Device and method for manual aspiration and removal of an undesirable material
The present invention is directed to a manually actuated aspiration device, aspiration system and a method of use to enable and facilitate en bloc removal of undesirable intravascular material, including, but not limited to, thrombus, embolus, or vegetation through a working lumen of a suction cannula during minimally invasive percutaneous procedures. The aspiration device includes valves oriented in opposite direction to control the fluid flow through the aspiration system and into a waste collection component. Alternatively, the aspiration system further comprises a filter that removes undesirable intravascular material prior to reinfusing blood into a patient's vasculature.
1 . A system to remove an undesirable material from a vessel, the system comprising:
an aspiration catheter;
a pump comprising a pump chamber, an inlet port, and an outlet port, the inlet port being configured to be in fluid communication with the aspiration catheter;
a filter assembly comprising a filter, the filter assembly being configured to be in fluid communication with the outlet port of the pump;
a first one-way valve positioned between the aspiration catheter and the pump;
a second one-way valve positioned between the pump and the filter assembly;
wherein the pump is configured to generate a suction force to cause aspirated blood and aspirated undesirable material to flow from the aspiration catheter through the first one-way valve and into the pump chamber; and the pump is configured to generate a drive force to cause the aspirated fluid to flow from the pump chamber through the second one-way valve, into the filter assembly and across the filter thereby filtering the aspirated undesirable material from the aspirated blood;
a pressure sensor coupled to the aspiration catheter and configured to measure a change in pressure when the undesirable material is aspirated through the aspiration catheter.
2 . The system of claim 1 , wherein the pump further includes a plunger, and the plunger is configured to move in a first direction to generate the suction force and move in a second direction to generate the drive force.
3 . The system of claim 2 , wherein the filter assembly is comprised of a translucent material and configured to allow a user to visualize the filtered undesirable material within the filter assembly.
4 . The system of claim 3 , wherein the pump chamber comprises a volume of up to 30 cubic centimeters.
5 . The system of claim 1 , wherein the first one-way valve and the second one-way valve both comprise a predetermined pressure threshold of at least 30 mm of mercury.
6 . The system of claim 5 , wherein the pressure sensor is configured to detect a pressure change within the vessel when the undesirable material is engaged with the aspiration catheter.
7 . The system of claim 6 , wherein the pressure sensor is configured to provide a visual feedback to a user to notify the user of the pressure change.
8 . The system of claim 1 , wherein the undesirable material includes at least one of: thrombus; embolus; clot; vegetative growth; infected vegetative growth; endocarditis; pulmonary embolism; tumor; arterial clots; and undesirable material trapped in dialysis grafts and/or stents.
9 . The system of claim 1 , wherein the pump is configured to be coupled in fluid communication to the aspiration catheter via a connector.
10 . The system of claim 1 , wherein the aspiration catheter, the pump, and the filter assembly are all in fluid communication during use.
11 . A system to remove an undesirable material from a vessel of a patient, the system comprising:
an aspiration catheter;
a pump comprising a barrel, a pump inlet port, and a pump outlet port, the pump inlet port being configured to be fluidly coupled to the aspiration catheter, and the pump outlet port being configured to be fluidly coupled to an accessory cannula;
a filter assembly comprising a filter and a filter housing, the filter assembly being configured to be fluidly coupled to the accessory cannula,
a first one-way valve positioned between the aspiration catheter and the pump;
a second one-way valve positioned between the pump and the filter assembly;
wherein the pump is configured to generate an aspiration force sufficient to aspirate blood and undesirable material from the vessel, through the aspiration catheter, the first one-way valve, and into the barrel of the pump;
wherein the pump is configured to generate a drive force to cause the aspirated blood and aspirated undesirable material to flow from the barrel of the pump, through the second one-way valve, the accessory cannula, and into filter assembly, the drive force generated by the pump being sufficient to flow the aspirated blood and aspirated undesirable material across the filter thereby filtering the aspirated undesirable material from the aspirated blood so that the aspirated undesirable material can be visualized; and
a pressure sensor assembly coupled to the aspiration catheter and configured to measure a change in pressure within the vessel.
12 . The system of claim 11 , further comprising:
a reinfusion assembly in fluid communication with the filter assembly and configured to receive the filtered blood separated from the undesirable material.
13 . The system of claim 12 , wherein the pump further includes a plunger.
14 . The system of claim 13 , wherein the plunger is configured to be activated in a first direction to generate the aspiration force sufficient to open the first one-way valve but insufficient to open the second one-way valve.
15 . The system of claim 14 , wherein the plunger is configured to be activated in a second direction to generate the drive force sufficient to open the second one-way valve but insufficient to open the first one-way valve.
16 . A system to remove an undesirable material from a vessel of a patient, the system comprising:
an aspiration catheter;
a manually operated pump comprising a plunger and a barrel, the pump being configured to be in fluid communication with the aspiration catheter and a filter assembly;
the filter assembly comprising a filter and a filter housing;
a first check valve positioned between the aspiration catheter and the manually operated pump;
a second check valve positioned between the manually operated pump and the filter assembly;
wherein movement of the plunger in a first direction is configured to generate an aspiration force sufficient to aspirate blood and undesirable material from the vessel, through the aspiration catheter, the first check valve, and into the barrel;
wherein movement of the plunger in a second direction is configured to generate a drive force sufficient to drive the aspirated blood and aspirated undesirable material out of the barrel through the second check valve, into the filter assembly, and drive the aspirated blood and aspirated undesirable material across the filter thereby capturing the aspirated undesirable material in the filter housing to visualize the captured aspirated undesirable material that has been separated from the filtered blood; and
a pressure sensor assembly coupled to the aspiration catheter and configured to provide a user with a visual feedback of a change in measured pressure from within the vessel.
17 . The system of claim 16 , wherein the pressure sensor is configured to measure an increase or decrease in pressure within the vessel when the aspiration catheter is engaged with the undesirable material.
18 . The device of claim 17 , wherein the barrel comprises a volume of up to 30 cubic centimeters.
19 . The device of claim 18 , wherein the first check valve and the second check valve both comprise a cracking pressure of at least 30 mm of mercury.
20 . The device of claim 19 , further comprising a reinfusion assembly configured to receive the filtered blood separated from the undesirable material.