Patent Application
20050038454
The present invention relates to anastomotic connector and delivery systems therefor.
Anastomotic connectors that connect a grafted vessel with a host vessel, for example an interior mammary artery with a coronary artery, are known in the art. An exemplary embodiment of a coronary anastomotic connector and a method of deployment are shown in
A brief review of
In
In
In
An anastomotic connection between grafted vessel 140 and host blood vessel 144, for example between an interior mammary artery and a coronary artery, is a delicate procedure. There may be situations, for example in making an anastomotic connection in an adolescent or child, where the chest cavity is narrow. In narrow areas, hooks 220 may be manipulated to an extent that they are pressed, inappropriately, against a biologic tissue with force sufficient to bend, twist or knot hooks 220. While inadvertent damage of hooks 220 is not a common occurrence, it may result in an improper anastomosis between grafted vessel 140 and host vessel 144, a significant problem in a coronary artery upon which the heart depends for a continuous supply of nutrients, even if no leaking occurs. Following are exemplary acts where some difficulty in execution may cause the connection to fail:
Typically, a small “keyhole” incision in the chest is made through which the anastomosis procedure is performed. Working through the keyhole incision with the slippery, moving and wet structures of the heart and its milieu, can result in damage to connector 101, hooks 220 and/or an improper anastomosis.
An aspect of some embodiments of the invention relates to a blood vessel cutter adapted to form an aperture in a blood vessel suitable for entry and alignment of an anastomotic connector. In an exemplary embodiment, the blood vessel cutter comprises a handle adapted to rotate around a longitudinal axis with a horn shaped cutting edge perpendicularly connected to one end of said handle. In an exemplary embodiment, upon rotating said handle around its longitudinal axis, said cutting edge rotates around said handle. When held proximate to a vessel, for example, by placing the cutting edge along the longitudinal axis of a blood vessel, the cutting edge cuts an aperture into said vessel during rotation of the handle. In an exemplary embodiment of the invention, the horn shape comprises an outside curve and an inside curve, which optionally have the same radius. The tip and at least part of the inner curve are sharp. Alternatively or additionally, the outside curve is sharp. In an exemplary embodiment of the invention, the width of the blade matches a desired incision width. Alternatively or additionally, different widths may be provided by rotating the cutter more. Optionally, a sharp even width section is provided at the tip, for assistance in piercing the blood vessel.
In an exemplary embodiment, said horn-shaped cutting edge is of a length appropriate to cut an aperture in a surface of the blood vessel that allows the hooks to enter the vessel easily and hook into the walls of the vessel around said aperture. Optionally, said aperture is cut in said vessel by said vessel cutter during a single rotation thereof and comprises a longitudinal cut, the length of said cutting edge. Alternatively or additionally, said cutter is rotated multiple times in relation to said vessel and optionally moved longitudinally along said vessel to create said aperture.
A broad aspect of the invention relates to a delivery system for delivering an anastomotic connector to a target vessel.
An aspect of some embodiments of the invention relates to an anastomotic delivery system for delivering an anastomotic connector into a blood vessel and tearing extensions of spikes of the anastomotic connector. In an exemplary embodiment of the invention, the extensions are coupled to a body, to which also a tensioned spring may be coupled. A means for retracting the body, and thus the extensions, is provided. However, when a certain degree of retracting is reached, an interlock locking the spring is released and the spring forcefully retracts the body with a strong force. A potential advantage of this system is that an operator does not apply this force himself and may be less likely to cause inadvertent motion of the delivery system during application of this force. In an exemplary embodiment of the invention, a rotation knob, for example rotated using a thumb, is used to retract the body, for example a tube.
An aspect of some embodiments of the invention relates to using a separable capsule in conjunction with a delivery system. In an exemplary embodiment of the invention, the capsule includes the mounting for an anastomosis connector and for a graft. In an exemplary embodiment of the invention, the capsule includes a mechanism for selectively advancing an retracting spikes of the connector, for example retracting them so that they are shorter and stiffer during eversion. Optionally, the mechanism is a retracting pin. Alternatively or additionally, the mechanism is a relative rotation of two parts of the capsule. In an exemplary embodiment of the invention, when the capsule is inserted into the rest of the delivery system, the rotating mechanism is hidden, so an operator will not inadvertently operate it.
An aspect of some embodiments of the invention relates to a delivery system in which a tip of the delivery system, for example a capsule portion thereof can rotate relative to a handle portion thereof. In an exemplary embodiment, the rotation takes place while the hooks and/or spikes of a connector are being placed and/or being deployed in an aperture in a blood vessel. In an exemplary embodiment, the anastomotic connector is rotated so that its movement and/or the movement of its levers and/or other moving parts, are not restricted in their motion by biologic tissue in the surgical area, for example, portions of a keyhole in a chest.
