Granted Patent B2

US 12,465,380 · App. 18/946,766 · Granted Nov 11, 2025

Inventors: Derek Dee Deville (Coral Gables, FL); Matthew A. Palmer (Miami, 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)

Assignee: RapidPulse, Inc.

A61B17/22A61F2/013A61M25/0075A61B2017/00022A61B2017/00154A61B2017/22079A61B2017/22082A61B2217/007A61F2/011

Abstract

Claims (58)

1 . A thrombectomy aspiration system, comprising:

a vacuum source;

a vacuum valve fluidically coupled to the vacuum source;

a vent valve configured to be fluidically coupled to a vent fluid source;

an aspiration catheter having a proximal end fluidically coupled the vacuum valve and the vent valve; and

a controller configured to open and close the vacuum valve and the vent valve in a predetermined sequence to change a level of vacuum at the distal end of the aspiration catheter, wherein timing of opening and closing the vacuum valve and the vent valve in the sequence is set, at least in part, based on (a) a time to cause an exit volume of fluid to flow out of the distal end of the catheter because of one pressure wave resulting from closing the vacuum valve and/or another pressure wave resulting from subsequently opening the vent valve, and (b) a time at which the vacuum valve is reopened to control the exit volume of fluid such that reapplication of vacuum draws at least a portion of a thrombus toward the distal end of the aspiration catheter.

2 . The thrombectomy aspiration system of claim 1 wherein the vacuum valve and the vent valve are in a housing located close to the proximal end of the aspiration catheter, and wherein the vacuum source is outside of and separated from the housing.

3 . The thrombectomy system of claim 1 wherein the controlled exit volume of fluid that flows out of the distal end of the catheter each cycle is approximately 0.1 ml to approximately 0.5 ml.

4 . The thrombectomy aspiration system of claim 1 wherein the controlled exit volume of fluid that flows out of the distal end of the catheter each cycle is approximately 0.001 ml to approximately 1.0 ml.

5 . The thrombectomy aspiration system of claim 1 wherein:

the vacuum valve comprises a first solenoid-driven pinch valve and the vent valve comprises a second solenoid-driven pinch valve; and

the timing of reopening the vacuum valve is set such that a distal shift of the fluid column caused by pinching the vacuum line closed is reversed before the distal shift of the fluid column caused by pinching the vacuum line moves the thrombus downstream through a blood vessel to the extent that reapplying vacuum in unable to draw at least a portion of the thrombus into the distal end of the catheter.

6 . The thrombectomy aspiration system of claim 1 wherein the controller is configured to open and close the vacuum valve and the vent valve in a predetermined sequence in which:

(a) the vacuum valve closes while the vent valve is closed;

(b) the vent valve opens after the vacuum valve has closed;

(c) the vent valve closes while the vacuum valve is closed;

(d) the vacuum valve reopens to reapply vacuum; and

wherein the timing of acts (a)-(d) of the sequence are set such that (a) the one pressure wave resulting from closing the vacuum valve and the other pressure wave resulting from opening the vent valve impart a small distal movement to the thrombus and (b) the time at which the vacuum valve reopens controls the exit volume of fluid such that reapplication of vacuum macerates at least a portion of the thrombus at the distal end of the aspiration catheter.

7 . The thrombectomy aspiration system of claim 6 wherein the timing of acts (a)-(d) of the sequence are set such that the controlled exit flow out of the distal end of the catheter is reversed before the pressure pulses move the thrombus downstream through a neurovascular vessel.

8 . The thrombectomy aspiration system of claim 7 wherein the controlled exit volume of fluid that flows out of the distal end of the catheter each cycle is approximately 0.001 ml to approximately 1.0 ml.

9 . The thrombectomy aspiration system of claim 7 wherein the controlled exit volume of fluid that flows out of the distal end of the catheter each cycle is approximately 0.1 ml to approximately 0.5 ml.

10 . A thrombectomy aspiration system, comprising:

a vacuum source;

a vacuum valve fluidically coupled to the vacuum source;

a vent valve configured to be fluidically coupled to a vent fluid source;

an aspiration catheter having a proximal end fluidically coupled the vacuum valve and the vent valve; and

a controller configured to open and close the vacuum valve and the vent valve in a predetermined sequence to change a level of vacuum at the distal end of the aspiration catheter, wherein the timing of opening and closing the vacuum valve and the vent valve in the sequence is tuned, at least in part, such that (a) an exit volume of fluid flows out of the distal end of the catheter and thereby imparts distal movement to a thrombus because of one pressure wave resulting from closing the vacuum valve and/or another pressure wave resulting from expansion of the aspiration catheter as the vent valve opens, and (b) the time at which the vacuum valve reopens controls the exit volume of fluid such that reapplication of vacuum draws at least a portion of the thrombus toward the distal end of the aspiration catheter.

