Rotational atherectomy device with eccentric abrasive element and method of use

• US 8,663,260 B2
• Filed: 04/06/2010
• Issued: 03/04/2014
• Est. Priority Date: 04/03/2009
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Primary Examiner(s): McEvoy, Thomas
• Assistant Examiner(s): TANNER, JOCELIN C
• Application Number:
  US13/262,795
• Publication Number:
  US 20120035633A1
• Time in Patent Office: 1,428 Days
• Field of Search: 606/159, 606/170, 606/128, 606/130, 606/167, 606/180, 606/194, 606/171, 600/566, 600/567, 600/564, 600/113, 604/22, 604/101.01, 604/101.05
• 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 shaft 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 an iliac artery of a patient using such a rotational atherectomy device.

Claims

1. A rotational atherectomy device for removing a stenotic tissue from the iliac artery of a patient, the device comprising a flexible, rotatable drive shaft having an elongated proximal portion, an elongated distal portion, and an eccentric abrasive element mounted to the drive shaft between the elongated proximal and distal portions of the drive shaft 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 being configured for rapid rotation together with the drive shaft, the drive shaft being configured for extending throughout an entire length of the iliac artery to be treated and having one elongated portion of the drive shaft extending out of the patient through a first access opening located in a femoral artery which is ipsilateral to the treated artery, and the other elongated portion of the drive shaft extending through a second access opening located in another peripheral artery of the patient, wherein the device includes a pair of prime movers and each of the elongated portions of the drive shaft is configured to be connected to a rotatable shaft of one of the two prime movers, the prime movers being configured for rotating the drive shaft, and wherein each of the prime movers is slidably received within a housing of an advancer mechanism so that an operator can alternately pull on distal and proximal portions of the drive shaft by alternately moving the prime movers away from distal ends of the housings of the advancer mechanisms.

2. A rotational atherectomy device according to claim 1, wherein the device includes a pair of elongated drive shaft sheaths, one drive shaft sheath configured for slidably receiving the elongated proximal portion of the drive shaft and the other drive shaft sheath configured for slidably receiving the elongated distal portion of the drive shaft, the drive shaft sheaths having distal ends and being configured for advancement around corresponding portions of the drive shaft into the treated iliac artery such that the distal ends of the sheaths become positioned spaced away from the counterweights, the space between the distal ends of the drive shaft sheaths allowing to repeatedly move the rotating abrasive element back and forth along the treated iliac artery and abrade the stenotic lesion.

3. A rotational atherectomy device according to claim 2, wherein one of the drive shaft sheaths is in a fluid communication with a source of pressurized fluid, said pressurized fluid flows into the treated artery through said one drive shaft sheath, entrains abraded embolic particles, and is drained out from the treated artery through the other drive shaft sheath.

4. A rotational atherectomy device according to claim 3, wherein an inflatable occlusion balloon is mounted to the distal drive shaft sheath, the inflatable occlusion balloon being configured, when inflated, to restrict the flow fluids and abraded particles from the treated stenotic lesion into the femoral artery.

5. A rotational atherectomy device for removing a stenotic tissue from an artery of a patient, the device comprising a flexible, rotatable drive shaft having an elongated proximal portion, an elongated distal portion, and an eccentric abrasive element mounted to the drive shaft between the elongated proximal and distal portions of the drive shaft 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 being configured for rapid rotation together with the drive shaft, the drive shaft being configured for extending throughout an entire length of the artery to be treated and having one elongated portion of the drive shaft extending out of the patient through a first access opening located in a femoral artery, and the other elongated portion of the drive shaft extending through a second access opening located in another peripheral artery of the patient, wherein the device includes a pair of prime movers and each of the elongated portions of the drive shaft is configured to be connected to a rotatable shaft of one of the two prime movers, the prime movers being configured for rotating the drive shaft, and wherein each of the prime movers is slidably received within a housing of an advancer mechanism so that an operator can alternately pull on distal and proximal portions of the drive shaft by alternately moving the prime movers away from distal ends of the housings of the advancer mechanisms.

6. A rotational atherectomy device according to claim 5, wherein the device includes a pair of elongated drive shaft sheaths, one drive shaft sheath configured for slidably receiving the elongated proximal portion of the drive shaft and the other drive shaft sheath configured for slidably receiving the elongated distal portion of the drive shaft, the drive shaft sheaths having distal ends and being configured for advancement around corresponding portions of the drive shaft into the treated artery such that the distal ends of the sheaths become positioned spaced away from the counterweights, the space between the distal ends of the drive shaft sheaths allowing to repeatedly move the rotating abrasive element back and forth along the treated artery and abrade the stenotic lesion.

7. A rotational atherectomy device according to claim 6, wherein one of the drive shaft sheaths is in a fluid communication with a source of pressurized fluid, said pressurized fluid flows into the treated artery through said one drive shaft sheath, entrains abraded embolic particles, and is drained out from the treated artery through the other drive shaft sheath.

8. A rotational atherectomy device according to claim 6, wherein the other elongated drive shaft sheath includes a separate drainage lumen which is configured exclusively for draining fluid and abraded particles out from the treated artery.

9. A rotational atherectomy device according to claim 8, wherein the other elongated drive shaft sheath includes an occlusion balloon inflation lumen.

10. A rotational atherectomy device according to claim 5, the drive shaft has a longitudinal axis, and the center of mass of the eccentric abrasive element and the centers of mass of the counterweights are spaced in opposite directions with respect to the longitudinal axis of the drive shaft.

11. A rotational atherectomy device according to claim 5, wherein each of the two elongated portions of the drive shaft is at least 15 centimeters long.

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

providing a flexible, rotatable drive shaft having an elongated proximal portion, an elongated distal portion, and an abrasive element mounted to the drive shaft between the elongated proximal and distal portions of the drive shaft 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 being configured for rapid rotation together with the drive shaft;

providing a pair of elongate drive shaft sheaths configured for slidably receiving the proximal portion of the drive shaft within one sheath and the distal portion of the drive shaft within the other sheath, the drive shaft sheaths having distal ends and configured for extending around the drive shaft into the treated iliac artery such that the distal ends of the sheaths are positioned in the artery spaced away from the abrasive element, the space between the distal ends of the drive shaft sheaths allowing the rotating abrasive element to move back and forth along the treated iliac artery and abrade the treated stenotic lesion;

providing a prime mover for rotating the drive shaft and a source of pressurized fluid for pumping a fluid through one sheath and draining said fluid and abraded particles through the another) sheath;

providing an advancer mechanism for repeatedly moving the rotating drive shaft and its abrasive element back and forth across the treated stenotic lesion; and

positioning the drive shaft such that the drive shaft extends throughout an entire length of the iliac artery to be treated, one elongated portion of the drive shaft extending out of the patient through a first access opening located in one peripheral artery of the patient and the other elongated portion of the drive shaft extending through a second access opening located in another peripheral artery of the patient.

13. A method of treating an iliac artery of a patient according to claim 12, wherein the first access opening is located in a femoral artery which is ipsilateral with respect to the treated iliac artery and the second access opening is located in a femoral artery which is contralateral with respect to the iliac artery to be treated.

14. A method of treating an iliac artery of a patient according to claim 13, comprising the step of positioning the abrasive element within stenotic lesion to be treated and locating the drive shaft sheaths in the treated artery such that their distal ends are spaced away from the counterweights.

15. A method of treating an iliac artery of a patient according to claim 12, wherein the first access opening is located in a femoral artery which is ipsilateral with respect to the treated iliac artery and the second access opening is located in an artery of the upper extremity of the patient.