Systems and methods for transcatheter aortic valve therapy

Abstract

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

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] Pursuant to 35 U.S.C. §119(e), this application claims priority to U.S. Provisional Patent Application Serial No. 63 / 352,143, filed on June 14, 2022, entitled “SYSTEMS AND METHODS FOR TRANSCATHETER AORTIC VALVE THERAPY,” and U.S. Provisional Patent Application Serial No. 63 / 486,341, filed on February 22, 2023, entitled “SYSTEMS AND METHODS FOR TRANSCATHETER AORTIC VALVE THERAPY,” the entire contents of which are incorporated herein by reference. Background Art

[0003] The present invention relates to methods and devices for replacing heart valves.

[0004] Patients with defective aortic heart valves are often candidates for heart valve replacement. Traditional treatment involves surgical replacement of the heart valve with a prosthetic valve. This surgery, which involves a gross thoracotomy or median sternotomy, cardiopulmonary bypass and cardiac arrest, surgical access and removal of the diseased heart valve, and replacement of the heart valve, offers patients excellent long-term outcomes with up to 10 or 15 years of durability for tissue valves and even longer durability for mechanical valves. However, heart valve replacement surgery is highly invasive, can require lengthy recovery times, and is associated with short- and long-term complications. This procedure may not be an option for patients who are high risk for surgery or who are not candidates for surgery.

[0005] A minimally invasive method of replacing a heart valve has been developed. This method, called transcatheter aortic valve implantation (TAVI) or replacement (TAVR), relies on the development of a collapsible prosthetic valve mounted on a catheter-based delivery system. This type of prosthetic valve can be inserted into the patient through a relatively small incision or vascular access site and can be implanted in a beating heart without the need for cardiac arrest. Advantages of this method include less invasive surgery, faster recovery time, and lower complication rates. This method is a good alternative to traditional surgery for patients who are high risk for surgery or who are not candidates for surgery. Summary of the invention

[0006] There is a need for an access system for endovascular prosthetic aortic valve implantation that provides an overall shorter and straighter access path than current systems and methods. In addition, there is a need for an access system that provides protection from cerebral embolic complications during surgery.

[0007] Disclosed herein are devices and methods that allow transcarotid or subclavian access to the native aortic valve via the common carotid artery and transcatheter implantation of a prosthetic aortic valve into the heart or aorta. The devices and methods also provide a means of embolic protection during such an intravascular aortic valve implantation procedure.

[0008] In one aspect, a system for treating an artery is disclosed, comprising: an outer delivery sheath configured for delivery to a vascular location connected to an aortic arch; an inner catheter defining an inner lumen, the inner catheter being slidably positioned within the outer delivery sheath so 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 positioned at the distal end of the inner catheter, the filter being configured to direct debris from the blood vessel into the inner lumen of the inner catheter via blood flow to the filter; an extracorporeal shunt configured to receive blood flow from the inner lumen; and a filter coupled to the shunt.

[0009] Other aspects, features and advantages will become apparent from the following description of various embodiments, which illustrate, by way of example, the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 A side view of an exemplary access sheath with an occluding element mounted on the sheath is shown.

[0011] Figure 2 A side view of an exemplary access sheath with a filter element mounted on the sheath is shown.

[0012] Figure 3 Shown is a front view of the filter element.

[0013] Figure 4 , Figure 5A and Figure 5B An alternative embodiment of an access sheath is shown.

[0014] Figure 6 A view of the vascular system showing normal circulation is schematically depicted.

[0015] Fig. 7A and Figure 7B Other embodiments of access sheaths deployed in a vascular system are shown.

[0016] Fig. 8A and Figure 8B Other embodiments of access sheaths deployed in a vascular system are shown.

[0017] Fig. 9 One embodiment of a transcarotid aortic valve prosthesis and delivery system is shown.

[0018] Fig.10An alternative embodiment of a transcarotid aortic valve prosthesis and delivery system is shown.

[0019] Fig.11 Another embodiment of an access sheath deployed in a vascular system with an occluding element occluding the left common carotid artery is shown.

[0020] Fig.12 Another embodiment of an access sheath deployed in a vascular system with an occluding element occluding the right common carotid artery is shown.

[0021] Fig.13 Another embodiment of an access sheath deployed in a vascular system with an occluding element occluding the innominate artery is shown.

[0022] Fig.14 A delivery system for deploying an intravascular prosthetic valve via an access sheath 110 and a guidewire 119 is shown.

[0023] Fig.15A A schematic diagram of one embodiment is shown in which an access sheath is used to gain transcervical access to a blood vessel.

[0024] Fig. 15B A schematic diagram of the vascular system is shown with a catheter positioned to enter the aortic arch.

[0025] Fig. 15C Schematic diagram showing the vascular system with a catheter positioned via the LCCA to enable fluid infusion into the aortic arch.

[0026] Fig.15D Schematic diagram showing the vascular system with a catheter (or sheath) inserted into the right common carotid artery to gain access to the aortic arch.

[0027] Fig.15E Schematic diagram showing the distal region of a catheter positioned in the aortic arch.

[0028] Fig.16A A schematic diagram of another embodiment is shown in which an arterial shunt is integrated with or otherwise coupled to an access sheath.

[0029] Fig. 16B Schematic diagram showing possible flow routes that can be achieved through the use of flow splitters.

[0030] Fig.17 An embodiment is shown in which a balloon is placed in the contralateral CCA.

[0031] 18A to 18C Additional embodiments are shown in which one or more occlusion balloon catheters are used.

[0032] Fig.19An embodiment is shown in which blood is withdrawn through an aspiration catheter placed in the contralateral CCA.

[0033] Fig. 20 An embodiment is shown in which a vascular valve is placed in the contralateral CCA.

[0034] Fig.21A A schematic diagram showing one embodiment of a piping and flow diversion system.

[0035] Fig.21B A schematic diagram showing the distal region of the conduit, wherein the distal region of the secondary catheter provides a pathway extending into a blood vessel.

[0036] Fig.22A One embodiment of a distal region of a catheter device configured to capture plunger debris from other devices and / or a patient's vasculature is shown.

[0037] Fig. 22B Show Fig.22A Cross section of the device.

[0038] Fig.23 A nerve protection sheath is shown deployed in the vasculature.

[0039] Fig.24 A transparent view of the sheath is shown.

[0040] Fig.25 Show Fig.24 Cross-sectional view of the sheath.

[0041] Fig.26 A view of the vascular system showing normal antegrade circulation is schematically depicted.

[0042] Fig.27A A schematic side view representation of the distal region of the filter system is shown.

[0043] Fig.27B Another embodiment of a filter system is shown.

[0044] Fig.28 A schematic diagram showing a filter system.

[0045] Fig.29 Schematic diagram showing a cross section of a filter system.

[0046] Fig.30 A schematic diagram of the vascular system is shown with a filter deployed in the aortic arch via a delivery sheath.

[0047] Fig.31 The filter basket is shown schematically.

[0048] Fig.32An embodiment is shown in which one or more filters are deployed to blood vessels branching from the aortic arch. DETAILED DESCRIPTION

[0049] Disclosed herein are devices and methods that allow arterial access, such as a transcarotid access via the common carotid artery, or a subclavian access via the subclavian artery to a native aortic valve, and implantation of a prosthetic aortic valve into the heart or aorta. The devices and methods also provide a means for embolic protection during such an intravascular aortic valve implantation procedure. It should be understood that the disclosed systems and methods may also be configured for use via a transfemoral access location and are not limited to use via a specific access location.

[0050] In one embodiment, the transcarotid or subclavian approach to the aortic valve is completed via percutaneous puncture or direct arterial incision. Since the larger arteriotomy in the common carotid artery is difficult to perform percutaneous vascular closure, the incision may be advantageous. If necessary, the arteriotomy site can be pre-sutured so that it can be closed at the end of the operation. An access sheath with an associated dilator and guide wire is provided, and its size is set to be fitted into the common carotid artery or subclavian artery. The access sheath is inserted into the artery toward the aortic arch from the lower side. The left or right common carotid artery or subclavian artery can be selected as the access site based on factors including, for example, the disease state of the proximal artery and / or the aorta and the angle at which the carotid artery or innominate artery enters the aorta. Then, the carotid artery can be occluded at the distal end of the access site. If access is achieved via direct surgical incision and arteriotomy, occlusion can be completed via a vascular clamp, a vascular ring or a Rummel tourniquet. Alternatively, the access sheath itself may include an occlusive element, such as an occlusive balloon, adapted to occlude the artery to prevent embolic particles from entering the carotid artery distal to the access site during the procedure.

