DEVICE AND METHOD FOR TREATING VASCULAR OCCLUSION

• US 20170189041A1
• Filed: 03/22/2017
• Published: 07/06/2017
• Est. Priority Date: 09/24/2012
• Status: Active Grant

• Current Assignee: Inari Medical, Inc.
• Original Assignee: Inceptus Medical, Llc
• Inventors: Cox, Brian J., Lubock, Paul, Rosenbluth, Robert F.
• Granted Patent: US 10,045,790 B2
• Time in Patent Office: 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 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 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 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: F04C 2270/0421 Controlled or regulated

Abstract

A system and method for managing an occlusion, such as a blood clot, within a lumen or passageway of a patient. More particularly, a system and method for rapidly restoring blood flow through an occlusion including a self-expanding, tubular member through which blood may flow when in an expanded state. The tubular member has a structure configured to engage the occlusive material, thereby allowing for extraction of at least a portion of the occlusive material. The system may further employ a material extraction member that is deployed distally of the tubular member.

Claims

1. An occlusion management system comprising:

a catheter having an elongate shaft defining a first lumen;

a pusher having a proximal end and a distal end, wherein the pusher is coaxial the first lumen;

a self-expanding scaffold member formed of a tubular fenestrated structure with an open proximal end having a perimeter and an open distal end; and

a capture member formed of a braided mesh and having a proximal end attached to the pusher, an everted distal portion, and a distal end attached to the perimeter of the proximal end of the scaffold member.

2. The occlusion management system of claim 1, wherein the capture member is self-expanding.

3. The occlusion management system of claim 2, wherein the distal end of the capture member is biased to evert in a relaxed state.

4. The occlusion management system of claim 1, wherein the scaffold member and the capture member form a continuous structure.

5. The occlusion management system of claim 1, wherein a diameter of the distal end of the capture member is no larger than a diameter of the proximal end of the scaffold member.

6. The occlusion management system of claim 1, further comprising a control feature controllably coupled to the distal end of the scaffold member through the first lumen of the catheter, wherein the control feature is manipulable to control the formation of the everted distal portion of the scaffold member.

7. The occlusion management system of claim 6, wherein the control feature is controllably coupled to the distal end of the scaffold member via an elongate retraction member.

8. The occlusion management system of claim 7, wherein a portion of the capture member extends proximally through scaffold member.

9. A method for removal of thrombus from a peripheral blood vessel in a body of a patient, the method comprising:

providing a thrombus extraction device thrombus extraction device comprising a scaffold member formed of a tubular fenestrated structure with an open proximal end having a perimeter and an open distal end, a proximal capture member formed of a mesh structure which is attached to the proximal end of the scaffold member, and a pusher connected to a proximal end of the mesh structure;

advancing a catheter constraining the thrombus extraction device through the thrombus located in the peripheral vasculature of a patient'"'"'s body;

deploying the thrombus extraction device, wherein the deployed thrombus extraction device comprises an everted distal portion of the capture member, and wherein deploying the thrombus extraction device comprises expanding the scaffold member and expanding the everted distal portion of the capture member;

retracting the thrombus extraction device to capture thrombus within an everted distal portion of the capture member; and

withdrawing the thrombus extraction device from the body of the patient.

10. The method of claim 9, wherein deploying the thrombus extraction device further comprises everting a distal portion of the capture member.

11. The method of claim 10, wherein the distal end of the capture member is biased to evert in a relaxed state.

12. The method of claim 9, wherein retracting the thrombus extraction device into the catheter constrains the thrombus extraction device and the captured thrombus within the catheter.

13. An occlusion management system comprising:

a catheter having an elongate shaft defining a first lumen;

a pusher having a proximal end and a distal end, wherein the pusher is coaxial the first lumen;

a self-expanding scaffold member formed of a tubular fenestrated structure with an open proximal end coupled to the distal end of the pusher and with an open distal end having a perimeter; and

a tapered capture member formed of a braided mesh and having a proximal end attached to the perimeter of the distal end of the scaffold member.

14. The occlusion management system of claim 13, wherein a diameter of the proximal end of the capture member is no larger than a diameter of the distal end of the scaffold member.

15. The occlusion management system of claim 13, wherein the capture member is a self-expanding braid.

16. The occlusion management system of claim 13, wherein the expansion of the capture member is controllable independent of the expansion of the scaffold member.

17. The occlusion management system of claim 13, wherein the perimeter of the open distal end of the scaffold member in an expanded configuration is circular.

18. The occlusion management system of claim 13, wherein the scaffold member and the capture member form a continuous structure.

19. A method for removal of thrombus from a peripheral blood vessel in a body of a patient, the method comprising:

providing a thrombus extraction device thrombus extraction device comprising a scaffold member formed of a tubular fenestrated structure with an open proximal end having a perimeter and an open distal end, a tapered capture member formed of a mesh structure which is attached to the distal end of the scaffold member, and a pusher connected to a proximal end of the scaffold member;

advancing a catheter constraining the thrombus extraction device through the thrombus located in the peripheral vasculature of a patient'"'"'s body;

deploying the thrombus extraction device, wherein the deploying the thrombus extraction device comprises expanding the scaffold member;

retracting the thrombus extraction device through the thrombus;

separating the thrombus from the peripheral blood vessel with the scaffold member; and

capturing the thrombus within the tapered capture member.

20. The method of claim 19, further comprising withdrawing the thrombus extraction device from the body of the patient.

21. The method of claim 19, wherein the deploying the thrombus extraction device comprises expanding the tapered capture member.

22. The method of claim 19, wherein the deploying the thrombus extraction device comprises expanding the tapered capture member subsequent to expanding the scaffold member.

23. The method of claim 19, wherein the deploying the thrombus extraction device retracting the catheter relative to the pusher until the scaffold member is exposed.

24. The method of claim 19, wherein retracting the thrombus extraction device through the thrombus comprises retracting the pusher relative to the catheter through a lumen of the catheter.