Methods of managing neurovascular obstructions

• US 10,123,803 B2
• Filed: 06/29/2011
• Issued: 11/13/2018
• Est. Priority Date: 10/17/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Ferrera, David A., Cragg, Andrew H., Fulkerson, John
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): Bachman, L
• Application Number:
  US13/172,778
• Publication Number:
  US 20110319917A1
• Time in Patent Office: 2,694 Days
• Field of Search: 623 112
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/32096 for slowly cutting through tissue, e.g. stent like temporary implants having sharp edges
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/104 used for angioplasty

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 include 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, maceration, and/or removal.

Claims

1. A method of managing a thrombus in neurovasculature without distal embolic protection for the treatment of acute ischemic stroke, the method comprising:

identifying an occluded artery of the neurovasculature of a subject having a thrombus;

inserting a balloon guide catheter within the subject and advancing a distal end of the balloon guide catheter to an arterial location proximal to the occluded artery;

inserting a guidewire through the balloon guide catheter and advancing a distal end of the guidewire within the occluded artery and through or to the side of the thrombus,

inserting a distal access catheter through the guide catheter and advancing a distal end of the distal access catheter to a location within the occluded artery proximate the thrombus;

inserting a microcatheter through the distal access catheter and advancing a distal end of the microcatheter through or to the side of the thrombus;

positioning the distal end of the microcatheter 0.5 to 10 mm past a distal end of the thrombus;

inserting an expandable tip assembly comprising a self-expandable scaffold tethered to a distal end of an elongate delivery member through the microcatheter,

wherein said self-expandable scaffold has an open downstream end and comprises a generally cylindrical body comprised of a plurality of struts and bridges forming a plurality of cells,

wherein the cells are sized and shaped to impact, compress and engage thrombus material upon radial expansion of the self-expandable scaffold;

retracting the microcatheter proximally, thereby causing the self-expandable scaffold to span at least a segment of the length of the thrombus;

wherein said expansion impacts and compresses the thrombus against a wall of the occluded artery,

wherein said compression of the thrombus restores blood flow within the occluded artery,

wherein said restored blood flow facilitates natural lysis of the thrombus;

while the expandable tip remains stationary, macerating the thrombus by resheathing the self-expandable scaffold and unsheathing the self-expandable scaffold, 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 member, but are instead lysed through the natural lysis process due to the restored blood flow; and

removing said expandable tip assembly from the subject, thereby removing any portions of the thrombus engaged by the self-expandable scaffold from the occluded artery.

2. The thrombus management method of claim 1, further comprising providing local aspiration at a location proximal to the thrombus within the occluded artery through the distal access catheter.

3. The thrombus management method of claim 1, further comprising providing proximal aspiration at a location proximal to and remote from the location of thrombus through the balloon guide catheter.

4. The thrombus management method of claim 1, further comprising temporarily restricting flow through the occluded artery while removing the expandable tip assembly by inflating a balloon of the balloon guide catheter.

5. The thrombus management method of claim 1, further comprising inserting the distal access catheter, the microcatheter, and/or the expandable tip assembly over the guidewire.

6. The thrombus management method of claim 1, wherein the occluded artery is a middle cerebral artery and wherein the distal end of the distal access catheter is inserted to a location within the middle cerebral artery or within an internal carotid artery.

7. The thrombus management method of claim 1, further comprising delivering one or more agents configured to promote thrombus adhesion or platelet activation to a location of the thrombus through or over the expandable tip assembly.

8. The thrombus management method of claim 1, further comprising delivering one or more lytic agents to a location of the thrombus through or over the expandable tip assembly.

9. The thrombus management method of claim 1, wherein blood flow is restored in less than two minutes from deployment of the scaffold within the thrombus.

10. A thrombus management method for the treatment of acute ischemic stroke, the method comprising:

identifying an occluded artery in the neurovasculature of a subject having a thrombus;

inserting a guide catheter within the subject and advancing a distal end of the guide catheter to an arterial location proximal to the occluded artery;

inserting a microcatheter through the guide catheter and advancing a distal end of the microcatheter through or to the side of the thrombus;

inserting an expandable tip assembly comprising a self-expandable scaffold, tethered to a distal end portion of an elongate delivery member, through the microcatheter such that a distal end of the expandable tip assembly is distal to a distal end of the thrombus,

wherein said self-expandable scaffold has an open downstream end and forms a plurality of cells,

retracting the microcatheter proximally such that the self-expandable scaffold expands at the location of the thrombus and against the thrombus;

while the expandable tip remains stationary, resheathing the self-expandable scaffold and unsheathing the self-expandable scaffold, thereby facilitating fragmentation of the thrombus to release embolic particles; and

wherein the embolic particles flow in the direction of the blood flow and are not captured by any distal embolic protection member; and

removing said expandable tip assembly from the subject, thereby removing a captured portion of the thrombus engaged by the self-expandable scaffold from the occluded artery.

11. The thrombus management method of claim 10, wherein the captured portion comprises an inner core of the thrombus.

12. The thrombus management method of claim 10, further comprising providing proximal aspiration at a location proximal to and remote from the location of thrombus through the guide catheter.

13. The thrombus management method of claim 10, further comprising inserting a guidewire through the guide catheter and advancing a distal end of the guidewire within the occluded artery and through or to the side of the thrombus.

14. The thrombus management method of claim 10, further comprising inserting the microcatheter and/or the expandable tip assembly over the guidewire.

15. The thrombus management method of claim 10, wherein the occluded artery is a middle cerebral artery and wherein the distal end of the guide catheter is inserted to a location within the middle cerebral artery or within an internal carotid artery.

16. A thrombus management method without distal embolic protection for the treatment of ischemic stroke, the method comprising:

identifying an occluded blood vessel having a thrombus;

inserting a microcatheter within a guide catheter to a location of the thrombus;

positioning a distal end of the microcatheter 0.5 to 20 mm past a distal end of the thrombus;

inserting an expandable tip assembly comprising a self-expandable scaffold permanently tethered to a distal end of a flexible, elongate delivery member through the microcatheter, the self-expandable scaffold having an open downstream end;

advancing the expandable tip assembly within the microcatheter to a position within the microcatheter such that, upon retraction of the microcatheter, the self-expandable scaffold will at least partially span the thrombus;

retracting the microcatheter proximally, thereby causing the self-expandable scaffold to expand across at least a segment of the length of the thrombus;

wherein said expansion radially compresses the thrombus against a wall of the blood vessel;

wherein said radial compression of the thrombus restores blood flow within the blood vessel;

wherein said restored blood flow facilitates natural lysis of at least outer layers of the thrombus;

while the expandable tip remains stationary, macerating the thrombus by resheathing the scaffold and unsheathing the scaffold, 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 member, but are instead lysed through the natural lysis process due to the restored blood flow;

engaging a remaining core portion of the thrombus after said maceration on an external surface of the self-expandable scaffold; and

extracting said remaining core portion of the thrombus from the blood vessel by removing the expandable tip assembly from the subject.

17. The thrombus management method of claim 16, wherein engaging the remaining core portion of the thrombus and extracting the remaining core portion of the thrombus are performed by the self-expandable scaffold of the expandable tip assembly.

18. The thrombus management method of claim 16, wherein engaging the remaining core portion of the thrombus and extracting the remaining core portion of the thrombus are performed by a second expandable tip assembly having a second self-expandable scaffold, wherein said second expandable tip assembly is inserted into the microcatheter after removing the first expandable tip assembly from the microcatheter.