Definitions

• the present invention relates to the field of attaching two blood conduits to each other.
• a sub-task of eversion for some types of anastomotic devices is proper penetration of the everted vessel by sharp spikes of the anastomotic connector.
• An aspect of some embodiments of the invention relates to treating the vessel tissue of at least one of the vessel of an anastomotic connection, as a non-passive tissue.
• various properties of the tissue are taken into account and/or utilized as part of anastomotic connection, including, for example, elasticity, plasticity and/or compressibility.
• An aspect of some embodiments of the invention relates to distorting a graft or blood vessel (hereinafter the term graft is used for either or both), to simulate eversion and/or shaping of the graft tip.
• the end of the graft is thickened to allow spikes of anastomotic device to transfix the graft parallel to its axis. These spikes may also maintain the thickening of the graft.
• the tip is stretched, to thin its wall.
• the end of the graft is compressed so that an intima portion of the graft is presented to the front or outside of the compressed graft.
• the graft is distorted so that it supports a non-pe ⁇ endicular anastomosis, by an elastic desire of the graft to return to a less-distorted shape. Possibly, the angle of the connection and/or tendency to kink is modified by appropriate shaping of the graft.
• the compression and/or other distortion of the graft is performed by the anastomotic connector. Alternatively or additionally, the distortion is performed by a separate tool. Alternatively or additionally, the distortion is performed by a delivery system.
• the anastomotic connections may be, for example, side to side, side to end or end to end.
• an aorta is axially compressed about a holed formed therein, to assist in everting the lips of the hole and/or distorting the lips of the hole.
• distorting the lips for an anastomotic connection such distortion may be applied to lips of a hole in a blood vessel, for example to effect a better seal.
• An aspect of some embodiments of the invention relates to controlling a shape of an anastomosis connection using an anastomosis device and/or a graft that take part in the connection.
• connection is made at a pe ⁇ endicular angle and then the connection is modified, for example self-modified, to a new, oblique orientation.
• anastomosis connector accepts bending after being deployed. Possibly, even relatively small forces suffice to bend the connector, for example, forces applied by the graft or by an external tool.
• An aspect of some embodiments of the invention relates to reducing a profile (e.g., projection from a surface of a blood vessel) of an anastomosis connector after it is attached.
• the profile is reduced by one or more of cutting, bending, twisting and/or bucking of parts of the connector. It is expected that, at least in some cases, the reduced profile will reduce the incidence of kinking of the graft. Alternatively or additionally, the pre-stressing of the graft will assist in reducing kinking.
• An aspect of some embodiments of the invention relates to a vessel punch having mounted thereon an anastomotic connector.
• the act of punching inserts the connector into the vessel, so that once it is released from the punch, the anastomosis can be completed.
• the connector is released by rotating the punch relative to the connector.
• An aspect of some embodiments of the invention relates to methods of manipulation of a graft to achieve a desired eversion, which eversion is penetrated by spikes of a connector.
• the manipulation consists of eversion.
• the manipulation consists of converting a straight eversion into an oblique eversion, so as to pre-stress the connector so that a completed anastomosis will be oblique.
• the manipulation consists of method of advancing the spikes to transfix the graft. It should be noted that in some embodiments of the invention, the spikes on the connector are not pe ⁇ endicular to the graft at the penetration point.
• the spikes are assisted in penetrating the graft by suddenly releasing the spikes form a constraint, inside the everted part of the graft. Sudden release can be, for example, by releasing a lasso that holds the spikes radially compressed, by retracting an outer tube that confines the spikes or by rotating a slotted tube mounted over the connector, so that the spikes are released into the slots, simultaneously or in sequence.
• the spikes penetrate the graft with the help of a cap, mounted on the graft.
• the cap can be condom-like, including a portion that extends into the lumen of the graft and a flexible membrane that can be inverted over the graft, everting the end of the graft with it.
• the cap can be a rigid cap. Twisting the cap on an everted graft will cause the spike tips to penetrate the graft, if they have not yet penetrated.
• the cap has uneven sides, for example including barbs, to unevenly pull-down the two sides.
• the spikes may be restrained by a lasso or over tube, during the pulling down of the cap.
• the graft is mounted on a mold, which support uneven eversion, for example, using tweezers.
• the mold comprises a cylinder with two axially extending and adjacent fingers. One spike of the connector rest between the fingers. During eversion, the tip of the vessel is brought over the finger and onto the spike.
• an external tool is used, for example a pad having an inwards pointing barb. The pad slides along a tube enclosing the graft and the barb selectively engages only that part of the graft that is to be pulled down, thus stretching only that part.
• a manual probe is used to ensure that all the spikes penetrate the graft.
• the probe is a Y shaped probe with a wire between the two prongs of the Y. This wire can be used to urge the graft, adjacent the spike tip, onto the spike. Alternatively or additionally, this wire is used to push back the spike, so that it can be suddenly released to penetrate the graft.
• An aspect of some embodiments of the invention relates to an angular eversion tool that includes markings thereon to allow a person everting the graft to achieve a desired oblique angle in an anastomosis by using a graft everted using the marked tool.
• An aspect of some embodiments of the invention relates to a split delivery system, in which the delivery system is split after the anastomosis is completed, to remove the system from the graft.
• a line on which the system is split is not straight.
• the split line meanders so that, at a point where the graft is inserted into the delivery system, the split line will not lie along a line between the graft and the system tip. Thus, the vessel is less likely to catch on the split line.
• An aspect of some embodiments of the invention relates to a two part anastomotic connector in which the connector defines a ring around the outside of the anastomosis location.
• this ring is used to guide a desirable distortion of a vessel tip of at least one of the attached vessels.
• the ring is defined by a part of the device mounted on a side vessel of an end-to-side connection.
• a potential advantage of the two part device is that the locking mechanism is thin, so the profile of the device can be low.
• Another potential advantage is that the distortion of the vessel forms a thickening and/or eversion, so that a better seal may be achieved.
• a method of preparing a graft for an anastomosis comprising: providing a graft having a lip at an opening therein; and compressing said lip of said graft to form at least one thickened portion adjacent said opening.
• said thickening is uniform around said opening.
• said thickening is non-uniform around said opening.
• said thickening is non-uniform in length.
• said thickening is non-uniform in thickness.
