance with an exemplary embodiment of the invention;  
         [0100]    [0100]FIGS. 6A and 6B illustrate a clip-ring connector, in accordance with an exemplary embodiment of the invention;  
         [0101]    FIGS.  7 A- 7 E illustrate apertured-base anastomotic connectors, in accordance with an exemplary embodiment of the invention;  
         [0102]    FIGS.  8 A- 8 D illustrate an extendible delivery system in accordance with an exemplary embodiment of the invention;  
         [0103]    FIGS.  8 E- 8 H illustrate distortable and bendable delivery systems, in accordance with exemplary embodiments of the invention;  
         [0104]    FIGS.  9 A- 9 E illustrate an alternative embodiment of a capsule based delivery system, in accordance with an exemplary embodiment of the invention;  
         [0105]    [0105]FIG. 10 illustrates a cutter for forming an opening in a target vessel, in accordance with an exemplary embodiment of the invention;  
         [0106]    [0106]FIGS. 11A and 11B illustrate a connector and an associated graft mounting system, in which the connector is distorted to assist in mounting a graft thereon, in accordance with an exemplary embodiment of the invention; and  
         [0107]    FIGS.  12 A- 12 D illustrate a connector removing device, in accordance with an exemplary embodiment of the invention. 
     
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS  
       [0108]    [0108]FIG. 1 illustrate an anastomosis clip set  101  mounted on a clip deployment system  100  that includes a plurality of pullers  118  and  120 , in accordance with an exemplary embodiment of the invention.  
         [0109]    An anastomotic connection is performed by inserting pullers  118  into an opening in a target side vessel and pulling the vessel wall into a plurality of clips  102  using the pullers. The tissue of an end vessel is also pulled into the clip using the same or other pullers. The clips are then closed, locking together the two blood vessels. Various configurations of pullers and blood vessels have been suggested in pervious applications of the present assignee. In the particular example shown, a pair of pullers may be provided for each clip, although not shown for clarity.  
         [0110]    In an exemplary embodiment of the invention, one or both of the pullers are provided through an aperture  104  formed in a body  106  of each clip. In FIG. 1, not all clips  102  have pullers, while this is done for clarity of presentation, in some embodiments of the invention, not all clips are actually provided with one or both pullers.  
         [0111]    In the particular embodiment shown, the clips rest on a holder  112  comprising an inner ring  116  and an outer ring  114 . Closing the clips can be achieved, for example, by retracting the clips, for example using additional pullers (not shown) on either side of the clip. Alternatively, the pullers are used to close the clips. In one embodiment of the invention, the hooked tips of the pullers urge the tissue forcefully against body  106  of clip  102 , so as to cause it to close. Alternatively, the puller tip may be wide enough to directly apply force to clip body  104 . The puller may then be distorted (open) as it is further pulled out or it may be cut. One or both of the puller tips is optionally designed to penetrate the vessel tissue. Alternatively, they may be designed to not penetrate the tissue.  
         [0112]    In an exemplary embodiment of the invention, the pullers are side by side, for example pullers  118  and  120 . Alternatively, the pullers are coaxial, for example, a puller  122  has a slotted shaft  124  through which a puller  118  can fit. A tip  126  as shown is wide enough to distort clip  102 .  
         [0113]    The ends of the clips are optionally serrated, for example having four teeth  108  and  110  on either side of the clip. Fewer teeth (e.g., two) may be provided. Optionally, the teeth interlock (not shown). Alternatively, spikes that penetrate the vessel tissue to a significant depth and/or transfix one or more layers of tissue, are provided at the ends of the clips. Alternatively, the clips do not penetrate or do not transfix the blood vessels.  
         [0114]    Alternatively to plastically deforming the clips, in an exemplary embodiment of the invention, the clips are self-deforming, for example, being elastic, super elastic of shape-memory. FIG. 2 illustrates a delivery system  200  for elastic clips, in accordance with an exemplary embodiment of the invention. Only a single clip and pullers is shown, for clarity, however, typically more than one clip is deployed at a time. An exemplary elastic clip  202 , that can have the same geometry as clip  102  (e.g., with an aperture  206 ), except that it is self-deforming, is restrained from closing by a tab  212  and a tab  210 . The tabs may hold the clip from its ends, for example from inside its aperture  206  as shown for tab  212  and/or from outside, for example as shown for tab  210 . Alternatively the clip may be held from the side (and optionally released by rotation of the holder).  
