ROTATIONAL ATHERECTOMY DEVICE WITH FLUID INFLATABLE SUPPORT ELEMENTS SUPPORTED BY FLUID BEARINGS

• US 20090326568A1
• Filed: 06/28/2007
• Published: 12/31/2009
• Est. Priority Date: 07/13/2006
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Lela Nadirashvili
• Inventors: Shturman, Leonid
• Granted Patent: US 8,137,369 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 2017/22051 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 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320008 Scrapers
• CPC Class Codes: A61B 2017/320766 eccentric

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 an open distal end. The drive shaft comprising a fluid impermeable wall, an abrasive element mounted to the drive shaft proximal to and spaced away from its distal end, the fluid impermeable wall being formed from a torque transmitting coil and at least one fluid impermeable membrane which define a lumen for the antegrade flow of pressurized fluid through the drive shaft and into a distal fluid inflatable support element to inflate said fluid inflatable support element. The distal fluid inflatable support element is located at the distal end of the drive shaft and has an outer wall comprising an outflow opening located such that said outflow opening faces an inner surface of a treated vessel during rotation of the drive shaft so that a flow of fluid out of said opening forms a layer of fluid between the outer wall of the fluid inflatable distal support element and a wall of the treated vessel. The layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated distal support element and the wall of the treated vessel.

Claims

1. A rotational atherectomy device for removing a stenotic lesion from a vessel of a patient, the device comprising an abrasive element mounted to a distal end portion of a rotatable, flexible, hollow drive shaft proximal to and spaced away from a fluid inflatable distal support element located at a distal end of the drive shaft, the drive shaft having a longitudinal axis and a fluid impermeable wall which extends along an entire length of the drive shaft and defines a fluid impermeable guide wire lumen of the drive shaft, the fluid impermeable guide wire lumen being configured for advancement of the drive shaft over a guidewire across the stenotic lesion and for transfer of pressurized fluid into a fluid inflatable space of the distal support element after crossing the stenotic lesion and removing the guidewire from the drive shaft or withdrawing it into the drive shaft, the distal support element being inflatable by pressurized fluid which is pumped into a proximal end portion of the fluid impermeable guide wire lumen, flows in an antegrade direction through the lumen and is at least partially re-directed into the distal fluid inflatable support element, the proximal end portion of the fluid impermeable guide wire lumen being located outside of a body of the patient, the distal fluid inflatable support element having an outer wall comprising an outflow opening located such that said outflow opening faces an inner surface of a treated vessel during rotation of the drive shaft, the outflow opening having an axis which forms an angle of at least about seventy five (75) degrees with the longitudinal axis of the drive shaft when the distal fluid inflatable support element is inflated, so that in a rotating fluid inflated distal support element flow of fluid through the outflow opening forms a layer of fluid between the outer wall of the rotating fluid inflated distal support element and a wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated distal support element and the wall of the treated vessel, the fluid bearing permitting safe rotation and back and forth movements of the drive shaft within the treated vessel after removing the guidewire from the drive shaft or withdrawing it into the drive shaft.

14. A rotational atherectomy device according to claim 1, wherein the drive shaft is provided with a valve, said valve being located at the distal end of the drive shaft and configured to occlude the fluid impermeable guide wire lumen at its distal end and thereby prevent flow of fluid through the very distal end of the guide wire lumen and assist in re-directing flow of fluid into the distal fluid inflatable support element.

15. A rotational atherectomy device according to claim 14, wherein the valve is a flexible leaf valve, the flexible leaf valve configured to be moved to its closed position by pressure of fluid which is pumped in the antegrade direction through the drive shaft after advancing the drive shaft over the guidewire across a stenotic lesion to be treated and removing the guide wire from the drive shaft or withdrawing it into the drive shaft.

3. A rotational atherectomy device according to claim 2, wherein the fluid inflatable space within the distal fluid inflatable support element extends only partially around a circumference of the drive shaft so that, when the distal inflatable support element is inflated with fluid its centre of mass is offset from the longitudinal axis of the drive shaft in one direction so that it acts as a counterweight to the abrasive element, which has its centre of mass offset from the longitudinal axis of the drive shaft in the opposite direction.