• said thickening is selected to achieve a desired pre-stressing of said graft for an oblique anastomotic connection.
• said thickening is selected to achieve a match between the lips of two vessels.
• said thickening is selected to achieve a size match between the lip of the graft and the lip of an opening in a target vessel.
• said thickening is selected to achieve a minimum size of seal area between the lip of the graft and the lip of an opening in a target vessel.
• the method comprises transfixing said thickening with at least one spike.
• said spike is axially disposed with respect to said graft.
• said spike is obliquely disposed with respect to said graft.
• said thickening is maintained in shape by a connector.
• compressing said lip comprises compressing using an anastomotic connector. Alternatively or additionally, compressing said lip comprises compressing using a graft compression tool.
• compressing said lip comprises everting an intima of said graft at least 90°. Alternatively or additionally, compressing said lip comprises everting an intima of said graft at least 120°. Alternatively or additionally, compressing said lip comprises everting an intima of said graft at least 160°.
• said everting matches said intima to an intima of a target vessel.
• said opening is an opening in side of said graft.
• said opening is an opening in an end of said graft.
• said graft is a blood vessel.
• said graft is a mammary artery.
• said graft is a synthetic graft.
• the method comprises attaching said graft to a blood vessel. Alternatively or additionally, the method comprises attaching said graft to a synthetic graft.
• a connector adapter to be distorted for oblique connections comprising: a plurality of interconnected segments, at least some of said segments including a forward spike or a backward spike; and a plurality of distortable portions defined between said segments, wherein said portions are adapted to support a distortion from a straight anastomosis to an oblique anastomosis.
• said distortable portions comprise at least one ring. Alternatively or additionally, are designated in a ring that interconnects said segments.
• said distortable portions are annealed.
• said spikes are self extending.
• said distortable portions are plastically deformable.
• said distortable portions are pre-stressed to mach an oblique connection configuration.
• said distortable portions are unevenly distributed on said connector.
• said distribution matches an expected amount of distortion at the different parts of said connector.
• a method of creating an oblique eversion in a graft comprising: everting a graft to have a straight everted sleeve; and differentially extending one side of the sleeve, to form an oblique eversion.
• said everting comprises everting over a connector having spikes.
• said spikes are fully extended during said everting.
• said method comprises assisting said spikes to penetrate said sleeve after said differentially extending.
• said spikes are partially extended during said everting.
• the method comprises fully extending said spikes to penetrate said sleeve.
• differentially extending comprises extending only part of said sleeve.
• differentially extending comprises extending all of said sleeve.
• differentially extending comprises manually pulling down said side using tweezers.
• differentially extending comprises pulling down said side using a pad that slides along said graft, which pad includes a vessel engaging element to engage said side.
• differentially extending comprises pulling down said side using a tube that slides along said graft, which tube includes a vessel engaging element to engage said side.
• said tube comprises at least a second vessel engaging element, to engage an opposite side of said sleeve.
• said tube is capped, to prevent over sliding of said tube over said graft.
• a method of creating an oblique eversion in a graft comprising: mounting said graft inside a graft holder having a slotted axial extension; mounting a connector on said graft such that a spike of said connector exits through said slot; and everting said graft on said tube, such that a portion everted over said extension is longer than a portion everted not over said extension.
• a method of penetrating non-pe ⁇ endicular pointing spikes of a connector into an everted graft comprising: radially compressing said spikes; everting said graft over said connector; and suddenly releasing said spikes, to penetrate said graft.
• said radially compressing aligns said spikes to be more pe ⁇ endicular to said graft.
• radially compressing comprises restraining said spikes using a slotted tube and wherein suddenly releasing comprises rotating said tube so that said spikes align with and pass through said slots.
• all of said spikes are aligned simultaneously with said slots by said rotation.
• radially compressing comprises restraining said spikes using an over-tube and wherein suddenly releasing comprises retracting said tube relative to said spikes so that said spikes are released.
• said over-tube comprises a graft holder for said graft.
• said over-tube is separate from a graft holder for said graft.
• retracting said tube relative to said spikes comprises advancing said connector.
• retracting said tube relative to said spikes comprises retracting said over-tube.
• said spikes are partially extended so they can contact said graft, prior to said suddenly releasing.
• said spikes are not all the same length, so that when released they do not all penetrate said graft at a same time.
• said tube is oblique.
• radially compressing comprises restraining said spikes using a looped thread.
• said looped thread comprises a slipknot.
• a method of penetrating non-pe ⁇ endicular pointing spikes of a connector into an everted graft comprising: everting said graft over said connector; placing a cap on said everted graft; and manipulating said cap to cause penetration of said spikes into said graft.
• manipulating comprises rotating said cap.
• manipulating comprises axially displacing said cap.
• a method of everting a graft comprising: mounting said graft in a graft holding tube; providing a conical membrane inside a lumen of said graft; and everting said membrane to effect an eversion of said graft.
• said conical membrane comprises a relatively rigid base ring.
• said conical membrane comprises a relatively rigid extension from its tip.
• said everting comprises obliquely everting said conical membrane.
• a split graft holder comprising: a tube having a tip for the exit of a graft, defining: a side opening for receiving the graft through a lumen of said tube to said tip; and a split line along said tube axis and meeting said side opening, for splitting said holder to remove said holder from a graft, after said graft is attached to another blood conduit, wherein said split line does not axially meet said side opening, at a side of said opening near said tip of said tube.
• said split line meets said opening from its side.
• a reducing profile anastomotic connector comprising: a ring section; a spikes section comprises a plurality of spikes, wherein said spikes section defines a collapsing portion, for axial collapsing of said spikes section.
• said collapsing portion buckles.
• said collapsing portion twists.
• said collapsing portion folds out.
• a combined hole punching and graft delivery device comprising: a body, having therein at least one recess for receiving a spike of a connector; and a sha ⁇ tip retractable relative to said body, wherein said sha ⁇ tip and said body define between them a blood vessel wall receiving area.
• said recess includes a protrusion, for selectively releasing said spike when said body is rotated relative to said spike.
• said spike is pre-stressed to self extend out of said recess.
• said spike radially extends out of said recess when it is retracted.
• a graft everting tool comprising: a base ring; an extension adapted to be inserted in a graft; and a conical membrane-like element connecting said base and said extension, and adapted to engage an inside of a blood vessel, wherein said membrane is flexible enough to be everted.
