Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/32—Surgical cutting instruments
  • A61B17/3205—Excision instruments
  • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/064—Surgical staples, i.e. penetrating the tissue
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/064—Surgical staples, i.e. penetrating the tissue
  • A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
  • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
  • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/28—Surgical forceps
  • A61B17/29—Forceps for use in minimally invasive surgery
  • A61B2017/2901—Details of shaft
  • A61B2017/2905—Details of shaft flexible
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
  • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
  • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
  • A61B2017/3488—Fixation to inner organ or inner body tissue

Definitions

• the present invention relates generally to the field of creating anastomotic connections, especially between blood vessels. BACKGROUND OF THE INVENTION
• 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, h addition, forces acting on the side blood vessel may extend any incision or hole formed in the vessel, potentially causing a leakage of blood.
• An aspect of some embodiments ofthe 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.
• some clips are more loosely coupled (if at all coupled) than other clips.
• 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, hi 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.
• tissue attachment points for example spikes of a connector or individual clips, which attachment points can move relative to each other, for example, expand, hi 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.
• a double, angled, clip is optionally provided for the incision ends.
• 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.
• 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), hi an exemplary embodiment of the invention, the virtual ring and the ring are not congruent rings.
• the rings are offset in the plane of the ring and/or along a direction perpendicular to the plane of the ring.
• the rings have different diameters.
• the ring has a different degree of obliqueness and/or orientation than the virtual ring.
• the differences in ring geometries cause the clips to be twisted relative to the ring.
• each clip can move separately, so that the clamp points define a non-planar ring that better conforms to the side blood vessel geometry.
• the degree of twisting of each clip can change.
• the clips are designed to have a preferential twist direction, thus encouraging a desired blood vessel conformance.
• 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.
• the ring is thin or twist joints interconnect the clips and the ring, to allow the twisting.
• the clips are interconnected by straight segment.
• the clips are interconnected by bent segments, which allow radial expansion and/or support twisting.
• an anastomotic connector comprises a plurality of clips and a plurality of tissue pullers that pull vascular tissue into the clip.
• 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.
• the individual clips or portions of the base plate do not substantially distort when the connector as a whole is distorted.
• 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.
• the ring defines a desired anastomosis radius.
• the ring may be resihently or plastically deformed to support a greater radius if the blood vessel expands. Alternatively or additionally, the ring may resihently 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.
• a similar design is used for hole closure devices, for example to allow for distortion of the blood vessel.
• 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.
• the aperture also accommodates a clip holder for holding the clip during tissue pulling.
• the aperture is used to hold the clip in place during deployment or for guiding a clip deforming element.
• 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.
• one puller fits along a slot defined in the other puller.
• an anastomotic connector comprises an apertured base, through which a plurality of hooked pullers extend.
• each aperture has associated therewith one or more tabs that cooperates with a geometry of the puller to prevent disengagement ofthe puller once the puller is retracted through the aperture.
• 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.
• the base plate is apertured and/or is sparse (i.e., does not fill space), to allow room for insertion of a needle therethrough.
• the base plate is made of a piercable material.
• the base plate is flexible to allow distortion ofthe base plate and or anastomotic connection during stitching.
• An aspect of some embodiments of the invention relates to the design of a puller engagement element.
• the element includes a tab that prevents disengagement of the puller once the puller is retracted.
• 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.
• 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 ofthe pullers, h an exemplary embodiment ofthe 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 ofthe puller extends into the other opening.
• An aspect of some embodiments ofthe invention relates to a method of holding a base part of an anastomotic connector during deployment.
• at least two hinged tabs hold the base portion against a delivery system.
• the tabs are released and allowed to rotate, so they do not block the motion ofthe base plate, h an exemplary embodiment ofthe 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.
• 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.
• the pullers include recurved tips, that curve back 180°.
• 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.
• the pullers are released to straighten.
• the extra length of the pullers is compensated for by an extra long retraction, during deployment.
• an aspect of some embodiments ofthe invention relates to an extension mechanism for an anastomosis delivery and/or hole punching system.
• a same system can be used for open chest, for keyhole and/or for endoscopic surgery.
• 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.
• 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.
• 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.
• an anastomosis delivery mechanism is provided as a modular capsule that can be attached to the delivery system and/or an extension.
• 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.
• 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, h an exemplary embodiment of the invention, the lever locks in at least one and optionally two puller positions.
