Rotational Atherectomy Device with Distal Protection Capability and Method of Use

• US 20130178881A1
• Filed: 03/04/2013
• Published: 07/11/2013
• Est. Priority Date: 05/26/2005
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Granted Patent: US 9,387,006 B2
• Time in Patent Office: Days
• 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• 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 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22052 eccentric
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320766 eccentric
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A rotational device for removing a stenotic lesion from within a vessel of a patient is disclosed. The device comprises a flexible hollow drive shaft having a distal end insertable into the vessel and an abrasive element located on the drive shaft proximal to the distal end of the drive shaft to abrade a stenotic lesion when the drive shaft rotates. The hollow drive shaft defines a lumen for fluid supplied into the drive shaft to flow in an antegrade direction along the lumen and into the vessel from the drive shaft distal to the abrasive element so that the fluid entering the vessel flows in a retrograde direction over the abrasive element and the drive shaft to entrain debris abraded by the abrasive element for removal of said debris from the patient.

Claims

1. A method of using a rotational atherectomy device to remove a stenotic lesion from within a coronary or peripheral artery, comprising:

advancing a distal fluid inflatable counterweight located at a distal tip of a rotational atherectomy device to a position distal of a stenotic lesion in a coronary or peripheral artery while an eccentric abrasive element of the rotational atherectomy device is positioned proximal of the stenotic lesion in the coronary or peripheral artery, wherein the rotational atherectomy device comprises a rotatable, flexible drive shaft defining a fluid flow path to the distal fluid inflatable counterweight, and wherein the eccentric abrasive element is fixed to a region of the drive shaft at a position that is proximal to and spaced away from the distal fluid inflatable counterweight and that is proximal to and spaced away from a proximal counterweight;

inflating the distal fluid inflatable counterweight of the rotational atherectomy device to a larger size after the distal fluid inflatable counterweight is advanced to the position distal of the stenotic lesion in the coronary or peripheral artery;

rotating the drive shaft of the rotational atherectomy device such that the eccentric abrasive element, the distal fluid inflatable counterweight, and the proximal counterweight rotate together with the drive shaft; and

at least partially removing the stenotic lesion in the coronary or peripheral artery with the eccentric abrasive element with while the eccentric abrasive element rotates together with the distal fluid inflatable counterweight, the proximal counterweight, and the drive shaft.

2. The method of claim 1, wherein the proximal counterweight is a proximal fluid inflatable counterweight, the method further comprising inflating the proximal fluid inflatable counterweight of the rotational atherectomy device to a larger size after the distal fluid inflatable counterweight is advanced to the position distal of the stenotic lesion in the coronary or peripheral artery.

3. The method of claim 2, wherein the distal and proximal fluid inflatable counterweights are equally spaced from the abrasive element.

4. The method of claim 1, wherein the distal fluid inflatable counterweight and the proximal counterweight have a maximum outer diameter that is smaller than a maximum outer diameter of the eccentric abrasive element.

5. The method claim 1, wherein the distal fluid inflatable counterweight includes at least one inflow opening communicating with a lumen of the drive shaft so that an interior space of the distal fluid inflatable counterweight is configured to receive fluid from the lumen of the drive shaft during said step of inflating the distal fluid inflatable counterweight, said interior space of the distal fluid inflatable counterweight being at least partially defined by a fluid impermeable membrane.

6. The method claim 5, wherein the distal fluid inflatable counterweight includes at least one outflow opening between the interior space of the distal fluid inflatable counterweight and a vascular space within the coronary or peripheral artery, the method further comprising dispensing a portion of fluid from the interior space of the distal fluid inflatable counterweight through the outflow opening during rotation of the distal fluid inflatable counterweight.

7. The method claim 1, wherein a center of mass of each of the proximal counterweight and the distal fluid inflatable counterweight is located in the same plane as a center of mass of the eccentric abrasive element, but diametrically opposite with respect to a rotational axis of the drive shaft.

