System and method for transcatheter aortic valve treatment

Abstract

A system for treating an artery is configured. The system includes an outer delivery sheath configured to be delivered to a vascular location in communication with the aortic arch and an inner catheter defining an inner lumen. An outer lumen is formed between the outer wall of the inner catheter and the inner wall of the outer delivery sheath, and a filter is disposed at the distal end of the inner catheter. An extracorporeal shunt is configured to receive blood flow from the inner lumen, and the filter is coupled to the shunt.

Description

Technical Field

[0001] The present disclosure relates to methods and devices for replacing heart valves.

Background Art

[0002] Patients with defects in the aortic heart valve are often candidates for heart valve replacement procedures. Conventional treatment is surgical replacement of the heart valve with an artificial valve. This surgery involves full sternotomy or median sternotomy, cardiopulmonary bypass and cardiac arrest, surgical access to and excision of the diseased heart valve, and replacement of the heart valve, providing good long-term prognosis with durability up to 10 or 15 years for bioprosthetic valves and even longer for mechanical valves for these patients. However, heart valve replacement surgery is very invasive and may require a long recovery time, with short-term and long-term complications. For patients with high surgical risk or who are inoperable, this procedure may not be an option.

[0003] Minimally invasive techniques for heart valve replacement have been developed. This technique, known as transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR), relies on the development of a collapsible artificial valve attached to a catheter-based delivery system. This type of prosthesis can be inserted into the patient through a relatively small incision or vascular access site and can be implanted in the beating heart without cardiac arrest. Advantages of this technique include less surgical trauma, faster recovery time, and lower complication rates. For patients with high surgical risk or who are inoperable, this technique provides a good alternative to conventional surgery.

Summary of the Invention

[0004] There is a need for an access system for implanting a prosthetic aortic valve that provides a generally shorter and more linear access path than current systems and methods. There is also a need for an access system that provides protection from cerebroembolic complications during the procedure.

[0005] Disclosed herein are devices and methods that enable transcarotid access via the common carotid artery or subclavian access to the native aortic valve, and transcatheter implantation of a prosthetic aortic valve into the heart or aorta. The devices and methods also provide means for embolic protection during such vascular aortic valve implantation procedures.

[0006] In one aspect, a system for treating an artery includes an outer delivery sheath configured to be delivered to a vascular location in communication with the aortic arch, an inner catheter defining an inner lumen and slidably disposed within the outer delivery sheath such that an outer lumen is formed between an outer wall of the inner catheter and an inner wall of the outer delivery sheath, a filter disposed at a distal end of the inner catheter and configured to direct debris from the blood vessel through blood flow to the filter and into the inner lumen of the inner catheter, an extracorporeal shunt configured to receive blood flow from the inner lumen, and a filter coupled to the shunt.

[0007] Other aspects, features, and advantages should become apparent from the following description of various embodiments, which illustrate the principles of the disclosure by way of example. BRIEF DESCRIPTION OF THE DRAWINGS

[0008]

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DETAILED DESCRIPTION OF THE INVENTION

[0009] Disclosed herein are devices and methods that enable arterial access, such as transcarotid access via the common carotid artery to the native aortic valve or subclavian access via the subclavian artery, and the implantation of an artificial aortic valve into the heart or aorta. The devices and methods also provide means for embolic protection during such vascular aortic valve implantation procedures. It should be understood that the disclosed systems and methods can also be configured for use via a transfemoral arterial access site and are not limited to use via a specific access site.

[0010] In one embodiment, carotid or subclavian artery access to the aortic valve is achieved via either percutaneous puncture of the artery or direct incision. An incision may be advantageous because percutaneous vascular closure of a larger arterial opening in the common carotid artery is difficult. If desired, a pre-stitch can be placed at the arterial opening site to facilitate closure at the end of the procedure. An access sheath is provided that is sized to fit the common carotid artery or subclavian artery and has an associated dilator and guide wire. The access sheath is inserted into the artery downward toward the aortic arch. Either the left or right common carotid artery or subclavian artery can be selected as the access site based on factors including, for example, the proximal artery and / or aortic pathology, and the angle of entry of the carotid or innominate artery into the aorta. The carotid artery can then be occluded distal to the access site. If the access is via a direct surgical incision and arterial opening, occlusion can be achieved via a vascular clamp, vascular loop, or Rummel tourniquet. Alternatively, the access sheath itself can include an occlusion element, such as an occlusion balloon, adapted to occlude the artery, and embolic particles can be prevented from entering the carotid artery distal to the access site during the procedure.

[0011] Figure 1 shows a side view of an exemplary arterial access sheath 110 formed from an elongated body having an internal lumen. In one embodiment, the sheath has a working length of 10-60 cm, which is the portion of the sheath that can be inserted into the artery during use. The lumen of the sheath has an inner diameter sized to accommodate the insertion of a vascular valve delivery system, such as a 18 French to 22 French (.236” to.288”) system. In one embodiment, the delivery system has a small inner diameter of about.182”. The access sheath 110 can have an expandable occlusion element 129 disposed within the access sheath. The occlusion element 129 is configured to expand to a size for occluding the flow through the artery. The occlusion element 129 can be placed anywhere in the artery or aorta. In one embodiment, the occlusion element is an occlusion balloon.

[0012] When the sheath 110 is placed in an artery, the occlusion element 129, if present, is optionally expanded in the artery to occlude the artery and, in some cases, anchor the sheath in place. The arterial access sheath 110 can include a Y-arm for aspiration for delivery of contrast agent or saline flushing and / or can be fluidly connected to a shunt, which provides a shunt lumen or path for blood to flow from the arterial access sheath 110 to a return site such as a vascular return site or collection reservoir. In this regard, a retrograde or blood reflux state can be established in at least a portion of the artery. The sheath 110 can also include a Y-arm for inflating an occlusion balloon via an inflation lumen and a hemostatic valve for introducing a vascular valve delivery system into the sheath. Alternatively, the sheath 110 can include an actuating element if the occlusion element is a mechanical occlusion structure. The vascular valve delivery system can include an artificial valve and a delivery catheter. In some embodiments, the delivery catheter has a working length of 30-80 cm, including 30, 40, 60, 70, or 80 cm, although the length can vary.

[0013] In some embodiments, aspiration can be applied to the artery via the access sheath 110. In this regard, the access sheath 110 can be connected to an aspiration source via the Y-arm 112, such that embolic debris that might otherwise enter the remaining head and neck vessels or move downstream into the peripheral vessels can be captured. The aspiration source can be active, for example, a cardiotomy suction source, a pump, or a syringe. Alternatively, a passive flow state can be established, for example, by fluidly connecting the Y-arm 112 to a low-pressure source such as a collection reservoir at atmospheric or negative pressure or to a shunt connected to the patient's venous return site. The passive flow rate can be adjusted, for example, by controlling the restriction of the shunt flow path.

[0014] In one embodiment, the access system can comprise one or more embolic protection elements to provide embolic protection of one or both carotid arteries and one or all of the head or neck vessels. For example, a filter can be included in the access system to provide embolic protection of one or both carotid arteries. In a variation of this embodiment, the filter is deployed via the contralateral carotid artery, brachial artery, or subclavian artery and positioned across the ostium into the aortic arch. If the sheath access site is the left common carotid artery, the filter can be positioned across the ostium of the innominate artery (also known as the brachiocephalic artery). If the sheath access site is the right common carotid artery, the filter can be positioned across the ostium of the left common carotid artery. In a variation of this embodiment, the filter is deployed across both the innominate artery and the left common carotid artery, or across all three of the head and neck vessels (the innominate artery, left common carotid artery, and left subclavian artery). The filter element can be incorporated within the access sheath 110. Alternatively, the filter element can be a separate element that mates with the access sheath 110. For example, the filter element can be a coaxial element slidably connected to the access sheath, or an element positioned alongside the access sheath. The filter element can comprise an expandable frame such that it can be expanded at the target site so that it is positioned across the openings of one or more arteries after being inserted into the artery in a collapsed state.

[0015] Figure 2 shows a side view of an exemplary access sheath 110 having a filter element 111 attached to the sheath. Figure 3 shows a front view of the filter element 111 showing an exemplary outer shape of the filter element 111. In the embodiment of Figure 3, the filter element 111 is sized and shaped to fit over and occlude the head and neck vessels. In certain embodiments, the deployed filter has a longitudinal dimension of about 2, 3, 4, or 5 cm and a transverse dimension of about 1, 1.5, or 2 cm. It should be understood that the outer shape shown in Figure 3 is exemplary and that the shape of the filter element 111 can vary. For example, the shape of the filter element can be oval, circular, elliptical, or rectangular. The filter material can be a woven or knitted fabric material or a porous polymer membrane such as polyurethane. The filter material can be nitinol. The filter porosity can be 50, 100, 150, 200, or 300 microns, or any porosity therebetween. The expandable frame of the filter element can be made from a spring material such as a wire or ribbon of stainless steel or nitinol.

