Patent Grant
10779976
1. Field
The invention relates to improved methods and apparatus used in catheter based interventional procedures, mainly involving hostile vessels, and access for semi-invasive procedures, such as stenting.
2. Related Art
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.
The arch types are defined by the height of the top of the aortic arch 3 from the base location where the innominate 4 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 3 from the base of the innominate 4 is of the order of 1 to 2 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 and also for any other type of intracranial arterial intervention, such as for aneurysm repair. Subsequent placement of a stent delivery system or stroke interventional devices in a stable mode into the arterial system above the tortuous aortic arch therefore becomes more difficult. The stenting and other interventional procedures are meant to re-establish a more normalized blood flow through the carotid and internal carotid artery into the brain either by opening up regions of the artery constricted by plaque deposits which inhibit flow or by eliminating aneurysms that can burst and leak blood, there by 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. Stenting in the neck and procedures above the neck are challenging when confronted with a type-three hostile aorta, in particular stenting of the left or right carotid artery. During the insertion, manipulation and stabilization of the stent delivery mechanism and also 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 injure 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 white blood cells, which is a natural reaction to vessel injury, which 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 (e.g., the flow diverters used in wide necked aneurysm repair) are relatively stiff and can push the sheath and device itself out of its location and the intracranial vascularity creating major complications.
The following summary of the invention is included in order to provide a basic understanding of some aspects and features of the invention. This summary is not an extensive overview of the invention and as such it is not intended to particularly identify key or critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented below.
Embodiments of the invention are directed to ways to stabilize the sheath, the EPD and the stent delivery system within the carotid arterial system 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.
In accordance with one aspect of the invention, a percutaneous intervention system is disclosed that includes a bifurcated sheath catheter having a proximal end and a distal end, wherein the bifurcated sheath catheter comprises two lumens at its distal end, the two lumens comprising a procedural lumen and a stabilization lumen; a procedural catheter slideably insertable through the procedural lumen and configured to be delivered to a treatment site; and a stabilizer slideably insertable through the stabilization lumen of the bifurcated sheath catheter, the stabilizer configured such that when tension is applied to the stabilizer, the bifurcated sheath catheter is stabilized such that the procedural catheter easily accesses a procedural site through tortuous entries and the procedural catheter is also stabilized during subsequent procedures at the treatment site.
The stabilizer may be a modified Fogarty balloon catheter having a modified Fogarty balloon at its distal end used as a stabilization catheter. The modified Fogarty balloon may be an elongated Fogarty Balloon, which, when inflated, provides an increased frictional contact with sidewalls of a secondary vessel in which it is positioned than the Fogarty balloon.
The stabilizer may be configured to stabilize the bifurcated sheath and the procedural catheter during a carotid artery intervention by inflating the modified Fogarty balloon within the secondary vessel, wherein the secondary vessel is a right brachial artery.
The stabilizer may be a guide wire comprising a micro-anchor at its distal end used as a stabilization wire. Insertion of a pin through the expanded micro-anchor from outside a secondary vessel may enable fixing of the micro-anchor in place inside the secondary vessel.
The stabilizer may be configured to provide stabilization of the bifurcated sheath and a procedural catheter during carotid artery interventions by pinning the micro-anchor in place within a right brachial artery using the pin inserted from outside.
The application of tension to stabilize the stabilizer slidably inserted through the stabilization lumen of the bifurcated catheter may enable stabilization of the procedural catheter slidably inserted through the procedural lumen of the bifurcated catheter, during access to the treatment site and during procedure at the treatment site.
The bifurcated sheath catheter may have an ovoid cross-sectional shape away from its distal end.
In accordance with another aspect of the invention, a percutaneous intervention system is disclosed that includes a bifurcated sheath catheter comprising a first procedural lumen and a second stabilization lumen; a procedural catheter slideably insertable through the first procedural lumen and configured to be delivered to a treatment site; and a stabilizer, slideably insertable through the stabilization lumen and extend into a secondary vessel to be fixed therein and configured for application of tension.
The stabilizer may include an expandable micro-anchor at a distal end of a stabilization wire; and the percutaneous intervention system may further include a pin engageable with the expanded micro-anchor from outside the secondary vessel to fix the distal end of the stabilization wire within the secondary vessel and enable application of tension to the stabilizer.