6. A rotational atherectomy device according to claim 13, wherein the proximal support element is inflatable by pressurized fluid which flows in the antegrade direction through the fluid impermeable lumen of the drive shaft and is re-directed into the proximal fluid inflatable support element, the proximal fluid inflatable support element having an outer wall which comprises an outflow opening located such that an axis of the outflow opening forms an angle of at least about seventy five (75) degrees with the longitudinal axis of the drive shaft when the proximal fluid inflatable support element is inflated, said outflow opening facing an inner surface of a treated vessel during rotation of the drive shaft and a flow of fluid through the outflow opening forming a layer of fluid between the outer wall of the rotating fluid inflated proximal support element and the wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated proximal support element and the wall of the treated vessel.

13. A rotational atherectomy device according to claim 3, wherein the drive shaft is provided with a proximal fluid inflatable support element which has a fluid inflatable space and is located proximal to and spaced away from the abrasive element, both the distal and proximal fluid inflatable support elements having fluid inflatable spaces that extend circumferentially only partially around a circumference of the drive shaft so that, when both the distal and proximal fluid inflatable support elements are inflated by fluid, their centers of mass become offset from a longitudinal axis of the drive shaft in one direction and the distal and proximal fluid inflatable support elements act as counterweights to the abrasive element which is located on the drive shaft between the support elements and has its centre of mass offset from the longitudinal axis of the drive shaft in the opposite direction.

4. A rotational atherectomy device according to claim 1, wherein the distal fluid inflatable support element has a centre of mass which coincides with the longitudinal axis of the drive shaft when the distal support element is fluid inflated, the distal fluid inflatable support element having a plurality of outflow openings in its outer wall, said openings being located around a maximum circumference of the outer wall of the fluid inflatable distal support element, the outflow openings having axes which form angles of about ninety (90) degrees with the longitudinal axis of the drive shaft when the distal support element is fluid inflated, so that flows of fluid through the openings form a layer of fluid between the outer wall of the fluid inflatable distal support element and the wall of the treated vessel, said layer of fluid forming a fluid bearing between the outer wall of the rotating fluid inflated distal support element and the wall of the treated vessel, the fluid bearing permitting safe rotation and back and forth movements of the drive shaft within the treated vessel after removing the guidewire from the drive shaft or withdrawing it into the drive shaft.

11. A rotational atherectomy device according to claim 4, wherein the abrasive element has its centre of mass spaced radially away from the longitudinal axis of the drive shaft.

12. A rotational atherectomy device according to claim 4, wherein the centre of mass of the abrasive element coincides with the longitudinal axis of the drive shaft.

21. A rotational atherectomy device according to claim 4, wherein the drive shaft is provided with a proximal fluid inflatable support element located proximal to and spaced away from the abrasive element, both the distal and proximal support elements being inflatable by pressurized fluid which flows in the antegrade direction through the fluid impermeable guide wire lumen and is re-directed into the inflatable support elements, both the distal and proximal support elements having fluid inflatable spaces that extend uniformly around an entire circumference of the drive shaft and are defined by outer walls of the support elements, the outer walls of the inflatable support elements comprising multiple outflow openings, said openings being located around a maximum circumference of the outer walls of the fluid inflatable support elements such that, during rotation of the drive shaft, said openings face an inner surface of the treated vessel and flows of fluid through the openings form layers of fluid between the outer walls of the fluid inflated support elements and the wall of the treated vessel, said layers of fluid forming fluid bearings between the outer walls of the rotating fluid inflated support elements and the wall of the treated vessel, the fluid bearings permitting safe rotation and back and forth movements of the drive shaft within the treated vessel after removing the guidewire from the drive shaft or withdrawing it into the drive shaft.

22. A rotational atherectomy device according to claim 21, wherein the abrasive element has its centre of mass spaced radially away from the longitudinal axis of the drive shaft.

23. A rotational atherectomy device according to claim 21, wherein the centre of mass of the abrasive element coincides with the longitudinal axis of the drive shaft.

5. (canceled)

7. (canceled)

8. (canceled)

9. (canceled)

10. (canceled)

16. (canceled)

17. (canceled)

17-1. (canceled)

18-2. A rotational atherectomy device according to claim 20, wherein the cylindrical stationary fluid supply tube is received within the hollow rotatable turbine shaft such that pressurised fluid flowing in the antegrade direction out of the distal end of the stationary fluid supply tube traverses a portion of the hollow rotatable turbine shaft prior to flowing into the fluid impermeable lumen of the drive shaft.