• said tool is adapted to evert obliquely.
• said tool has a non-uniform graft property, so as to effect an oblique eversion when it is used to evert a graft.
• a tool for compressing a tip of a graft comprising: an outer mandrel mounted over the graft and reaching to about an opening in the graft; an inner mandrel mounted inside the graft and reaching to about said opening; and a base, wherein said base and said two mandrel define a space for said graft to extend into when the mandrels are brought together.
• said inner mandrel is mounted on said base.
• said inner mandrel is expandable.
• said inner mandrel is adapted to engage at least a portion of said graft.
• said outer mandrel is adapted to engage at least a portion of said graft.
• a tool for forming an oblique eversion from a graft everted over a graft holder comprising: a body shaped to slide over said everted graft; and at least one graft engaging element for selectively engaging only one side of said everted graft.
• said body comprises a tube.
• said body comprises a tube segment.
• said body is capped to prevent axial motion beyond a certain amount.
• the tool comprises at least a second graft engaging element for engaging a second side of said everted graft.
• a tool for forming an oblique eversion for a graft comprising: a tube; and at least one axial extension of said tube, such that a spiked connector disposed in said tube can project at least one of its spikes near a base of said projection.
• said at least one projection comprises at least two projections defining a slot between them, with said spike extending through said slot.
• a tool for forming an oblique eversion for a graft comprising: a tube adapted for having a graft and a connector mounted therein; and an over-tube which radially restrains at least one spike of said connector, wherein said connector can be moved relative to said over-tube.
• said over tube is slotted and wherein said motion is rotation.
• said motion comprises axial motion of said connector relative to said over-tube.
• said tube is a same element as said over tube.
• said over-tube is oblique.
• a tool for assisting spike penetration into an everted graft comprising: a graft and connector holder having a graft everted thereon; and a cap having an inner diameter larger than an outer diameter of said graft and connector holder, for mounting on said everting graft.
• a tool for assisting spike penetration into an everted graft comprising: a handle, defining at least two arms; and a wire between said two arms, wherein said tool is adapted for assisting penetration of a spike into an everted graft.
• Figs. 1A-1D show an everted graft and grafts with simulated eversion, in accordance with exemplary embodiments of the invention
• Figs. 2A-2C illustrate various anastomotic connections using thickened grafts, in accordance with exemplary embodiments of the invention
• Figs. 2D and 2E illustrate the use of graft distortion to vary the graft layout, in accordance with an exemplary embodiment of the invention
• Fig. 3 illustrates a blood vessel distorter, in accordance with an exemplary embodiment of the invention
• FIGS. 4A and 4B illustrate a distortable connector, in straight and distorted configurations, in accordance with an exemplary embodiment of the invention
• FIGs. 4C and 4D are side cross-sectional views of an anastomotic connection utilizing the connector of figs. 4A and 4B, before and after relaxation of strain;
• FIGs. 5A-5E illustrate a two part connector and a method of deploying such a connector, in accordance with an exemplary embodiment of the invention
• Figs. 6A-6E illustrate methods and apparatus for reducing an axial profile of an anastomotic device, in accordance with exemplary embodiments of the invention
• Figs. 7A and 7B illustrate the working of a flexible graft everter, in accordance with an exemplary embodiment of the invention
• FIGs. 8A-8D illustrate a lasso-based release mechanism, in accordance with an exemplary embodiment of the invention
• Figs. 8E-8F show two different lasso configurations for use with the embodiments shown in Figs. 8A-8D;
• Figs. 9A-9D illustrate a slotted-tube mechanism for sudden release of spikes of a connector
• Fig. 10A and 10B illustrate an over-tube based spike penetration method and apparatus, in accordance with an exemplary embodiment of the invention
• FIGS. 11A-11C illustrate a cap based technique and apparatus for spike penetration, in accordance with an exemplary embodiment of the invention
• Figs. 12A-12C illustrate a probe and a spike penetration method using the probe, in accordance with an exemplary embodiment of the invention
• Figs. 13 A and 13B illustrate a tool for oblique eversion, in accordance with an exemplary embodiment of the invention
• Figs. 14A and 14B illustrate a method of converting an even eversion into an oblique eversion, in accordance with an exemplary embodiment of the invention
• Figs. 15A-15C illustrate an alternative method of converting an even eversion into an oblique eversion, in accordance with an exemplary embodiment of the invention
• Figs. 16A and 16B illustrate a cap-like tool for converting a pe ⁇ endicular eversion into an oblique eversion, in accordance with an exemplary embodiment of the invention
• Fig. 17 illustrates an exemplary combined hole punch and connector inserter tool, in accordance with an exemplary embodiment of the invention
• Figs. 18A and 18B illustrate a graft delivery system, in accordance with an exemplary embodiment of the invention.
• the ends of a graft vessel are compressed, to achieve various effects, for example, pre-stressing the graft to be inclined to a certain post-anastomotic shape, thickening the graft to support transfixing of the graft, at non-pe ⁇ endicular angles, using spikes of a connector and/or presenting an intima to an anastomosis connection, without a complete eversion of the graft. It is noted that thickening the ends of the graft may also improve the leakage-prevention properties of the anastomotic connection. In some embodiments of the invention, a graft having the desired thickening and/or distortion is manufactured.
• Figs. 1A-1D show an everted graft and grafts with simulated eversion, in accordance with exemplary embodiments of the invention.
• Fig. 1A shows a standard everted vessel 100, having everted lips 102.
• Fig. IB shows vessel 100 with its end compressed, so that a thickened portion 104 is formed at the distal end of the graft.
• This thickening may, for example, match a greater vessel thickness of a target vessel and/or provide for a better seal.
• Fig. 1 C shows vessel 100 with its end unevenly compressed, so that thickened portions 106 and 108 are of different lengths.
• the end-face of the vessel is pe ⁇ endicular to the vessel axis.
• this type of distortion pre-stresses the graft, so that when the anastomosis is completed, the graft will naturally curve in a desired connection, for an oblique connection or for a pe ⁇ endicular connection with a curving graft. It is expected that thus pre-stressing may, in some cases, reduce a tendency to kink.
• Fig. ID shows an alternative uneven thickening, in which thickened ends 1 10 and 1 12 define an oblique end face for vessel 100.
