Patent Description:
Stenting of the carotid artery (CA) is relatively new to interventional procedures. It is a challenging procedure because accessing the left or right carotid artery can be dependent on the anatomical disposition of the aortic arch.

<FIG> illustrates the aortic arch. As shown in <FIG>, the aorta <NUM> includes an aortic arch region <NUM>, a descending aorta <NUM>, and an innominate <NUM>. Three types of arches shown in <FIG>: Type I, Type II and Type III arches. Also shown in <FIG> is the right subclavian artery (RSA) <NUM>, left subclavian artery (LSA) <NUM>, right common carotid artery (RCCA) <NUM> and left common carotid artery (LCCA) <NUM>.

The arch types are defined by the height of the top of the aortic arch <NUM> from the base location where the innominate <NUM> attaches to the aorta. In a type I arch, the height is less than the diameter of the common carotid artery (CCA). Similarly, in a type II arch, the height of the top of the arch <NUM> from the base of the innominate <NUM> is of the order of <NUM> to <NUM> times the diameter of the CCA. In a type III arch, the height is more than twice the diameter of the CCA. As the height of the arch increases the procedures within the carotid arteries become more and more difficult due to the tortuous nature of the arterial connections to the aorta at the arch.

In type III hostile aortic arches, the angle of origin of the innominate artery or left common carotid artery can be very acute thus making the access of the left or right carotid arteries ostium difficult. This access is needed for endovascular stroke intervention for placement of stents as well as other intracranial arterial interventions, such as aneurysm repair. Subsequent placement of a stent delivery system or other interventional repair devices in a stable mode into the tortuous arterial system above it therefore becomes more difficult. The stenting and other interventional procedures itself are meant to re-establish a more normalized blood flow through the carotid and internal carotid artery into the brain by opening up regions of the artery constricted by plaque deposits which inhibit flow or by eliminating aneurysms that can burst and lead blood thereby starving the brain of oxygen.

The stents themselves can be self-expanding, balloon expandable, bio-absorbable, and/or covered. The stent delivery systems are designed to accommodate very acute bends but are reliant upon the guide catheter and guide wires and or embolic protection devices to stabilize them during deployment. Stents have been used to open "stenosis"- semi-occluded sections of the arterial system - for many years. They come in a wide variety and are designed for specific areas of the body, these include: balloon expandable, self-expanding, covered and bio-absorbable stents. Stenting in the neck and procedures above the neck are challenging when confronted with a type III hostile aorta, in particular stenting of the left or right carotid artery. During the insertion, manipulation and stabilization of the stent delivery mechanism and during removal of the guide wire and secondary wire, injuries to the subclavian artery and the tortuous aortic arch can happen. This can be caused by uncontrolled collapse of the sheath, embolic protection device (EPD) and stent / stent delivery system in the ascending aorta during procedure. This type of prolapse can result in the patient suffering cerebral embolism or stroke by dragging the fully deployed EPD over the carotid stenosis. Further, dragging the guide wires over the tortuous arterial regions can cause cutting into the arterial walls or otherwise injuring the artery resulting in dissections and trauma to the vessels involved. These traumas can be dangerous to the patient as they can ultimately directly affect blood flow by leakage at the dissections or by creating accumulation of thrombus, an organization of blood cells, which is a natural reaction to vessel injury. These may require additional procedures to repair and heal the damaged artery walls and prevent problems.

Similarly in the case of endovascular stroke interventions and other types of arterial interventions, such as aneurysm repair, some of the devices used are relatively stiff (e.g. the flow diverters used in wide necked aneurysm repair) and can push the sheath and device itself out of its location and the intracranial vascularity, creating major complications.

Patent document <CIT> describes a percutaneous intervention system comprising a bifurcated catheter comprising a proximal end and a distal end having at least a pair of lumens, wherein a stabilization wire is slidably insertable through the stabilization lumen and configured to be captured by a snare. The catheter has a working lumen that can be used to deliver and position a wide variety of interventional tools.

Even with the stabilization methods and systems described in background art, there is still the problem due to the need for stiff catheters and wires that are to be used to access the ostium of the tortuous vessels where treatment, such as stenting, has to be carried out. This is especially true in the case of acute type III aortic arches, which have to be navigated through, to access the carotid artery for above the neck procedures. Due to the tortuosity of the vessels originating from the aortic arch, the guiding catheter or sheath (even with a guidewire in place) can be unstable and as a result can "flip out" into the aortic arch during carotid stent delivery.

The invention proposes a percutaneous intervention system for a carotid percutaneous intervention of the vessels originating from a tortuous aortic arch as set out in claims <NUM> to <NUM>. Embodiments of the invention are directed to ways to access and stabilize the sheath, the EPD and the stent delivery system within the tortuous arterial system, such as the carotid arterial system, using softer wires and catheters, without undue pushing from one end, to reduce the injuries caused to the arterial walls during stenting and other minimally invasive treatment of the carotid arteries and above the neck procedures.

The percutaneous intervention system of the invention includes a bifurcated catheter comprising a first procedural lumen and a second stabilization lumen, the bifurcated catheter comprising a proximal end and a distal end; a procedural catheter slidably insertable through the first procedural lumen, the procedural catheter configured to be delivered to a treatment site within a carotid artery for a treatment procedure; a stabilization cathether comprising a wire having a snare at the end configured to be inserted via a second percutaneous access; the stabilization wire is configured to be captured by the snare and to exit at the proximal end of the stabilization catheter, to provide the end-to-end tension stabilization; and the stabilization wire is lockable at one end to the proximal end of the bifurcated catheter using a first locking mechanism and the other end of the stabilization wire is lockable to the proximal end of the stabilization catheter by a second locking mechanism to enable the bifurcated catheter to be pushed from the proximal end and pulled from the distal end by the stabilization wire during delivery of the procedural catheter to the treatment site within a carotid artery.

The first percutaneous access may be a groin access.

The stabilization wire is slideably inserted through the first percutaneous access to extend through the stabilization lumen of the bifurcated catheter to be captured by a snare from a stabilization catheter, inserted via a second percutaneous access, to exit at the proximal end of the stabilization catheter, providing an end to end tension and stabilization capability.

The stabilization wire is locked to the proximal end of the bifurcated catheter on one end, and the stabilization wire is locked to the proximal end of the stabilization catheter on the other end, enabling the bifurcated catheter to be pushed from its proximal end, and pulled from its distal end by the stabilization wire, during delivery of the procedural catheter to the treatment site.

The percutaneous system may be configured to enable easy placement of the procedural catheter at the treatment site within a carotid artery through a type-III aortic arch using the push-pull configuration. The procedural catheter may be configured for stenting and treatment of problems within the carotid artery. The percutaneous intervention system may be configured for treatment of at least one of contralateral lower extremity peripheral arterial disease, renal disease, cancer, and spenic arterial disease. The procedural catheter may be configured for at least one of a steep aortobifemoral bypass graft, renal intervention, SMA, stenting, and cancer hepatic embolization.

The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate one or more examples of embodiments and, together with the description of example embodiments, serve to explain the principles and implementations of the embodiments.

The following <FIG>, <FIG>, <FIG>, <FIG> are not according to the invention and are present for illustration purposes only.

Embodiments of the invention are directed to new devices for the placement of stents in the carotid artery, and especially into the left or right carotid arteries, for procedures above the neck. These new devices stabilize the working lumen or delivery sheath for the carotid stent delivery system. These new devices also protect the innominate and subclavian artery as well as the aortic arch from trauma during stenting and other procedures above the neck where there is a possibility for trauma to the arteries as a result of tension on the secondary or stabilization guidewire. This is especially true in the case of patients with type II and Type III aortic arch.

Embodiments of the invention are directed to the application and use of guide wires for stabilization of the catheters used to access the left or right carotid arteries (CA) for carotid percutaneous intervention of the vessels originating from a tortuous aortic arch.

Embodiments of the invention use a bifurcated catheter having a main catheter arm that is used to extend into the region of the procedure and a support catheter arm that extends into the right subclavian artery to provide protection to that vessel during tightening of a support and stabilization wire through the right subclavian artery. The head of a sheath/ guide catheter is at that time placed in the aorta, at the branching of either innominate or the left or right carotid artery through which the procedural arm of the bifurcated catheter, that is the second branch of the bifurcated catheter, has to be extended to conduct the procedure or place the stent. The correct placement of the head of the sheath catheter and the extension of the support catheter to cover the support wire enable the wires to be extended and retracted without damage to the arch and the arterial vessels used during procedure.