[0016] In embodiments with a filter element, the occlusion and / or aspiration means can continue to be part of the system and can provide embolic protection during filter deployment prior to valve implantation and during filter retrieval after valve implantation. The filter element itself can be the primary means of embolic protection during the implantation procedure. The sheath 110 can also include both an occlusion element 129 and a filter element 111, as shown in Figure 4.

[0017] In another variation of this embodiment, shown in FIG. 5A, the sheath 110 includes an aortic filter element 113 that is deployed across the ascending aorta and is thus sized and shaped to protect all head and neck vessels from embolic debris. The shape of the filter element can be various. In one embodiment, the shape of the filter element can be a cone or a closed-end tube. The expandable frame of the filter frame is sized and shaped to traverse the entire diameter of the aorta when deployed. For example, the expandable frame can be a loop that can expand from 12 mm to 30 mm in diameter. Alternatively, the expandable frame can be a series of struts that are connected at one or both ends and expand outwardly to deploy the filter element across the diameter of the aorta. The filter material can be a woven or knitted fabric material or a porous polymer membrane such as polyurethane. The filter porosity can be about 40, 100, 150, 200, or 300 microns, or any porosity in between.

[0018] The expandable frame of the filter element can be made from a spring material such as a wire or ribbon made of stainless steel or nitinol. Similar to the previous variation, occlusion and aspiration means can be included in this variation to provide protection during filter deployment and filter retrieval. The aortic filter element 113 can be integral with the sheath or a separate device that fits the sheath, for example, coaxial with the access sheath or can be juxtaposed with the access sheath. As shown in FIG. 5B, an embodiment of the sheath 110 can include both an aortic filter element 113 and an occlusion element 129.

[0019] FIG. 6 schematically shows a diagram of the vascular system showing normal antegrade circulation. The blood vessels are labeled in FIG. 6 as follows: ACA: anterior cerebral artery, MCA: middle cerebral artery, PCA: posterior cerebral artery, ICA: internal carotid artery, ECA: external carotid artery, LCCA: left common carotid artery, RCCA: right common carotid artery, LSCA: left subclavian artery, RSCA: right subclavian artery, IA: innominate artery, AAO: ascending aorta, DAo: descending aorta, AV: aortic valve.

[0020] In certain situations, it may be desirable to provide a mechanism for perfusing the carotid artery upstream of the entry point of the access sheath 110 into the carotid or brachiocephalic artery. If the access sheath 110 is of a size similar to that of the carotid or brachiocephalic artery, when the sheath is inserted into the artery, the flow through the artery may be essentially blocked by the access sheath. In this situation, due to the blockage of the carotid artery by the sheath, the upstream cerebral blood vessels may not be adequately perfused. In an embodiment of the access sheath 110, the sheath includes a mechanism for perfusing the upstream carotid artery and cerebral blood vessels.

[0021] FIG. 7A shows an exemplary embodiment of such an access sheath 110 deployed in the vasculature. The proximal portion of the access sheath has two parallel internal lumens that are part of one monolithic structure of the access sheath. A first lumen 775 extends from the proximal end of the sheath to the distal tip of the sheath and is fluidly connected at its proximal end to a shunt Y - arm 755 and a hemostatic valve 777 located at the proximal end of the sheath. The first lumen 775 is sized and shaped to receive and enable the delivery of a trans - catheter aortic valve and delivery system through the hemostatic valve 777. For example, the first lumen has a length such that its distal opening is positioned in the heart or aorta. A second lumen 769 is disposed adjacent to the first lumen and extends from the proximal end of the sheath to a distal opening at the shaft intermediate position 765 and is fluidly connected at its proximal end to a second perfusion Y - arm 767. There is an opening at the distal end of the second lumen at the intermediate position 765. The second lumen 769 is sized and shaped to enable the diversion of blood to the carotid artery distal to the access sheath insertion site. An X - ray radiopaque shaft marker can be placed at this position of the sheath to make this opening readily visible to the user under fluoroscopy. The perfusion lumen has a length such that, in use, its distal opening is positioned in the distal carotid artery and can be perfused. The proximal end of the first lumen has a proximal connector with the hemostatic valve 777 and Y - arm. As described above, the hemostatic valve is sized such that the arterial valve delivery system can be inserted and fit through it. The proximal end of the perfusion lumen also has a proximal connector. The proximal connector and / or Y - arm enable the attachment of the shunt.

[0022] The Y-arm 755 is removably connected to a flow shunt 760 that is removably connected to a second Y-arm 767. The shunt defines an inner shunt lumen that fluidly connects a first lumen 775 to a second lumen 769. A valve 779 can be disposed between the Y-arm 755 and the flow shunt 760 to enable cleaning and contrast agent injection while the shunt 760 is connected. When the sheath is disposed in the artery, arterial pressure feeds blood flow into the distal end of the first lumen 775 of the arterial access sheath, sends it out from the first lumen by the Y-arm 755, then feeds it into the shunt 760, and returns it to the sheath via the Y-arm 767. The blood then flows into the parallel second lumen 769 and flows into the distal jugular artery at position 765 to perfuse the vasculature distal to the arterial sheath 110. An in-line filter element 762 can be included in the flow shunt 760 so that emboli generated during the procedure do not perfuse the cerebral arteries. If the sheath 110, the shunt 760, and the lumen 769 generate a flow restriction that limits adequate perfusion, an active pump 770 can be incorporated into the flow shunt 760 to drive blood flow and provide the required level of cerebral perfusion. This may be particularly applicable when the valve is being delivered through the first lumen 775 of the access sheath 110.

[0023] Figure 7B shows a modification of the embodiment of Figure 7A. The Y-arm 767 fluidly connects the shunt 760 to a second lumen 769 that is parallel and reintroduces blood from the shunt 760 to the artery at location 765 when disposed in the artery. The shunt 760 of this embodiment is not fluidly connected to the first lumen 775 of the sheath. Instead of receiving blood from the access sheath via the Y-arm 755, the shunt 760 can be connected to another arterial blood source, such as the femoral artery, subclavian artery, or contralateral carotid artery, via a second sheath. In this modification, the diverted blood flow is not restricted by the delivery of a valve through the first lumen 775 of the access sheath. In this embodiment, since the blood source is far from the treatment area and the risk of distal embolism in the diverted blood is minimal, a filter 762 is not required in the shunt line. The Y-arm 755 can continue to be used for flushing and contrast agent injection into the sheath. In another modification shown in Figure 8A, the arterial access sheath 110 has one lumen 775 that is fluidly connected to the Y-arm 755 in the proximal region. The lumen 775 is sized and shaped to receive and enable the delivery of a transcatheter aortic valve and delivery system through a hemostatic valve 777. The Y-arm 755 is connected to a flow shunt 760 that is connected to a second arterial sheath 802 that is sized and shaped to be introduced into the carotid artery distal to the arterial access point where the access sheath 110 is introduced. A stopcock 779 can be placed between the Y-arm 755 and the flow shunt 760 to enable flushing and contrast agent injection while the shunt 760 is connected. When the sheath is properly positioned in the artery, arterial pressure drives the flow into the lumen 775 of the sheath 110, out of the first lumen via the Y-arm 755, through the shunt 760, through the second catheter 802, and back into the carotid artery upstream from the arterial access point to perfuse the vasculature distal to the arterial sheath 110. As described above, a filter element 762 can be included in the flow shunt 760 so that emboli generated during the procedure do not perfuse the cerebral arteries.When the sheath 110 and the shunt 760 are subject to flow restrictions that limit proper perfusion, for example, when a valve is being delivered through the lumen 775 of the access sheath 110, an active pump 770 can be incorporated into the flow shunt to drive blood flow and provide the necessary level of cerebral perfusion.

[0024] FIG. 8B shows a variation of the embodiment of FIG. 8A. Here, the second arterial sheath 802 is removably or fixedly connected to a shunt or flow line 760 that is connected to another arterial source, such as the femoral artery, subclavian artery, or contralateral carotid artery, via another sheath. In this variation, the shunted blood flow is not restricted by the delivery of a valve through the lumen 775 of the access sheath. In this embodiment, since the blood source is far from the treatment area and the risk of distal embolism in the shunted blood is minimal, a filter 762 is not required in the shunt line. The Y-arm 755 can continue to be used for sheath flushing and contrast agent injection.