         [0115]    In an exemplary embodiment of the invention, a plurality of tabs  210  is mounted on an outer ring  214  and a plurality of tabs  212  is mounted on an inner ring  216 . In use, pullers  122  and  118  (or only one puller) are used to retract tissue into clip  202  and then inner ring  216  is retracted and/or outer ring  214  advanced, to release the clip to self-deform to a closed configuration.  
         [0116]    [0116]FIG. 3 illustrates a delivery system  300  for plastic deforming of clips  102 , in accordance with an exemplary embodiment of the invention. Two clip holders  304  and  306  are shown for engaging the sides of clip  102 . As shown, the holders are shaped like pullers and also pass through aperture  105 . Optionally, the holders separate the two pullers. Alternatively or additionally, the holders are provided from outside of clip  102 . In use, after pullers  118  and  120  pull tissue into clip  102 , holders  304  and  306  retract the clip, which is bent by as the clip is longer (in its open configuration) than a space between a pair of rings  314  and  316  that hold it. Alternatively or additionally, the two rings advance towards each other to squeeze the clip shut. Optionally, the rings do not change in diameter, and supported on shafts that are not coaxial, so that when one ring is rotated the spacing between the rings changes.  
         [0117]    Holders  304  and  306  are optionally removed by further retraction that deforms the shape of their tips.  
         [0118]    [0118]FIG. 4 illustrates an alternative clip system  400  in which a plurality of clips  402  face inwards rather than axially. In one example, clips  402  are always in a closed configuration as shown and the pullers (not shown), which are optionally provided through apertures  404  of clips  402 , pull the tissue past one or more spikes  408  of clips  402 . Alternatively, clips  402  are self-deforming and the pullers retract the tissue while the clips (but optionally not the spikes) are flat. The clips are then released to self deform to the configuration shown in FIG. 4. Optionally, a base ring  410  is attached to the clips and controls their relative positions and/or holds down one side of the clips. Optionally the ring is detached after the anastomosis is completed. Alternatively ring  410  remains in the body, the ring can be deformable, for example, as described below. In one example, a plurality of clip holders (not shown) urge clips  402  against ring  410  during deployment. Other clip orientations can also be provided.  
         [0119]    [0119]FIG. 5 illustrates an alternative clip design  502 , in accordance with an exemplary embodiment of the invention. One or more spikes  508  of clip  502  can be, for example curved (as shown) or re-curved (as shown in FIG. 4). The size and shape of an aperture  506  in a body  504  of the clip can also vary. As shown below in FIG. 7, in some cases, the aperture is split into two parts.  
         [0120]    [0120]FIGS. 6A and 6B illustrate a clip-ring connector  600 , in accordance with an exemplary embodiment of the invention.  
         [0121]    Connector  600  comprises a plurality of individually patent clip elements  602  that are interconnected by a ring of short segments  616 . In the particular embodiment shown, the clips are all of one type, but this is not essential. As shown the clips comprise an elliptical body  604  having two inward pointing extensions  608  and  610  that terminate in contact surfaces  612  and  614 . Alternative clip designs, such as using spikes, using a unenclosed body or a non-elliptical body, may also be provided. Optionally, an aperture  606  defined by enclosing body  604  serves as a channel for one or more tissue pullers.  
         [0122]    In an exemplary embodiment of the invention, a clip  602  is closed by bending, while the extensions which optionally also bend, meet at their tips, at surfaces  612  and  614 . FIG. 6B shows a side view of such a closed clip. The curved shape can be achieved, for example, if the clip is self-deforming. A device similar to that of FIG. 2 is optionally used for deployment  
         [0123]    In an exemplary embodiment of the invention, extensions  608  and  610  are designed to meet off-center from ring  610 , along a virtual ring  618 , which can have a varying diameter. If spikes are used instead of extensions, the spikes optionally include tissue stops to ensure that the clamped tissue meets at virtual ring  618 . FIG. 6B shows the contact between surfaces  612  and  614 .  
         [0124]    In an exemplary embodiment of the invention, the closed clips twist and/or bend around ring  616 , allowing the connector as a whole to better adapt to a blood vessel diameter change and/or to better conform to the surface of the side vessel and prevent over-straining of the side vessel.  
         [0125]    Optionally, ring  616  is extendible, for example as described below if the segments are curved rather than straight.  
