BACKGROUND OF THE INVENTION The present invention relates generally to vasculature repair and more particularly to methods and devices for accomplishing in situ assembly of a repair device for treating abdominal aortic aneurysms.
It is well established that various fluid conducting body or corporeal lumens, such as veins and arteries, may deteriorate or suffer trauma so that repair is necessary. For example, various types of aneurysms or other deteriorative diseases may affect the ability of the lumen to conduct fluids and, in turn, may be life threatening. In some cases, the damage to the lumen is repairable only with the use of prosthesis such as an artificial vessel or graft.
For repair of vital lumens such as the aorta, surgical repair is significantly life threatening or subject to significant morbidity. Surgical techniques known in the art involve major surgery in which a graft resembling the natural vessel is spliced into the diseased or obstructed section of the natural vessel. Known procedures include surgically removing the damaged or diseased portion of the vessel and inserting an artificial or donor graft portion inserted and stitched to the ends of the vessel which were created by the removal of the diseased portion. More recently, devices have been developed for treating diseased vasculature through intraluminal repair. Rather than removing the diseased portion of the vasculature, the art has taught bypassing the diseased portion with a prosthesis and implanting the prosthesis within the vasculature. An intra arterial prosthesis of this type has two components: a flexible conduit, the graft, and the expandable framework, the stent (or stents). Such a prosthesis is called an endovascular graft.
It has been found that many abdominal aortic aneurysms extend to the aortic bifurcation. Accordingly, a majority of cases of endovascular aneurysm repair employ a graft having a bifurcated shape with a trunk portion and two limbs, each limb extending into separate branches of vasculature. Currently available bifurcated endovascular grafts fall into two categories. One category of grafts are those in which a preformed graft is inserted whole into the arterial system and manipulated into position about the area to be treated. This is a unibody graft. The other category of endovascular grafts are those in which a graft is assembled in-situ from two or more endovascular graft components. This latter endovascular graft is referred to as a modular endovascular graft. Because a modular endovascular graft facilitates greater versatility of matching the individual components to the dimensions of the patient's anatomy, the art has taught the use of modular endovascular grafts in order to minimize difficulties encountered with insertion of the devices into vasculature and sizing to the patient's vasculature.
Although the use of modular endovascular grafts minimize some of the difficulties, there are still drawbacks associated with the current methods. Where it is desirable to repair vasculature with a repair device that is assembled in situ, it can be difficult to accomplish mating the various components of the repair device. For example, it can be difficult to access an inferior opening of a bifurcated graft or repair device. That is, components that are designed to mate with contralateral limbs of a graft or repair device are sometimes difficult to align with a contralateral opening. Remote imaging techniques such as fluoroscopy provide a two dimensional display of components residing in a three-dimensional environment. Thus, gaining access to inferior openings can be a challenge. Often the challenge involves attempting to thread a guidewire through a contralateral limb opening of a repair device which later provides a track for delivering additional components designed to mate with the repair device. This challenge can also apply to any component which terminates in an opening having a smaller cross-section than the anatomy, such as a repair device with a target opening residing in an aneurysm.
Accordingly, there exists a need for methods or devices which overcome or tend to minimize the challenges associated with assembling components that have cross-sections less than the vasculature being repaired or where two dimensional imaging is found to be lacking. The present invention addresses these and other needs.
SUMMARY OF THE INVENTION Briefly and in general terms, the present invention relates to methods and devices for use in the repair of vasculature and more particularly for use in connection with the in situ assembly of a modular endovascular graft. In one or more aspects, the present invention is directed at facilitating the snaring of a guidewire placed within vasculature. In other aspects, the present invention is concerned with accomplishing the advancement of a guidewire through an opening of an endovascular graft or repair device.
In one embodiment, there is provided a main catheter carrying a first modular component and being equipped with a snare target wire having a snare target ball formed at a terminal end thereof. A soft magnet snare is further provided and is designed to engage the snare target ball to facilitate placement of a guidewire in the opening of the first endovascular graft component to then accomplish placing a second modular component in contact with the first component. In an alternative embodiment, the snare target ball is contemplated to be ferromagnetic to further facilitate the engagement of the snare target ball and the snare. Radiopacity of the snare target ball is highly beneficial.
In another embodiment, advancement of a guidewire to a specific location within the first endovascular component or patient's vasculature is accomplished by creating retrograde blood flow within a vessel. A guidewire configured with a balloon or other retractable occlusion structure is advanced within vasculature to a target site. The occlusion structure is expanded to create a pressure gradient at the target site. The occlusion structure is then retracted or compressed and the guidewire is allowed to be advanced further within the vasculature through the aid of the retrograde flow created.
In a further embodiment, a guidewire is equipped with structure which provides both physical or visual feedback (through remote imaging techniques) and steering through blood flow. The guidewire tip includes atraumatic fins/rudders or wind socks which act to aid in progressing the guidewire straight up a course of flow of blood. Any misdirection of the guidewire tip results in a dramatic lateral change in position of the tip.
In yet another embodiment, the tip of a guidewire can be coiled into a flat spiral or a spherical or conical shape to thereby provide an enlarged structure to aim at a target site. In this embodiment, a proximal end of the guidewire can be manipulated to cause the enlarged terminal end of the guidewire to become straightened or reduced in dimension for insertion within a target lumen or opening.
In another embodiment, a temporary tunnel or pathway is created within vasculature by a balloon catheter or tampon structure through which a guidewire is advanced to a target site. By minimizing the area through which the guidewire can move laterally, there can be a more efficient placement of the guidewire at the target site.