[0025] In the embodiments described above with reference to FIGS. 7A and 7B and FIGS. 8A and 8B, the arterial access sheath 110 can include an occlusion element (not shown) at the distal end of the sheath configured to occlude the carotid artery and help prevent the entry of emboli into the carotid artery. Additionally, in these embodiments, the flow shunt 760, and where applicable, the pump 770 and / or the second sheath 802, can be provided as separate components within one kit to enable transcarotid access and carotid shunting during a catheter-based aortic valve replacement procedure.

[0026] The figure shows sheath insertion into the common carotid artery, but a similar sheath or sheath / shunt system can be designed for subclavian artery access. An exemplary valve and delivery system configured to be delivered through a transcarotid access sheath 110 is shown in FIG. 9. The path from the transcarotid access site is considerably shorter and more linear compared to the transfemoral or subclavian approaches. As a result, the delivery system can be made shorter and the proximal portion can be made very rigid, both of which enable greater push and torque control and improve the accuracy of prosthetic valve placement and deployment. The distal portion is highly flexible to enable accurate tracking around the ascending aorta and entry into the position of the aortic valve annulus. The material for the delivery system can include a material that is reinforced, has a high durometer, and / or has a thick wall compared to current delivery systems to provide this high rigidity.

[0027] The balloon-expandable prosthetic aortic valve 205 is attached to the distal end of a vascular valve delivery system 200. The delivery system has a distal tapered tip 220 and an expandable balloon 215 at the distal end of an inner shaft 210. In some embodiments, the system also has an outer sleeve, such as a pusher sleeve 230, that is slidable along the long axis of the device and maintains the valve in a fixed position on the balloon during delivery. A proximal control assembly houses a mechanism for storing the pusher sleeve, such as a sliding button 270 at the proximal handle 240. In FIG. 9, the pusher sleeve 230 is shown retracted from the valve and proximal balloon so that the valve can be expanded without interference from the pusher sleeve 230. A connector 250 enables connection of an inflation device to the balloon inflation lumen of the balloon 215. A proximal rotary hemostatic valve 260 enables system flushing and sealing around a guide wire (not shown) when the valve delivery system is advanced into position on the guide wire.

[0028] The working length of the valve delivery system is configured to enable delivery of the valve from the transcarotid access site to the aortic valve annulus. Specifically, the working length of the valve delivery system 200 can be 45-60 cm. The delivery system shaft is also configured for delivery from a right or left carotid access site. Specifically, the shaft has a proximal rigid portion 280 and a more flexible distal portion 290. In some embodiments, the distal portion has 2-4 times the flexibility of the proximal rigid portion. In some embodiments, the distal flexible portion is 1 / 4 to 1 / 3 of the total operable length of the valve delivery system. Specifically, the distal flexible portion ranges from 10 cm to 20 cm. In an alternative embodiment, the valve delivery system has a transition portion consisting of one or more flexible lengths that provide flexibility between the distal flexible portion and the proximal flexible portion.

[0029] Another exemplary valve and delivery system configured for transcarotid delivery is shown in FIG. 10. The self-expanding prosthetic aortic valve 305 is attached to the distal end of the vascular valve delivery system 300. The delivery system has a distal tapered tip 320 at the distal end of the inner shaft 310. The valve 305 is disposed within the inner shaft 310 and is housed within a retractable sleeve 330 that is slidable along the longitudinal axis of the device. The proximal control assembly houses a mechanism for housing the retractable sleeve, such as a sliding button 370. In some embodiments, the design of the valve 305 and sleeve 330 is such that the sleeve can be advanced distally again into contact with the valve to reposition the valve 305 if the initial position is inaccurate and the valve can be folded. The proximal rotary hemostatic valve 360 enables system flushing and sealing around a guidewire (not shown) when the valve delivery system is advanced to a fixed position on the guidewire.

[0030] Similar to the previous embodiments, the working length of the valve delivery system is configured to enable delivery of the valve from the transcarotid access site to the aortic valve annulus. Specifically, the working length of the valve delivery system 300 is 45 to 60 cm. The delivery system shaft is also configured for delivery from a right or left carotid access site. Specifically, the shaft has a proximal rigid portion 380 and a more flexible distal portion 390. In certain embodiments, the distal portion has 2 to 4 times the flexibility of the proximal rigid portion. In certain embodiments, the distal flexible portion is one quarter to one third of the total operative length of the valve delivery system. Specifically, the distal flexible portion ranges from 10 cm to 20 cm. In an alternative embodiment, the valve delivery system has a transition portion consisting of one or more flexible lengths that are flexible between the distal flexible portion and the proximal flexible portion.

[0031] An exemplary method of use will now be described. In certain embodiments, the general method includes forming an entry into the wall of the common carotid artery from the patient's neck (or other access location such that the present disclosure is not limited to entry in the common carotid artery), introducing an access sheath through the entry with the tip directed downward toward the ostium of the artery, inserting a guidewire through the access sheath across the native aortic valve into the ascending aorta, and introducing an artificial valve through the access sheath and deploying the artificial valve percutaneously at or near the location of the native aortic valve. In certain embodiments, the artery is occluded distally (upstream) from the tip of the sheath.

[0032] In particular, the access sheath 110 is first inserted into the vasculature via, for example, either percutaneous puncture of the carotid artery or direct surgical incision and puncture. As described above, a transcarotid approach to the aortic valve can be achieved via the LCCA. When appropriately positioned, the occlusion element 129 can be expanded to occlude the LCCA, as schematically shown in FIG. 11. In another embodiment, a transcarotid approach to the aortic valve can be achieved via the RCCA with the occlusion element 129 occluding the RCCA, as shown in FIG. 12. In another embodiment, a transcarotid approach to the aortic valve can be achieved via the RCCA with the occlusion element 129 occluding the innominate artery IA, as shown in FIG. 13. The occlusion achieved via the occlusion element 129 can also be realized, for example, by directly clamping the carotid blood vessel using a vascular clamp, a vascular loop, or a Rummel tourniquet.

[0033] Once the access sheath is positioned and the embolic protection means is deployed via the occlusion element, the aspiration element, and / or the filter element, access to the aortic valve is obtained via a guidewire 119 (such as a 0.035” or 0.038” guidewire) inserted into the sheath 110 and directed downward into the ascending aorta to cross the native aortic valve. Pre-dilation of the native aortic valve can be performed using an appropriately sized dilation balloon, such as a valvuloplasty balloon, prior to valve implantation. The guidewire 119 is used to position the balloon across the valve, and the balloon is inflated and deflated and then removed while the guidewire remains in place.

[0034] Next, the prosthetic heart valve 205 and the delivery system 200 (or delivery system 300) are inserted over the guide wire 119 through the access sheath 110, and the valve 205 is positioned at the native aortic valve site (as shown in FIG. 14). Next, the prosthetic valve 205 is deployed. Once the deployment step is complete, the function of the deployed prosthetic valve 205 can be accessed via ultrasound, injection of a contrast agent under fluoroscopy, or other imaging means. Depending on the design of the delivery system 200, the prosthetic valve 205 can be adjusted as needed to achieve optimal valve function and position prior to final deployment. Next, the delivery system 200 and the guide wire 119 are removed from the access sheath 110. After removing the delivery system 200 and the guide wire 119, the embolic protection element is removed. Suction can be continued during this time to capture embolic debris trapped in the sheath tip, occlusion element, and / or filter element.

[0035] Next, the access sheath 110 is removed and the access site is closed. If the access was by direct puncture of a surgical incision, the vessel is closed by ligating pre-placed stitches, by manual suturing, or by a surgical vessel closure device, as described in more detail below. If the access was percutaneous, percutaneous closure methods and devices can be employed to achieve hemostasis at the access site. In one embodiment, the closure device is applied at the site of the introducer prior to introducing the arterial access sheath through the introducer. The type of closure device can vary.

[0036] The above access site is either the left common carotid artery or the right common carotid artery. Other access sites, such as the left subclavian artery or the right subclavian artery or the left brachial artery or the right brachial artery, are also possible. These arteries may require a longer and / or more tortuous path to the aorta, but have other advantages over carotid access, such as being able to work away from the patient's head, avoiding poor neck anatomical structures such as previous carotid endarterectomy or other neck surgeries or radiation, or resulting in a lower risk in cases where the access site is complex. In addition, carotid artery disease or small carotid arteries may prevent common carotid artery access. In any of these access site cases, occlusion, aspiration, and / or filtration of the head and neck blood vessels during TAVI can increase the speed and accuracy of the procedure and reduce the embolic complication rate.

