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

• US 9,700,332 B2
• Filed: 09/16/2016
• Issued: 07/11/2017
• 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:
  US15/268,296
• Publication Number:
  US 20170112513A1
• Time in Patent Office: 298 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:

providing a thrombus extraction device comprising 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, wherein the mesh structure is integrally formed with the fenestrated structure so that a proximal end of the mesh structure is attached to a distal end of the fenestrated structure;

advancing a catheter constraining the thrombus extraction device through a vascular thrombus in a venous vessel, wherein an intermediate shaft slidably extends through the catheter and a distal end thereof is coupled to a proximal end of the fenestrated structure, and wherein an inner shaft slidably extends through the intermediate shaft and a distal end thereof is coupled to a distal end of the mesh structure;

deploying the thrombus extraction device from the catheter from a constrained configuration to an expanded configuration, wherein the thrombus extraction device in an expanded state engages at least a wall of the vessel distally past a portion of the vascular thrombus;

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 venous vessel.

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

3. The method of claim 1, wherein deploying the thrombus extraction device from the catheter from the constrained configuration to the expanded configuration comprises advancing the intermediate shaft distally until the coring portion of the thrombus extraction device is beyond a distal end of the catheter.

4. The method of claim 3, wherein deploying the thrombus extraction device further comprises:

locking the intermediate shaft with respect to the catheter;

retracting the inner shaft with respect to the catheter and the intermediate shaft until a stop feature fixed on the inner shaft engages a corresponding feature on the coring portion slidably connected to the inner shaft for expansion of the thrombus extraction device, wherein the coring portion has a coring angle between 30 degrees and 45 degrees when the thrombus extraction device is in the expanded state, wherein the coring portion maintains sufficient radial force on the venous vessel wall to core and separate the vascular thrombus portion in the expanded state; and

dynamically coupling the inner shaft with respect to the intermediate shaft.

5. The method of claim 3, wherein deploying the thrombus extraction device further comprises determining a position of the thrombus extraction device with respect to the catheter via imaging of a first radiopaque marker located on the catheter and a second radiopaque marker located on at least one of the intermediate shaft, the inner shaft, coring portion, or mesh structure.

6. The method of claim 1, wherein the vascular thrombus portion is captured into the mesh structure by entering the expandable tubular portion via at least opening or aperture located at the proximal end of the self-expanding coring portion.

7. The method of claim 1, further comprising inserting the catheter into the venous vessel through an access site, wherein the access site comprises a popliteal access site, a femoral access site, or an internal jugular access site.

8. The method of claim 1, wherein the venous vessel has a diameter of at least 5 millimeters and comprises at least one of a femoral vein, an iliac vein, a popliteal vein, a posterior tibial vein, an anterior tibial vein, or a peroneal vein.

9. The method of claim 1, further comprising:

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

advancing a distal end of the introducer sheath to a position proximal of the vascular thrombus;

deploying a self-expanding funnel on the distal end of the introducer sheath; and

inserting the catheter through a lumen of the introducer sheath so that a distal tip of the catheter is distally past the vascular thrombus portion.

10. The method of claim 9, wherein deploying the self-expanding funnel comprises:

advancing an obturator having a capture sheath feature on a distal end thereof to unsheathe the self-expanding funnel from a constrained configuration within the capture sheath feature to a deployed configuration free of the capture sheath feature; and

removing the obturator from the introducer sheath by retracting the obturator through the deployed self-expanding funnel and through the lumen of the introducer sheath.

11. The method of claim 9, wherein withdrawing the thrombus extraction device from the patient comprises:

retracting the thrombus extraction device relative to the introducer sheath until an opening of the self-expanding coring portion is within the self-expanding funnel;

collapsing the coring portion and mesh structure so as to restrain and/or compress the vascular thrombus portion therein;

retracting the coring portion and mesh structure into the introducer sheath; and

removing the thrombus extraction device from the introducer sheath.

12. The method of claim 11, further comprising extruding at least one piece of the vascular thrombus portion through pores located at a distal portion of the expandable tubular portion and capturing the at least one piece of the vascular thrombus portion in the self-expanding funnel or further compressing the at least one piece of the vascular thrombus portion through a mesh of the self-expanding funnel.

13. The method of claim 11, further comprising aspirating at least one piece of the vascular thrombus portion remaining within the self-expanding funnel from the venous vessel and through an aspiration port connected to a proximal end of the introducer sheath.

14. The method of claim 11, further comprising verifying that the opening of the self-expanding coring portion is within the self-expanding funnel via fluoroscopy prior to collapsing the coring portion and mesh structure.

15. The method of claim 11, wherein collapsing the coring portion and mesh structure comprises:

decoupling the inner shaft and the intermediate shaft; and

advancing the inner shaft distally relative to the intermediate shaft.

16. The method of claim 1, further comprising aspirating or infusing a thrombolytic agent into or from the venous vessel before, during, or after thrombus extraction.

