Atherectomy device supported by fluid bearings

• US 8,157,825 B2
• Filed: 06/28/2007
• Issued: 04/17/2012
• Est. Priority Date: 07/13/2006
• Status: Expired due to Fees

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Lela Nadirashvili
• Inventors: Shturman, Leonid
• Primary Examiner(s): Nguyen, Tuan
• Assistant Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US12/373,461
• Publication Number:
  US 20090312777A1
• Time in Patent Office: 1,755 Days
• Field of Search: 606/110, 606/112, 606/114, 606/127, 606/128, 606/170, 606/180, 606/191, 606/15, 604/22, 604/103.01, 604/103.02
• US Class Current: 606/159
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• 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

Abstract

A rotational atherectomy device for removing a stenotic tissue (330, 360) from a vessel (300) of a patient comprises a flexible hollow drive shaft (2) and an abrasive element (101, 102) mounted to the drive shaft proximal to and spaced from a solid support element (10, 10s) mounted at the distal end (6) of the drive shaft, the solid support element having a rounded outer surface and an outflow channel (20, 20s) with an outflow opening in said rounded outer surface. The drive shaft comprises a torque transmitting coil (4) and at least one fluid impermeable membrane (3) forming a fluid impermeable lumen for the antegrade flow (FF) of fluid into the outflow channel such that, during rotation of the drive shaft, a flow of fluid out of said outflow opening forms a fluid bearing between the rotating solid support element and the wall of the treated vessel.

Claims

1. A rotational atherectomy device for removing a stenotic tissue from a vessel of a patient, the device comprising an abrasive element mounted to a rotatable, flexible, hollow drive shaft having a longitudinal axis and a distal end, the abrasive element being mounted to the drive shaft between a distal solid support element and a proximal solid support element, the abrasive element being positioned proximal to and spaced away from the distal solid support element which is mounted at the distal end of the drive shaft, and the abrasive element being positioned distal to and spaced away from the proximal solid support element, each of the distal and proximal solid support elements being substantially smaller than the abrasive element and having a surface texture that is different from an abrasive surface texture of the abrasive element, the drive shaft comprising a torque transmitting coil and at least one fluid impermeable membrane positioned radially inward of the torque transmitting coil to form a fluid impermeable lumen along a central longitudinal axis of the drive shaft for an antegrade flow of fluid through the drive shaft, the distal solid support element having a rounded outer surface and comprising an outflow channel which is in fluid communication with the fluid impermeable lumen of the drive shaft and which extends through the solid distal support element in a generally radially outward direction with respect to the longitudinal axis of the drive shaft, the outflow channel having an outflow opening in said rounded outer surface located such that, during rotation of the drive shaft, said outflow opening is configured to output fluid flow for forming a fluid layer between the solid distal support element and a wall of a vessel, said layer of fluid being operable to form a fluid bearing between the rotating solid distal support element and the wall of the vessel during rotation and back and forth movements of the drive shaft within the vessel, wherein said distal and proximal solid support elements are configured to act as counterweights to the abrasive element.

2. A rotational atherectomy device according to claim 1, wherein the solid proximal support element has a rounded outer surface and comprising an outflow channel which is in fluid communication with the fluid impermeable lumen of the drive shaft and which extends through the solid proximal support element in a generally radially outward direction with respect to the longitudinal axis of the drive shaft, the outflow channel having an outflow opening in said rounded outer surface of the solid proximal support element located such that, during rotation of the drive shaft, said outflow opening is configured to output fluid flow for forming a fluid layer between the solid proximal support element and the wall of the vessel, said layer of fluid being operable to form a fluid bearing between the rotating solid proximal support element and the wall of the vessel.

3. A rotational atherectomy device according to claim 2, wherein the abrasive element and each of the distal and proximal solid support elements have their individual centers of mass, the centers of mass of both the distal and proximal solid support elements being spaced radially away from a longitudinal axis of the drive shaft but in a direction diametrically opposite to the direction in which a center of mass of the abrasive element is spaced radially away from the longitudinal axis of the drive shaft so that the distal and proximal solid support elements act as counterweights to the abrasive element.

4. A rotational atherectomy device according to claim 1, wherein the fluid impermeable membrane lines the torque transmitting coil.

5. A rotational atherectomy device according to claim 1, wherein the fluid impermeable lumen of the drive shaft is configured for advancement of the drive shaft over a guidewire across a stenotic lesion to be treated and for transfer of pressurized fluid into the outflow channel of the distal solid support element after crossing the stenotic lesion.

6. A rotational atherectomy device for removing a stenotic lesion from within a vessel of a patient, the device comprising a rotatable, flexible, hollow drive shaft having a longitudinal axis of rotation and an abrasive element mounted proximal to and spaced away from a distal end of the drive shaft, the drive shaft including a distal solid support element located at the distal end of the drive shaft and spaced away from the abrasive element and including a proximal solid support element located proximal to and spaced away from the abrasive element, each of the distal and proximal solid support elements being substantially smaller than the abrasive element and having a surface texture that is different from an abrasive surface texture of the abrasive element, the drive shaft having a fluid impermeable wall defining a fluid impermeable lumen for an antegrade flow of fluid through the drive shaft, wherein both the distal and proximal solid support elements have an outflow channel that is in fluid communication with the fluid impermeable lumen of the drive shaft and extend through each of the support elements in a generally radially outward direction with respect to the longitudinal axis of the drive shaft, the outflow channels have axes that form angles of about ninety (90) degrees with the longitudinal axis of the drive shaft and have outflow openings along circumferences of the support elements such that, during rotation of the drive shaft, the outflow openings are configured to output fluid flow for forming layers of fluid between the solid support elements and a wall of the vessel, said layers of fluid being operable to form fluid bearings between the rotating solid support elements and the wall of the vessel during rotation and back and forth movements of the drive shaft within the vessel, wherein said distal and proximal solid support elements are configured to act as counterweights to the abrasive element.

7. A rotational atherectomy device according to claim 6, wherein the fluid impermeable lumen of the drive shaft is configured for advancement of the drive shaft over a guidewire across a stenotic lesion to be treated and for transfer of pressurized fluid into the outflow channels of both the distal and proximal solid support elements after crossing the stenotic lesion.

8. A rotational atherectomy device according to claim 6, wherein the abrasive element and each of the distal and proximal solid support elements have their individual centers of mass, the centers of mass of both the distal and proximal solid support elements being spaced radially away from the longitudinal axis of the drive shaft but in a direction diametrically opposite to the direction in which a center of mass of the abrasive element is spaced radially away from the longitudinal axis of the drive shaft so that the distal and proximal solid support elements act as counterweights to the abrasive element.

9. A rotational atherectomy device according to claim 6, wherein the fluid impermeable wall lines the torque transmitting coil.