Revascularization devices
First Claim
1. A temporary revascularization device configured to immediately restore flow within a cerebral artery having an occlusive thrombus without distal embolic protection, comprising:
- an elongate member having a proximal end and a distal end;
a self-expandable and reconstrainable scaffold having a proximal end and an open, non-filtering distal end, the proximal end of the scaffold being eccentrically coupled to the distal end of the elongate member with a plurality of tethers extending from a proximal end of the scaffold, the scaffold being adapted to radially self-expand from a non-expanded configuration to an expanded configuration upon unsheathing of the scaffold and to transition from the expanded configuration to the non-expanded configuration upon re-sheathing of the scaffold;
wherein the scaffold is a nitinol tube comprising a generally cylindrical body having a plurality of open cells defined by struts and connected by bridges,wherein each strut has two ends, with each end connected to one of the bridges,wherein the proximal end of the scaffold comprises a tapered structure configured to facilitate re-sheathing of the scaffold and to facilitate unobstructed blood flow,wherein the scaffold has a length sufficient to at least partially span the thrombus,wherein the scaffold has a chronic outward force (COF) per unit length that does not decrease by more than 50% and is non-zero from a diameter of 1.5 mm to a diameter of 2.5 mm,wherein, in use, the scaffold is configured to at least partially span the thrombus within a cerebral artery in its non-expanded configuration within a microcatheter and then be unsheathed from the microcatheter, thereby causing the generally cylindrical body of the scaffold to self-expand and compress the thrombus against a luminal wall of the cerebral artery to restore blood flow through the cerebral artery;
wherein said restored blood flow facilitates natural lysis of the thrombus; and
wherein, as the thrombus lyses, the generally cylindrical body of the scaffold is configured to apply continuous radial pressure at the location of the thrombus, thereby further facilitating blood flow.
3 Assignments
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Accused Products
Abstract
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.
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Citations
23 Claims
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1. A temporary revascularization device configured to immediately restore flow within a cerebral artery having an occlusive thrombus without distal embolic protection, comprising:
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an elongate member having a proximal end and a distal end; a self-expandable and reconstrainable scaffold having a proximal end and an open, non-filtering distal end, the proximal end of the scaffold being eccentrically coupled to the distal end of the elongate member with a plurality of tethers extending from a proximal end of the scaffold, the scaffold being adapted to radially self-expand from a non-expanded configuration to an expanded configuration upon unsheathing of the scaffold and to transition from the expanded configuration to the non-expanded configuration upon re-sheathing of the scaffold; wherein the scaffold is a nitinol tube comprising a generally cylindrical body having a plurality of open cells defined by struts and connected by bridges, wherein each strut has two ends, with each end connected to one of the bridges, wherein the proximal end of the scaffold comprises a tapered structure configured to facilitate re-sheathing of the scaffold and to facilitate unobstructed blood flow, wherein the scaffold has a length sufficient to at least partially span the thrombus, wherein the scaffold has a chronic outward force (COF) per unit length that does not decrease by more than 50% and is non-zero from a diameter of 1.5 mm to a diameter of 2.5 mm, wherein, in use, the scaffold is configured to at least partially span the thrombus within a cerebral artery in its non-expanded configuration within a microcatheter and then be unsheathed from the microcatheter, thereby causing the generally cylindrical body of the scaffold to self-expand and compress the thrombus against a luminal wall of the cerebral artery to restore blood flow through the cerebral artery; wherein said restored blood flow facilitates natural lysis of the thrombus; and wherein, as the thrombus lyses, the generally cylindrical body of the scaffold is configured to apply continuous radial pressure at the location of the thrombus, thereby further facilitating blood flow. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. An acute ischemic stroke revascularization device configured to address an occlusive thrombus within a cerebral artery without distal embolic protection, comprising:
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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 scaffold having a proximal end and a distal end, the proximal end of the scaffold being eccentrically coupled to the distal end of the flexible wire, the scaffold being adapted to radially self-expand from a non-expanded configuration to an expanded configuration upon unsheathing of the scaffold and to transition from the expanded configuration to the non-expanded configuration upon re-sheathing of the scaffold; wherein the scaffold comprises a longitudinally-open, generally cylindrical body having a plurality of open cells defined by struts and connected by bridges, wherein each strut has two ends, with each end connected to one of the bridges, wherein the open cells are sized and shaped to facilitate at least one of thrombus compression or thrombus engagement, wherein the scaffold comprises an open, non-filtering distal end, wherein the scaffold has a length sufficient to at least partially span the thrombus, wherein the scaffold has a chronic outward force (COF) per unit length that does not decrease by more than 50% and is non-zero from a diameter of 1.5 mm to a diameter of 2.5 mm, wherein a proximal end of the scaffold comprises an open, tapered structure configured to facilitate re-sheathing of the scaffold and to facilitate unobstructed blood flow, wherein, in use, the scaffold is configured to be positioned at a location of the thrombus within a cerebral artery in its non-expanded configuration within a microcatheter and then be unsheathed from the microcatheter, thereby causing the body of the scaffold to self-expand and compress the thrombus against a luminal wall of the cerebral artery to restore blood flow through the cerebral artery; wherein said restored blood flow facilitates natural lysis of the thrombus, and wherein, as the thrombus lyses, the body of the scaffold is configured to apply continuous radial pressure at the location of the thrombus, thereby further facilitating blood flow. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21)
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22. An acute ischemic stroke revascularization device configured to address an occlusive thrombus within a blood vessel without distal embolic protection, comprising:
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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 scaffold having a proximal end and a distal end, the proximal end of the scaffold being eccentrically coupled to the distal end of the elongate member, the scaffold being adapted to radially self-expand from a non-expanded configuration to an expanded configuration upon unsheathing of the scaffold and to transition from the expanded configuration to the non-expanded configuration upon re-sheathing of the scaffold; wherein the scaffold comprises a laser-cut, longitudinally-open, cylindrical body having a plurality of cells defined by struts and connected by bridges, wherein each strut has two ends, with each end connected to one of the bridges, wherein the struts have variable thickness across the length of the struts and the bridges have a greater thickness than adjacent portions of the struts connected to the bridges; wherein the scaffold comprises an open, non-filtering distal end, wherein the scaffold has a length sufficient to at least partially span the thrombus, wherein the scaffold has a chronic outward force (COF) per unit length that does not decrease by more than 50% and is non-zero from a diameter of 1.5 mm to a diameter of 2.5 mm, wherein a proximal end of the scaffold comprises a tapered structure configured to facilitate re-sheathing of the scaffold and to facilitate unobstructed blood flow, wherein, in use, the scaffold is configured to be positioned at a location of the thrombus within the blood vessel in its non-expanded configuration within a microcatheter and then be unsheathed from the microcatheter, thereby causing the body of the scaffold to self-expand and compress the thrombus against a luminal wall of the blood vessel to restore blood flow through the blood vessel; wherein said restored blood flow facilitates natural lysis of the thrombus, and wherein, as the thrombus lyses, the body of the scaffold is configured to apply continuous radial pressure at the location of the thrombus, thereby further facilitating blood flow. - View Dependent Claims (23)
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Specification