Rotational atherectomy device with counterweighting

• US 8,348,965 B2
• Filed: 10/23/2007
• Issued: 01/08/2013
• Est. Priority Date: 10/23/2007
• Status: Active Grant

• Current Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Inventors: Prudnikov, Dmitriy, Walter, Larry A., McBroom, Jeffrey A.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): CRONIN, ASHLEY L
• Application Number:
  US11/876,891
• Publication Number:
  US 20090105736A1
• Time in Patent Office: 1,904 Days
• Field of Search: 606/108, 606/159, 606/170, 606/180, 606/194, 606/200, 604/264
• US Class Current: 606/159
• 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 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320766 eccentric

Abstract

The invention provides a rotational atherectomy device having a flexible, elongated, rotatable drive shaft with an abrasive section comprising an enlarged diameter section of the drive shaft or, alternatively, a solid abrasive crown which may be attached to the drive shaft. The device further comprises a proximal and/or a distal counterweight attached to the drive shaft, spaced from the abrasive section wherein each counterweight has its center of mass offset from the longitudinal axis of the drive shaft to stimulate orbital motion by the abrasive section. When placed within an artery against stenotic tissue and rotated at sufficiently high speeds (e.g., in the range of about 20,000 rpm to about 200,000 rpm) the orbiting nature of the abrasive section causes such section to rotate as to open the stenotic lesion to a diameter substantially larger than the resting outer diameter of the abrasive section.

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 abrasive section, the abrasive section comprising a geometrically concentric profile and further comprising a first side comprising a first material having a density and a second side comprising a second material having a density higher than that of the density of the first material, and a center of mass, the center of mass spaced radially from the rotational axis of the drive shaft into the second side of the drive shaft in a longitudinal plane as a result of the densities of the first and second materials;

a proximal counterweight on the drive shaft on the proximal side of the abrasive section, the proximal counterweight comprising a geometrically concentric profile and a first side comprising a first material having a density and a second side comprising a second material having a density higher than that of the density of the first material, and a center of mass, the center of mass spaced radially from the rotational axis of the drive shaft into the second side of the proximal counterweight as a result of the densities of the first and second materials, the center of mass of the proximal counterweight spaced radially from the rotational axis of the drive shaft in the same longitudinal plane as the center of mass of the abrasive element;

and a distal counterweight on the drive shaft on the distal side of the abrasive section, the distal counterweight comprising a geometrically concentric profile and a first side comprising a first material having a density and a second side comprising a second material having a density higher than that of the density of the first material, and a center of mass, the center of mass spaced radially from the rotational axis of the drive shaft into the second side of the distal counterweight as a result of the densities of the first and second materials, the center of mass of the distal counterweight spaced radially from the rotational axis of the drive shaft in the same longitudinal plane as the center of mass of the abrasive element

wherein the center of mass of the proximal counterweight is radially offset from the center of mass of the distal counterweight at a rotational angle of 180 degrees,

wherein the center of mass of only one of the proximal counterweight and the distal counterweight is radially offset at a rotational angle of 180 degrees from the center of mass of the abrasive element in the longitudinal plane.

2. The high-speed rotational atherectomy device of claim 1, further comprising the radial spacing center of mass of the proximal counterweight comprising a first distance from the center of mass to the rotational axis of the drive shaft, and the radial spacing of the distal counterweight from the rotational axis of the drive shaft comprising a second distance from the center of mass to the rotational axis of the drive shaft, the first and second distances being equivalent.

3. 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 abrasive section, the abrasive section comprising a geometrically concentric profile and further comprising a first side comprising a first material having a density and a second side comprising a second material having a density higher than that of the density of the first material, and a center of mass, the center of mass spaced radially from the rotational axis of the drive shaft into the second side of the drive shaft in a longitudinal plane as a result of the densities of the first and second materials;

a proximal counterweight on the drive shaft on the proximal side of the abrasive section, the proximal counterweight comprising a geometrically eccentric profile and a center of mass spaced radially from the rotational axis of the drive shaft as a result of the geometric eccentric profile, the center of mass of the proximal counterweight spaced radially from the rotational axis of the drive shaft in the same longitudinal plane as the center of mass of the abrasive element;

and a distal counterweight on the drive shaft on the distal side of the abrasive section, the distal counterweight comprising a geometrically eccentric profile and a center of mass spaced radially from the rotational axis of the drive shaft as a result of the geometric eccentric profile, the center of mass of the distal counterweight spaced radially from the rotational axis of the drive shaft in the same longitudinal plane as the center of mass of the abrasive element,

wherein the center of mass of the proximal counterweight is radially offset from the center of mass of the distal counterweight at a rotational angle of 180 degrees,

wherein the center of mass of only one of the proximal counterweight and the distal counterweight is radially offset at a rotational angle of 180 degrees from the center of mass of the abrasive element in the longitudinal plane.

4. The high-speed rotational atherectomy device of claim 3, further comprising the radial spacing center of mass of the proximal counterweight comprising a first distance from the center of mass to the rotational axis of the drive shaft, and the radial spacing of the distal counterweight from the rotational axis of the drive shaft comprising a second distance from the center of mass to the rotational axis of the drive shaft, the first and second distances being equivalent.

5. 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 abrasive section, the abrasive section comprising a geometrically eccentric profile the center of mass spaced radially from the rotational axis of the drive shaft in a longitudinal plane as a result of the geometrically eccentric profile;

a proximal counterweight on the drive shaft on the proximal side of the abrasive section, the proximal counterweight comprising a geometrically concentric profile and a first side comprising a first material having a density and a second side comprising a second material having a density higher than that of the density of the first material, and a center of mass, the center of mass spaced radially from the rotational axis of the drive shaft into the second side of the proximal counterweight as a result of the densities of the first and second materials, the center of mass of the proximal counterweight spaced radially from the rotational axis of the drive shaft in the same longitudinal plane as the center of mass of the abrasive element,

and a distal counterweight on the drive shaft on the distal side of the abrasive section, the distal counterweight comprising a geometrically concentric profile and a first side comprising a first material having a density and a second side comprising a second material having a density higher than that of the density of the first material, and a center of mass, the center of mass spaced radially from the rotational axis of the drive shaft into the second side of the distal counterweight as a result of the densities of the first and second materials, the center of mass of the distal counterweight spaced radially from the rotational axis of the drive shaft in the same longitudinal plane as the center of mass of the abrasive element

wherein the center of mass of the proximal counterweight is radially offset from the center of mass of the distal counterweight at a rotational angle of 180 degrees,

wherein the center of mass of only one of the proximal counterweight and the distal counterweight is radially offset at a rotational angle of 180 degrees from the center of mass of the abrasive element in the longitudinal plane.

6. The high-speed rotational atherectomy device of claim 5, further comprising the radial spacing center of mass of the proximal counterweight comprising a first distance from the center of mass to the rotational axis of the drive shaft, and the radial spacing of the distal counterweight from the rotational axis of the drive shaft comprising a second distance from the center of mass to the rotational axis of the drive shaft, the first and second distances being equivalent.