         [0126]    FIGS.  7 A- 7 E illustrate apertured-base anastomotic connectors, in accordance with an exemplary embodiment of the invention. In such a connector, a plurality of pullers  704  pull tissue towards a base plate  702  and then the pullers are sheared leaving only their tips  706  urging the tissue against the base plate. Both tips and base plate remain in the body. It should be noted, however, that the various features described below (e.g., flexible base plate) may also be applied towards clip-based devices (e.g., as a flexible clip ring), in which the tips do not remain in the body.  
         [0127]    [0127]FIG. 7A illustrates a hybrid base-plate connector  700  in which some of the apertures of the base plate are provided as individual elements and some as mini-base plates including two or more apertures. The elements are optionally held together by the delivery system (e.g., the continuation of the pullers may meet) and/or by the blood vessel, after deployment. In the embodiment shown, a plurality of individual-aperture plates  712  each include an aperture  716  and a pair of tabs  718  to control the passage of a puller  704  therethrough. At the ends of the connector, a larger base-plate  714  having two apertures is provided. In an exemplary embodiment of the invention, the connector is inserted through an incision in a blood vessel. The larger base plate is provided to prevent or reduce relative motion of two tissue attachment points at the ends of the incision, which might extend the incision and cause a blood leak. As the connection process causes stress in the vessels, in some embodiments, the aperture plates are not interconnected, but the guides for retracting the pullers are interconnected to prevent motion at the ends of the incision.  
         [0128]    In the exemplary embodiment shown, each puller  704  comprises a shaft  710  having protrusions  708  that match tabs  718 . An optional puller shearing point (e.g., a thinning) is not shown. As described in other applications of the present assignee, the puller includes a tab that prevents the puller tip from falling out of the aperture. The tab cannot pass by the cutting plate ( 744 , FIG. 7C) so further attempted retraction of the puller tears the puller, at the shearing point, which is, for example, a thinner portion of the puller shaft.  
         [0129]    Optionally, the other aperture-plates are also interconnected, for example using a resilient spring which will allow relative radial and/or twisting motion of the aperture plates. An exemplary such base plate  720  is shown in FIG. 7B.  
         [0130]    Base plate  720  comprise a plurality of apertures element  722  interconnected by resilient spring segments  726 . Optionally, at the ends of the ring, relatively rigid connection segments  724  are provided.  
         [0131]    Each aperture element  722  optionally comprises a bar  730  that separates the aperture into two parts, a passage aperture  734  for passage of the puller and a hook aperture  736  for receiving the tip of the puller. In an exemplary embodiment of the invention, the tip of the puller passes past the plane of bar  730 . Optionally, the hook aperture is larger than the passage aperture, to compensate for freedom of movement of the tip. In other embodiments, the tip of the puller does not enter an aperture. The tip may penetrate the target tissue or not.  
         [0132]    In an exemplary embodiment of the invention, one or more tabs  728  is provided to engage protrusions  708  and prevent the puller from falling out once it is retracted past the tabs. After deployment, the tabs themselves, or the tabs backed by the vessel wall, possibly prevent reverse motion of the tabs. Optionally, the tabs are curved, to allow a longer length in the limited space of aperture element  722 .  
         [0133]    In an exemplary embodiment of the invention, base plate  720  is made sparse to allow an anastomosis connection to be enhanced or corrected by passing a manual suture.  
         [0134]    [0134]FIG. 7C shows base plate  720  in a radially contracted configuration, with spring segment  726  bend to allow aperture elements  722 , which are generally not affected by the radial compression, to be closer together. Base plate  720  may be elastically or plastically deformed. In an exemplary embodiment of the invention, base plate  720  is used to control the deformation of the blood vessels of the anastomosis. In one example, base plate  720  is pre-stressed to a desired diameter which is smaller or lager than the current diameter. In another example, base plate  720  acts against undue expansion of the blood vessel. In an exemplary embodiment of the invention, the diameter of the anastomosis is selected to allow enough blood to flow both downstream (e.g., in a coronary vessel tree) and upstream (to possible collateral vessels).  
         [0135]    In an exemplary embodiment of the invention, the circumference of base plate  720  increases or decreases by 5%, 10%, 20% or any smaller larger or intermediate percentage. Optionally, aperture elements  722  also provide a clip function, for example, as described above.  