[0037] If access to the carotid artery was by surgical incision, the access site can be closed using standard vascular surgical techniques. A purse-string suture can be applied before sheath insertion and then used to ligate the access site after sheath removal. If the access site was a percutaneous access, a variety of vascular closure elements can be utilized. In one embodiment, the vascular closure element is a mechanical element that includes an anchoring portion and a closure portion such as a self-closing portion. The anchoring portion can include hooks, pins, staples, clips, tines, sutures, etc., which are engaged to the outer surface of the common carotid artery around the penetration site to secure the self-closing element when the penetration site is fully open. The self-closing element can also include a spring-like or other self-closing portion that closes the anchoring portion to draw the arterial wall tissue together to effect closure upon sheath removal. Usually, the closure is sufficient such that no further measures are needed to close or seal the penetration site. However, optionally, it may be desirable to effect an auxiliary seal of the self-closing element after the sheath has been withdrawn. For example, the self-closing element and / or the tissue tract within the element can be treated with a hemostatic material such as a bioabsorbable polymer, a collagen plug, an adhesive, a sealant, a coagulation factor, or other coagulation promoter. Alternatively, the tissue or self-closing element can be sealed using other sealing protocols such as electrocautery, suturing, clipping, stapling, etc. In another method, the self-closing element is a self-sealing membrane or gasket material that is attached to the outer wall of the blood vessel by a clip, an adhesive, a band, or other means. The self-sealing membrane can have an internal opening such as a slit or a cross-cut that is normally closed against blood pressure. Any of these self-closing elements can be designed to be placed in an open surgical procedure or deployed percutaneously.

[0038] In an alternative embodiment, the vascular closure element is a suture-based vascular closure device. The suture-based vascular closure device can place one or more sutures across the vascular access site such that when the suture ends are ligated after sheath removal, one or more stitches provide hemostasis for the access site. The sutures can be applied either before inserting the treatment sheath through the arterial opening or after removing the sheath from the arterial opening. The device can maintain temporary hemostasis of the arterial opening after placement of the sutures but before and during placement of the treatment sheath, and can also maintain temporary hemostasis after withdrawing the treatment sheath but before ligating the sutures. U.S. Patent Application No. 12 / 834,869, titled "SYSTEMS AND METHODS FOR TREATING A CAROTID ARTERY," which is hereby incorporated by reference in its entirety, describes exemplary closure devices and also describes various other devices, systems, and methods related to and combinable with the devices, systems, and methods disclosed herein.

[0039] Figure 15A shows a schematic view of an embodiment in which access sheath 2605 is used to obtain trans-cervical access to the RCCA. Flow catheter 2610 also accesses the LCCA via insertion through access sheath 2605. The RCCA is clamped (or occluded) to stop or partially stop blood flow through the RCCA. Flow catheter 2610 can be used to inject fluid (e.g., saline, etc.) into the contralateral common carotid artery (or other location), such as when the interventional procedure can generate embolic particles. The injected fluid is configured to divert those particles away from the neurovascular system, e.g., from a predetermined location in the neurovascular system. The injected fluid may be referred to as a "fluid curtain," and the fluid curtain or the injected fluid creates flow conditions, such as flow velocity or direction, that redirect embolic debris along a modified flow trajectory that is different from the original flow trajectory that would occur in the absence of the fluid curtain.

[0040] In this embodiment, there can be two non-limiting exemplary modes of operation. Sub-systolic pressure: A predetermined pressure, such as a pressure of about 100 mmHg, is maintained that flows forward only during the time when the patient's blood pressure drops significantly, changing the flow path of the flow and the embolic particles. When temporary pacing is performed to stabilize the aortic valve, the blood pressure drops during the placement of the aortic valve. This step of the procedure may generate a significant number of embolic particles, and the change in the flow path is caused naturally by the drop in the patient's blood pressure.

[0041] Supra-systolic pressure: To block the inflowing blood flow and minimize the passage of embolic particles from the aortic valve to the carotid artery, the flow path change is actuated via a fluid injected at a pressure slightly higher than the systolic blood pressure during an individual period of the procedure.

[0042] The exemplary treatment steps according to the embodiment of FIG. 15A include the following. First, access to the desired CCA is achieved, and an access system (such as access sheath 2605 or other catheter, etc.) is used to gain access to the vasculature. Next, the accessed CCA is occluded to stop or otherwise limit the flow through it. The occlusion can occur, for example, via an expandable element such as a clamp or balloon sheath. Then, the flow catheter 2610 is delivered to the contralateral CCA (through or adjacent to the access sheath 2605). Next, saline (or other fluid) is injected into the CCA as desired by the mechanism described herein. Treatment of the heart or aorta is performed as intended through the access system. Optionally, reversal of the flow can be achieved on the access side CCA to increase neuroperfusion.

[0043] FIG. 15B shows a schematic view of a vasculature arranged such that catheter 2620 accesses the aortic arch (defining the aortic valve annulus) via the RCCA so that catheter 2620 can inject fluid into the aortic arch or other desired location. In an alternative version, catheter 2620 can be an access sheath having at least one internal lumen and at least one outlet for injecting fluid in the same or a similar manner as described for catheter 2620. Catheter 2620 has at least one fluid outlet that directs the fluid flow from the catheter such that embolic debris 2625 follows a modified flow trajectory 2630 that is different from the original path. The redirected particles can be solid particles and / or air particles. Catheter 2620 can have one or more outlets configured to achieve a desired flow profile of the fluid directed outward from the outlet.

[0044] FIG. 15C shows a schematic view of a vasculature arranged such that catheter 2620 is disposed via the LCCA so that fluid can be injected into the aortic arch through the lumen of catheter 2620, etc., from which fluid exits from the distal region or opening at the distal end of catheter 2620. In this embodiment, catheter 2620 has more than one outlet to achieve at least two fluid flows that direct the fluid flow in at least two different directions. The injected fluid causes embolic debris 2625 to follow at least one modified flow trajectory 2630 that is different from the original flow trajectory 2635.

[0045] FIG. 15D shows a schematic view of a vascular system in which a catheter (or sheath) 2640 is inserted into the RCCA to access the aortic arch. The RCCA is clamped adjacent to the catheter 2640 (via a Rummel loop 2641, etc.). The catheter 2640 is configured to inject fluid into a vascular system such as the aortic arch. The catheter 2640 is attached to (or can be used to deliver) an aerodynamic or hydrodynamic deflection element such as a spoiler 2645 disposed at or near the distal end of the catheter 2640. The catheter can be used to place the spoiler 2645 in the aortic arch such that the spoiler obstructs or otherwise modulates the flow of fluid through the aortic arch in a desired manner. The spoiler is configured to have at least one outer surface that interacts with the fluid flow to regulate or modify the fluid flow. In certain embodiments, the spoiler 2645 generates a flow bias of the blood flow coming from the aortic valve such that it is deflected away from the CCA or away from a predetermined location in the vascular system. A flow curtain occurs posteriorly (e.g., closer to the CCA) such that deflected particles swirl or otherwise minimize entry into the CCA. The flow curtain can be generated by a hydrodynamic spoiler effect or the flow curtain can be used in combination with a spoiler that does not generate a flow curtain. The spoiler 2645 can be made of various materials. In one example, the spoiler 2645 is made of ultra-high molecular weight polyethylene (UHMWPE) supported by a wireframe.

[0046] FIG. 15E shows a schematic view (not to scale) of the distal region of catheter 2640 disposed in the aortic arch via the RCCA. Spoiler 2645 is disposed in the aortic arch downstream of the laminar aortic blood flow 2650. Catheter 2640 includes a proximal large-diameter region that transitions to a smaller-diameter region having an internal lumen 2655 that can be fluidly coupled to a fluid source (such as blood diverted from another vascular location). The outlet 2657 of the internal lumen 2655 provides a path for the fluid (such as diverted fluid) to be injected into the aortic arch. The fluid injected through the outlet 2657 can initially be laminar flow 2660. Additionally, the spoiler 2645 disrupts or otherwise modifies the laminar aortic blood flow 2650 to create a region of turbulent aortic blood flow 2663.

[0047] Continuing to refer to FIG. 15E, catheter 2640 also includes an opening 2665 that communicates with the larger internal lumen of catheter 2640. The larger internal lumen and the opening 2665 can be used to deliver an intervention device such as a valve delivery device. It should be understood that the embodiments shown in FIGS. 15D and 15E can be modified for a technique via the LCCA. The relative positions of the lumens and spoilers of the device can be changed as appropriate.