In another embodiment, a snare assembly is provided with a catheter snare for grabbing a main catheter during an implantation procedure. The snare assembly additionally includes a dual lumen or peelaway structure housing a contralateral guidewire. In a disclosed method, after engaging the main catheter with the catheter snare, the snare assembly is aligned with a marker attached to the target site. The contralateral guidewire is then advanced to the target site and thereafter, the snare is disengaged from the main catheter.
In another embodiment, a snare catheter is included in the main catheter and a swiveling guide is provided to direct the snare catheter over the bifurcation of the repair device and out the contralateral port. In a disclosed method, the snare catheter is utilized to capture a guidewire inserted into the contralateral vessel and pull the guidewire into the main body of the repair device.
Other features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is a cutaway view, depicting a typical repair site within vasculature;
FIG. 2 is a partial side view, depicting a catheter equipped with a snare target;
FIG. 3 is a partial cross-sectional side view, depicting the catheter ofFIG. 2 inside a repair device deployed within vasculature;
FIG. 4 is a partial cross-sectional view, depicting the assembly ofFIG. 3 in which the snare target is positioned extending through a small opening in the repair device;
FIG. 5 is a partial cross-sectional view, depicting a snare placed into engagement with the snare target ofFIG. 4;
FIG. 6 is a partial cross-sectional view, depicting the superior advancement of the snare target and snare within the repair device;
FIG. 7 is a partial cross-sectional view, depicting the retraction of the snare target and snare ofFIG. 5 into the repair device;
FIG. 8 is a partial cross-sectional view, depicting a first modular component of a repair device placed within vasculature and an expandable device placed to change the flow of blood;
FIG. 9 is a partial cross-sectional view, depicting the expandable device ofFIG. 8 advanced within a repair device with the aid of retrograde flow;
FIG. 10 is a partial cross-sectional view, depicting a system placed in vasculature that is responsive to blood flow;
FIG. 11 is a side view, depicting an alternative embodiment of a device responsive to blood flow;
FIG. 12 is a side view, depicting one embodiment of a curved terminal end of an elongate member;
FIG. 13 is a side view, depicting a second embodiment of a curved terminal end of an elongate member;
FIG. 14 is a side view, depicting a third embodiment of a curved terminal end of an elongate member;
FIG. 15 is a partial cross-sectional view, depicting a device for creating a temporary pathway within vasculature;
FIG. 16 is a partial cross-sectional view, depicting a snare device deployed within vasculature;
FIG. 17 is a partial cross-sectional view, depicting an in-situ assembly method involving the snare ofFIG. 16;
FIG. 18 is a partial cross-sectional view, depicting a limb component attached to a main body component utilizing a method involving the snare ofFIG. 16;
FIG. 19 is a side elevational view, depicting a crimped tubular graft leg having an inferior end with a larger diameter than a superior end;
FIG. 20 is a side elevational view, depicting a crimped tubular graft leg having an inferior end with a smaller diameter than a superior end;
FIG. 21 is a side elevational view, depicting another embodiment of the snare ofFIG. 16;
FIG. 22 is a side elevational view, depicting another embodiment of the snare ofFIG. 16;
FIG. 23 is a side elevational view, depicting an in-situ assembly method involving the snare ofFIG. 22;
FIG. 24 is a partial perspective view, depicting the superior end of the snare ofFIG. 22;
FIG. 25 is a side elevational view, depicting a method of correcting for angulation of the superior anchor stent of a repair device;
FIG. 26 is a side elevational view, depicting the correction of angulation of the superior anchor stent of a repair device utilizing the method ofFIG. 25;
FIG. 27 is a partial side view, depicting a main catheter equipped with a snare catheter and swiveling guide;
FIG. 28 is a partial side view, depicting the swiveling guide shown inFIG. 27 rotated clockwise by the snare catheter;
FIG. 29 is a partial side view, depicting the swiveling guide shown inFIG. 27 rotated counter-clockwise by the snare catheter;
FIG. 30 is a partial cross-sectional side view, depicting the main catheter ofFIG. 27 inside a repair device deployed within vasculature, the repair device shown as transparent;
FIG. 31 is a partial cross-sectional view, depicting the assembly ofFIG. 30 in which the snare catheter has been advanced through the swiveling guide to capture a guidewire inserted into the contralateral vessel;
FIG. 32 is a partial cross-sectional view, depicting the assembly ofFIG. 30 in which the snare catheter has been retracted into the swiveling guide with the captured guidewire; and
FIG. 33 is a partial cross-sectional view, depicting the assembly ofFIG. 30 in which the snare has been released from the guidewire and the snare catheter retracted into the main catheter.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS As shown in the drawings, which are included for illustration and not by way of limitation, the present inventions are embodied in methods and devices for facilitating in situ assembly of modular repair devices. The disclosed methods and devices address problems associated with conventional modular repair devices and catheters employed to deliver the repair devices within vasculature. The disclosed inventions can be employed to deliver components of any modular repair devices within various portions of a patient's vasculature. As will be developed below, the present inventions are particularly useful in the assembly of modular endovascular grafts within theaorta20 to repair an aneurysm22 (SeeFIG. 1) wherein the problem is that a small opening66 (SeeFIG. 3), in the firstmodular component60 lies within alarge cavity23 in the body just above a relativelysmall diameter vessel21 that has a lot of bends which makes it difficult to pass a conventional guidewire through the vessel across a portion of the large cavity and into the small opening66 (seeFIG. 3).
Referring now toFIGS. 2-7, a device and a method are described for accomplishing the cannulating of a contralateral opening of a modular abdominal aortic aneurysm endovascular graft implant. As stated, however, the disclosed system can be used anywhere in a patient's vasculature for the assembly of any repair device by altering the dimensions thereof. As shown inFIG. 2, arepair system30 includes an elongatemain catheter32 having an inferior portion (not shown) and asuperior portion36. Therepair system30 has atubular jacket38 which is sized to slide over themain catheter32. The jacket38 (shown retracted) is used to provide thesystem30 with a profile suitable for advancement within vasculature. At a repair site, the jacket is retracted to expose thesuperior portion36 of themain catheter32, the various components thereof, and a first modular component60 (shown deployed inFIG. 3).