• Connector 114 comprises, for example, a ring 1 16 and a set of longer spikes 118 that transfix the longer thickened portion 1 10 and a set of shorter spikes 120 that transfix the shorter thickened portion 1 12.
• the anastomotic connector may be material in maintaining the axially compressed condition of the vessel end, however, this is not required.
• graft In Figs. 1C and ID, the graft way be originally cut with at an angle, or not.
• the thickening may be, for example, a multiple of the original graft wall, for example, a factor of 1.1, 1.5. 2.0, 2.5, 3.0 or any greater, smaller or intermediate number. Alternatively or additionally, it may be absolute, for example, 0.5 mm, 1 mm, 1.5 mm or 2 mm, or any greater, smaller or intermediate size.
• the length of the thickening may vary, for example, being 0.3 mm, 0.6 mm, 1 mm, 2 mm, 4 mm or any greater, smaller or intermediate size. Alternatively or additionally, the length is a function of the graft diameter, for example, being a factor of 0.3, 0.5, 1 , 1.5 or any greater, smaller or intermediate number.
• the angle (possibly measured at a short distance from the anastomosis location) of an oblique connection may be, for example, 10°, 20°, 30°, 50°, 70°, 80° or any greater, smaller or intermediate angle. In some cases, the angle is with the flow direction, in others, pe ⁇ endicular or against the flow direction.
• Figs. 2A-2C illustrate various anastomotic connections using thickened grafts, in accordance with exemplary embodiments of the invention.
• the graft is vessel 200 and the target vessel is either an end vessel 202 or a side vessel 204.
• side vessel 204 is an aorta or other thick artery, which has a thick wall and may be difficult to invert. Alternatively, it may be a graft or a stent graft.
• Fig. 2A shows two exemplary end-to-end anastomosis connections, 206 and 208.
• the tips of the vessels are thickened, thereby possibly affording a better seal and/or compensating for any unevenness in the vessels.
• the marked area indicates the intima of the vessels.
• one or both vessels are distorted so that their intimas meet, even though the vessels are not completely everted. Such distortion can be achieved, for example, by pulling back the outer side of the thickened portion, pulling along the intima portion.
• the vessels may be distorted so that the outside of the vessels meet, for example by stretching the outside of the vessels, rather than the intima.
• Fig. 2B shows two exemplary end-to-side anastomosis connections, 210 and 212.
• connection 210 the lip of side vessel 204 is partially everted. Alternatively, it may be axially compressed, to make it thicker.
• connection 212 the vessel lip is not modified, and the thickening of the tip of vessel 200 may afford a better seal.
• the intima of vessel 200 may or may not be exposed, as shown in Fig. 2A.
• Fig. 2C shows two additional exemplary end-to-side anastomosis connections, 214 and 216.
• connection 214 the end of vessel 200 is thickened and distorted to have a non-uniform face, so that an extension of vessel 200 enters side vessel 204. Possibly, some or all of the extension exposes an intima, as shown in the Fig.
• a thickening of vessel 200 remains outside vessel 204 and in contact with its outer surface, for example for providing a better seal and/or a more stable seal.
• the lip of side vessel 204 is partially everted, to contact its intima with vessel 200.
• the front face of vessel 200 need not be planar, and can vary.
• the side profile of the thickened part can vary, for example to include a bump that abuts against the walls of the opening in the side vessel, possibly providing a sealing ring.
• an anastomosis connector is converted into a hole closure device by providing a membrane (e.g., part of a graft) across the lumen of the connector.
• a membrane e.g., part of a graft
• the various contact configurations and vessel distortions shown in Figs. 2A-2C may be maintained using a variety of methods, for example, sutures, tissue adhesive, connectors that transfix the distorted portion with a spike and/or connectors that apply a constraining force on the distorted portion.
• distortion of a vessel may be easier to achieve than eversion, for example if the vessel is fragile or calcified or if the tip of the vessel is in a hard to reach area.
• Figs. 2D and 2E illustrate the use of graft distortion to vary the graft layout, in accordance with an exemplary embodiment of the invention.
• a graft is bent by thickening only one side of the graft (or differentially thickening two sides) to form a thickening 222 are a bending location thereof.
• the thickening may be maintained, for example, by a pin or staple 224.
• a graft is shortened, by forming thickenings 228 at its center, optionally holding them together using a pin 230.
• the selective distortion of grafts is practiced after the anastomosis is completed, to assure that the graft will not kink or otherwise lay in an undesirable configuration.
• the distorted grafts and/or vessels may be of any type, for example synthetic, xenologous, autologus (e.g., veins and arteries), and cadaver tissue.
• the LIMA and RIMA mammary arteries appear to have significant potential for distortion.
• Other exemplary suitable target vessels include the radial and gastro-epiploic arteries.
• the methods described herein can be applied to a vessel that is connected at one or both ends to the body, or to a vessel that is not connected to the body.
• the vessel may be inside the body, for example being connected or being provided through a tube, for example endocscopically or transvascularly. Alternatively, at least a part of the vessel that is worked on outside the body.
• FIG. 3 illustrates an exemplary blood vessel distorter 300, in accordance with an exemplary embodiment of the invention.
• a vessel 302 is mounted on an inner tubular support 304.
• An outer tube 306 engages vessel 302 at least at an engagement portion 308.
• At the base of tube 312 there is defined a moat 315 by a surrounding wall 312 and a base element 313.
• tube 306 When tube 306 is advanced, it pushes vessel 302 into the moat, where unduly radial expansion is prevented by wall 312. If tube 306 is slightly shy from the vessel edges, as shown, the vessel end will distort to the form shown as a dotted line by reference 314.
• tube 306 engages vessel 302 by providing an over tube 310 that radially compress tube 306, or at least engaging portion 308 thereof.
• vessel 302 is held by tube 304, for example by forcing a widening wedge 316 into a lumen of tube 304.
• the outer surface of tube 304 and the inner surface of tube 306 may be smooth or it may be rough, at least at some locations. By suitable selection of rough locations and the tube that engages vessel 302, various effects can be achieved.
• engaging vessel 302 via its inner surface prevents motion of the intima.
• tube 304 is expanded to hold the intima and tube 306 is slightly retracted, causing the intima to be exposed at the front or outside of vessel 302.
