Granted Patent B2

US 12,245,789 · App. 17/451,885 · Granted Mar 11, 2025

Inventors: Yuki Masubuchi (Kanagawa, JP); Steve Woodard (Newark, CA); Mansour Saleki (Newark, CA)

Assignee: TERUMO KABUSHIKI KAISHA

A61B17/32075A61B17/320725A61B2017/00017A61B2017/00075A61B2017/00398A61B2017/00867A61B2017/00893

Abstract

Claims (67)

1. A device handle for cutting substances inside a body lumen, the device handle comprising:

a motor configured to impart a rotational force to a drive shaft assembly and a processor, wherein the processor is configured to:

control a driving of the drive shaft assembly at a target rotational speed in a first direction;

detect an actual rotational speed of the drive shaft assembly in the first direction;

compare the target rotational speed and the actual rotational speed of the drive shaft assembly in the first direction; and

stop the driving of the drive shaft assembly in the first direction before a completion of predetermined number of rotations in the first direction when the actual rotational speed decreases a predetermined percentage over a predetermined time frame.

2. The device handle of claim 1 , wherein the processor is configured to:

change a rotational direction of the drive shaft assembly from the first direction to a second direction.

3. The device handle of claim 2 , wherein the processor is configured to:

monitor the actual rotational speed of the drive shaft assembly in the first and the second directions; and

update a predetermined torque limitation to achieve the target rotational speed for the drive shaft assembly in a same direction as the rotational speed of the drive shaft assembly obtained during the monitoring of the actual rotational speed.

4. The device handle of claim 3 , wherein the processor is configured to change the rotational direction of the drive shaft assembly by:

reducing the torque applied to the drive shaft assembly to zero after a predetermined number of rotations in the first direction;

allowing the drive shaft assembly to come to a stop; and

stopping a rotation of the drive shaft assembly for a predetermined time before rotating the drive shaft assembly in the second direction.

5. The device handle of claim 4 , wherein the processor is configured to:

control the rotation of the drive shaft assembly in the second direction for the predetermined number of rotations in the second direction;

reduce the torque applied to the drive shaft assembly to zero after the predetermined number of rotations in the second direction;

allow the drive shaft assembly to come to a stop; and

stop the rotation of the drive shaft assembly for the predetermined time before rotating the drive shaft assembly in the first direction.

6. The device handle of claim 5 , wherein the processor is configured to:

control repeating the rotation of the drive shaft assembly in the first and the second directions.

7. The device handle of claim 1 , further comprising:

an agitator, the drive shaft assembly configured to rotate the agitator, and wherein the agitator is configured to cut a stenosed site inside a body lumen.

8. The device handle of claim 1 , wherein the target rotational speed is up to 3200 revolutions per minute (rpm).

9. The device handle of claim 1 , wherein the rotational direction in each of the first and the second directions at the target rotational speed is eight (8) revolutions of the drive shaft assembly.

10. The device handle of claim 1 , wherein the processor is configured to:

stop the driving of the drive shaft assembly in the first direction before the completion of the predetermined number of rotations in the first direction occurs when the actual rotational speed decreases the predetermined percentage over the predetermined time frame.

11. A method for detecting torque of a drive shaft assembly under various rotational loads, the method comprising:

driving the drive shaft assembly at a target rotational speed in a first direction;

detecting an actual rotational speed of the drive shaft assembly in the first direction;

comparing the target rotational speed and the actual rotational speed of the drive shaft assembly in the first direction; and

stopping the driving of the drive shaft assembly in the first direction before a completion of predetermined number of rotations in the first direction when the actual rotational speed decreases a predetermined value over a predetermined time frame.

12. The method of claim 11 , further comprising:

changing a rotational direction of the drive shaft assembly from the first direction to a second direction.

13. The method of claim 12 , further comprising:

monitoring the actual rotational speed of the drive shaft assembly in the first and the second directions; and

updating a predetermined torque limitation to achieve the target rotational speed for the drive shaft assembly in a same direction as the rotational speed of the drive shaft assembly obtained during the monitoring of the actual rotational speed.

14. The method of claim 12 , wherein the changing of the rotational direction of the drive shaft assembly comprises:

reducing the torque applied to the drive shaft assembly to zero after a predetermined number of rotations in the first direction;

allowing the drive shaft assembly to come to a stop; and

stopping the rotation of the drive shaft assembly for a predetermined time before rotating the drive shaft assembly in the second direction.

15. The method of claim 14 , further comprising:

rotating the drive shaft assembly in the second direction for the predetermined number of rotations in the second direction;

reducing the torque applied to the drive shaft assembly to zero after the predetermined number of rotations in the second direction;

allowing the drive shaft assembly to come to a stop;

stopping the rotation of the drive shaft assembly for the predetermined time before rotating the drive shaft assembly in the first direction; and

repeating the rotation of the drive shaft assembly in the first and the second directions.

16. The method of claim 15 , further comprising:

averaging the actual rotational speed of the drive shaft assembly in the first and the second directions during the detection of the actual rotational speed to address for variations in the detected actual rotational speed as a result of noise.

17. The method of claim 11 , further comprising:

attaching a motor to the drive shaft assembly with an agitator;

inserting the agitator into a body lumen;

arranging the agitator on a distal side of a stenosed site in the body lumen; and

cutting the stenosed site inside the body lumen with the agitator.

18. The method of claim 11 , wherein the stopping the driving of the drive shaft assembly in the first direction before the completion of the predetermined number of rotations in the first direction occurs when the actual rotational speed decreases the predetermined value comprising a predetermined percentage over the predetermined time frame.

19. A method for detecting torque of a drive shaft assembly connected to an agitator and a catheter assembly, the method comprising:

inserting the catheter assembly into a body lumen;

arranging the agitator on a distal side of a stenosed site in the body lumen;

driving the drive shaft assembly at a target rotational speed in a first direction and causing the catheter assembly and agitator to rotate;

detecting an actual rotational speed of the drive shaft assembly in the first direction;

comparing the target rotational speed and the actual rotational speed of the drive shaft assembly in the first direction; and

stopping the driving of the drive shaft assembly in the first direction before a completion of predetermined number of rotations in the first direction when the actual rotational speed decreases a predetermined value over a predetermined time frame.

20. The method of claim 19 , further comprising:

changing a rotational direction of the drive shaft assembly from the first direction to a second direction;

monitoring the actual rotational speed of the drive shaft assembly in the first and the second directions; and

updating a predetermined torque limitation to achieve the target rotational speed for the drive shaft assembly in a same direction as the rotational speed of the drive shaft assembly obtained during the monitoring of the actual rotational speed.

Assignments (1)

Continuity (2)

References Cited (23)