The stabilizer may include a modified Fogarty balloon catheter with an inflatable modified Fogarty balloon at its distal end; the modified Fogarty balloon configured to be inflated within a secondary vessel to provide frictional contact with sidewalls of the secondary vessel fixing the distal end of the modified Fogarty balloon catheter within the secondary vessel and providing the capability for application of the tension to the stabilizer.
The interventional system may be for interventional procedures through a common carotid artery, the secondary vessel being a right brachial artery.
The bifurcated sheath catheter may have an ovoid cross section away from its distal end.
The interventional system may be for interventional procedures within the superficial femoral arteries, the secondary vessel is the deep femoral artery.
In accordance with a further aspect of the invention, a method is disclosed that includes advancing a stabilizer to a secondary vessel beyond a treatment site access region using radiographic imaging; fixing the distal end of the stabilizer within the secondary vessel; advancing a bifurcated sheath catheter over the stabilizer to the treatment site access region; and advancing a procedural catheter through the bifurcated sheath catheter to the treatment site.
The method may further include inserting the stabilizer via percutaneous femoral artery access.
The bifurcated sheath catheter may include a stabilization lumen and an operational lumen, and wherein advancing the bifurcated sheath catheter include advancing the stabilization lumen over the stabilizer.
Advancing the stabilizer to the secondary vessel and fixing the distal end of the stabilizer within the secondary vessel may further include delivering a stabilization catheter comprising an inflatable balloon past the access to the treatment site into the secondary vessel; and inflating the inflatable balloon within the secondary vessel to fix the distal end of the stabilizer within the secondary vessel by friction with walls of the secondary vessel.
The stabilizer may be a stabilization catheter that is a modified Fogarty balloon catheter.
Advancing the stabilizer to the secondary vessel and fixing the distal end of the stabilizer within the secondary vessel may include delivering a stabilization guidewire comprising a micro-anchor to the secondary vessel past the access to the treatment site; inserting a pin into the patient from outside the patient's body; and engaging the pin with an expanded micro-anchor within the secondary vessel to fix the distal end of the stabilization guide wire within the secondary vessel.
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.
Embodiments of the invention are directed to new devices and associated methods 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 and associated methods stabilize the working lumen or delivery sheath for the carotid stent delivery system. These new devices and associated methods 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 innominately artery rather than directly from the aotic arch), tortuousity 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 0.014 inch or 0.018 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., 0.014 or 0.016 inch, is guided through a, for example, Fr-3 or Fr-5, 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.
In one embodiment, another practical device and method for safely accessing the carotid artery is disclosed. In this 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 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., 0.014 or 0.018 inch diameter, the micro-sheath has a 3 Fr. Diameter, and the sheath catheter has a 5 Fr. Diameter. 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
As shown in
A second stabilization wire 19 is inserted through the radial artery and guided through the subclavian artery 14 to the aortic arch 13. In one embodiment, the second stabilization wire has about a 0.014 inch diameter. The stabilization wire 19 is captured by the snare 21 and then pulled into the sheath catheter 18, as shown in
A reverse curve catheter 24 with an atraumatic tip is then inserted in parallel with the stabilization wire 19 through the sheath catheter 18, as shown in
Next, the reverse curve catheter 24 is removed, leaving the stiff wire 23 in the area of the procedure and the stabilization wire 19 in place, as shown in
A bifurcated catheter having bifurcations 25 and 26 is then advanced over both the stiff wire 23 and the stabilization wire 19 respectively and out of the guide catheter 18. The large leg (or bifurcation) 25 which contains a procedural catheter tracks along the stiff guide wire 23 into the left common carotid artery 15. The small leg (or bifurcation) 26 tracks along the stabilization wire 19 coming from the right subclavian/innominate artery. Both legs 25, 26 have atraumatic tips 28 to reduce trauma, as shown in
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
The bifurcated catheter is now ready for stenting or other procedures in the left internal carotid artery 16.
