Apparatus and methods for controlled clot aspiration

Patent metadata

Field	Value
Publication number	US-11944328-B2
Application number	US-202017010737-A
Country	US
Kind code	B2
Filing date	Sep 2, 2020
Priority date	Jul 24, 2018
Publication date	Apr 2, 2024
Grant date	Apr 2, 2024

Abstract

A vacuum aspiration control system for use with a vacuum source and an aspiration catheter includes a connecting tube configured to connect the vacuum source with a lumen of an aspiration catheter. An on-off valve is operatively coupled to the connecting tube, and a sensing unit is configured to detect flow within the connecting tube and provide a signal representative of flow. A controller receives the signal to decide whether to open or close the valve. The controller may automatically close the valve to stop flow when flow through the connecting tube is unrestricted, or according to a predetermined timing sequence. The controller can further periodically open a closed valve to determine whether flow has entered an acceptable range. The controller can still further engage pulsed aspiration with a pressure manipulation assembly when flow is restricted or occluded.

First claim

The invention claimed is:

1. A dynamic aspiration system for use with a vacuum source, a pressure source, and an aspiration catheter, the system comprising:
a connecting tube configured to place the vacuum source, the pressure source, and the aspiration catheter in fluid communication;
a first controllable valve configured to control a level of negative pressure in the connecting tube provided by the vacuum source;
a second controllable valve configured to control a level of positive pressure in the connecting tube provided by the pressure source;
one or more pressure sensors configured to detect one or more pressure sensor readings associated with a flow state within the aspiration catheter or the connecting tube; and
a controller configured to:
modulate one or more of the controllable valves in a first pressure pulse protocol of a plurality of pressure pulse protocols each comprising one or more pressure pulses, wherein one or more of the pressure pulses of the first pressure pulse protocol generate one or more pressure differentials within the aspiration catheter or the connecting tube;
determine, for each pressure pulse of the first pressure pulse protocol, a degree of success corresponding to a change in a flow rate in the aspiration catheter or the connecting tube responsive to the pressure pulse; and
modulate one or more of the controllable valves in a second pressure pulse protocol of the plurality of pressure pulse protocols, wherein the second pressure pulse protocol is determined based at least in part on the degrees of success determined for the one or more pressure pulses of the first pressure pulse protocol.

2. The dynamic aspiration system of claim 1 ,
wherein the flow state within the aspiration catheter or the connecting tube is one of a plurality of flow states comprising (1) a restricted flow state, (2) an unrestricted flow state, (3) a clogged flow state, or (4) a partially clogged flow state.

3. The dynamic aspiration system of claim 2 , wherein the pressure differentials increase in magnitude while the flow state is a clogged flow state or a partially clogged flow state.

4. The dynamic aspiration system of claim 2 , wherein a magnitude of the pressure differentials is held constant when the flow state is a restricted flow state.

5. The dynamic aspiration system of claim 2 , wherein the controller modulates the one or more of the controllable valves in the first pressure pulse protocol based on a current flow state corresponding to one of the plurality of flow states.

6. The dynamic aspiration system of claim 1 , wherein the opening the second controllable valve increases a pressure within the aspiration catheter or the connecting tube.

7. The dynamic aspiration system of claim 6 , wherein the opening of the second controllable valve increases a pressure at a distal tip of the aspiration catheter.

8. The dynamic aspiration system of claim 6 , wherein the pressure source has a pressure higher than a pressure of the vacuum source.

9. The dynamic aspiration system of claim 1 , wherein the connecting tube is linear in an unconstrained configuration, has a length, and includes a first end configured to connect to the vacuum source and a second end configured to connect to the aspiration catheter.

10. The dynamic aspiration system of claim 9 , including a three-way joint configured to place the pressure source in fluid communication with the connecting.

11. The dynamic aspiration system of claim 10 , wherein the connecting tube provides a common conduit for the vacuum source and the pressure source.

12. The dynamic aspiration system of claim 10 , wherein the three-way joint is located proximate to the second end.

13. The dynamic aspiration system of claim 10 , wherein the three-way joint is a T-joint, a Y-joint, or an angled joint.

14. The dynamic aspiration system of claim 10 , wherein the three-way joint functions as a hemostatic valve or is incorporated into a hemostatic valve.

15. The dynamic aspiration system of claim 10 , wherein the three-way joint includes an angled injection tube that directs fluid from the pressure source towards the second end of the connecting tube.

16. The dynamic aspiration system of claim 15 , wherein the angled injection tube extends from the three-way joint into a lumen of the aspiration catheter.

17. The dynamic aspiration system of claim 15 , wherein the angled injection tube extends proximate to a distal end of the aspiration catheter.

18. The dynamic aspiration system of claim 10 , wherein the three-way joint is angled to direct fluid from the pressure source towards the second end of the connecting tube.

19. The dynamic aspiration system of claim 10 , wherein the first controllable valve and the second controllable valve are comprised of a single gate valve at the three-way joint, wherein the gate valve pivots to alternate between restricting the vacuum source and the pressure source.

20. The dynamic aspiration system of claim 10 , wherein the three-way joint is connected to a second three-way joint, wherein the second three-way joint is a T-joint, a Y-joint, or an angled joint.

21. The dynamic aspiration system of claim 20 , wherein the second three-way joint is configured for attachment to the pressure source and a pressure chamber.

22. The dynamic aspiration system of claims 21 , including a pump configured to transfer fluid from the pressure source to the pressure chamber, wherein the pressure chamber becomes pressurized based on selective operation of the pump.

23. The dynamic aspiration system of claim 1 , wherein the first controllable valve is in fluid communication with the vacuum source and the connecting tube and the second controllable valve is in fluid communication with the pressure source and the connecting tube, whereby the controllable valves control a level of pressure provided to the aspiration catheter or the connecting tube.

24. The dynamic aspiration system of claim 1 , wherein a frequency and an amplitude of one or more of the pressure differentials is selected from a library of pressure pulses.

25. The dynamic aspiration system of claim 24 , wherein the controller cycles through the library of pressure pulses, and then repeats one or more pressure pulses that resulted in increased flow.

26. A dynamic aspiration system for use with a vacuum source, a pressure chamber, and an aspiration catheter, the system comprising:
a connecting tube configured to place the vacuum source, the pressure chamber, and the aspiration catheter in fluid communication;
a first controllable valve configured to control a level of negative pressure in the connecting tube provided by the vacuum source;
one or more pressure sensors configured to detect one or more pressure sensor readings associated with a flow state within the aspiration catheter or the connecting tube; and
a controller configured to:
modulate the the first controllable valve and actuate a piston in the pressure chamber in a first pressure pulse protocol of a plurality of pressure pulse protocols each comprising one or more pressure pulses, wherein one or more of the pressure pulses of the first pressure pulse protocol generate one or more pressure differentials in the aspiration catheter or the connecting tube;
determine, for each pressure pulse of the first pressure pulse protocol, a degree of success corresponding to a change in a flow rate in the aspiration catheter or t

Assignees

• Penumbra Inc

Inventors

• Teigen Scott
• Loisel Steven
• Pons Stephen
• Tompkins Ben

Classifications

• A61B17/22 Primary

  Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for · CPC title

• A61M1/75

  Intermittent or pulsating suction (A61M1/63, A61M1/772 take precedence) · CPC title

• A61M1/76

  Handpieces (specially for suction-irrigation A61M1/774, aspiration tips A61M1/84) · CPC title

• A61M1/77

  Suction-irrigation systems (aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463) · CPC title

• A61M1/774

  Handpieces specially adapted for providing suction as well as irrigation, either simultaneously or independently · CPC title