Thesuperior portion36 of themain catheter32 includes a terminal end configured with a tapered nosecone41 and a generallyblunt jacket guard40 which mates with thejacket38 when thesystem30 is assembled for advancement through vasculature. Thejacket guard40, tapered nosecone41 andjacket38 define an atraumatic superior end. Themain catheter32 further includes a repair device or modular endovascular graft mounting or receivingportion42 as well as arelease wire port44. Therelease wire port44 is designed to provide an opening for a release wire (not shown) that can be configured to maintain a repair device on themain catheter32 in a compressed condition then subsequently pulled to allow the repair device to expand. Thesystem30 can also be equipped with an expandable member such as a balloon.
Thedelivery system30 further includes asnare target wire50 having a terminal end configured with asnare target ball52. The target wire can be made from a number of materials that allow the wire to be compressed to lay alongside of the main catheter shaft and then spring back to its laterally extending position as shown inFIGS. 2-4. One preferred material is nitinol. In another embodiment, the snare target wire can be retractable to within a lumen in the main catheter shaft for storage and extended to aid in the delivery procedure. In the embodiment shown, the snare target wire extends from the superior end of themain catheter32 in an inferior direction. In an alternate embodiment it can be routed initially in a superior direction and then folded or bent to extend in an inferior direction. Thetarget wire50 is attached to thecatheter32 preferably by crimping a band over the wire and catheter but can be attached in other ways just as by adhesive or molding into the catheter.
Turning now toFIGS. 3-7, a method involving employing asystem30 including asnare target wire50 is described. In a typical implant scenario, thedelivery system30 carrying a first endovascularcomponent repair device60 is advanced within vasculature to arepair site22 and thejacket38 is withdrawn to expose the superior portion of themain catheter36. In the embodiment shown, the jacket is withdrawn far enough forcontralateral opening66 to open but still covering the ipsilateral portion of therepair device60 so that the repair device is held relatively stable whilecontralateral opening66 is cannulated. Asuperior end62 of arepair device60 is expanded or permitted to expand by withdrawing a release wire (not shown) to thereby be implanted in the region of the repair site. Thetarget ball52 of thetarget snare wire50 is then positioned adjacent to a mating orengagement area64. The mating orengagement area64 in the scenario shown in the figures is adjacent and interior of acontralateral opening66 of therepair device60. Thesnare target wire50 is pushed out through thecontralateral opening66 by moving the receivingportion42 down whilemain catheter32 is held relatively stable or by extending thewire50 by a separate control (not shown) at the control handle of the delivery catheter so that thesnare target ball52 provides a target for engaging asnare70.
In one contemplated method thesystem30 is assembled so that thesnare target ball52 is initially positioned within acontralateral leg68 of therepair device60 so that withdrawal of the receivingportion42 with respect to therepair device60 causes thesnare target ball52 to exit thecontralateral opening66 of therepair device60. Next, thesnare70 inside of its delivery catheter orsheath71 can be advanced within vasculature to theengagement area64 and the target wire with the target ball can be lowered into engagement with the snare loop. It is to be recognized that the delivery catheter orsheath71 can be single or multi-lumened such as that described below so that an exchange need not be done. That is, for example, a second lumen can be incorporated into the delivery sheath and be configured for passage of an auxiliary guidewire that is contemplated to be used as a platform for other medical components or to maintain access to the repair site. Once the snare loop engages thesnare target ball52, the receivingportion42 is moved in a superior direction to pull thesnare70 up within therepair device60. Once the superior end of the snare catheter or sheath is within theopening66 then the snare can be removed from within the snare catheter or sheath and a conventional guidewire passed up through the snare catheter or sheath into therepair device60. The guidewire is left in place and the snare catheter or sheath is removed. Then a delivery catheter with the second modular repair device component is advanced over the guidewire. The second component is then released from the delivery catheter. The entire procedure can be observed using remote engaging techniques such as fluoroscopy. Wheresystem30 is used with other repair devices, such as one in which the ipsilateral portion ofrepair device60 is long enough to reach into the iliac artery, similar relative motion can be used to position thesnare target wire50 at an engagement site and to accomplish joining component parts of a repair device or to simply gain access thereto. For example, the jacket would be withdrawn completely to allowopening66 to open and the ipsilateral limb to anchor in the iliac artery. Then movement of the main catheter (as opposed to just the receiving portion42) would position the snare target.
If there is a desire to cross over the repair device bifurcation, thesnare70 can be pulled over abifurcation64 within therepair device60 by moving the receivingportion42 inferiorly as needed (seeFIGS. 6 and 7).
To facilitate the engagement of thesnare target ball52 and thesnare70, it is contemplated that a soft magnet be used as a snare loop. Thesnare target ball52 can have magnetic properties and is therefore contemplated to be made from ferromagnetic materials such as a ferritic stainless steel. The soft magnet can embody an Fe-44.4% Ni alloy or other equivalent materials with or without a thin protective coating provided for biocompatibility. In one aspect the snare embodies a loop so that in combination with a soft magnet, a closed-loop field is generated, one that does not interfere with other magnetic fields. Permanent magnets are less suitable for this application because they can potentially cause problems with other electrical equipment in an operating room and can also attract undesirable particles or small objects but they can be used.
