Systems and methods for removing undesirable material within a circulatory system during a surgical procedure

1 . A system for aspirating and filtering undesirable material from a vasculature, the system comprising:

a cannula comprising a funnel shaped distal end and a lumen, the funnel shaped distal end comprising an expandable reinforcement structure and an impermeable membrane, the impermeable membrane being coupled to the expandable reinforcement structure;

a pump configured to be operably coupled to the cannula, wherein the pump is configured to create a suction force sufficient to aspirate the undesirable material and blood through the cannula lumen, and the funnel distal end facilitates a vortex flow of the undesirable material and blood within the funnel shaped distal end to facilitate conforming the undesirable material into the cannula lumen; and

a filter assembly configured to receive the aspirated undesirable material and blood, the filter assembly comprising an inlet, an outlet, a filter membrane, and a fluid path extending from the inlet through the filter membrane and to the outlet, wherein the filter membrane is configured to permit the aspirated blood to flow along the fluid path from the inlet to the outlet and inhibit the aspirated undesirable material from flowing along the fluid path from the inlet to the outlet,

wherein the filter assembly includes a venting aperture configured to displace air from the filter assembly, the venting aperture being positioned above a fluid level of the filter assembly.

2 . The system of claim 1 , further comprising an agitator positioned within the funnel shaped distal end to agitate the undesirable material within the funnel shaped distal end.

3 . The system of claim 2 , wherein the funnel shaped distal end is configured to aspirate the undesirable material substantially en bloc.

4 . The system of claim 2 , wherein:

the expandable reinforcement structure is a polymer material; and the expandable reinforcement structure is balloon actuated;

the expandable reinforcement structure comprises at least two strips; and the pump is an automated pump;

the agitator is a balloon embolectomy catheter;

the funnel shaped distal end further comprises a mechanism configured to deploy the expandable reinforcement structure; and

the pump is configured to generate a drive force simultaneously with the suction force.

5 . The system of claim 1 , wherein the filter assembly is configured to permit captured undesirable material to be visualized within the filter assembly.

6 . The system of claim 1 , further comprising another pump, the another pump being a manually operated pump configured to flow the aspired blood and undesirable material along the fluid path within the filter assembly for a desired duration or until the filtered undesirable material has been visually confirmed within the filter assembly.

7 . The system of claim 1 , wherein a diameter of the funnel shaped distal end is at least three times larger than a diameter of the cannula lumen.

8 . The system of claim 1 , wherein:

the expandable reinforcement structure further comprises a base and a distal most end;

the impermeable membrane is configured to extend from the expandable reinforcement structure base to the expandable reinforcement structure distal most end;

the funnel shaped distal end further comprises a radiopaque marker; and

the impermeable membrane is coupled to either an inner surface of the expandable reinforcement structure, an outer surface of the expandable reinforcement structure, or both the inner surface and the outer surface of the expandable reinforcement structure.

9 . The system of claim 1 , further comprising:

a first container configured to receive the aspirated undesirable material and blood, the first container is configured to be operably coupled to the filter assembly;

a second container configured to receive the aspirated blood that passed through the filter membrane, the second container is configured to be operably coupled to a reinfusion cannula configured to be placed in the vasculature; and

another pump configured to be operably coupled to the reinfusion cannula and configured to generate a reinfusion force sufficient to drive the filtered blood through the reinfusion cannula into the vasculature.

10 . The system of claim 9 , wherein the filter membrane further comprises a first filter material having a first pore size and a second filter material having a second pore size; the first pore size is different than the second pore size; and the first filter material and the second filter material are configured to minimize any occurrence of the aspirated undesirable material from flowing along the fluid path from the inlet to the outlet.

11 . A system comprising:

a cannula comprising an expandable funnel shaped distal end and a lumen, the expandable funnel shaped distal end comprising a reinforcement structure and an impermeable membrane, the impermeable membrane being coupled to the reinforcement structure, and the cannula being configured to be placed into a vasculature;

a manually operated pump configured to be in fluid communication with the cannula, wherein the manually operated pump is configured to create a suction force sufficient to aspirate an undesirable material and blood through the cannula lumen; and

a filter assembly configured to receive the aspirated undesirable material and blood, the filter assembly comprising an inlet, an outlet, a first filter membrane, a second filter membrane, and a fluid path extending from the inlet through the first and second filter membranes and to the outlet,

wherein the second filter membrane is positioned downstream from the first filter membrane, and the first filter membrane comprises a first filter pore size and the second filter membrane comprises a second filter pore size, the first filter pore size being larger than the second filter pore size,

wherein the first and second filter membranes are configured to permit the aspirated blood to flow along the fluid path from the inlet to the outlet and inhibit the undesirable material from flowing along the fluid path from the inlet to the outlet, and

wherein the filter assembly is configured to permit the filtered undesirable material to be visualized therein.

12 . The system of claim 11 , wherein:

the expandable funnel shaped distal end is configured to transition from a compressed state to an expanded state;

the cannula further comprises a cannula reinforcement element;

the reinforcement structure is configured to withstand a negative pressure generated from the suction force and prevent the expandable funnel shaped distal end from unintentionally transitioning from the expanded state to the compressed state; and

the cannula reinforcement element is configured to withstand the negative pressure generated from the suction force and prevent the cannula from collapsing.

13 . The system of claim 11 , further comprising:

a first container configured to receive the aspirated undesirable material and blood;

a second container configured to receive the filtered blood that passed through the first and second filter membranes; and

a reinfusion cannula configured to be operably coupled to the second container, placed in the vasculature, and reinfuse the filtered blood into the vasculature.