[0051] Figure 1 A side view of an exemplary arterial access sheath 110 formed of an elongated body having an inner lumen is shown. In one embodiment, the sheath has a working length of 10-60 cm, where the working length is the portion of the sheath that is inserted into the artery during use. The lumen of the sheath has an inner diameter large enough to accommodate insertion of an intravascular valve delivery system, such as an 18 French to 22 French (0.236" to 0.288") system. In one embodiment, the delivery system has an inner diameter as low as about 0.182". The access sheath 110 may have an expandable occlusion element 129 positioned on the access sheath. The occlusion element 129 is configured to expand to a size for occluding flow through the artery. The occlusion element 129 may be placed at any location in the artery or aorta. In one embodiment, the occlusion element is an occlusion balloon.

[0052] Once the sheath 110 is positioned in the artery, the occluding element 129 (if present) is optionally expanded in the artery to occlude the artery and may anchor the sheath to a suitable position. The arterial access sheath 110 may include a Y-arm for conveying contrast media or saline flushing fluid, for suction and / or may be fluidly connected to a shunt, wherein the shunt provides a shunt cavity or path so that blood flows from the arterial access sheath 110 to a reflux site, such as a vascular reflux site or a collection reservoir. In this regard, a retrograde or reverse blood flow state can be established in at least a portion of the artery. The sheath 110 may also include a Y-arm for inflating an occluding balloon via an inflation cavity, and a hemostatic valve for introducing an intravascular valve delivery system into the sheath. Alternatively, if the occluding element is a mechanical occluding structure, the sheath 110 may include an actuating element. The intravascular valve delivery system may include an artificial valve and a delivery catheter. In one embodiment, the delivery catheter has a working length of 30-80 cm, including 30, 40, 60, 70, or 80 cm, although the length may vary.

[0053] In one embodiment, suction can be applied to the artery via the access sheath 110. In this regard, the access sheath 110 can be connected to a suction source via a Y-arm 112 so that embolic debris can be captured, which otherwise might enter the remaining head and neck vessels, or travel downstream into the peripheral vessels. The suction source can be active, for example, a cardiotomy suction source, a pump, or a syringe. Alternatively, passive flow conditions can also be established, for example, by connecting the Y-arm 112 fluid to a shunt, which in turn is connected to a low pressure source, such as a collection reservoir or a venous return site in the patient's body at atmospheric pressure or negative pressure. For example, the passive flow rate can be adjusted by controlling the restriction of the flow path in the shunt.

[0054] In one embodiment, the access system may be equipped with one or more embolic protection elements to provide embolic protection to one or both carotid arteries, and one or all head or neck vessels. For example, a filter may be included in the access system to provide embolic protection to 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 is positioned in the aortic arch through the orifice. If the sheath access site is the left common carotid artery, the filter may be positioned through the orifice of the innominate artery (also known as the brachiocephalic artery). If the sheath access site is the right common carotid artery, the filter may be positioned through the orifice of the left common carotid artery. In a variation of this embodiment, the filter is deployed through both the innominate artery and the left common carotid artery, or through all three head and neck vessels (the innominate artery, the left common carotid artery, and the left subclavian artery). The filter element may be built into the access sheath 110. Alternatively, the filter element may be a separate element compatible with the access sheath 110. For example, the filter element can be a coaxial element slidably connected to an access sheath, or an element placed alongside an access sheath. The filter element can include an expandable frame so that it can be inserted into an artery in a collapsed state, but expanded at the target site to position the filter element across the opening of the artery or multiple arteries.

[0055] Figure 2 A side view of an exemplary access sheath 110 is shown with a filter element 111 mounted on the sheath. Figure 3 FIG. 1 shows a front view of the filter element 111, which shows an exemplary outline of the filter element 111. Figure 3 In an embodiment, the filter element 111 is sized and shaped to fit within and block the head and neck vessels. In an embodiment, the deployed filter has a long dimension of about 2, 3, 4, or 5 cm and a short dimension of about 1, 1.5, or 2 cm. Figure 3 The outline shown in is only an example, and it should be understood that the shape of the filter element 111 can be varied. For example, the shape of the filter element can be oval, circular, elliptical or rectangular. The filter material can be a woven or knitted textile material, or can be a perforated polymer film, such as polyurethane. The filter material can also be nitinol. The porosity of the filter can be 50, 100, 150, 200 or 300 microns, or any porosity between the two. The expandable frame of the filter element can be made of spring material, such as stainless steel or nitinol wire or band.

[0056] In embodiments with a filter element, occlusion and / or suction devices may still be part of the system to provide embolic protection during filter deployment prior to valve implantation and during filter retrieval after valve implantation. During the implantation procedure, the filter element itself may be a primary method of embolic protection. Figure 4As shown, the sheath 110 may also be equipped with both an occluding element 129 and a filter element 111 .

[0057] exist Figure 5A In another variation of the embodiment shown, the sheath 110 includes an aortic filter element 113, which is sized and shaped to be deployed through the ascending aorta, thereby protecting all head and neck vessels from embolic debris. The shape of the filter element can be varied. In one embodiment, the shape of the filter element can be a cone or a closed-end tube. The size and shape of the expandable frame of the filter frame are set to cross the entire diameter of the aorta when deployed. For example, the expandable frame can be a ring with a diameter that can be expanded from 12mm to 30mm. Alternatively, the expandable frame can be a series of struts connected at one end or both ends, which expand outward to deploy the filter element across the diameter of the aorta. The filter material can be a woven or knitted textile material, or it can be a perforated polymer film, such as polyurethane. The porosity of the filter can be about 40, 100, 150, 200 or 300 microns, or any porosity between the two.

[0058] The expandable frame of the filter element may be made of a spring material, such as stainless steel or nitinol wire or ribbon. As with the previous variation, an occlusion and suction device may be included in this variation to provide protection during filter deployment and filter retrieval. The aortic filter element 113 may be integral with the sheath, or may be a separate device that is compatible with the sheath, for example, coaxial with or in parallel with the access sheath. Figure 5B As shown, one embodiment of the sheath 110 may include both an aortic filter element 113 and an occlusive element 129 .

[0059] Figure 6 A view of the vascular system is schematically depicted, showing normal antegrade circulation. Figure 6 The vessels in the figure are labeled 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.

[0060] In some cases, it may be desirable to provide a mechanism for perfusing the carotid artery upstream of the entry point of the access sheath 110 to the carotid artery or the innominate artery. If the size of the access sheath 110 is similar to the carotid artery or the innominate artery, flow through the artery may be substantially blocked by the access sheath when the sheath is inserted into the artery. In this case, the upstream cerebral vessels may not be adequately perfused because the sheath blocks the carotid artery. In one embodiment of the access sheath 110, the sheath includes a mechanism for perfusing the upstream carotid artery and cerebral vessels.

[0061] Fig. 7A An exemplary embodiment of such an access sheath 110 deployed in a vascular system is shown. The proximal portion of the access sheath has two parallel lumens, which are part of a single integral structure of the access sheath. The first lumen 775 extends from the proximal end of the sheath to the distal tip of the sheath and is fluidly connected to the shunt Y-arm 755 and the hemostatic valve 777 at the proximal end of the sheath. The size and shape of the first lumen 775 are configured to receive a transcatheter aortic valve and a delivery system and to achieve the delivery of the transcatheter aortic valve and the delivery system via the hemostatic valve 777. For example, the first lumen has a length such that its distal opening is positioned at the heart or aorta. The second lumen 769 is positioned near the first lumen and extends from the proximal end of the sheath to the distal opening at the position of the mid-axis 765, and is fluidly connected to the second perfusion Y-arm 767 at the proximal end. There is an opening at the position 765 at the distal end of the second lumen. The size and shape of the second lumen 769 are configured to enable blood to be shunted to the carotid artery located distal to the insertion site of the access sheath. A radiopaque axis marker can be positioned on the sheath at this location so that the opening can be visualized to the user under fluoroscopy. The length of the perfusion chamber is such that the distal opening of the perfusion chamber can be positioned in the distal carotid artery and perfused when in use. The proximal end of the first chamber has a proximal connector with a hemostatic valve 777 and a Y-arm. As mentioned, the hemostatic valve is sized to fit the arterial valve delivery system therethrough. The proximal end of the perfusion chamber also has a proximal connector. The proximal connector and / or the Y-arm allow for the attachment of a shunt.