With reference toFIGS. 8 and 9, there is shown a portion of amodular repair device100 which has been deployed withinvasculature102 at arepair site104. In the implanted condition, blood is flowing in aninferior direction105 through therepair device100. In the embodiment depicted, therepair device100 is in the form of a bifurcated graft with ipsilateral106 and contralateral108 limbs, theipsilateral limb106 being positioned in afirst branch vessel120. In order to attach an additional component to thecontralateral limb108 or to otherwise gain access to an interior of therepair device100, a contralateral approach can be taken.
An elongate element in the form of aguidewire130 is placed within vasculature and advanced through asecond branch vessel122 to the vicinity of therepair site104. A superior end of theguidewire130 is equipped with anexpandable member132 and anexpandable occlusive member134 designed to cause a pressure gradient within the vasculature sufficient to create retrograde flow withincavity space23 andlimb108.Occlusive member134 and theexpandable member132 can be in the form of inflatable balloons and the guidewire is formed from a hypotube. The balloons can be configured with multi-lumen cores or concentric lumens that allow a guidewire to pass through.
In a method of use, while positioned adjacent to the repair site, theexpandable occlusion member134 is expanded to block flow through thesecond branch vessel122. Being that the flow of blood has only one major outlet, namely through the first branch vessel via therepair device100, the vasculature is primed for retrograde flow withincavity space23 andlimb108. Once the “floppy”expandable member132 is advanced it is permitted to follow the path140 (FIG. 9) taken by the retrograde flow through therepair device100. In this way, theguidewire130 can be selectively placed within therepair device100. Such a method can be employed to advance any member to or within a target site within vasculature.
In another aspect of the invention, flow of blood in the inferior direction is utilized to aid in directing a medical component in a superior direction to a target. As shown inFIGS. 10 and 11, with arepair device200 in place in a bifurcated section ofvasculature202, amedical device210 can be advanced againstflow220 of blood to a target site. In the depicted embodiment, asuperior end230 of arepair device200 in the form of a bifurcated graft component is implanted at a superior location of amain vessel240. Anipsilateral leg portion242 of the graft is implanted in afirst branch vessel244. Flow of blood is traveling through thegraft200 from themain vessel240 to the first244 and second246 branch vessels. An elongate guidewire or other medical device configured with rudders orfins250 at asuperior end portion252 is advanced through thesecond branch vessel246 proximate to the repair site where thegraft200 has been implanted.
Due to the rudders orfins250, theguidewire210 is provided with physical and visual feedback regarding its advancement to within or to an engagement junction with the graft or repair device. Like a jet fighter landing on an aircraft carrier using laser guided feedback, any misdirection through theflow220 results in pushing atip260 of theguidewire210 away in a dramatic fashion, thus providing important physical and visual feedback (under remote imaging) to the goal of guidewires or other medical devices reaching a target. Moreover, by embodying a plurality of rudders orfins250, the medical device can be enabled to progress straight through the inferior flow to the desired destination.
As shown inFIG. 11, theguidewire210 could alternatively be configured with other structure capable of taking advantage of inferior flow such as anopen sock structure270. The open sock acts to funnel and steer the guidewire to a mating junction by allowingflow220 in and out, in line with theguidewire tip260. In order to enhance the effect of flow through which it is desirable to advance a medical device, steps can be taken to close one or more branch vessels in the vicinity. For example, a balloon catheter (not shown) can be employed to cease flow in abranch vessel244 so that the majority of blood flowing in the areas passes through thesecond branch vessel246.
Turning now toFIGS. 12-14, there is shown medical devices with various configurations of terminal ends. Each of the depicted medical devices include enlarged terminal ends providing an increased surface area for engaging or accessing a target. For example, an elongate guidewire or othermedical device300 can be configured with a flat spiral structure304 (FIG. 12), a conical structure308 (FIG. 13) or a spherical structure312 (FIG. 14). Such structures can be formed by coiling the elongate member or by other equivalent methods. In all cases, it is contemplated that the enlarged terminal ends be reduced in cross-section as needed.
In one aspect, the terminal ends are contemplated to be placed in a substantially straightened configuration by manipulating an inferior end portion of the particularmedical device300. In this way, themedical device300 can assume an enlarged profile for aid in reaching the target site and then take on a small profile for insertion into the target or for the purpose of simply taking up less room. The devices can therefore be employed to engage or gain access to an opening in a graft or other repair device, for example, so that a path can be made for assembling components embodying the graft or repair device in situ as previously described.
Another approach to accomplishing the in situ assembly of a repair device is shown inFIG. 15. This embodiment reduces or eliminates lateral movement of a guidewire within vasculature to thereby provide a more direct path acrosscavity space23 to a target. As with the use of retrograde and inferior flows, providing a more direct path by reducing lateral movement helps to compensate for difficulties associated with attempting three-dimensional procedures while observing the procedure via two-dimensional fluoroscopic techniques. These approaches also facilitate accomplishing the difficult task of hitting remote targets with free floating ends of elongate members. In one aspect of the present approach, an expandable member, for example, aballoon400 configured with aninterior pathway402 is placed inferior a target site incavity space23 or partially insidevessel430. In the scenario depicted in the figures, theballoon400 is providing apathway406 to acontralateral opening410 in arepair device412 that has been partially implanted at arepair site420.
Various devices can be provided to accomplish placement of anexpandable member400 adjacent to a target within vasculature. A system like that shown inFIG. 2 could be employed except thesnare target wire50 could be replaced with a tubular structure having a terminal end configured with aballoon400. In such an arrangement, the tubular structure would be placed in fluid communication with a conventional pump or syringe to achieve expansion of theballoon400. Alternatively, theballoon400 could be a terminal end of acatheter440 placed within thebranch vessel430 in line with thecontralateral opening410 or ultimate target. In yet other aspects, the expandable member can embody a permanent or temporary tampon structure such as collagen that is strategically placed to provide a path to the destination envisioned for an elongate guidewire or medical device.