• a lever may also be supplied as a separate control in a non-capsule embodiment of the invention.
• the extension is flexible, rather than rigid as in other embodiments.
• a channel for a camera and/or light source is provided in the extension, for assisting endoscopic surgery.
• the delivery system is a split system in which retraction ofthe rod causes the system to split and release a delivered blood vessel.
• 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.
• 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.
• the delivery system includes a flexible cable for transferring force (retracting force) from the delivery system handle to the connector, h one embodiment of the invention, the delivery system is hinged, for example in one, two, three or more dimensions, hi another embodiments of the invention, the delivery system is flexible over its entire length, like a goose-neck.
• 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.
• 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 ofthe cutter, hi an exemplary embodiment ofthe invention, the cutting arm is flexible and twisted in towards the plane ofthe base.
• 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.
• the connector comprises a ring around one blood vessel (or graft) and a plurality of spikes that extend from the ring (e.g.
• 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.
• the ring serves to straighten the spike as it is retracted.
• the device does not block the motion of a tab part of the ring, which tab part is designed to prevent retraction ofthe spike under normal conditions.
• the device includes a protrusion that bends the tab out ofthe way.
• the pincer also engages and pulls back the tab.
• an anastomotic connector comprising: a plurality of clip segments; and a plurality of twistable resilient segments that interconnect the clip segments.
• said segments are bendable out of a plane defined by said clip segments.
• a resilience of said attachment segments is defined to control a diameter changing behavior of said connector.
• said clip segments do not penetrate target tissue when the clip closes.
• said clip segments do penetrate target tissue when the clip closes, but do not transfix said tissue.
• an anastomotic connector comprising: a plurality of clip segments each defining a clip contact area at which opposite sides of the clip engage tissue; and 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.
• a resilience of said attachment segments is defined to control a diameter changing behavior of said connector.
• said circumferences are not on a same plane.
• an anastomotic connector comprising: a plurality of connection segments each defining a contact area between the segment and a target blood vessel; and 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.
• said connection segments each comprises an apertured segments through which a puller that engages the target vessel can be advanced and retracted.
• the connector comprises a base plate, and said connection segments each comprises an apertured area the base plate.
• said connection segments each comprises a clip element.
• 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.
• said connection segments are arranged in the form of an ellipse and relative motion between segments is reduced at narrow ends ofthe ellipse.
• an anastomosis connector comprising: a base plate having a plurality of apertures defined therein; and a set of pullers adapted to pass through at least some of said apertures during deployment of said connector, wherein said base palate is made spatially sparse enough to allow suturing of an anastomotic connection, using a needle, through the base plate.
• an anastomosis connector comprising: a plurality of clip segments, each clip defining an engagement volume in which the clip engages tissue; a plurality of attachment segments interconnecting the clip segments; and a set of tissue pullers each including at least one tissue engager, 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.
• said apertures are adapted for holding the connector using a connector holder.
• said tissue pullers comprises pairs of axially elongate pullers, each pair comprising two pullers co-axially disposed with respect to each other.
• 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.
• 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.
• an anastomosis connector comprising: a base plate defining a plurality of apertures therein; and 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, 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.
• the connector comprises a bar around which said puller hooks, which bar defines a separation between said pair of apertures.
• an anastomosis connector comprising: a base plate defining a plurality of apertures therein; and a set of pullers adapted to pass through at least some of said apertures during deployment of said connector, wherein said each of said pullers comprises : a tip; and a tab section adapted to distort out of a plane of said puller when said puller is disconnected adjacent said tab.
• a delivery system for an anastomosis connector comprising: a body; and 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, wherein said forward plate is adapted to bend out of the way of axial motion of said base plate, when said connector is deployed.
• said forward plate is mounted on at least one hinge.
• said forward plate is divided into at least two coplanar plates.
• said forward plate is attached to said body via a distortable attachment.
• 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 selectively connected between said body and said capsule, thereby extending a reach of said delivery system.
• said extension is bendable.
• a delivery system for an anastomosis connector comprising: a body including a handle for applying force; 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 a non-limp geometry changing elongate section bridging between said body and said area.
• said elongate section is hinged.
• said elongate section is distortable.
• the system comprises a flexible cable for transferring said force between said handle and said area.
• 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.
• a delivery system for an anastomosis connector comprising: a body including a handle for applying force; 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 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.