In an exemplary embodiment, the anastomotic rotating device allows rotation of the body while the spikes and hooks remain stable in position (e.g., held by hand) in an aperture in a blood vessel, for example a coronary artery. Additionally or alternatively, the anastomotic rotating device allows rotation of the grafted vessel, for example the Left Interior Mammary Artery (LIMA) in relation to the aperture in the host vessel. In this fashion, for example, when the LIMA or TMA are cut obliquely to their longitudinal axis, and the rotatable anastomotic connector is held at an oblique angle to the aperture, the cut end of the grafted vessel can be aligned with the aperture.
An aspect of some embodiments of the invention relates to a transfixing assistance device for transfixing a blood vessel on one or more hooks of an anastomotic connector. In an exemplary embodiment, the transfixing device comprises a handle defining a longitudinal axis and an extension offset at an angle to said longitudinal axis. In an exemplary embodiment, when said handle is rotated during said transfixing, the tip of the extension-offset circumducts, for example, according to the curvature of a hook on an anastomotic connector. In an exemplary embodiment, the tip of the extension comprises an orifice (e.g., an aperture or a slot) adapted fit over the hook and to encourage movement of blood vessel tissue in relation to said one or more hooks without damaging the vessel and/or hook during transfixing.
In an alternative embodiment, a transfixing assistance device comprises a transfixing forceps with two legs, one or both legs ending in a transfixing extension with an orifice adapted for encouraging movement of a blood vessel tissue on said one ore more hooks. In an exemplary embodiment of the invention, this forceps is used to evert part of the vessel onto the hook, so that it catches on it and then the orifice is used to complete the transfixing by circumducting.
An aspect of some embodiments of the invention relates to an arrangement device that arranges a plurality of anastomotic hooks during placement in an aperture in a blood vessel. In an exemplary embodiment, the hooks are maintained in a. flat plane or a curved plane or another shape, for example that matches the configuration of the aperture in the blood vessel. Optionally, the hooks are arranged so that no sharp points project in a manner that can inadvertently engage tissue.
In an exemplary embodiment, the anastomotic hook arranging device comprises one or more plates that arrange a plurality of hooks projecting from an anastomotic connector, for example by pressing against said hooks. Optionally, the one or more plates comprise two or more plates. Alternatively or additionally, the one or more plates comprise one or more hook spacers, adapted to space the hooks in relation to each other on said anastomotic connector.
An aspect of some embodiments of the invention relates to an anastomotic hook guide comprising one or more walls for guiding a plurality of anastomotic hooks into a blood vessel. In an exemplary embodiment, the guide is placed within and/or near an aperture in a blood vessel and guides the anastomotic hooks into the vessel, thereby preventing inadvertent damage to the plurality of hooks from contact with the vessel and/or other biologic tissue in the area.
In an exemplary embodiment of the invention, the guide defines a tip that is inserted in the blood vessel and a narrow slot, along which the hooks are guided and which ensures that the hooks are together and do not contact nearby tissue. In an exemplary embodiment of the invention, the guide comprises a slofted tube with a flared entry at one side and a narrower tip at the other. Optionally, the tip is used for piercing and/or forming an incision in the blood vessel.
Optionally, the guide and/or the assistance device are permanently or removably mounted on a delivery system. In an exemplary embodiment of the invention, the guide is rotatably mounted in a plane of the axis of the delivery system.
An aspect of some embodiments of the invention relates to a releasable grasper for grasping a plurality of hooks on an anastomotic connector in a receptacle thereof. In an exemplary embodiment, the grasper comprises a grasping wire loop, which when contracted, compresses a plurality of connector hooks towards each other. Optionally, when the wire is further contracted, for example, by retracting against a tube, the wire is torn and the hooks released. This additional retraction may be practiced, for example, after the hooks are inserted in a blood vessel. The grasper is optionally mounted on a deliver system. Alternatively, it may be a separate device. Alternatively to a tearing wire, one or more bent wires may be used, which when retracted, pull through the tube, leaving the hooks free.
An aspect of some embodiments of the invention relates to a clip for anastomotic connection including an interlock mechanism. In an exemplary embodiment of the invention, the clip comprises an eye segment and a hook segment, where an interlock mechanism is defined, one part on each segment, to interlocks the two segments, using a single interlock mechanism. In an exemplary embodiment of the invention, the interlocking substantially prevents movement in any direction, possibly providing some elasticity or some freedom of motion due to spaces, however.
In an exemplary embodiment of the invention, the interlocking mechanism comprises one or more tabs and one or more matching apertures for the tabs to enter or pass through, optionally perpendicular to the hook axis. In an exemplary embodiment of the invention, the tabs are formed on the eye and the apertures are formed on the hook. In an exemplary embodiment of the invention, the eye is pre-stressed to distort it such that the tab interlocks with the aperture. However, the hook is aligned to allow such interlocking only when the connector is deployed, for example, by retracting the hook. In some exemplary embodiments of the invention, the tab is formed on a part of the eye that, when distorted, does not change the external shape of the eye. Alternatively, the tab is formed on an external portion of the eye, which distorts to provide interlocking.