[0062] The Y-arm 755 is removably connected to a shunt 760, which in turn is removably connected to a second Y-arm 767. The shunt defines an internal shunt chamber that fluidically connects the first chamber 775 to the second chamber 769. A stopcock 779 may be positioned between the Y-arm 755 and the shunt 760 to allow flushing and contrast injection when the shunt 760 is connected. When the sheath is positioned in the artery, arterial pressure drives blood flow into the distal end of the first chamber 775 of the arterial access sheath, exits the first chamber from the Y-arm 755, enters the shunt 760, and then returns to the sheath via the Y-arm 767. The blood then flows into the parallel chamber 769 and flows into the distal carotid artery at position 765 to perfuse the vascular system distal to the arterial sheath 110. An in-line filter element 762 may be included in the shunt 760 so that emboli generated during surgery are not perfused into the cerebral arteries. If the sheath 110, shunt 760, and lumen 769 create a flow restriction that limits adequate perfusion, the shunt 760 may be combined with an active pump 770 to drive blood flow and provide the desired level of cerebral perfusion. This may be particularly true when the valve is delivered through the first lumen 775 of the access sheath 110.

[0063] Figure 7B Show Fig. 7A A variation of an embodiment. A Y-arm 767 fluidly connects the shunt 760 to a parallel lumen 769 which, when positioned in the artery, reintroduces blood from the shunt 760 into the artery at position 765. The shunt 760 in this embodiment is not fluidly connected to a first lumen 775 in the sheath. Instead of receiving blood from the access sheath via the Y-arm 755, the shunt 760 may be connected to another arterial blood source, such as the femoral artery or the subclavian artery or the contralateral carotid artery, via a second sheath. In this variation, the shunt blood flow is not restricted by the valve being delivered through the first lumen 775 of the access sheath. In this embodiment, a filter 762 in the shunt line is not required because the blood source is remote from the treatment area and the risk of distal emboli in the shunt blood is extremely low. The Y-arm 755 can still be used for flushing and injection of contrast agent into the sheath. In Fig. 8AIn another variation shown, the arterial access sheath 110 has a single lumen 775 that is fluidly connected to a Y-arm 755 at a proximal region. The lumen 775 is sized and shaped to receive a transcatheter aortic valve and delivery system and enable delivery of the transcatheter aortic valve and delivery system via a hemostatic valve 777. The Y-arm 755 is connected to a shunt 760, which in turn 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 may be located between the Y-arm 755 and the shunt 760 to allow flushing and contrast injection when the shunt 760 is connected. When the sheath is properly positioned in the artery, arterial pressure drives flow into the lumen 775 of the sheath 110, out of the first lumen via the Y-arm 755, then through the shunt 760, through the second catheter 802 and upstream from the arterial access point back into the carotid artery to perfuse the vasculature distal to the arterial sheath 110. As described above, a filter element 762 may be included in the shunt 760 so that emboli generated during surgery are not perfused into the cerebral arteries. When the sheath 110 and shunt 760 encounter flow restrictions that limit adequate perfusion, such as when a valve is delivered through the lumen 775 of the access sheath 110, the shunt may incorporate an active pump 770 to drive blood flow and provide the desired level of cerebral perfusion.

[0064] Figure 8B Show Fig. 8A A variation of an embodiment. Here, a second arterial sheath 802 is removably or fixedly connected to a shunt or flow line 760, which in turn is connected via another sheath to another arterial source, for example, the femoral artery or the subclavian artery or the contralateral carotid artery. In this variation, the shunted blood flow is not restricted by the valve being delivered through the lumen 775 of the access sheath. In this embodiment, a filter 762 in the shunt line is not required because the blood source is remote from the treatment area and the risk of distal emboli in the shunted blood is extremely low. The Y-arm 755 can still be used for flushing and injection of contrast agent into the sheath.

[0065] In the above Fig. 7A and Figure 7B as well as Fig. 8A and Figure 8B In the depicted embodiments, the arterial access sheath 110 may include an occlusive element (not shown) at the distal end of the sheath that is configured to occlude the carotid artery and assist in preventing emboli from entering the carotid artery. Additionally, in these embodiments, the shunt 760 and pump 770 and / or second sheath 820 (if applicable) may be provided as separate components in a single kit to enable transcarotid access and carotid shunt during catheter-based aortic valve replacement surgery.

[0066] Although the figures show sheath insertion in the common carotid artery, similar sheaths or sheath / shunt systems can also be designed for subclavian approaches.

[0067] Fig. 9 An exemplary valve and delivery system is shown that is configured for delivery through a transcarotid access sheath 110. The route from the transcarotid access site is relatively short and straight compared to the transfemoral or subclavian routes. Therefore, the delivery system can be shorter and the proximal segment can have considerable rigidity, both of which will allow greater thrust and torque control, thereby improving the accuracy of positioning and deploying the prosthetic valve. The distal segment has greater flexibility to allow accurate tracking around the ascending aorta and to the appropriate position in the aortic annulus. Compared to current delivery systems, the materials used in the delivery system may include reinforced, higher stiffness and / or thicker wall materials to provide this greater rigidity.

[0068] A balloon expandable prosthetic aortic valve 205 is mounted on the distal end of an intravascular valve delivery system 200. The delivery system has a distal tapered tip 220 and an expandable balloon 215 on the distal end of an inner shaft 210. In one embodiment, the system also has an outer sleeve, such as, for example, a pusher sleeve 230 that can slide along the long axis of the device and maintain the valve in place on the balloon during delivery. The proximal control assembly includes a mechanism for retracting the pusher sleeve, such as a sliding button 270 on a proximal handle 240. Fig. 9 , the pusher sleeve 230 is shown retracted from the valve and proximal balloon so that the valve can expand without interference from the pusher sleeve 230. Connector 250 allows an inflation device to be connected to the balloon inflation lumen of balloon 215. Proximal rotary hemostasis valve 260 allows the system to be flushed and sealed around the guidewire as the valve delivery system is advanced over the guidewire and into position (not shown).

[0069] The working length of the valve delivery system is configured to allow the valve to be delivered from a transcarotid access site to the aortic annulus. Specifically, the working length of the valve delivery system 200 can be between 45 cm and 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 section 280 and a more flexible distal section 290. In one embodiment, the flexibility of the distal section is 2 to 4 times that of the proximal rigid section. In one embodiment, the distal flexible section accounts for one-quarter to one-third of the total working length of the valve delivery system. Specifically, the distal flexible section is in the range of 10 cm to 20 cm. In an alternative embodiment, the valve delivery system has a transition section having one or more flexible lengths that fall between the flexibility of the distal flexible section and the proximal flexible section.

[0070] Fig.10Another exemplary valve and delivery system configured for transcarotid delivery is shown. A self-expanding artificial aortic valve 305 is mounted on the distal end of an intravascular valve delivery system 300. The delivery system has a distal conical tip 320 on the distal end of an inner shaft 310. The valve 305 is positioned on the inner shaft 310 and contained in a retractable sleeve 330 that can slide along the longitudinal axis of the device. The proximal control assembly includes a mechanism for retracting the retractable sleeve, such as a sliding button 370. In one embodiment, the design of the valve 305 and sleeve 330 allows the sleeve to be re-advanced in the distal direction to abut against the valve and collapse the valve so that the valve 305 can be repositioned if the first position is not accurate. A proximal rotary hemostatic valve 360 ​​allows the system to be flushed and sealed around the guidewire when the valve delivery system is advanced over the guidewire and in place (not shown).

[0071] As with the previous embodiment, the working length of the valve delivery system is configured to allow the valve to be delivered from a transcarotid access site to the aortic annulus. Specifically, the working length of the valve delivery system 300 is between 45 cm and 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 section 380 and a more flexible distal section 390. In one embodiment, the flexibility of the distal section is 2 to 4 times that of the proximal rigid section. In one embodiment, the distal flexible section accounts for one-quarter to one-third of the total working length of the valve delivery system. Specifically, the distal flexible section is in the range of 10 cm to 20 cm. In an alternative embodiment, the valve delivery system has a transition section having one or more flexible lengths that fall between the flexibility of the distal flexible section and the proximal flexible section.

[0072] An exemplary method of use is now described. In one embodiment, the general method includes the following steps: forming a perforation from the patient's neck to the wall of the common carotid artery (or other access location, so that the present invention is not limited to access at the common carotid artery); introducing an access sheath through the perforation with the tip pointing downwardly toward the orifice of the artery; inserting a guide wire through the access sheath into the ascending aorta and through the native aortic valve; and introducing a prosthetic valve through the access sheath and deploying the prosthetic valve percutaneously at or near the location of the native aortic valve. In one embodiment, the artery is occluded distally (upstream) from the tip of the sheath.

