Rotational atherectomy device with a system of eccentric abrading heads

• US 10,052,124 B2
• Filed: 03/03/2016
• Issued: 08/21/2018
• Est. Priority Date: 09/17/2012
• Status: Active Grant

• Current Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Inventors: Cambronne, Matthew David
• Primary Examiner(s): Lynch, Robert
• Application Number:
  US15/059,349
• Publication Number:
  US 20160183968A1
• Time in Patent Office: 901 Days
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft
• CPC Class Codes: A61B 2017/320766 eccentric
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The invention provides a rotational atherectomy device having a flexible, elongated, rotatable drive shaft with a system of eccentric abrading heads attached thereto. The eccentric enlarged abrading heads may have centers of mass spaced radially from the rotational axis of the drive shaft, wherein adjacent eccentric abrading heads, and centers of mass thereof, are rotationally separated from each other on the drive shaft.

Claims

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; and

an unbalanced system of more than one eccentric abrading head in spaced apart longitudinal disposition along the drive shaft, the more than one eccentric abrading heads each having a resting diameter, wherein a distal eccentric abrading head comprises a resting diameter that is the smallest resting diameter in the unbalanced system and the remaining eccentric abrading heads in the unbalanced system comprise resting diameters that increase successively from distal to proximal, wherein the most proximal eccentric abrading head comprises the largest resting diameter in the unbalanced system, each eccentric abrading head in the unbalanced system further comprising a geometric center and a center of mass, wherein the geometric center and center of mass are radially offset from the rotational axis of the drive shaft; and

a spiral channel disposed between the successively spaced apart eccentric abrading heads defined by a rotational separation between adjacent eccentric abrading heads in the unbalanced system.

2. The rotational atherectomy device of claim 1, further comprising at least one of the more than one eccentric abrading heads comprising proximal, intermediate and distal portions, wherein the proximal portion comprises a proximal outer surface, the intermediate portion comprises an intermediate outer surface and the distal portion comprises a distal outer surface, the proximal outer surface having diameters that increase distally, the distal outer surface having diameters that decrease distally, and the intermediate outer surface being cylindrical, wherein at least the intermediate outer surface comprise tissue removal sections and wherein the at least one of the more than one eccentric abrading heads defines a drive shaft lumen therethrough and a hollow cavity, the drive shaft at least partially traversing the drive shaft lumen.

3. The rotational atherectomy device of claim 1, further comprising at least one of the eccentric abrading heads comprising an enlarged section of the drive shaft.

4. The rotational atherectomy device of claim 3, further comprising at least one of the more than one eccentric abrading heads comprising proximal, intermediate and distal portions, wherein the proximal portion comprises a proximal outer surface, the intermediate portion comprises an intermediate outer surface and the distal portion comprises a distal outer surface, the proximal outer surface having diameters that increase distally, the distal outer surface having diameters that decrease distally, and the intermediate outer surface being cylindrical, wherein at least the intermediate outer surface comprise tissue removal sections and wherein each of the at least one of the more than one eccentric abrading heads defines a drive shaft lumen therethrough and a hollow cavity, the drive shaft at least partially traversing the drive shaft lumen.

5. The rotational atherectomy device of claim 4, wherein the proximal outer surface of the at least one eccentric abrading head is substantially defined by a lateral surface of a cone, the cone having an axis that intersects the rotational axis of the drive shaft.

6. The rotational atherectomy device of claim 5, wherein the distal outer surface of the at least one eccentric abrading head is substantially defined by a lateral surface of a cone, the cone having an axis that intersects the rotational axis of the drive shaft.

7. The rotational atherectomy device of claim 1, wherein each of the more than one eccentric abrading heads defines a drive shaft lumen therethrough and wherein the portion of the drive shaft traversing the drive shaft lumen and attaching thereto comprises a single, unbroken drive shaft.

8. The rotational atherectomy device of claim 1, wherein the each of the more than one eccentric abrading heads defines a drive shaft lumen therethrough and wherein the portion of the drive shaft traversing the drive shaft lumen and attaching thereto comprises at least two sections, each section attached to the drive shaft lumen with a gap between the at least two drive shaft sections.

9. The device of claim 1, wherein the rotational separation between adjacent eccentric abrading heads is between 0 degrees and 45 degrees.