In an exemplary embodiment of the invention, the eyes segments are not interconnected and the hooks segments are interconnect prior to tearing.
An aspect of some embodiments of the invention relates to a tearing mechanism for a hook and eye based connector in which the tearing mechanism is independent of a locking mechanism used to lock or interlock the hook and eye, which locking is applied prior to tearing.
An aspect of some embodiments of the invention relates to an anastomotic connector for side to end connection, in which the lips of the side vessel are minimally distorted during and after the connection is made. In an exemplary embodiment of the invention, the lips of the end vessel are everted less than 180°, for example about 9020 .
An aspect of some embodiments of the invention relates to a stitching connector for an end-to-side or end-to-end anastomosis, which transfixes the end vessel lip twice. In an exemplary embodiment of the invention, the first transfixing is during eversion while mounting the connector on the end vessel. the second eversion is during deployment. In an exemplary embodiment of the invention, the first transfixing is radially outside of the second transfixing.
There is thus provided in accordance with an exemplary embodiment of the invention, a transfixing assistance device for transfixing a blood vessel on one or more hooks of an anastomotic connector, said transfixing device comprising:
In an exemplary embodiment of the invention, said device comprises two or more opposable extension projection from said handle, arranged to function as a forceps.
In an exemplary embodiment of the invention, said orifice comprises a closed aperture.
There is also provided in accordance with an exemplary embodiment of the invention, a transfixing assistance device for transfixing a blood vessel on one or more hooks of an anastomotic connector, said transfixing device comprising:
There is also provided in accordance with an exemplary embodiment of the invention, a method of guiding hooks of an anastomotic connector into an aperture of a blood vessel, comprising:
There is also provided in accordance with an exemplary embodiment of the invention, a hook arranging device for arranging a plurality of anastomotic hooks projecting from an anastomotic connector, said hook arranging device comprising:
In an exemplary embodiment of the invention, said one or more plates comprise two edges that presses said plurality of hooks between them. Alternatively or additionally, said one or more plates comprise one or more spacers that space two or more of said plurality of hooks.
There is also provided in accordance with an exemplary embodiment of the invention, a guide for guiding a plurality of anastomotic hooks into a blood vessel, said guide comprising:
In an exemplary embodiment of the invention, said tip comprises a blunt end. Alternatively, said tip comprises a sharp end adapted to form said aperture.
In an exemplary embodiment of the invention, said at least one wall comprises two or more walls. Optionally, said two or more walls are connected to each other.
In an exemplary embodiment of the invention, said guide is adapted to remove from said blood vessel following guiding said plurality of anastomotic hooks.
In an exemplary embodiment of the invention, said guide is rotatably mounted on an anastomotic connector delivery system, such that said hooks selectively enter said guide by said rotation.
There is also provided in accordance with an exemplary embodiment of the invention, a retractable hook grasper for retractably grasping a plurality of anastomotic connector hooks, comprising:
In an exemplary embodiment of the invention, said extensions comprises progressive retraction positions of said wire.
In an exemplary embodiment of the invention, said hook grasper on a connector delivery system.
In an exemplary embodiment of the invention, said grasper comprises a tube into which said wire is retracted between the extension position.
There is also provided in accordance with an exemplary embodiment of the invention, a blood vessel cutter for cutting an aperture in a blood vessel, comprising:
There is also provided in accordance with an exemplary embodiment of the invention, an anastomotic delivery system for delivering an anastomotic connector into a blood vessel and tearing one or more extensions off of said connector, said system comprising:
an interlock release, coupled to said manual input, and operative to release said interlock depending on a retraction of said puller, wherein releasing said interlock releases said spring to tear said extensions. Optionally, said system comprises a shock absorber to reduce a delivery of shock from said spring to a housing of said system, when said spring is released.
There is also provided in accordance with an exemplary embodiment of the invention, an anastomotic connector rotating device, comprising:
In an exemplary embodiment of the invention, said device comprises a rotational extent indicator.
There is also provided in accordance with an exemplary embodiment of the invention, an two part anastomosis delivery system, comprising:
In an exemplary embodiment of the invention, said capsule comprises a stop which restricts axial motion of said hooks.
There is also provided in accordance with an exemplary embodiment of the invention, an anastomotic connector for attaching two blood vessels comprising:
In an exemplary embodiment of the invention, said eye segment comprises a body of a closed ring.
In an exemplary embodiment of the invention, said eye segment comprises a body which is open at at least one point of its circumference.
In an exemplary embodiment of the invention, said interlocking mechanism is stiff enough and strong enough to hold said hook segment while it is being torn off an extension thereof, by pulling on the extension.
In an exemplary embodiment of the invention, said hook segment includes an extension which is torn off said hook segment during deployment by pulling, said hook segment defining a rest stop where said hook segment is held during said pulling. Optionally, said extension defines a slot terminating at said rest stop.
In an exemplary embodiment of the invention, said interlocking mechanism is substantially all on a plane of said eye segment, once interlocked.