14 . The system of claim 11 , wherein: the impermeable membrane is a continuous membrane extending from a base of the reinforcement structure to a distal most end of the reinforcement structure; and an inner surface of the expandable funnel shaped distal end is configured to enhance a laminar flow circumferentially along the inner surface to generate a vortex effect during the suction force.

15 . The system of claim 14 , further comprising a fragmentor configured to fragment undesirable material entrapped within the expandable funnel shaped distal end and thereby enhance the suction force to aspirate the undesirable material substantially en bloc.

16 . The system of claim 11 , wherein: the cannula is comprised of a pliable material and a reinforcement wire; and the cannula is configured to optimize maneuverability within the vasculature without kinking.

17 . The system of claim 11 , wherein a combination of the first filter membrane and the second filter membrane is configured to result in an enhanced filtration such that substantially all of the undesirable material is filtered from the aspirated blood, thereby reducing the probability of substantially any of the undesirable material from exiting the outlet.

18 . A system comprising:

a cannula comprising a funnel shaped distal end and a lumen, the funnel shaped distal end comprising an expandable reinforcement structure and an impermeable membrane, the impermeable membrane being coupled to the expandable reinforcement structure;

a pump configured to be operably coupled to the cannula, wherein the pump is configured to create a suction force sufficient to aspirate undesirable material and blood from a vasculature towards the cannula lumen;

an agitator configured to engage with the undesirable material when positioned within the funnel shaped distal end; and

a filter assembly configured to receive the aspirated undesirable material and blood, the filter assembly comprising an inlet, an outlet, a first filter membrane, a second filter membrane, and a fluid path extending from the inlet through the first and second filter membranes and to the outlet, wherein the first and second filter membranes are configured to permit the aspirated blood to flow along the fluid path from the inlet to the outlet and inhibit the undesirable material from flowing along the fluid path from the inlet to the outlet,

wherein the second filter membrane is positioned downstream from the first filter membrane, and the first filter membrane comprises a first filter pore size and the second filter membrane comprises a second filter pore size, the first filter pore size being larger than the second filter pore size, and

wherein the filter assembly further comprises a venting aperture for displacing air from the filter assembly.

19 . The system of claim 18 , wherein the funnel shaped distal end and the agitator together are configured to generate a vortex effect when the suction force is applied by the pump.

20 . The system of claim 18 , further comprising:

a first container configured to receive the aspirated undesirable material from the cannula and operably couple to the filter assembly;

a second container configured to operably couple to the filter assembly and receive the filtered blood; and

a reinfusion cannula configured to operably couple to the second container, and the reinfusion cannula being configured to be placed in the vasculature, and flow the filtered blood into the vasculature.

21 . The system of claim 18 , wherein the agitator includes a rheolytic or fragmentation device.

22 . A system comprising:

a blood collection and filtration assembly;

a cannula comprising a funnel shaped distal end and a lumen, the funnel shaped distal end comprising an expandable reinforcement structure and an impermeable membrane, the cannula being configured to be operably coupled to the blood collection and filtration assembly;

a vacuum source configured to create a negative pressure through the cannula lumen and the blood collection and filtration assembly sufficient to aspirate undesirable material and blood from a vasculature;

wherein the blood collection and filtration assembly comprises an inlet, a first filter assembly, a second filter assembly, a reservoir, an outlet, and a fluid path extending from the inlet, through the first filter assembly, the second filter assembly, the reservoir, and to the outlet; and

wherein the blood collection and filtration assembly is configured to receive the aspirated undesirable material and aspirated blood from the cannula through the inlet, and both the first filter assembly and the second filter assembly are configured to permit the aspirated blood to flow along the fluid path from the inlet to the outlet and inhibit the undesirable material from flowing along the fluid path from the inlet to the outlet, thereby filtering the aspirated undesirable material from the aspirated blood to produce filtered blood, the reservoir is configured to capture the undesirable material, and

wherein the second filter assembly is positioned downstream from the first filter assembly, and the first filter assembly comprises a first filter pore size and the second filter assembly comprises a second filter pore size, the first filter pore size being larger than the second filter pore size, and wherein a combination of the first filter assembly and the second filter assembly is configured to result in an enhanced filtration such that substantially all of the undesirable material is filtered from the aspirated blood, thereby reducing the probability of substantially any of the undesirable material from exiting the outlet.

23 . The system of claim 22 , further comprising an agitator to aid in removal of the undesirable material from the vasculature, where the agitator is configured to engage with the undesirable material within the funnel shaped distal end.

24 . The system of claim 22 , wherein the blood collection and filtration assembly further comprises a venting aperture configured to vent air from the blood collection assembly, the venting aperture is configured to be above a fluid level of the reservoir.

25 . The system of claim 24 , wherein the reservoir is configured to visualize the captured undesirable material.

26 . The system of claim 22 , wherein the funnel shaped distal end is configured to generate a vortex flow.

27 . The system of claim 22 , further comprising a reinfusion assembly configured to receive the filtered blood, wherein the reinfusion assembly comprises a reinfusion cannula configured to be placed in the vasculature and reinfuse the filtered blood into the vasculature.

28 . The system of claim 22 , wherein the vacuum source is configured to be in operative fluid communication with the blood collection and filtration assembly and the cannula.

29 . The system of claim 22 , wherein the blood collection and filtration assembly further comprises a first conduit coupled to the inlet and a second conduit coupled to the outlet, wherein the first conduit is configured to be operably coupled to the cannula and the second conduit is configured to be operably coupled to the vacuum source.

30 . The system of claim 22 , wherein the blood collection and filtration assembly is positioned between the cannula and the vacuum source.