• said control comprises a rotating knob.
• said control is mounted on a separate capsule element that includes said connector holder area.
• said tissue engaging elements form part of a connector.
• said tissue engaging elements form part of said delivery system.
• a connector removal device for removing a spike that completes an anastomotic connection in a spike and base type connector, comprising: at least one spike engager adapted to engage at least one spike of a deployed connector; 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.
• said spike engager engages said spike by friction.
• said spike engager comprises a split tube.
• 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.
• said spike engager engages a plurality of spikes at a time.
• 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 ofthe connector comprising: bending each spike such that the spike points inwards towards the axis and the tip points outwards away from the axis; bringing a graft to said axis between the inward pointing spikes; and mounting the graft on the spike points.
• bringing comprises conveying the graft between the spikes from a proximal end of the connector to the spike tips.
• mounting comprises mounting the graft sequentially over the tips.
• bending comprises mounting the connector in a jig.
• bending comprises bending the spikes outwards and then bending inwards so that the bent part ofthe spikes define a diameter greater than that of unbent spikes.
• a jig for holding a spiked connector in a configuration in which the spikes bend inwards comprising; a body defining an axial channel for receiving a connector; and 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.
• said plate comprises a slotted disk.
• the jig comprises at least one rotatable disk underlying said plate for selectively defining slots along which said spikes can be conveyed when twisted.
• the jig comprises at least one rotatable slotted disk overlying said plate for selectively aligning slots of said disk with slots of said plate.
• said slots in said disk are arranged so that said selective alignment can be sequential for different ones of said slots of said plate.
• a blood vessel cutter for forming an aperture in a blood vessel, comprising: a first section having a cutting face; and 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, wherein, said second section comprises a pointed tip adapted for piercing a blood vessel; and 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.
• said cutting face of said second section is sharp.
• said cutting faces are not parallel to each other in a plane generally common to the two cutting faces.
• said second cutting face is not perpendicular to said axial motion.
• said pointed tip points away from said first plane.
• 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 ofthe invention
• Fig. 2 illustrates a delivery system for elastic clips, in accordance with an exemplary embodiment ofthe invention
• Fig. 3 illustrates a portion of a delivery system for plastic deforming of clips, in accordance with an exemplary embodiment ofthe invention
• Fig. 4 illustrates an alternative clip system in which clips face inwards rather than axially, in accordance with an exemplary embodiment ofthe invention
• Fig. 5 illustrates an alternative clip design, in accordance with an exemplary embodiment ofthe invention
• FIG. 6 A and 6B illustrate a clip-ring connector, in accordance with an exemplary embodiment ofthe invention
• Figs. 7A-7E illustrate apertured-base anastomotic connectors, in accordance with an exemplary embodiment ofthe invention
• Figs. 8A-8D illustrate an extendible delivery system in accordance with an exemplary embodiment ofthe invention
• Figs. 8E-8H illustrate distortable and bendable delivery systems, in accordance with exemplary embodiments ofthe invention
• Figs. 9A-9E illustrate an alternative embodiment of a capsule based delivery system, in accordance with an exemplary embodiment ofthe invention.
• Fig. 10 illustrates a cutter for forming an opening in a target vessel, in accordance with an exemplary embodiment ofthe invention
• 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 ofthe invention
• Figs. 12A-12D illustrate a connector removing device, in accordance with an exemplary embodiment ofthe invention.
• 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 ofthe invention.
• 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.
• 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, hi the particular example shown, a pair of pullers may be provided for each clip, although not shown for clarity.
• one or both of the pullers are provided through an aperture 104 formed in a body 106 of each clip.
• the pullers are 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.
• 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.
• the pullers are used to close the clips, hi one embodiment of the invention, the hooked tips ofthe pullers urge the tissue forcefully against body 106 of clip 102, so as to cause it to close.
• 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.
• the pullers are side by side, for example pullers 118 and 120.
• 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.
• the ends ofthe 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.
• 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.
• the clip may be held from the side (and optionally released by rotation ofthe holder).
• 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.
• pullers 122 and 118 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.
• Fig. 3 illustrates a delivery system 300 for plastic deforming of clips 102, in accordance with an exemplary embodiment ofthe invention.
• Two clip holders 304 and 306 are shown for engaging the sides of clip 102.
• the holders are shaped like pullers and also pass through aperture 105.
• the holders separate the two pullers.
