Granted Patent B2

US 12,433,617 · App. 18/346,008 · Granted Oct 7, 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 (14)

1. A method for removing thromboembolic material, comprising:

positioning the distal end of a catheter at least proximate to thromboembolic material in a blood vessel of a person, wherein the catheter has a proximal portion, a distal end and a lumen extending from the proximal portion to the distal end;

providing a vent liquid at a pressure from above atmospheric pressure to approximately equal to body pressure of a human; and

controlling a vacuum valve fluidically coupled to a vacuum source and the catheter and a vent valve fluidically coupled to the vent liquid and the catheter according to a first predetermined sequence at a first frequency at approximately 6 Hz to approximately 16 Hz and a second predetermined sequence at a second frequency at approximately 6 Hz to 16 Hz, wherein

(a) the first frequency is different than the second frequency,

(b) the first predetermined sequence and the second predetermined sequence each have a vacuum-only state in which the vacuum valve is open and the vent valve is closed, a first off-off state following the vacuum-only state in which both the vacuum valve and the vent valve are closed, a vent-only state in which the vent valve is open and the vacuum valve is closed, and a second off-off state after the vent-only state in which both the vacuum valve and the vent valve are closed,

(c) the first off-off state lasts a predetermined period of time from 5.2 ms to 13.9 ms, and

(d) the second off-off state lasts a predetermined period of time.

2. The method of claim 1 wherein and the second off-off state is from 5.2 ms to 13.9 ms.

3. The method of claim 1 wherein the first off-off state and the second off-off state are about 10 ms.

4. The method of claim 1 wherein controlling the vacuum valve and the vent valve comprises cyclically opening and closing the vacuum valve and the vent valve to alternate between a negative pressure during a vacuum phase and a positive pressure at the distal end of the catheter during a vent phase such that an exit flow occurs at the distal end during at least a portion of the vent phase, and wherein the exit flow is less than about 0.02 ml.

5. The method of claim 1 wherein the controlling the vacuum valve and the vent valve comprises imparting an amount of momentum transfer from the fluid column in the catheter lumen in a distal direction sufficient to unstick thromboembolic material at the distal end of the catheter.

6. The method of claim 1 wherein controlling the vacuum valve and the vent valve comprises opening and closing the vacuum valve and the vent valve in a predetermined cycle adapted to at least a compliance of the catheter such that a pressure pulse from a vent phase is reversed before the thromboembolic material moves uncontrollably downstream off the distal end in the distal direction.

7. The method of claim 1 wherein controlling the vacuum valve and the vent valve comprises opening the vacuum valve for approximately 60% of each cycle and opening the vent valve for approximately 20%-25% of each cycle.

Assignments (4)

Continuity (7)

References Cited (369)