In some embodiments, the bifurcated catheter includes a main catheter that divides into two separate catheters forming a "Y" shape. One leg of the bifurcated catheter has a smaller diameter with a smaller working lumen (inner diameter) to carry the stabilizing wire and the second leg of the bifurcated catheter has a larger working lumen for arterial stenting operations/procedures. This bifurcated catheter addresses the percutaneous intervention related trauma to the vessels that arise from type-II or type-III hostile aortic arches, from uncontrolled prolapse of the sheath, embolic protection device and stent delivery system, by stabilizing the systems, using a through-and-through stabilization wire for applying tension during stenting of the left and right carotid arteries.

Similar to type III aortic arches, tortuosity due to a bovine arch (origin of left common carotid artery from the innominate artery rather than directly from the aortic arch), tortuosity of the common carotid artery and even internal carotid artery (including angulated takeoff of the internal carotid artery) may be quite amenable to the disclosed unique sheath system. In addition, standard technique depends on placing a stiff wire in the external carotid artery for support to advance the sheath into the distal common carotid artery. The sheath described herein circumvents the need for an external carotid artery access which is otherwise crucial for the standard technique. Also, the device, due to its unique stability, may also allow larger caliber proximal protection devices (which depend on reversal of internal carotid flow during stenting to prevent cerebral embolization) to be deployed more easily. Similarly, the bifurcated catheter is useful in complex or hostile aortic bifurcation application and visceral interventions.

In one embodiment, a sheath catheter is percutaneously inserted at the groin and directed through the descending aorta to the aortic arch. A snare is inserted through the sheath and linked with a <NUM> (. <NUM> inch) or <NUM> (. <NUM> inch) guide wire from the right subclavian artery (via the right radial or brachial artery access) to provide a stabilization wire for the operational catheter. At this stage, the stabilization wire and the main guide wire occupy the sheath catheter. A reverse curve catheter is then inserted through the sheath catheter over the main guide wire, parallel to the stabilization wire and guided to the common carotid artery from the aortic arch. A stiff guide wire is then inserted through the reverse catheter to the location of the procedure. The reverse curve catheter is then removed leaving the guide wire in the location of the procedure. The bifurcated catheter is then guided to the aortic arch with one stabilization leg over the stabilization wire and the other operational leg over the stiff guide wire such that the operational leg is guided into the common carotid artery while the stabilization leg is guided over the stabilization wire into the subclavian artery. The stiff guide wire is then removed leaving the operational leg of the bifurcated catheter in place for treatment procedures.

In one embodiment, a secondary stabilization wire having a small diameter, e.g., <NUM> or <NUM> (. <NUM> inch), is guided through a, for example, Fr-<NUM> or Fr-<NUM>, micro sheath, which is placed percutaneously through the right radial or brachial artery and threaded through the subclavian artery and snared into the main guide catheter to stabilize the distal tip. This way, the tension can be applied to the distal tip of the guide catheter to stabilize it in a more planar orientation by putting tension on the stabilization wire, as discussed above, to aid in the stabilization of the guide catheter, which is placed under fluoroscopy (C Arm) in the aorta using percutaneous access. This secondary stabilization wire is hence inserted into the right radial or brachial artery and guided through the right subclavian artery and down and out of the guide catheter. Though the description is provided for the secondary access via the right radial of brachial artery, it should not be considered limiting. It is possible to provide the secondary access via the left radial or brachial artery, external carotid artery or common carotid artery (instead of just the right radial or brachial artery). It may also be possible to have more than one accessory access to complete the procedure using the device. Once the stabilization wire is established, a tension is applied to one or both ends of the secondary stabilization wire to help stabilize the distal end of the guide catheter during the accessing of the left or right internal carotid artery. This allows the stent delivery system to track more easily through the acute anatomy of the arch, especially one such as a type III arch.

In another embodiment, the bifurcated catheter is pre-loaded into the end of the main guide catheter or long sheath. In this embodiment, the bifurcated catheter has a procedural lumen and a second lumen that can accommodate a snare catheter and wire. It will be appreciated, however, that a potential disadvantage of this device is that the catheter will need to be a bigger device to accommodate the two lumens, but the advantage is that it separates the wires from the beginning so that the wires do not inadvertently wrap around each other during the procedure and cause problems. In this embodiment, the guide catheter is provided with a bifurcated distal configuration having two legs in the form of a Y at the distal end. One leg is of a large diameter, typically having an inner diameter or "working lumen" sufficient to allow the passage of a stent delivery system or other therapeutic devices. The second leg is of a smaller diameter than the first leg with an inner diameter sufficient to accept a snare wire and snare the stabilization guide wire. This bifurcated catheter is sized so as to fit easily through the main guide catheter placed at the start of the procedure and is of sufficient length so as to allow the main leg of the bifurcated catheter to be placed into the carotid artery for stenting and other procedures there and above the neck. The secondary leg is of sufficient length so as to be placed over a stabilization wire from the right subclavian artery and cover it sufficiently to prevent damage to the vessels it passes through while providing the necessary stabilization to the main guide catheter and the bifurcated catheter, during procedural manipulations. Both legs of the bifurcated catheter need not be of the same stiffness or durometer to be able to navigate their respective vessels. For instances the main carotid leg may be of a lesser durometer so as to navigate the arch into the selected carotid artery without affecting the natural anatomic configuration whereas the small leg may be stiffer so as to help with the stabilization of the main guide catheter.

Embodiments of the invention are directed to new devices for the placement of stents in the carotid artery, and especially into the left or right carotid arteries, for procedures above the neck. These devices stabilize the working lumen or delivery sheath for the carotid stent delivery system. These devices also protect the innominate and subclavian artery as well as the aortic arch from trauma during stenting and procedures above the neck where there is a possibility for trauma to the arteries as a result of tension on the secondary or stabilization guide wire. This is especially true in the case of patients with type II and Type III aortic arch. Embodiments of the invention use a bifurcated catheter having a main catheter arm that is used to extend into the region of the procedure and a support catheter arm that extends into the right subclavian artery to provide protection to that vessel during tightening of a support and stabilization wire through the right subclavian artery. The head of a sheath/ guide catheter is at that time placed in the aorta at the branching of either innominate or the left or right carotid artery through which the procedural arm of the bifurcated catheter (i.e., second branch of the bifurcated catheter) has to be extended to conduct the procedure or place the stent. The correct placement of the head of the sheath catheter and the extension of the support catheter to cover the support wire enable the wires to be extended and retracted without damage to the arch and the arterial vessels used during procedure.

In one embodiment, another practical device and method for safely accessing the carotid artery is disclosed. In this embodiment, a first reverse curve catheter is inserted percutaneously and directed into the right or left common carotid artery (RCCA or LCCA). A secondary wire is inserted in the reverse curve catheter and out of a hole in the catheter at the location of the arch to be captured by a snare wire that is extended out of a protective sheath extended through the subclavian artery (typically via right radial artery access). Once the snare has captured the stabilization wire a more rigid guide wire is extended through the reverse catheter into the common carotid artery towards the location of the procedure. The reverse catheter is then removed leaving both the rigid guide wire and the stabilization wire in place. A sheath/ procedural catheter with a conical atraumatic tip and also having therein a second chamber with a hole close to the distal end for providing an exit for the stabilization wire is advanced over the guide wire and stabilization wires to the aortic arch and the sheath catheter is extended on to the location of procedure. Tension is applied to the stabilization wire for providing support to any working catheter that is inserted through the sheath catheter after removal of the stiff guide wire for conducting the procedure as needed.

In some embodiments, a sheath cover may be used for the stabilization wire as it extends into the subclavian artery when tension is applied prevent unwanted damage to the artery. The stabilized main sheath helps the procedure to be completed and the operational catheter and the sheath catheter to be removed safely.

In some embodiments, a reverse curve guide catheter with a lumen large enough for stenting is used to select the common carotid artery. A secondary wire is inserted in the reverse curve catheter through a parallel lumen in the reverse curve catheter and out of a hole in the catheter at the location of the arch. This secondary wire is then captured by a snare wire with a loop that is extended out of a protective sheath extended through the subclavian artery, typically inserted via right radial artery access. The carotid stenting procedure can now proceed in the standard way described above since the reverse curve guiding catheter itself is stabilized and is usable for procedure.

Further to the above, the bifurcated catheter is ideal for providing stabilization to the procedural catheters used in treatment of contralateral lower extremity peripheral arterial disease with a complex or hostile aortic bifurcation (due to a fixed and narrow aortic bifurcation, iliac stenosis, ectasia, or tortuosity, aneurysm of the distal aorta, previous iliac stenting, previous endovascular aneurym repair and previous aortofemoral/aortoiliac bypass grafting) using bilateral groin access. In addition, the stabilized sheath and operational catheters are optimal in use of super long sheath procedures that require pushability, especially in the case of obese patients requiring procedures below the knee. These and other exemplary embodiments are described below.