In an exemplary embodiment of the invention, said interlocking mechanism comprises at least one tab that is perpendicular to an axis of said hook segment, at said channel.
In an exemplary embodiment of the invention, said tab enters a matching aperture formed in said hook segment. Alternatively or additionally, said tab transfixes a matching aperture formed in said hook segment. Alternatively or additionally, said tab transfixes a matching open slot formed in said hook segment.
In an exemplary embodiment of the invention, the connector comprises at least one spring element which approximates said channel and said tab. Optionally, said tab is mounted on said spring element. Alternatively said tab is not mounted on said spring element. Optionally, said spring element urges said hook element against said tab.
In an exemplary embodiment of the invention, said spring element is formed of an outer portion of said eye segment.
In an exemplary embodiment of the invention, said spring element is attached to said eye segment near said channel.
In an exemplary embodiment of the invention, said spring element is attached to said eye segment far from said channel.
In an exemplary. embodiment of the invention, said eye segment includes a support bar on which said spring element is attached.
In an exemplary embodiment of the invention, said at least one tab comprises only a single tab.
In an exemplary embodiment of the invention, said at least one tab comprises at least two tabs.
In an exemplary embodiment of the invention, said hook element includes an extension which is torn off during deployment, said extension defining an alternative aperture for locking said tab spaced from said tissue holding area.
In an exemplary embodiment of the invention, said eye segments are interconnected after deployment.
In an exemplary embodiment of the invention, said eye segments are not interconnected after deployment.
There is also provided in accordance with an exemplary embodiment of the invention, an anastomotic connection clip element, comprising:
Non-limiting embodiments of the invention will be described with reference to the following description of exemplary embodiments, in conjunction with the figures. The Figures. are generally not shown to scale and any sizes are only meant to be exemplary and not necessarily limiting. In the figures, identical structures, elements or parts that appear in more than one figure are preferably labeled with a same or similar number in all the figures in which they appear, in which:
FIGS. 11A-C demonstrate the operation of a hook stabilizing device, in accordance with an exemplary embodiment of the invention;
In an exemplary embodiment of the invention, the connector is mounted on a rotation sleeve 250, which allows the connector to be rotated relative to body 214.
In an exemplary embodiment, protector overtube 240 surrounds hooks 220 to protect delicate hooks 220 from being damaged during placement in a host vessel. The tips of the hooks are optionally covered by a cap (not shown) that mounts over overtube 240. A graft (not shown) enters through a side opening in tube 240 and is everted over hooks 220.
Rotation sleeve 250 allows rotation of handle 210 and/or levers 230 and/or 232 in relation to anastomotic connector hooks 220 (
As described for example in WO 00/56226, the disclosure of which is incorporated herein by reference, overtube 240 may be splittable lengthwise, for example using a pin 260, so that overtube 240 and/or rotation sleeve 250 may be split open and removed following anastomosis of a vessel using hooks 220.
Additionally or alternatively, pin 260 may have other functions, for example, to control longitudinal movement of spikes 228 and/or hooks 220 in relation to rotation sleeve 250. Pin 260, for example, pulled in direction 206 retracts hooks 220 into rotation sleeve 250, and advanced to exposing hooks 220, for example during an anastomosis procedure. Exposed hooks 220 are thereby free to enter an aperture in a blood vessel and/or connect the grafted vessel to the host vessel. In an exemplary embodiment of the invention, the retraction is practiced during eversion of the graft. In an exemplary embodiment of the invention, retracted hooks are shorter and therefor stiffer, which may be important during eversion if the hooks are too flexible.
In an exemplary embodiment, as rotation sleeve 250 is rotated in relation to handle 210, audible clicking noises are provided (for example generated by the hexagonal coupling shown in
In an exemplary embodiment of the invention, rotation sleeve 250 is part of a separable capsule (e.g., as shown in
In an exemplary embodiment of the invention, capsule 400 includes a mechanism for selective retraction and extension of hooks 220. Not all connectors will require such a mechanism but it may be useful for connectors with very flexible and/or long hooks, to simplify eversion. Alternatively or additionally, this may be useful for matching the projecting length of the hooks with the diameter of the target vessel, for example to ensure that the hooks enter and/or to prevent them contacting the far wall of the target vessel.
Optionally, hooks 220 are pre-stressed to form a cone shape. In an exemplary embodiment of the invention, when the hooks are retracted, the cone shape is opened, for example as shown in
Stop 304 of extent channel 302 prevents further rotational movement and locks the position of hooks 220 as a pin (not shown) presses against stop 304.
