REVASCULARIZATION DEVICES

• US 20120022576A1
• Filed: 09/26/2011
• Published: 01/26/2012
• Est. Priority Date: 10/17/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Mindframe LLC
• Inventors: Ferrera, David A., Cragg, Andrew H., Fulkerson, John
• Granted Patent: US 8,574,262 B2
• Time in Patent Office: Days
• US Class Current: 606/198
• 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 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22079 with suction of debris
• 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: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable

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.

Claims

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, 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.

2. The device of claim 1, wherein the scaffold is coupled to the distal end of the elongate member by a plurality of tether lines that extend eccentrically from less than half of the circumference of the distal end of the elongate member.

3. The device of claim 2, wherein the tether lines 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.

4. The device of claim 1, 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 4.5 mm.

5. 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.

6. The device of claim 1, wherein the elongate member is a variable-pitch hypotube.

7. The device of claim 1, wherein the elongate member is a flexible wire without a lumen.

8. The device of claim 1, wherein the scaffold length is from 10 mm to 40 mm.

9. The device of claim 1, wherein an exterior, contact surface of the struts comprises a squared-off or rounded configuration to increase the contact surface area of the scaffold, thereby enhancing compression of the thrombus.

10. The device of claim 1, wherein the struts have variable thickness across the length of the struts and/or the bridges have a greater thickness than adjacent portions of the struts connected to the bridges.

11. The device of claim 1, wherein each bridge is connected to four struts and wherein the bridges form X-shaped connections between the cells of the scaffold.

12. The device of claim 1, wherein the cells have variable cell size.

13. The device of claim 1, wherein the scaffold comprises a coating configured to increase platelet activation or adhesion of the thrombus to the scaffold.

14. The device of claim 1, wherein the scaffold is not configured to overlap on itself.

15. An acute ischemic stroke revascularization device configured to address an occlusive thrombus within a cerebral artery without distal embolic protection, 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 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 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.

16. The device of claim 15, 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.

17. The device of claim 15, 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 4.5 mm.

18. The device of claim 15, 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.

19. The device of claim 15, wherein the scaffold length is from 10 mm to 40 mm.

20. The device of claim 15, wherein the struts have variable thickness across the length of the struts and/or the bridges have a greater thickness than adjacent portions of the struts connected to the bridges.

21. The device of claim 15, wherein each bridge is connected to four struts and wherein the bridges form X-shaped connections between the cells of the scaffold.

22. The device of claim 15, wherein the scaffold comprises a coating configured to increase platelet activation or adhesion of the thrombus to the scaffold.

23. The device of claim 15, wherein the scaffold is not configured to overlap on itself.

24. An acute ischemic stroke revascularization device configured to address an occlusive thrombus within a cerebral artery without distal embolic protection, 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 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 a proximal end of the scaffold comprises an 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.

25. The device of claim 24, wherein each bridge is connected to four struts and wherein the bridges form X-shaped connections between the cells of the scaffold.

26. The device of claim 24, 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 4.5 mm.