METHOD FOR PROVIDING PROGRESSIVE THERAPY FOR THROMBUS MANAGEMENT

• US 20110160742A1
• Filed: 12/29/2010
• Published: 06/30/2011
• Est. Priority Date: 10/17/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Mindframe LLC
• Inventors: Cragg, Andrew H., Fulkerson, John, Benjamin, Joshua, Ferrera, David
• Granted Patent: US 8,197,493 B2
• Time in Patent Office: Days
• US Class Current: 606/127
• 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 method for providing progressive therapy for thrombus management in blood vessels, the method comprising:

identifying a thrombus within a blood vessel;

inserting an expandable reperfusion device within the blood vessel to the location of the thrombus,

wherein the expandable reperfusion device comprises an expandable reperfusion scaffold having a plurality of interconnected struts that form cells having a cell size that is sized and configured to reduce protrusion of the thrombus within the reperfusion scaffold, thereby increasing a diameter of a flow path established by the reperfusion scaffold;

deploying the reperfusion device within the thrombus, thereby compressing the thrombus against the inner vessel wall and establishing one or more blood flow channels through the thrombus,

wherein the one or more blood flow channels facilitate natural lysis of the thrombus;

removing the reperfusion device;

inserting an expandable thrombus removal device within the blood vessel to the location of the thrombus,

wherein the expandable thrombus removal device comprises an expandable removal scaffold having a plurality of interconnected struts that form cells having a cell size that is sized and configured to allow thrombus penetration within the cells, thereby facilitating engagement of the thrombus by the removal scaffold;

deploying the thrombus removal device within a remaining portion of the thrombus, thereby engaging the remaining portion of the thrombus;

extracting the remaining portion of the thrombus engaged by the thrombus removal device from the blood vessel; and

removing the thrombus removal device.

2. The method of claim 1, wherein the expandable reperfusion device and the expandable thrombus removal device comprise self-expanding devices.

3. The method of claim 2, wherein the expandable reperfusion device and the expandable thrombus removal device are inserted into the blood vessel within a microcatheter to the location of the thrombus.

4. The method of claim 3, wherein deploying the reperfusion device comprises retracting the microcatheter, thereby allowing the reperfusion device to expand within the thrombus.

5. The method of claim 3, wherein deploying the thrombus removal device comprises retracting the microcatheter, thereby allowing the thrombus removal device to expand within the thrombus.

6. The method of claim 3, wherein removing the reperfusion device comprises resheathing the reperfusion device by advancing the microcatheter over the reperfusion device while keeping the reperfusion device stationary and then removing the microcatheter with the reperfusion device together.

7. The method of claim 1, wherein an expansion diameter of the reperfusion device is configured to provide increased cell deformation of the reperfusion scaffold, thereby reducing protrusion of the thrombus within the reperfusion scaffold.

8. The method of claim 1, wherein an expansion diameter of the thrombus removal device is configured to provide reduced cell deformation of the removal scaffold, thereby increasing thrombus penetration within the removal scaffold.

9. The method of claim 4, further comprising resheathing the reperfusion device within the microcatheter by advancing the microcatheter and then unsheathing the reperfusion device by retracting the microcatheter to provide maceration of the thrombus.

10. The method of claim 1, wherein the cells of the reperfusion scaffold in an expanded configuration have a cell length of between 2 mm and 4 mm and a cell height between 1 mm and 3 mm and wherein the cells of the removal scaffold in an expanded configuration have a cell length of between 4 mm and 6 mm and a cell height between 2 mm and 4 mm.

11. A method for providing progressive therapy for thrombus management, the method comprising:

inserting an expandable reperfusion device within an occluded blood vessel having a thrombus;

positioning the expandable reperfusion device to span at least a portion of a length of the thrombus;

wherein the expandable reperfusion device comprises a self-expanding reperfusion scaffold having a plurality of interconnected struts that form cells sized and configured to inhibit protrusion of the thrombus into the reperfusion scaffold, thereby increasing a diameter of a flow path established by the reperfusion scaffold;

deploying the reperfusion device within the thrombus, thereby compressing the thrombus against the inner vessel wall and establishing blood flow through the occluded blood vessel,

wherein the established blood flow facilitates natural lysis of the thrombus;

macerating the thrombus;

wherein at least one of the natural lysis and the maceration fragment the thrombus until only a portion of the thrombus remains;

removing the reperfusion device;

inserting a thrombus removal device within the blood vessel to span at least a portion of a length of the remaining thrombus,

wherein the thrombus removal device comprises a self-expanding removal scaffold having a plurality of interconnected struts that form cells having a cell size that is sized and configured to allow thrombus protrusion within the cells, thereby facilitating engagement of the remaining thrombus by the removal scaffold;

deploying the thrombus removal device within the remaining thrombus to engage the remaining thrombus; and

removing the thrombus removal device, thereby extracting the remaining thrombus.

12. The method of claim 11, wherein macerating the thrombus comprises sheathing and unsheathing of the reperfusion scaffold, wherein said sheathing and unsheathing causes the reperfusion scaffold to compress and expand.

13. The method of claim 11, wherein the reperfusion device and the thrombus removal device are inserted into the blood vessel within a microcatheter.

14. The method of claim 13, wherein deploying the reperfusion device comprises retracting the microcatheter, thereby allowing the reperfusion device to expand within the thrombus.

15. The method of claim 13, wherein deploying the thrombus removal device comprises retracting the microcatheter, thereby allowing the thrombus removal device to expand within the thrombus.

16. The method of claim 13, wherein removing the reperfusion device comprises resheathing the reperfusion device by advancing the microcatheter over the reperfusion device while keeping the reperfusion device stationary and then removing the microcatheter with the reperfusion device together.

17. The method of claim 11, wherein an expansion diameter of the reperfusion device is configured to provide increased cell deformation of the reperfusion scaffold, thereby reducing thrombus penetration within the reperfusion scaffold.

18. The method of claim 11, wherein an expansion diameter of the thrombus removal device is configured to provide reduced cell deformation of the removal scaffold, thereby increasing thrombus protrusion within the removal scaffold.

19. The method of claim 11, wherein the cells of the expandable reperfusion device in an expanded configuration have a cell length of between 2 mm and 4 mm and a cell height between 1 mm and 3 mm and wherein the cells of the expandable thrombus removal device in an expanded configuration have a cell length of between 4 mm and 6 mm and a cell height between 2 mm and 4 mm.

20. The method of claim 11, wherein the struts of the thrombus removal device have a pointed or tapered configuration to facilitate engagement of the thrombus.

21. The method of claim 11, wherein the cell size wherein the cell size of the removal scaffold is variable along the length of the removal scaffold, and further wherein the cell size of the cells at the end portions of the removal scaffold are smaller than the cell size of the cells of the middle portion of the removal scaffold.