The process 800A begins by inserting a sheath catheter 18 catheter through the groin access and guided using radiographic imaging using the opaque ring 20 at its distal end through the descending aorta 12 to a location in the aortic arch 13 suitable for access into the left common carotid artery 15 (block S801A).
The process 800A continues by inserting and advancing a snare wire through the sheath catheter 18 and out its distal end into the aortic arch 13 (block S802A).
The process 800A continues by inserting a second stabilization guide wire 19 through the radial artery and guiding it through the right subclavian artery 14 to the aortic arch 13 (block S 803 A).
The process 800A continues by using the snare loop 21 of the snare wire to capture the guide wire 19 and pull it through the sheath catheter 18 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 24 up the lumen of the sheath catheter 18 and into the left common carotid artery 15, again using the opaque ring 25 at its distal end (block S805A).
The process 800A continues by advancing a reasonably stiff guide wire 23 up the reverse curve catheter 24 and into the left common carotid artery 15 to the location of the procedure near the left internal carotid artery 16 (block S806A).
The process 800A continues by removing the reverse curve catheter 24, leaving the stabilization wire 19 and the stiff guide wire 23 in place, both occupying the lumen of the sheath catheter 18 (block S807A).
The process 800A continues by inserting a bifurcated catheter having a main operational leg 25 over the stiff guide wire 23 and having a stabilization leg 26 over the stabilization wire 19 (block S808A).
The process 800A continues by advancing the bifurcated catheter having atraumatic tips 28 on the end of the main operational catheter leg 25 to the aortic arch 13 through the sheath catheter 18 (block S809A).
The process 800A continues by advancing the main operational leg 25 to the location of the procedure by advancing the main operational catheter leg 25 over the stiff wire 23 (block S810A).
The process 800A continues by extending the second leg 26 of the bifurcated catheter over the stabilization wire 19 through the innominate and the subclavian artery 14 (block S811A).
The process 800A continues by removing the stiff wire 23 and the atraumatic tips 28 and applying tension to the stabilization wire 19 to stabilize the working lumen leg 25 at just below the left internal carotid artery 16 (block S812A).
The process continues by performing any treatment procedure, including stenting of the left internal carotid artery 16, through the main operational catheter leg 25 (block S813A).
In another embodiment, the bifurcated catheter accommodates the snare catheter in the secondary lumen. In this embodiment, one leg 25 of the bifurcated catheter is used as the procedural catheter and the other leg of the bifurcated catheter 26 is used initially to send in the snare loop 21 and capture the stabilization wire 19. A reverse curve catheter 24 is sent through the procedural leg 25 of the bifurcated catheter into the LCCA 15 or RCCA and the stiff guide wire 23 is placed at the location of the procedure site. The second leg of the bifurcated catheter already at the aortic arch 13 is equipped with an atraumatic tip 28 and guided along the wire 23 to the location of the procedure. At the same time, the first leg 26 of the bifurcated catheter is extended to cover the stabilization wire 19 into the subclavian artery 15. The atraumatic tip 28 and the stiff wire 23 are then removed and the second leg 25 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
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
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.
The process 800B begins by inserting a guide wire 23 through the femoral artery percutaneously (block S801B).
The process 800B continues by advancing the guide wire 23 through the descending thoracic aorta 12 to the aortic arch 13 using radiographic imaging (block S802B).
The process 800B continues by inserting a guide or sheath catheterl8 having a platinum ring 20 that is opaque to X-ray at its distal end through the groin access and guiding the sheath catheter 18 through the descending aorta over the guide wire to the aortic arch 13 to a location suitable for access into the left common carotid artery 15 and the left internal carotid artery 16 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 25 with the smaller leg 26 arranged parallel to it and guiding the bifurcated catheter over the guide wire 23 to the distal edge 20 of the sheath catheter 18 (block S804B).
The process 800B continues by inserting a stabilization guide wire 19 through the brachial artery preferably using a micro sheath and advancing the stabilization guide wire 19 through the right subclavian artery 14 into the aortic arch 13 (block S805B).