Other methods and devices are contemplated to solve problems associated with in situ assembly. Several methods rely upon a second catheter placed in a second branch vessel to provide a stabilizing location upon which a first catheter placed in a first branch vessel may be temporarily secured while maneuvering a guidewire from the first catheter to a desired destination.
As shown inFIGS. 16 and 17, asnare catheter500 can be placed within vasculature and configured to extend from afirst branch vessel510 to amain vessel520. Thesnare catheter500 embodies an elongatetubular member540 having an internal lumen that slideably receives an elongate member or snare542 having a terminal end defining a loop orother capture structure544. Upon relative movement between the elongate member or snare542 and the elongatetubular member540, thecapture structure544 is placed in a position to engage or receive adelivery catheter560 carrying arepair device570, such as a bifurcated graft, that is placed to extend from asecond branch vessel550 to within themain vessel520.
In order to accomplish in situ assembly of repair device components or to gain access to a target, thesnare catheter540 further includes a marker (not shown) that aids in orienting thesnare catheter540 with the target. InFIG. 17, the target is shown as anopening572 in a limb of abifurcated graft570. The terminal end of thesnare catheter540 can be equipped with amarker580 that is aligned with a marker associated with theopening572 or other structure placed at the repair site. Once marker alignment is achieved, aguidewire590 is advanced through thesnare catheter540 to the desired destination. In one contemplated aspect, theguidewire590 is advanced through a second lumen formed in the snare catheter or is provided by way of tearaway structure of the snare catheter.
Upon placement of the guidewire at the appropriate destination, further components can be delivered to the repair site or further procedures can be performed using the guidewire as a platform. For example, as shown inFIG. 18, alimb component600 may be delivered and deployed inside theopening572, with thesuperior end614 of the limb component attached to the limb of thebifurcated graft570 and theinferior end616 anchored in thevessel510. To help guide the elongatetubular member540 and thecapture structure544 one or more asymmetric concentrically arranged balloon members can be incorporated into thesnare catheter500.
A crimped tubular leg graft, generally designated600, is shown inFIGS. 19 and 20, and may be used in connection with thebifurcated graft570 shown inFIGS. 16-18. The crimpedtubular legs600 ofFIGS. 19 and 20 each have atubular body612 with superior614 and inferior616 ends. There is asuperior cylinder618 located at thesuperior end614 of thetubular leg600 with a specific diameter including alock stent620 havinghooks621 to secure the tubular leg to the main limb implant, for example, at theopening572 inbifurcated graft570. Thetubular leg600 also includes acrimped cylinder622 with a plurality ofcrimps624 along a longitudinal axis, and an uncrimped flaredcylinder626. At theinferior end616 of thetubular leg600 is aninferior cylinder628 with a specific diameter including alimb stent630 and hooks634 for securing the tubular leg to the corporeal lumen, for example,first branch vessel510. The diameter of theinferior cylinder628 can vary in size depending on the size of the vessel where it will be located.
Referring toFIG. 19, atubular leg600 is shown where the diameter of theinferior cylinder628 is larger than the diameter of thesuperior cylinder618. Thetubular leg600 inFIG. 19 has a pattern from thesuperior end614 to theinferior end616, starting with thesuperior cylinder618 with thelock stent620, followed by the crimpedcylinder622, which leads to the uncrimped flaredcylinder626 that flares out to the larger diameter of theinferior cylinder628 with thelimb stent630. The diameter of the crimpedcylinder622 is essentially equal to the diameter of thesuperior cylinder618.
Referring now toFIG. 20, thetubular leg600 has aninferior cylinder628 with a diameter smaller than the diameter of thesuperior cylinder614. Thetubular leg600 inFIG. 20 has a pattern from thesuperior end614 to theinferior end616, starting with thesuperior cylinder618 with thelock stent620, followed by the uncrimped flaredcylinder626 that flares out toward the superior end and tapers down to the smaller diameter of the crimpedcylinder622 which follows, and leads into theinferior cylinder628 with thelimb stent630. The diameter of the crimpedcylinder622 is essentially equal to the diameter of theinferior cylinder628.
Thelock stent620 shown inFIGS. 19 and 20 is located internal to the graft material and is self-expanding with a series of caudal hooks orbarbs621 that extend throughrelief holes632 that are spaced around the circumference of thesuperior cylinder618 to correspond to the hooks orbarbs621. Thelock stent620 is attached to thesuperior cylinder618 using sutures such that the hooks orbarbs621 protrude through theholes632 when thetubular leg600 is compressed for delivery, thereby preventing the compressed hook orbarb621 from tearing the graft material. Thelock stent620 is designed to be attached to an inferior end of thebifurcated graft570 inside either the ipsilateral or contralateral leg. It is preferred that there are five hooks orbarbs621 equally spaced around thelock stent620, however the number of hooks can vary.
Thelimb stent630 is also self-expanding and is designed to be attached to the vessel wall to anchor theinferior end616 of thetubular leg600. Thelimb stent630 can be located internal to the graft material of theinferior cylinder628 as shown inFIG. 19, or it may be located on the exterior of the inferior cylinder as shown inFIG. 20, however it is preferred for the limb stent to be on the interior (internal to graft material) to aid in the apposition of graft material to the wall of the vessel for purposes of sealing the anastamosis. Thelimb stent630 is shown to have threehooks634 extending beyond theinferior end616 of the tubular leg, however any number of hooks may be used, and they may also be located inside theinferior cylinder628 and extending through relief holes.