19. (canceled)

19-3. (canceled)

20. A rotational atherectomy device for removing a stenotic tissue from a vessel of a patient, the device comprising a turbine housing and a rotatable, flexible, hollow drive shaft having a distal end, a proximal end and an abrasive element mounted to the drive shaft, the drive shaft comprising a torque transmitting coil and at least one fluid impermeable membrane forming a fluid impermeable lumen for an antegrade flow of fluid through the drive shaft from the proximal end of the drive shaft towards its distal end, wherein a proximal end portion of the drive shaft is attached to a distal end portion of a hollow turbine shaft rotatably mounted in the turbine housing and, a cylindrical stationary fluid supply tube is received within the hollow turbine shaft to provide a flow of pressurised fluid from a fluid source into the fluid impermeable lumen of the drive shaft, the cylindrical wall of the stationary fluid supply tube comprising a plurality of openings which extend in a radially outward direction relative to an axis of rotation of the rotatable turbine shaft, the openings facing an inner surface of the rotatable turbine shaft, said openings in the cylindrical wall of the stationary fluid supply tube configured such that a portion of the pressurised fluid flowing in the antegrade direction through the stationary fluid supply tube is re-directed through the openings to form a layer of fluid between the outer surface of the stationary fluid supply tube and the inner surface of the hollow rotatable turbine shaft, said layer of fluid forming a fluid bearing between the stationary fluid supply tube and the rotatable turbine shaft.

2. A rotational atherectomy device according to claim 1, wherein the drive shaft comprised of a torque transmitting coil and at least one fluid impermeable membrane.

18. (canceled)

20-4. (canceled)

24. A rotational atherectomy device for removing a stenotic tissue from a vessel of a patient, the device comprising an abrasive element mounted to a distal end portion of a rotatable, flexible, hollow drive shaft between a pair of support elements located on the drive shaft distal and proximal to the abrasive element, the distal support element being located at a distal end of the drive shaft and both support elements being spaced away from the abrasive element, the drive shaft having a longitudinal axis and the abrasive element and each of the support elements having their individual centers of mass, the center of mass of the abrasive element being spaced radially away from the longitudinal axis of the drive shaft while the center of mass of the distal support element and the centre of mass of the proximal support element each coincide with the longitudinal axis of the drive shaft.

25. A rotational atherectomy device according to claim 24, wherein the distal support element is fluid inflatable and is in fluid communication with a fluid impermeable guide wire lumen of the drive shaft, said lumen being defined by a fluid impermeable wall of the drive shaft, the distal support element being inflatable by pressurized fluid which flows in an antegrade direction through the fluid impermeable guide wire lumen and is at least partially re-directed into the distal fluid inflatable support element.

26. A rotational atherectomy device for removing a stenotic lesion from a vessel of a patient, the device comprising an abrasive element mounted to a distal end portion of a rotatable, flexible, hollow drive shaft between and spaced away from a pair of support elements located on the drive shaft distal and proximal to the abrasive element, the distal support element being located at a distal end of the drive shaft and having a fluid inflatable space which is in fluid communication with a distal end portion of a guide wire lumen of the drive shaft, the guide wire lumen having a proximal end portion located outside of the patient and a fluid impermeable wall which extends along an entire length of the guide wire lumen, the distal support element being inflatable by pressurized fluid which is pumped into the proximal end portion of the fluid impermeable guide wire lumen, flows in an antegrade direction through said lumen and is at least partially re-directed into the distal fluid inflatable support element, the fluid impermeable guide wire lumen being configured for advancement of the drive shaft over a guidewire across the stenotic lesion to be treated and for transfer of pressurized fluid into the fluid inflatable space of the distal support element after removing the guidewire from the drive shaft or withdrawing it into the drive shaft, the drive shaft having a longitudinal axis and the abrasive element and each of the support elements having their individual centers of mass, the center of mass of the abrasive element being spaced radially away from the longitudinal axis of the drive shaft while the center of mass of the distal support element and the centre of mass of the proximal support element each coincide with the longitudinal axis of the drive shaft.