Rotational atherectomy device with fluid inflatable support elements and two torque transmitting coils

• US 8,500,765 B2
• Filed: 03/08/2012
• Issued: 08/06/2013
• Est. Priority Date: 07/13/2006
• Status: Expired due to Fees

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US13/415,221
• Publication Number:
  US 20120172903A1
• Time in Patent Office: 516 Days
• Field of Search: 606/110, 606/113, 606/114, 606/127, 606/128, 606/159, 606/170, 606/180, 606/191, 604/22, 604/103.01, 604/103.02
• 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 rotational atherectomy device for removing a stenotic tissue from a vessel of a patient, the device comprising:

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

an abrasive element mounted to a distal end portion of the drive shaft, the entire abrasive element extending around less than half of the circumference of the drive shaft and being fixedly positioned relative to the circumference of the drive shaft;

proximal and distal inflatable counterweights fixedly positioned on the drive shaft along the distal end portion of the drive shaft such that the proximal and distal inflatable counterweights rotate together with the abrasive element in response to rotation of the drive shaft, wherein the abrasive element is positioned between and longitudinally spaced apart from the proximal and distal inflatable counterweights, wherein each of the proximal and distal inflatable counterweights is in fluid communication with the fluid delivery lumen of the drive shaft, wherein a center of mass of each of the proximal and distal 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

wherein the distal end of the drive shaft includes a distal facing port, and the distal facing port of the drive shaft is adjusted from an opened condition to an occluded condition in response to fluid flow passing through the fluid delivery lumen of the drive shaft toward the distal end portion of the drive shaft.

2. The device of claim 1, further comprising a movable element is arranged in the fluid delivery lumen so as to adjust the distal facing port of the drive shaft from the opened condition to the occluded condition.

3. The device of claim 2, 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.

4. The device of claim 3, 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 flowing through the fluid delivery lumen is directed to an internal space of the distal inflatable counterweight and an internal space of the proximal inflatable counterweight.

5. The device of claim 4, 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, the rounded element configured to at least partially occlude the fluid delivery lumen to thereby inhibit flow of fluid through the distal facing port.

6. The device of claim 1, further comprising a guidewire, wherein the fluid delivery lumen is configured to receive the guidewire for advancement across a stenotic lesion in a vessel and for transfer of pressurized fluid into the proximal and distal inflatable counterweights after crossing the stenotic lesion and withdrawing the guidewire away from the distal end portion of the drive shaft.

7. The device of claim 1, wherein the distal inflatable counterweight has a flexible outer wall which comprises at least one outflow opening configured to face toward an inner surface of a vessel during rotation of the drive shaft, the flexible outer wall of the distal inflatable counterweight at least partially defining a fluid inflatable space to receive fluid from the fluid delivery lumen of the drive shaft.

8. The device of claim 7, wherein the outflow opening of the distal inflatable counterweight has an axis which form angles of about ninety (90) degrees with the longitudinal axis of the drive shaft when the distal fluid inflatable support element is inflated, wherein the outflow opening is configured to output fluid flow for forming a fluid bearing between the outer wall of the rotating distal inflatable counterweight and the vessel during rotation and back and forth movements of the drive shaft within the vessel.

9. The device of claim 7, wherein the proximal inflatable counterweight has a flexible outer wall which comprises at least one outflow opening configured to face toward an inner surface of a vessel during rotation of the drive shaft, the flexible outer wall of the proximal inflatable counterweight at least partially defining a fluid inflatable space to receive fluid from the fluid delivery lumen of the drive shaft.

10. The device of claim 9, wherein the outflow opening of the proximal inflatable counterweight has an axis which form angles of about ninety (90) degrees with the longitudinal axis of the drive shaft when the distal fluid inflatable support element is inflated, wherein the outflow opening is configured to output fluid flow for forming a fluid bearing between the outer wall of the rotating distal inflatable counterweight and the vessel during rotation and back and forth movements of the drive shaft within the vessel.