In percutaneous procedures of the vessels originating from a tortuous aortic arch, the use of stabilization wires in addition to guide wires to guide and stabilize the delivery catheters used to access the left or right carotid arteries is disclosed. The need for the stabilization of the sheath, the embolic protection device (EPD) and the stent delivery system (SDS) is to prevent the uncontrolled prolapse of the sheath, EPD and SDD during stenting procedure in the ascending aorta. This type of prolapse can result in cerebral embolism or stroke in patients by the dragging of the fully deployed EPD across critical carotid internal artery stenosis. Embodiments of the invention provide for stabilizing the sheath, the EPD and the SDS within the left or right carotid arteries by providing a secondary stabilization wire that holds the primary sheath in place within the tortuous aortic arch during the procedure, thereby providing the necessary stability for the SDS within the carotid artery during the procedure. These stabilizing wires typically originate from a low profile radial or brachial artery access and provide a through-and-through tension and support to the sheath by enabling the application of tension to one or either end of the stabilization wire through a typical micro-sheath or catheter. In this embodiment the brachial artery or a small radial artery is usable with the micro-sheath, and similarly in the case of another embodiment described the sheath catheter is used to puncture the radial artery or the brachial artery for entry, to provide adequate hemostasis while keeping the entry profile low. In one embodiment, the stabilization wire has a small diameter, e.g., <NUM> or <NUM> (<NUM> or <NUM> inch) diameter, the micro-sheath has a <NUM> Fr. Diameter, and the sheath catheter has a <NUM> Fr. The use of the small size wire and micro-sheath is useful in preventing hematoma in the brachial artery, which can be devastating in patients receiving anticoagulation drugs, such as Heparin, and anti-platelet therapy such as Plavix, during or after the procedure. The stabilizing wire from the brachial artery enters the aortic arch through the right subclavian artery to be captured and brought out through the sheath at its proximal end. Due to their diameter and forces applied during the procedures, the guide wires, if used without proper covering can inadvertently cause trauma to the associated tortuous vessels walls. The bifurcated catheter disclosed herein provides the necessary protection to the arch and the subclavian artery while providing the necessary stabilization to the sheath, SDS and EPD for access and procedures within the carotid arteries, especially for above the neck procedures. The bifurcated catheter disclosed includes a main catheter that divides into two separate catheters forming a "Y" shape. One leg of the catheter has a smaller diameter with a smaller working lumen (inner diameter), to carry the stabilizing wire, than the second leg of the catheter that has a larger working lumen for arterial stenting operations. This device provides the necessary stability to the system for stenting of the carotid arteries while addressing the percutaneous intervention related trauma to the vessels associated with type-III hostile aortic arches that arise therefrom. Multiple embodiments of the invention are described here under. Even though in the examples described the secondary access is shown as being established via the right radial or brachial artery, it should not be considered limiting in any way. The secondary access may be established via any of the left radial or brachial artery, external carotid artery or common carotid artery (instead of just the right radial or brachial artery). It may also be possible to have more than one accessory access to complete the procedure using the device.

A first embodiment of the invention is described with reference to the schematic diagrams shown in <FIG> and the flow chart of <FIG>. This embodiment illustrates the ability to conduct procedures such as stenting in the left internal carotid artery (LICA) <NUM> using a procedural catheter that can be inserted through the aortic arch <NUM> and left common carotid artery <NUM>.

As shown in <FIG>, a sheath catheter <NUM> is initially inserted percutaneously and guided using fluoroscopic tracking using the opaque metal ring <NUM> at its distal end. In one embodiment, the sheath catheter <NUM> is a <NUM> French (Fr) or <NUM> Fr sheath; it will be appreciated that differently sized sheath catheters may be used as known to those of skill in the art. The sheath <NUM> is guided through the femoral artery and the descending thoracic aorta <NUM> to the aortic arch <NUM>. A snare wire is inserted through the sheath <NUM> and extended to the aortic arch <NUM> with a snare loop <NUM>. In one embodiment, the snare loop has a diameter that is any value or range of values between about <NUM> to <NUM>; it will be appreciated that the diameter may be less than about <NUM> or greater than about <NUM>.

A second stabilization wire <NUM> is inserted through the radial artery and guided through the subclavian artery <NUM> to the aortic arch <NUM>. In one embodiment, the second stabilization wire has about a <NUM> (<NUM> inch) diameter. The stabilization wire <NUM> is captured by the snare <NUM> and then pulled into the sheath catheter <NUM>, as shown in <FIG>. In one embodiment, the snare <NUM> pulls the stabilization wire such that it exits the proximal end of the sheath <NUM> to form a through-and-through stabilization wire. In one embodiment, a <NUM> Fr. to <NUM> Fr. sheath may be used over the <NUM> (<NUM> in) stabilization wire <NUM> to reduce slicing and trauma to the arteries the wire is guided through.

A reverse curve catheter <NUM> with an atraumatic tip is then inserted in parallel with the stabilization wire <NUM> through the sheath catheter <NUM>, as shown in <FIG>. The reverse curve catheter <NUM> is used to select the left common carotid artery <NUM>. A stiff wire <NUM> is then inserted through the reverse curve catheter <NUM> to the site of the procedure. In one embodiment, the stiff wire has an approximately <NUM> (<NUM> inch) diameter.

Next, the reverse curve catheter <NUM> is removed, leaving the stiff wire <NUM> in the area of the procedure and the stabilization wire <NUM> in place, as shown in <FIG>. Both the stiff wire <NUM> and stabilization wire <NUM> occupy the large sheath catheter <NUM>, as shown in <FIG>.

A bifurcated catheter having bifurcations <NUM> and <NUM> is then advanced over both the stiff wire <NUM> and the stabilization wire <NUM> respectively and out of the guide catheter <NUM>. The large leg (or bifurcation) <NUM> which contains a procedural catheter tracks along the stiff guide wire <NUM> into the left common carotid artery <NUM>. The small leg (or bifurcation) <NUM> tracks along the stabilization wire <NUM> coming from the right subclavian /innominate artery. Both legs <NUM>, <NUM> have atraumatic tips <NUM> to reduce trauma, as shown in <FIG>.

<FIG> is a cross-sectional view of a portion of the bifurcation catheter within the sheath catheter <NUM>. The bifurcation catheter includes a common catheter portion that bifurcates into two separate bifurcations or legs <NUM>, <NUM> at junction <NUM>. As shown in <FIG>, each of the bifurcations of legs <NUM>, <NUM> include lumens that extend from a distal end of the bifurcation catheter to a proximal end of the bifurcation catheter. As shown in <FIG>, the bifurcated leg <NUM> is configured to slideably receive the guidewire <NUM>, and the bifurcated leg <NUM> is configured to slideably receive the stabilization wire <NUM>.

Once the bifurcated catheter is in place, the stiff wire and the atraumatic tips are removed and tension is applied to the stabilization wire from both ends to stabilize and position the operational end of the bifurcated catheter, as shown in <FIG>.

The bifurcated catheter is now ready for stenting or other procedures in the left internal carotid artery <NUM>.

<FIG> illustrates the process 800A described above with reference to <FIG>.

The process 800A begins by inserting a sheath catheter <NUM> catheter through the groin access and guided using radiographic imaging using the opaque ring <NUM> at its distal end through the descending aorta <NUM> to a location in the aortic arch <NUM> suitable for access into the left common carotid artery <NUM> (block S801A).

The process 800A continues by inserting and advancing a snare wire through the sheath catheter <NUM> and out its distal end into the aortic arch <NUM> (block S802A).

The process 800A continues by inserting a second stabilization guide wire <NUM> through the radial artery and guiding it through the right subclavian artery <NUM> to the aortic arch <NUM> (block S803A).

The process 800A continues by using the snare loop <NUM> of the snare wire to capture the guide wire <NUM> and pull it through the sheath catheter <NUM> to its proximal end to provide an end-to-end stabilization wire over which tensions can be applied (block S804A).

The process 800A continues by advancing a reverse curve catheter <NUM> up the lumen of the sheath catheter <NUM> and into the left common carotid artery <NUM>, again using the opaque ring <NUM> at its distal end (block S805A).

The process 800A continues by advancing a reasonably stiff guide wire <NUM> up the reverse curve catheter <NUM> and into the left common carotid artery <NUM> to the location of the procedure near the left internal carotid artery <NUM> (block S806A).

The process 800A continues by removing the reverse curve catheter <NUM>, leaving the stabilization wire <NUM> and the stiff guide wire <NUM> in place, both occupying the lumen of the sheath catheter <NUM> (block S807A).