         [0136]    [0136]FIG. 7D is a partial cut-away view showing base plate  720  during exemplary deployment (some parts removed for clarity and some parts shown covering only part of base plate  720 , instead of all the base plate). An optional spacer  740  is provided, that includes tabs  742  for preventing motion of bar  730  (not shown), while allowing motion of tabs  728  and passage of the puller. A cutting plate  744  having a plurality of apertures  746  provides a strong base against which the pullers can be sheared by retraction. FIG. 7E, also a partial cut-away view, shows the addition of an optional holder  750  which prevents base plate  720  falling into the body. After the anastomosis is started or completed, holder  750  is pulled back. In one example, holder  750  is hinged and it unfolds. In another embodiment, holder  750  is distorted by the retraction. In another embodiment, holder  750  is pulled out radially.  
         [0137]    FIGS.  8 A- 8 D illustrate an extendible delivery system  800  in accordance with an exemplary embodiment of the invention, in which the actual delivery of a connector is performed by a modular capsule  802 . A similar design may be used for other types of anastomosis delivery systems and/or for other endoscopic activities, such as punching holes and suturing. A potential advantage of such a modular design is that a same system can be used for different surgical approaches and methods, for example, endoscopic, key-hole and open chest. Another potential advantage is that a single handle can be used for multiple parts of a procedure, reducing the size and/or number of components in a kit.  
         [0138]    In an exemplary embodiment of the invention, any endoscopic tool that is activated using rotation, retraction or advancing of a rod can be made modular by providing a suitable coupling for the power and control mechanism. Typically, both power and control are provided by a same element.  
         [0139]    [0139]FIG. 8A shows a connector capsule  802  including a connector  804  as described in FIGS.  7 B- 7 E, an aperture  806  for insertion of a blood vessel and including an optional spilt for splitting the capsule for removal after the anastomosis is performed. A locking mechanism  810  is provided for locking to the rest of the delivery system and a rod extension  808  is provided to transfer retraction from the handle (FIG. 8B) to retract the pullers. Extension  808  may be polygonal or slotted, to support rotation. In other connector types, advancing of the connector or retraction of an over tube may be practiced instead, for example. Optionally, capsule  802  includes a power train for changing displacement amounts to allow a same handle to be used with different capsules that require different amounts and/or directions of motion. Alternatively or additionally, the handle includes such a power train and/or includes means for allowing both retraction and advancing.  
         [0140]    [0140]FIG. 8B shows a complete system  800  including capsule  802  coupled via a coupler  814  to a handle segment  812 . Optionally, a retraction indicator  816  is provided on the handle to indicate a degree of retraction. In an alternative embodiment, reference  816  indicates a locking switch.  
         [0141]    [0141]FIG. 8C illustrates an extender  820  that fits between coupler  814  and capsule  802 . A part of capsule  802  is also shown coupled to a coupler  826  that corresponds to coupler  814  in FIG. 8B. A shaft  824  serves to extend the reach of the device and terminates in a rod extension  822 , corresponding to extension  808  of FIG. 8A. Shaft  824  may be rigid, or it may be partly or completely flexible or hinged, at one or more points along its length, for example as shown below in FIGS.  8 E- 8 H. Optionally, shaft  824  is deformable, for example like a goose-neck. Optionally, shaft  824  includes a channel or slot (not shown) to act as a working channel, for example, to provide a camera, light source, material or tool to the tip of system  800 . Such a channel is optionally provided also in handle  812  and/or in the capsule.  
         [0142]    [0142]FIG. 8D shows a complete extended system.  
         [0143]    Optionally, system  800  is used for an anastomotic connection in which leakage of blood is to be prevented after hole punching. In an exemplary embodiment of the invention, a shaft  850  including a homeostatic valve  856  (e.g., a leaflet valve) is used as a guide for punching and anastomosis delivery. In one exemplary implementation, a punch capsule is provided through a bore  854  of shaft  850 . After the hole is punched, narrowing  852  is advanced over the punch into the holed blood vessel. The punch is then retracted and blood leakage is prevented or reduced by valve  856 . A device delivery capsule (e.g., like capsule  802 ) is then provided through bore  854  and used to perform the anastomosis. Optionally, shaft  850  includes an axial tear line (not shown, for clarity) so that it can be torn off of the delivery system once capsule  802  is in place. Shaft  854  may be, for example, short, like a capsule or long enough to reach outside the body.  
         [0144]    FIGS.  8 E- 8 H illustrate distortable and bendable delivery systems, in accordance with exemplary embodiments of the invention.  
