Apparatus and methods for controlled clot aspiration

Patent metadata

Field	Value
Publication number	US-12408933-B2
Application number	US-202318469445-A
Country	US
Kind code	B2
Filing date	Sep 18, 2023
Priority date	Jul 24, 2018
Publication date	Sep 9, 2025
Grant date	Sep 9, 2025

Abstract

A vacuum aspiration control system for use with a vacuum source and an aspiration catheter includes a connection tubing configured to act as a fluid conduit between the vacuum source and the aspiration catheter. A controllable valve is configured to control a level of vacuum in the connection tubing provided by the vacuum source, and one or more pressure sensors are associated with the connection tubing. A controller is configured to periodically sample flow when the current flow state is unrestricted, utilize an artificial neural network to classify a flow state for the sampled flow, close the controllable valve if the flow state for the sampled flow is classified as unrestricted, and hold the controllable valve open if the flow state for the sampled flow is classified as restricted or obstructed.

First claim

The invention claimed is:

1. A vacuum aspiration control system for use with a vacuum source and an aspiration catheter, wherein the vacuum aspiration control system comprises:
connection tubing configured to act as a fluid conduit between the vacuum source and the aspiration catheter;
a controllable valve configured to control a level of vacuum in the connection tubing provided by the vacuum source;
one or more pressure sensors associated with the connection tubing; and
a controller configured to utilize an artificial neural network to classify a flow state in the connection tubing based on one or more pressure readings received from the one or more pressure sensors, wherein the controller is further configured to:
responsive to a current flow state being classified as unrestricted, periodically open the controllable valve for a time interval to sample flow;
utilize the artificial neural network to classify the flow state for the sampled flow;
close the controllable valve if the flow state for the sampled flow is classified as unrestricted; and
hold the controllable valve open if the flow state for the sampled flow is classified as restricted or obstructed, wherein the controller is configured to hold the controllable valve open until a subsequent flow state is classified as unrestricted.

2. The vacuum aspiration control system of claim 1 , wherein the controller includes a sampling delay between the current flow state being classified as unrestricted and opening the controllable valve to sample flow.

3. The vacuum aspiration control system of claim 2 , wherein the sampling delay progressively changes in duration when the current flow state continues to be classified as unrestricted.

4. The vacuum aspiration control system of claim 3 , wherein the sampling delay progressively changes in duration by incrementally increasing in duration.

5. The vacuum aspiration control system of claim 1 , wherein the flow being sampled and a determination of whether to close the controllable valve or hold open the controllable valve occurs within a millisecond time frame.

6. The vacuum aspiration control system of claim 1 , wherein the connection tubing is linear in an unconstrained configuration, wherein a first end of the connection tubing is configured to be attached to the vacuum source, and wherein a second end of the connection tubing is configured to be attached to the aspiration catheter.

7. The vacuum aspiration control system of claim 1 , wherein classifying the flow state is further based on one or more readings received from one or more of differential pressure sensors, magnetic flow sensors, acoustic flow sensors, optical flow sensors, thermal flow sensors, and sensors configured to detect circumferential expansion or contraction of the connection tubing.

8. The vacuum aspiration control system of claim 1 , wherein the controllable valve comprises a pinch valve or an angle valve.

9. The vacuum aspiration control system of claim 1 , wherein the controllable valve is configured to be manually opened by a user, and wherein the controller is configured to close the controllable valve responsive to the subsequent flow state being classified as unrestricted.

10. The vacuum aspiration control system of claim 9 , further comprising a manual switch, wherein the controllable valve is configured to be manually opened by the user via the manual switch.

11. The vacuum aspiration control system of claim 1 , further comprising a base unit comprising the controllable valve and the controller.

12. The vacuum aspiration control system of claim 11 , further comprising an external unit, wherein the connection tubing has a proximal end associated with the vacuum source and a distal end associated with the aspiration catheter, and wherein the external unit is associated with a portion of the connection tubing between the distal end and the proximal end.

13. The vacuum aspiration control system of claim 12 , wherein the external unit comprises at least a first pressure sensor of the one or more pressure sensors.

14. The vacuum aspiration control system of claim 13 , wherein the base unit comprises at least a second pressure sensor of the one or more pressure sensors, and wherein the controller is configured to determine a differential pressure based on pressure readings received from the first and second pressure sensors.

15. The vacuum aspiration control system of claim 1 , wherein the pressure readings received from one or more of the pressure sensors are analyzed by the controller to determine one or more local extrema based on one or more discrete portions of a data set, the local extrema comprising one or more of a local minimum pressure reading and a local maximum pressure reading.

16. The vacuum aspiration control system of claim 15 , wherein the local extrema are compared by the controller to one or more global extrema of the data set, the global extrema comprising one or more of a global minimum pressure reading and a global maximum pressure reading.

17. The vacuum aspiration control system of claim 15 , wherein one or more of the discrete portions of the data set are analyzed by the controller to determine one or more of a mean flow rate and a standard deviation of a flow rate associated with the connection tubing.

18. The vacuum aspiration control system of claim 1 , wherein the artificial neural network uses a multinomial logistic regression algorithm to classify the flow state for the sampled flow.

Assignees

• Penumbra Inc

Inventors

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

Classifications

• A61M2205/3344

  Measuring or controlling pressure at the body treatment site · CPC title

• A61B17/00

  Surgical instruments, devices or methods (A61B18/00 takes precedence; dental tools A61C3/00; eye surgery A61F9/007; ear surgery A61F11/20) · CPC title

• A61M1/75

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

• A61M1/774

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

• A61B17/32037

  for removing obstructions from inner organs or blood vessels, e.g. for atherectomy · CPC title