Thrombectomy system and methods of extracting a thrombus from a thrombus site in a blood vessel of a patient

1 . A thrombectomy system, comprising:

a delivery catheter configured to be advanced through vasculature of a patient to a thrombus site within a blood vessel;

an aspiration catheter adapted to apply suction to an expandable aspiration funnel extending from a distal end of the aspiration catheter, the aspiration funnel being configured to be movably disposed within the delivery catheter in a retracted position in a compressed state and at least partially outside the delivery catheter in an expanded position,

the aspiration funnel having a first tubular section and a second tubular section, the second tubular section proximal to the first tubular section, the second tubular section comprising a first sub-section having a shape with a progressive reduction of diameter configured to open and create a space for the thrombus, and a second sub-section of a tubular uniform diameter extending between aspiration catheter and the first sub-section, wherein each of the first tubular section and the second tubular section is formed by a mesh of at least two helicoidal filaments turning respectively in opposite directions and being intertwined, and extending continuously through the first tubular section and the second tubular section, wherein a braiding angle of the at least two sets of helicoidal filaments within the first tubular section is configured to provide outward radial forces higher than in the second tubular section, wherein the at least two sets of helicoidal filaments form closed loops at a distal end of the first tubular section to act as a spring to further provide the outward radial forces, the aspiration funnel comprising a non-permeable covering, wherein in the expanded position the second tubular section has a diameter smaller than a diameter of the first tubular section, and a diameter of a distal end of the aspiration funnel being greater in the expanded position than in the retracted position, the aspiration funnel being configured to adapt its shape and length to an inner wall of the blood vessel such that in the expanded position a length of the first tubular section from the closed loops to the first sub-section becomes appositioned against the inner wall of the blood vessel to occlude blood flow through the blood vessel, and further wherein the aspiration funnel length increases when it narrows to retain a thrombus within the aspiration funnel;

a clot-capture element comprising closed cells configured to capture the thrombus and to be at least partially withdrawn with the captured thrombus into the aspiration funnel; and

a microcatheter adapted to carry the clot-capture element to the thrombus site,

wherein the clot-capture element is configured to be movably disposed within the microcatheter in a retracted position, and

wherein the microcatheter is configured to be movably disposed within the aspiration catheter.

2 . The thrombectomy system according to claim 1 , wherein the delivery catheter, the aspiration funnel, the microcatheter and the clot-capture element are oriented on a same axis, are coaxially configured and movable to each other.

3 . The thrombectomy system according to claim 1 , wherein the aspiration funnel is self-expandable.

4 . The thrombectomy system according to claim 1 , wherein the clot-capture element is a stent retriever device.

5 . The thrombectomy system according to claim 1 , wherein the clot capture element has a continuous scaffold.

6 . The thrombectomy system according to claim 1 , wherein the first sub-section is cone-shaped.

7 . The thrombectomy system according to claim 1 , wherein the at least two sets of helicoidal filaments are adapted to become more longitudinally aligned as the aspiration funnel lengthens and narrows.

8 . The thrombectomy system according to claim 1 , wherein the at least two sets of helicoidal filaments are made of a metal, a metal alloy or a composite including Nitinol or Nitinol/Platinum.

9 . The thrombectomy system according to claim 8 , wherein the helicoidal filaments of the mesh are made of a composite comprising Nitinol/Platinum with a percentage of Platinum from 10% to 40%.

10 . The thrombectomy system according to claim 1 , wherein: the at least two sets of helicoidal filaments comprise a number ranging between 24 and 48, said filaments having a cross section comprised in a range between 40 and 60 pm; and the angle of the at least two sets of helicoidal filaments with regard to a longitudinal axis of the aspiration funnel is comprised between 50 and 65 degrees for the first section, and between 15 and 50 for the second section.

11 . The thrombectomy system according to claim 10 , wherein:

the first section comprises a length ranging between 4 and 40 millimeters and the second section comprises a length ranging between 1 and 10 millimeters;

the first section comprises an outer diameter ranging between 3.5 and 6 millimeters and the second section comprises an outer diameter ranging between 1 and 2 millimeters; and

the shape of the first sub-section comprises a generatrix with an angle comprised between 15 and 45 degrees with regard to a longitudinal axis of the aspiration funnel.

12 . The thrombectomy system according to claim 1 , wherein the non-permeable covering comprises a polymer including silicone or polyurethane.

13 . A method of extracting a thrombus from a thrombus site in a blood vessel of a patient, the method comprising:

advancing a delivery catheter through vasculature toward the thrombus site;

placing a distal end of the delivery catheter proximal to the thrombus in the blood vessel;

advancing an aspiration catheter within the delivery catheter, an aspiration funnel extending distally from the aspiration catheter, the aspiration funnel comprising a mesh of at least two sets of helicoidal filaments turning respectively in opposite directions and being intertwined, and wherein the at least two sets of helicoidal filaments of the mesh extend continuously through a first tubular section and a second tubular section distinct from and proximal to the a first tubular section wherein a braiding angle of the at least two sets of helicoidal filaments of the first tubular section is configured to provide outward radial forces higher than in the second tubular section, the aspiration funnel further comprising a first sub-section having a shape with a progressive reduction of diameter configured to open and create a space for the thrombus, and a second sub-section of a tubular uniform diameter configured to provide a connection to the aspiration catheter;

moving the aspiration catheter and delivery catheter with respect to each other to place the aspiration funnel outside of the delivery catheter proximal to the thrombus;

expanding the first section and the second section of the aspiration funnel with closed loops formed by the at least two sets of helicoidal filaments at the distal end of the first tubular section, wherein the closed loops act as springs to expand the first tubular section and place a length of the first tubular section from the closed loops to the first sub-section into contact with an inner wall of the blood vessel;

occluding blood flow past the aspiration funnel;

advancing a clot-capture element distally through the aspiration funnel toward the thrombus;

deploying the clot-capture element to capture the clot;

moving the clot-capture element and thrombus proximally toward the aspiration funnel;

applying suction through the aspiration catheter to the aspiration funnel to aspirate the thrombus at least partially into the aspiration funnel; and

moving the aspiration funnel and the thrombus proximally within the vasculature, the aspiration funnel adapting its shape and length to a surrounding blood vessel by lengthening as it narrows to retain the thrombus within the aspiration funnel.

14 . The method of claim 13 , further comprising advancing a microcatheter within the aspiration catheter, the clot-capture element being disposed within the microcatheter.

15 . The method of claim 14 , further comprising:

moving the microcatheter and clot-capture device with respect to each other to place the clot-capture device outside of the microcatheter; and

expanding the clot-capture device.

16 . The method of claim 15 , wherein expanding the clot-capture device comprises allowing the clot capture device to self-expand.

17 . The method of claim 16 , wherein advancing the microcatheter comprises advancing a distal end of the microcatheter through the thrombus.

18 . The method of claim 13 , further comprising moving the clot-capture device proximally at least partially into the aspiration funnel.

19 . The method of claim 13 , wherein expanding the aspiration funnel comprises allowing the aspiration funnel to self-expand.

20 . The method of claim 13 , further comprising moving the two sets of helicoidal filaments to a more longitudinally aligned position as the aspiration funnel lengthens and narrows.

21 . An automated system configured for automated maneuvering of the thrombectomy system of claim 1 to the blood vessel, the system comprising an automated proximal device configured to provide a guidance system to deploy the thrombectomy system, an imaging device, a communications channel, a control module configured to allow for guidance of the deployment of the thrombectomy apparatus, a data storage device, and a computer assisted controller configured to guide the control module.