Rotational atherectomy segmented abrading head and method to improve abrading efficiency
View Patent ↗The invention provides a rotational atherectomy system, device and method having, in various embodiments, a flexible, elongated, rotatable drive shaft comprising an eccentric abrading head comprising at least one eccentric abrading cylindrical segments attached to the drive shaft and in spaced proximity with proximal and a distal conical segments. Each individual abrading segment, comprises a first tissue removing surface, typically an abrasive coating on the outer surface, that is designed to abrade calcified, hard tissue and abrasive coating on the leading and trailing surfaces designed to abrade non-calcified, soft tissue. Each abrading segment, as well as the abrading head comprising the collective segments, has a center of mass spaced radially from the rotational axis of the drive shaft, facilitating the ability of the device to open the stenotic lesion to a diameter larger than the outer diameter of the enlarged abrading head when operated at high speeds.
1. A high-speed rotational atherectomy device for opening a stenosis in an artery having a given diameter, comprising:
a guide wire having a maximum diameter less than the diameter of the artery;
a flexible elongated, rotatable drive shaft advanceable over the guide wire, the drive shaft having a rotational axis;
an eccentric proximal segment defining a drive shaft lumen therethrough, wherein the proximal segment is mounted on the drive shaft;
at least one eccentric cylindrical segment separate from the eccentric proximal segment, the at least one eccentric cylindrical segment defining a drive shaft lumen therethrough, wherein the at least one eccentric cylindrical segment is mounted distally and separately from the proximal segment on the drive shaft, wherein the at least one eccentric cylindrical segment and the proximal segment are spaced apart along the drive shaft by a first flexibility gap;
an eccentric distal segment separate from the at least one eccentric cylindrical segment, the distal segment defining a drive shaft lumen therethrough, wherein the distal segment is mounted distally and separately from the at least one eccentric cylindrical segment on the drive shaft, wherein the at least one eccentric cylindrical segment and the distal segment are spaced apart along the drive shaft by a second flexibility gap.
2. The rotational atherectomy device of claim 1 , wherein the proximal segment comprises a proximal conical section.
3. The rotational atherectomy device of claim 2 , wherein the proximal segment further comprises a proximal cylindrical section.
4. The rotational atherectomy device of claim 2 , wherein the distal segment comprises a distal conical section.
5. The rotational atherectomy device of claim 4 , wherein the distal segment comprises a distal conical section and a distal cylindrical section.
6. The rotational atherectomy device of claim 1 , wherein the at least one eccentric cylindrical segment comprises at least one eccentric abrading cylindrical segment.
7. The rotational atherectomy device of claim 6 , further comprising two or more eccentric abrading cylindrical segments, wherein each of the two or more eccentric abrading cylindrical segments are adjacent to at least one eccentric abrading cylindrical segment and in spaced proximity with the at least one adjacent eccentric abrading cylindrical segment.
8. The rotational atherectomy device of claim 6 , wherein the total number of flexibility gaps comprises the number of eccentric abrading cylindrical segments plus one.
9. The rotational atherectomy device of claim 6 , wherein the at least one eccentric abrading cylindrical segment comprises an outer surface and a proximal inner surface and a distal inner surface, the outer surface, proximal inner surface and distal inner surface comprising abrasive surfaces.
10. The rotational atherectomy device of claim 9 , wherein the outer surface comprises abrasive that is optimized for calcified stenotic tissue and wherein the proximal inner surface and distal inner surface comprise abrasive that is optimized for soft, non-calcified stenotic tissue.
11. The rotational atherectomy device of claim 1 , wherein the proximal segment and distal segment each comprise a center of mass that is offset from the rotational axis of the drive shaft.
12. The rotational atherectomy device of claim 6 , wherein the at least one eccentric cylindrical segment comprises a center of mass that is spaced radially away from the rotational axis of the drive shaft.
13. The rotational atherectomy device of claim 12 , wherein the center of mass of the eccentric proximal segment, distal segment and at least one eccentric abrading cylindrical segment comprises an offset from the rotational axis of the drive shaft that may be controlled by adding or removing one or more of the at least one eccentric abrading cylindrical segments.
14. The rotational atherectomy device of claim 1 , wherein the at least two flexibility gaps allow for flexion between the at least one eccentric abrading cylindrical segment, the proximal segment and the distal segment.