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

• US 10,342,571 B2
• Filed: 09/16/2016
• Issued: 07/09/2019
• 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:
  US15/268,406
• Publication Number:
  US 20170112514A1
• Time in Patent Office: 1,026 Days
• Field of Search: None
• 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 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• 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

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 unitary fenestrated structure, a distal substantially cylindrical portion formed of a net-like filament mesh structure, and an inner shaft member connected to a distal end of the net-like filament mesh structure; advancing a catheter constraining the thrombus extraction device through a vascular thrombus, deploying the thrombus extraction; retracting the thrombus extraction device 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.

Claims

1. 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 a proximal end and a distal end, an outer shaft defining a first lumen, an intermediate shaft defining a second lumen, and an inner shaft, wherein the intermediate shaft is coaxial the first lumen and the inner shaft is coaxial the second lumen;

a proximal self-expanding coring element formed of a unitary fenestrated structure having a proximal end and a distal end and configured to core and separate a portion of the vascular thrombus from the blood vessel, wherein the proximal end of the fenestrated structure is coupled to the distal end of the intermediate shaft; and

a distal expandable cylindrical portion formed of a braided filament 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 attached to the distal end of the fenestrated structure, and wherein the distal end of the mesh structure is coupled to the distal end of the inner shaft, wherein full expansion of the mesh structure and fenestrated structure varies based on a position of the intermediate shaft relative the inner shaft of the catheter.

2. The thrombus extraction device of claim 1, wherein the coring element is a stent, and wherein the stent is formed of the unitary fenestrated structure having the proximal end and the distal end.

3. The thrombus extraction device of claim 2, wherein the stent includes a ring feature slidably coupled to the inner shaft and the inner shaft comprises a stop feature fixed to the inner shaft, wherein the stop feature is configured to engage with the ring feature when the mesh structure and the stent are in full expansion.

4. The thrombus extraction device of claim 3, further comprising a locking mechanism configured to secure the inner shaft relative to the intermediate shaft when the mesh structure and the stent are in full expansion.

5. The thrombus extraction device of claim 4, wherein the locking mechanism is configured to maintain a desired radial force on a vessel wall when the stent is compressed.

6. The thrombus extraction device of claim 4, wherein the locking mechanism moveably secures the inner shaft relative to the intermediate shaft via a spring.

7. The thrombus extraction device of claim 1, wherein the proximal end of the mesh structure is integrally formed with the distal end of the fenestrated structure to create a unitary structure.

8. The thrombus extraction device of claim 1, wherein the coring element and the mesh structure are receivable within the outer shaft, and wherein the coring element and mesh structure are in a constrained configuration when received within the outer shaft and an expanded configuration when free of the constraining outer shaft.

9. The thrombus extraction device of claim 1, wherein the mesh structure comprises a plurality of radial ribs or grooves longitudinally spaced between the proximal and distal ends of the mesh structure.

10. The thrombus extraction device of claim 1, wherein the mesh structure has a first pore size at a proximal portion and a second pore size at a distal portion, wherein the first pore size is different from the second pore size.

11. The thrombus extraction device of claim 10, wherein the second pore size is greater than the first pore size.

12. The thrombus extraction device of claim 1, wherein the proximal end of the fenestrated structure is coupled to the distal end of the intermediate shaft via a plurality of struts extending at a coring angle relative to a longitudinal axis of the thrombus extraction device.

13. The thrombus extraction device of claim 12, wherein the coring angle is in a range between 30 degrees and 45 degrees.

14. The thrombus extraction device of claim 1, wherein the coring element has a length in a range between 25 millimeters and 100 millimeters and the mesh structure has a length in a range between 100 millimeters and 500 millimeters.

15. The thrombus extraction device of claim 1, wherein the coring element has a diameter in a range between 8 millimeters and 25 millimeters at full expansion and the mesh structure has a diameter in a range between 8 millimeters and 25 millimeters at full expansion.

16. The thrombus extraction device of claim 1, wherein the fenestrated structure comprises a plurality of interconnected struts, and wherein the proximal end of the fenestrated structure has fewer struts than the distal end of the fenestrated structure to thereby facilitate collapse of the coring element and to facilitate maintenance of a coring orientation when the blood vessel is tortuous.

17. The thrombus extraction device of claim 1, wherein the fenestrated structure comprises a plurality of interconnected struts defining an opening at the proximal end of the fenestrated structure, wherein at least some of the plurality of interconnected struts defining the opening comprise a sharpened proximal edge.

18. The thrombus extraction device of claim 1, further comprising a first radiopaque marker located on the outer shaft and a second radiopaque marker located on the distal end of the inner shaft.

19. 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 a proximal end and a distal end, an outer shaft defining a first lumen, an intermediate shaft defining a second lumen, and an inner shaft, wherein the intermediate shaft is coaxial the first lumen and the inner shaft is coaxial the second lumen;

a locking mechanism configured to secure a relative position of the outer shaft with respect to the intermediate shaft;

a proximal self-expanding coring element formed of a unitary fenestrated structure having a proximal end and a distal end and configured to core and separate a portion of the vascular thrombus from the blood vessel, wherein the proximal end of the fenestrated structure is coupled to the distal end of the intermediate shaft; and

a distal expandable cylindrical portion formed of a braided filament 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 attached to the distal end of the fenestrated structure, and wherein the distal end of the mesh structure is coupled to the distal end of the inner shaft, wherein full expansion of the mesh structure and fenestrated structure varies based on a position of the intermediate shaft relative the inner shaft of the catheter.

20. 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 a proximal end and a distal end, an outer shaft defining a first lumen, an intermediate shaft defining a second lumen, and an inner shaft, wherein the intermediate shaft is coaxial the first lumen and the inner shaft is coaxial the second lumen;

a handle comprising a plunger configured to control a relative position of the inner shaft with respect to the intermediate shaft and to selectively secure the relative position of the inner shaft with respect to the intermediate shaft;

a proximal self-expanding coring element formed of a unitary fenestrated structure having a proximal end and a distal end and configured to core and separate a portion of the vascular thrombus from the blood vessel, wherein the proximal end of the fenestrated structure is coupled to the distal end of the intermediate shaft; and

a distal expandable cylindrical portion formed of a braided filament 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 attached to the distal end of the fenestrated structure, and wherein the distal end of the mesh structure is coupled to the distal end of the inner shaft, wherein full expansion of the mesh structure and fenestrated structure varies based on a position of the intermediate shaft relative the inner shaft of the catheter.