In an exemplary embodiment of the invention, one or more projections, for example a sleeve, project out of capsule 400 in the direction of system 200 and prevent interlocking of capsule 400 and system 200 if hooks 220 are not in a desirable retracted or extended position. The axial position of the projection is controlled by the rotation mechanism, for example the coupling of
In an exemplary embodiment of the invention, when handle. 210 is assembled with capsule 400, handle 210 covers capsule 400, leaving, for example, extent channel 302 projecting forward of edge 420. With capsule 400 covered by handle 210, an operator is prevented from inadvertently rotating capsule 400 in relation to handle 210 in a mistaken attempt to advance/retract hooks 220. Alternatively or additionally, capsule 400 may have an oval cross-section, which prevents rotation. Alternatively or additionally, where a pin is used for moving the hooks, this pin is covered by the delivery system, Alternatively to an axial moving pin or a rotating sleeve, a rotating pin may be used, in which only a pin that extends through a slot in capsule 400 rotates around the axis of capsule 400 and not an entire sleeve 250.
Hook 220 has a curved head 680 upon which a vessel wall 682 is transfixed. In an exemplary embodiment, extension 632 circumducts 668 around longitudinal axis 636 so that tip 620 follows the trajectory of curved head 680.
In
In various exemplary embodiments, orifice 628 may have a variety of shapes: oval, rectangular or triangular, and/or a variety of orifice sizes, to accommodate a variety of vessel wall 682 thicknesses and/or tissue configurations. In an exemplary embodiment, tip 620 incorporates soft materials and/or coatings that are soft, absorb shock and/or move easily over wet, moving tissue. In another example, an open orifice, for example a slot, is used. The size of the aperture and the direction of offset 632 are exaggerated, for clarity.
Even if the hooks are arranged to have their tips in the shape of a cone (possibly a flattened cone), it may be difficult to fit the hooks into an incision, which may be a linear or curved cut, rather than a hole. Also, if the target vessel is collapsed, it may be difficult to manipulate the hooks.
Additionally or alternatively, hook arranger 750 presses hooks 220 together so that there are no projecting sharp edges that can brush against vessel 810 and bend. This arrangement of hooks 220 is shown in
In an exemplary embodiment, arranger 750 maintains hooks 220 in a straight linear formation. Additionally or alternatively, arranger 750 maintains hooks 220 in a curvilinear formation so that hooks 220 conform to a curvilinear aperture 812 in blood vessel 810 (not shown), in which the tips optionally protect each other. Alternatively or additionally, plates 754 define guiding slots, one for each hook, possibly covering the hooks from the outside. In an exemplary embodiment a handle 764 attached to plate 754, and a handle 762 attached to plate 752, cause plates 752 and 754 to move away from each other when handles 762 and 764 are pressed toward each other, thereby releasing the hooks.
Alternatively or additionally plates 752 and/or 754 comprise one or more spacers 780 that, for example, press against a hook 220 and/or pass between two or more hooks 220. In an exemplary embodiment, spacers 780 are removed from hooks 220 as handles 762 and 764 are pressed toward each other as they pivot on a pin 772.
In an exemplary embodiment, a safety pin 782 is provided that splits cone 250 and/or other parts of capsule 700 following an anastomotic connection, as mentioned above.
Guide 800 comprises at least one wall 860 that guide hooks 220 as anastomotic delivery system 200 is moved toward blood vessel 810, thereby preventing hooks 220 from coming in contact with blood vessel 810 and/or biologic structures around blood vessel 810. Such contact could cause, for example, hooks 220 to become bent so they improperly align with aperture 816 in blood vessel 810 and, provide a less than optimal anastomosis with blood vessel 810.
In an exemplary embodiment, guide 800 comprises a guide tip 840 designed to enter blood vessel 810 between edges 812 and 814 (into aperture 816) without damaging edges 812, 814. Optionally, guide tip 840 prevents damage to hooks 220 during placement in blood vessel 810.
In an exemplary embodiment, guide 800 and/or tip 840 comprise a curved tube, with a guidance slot defined along the inside of the curve. In an exemplary embodiment, walls 860 and/or 862 are spaced (e.g., the width of the slot) so that hooks 220 move easily through guide 800 without contacting blood vessel 810 and/or surrounding biologic tissue. Alternatively or additionally, walls 860 and/or 862 spaced from each other to facilitate easy movement of hooks 220 into blood vessel 810. In an exemplary embodiment, two or more walls 860 and 862 comprise one or more flared openings, for example at one or both ends, to facilitate entry and/or exit of hooks 220 from guide 800. The spacing may or may not be constant along the length of the guide, for example, it may become progressively narrower, independent of any flaring.
In an exemplary embodiment, guide tip 840 is configured so that following its placement through aperture 816 and setting hooks 220 in blood vessel 810, guide 800 is easily removed from aperture 816 while hooks 220 remain in place (
In an exemplary embodiment, guide 900 is pivotally attached to extension 450 with a pivot pin 922 so that with guide 900 in blood vessel 810, capsule 400 is rotated in a direction 970 bringing hooks 220 into blood vessel 810.
