Devices and methods for treating vascular occlusion

• US 10,098,651 B2
• Filed: 04/26/2017
• Issued: 10/16/2018
• Est. Priority Date: 01/10/2017
• Status: Active Grant

• Current Assignee: Inari Medical, Inc.
• Original Assignee: Inari Medical, Inc.
• Inventors: Marchand, Phil, Merritt, Benjamin E., Thress, John C., Louw, Jacob F., Lubock, Paul, Cox, Brian J.
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US15/498,320
• Publication Number:
  US 20180193043A1
• Time in Patent Office: 538 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 2017/22094 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: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/016 made from wire-like elements

Abstract

Systems and methods for removal of thrombus from a blood vessel in a body of a patient are disclosed herein. The method can include: providing a thrombus extraction device including a proximal self-expanding member formed of a fenestrated structure, a substantially cylindrical portion formed of a net-like filament mesh structure having a proximal end coupled to a distal end of the fenestrated structure; advancing a catheter constraining the thrombus extraction device through a vascular thrombus, deploying the thrombus extraction device by stacking a portion of the net-like filament mesh structure outside of the catheter by distally advancing the self-expanding member until the self-expanding member is beyond a distal end of the catheter; retracting the self-expanding member to unstack the portion of the net-like filament mesh structure and to capture the portion of the thrombus; and withdrawing the thrombus extraction device from the body.

Claims

1. A method for removal of thrombus from a blood vessel in a body of a patient, the method comprising;

providing a thrombus extraction device comprising a proximal self-expanding member formed of a fenestrated structure, and a substantially cylindrical portion formed of a net-like filament mesh structure having a proximal end coupled to a distal end of the fenestrated structure;

advancing a catheter constraining the thrombus extraction device through a vascular thrombus,

deploying the thrombus extraction device by stacking a portion of the net-like filament mesh structure outside of the catheter by distally advancing the self-expanding member until the self-expanding member is beyond a distal end of the catheter;

retracting the self-expanding member relative to the distal end of the net-like filament mesh structure to unstack the portion of the net-like filament mesh structure and to separate a portion of the thrombus from the vessel wall and to capture the portion of the thrombus within the net-like filament mesh structure; and

withdrawing the thrombus extraction device from the body to remove thrombus from the patient.

2. The method of claim 1, wherein advancing the catheter through the vascular thrombus comprises inserting the catheter into the blood vessel until a radiopaque distal tip of the catheter is past the thrombus portion.

3. The method of claim 1, wherein stacking the portion of the net-like filament mesh structure comprises:

fixing a position of the distal end of the net-like filament mesh structure; and

distally advancing the self-expanding member relative to the distal end of the net-like filament mesh structure.

4. The method of claim 3, wherein the position of the distal end of the net-like filament mesh structure is fixed proximal relative to a valve in the body of the patient.

5. The method of claim 4, wherein the valve is located in the blood vessel containing the thrombus.

6. The method of claim 4, wherein the position of the distal end of the net-like filament mesh structure is fixed in a second blood vessel, wherein the second blood vessel is connected to the blood vessel containing the thrombus.

7. The method of claim 3, wherein stacking the portion of the net-like filament mesh structure comprises changing a braid angle of portion of the net-like filament mesh structure.

8. The method of claim 7, wherein the braid angle of the portion of the net-like filament mesh structure is greater than 45°

when stacked.

9. The method of claim 1, wherein a diameter of the portion of the net-like filament mesh structure is greater than a diameter of the fenestrated structure.

10. The method of claim 1, wherein the catheter is inserted into the blood vessel through a popliteal access site and the catheter is distally advanced from the popliteal access site.

11. The method of claim 1, wherein the net-like filament mesh structure is interwoven on the fenestrated structure.

12. The method of claim 1, further comprising moving the fenestrated structure to full expansion.

13. The method of claim 12, wherein moving the fenestrated structure to full expansion comprises retracting a stop shaft relative to the fenestrated structure.

14. The method of claim 13, wherein the stop shaft is retracted relative to the fenestrated structure via movement of a plunger from a first position to a second position.

