Thrombectomy systems and methods for controlled clot aspiration

Patent metadata

Field	Value
Publication number	US-12239777-B2
Application number	US-202418658292-A
Country	US
Kind code	B2
Filing date	May 8, 2024
Priority date	Jul 24, 2018
Publication date	Mar 4, 2025
Grant date	Mar 4, 2025

Abstract

A thrombectomy system includes a catheter having a proximal end and a distal end, a valve in fluid communication with the catheter, and a cutting instrument associated with the distal end of the catheter. The cutting instrument may be configured for axial and/or rotational motion. A controller of the system may be configured to detect operational parameters of the cutting instrument. The controller may determine whether the cutting instrument is engaging with occlusive material based on the detected operational parameters. The controller may operate the valve in one or more operating modes to alter a level of pressure in the catheter based on whether the cutting instrument is engaging with the occlusive material.

First claim

What is claimed is:

1. A thrombectomy system, comprising:
a catheter having a proximal end and a distal end, wherein the catheter comprises a lumen configured to accommodate fluid;
a first valve, wherein the first valve is in fluid communication with the catheter, and wherein the first valve is configured to operate in a plurality of operating modes, wherein one or more of the operating modes is configured to alter a level of pressure in the catheter;
a cutting instrument at the distal end of the catheter, wherein the cutting instrument is configured for one or more motions comprising one or more of axial motion and rotational motion;
a first sensor associated with the cutting instrument; and
a controller configured to:
detect, via the first sensor, one or more operational parameters associated with the cutting instrument;
determine, based on one or more of the detected operational parameters associated with the cutting instrument at the distal end of the catheter, a current flow state indicating whether the distal end of the catheter is engaging with occlusive material, wherein the current flow state is determined via a machine learning algorithm trained on training data to predict one or more flow states associated with the catheter based on one or more of the operational parameters associated with the cutting instrument at the distal end of the catheter;
operate, based on a determination that the current flow state indicates that the distal end of the catheter is engaging with the occlusive material, the first valve in a first operating mode of the plurality of operating modes to alter the level of pressure in the catheter, and
operate, based on a determination that the current flow state indicates that the distal end of the catheter is not engaging with the occlusive material, the first valve in a second operating mode of the plurality of operating modes.

2. The thrombectomy system of claim 1 , wherein the first operating mode is configured to alter the level of pressure by moving at least a portion of the occlusive material through the lumen towards a proximal region of the catheter.

3. The thrombectomy system of claim 1 , wherein the first valve is configured to allow fluid communication between the distal end of the catheter and an aspiration source.

4. The thrombectomy system of claim 3 , wherein the first operating mode is configured to remove fluid from the catheter.

5. The thrombectomy system of claim 4 , wherein the second operating mode is configured to stop the removal of fluid from the catheter associated with the first operating mode.

6. The thrombectomy system of claim 1 , wherein a first set of the operational parameters associated with the cutting instrument comprise one or more of (i) one or more torque levels, (ii) one or more rotational rates, (iii) one or more motor current levels, (iv) a rotational direction, or (v) a change of a rotational direction.

7. The thrombectomy system of claim 1 , wherein a second set of the operational parameters associated with the cutting instrument comprise one or more of (i) one or more axial positions, (ii) one or more axial motion rates, (iii) one or more axial motion acceleration levels, (iv) one or more axial motion force levels, or (v) one or more motor torque levels associated with the axial motion.

8. The thrombectomy system of claim 1 , wherein the cutting instrument is configured to distally advance outside of the lumen of the catheter.

9. The thrombectomy system of claim 1 , wherein the cutting instrument is configured to proximally retract inside of the lumen of the catheter.

10. The thrombectomy system of claim 1 , wherein the axial motion comprises a reciprocal axial motion.

11. The thrombectomy system of claim 1 , wherein the rotational motion comprises a rotationally oscillating motion.

12. The thrombectomy system of claim 1 , further comprising at least one motor operatively coupled with the cutting instrument, wherein the at least one motor is configured to operate the cutting instrument based on one or more of the rotational motion and the axial motion.

13. The thrombectomy system of claim 1 , wherein the cutting instrument comprises a spiral body having one or more helical structures.

14. The thrombectomy system of claim 13 , wherein the cutting instrument is configured to fragment the occlusive material, and wherein the fragmenting of the occlusive material is confined within the lumen of the catheter based at least in part on one or more of the helical structures of the cutting instrument and the first operating mode configured to alter the level of pressure.

15. The thrombectomy system of claim 1 , wherein the cutting instrument comprises one or more of a rounded element and a macerating portion.

16. The thrombectomy system of claim 1 , further comprising a second valve in fluid communication with the catheter, wherein the second valve is configured to control an introduction of a fluid medium into the catheter via one or more portions of a set of connection tubing.

17. The thrombectomy system of claim 16 , further comprising one or more pressure sensors associated with one or more of the connection tubing and the catheter.

18. A thrombectomy method for removal of occlusive material from a body passageway, comprising:
positioning a cutting instrument within the body passageway, wherein the cutting instrument is at a distal end of a catheter of a thrombectomy system, and wherein the cutting instrument is configured for one or more motions comprising one or more of axial motion and rotational motion;
detecting, via a first sensor associated with the cutting instrument, one or more operational parameters associated with the cutting instrument;
determining, by a controller, based on one or more of the detected operational parameters associated with the at the distal end of the catheter, a current flow state indicating whether the distal end of the catheter is engaging with the occlusive material, wherein the current flow state is determined via a machine learning algorithm trained on training data to predict one or more flow states associated with the catheter based on one or more of the operational parameters associated with the cutting instrument at the distal end of the catheter;
operating, by the controller, based on a determination that the current flow state indicates that the distal end of the catheter is engaging with the occlusive material, a first valve of the thrombectomy system in a first operating mode of a plurality of operating modes to alter a level of pressure in the catheter, and
operating, by the controller, based on a determination that the current flow state indicates that the distal end of the catheter is not engaging with the occlusive material, the first valve in a second operating mode of the plurality of operating modes.

19. The method of claim 18 , wherein the first operating mode is configured to alter the level of pressure to remove fluid from the catheter.

20. The method of claim 18 , wherein the second operating mode is configured to stop the removal of fluid from the catheter associated with the first operating mode.

Assignees

• Penumbra Inc

Inventors

• Su Bo-Yu
• Verma Vinita
• Teigen Scott
• Loisel Steven
• Pons Stephen
• Tompkins Ben

Classifications

• A61B2017/00123

  and automatic shutdown · CPC title

• A61B2017/00075

  Motion · CPC title

• A61B2017/320775

  Morcellators, impeller or propeller like means · CPC title

• 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