         [0145]    [0145]FIG. 8E shows a delivery system  860  including a hinged extension  864 . In the example shown, a separate capsule  872  is provided, for example the same capsule as capsule  802 , describe above. Alternatively, the extension is integral with the capsule. In an exemplary embodiment of the invention, extension  864  is connected to a handle portion  862  of system  860  at a rotational hinge  866 . A second rotational hinge  870 , for example, integral with the capsule connection mechanism provides a second degree of rotation.  
         [0146]    Optionally, a bending hinge  868  is provided between the two rotational hinges. In an exemplary embodiment of the invention, the total effect of the three hinges is to allow three angular degrees of freedom in positioning the tip of capsule  872 .  
         [0147]    [0147]FIG. 8F is a cut-through view of system  860  including a showing of a possible mechanism for transferring power from handle  862  to retract a connector device held in capsule  872 . A cable  874  is substantially unaffected by the changes in geometry of extension  864 , while still being able to retract a connector when force is applied to handle  862 . In some embodiments, cable  874  is not taunt, until handle  862  is activated. Non-cable means, such as a chain or interlocking rails or rods may be used for transferring the force.  
         [0148]    It should be appreciated that other numbers and/or types of hinges may be provided instead of as shown, possibly yielding fewer or greater degrees of freedom and/or different limitations on angular positioning.  
         [0149]    [0149]FIG. 8G shows an exemplary delivery system  880  having a flexible, optionally flaccid, extension  882 . FIG. 8H shows an exemplary delivery system  890  having a gooseneck-type extension  892 . These extensions may be integral or they may be selectively removable. In an exemplary embodiments of the invention, extensions  882  and  892  can bend 90°, 180°, 270° or even 360° or more degrees. Alternatively or additionally, the extensions can bend at two or more locations. In an alternative exemplary application, the delivery system is rigid and bent. A plurality of different degrees of bending and types of bending may be provided, for example, for access to various blood vessels inside the body, from outside the body, for example via keyholes.  
         [0150]    FIGS.  9 A- 9 E illustrate an alternative embodiment of a capsule based delivery system  900 , in accordance with an exemplary embodiment of the invention.  
         [0151]    [0151]FIG. 9A shows system  900  including a handle  912 , an optional safety switch  916  (e.g., to prevent motion of the handle and retraction of a connector), a capsule  902  and an optional locking lever  914  for selectively locking and releasing capsule  902  from system  900 . An extension element (not shown) can be added between the body of system  900  and capsule  902 .  
         [0152]    [0152]FIG. 9B is an enlarged view of capsule  902  in a perspective view. A vessel opening  906  is provided for inserting a graft. The capsule as a whole is optionally splittable. A connector  904 , for example one of the types described above, is schematically shown at a distal end of capsule  902 . Unlike capsule  802 , capsule  902  optionally includes a means for extending the forward spikes (not shown in this figure) of connector  904 . In an exemplary embodiment of the invention, a rotating knob  918  is provided with at least one and optionally two locking positions, one with spikes extended and/or one with spikes retracted. Independently of this spike moving mechanism, the spikes as a whole may be retracted a considerable distance when handle  612  (FIG. 9A) is activated. Alternatively, knob  918  is used also to tear the spikes, as described above.  
         [0153]    This selective extension of the spikes optionally serves to protect the spikes while guiding system  900  to an anastomosis location.  
         [0154]    The operation of knob  918  is described with reference to FIGS.  9 C- 9 E, in which FIGS. 9C and 9D show the outside of capsule  902  and FIG. 9E shows its inside mechanism. FIG. 9E shows a cut-through view of capsule  902 , in accordance with an exemplary embodiment of the invention. Capsule  902  comprises, for example, an external shell  936  and an internal mandrel  930  including a proximal locking mechanism  908  for attaching to system  900 . In an exemplary embodiment of the invention, mandrel  930  includes a peg  932  that interacts with a slot  920 , for example a “Z” shaped slot, formed in knob  918 . The sides of the “Z” define locking positions and the connecting line defines the motion of mandrel  930 . In an exemplary embodiment of the invention, mandrel  930  includes a concentric depression  934  for receiving a spike section of a connector  904  (not shown). Mandrel  930  is optionally hollow for passage of a graft therethrough.  