The process 800B continues by extending a second segment of the stabilization guide wire having a snare 21 at its distal end out of the smaller leg 26 of the bifurcated catheter to capture the stabilization wire 19 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 24 through the tortuous connection of the left common carotid artery 15 to the aorta at the aortic arch 13 over a reasonably stiff wire 23 up the working lumen of the larger leg of the bifurcated catheter through the left common carotid artery 15 just below the left internal carotid artery 16 where the procedure is to be carried out (block S807B).
The process 800B continues by removing the reverse guide catheter 24 and leaving the stiff guide wire 23 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 25 of the bifurcated catheter tracking along the stiff guide wire 23 into the left common carotid artery 15 and the small leg 26 tracking along the guide wire 19 coming from the right subclavian/innominate artery (block S809).
The process 800B continues by removing the guide wire 23 and the atraumatic tips 28 and applying tension to the stabilization wire 19 to stabilize the main catheter leg 25 extending to just below the left internal carotid artery 16 (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).
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.
The process 1600 begins by inserting a wire with a snare 51 through a sheath 52 that is inserted through the radial artery and directed through the right subclavian artery 14 such that the snare is in the aortic arch 13 (block S1601).
The process 1600 continues by percutaneously inserting and advancing a reverse curve catheter 53 up the femoral artery into the descending thoracic aorta 12 into the left common carotid artery 15 using radiographic imaging (block S1602).
The process 1600 continues by inserting a secondary stabilization wire 55 into the reverse curve catheter 53 at the proximal end and exited from a hole 56 near the distal end of the reverse curve catheter at the aortic arch 13 to be snared by the snare 51 from the subclavian artery 14 (block S1603).
The process 1600 continues by snaring the stabilization wire 55 to provide an end to end stabilization (55) to the catheter, and extending a stiff guide wire 57 through the reverse curve catheter 53 into the left common carotid artery 15 to the location of the procedure (block S1604).
The process 1600 continues by removing the reverse curve catheter 53, leaving both the stabilization wire 55 and the stiff guide wire 57 in place in the arteries (block S1605).
The process 1600 continues by advancing a bifurcated sheath catheter 58 having two partitions (one for the stabilization wire 55 with a side hole 60 near the distal end and another with a dilator tip 59 for the guide wire 57) over the two wires into position such that the sheath catheter for process 58 is extended into the carotid artery 16 while the stabilization wire 55 through the hole 60 in the bifurcated sheath catheter 58 extends from the proximal end of the sheath catheter 58 through the hole 60, through the aortic arch13 and subclavian artery 14 to provide a through and through capability to provide tension and stabilization to the operating catheter 58 (block S1606).
The process 1600 continues by extending the sheath catheter into the left internal carotid artery 16 to the location of the procedure (block S1607).
The process 1600 continues by removing the stiff guide wire 57 and the atraumatic dilator tip 58 and tensioning the stabilization wire 55 to provide stability to the sheath catheter 58 (block S1608).
The process 1600 continues by inserting the catheter for the procedure through the main chamber of the sheath 58 to the location of the procedure in the left internal carotid artery 16 (block S1609).
The process 1600 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.17, 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 1707 and snare wire 1708 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 1707 and a snare wire 1708, there is a possibility for entanglement and twisting of the two independent catheters or the catheter 1707 and the wire 1708. This can cause difficulty in proper insertion to the site as well as during extraction of the catheter 1707 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
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 1707 and a snare wire 1708 within the same sheath 1706. 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 8 French 70 cm sheath with a coaxial longer 6 French 90 cm catheter and a 0.18 or 0.14 inch snare wire. In this case, the procedure would be complicated by potential wire wrap of the 0.018 inch wire around the 6 French catheter causing entanglements. Furthermore, there would be persistent leakage of blood at the 8 French sheath valve, similar to the twin catheter case, which has both the 0.018 inch wire and 6 French catheter. This can be life threatening.
Another way to provide stabilization to the procedural catheter or sheath is shown in
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 use of disclosed bifurcated sheath, the dual sheath/catheter, or catheter and stabilization wire, for in 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.
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.
Additional implementations using the bifurcated and dual sheath catheters for providing stabilization to the procedural catheter during access into tortuous vessels and during procedures are disclosed. In the previously disclosed embodiments, the stabilization wire or catheter was snared to provide the end to end tension and stabilization via a second percutaneous access through a different vessel. In some procedures this may be difficult or unwanted. Accordingly, additional techniques for providing the necessary tension and stabilization to the procedural catheter using any of the previously discussed bifurcated or dual catheters without a second percutaneous access are disclosed.