The process 800A continues by inserting a bifurcated catheter having a main operational leg <NUM> over the stiff guide wire <NUM> and having a stabilization leg <NUM> over the stabilization wire <NUM> (block S808A).

The process 800A continues by advancing the bifurcated catheter having atraumatic tips <NUM> on the end of the main operational catheter leg <NUM> to the aortic arch <NUM> through the sheath catheter <NUM> (block S809A).

The process 800A continues by advancing the main operational leg <NUM> to the location of the procedure by advancing the main operational catheter leg <NUM> over the stiff wire <NUM> (block S810A).

The process 800A continues by extending the second leg <NUM> of the bifurcated catheter over the stabilization wire <NUM> through the innominate and the subclavian artery <NUM> (block S811A).

The process 800A continues by removing the stiff wire <NUM> and the atraumatic tips <NUM> and applying tension to the stabilization wire <NUM> to stabilize the working lumen leg <NUM> at just below the left internal carotid artery <NUM> (block S812A).

The process continues by performing any treatment procedure, including stenting of the left internal carotid artery <NUM>, through the main operational catheter leg <NUM> (block S813A).

In another embodiment, the bifurcated catheter accommodates the snare catheter in the secondary lumen. In this embodiment, one leg <NUM> of the bifurcated catheter is used as the procedural catheter and the other leg of the bifurcated catheter <NUM> is used initially to send in the snare loop <NUM> and capture the stabilization wire <NUM>. A reverse curve catheter <NUM> is sent through the procedural leg <NUM> of the bifurcated catheter into the LCCA <NUM> or RCCA and the stiff guide wire <NUM> is placed at the location of the procedure site. The second leg of the bifurcated catheter already at the aortic arch <NUM> is equipped with an atraumatic tip <NUM> and guided along the wire <NUM> to the location of the procedure. At the same time, the first leg <NUM> of the bifurcated catheter is extended to cover the stabilization wire <NUM> into the subclavian artery <NUM>. The atraumatic tip <NUM> and the stiff wire <NUM> are then removed and the second leg <NUM> of the bifurcated catheter is ready for the next treatment steps at the site, including stenting or other procedures. This embodiment is further described with reference to <FIG> and <FIG>.

In this embodiment, a bifurcated catheter is inserted with the main sheath catheter. In this embodiment, the bifurcated catheter has two chambers therein, one for the procedure and the second chamber for the snare catheter, snare loop/wire, and stabilization wire. This enables passing a snare catheter, snare loop/wire and stabilization wire all through a second chamber/branch of the bifurcated catheter when it is at the apex of the curve of the aortic arch similar to the process described earlier. The process is described below with reference to <FIG> and flow chart 800b of <FIG>.

<FIG> illustrates the distal end of sheath catheter device <NUM>, showing the distal end <NUM> of the device percutaneously inserted and advanced through the descending thoracic aorta <NUM> to the aortic arch <NUM>. The bifurcated catheter (not shown) is inserted with the sheath catheter and advanced to the aortic arch <NUM>. A snare wire with a <NUM> to <NUM> snare is shown extended from the sheath catheter in <FIG>. In this embodiment, the snare is within the smaller chamber of the bifurcated catheter within the sheath catheter. The snare captures a stabilization wire <NUM> that is extended into the aortic arch <NUM> from the right subclavian artery (RSA) <NUM>, as shown in <FIG> further shows the ascending aorta <NUM>, the LCCA <NUM>, the left internal carotid artery <NUM> and the heart <NUM>. As an alternative, a piece of stabilization wire attached to a catheter may be used as the wire <NUM> to be extended into the aortic arch <NUM> from the right subclavian artery.

<FIG> shows the snare being tightened <NUM>. In this embodiment, the snared stabilization wire <NUM> is pulled into the smaller lumen of the bifurcated catheter (not shown) and to the proximal end of the same to provide and end-to-end stabilization for the procedural catheter.

<FIG> shows a reverse curve catheter <NUM> such as a Simmons catheter with a stiff wire <NUM> being extended from the sheath catheter <NUM>. The reverse curve catheter <NUM> is extended through the second, larger chamber of the bifurcated catheter into the CCA <NUM> and advanced to the site of the procedure at just below the left internal carotid artery <NUM>.

The left carotid artery is shown in the figures but it is not meant to be limiting as procedures in both right and left carotid can be addressed with this implementation. Also the carotid artery may be selected with the same reverse guide catheter and a softer guidewire. Once selection has occurred the softer guidewire may be exchanged for the stiffer guidewire.

<FIG> shows the stiff wire /guide wire <NUM> being left at the intended site of the procedure after removal of the reverse catheter.

<FIG> shows the bifurcated catheter being advanced with the large lumen <NUM> over the stiff wire <NUM> to the site of the procedure and the small lumen <NUM> over the stabilization wire <NUM>. An atraumatic tip is used to reduce trauma to the artery during this catheter advance.

<FIG> shows the catheter <NUM> with the wire and the atraumatic tips removed and ready for the procedure. Stabilization for the process catheter is provided by applying tension to the stabilization wire <NUM>, to stabilize and fix the location of the sheath catheter and the position of the bifurcation.

<FIG> illustrates a process 800B for stabilizing and fixing the location of the sheath catheter and the position of the bifurcation catheter in accordance with one embodiment of the invention.

The process 800B begins by inserting a guide wire <NUM> through the femoral artery percutaneously (block S801B).

The process 800B continues by advancing the guide wire <NUM> through the descending thoracic aorta <NUM> to the aortic arch <NUM> using radiographic imaging (block S802B).

The process 800B continues by inserting a guide or sheath catheter18 having a platinum ring <NUM> that is opaque to X-ray at its distal end through the groin access and guiding the sheath catheter <NUM> through the descending aorta over the guide wire to the aortic arch <NUM> to a location suitable for access into the left common carotid artery <NUM> and the left internal carotid artery <NUM> that is being accessed for the procedure using x-ray fluoroscopy (block S803B).

The process 800B continues by inserting the larger leg of the bifurcated catheter <NUM> with the smaller leg <NUM> arranged parallel to it and guiding the bifurcated catheter over the guide wire <NUM> to the distal edge <NUM> of the sheath catheter <NUM> (block S804B).

The process 800B continues by inserting a stabilization guide wire <NUM> through the brachial artery preferably using a micro sheath and advancing the stabilization guide wire <NUM> through the right subclavian artery <NUM> into the aortic arch <NUM> (block S805B).

The process 800B continues by extending a second segment of the stabilization guide wire having a snare <NUM> at its distal end out of the smaller leg <NUM> of the bifurcated catheter to capture the stabilization wire <NUM> from the subclavian artery and pull it through the smaller leg of the bifurcated catheter and out to its proximal end providing an end to end stabilization wire for stabilizing the sheath and the bifurcated catheter (block S806B).

The process 800B continues by advancing a reverse guide catheter <NUM> through the tortuous connection of the left common carotid artery <NUM> to the aorta at the aortic arch <NUM> over a reasonably stiff wire <NUM> up the working lumen of the larger leg of the bifurcated catheter through the left common carotid artery <NUM> just below the left internal carotid artery <NUM> where the procedure is to be carried out (block S807B). The left carotid artery is shown in the figures but it is not meant to be limiting as procedures in both right and left carotid can be addressed with this implementation. Also, the carotid artery may be selected with the same reverse guide catheter and a softer guide wire. Once selection has occurred the softer guide wire may be exchanged for the stiffer guide wire.

The process 800B continues by removing the reverse guide catheter <NUM> and leaving the stiff guide wire <NUM> in place as a guide to the bifurcated catheter (block S808).

The process 800B continues by advancing the bifurcated catheter out of the guide catheter, the large leg <NUM> of the bifurcated catheter tracking along the stiff guide wire <NUM> into the left common carotid artery <NUM> and the small leg <NUM> tracking along the guide wire <NUM> coming from the right subclavian /innominate artery (block S809). In some embodiments, both legs may have atraumatic tips <NUM> to reduce trauma.

The process 800B continues by removing the guide wire <NUM> and the atraumatic tips <NUM> and applying tension to the stabilization wire <NUM> to stabilize the main catheter leg <NUM> extending to just below the left internal carotid artery <NUM> (block S810).

The process 800B continues by performing a treatment procedure, such as stenting or other procedures as needed, at the treatment site (block S811).

<FIG> and <FIG> illustrate another embodiment of the invention in which a modified snare bifurcated sheath with a side hole is used instead of the bifurcated catheter to provide stability to the procedural catheter used for stenting and other procedures in the carotid arteries. In this embodiment, the snare loop is inserted through the subclavian artery to capture the snare wire and provide a through-and-through capability for stabilization of the procedural catheter. In some embodiments, the snare loop is inserted through the subclavian artery via a right radial or brachial artery access.