• a connector may be mounted on the compressed vessel in various manners.
• the connector sits inside moat 315.
• the connector is between tubes 304 and 306.
• portion 308 is axially slotted, to receive spikes of the connector.
• the connector is mounted in a recess in portion 308.
• base 313 and/or tube 306 are slotted, to accommodate the connector.
• tubes 304 and 306 can have a non-circular cross-section, for example, elliptical or polygonal cross-sections.
• the distortion includes twisting of vessel 302. In some embodiments, this twisting will be assisted by a spiral pattern on tube 304 and/or tube 306. Further, base 313 may not be flat, for example to assist in achieving the distortions shown in Fig. 2C.
• the distorted blood vessel may be distorted plastically, elastically or a combination of elastic and plastic distortion.
• the vessel may be cooled, to prevent it from returning to the undistorted configuration
• the inner tube When compressing the lips of a side opening, the inner tube may have the form of a T- shaped mandrel, for example, and the outer tube may be slotted, to receive the graft.
• the graft when the graft is released, for example after an anastomosis is completed, the graft will tend to assume a non-pe ⁇ endicular orientation to a side vessel to which it is attached. This is also the case where a graft is everted in a non-even manner. The strain caused by the uneven eversion or the uneven compression will tend to curve the graft. Such curvature may be desirable in an anastomotic connection.
• the curving of the graft can proceed without the connector itself affecting the curve.
• the connector itself may be oblique.
• a connector that is naturally distortable into an oblique configuration.
• Such a connector supports an oblique connection.
• the connector may be pre-stressed into a distorted configuration.
• the connector may be distorted by strain release in the graft.
• the connector may be manually distorted after the anastomosis is completed.
• Figs. 4A and 4B illustrate a side of a distortable connector 400, in straight and in distorted configurations, in accordance with an exemplary embodiment of the invention.
• Connector 400 comprises a plurality of forward spikes 404 and a plurality of backward spikes 402.
• the sets of spikes are interconnected using a ring 408 that includes distortable sections 406.
• sections 406 are designed to act as hinges.
• sections 406 distort in a manner which allows them to return to a pre-stressed shape, for example by being elastic, super-elastic or shape-memory pre-stressed.
• sections 406 are plastically deformable.
• sections 406 may be uniform or non-uniform, for example being greater at ring areas where a greater distortion is required (as shown).
• This general design may be applied to other anastomotic connectors, for example, to annular ring connectors (on the ring itself) two- part connectors (on one or both parts) or to connectors with multiple axial rings or cell elements (at spaced apart radial locations).
• Connector 400 may be pre-stressed to the configuration shown in Fig. 4B, however, it is deployed as shown in Fig. 4A, for example using an axial restraining element (e.g., a slotted over-tube), that limits the axial position of the ring 408.
• an axial restraining element e.g., a slotted over-tube
• pairs of distortable sections 406 are provided on axially pointing sections of ring 408, so that axial distortion can be achieved by non-axial motion of the axial sections between distortable sections 406.
• Figs. 4C and 4D are side cross-sectional views of an anastomotic connection utilizing connector 400, before and after relaxation of strain.
• the anastomosis is just completed, for example, using a pe ⁇ endicular hole-punch and a pe ⁇ endicular delivery system.
• a tube 410 may be provided to maintain this pe ⁇ endicular orientation.
• Tube 410 may be a same tube that is used as a graft holder for providing the vessel and the connector to the anastomosis connection.
• connection distorts and assumes the oblique configuration shown in Fig. 4D.
• the shape of the lumen may remain circular or it may also distort, for example into an ellipse.
• the distortion of connector 400 also involves radial expansion, for example, in a self-deforming connector, thereby sealing the anastomotic connection.
• the device may elastically expand radially, while being plastically distorted, for example by selective annealing of sections 406, for example using a contact heater, or an energy beam.
• the connector itself may perform the eversion and/or other distortion of the graft.
• FIGs. 5A-5E illustrate a two part connector and a method of deploying such a connector, in accordance with an exemplary embodiment of the invention.
• Fig. 5A shows a configuration 500 including two parts, an end configuration 502 and a side configuration 504.
• End configuration 502 includes a graft 506 having a first connector part 508 mounted thereon.
• connector 508 includes a plurality of spikes 510 that penetrate graft 506.
• the spikes may be interconnected by a ring 514 and include a locking mechanism 512.
• an intra-wall spike 509 is provided to guide the distortion of the tip of graft 506.
• Connector 508 is held by an outer holder 516 and optionally abuts against a pusher 518.
• Side configuration 504 comprises a side vessel 530 having mounted thereon a second connector part 520.
• Connector part 520 comprises a plurality of spikes 522 that pierce vessel 530, optionally attached to a ring 524.
• a locking mechanism 526 may be provided, which optionally mates with locking mechanism 512 of part 508.
• An outer holder 528 is provided outside of part 520. In some embodiments of the invention, holders 528 and 516 provide radially rigidity to the connector during the deployment process and may possibly replace the use of ring like elements (514, 524) in one or both connector parts.
• configuration 502 is being inserted into configuration 504.
• holder 506 snugly fits into holder 528.
• the two holders are slotted, to enforce certain relative rotational positions of the connectors, for example for oblique connections.
• holder 528 and/or holder 516 include an inner thread, to support twisting of holder 516, while it is advanced.
• holder 516 is locked into position relative to holder 528. Attention should be taken of a volume 532 defined between connector parts 508 and 520. It should be noted that graft 506 and graft 530 are prevented from expansion into the anastomosis lumen, by spikes 522 and 510. However, expansion towards holder 528 is possible, due to a difference in radiuses between the two connector parts. In some embodiments, eversion is achieved instead of distortion.
• Fig. 5D pusher 518 is advanced, possibly in a spiral motion, first compressing the very end of graft 506 and then completing the anastomosis by the interlocking of locking elements 512 and 526.
• the locking elements comprises a tab punched out of a metal sheet in one element and a matching slot for the tab in the other element.
• Fig. 5E the holders are removed, leaving a completed anastomosis connection.
• the parts of the connector that remain in the blood flow are thin wires, for example metal or plastic.
• side configuration 504 is inserted with spikes 522 in a straight configuration.
• the spikes may be pre-stressed to be bent, and prevented from bending by bars that are later retracted.