For percutaneous intervention of the vessels originating from a tortuous aortic arch, or other tortuous vessels, guide wires and guide catheters are used to enable the placement of procedural catheters accessing the left or right carotid arteries (CA) and other vessels requiring treatment. Due to their diameter and forces applied they can cause trauma to the associated vessels' walls. The use of a bifurcated catheter is disclosed above for stabilizing the working catheters. An alternate to the disclosed device is to use two independent catheters or a catheter and snare wire within a single sheath. All the previously disclosed stabilization methods use a second percutaneous access for the entity used to provide stabilization. Additional techniques for fixing the stabilization entity such as a stabilization wire/a stabilization catheter and providing the tension and stabilization necessary are disclosed: (1) using a stabilization wire with a micro-anchor and pin as shown in, for example,
In order for the bifurcated sheath/catheter 80 to accommodate the procedural catheter 78, typically a 6Fr size, and the modified fogarty catheter 70, typically having a 3Fr size, the bifurcated catheter is modified as ovoid, as shown in
In modifying the Fogarty balloon to improve the functionality of stabilization, the balloon is made elongated (oval) in shape to provide more contact area with the second vessel within which it is expanded, and providing a larger frictional force to be overcome to move the balloon anchor.
Another limitation when using the modified Fogarty balloon is the need to release the balloon to allow blood flow in the secondary vessel used as the anchor vessel. Hence, the modified Fogarty balloon is used to provide the stabilization only during the period when it is needed and is not continuous during the procedure.
A thin stabilization guide wire (SGW) having a compressed micro-anchor at its distal end is introduced into the femoral artery percutaneously as usually done (block S4201).
The SGW is advanced up the femoral artery and into the descending aorta, to the aortic arch the arch, using radiographic imaging (block S4202).
The SGW then selects the right subclavian artery (RSA) and moves into it and through it into the right brachial artery (RBA) (block S4203).
Once inside the RBA the micro-anchor at the distal end of the SGW is expanded and a pin having a sharp pin section and a pin head is inserted from outside the body into the expanded micro-anchor to pin the distal end of the stabilization guide wire in place within the RBA to provide tension and stability for access of the catheters to the procedural site (block S4204).
A Bifurcated (‘Y’) sheath catheter is then advanced over the SGW with the SGW occupying the smaller lumen of the bifurcated sheath catheter to the aortic arch for access into the innominate artery and into the carotid artery (block S4205).
A reverse curve catheter with a stiff 0.35″ guide wire, is guided up through the larger lumen of the sheath catheter to the aortic arch and into the left common carotid artery (LCA) and to the location of the procedure (block S4206).
The reverse curve catheter is now withdrawn leaving the stiff guide wire in place within the LCA as a guide to the procedural arm of the sheath catheter (block S4207).
The procedural arm of the Y sheath catheter having the larger lumen and an atraumatic tip is now advances over the stiff guide wire through the LCA to the location of the procedure, while the second arm of the Y sheath catheter is extended over the stabilization wire into the RSA (block S4208).
The guide wire and the atraumatic tips are now removed from the procedural arm of the ‘Y’ sheath catheter and tension is applied to the stabilization guide wire to enable a stable operational capability for the procedural catheters (block S4209).
The catheter is now at the site and ready for introduction of the procedural instruments and catheters for stenting within the carotids or other procedures at that site as needed (block S4210).
A MFBC having a deflated modified Fogarty balloon at its distal end is introduced into the femoral artery percutaneously as usually done (block S4301).
The MFBC is advanced up the femoral artery and into the descending aorta, to the aortic arch the arch, using radiographic imaging (block S4302).
The MFBC then selects the right subclavian artery (RSA) and moves into it and through it into the right brachial artery (RBA) (block S4303).
Once inside the RBA the modified Fogarty balloon at the distal end of the MFBC is inflated to make firm frictional contact with the side walls of the RBA to provide tension and stability for access of the catheters to the procedural site (block S4304).