<FIG> shows a snare wire <NUM> having a snare loop at its distal end inserted through the radial artery using a sheath <NUM> extended through the right subclavian artery <NUM> into the aortic arch <NUM>. In one embodiment, the sheath <NUM> is a Fr <NUM> sheath. In one embodiment, the snare loop <NUM> has a <NUM> to <NUM> diameter. A reverse curve catheter <NUM>, such as a Simmons catheter, is inserted through the groin access and guided through the descending aorta <NUM> to select the left common carotid artery <NUM> (it can also be used to select the right carotid artery). In one embodiment, the reverse curve catheter <NUM> is a Fr. <NUM> catheter.

<FIG> further shows a secondary stabilization wire <NUM> that is inserted from the proximal end of the reverse curve catheter <NUM> and exited out of a hole <NUM> on the side of the catheter <NUM> at the location at the apex of the curve of the aortic arch <NUM>. In one embodiment, the secondary stabilization wire has a <NUM> (<NUM> in) diameter.

<FIG> shows the stabilization wire <NUM> being snared by the snare <NUM> to provide a tensionable stabilization capability comprising the snare <NUM> from the sheath catheter <NUM> coming from the right subclavian artery and the snared wire <NUM> coming from the reverse curve catheter <NUM>.

<FIG> further shows a stiff guide wire <NUM> being extended from the reverse catheter <NUM> into the left common carotid artery <NUM> and below the left internal carotid artery <NUM> where the procedure is expected to be carried out once the tensionable stabilization is established.

<FIG> shows the withdrawal of the reverse catheter <NUM> leaving both the snare <NUM>, snared stabilization wire <NUM>, and the stiff guide wire <NUM> into the left common carotid artery <NUM>, and below the left internal carotid artery <NUM>.

<FIG> shows a bifurcated sheath catheter <NUM> having two chambers - one for the stabilization wire and the other for the process catheter with an atraumatic dilator tip <NUM>, being guided over the stiff guide wire and the stabilization wire <NUM>, which exits the sheath through a hole <NUM>, in the sheath catheter <NUM>. In one embodiment, the bifurcated sheath catheter <NUM> is a Fr. <NUM> or Fr. <NUM> sized catheter.

<FIG> shows the sheath catheter <NUM> with the stiff wire and atraumatic tip removed with the snared stabilization wire <NUM>, forming an end-to-end wire enabling stabilization tension to be applied to stabilize the sheath catheter <NUM> extending into the left internal carotid artery <NUM> for inserting the procedural catheter for stenting and other procedures from the aortic arch <NUM>.

In yet another embodiment, the initial sheath catheter may have two lumens, one for the support and stabilization wire and a second as the operational catheter. Further, the operational catheter may be made with a softer operational leg at its distal end which can be used as a reverse curve guiding catheter as well. By combining the application capabilities of such a catheter, it is possible to reduce the number of catheters used and hence the number of steps needed for set up and completion of the procedure.

<FIG> is flow chart illustrating a process <NUM> according to another embodiment of the invention.

The process <NUM> begins by inserting a wire with a snare <NUM> through a sheath <NUM> that is inserted through the radial artery and directed through the right subclavian artery <NUM> such that the snare is in the aortic arch <NUM> (block S1601).

The process <NUM> continues by percutaneously inserting and advancing a reverse curve catheter <NUM> up the femoral artery into the descending thoracic aorta <NUM> into the left common carotid artery <NUM> using radiographic imaging (block S1602).

The process <NUM> continues by inserting a secondary stabilization wire <NUM> into the reverse curve catheter <NUM> at the proximal end and exited from a hole <NUM> near the distal end of the reverse curve catheter at the aortic arch <NUM> to be snared by the snare <NUM> from the subclavian artery <NUM> (block S1603).

The process <NUM> continues by snaring the stabilization wire <NUM> to provide an end to end stabilization (<NUM>) to the catheter, and extending a stiff guide wire <NUM> through the reverse curve catheter <NUM> into the left common carotid artery <NUM> to the location of the procedure (block S1604).

The process <NUM> continues by removing the reverse curve catheter <NUM>, leaving both the stabilization wire <NUM> and the stiff guide wire <NUM> in place in the arteries (block S1605).

The process <NUM> continues by advancing a bifurcated sheath catheter <NUM> having two partitions (one for the stabilization wire <NUM> with a side hole <NUM> near the distal end and another with a dilator tip <NUM> for the guide wire <NUM>) over the two wires into position such that the sheath catheter for process <NUM> is extended into the carotid artery <NUM> while the stabilization wire <NUM> through the hole <NUM> in the bifurcated sheath catheter <NUM> extends from the proximal end of the sheath catheter <NUM> through the hole <NUM>, through the aortic arch13 and subclavian artery <NUM> to provide a through and through capability to provide tension and stabilization to the operating catheter <NUM> (block S1606).

The process <NUM> continues by extending the sheath catheter into the left internal carotid artery <NUM> to the location of the procedure (block S1607).

The process <NUM> continues by removing the stiff guide wire <NUM> and the atraumatic dilator tip <NUM> and tensioning the stabilization wire <NUM> to provide stability to the sheath catheter <NUM> (block S1608).

The process <NUM> continues by inserting the catheter for the procedure through the main chamber of the sheath <NUM> to the location of the procedure in the left internal carotid artery <NUM> (block S1609).

The process <NUM> continues by performing a stenting or other procedure at the treatment site (block S1610).

In another embodiment, a reverse curve catheter with a lumen sufficiently large for stenting instead of a sheath catheter may be used. In this embodiment, the reverse curve catheter having two lumens, one large procedural lumen and the other a smaller stabilization lumen, is used to select the carotid artery. A secondary wire is inserted in the reverse curve catheter (through the stabilization lumen) and out of a hole in the reverse curve catheter at the location of the arch. This secondary wire is then captured by a snare wire with a loop that is extended out of a protective sheath extended through the subclavian artery. The carotid stenting procedure can now proceed in the standard way using the procedural lumen of the reverse curve catheter since the reverse curve guiding catheter itself is stabilized and is usable for procedure.

Yet another implementation or embodiment is the use of two catheters or a catheter and a snare wire within a single sheath, as shown in <FIG>, for providing the necessary stabilization to the catheter used for the procedure. In the first embodiment, the second catheter contains the snare wire that will be used to capture the stabilization wire and provide the necessary stabilization to the catheter used for the procedure. Alternately, the snare wire and a catheter are in a single sheath. Though this twin catheter or the catheter <NUM> and snare wire <NUM> may provide a solution it comes with a plurality of problems. In the case where two catheters are used, there is need for a larger sheath which will accommodate the twin catheters. In many cases, it is not practical to use such a large sheath. In using twin catheters or a catheter <NUM> and a snare wire <NUM>, there is a possibility for entanglement and twisting of the two independent catheters or the catheter <NUM> and the wire <NUM>. This can cause difficulty in proper insertion to the site as well as during extraction of the catheter <NUM> after the procedure. Also, in these cases, there is a possibility of blood leakage from the access site, as is well understood by the surgeons. In order to prevent the blood leakage, a Tuohy Borst adapter as shown in <FIG> is used. One access <NUM> is made to fit the exact size of the catheter <NUM> and the other access <NUM> is used to isolate the snare wire used as shown. The Tuohy Borst adapter of <FIG> is attached by the adapter <NUM> to a catheter handle <NUM>/<NUM> combination. The handle has a fixed holder portion <NUM> connected to a manipulator section <NUM>.

The typical implementation of the embodiment having dual catheters without the Tuohy Borst adapter, due to the problems discussed, is not an optimum solutions and is not recommended over the more optimum solutions disclosed. Another solution is the use of the procedural catheter <NUM> and a snare wire <NUM> within the same sheath <NUM>. This solution also has the major problem of entanglement of the wire with the catheter, as the wire used is much lighter and less rigid than the catheter, with the associated problems of insertion and extraction as well as the problem of blood leakage as discussed previously. Hence, this is also not a recommended solution. As an example, the procedure may be performed using a long <NUM> French <NUM> sheath with a coaxial longer <NUM> French <NUM> catheter and a <NUM> or <NUM> (<NUM> or <NUM> inch) snare wire. In this case, the procedure would be complicated by potential wire wrap of the <NUM> mm (. <NUM> inch) wire around the <NUM> French catheter causing entanglements. Furthermore, there would be persistent leakage of blood at the <NUM> French sheath valve, similar to the twin catheter case, which has both the <NUM> (. <NUM> inch) wire and <NUM> French catheter. This can be life threatening.