10. The device of claim 1, wherein the rotational separation between adjacent eccentric abrading heads is between 0 degrees and 90 degrees.

11. The device of claim 1, wherein the unbalanced system of at least one eccentric abrading head comprises a proximal eccentric abrading head and a distal eccentric abrading head and wherein the rotational separation between the proximal and distal eccentric abrading heads is about 45 degrees.

12. The device of claim 11, wherein the unbalanced system of at least one eccentric abrading head comprises a third eccentric abrading head in spaced apart longitudinal disposition between the proximal and the distal eccentric abrading heads, the distal eccentric abrading head having a resting diameter, the third eccentric abrading head having a resting diameter that is larger than the resting diameter of the distal eccentric abrading head, the proximal eccentric abrading having a resting diameter that is larger than the resting diameter of the third eccentric abrading head, wherein the rotational separation between the proximal and third eccentric abrading head is about 45 degrees and the rotational separation between the third eccentric abrading and the distal eccentric abrading head is about 45 degrees.

13. The device of claim 1, wherein the balanced system of at least one eccentric abrading head comprises an even number of eccentric abrading heads and wherein the rotational separation between each adjacent eccentric abrading heads in the balanced system is the same and between 0 degrees and 90 degrees.

14. The device of claim 13, wherein the rotational separation between adjacent eccentric abrading heads is the same and between 0 degrees and 45 degrees.

15. 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; and

an balanced system of more than one eccentric abrading head in spaced apart longitudinal disposition along the drive shaft and comprising a distal eccentric abrading head and a proximal eccentric abrading head, the more than one eccentric abrading heads each having a resting diameter, wherein the distal eccentric abrading head comprises a resting diameter that is the smallest resting diameter in the unbalanced system and the remaining eccentric abrading heads in the balanced system comprise resting diameters that increase successively, wherein the proximal eccentric abrading head comprises a resting diameter that is the largest resting diameter in the balanced system, each eccentric abrading head in the balanced system further comprising a geometric center and a center of mass, wherein the geometric center and center of mass are radially offset from the rotational axis of the drive shaft; and

a spiral channel disposed between the successively spaced apart eccentric abrading heads defined by a rotational separation between adjacent eccentric abrading heads in the balanced system.

16. The rotational atherectomy device of claim 15, further comprising at least one of the more than one eccentric abrading heads comprising proximal, intermediate and distal portions, wherein the proximal portion comprises a proximal outer surface, the intermediate portion comprises an intermediate outer surface and the distal portion comprises a distal outer surface, the proximal outer surface having diameters that increase distally, the distal outer surface having diameters that decrease distally, and the intermediate outer surface being cylindrical, wherein at least the intermediate outer surface comprise tissue removal sections and wherein the abrading head defines a drive shaft lumen therethrough and a hollow cavity, the drive shaft at least partially traversing the drive shaft lumen.

17. The rotational atherectomy device of claim 15, further comprising at least one of the eccentric abrading heads comprising an enlarged section of the drive shaft.

18. The rotational atherectomy device of claim 17, further comprising least one of the more than one eccentric abrading heads comprising proximal, intermediate and distal portions, wherein the proximal portion comprises a proximal outer surface, the intermediate portion comprises an intermediate outer surface and the distal portion comprises a distal outer surface, the proximal outer surface having diameters that increase distally, the distal outer surface having diameters that decrease distally, and the intermediate outer surface being cylindrical, wherein at least the intermediate outer surface comprise tissue removal sections and wherein the abrading head defines a drive shaft lumen therethrough and a hollow cavity, the drive shaft at least partially traversing the drive shaft lumen.

19. The rotational atherectomy device of claim 15, wherein each of the more than one eccentric abrading heads comprises a drive shaft lumen therethrough, the portion of the drive shaft traversing the drive shaft lumen and attaching thereto comprises a single, unbroken drive shaft.

20. 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; and

an unbalanced system of more than one eccentric abrading head in spaced apart longitudinal disposition along the drive shaft, the more than one eccentric abrading heads each having a resting diameter, wherein each eccentric abrading head in the unbalanced system comprises a geometric center and a center of mass, wherein the geometric center and center of mass are radially offset from the rotational axis of the drive shaft and wherein the centers of mass are all offset radially in different directions and in different planes.