IP Library Granted Patent US 12,059,161
Granted Patent B2
US 12,059,161 · App. 16/899,514 · Granted Aug 13, 2024

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, Jr. (Miami, FL); Carlos Rivera (Cooper City, FL)
Assignee: RapidPulse, Inc.
A61B17/22A61F2/013A61M25/0075A61B2017/00022A61B2017/00154A61B2017/22079A61B2017/22082A61B2217/007A61F2/011
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Quick Facts
Patent No.
US 12,059,161
App. No.
16/899,514
Filed
Jun 11, 2020
Granted
Aug 13, 2024
Kind
B2
Art Unit
3771
USPC
606/127
Abstract

A clot removal system comprises a catheter, a vacuum source, and a controller. The catheter comprises a proximal end, a distal end, and controller operating parameters and defines a lumen configured to be filled with a liquid column having a proximal portion. The vacuum source is configured to supply vacuum. The controller is configured to carry out a control pattern of turning on and off the vacuum based upon the controller operating parameters and is configured to receive the controller operating parameters in an automatic response to the catheter being operatively connected to at least one of the vacuum source and the controller and, responsive to the connection, to carry out the control pattern to change a level of vacuum at the distal end of the catheter.

Claims (122)

1. A clot removal system, comprising:

a catheter:

comprising a proximal end, a distal end, and controller operating parameters; and

defining a lumen configured to be filled with a liquid column having a proximal portion;

a vacuum source configured to supply vacuum; and

a controller:

configured to carry out a control pattern of turning on and off the vacuum based upon the controller operating parameters; and

configured to receive the controller operating parameters in an automatic response to the catheter being operatively connected to at least one of the vacuum source and the controller and, responsive to the connection, to carry out the control pattern to change a level of vacuum at the distal end of the catheter.

2. The system according to claim 1 , wherein the controller operating parameters are stored in the catheter and are provided to the controller responsive to the connection.

3. The system according to claim 1 , wherein the catheter comprises an extension line:

having a first end connected to the catheter and a second end connected to at least one of the vacuum source and the controller; and

comprising the controller operating parameters and, responsive to the connection:

configured to provide the controller operating parameters to the controller; and

fluidically connecting the proximal end of the catheter with the vacuum source.

4. The system according to claim 3 , wherein:

the controller is part of the vacuum source; and

the controller is configured to receive the controller operating parameters in the automatic response to the catheter being operatively connected to the vacuum source.

5. The system according to claim 3 , wherein:

the controller is separate from the vacuum source; and

the controller is configured to receive the controller operating parameters in the automatic response to the catheter being operatively connected to the controller.

6. The system according to claim 3 , wherein the extension line comprises an identification subassembly including system controls for operating the aspiration thrombectomy system.

7. The system according to claim 3 , wherein one of:

the controller is part of the vacuum source and the extension line fluidically connects the proximal end of the catheter to the vacuum source; and

the controller is separate from the vacuum source and is removably coupleable to the vacuum source and the extension line fluidically connects the proximal end of the catheter to the controller.

8. The system according to claim 3 , further comprising an identification sub-assembly disposed at the connection between the catheter and the extension line.

9. The system according to claim 8 , wherein the identification sub-assembly is at least one of:

an inductive sensor and sensed part;

an RFID tag and reader;

an NFC tag and reader;

a 1-wire detection system;

a 2-wire detection configuration;

a Bluetooth low energy device;

metallic touch pads;

at least one passive resistor configuration; and

at least one hall sensor.

10. The system according to claim 8 , wherein the identification sub-assembly is at least one of:

a manual user interface in which a user communicates to the controller which controller operating parameters to use with the catheter;

a QR code and a QR code reader in which the QR code provided with the catheter communicates to the controller which controller operating parameters to use with the catheter;

a bar code and a bar code reader in which the bar code provided with the catheter communicates to the controller which controller operating parameters to use with the catheter; and

a punch-card and a punch-card reader in which the punch-card provided with the catheter communicates to the controller which controller operating parameters to use with the catheter.

11. The system according to claim 8 , wherein the identification

sub-assembly comprises a reader disposed at least at:

the vacuum source; and/or

the controller.

12. The system according to claim 3 , wherein the operative connection of at least one of the catheter and the extension line to the at least one of the vacuum source and the controller is an identification sub-assembly.

13. The system according to claim 1 , wherein:

the controller operating parameters comprise a catheter identifier; and

the controller is configured to receive the catheter identifier in the automatic response to the catheter being operatively connected to at least one of the vacuum source and the controller and, responsive to the connection, to carry out a pre-determined control pattern associated with the catheter identifier to change the level of vacuum at the distal end of the catheter.

14. The system according to claim 13 , wherein:

the controller is part of the vacuum source; and

the controller is configured to receive the catheter identifier in the automatic response to the catheter being operatively connected to the vacuum source.

15. The system according to claim 13 , wherein:

the controller is separate from the vacuum source; and

the controller is configured to receive the catheter identifier in the automatic response to the catheter being operatively connected to the controller.

16. The system according to claim 1 , wherein:

the controller operating parameters comprise a catheter identifier; and

the catheter comprises an extension line:

having a first end connected to the catheter and a second end connected to at least one of the vacuum source and the controller;

comprising the catheter identifier; and

responsive to the connection, the extension line:

is configured to provide the catheter identifier to the controller; and

fluidically connects the proximal end of the catheter with the vacuum source.