[0048] FIG. 16A shows a schematic diagram of another embodiment in which the arterial shunt 2705 is combined with or otherwise coupled to the access sheath 2605. The shunt 2705 has an internal lumen such that blood flow can be sent from a first position to a second position through the shunt 2705. According to an exemplary procedure, access to the desired CCA (left or right) is achieved and an access system (access sheath 2605 or other catheter, etc.) is used to gain access to the vasculature. Next, the accessed CCA is occluded, such as by using a clamp or an expandable balloon to form a carotid stump region over the clamp (or balloon). The carotid stump region above the position of the clamp is also accessed using the arterial shunt 2705. As described above, the arterial shunt 2705 has an internal lumen that forms an antegrade flow path (bypass or shunt) between two access points across the position of the clamp. Next, a procedure on the heart or aorta is performed via the access sheath 2605.

[0049] Continuing to refer to FIG. 16A, the shunt 2705 can include one or more blood flow control elements 2720 configured to modify or regulate the state of blood flow through the shunt 2705. For example, the flow control element 2720 can include a filter for capturing debris such as embolic particles of a predetermined size. The flow control element 2720 can also include an air trap or bubble trap for capturing air. This addresses the risk of air being introduced into the blood flow during a procedure via the shunt. The flow control element 2720 can also be configured to adjust the profile of the blood flow so as to achieve desired flow conditions and / or to meet the patient's tolerance. The size of the filter (or any filter described herein) can vary. In a non-limiting example, the filter is a 200 micrometer pore size filter, or a smaller filter such as a 50 μm or 100 μm pore size filter.

[0050] The flow through the shunt can occur passively such that the blood flow is driven by a naturally occurring pressure differential. For example, a higher pressure can exist from the RCCA below the carotid clamp and a lower pressure can exist from the RCCA above the carotid clamp. The flow can also occur actively such that the flow is driven by a pump mechanism. In non-limiting examples, blood is pushed passively or actively across the Circle of Willis (CoW) to provide neuroperfusion during a treatment procedure. The forward flow across the CoW can prevent particles from moving to the contralateral side, as represented by the dashed arrow elements in FIG. 16A.

[0051] This procedure enables the manipulation of blood to safely achieve neuroprotective benefits such as perfusion of blood to the brain, capture of debris from the blood flow during the procedure, and pushing of anterograde blood flow through or to the brain that prevents debris from ascending into the contralateral vessel.

[0052] The arterial shunt 2705 can have any of a variety of lengths and sizes to achieve the desired flow characteristics and to effect a connection between different locations in the vasculature. The length can be made shorter to divert the flow across more local vessels (such as the carotid-carotid pathway or the carotid-jugular pathway), or longer to divert the flow across more distant locations (such as the carotid-iliac pathway). FIG. 16B shows a schematic of possible flow paths that can be achieved by use of the shunt 2705. FIG. 16B shows this in relation to right carotid access, but left access is within the scope of the present disclosure.

[0053] The shunt 2705 can be connected to the blood flow in a variety of ways, such as via a sheath 2605 (as shown in FIG. 16A), or via a secure connection to a conforming device, or through a surgically attached conduit.

[0054] FIG. 17 shows an embodiment where balloon 2607 is placed in the contralateral CCA to occlude (or partially occlude) the flow in the contralateral CCA, providing additional brain protection. Partial occlusion may also be sufficient to reduce flow and embolic particles. In an alternative embodiment, an embolic filter can be placed in the contralateral CCA (or other location) to provide additional brain protection without occluding the flow. According to an exemplary procedure, access to the desired CCA is achieved and an access system (such as access sheath 2605 or other catheter) is used to gain access to the vasculature. Next, the accessed CCA is occluded. A balloon catheter or embolic filter 2609 is deployed into the contralateral CCA via the access system. A treatment of the heart or aorta is performed as intended through the access system.

[0055] FIGS. 18A - 18C show additional embodiments where one or more occlusion balloon catheters are used. These can be used, for example, to achieve embolic protection of large blood vessels during large - bore procedures. The use of occlusion balloons can achieve flow occlusion and back - flow mechanisms to provide both embolic protection and cerebral perfusion. Any catheter used can be steerable to enable or improve guidance to adjacent blood vessels. Any of these and the disclosed configurations can be adjusted to access from both the right and left carotid arteries. Various features can be adjusted to accommodate multiple anatomical configurations, such as the number, size, and position of the balloons, and the position of any openings for device access. The balloons can also be sized to cover a wider diameter range to enable occlusion of both the carotid and innominate arteries, thereby providing a more versatile and adaptable device.

[0056] Figure 18A shows an embodiment in which the balloon catheter 2905 is deployed in the RCCA. The balloon catheter 2905 has a first balloon 2910 that can be positioned in the innominate artery and a second balloon 2915 that can be positioned in the LCCA. The balloons can be inflated to achieve partial or complete flow occlusion through the respective blood vessels.

[0057] Figure 18B shows another embodiment in which the balloon catheter 2905 is deployed in the RCCA and further extends to the LCCA via the aortic arch. The balloon catheter 2905 has a first balloon 2920 that can be positioned in the RCCA and a second balloon 2925 that can be positioned in the LCCA.

[0058] Figure 18C shows an embodiment in which the balloon catheter 2905 is deployed in the RCCA. The balloon catheter 2905 has a balloon 2930 that can be positioned in the LCCA. The catheter 2905 also has an opening 2935 along its length that can be positioned to provide access to the aorta through the catheter 2905. The opening 2935 can be used to insert an intervention device to enable aortic valve delivery. The size of the opening 2935 can vary to provide access for different sized devices therethrough.

[0059] FIG. 19 shows an embodiment in which blood is passed through a suction catheter placed in the contralateral CCA to improve perfusion and divert particles away from the neurovascular system. The blood can be passed through a shunt coming from the contralateral CCA to improve perfusion and divert particles away from the neurovascular system. First, access to the desired CCA is achieved, and an access system (access sheath 2605 or other conduit, etc.) is used to gain access to the vasculature. Next, the accessed CCA is occluded. A flow catheter is delivered to the contralateral CCA, for example, through or adjacent to the access system. Then, suction or retrograde flow through the shunt is performed. A treatment of the heart or aorta is performed as intended through the access system. Optionally, reversal of flow can be achieved in the access side CCA to increase neuroperfusion.

[0060] FIG. 20 shows an embodiment in which a vascular valve 3105 is placed in the contralateral CCA to prevent debris from flowing into the brain. The valve can be configured to allow some pulsatile retrograde flow to support perfusion. The valve can be combined with a suction procedure or a shunt mechanism to discharge the trapped debris from the valve and further promote perfusion. By reversing the orientation of the valve, it can act as a pressure-sensing check valve, allowing forward (upward) blood flow during high pressure and blocking the flow during low pressure (e.g., during pacing). First, access to the desired CCA is achieved, and an access system (access sheath 2605 or other conduit, etc.) is used to gain access to the vasculature. Next, the accessed CCA is occluded. The valve is delivered to the contralateral CCA. A treatment of the heart or aorta is performed as intended through the access system. Optionally, reversal of flow can be achieved in the access side CCA to prevent or reduce valve debris accumulation and increase neuroperfusion.

[0061] Figure 21A shows a schematic view of an embodiment of a conduit and shunt system 3200. System 3200 includes a conduit 3205 that can be sutured or otherwise attached to a blood vessel such as the CCA. When attached in such a manner, conduit 3205 forms a pathway between the internal lumen of the CCA and the internal lumen of conduit 3205. U.S. Patent Application No. 17 / 555,127, titled "Vascular conduit to facilitate temporary direct access of a vessel", describes an exemplary conduit, which is hereby incorporated by reference in its entirety. Conduit 3205 has an integrated hub 3210 that communicates with the internal lumen of the CCA. Hub 3210 can include a hemostatic valve to provide access to one or more devices to the CCA via conduit 3205. Conduit 3205 can further include at least one side port 3215 for flushing and / or shunting from one location to another location via hub 3210. Side port 3215 can be used to divert blood flow through the conduit to a neuroprotection system (NPS) that includes a blood filter and / or an air trap. The neuroprotection system can be, for example, a housing that houses the filter and / or the air trap and through which the diverted blood flows. The integrated hub of the conduit provides access to a blood vessel in a direction opposite to the direction of blood flow.

[0062] In the embodiment of Figure 21A, system 3200 includes one or more sheaths 3225 and 3230 that similarly access the blood vessel, such as by being inserted through the lumen of conduit 3205. The sheaths can be configured to support an interventional procedure such as a TAVR procedure or other procedure. Each sheath can have a respective side port for flushing and / or shunting. The side port can also direct blood through the neuroprotection system.

