ROTATIONAL ATHERECTOMY DEVICE WITH ECCENTRIC ABRASIVE ELEMENT AND METHOD OF USE

• US 20140180317A1
• Filed: 02/03/2014
• Published: 06/26/2014
• Est. Priority Date: 04/03/2009
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Granted Patent: US 9,089,362 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• 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 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/32006 with a cutting strip, band or chain, e.g. like a chainsaw
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61B 2017/320766 eccentric

Abstract

A rotational atherectomy device for removing a stenotic tissue from the iliac artery of a patient. The device comprises a flexible, rotatable drive shaft having an elongated proximal portion, an elongated distal portion. An abrasive element is mounted to the drive shaft between the elongated proximal and distal portions of the drive shad and between and spaced away from a pair of counterweights which are mounted to said elongated portions of the drive shaft. The eccentric abrasive element and the counterweights are configured for rapid rotation together with the drive shaft, the drive shaft is configured to extend throughout an entire length of the iliac artery to be treated. One elongated portion of the drive shaft extends out of the patient through a first access opening located in a femoral artery which is ipsilateral to the treated artery. Another elongated portion of the drive shaft extending through a second access opening located in another peripheral artery of the patient. A method of treating are iliac artery of a patient using such a rotational atherectomy device.

Claims

1-45. -45. (canceled)

46. A system for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient, the system comprising:

an elongate drainage catheter defining a first lumen and a second lumen, the drainage catheter including an inflatable balloon member attached to and surrounding an outer diameter of an end portion of the drainage catheter, the balloon member in fluid communication with the first lumen, the balloon member configured to contact a blood vessel wall when the balloon member is in an inflated configuration; and

a rotational atherectomy device comprising;

an elongate flexible drive shaft defining a central lumen and a longitudinal axis, the drive shaft configured for rotation about the longitudinal axis, the drive shaft configured to be at least partially disposed within the blood vessel and at least partially disposed within the second lumen when the system is used for performing the rotational atherectomy;

an eccentric abrasive element that is mounted to the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis of the drive shaft; and

a pair of stability elements including a first stability element that is fixed to the drive shaft at a location proximal to the abrasive element, and a second stability element that is fixed to the drive shaft at a location distal to the abrasive element, wherein a distal portion of the drive shaft extends distally of the second stability element for a length that is greater than an axial length of the second stability element.

47. The system of claim 46, wherein the distal portion extends at least 10 centimeters.

48. The system of claim 46, wherein the first and second stability elements are equally spaced apart from the abrasive element.

49. The system of claim 46, further comprising a guidewire configured to be slidably disposed within the central lumen of the drive shaft.

50. The system of claim 46, further comprising a prime mover configured for rotating the drive shaft.

51. The system of claim 46, wherein the first stability element is a first counterweight, and the second stability element is a second counterweight.

52. A method of treating an iliac artery of a patient comprising the steps of:

positioning an elongate drainage catheter of a system for performing rotational atherectomy in a blood vessel of a patient, the elongate drainage catheter defining a first lumen and a second lumen, the drainage catheter including an inflatable balloon member attached to and surrounding an outer diameter of an end portion of the drainage catheter, the balloon member in fluid communication with the first lumen, the balloon member configured to contact a blood vessel wall when the balloon member is in an inflated configuration; and

rotating a rotational atherectomy device of the system while the rotational atherectomy device is at least partially disposed with the second lumen of the elongate drainage catheter, the rotational atherectomy device comprising an elongate flexible drive shaft defining a central lumen and a longitudinal axis, the drive shaft configured for rotation about the longitudinal axis,an eccentric abrasive element that is mounted to the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis of the drive shaft, and a pair of stability elements including a first stability element that is fixed to the drive shaft at a location proximal to the abrasive element, and a second stability element that is fixed to the drive shaft at a location distal to the abrasive element, wherein a distal portion of the drive shaft extends distally of the second stability element, wherein said rotating the rotational atherectomy device is caused by a prime mover for rotating the drive shaft;

repeatedly moving the rotating drive shaft and its abrasive element back and forth across a stenotic lesion to remove stenotic lesion material from the blood vessel, wherein the abrasive element abrades the stenotic lesion material from the blood vessel.

53. The method of claim 52, further comprising locating the drainage catheter in the blood vessel such that a distal end of the drainage catheter is spaced away from the first stability element.

54. The method of claim 52, wherein the first stability element is a first counterweight, and the second stability element is a second counterweight.

55. The method of claim 54, further comprising inflating the inflatable balloon member and aspirating stenotic lesion material through the second lumen of the drainage catheter.

56. The method of claim 55, further comprising:

deflating the inflatable balloon member;

repositioning the drive shaft within the blood vessel; and

repeating the steps of rotating the rotational atherectomy device and repeatedly moving the rotating drive shaft and its abrasive element back and forth across the stenotic lesion.

57. The method of claim 52, further comprising:

advancing the intravascular ultrasound imaging catheter over the drive shaft into the blood vessel and across the stenotic lesion, and

acquiring cross-sectional images of the stenotic lesion area.