Rotational Atherectomy Device with Fluid Inflatable Support Elements and Distal Protection Capability

• US 20140180318A1
• Filed: 02/25/2014
• Published: 06/26/2014
• Est. Priority Date: 11/23/2006
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Granted Patent: US 8,936,589 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 2017/00557 inflatable A61B2017/22051 takes 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 2017/22071 Steering
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft
• CPC Class Codes: A61B 2017/320766 eccentric
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• 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 abrading a stenotic lesion from a vessel of a patient comprises a flexible drive shaft (1) which extends towards a distal end of the device, a distal fluid inflatable support element (3, 3″) located at a distal end of the drive shaft and an abrasive element (5) mounted to the drive shaft proximal to and spaced away from the distal fluid inflatable support element. Both the abrasive element and the distal fluid inflatable support element are rotatable together with the drive shaft and the drive shaft comprises a torque transmitting coil (2) which defines a long lumen of the drive shaft. The distal fluid inflatable support element is formed from a fluid impermeable membrane (9, 9″) that crosses a longitudinal axis (x-x) common to the torque transmitting coil and the lumen of the drive shaft at the distal end of the device, thereby preventing pressurized fluid flowing along the lumen of the drive shaft from entering the vessel in the direction of said longitudinal axis so that fluid has to pass through the fluid inflatable support element, inflating said support element and exiting from the device through an outflow opening (66) in the fluid inflatable support element in a direction different from the direction of the longitudinal axis of the coil and the lumen.

Claims

1. A method of using a rotational atherectomy device to remove a stenotic lesion from within a blood vessel, 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 blood vessel while an abrasive element of the rotational atherectomy device is positioned proximal of the stenotic lesion in the blood vessel and a proximal fluid inflatable counterweight is located proximal of the abrasive element, wherein the rotational atherectomy device comprises a rotatable, flexible drive shaft defining a fluid transport to the distal and proximal fluid inflatable counterweight, and wherein a distal end of the fluid transport lumen of the drive shaft is continuously closed by a fluid impermeable wall that crosses a longitudinal axis of the drive shaft such that fluid is prevented from exiting the fluid transport lumen in a longitudinal direction when fluid is moved through the fluid transport lumen;

inflating the distal and proximal fluid inflatable counterweights 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 blood vessel;

rotating the drive shaft of the rotational atherectomy device such that the 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 blood vessel with the abrasive element with while the abrasive element rotates together with the distal fluid inflatable counterweight, the proximal counterweight, and the drive shaft.