Revascularization devices
Systems, methods, and devices for the treatment of acute ischemic stroke that provide immediate blood flow restoration to a vessel occluded by a clot and, after reestablishing blood flow, address the clot itself. Immediate blood flow restoration advantageously can facilitate natural lysis of the clot and also can reduce or obviate the concern for distal embolization due to fragmentation of the clot. Several embodiments of the invention provide for progressive, or modular, treatment based upon the nature of the clot. For example, the progressive treatment can comprise a three-step progressive treatment process that includes immediate restoration of blood flow, in-situ clot management, and/or clot removal depending on the particular circumstances of the treatment. The in-situ clot management can include, for example, lysis and maceration. The progressive, or modular, treatment can be provided by a system or kit of one or more treatment devices.
1. A revascularization device configured to restore flow within a cerebral artery having an occlusive thrombus, comprising:
an elongate member having a proximal end and a distal end;
a tubular scaffold having a proximal end and an open, non-filtering distal end, the scaffold comprising a plurality of cells, the proximal end of the scaffold being coupled to the distal end of the elongate member, the scaffold being adapted to radially self-expand from a non-expanded configuration within a catheter to an expanded configuration upon unsheathing of the scaffold from the catheter, the scaffold having a chronic outward force (COF) per unit length that does not decrease by more than 50% and is non-zero from a scaffold diameter of 1.5 mm to a scaffold diameter of 2.5 mm.
2. The device of claim 1 , wherein the proximal end of the scaffold comprises a tapered structure configured to facilitate re-sheathing of the scaffold.
3. The device of claim 1 , wherein the proximal end of the scaffold is eccentrically coupled to the distal end of the elongate member with a plurality of tethers extending from a proximal end of the scaffold.
4. The device of claim 3 , wherein the plurality of tethers extend eccentrically from less than half of the circumference of the distal end of the elongate member.
5. The device of claim 4 , wherein the tethers are soldered to a distal end of the elongate member using a radiopaque band that is made of a different material than the material of the elongate member and the scaffold.
6. The device of claim 1 , wherein the cells of the scaffold have a cell length of between 2 mm and 6 mm and a cell height between 1 mm and 3 mm in the expanded configuration.
7. The device of claim 1 , wherein the elongate member is a variable-pitch hypotube.
8. The device of claim 1 , wherein the elongate member is a flexible wire without a lumen.
9. The device of claim 1 , wherein the scaffold length is from 10 mm to 40 mm.
10. The device of claim 1 , wherein the cells have variable cell size.
11. The device of claim 1 , wherein the scaffold is not configured to overlap on itself.
12. An acute ischemic stroke revascularization device configured to address an occlusive thrombus within a cerebral artery, comprising:
a flexible wire having a proximal end and a distal end, the flexible wire having sufficient flexibility to navigate tortuous vasculature to access a thrombus within a cerebral artery;
a self-expandable, longitudinally-open scaffold comprising a plurality of cells and having a proximal end and an open, non-filtering distal end, the proximal end of the scaffold being coupled to the distal end of the flexible wire, the scaffold being adapted to radially self-expand from a non-expanded configuration within a catheter to an expanded configuration upon unsheathing of the scaffold from the catheter, the cells being sized and shaped to facilitate at least one of thrombus compression or thrombus engagement, the scaffold having a chronic outward force (COF) per unit length that does not decrease by more than 50% and is non-zero from a scaffold diameter of 1.5 mm to a scaffold diameter of 2.5 mm.
13. The device of claim 12 , wherein the proximal end of the scaffold comprises an open, tapered structure configured to facilitate re-sheathing of the scaffold.
14. The device of claim 12 , wherein the proximal end of the scaffold is eccentrically coupled to the distal end of the flexible wire.
15. The device of claim 14 , wherein the scaffold is coupled to the distal end of the flexible wire by a plurality of tether lines that extend eccentrically from less than half of the circumference of the distal end of the flexible wire.
16. The device of claim 12 , wherein the scaffold is not configured to overlap on itself.
17. An acute ischemic stroke revascularization device configured to address an occlusive thrombus within a cerebral artery, comprising:
an elongate member having a proximal end and a distal end, the elongate member having sufficient flexibility to navigate tortuous vasculature to access a thrombus within a blood vessel;
a self-expandable, longitudinally-open scaffold comprising a plurality of cells and having a proximal end and an open, non-filtering distal end, the proximal end of the scaffold being coupled to the distal end of the elongate member, the scaffold having a chronic outward force (COF) per unit length that does not decrease by more than 50% and is non-zero from a scaffold diameter of 1.5 mm to a scaffold diameter of 2.5 mm.
18. The device of claim 17 , wherein the proximal end of the scaffold is eccentrically coupled to the distal end of the elongate member.
19. The device of claim 17 , wherein a proximal end of the scaffold comprises a tapered structure configured to facilitate re-sheathing of the scaffold.
20. The device of claim 17 , wherein the scaffold is not configured to overlap on itself.