• spikes 522 are plastically bent, for example using an anvil provide through the hole in vessel 530 (not shown). Punching out of the hole may, in some embodiments of the invention, be performed after the spikes are inserted.
• Figs. 5A-5E are shown for an end-to-side connection, it should be appreciated that a similar device may be used for an end-to-end connection and/or a end-to-side connection. In such connections, as well as a side-to-end connection, the lips of one or both vessel may be distorted.
• Figs. 6A-6E illustrate methods of reducing an axial profile of an anastomotic device, in accordance with exemplary embodiments of the invention. These illustrations are shown on a simple two part anastomotic device. However, they may be applied to other two part devices or to one part devices that include ring and spike portions, for example as shown in the above referenced PCT applications.
• Fig. 6A illustrates a two part anastomotic connector 600 comprising a ring portion 602, for mounting outside an "end" vessel and a spike portion 604 for penetrating a side vessel and/or an everted portion of the end vessel.
• the ring portion and the spike portion may be integral, or may be separate parts, for example slots or openings formed in the ring portion, for the spike portion.
• An extension 606 of spike portion 604 may be used, for example, for holding, pushing and/or pulling spike portion 604. Once the connection is completed, extension 606 is bent outwards, as shown, to reduce the axial profile of the anastomotic connection. Such bending may also server to lock the anastomotic connection.
• Such bending can be achieved, for example, by advancing an over-tube that has an inclined front edge, over the side vessel.
• the smallest diameter of the over-tube fits between extension 606 and the vessel.
• the larger diameter is significantly greater, causing extension 606 to be bent.
• extension 606 may be twisted in place and/or sniped off.
• FIGs. 6B and 6C illustrate a twist based profile reduction method.
• a connector 610 comprises a ring 612 and a spike portion comprising a set of spikes 613 also connected to a ring 614.
• An extension 618 of the spikes portion protrudes above ring 612.
• extension 618 has been axially retracted to a degree sufficient for performing the anastomosis, for example by bringing a vessel engaged by the spikes into contact with a graft everted on the spikes and/or ring.
• Extension 618 is then twisted, thereby reducing the axial extent of extension 618 and/or locking the anastomotic connection.
• FIGs. 6D and 6E illustrate a bending based profile reduction method.
• a connector 620 comprises a ring 622 and a spike 624, of which an extension 626 protrudes above the ring 622.
• extension 626 is advanced, so that it buckles, reducing its axial extent.
• ring 622 is axially rotated twisted relative to spikes 624. Such rotation is useful if the slots in ring 622, through which spikes 624 fit, have a wedge profile. The rotation, urges the spikes into the narrower part of the wedge, to be snugly engaged by the ring, so that the advancing of extension 626 does not cause the post-ring parts of spikes 624 to advance.
• the spikes portions in the above embodiments of Fig. 6 may be plastically deformed, in an alternative embodiment of the invention, the spikes are elastic, super-elastic or shape-memory materials, which self deform when a restraint (not shown) is released.
• Figs. 7A and 7B illustrate the working of a flexible graft everter 706 in accordance with an exemplary embodiment of the invention.
• a graft 702 is mounted inside a holding tube 704, which may also be used for providing a connector (not shown).
• Everter 706 is inserted into the lumen of graft 702.
• everter 706 comprises an extension 708, that fits into graft 702, a flexible portion 710 and a relatively rigid ring portion 712.
• Everter 706 may have the general form of a cone or a condom, for example as shown.
• the outer surface of everter 706 may be rough or barbed, to better engage the inner surface of graft 702.
• the membrane is not continuous, for example comprising a plurality of flexible rods connecting ring 712 and extension 708, or the membranes having apertures formed therein.
• ring portion 712 is advanced towards graft 702, causing membrane 710 to fold, carrying graft 702 along with it, to be everted.
• membrane 710 is designed to effect an oblique eversion, for example, by membrane 710 having a non-radially uniform flexibility, so that it does not evert uniformly.
• different parts of membrane 710 have different friction coefficients with the grafts so that some parts pull the graft more when the membrane is everted.
• holding tube 704 is oblique.
• the graft instead of everting the graft, is provided with an intima on its outside or front surfaces, for example, patterned to match a particular anastomosis connection configuration.
• the graft is manufactured to include the intima.
• a layer of intima for example an inverted graft section or a vessel flap is glued on the graft.
• an inner surface of the tip of the graft may be manufactured to not include an intima, for example to facilitate attachment to an outside surface of a blood vessel.
• the graft may be everted directly onto the spikes of the anastomotic connector.
• the spikes may point sideways or even backwards, rather than forwards.
• the graft may be tough enough to resist penetration by self-expanding spikes or to bend spikes that are advanced relative to the graft.
• Figs. 8-10 illustrate three sudden-release mechanisms by which the spikes can be restrained and then released suddenly, to penetrate the graft.
• Figs. 8A-8D illustrate a lasso-based release mechanism, in accordance with an exemplary embodiment of the invention.
• a graft 802 is inserted through a graft holder 804 having mounted thereon a connector 806 with backwards pointing spikes 808.
• a lasso 810 having a loop 812 is tied on spikes 808, bending them radially inwards, so that the spikes point substantially forward. Graft 802 is then everted over the lassoed connector, for example using the method shown in Fig. 7 A and 7B, or using any other method.
• lasso 810 is released allowing spikes 808 to spring out and penetrate graft 802.
• spikes 808 have completed their penetration, possibly with some manual assistance (for example as described below), and the mounting is completed.
• Figs. 8E-8F show iwo different lasso configurations for use with in Figs. 8A-8D.
• lasso 810 includes only a single loop 812.
• the lasso includes multiple loops. Both lassoes, however, can be released by pulling on the thread. Possibly, the lassoes are formed of a surgical suture material or of a thin Dacron filament.
• Figs. 9A-9D illustrate a slotted-tube mechanism 900 for sudden release of spikes of a connector.
• Fig. 9A shows a graft 902 mounted in a graft holder 904, along with a connector 906 having backward bending spikes 908.
• a slotted over-tube 910 is provided.
• over- tube 910 includes a shield 912 (described below).
• over-tube 910 is advanced, so that spikes 908 are bent back and held in a step resting place 914.
• shield 912 prevents spikes 908 from contacting graft 902, once it is everted. The graft may then be everted over over-tube 910.