17. The system according to claim 16 , wherein:

the controller is part of the vacuum source; and

the controller is configured to receive the catheter identifier in the automatic response to the extension line being operatively connected to the vacuum source.

18. The system according to claim 16 , wherein:

the controller is separate from the vacuum source; and

the controller is configured to receive the catheter identifier in the automatic response to the extension line being operatively connected to the controller.

19. The system according to claim 1 , wherein the controller is configured to repeatedly and periodically carry out the control pattern.

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

21. The system according to claim 1 , which further comprises an identification subassembly including a sensed part configured to be operatively connected to the catheter and, responsive to sensing the sensed part, the controller carries out the control pattern.

22. The system according to claim 1 , wherein the operative connection of the catheter to the at least one of the vacuum source and the controller is an identification sub-assembly.

23. The system according to claim 1 , wherein:

the catheter comprises an extension line having a first end connected to the catheter and a second end opposite the first end; and

the operative connection of the catheter is an identification sub-assembly comprising a reader disposed at least at:

the extension line;

the vacuum source; and/or

the controller.

24. A clot removal system, comprising:

a catheter:

comprising a proximal end, a distal end, and controller operating parameters; and

defining a lumen configured to be filled with a liquid column having a proximal portion;

a vacuum source configured to supply vacuum;

a vacuum modulator configured to fluidically communicate:

with the vacuum from the vacuum source; and

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

a controller:

configured to carry out a control pattern of modulating the vacuum modulator based upon the controller operating parameters; and

configured to receive the controller operating parameters in an automatic response to the catheter being operatively connected to at least one of the vacuum modulator and the controller and, responsive to the connection, to carry out the control pattern to change a level of vacuum at the distal end of the catheter.

25. The system according to claim 24 , further comprising:

a manifold comprising the vacuum modulator and an output; and

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

26. The system according to claim 24 , wherein the controller is configured to repeatedly and periodically carry out the control pattern.

27. The system according to claim 24 , which further comprises an extension line:

operatively connected to at least one the vacuum modulator and the controller; and

fluidically connecting the proximal end of the catheter to at least one the vacuum modulator and the controller.

28. The system according to claim 24 , wherein the operative connection of the catheter to the at least one of the vacuum modulator and the controller is an identification sub-assembly.

29. A clot removal system, comprising:

a catheter:

comprising a proximal end, a distal end, and controller operating parameters; and

defining a lumen configured to be filled with a liquid column having a proximal portion;

a vacuum source 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 source; and

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

a controller:

configured to carry out a control pattern of opening and closing the vent and vacuum valves based upon the controller operating parameters; and

configured to receive the controller operating parameters in an automatic response to the catheter being operatively connected to at least one of the vent valve, the vacuum valve, the vacuum source, and the controller and, responsive to the connection, to carry out the control pattern to change a level of vacuum at the distal end of the catheter.

30. The system according to claim 29 , wherein a portion of the control pattern includes a time period where both the vent and vacuum valves are closed.

31. The system according to claim 29 , wherein the controller is configured to repeatedly and periodically carry out the control pattern with the vent and vacuum valves.

32. The system according to claim 29 , 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.

33. The system according to claim 29 , 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 control pattern of opening and closing the vent and vacuum valves at a frequency of between approximately 2 Hz and approximately 16 Hz.

34. The system according to claim 29 , which further comprises an extension line:

operatively connected to at least one of the vent valve, the vacuum valve, and the controller; and

fluidically connecting the proximal end of the catheter to at least one of the vent valve, the vacuum valve, and the controller.

35. The system according to claim 34 , wherein the operative connection of the catheter to the at least one of the vent valve, the vacuum valve, the vacuum source, and the controller is an identification sub-assembly.

Assignments (6)
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 2.0, LLC
To: SYNTHEON NEUROVASCULAR LLC
Reel/Frame 056299/0001 →
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 Jun 11, 2020
From: DEVILLE, DEREK DEE; PALMER, MATTHEW A.; BALES, WILLIAM T.; MCBRAYER, M. SEAN; PETERSEN, ERIC; CARTLEDGE, RICHARD; BALES, THOMAS O., JR.; RIVERA, CARLOS
To: SYNTHEON 2.0, LLC
Reel/Frame 052919/0732 →
Continuity (7)
Continuation 16681564 · Nov 12, 2019
Continuation PCTUS2019042546 · Jul 19, 2019
Continuation 16516232 · Jul 18, 2019
Continuation 16516232 · Jul 18, 2019
Provisional Application 62750011 · Oct 24, 2018
Provisional Application 62701086 · Jul 20, 2018
Related Publication 20200297362A1 · Sep 24, 2020
Cited By (20)
US 1,119,865 US 12,232,838 US 12,329,397 US 12,376,928 US 12,377,206 US 12,419,703 US 12,433,702 US 12,440,289 US 12,446,979 US 12,447,317 US 12,508,093 US 12,558,175 US 12,564,414 US 12,564,458 US 12,569,308 US 12,605,523 US 12,636,022 US 12,661,193 US 12,678,249 US 12,702,509