11 . The thrombectomy aspiration system of claim 10 wherein the controller is configured to open and close the vacuum valve and the vent valve in a predetermined sequence in which:

(a) the vacuum valve closes while the vent valve is closed;

(b) the vent valve opens after the vacuum valve has closed;

(c) the vent valve closes while the vacuum valve is closed;

(d) the vacuum valve reopens to reapply vacuum; and

wherein reopening the vacuum valve to apply the vacuum reverses the one pressure wave resulting from closing the vacuum valve and/or the other pressure wave resulting from expansion of the catheter as the vent valve opens to thereby macerate the thrombus at the distal end of the catheter.

12 . A method of aspirating a thrombus from a blood vessel, comprising:

attaching a proximal end of an aspiration catheter to a valve system having a vacuum valve and a vent valve;

fluidically coupling a vacuum source to the vacuum valve;

fluidically coupling a vent fluid to the vent valve;

inserting a distal end of the aspiration catheter into a blood vessel such that the distal end of the catheter is proximate a thrombus; and

controlling opening and closing the vacuum valve and the vent valve in a predetermined sequence to impart a controlled amount of exit flow out from the distal end of the catheter, wherein the timing of opening and closing the vacuum valve and the vent valve in the sequence is set such that (a) an exit volume of fluid flows out of the distal end of the catheter because of one pressure wave resulting from closing the vacuum valve and/or another pressure wave resulting from subsequently opening the vent valve, and (b) the time at which the vacuum valve reopens controls the exit volume of fluid such that reapplication of vacuum draws at least a portion of the thrombus toward the distal end of the aspiration catheter.

13 . The method of claim 12 wherein the controlled volume of fluid that flows out of the distal end of the catheter each cycle is approximately 0.1 ml to approximately 0.5 ml.

14 . The method of claim 12 wherein the controlled volume of fluid that flows out of the distal end of the catheter each cycle is approximately 0.001 ml to approximately 1.0 ml.

15 . The thrombectomy aspiration system of claim 12 wherein:

the vacuum valve comprises a first solenoid-driven pinch valve and the vent valve comprises a second solenoid-driven pinch valve; and

the timing of reopening the vacuum valve is set such that a distal shift of the fluid column caused by pinching the vacuum line closed is reversed before the distal shift of the fluid column caused by pinching the vacuum line moves the thrombus downstream through a blood vessel to the extent that reapplying vacuum in unable to draw at least a portion of the thrombus into the distal end of the catheter.

16 . The method of claim 12 wherein controlling opening and closing the vacuum valve and the vent valve in a predetermined sequence comprises:

(a) closing the vacuum valve while the vent valve is closed;

(b) opening the vent valve after the vacuum valve has closed;

(c) closing the vent valve while the vacuum valve is closed;

(d) reopening the vacuum to reapply vacuum; and

wherein the timing of acts (a)-(d) of the sequence are set such (a) the one pressure wave resulting from closing the vacuum valve and/or the other pressure wave resulting from opening the vent valve impart a small distal movement to the thrombus and (b) the time at which the vacuum valve reopens controls the exit volume of fluid such that reapplication of vacuum macerates at least a portion of the thrombus at the distal end of the aspiration catheter.

17 . The method of claim 15 wherein the flow out from the distal end of the aspiration catheter is from approximately 0.001 ml to approximately 1.0 ml before reapplying the vacuum draws fluid back into the aspiration catheter.

18 . The thrombectomy aspiration system of claim 12 wherein controlling opening and closing the vacuum valve and the vent valve in a predetermined sequence comprises:

(a) closing the vacuum valve while the vent valve is closed;

(b) opening the vent valve after the vacuum valve has closed;

(c) closing the vent valve while the vacuum valve is closed;

(d) reopening the vacuum to reapply vacuum; and

wherein reopening the vacuum valve to apply the vacuum reverses the one pressure wave resulting from closing the vacuum valve and/or the other pressure wave resulting from expansion of the catheter as the vent valve opens to thereby macerate the thrombus at the distal end of the catheter.

19 . The method of claim 12 wherein inserting a distal end of the catheter into a blood vessel comprises inserting the distal end of the catheter into a neurovascular blood vessel to treat ischemic stroke.

Continuity (11)

References Cited (373)