• over-tube 910 is rotated, so that spikes 908 are aligned with slots 916 formed in over- tube 910, causing the spikes to exit over-tube 910 and penetrate the everted graft 902.
• Fig. 9D is a top view of over-tube 910 showing slots 916, shield 912 and step-resting place 914 for spikes 908.
• a real connector may include greater number of spikes, for example, 4, 6, 8 or more.
• FIG. 10A and 10B illustrate an over-tube based spike penetration method, in accordance with an exemplary embodiment of the invention.
• Fig. 10A shows a configuration 1000, in which a graft 1002 is shown mounted on a graft holder 1004 and everted over an over-tube 1010.
• a connector 1006 including backward pointing spikes 1008, is separated from an everted portion of graft 1002, by over-tube 1010, which over-tube also bends back spikes 1008.
• over-tube 1010 is retracted, allowing spikes 1008 to spring out and transfix graft 1002.
• graft holder 1004 itself may serve as an over- tube, for example, by connector 1006 being axially advanced in graft holder 1004 by a pusher or a tube on which the connector is mounted (not shown).
• the above methods are varied so that an oblique eversion is achieved.
• over-tube 1010 is oblique, so some spikes are released first, and can pull down the graft before other spikes are released.
• not all spikes are the same length, so that some are released first, even of over- tube 1010 is not oblique.
• Figs. 1 1A-1 1C illustrate a cap based technique for spike penetration, in accordance with an exemplary embodiment of the invention.
• Fig. 1 1A shows a graft 1 102 that is everted over a graft holder 1 104 and a connector 1106 having backwards pointing spikes 1 108. Some of the spikes may have penetrated graft 1102.
• a cap 1 1 10 is provided that has an inner radius slightly greater than the outer radius of the everted graft.
• cap 1110 is mounted on the everted portion of graft 1 102. This mounting typically bends the spike tips further backwards and inwards. Axial and rotational manipulation of cap 1110 has been found to cause the spikes to penetrate the everted portion of graft 1102, as shown in Fig. 1 lC.
• Figs. 12A-12C illustrate a probe 1200 and a spike penetration method using the probe, in accordance with an exemplary embodiment of the invention.
• the probe is used to individually force parts of a graft 1202 between a spike 1208 and a graft holder 1204, thus causing the spike to penetrate the graft, possibly due to a pe ⁇ endicular angle crated between the spike tip and the graft.
• a wire probe is used.
• other probe designs may be used.
• the probe is used to manipulate the spikes through the graft. For example, the spikes are pushed back using the probe so that they can be suddenly released and thus penetrate the graft.
• Fig. 12A illustrates a Y shaped probe 1200, comprising a handle 1216, two arms 1212 and a thread 1214 connecting the two arms.
• a probe may be similar in design to a commonly used teeth cleaning (flossing) probe.
• Fig. 12B shows a graft 1202 everted over a graft holder 1204 and a connector 1206 having backwards pointing spikes 1208.
• Thread 1214 of probe 1200 is shown engaging a portion of the everted graft between a spike tip and graft holder 1204.
• the thread is brought up, causing the spike tip to penetrate the graft. The rest of the spikes may be handled in turn.
• the spikes of the connector are mounted in a short hollow and sha ⁇ tipped tube.
• This tube maintains the spikes to be axial, so that they can more easily penetrate the vessel. Possibly, the spike tips are not sha ⁇ , for example to prevent inadvertent tissue penetration when deployed.
• the tubes are removed, for example using tweezers, so that the spike scan bend to their backwards pointing configuration.
• Figs. 13A and 13B illustrate a tool 1300 for oblique eversion, in accordance with an exemplary embodiment of the invention.
• Tool 1300 comprises a graft holding tube 1304, having at its end one or more finger extensions 1314. As will be shown in Fig. 13B, these finger extensions serve to assist in everting some parts of a graft 1302 more than others.
• the graft holder may be used for delivering the graft and/or the connector to the anastomotic connection. Alternatively, a separate graft holder for delivery may be provided.
• Fig. 13B shows tool 1300 in operation.
• a graft 1302 is everted over the end of tube
• a portion 1310 of graft 1302 is everted over one spike 1308. However, when a portion 1312 of graft 1302 is everted, portion 1312 is first be brought over a finger 1314, thus providing an uneven eversion.
• the length of finger 1314 is controllable, for example, by finger 1314 comprising a movable bar mounted on an outside of tube 1304.
• fingers 1314 are part of an inner tube (not shown) which is optionally later retracted or removed.
• Figs. 14A and 14B illustrate a method of converting an even eversion into an oblique eversion, in accordance with an exemplary embodiment of the invention.
• a graft 1402 is shown everted over a graft holder 1404 and a pair of spikes 1408 of a connector (not shown).
• a portion 1412 of graft 1402 is to be everted more.
• portion 1412 is grasped by a tool, for example a tweezers, and pulled down, to the position shown in Fig. 14B.
• Spike 1408 may be pulled out of the graft by the motion. Possibly, the graft is first pulled off the spike.
• a plurality of positioning lines 1416 is shown. These lines may be used to indicate to the everter, how much of an oblique angle is generated by what amount of differential eversion. Alternatively or additionally, a line may be provided to mark a desired minimum eversion for portion 1410.
• Figs. 15A-15C illustrate an alternative method of converting an even eversion into an oblique eversion, in accordance with an exemplary embodiment of the invention.
• Fig. 15A is similar to Fig. 14A, except that a sliding pad 1516 is used instead of tweezers, to pull down a portion 1512 of a graft 1502 that is everted over a graft holder 1504 and spikes 1508.
• Fig. 15B is a top view of fig. 15A, showing one or more inner barbs 1518 of pad 1516, engaging portion 1512, at or near spike 1508 or axially displaced therefrom.
• pad 15C pad
• positional lines may be provided to indicate to an everted a desired degree of differential eversion.
• Figs. 16A and 16B illustrate a cap-like tool 1616 for converting a pe ⁇ endicular eversion into an oblique eversion, in accordance with an exemplary embodiment of the invention.
• a graft 1602 is shown everted over a graft holder 1640, with two everted portions 1610 and 1614 having substantially equal lengths.
• a cut-through figure is shown, focusing on only two points along the graft circumference (and only two spikes, if any).