15. The method of claim 13, wherein the stop shaft is retracted relative to the fenestrated structure via movement of a shuttle from a first position to a second position, wherein the shuttle is moved from a first position to a second position via a force applied to the shuttle by a spring.

16. The method of claim 1, wherein advancing the catheter through the vascular thrombus comprises inserting the catheter into the blood vessel through a funnel catheter comprising:

an elongate sheath; and

a self-expanding funnel coupled to a distal end of the elongate sheath.

17. The method of claim 16, withdrawing the thrombus extraction device from the body to remove thrombus from the patient comprises retracting the thrombus extraction device until at least a portion of the self-expanding member is contained within the self-expanding funnel.

18. The method of claim 16, wherein the at least a portion of the self-expanding member contained within the self-expanding funnel comprises an opening of the self-expanding member.

19. The method of claim 18, further comprising simultaneously proximally retracting the thrombus extraction device and the funnel catheter from the patient.

20. The method of claim 19, wherein the opening of the thrombus extraction device is maintained within the self-expanding funnel during the simultaneous proximal retraction of the thrombus extraction device and the funnel catheter from the patient.

21. A method for removal of thrombus from a blood vessel in a body of a patient, the method comprising;

advancing a catheter constraining a thrombus extraction device through a vascular thrombus, the thrombus extraction device comprising a proximal self-expanding member formed of a fenestrated structure, and a substantially cylindrical portion formed of a net-like filament mesh structure having a proximal end coupled to a distal end of the fenestrated structure,

deploying the thrombus extraction device by distally advancing the self-expanding member with respect to the catheter until the self-expanding member is beyond a distal end of the catheter, wherein deploying the thrombus extraction device comprises stacking a portion of the net-like filament mesh structure, wherein stacking a portion of the net-like filament mesh structure comprises;

fixing a position of the distal end of the net-like filament mesh structure; and

distally advancing the self-expanding member relative to the distal end of the net-like filament mesh structure;

retracting the self-expanding member relative to a distal end of the net-like filament mesh structure to increase a distal length of the net-like filament mesh structure and to separate a portion of the thrombus from the vessel wall and to capture the portion of the thrombus within the net-like filament mesh structure; and

withdrawing the thrombus extraction device from the body to remove thrombus from the patient.

22. The method of claim 21, wherein advancing the catheter through the vascular thrombus comprises inserting the catheter into the blood vessel until a radiopaque distal tip of the catheter is past the thrombus portion.

23. The method of claim 21, wherein stacking a portion of the net-like filament mesh structure comprises changing a braid angle of portion of the net-like filament mesh structure.

24. The method of claim 23, wherein the braid angle of the portion of the net-like filament mesh structure is greater than 45°

when stacked.

25. The method of claim 21, wherein a diameter of the portion of the net-like filament mesh structure is greater than a diameter of the fenestrated structure.

26. The method of claim 21, wherein the catheter is inserted into the blood vessel through a popliteal access site and the catheter is distally advanced from the popliteal access site.

27. The method of claim 21, wherein the net-like filament mesh structure is interwoven on the fenestrated structure.

28. The method of claim 21, further comprising moving the fenestrated structure to full expansion.

29. A method for removal of thrombus from a blood vessel in a body of a patient, the method comprising;

advancing a catheter constraining a thrombus extraction device through a vascular thrombus, the thrombus extraction device comprising a proximal self-expanding member formed of a fenestrated structure, and a substantially cylindrical portion formed of a net-like filament mesh structure having a proximal end coupled to a distal end of the fenestrated structure, wherein advancing the catheter through the vascular thrombus comprises inserting the catheter into the blood vessel through a funnel catheter comprising;

an elongate sheath; and

a self-expanding funnel coupled to a distal end of the elongate sheath,

deploying the thrombus extraction device by distally advancing the self-expanding member with respect to the catheter until the self-expanding member is beyond a distal end of the catheter;

retracting the self-expanding member relative to a distal end of the net-like filament mesh structure to increase a distal length of the net-like filament mesh structure and to separate a portion of the thrombus from the vessel wall and to capture the portion of the thrombus within the net-like filament mesh structure; and

withdrawing the thrombus extraction device from the body to remove thrombus from the patient.