         [0155]    [0155]FIG. 9C shows capsule  902  in one position, with spikes of connector  904  being retracted. In FIG. 9D, knob  918  is rotated so that the spikes extend forward. In an exemplary embodiment of the invention, the motion is accompanied by retraction of shell  936 .  
         [0156]    [0156]FIG. 10 illustrates an incision maker  1000  for forming an opening in a target vessel, from outside the blood vessel, in accordance with an exemplary embodiment of the invention. Two moving parts are provided, a base face  1010  coupled to a first handle  1014  and an ‘L” shaped spike  1004  coupled to a second handle  1012 . In the exemplary embodiment shown, the two handles are connected using a hinge  1020  and an arm  1022 . Other handle designs may be used, for example a syringe-like design and/or a gooseneck extension mechanism as described above. The two parts are optionally coupled using a spring  1016 , or a spring in hinge  1020  (not shown). In an exemplary use, a tip  1006  of an arm  1009  of spike  1004  is inserted into a blood vessel, for example a coronary artery. Incision maker  1000  is then turned so that arm  1009  is inside the vessel and parallel to the vessel axis (assuming that is the desired cut direction, as an oblique cut or a trans-axial cut may be desired). Arm  1009  is then retracted towards face  1010  and the vessel wall is cut using a shearing cut. Optionally an inner face  1008  of arm  1009  is sharp and functions as a knife. In an exemplary embodiment of the invention, tip  1006  is flexible. Optionally, face  1010  is formed at the end of a flat plate  1002  and tip  1006  is bent inwards towards the plane of plate  1002 .  
         [0157]    Face  1010  and face  1008  are optionally substantially parallel to each other. Alternatively, the faces are not parallel to each other, for example, spreading out (as shown) or pointing in. One or both the faces may be perpendicular to the axis of motion incision maker  1000  or be oblique thereto.  
         [0158]    The above description has focused on devices that are applied from outside a blood vessel. However, they can also be applied from inside of blood vessels.  
         [0159]    [0159]FIGS. 11A and 11B illustrate a connector  1102  and an associated graft mounting system  1100 , in which the connector is distorted to assist in mounting a graft thereon, in accordance with an exemplary embodiment of the invention. Both these figures show connector  1102  already mounted in system  1100 .  
         [0160]    A connector  1102  comprises a plurality of extending spikes  1104 , having recurved tips  1106 . When the spikes point forward, mounting a graft  1126  on connector  1102  may be difficult, due to the direction of tips  1106 . In an exemplary embodiment of the invention, mounting system  1100  bends spikes  1104  so that tips  1106  point radially out. Then graft  1126  can be mounted by providing the graft inside connector  1102  and pulling (e.g., with tweezers) the lip of graft  1126  over tips  1106  , to be impaled by tips  1106 . In one example, the lip is everted manually over the tips one by one. Alternatively, a mechanical device may be used to grab the lip at a plurality of locations and extend it over the spike tips. Optionally, the spike tips are closer together than the graft diameter, to reduce the need to stretch the graft lip. (e.g., one by one).  
         [0161]    System  1100  is shown in perspective in FIG. 11A from underneath and in FIG. 11B from its top. In general, system  1100  comprises three slotted disks  1120 ,  1110  and  1112 . Spikes  1104  are held in slots  1128  formed in disk  1110 . Optionally, the slots include a section of a tab-and-tear portion  1130  of each spike. In operation, all spikes  1104  are extended through an aperture  1108  formed in the disks. Disk  1112  is rotated and aligned with disk  1110 , so that a plurality of slots  1114  formed in disk  1112  and especially a wide slot portion  1116  are aligned with slots  1130 . In an exemplary embodiment of the invention, the slots are aligned to be partially overlapping, so that the overlapping portion is smaller than the width of a spike, but wider than a spike thickness. Each spike is twisted (e.g., using tweezers) and guided along the thus formed overlapping slot and allowed to untwist in wide slot portion  1116 . Then, a plurality of slots  1122 ,  1124 , etc. in disk  1120  are aligned in turn with the bent spikes. As shown in FIG. 11B, the distance between the slots and/or their width is non-uniform, allowing each spike to be dealt with in turn, when only its associated slot overlies a particular slot  1130 . Each spike is pushed down into slot  1128 . When this process is completed, graft  1126  may be mounted on the outward pointing sharp tips  1106 . Once mounted, capsule  802  or  902  may be brought over the base of connector  1102 . In an exemplary embodiment of the invention, connector  1102  is mounted first over a mandrel portion of the capsule and then the casing of the capsule is brought over the mandrel (e.g., as in FIG. 9). In an exemplary embodiment of the invention, the capsule design and/or delivery system is modified to account for a longer retraction of the connector, which longer retraction compensates for longer spikes that might be used in the embodiments of FIG. 11.  