Note that the hooks orbarbs621 at thesuperior end614 are angled in the inferior direction, which is the direction of blood flow in the vessel. This angling helps to ensure better attachment of thetubular leg600 to themain implant570. The barbs on theinferior end616 of the tubular leg point opposite to the blood flow. When thetubular leg600 is compressed for delivery, the hooks orbarbs621 and634 of thestents620 and630 are also at least partially compressed. In a preferred embodiment, the relief holes632 are pre-punctured using a hot pin to melt the graft material, or ultrasonically punched, allowing the five stent hooks621 to protrude through the graft material when thetubular leg600 is compressed for delivery. When thetubular leg600 is deployed within the ipsilateral or contralateral limb of amain implant570, thestent620 will expand, thereby causing thehooks621 to penetrate the graft material of themain body component570, forming a seal and anchoring thetubular leg600 within themain body component570. A balloon can also be used to set the hooks. A “tug” in the distal direction can also set the hooks.
Radiopaque markers633 are also disposed on the surfaces of thetubular legs600 as shown inFIGS. 19 and 20. In this embodiment, a pair ofmarkers633 are aligned longitudinally along thetubular leg600 and are attached to the crimped cylinder and the uncrimped flared cylinder. The alignment of twomarkers633 along the tubular graft is enough to show twists when the graft is viewed under fluoroscopy. An asymmetric pattern ofmarkers633 may also be disposed along thetubular graft600. The embodiments shown in the figures also includeradiopaque markers633 attached to thesuperior end614 of theleg600 and theinferior end616 of the leg to indicate under fluoroscopy where the ends of the tubular leg are located inside the vessel. The pair ofmarkers633 aligned on thetubular leg600 are spaced two crimps from each other, and about 7 mm-9 mm from the inferior edge of thelock stent620 to the first pair of radiopaque markers. The pair ofmarkers633 disposed on the uncrimped flaredcylinder626 nearest to thecrimped cylinder622 are spaced about 11 mm-13 mm from the nearest pair of markers located on the crimped cylinder. Although the figures show nine pairs ofmarkers633 aligned on thetubular leg600, the number may vary depending on the length of the tubular graft. The size of themarkers633 may vary and the location of the pairs of markers may also vary on thetubular legs600.
The above embodiments are used by visualizing the marker images under fluoroscopy during deployment of the implant. An operator can observe the relative position and/or movement of the marker images during the procedure to help ensure proper deployment of the implant. The marker patterns can also be viewed post procedure on a still image to see the orientation of the implant in the vessel.
As shown inFIG. 21, thesnare catheter500 may also include anexpandable member546 to aid in the precise positioning of theguidewire590 at the desired destination. With thecapture structure544 engaging thedelivery catheter560, theguidewire590 may be adjacent the delivery catheter rather than directly under the desired destination, for example theopening572 in the contralateral port of abifurcated graft570. Theexpandable member546, for example a balloon or equivalent means, facilitates displacing or deflecting the tip of the guidewire590 a given distance away from theadjacent delivery catheter560 so that it is precisely under theopening572.
With the tip of theguidewire590 positioned along the radial path of the center of theopening572, advancing the guidewire would likely facilitate rapid cannulation of the contralateral port. Even if the tip of theguidewire590 is not precisely positioned along the radial path of the center of theopening572, it is likely to be along the radial/orbiting path of the center of the opening such that torquable manipulation of thesnare catheter500 to rotate around and relative to the radial path of the center of the opening would precisely position the tip of the guidewire and facilitate rapid cannulation.
Since the contralateral port of thebifurcated graft570 is a relatively constant distance from thedelivery catheter560 placed in theipsilateral branch vessel550, theexpandable member546 may be designed to displace the tip of theguidewire590 that distance. It is further contemplated that theexpandable member546 may be slowly expanded and themarker580 utilized to monitor theguidewire590 tip in order to precisely position the tip relative to the marker associated with theopening572. In one embodiment, theexpandable member546 is positioned adjacent thesnare catheter500 such that inflation of the expandable member does not force the tip of theguidewire590 away from theopening572 and expansion of the member displaces only the guidewire tip.
When thedelivery catheter560 is placed in the second branch oripsilateral vessel550 such that it extends into themain vessel520 and therepair device570 is partially deployed, the target, for example theopening572 in the contralateral port, may still be a moderate distance from the delivery catheter. Cannulation of the contralateral port, a three-dimensional process, must be accomplished while viewed through a two-dimensional fluoroscope and, therefore, may not be accomplished in a timely manner.
As shown inFIGS. 22 and 23, thesnare catheter500 may includefins548 rather than theelongate snare542. In one aspect, thefins548 can be defined by loops or similar structures deployed under a thin compliant webbing or skin such as a web foot. In another aspect, thefins548 can be defined by partial hooked members that are heat set so that terminal ends of the hooked members return to a slightly spaced configuration for grabbing. In this way, thedelivery catheter560 need not pass through bothfins548 at any given stage. Additionally, thefins548 may be used to align thesnare catheter500 adjacent to thedelivery catheter560 in a fixed plane, thereby providing tactile constraints that reduce the alignment and orientation of theguidewire590 tip from a three-dimensional process to a two dimensional process. Manipulation of theguidewire590 tip is much easier as a two-dimensional process and cannulation of the contralateral port is simplified.
In one method of use, one of thefins548 is actuated such that it projects from thesnare catheter500 and the snare catheter is rotated until physical contact is made with thedelivery catheter560. At this point, rotation of thesnare catheter500 is partially restrained. Asecond fin548 is then actuated, the second fin designed to constrain or “saddle” thedelivery catheter560 between the two fins. Further actuation or manipulation of thefins548 may bring them closer together or further apart, thereby translating thesnare catheter500 further from or closer to thedelivery catheter560 and, by moderate or incremental rotation about the delivery catheter, the tip of theguidewire590 may be precisely oriented with theopening572. Thesnare catheter500 may also be advanced in the superior or inferior directions in order to bring theguidewire tip590 closer to or further from theopening572. Upon withdrawal of thedelivery catheter560, thesnare catheter500 can be retracted and removed from the repair site.
