Granted Patent B2

US 12,471,937 · App. 18/420,094 · Granted Nov 18, 2025

Inventors: Alejandro N. Calderon (Miami, FL); Matthew A. Palmer (Coral Gables, FL); Derek Dee Deville (Coral Gables, FL); William T. Bales (Miami, FL); M. Sean McBrayer (Coral Gables, FL); Eric Petersen (Homestead, FL); Richard Cartledge (Boca Raton, FL); Thomas O. Bales, Jr. (Miami, FL); Carlos Rivera (Cooper City, FL); Carlos Rivera, III (Cooper City, FL)

Assignee: SYNTHEON PV, LLC

A61B17/22A61B2017/00022A61B2017/00154A61B2017/00292A61B2017/00544A61B2017/22079

Abstract

Claims (36)

1 . An aspiration thrombectomy system, comprising:

a vacuum source;

a catheter including a catheter lumen having a proximal end and a distal end;

a manifold having a manifold input fluidically connected to the proximal end of the catheter lumen and a manifold output;

a sensor to detect flow through the manifold and produce a signal indicative of the detected flow;

a vacuum valve having a vacuum valve input fluidically connected to the manifold output and a vacuum valve output fluidically connected to the vacuum source; 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 held only partially open for a period of time 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.

2 . The aspiration thrombectomy system of claim 1 , wherein the period of time in which the vacuum valve is held only partially open comprises a duration of the idle state.

3 . The aspiration thrombectomy system of claim 2 , wherein a first of the at least one aspiration state 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 the idle state to the first aspiration state in response to the signal indicating that a hard clot or thrombus is detected.

5 . The aspiration thrombectomy system of claim 2 , wherein a first of the at least one aspiration state 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 the idle state to the first aspiration state in response to the signal indicating that a soft clot or thrombus is detected.

7 . The aspiration thrombectomy system of claim 6 , wherein a second 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.

8 . The aspiration thrombectomy system of claim 7 further comprising:

a vent source; and

a vent valve having a vent valve input fluidically coupled to the vent source and a vent valve output fluidically coupled to the catheter at a position distal of the manifold.

9 . The aspiration thrombectomy system of claim 8 , wherein during the pulsed aspiration state, the vent valve is at least partially open to prolong an energy of pulsed aspiration and the energy of pulsed aspiration is maintained for greater than 30 seconds.

10 . The aspiration thrombectomy system of claim 5 , wherein a second of the at least one aspiration state 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 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.

12 . The aspiration thrombectomy system of claim 11 , wherein during the unclogging routine, between 100 microliters and 200 microliters of fluid in the catheter is displaced distally.

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 the one of the first or second aspiration states back to the idle state.

14 . The aspiration thrombectomy system of claim 2 , wherein during the idle state, the vacuum valve is at least 5% open.

15 . The aspiration thrombectomy system of claim 2 , wherein during the idle state, the vacuum valve is between at least 5% open and 20% open.

16 . The aspiration thrombectomy system of claim 2 , wherein during the idle state, a flow of fluid through the manifold is less than 10 cc/min.

17 . The aspiration thrombectomy system of claim 2 , wherein the sensor is a single pressure sensor disposed in the manifold distal of the vacuum valve.

18 . The aspiration thrombectomy system of claim 17 , 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.

19 . The aspiration thrombectomy system of claim 2 , further comprising:

a vent source; and

a vent valve having a vent valve input fluidically coupled to the vent source and a vent valve output fluidically coupled to the catheter at a position distal of the manifold.

20 . The aspiration thrombectomy system of claim 19 , wherein the plurality of states includes a clogged state in which the controller initiates an unclogging routine wherein between 100 microliters and 200 microliters of fluid in the catheter is displaced distally.

21 . The aspiration thrombectomy system of claim 20 , wherein during the idle state, a flow of fluid through the manifold is less than 10 cc/min.

22 . The aspiration thrombectomy system of claim 21 , wherein during the idle state, a majority of the flow of fluid through the manifold is from the vent source.

23 . The aspiration thrombectomy system of claim 19 , further comprising an extension line having a proximal end fluidly coupled to the manifold inlet and a distal end fluidly coupled to the proximal end of the catheter, wherein the vent valve output is disposed at a coupling between the proximal end of the catheter and the distal end of the extension line.

24 . The aspiration thrombectomy system of claim 19 , wherein during the idle state, the vent valve is at least partially open.

25 . The aspiration thrombectomy system of claim 24 , wherein during the idle state, the vent valve is at least partially open for the duration of the idle state.

Assignments (1)

Continuity (3)

References Cited (397)