• the techniques are generally applied to complete grafts (and connectors with multiple, e.g., 6-8 spikes).
• a cap 1616 is provided, having an inner diameter slightly greater than the outer diameter of graft holder 1604.
• the cap includes a lip 1618, which may be longer adjacent portion 1612 than adjacent portion 1610.
• a barb 1620, or other means for engaging portion 1612 are provide inside lip 1618. In some cases, simply a roughening of the inner surface is sufficient to engage the graft.
• An optional barb 1622 is provided for portion 1610 as well. This optional barb may be used to ensure that portion 1612 is not pulled too much relative to portion 1610 - by pulling down portion 1610 as well, when a desired relative eversion is reached.
• the barbs may be movable, for example, to allow a user to select different relative eversion amount.
• the barbs comprises an oblique tube removably mounted inside cap 1616.
• the degree of differential eversion depends of the application. For example, a normal eversion may be 1-3 mm, with a longer eversion being 1-7 mm. This can result in an eversion angle of between, for example 85° and 25°.
• Figs. 3 and 8-16 show tools that may be used outside the body or inside the body, for example, transvascularly, endoscopicly or throactoscopicly.
• the various caps are radially compressed and provided through the lumen of the graft.
• the caps may be provided as an over tube.
• the various probes, tweezers and pads may be provided as an over tube. Wires or bars may be provided to providing retraction and rotation forces, respectively.
• the incision is formed using a hole punch.
• the hole punch also carries forward spikes of the anastomotic connector into the target vessel.
• Fig. 17 illustrates an exemplary combined hole punch and connector inserter tool 1700, in accordance with an exemplary embodiment of the invention.
• Tool 1700 comprises a body 1712 and a retractable tip 1714, that define a tissue receptacle 1716 between them.
• tip 1714 is inserted into a blood vessel (e.g., making a hole by virtue of its sha ⁇ tip or entering into an existing incision), so that the blood vessel tissue is captured by receptacle 1716.
• a blood vessel e.g., making a hole by virtue of its sha ⁇ tip or entering into an existing incision
• the tissue in the receptacle is punched out.
• Body 1712 is then advanced into the punched out hole.
• the sha ⁇ tip portion of tip 1714 is retractable, to prevent damage to the opposite side of the target vessel, during the motion.
• an anastomotic connector is provided into the blood vessel by body 1712.
• the connector is a two part connector, comprising a ring 1708 and a set of spikes 1710 inserted through the ring and an everted portion of a graft 1702.
• spikes 1710 are mounted on a base 1706, which can be retracted, to perform the anastomosis.
• spikes 1710 include curved tips 1718 which are held in a recess 1720 in body 172.
• the tips 1718 enter the vessel. Then the tips are retracted, they engage the vessel and pull the rest of the connector and everted graft 1702 to complete the anastomosis.
• tips 1718 are pre-disposed (e.g. pre-bent or pre- stressed) to be bent inwards. Tips 1718 may be radially extended when spikes 1710 are retracted, by ring 1708 or by the widening of body 1712 outside of the recesses.
• tips 1718 may be mechanically held in recesses 1720.
• recesses 1720 include a protrusion 1721 that is pe ⁇ endicular to the figure plane.
• the front view of recesses 1720 having the form of an "I".
• body 1712 is rotated relative to tips 1720, the tips bypass the protrusion and can self-expand radially.
• Figs. 18A and 18B illustrate a graft delivery system 1800, in accordance with an exemplary embodiment of the invention.
• a graft 1802 is shown inserted through a hole 1814 in a graft holder 1804.
• the everted tip of graft 1802 is not shown, however, it exits through an opening 1805 at the tip of graft holder 1804. Tips of a plurality of spikes 1808 are shown, such that graft holder maintains the spikes bent inwards, for example as shown in Fig. 10A and 10B, except that the tips of the spikes are allowed to protrude, for example as shown in Fig. 15A.
• a switch 1816 is provided to advance spikes 1808, thereby causing them to spring out and penetrate the graft
• a knob 1820 is provided for advancing the connector relative to graft holder 1804 and then retracting and removing the graft holder. Possibly, a safety 1818 is provided, to prevent inadvertent actuation of tool 1800.
• graft holder 1804 is removed by its retracting over a knife 1810, which splits the graft holder into two. The rest of graft holder
• the splitting line is not a shortest straight line, at least not between opening 1814 and knife 1810 (indicated by reference 1812), to prevent graft 1802 from catching on split line 1812.
• graft 1802 is inserted to opening 1805 by pushing it into opening 1814.
• graft 1802 is pulled, for example using a lasso (possibly similar to that described above) around its end, which is provided through opening 1804.
• a lasso possibly similar to that described above
• the above described methods and devices of vascular manipulation may be varied in many ways, including, changing the order of steps, which steps are performed inside the body and which outside, the order of making the anastomosis connections, the order of steps inside each anastomosis, the exact materials used for the anastomotic connectors, which vessel is a "side" side and which vessel (or graft) is an "end" side of an end-to-side anastomosis and/or whether two lips that are connected are from a same vessel or from different vessels.
• the location of various elements may be switched, without exceeding the sprit of the disclosure, for example, switching the moving elements for non-moving elements where relative motion is required.
• surgical kits which include sets of medical devices suitable for making a single or a small number of anastomosis connections. Measurements are provided to serve only as exemplary measurements for particular cases, the exact measurements applied will vary depending on the application.
• the terms "comprises”, “comprising”, “includes”, “including” or the like means “including but not limited to”.

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• 2000
  • 2000-09-28 AU AU75527/00A patent/AU7552700A/en not_active Abandoned
  • 2000-09-28 EP EP00964605A patent/EP1259169A2/en not_active Withdrawn
  • 2000-09-28 CA CA002393508A patent/CA2393508A1/en not_active Abandoned
  • 2000-09-28 JP JP2001542803A patent/JP2004513670A/ja active Pending
  • 2000-09-28 BR BR0016247-7A patent/BR0016247A/pt not_active IP Right Cessation
  • 2000-09-28 AU AU75525/00A patent/AU7552500A/en not_active Abandoned
  • 2000-09-28 CA CA002393486A patent/CA2393486A1/en not_active Abandoned
  • 2000-09-28 EP EP00964603A patent/EP1237485A2/en not_active Withdrawn
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