In one embodiment shown inFIG. 24, amulti-lumen snare catheter500 with an 0.035″ guidewire lumen may be used to pass parallelsuperelastic wires592,594 to be exposed through along skive596 and fixed at the superior end, causing the exposed wires to buckle out of the skive and project as two-dimensional fins548. The diameter or heat-set shape of thewires592,594 may vary such that modulating the amount of buckling (i.e. by retracting or extending the wires in the direction of the arrows inFIG. 24) may alter how close thefins548 allow thesnare catheter500 to come in proximity to thedelivery catheter560. It is contemplated that thewires592,594 may be covered or uncovered. It is further contemplated that thewires592,594 may be more mechanically actuated to project from thesnare catheter500 or more visceral in construction.
Thesnare catheter500 of the present invention may also be utilized to correct for angulation of a superior anchor stent (not shown) of arepair device570 due to a severely angulated neck in the aorta. As shown inFIGS. 25 and 26, adelivery catheter560 inserted in theipsilateral vessel550 may be up against thewall522 of the aorta and encounter a great deal of resistance if theneck524 of the aorta is severely angulated. If the superior anchor stent is released when thedelivery catheter560 is in such a position, the stent may not penetrate the lumen wall on both sides, thereby not properly anchoring therepair device570.
A snare catheter, inserted in thecontralateral vessel510, may be used by the physician to straighten thedelivery catheter560, thereby correcting for the angulation of theneck524 prior to deploying the superior anchor stent of therepair device570. Thesnare catheter500 has ahousing tube592 with acapture structure595 at the superior end. Thecapture structure595 may be similar to thewire loop544 illustrated inFIG. 16, except that the ends are free and lockable, such as with a clip. Alternatively, thecapture structure595 may be a two-part ring similar to forceps in any of the described embodiments. Additionally, aspects of the various embodiments of snares can be combined. It is contemplated that thehousing592 may include a dual or tri-lumen, thereby allowing for a guidewire lumen.
In one method of use, thesnare catheter500 may be inserted into the body through the first orcontralateral branch vessel510 and thecapture structure595, in the form of a wire with free ends, expanded in themain vessel520. Thedelivery catheter560 may then be inserted into the body through the second oripsilateral branch vessel550 and through thecapture structure595. Thecapture structure595 may then be tightened and the free ends locked together. With thedelivery catheter560 secured to thesnare catheter500, the physician may correct for angulation of the delivery catheter by manipulating the inferior end of the snare catheter, thereby straightening the delivery catheter prior to deploying the superior anchor stent. Once the superior anchor stent is deployed and seated properly in the vessel walls, the free ends of thecapture structure595 are loosened and the wire that embodies the capture structure may be pulled out of thesnare catheter500 to release thedelivery catheter560.
Another method and device contemplated to solve problems associated with in situ assembly departs from the aforementioned methods and devices in that a snare catheter is inserted into a first port of the repair device in order to snare a guidewire inserted into the second branch vessel. The snare catheter is part of a first catheter inserted into the first branch vessel and the guidewire inserted into the second branch vessel is snared and brought into a second port of the repair device. A second catheter may then be inserted into the second branch vessel over the guidewire in order to deploy a limb within the second port of the repair device.
Referring now toFIGS. 27-33, a device and a method are described for accomplishing the cannulating of a contralateral opening of a modular abdominal aortic aneurysm endovascular graft implant utilizing a snare catheter inserted from the ipsilateral side. The disclosed system can be used anywhere in a patient's vasculature for the assembly of any repair device by altering the dimensions thereof. As shown inFIG. 27, arepair system730 includes an elongatemain catheter732 having an inferior portion (not shown) and asuperior portion736. The main catheter further includes a multi-lumeninner catheter733 having an inferior portion (not shown) and asuperior portion737. Therepair system730 has atubular jacket738 which is sized to slide over themain catheter732 and implant (not shown). The jacket738 (shown retracted) is used to provide thesystem730 with a profile suitable for advancement within vasculature. At a repair site, thejacket738 is retracted to expose thesuperior portion737 of theinner catheter733, the various components thereof, and a first modular component (shown deployed inFIG. 30).
Thesuperior portion737 of theinner catheter733 includes a terminal end configured with atapered nosecone741 and a generallyblunt jacket guard740 which mates with thejacket738 when thesystem730 is assembled for advancement through vasculature. Thejacket guard740, taperednosecone741 andjacket738 define an atraumatic superior end. Theinner catheter733 further includes a repair device or modular endovascular graft mounting or receivingportion742 as well as arelease wire port744. Therelease wire port744 is designed to provide an opening for a release wire (not shown) that can be configured to maintain a repair device (or implant) on theinner catheter733 in a compressed condition upon jacket retraction, then subsequently released to allow the repair device to expand and seal. Thesystem730 can also be equipped with an expandable member such as a balloon (not shown).
Thedelivery system730 further includes asnare lumen750 and apivot guide755. Thepivot guide755 is located on theinner catheter733 betweenmain catheter736 andrelease wire port744. Thepivot guide755 receives thesnare lumen750 and guides it over a broad curve such that the snare catheter may be directed from the ipsilateral port63 of the implantedrepair device60 over thebifurcation64 and out thecontralateral port66.
Thesnare lumen750 has a first end (not shown) that extends from outside the patient at the inferior portion of themain catheter732 and may be advanced in the superior direction such that asecond end751 extends out of thesuperior portion736 of the main catheter. Thesnare lumen750 may be located in the gap between themain catheter732 andinner catheter733 and is configured to slideably receive asnare754. In a preferred embodiment, themain catheter732 is a dual lumen catheter, thereby providing a main port for theinner catheter733 and a second port for thesnare lumen750.