[0063] System 3200 can also include a secondary shunt catheter 3235 that can also be used to access the blood vessel in a forward flow pattern. The secondary shunt catheter 3235 has an inner lumen that allows blood to shunt the blood flow through the catheter hub 3210 after the blood has passed through the neuroprotection system. The arrow in FIG. 21A represents the blood flow to the secondary shunt catheter 3235. In this way, the shunted blood flow does not contain emboli larger than a certain size, such as larger than 40-100 microns. The neuroprotection system also removes air bubbles from the shunted blood.

[0064] FIG. 21B shows a schematic view of the distal region of the catheter 3235 providing a path for the distal region of the secondary catheter 3205 to extend into the blood vessel. The secondary shunt catheter 3235 can have an expandable balloon 3250 disposed at or near the distal tip of the secondary shunt catheter 3235 that can be expanded via an inflation lumen and port 3240 (FIG. 21A) in the proximal region of the secondary shunt catheter 3235. The balloon 3250 is shown in an expanded state by a phantom line (not to scale). The balloon can be disposed in the blood vessel and expanded to stop the forward blood flow and redirect such flow back to the return position through a path including the catheter 3205, the neuroprotection system, and the secondary shunt catheter 3235. The secondary shunt catheter 3235 can also have a predetermined shape, such as a curved or steerable distal region configured to direct the secondary shunt catheter 3235 in the forward direction when the secondary shunt catheter enters the blood vessel through the catheter 3205.

[0065] In certain embodiments, the secondary shunt catheter 3235 includes a region 3255 configured to couple to a blood vessel clamp, the region configured to stop the forward flow through the blood vessel while sealing around the outer diameter of the secondary shunt catheter 3235 without causing any folding of the secondary shunt catheter 3235.

[0066] In one embodiment, the delivery catheter is deployed through a hemostatic valve of the conduit. The delivery catheter can be used for various activities when the inner lumen of the conduit is not occluded via a device such as an implant delivery device. For example, the inner lumen of the delivery catheter can be used to divert blood flow in a similar manner as the conduit. A sheath can be used with the conduit to provide an additional level of embolic protection. It can also increase the amount of blood diverted to a distal location such as an organ. It can also be used when a conduit or anastomosis is not used.

[0067] The delivery catheter can also have a dedicated hub that includes an adapter that allows for purging and flushing of the catheter in addition to the use of a nerve protection device. In situations where a conduit is not used, a dedicated clamp can be used to stop blood flow around the outer diameter of the sheath.

[0068] FIG. 22A shows an embodiment of the distal region of a catheter device 3305 configured to capture embolic debris from other devices and / or the patient's vasculature. FIG. 22B shows a cross-sectional view of the device 3305. The device 3305 can also be configured to capture air emboli released during an intervention such as during implant delivery. The device 3305 can be placed in a blood vessel such that blood flow through the vascular path is sent through a nerve protection system (neural protection system) that includes a filter and an air trap that captures blood flow and captures emboli larger than a certain size, such as 40 - 200 microns. The device 3305 advantageously maintains perfusion along the path by safely returning blood back through the coaxial or eccentric path of the device 3305, as described below.

[0069] Referring to FIGS. 22A and 22B, the device 3305 includes an outer tube 3310 with a coaxial (or eccentric) inner tube 3315 disposed therein. An annular flow return lumen 3317 (FIG. 22B) is disposed between the outer tube 3310 and the inner tube 3315. A funnel member 3320 is disposed within the inner tube 3315 such that the funnel shape of the funnel member 3320 guides fluid into the inner lumen of the inner tube 3315. The funnel member 3320 can initially have its radial size contracted by the inner tube 3315, such as when the funnel member is first stored inside the lumen of the inner tube 3315. The inner tube 3315 can be stored away from the funnel member 3320 or otherwise moved relative thereto such that the funnel member 3320 expands to the shape shown in FIG. 22A. A guide wire can also be deployed through the device. The funnel can be a filter.

[0070] Next, some exemplary and non-limiting specifications of the device 3305 are given. The outer tube can have an outer diameter of 0.093 inches and an inner diameter of 0.085 inches. The inner tube can have an inner diameter of 0.057 inches and an outer diameter of 0.070 inches. The device 3305 can be sized to be deployed through a guide sheath. As noted above, these sizes are non-limiting examples. The funnel member 3320 can be, for example, a nitinol funnel covered with expanded polytetrafluoroethylene (ePTFE).

[0071] The device 3305 can be used at various locations, including, for example, the brachiocephalic artery via a right radial artery approach, or the left subclavian artery via a left radial artery approach. The device can also, in non-limiting examples, be delivered via the common carotid artery.

[0072] Device 3305 can be used as follows. The device is delivered to the vasculature via an access site. The inner tube 3315 is retracted to deploy the funnel member 3320 into its funnel shape, such as by expanding the funnel member 3320 from a stowed size to an expanded funnel shape size. The funnel member 3320 directs blood flow toward the lumen of the inner tube 3315, as represented by arrow 3340 in FIG. 22. The inner lumen has an outlet that is connected to a neuroprotection system, such as a neuroprotection filter having air purged and a bubble trap. That is, the inner lumen is in fluid connection with a shunt or other flow path, and fluid (such as blood and embolic debris) flows through a neuroprotection filter that captures debris. The neuroprotection system is in fluid connection with the annular flow return lumen 3317 (FIG. 22B) of the device 3305 via a return flow path. The resulting shunted and filtered blood flow is returned to the patient (as represented by arrow 3323 in FIG. 22A) to a location proximal (such as about 1 cm proximal) to the location where the distal ends of the funnel and inner tube are deployed in the blood vessel. In certain embodiments, the inner tube 3315 extends distally beyond the distal end of the outer tube 3310 by a distance of about 1 cm.

[0073] Device 3305 can include or be coupled to a suction device, such as a syringe. During the procedure, the user can apply suction via the suction device to improve debris capture and / or remove debris from the filter, such as during treatment of a portion with a high embolization risk.

[0074] Once the interventional procedure is complete, the shunted blood flow can be interrupted. The funnel member 3320 can then be recaptured into the device 3305. This device and procedure can be used for retrograde popliteal artery access for treating iliac artery and / or femoral artery disease and at other locations such as cannulation / windowing of a thoracic endograft (TEVAR).

[0075] Figure 23 shows a nerve protection sheath 3410 deployed in the vasculature such that the sheath includes a proximal end or distal region that is either present in the aortic arch or has access to the aortic arch. The sheath 3410 is configured to provide cerebral perfusion during a large-bore interventional procedure such as a TAVR procedure (or other procedure). The sheath 3410 has a proximal hub that provides hemostatic access to the internal lumen of the sheath 3410. The sheath 3410 includes or is coupled to a shunt 3415 configured to divert perfusion fluid to the brain via a jugular vein or the like where the distal fluid outlet of the shunt 3415 is disposed. The shunt 3415 can have one outlet or more than two outlets, and each outlet is configured to discharge filtered and diverted blood in one or more directions of the blood vessel in which the outlet is disposed.

[0076] In accordance with this process, blood is diverted from the carotid artery to the ipsilateral jugular vein via the shunt 3415. The diverted blood passes through a filter element 3420 before being reintroduced into the patient's body. The shunt 3415 can include a flow control element configured to control the state of the blood flow, such as controlling the blood flow rate between a low flow rate and a high flow rate. The device can be used via an LCCA or RCCA access position.

[0077] Figure 24 shows a perspective view of a sheath or cannula 2405 formed from a flexible elongate body that is sized and shaped to be delivered to the vasculature via a percutaneous technique or a surgical incision or cut down technique at the patient's access site. The cannula 2405 is configured for at least four functions, namely, (1) embolic protection via occlusion of a blood vessel (such as a carotid artery that can be alternately occluded by clamping), (2) capture of embolic material from an artery via passive flow of blood to a filter or active suction or the like, (3) reperfusion of a blood vessel at a distal location of the access site, and / or (4) delivery of a therapeutic device via the internal lumen of the cannula.

[0078] The elongated body has at least one internal lumen that includes a delivery lumen configured for delivery of a treatment device, and a lumen for capture of an embolus and / or perfusion of an artery. The delivery lumen communicates with an access port 2410 in the proximal region of cannula 2405 through which a treatment delivery device can be inserted. The delivery lumen also communicates with a perfusion port 2412 through which perfusion or diversion of blood to or from the blood vessel can be effected.

