Rotational atherectomy devices and methods
Some embodiments of a rotational atherectomy device can remove (partially or completely) stenotic lesions in blood vessels by rotating one or more abrasive elements in an orbital path to abrade and breakdown the lesion. In particular implementations, multiple abrasive elements are arranged along a distal portion of a drive shaft with an improved configuration so as to facilitate both efficient navigation into smaller blood vessels below the ankle or in the heart and effective orbital paths for abrading stenotic material in such smaller vessels.
1. A rotational atherectomy system for slidable insertion through a 4-French introducer sheath, comprising:
a 4-French introducible rotational atherectomy device, comprising:
a torque-transmitting coil of one or more filars that are helically wound around in a filar wind direction from a distal end to a proximal end to define an outer coil diameter and a drive shaft axis;
a concentric tip member fixed to and extending distally from a distal-most end of the torque-transmitting coil;
a distal concentric cylindrical abrasive element fixedly mounted to an exterior of the torque-transmitting coil such that the distal-most end of the torque-transmitting coil concealed by the distal stability element and the concentric tip member; and
a series of abrasive eccentric burrs fixedly mounted to the torque-transmitting coil at a position spaced proximally from the distal concentric cylindrical abrasive element and having a maximum burr diameter of no greater than 1.25 mm such that a burr-to-coil diameter ratio defined by each respective burr diameter and the outer coil diameter is 1.7 or less, wherein the series of abrasive eccentric burrs includes a distal eccentric abrasive burr, an intermediate eccentric abrasive burr, and a proximal eccentric abrasive burr that are equally sized and mounted in an eccentric spiral arrangement along the torque-transmitting coil so that centers of mass for the distal, intermediate, and proximal abrasive eccentric burrs are offset from the drive shaft axis in different planes; and
a rotational atherectomy handle assembly coupled to a proximal end of the torque-transmitting coil and housing an electric motor configured to, responsive to user input at an actuator of the rotational atherectomy handle assembly, drive rotation of the series of abrasive burrs about the drive shaft axis in a rotational drive direction.
2. The rotational atherectomy system claim 1 , further comprising a sheath that extends from the rotational atherectomy handle assembly and over the torque transmitting coil, wherein the rotational atherectomy handle assembly is configured to longitudinally adjust the torque-transmitting coil relative to the sheath such that, in a proximal position, the series of abrasive burrs are housed within a distal-most end of the sheath.
3. The rotational atherectomy system of claim 2 , wherein responsive to distal longitudinal movement of the actuator of the rotational atherectomy handle, the series of abrasive burrs are adjusted to a distal position so as to extend distally from the distal-most end of the sheath.
4. The rotational atherectomy system of claim 3 , wherein the electric motor housed within the rotational atherectomy handle is prevented from rotating the torque-transmitting coil when the series of abrasive burrs are in the proximal position and housed within the distal-most end of the sheath.
5. The rotational atherectomy system of claim 4 , wherein when the series of abrasive burrs are adjusted to the distal position to extend distally from the distal-most end of the sheath, a switch that is housed within the rotational atherectomy handle is triggered and the electric motor is selectively activatable to drive rotation of the series of abrasive burrs.
6. The rotational atherectomy system of claim 5 , wherein when the actuator of the rotational atherectomy handle assembly is adjusted to a location proximal of a threshold position along an upper face of the rotational atherectomy handle assembly, the series of abrasive burrs are in the proximal position and housed within the distal-most end of the sheath.
7. The rotational atherectomy system of claim 6 , wherein when the actuator of the rotational atherectomy handle assembly is adjusted to a location distal of the threshold position along the upper face of the rotational atherectomy handle assembly, the series of abrasive burrs are in the distal position and extend distally from the distal-most end of the sheath.
8. The rotational atherectomy system of claim 1 , wherein the distal abrasive eccentric burr has a center of mass offset if a first plane, and the intermediate abrasive eccentric burr has a center of mass offset in a second plane that is radially spaced from the first plane at the radial spacing angle of 20 degrees to 60 degrees.
9. The rotational atherectomy system of claim 8 , wherein the proximal abrasive eccentric burr has a center of mass offset in a third plane that is radially spaced from the second plane at the radial spacing angle of 20 degrees to 60 degrees.
10. The rotational atherectomy system of claim 8 , wherein a combined radial spacing angle for all abrasive eccentric burrs in the series of abrasive eccentric burrs is less than 90 degrees.
11. The rotational atherectomy system of claim 1 , wherein each abrasive burr of the series of abrasive burrs is a metallic burr coated with diamond grit.
12. The rotational atherectomy system of claim 1 , wherein said the electric motor housed within the rotational atherectomy handle is configured to rotate the torque-transmitting coil so that the series of abrasive burrs orbit in the rotational drive direction about the drive shaft axis.
13. The rotational atherectomy system of claim 12 , wherein said filar wind direction from the distal end to the proximal end of torque-transmitting coil is opposite from the rotational drive direction urged by the electric motor housed within the rotational atherectomy handle.
14. The rotational atherectomy system of claim 1 , wherein the concentric tip member comprises a smoother outer surface than the series of eccentric abrasive burrs.
15. The rotational atherectomy system of claim 1 , wherein the sheath includes a radiopaque marker at a distal end of the sheath.
16. The rotational atherectomy system of claim 1 , wherein the torque transmitting coil is selectively translatable distally and proximally along the drive shaft axis while the electric motor drives rotation of the series of abrasive burrs.
17. The rotational atherectomy system of claim 16 , further comprising a power button positioned on the actuator of the rotational atherectomy handle assembly and being selectable to activate the electric motor.
18. The rotational atherectomy system of claim 1 , wherein all of the concentric tip member, the distal concentric cylindrical abrasive element, and the abrasive eccentric burrs are metallic components welded to the torque-transmitting coil.
19. The rotational atherectomy system of claim 18 , wherein the distal concentric cylindrical abrasive element is positioned closer to the concentric tip member than to the distal eccentric abrasive burr, the distal eccentric abrasive burr is positioned closer to the intermediate eccentric abrasive burr than to the distal concentric cylindrical abrasive element, and the proximal eccentric abrasive burr and the distal eccentric abrasive burr are spaced apart equally from the intermediate eccentric abrasive burr.
20. The rotational atherectomy system of claim 18 , wherein the concentric tip member has an outer diameter equal to the outer coil diameter of the torque-transmitting coil.
21. The rotational atherectomy system of claim 1 , wherein series of abrasive eccentric burrs consists of three equally sized spherical burrs fixedly mounted in the eccentric spiral arrangement along the torque-transmitting coil.