ROTATIONAL ATHERECTOMY DEVICE WITH FLUID INFLATABLE SUPPORT ELEMENTS AND TWO TORQUE TRANSMITTING COILS

• US 20130296904A1
• Filed: 07/08/2013
• Published: 11/07/2013
• Est. Priority Date: 07/13/2006
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Granted Patent: US 9,192,405 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320008 Scrapers
• 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: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208

Abstract

A rotational atherectomy device for removing a stenotic tissue from a vessel of a patient is disclosed. The device comprises a rotatable, flexible, hollow drive shaft having a fluid impermeable wall defining a fluid impermeable lumen of the drive shaft and, an abrasive element mounted to a distal end portion of the drive shaft proximal to and spaced away from a distal support element formed at a distal end of the drive shaft, the distal support element being inflatable by pressurized fluid which flows in an antegrade direction through said lumen of the drive shaft and is at least partially re-directed into the distal fluid inflatable support element.

Claims

1. A method of using a rotational atherectomy device for removing a stenotic tissue from a blood vessel, the method comprising:

inserting a rotational atherectomy device into a blood vessel such that an abrasive element of the rotational atherectomy device is positioned proximate to a stenotic lesion, the rotational atherectomy device including;

a rotatable, flexible, hollow drive shaft including a torque transmitting coil and a fluid delivery lumen for communicating fluid to the distal end portion of the drive shaft;

the ail-abrasive element mounted to a distal end portion of the drive shaft and being fixedly positioned relative to the circumference of the drive shaft; and

proximal and distal fluid inflatable counterweights fixedly positioned along the distal end portion of the drive shaft on opposite sides of the abrasive element and being in fluid communication with the fluid delivery lumen of the drive shaft;

rotating the drive shaft of the rotational atherectomy device so that the abrasive element, the distal fluid inflatable counterweight, and the proximal fluid inflatable counterweight rotate together with the distal end portion of the drive, wherein a center of mass of each of the proximal and distal fluid inflatable counterweights is offset from the longitudinal axis of the drive shaft in a first direction while the center of mass of the abrasive element is offset from the longitudinal axis of the drive shaft in a second opposite direction; and

delivering fluid through the fluid delivery lumen of the drive shaft toward the distal end portion of the drive shaft so as to cause a distal facing port at a distal-most end of the drive shaft is adjusted from an opened condition to a closed condition.

2. The method of claim 1, further comprising maintaining the distal facing port of the drive shaft in the occluded condition during said rotating of the drive shaft of the the rotational atherectomy device.

3. The method of claim 1, wherein said delivering the fluid causes a movable element arranged in the drive shaft to adjust the distal facing port of the drive shaft from the opened condition to the closed condition.

4. The method of claim 3, wherein the movable element has a size larger than the distal facing port of the drive shaft so that the movable element is retained inside the fluid delivery lumen, wherein the movable element shifts to an occlusion position at the distal facing port of the drive shaft in response to fluid flow passing through the fluid delivery lumen of the drive shaft toward the distal end portion of the drive shaft.

5. The method of claim 4, wherein the movable element is configured to at least partially occlude the distal facing port of the drive shaft when shifted to the occlusion position so that the fluid delivered through the fluid delivery lumen is directed to an internal space of the distal fluid inflatable counterweight and an internal space of the proximal fluid inflatable counterweight.

6. The method of claim 5, wherein the movable element comprises a rounded element configured to be advanced to the distal facing port of the drive shaft where it is prevented from exiting the distal facing port by a radially inwardly extending shoulder.

7. The method of claim 1, further comprising:

advancing a guide wire though the blood vessel toward the stenotic lesion, receiving the guide wire in the fluid delivery lumen of the drive shaft during advancement of the distal fluid inflatable counterweight across the stenotic lesion in the blood vessel, and withdrawing the guide wire away from the distal end portion of the drive shaft after the distal fluid inflatable counterweight advances across the stenotic lesion in the blood vessel and before said rotating of the drive shaft.

8. The method of claim 1, further comprising, during said rotating, outputting fluid flow through at least one outflow opening of a flexible outer wall of each of the proximal and distal fluid inflatable counterweights.

9. The method of claim 8, wherein the outflow opening of the distal fluid inflatable counterweight has an axis which form an angle of about ninety (90) degrees with the longitudinal axis of the drive shaft when the distal fluid inflatable support element is inflated.

10. The method of claim 8, further comprising forming a distal fluid bearing between the outer wall of the distal fluid inflatable counterweight and a wall of the blood vessel during said outputting fluid flow through said at least one outflow opening of the distal fluid inflatable counterweight.

11. The method of claim 8, wherein the outflow opening of the proximal fluid inflatable counterweight has an axis which form an angle of about ninety (90) degrees with the longitudinal axis of the drive shaft when the proximal fluid inflatable support element is inflated.

12. The method of claim 8, further comprising forming a proximal fluid bearing between the outer wall of the proximal fluid inflatable counterweight and a wall of the blood vessel during said outputting fluid flow through said at least one outflow opening of the proximal fluid inflatable counterweight.