IP Library Granted Patent US 10,722,253
Granted Patent B2
US 10,722,253 · App. 16/681,564 · Granted Jul 28, 2020

Aspiration thrombectomy system and methods for thrombus removal with aspiration catheter

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 (Miami, FL); Carlos Rivera (Cooper City, FL)
Assignee: Syntheon 2.0, LLC
A61B17/22A61F2/013A61M25/0075A61B2017/00022A61B2017/22079A61B2017/22082A61B2217/007A61F2/011
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Quick Facts
Patent No.
US 10,722,253
App. No.
16/681,564
Filed
Nov 12, 2019
Granted
Jul 28, 2020
Kind
B2
Art Unit
3771
USPC
606/127
Abstract

A clot removal system includes a catheter having proximal and distal ends and defining a lumen configured to be filled with a liquid column having a proximal portion, a vacuum pump supplying vacuum, a vent container holding vent liquid, a vent valve configured to fluidically communicate with the vent liquid and with the proximal portion of the liquid column at the proximal end of the catheter, a vacuum valve configured to fluidically communicate with the vacuum and with the proximal portion of the liquid column at the proximal end of the catheter, and a controller configured to carry out a pre-determined pattern of opening and closing the vent and vacuum valves to change a level of vacuum at the distal end and, while changing the level of vacuum at the distal end, to substantially prevent forward flow of the liquid at a distal end of the liquid column.

Claims (54)

1. A clot removal system, comprising:

a catheter having a proximal end and a distal end and defining a lumen configured to be filled with a liquid column having a proximal portion;

a vacuum pump configured to supply vacuum;

a vent container holding a vent liquid;

a vent valve configured to fluidically communicate:

with the vent liquid in the vent container; and

with the proximal portion of the liquid column at the proximal end of the catheter;

a vacuum valve configured to fluidically communicate:

with the vacuum from the vacuum pump; and

with the proximal portion of the liquid column at the proximal end of the catheter; and

a controller configured to carry out a pre-determined pattern of opening and closing the vent and vacuum valves to change a level of vacuum at the distal end and, while changing the level of vacuum at the distal end, to substantially prevent forward flow of liquid at a distal end of the liquid column.

2. The system according to claim 1 , wherein the liquid at the distal end of the liquid column is one or more of albumin, d5W water, normal saline, half-normal saline, lactated Ringer's solution, and blood, and mixtures thereof.

3. The system according to claim 1 , further comprising:

a manifold comprising the vent valve, the vacuum valve, and an output; and

an extension line fluidically connecting the proximal end of the catheter to the output of the manifold.

4. The system according to claim 1 , wherein a portion of the pre-determined pattern includes a time period where both the vent and vacuum valves are closed.

5. The system according to claim 4 , wherein the controller is configured to open and close the vent and vacuum valves in a repeated cycle comprising a double-closed state in which both the vent and vacuum valves are closed.

6. The system according to claim 5 , wherein a time of the double-closed state is no greater than 30 ms.

7. The system according to claim 1 , wherein the controller is configured to open and close the vent and vacuum valves in a repeated cycle comprising a vent-only state in which the vacuum valve is closed and the vent valve is open, and a time of the vent-only state is no greater than 50 ms.

8. The system according to claim 1 , wherein the controller is configured to repeatedly and periodically carry out the pre-determined pattern.

9. The system according to claim 1 , wherein the controller is configured to selectively open and close the vent and vacuum valves in a repeated cycle comprising:

a vacuum-only state in which the vacuum valve is open and the vent valve is closed;

a first double-closed state in which the vacuum valve is closed and the vent valve is closed;

a vent-only state in which the vacuum valve is closed and the vent valve is open; and

a second double-closed state in which the vacuum valve is closed and the vent valve is closed.

10. The system according to claim 1 , wherein the controller is configured to selectively open and close the vent and vacuum valves in a repeated cycle comprising a vacuum-only state in which the vacuum valve is open and the vent valve is closed, followed by a first double-closed state in which the vacuum valve is closed and the vent valve is closed and a time of the first double-closed state is no greater than 30 ms, followed by a vent-only state in which the vacuum valve is closed and the vent valve is open, followed by a second double-closed state in which the vacuum valve is closed and the vent valve is closed.