In an exemplary embodiment, after hooks 220 are in place in blood vessel 810, guide 900 is pivoted in a direction 972 (
While an arc shaped guide is shown, other shapes may be used. For example, a spiral shaped guide, with one, fewer or more turns may be useful for narrow areas. Instead of merely rotating the delivery system relative to the guide, the tip of the delivery system may move in the shape of a spiral, to follow the guide shape. A gimbaling hinge may be used in stead of a planar pivot hinge shown.
In an exemplary embodiment, guide 1000 comprises a channel 1040 with a blunt tip 1010 designed for entry into aperture 816 in blood vessel 810. In an exemplary embodiment, tip 1010 is sharp, (not shown) allowing it to pierce blood vessel 810 and/or modify aperture 816.
Additionally or alternatively, guide 1000 has one or more sharp edges along channel 1040 to aid in piercing blood vessel 810. Additionally or alternatively, the edges along channel 1040 are manufactured to be blunt to prevent modification of aperture edge 816 during insertion of channel 1040. In an exemplary embodiment, sharp tip is pressed into vessel 810 until wall 1020 contacts aperture edge 816, thereby properly modifying aperture edge 816 to form aperture 812 and/or positioning channel 1040 fully (and properly) in vessel 810.
In an exemplary embodiment of the invention, a sharp edge is defined between tip 1010 and wall 1020. Optionally, wall 1020 serves to define the length of the incision. Alternatively or additionally, the length of the cutting edge is selected to match a desired incision length.
In an exemplary embodiment, channel 2040 has a flare 1012 that defines, for example, a wider space than channel 1040 to facilitate movement of hooks 220 into channel 1040 without damage due to contact with channel 1040. Alternatively or additionally, flare 1012 prevents damage of hooks 220 through contact with surrounding tissue.
FIGS. 11A-C demonstrate the operation of a releasable grasper 1100 for grasping hooks 220 projecting from rotation sleeve 250 (or overtube 240), in accordance with an exemplary embodiment of the invention. In an exemplary embodiment, releasable grasper 1100 comprises a handle 1130 with one or more grasper wires 1120 and/or 1122 projecting from it. Grasper wires 1120 and/or 1122 comprise a grasper area 1190, adapted to grasp a plurality of hooks 220 during placement in blood vessel 810 without damaging hooks 220. Possibly, as hooks 220 are pressed together, they support each other, thereby providing strength against damage caused by inadvertent contact with vessel 810.
In an exemplary embodiment, grasper wires 1120 and/or 1122 are attached to grasper wire deployment button 1150. Upon pressing button 1150 on a grip 1140 in a direction 1112, grasper wires 1120 and/or 1122 move away from each other, expanding grasper area 1190 and thereby releasing hooks 220. Alternatively or additionally, the wires are retracted, possibly all the way into body 1130, thereby releasing hooks 220.
In an exemplary embodiment of the invention, one grasper wire, in the shape of a loop is used. Optionally, wires 1120 and/or 1122 remove from handle 1130, upon pulling grip 1140 in a direction 1114, without causing damage to hooks 220. In an exemplary embodiment, the loop tears when retracted into body 1130. A particular implementation is shown in
In an exemplary embodiment, blood vessel cutter 1200 comprises a handle 1202 adapted to rotate in a direction 1210 around a longitudinal axis 1204.
Handle 1202 comprises a horn-shaped cutting edge 1220 perpendicularly connected to handle 1202. In an exemplary embodiment, upon rotating handle 1202 around longitudinal axis 1204, cutting edge 1220 rotates around handle 1202. When blood vessel cutter 1200 is held proximate to blood vessel 810, for example, by placing cutting edge 1222 along a longitudinal axis of blood vessel 810, cutting edge 1220 cuts an aperture 1222 into vessel 810 during rotation of handle 1202 in direction 1210. Aperture 1222, for example, is suitable for insertion of hooks 220 on anastomotic connector 101 (
In an exemplary embodiment, horn-shaped cutting edge 220 is of a length appropriate to cut aperture 1222 in a surface of blood vessel 810 that allows hooks 220 to enter vessel 810 easily and hook into the walls of vessel 810 around aperture 1222. Optionally, aperture 122 is cut into vessel 810 by vessel cutter 1200 during a single rotation in direction 1220 around axis 1204, said aperture 1222 comprising a longitudinal cut, the length of cutting edge 1222. Alternatively or additionally, cutter 1200 is rotated multiple times around axis 1210 and in relation to vessel 810. Optionally cutter 1200 is moved longitudinally along vessel 810 during said multiple rotations, thereby creating aperture 1222.
Depending on the particular procedural method followed, the target vessel may or may not be clamped or pressed against (e.g., using a finger) to prevent or reduce bleeding.
In an exemplary embodiment of the invention, a manual retraction device, for example a knob 1306 (and an optional associated gear 1304) are used to retract a tube 1310 which pulls back on hooks 220. The hooks are prevented from moving by ring 102 being held in place, for example, by a non-moving tip 1346 of system 1300. This pulling back also releases an interlock mechanism, thereby releasing spring 1302. In an exemplary embodiment of the invention, a base 1309, optionally with a shock absorbing function, interconnects tube 1310 and spring 1302. However, as long as the interlock is in place, spring 1302 is constrained by a housing 1338. In an exemplary embodiment of the invention, knob 1306 is actually used to push retract housing 1338 and with it base 1309 and tube 1310. Other coupling methods may be used as well.