[0079] Continuing to refer to FIG. 24, cannula 2405 includes an expandable element 2415, such as an expandable balloon, that can be expanded within an artery to occlude or partially occlude the artery. The expandable element 2415 is located in the distal region of cannula 2405. Cannula 2405 includes an inflation lumen that communicates with the expandable element 2415 via an inflation hub 2420 in the proximal region of cannula 2405.

[0080] FIG. 25 shows a cross-sectional view of the cannula 2405 and shows the configuration of the lumen. The cannula 2405 includes a delivery lumen 2510. The delivery lumen 2510 occupies the central region of the cannula 2405 and can optionally be coaxial with the long axis of the cannula 2405. The delivery lumen 2510 can be of various sizes. In an exemplary embodiment, the delivery lumen 2510 has a diameter of 6 to 30 French (Fr). The delivery lumen 2510 can be used to deliver a therapeutic device such as a guidewire, stent, laser fenestrated catheter, needle, or any other device to a blood vessel. The delivery lumen 2510 can also be used to capture an embolus through an opening at the distal end of the cannula that communicates with the delivery lumen 2510. In this regard, the therapeutic device can be used to capture the embolus, or the embolus can be captured during the delivery or deployment of a thoracic endovascular aortic repair (TEVAR) implant. The delivery lumen 2510 can also be used for reperfusion via a deflated balloon. As described above, the delivery lumen 2510 communicates with the perfusion port 2412 (FIG. 24), and the perfusion port can be coupled to a Y adapter or hemostatic hub that allows passage of the device and a path for suction or diversion to a flow control device having a filter.

[0081] Continuing to refer to FIG. 25, the cannula 2405 also includes a shunt lumen 2515 that is offset or non-coaxial with respect to the long axis of the cannula 2405. The shunt lumen 2515 is separated from the delivery lumen 2510 by a wall 2520 that can be an annular wall. The non-coaxial arrangement of the shunt lumen 2515 (with respect to the long axis of the cannula 2405) functions to increase or maximize the flow rate within the shunt lumen 2515. The shunt lumen 2515 allows for diversion of blood flow to / from the blood vessel and diversion from the delivery lumen 2510 or diversion from different blood supplies to maintain neuroperfusion during a procedure.

[0082] The cannula 2405 also includes an inflation lumen 2525 disposed between a delivery lumen 2510 and a shunt lumen 2515. As described above, the inflation lumen 2525 communicates with an inflation port 2420 as shown in FIG. 24.

[0083] According to the method of use, access to the vasculature is achieved via a surgical incision or percutaneous access in the axillary artery, subclavian artery, carotid artery, or other artery, etc. The cannula 2405 is then inserted into the vasculature to the target location. The insertion can be performed with or without using a guidewire and / or dilator. The expandable element 2415 is then expanded to occlude and / or seal the arterial inner wall of the blood vessel at the target location. The dilator and / or guidewire are then removed. The delivery lumen 2510 (FIG. 25) can then be used to capture the embolus and divert the blood flow to perfuse the artery. These steps can be repeated at the desired location using one or more auxiliary devices as needed or desired. A TEVAR endograft can be delivered and deployed via the delivery lumen 2510. One or more arteries can be reperfused as needed.

[0084] FIG. 26 schematically shows a diagram of a vasculature showing normal antegrade circulation. A treatment delivery device such as a TAVR delivery device 2605 is deployed via an access location to the aortic arch (such as via the LCCA or other location) via a sheath or cannula device which can be, for example, the above-described cannula 2405 or other device. The cannula device can be, for example, a large-bore sheath of 16-24 French. The RCCA can be occluded in a retrograde direction with respect to the access location (such as via a clamp or an expandable element inside the artery, etc.). A shunt assembly 2615 is deployed in fluid communication with the cannula device to divert blood to the LCCA in an antegrade position with respect to the access location. Thus, the shunt assembly 2615 diverts arterial blood flow from the artery, thereby maintaining cerebral perfusion.

[0085] Continuing to refer to FIG. 26, a filter system 2610 is deployed in the vasculature communicating with the aortic arch. The filter system 2610 is configured to be deployed in a direction reverse to the direction of blood flow so that the filter system 2610 can capture emboli, as will be more fully described below. The filter system 2610 has at least three mechanisms for embolus capture that improve upon existing embolic protection devices (EPDs) that use only a filter to capture emboli. The filter system 2610 includes a filter 2620 attached to an inner delivery catheter 2625 that is delivered through the inner lumen of an outer delivery sheath 2630. The sheath 2630 can be, for example, a 4F, 5Fr sheath, 6Fr sheath, or 7Fr sheath, and has a reduced outer profile compared to existing structural cardiac embolic protection devices in the size range of 6F to 16F. The filter can be stored in the inner lumen of the inner catheter so that the filter is folded to a smaller size that fits within the inner lumen. The filter can be funnel-shaped, with the narrow region of the funnel attached directly to the inner catheter.

[0086] The filter 2620 can be a double-layer filter (including an inner filter layer and an outer filter layer) attached to a frame such as a nitinol frame. The inner filter layer can have a set of holes that are different in size from the holes of the outer filter layer. For example, in one embodiment, the inner filter layer can have a set of first holes that are smaller than a set of second holes of the outer filter layer such that the inner filter layer has smaller holes or openings than the outer layer. The difference in pore size between the inner filter layer and the outer filter layer allows substances (such as embolic substances) that pass through the inner layer but not the outer layer to be trapped between the two layers. In another embodiment, the inner filter layer can have a first set of holes that are larger than a set of second holes of the outer filter layer such that the inner filter layer has larger holes or openings than the outer layer. In an alternative embodiment, the filter is only one layer.

[0087] The inner delivery catheter 2625 has an inner diameter (ID) that forms an inner lumen through which the inner delivery catheter 2625 can be delivered over a guide wire. The lumen can also be used to capture substances entering the filter 2620 via the flow of blood entering the inner lumen through the filter 2620. Such substances pass through the lumen of the inner delivery catheter 2625. The substances can then flow into an artery or vein after passing through an extracorporeal nerve protection system that is in fluid communication with the delivery catheter 2625. As described above, the nerve protection system can include a filter.

[0088] In an alternative embodiment, the inner lumen of the inner delivery catheter 2625 has one or more openings or channels that allow for fluid communication with an annular space (or outer lumen) between the outer delivery sheath 2630 and the inner delivery catheter 2625. This allows for flow to occur simultaneously through both paths (i.e., through the lumen of the inner delivery catheter and the annular space). This can be used to increase flow rate, mitigate issues in the event that one lumen is blocked, and help prevent the formation of blood clots throughout the system. A guide wire or microcatheter can be partially inserted into the inner lumen of the delivery catheter 2625 to remove substances that may be blocking the inner lumen.

[0089] The inner lumen of the delivery catheter 2625 can also be used for aspiration of emboli or to preferentially facilitate maintaining particles inside the filter 2620 during recapture. The aspirated blood can be reinjected into the patient via the extracorporeal nerve protection system.

[0090] Figure 27A shows a schematic side view of the distal region of a filter system 2610 that includes a filter 2620. As described above, the filter 2620 is shaped such that an inner filter layer 2710 is disposed within an outer filter layer 2715. The filter 2620 has a funnel shape that passes through the lumen of an inner delivery catheter 2625. In an exemplary embodiment, the inner filter layer 2710 is a polyurethane film having pores that are smaller in size than the pores of the outer filter layer 2715. Alternatively, in an alternative embodiment, the inner filter layer 2710 can have pores that are larger in size than the pores of the outer filter layer 2715. The outer filter layer can also be formed from a polyurethane film. In use, blood can pass through the pores of the filter membrane and enter an inner delivery catheter 2625 disposed within the inner side of an outer delivery sheath 2630. Blood can also flow through an annular space 2637 between the outer delivery sheath 2630 and the inner delivery catheter 2625. As described above, the inner delivery catheter 2625 can be permeable to allow blood flow into the annular space 2637, and blood flows between the inner diameter of the inner delivery catheter 2625 and the inner wall of the outer delivery sheath 2630.

[0091] The filter system 2610 is configured to effect a diversion and / or aspiration of blood flow. In this regard, the filter system 2610 is configured to divert and / or aspirate blood through only the inner delivery catheter 2625, through only the annular space 2637, or through both the inner delivery catheter 2625 and the annular space 2637. During removal of the filter system 2610 from the vasculature, or at any point during use, aspiration of blood can be effected through any of these paths.

