ASPIRATION THROMBECTOMY SYSTEMS AND METHODS FOR THROMBUS REMOVAL WITH ASPIRATION CATHETER
An aspiration thrombectomy system includes a thrombectomy catheter assembly that maintains pulsatile energy of cyclic aspiration while the catheter is occluded. A system configuration includes a catheter, vacuum and vent fluid sources respectively connected to vacuum and vent valves, a vent catheter valve connecting a catheter lumen to the vent fluid source, a manifold connected to the catheter and vacuum and vent valves, a pressure sensor upstream of the vacuum valve, and a controller configured to operate the vacuum, vent, and vent catheter valves, receive sensor pressure data, control the vent catheter valve dependent upon the data. An operable lumen of the system includes a volume of the catheter lumen and an interior of the manifold up to an input of the vacuum valve input and an output of the vent valve.
1 - 25 . (canceled)
26 . An aspiration thrombectomy system, comprising:
a catheter assembly including a catheter lumen fluidly connected to an extension line;
a manifold having a manifold output and a manifold input fluidly connected to a proximal end of the catheter assembly;
a vacuum valve having a vacuum valve input fluidly connected to the manifold output and a vacuum valve output to fluidly connect to a vacuum source; and
a vent valve having a vent valve input to fluidly connect to a vent fluid source and a vent valve output fluidly connected to the catheter assembly;
wherein a ratio of non-degassed fluid volume to a volume of an operable lumen is greater than approximately 0.4, wherein the volume of the operable lumen is a sum of a volume of the catheter assembly, a volume of the vent valve output to the catheter assembly, and a volume of the manifold to the vacuum valve input, and wherein the non-degassed fluid volume is a sum of the volume of the vent valve output to the catheter assembly, a volume of the catheter assembly proximal of the vent valve output, and the volume of the manifold to the vacuum valve input.
27 . The aspiration thrombectomy system of claim 26 , wherein the ratio of the non-degassed fluid volume to the volume of the operable lumen is greater than 0.7.
28 . The aspiration thrombectomy system of claim 26 , wherein:
the catheter lumen and the extension line each has a proximal end and a distal end, the distal end of the extension line is fluidly connected to the proximal end of the catheter lumen, and the distal end of the extension line is fluidly connected to the manifold input; and
the vent valve output is fluidly connected to the catheter lumen proximate the distal end of the catheter lumen.
29 . The aspiration thrombectomy system of claim 26 , wherein:
the catheter lumen and the extension line each has a proximal end and a distal end, the distal end of the extension line is fluidly connected to the proximal end of the catheter lumen, and the distal end of the extension line is fluidly connected to the manifold input; and
the vent valve output is fluidly connected to the extension line between the proximal and distal ends of the extension line.
30 . The aspiration thrombectomy system of claim 26 , wherein:
the catheter lumen and the extension line each has a proximal end and a distal end, the distal end of the extension line is fluidly connected to the proximal end of the catheter lumen, and the distal end of the extension line is fluidly connected to the manifold input; and
the vent valve output is fluidly connected to the catheter lumen and the extension line at a junction of the proximal end of the catheter lumen and the distal end of the extension line.
31 . The aspiration thrombectomy system of claim 30 , further comprising:
a sensor to detect flow through the manifold and produce a signal indicative of the detected flow; and
a controller to receive the signal indicative of the detected flow and modulate the vacuum valve based on the signal, the controller having a plurality of states including an idle state in which the vacuum valve is only partially open and at least one aspiration state in which the vacuum valve is fully open;
wherein the controller is in the idle state in response to the signal indicating the detected flow is open flow, and wherein the controller transitions from the idle state to an aspiration state of the at least one aspiration state in response to the signal indicating a clot or thrombus is detected.
32 . The aspiration thrombectomy system of claim 31 , wherein a first aspiration state of the at least one aspiration state includes a pulsed aspiration state in which the vacuum valve is pulsed fully open and closed.
33 . The aspiration thrombectomy system of claim 32 , wherein the controller transitions from the idle state to the first aspiration state in response to the signal indicating that a hard clot or thrombus is detected.
34 . The aspiration thrombectomy system of claim 31 , wherein a first aspiration state of the at least one aspiration state includes a standard aspiration state in which the vacuum valve is held fully open.
35 . The aspiration thrombectomy system of claim 34 , wherein the controller transitions from the idle state to the first aspiration state in response to the signal indicating that a soft clot or thrombus is detected.
36 . The aspiration thrombectomy system of claim 35 , wherein a second aspiration state of the at least one aspiration state includes a pulsed aspiration state in which the vacuum valve is pulsed fully open and closed, and wherein the controller transitions from the idle state to the second aspiration state in response to the signal indicating that a hard clot or thrombus is detected.
37 . The aspiration thrombectomy system of claim 36 , wherein during the pulsed aspiration state, the vent valve is at least partially open.
38 . The aspiration thrombectomy system of claim 37 , wherein during the pulsed aspiration state, the energy of pulsed aspiration is maintained for greater than 30 seconds.
39 . The aspiration thrombectomy system of claim 34 , wherein a second aspiration state of the at least one aspiration state includes a pulsed aspiration state in which the vacuum valve is pulsed fully open and closed.
40 . The aspiration thrombectomy system of claim 39 , wherein the plurality of states further includes a clogged state in which the controller initiates an unclogging routine, wherein the controller transitions from the pulsed aspiration state to the clogged state in response to the signal indicating the clot or thrombus has not been cleared.
41 . The aspiration thrombectomy system of claim 40 , wherein during the unclogging routine, between 100 microliters and 200 microliters of fluid in the catheter lumen is displaced distally.
42 . The aspiration thrombectomy system of claim 39 , wherein responsive to the signal indicating the clot or thrombus is cleared, the controller transitions from one of the first or second aspiration states back to the idle state.
43 . The aspiration thrombectomy system of claim 31 , wherein the sensor is a single pressure sensor disposed in the manifold distal of the vacuum valve, wherein the signal indicating the detected flow is open flow is a pressure greater than approximately 11 PSI absolute, and wherein the signal indicating the clot or thrombus is detected is a pressure less than approximately 11 PSI absolute.
44 . The aspiration thrombectomy system of claim 31 , wherein during the idle state, the vent valve is at least partially open.
45 . The aspiration thrombectomy system of claim 31 , wherein during the idle state, a flow of fluid through the manifold is approximately 10 cc/min.
46 . The aspiration thrombectomy system of claim 31 , wherein during the idle state, a majority of a flow of fluid through the manifold is from the vent fluid source.
47 . The aspiration thrombectomy system of claim 26 , further comprising a manifold vent valve having a manifold vent valve output fluidly connected to the manifold and a manifold vent valve input fluidly coupled to the vent fluid source.