[0073] In particular, the access sheath 110 is first inserted into the vascular system, such as via percutaneous puncture or direct surgical incision and carotid puncture. As mentioned, transcarotid access to the aortic valve can be achieved via the LCCA. Once properly positioned, the occluding element 129 can be expanded to occlude the LCCA, such as Fig.11In another embodiment, transcarotid access to the aortic valve can be achieved via the RCCA, wherein the occluding element 129 occludes the RCCA, such as Fig.12 In another embodiment, transcarotid access to the aortic valve can be achieved via the RCCA, wherein the occluding element 129 occludes the innominate artery LA, as shown in FIG. Fig.13 Occlusion via the occluding element 129 may also be achieved via direct clamping of the carotid vessel, for example, with a vessel clamp, a vessel ring, or a Rummel tourniquet.

[0074] Once the access sheath is positioned and the embolic protection device is deployed via occlusion, aspiration, and / or filter elements, access to the aortic valve is obtained via a guidewire 119 (e.g., a 0.035" or 0.038" guidewire) inserted into the sheath 110 and directed inferiorly toward the ascending aorta and across the native aortic valve. Prior to valve implantation, the native aortic valve may be pre-dilated with an appropriately sized dilatation balloon, such as a valvuloplasty balloon. The balloon is positioned across the valve using the guidewire 119 and is inflated, deflated, and then removed while the guidewire remains in place.

[0075] The intravascular prosthetic valve 205 and the delivery system 200 (or delivery system 300) are then inserted through the access sheath 110 over the guidewire 119, and the valve 205 is positioned at the native aortic valve site (eg, Fig.14 ). The artificial valve 205 is then implanted. At the end of the implantation step, the function of the implanted artificial valve 205 can be obtained via ultrasound, contrast injection under fluoroscopy, or other imaging methods. Depending on the design of the delivery system 200, the artificial valve 205 can be adjusted as needed to achieve optimal valve function and position before final deployment. The delivery system 200 and the guide wire 119 are then removed from the access sheath 110. After removing the delivery system 200 and the guide wire 119, the embolic protection element is removed. Aspiration can continue at this time to capture any embolic debris stuck in the sheath tip, occlusion element and / or filter element.

[0076] The access sheath 110 is then removed and the access site is closed. If the access is a surgical incision with direct puncture, the vessel is closed via tying of pre-placed sutures or with manual suturing or with a surgical vessel closure device, as described in more detail below. If the access is percutaneous, percutaneous closure methods and devices can be used to achieve hemostasis at the access site. In one embodiment, a closure device is applied to the perforation site before the arterial access sheath is introduced through the perforation. The type of closure device may vary.

[0077] The access site described above is the left or right common carotid artery. Other access sites may also be used, for example, the left or right subclavian artery or the left or right brachial artery. These arteries may require a longer and / or more tortuous path to reach the aortic valve, but they can provide other advantages over the carotid access, such as the ability to work away from the patient's head, the ability to avoid adverse neck anatomy, such as previous carotid endarterectomy or other neck surgery or neck surgery or radiation, or lower risk in the case of access site implantation. In addition, carotid artery disease or smaller carotid arteries may make common carotid artery access impractical. In the case of any of these access sites, occlusion, aspiration and / or filtration of the head and neck vessels during TAVI can improve the speed and accuracy of the procedure and reduce the rate of embolic complications.

[0078] If the access to the carotid artery is performed via surgical incision, standard vascular surgery techniques can be used to close the access site. Purse-string sutures can be performed before inserting the sheath, and then purse-string sutures are used to tie the access site after removing the sheath. If the access site is a percutaneous approach, a variety of vascular closure elements can be used. In one embodiment, the vascular closure element is a mechanical element, which includes an anchoring portion and a closing portion, such as a self-closing portion. The anchoring portion may include a hook, a needle, a suture staple, a clip, a tines, a suture, etc., which engage in the outer surface of the common carotid artery around the perforation when the perforation is fully opened to fix the self-closing element. The self-closing element may also include a spring-like or other self-closing portion, which, after removing the sheath, closes the anchoring portion to pull the tissue in the arterial wall together to provide closure. Typically, the closure is sufficient so that no further measures need to be taken to close or seal the perforation. However, optionally, a supplementary seal to the self-closing element may be provided after the sheath is withdrawn. For example, available hemostatic materials, such as bioabsorbable polymers, collagen plugs, glue, sealants, coagulation factors or other coagulation accelerators, process self-closing elements and / or the tissue tract in the element area.Alternately, other sealing schemes may also be used, such as electrocautery, suturing, clamping, stapling etc. to seal tissue or self-closing elements.In another method, self-closing elements will be self-sealing membranes or gasket materials, which are attached to the outer wall of blood vessel with clips, glue, bands or other modes.Self-sealing membranes may have inner openings, such as slits or cross cuts, which are closed under blood pressure effects conventionally.Any one of these self-closing elements may be designed to be placed in open surgery, or percutaneous deployment.

[0079] In an alternative embodiment, the vascular closure element is a suture-based vascular closure device. A suture-based vascular closure device can place one or more sutures across a vascular access site so that when the suture ends are tied after the sheath is removed, the sutures can provide hemostasis for the access site. Sutures can be applied before the surgical sheath is inserted through the arteriotomy or after the sheath is removed from the arteriotomy. The device can maintain temporary hemostasis of the arteriotomy after the suture is placed, but before and during the placement of the surgical sheath, and can also maintain temporary hemostasis after the surgical sheath is withdrawn, but before the suture is tied. U.S. patent application serial number 12 / 834,869, entitled "Systems and methods for treating carotid arteries," which is incorporated herein by reference in its entirety, describes an exemplary closure device, and also describes other devices, systems, and methods related to and in combination with the devices, systems, and methods disclosed herein.

[0080] Fig.15A A schematic diagram of one embodiment is shown in which an access sheath 2605 is used to obtain transcervical access to the RCCA. A flow catheter 2610 also enters the LCCA via insertion through the access sheath 2605. The RCCA is clamped (or otherwise occluded) to prevent or otherwise partially prevent blood flow through the RCCA. The flow catheter 2610 can be used to inject a fluid (such as, for example, saline) into the contralateral common carotid artery (or other location), such as in cases where an interventional procedure may generate embolic particles. The injected fluid is configured to divert these particles away from the neurovascular system, such as away from a predetermined location of the neurovascular system. The injected fluid may be referred to as a "fluid curtain", wherein the fluid curtain or injected fluid achieves flow conditions, such as a flow velocity or flow direction that causes embolic debris to change direction along a modified flow trajectory, which is different from the original flow trajectory that would occur in the absence of the fluid curtain.

[0081] In this embodiment, two non-limiting example modes of operation are possible:

[0082] Subsystolic: Maintains a predetermined pressure, such as about 100 mmHg, that flows forward and diverts flow and embolic particles only when the patient's blood pressure drops significantly. Such as during aortic valve implantation, blood pressure drops while temporary pacing is performed to stabilize the aortic valve. This step of the procedure may generate a large number of embolic particles, and the drop in the patient's blood pressure will naturally trigger the flow diversion.

[0083] Suprasystolic: During discrete periods of the procedure, flow diversion is activated via fluid injected at a pressure slightly above systolic blood pressure to occlude inflowing blood flow to minimize embolic particles passing from the aortic valve to the carotid arteries.

[0084] according to Fig.15AAn example surgical procedure of an embodiment of the invention includes: first, access to the desired CCA is achieved and access to the vascular system is obtained using an access system (such as an access sheath 2605 or other conduit). Next, the accessed CCA is occluded to prevent or otherwise restrict flow through it. The occlusion may be performed, for example, via a clamp or an expandable element, such as a balloon sheath. The flow conduit 2610 is then delivered to the contralateral CCA (through or adjacent to the access sheath 2605). Saline (or other fluid) is then injected into the CCA as needed, in accordance with the mechanisms described herein. As desired, cardiac or aortic surgery is performed through the access system. Optionally, flow reversal may be achieved in the access-side CCA to increase neural perfusion.

[0085] Fig. 15B A schematic diagram of a vascular system is shown in which a catheter 2620 is positioned to enter the aortic arch (which defines the aortic valve annulus) via the RCCA so that the catheter 2620 can inject fluid into the aortic arch or other desired location. In an alternative version, the catheter 2620 can be an access sheath having at least one lumen and at least one outlet for injecting fluid in the same or similar manner as described above for the catheter 2620. The catheter 2620 has at least one fluid outlet that directs the fluid out of the catheter so that the embolic debris 2625 follows a modified flow trajectory 2630 that is different from the original trajectory. The particles that change direction can be solid particles and / or air particles. The catheter 2620 may have one or more outlets configured to achieve a desired flow profile for the fluid directed to leave the outlet.

[0086] Fig. 15C A schematic diagram of a vascular system is shown in which a catheter 2620 is positioned via the LCCA to enable injection of fluid into the aortic arch, such as via the lumen of the catheter 2620, wherein the fluid exits openings in the distal region and distal end of the catheter 2620. In this embodiment, the catheter 2620 has two or more outlets to enable at least two fluid streams that direct fluid flow in at least two different directions. The injected fluid causes the embolic debris 2625 to follow at least one modified flow trajectory 2630 that is different from the original flow trajectory 2635.