11. The system according to claim 9 , wherein a time between an opening of the vent valve and a closing of the vent valve is between approximately 10 ms and approximately 50 ms.

12. The system according to claim 9 , wherein a frequency of the cycle is between approximately 6 Hz and approximately 16 Hz.

13. The system according to claim 9 , wherein a frequency of the cycle is between approximately 8 Hz and 12 Hz.

14. The system according to claim 1 , wherein the change in the level of vacuum at the distal end is one of:

greater than approximately 15 inHg and occurs in no greater than approximately 50 ms;

greater than approximately 20 inHg and occurs in no greater than approximately 30 ms; and

greater than approximately 25 inHg and occurs in no greater than approximately 20 ms.

15. The system according to claim 1 , wherein:

the lumen has a diameter of between approximately 0.038″ and approximately 0.106″; and

the controller is configured to repeatedly and periodically carry out the pre-determined pattern of opening and closing the vent and vacuum valves at a frequency of between 2 and 16 Hz.

16. The system according to claim 1 , wherein:

the lumen has an internal diameter of between approximately 0.068″ and approximately 0.088″; and

the controller is configured to repeatedly and periodically carry out the pre-determined pattern of opening and closing the vent and vacuum valves at a frequency of between 6 and 12 Hz.

17. The system according to claim 1 , wherein the controller is configured to open and close the vent and vacuum valves in a repeated cycle of the pre-determined pattern and prevent forward flow of the liquid column out from the distal end during each cycle by regulating timing of the vent valve.

18. The system according to claim 1 , wherein the controller is configured to open and close the vacuum valve and the vent valve in a repeated cycle of the pre-determined pattern to retain a level of pressure at the distal end at less than physiological pressure.

19. The system according to claim 1 , wherein the controller is one of a mechanical valve controller and an electronic valve controller.

20. The system according to claim 1 , which further comprises a shaft and the vent and vacuum valves are cam-driven valves with respective cams mounted together on the shaft.

21. A clot removal system, comprising:

a catheter having a proximal end and a distal end and defining a lumen configured to be filled with a liquid column having a proximal portion;

a vacuum pump configured to supply vacuum;

a vent liquid container holding a vent liquid;

a vent valve configured to fluidically communicate:

with the vent liquid in the liquid container; and

with the proximal portion of the liquid column at the proximal end of the catheter;

a vacuum valve configured to fluidically communicate:

with the vacuum from the vacuum pump; and

with the proximal portion of the liquid column at the proximal end of the catheter; and

a controller configured to carry out a pre-determined cycle of opening and closing the vent and vacuum valves to change a level of vacuum at the distal end and, during each cycle, to substantially prevent forward flow of liquid at the distal end of the liquid column.

Assignments (5)
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNOR'S STATE OF INCORPORATION IN THE ASSIGNMENT DOCUMENT PREVIOUSLY RECORDED AT REEL: 056299 FRAME: 0002. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT . Recorded Dec 23, 2021
From: SYNTHEON 2.0, LLC
To: SYNTHEON NEUROVASCULAR LLC
Reel/Frame 058569/0338 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 29, 2021
From: SYNTHEON 2.0, LLC
To: RAPIDPULSE, INC.
Reel/Frame 056709/0132 →
CHANGE OF NAME Recorded Jun 29, 2021
From: PULSEON, INC.
To: RAPIDPULSE, INC.
Reel/Frame 056713/0483 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 20, 2021
From: SYNTHEON NEUROVASCULAR LLC
To: PULSEON, INC.
Reel/Frame 056299/0016 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 21, 2019
From: DEVILLE, DEREK DEE; PALMER, MATTHEW A.; BALES, WILLIAM T.; MCBRAYER, M. SEAN; PETERSEN, ERIC; CARTLEDGE, RICHARD; BALES, THOMAS O.; RIVERA, CARLOS
To: SYNTHEON 2.0, LLC
Reel/Frame 051072/0981 →
Continuity (6)
Continuation 16516232 · Jul 18, 2019
Continuation PCTUS2019042546 · Jul 19, 2019
Continuation 16516232 · Jul 18, 2019
Provisional Application 62701086 · Jul 20, 2018
Provisional Application 62750011 · Oct 24, 2018
Related Publication 20200093503A1 · Mar 26, 2020
Cited By (61)
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