• the holders are provided from outside of 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.
• the two rings advance towards each other to squeeze the clip shut.
• 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.
• FIG. 4 illustrates an alternative clip system 400 in which a plurality of clips 402 face inwards rather than axially.
• 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.
• 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.
• a base ring 410 is attached to the clips and controls their relative positions and/or holds down one side of the clips.
• the ring is detached after the anastomosis is completed.
• ring 410 remains in the body, the ring can be deformable, for example, as described below.
• a plurality of clip holders urge clips 402 against ring 410 during deployment.
• Other clip orientations can also be provided.
• 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 ofthe clip can also vary. As shown below in Fig. 7, in some cases, the aperture is split into two parts.
• Figs. 6A and 6B illustrate a clip-ring connector 600, in accordance with an exemplary embodiment ofthe invention.
• Connector 600 comprises a plurality of individually patent clip elements 602 that are interconnected by a ring of short segments 616.
• the clips are all of one type, but this is not essential.
• 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.
• an aperture 606 defined by enclosing body 604 serves as a channel for one or more tissue pullers.
• 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
• 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.
• 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.
• ring 616 is extendible, for example as described below if the segments are curved rather than straight.
• Figs. 7A-7E illustrate apertured-base anastomotic connectors, in accordance with an exemplary embodiment of the invention, hi 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.
• Fig. 7A illustrates a hybrid base-plate connector 700 in which some ofthe 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, hi 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.
• a larger base-plate 714 having two apertures is provided.
• the connector is inserted through an incision in a blood vessel.
• 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.
• the puller includes a tab that prevents the puller tip from falling out ofthe 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.
• 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.
• Base plate 720 comprise a plurality of apertures element 722 interconnected by resilient spring segments 726.
• resilient spring segments 726 At the ends of the ring, relatively rigid connection segments 724 are provided.
• 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, hi an exemplary embodiment of the invention, the tip of the puller passes past the plane of bar 730.
• the hook aperture is larger than the passage aperture, to compensate for freedom of movement of the tip.
• the tip of the puller does not enter an aperture. The tip may penetrate the target tissue or not.
• 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.
• base plate 720 is made sparse to allow an anastomosis connection to be enhanced or corrected by passing a manual suture.
• 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.
• base plate 720 is used to control the deformation of the blood vessels of the anastomosis.
• base plate 720 is pre- stressed to a desired diameter which is smaller or lager than the current diameter.
• base plate 720 acts against undue expansion of the blood vessel
• 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).
• the circumference of base plate 720 increases or decreases by 5%, 10%, 20% or any smaller larger or intermediate percentage.
• aperture elements 722 also provide a clip function, for example, as described above.
• 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.
• Figs. 8A-8D 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.
• 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.
• Fig. 8A shows a connector capsule 802 including a connector 804 as described in Figs.
• 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 ofthe 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, h other connector types, advancing of the connector or retraction of an over tube may be practiced instead, for example.
• 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.
• the handle includes such a power train and/or includes means for allowing both retraction and advancing.
• Fig. 8B shows a complete system 800 including capsule 802 coupled via a coupler 814 to a handle segment 812.
• a retraction indicator 816 is provided on the handle to indicate a degree of retraction.
• reference 816 indicates a locking switch.
• 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 ofthe device and terminates in a rod extension 822, corresponding to extension 808 of Fig. 8 A.
• 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. 8E-8H.
• shaft 824 is deformable, for example like a goose-neck.
• 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.
• a channel is optionally provided also in handle 812 and/or in the capsule.
• Fig. 8D shows a complete extended system.
• system 800 is used for an anastomotic connection in which leakage of blood is to be prevented after hole punching, hi 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.
• 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.
• 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.
• Figs. 8E-8H illustrate distortable and bendable delivery systems, in accordance with exemplary embodiments ofthe invention.
• Fig. 8E shows a delivery system 860 including a hinged extension 864.
• a separate capsule 872 is provided, for example the same capsule as capsule 802, describe above.
• the extension is integral with the capsule, h 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.
• a bending hinge 868 is provided between the two rotational hinges.
• the total effect of the three hinges is to allow three angular degrees of freedom in positioning the tip of capsule 872.
• 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. hi 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. 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.
• 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.
• extensions 882 and 892 can bend 90°, 180°, 270° or even 360° or more degrees.
• the extensions can bend at two or more locations, hi 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.
