Granted Patent B1

US 12,193,702 · App. 18/658,372 · Granted Jan 14, 2025

Inventors: Jihad A. Mustapha (St Paul, MN); Gary M. Petrucci (Long Lake, MN); Albert Selden Benjamin (St Paul, MN); Ryan D. Welty (Blaine, MN)

Assignee: Cardio Flow, Inc.

A61B17/320758A61B17/3207A61B17/320725A61B2017/320766

Abstract

Claims (21)

1. A method for rotational atherectomy in a pedal artery below an ankle, comprising:

advancing a torque-transmitting coil of a rotation atherectomy device over a guidewire and into a pedal artery below an ankle so that at least one abrasive burr of a set of abrasive burrs mounted to a distal end portion of the torque-transmitting coil is proximate to a stenotic lesion within the pedal artery; and

rotating the torque-transmitting coil of the rotation atherectomy device so that the at least one abrasive burr mounted to the torque-transmitting coil abrades the stenotic lesion within the pedal artery, wherein the torque-transmitting coil has an outer coil diameter and each abrasive burr in the set of abrasive burrs has a respective burr diameter, wherein a burr-to-coil diameter ratio defined by each respective burr diameter and the outer coil diameter is about 1.3-1.7.

2. The method of claim 1 , wherein said rotating the torque-transmitting coil comprises manually actuating an actuator of a rotational atherectomy handle assembly to activate an electric motor housed with the rotational atherectomy handle assembly so that the electric motor drives rotation of the set of abrasive burrs in a rotational direction.

3. The method of claim 2 , further comprising retracting a sheath positioned over the set of abrasive burrs until the at least one abrasive burr is exposed within the pedal artery.

4. The method of claim 3 , wherein the sheath extends from the rotational atherectomy handle assembly and over the torque transmitting coil, further comprising sliding the actuator of the rotational atherectomy handle assembly along an upper face of the rotational atherectomy handle assembly to longitudinally adjust the torque-transmitting coil relative to the sheath.

5. The method of claim 4 , further comprising slidably moving the actuator of the rotational atherectomy handle to adjust the set of abrasive burrs from a proximal position in which the abrasive burrs are housed within a distal-most end of the sheath to a distal position in which the abrasive burrs extend distally from the distal-most end of the sheath.

6. The method of claim 5 , wherein the electric motor housed within the rotational atherectomy handle is prevented from rotating the torque-transmitting coil when the set of abrasive burrs is in the proximal position and housed within the distal-most end of the sheath.

7. The method of claim 6 , wherein the rotational atherectomy handle comprises a power button that is selectable to activate the electric motor, wherein the electric motor remains disengaged responsive to selection of the power button with the set of abrasive burrs in the proximal position.

8. The method of claim 2 , wherein the electric motor housed within the rotational atherectomy handle is configured to rotate the torque-transmitting coil so that the set of abrasive burrs orbits in the rotational direction opposite of a filar wind direction.

9. The method of claim 1 , wherein the rotation atherectomy device is a 4-French introducible rotational atherectomy device.

10. The method of claim 9 , wherein the set of abrasive burrs comprises three spherical abrasive burrs including a distal-most concentric abrasive burr, an intermediate eccentric abrasive burr, and a proximal-most concentric abrasive burr.

11. The method of claim 10 , wherein the distal-most concentric abrasive burr is mounted directly to a distal-most end of the torque-transmitting coil and the proximal-most concentric abrasive burr is mounted to the torque-transmitting coil at a position no greater than 0.5-inches from the distal-most end of the torque-transmitting coil.

12. The method of claim 11 , wherein a diameter of the proximal-most concentric abrasive burr is equal to the diameter of the distal-most concentric abrasive burr, and wherein the diameter of the proximal-most and distal-most concentric abrasive burrs is less than a diameter of the intermediate eccentric abrasive burr.

13. The method of claim 1 , wherein contemporaneous with selective activation to drive rotation of the set of abrasive burrs, the torque transmitting coil is selectively translatable distally and proximally along a drive shaft axis.

14. The method of claim 13 , wherein the rotational atherectomy handle comprises a power button that is selectable to activate an electric motor.

15. The method of claim 14 , wherein, responsive to selection of the power button with the set of abrasive burrs in the distal position, the electric motor activates to drive rotation of the set of abrasive burs.

16. The method of claim 1 , wherein each abrasive burr in the set of abrasive burrs has a maximum burr diameter of no greater than 1.25 mm.

17. The method of claim 1 , wherein the rotational atherectomy device further comprises a concentric tip member positioned distally of the set of abrasive burrs.

18. The method of claim 17 , wherein the concentric tip member comprises a smoother outer surface than each abrasive burr in the set of abrasive burrs.

19. The method of claim 1 , wherein the torque transmitting coil is laterally flexible.

Assignments (1)

Continuity (3)

References Cited (295)

Cited By (1)

US 12,551,206