[0087] Fig.15DA schematic diagram of a vascular system is shown, wherein a catheter (or sheath) 2640 is inserted into the RCCA to enter the aortic arch. The adjacent catheter 2640 clamps (such as, via a Rummel loop) the RCCA. The catheter 2640 is configured to inject fluid into the vascular system, such as into the aortic arch. The catheter 2640 is attached to an aerodynamic or fluid dynamic deflector element, such as a spoiler 2645, which is positioned at or near the distal end of the catheter 2640 (or can be used to deliver it). The catheter can be used to position the spoiler 2645 in the aortic arch so that the spoiler disturbs or otherwise adjusts the fluid flow through the aortic arch in a desired manner. The spoiler has at least one outer surface, which is configured to interact with the flow flow in a manner that adjusts or changes the flow of fluid. In one embodiment, the spoiler 2645 creates a flow bias of the blood flow from the aortic valve to turn away from the CCA or away from a predetermined position in the vascular system. The flow curtain appears at the back (such as closer to the CCA) to minimize the situation where the deflected particles rotate or otherwise flow into the CCA. The flow curtain can be created by the hydrodynamic spoiler effect or the flow curtain can be used in combination with spoilers that do not produce 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 wire frame.

[0088] Fig.15E A schematic diagram (not to scale) showing a distal region of a catheter 2640 positioned in the aortic arch via an RCCA. A spoiler 2645 is positioned in the aortic arch downstream of the aortic blood laminar flow. The catheter 2640 includes a proximal large-caliber region that transitions to a region of smaller diameter having an inner cavity 2655 that can be fluidically coupled to a fluid source (such as blood shunted from another vascular location). An outlet 2657 of the inner cavity 2655 provides a path for fluid (such as a shunting fluid) to be injected into the aortic arch. The fluid injected via the outlet 2657 may initially be a laminar flow 2660. In addition, the spoiler 2645 disrupts or otherwise alters the aortic blood laminar flow 2650 to produce an area of ​​aortic blood turbulence 2663.

[0089] Still reference Fig.15E , catheter 2640 also includes an opening 2665 that communicates with the larger lumen of catheter 2640. The larger lumen and opening 2665 can be used to deliver an interventional device, such as a valve delivery device. It should be understood that Fig.15D and Fig.15E The embodiment shown in can be modified to allow access via the LCCA. The relative positions of the cavity of the device and the spoiler can be modified accordingly.

[0090] Fig.16AA schematic diagram of another embodiment is shown, in which an arterial shunt 2705 is combined with an access sheath 2605 or otherwise connected to the access sheath 2605. The shunt 2705 has an inner lumen so that blood flow can be routed from a first position to a second position via the shunt 2705. According to the example surgery, access to the desired CCA (left or right) is achieved, and access to the vascular system is obtained using an access system (such as, access sheath 2605 or other conduit). Next, the CCA entered is occluded, such as by using a clamp or an expandable balloon to form a carotid stump region above the clamp (or balloon). The arterial shunt 2705 can also be used to enter the carotid stump region above the clamp position. As mentioned, the arterial shunt 2705 has an inner lumen that forms an antegrade flow path (bypass or shunt) between two access points across the position of the clamp. Then, a heart or aortic surgery is performed via the access sheath 2605.

[0091] Still refer to Fig.16A , the shunt 2705 may include one or more blood flow control elements 2720, which are configured to change or adjust the state of blood flow through the shunt 2705. For example, the flow control element 2720 may include a filter to capture debris, such as embolic particles of a certain size. The flow control element 2720 may also include an air trap or bubble trap to capture air. This solves the risk of introducing air into the blood flow via the shunt during surgery. The flow control element 2720 may also be configured to adjust an aspect of blood flow, such as to achieve desired flow conditions and / or meet patient tolerance. The size of the filter (or any filter discussed herein) may vary. In a non-limiting example, the filter is a filter with a pore size of 200 microns or a smaller filter, such as a filter with a pore size of 50um or 100um.

[0092] Flow through the shunt may be passive, such that blood flow is driven by a naturally occurring pressure differential. For example, there may be a higher pressure from the RCCA below the carotid clamp, and a lower pressure from the RCCA above the carotid clamp. Flow may also occur actively, such that flow is driven by a pump mechanism. In one non-limiting example, blood is passively or actively pushed through the Circle of Willis (CoW) to provide neural perfusion during therapeutic surgery. Forward flow through the CoW may prevent particles from traveling upward along the contralateral side, such as Fig.16A Indicated by the dotted arrow element in .

[0093] The procedure allows manipulation of blood to safely achieve neuroprotective benefits, such as perfusing blood to the brain, capturing debris from the blood flow during surgery, and driving antegrade blood flow through or to the brain, such as to prevent debris from flowing up contralateral vessels.

[0094] Arterial shunt 2705 can have any of a variety of lengths and sizes to achieve desired flow characteristics and to achieve connections between different locations in the vascular system. The length can be shorter, such as to shunt flow across more localized vessels (such as a carotid-carotid or carotid-jugular pathway), or longer to shunt flow across more distant locations (such as a carotid-iliac pathway). Fig. 16B Schematic diagram showing possible flow routes that can be achieved through the use of flow splitter 2705. Fig. 16B This situation is shown in the context of a right carotid approach, however a left sided approach is also within the scope of the present invention.

[0095] The shunt 2705 can be provided in a variety of ways, such as via a sheath 2605 (eg, Fig.16A ) or connected to the blood stream via a secure connection to a compatible device or through tubing near the surgery.

[0096] Fig.17 An embodiment is shown in which a balloon 2607 is placed in the contralateral CCA to provide additional brain protection by occluding flow (or partially occluding flow) in the contralateral CCA. Partial occlusion may also be sufficient to reduce flow and reduce embolic particles. In an alternative embodiment, an embolic filter may be positioned in the contralateral CCA (or other location) to provide additional brain protection without occluding flow. According to the example surgery, access to the desired CCA is achieved and access to the vascular system is obtained using an access system (such as, an access sheath 2605 or other conduit). Next, the entered CCA is occluded. A balloon catheter or embolic filter 2609 is deployed to the contralateral CCA via the access system. As intended, cardiac or aortic surgery is performed via the access system.

[0097] 18A to 18C Additional embodiments are shown in which one or more occlusion balloon catheters are used. For example, these can be used to achieve embolic protection of large vessels during large-caliber surgery. Occlusion and reverse flow mechanisms can be achieved using occlusion balloons to provide both embolic protection and cerebral perfusion. Any catheter used can be turned to allow or enhance guidance to adjacent vessels. Any of these configurations and the disclosed configurations can be customized to enter from both the right and left carotid arteries. Various features can be customized to accommodate a variety of anatomical structures, such as the number, size and position of balloons, and the location of any openings for device entry. The balloon size can be set to cover a wider range of diameters to enable occlusion of both the carotid artery and the innominate artery, which can provide a more versatile and adaptable device.

[0098] Fig.18AAn embodiment is shown in which a balloon catheter 2905 is deployed into the RCCA. The balloon catheter 2905 has a first balloon 2910 positionable in the innominate artery and a second balloon 2915 positionable in the LCCA. The balloons can be expanded to achieve partial or complete flow occlusion through the respective vessels.

[0099] Fig.18B Another embodiment is shown in which a balloon catheter 2905 is deployed into the RCCA and further extended into the LCCA via the aortic arch. The balloon catheter 2905 has a first balloon 2920 positionable in the RCCA and a second balloon 2925 positionable in the LCCA.

[0100] Fig. 18C An embodiment is shown in which a balloon catheter 2905 is deployed into 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 via the catheter 2905. The opening 2935 can be used to insert an interventional device, such as to allow aortic valve delivery. The size of the opening 2935 can vary to facilitate the entry of devices of different sizes therethrough.

[0101] Fig.19 An embodiment is shown in which blood is withdrawn through an aspiration catheter placed in the contralateral CCA to improve perfusion and divert particles away from the neurovasculature. Blood can be withdrawn through a shunt originating in the contralateral CCA to improve perfusion and divert particles away from the neurovasculature. First, access to the desired CCA is achieved and access to the vascular system is obtained using an access system (such as, an access sheath 2605 or other conduit). Next, the entered CCA is occluded. A flow catheter is delivered to the contralateral CCA, such as through or adjacent to the access system. Then, aspiration or reverse flow via the shunt is engaged. As desired, cardiac or aortic surgery is performed through the access system. Optionally, flow reversal can be achieved in the access-side CCA to increase neural perfusion.