         [0162]    Although a particular example is shown, it should be appreciated that other disk patterns and alignment mechanism may be used as well for sequentially arranging the spikes in systems  1100 . For example, different slot patterns or different motion of the disks may be provided.  
         [0163]    FIGS.  12 A- 12 D illustrate a connector remover  1200 , in accordance with an exemplary embodiment of the invention. Remover  1200  may be used to remove an anastomotic connector during implantation or after complete implantation. Generally, remover  1200  comprises a handle  1202  that retracts a tip  1206  relative to a body  1204 .  
         [0164]    FIGS.  12 B- 12 D show remover  1200  is use. Tip  1026  comprises a fixed outer tube  1214  and a spike gripper, for example, a retractable split inner tube  1212  or a tweezers.  
         [0165]    Tube  1212  is advanced until it meets a base ring portion  1210  of a connector (FIG. 12B), so that a spike  1208  extends into a hollow  1206  defined between two sides  1216  and  1218  of split tube  1212 . In FIG. 12C, tube  1212  is retracted relative to tube  1214 , while pressing the whole remover forward, thus the effect is that of advancing tube  1214  over tube  1212 . In an exemplary embodiment of the invention, tube  1212  includes one or more protrusions  1220  at its distal end, that increase its diameter, tube  1212  has an increasing outer diameter at its distal end and/or outer tube  1214  has a narrowing inner diameter. Thus, when tube  1214  reaches base  1210 , (or, possibly, before that time) spike  1208  is gripped by inner tube  1212 . Continued retraction of inner tube  1212 , for example as shown in FIG. 12D pulls spike  1208  through base ring portion  1210 . In an embodiment where base ring  1210  includes a spring tab (e.g.,  718 , FIG. 7A) to prevent retraction of spike  1208  (under normal conditions), inner tube  1212  and/or outer tube  1214  are optionally designed to allow freedom of motion for the tab. Spike  1208  is optionally straightened by the retraction through base ring  1210 .  
         [0166]    Alternatively or additionally to friction engaging of the spike, in some embodiments of the invention, protrusions  1220  engage a tab portion or an aperture formed in the spike.  
         [0167]    In another embodiment of the invention, a remover  1200  is adapted to remove a plurality or even all the spikes of a connector at one time. In this case, inner tube  1212  is optionally made of sufficient diameter to enclose the graft and the spikes are engaged between the inner tube and the outer tube. A separate further outer tube relative to which the two other tubes are retracted and which provides a contra against the base ring, may be provided.  
         [0168]    Thus, in some embodiments of the invention, inner tube  1212  or a different type of spike gripper is not activated by a same overtube as used for applying a contra force against the base ring.  
         [0169]    In an exemplary embodiment of the invention, the above devices are used in combination with anastomosis-related tools as described in PCT applications and publications WO 99/62415, WO 00/56226, WO 00/56228, WO 01/41623, WO 01/41624, PCT/IL01/00267, PCT/IL01/00069, PCT/IL01/00074, PCT/IL01/00266 and PCT/IL01/00600, the disclosures of which are incorporated herein by reference. However, they may also be used as stand alone devices or as part of surgical kits for other uses and/or anastomosis connectors.  
         [0170]    It will be appreciated that the above described methods and devices of vascular manipulation may be varied in many ways, including, changing the order of steps, the exact materials used for the devices, which vessel is a “side” side and which vessel (or graft) is an “end” side of an end-to-side anastomosis and/or whether the end vessel is everted over the connector. Further, in the mechanical embodiments, the location of various elements may be switched, without exceeding the spirit of the disclosure, for example, switching the moving elements for non-moving elements where relative motion is required. 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 the above features, from different described embodiments 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 used to illustrate the invention should not be considered as necessarily limiting the invention in its broadest aspect to only those forms, for example, where a circular lumen is shown, in other embodiments an oval lumen may be used.  
         [0171]    Also within the scope of the invention are surgical kits which include sets of medical devices suitable for making a single or a small number of anastomosis connections and/or apertures. 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”.  
         [0172]    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.