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

• US 9,192,405 B2
• Filed: 07/08/2013
• Issued: 11/24/2015
• Est. Priority Date: 07/13/2006
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US13/936,338
• Publication Number:
  US 20130296904A1
• Time in Patent Office: 869 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: 1/1
• 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 stenotic lesion material from a blood vessel of a patient, the device comprising:

an elongate flexible drive shaft comprising an inner torque transmitting coil, the drive shaft defining a central lumen and a longitudinal axis, the drive shaft configured to rotate about the longitudinal axis;

an abrasive element that is mounted to the drive shaft and extends around less than half of a circumference of the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis of the drive shaft, wherein the abrasive element comprises an abrasive outer surface that is fixedly positioned relative to the drive shaft;

a proximal stability element that is fixed to the drive shaft and that has a center of mass aligned with the longitudinal axis of the drive shaft;

a distal stability element that is fixed to the drive shaft and that has a center of mass aligned with the longitudinal axis of the drive shaft; and

a fluid impermeable membrane along the drive shaft and surrounding the inner torque- transmitting coil, wherein the inner torque transmitting coil and the fluid impermeable membrane each extend distally beyond the abrasive element;

wherein the drive shaft further comprises an outer torque transmitting coil surrounding at least a portion of the fluid impermeable membrane.

2. The device of claim 1, wherein the proximal and distal stability elements comprise inflatable stability elements.

3. The device of claim 1, wherein the central lumen is configured to receive a guidewire.

4. The device of claim 1, wherein the proximal and distal stability elements are equally spaced apart from the abrasive element.

5. The device of claim 1, wherein the fluid impermeable membrane provides a fluid-impermeable lumen along the drive shaft.

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

an elongate drive shaft sheath defining a sheath lumen therethrough, the drive shaft sheath being configured to be at least partially disposed within the blood vessel; and

a rotational atherectomy device slidable through the elongate drive shaft sheath toward stenotic lesion material in a blood vessel, comprising;

an elongate flexible drive shaft comprising an inner torque transmitting coil, the drive shaft defining a central lumen and a longitudinal axis, the drive shaft configured to rotate about the longitudinal axis, the drive shaft configured to be at least partially disposed within the sheath lumen when the system is used for performing the rotational atherectomy;

an abrasive element that is mounted to the drive shaft and extends around less than half of a circumference of the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis of the drive shaft, wherein the abrasive element comprises an abrasive outer surface that is fixedly positioned relative to the drive shaft; and

a first stability element that is fixed to the drive shaft and that has a center of mass coaxial with the longitudinal axis, the first stability element being distally spaced apart from the abrasive element; and

a fluid impermeable membrane along the drive shaft and surrounding the inner torque-transmitting coil, wherein the inner torque transmitting coil and the fluid impermeable membrane each extend distally beyond the abrasive element;

wherein the drive shaft further comprises an outer torque transmitting coil surrounding at least a portion of the fluid impermeable membrane.

7. The system of claim 6, wherein the first stability elements comprises an inflatable stability elements.

8. The system of claim 6, further comprising a second stability element that is fixed to the drive shaft and that has a center of mass coaxial with the longitudinal axis, the second stability element being proximally spaced apart from the abrasive element.

9. The system of claim 8, wherein the first and second stability elements are equally spaced apart from the abrasive element.

10. The system of claim 6, further comprising a guidewire configured to be slidably withdrawn into a fluid-impermeable lumen of the drive shaft.

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

delivering a rotational atherectomy device into the blood vessel, wherein the rotational atherectomy device comprises;

an elongate flexible drive shaft comprising an inner torque transmitting coil, the drive shaft defining a central lumen and a longitudinal axis, the drive shaft configured to rotate about the longitudinal axis;

an abrasive element that is mounted to the drive shaft and extends around less than half of a circumference of the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis of the drive shaft, wherein the abrasive element comprises an abrasive outer surface that is fixedly positioned relative to the drive shaft;

a proximal stability element that is fixed to the drive shaft and that has a center of mass coaxial with the longitudinal axis of the drive shaft;

a distal stability element that is fixed to the drive shaft and that has a center of mass coaxial with the longitudinal axis of the drive shaft; and

a fluid impermeable membrane along the drive shaft and surrounding the inner torque-transmitting coil, wherein the inner torque transmitting coil and the fluid impermeable membrane each extend distally beyond the abrasive element.; and

rotating the drive shaft about the longitudinal axis such that the abrasive element contacts the stenotic lesion;

wherein the drive shaft further comprises an outer torque transmitting coil surrounding at least a portion of the fluid impermeable membrane.

12. The method of claim 11, wherein during said rotation, the abrasive element has an orbital path about an axis of rotation, the orbital path having a substantially greater diameter than a travel path of each of the proximal and distal stability elements.

13. The method of claim 11, wherein the delivering the rotational atherectomy device into the blood vessel comprises advancing the drive shaft over a guidewire across the stenotic lesion.

14. The method of claim 11, wherein the rotating causes the abrasive element to remove lesion material particles from the stenotic lesion.

15. The method of claim 14, further comprising:

delivering an elongate drive shaft sheath at least partially into the blood vessel, the drive shaft sheath defining a sheath lumen therethrough, at least a portion of the drive shaft being disposed within the sheath lumen.

16. The method of claim 15, further comprising:

aspirating the lesion material particles into the sheath lumen.