As illustrated in greater detail inFIGS. 28 and 29, thepivot guide755 is attached to theinner catheter733 at apivot point763 and may be rotated (or oriented) from a substantially parallel position to a substantially perpendicular position relative to theinner catheter733. Astop765 limits the rotation of the swivelingguide755.
In operation, the swivelingguide755, preferably in the shape of an elbow, facilitates sliding thesecond end751 of thesnare lumen750 into thefirst end757 of the swiveling guide such that it extends therethrough and protrudes out thesecond end759 of the swiveling guide. However, the swivelingguide755 andsnare lumen750 are also adapted such that the swivelingguide755 restrains thesecond end751 of thesnare lumen750 from being retracted completely therefrom once the snare catheter is inserted. In this way, thesnare lumen750 acts upon the swivelingguide755 to control the relative position of the swiveling guide with respect to theinner catheter733 once it is inserted therethrough.
It is contemplated that thesecond end751 of thesnare lumen750 may have a taper or a localized narrowing in diameter and the swiveling guide may be formed from a material that allows the second end of the snare catheter to be easily inserted into thefirst end757 of the swiveling guide and advanced therethrough while restraining the snare lumen from being retracted in the inferior direction and completely back out of the first end of the swiveling guide. It is further contemplated that the swivelingguide755 may be adapted such that thesecond end751 of thesnare lumen750 may be retracted inside thesecond end759 of the swiveling guide but not out thefirst end757. Thesnare lumen750 may also have a second localized expanding or funneling in diameter (not shown) at an inferior position such that when the snare lumen is inserted into the swivelingguide755, the second localized rise in diameter acts upon thefirst end757 of the swiveling guide to rotate it in a clockwise direction.
Turning now toFIGS. 30-33, a method utilizing therepair system730 is described. It is contemplated that therepair system730 may be adapted to use “off the shelf” snare catheters having dimensions from 3 Fr. to 12 Fr.
In a typical implant scenario, thedelivery system730 carrying a first endovascularcomponent repair device60 is advanced within vasculature to arepair site22 and thejacket738 is withdrawn far enough for thesuperior end62 of the repair device to be deployed and both thecontralateral port66 andipsilateral port67 of therepair device60 to open. Thesuperior end62 of therepair device60 may be self-expanding upon withdrawing a release wire (not shown) or expanded by a balloon (not shown) to thereby be implanted in the region of therepair site22. In the delivery configuration, thesnare lumen750 is retracted in the inferior direction and the swivelingguide755 is substantially parallel to theinner catheter733.
Thesnare lumen750 is then advanced in the superior direction and through the swivelingguide755 as illustrated inFIG. 31. Thesnare lumen750 causes the swivelingguide755 to rotate clockwise until thestop765 prevents further rotation. In this configuration, the swivelingguide755 is substantially perpendicular to theinner catheter733 and causes thesnare lumen750 to be advanced over thebifurcation64 of therepair device60 and out thecontralateral port66.
With further reference toFIG. 31, aguidewire800 is then advanced through the contralateraliliac vessel21 and thesnare754 is advanced out of thesnare lumen750. Thesnare754 captures theguidewire800.
Thesnare lumen750 is then retracted in the inferior direction, as shown inFIG. 32, such that it pulls theguidewire800 into thecontralateral port66 of therepair device60. In this configuration, further movement is restrained by the swivelingguide755. Thesnare lumen750 may have a marking on the inferior portion that protrudes outside the patient at the inferior portion of themain catheter732 such that the physician can determine when the snare catheter has been advanced to the point where the swivelingguide755 restrains further movement in the inferior direction. Alternately, the physician may retract the snare catheter until he feels increased resistance to further movement. Furthermore, it is contemplated that thesnare lumen750second end751 and swivelingguide755second end759 may have radiopaque markers such that their relative locations may be detected under fluoroscopy.
Once thesnare lumen750 has been advanced in the inferior direction such that further movement is restrained by the swivelingguide755, the snare catheter will operate on the swiveling guide such that the swiveling guide pivots counter clockwise until thestop765 prevents further rotation. In this configuration, the swivelingguide755 is again substantially parallel to theinner catheter733, similar to the configuration illustrated inFIG. 30. Thesnare lumen750 is then fixed to theinner catheter733 shaft by a mechanism at the inferior end of the inner catheter (not shown). If desired, theinner catheter733 andsnare lumen750 may be retracted in the superior direction in order to pull theguidewire800 across thebifurcation64 of therepair device60. Once theguidewire800 is positioned as desired, thesnare754 is released.
With the swivelingguide755 substantially parallel to theinner catheter733 and thesnare lumen750 fixed to the inner catheter, the inner catheter may be retracted into themain catheter732 as illustrated inFIG. 33. The substantially parallel position of the swivelingguide755 facilitates removal of the inner catheter from therepair device60 through theipsilateral port67. Deployment of the contralateral limb utilizing a catheter inserted into the contralateral vessel over theguidewire800 may then be accomplished by methods known in the art.
It is contemplated that therepair system730 may be utilized in any surgical procedure where it is desired to insert a snare catheter into a vessel and have the snare catheter guided over a broad curve such that it faces the direction of the physician while maintaining control of the location of the inferior end of the snare catheter.
Thus, it will be apparent from the foregoing that, while particular forms of the invention have been illustrated and described, various modifications can be made without departing from the spirit and scope of the invention. For example, the repair device can take on any contemplated form and the disclosed systems can be used to assemble components or hit targets in any area of vasculature. Accordingly, it is not intended that the invention be limited, except as by the appended claims.