• Figs. 9A-9E illustrate an alternative embodiment of a capsule based delivery system 900, in accordance with an exemplary embodiment ofthe invention.
• 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.
• 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.
• capsule 902 optionally includes a means for extending the forward spikes (not shown in this figure) of connector 904.
• 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. 9 A) is activated.
• knob 918 is used also to tear the spikes, as described above. This selective extension of the spikes optionally serves to protect the spikes while guiding system 900 to an anastomosis location.
• knob 918 is described with reference to Figs. 9C-9E, 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 ofthe 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.
• mandrel 930 includes a peg 932 that interacts with a slot 920, for example a "Z" shaped slot, formed in knob 918.
• 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.
• Fig. 9C shows capsule 902 in one position, with spikes of connector 904 being retracted.
• knob 918 is rotated so that the spikes extend forward.
• the motion is accompanied by retraction of shell 936.
• 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.
• 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.
• 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.
• an inner face 1008 of arm 1009 is sharp and functions as a knife, h an exemplary embodiment of the invention, tip 1006 is flexible.
• face 1010 is formed at the end of a flat plate 1002 and tip 1006 is bent inwards towards the plane of plate 1002.
• 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.
• FIGs. 1 IA and 1 IB 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.
• a connector 1102 comprises a plurality of extending spikes 1104, having recurved tips 1106.
• mounting system 1100 bends spikes 1104 so that tips 1106 point radially out.
• 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.
• the lip is everted manually over the tips one by one.
• a mechanical device may be used to grab the lip at a plurality of locations and extend it over the spike tips.
• the spike tips are closer together than the graft diameter, to reduce the need to stretch the graft lip. (e.g., one by one).
• System 1100 is shown in perspective in Fig. 11A from underneath and in Fig. 11B from its top.
• system 1100 comprises three slotted disks 1120, 1110 and 1112.
• Spikes 1104 are held in slots 1128 formed in disk 1110.
• the slots include a section of a tab-and-tear portion 1130 of each spike, h 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.
• 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.
• a plurality of slots 1122, 1124, etc. in disk 1120 are aligned in turn with the bent spikes.
• 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.
• graft 1126 may be mounted on the outward pointing sharp tips 1106.
• capsule 802 or 902 may be brought over the base of connector 1102.
• 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).
• 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.
• FIGs. 12A-12D illustrate a connector remover 1200, in accordance with an exemplary embodiment ofthe invention.
• Remover 1200 may be used to remove an anastomotic connector during implantation or after complete implantation.
• remover 1200 comprises a handle 1202 that retracts a tip 1206 relative to a body 1204.
• Tip 1026 comprises a fixed outer tube 1214 and a spike gripper, for example, a retractable split inner tube 1212 or a tweezers.
• 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.
• 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.
• 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.
• spike 1208 is gripped by inner tube 1212.
• inner tube 1212 for example as shown in Fig. 12D pulls spike 1208 through base ring portion 1210.
• 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.
• protrusions 1220 engage a tab portion or an aperture formed in the spike.
• a remover 1200 is adapted to remove a plurality or even all the spikes of a connector at one time.
• 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.
• 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.
• 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/ILOl/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.
• 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.
• the terms "comprises”, “comprising”, “includes”, “including” or the like means “including but not limited to”.

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• 2001
  • 2001-09-25 EP EP01976583A patent/EP1359850A2/en not_active Withdrawn
  • 2001-09-25 KR KR10-2003-7004275A patent/KR20030068134A/ko not_active Application Discontinuation
  • 2001-09-25 JP JP2002533625A patent/JP2005506095A/ja active Pending
  • 2001-09-25 BR BRPI0114275-5A patent/BR0114275A/pt unknown
  • 2001-09-25 AU AU2001295847A patent/AU2001295847A1/en not_active Abandoned
  • 2001-09-25 WO PCT/IL2001/000903 patent/WO2002030172A2/en not_active Application Discontinuation
  • 2001-09-25 CA CA002425336A patent/CA2425336A1/en not_active Abandoned
• 2002
  • 2002-03-18 CA CA002442056A patent/CA2442056A1/en not_active Abandoned
  • 2002-03-18 EP EP02707066A patent/EP1414367A2/en not_active Withdrawn
  • 2002-03-18 WO PCT/IL2002/000215 patent/WO2002074188A2/en not_active Application Discontinuation
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