[0102] Fig. 20An embodiment is shown in which a vascular valve 3105 is placed in the contralateral CCA to prevent debris from flowing to the brain. The valve can be configured to allow some pulsatile backflow to support perfusion. The valve can be combined with aspiration or a shunt mechanism to evacuate any debris trapped in the valve and further promote perfusion. The orientation of the valve can be reversed to act as a pressure-sensitive check valve to allow forward (upward) blood flow at high pressure and block flow at low pressure (e.g., during pacing). First, access to the desired CCA is achieved and access to the vascular system is obtained using an access system (such as an access sheath 2605 or other conduit). Next, the CCA being accessed is occluded. The valve is delivered to the contralateral CCA. As desired, cardiac or aortic surgery is performed through the access system. Optionally, flow reversal can be achieved in the access-side CCA to prevent or reduce the accumulation of valve debris and increase neural perfusion.

[0103] Fig.21A A schematic diagram of one embodiment of a conduit and shunt system 3200 is shown. System 3200 includes a conduit 3205 that can be sutured or otherwise attached to a blood vessel, such as a CCA. When so attached, the conduit 3205 forms a path between the lumen of the CCA and the lumen of the conduit 3205. U.S. Patent Application Serial No. 17 / 555,127, entitled "Vascular Conduit for Facilitating Temporary Direct Access to a Blood Vessel," describes an example conduit and is incorporated herein by reference in its entirety. The conduit 3205 has an integrated hub 3210 that communicates with the lumen of the CCA. The hub 3210 may include a hemostatic valve to provide access to the CCA via the conduit 3205 to one or more devices. The conduit 3205 may also include at least one side port 3215 for flushing and / or shunting from one location to another via the hub 3210. The side port 3215 may be used to shunt blood flow through the conduit to a neuroprotective system (NPS) that includes a blood filter and / or an air trap. For example, the neuroprotection system can be a housing that contains a filter and / or air trap and through which the diverted blood flows. An integrated hub of the tubing provides access to the vessel retrograde in the direction of blood flow.

[0104] exist Fig.21A In an embodiment of the present invention, system 3200 includes one or more sheaths 3225 and 3230, which also enter the blood vessel, such as by being inserted through the lumen of conduit 3205. The sheaths can be configured to support interventional procedures, such as TAVR procedures or other procedures. Each of the sheaths can have a corresponding side port for flushing and / or shunting. The side ports can also direct blood through the NPS.

[0105] The system 3200 may also include a secondary shunt catheter 3235, which may also be used to access a vessel in a retrograde flow manner. The secondary shunt catheter 3235 has an inner lumen that enables blood flow to be shunted via the tubing hub 3210 after the blood passes through the NPS. Fig.21A The arrows in represent the blood flow to the secondary shunt catheter 3235. In this way, the shunted blood flow is free of emboli larger than a certain size, such as, for example, emboli larger than 40-100 microns. The NPS also removes air bubbles in the shunted blood.

[0106] Fig.21B A schematic diagram of the distal region of the conduit 3205 is shown, wherein the distal region of the secondary conduit 3205 provides a path extending into a blood vessel. The secondary shunt conduit 3235 can have an expandable balloon 3250 positioned at or near the distal tip of the secondary shunt conduit 3235, which can be expanded via an inflation lumen and port 3240 ( Fig.21A ) is inflated. The balloon 3250 is shown in a dotted line in an expanded state (not to scale). The balloon can be positioned in a blood vessel and expanded to stop retrograde blood flow and redirect the flow through a path including the conduit 3205, the NPS, the secondary shunt catheter 3235, and to a reflux location. The secondary shunt catheter 3235 can also have a predetermined shape, such as a curved or steerable distal region, which is configured to direct the secondary shunt catheter 3235 in an antegrade direction when the secondary shunt catheter enters the blood vessel via the conduit 3205.

[0107] In one embodiment, the secondary shunt catheter 3235 includes a region 3255 configured to couple with a vascular clamp configured to prevent antegrade flow through the vessel while sealing around the outer diameter of the secondary shunt catheter, but without causing any collapse of the secondary shunt catheter 3235.

[0108] In one embodiment, the delivery catheter is deployed through the hemostatic valve of the conduit. When the lumen of the conduit is not occluded by a device, such as an implant delivery device, the delivery catheter can be used for various activities. For example, the lumen of the delivery catheter can be used to shunt blood flow in a manner similar to the conduit. A sheath can be used in conjunction with the conduit to provide an additional level of embolic protection. This can also increase the amount of blood shunted to a terminal location, such as an organ. This can also be used in situations where no conduit or anastomosis is used.

[0109] The delivery catheter may also have a specialized hub that includes an adapter that allows the catheter to be cleaned and flushed outside of the use of a nerve protection device. In the absence of tubing, a specialized clamp may be used to stop blood flow around the outer diameter of the sheath.

[0110] Fig.22AOne embodiment of a distal region of a catheter device 3305 configured to capture plunger debris from other devices and / or the patient's vasculature is shown. Fig. 22B A cross section of the device 3305 is shown. The device 3305 may also be configured to capture air emboli released during an intervention, such as during implant delivery. The device 3305 may be positioned into a vessel of the vascular system such that it captures blood flow through a vascular path and routes the blood flow through a neuroprotective system (NPS) that includes a filter and an air trap that captures emboli larger than a certain size, such as 40-200 microns. As described below, the device 3305 advantageously maintains perfusion along the path by safely returning blood via a coaxial or eccentric path of the device 3305.

[0111] refer to Fig.22A and Fig. 22B , the device 3305 includes an outer tube 3310, wherein a coaxial (or eccentric) inner tube 3315 is positioned in the outer tube 3310. An annular reflux chamber 3317 ( Fig. 22B ) is positioned between the outer tube 3310 and the inner tube 3315. The funnel member 3320 is positioned within the inner tube 3315 so that the funnel shape of the funnel member 3320 guides the fluid into the lumen of the inner tube 3315. Initially, the radial dimension of the funnel member 3320 is limited by the inner tube 3315, such as when the funnel member is retracted within the lumen of the inner tube 3315. The inner tube 3315 can be retracted or otherwise moved relative to or from the funnel member 3320 so that the funnel member 3320 expands to the shape shown in Figure 22. The guidewire can also be deployed via the device. The funnel can be a filter.

[0112] Some exemplary and non-limiting specifications of the device 3305 are now listed. The outer tube may have an outer diameter of 0.093 inches and an inner diameter of 0.085 inches. The inner tube may have an inner diameter of 0.057 inches and an outer diameter of 0.070 inches. The device 3305 may be sized to be deployed through a guide sheath. As mentioned, these dimensions are non-limiting examples. The funnel member 3320 may be, for example, a polytetrafluoroethylene (ePTFE) covered nitinol funnel.

[0113] Device 3305 can be used in various locations, including, for example, the brachiocephalic artery via right radial artery access or the left subclavian artery via left radial artery access. In a non-limiting example, the device can also be delivered via the common carotid artery.

[0114] Device 3305 can be used as follows. The device is delivered into the vascular system via an access site. The inner tube 3315 is retracted to deploy the funnel member 3320 to its funnel shape, such as by allowing the funnel member 3320 to expand from a retracted size to an expanded funnel shape size. As indicated by arrow 3340 in Figure 22, the funnel member 3320 directs blood flow into the cavity of the inner tube 3315. The inner cavity has an outlet that exhausts air and is connected to a neuroprotective system, such as a neuroprotective filter with a bubble trap. That is, the inner cavity is fluidly connected to a shunt or other flow path, wherein fluid (such as blood and embolic debris) flows through a neuroprotective filter that captures the debris. The neuroprotective system is connected to the annular reflux chamber 3317 ( Fig. 22B The resulting diverted and filtered blood is returned to the patient (eg Fig.22A 3323 in the figure) reaches a position proximal to the position where the distal end of the funnel and the inner tube is deployed in the blood vessel (such as, about 1 cm proximal to it). In one embodiment, the inner tube 3315 extends distally beyond the distal end of the outer tube 3310 by a distance of about 1 cm.

[0115] Device 3305 may include or be coupled to a suction device, such as a syringe. During surgery, a user may apply suction via the suction device to enhance capture of debris and / or clear debris from the filter, such as during a high embolic risk portion of a surgery.

[0116] At the completion of the interventional procedure, the shunted blood flow can be stopped. The funnel member 3320 can then be recaptured into the device 3305. The device and procedure can be used in other locations, such as in a retrograde popliteal approach to treat iliac and / or femoral artery disease, and to perform cannulation / fenestration of thoracic endografts (TEVAR).

