Aspiration thrombectomy system and methods for dynamic system state detection
An aspiration thrombectomy system includes a vacuum source, a catheter having a proximal end and a distal end, a junction fluidically connected to the proximal end of the catheter, a sensor to detect flow through the proximal end of the catheter or the junction and produce a flow signal, a vacuum valve fluidically connected to the junction and to the vacuum source, and a controller. The controller may receive the flow signal and modulate the vacuum valve based on the signal. The controller may have a sampling state in which the vacuum valve is not held fully open for a period of time and at least one aspiration state in which the vacuum valve is fully open. The controller may idle in the sampling state in response to the signal indicating open flow, and transition to an aspiration state in response to the signal indicating a clot or thrombus.
1 . An aspiration thrombectomy system, comprising:
a vacuum console unit comprising a vacuum source and a collection canister;
a catheter including a catheter lumen having a proximal end and a distal end;
a junction unit comprising a distal pressure sensor, wherein the junction unit is physically separated in a position upstream from the vacuum console unit and downstream from the proximal end of the catheter, wherein the junction unit is fluidically connected to the proximal end of the catheter lumen, wherein the junction unit is fluidically connected to the vacuum console unit via a vacuum valve, wherein the vacuum valve is positioned at a proximal location relative to the junction unit and the catheter
, and wherein the distal pressure sensor is configured to detect flow through the junction unit and produce a signal indicative of the detected flow; and
a controller configured to utilize a dynamic system state detection algorithm to:
receive the signal indicative of the detected flow;
determine, using the dynamic system state detection algorithm, a current flow state at one or more distal locations in the aspiration thrombectomy system distally upstream relative to the vacuum valve; and
modulate the vacuum valve based on the signal,
wherein the controller is configured to operate in a plurality of operational states including a sampling state in which the vacuum valve is not held fully open for a period of time and at least one aspiration state in which the vacuum valve is fully open, wherein an extent to which the vacuum valve is not held fully open is dynamically controlled by the controller based on the current flow state determined using the dynamic system state detection algorithm; and
wherein the controller idles in the sampling state in response to the signal indicating the detected flow is open flow, wherein the controller transitions from idling in the sampling state to the at least one aspiration state in response to the signal indicating a clot or thrombus is detected.
2 . The aspiration thrombectomy system of claim 1 , wherein the period of time in which the vacuum valve is not held fully open is based on a predetermined timing.
3 . The aspiration thrombectomy system of claim 2 , wherein the at least one aspiration state comprises a first aspiration state that includes a pulsed aspiration state in which the vacuum valve is pulsed fully open and closed.
4 . The aspiration thrombectomy system of claim 3 , wherein the controller transitions from idling in the sampling state to the first aspiration state in response to the signal indicating that a clot or thrombus having a first deformability characteristic is detected.
5 . The aspiration thrombectomy system of claim 2 , wherein the at least one aspiration state comprises a first aspiration state that includes a standard aspiration state in which the vacuum valve is held fully open.
6 . The aspiration thrombectomy system of claim 5 , wherein the controller transitions from idling in the sampling state to the first aspiration state in response to the signal indicating that a clot or thrombus having a first deformability characteristic is detected.
7 . The aspiration thrombectomy system of claim 6 , wherein the at least one aspiration state further comprises a second aspiration state that includes a pulsed aspiration state in which the vacuum valve is pulsed fully open and closed, and wherein the controller transitions from idling in the sampling state to the second aspiration state in response to the signal indicating that a clot or thrombus having a first deformability characteristic is detected.
8 . The aspiration thrombectomy system of claim 7 further comprising:
a vent source; and
a vent valve fluidically coupled to the vent source and to the catheter.
9 . The aspiration thrombectomy system of claim 8 , wherein during the pulsed aspiration state, the vent valve is at least partially open for at least a predetermined period of time.
10 . The aspiration thrombectomy system of claim 5 , wherein the at least one aspiration state further comprises a second aspiration state that includes a pulsed aspiration state in which the vacuum valve is pulsed fully open and closed.
11 . The aspiration thrombectomy system of claim 10 , wherein the plurality of operational states further includes a clogged extraction state in which the controller initiates a clog extraction cycle, wherein the controller transitions from the pulsed aspiration state to the clogged extraction state in response to the signal indicating the clot or thrombus has not been cleared.
12 . The aspiration thrombectomy system of claim 11 , wherein during the clog extraction cycle, a predetermined amount of fluid is injected distally by a vent valve.
13 . The aspiration thrombectomy system of claim 10 , wherein responsive to the signal indicating the detected clot or thrombus is cleared, the controller transitions from one of the first aspiration state or the second aspiration state back to idling in the sampling state.
14 . The aspiration thrombectomy system of claim 2 , wherein during the sampling state, a flow of fluid through the proximal end of the catheter lumen or the junction unit is limited to minimize blood loss.
15 . The aspiration thrombectomy system of claim 2 , wherein the distal pressure sensor is a single pressure sensor positioned in association with the proximal end of the catheter lumen or the junction unit distal of the vacuum valve.
16 . The aspiration thrombectomy system of claim 15 , wherein the signal indicating the detected flow is open flow is a pressure greater than a threshold pressure level and wherein the signal indicating the clot or thrombus is detected is a pressure less than the threshold pressure level.
17 . The aspiration thrombectomy system of claim 2 , further comprising:
a vent source; and
a vent valve fluidically coupled to the vent source and to the catheter.
18 . The aspiration thrombectomy system of claim 17 , wherein the plurality of operational states further includes a clogged extraction state in which the controller initiates a clog extraction cycle, and wherein a predetermined amount of fluid is injected distally by the vent valve.
19 . The aspiration thrombectomy system of claim 17 , further comprising an external unit having a proximal end fluidly coupled to the junction unit and a distal end fluidly coupled to the proximal end of the catheter.
20 . The aspiration thrombectomy system of claim 18 , wherein during the sampling state, a flow of fluid through the proximal end of the catheter lumen or the junction unit is limited to minimize blood loss.
21 . The aspiration thrombectomy system of claim 1 , wherein determining the current flow state using the dynamic system state detection algorithm is based at least in part on generating one or more pressure changes in the catheter, and identifying, responsive to the one or more generated pressure changes, one or more pressure profiles indicative of a current flow state in the catheter.
22 . The aspiration thrombectomy system of claim 21 , wherein identifying the one or more pressure profiles is based at least in part on one or more system state scores calculated based on the one or more generated pressure changes, and wherein the system state scores are indicative of a measure of occlusion in the catheter.