A Bifurcated (‘Y’) sheath catheter is then advanced over the MFBC with the MFBC occupying the smaller lumen of the bifurcated sheath catheter to the aortic arch for access into the innominate artery and into the carotid artery (block S4305).
A reverse curve catheter with a stiff 0.35″ guide wire, is guided up through the larger lumen of the sheath catheter to the aortic arch and into the left common carotid artery (LCA) and to the location of the procedure (block S4306).
The reverse curve catheter is now withdrawn leaving the stiff guide wire in place within the LCA as a guide to the procedural arm of the sheath catheter (block S4307).
The procedural arm of the bifurcated Y sheath catheter having the larger lumen and an atraumatic tip is now advances over the stiff guide wire through the LCA to the location of the procedure, while the second arm of the Y sheath catheter is extended over the stabilization wire into the RSA (block S4308).
The guide wire and the atraumatic tips are now removed from the procedural arm of the ‘Y’ sheath catheter and tension is applied to the stabilization guide wire to enable a stable operational capability for the procedural catheters (block S4309).
The catheter is now at the site and ready for introduction of the procedural instruments and catheters for stenting within the carotids or other procedures at that site as needed (block S4310).
One problem of using the Fogarty balloon is that it blocks the flow of blood in the vessel where it is placed when inflated. Hence it is necessary to intermittently deflate the modified Fogarty balloon to keep blood flowing in the vessel and preferably keep the balloon in its deflated state when application of tension for stability is not needed during procedure.
A major advantage of the disclosed devices and methods 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 flow diverters for wide necked aneurysm repair, are relatively stiff and can push the sheath and the device itself out of the treatment location and even the intracranial vascularity creating complications and trauma to the patient. The use of the stabilization device and method can reduce these unwanted incidences and improve the success rate of these procedures.
Yet another advantage of the disclosed devices and methods is the ability provided to safely use a larger caliber device that can easily accommodate larger caliber (8-10 French) flow reversal devices used in carotid stenting. This can be an alternative to using embolic protection devices (EPDs).
Though the above examples show specific examples with access points for the procedural catheter and the stabilization catheter/wires, it is not meant to be limiting. There may be other scenarios possible for access and stabilization of procedural catheter or sheath depending on the location of the procedure and the nature of the patient. The stabilization schemes proposed using either the bifurcated ‘Y’ catheter, the bifurcated side hole catheter or the dual catheter and the modified sheath catheter with the latching mechanism, are all usable to provide stability where the procedures are conducted in tortuous branches of major vessels. As is well understood the preferred method will vary based on the location of the procedure and the nature of the patient.
As will be understood by those familiar with the art, the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. Likewise, the particular naming and division of the members, features, attributes, and other aspects are not mandatory or significant, and the mechanisms that implement the invention or its features may have different structural construct, names, and divisions. Accordingly, the disclosure of the invention is intended to be illustrative, but not limiting, of the scope of the invention.
While the invention has been described in terms of several embodiments, those of ordinary skill in the art will recognize that the invention is not limited to the embodiments described, but can be practiced with modification and alteration within the spirit and scope of the appended claims. The description is thus to be regarded as illustrative instead of limiting. There are numerous other variations to different aspects of the invention described above, which in the interest of conciseness have not been provided in detail. Accordingly, other embodiments are within the scope of the claims.
The invention has been described in relation to particular examples, which are intended in all respects to be illustrative rather than restrictive. Those skilled in the art will appreciate that many different combinations will be suitable for practicing the present invention. Other implementations of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. Various aspects and/or components of the described embodiments may be used singly or in any combination. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
The application is a continuation-in-part of U.S. patent application Ser. No. 15/227,189, filed on Aug. 3, 2016, which claims priority to U.S. Provisional Application No. 62/352,353, filed on Jun. 20, 2016, and is a continuation-in-part of U.S. patent application Ser. No. 14/929,030, filed on Oct. 30, 2015, the entireties of which are herein incorporated by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20170135833 A1 | May 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62352353 | Jun 2016 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15227189 | Aug 2016 | US |
| Child | 15420790 | US | |
| Parent | 14929030 | Oct 2015 | US |
| Child | 15227189 | US |