[0117] Fig.23 A nerve protection sheath 3410 is shown, which is deployed in a vascular system so that the sheath includes a distal end or distal region located in the aortic arch or otherwise having access to the aortic arch. The sheath 3410 is configured to provide blood perfusion to the brain during a large-caliber interventional procedure, such as a TAVR procedure (or other procedure). The sheath 3410 has a proximal hub that provides hemostatic access to the lumen of the sheath 3410. The sheath 3410 includes or is connected to a shunt 3415, which is configured to shunt the perfusion fluid to the brain, such as via a jugular vein, wherein the distal fluid outlet of the shunt 3415 is positioned in the jugular vein. The shunt 3415 may have a single outlet, or may have two or more outlets, each of which is configured to discharge filtered shunt blood in one or more directions of the blood vessel in which the outlet is located.

[0118] According to this procedure, blood is shunted from the carotid artery to the ipsilateral jugular vein via a shunt 3415. The shunted blood passes through a filter element 3420 before being reintroduced into the patient. The shunt 3415 may include a flow control element configured to control the state of blood flow, such as controlling the blood flow rate between a low rate and a high rate. The device may be used via an LCCA or RCCA access site.

[0119] Fig.24 A perspective view of a sheath or cannula 2405 formed of a flexible, elongated body sized and shaped for delivery into a vascular system, such as via a percutaneous route or surgical incision or open access at a patient access site is shown. Cannula 2405 is configured for at least four functions, including (1) embolic protection via an occluded vessel (such as a carotid artery, which may alternatively be occluded via clamping); (2) capture of embolic material from an artery, such as via passive flow of blood into a filter or via active suction; (3) reperfusion of a vessel, such as at a location distal to the access site; and / or (4) delivery of a therapeutic device via the lumen of the cannula.

[0120] The elongated body has at least one lumen, including a delivery lumen configured for delivering a therapeutic device, and a lumen for capturing emboli and / or perfusing an artery. The delivery lumen is in communication with an access port 2410 at a proximal region of the cannula 2405, through which a therapeutic delivery device may be inserted. The delivery lumen is also in communication with a perfusion port 2412, through which perfusion or shunting of blood to or from a blood vessel may be achieved.

[0121] Still refer to Fig.24 , cannula 2405 includes an expandable element 2415, such as an expandable balloon, which can be expanded in the artery to occlude or partially occlude the artery. The expandable element 2415 is located at the distal region of the cannula 2405. The cannula 2405 includes an inflation lumen, which is in communication with the expandable element 2415 via an inflation hub 2420 at the proximal region of the cannula 2405.

[0122] Fig.25A cross-sectional view of the cannula 2405 is shown and the configuration of the lumen is shown. The cannula 2405 includes a delivery lumen 2510 that occupies a central region of the cannula 2405 and is optionally coaxial with the long axis of the cannula 2405. The size of the delivery lumen 2510 can vary. In an exemplary embodiment, the diameter of the delivery lumen 2510 is 6-30 French (Fr). The delivery lumen 2510 can be used to deliver a therapeutic device, such as a guidewire, a stent, a laser fenestration catheter, a needle, or any other device to a blood vessel. The delivery lumen 2510 can also be used to capture emboli via an opening at the distal end of the cannula that is in communication with the delivery lumen 2510. In this regard, the therapeutic device can be used to capture emboli, or emboli can be captured during delivery or deployment of a thoracic endovascular aortic repair (TEVAR) implant. The delivery lumen 2510 can also be used for reperfusion via a zoom balloon. As mentioned, the delivery lumen 2510 is connected to the perfusion port 2412 ( Fig.24 ) is connected to the infusion port 2412, which can be connected to a Y-type adapter or hemostasis hub that allows the passage of the device therethrough and diverts the suction or flow to the path of the flow controller device with a filter.

[0123] Still refer to Fig.25 , cannula 2405 also includes a shunt lumen 2515 that is offset from or coaxial with the long axis of cannula 2405. Shunt lumen 2515 is separated from delivery lumen 2510 by wall 2520, which may be an annular wall. The non-coaxial arrangement of shunt lumen 2515 (relative to the long axis of cannula 2405) is used to increase or maximize the flow within shunt lumen 2515. Shunt lumen 2515 enables blood flow diversion to / from a blood vessel, as well as diversion from delivery lumen 2510 or from a different blood supply, such as to maintain neural perfusion during surgery.

[0124] Cannula 2405 also includes an inflation lumen 2525 positioned between delivery lumen 2510 and shunt lumen 2515. As mentioned, inflation lumen 2525 is in communication with inflation port 2420, as shown in FIG. Fig.24 shown.

[0125] According to one method of use, access to the vascular system is achieved via surgical incision or percutaneous access, such as at the axillary artery, subclavian artery, carotid artery or other artery. Cannula 2405 is then inserted into the vascular system to the target location. The insertion may be accomplished with or without a guidewire and / or dilator. The expandable element 2415 is then inflated to occlude and / or seal the inner arterial wall of the vessel at the target location. The dilator and / or guidewire are then removed. The delivery lumen 2510 ( Fig.25) can be used to capture emboli and blood flow can be diverted to perfuse the artery. These steps can be repeated with one or more additional devices at desired locations as needed or desired. The TEVAR endoprosthesis can be delivered and deployed via delivery lumen 2510. The artery or multiple arteries can be reperfused as needed.

[0126] Fig.26 A view of a vascular system showing normal antegrade circulation is schematically depicted. A therapeutic delivery device, such as a TAVR delivery device 2605, is deployed to the aortic arch via a sheath or cannula device, which can be, for example, the cannula 2405 described above or other devices, via an access position (such as, via the LCCA or other position). The cannula device can be, for example, a 16-24 French large-bore sheath. The RCCA can be occluded in a retrograde direction relative to the access position (such as, via a clamp or via an expandable element inside the artery). The shunt assembly 2615 can be deployed in a manner that is fluidly connected to the cannula device so that blood is shunted to the LCCA at an antegrade position relative to the access position. Thus, the shunt assembly 2615 shunts arterial blood flow from the artery and thereby maintains cerebral perfusion.

[0127] Still refer to Fig.26 , the filter system 2610 is deployed in the vascular system connected to the aortic arch. The filter system 2610 is configured to be deployed in the reverse direction of the blood flow so that the filter system 2610 can capture emboli, as described more fully below. The filter system 2610 has at least three mechanisms for embolic capture, which improves the existing embolic protection device (EPD) that only uses filters to capture emboli. The filter system 2610 includes a filter 2620 mounted on an inner delivery catheter 2625, which is delivered via the inner cavity of an outer delivery sheath 2630. For example, the sheath 2630 can be, for example, a 4F, 5Fr sheath, a 6Fr sheath, or a 7Fr sheath, which reduces the outer profile compared to existing structural cardiac embolic protection devices (which range in size from 6F to 16F). The filter can be retracted into the lumen of the inner catheter to collapse the filter to a smaller size that fits within the lumen. The filter can be funnel-shaped, with the narrow area of ​​the funnel directly attached to the inner catheter.

[0128] The filter 2620 can be a double layer filter (including an inner filter layer and an outer filter layer) that is mounted 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 on 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 in the outer filter layer, so that the inner filter layer has smaller holes or openings relative to the outer layer. The difference in pore size between the inner filter layer and the outer filter layer allows materials that pass through the inner layer but not the outer layer (such as embolic materials) to be trapped between the two layers. In another embodiment, the inner filter layer can have a set of first holes that are larger than a set of second holes in the outer filter layer, so that the inner filter layer has larger holes or openings relative to the outer layer. In an alternative embodiment, the filter is only a single layer.

[0129] The inner delivery catheter 2625 has an inner diameter (ID) that forms an inner lumen so that the inner delivery catheter 2625 can be delivered over a guidewire. The lumen can also be used to capture any material that enters the filter 2620 via the flow of blood flow through the filter 2620 into the inner lumen. These materials pass into the lumen of the inner delivery catheter 2625. The material can then flow through an extracorporeal neuroprotective system in fluid communication with the delivery catheter 2625 and subsequently into an artery or vein. As discussed, the neuroprotective system can include a filter.

[0130] In an alternative embodiment, the lumen of the inner delivery catheter 2625 has one or more openings or channels that allow fluid communication with the annular space (or outer lumen) between the outer delivery sheath 2630 and the inner delivery catheter 2625. This enables flow to occur through two paths simultaneously (i.e., through the lumen of the inner delivery catheter and the annular space). This can be used to increase flow rates, alleviate challenges encountered when one lumen is blocked, and help prevent clot formation on the entire system. A guidewire or microcatheter can be partially inserted into the lumen of the delivery catheter 2625 to remove material that may be blocking the lumen.