8. The method claim 1, further comprising flushing fluid out of at least one port of the drive shaft located distally of the abrasive element and into the coronary or peripheral artery during the step of at least partially removing the stenotic lesion.

9. The method claim 1, further comprising advancing a guidewire distally of the stenotic lesion in the coronary or peripheral artery before the step of advancing the distal fluid inflatable counterweight of the rotational atherectomy device to the position distal of the stenotic lesion in the coronary or peripheral artery, wherein the guidewire is slidably receivable in a lumen of the drive shaft.

10. The method of claim 9, further comprising withdrawing the guidewire proximally away from the proximal counterweight before the step of rotating the drive shaft of the rotational atherectomy device.

11. The method of claim 10, wherein a center of mass of each of the eccentric abrasive element, the distal fluid inflatable counterweight, and the proximal counterweight is offset from a longitudinal axis of rotation of the drive shaft such that a distal end section of the drive shaft located between the distal fluid inflatable counterweight and the proximal counterweight flexes to a curved shape in response to rotation of the drive shaft after the guidewire is withdrawn.

12. A method of using a rotational atherectomy device to remove a stenotic lesion from within a coronary or peripheral artery, comprising:

advancing a distal fluid inflatable counterweight located at a distal tip of a rotational atherectomy device to a position distal of a stenotic lesion in a coronary or peripheral artery while an eccentric abrasive element of the rotational atherectomy device is positioned proximal of the stenotic lesion in the coronary or peripheral artery, wherein the rotational atherectomy device comprises a rotatable, flexible drive shaft defining a fluid flow path to the distal fluid inflatable counterweight;

adjusting the distal fluid inflatable counterweight of the rotational atherectomy device to a larger size after the distal fluid inflatable counterweight is advanced to the position distal of the stenotic lesion in the coronary or peripheral artery;

at least partially removing the stenotic lesion in the coronary or peripheral artery with the eccentric abrasive element with while the eccentric abrasive element rotates together with the distal fluid inflatable counterweight and the drive shaft.

13. The method of claim 12, wherein the rotational atherectomy device comprises a proximal counterweight fixed to the drive shaft at a position that is that is proximal to and spaced away from the eccentric abrasive element.

14. The method of claim 13, wherein the proximal counterweight is a proximal fluid inflatable counterweight, the method further comprising inflating the proximal fluid inflatable counterweight of the rotational atherectomy device to a larger size after the distal fluid inflatable counterweight is advanced to the position distal of the stenotic lesion in the coronary or peripheral artery.

15. The method of claim 14, wherein the distal and proximal fluid inflatable counterweights are equally spaced from the abrasive element.

16. The method of claim 13, wherein the distal fluid inflatable counterweight and the proximal counterweight have a maximum outer diameter that is smaller than a maximum outer diameter of the eccentric abrasive element.

17. The method claim 12, further comprising flushing fluid out of at least one port of the drive shaft located distally of the abrasive element and into the coronary or peripheral artery during the step of at least partially removing the stenotic lesion.

18. The method claim 12, further comprising advancing a guidewire distally of the stenotic lesion in the coronary or peripheral artery before the step of advancing the distal fluid inflatable counterweight of the rotational atherectomy device to the position distal of the stenotic lesion in the coronary or peripheral artery, wherein the guidewire is slidably receivable in a lumen of the drive shaft.

19. The method of claim 18, further comprising withdrawing the guidewire proximally away from the abrasive element before the step of rotating the drive shaft of the rotational atherectomy device.

20. The method of claim 19, wherein a center of mass of each of the eccentric abrasive element and the distal fluid inflatable counterweight is offset from a longitudinal axis of rotation of the drive shaft such that a distal end section of the drive shaft located proximate to the eccentric abrasive element flexes to a curved shape in response to rotation of the drive shaft after the guidewire is withdrawn.