Another way to provide stabilization to the procedural catheter or sheath is shown in <FIG>. Here a modified sheath/ reverse curve guide catheter 24A is percutaneously inserted and advanced up the femoral artery through the descending thorasic aorta <NUM> into the aortic arch <NUM>, using radiographic imaging as described previously. The modified sheath catheter 18A is reinforced with graspable sections <NUM> for example: <NUM>-<NUM>, <NUM>-<NUM> and <NUM>-<NUM> shown at the appropriate locations using ferro-magnetic material. A second stabilization catheter 52A with a magnetic gripper 51A that is a latching mechanism is now introduced into the aortic arch <NUM> using right subclavian artery <NUM> access via radial or brachial artery. The magnetic latching mechanism attaches to one of the graspable reinforced ferro-magnetic sections <NUM> of the modified sheath catheter 18A to provide stabilization to the modified sheath catheter 18A. A reverse curve catheter 24A is now used to access the left common carotid artery <NUM> through the stabilized modified sheath catheter 18A as described previously for establishing a path for the procedural catheter and for conducting the procedure as described previously.

In certain embodiments the modified sheath catheter 18A may be replaced by the reverse curve guide catheter 24A having the required modifications and reinforcements for the gripper or latching mechanism to engage with it directly.

In certain other embodiment the gripper or latching mechanism is not magnetic, but is a mechanical attach mechanisms that attaches to or grips the reinforced portion of the sheath catheter 18A.

Though embodiments the invention has been described mainly as being applicable to the tortuous arterial procedures above the neck, it should not be considered limiting. The bifurcated sheath can be modified to treat contralateral lower extremity peripheral arterial disease with a complex or hostile aortic bifurcation (due to a fixed and narrow aortic bifurcation, iliac stenosis, ectasia, or tortuosity, aneurysm of the distal aorta, previous iliac stenting, previous endovascular aneurysm repair and previous aortofemoral/aortoiliac bypass grafting) using bilateral groin access. It can also be useful for renal and other visceral interventions such as renal and SMA stenting and cancer hepatic embolizations and splenic arterial interventions (using groin and radial artery access). The advantage of this device is that it can conquer adverse tortuous anatomy by providing stabilization during procedures in adverse tortuous anatomy for minimally invasive procedures through both venous or arterial access.

The disclosed bifurcated sheath, the dual sheath/catheter, or catheter and stabilization wire or modified sheath catheter with stabilization catheter (including modified fogarty balloon access and mirco-anchor/pin) can also be used for treatment of contralateral lower extremity peripheral arterial disease with a steep aortobifemoral bypass graft (using bilateral groin access), renal and other visceral interventions such as renal and SMA, stenting and cancer hepatic embolizations, and splenic arterial interventions (using groin and radial artery access) are disclosed. Two examples of such use are discussed below.

<FIG> show the exemplary use of the bifurcated catheter with a side hole (the side hole catheter) for stabilization of the procedural catheter in Aorto Bifemoral Bypass application. The figures identify the main arterial branches that are involved - the left renal artery <NUM> goes off the abdominal Aorta <NUM>. The abdominal aorta <NUM> bifurcates into the right iliac <NUM> and the left iliac <NUM> both of which continue as right external iliac <NUM> and left external iliac <NUM> after the right and left internal iliacs go off the right iliac <NUM> and left iliac <NUM>. As they transition down the body the right external iliac continues as the right common femoral artery <NUM> and the left external iliac continues as the left common femoral artery <NUM> which further down becomes the right superficial femoral <NUM> and the left superficial femoral artery <NUM>. During aorto bifemoral bypass application as shown in <FIG> the main sheath <NUM> access <NUM> is made through the right common femoral artery <NUM> and stabilization wire <NUM> of <NUM> (<NUM>") access <NUM> through the left common femoral artery <NUM>. As shown in <FIG> and <FIG> the main sheath <NUM> is extended into the right common iliac <NUM>, close to the aortic bifurcation <NUM> and a reverse curve catheter <NUM> with a thick guide wire <NUM>, typically of <NUM> (<NUM>") is inserted through the sheath <NUM> and placed at the bifurcation <NUM> as shown at <NUM> to gain access to the left iliac <NUM>. The thick guide <NUM> is now extended down the left iliac <NUM> to the left common femoral artery <NUM>. <FIG> shows the introduction of a snare catheter <NUM> using a snare manipulator <NUM> into the main sheath to have a snare <NUM> at the aortic bifurcation <NUM>. The snare <NUM> is used to capture the stabilization wire <NUM> and pull it into and out of the main sheath <NUM> at the proximal end, to create an end to end stabilization capability. In <FIG>, the reveres curve catheter <NUM> is now removed and a bifurcated "Y" or side hole sheath catheter <NUM> is introduced through the main sheath <NUM> with the thick guide wire <NUM> through the larger arm of the 'Y' catheter 2101and guided over the thick guide wire <NUM> such that the side hole <NUM> of the bifurcated catheter <NUM> is at the access point on the LCFA <NUM> of the stabilization wire <NUM>. The side hole of the bifurcated catheter <NUM> carries the stabilization wire <NUM>. <FIG> shows the main sheath <NUM> extended over the bifurcated catheter <NUM> to the access point of the stabilization wire <NUM>, through the LCFA <NUM>. <FIG> shows the use of the stabilization wire <NUM> to anchor and stabilize the procedural catheter <NUM> so that deeper penetration in a stable way is made possible for procedures in the LSFA <NUM>.

<FIG> illustrate an example of the use of the stabilization technique using bifurcated sheath/catheter for visceral interventions. An intervention in the left renal artery <NUM> is shown in these figures. The access of the main catheter <NUM> as in the previous case is via the right common femoral artery <NUM>. The main sheath <NUM> is guided up into the abdominal aorta <NUM> using the visibility provided by the radio opaque tip <NUM>. A snare <NUM> is introduced through the main sheath <NUM> to capture a stabilization wire <NUM>. The access for the stabilization wire <NUM> is from the left radial artery through the aortic arch into the abdominal aorta <NUM>. <FIG> shows the stabilization wire <NUM> snared and pulled into the smaller branch <NUM> of the bifurcated 'Y' catheter and out of the proximal end of the main sheath to provide an end to end stabilization for the procedural catheter. A common reverse curve catheter <NUM> from the wider arm <NUM> of the bifurcated 'Y' catheter is used to extent a thick guide wire <NUM> into the left renal artery <NUM>. <FIG> shows the removal of the common reverse catheter <NUM> and extension of the larger arm of the 'Y' catheter over the thick guide wire <NUM>. <FIG> shows the bifurcated catheter <NUM> is extended out of the main catheter <NUM> with the smaller or narrow arm <NUM> moving up the abdominal aorta along the stabilization wire <NUM> and the wider arm <NUM> moving further into the left renal artery <NUM> ready for any procedure needed.

Another need for stabilization of the procedural catheter or the sheath carrying the procedural catheter is when using very long catheters to reach the location of the procedure. <FIG> shows such an application. As is well understood Retrograde, and especially antegrade femoral puncture or access is very difficult in obese patients. Hence a super-long radial artery sheath or super-long sheath that extends to the left common femoral <NUM> or the right common femoral <NUM> or below-knee arteries such as right superficial femoral <NUM> or left superficial femoral <NUM> is used for arterial interventions in the femoral artery of these patients. As sheaths become super-long they lack stability and pushablity for common femoral artery and below-knee arterial interventions, especially for chronic total occlusion traversals. In these cases it is possible to provide stabilization and improve the pushability to the super-long sheath carrying the procedural catheter <NUM> using the modified super-long sheath like the <NUM> with reinforced sections <NUM> (<NUM>-<NUM> to <NUM>-<NUM>) and enabling a gripper or grasping attachment <NUM> attached to a second stabilization catheter <NUM> to attach the second stabilization catheter <NUM> to the super-long sheath <NUM> to provide stability. <FIG> shows the super-long modified sheath <NUM> extending down the abdominal aorta <NUM> to the left common illiaac artery <NUM> to the left external iliac1804. The modified super-long sheath <NUM> has reinforced gripper sections <NUM>-<NUM> to <NUM>-<NUM>. A stabilization catheter <NUM>, with access from the right common femoral artery <NUM> having s a mechanical gripper attachment <NUM> at the end is moved up the right common iliac <NUM> to make contact with the modified super-long sheath <NUM> at the apex of the fork of the iliac arteries and capture one of the reinforced regions such as <NUM>-<NUM>. In an alternate case, the magnetic attachment previously described may be used instead of the mechanical gripper attachment. By capturing and getting attached to the modified super long sheath <NUM>, the stabilization catheter <NUM> is able to enhance the stability and pushability to the modified super long sheath <NUM>. The procedural catheter <NUM> is now able to be extended into the left common and left superficial femoral arteries to conclude procedures. It should be noted that further stabilization methods already disclosed such as side hole stabilization or stabilization using bifurcated Y catheter, or even an additional stabilization by use of a magnetic or mechanical gripper attachment may be used in conjunction with the above, when needed to improve the success of the procedure.

