Method for providing progressive therapy for thrombus management

• US 8,197,493 B2
• Filed: 12/29/2010
• Issued: 06/12/2012
• Est. Priority Date: 10/17/2007
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Mindframe LLC (Medtronic Plc)
• Inventors: Ferrera, David A., Cragg, Andrew H., Fulkerson, John, Benjamin, Joshua
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US12/981,336
• Publication Number:
  US 20110160742A1
• Time in Patent Office: 531 Days
• Field of Search: 606/159, 606/200, 606/127, 606/108, 606/110, 606/113, 606/114, 606/170, 606/174, 606/180, 606/191, 606/192, 606/194, 606/198, 623/1.11, 623/1.12
• 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
• 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 of using a plurality of expandable tip assemblies adapted to address an occlusive thrombus within a blood vessel for providing progressive therapy, the method comprising:

identifying a thrombus within a blood vessel;

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

wherein the expandable reperfusion device comprises a self-expandable reperfusion scaffold having a plurality of interconnected struts that form cells sized and configured to reduce protrusion of the thrombus within the reperfusion scaffold,

wherein the self-expandable reperfusion scaffold has an open, non-filtering distal end;

deploying the self-expandable reperfusion scaffold within the thrombus by retracting the microcatheter to unsheath the reperfusion scaffold and allow the reperfusion scaffold to expand 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;

resheathing the reperfusion scaffold within the microcatheter by advancing the microcatheter and then unsheathing the reperfusion device by retracting the microcatheter to provide maceration of the thrombus;

removing the reperfusion device;

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

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

deploying the removal scaffold 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 removal scaffold from the blood vessel; and

removing the thrombus removal device.

2. The method of claim 1, wherein deploying the thrombus removal device comprises retracting the microcatheter, thereby allowing the thrombus removal device to expand within the thrombus.

3. The method of claim 1, 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.

4. 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.

5. The method of claim 1, wherein inserting an expandable reperfusion device within the blood vessel to the location of the thrombus comprises positioning the expandable reperfusion device to span at least a portion of a length of the thrombus.

6. The method of claim 1, wherein inserting an expandable thrombus removal device within the blood vessel to the location of the thrombus comprises positioning the expandable thrombus removal device to span at least a portion of a length of the thrombus.

7. The method of claim 1, wherein the struts of the thrombus removal device have a pointed or tapered configuration to facilitate engagement of the thrombus.

8. The method of claim 1, wherein the expandable reperfusion scaffold and/or the expandable removal scaffold comprises a generally cylindrical body with an open proximal end.

9. The method of claim 1, wherein the expandable reperfusion scaffold and/or the expandable removal scaffold is eccentrically coupled to a distal end of a pusher by a plurality of tethers.

10. The method of claim 9, wherein the pusher is a solid wire or a laser-cut hypotube having variable stiffness to navigate tortuous regions of cerebral vasculature.

11. The method of claim 1, further comprising tracking the reperfusion scaffold and the removal scaffold with radiopaque markers disposed on or adjacent the scaffolds and/or visualizing the thrombus in-situ.

12. The method of claim 1, wherein said natural lysis facilitates removal of one or more softer outer layers of the thrombus and wherein the remaining portion of the thrombus comprises a firm inner core of the thrombus.

13. The method of claim 1,

wherein the blood vessel is a cerebral artery;

wherein the therapy is performed without occluding or blocking blood flow; and

wherein the therapy is performed without additional structures configured to address distal embolization.

14. The method of claim 1, wherein the reperfusion scaffold and/or the removal scaffold further comprises a tapered proximal end with a cut-out or everted section and struts having projections or protrusions configured to increase clot engagement.

15. A method of using a plurality of expandable tip assemblies adapted to address an occlusive thrombus within a blood vessel for providing progressive therapy, the method comprising:

identifying a thrombus within a blood vessel;

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

wherein the expandable reperfusion device comprises a self-expandable reperfusion scaffold having a plurality of interconnected struts that form cells sized and configured to reduce protrusion of the thrombus within the reperfusion scaffold,

wherein the self-expandable reperfusion scaffold has an open, non-filtering distal end;

deploying the self-expandable reperfusion scaffold within the thrombus by retracting the microcatheter and allowing the reperfusion scaffold to expand 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;

macerating the thrombus with the reperfusion scaffold by sheathing and unsheathing of the reperfusion scaffold caused by advancement and retraction of the microcatheter, wherein said sheathing and unsheathing causes the reperfusion scaffold to compress and expand, thereby fragmenting, dissolving, or imploding the thrombus;

removing the reperfusion device;

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

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

deploying the removal scaffold 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 removal scaffold from the blood vessel; and

removing the thrombus removal device.

16. The method of claim 15, wherein the expandable reperfusion device is inserted into the blood vessel within the microcatheter after the microcatheter is inserted into the blood vessel.

17. The method of claim 15, wherein the expandable reperfusion scaffold comprises a generally cylindrical body having a tapered proximal end with a cut-out or everted section.

18. The method of claim 15, wherein the expandable reperfusion scaffold is eccentrically coupled to a distal end of a pusher by a plurality of tethers.

19. The method of claim 18, wherein the pusher is a solid wire or a laser-cut hypotube having variable stiffness to navigate tortuous regions of cerebral vasculature.

20. A method of using a plurality of expandable tip assemblies adapted to address an occlusive thrombus within a blood vessel for providing progressive therapy, the method comprising:

identifying a thrombus within a blood vessel;

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

wherein the expandable reperfusion device comprises a self-expandable reperfusion scaffold having a plurality of interconnected struts that form cells sized and configured to reduce protrusion of the thrombus within the reperfusion scaffold,

wherein the self-expandable reperfusion scaffold has an open, non-filtering distal end;

deploying the self-expandable reperfusion scaffold 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 into the microcatheter within the blood vessel and advancing the expandable thrombus removal device to the location of the thrombus,

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

deploying the removal scaffold within a remaining portion of the thrombus by retracting the microcatheter and allowing the removal scaffold to expand, thereby engaging the remaining portion of the thrombus;

macerating the thrombus with the removal scaffold by sheathing and unsheathing of the removal scaffold caused by advancement and retraction of the microcatheter, wherein said sheathing and unsheathing causes the removal scaffold to compress and expand, thereby fragmenting, dissolving, or imploding the thrombus;

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

removing the thrombus removal device.

21. The method of claim 20, wherein the expandable reperfusion device is inserted into the blood vessel within the microcatheter after the microcatheter is inserted into the blood vessel.

22. The method of claim 20, wherein the expandable removal scaffold comprises a generally cylindrical body having a tapered proximal end with a cut-out or everted section.

23. The method of claim 20, wherein the expandable removal scaffold is eccentrically coupled to a distal end of a pusher by a plurality of tethers.

24. The method of claim 23, wherein the pusher is a solid wire or a laser-cut hypotube having variable stiffness to navigate tortuous regions of cerebral vasculature.