Rotational atherectomy device

Patent metadata

Field	Value
Publication number	US-9364256-B2
Application number	US-201313953012-A
Country	US
Kind code	B2
Filing date	Jul 29, 2013
Priority date	Jul 13, 2006
Publication date	Jun 14, 2016
Grant date	Jun 14, 2016

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 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 is inflatable by pressurized fluid which flows in an antegrade direction through said lumen of the drive shaft and is least partially re-directed into the distal fluid inflatable support element. The distal fluid inflatable support element has an outer wall comprising an outflow opening.

First claim

The invention claimed is:

1. 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 having a fluid impermeable membrane defining a central lumen and a longitudinal axis, the drive shaft configured for rotation about the longitudinal axis, the drive shaft having a torque-transmitting coil along a first portion of the drive shaft and extending to a distal portion of the drive shaft, the first portion of the drive shaft configured to be at least partially disposed within the sheath lumen while the distal portion of the drive shaft extends distally of the sheath lumen when the system is used for performing the rotational atherectomy, wherein the torque-transmitting coil is exposed along an exterior circumference of the first portion of the drive shaft;
a solid abrasive element that is mounted to the distal portion of the drive shaft and extends around less than half of a circumference of the drive shaft such that a center of mass of the solid abrasive element is offset from the longitudinal axis of the drive shaft, wherein the solid 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 distal portion the drive shaft and that has a center of mass aligned with the longitudinal axis, the first stability element being distally spaced apart from the solid abrasive element.

2. The system of claim 1 , wherein the first and second stability elements comprise inflatable stability elements.

3. The system of claim 1 , wherein the drive shaft and fluid impermeable membrane extend distally beyond the solid abrasive element.

4. 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 solid abrasive element.

5. The system of claim 4 , wherein the first and second stability elements are equally spaced apart from the solid abrasive element.

6. The system of claim 1 , further comprising a guidewire configured to be slidably withdrawn into a fluid-impermeable lumen of the drive shaft.

7. 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 through a sheath lumen of an elongate drive shaft sheath and into the blood vessel, wherein the rotational atherectomy device comprises:
an elongate flexible drive shaft comprising a fluid impermeable membrane along the drive shaft, a torque-transmitting coil along a first portion of the drive shaft and extending to a distal portion of the drive shaft, the drive shaft defining a central lumen and a longitudinal axis, the drive shaft configured to rotate about the longitudinal axis, the first portion of the drive shaft configured to be at least partially disposed within the sheath lumen while the distal portion of the drive shaft extends distally of the sheath lumen when the system is used for performing the rotational atherectomy, wherein the torque-transmitting coil is exposed along an exterior circumference of the first portion of the drive shaft;
a solid 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 solid abrasive element is offset from the longitudinal axis of the drive shaft, wherein the solid abrasive element comprises an abrasive outer surface that is fixedly positioned relative to the drive shaft; and
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, the proximal stability element being proximally spaced apart from the solid abrasive element by a first distance;
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, the distal stability element being distally spaced apart from the solid abrasive element by the first distance; and
rotating the drive shaft about the longitudinal axis such that the solid abrasive element contacts the stenotic lesion.

8. The method of claim 7 , wherein during said rotation, the solid 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.

9. The method of claim 7 , wherein the delivering the rotational atherectomy device into the blood vessel comprises advancing the drive shaft over a guidewire across the stenotic lesion.

10. The method of claim 7 , wherein the rotating causes the solid abrasive element to remove lesion material particles from the stenotic lesion.

11. The method of claim 10 , further comprising: aspirating the lesion material particles into the sheath lumen.

12. The system of claim 1 , wherein the solid abrasive element defines a slot.

13. The system of claim 12 , wherein the solid abrasive element is mounted to the drive shaft by a flexible strap which extends through said slot and is connected to the drive shaft.

14. The system of claim 1 , wherein the solid abrasive element has a leading edge and a trailing edge relative to a rotational direction of the drive shaft, the leading edge of the abrasive element being thinner than the trailing edge.

15. The system of claim 1 , wherein the solid abrasive element extends around less than a third of the circumference of the drive shaft.

16. The system of claim 1 , wherein the first stability element is fixedly positioned at a distal tip of the drive shaft.

17. The system of claim 1 , wherein the first stability element comprises an inflatable stability element.

18. The system of claim 17 , wherein the first stability element comprises a fluid inflatable distal counterweight that rotates together with the abrasive element in response to rotation of the drive shaft, wherein the fluid inflatable distal counterweight is inflatable in response to fluid transferring into an inflatable space of the fluid inflatable distal counterweight.

19. The system of claim 18 , wherein the fluid inflatable distal counterweight includes a flexible outer wall comprising at least one outflow opening configured to output fluid flow from the inflatable space of the fluid inflatable distal counterweight during rotation of the fluid inflatable distal counterweight.

20. The system of claim 1 , wherein the drive shaft comprises a closable valve positioned proximate to a distal end of the drive shaft.

Assignees

• Cardio Flow Inc
• Nadirashvili Lela

Inventors

• Shturman Leonid

Classifications

• A61B2017/22062

  to be filled with liquid · CPC title

• A61B17/320725

  with radially expandable cutting or abrading elements (A61B17/32075 takes precedence) · CPC title

• A61B2217/007

  with irrigation system · CPC title

• A61B2017/320716

  comprising means for preventing embolism by dislodged material · CPC title

• A61B2017/320004

  abrasive · CPC title