Systems and methods for transcatheter aortic valve treatment
Devices and methods are configured to allow transcervical or subclavian access via the common carotid artery to the native aortic valve, and implantation of a prosthetic aortic valve into the heart. The devices and methods also provide means for embolic protection during such an endovascular aortic valve implantation procedure.
1. A system for treating an aortic valve, comprising:
an arterial access sheath configured to be inserted into an access point in a common carotid artery through a penetration in a neck of a patient, the arterial access sheath having an internal lumen;
wherein the arterial access sheath has a first lumen configured to receive a valve delivery system, the valve delivery system configured to deliver a prosthetic valve into a heart or aorta through the arterial access sheath, the first lumen having a first opening at a proximal end of the arterial access sheath and a second opening at a distal most end of the arterial access sheath;
wherein the arterial access sheath further has a first Y-arm located at a proximal region of the arterial access sheath, the first Y-arm splitting into a flow shunt and into the first opening at the proximal end of the arterial access sheath such that the Y-arm communicates with the flow shunt that is configured to reintroduce blood flow into the carotid artery at a location upstream from the access point into the carotid artery, the flow shunt connected to the first Y-arm of the arterial access sheath at a first end of the shunt and such that the first Y-arm also communicates with the first opening at the proximal end of the arterial access sheath;
a second Y-arm connected to the flow shunt at a second end of the flow shunt wherein the second Y-arm fluidly connects the flow shunt to a second, parallel lumen of the arterial access sheath, the parallel lumen being positioned parallel with at least a portion of the internal lumen of the arterial access sheath such that the arterial access sheath contains two lumens that are simultaneously open, and wherein the second, parallel lumen forms a third opening of the arterial access sheath, the third opening being positioned along the arterial access sheath proximal of the second opening and wherein blood flows out of the third opening solely from the second, parallel lumen, and wherein the internal lumen of the arterial access sheath has a uniform diameter distal of the third opening, and wherein the parallel lumen and the first lumen concurrently provide fixed flow paths and are separated by a fixed wall;
a guidewire sized and shaped to be inserted through the arterial access sheath and across a native aortic valve;
a filter configured to be deployed in an artery via the penetration, the filter being sized and shaped to be deployed within the aortic arch so that all the head and neck vessels are protected by the filter from embolic debris during a valve implantation procedure, wherein the filter has a substantially conical shape when positioned in the aortic arch such that a widened portion of the filter traverses an entire diameter of an ascending portion of the aorta when deployed in the aorta, wherein the filter is positioned substantially on one side of the sheath when deployed; and
a prosthetic valve configured to be inserted through the arterial access sheath and percutaneously deployed at or near the position of the native aortic valve.
2. The system of claim 1 , wherein the filter is attached to the sheath.
3. The system of claim 1 , wherein the filter further has a narrowed portion such that the narrowed portion of the filter extends into a descending portion of the aorta when deployed in the aorta.
4. The system of claim 3 , wherein the widened portion of the filter forms an open mouth that is open toward the ascending portion of aorta.
5. The system of claim 4 , wherein the narrowed portion of the filter forms an enclosed portion of the filter.
6. A system for treating an aortic valve, comprising:
an arterial access sheath configured to be inserted into an access point in a common carotid artery through a penetration in a neck of a patient, the arterial access sheath having a proximal end, a proximal opening at the proximal end, a distal end, a distal opening at the distal end;
wherein a first lumen is defined in the arterial access sheath that extends from the proximal opening of the arterial access sheath to the distal opening of the arterial access sheath;
wherein the first lumen configured to receive a valve delivery system, the valve delivery system being configured to deliver a prosthetic valve into a heart or aorta through the arterial access sheath;
a hub coupled to the proximal end of the arterial access sheath, the hub including a first Y-arm in fluid communication with the first lumen;
wherein the hub includes a second Y-arm in fluid communication with a second lumen defined in the arterial access sheath, the second lumen extending to a distal port disposed proximally of the distal end of the arterial access sheath;
wherein the arterial access sheath includes a fixed internal wall that separates the first lumen from the second lumen so that the first lumen and the second lumen are simultaneously open during use of the arterial access sheath; and
a shunt coupled to the first Y-arm and to the second Y-arm, the shunt being configured to reintroduce blood flow into the carotid artery at a location upstream from the access point into the carotid artery.
7. The system of claim 6 , further comprising a guidewire sized and shaped to be inserted through the arterial access sheath and across a native aortic valve.
8. The system of claim 6 , further comprising a filter configured to be deployed in an artery via the penetration, the filter being sized and shaped to be deployed within the aortic arch so that all the head and neck vessels are protected by the filter from embolic debris during a valve implantation procedure.
9. The system of claim 8 , wherein the filter has a substantially conical shape when positioned in the aortic arch such that a widened portion of the filter traverses an entire diameter of an ascending portion of the aorta when deployed in the aorta.
10. The system of claim 8 , wherein the filter is positioned substantially on one side of the sheath when deployed.
11. The system of claim 8 , wherein the filter is attached to the sheath.
12. The system of claim 8 , wherein the filter further has a narrowed portion such that the narrowed portion of the filter extends into a descending portion of the aorta when deployed in the aorta.
13. The system of claim 12 , wherein the widened portion of the filter forms an open mouth that is open toward the ascending portion of aorta.
14. The system of claim 13 , wherein the narrowed portion of the filter forms an enclosed portion of the filter.
15. The system of claim 6 , further comprising a prosthetic valve configured to be inserted through the arterial access sheath and percutaneously deployed at or near the position of the native aortic valve.
16. A system for treating an aortic valve, comprising:
an arterial access sheath configured to be inserted into an access point in a common carotid artery through a penetration in a neck of a patient, the arterial access sheath having a proximal end, a proximal opening at the proximal end, a distal end, a distal opening at the distal end;
wherein a first lumen is defined in the arterial access sheath that extends from the proximal opening of the arterial access sheath to the distal opening of the arterial access sheath;
wherein the first lumen configured to receive a valve delivery system, the valve delivery system being configured to deliver a prosthetic valve into a heart or aorta through the arterial access sheath;
a hub coupled to the proximal end of the arterial access sheath, the hub including a first Y-arm in fluid communication with the first lumen;
wherein the hub includes a second Y-arm in fluid communication with a second lumen defined in the arterial access sheath, the second lumen extending to a distal port disposed proximally of the distal end of the arterial access sheath;
wherein the arterial access sheath includes an immovable internal wall that separates the first lumen from the second lumen so that the first lumen and the second lumen are simultaneously open during use of the arterial access sheath; and
a shunt coupled to the first Y-arm and to the second Y-arm, the shunt being configured to reintroduce blood flow into the carotid artery at a location upstream from the access point into the carotid artery.