Another need for stabilization of the procedural catheter or the sheath carrying the procedural catheter is when using very long catheters to reach the location of the procedure. <FIG> shows such an application. As is well understood, retrograde, and especially antegrade, femoral puncture or access is very difficult in obese patients. Hence, a super-long radial artery sheath or super-long sheath that extends to the left common femoral <NUM> or the right common femoral <NUM> or below-knee arteries such as right superficial femoral <NUM> or left superficial femoral <NUM> is used for arterial interventions in the femoral artery of these patients. As sheaths become super-long they lack stability and pushablity for common femoral artery and below-knee arterial interventions, especially for chronic total occlusion traversals. In these cases, it is possible to provide stabilization and improve the pushability to the super-long sheath carrying the procedural catheter <NUM> using the modified super-long sheath like the <NUM> with reinforced sections <NUM> (<NUM>-<NUM> to <NUM>-<NUM>) and enabling a gripper or grasping attachment <NUM> attached to a second stabilization catheter <NUM> to attach the second stabilization catheter <NUM> to the super-long sheath <NUM> to provide stability. <FIG> shows the super-long modified sheath <NUM> extending down the abdominal aorta <NUM> to the left common iliac artery <NUM> to the left external iliac1804. The modified super-long sheath <NUM> has reinforced gripper sections <NUM>-<NUM> to <NUM>-<NUM>. A stabilization catheter <NUM>, with access from the right common femoral artery <NUM> having s a mechanical gripper attachment <NUM> at the end is moved up the right common iliac <NUM> to make contact with the modified super-long sheath <NUM> at the apex of the fork of the iliac arteries and capture one of the reinforced regions such as <NUM>-<NUM>. In an alternate embodiment, the magnetic attachment previously described may be used instead of the mechanical gripper attachment. By capturing and being attached to the modified super long sheath <NUM>, the stabilization catheter <NUM> is able to enhance the stability and pushability of the modified super long sheath <NUM>. The procedural catheter <NUM> is now able to be extended into the left common and left superficial femoral arteries to conclude procedures. It should be noted that further stabilization methods already disclosed such as side hole stabilization or stabilization using bifurcated Y catheter, or even an additional stabilization by use of a magnetic or mechanical gripper attachment may be used in conjunction with the above, when needed to improve the success of the procedure.

Additional implementations for improving the access to the location of the procedure through the tortuous arterial access using a new method of applying a pull force near the access location of the procedural catheter via the stabilization catheter or stabilization wire in addition to the push force from the proximal end are disclosed. Embodiments of the invention are directed to using a push pull method that is suitable for use with the bifurcated and dual or single sheath catheters, for providing improved accessing capability while still providing stabilization to the procedural catheter during access into tortuous vessels and during procedures.

In one embodiment, the stabilization catheter from the brachial artery with a stabilization wire is used to capture and dock with the bifurcated catheter by invagination of the smaller lumen of the bifurcated catheter to its origin. Once docked, the stabilization catheter and the bifurcated catheter are locked in place using a locking mechanism at the groin access location and the brachial access location such that the stabilization wire can be used exert a pull force in addition to the normal push force, on the procedural catheter that is within the larger lumen of the bifurcated catheter to guide it over a guide wire into the location of the treatment.

In another embodiment, a mechanical device such as the one shown in <FIG> can be used as part of the pull and stabilization apparatus to capture the distal portion of the main sheath through which the reverse curve catheter is introduced to place the guide wire in place at the site of the procedure and the procedural catheter is guided through. A pull on the stabilization apparatus will hence provide a pull force on the procedural catheter as it is guided into the location of the procedure. This will enhance and ease the difficulty of guiding the procedural catheter into the location of the procedure via tortuous access.

The use of a pull force makes the access easier for catheter placement for stenting and other procedures, and also reduces the need for stiffer and harder wires and catheters to be used. This in turn reduces the trauma to the patient while accessing and withdrawing the catheters and wires.

<FIG> shows the cross section of a bifurcated catheter distal end <NUM>. The main sheath catheter <NUM> carries the bifurcated catheter <NUM>. At its distal-end, the bifurcated catheter <NUM> splits into two legs: a large leg <NUM> having a large lumen for the procedural catheter and a small leg <NUM> having a small lumen for a stabilization wire. Radio opaque bands or tips are provided at the bifurcation <NUM> and at the distal end of the two lumens <NUM> to enable guiding the bifurcated catheter <NUM> within the body.

<FIG> shows a small stabilization catheter <NUM> with access into the right brachial artery <NUM> or alternately a radial artery access, being advanced to the ostium of the right brachiocephalic artery <NUM> from right brachial <NUM> or radial artery access while a main sheath, <NUM>, which will carry the bifurcated sheath, is advanced from a groin access through the descending thoracic aorta <NUM> to have its distal end <NUM> at a location close to the ostium of the carotid artery <NUM> in the aortic arch. Typically the main sheath <NUM> that has to carry the bifurcated catheter <NUM> has a size of <NUM> Fr. In one embodiment, the small stabilization catheter <NUM> is typically about <NUM> Fr. The figures also show the heart <NUM>.

<FIG> shows a snare <NUM> at the end of a wire <NUM> being extended from the sheath <NUM> to capture a thin stabilization guide wire <NUM> extending out of the stabilization catheter <NUM> in at the ostium of the brachiocephalic artery. In one embodiment, the snare <NUM> is about <NUM> to <NUM>, and the thin stabilization wire or stabilization wire <NUM> is of the order of <NUM> (<NUM> in) in diameter.

Alternately as shown in <FIG>, the snare <NUM> may be introduced via the small stabilization catheter <NUM> through the ostium of the brachiocephalic artery into the aortic arch to capture a thin <NUM> (<NUM> in) guide wire extending from the main sheath catheter distal end <NUM> from within the main sheath <NUM>.

<FIG> shows the stabilization wire <NUM> being captured by the snare <NUM> at the end of the wire <NUM> within the aortic arch.

<FIG> shows the stabilization wire <NUM> being pulled into and exiting out the proximal end of the sheath <NUM>. The captured stabilization wire <NUM> extending from proximal end of the sheath <NUM> to the proximal end of the stabilization catheter <NUM> is enabled to provide end to end stabilization and tension as has been disclosed previously in co-pending applications when the bifurcated catheter is introduced.

<FIG> shows the bifurcated catheter <NUM> being inserted with its small or narrow lumen <NUM> carrying the stabilization wire <NUM> to be guided within the main sheath and guided to its distal end <NUM>.

<FIG> shows a reverse curve catheter <NUM> with a stiff hydrophilic wire <NUM> being extended through the large lumen <NUM> of the bifurcated catheter within the main sheath <NUM> to access the ostium of the LCCA <NUM>. The reverse curve catheter carries the stiff hydrophilic guide wire <NUM> into the LCCA. The bifurcated catheter with the thin stabilization wire <NUM> and the reverse curve catheter <NUM> with the hydrophilic wire <NUM> are shown going into the proximal end of the bifurcated catheter which is being pushed into the main sheath <NUM>.

<FIG> shows the hydrophilic wire <NUM> being exchanged for a guide wire <NUM> and the guide wire <NUM> and the reverse curve catheter being moved up into the left common carotid artery <NUM>. The stabilization wire remains in place for end to end stabilization.

<FIG> shows the main sheath <NUM> being pulled back such that its edge <NUM> moves down the bifurcated catheter <NUM> to the bifurcation <NUM> to expose the small leg with small lumen <NUM> and the large leg with the large lumen <NUM> of the bifurcated catheter <NUM>.

<FIG> shows the small stabilization catheter <NUM> being pushed to extend over the stabilization wire <NUM> to cover the small side arm <NUM> of the bifurcated catheter <NUM> to dock at the bifurcation <NUM> of the bifurcated catheter <NUM>. This docking with the small arm having the small lumen <NUM> of the bifurcated catheter engulfed within the stabilization catheter <NUM> provide a continuity from the bifurcation of the bifurcated catheter <NUM> to the stabilization catheter <NUM>.