In an exemplary embodiment of the invention, the interlock mechanism comprises a ball 1330 which is constrained by a sleeve 1340. However, ball 1330 moves back with housing 1338, until sleeve 1340 no longer constrains it and it is released into a space 1332 formed in a body 1339 of system 1300. This releases the constraining of spring 1302, applying an impulse force to base 1309 and tearing the extensions off of hooks. In an exemplary embodiment of the invention, system 1300 is designed so that the interlock is released only after the hooks are locked in place (e.g., as in
Alternatively or additionally, one or more levers 230 and/or 232 (shown in
In an exemplary embodiment, spikes 228 are maintained by grasper device 1400 in a cone configuration so that hooks 220 rest against each other. A cone configuration of spikes 220, for example, provides greater stability of spikes 228 than when spikes 228 are not resting against each other. Additionally or alternatively, spikes 228 are manufactured to be more rigid so that they are less prone to being damaged by inadvertent brushing against biologic tissue. In an exemplary embodiment, spike grasper wire 1408 of breakable grasper device 1300 extends from a handle 1402 and is retracted in a direction 1450 by movement of a shifter 1420. As shifter 1420 is moved in a direction 1422, grasper wire 1408 is pulled in direction 1450, compressing spikes 228 against each other.
Grasper wire 1408, for example, comprises at least one breakaway area 1452 that breaks when grasper wire 1408 is pulled away in direction 1450 away from compressed spikes 228. When grasper wire 1408 break away from spikes 228, spikes 228 are released, for example, in aperture 1222 of vessel 810, so that hooks 220 can be deployed therein.
Optionally, breakable spike grasper device 1400 is used in conjunction with an anastomotic connector 101 constructed with spikes 228 that withstand the breakaway force used to break grasper wire 1408 from connector 101.
In an exemplary embodiment of the invention, shifter 1420 has three resting positions, a first one where the loop 1408 is open for easy insertion of the hooks, a second one where the loop is made smaller and the hooks are compressed and a third one where the loop is compressed even more and is thus torn and the hooks released.
Referring to
In an exemplary embodiment of the invention, hook segment 1602 is originally connected to an extension and is torn off during deployment, for example at a tearing plane 1612, described below. Dotted lines 1614 indicate this extension.
Referring to
While a closed ring shape is shown, this is not essential but may be useful to prevent undesirable tearing of the blood vessels by projections of eye 1604.
In the embodiment shown, two tabs 1624 and 1626 are defined to engage aperture 1607, from either side, when hook 1602 passes through an aperture 1622 of eye segment 1604 and aperture 1607 is suitably aligned. In an exemplary embodiment of the invention, the two tabs are mounted on spring elements, for example, a section 1621 of body 1618 and a separate spring element 1619. As shown, a pair of channels 1628 are used to separate the two spring elements, to allow distribution of elastic distortion over relatively large areas, and thus allow it to act as a spring. In an exemplary embodiment of the invention, the spring elements are pre-stressed to be in a closed position. A pair of strain relief holes 1630 are also shown. Holes 1630 are also useful for some types of machining methods to ensure that the comer is at least complete and prevent binding of the hook element in the channel. Other exemplary spring element designs are shown below. In an exemplary embodiment of the invention, the distance between tabs 1624 and 1626 is designed to be less than a thickness of hook segment 1602.
It should be appreciated that in some embodiments of the invention, the interlocking is used not only to prevent the eye and hook segments from separating but also as a stop that holds the hook segments against the eye segment while an extension of the hook element is pulled and torn off. In other embodiments of the invention, a separate holding means is provided.
Optionally, the mechanism of
It should be noted that while the locking methods of
In an exemplary embodiment of the invention, the interlocking mechanism used is spring based, in that a tab is elastically (including shape memory and super-elastically) disposed to go in a certain direction, which is only available when the hook segment is properly aligned with the eye segment. Alternatively, a plastically deforming mechanism, for example with external clamp jaws that compress the eye segments, may be provided. optionally, a layer is provided between the eye segments and the side vessel, so that they are sandwiched between two layers and their distortion is prevented. Such a sandwich layer is described, for example in WO 02/30172, the disclosure of which is incorporated herein by reference.
The spring mechanism can be of various types. In particular, a long spring is generally useful for providing some flexibility in positioning and/or for distributing stress. A shorter spring, on the other hand, may be useful in preventing undesired motion along the axis of the hook segment. Various tradeoffs may be selected, for example based on the particular blood vessels being attached to each other.
For this an other springs, the spring element is optionally selectively treated, for example, by heat or chemical treatment, or thinned, to make it more or less elastic, as desired.
Alternatively or additionally, the rest of the eye segment may be treated to make it more rigid.