[0131] The lumen of the delivery catheter 2625 may also be used to aspirate emboli, or to preferentially promote the maintenance of particles within the filter 2620 during recapture. The aspirated blood may be reinjected into the patient via an extracorporeal neuroprotective system.

[0132] Fig.27AA schematic side view representation of a distal region of a filter system 2610 including a filter 2620 is shown. As mentioned, the filter 2620 is shaped such that an inner filter layer 2710 is positioned within an outer filter layer 2715. The filter 2620 has a funnel shape that converges into 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 relative to the pores of the outer filter layer 2715. Alternatively, in an alternative embodiment, the inner filter layer 2710 may have pores that are larger in size relative to the pores of the outer filter layer 2715. The outer filter layer may also be formed of a polyurethane film. In use, blood may pass through the pores of the filter membrane and enter the inner delivery catheter 2625 positioned within the outer delivery sheath 2630. Blood may also flow through the annular space 2637 between the outer delivery sheath 2630 and the inner delivery catheter 2625. As mentioned, the inner delivery catheter 2625 can be permeable to allow blood to flow to the annular space 2637, where the blood flows between the inner diameter of the inner delivery catheter 2625 and the inner wall of the outer delivery sheath 2630.

[0133] The filter system 2610 is configured to achieve diversion and / or aspiration of blood flow. In this aspect, the filter system 2610 is configured to divert and / or aspirate blood only via the inner delivery conduit 2625, only via the annular space 2637, or via both the inner delivery conduit 2625 and the annular space 2637. Aspiration of blood may be performed via any of these pathways during removal of the filter system 2610 from the vascular system or at any point during use.

[0134] Fig.27B Another embodiment of a filter system 2610 is shown, wherein the filter 2620 includes at least one non-porous region 2750 without any pores, such that the filtration pores are pre-set in the porous region 2760 toward the distal end of the filter 2620. The filter 2620 also includes a porous region 2760 that includes pores or openings. The porosity of the porous region 2760 can vary. In one embodiment, the porous region 2760 occupies approximately 70-95% of the total length of the filter 2620, but this can vary. Fig.27B The filter 2620 is configured to direct high flow rates in narrower regions where embolic particles may accumulate, such as the funnel-shaped non-porous region 2750. The non-porous region may be a proximal region or the region closest to the inner catheter. The non-porous region may be located in a narrower or constricted region of the filter, such as the narrower portion of the funnel shape.

[0135] Fig.28A schematic diagram of a filter system 2610 is shown. As mentioned, the filter 2620 is mounted on the distal end of an inner delivery catheter 2625, which is removably positioned within an outer delivery sheath 2630. A control element 2810 is located at a proximal region of the filter system 2610 and is configured to mechanically or electromechanically control 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 on the control element 2810. In this manner, the outer delivery sheath 2630 can be slidably moved to capture the filter 2620 within its lumen and release the filter 2620, such as by actuating an actuator 2820 on the control element 2810. Fig.28 as shown in .

[0136] In one embodiment, the user actuates the filter system during use so that the filter 2620 moves, such as in a back-and-forth motion, relative to the outer delivery sheath 2630 and / or the inner delivery catheter 2625 in conjunction with suction. Such movement may allow for improved retrieval of embolic particles before the filter is recaptured into the outer delivery sheath 2630. The filter 2620 may be connected to a wire or other element that enables such movement of the filter 2620.

[0137] The pump can be coupled to any of the embodiments described herein to provide active flow of fluid. The pump can be configured to achieve intermittent (or pulsed) flow or continuous flow. Passive blood flow can also be intermittent (or pulsed) flow or continuous flow.

[0138] Fig.29 A cross-sectional schematic diagram of the filter system 2610 is shown, wherein the filter 2620 is captured and collapsed within the outer delivery sheath 2630. Blood can flow in 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 mentioned, the blood flow can transition out of the lumen of the inner delivery catheter 2625 into the annular space via a small opening in the outer wall of the inner delivery catheter 2625. The inner delivery catheter 2625 can have a proximal hub 2910. The outer delivery catheter 2625 can also have a hub 2915 through which blood can be routed to an artery or vein via a nerve protection system.

[0139] Fig.30A schematic diagram of a vascular system is shown in which a filter 3005 has been deployed in the aortic arch by a delivery sheath 2630. The filter is positioned to cover openings in the IA, LCCA, and LSCA. The sheath 2630 is delivered via a radial artery access. The sheath 2630 is configured to provide a suction flow for capturing debris into the sheath 2630, such as an active flow or a passive flow via a pump. The second sheath 3010 is delivered to the aortic arch, such as via a femoral artery access. The TAVR device 3015 can be delivered to the aortic arch via the lumen of the second sheath 3010. The TAVR device can trigger the release of embolic particles into the aortic arch. The second sheath 3010 is configured to aspirate and capture embolic particles into its lumen via a passive or active suction flow, such as by being connected to a pump. The top of the second sheath 3010 can be positioned at various positions along the aortic arch.

[0140] Fig.31 Schematically illustrated is a filter basket 3102 deployed in the aortic arch to filter an area covering a large vessel originating from the aortic arch. For ease of illustration, the filter basket 3102 is cut away at line 3105. An aspiration catheter 3120 is deployed into the aortic arch with a distal end 3127 positioned 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 is bent back at an angle of about 180 degrees, to enable the tip to provide suction within an area 3110 in which the embolic debris is collected / captured. For example, the aspiration catheter 3120 may be delivered via a transfemoral approach.

[0141] exist Fig.31 In another embodiment shown, at least one conduit 3125 having a lumen is coupled to region 3110 of filter basket 3102. Conduit 3125 is configured to draw material from filter basket 3102. Conduit 3125 may be configured to remove material continuously or intermittently via active or passive flow.

[0142] Fig.32 An embodiment is shown in which one or more filters 3205 are deployed to a vessel branching from the aortic arch. One or more suction catheters 3210 can be deployed to the aortic arch, such as via a left radial artery approach or a right radial artery approach. The suction catheter has a curved distal tip 3220 having an opening through which embolic debris can be suctioned from the filter into the lumen of the suction catheter 3210. The curved distal tip 3220 can be hook-shaped, which can flare outward at the farthest end, such as in the shape of a shepherd's hook. In one embodiment, the catheter 3210 is a 6 French catheter and is connected to a device, such as a syringe or a pump, for active suction.

[0143] Although this specification contains many specific details, it should not be interpreted as a limitation on the scope of the claimed invention or the invention that may be claimed, but should be interpreted as a description of the features specific to a particular embodiment. Certain features described in the context of a single embodiment in this specification may also be implemented in combination in a single embodiment. Conversely, the various features described in the context of a single embodiment may also be implemented separately or in any suitable sub-combination in multiple embodiments. In addition, therefore, although the features may be described above as working in certain combinations and even initially claimed, in some cases, one or more features derived from the claimed combination may be removed from the combination, and the claimed combination may be for a sub-combination or a variation of the sub-combination. Similarly, although operations are depicted in a particular order in the accompanying drawings, this should not be understood as requiring such operations to be performed in the particular order shown or in sequence, or performing all the operations shown to achieve the desired result.

[0144] Although certain versions are described herein in detail to describe various embodiments of methods and apparatus, it should be understood that other versions, embodiments, methods of use and combinations thereof are also possible. Therefore, 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, comprising: 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, the inner catheter being slidably positioned within the interior of 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 positioned at a distal end of the inner catheter, the filter configured to direct debris from a blood vessel into the lumen of the inner catheter via blood flow to the filter; an extracorporeal shunt configured to receive blood flow from the lumen; and A filter is coupled to the diverter. 2 . The system of claim 1 , further comprising a pump coupled to the inner catheter, the pump configured to pump blood into the inner catheter and the shunt.

3. The system of claim 1, wherein the filter is funnel-shaped, wherein a narrow region of the funnel is directly attached to the inner conduit.

4. The system of claim 1, wherein the filter is formed by an inner filter layer positioned inside an outer filter layer.

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

6. The system of claim 4, wherein the inner filter layer has a first set of pores that is smaller than a second set of pores of the outer filter layer.

7. The system of claim 4, wherein the filter comprises at least one non-porous region and a porous region.

8. The system of claim 7, wherein the porous region comprises approximately 70-95% of the total length of the filter.

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

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

11. The system of claim 1, wherein the lumen is sized to receive a guidewire.

12. The system of claim 1, wherein the outer cavity is an annular space.

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

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

15. The system of claim 1, wherein the shunt is in communication with both the outer lumen and the inner lumen.

16. The system of claim 1, wherein the filter is configured to be retracted into the lumen to collapse the filter to a smaller size.

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

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

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

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

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

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