<FIG> shows one end of the stabilization wire <NUM> locked to the proximal end of the bifurcation catheter <NUM> at the groin access using a first locking mechanism <NUM> and the other end of the stabilization wire <NUM> further locked to the stabilization catheter <NUM> at its proximal end at the access point by a second locking mechanism <NUM>. This allows the bifurcated catheter distal end and the stabilization catheter distal end to be intimately pulled together. This intimate attachment of the distal end of the stabilization catheter <NUM> with the bifurcation at the distal end of the bifurcation catheter allow a pull force to be applied to the distal end of the bifurcated catheter <NUM>, when a pull is applied to the proximal end of the stabilization catheter <NUM> via a pull on the stabilization wire locked to the proximal end of the stabilization catheter <NUM>.

<FIG> shows the main arm <NUM> of the bifurcated catheter delivered over the guide wire <NUM> into the LCCA <NUM> to the location of the procedure, by application of a normal push force 4001to the proximal end of the bifurcated catheter <NUM> that is locked to the stabilization wire <NUM> using a fist lock <NUM> and at the same time by application of a pull force <NUM> to the other end of the stabilization wire <NUM> that is locked to the proximal end of the stabilization catheter <NUM> locked using the second lock <NUM>. Since the proximal end of the stabilization catheter is locked to the stabilization wire, applying a pull force to the the stabilization wire <NUM> at locked to the stabilization catheter <NUM> at its proximal end is same as applying a pull force on the stabilization catheter <NUM> at its proximal end. Since the stabilization catheter and the bifurcated catheter are linked at their distal ends as described before, any pull force <NUM> applied on the stabilization wire <NUM> locked to the stabilization catheter <NUM> at tits proximal end will be a pull force applied to the distal end of the bifurcated catheter <NUM>. The pull force <NUM> applied simultaneously with the push force <NUM>, enable a much easier access for the larger arm with the larger lumen of the bifurcation catheter <NUM> to follow the guidewire <NUM> into the LCCA <NUM> to the location of the procedure through the tortuous access from the aortic arch even when the access is from a tortuous type III aortic arch.

<FIG> shows the larger lumen <NUM> of the bifurcated catheter <NUM> with the guidewire <NUM> and any attached devices removed. The larger arm with the larger lumen <NUM> of the bifurcated catheter <NUM> is now at the treatment location as a well stabilized procedural catheter, within the LCCA <NUM> ready for stenting or other treatments such as stroke related thrombectomy within the LCCA3003 and its branches.

Application of a normal push <NUM> on the bifurcated catheter <NUM> locked to one end of the stabilization wire <NUM> at the percutaneous access location with a slight pull <NUM> on the stabilization catheter <NUM> at its access point locked to the other end of the stabilization wire <NUM> enable a smooth access of the arm with the larger lumen <NUM> of the bifurcated catheter <NUM> with any associated procedural catheters, through it, to access the common carotid <NUM> smoothly even via the tortuous access from a type III arch.

<FIG> is an exemplary and non-limiting flow chart of one method of the application of the push-pull implementation to access the left common carotid artery from a tortuous, type III aortic arch access.

A small stabilization catheter is advanced from a percutaneous entry into the right brachial or radial artery and advanced to the ostium of the brachiocephalic artery, and a thin stabilization guide wire (stabilization wire) is introduced through the small catheter to extend into the aortic arch (block S42001). In one embodiment, the small catheter is about 4fr. in size and the stabilization guide wire is about <NUM> (<NUM> inch) diameter.

A large sheath catheter with a bifurcated catheter within it is introduced percutaneously via the groin access and advanced up the descending thoracic aorta to the inomate using radiographic imaging (block S42002).

A snare at the end of a guide wire is extended out of the smaller lumen at the distal end of the bifurcated catheter within the main sheath to snare the stabilization wire introduced from the small catheter at the ostium of the brachiocephalic artery (block S42003).

The snare is tightened and the stabilization wire is pulled into the small lumen of the bifurcated catheter and out at its proximal end to provide a capability for end to end stabilization (block S42004).

A tension is established using the stabilization wire and a reverse curve catheter with a hydrophilic wire is introduced through the larger lumen of the bifurcated catheter to access the ostium of the left common carotid artery, and the hydrophilic wire is extended up into the LCCA. (block S42005).

The main sheath over the bifurcated catheter is now pulled back to the point of bifurcation to expose both the branches of the bifurcated catheter to the origin at the bifurcation (block S42006).

The small stabilization catheter (advanced from the right brachial or radial artery) is then advanced over the stabilization wire into the aortic arch and invaginates the member with the smaller lumen to the bifurcation point such that the smaller sheath catheter is snug with the bifurcated catheter sheath. This allows a continuous connectivity between the distal end of the bifurcation catheter and the distal end of the small stabilization catheter. (block S42007).

An end to end tension is applied over the stabilization wire and a first end of the stabilization wire is locked to the proximal end of the bifurcation catheter at the groin entry point, and the other end, the second end of the stabilization wire is locked to the proximal end of the small stabilization catheter at the brachial entry point using locking mechanisms. This allows any pull force applied to the second end stabilization wire or the small stabilization catheter at its proximal end is transferred to the distal end of the bifurcated catheter. (block S42008).

The reverse curve catheter and any dilator tips used are now removed leaving the guide wire in the LCCA (block S42009).

Application of a normal push on the bifurcated catheter locked to the first end of the stabilization wire at the percutaneous groin access location with a slight pull on the second end of the stabilization wire that is locked to the small stabilization catheter at its proximal end that is the brachial artery access point, allows the pull force to be transferred by the small stabilization catheter to the bifurcated catheter and enable a smooth access of the large procedural arm with the larger lumen of the bifurcated catheter to access the common carotid over the guide wire smoothly even via the tortuous access from a type III arch (block S42010).

The guide wire is now removed to put the arm of the bifurcated catheter having the larger lumen ready for any procedures within the LCCA and its branches. (block S42011).

As indicated all these above applications can be made easier by applying a pull force to the stabilization wire while a normal push force is applied to the procedural catheter at the percutaneous access location similar to the way described in the example previously described.

<FIG> shows another way of applying the pull force. The use of a mechanical connection to the main sheath may also be used to provide the stabilization capability and a pull capability for the main sheath itself. It will be appreciated that other mechanical means may be used to provide the necessary stabilization capability and exert a pull capability on a sheath catheter. This will allow a single procedural catheter, which may be a bifurcated catheter, within the sheath to be used with the push pull capability to access the location of the procedure through the tortuous access.

Another advantage of the disclosed devices is the capability to improve the treatment of endovascular stroke and any other type of intracranial arterial intervention such as for aneurysm repair. In particular, some of the devices for aneurysm repair used, such as a flow diverter for wide necked aneurysm repair, are relatively stiff and can push the sheath and the device itself out of the treatment location and the intracranial vascularity, creating complications and trauma to the patient. The use of the stabilization device and push pull methods can reduce these unwanted incidences and improve the success rate of these procedures.

Yet another advantage of the disclosed devices is the ability provided to safely use a larger caliber device that can easily accommodate larger caliber (<NUM>-<NUM> French) flow reversal devices used in carotid stenting. This can be an alternative to using embolic protection devices (EPDs).

Claim 1:
A percutaneous intervention system for a carotid percutaneous intervention of the vessels originating from a tortuous aortic arch, said system comprising:
a bifurcated catheter (<NUM>) configured to be inserted via a first percutaneous access comprising a first procedural lumen (<NUM>) and a second stabilization lumen (<NUM>), the bifurcated catheter (<NUM>) comprising a proximal end and a distal end (<NUM>);
a procedural catheter slideably insertable through the first procedural lumen (<NUM>), the procedural catheter configured to be delivered to a treatment site within a carotid artery for a treatment procedure;
a stabilization wire (<NUM>) slideably insertable through the second stabilization lumen (<NUM>),
characterised in that
the system further comprises a stabilization catheter (<NUM>) comprising a wire (<NUM>) having a snare (<NUM>) at the end configured to be inserted via a second percutaneous access;
the stabilization wire (<NUM>) is configured to be captured by the snare (<NUM>) and to exit at the proximal end of the stabilization catheter (<NUM>), to provide the end-to-end tension stabilization; and
the stabilization wire (<NUM>) is lockable at one end to the proximal end of the bifurcated catheter (<NUM>) using a first locking mechanism (<NUM>) and the other end of the stabilization wire (<NUM>) is lockable to the proximal end of the stabilization catheter (<NUM>) by a second locking mechanism (<NUM>), to enable the bifurcated catheter (<NUM>) to be pushed from its proximal end, and pulled from its distal end by the stabilization wire (<NUM>), during delivery of the procedural catheter at the treatment site within a carotid artery.