[0092] FIG. 27B shows another embodiment of the filter system 2610, where the filter 2620 includes at least one non-porous region 2750 without holes such that the filter holes are pre-arranged in the porous region 2760 towards the distal end of the filter 2620. The filter 2620 further includes a porous region 2760 that includes holes or openings. The porosity of the porous region 2760 can be various. In certain embodiments, the porous region 2760 is about 70% to 95% of the total length of the filter 2620, although this can vary. The filter 2620 of FIG. 27B is configured to direct high flow rates to a narrower region (such as the funnel-shaped non-porous region 2750) where embolic particles can accumulate. The non-porous region can be the proximal region or the region closest to the inner catheter. The non-porous region can be in a narrower or constricted region of the filter (such as the narrower portion of the funnel shape).

[0093] FIG. 28 shows a schematic view of the filter system 2610. As described above, the filter 2620 is attached to the distal end of an inner delivery catheter 2625 movably disposed inside an outer delivery sheath 2630. A control element 2810 is located in the proximal region of the filter system 2610 and is configured to mechanically or electromechanically control the components of the filter system 2610. The inner delivery catheter 2625 can be fixed to the control element 2810, and the outer delivery sheath 2630 can be moved relative to the inner delivery catheter 2625, such as by actuating an actuator 2820 of the control element 2810. In this way, the outer delivery sheath 2630 can be slid to capture the filter 2620 in its inner lumen and also release the filter 2620, as shown in FIG. 28.

[0094] In one embodiment, the user operates the filter system during use such that the filter 2620 moves back and forth relative to the outer delivery sheath 2630 and / or the inner delivery catheter 2625 in combination with suction. Such movement can achieve improved recovery of embolic particles before the filter is recaptured by the outer delivery sheath 2630. The filter 2620 can be connected to a wire or other element that enables such movement of the filter 2620.

[0095] To provide an active flow of fluid, a pump can be coupled to any of the embodiments described herein. The pump can be configured to achieve an intermittent (or pulsed) flow or a continuous flow. The passive blood flow can also be an intermittent (or pulsed) flow or a continuous flow.

[0096] FIG. 29 shows a schematic cross-sectional view of a filter system 2610 with the filter 2620 captured and folded within the outer delivery sheath 2630. Blood can flow through the annular space 2637 between the outer diameter of the inner delivery catheter 2625 and the inner diameter of the outer delivery sheath 2630. As described above, the blood flow can exit the inner lumen of the inner delivery catheter 2625 through small openings in the outer wall of the inner delivery catheter 2625 and transition to the annular space. The inner delivery catheter 2625 can have a proximal hub 2910. The outer delivery sheath 2630 can also have a hub 2915 that can deliver blood to an artery or vein via a nerve protection system.

[0097] Figure 30 shows a schematic diagram of the vasculature in which the filter 3005 is deployed to the aortic arch via the delivery sheath 2630. The filter is arranged to cover the openings to the IA, LCCA, and LSCA. The sheath 2630 is delivered via a radial artery approach. The sheath 2630 is configured to provide a suction flow, such as an active flow via a pump or a passive flow, to capture debris in the sheath 2630. A second sheath 3010 is delivered to the aortic arch via a transfemoral artery approach or the like. The TAVR device 3015 can be delivered to the aortic arch through the lumen of the second sheath 3010. The TAVR device can cause the release of embolic particles into the aortic arch. The second sheath 3010 is configured to aspirate and capture embolic particles in its internal lumen via a passive suction flow or an active suction flow, such as by being coupled to a pump. The distal end of the second sheath 3010 can be positioned at various locations along the aortic arch.

[0098] Figure 31 schematically shows a filter basket 3102 deployed to the aortic arch to filter the area covering the great vessels from the aortic arch. The filter basket 3102 is cut away by line 3105 for clarity of the figure. The aspiration catheter 3120 is deployed to the aortic arch in a state where the distal end 3127 is arranged and configured to provide a suction flow to capture embolic debris from the filter basket 3102. The aspiration catheter 3120 has a curved distal tip, such as a distal tip that curves backward at an angle of about 180 degrees, to enable the tip to aspirate within the region 3110 where embolic debris is collected / captured. The aspiration catheter 3120 can be delivered, for example, via a transfemoral artery approach.

[0099] In another embodiment also shown in Figure 31, at least one catheter 3125 having an internal lumen is coupled to the region 3110 of the filter basket 3102. The catheter 3125 is configured to aspirate substances from the filter basket 3102. The catheter 3125 can be configured to continuously or intermittently remove substances via an active or passive flow.

[0100] FIG. 32 shows an embodiment in which one or more filters 3205 are deployed in a blood vessel branching from the aortic arch. One or more aspiration catheters 3210 can be deployed in the aortic arch via left radial access, right radial access, or the like. The aspiration catheter has a curved distal tip 3220 having an opening capable of aspirating embolic debris from the filter into the internal lumen of the aspiration catheter 3210. The curved distal tip 3220 can have a hook shape that can flare outward at the most distal end, such as a shepherd's hook shape. In one embodiment, the catheter 3210 is a 6 French catheter and is connected to a device such as a syringe or pump for active aspiration.

[0101] Although this specification contains many details, these should not be construed as limiting the scope of the claimed invention or the scope of what may be claimed, but rather as descriptions of features specific to particular embodiments. The specific features described herein in connection with separate embodiments can also be implemented in combination in one embodiment. Conversely, the various features described in connection with one embodiment can also be implemented separately in multiple embodiments or in any suitable partial combination. Further, even if a feature is described above as acting in a particular combination and is first claimed as such, one or more features of the claimed combination can, in some cases, be deleted from the combination, and the claimed combination can be directed to a partial combination or a variant of a partial combination. Similarly, although operations are shown in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in a sequential order in order to achieve the desired result, or that all of the illustrated operations be performed.

[0102] Although embodiments of various methods and apparatuses are described in detail herein with reference to specific versions, it should be understood that other versions, embodiments, methods of use, and combinations thereof are also possible. Accordingly, the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.

Claims

1. A system for treating an artery, the system comprising an outer delivery sheath configured to be delivered to a vascular location in communication with the aortic arch, the system comprising an inner catheter defining an inner lumen, the inner catheter being slidably disposed inside the outer delivery sheath such that an outer lumen is formed between an outer wall of the inner catheter and an inner wall of the outer delivery sheath, the system comprising a filter disposed at a distal end of the inner catheter, the filter being configured to guide debris from the blood vessel into the inner lumen of the inner catheter via blood flow to the filter, the system comprising an extracorporeal shunt configured to receive blood flow from the inner lumen, the system comprising a filter coupled to the extracorporeal shunt, system.

2. The system according to claim 1, further comprising a pump coupled to the inner catheter, the pump being configured to pump blood into the inner catheter and the shunt.

3. The system according to claim 1, wherein the filter is funnel-shaped with a narrow region, the narrow region being directly attached to the inner catheter.

4. The system according to claim 1, wherein the filter is formed from an inner filter layer disposed inside an outer filter layer.

5. The system according to claim 4, wherein the filter is coupled to a nitinol frame.

6. The system according to claim 4, wherein the inner filter layer has a set of first holes, the set of first holes being smaller than a set of second holes of the outer filter layer.

7. The system according to claim 4, wherein the filter includes at least one non-porous region and a porous region.

8. The system according to claim 7, wherein the porous region is about 70% to 95% of the total length of the filter.

9. The system according to claim 1, wherein the outer delivery sheath is a 4Fr sheath or a 5Fr sheath.

10. The system according to claim 1, wherein the shunt communicates with a vein and delivers blood from the inner lumen to the blood vessel.

11. The system according to claim 1, wherein the inner lumen is sized to receive a guide wire.

12. The system according to claim 1, wherein the outer lumen is an annular space.

13. The system according to claim 1, wherein the outer wall of the inner catheter has at least one opening that enables fluid communication from the inner lumen to the outer lumen.

14. The system according to claim 13, wherein blood flows through the inner lumen and the outer lumen simultaneously.

15. The system according to claim 1, wherein the shunt communicates with both the outer lumen and the inner lumen.

16. The system according to claim 1, wherein the filter is configured to be stored in the inner lumen to fold the filter into a smaller size.

17. The system according to claim 1, wherein the inner catheter has a proximal hub that is fluidly connected to the shunt.

18. The system according to claim 1, wherein the blood vessel is the aortic valve annulus, the common carotid artery, or another blood vessel.

19. The system according to claim 1, wherein the filter is an elongated funnel shape configured to cover a plurality of blood vessels.

20. The system according to claim 4, wherein the inner filter layer has a set of first holes that are larger than a second set of holes in the outer filter layer.

21. The system according to claim 1, wherein the outer delivery sheath is a 6Fr sheath or a 7Fr sheath.

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