Rotational atherectomy system

• US 9,883,886 B2
• Filed: 04/30/2013
• Issued: 02/06/2018
• Est. Priority Date: 11/23/2007
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Primary Examiner(s): Rodjom, Katherine
• Application Number:
  US13/873,776
• Publication Number:
  US 20130274773A1
• Time in Patent Office: 1,743 Days
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• 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 17/3207 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 17/320758 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

Abstract

An atherectomy system for removing a stenotic lesion from within a vessel of a patient is disclosed. The system comprising an atherectomy device for reducing the lesion and a separate elongate drainage catheter for evacuating from the treated vessel embolic particles released into the vessel from the stenotic lesion during its reduction by the atherectomy device during an atherectomy procedure. The atherectomy device and the separate elongate drainage catheter are each configured for introduction into the patient'"'"'s vasculature though separate openings in at least one peripheral artery of the patient.

Claims

1. A system for performing rotational atherectomy to remove stenotic lesion material from within a peripheral artery of a leg of a patient, the system comprising:

a guidewire configured to be advanced within the peripheral artery and across a stenotic lesion within the peripheral artery such that a distal end portion of the guidewire is positioned below a knee of the leg;

a drive shaft sheath defining a sheath lumen, the sheath lumen configured to slidably receive a rotational atherectomy device such that a distal end portion of the rotational atherectomy device is advanceable out of a distal end of the sheath lumen to position a solid eccentric abrasive element of the rotational atherectomy device at the stenotic lesion and such that the rotational atherectomy device is rotatable within the drive shaft sheath while the drive shaft sheath is stationary; and

the rotational atherectomy device comprising;

a first stability element

an elongate flexible drive shaft comprising a torque transmitting coil that defines a central lumen and a longitudinal axis of the flexible draft shaft, the torque transmitting coil having a uniform coil diameter along a portion to which the abrasive element and the first stability element is mounted, and the central lumen configured to slidably receive the guidewire such that the drive shaft is advanceable over the guidewire to a location of the stenotic lesion and rotatable around the guidewire while the guidewire is stationary and extends distally of the torque transmitting coil and the drive shaft sheath; and

the abrasive element; and

wherein the abrasive element and the first stability element are 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 while a center of mass of the first stability element is aligned with the longitudinal axis of the drive shaft, the first stability element being distally spaced apart from the eccentric abrasive element and being configured to rotate contemporaneously with the eccentric abrasive element and the torque transmitting coil while the eccentric abrasive element and a portion of the torque transmitting coil to which the eccentric abrasive element is mounted on rotates in an orbital path around an axis of rotation of non-orbiting portions of the drive shaft to perform rotational atherectomy.

2. The system of claim 1, further comprising a fluid impermeable membrane along the drive shaft and surrounding an outer diameter of at least a portion of the drive shaft.

3. The system of claim 2, wherein the torque transmitting coil and the fluid impermeable membrane extend distally beyond the eccentric abrasive element.

4. The system of claim 2, wherein the fluid impermeable membrane surrounds the drive shaft extending between the first stability element and the eccentric abrasive element.

5. The system of claim 2, wherein the fluid impermeable membrane provides a fluid-impermeable lumen along the drive shaft.

6. The system of claim 2, wherein the fluid impermeable membrane surrounds the drive shaft extending between the first stability element and the eccentric abrasive element.

7. The system of claim 1, further comprising a second stability element that is fixed to the drive shaft and that has a center of mass aligned with the longitudinal axis, the second stability element being proximally spaced apart from the abrasive element.

8. The system of claim 7, wherein the first and second stability elements are equally spaced apart from the abrasive element.

9. The system of claim 1, wherein the first stability element is a solid element.

10. The system of claim 1, wherein said torque transmitting coil is an inner torque transmitting coil, and the drive shaft further comprises an outer torque transmitting coil that surrounds at least a portion of the inner torque transmitting coil.

11. The system of claim 1, wherein the abrasive element extends around less than a full circumference of the drive shaft, and wherein the abrasive element comprises an abrasive outer surface that is fixedly positioned relative to the drive shaft.

12. The system of claim 1, wherein, in response to rotation of the torque transmitting coil about the longitudinal axis, the torque transmitting coil of the drive shaft drives simultaneous rotation of both the eccentric abrasive element and the first stability element having the center of mass aligned with the longitudinal axis.

13. The system of claim 12, further comprising a fluid impermeable membrane along the drive shaft and surrounding an outer diameter of at least a portion of the drive shaft.

14. The system of claim 13, wherein the torque transmitting coil and the fluid impermeable membrane extend distally beyond the eccentric abrasive element.

15. The system of claim 1, wherein the drive shaft and eccentric abrasive element are sized and configured to rotate within a carotid artery to remove the stenotic lesion material from the carotid artery.

16. The system of claim 1, further 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 a distal end portion of the drainage catheter, the balloon member in fluid communication with the first lumen, the balloon member configured to contact a wall of the peripheral artery when the balloon member is in an inflated configuration, wherein the inflatable balloon member comprises an occlusion balloon to occlude the peripheral artery.

17. The system of claim 1, wherein the portion of the torque transmitting coil is cylindrical.

18. The system of claim 1, wherein the abrasive element extends a first distance in a first traverse direction away from the longitudinal axis of the drive shaft and extends a second distance in a second transverse direction away from the longitudinal axis of the drive shaft, the first distance being greater than the second distance, and the first transverse direction being different from the second transverse direction.

19. The system of claim 1, wherein the center of mass of the stability element is spaced apart from the center of mass of the abrasive element along the longitudinal axis of the drive shaft by a distance of at least one length of the abrasive element.

20. The system of claim 1, wherein the abrasive element and the first stability element move in orbital fashions around the axis of rotation of the drive shaft in orbits that are substantially larger than the respective diameters of the abrasive element or first stability element.

21. A system for performing rotational atherectomy to remove stenotic lesion material from within a peripheral artery of a leg of a patient, the system comprising:

a guidewire configured to be advanced within the peripheral artery and across a stenotic lesion within the peripheral artery such that a distal end portion of the guidewire is positioned below a knee of the leg;

a drive shaft sheath defining a sheath lumen, the sheath lumen configured to slidably receive a rotational atherectomy device such that a distal end portion of the rotational atherectomy device is advanceable out of a distal end of the sheath lumen to position a solid eccentric abrasive element of the rotational atherectomy device at the stenotic lesion and such that the rotational atherectomy device is rotatable within the drive shaft sheath while the drive shaft sheath is stationary; and

the rotational atherectomy device comprising;

an elongate flexible drive shaft comprising a torque transmitting coil that defines a central lumen and a longitudinal axis of the flexible draft shaft, and the central lumen configured to slidably receive the guidewire such that the drive shaft is advanceable over the guidewire to a location of the stenotic lesion and rotatable around the guidewire while the guidewire is stationary and extends distally of the torque transmitting coil and the drive shaft sheath;

the abrasive element 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 first stability element mounted to the drive shaft such that a center of mass of the first stability element is aligned with the longitudinal axis of the drive shaft, the first stability element being distally spaced apart from the eccentric abrasive element and being configured to rotate contemporaneously with the eccentric abrasive element and the torque transmitting coil while the eccentric abrasive element rotates in an orbital path of the peripheral artery to perform rotational atherectomy;

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

wherein the first and second stability elements comprise inflatable stability elements.