It should be noted that the description and FIGS. show generally perpendicular slots and/or apertures in the hooks segment and/or eye segments. However, this is not essential. For example, a slot 1943 for a hook segment in eye segment 1940 may be oblique to the plane of the eye segment. Alternatively or additionally, the aperture (of the hook segment) into which tab 1942 fits can be angled, for example anticipating forces applied in a certain direction and/or to assist in entry of the tab into the aperture.
In an exemplary embodiment of the invention, mechanism 2000 is placed at the end (e.g., on the tip of overtube 240 of capsule 400) of the delivery system, for example as described in
In an exemplary embodiment of the invention, a plurality of mushroom shaped protrusions 2014 are mounted on extensions 2004, and incidentally may be used to stabilize the hook segments, against bending. Other shape protrusions, such as even width fingers or spikes may be used instead. The mushroom shape may also b useful in preventing damage to the graft. When extensions 2004 are pulled back, the bottom of each mushroom protrusion contacts plane 1612 and then the hook extension tear at that point.
In
The PCT applications mentioned in the related application section as of the filing in the PCT of this application contain various delivery system and connector elements which may be practiced in conjunction with the embodiments described in the present application.
The above devices may be varied in various ways for adaptation for specific types of blood conduits. For example, larger devices may be designed for use in large blood vessels and/or softer coatings, for example a silicone rubber coating, may be applied to devices designed for used in conduits with delicate walls. In some embodiments of the invention, a device is packaged and/or sold with an instruction leaflet, describing the device dimensions and/or situations for which the device should be applied. The devices may be used, for example for aortic connections, for coronary vessels and with various types of grafts, including, for example, artificial grafts, xenografts, harvested veins, harvested arteries and in-situ arteries, such as the LIMA and RIMA. The dimensions, elasticity and/or strength of the various elements, for example hooks and eyes may be adapted for various situations, or, for example, as noted, one size may be sufficient for a wide range of situations. For example, the design may take into account blood vessel strength thickness, compressibility, incision size, and diameter.
It will be appreciated that the above described methods and devices of vascular manipulation may be varied in many ways, including, changing the order of steps, the order of making the anastomosis connection., the order in each anastomosis, the exact materials used and/or design of the anastomotic connectors and/or installation devices.
Further, in the mechanical embodiments, the location of various elements may be switched, without leaving the aspect of the invention, for example, switching moving elements for non-moving elements where relative motion is required. In addition, a multiplicity of features, and devices have been described. It should be appreciated that different features may be combined in different ways. In particular, not all the features shown above in a particular embodiment are necessary in every similar exemplary embodiment of the invention.
Further, combinations of the above features, from different described embodiments are also considered to be within the scope of some embodiments of the invention. In addition, some of the features of the invention described herein may be adapted for use with prior art devices, in accordance with other embodiments of the invention. The particular geometric forms used to illustrate the invention should not be considered limiting the invention in its broadest aspect to only those forms, for example, where a circular lumen is shown, in other embodiments an oval lumen may be used.
Also within the scope of the invention are surgical kits comprising 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. When used in the following claim, the terms “comprises”, “comprising”, “includes”, “including” or the like means “including but not limited to”.
It will be appreciated by a person skilled in the art that the present invention is not limited by what has thus far been described. Rather, the scope of the present invention is limited only by the following claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 124694 | May 1998 | IL | national |
| 129067 | Mar 1999 | IL | national |
| 144051 | Jun 2001 | IL | national |
| PCT/IL01/00903 | Sep 2001 | WO | international |
The present application is a continuation in part of PCT application PCT/IL01/00903, filed on Sep. 25, 2001, which designates the U.S., now published in English as WO 02/30172, the disclosure of which is incorporated herein by reference. This application is also a continuation-in-part of PCT/IL02/00215 filed on Mar. 18, 2002, PCT/IL01/01019, filed on Nov. 4, 2001, PCT/IL01/00903, filed on Sep. 25, 2001, PCT/IL01/00600, filed on Jun. 28, 2001, PCT/IL01/00267, filed on Mar. 20, 2001, PCT/IL01/00266, filed on Mar. 20, 2001, PCT/IL01/00074, filed on Jan. 25, 2001, PCT/IL01/00069, filed on Jan. 24, 2001, PCT/IL00/00611, filed on Sep. 28, 2000, PCT/IL00/00609, filed on Sep. 28, 2000, PCT/IB00/00310, filed on Mar. 20, 2000, PCT/IB00/00302, filed on Mar. 20, 2000, PCT/IL99/00674, filed on Dec. 9, 1999, PCT/IL99/00670 filed on Dec. 8, 1999, PCT/IL99/00285, filed on May 30, 1999, and PCT/IL99/00284, filed on May 30, 1999. The disclosure of all of these applications, which designate the U.S. and were filed in English, are incorporated herein by reference.
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| Parent | PCT/IL01/00600 | Jun 2001 | US |
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