Rotational atherectomy device with a system of eccentric abrading heads

• US 9,289,230 B2
• Filed: 09/17/2012
• Issued: 03/22/2016
• 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:
  US13/621,398
• Publication Number:
  US 20140081298A1
• Time in Patent Office: 1,282 Days
• Field of Search: None
• US Class Current: 1/1
• 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, in various embodiments, a flexible, elongated, rotatable drive shaft with a system of eccentric abrading heads attached thereto. At least part of the eccentric enlarged abrading heads in the system have a tissue removing surface—the abrading heads may be at least partially hollow. Preferably the abrading heads have centers of mass spaced radially from the rotational axis of the drive shaft, facilitating the ability of the system of abrading heads to work together to open the stenotic lesion to a diameter larger than the outer resting diameter of the abrading heads when operated at high speeds. Therefore, certain embodiments comprise a system having unbalanced centers of mass to not only stimulate greater rotational diameters but also arranged in a manner whereby a debris-removing augering effect occurs. Other embodiments may comprise systems having abrading heads with balanced centers of mass.

Claims

1. A high-speed rotational atherectomy device for opening a stenosis in a blood vessel having a diameter, comprising:

a guide wire having a maximum diameter less than the diameter of the blood vessel;

a flexible elongated, rotatable drive shaft advanceable over the guide wire, the drive shaft having a rotational axis; and

an eccentric system comprising a center of mass radially offset from the rotational axis of the drive shaft in a direction along a plane and two or more eccentric abrading heads in spaced apart longitudinal disposition along the drive shaft, each of the two or more eccentric abrading heads having a geometric center and a center of mass, wherein the center of mass for each of the two or more eccentric abrading heads is radially offset from the rotational axis of the drive shaft in the same direction and plane.

2. The high-speed rotational atherectomy device of claim 1, further comprising:

the two or more eccentric abrading heads each having a resting diameter, wherein the resting diameter for each of the two or more eccentric abrading heads in the eccentric system is not the same.

3. The high-speed rotational atherectomy device of claim 2, further comprising a most distal eccentric abrading head in the eccentric system, wherein the most distal eccentric abrading head comprises the smallest resting diameter in the eccentric system.

4. The high-speed rotational atherectomy device of claim 3, further comprising a most proximal eccentric abrading head in the eccentric system, wherein the most proximal eccentric abrading head comprises the largest resting diameter in the eccentric system.

5. The high-speed rotational atherectomy device of claim 3, further comprising the remaining eccentric heads in the eccentric system having resting diameters that increase successively from the most distal eccentric abrading to a most proximal eccentric abrading head.

6. The high-speed rotational atherectomy device of claim 1, further comprising a substantially unequal radial offset of the center of mass for each of the two or more eccentric abrading heads in the eccentric system.

7. The high-speed rotational atherectomy device of claim 1, further comprising a radial offset of the center of mass of a most distal eccentric abrading head that comprises the smallest radial offset of the center of mass in the eccentric system.

8. The high-speed rotational atherectomy device of claim 7, further comprising a radial offset of the center of mass of a most proximal eccentric abrading head that comprises the largest radial offset of the center of mass in the eccentric system.

9. The high-speed rotational atherectomy device of claim 1, wherein at least one of the two or more eccentric abrading heads comprises a hollowed section therein, with a size and a shape that partially determines the location of the radially offset center of mass along the plane.