Systems for transcarotid artery revascularization
A system for neuroprotection for use during carotid interventions comprising an arterial access devices comprising an arterial sheath and an extension device removably connected to the proximal end of the arterial sheath.
1 . A system for neuroprotection for use during carotid arterial interventions including transcarotid artery revascularization (TCAR), the system comprising:
an arterial access device comprising an arterial sheath having a distal and a proximal end, and an extension device removably connected to the proximal end of the arterial sheath,
the arterial sheath comprising:
(a) a first body having a proximal end, a distal end, a first lumen, and a first hemostatic valve positioned at the proximal end, and
(b) a second lock portion having a proximal end, a distal end, the second lock portion extending distally from the distal end of the second body, the second lock portion configured to releasably interlock with the first lock portion and
(c) a defeater configured to pierce the first hemostatic valve and at least partially disposed inside the second body, the Defeater having a proximal end, a distal end, and a Defeater lumen extending distally from a distal end of the second lumen, the Defeater configured to actuate the first hemostatic valve such that, when the extension device is connected to the arterial sheath, the first lumen, the Defeater lumen, and the one lumen form a continuous lumen;
a venous sheath fluidly connected with the arterial access device, and
wherein the distal end of the first body of the arterial sheath comprises a footplate configured to seal an insertion point in the carotid artery during the carotid arterial interventions.
2 . The system of claim 1 , wherein the arterial sheath comprises an inner tube at least partially disposed inside the first body, the inner tube forming a part of the first lumen, the inner tube having a proximal end and a distal end.
3 . The system of claim 1 , wherein the first body comprises a plurality of notches or fenestrations.
4 . The system of claim 1 , comprising a first branching tube having a proximal end, a distal end attached to the arterial sheath, and a first branching lumen in fluid communication with the first lumen, the first branching lumen having a proximal end and a distal end.
5 . The system of claim 4 , wherein the distal end of the first branching lumen forms a first lateral opening in the first lumen positioned between the proximal end of the inner tube and the first hemostatic valve.
6 . The system of claim 1 , wherein, when the extension device is connected to the arterial sheath, the first lock portion is at least partially disposed inside the second lock portion and the second lock portion comprises a slider mechanism configured to releasably lock the first lock portion to the second lock portion.
7 . The system of claim 1 , wherein the defeater has a frustoconical portion configured to at least partially fill a frustoconical portion of the lock lumen.
8 . The system of claim 1 , wherein the defeater has a cylindrical distal portion having a first diameter and a cylindrical proximal portion having a second diameter, wherein the second diameter is greater than the first diameter and the frustoconical portion of the defeater is disposed between the distal portion and the proximal portion of the defeater.
9 . The system of claim 1 , comprising a second branching tube having a proximal end, a distal end attached to the extension device, and a second branching lumen fluidically connected with the second lumen, the second branching lumen having a proximal end and a distal end.
10 . The system of claim 9 , wherein the distal end of the second branching lumen forms a second lateral opening in the second lumen positioned between the defeater and the second hemostatic valve.
11 . The system of claim 9 , comprising a flow controller having a proximal end, a distal end, and a lumen, the distal end of the flow controller being removably attached to the proximal end of the second branching tube, the lumen of the flow controller being fluidically connected with the first lumen and the second lumen.
12 . The system of claim 1 , wherein the venous sheath comprises:
(a) a third body having a proximal end, a distal end, a third lumen, and a third hemostatic valve positioned at the proximal end, and
(b) a third branching tube having a proximal end, a distal end attached to the third body of the venous sheath, and a third branching lumen in fluid communication with the third lumen, the third branching lumen having a proximal end and a distal end removably attached to the proximal end of the flow controller, the lumen of the flow controller being fluidically connected with the third lumen.
13 . The system of claim 2 , wherein the distal end of the inner tube of the arterial sheath further comprises a flexible tip configured to bend in a bending angle between 0° and 30°.
14 . The system of claim 2 , wherein the inner tube of the arterial sheath comprises a liner forming an innermost layer of at least a part of the inner tube.
15 . The system of claim 14 , wherein the inner tube of the arterial sheath comprises a coiled wire forming a layer around the liner in at least a part of the inner tube, wherein the coiled wire, the liner, or both, are coated with a polymer material.
16 . The system of claim 15 , wherein the inner tube of the arterial sheath comprises a segment A, wherein the liner extends distally from the distal end of the coiled wire, and the coiled wire and the liner are coated with a first material forming a first layer.
17 . The system of claim 14 , wherein the inner tube of the arterial sheath comprises a segment B proximal to segment A, wherein the coiled wire is coated with a second material forming a second layer contiguous with the first layer.
18 . The system of claim 17 , wherein the inner tube of the arterial sheath comprises a segment C proximal to segment B, wherein the coiled wire is coated with a third material forming a third layer contiguous with the second layer, the third material stiffer than the first material and second material.
19 . The system of claim 2 , wherein the inner tube of the venous sheath comprises a liner forming an innermost layer of at least a part of the inner tube.
20 . The system of claim 19 , wherein the inner tube of the venous sheath comprises a coiled wire forming a layer around the liner in at least a part of the inner tube, wherein the coiled wire, the liner, or both, are coated with a polymer material.
21 . The system of claim 20 , wherein the inner tube of the venous sheath comprises a segment D, wherein the liner extends distally from the distal end of the coiled wire, and the coiled wire and the liner are coated with a fourth material forming a fourth layer.
22 . The system of claim 20 , wherein the inner tube of the venous sheath comprises a segment E proximal to segment D, wherein the coiled wire is coated with a fifth material forming a fifth layer contiguous with the fourth layer.
23 . The system of claim 1 , further comprising an arterial dilator configured to traverse through the inner tube of the arterial sheath to make or expand an incision in the carotid artery for the inner tube to enter the carotid artery.
24 . The system of claim 23 , wherein the arterial dilator comprises:
an arterial dilator extrusion comprising a proximal end and a distal end, wherein the distal end of the arterial dilator extrusion includes an incision tip configured to make the incision in the artery to for the inner tube to enter the artery; and
an arterial dilator hub coupled to the proximal end of the arterial dilator extrusion via an arterial dilator hub connector.
25 . The system of claim 1 , further comprising a venous dilator configured to traverse through the inner tube of the venous sheath to make or expand an incision in a femoral vein for the inner tube to enter the femoral vein.
26 . The system of claim 25 , wherein the venous dilator comprises:
a venous dilator extrusion comprising a proximal end and a distal end, wherein the distal end of the venous dilator extrusion includes an incision tip configured to make the incision in the vein to for the inner tube to enter the vein; and
a venous dilator hub coupled to the proximal end of the venous dilator extrusion via a venous dilator hub connector.
27 . The system of claim 1 , further comprising a guidewire configured to traverse the inner tube of the arterial sheath or the venous sheath and deliver a stent to the carotid artery or the femoral vein.
28 . The system of claim 27 , wherein the guidewire comprises a first segment and a second segment, the first segment configured as a deformable hook, the first segment being more flexible than the second segment, wherein the first segment comprises a Nitinol core and a coiled wire layer wound around the core.