BLOOD FLOW RESTORATION AND THROMBUS MANAGEMENT METHODS
First Claim
1. A thrombus management method, comprising:
- identifying a cerebral vessel having a thrombus;
inserting a guidewire into the cerebral vessel and past the thrombus;
inserting a microcatheter over the guidewire to a location of the thrombus;
placing a distal end of the microcatheter 0.5 to 10 millimeters past the thrombus;
inserting an expandable tip assembly comprising a self-expanding member through the microcatheter;
advancing the expandable tip assembly within the microcatheter such that a distal end of the self-expanding member is proximate the distal end of the microcatheter;
retracting the microcatheter, thereby causing the self-expanding member to expand across at least a portion of the length of the thrombus,wherein said expansion compresses the thrombus against a wall of the cerebral vessel,wherein said compression of the thrombus restores blood flow within the cerebral vessel, andwherein said restored blood flow facilitates natural lysis of the thrombus;
macerating the thrombus by moving the microcatheter to expand and compress the self-expanding member, thereby facilitating mechanical lysis and fragmentation of the thrombus to release embolic particles;
wherein the embolic particles flow in the direction of the blood flow and are not captured by any distal embolic protection device but are instead lysed through the natural lysis process due to the restored blood flow;
engaging a remaining portion of the thrombus after said maceration; and
extracting said remaining portion of the thrombus from the blood vessel.
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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
20 Claims
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1. A thrombus management method, comprising:
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identifying a cerebral vessel having a thrombus; inserting a guidewire into the cerebral vessel and past the thrombus; inserting a microcatheter over the guidewire to a location of the thrombus; placing a distal end of the microcatheter 0.5 to 10 millimeters past the thrombus; inserting an expandable tip assembly comprising a self-expanding member through the microcatheter; advancing the expandable tip assembly within the microcatheter such that a distal end of the self-expanding member is proximate the distal end of the microcatheter; retracting the microcatheter, thereby causing the self-expanding member to expand across at least a portion of the length of the thrombus, wherein said expansion compresses the thrombus against a wall of the cerebral vessel, wherein said compression of the thrombus restores blood flow within the cerebral vessel, and wherein said restored blood flow facilitates natural lysis of the thrombus; macerating the thrombus by moving the microcatheter to expand and compress the self-expanding member, thereby facilitating mechanical lysis and fragmentation of the thrombus to release embolic particles; wherein the embolic particles flow in the direction of the blood flow and are not captured by any distal embolic protection device but are instead lysed through the natural lysis process due to the restored blood flow; engaging a remaining portion of the thrombus after said maceration; and extracting said remaining portion of the thrombus from the blood vessel. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A thrombus management method, comprising:
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identifying a blood vessel having a thrombus; inserting a guide wire into the blood vessel and past the thrombus; inserting a microcatheter over the guidewire to a location of the thrombus; positioning a distal end of the microcatheter past the thrombus; inserting an expandable tip assembly comprising a proximal elongate member and a distal self-expanding member through the microcatheter; advancing the expandable tip assembly within the microcatheter such that a distal end of the self-expanding member is proximate the distal end of the microcatheter; retracting the microcatheter in a proximal direction, thereby causing the self-expanding member to expand; wherein said expansion of the self-expanding member compresses the thrombus against a wall of the blood vessel; wherein said compression of the thrombus restores blood flow within the blood vessel; wherein said restored blood flow facilitates natural lysis of the thrombus; and macerating the thrombus by resheathing the self-expanding member within the microcatheter and unsheathing the self-expanding member from the microcatheter through advancement and retraction of the microcatheter, thereby facilitating mechanical lysis and fragmentation of the thrombus to release embolic particles; wherein the embolic particles flow in the direction of the blood flow and are lysed through natural lysis due to the restored blood flow. - View Dependent Claims (12, 13, 14, 15, 16)
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17. A thrombus management method for the treatment of ischemic stroke, the method comprising:
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identifying an occluded blood vessel having a thrombus; selecting an expandable tip assembly based, at least in part, on a diameter of the identified occluded blood vessel, the expandable tip assembly comprising a proximal elongate member and a distal self-expanding member; inserting the selected expandable tip assembly within the occluded vessel through a microcatheter such that the self-expanding member is positioned at a location of the thrombus in a non-expanded configuration; retracting the microcatheter, thereby causing the self-expanding member to expand to an expanded configuration, wherein said expansion of the self-expanding member compresses the thrombus against a wall of the blood vessel, wherein said compression of the thrombus restores blood flow within the blood vessel, wherein said restored blood flow facilitates natural lysis of the thrombus; engaging at least a portion of remaining thrombus material with the expandable tip assembly; and removing the at least a portion of remaining thrombus material with the expandable tip assembly. - View Dependent Claims (18, 19, 20)
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Specification