17. 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 a popliteal access site into the venous vessel of the patient;

inserting a catheter constraining a thrombus extraction device through a lumen of the introducer sheath so that a distal tip of the catheter is distally past a portion of a vascular thrombus in the venous vessel, wherein the thrombus extraction device comprises 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, wherein a proximal end of the mesh structure is attached to a distal end of the fenestrated structure;

deploying the thrombus extraction device from the catheter from a constrained configuration to an expanded configuration by advancing an intermediate shaft distally until the coring portion of the thrombus extraction device is beyond a distal end of the catheter, wherein the intermediate shaft slidably extends through the catheter and a distal end thereof is coupled to a proximal end of the fenestrated structure, wherein deploying the thrombus extraction device further comprises retracting an inner shaft with respect to the catheter and the intermediate shaft until a stop feature on the inner shaft engages a corresponding feature on the coring portion for further expansion of the thrombus extraction device to an expanded state, and wherein the inner shaft slidably extends through the intermediate shaft and a distal end thereof is coupled to a distal end of the mesh structure;

retracting the thrombus extraction device proximally so that the coring portion cores and separates a portion of the vascular thrombus from a venous vessel wall while the mesh structure captures the vascular thrombus portion, wherein the coring portion maintains sufficient radial force on the venous vessel wall to core and separate the vascular thrombus portion in the expanded state; and

withdrawing the thrombus extraction device from the patient.

18. The method of claim 17, further comprising deploying a self-expanding funnel on a distal end of the introducer sheath proximal of the vascular thrombus.

27. The method of claim 17, further comprising aspirating or infusing a thrombolytic agent into or from the venous vessel before, during, or after thrombus extraction.

28. The method of claim 17, wherein deploying the thrombus extraction device further comprises determining a position of the thrombus extraction device with respect to the catheter via imaging of a first radiopaque marker located on the catheter and a second radiopaque marker located on at least one of the intermediate shaft, the inner shaft, coring portion, or mesh structure.

29. The method of claim 17, wherein the vascular thrombus portion is captured into the mesh structure by entering the expandable tubular portion via at least opening or aperture located at the proximal end of the self-expanding coring portion.

30. The method of claim 18, wherein deploying the self-expanding funnel comprises:

advancing an obturator having a capture sheath feature on a distal end thereof to unsheathe the self-expanding funnel from a constrained configuration within the capture sheath feature to a deployed configuration free of the capture sheath feature; and

removing the obturator from the introducer sheath by retracting the obturator through the deployed self-expanding funnel and through the lumen of the introducer sheath.

19. 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;

deploying a self-expanding funnel on a distal end of the introducer sheath proximal of a vascular thrombus, wherein deploying the self-expanding funnel comprises advancing an obturator having a capture sheath feature on a distal end thereof to unsheathe the self-expanding funnel from a constrained configuration within the capture sheath feature to a deployed configuration free of the capture sheath feature;

removing the obturator from the introducer sheath by retracting the obturator through the deployed self-expanding funnel and through a lumen of the introducer sheath;

inserting a catheter constraining a thrombus extraction device through the lumen of the introducer sheath so that a distal tip of the catheter is distally past a portion of the vascular thrombus in the venous vessel, wherein the thrombus extraction device comprises a proximal self-expanding coring portion formed of a unitary fenestrated structure and a distal expandable tubular portion formed of a mesh structure, wherein a proximal end of the mesh structure is attached to a distal end of the fenestrated structure;

deploying the thrombus extraction device from the catheter from a constrained configuration to an expanded configuration by advancing an intermediate shaft distally until the coring portion of the thrombus extraction device is beyond a distal end of the catheter, wherein the intermediate shaft slidably extends through the catheter and a distal end thereof is coupled to a proximal end of the fenestrated structure;

retracting the thrombus extraction device proximally so that the coring portion cores and separates a 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.

20. The method of claim 19, wherein deploying the thrombus extraction device further comprises:

locking the intermediate shaft with respect to the catheter;

retracting an inner shaft with respect to the catheter and the intermediate shaft until a stop feature fixed on the inner shaft engages a corresponding feature on the coring portion for further expansion of the thrombus extraction device to an expanded state, wherein the coring portion has a coring angle between 30 degrees and 45 degrees when the thrombus extraction device is in the expanded state, wherein the coring portion maintains sufficient radial force on the venous vessel wall to core and separate the vascular thrombus portion in the expanded state; and

dynamically coupling the inner shaft with respect to the intermediate shaft.

21. The method of claim 20, wherein deploying the thrombus extraction device further comprises determining a position of the thrombus extraction device with respect to the catheter via imaging of a first radiopaque marker located on the catheter and a second radiopaque marker located on at least one of the intermediate shaft, the inner shaft, coring portion, or mesh structure.

22. The method of claim 19, wherein the vascular thrombus portion is captured into the mesh structure by entering the expandable tubular portion via at least opening or aperture located at the proximal end of the self-expanding coring portion.

23. The method of claim 19, wherein withdrawing the thrombus extraction device from the patient comprises:

retracting the thrombus extraction device relative to the introducer sheath until an opening of the self-expanding coring portion is within the self-expanding funnel;

collapsing the coring portion and mesh structure so as to restrain and/or compress the vascular thrombus portion therein;

retracting the coring portion and mesh structure into the introducer sheath; and

removing the thrombus extraction device from the introducer sheath.

24. The method of claim 23, further comprising extruding at least one piece of the vascular thrombus portion through pores located at a distal portion of the expandable tubular portion and capturing the at least one piece of the vascular thrombus portion in the self-expanding funnel or further compressing the at least one piece of the vascular thrombus portion through a mesh of the self-expanding funnel.

25. The method of claim 23, further comprising aspirating at least one piece of the vascular thrombus portion remaining within the self-expanding funnel from the venous vessel and through an aspiration port connected to a proximal end of the introducer sheath.

26. The method of claim 23, further comprising verifying that the opening of the self-expanding coring portion is within the self-expanding funnel via fluoroscopy prior to collapsing the coring portion and mesh structure.