Granted Patent B2

US 12,185,959 · App. 18/346,044 · Granted Jan 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 (31)

1. An aspiration thrombectomy system, comprising:

a body configured to house components;

a vacuum source coupled to the body;

a vacuum valve at the body and fluidically coupled to the vacuum source, wherein the vacuum valve is configured to control a vacuum applied to a catheter system;

a vent valve at the body and configured to be fluidically coupled to a vent fluid, wherein the vent valve is configured to control vent fluid applied to the catheter system; and

a controller configured to open and close the vacuum valve and the vent valve in a predetermined cycle such that when a fluid column is in the catheter system the fluid column shifts distally and proximally, wherein the controller is configured to control distal displacement of the fluid column to a specific volume liquid that exits the catheter system distally before vacuum is reapplied thereby avoiding thromboembolic material from being uncontrollably ejected further distally within the blood vessel.

2. The system of claim 1 wherein the vacuum valve is a first solenoid valve and the vent valve is a second solenoid valve.

3. The system of claim 1 wherein:

the controller is configured to cyclically open and close the vacuum valve and the vent valve in a cycle comprising a combination of a vacuum-only state in which the vacuum valve is open while the vent valve is closed, a first off-off state in which the vacuum valve is closed while the vent valve is closed, a vent-only state in which the vacuum valve is closed while the vent valve is open, and a second off-off state in which the vacuum valve is closed while the vent valve is closed; and

the cycle is repeated.

4. The system of claim 1 wherein the cycle is repeated at a frequency of 8 Hz to 12 Hz.

5. The system of claim 1 wherein the cycle is repeated at a frequency of 6 Hz to 8 Hz.

6. The system of claim 1 wherein:

the controller is configured to cyclically open and close the vacuum valve and the vent valve in a cycle comprising a combination of an off-off state in which the vacuum valve is closed while the vent valve is closed, a vacuum-only state in which the vacuum valve is open while the vent valve is closed, and a vent-only state in which the vacuum valve is closed while the vent valve is open; and

the cycle is repeated.

7. The system of claim 1 wherein the controller is configured to open and close the vacuum valve and the vent valve in a predetermined cycle adapted to at least a compliance of the catheter system such that a pressure pulse from a vent phase is reversed before the thromboembolic material moves further downstream off the distal end in the distal direction.

8. The system of claim 1 wherein:

the system further includes a vent fluid source fluidically coupled to the manifold, wherein the vent fluid source provides vent fluid at a pressure of atmospheric pressure to an elevated pressure caused by positioning the vent fluid at an elevation above the thromboembolic material; and

the controller is configured to open and close the vacuum valve and the vent valve in a cycle repeated at a frequency of 8 Hz to 16 Hz such that the change in level of vacuum each cycle is approximately 20 inHg in a time of not greater than approximately 20 ms.

9. A method for removing thromboembolic material, comprising:

activating a system for removing the thromboembolic material, the system including a body configured to house components, a vacuum source coupled to the body, a catheter system have a proximal portion coupled to the body and a distal end, a vacuum valve at the body and fluidically coupled to the vacuum source and the catheter system, and a vent valve at the body and configured to be fluidically coupled to a vent fluid and the catheter system;

positioning the distal end of a catheter system at least proximate to thromboembolic material in a blood vessel of a person; and

controlling the vacuum valve and the vent valve to operate at the body according to a predetermined cycle such that when a fluid column is in the catheter system the fluid column shifts distally and proximally, wherein the controller is configured to control distal displacement of the fluid column to a specific volume liquid that exits the catheter system distally before vacuum is reapplied thereby avoiding thromboembolic material from being uncontrollably ejected further distally within the blood vessel.

10. The method of claim 9 wherein:

the vent fluid source provides the vent fluid at a pressure at or greater than atmospheric pressure; and

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 phase and a positive pressure phase at the distal end of the catheter system during each cycle such that fluid exits the distal end of the catheter system during at least a portion of the positive pressure phase.

11. The method of claim 9 , further comprising:

cyclically opening and closing the vacuum valve and the vent valve in a cycle including a vacuum-only state in which the vacuum valve is open while the vent valve is closed, a first off-off state in which the vacuum valve is closed while the vent valve is closed, a vent-only state in which the vacuum valve is closed while the vent valve is open, and a second off-off state in which the vacuum valve is closed while the vent valve is closed; and

repeating the cycle.

12. The method of claim 11 wherein the vacuum valve is a first solenoid pinch valve and the vent valve is a second solenoid pinch valve.

13. The method of claim 9 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 further downstream off the distal end in the distal direction.

Assignments (5)

Continuity (8)

References Cited (347)