Intravascular treatment of vascular occlusion and associated devices, systems, and methods

• US 10,524,811 B2
• Filed: 11/22/2017
• Issued: 01/07/2020
• Est. Priority Date: 10/23/2015
• Status: Active Grant

• Current Assignee: Inari Medical, Inc.
• Original Assignee: Inari Medical, Inc.
• Inventors: Marchand, Phil, Thress, John C., Louw, Jacob F., Cox, Brian J., Quick, Richard
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US15/821,224
• Publication Number:
  US 20180092652A1
• Time in Patent Office: 776 Days
• 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 2017/22041 outside the catheter
• 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: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

Systems and methods for treating thrombosis and or emboli in a peripheral vasculature of a patient are disclosed herein. The method can include providing a thrombus extraction device including a proximal self-expanding coring portion formed of a unitary fenestrated structure and a distal expandable tubular portion formed of a braided filament mesh structure; advancing a catheter constraining the thrombus extraction device through a vascular thrombus in a vessel; deploying the thrombus extraction device from the catheter from a constrained configuration to an expanded configuration; retracting the thrombus extraction device proximally so that the coring portion cores and separates a portion of the vascular thrombus from the venous vessel wall while the mesh structure captures the vascular thrombus portion; and withdrawing the thrombus extraction device from the patient to remove the vascular thrombus portion from the vessel.

Claims

1. A method of treating deep vein thrombosis in a peripheral vasculature of a patient, the method comprising:

percutaneously accessing a venous vessel of a patient with an introducer sheath through an access site into the venous vessel of the patient;

inserting a catheter constraining a thrombus extraction device through a lumen of the introducer sheath to proximate the vascular thrombus in the venous vessel, wherein the thrombus extraction device comprises a proximal self-expanding coring portion having a substantially unobstructed flow path and a distal expandable tubular portion formed of a mesh structure, wherein a proximal end of the mesh structure is coupled to a distal end of the coring portion, wherein a proximal end of the coring portion is coupled to a distal end of a first shaft of the catheter, and wherein a distal end of the mesh structure is coupled to a distal end of a second shaft of the catheter that extends at least partially through the first shaft;

deploying the thrombus extraction device from the catheter from a constrained configuration to an expanded configuration until the coring portion of the thrombus extraction device is beyond a distal end of the catheter;

retracting the thrombus extraction device proximally so that the coring portion cores and separates the portion of the vascular thrombus from a venous vessel wall while the mesh structure captures the vascular thrombus portion; and

withdrawing the thrombus extraction device from the patient.

2. The method of claim 1, wherein the self-expanding coring portion comprises a scaffold member.

3. The method of claim 2, wherein the scaffold structure comprises a plurality of fenestrations.

4. The method of claim 1, wherein the coring portion has a length between 25 millimeters and 100 millimeters.

5. The method of claim 1, wherein deploying the thrombus extraction device from the catheter from the constrained configuration to the expanded configuration comprises transitioning the mesh structure from a collapsed state to an expanded state.

6. The method of claim 5, wherein the mesh structure has a length between 100 millimeters and 500 millimeters in a collapsed state.

7. The method of claim 1, wherein the self-expanding coring portion comprises an angled mouth.

8. The method of claim 7, wherein the angled mouth is defined by a pair of curved struts.

9. The method of claim 8, wherein an angle of the angled mouth defines a coring angle, and wherein the coring angle is in a range of between about 20 degrees and about 50 degrees when the thrombus extraction device is in the expanded configuration.

10. The method of claim 8, wherein the curved struts extend from the first shaft positioned off-center and along one side of at least a portion of the self-expanding coring portion.

11. A thrombus extraction device for removal of a vascular thrombus from a blood vessel of a patient, the thrombus extraction device comprising:

a catheter having an outer shaft defining a first lumen, an intermediate shaft defining a second lumen, and an inner shaft, where the intermediate shaft is coaxial the first lumen and the inner shaft is coaxial the second lumen;

a proximal self-expanding coring element having a proximal end and a distal end and configured to core and separate a portion of the vascular thrombus from the blood vessel, the self-expanding coring element having a substantially unobstructed flow path, wherein the proximal end of the coring element is coupled to a distal end of the intermediate shaft; and

a distal expandable tubular portion formed of a mesh structure having a proximal end and a distal end and configured to capture the vascular thrombus portion, wherein the proximal end of the mesh structure is coupled to the distal end of the coring element, and wherein the distal end of the mesh structure is coupled to a distal end of the inner shaft.

12. The thrombus extraction device of claim 11, wherein the self-expanding coring element is movable to an expanded state, and wherein the coring element defines a coring angle of between about 20 degrees and about 50 degrees when the self-expanding coring element is in the expanded state.

13. The thrombus extraction device of claim 11, wherein the self-expanding coring element comprises a scaffold member comprising a plurality of fenestrations.

14. The thrombus extraction device of claim 11, wherein the self-expanding coring element has a length between 25 millimeters and 100 millimeters.

15. The thrombus extraction device of claim 11, wherein the mesh structure is moveable between a collapsed state and an expanded state, and wherein the mesh structure has a length between 100 millimeters and 500 millimeters in the collapsed state.

16. The thrombus extraction device of claim 11, wherein the self-expanding coring element comprises an angled mouth.

17. The thrombus extraction device of claim 16, wherein the angled mouth is defined by a pair of curved struts.

18. The thrombus extraction device of claim 17, wherein an angle of the angled mouth defines the coring angle.

19. The thrombus extraction device of claim 17, wherein the curved struts extend from the intermediate shaft at an off-center position and wherein the inner shaft extends along at least a portion of a side of the self-expanding coring element.