Rotational atherectomy devices and methods

Patent metadata

Field	Value
Publication number	US-12440237-B2
Application number	US-202519210219-A
Country	US
Kind code	B2
Filing date	May 16, 2025
Priority date	Jun 27, 2023
Publication date	Oct 14, 2025
Grant date	Oct 14, 2025

Abstract

Some embodiments of a rotational atherectomy device can remove (partially or completely) stenotic lesions in blood vessels by rotating one or more abrasive elements in an orbital path to abrade and breakdown the lesion. In particular implementations, multiple abrasive elements are arranged along a distal portion of a drive shaft with an improved configuration so as to facilitate both efficient navigation into smaller blood vessels below the ankle or in the heart and effective orbital paths for abrading stenotic material in such smaller vessels.

First claim

What is claimed is:

1. A rotational atherectomy system for slidable insertion through a 4-French introducer sheath, comprising:
a 4-French introducible rotational atherectomy device, comprising:
a torque-transmitting coil of one or more filars that are helically wound around in a filar wind direction from a distal end to a proximal end to define an outer coil diameter and a drive shaft axis; and
a series of abrasive eccentric burrs fixedly mounted to a distal end portion of the torque-transmitting coil and having a maximum burr diameter of no greater than 1.25 mm such that a burr-to-coil diameter ratio defined by each respective burr diameter and the outer coil diameter is 1.7 or less, wherein the series of abrasive burrs includes a distal eccentric abrasive burr, an intermediate eccentric abrasive burr, and a proximal eccentric abrasive burr that are equally sized and mounted in an eccentric spiral arrangement along the torque-transmitting coil so that centers of mass for the distal, intermediate, and proximal abrasive eccentric burrs are offset from the drive shaft axis in different planes; and

a rotational atherectomy handle assembly coupled to a proximal end of the torque-transmitting coil and housing an electric motor configured to, responsive to user input at an actuator of the rotational atherectomy handle assembly, drive rotation of the series of abrasive burrs about the drive shaft axis in a rotational drive direction.

2. The rotational atherectomy system claim 1 , further comprising a sheath that extends from the rotational atherectomy handle assembly and over the torque transmitting coil, wherein the rotational atherectomy handle assembly is configured to longitudinally adjust the torque-transmitting coil relative to the sheath such that, in a proximal position, the series of abrasive burrs are housed within a distal-most end of the sheath.

3. The rotational atherectomy system of claim 2 , wherein responsive to distal longitudinal movement of the actuator of the rotational atherectomy handle assembly, the series of abrasive burrs are adjusted to a distal position so as to extend distally from the distal-most end of the sheath.

4. The rotational atherectomy system of claim 3 , wherein the electric motor housed within the rotational atherectomy handle assembly is prevented from rotating the torque-transmitting coil when the series of abrasive burrs are in the proximal position and housed within the distal-most end of the sheath.

5. The rotational atherectomy system of claim 4 , wherein when the series of abrasive burrs are adjusted to the distal position to extend distally from the distal-most end of the sheath, a switch that is housed within the rotational atherectomy handle assembly is triggered and the electric motor is selectively activatable to drive rotation of the series of abrasive burrs.

6. The rotational atherectomy system of claim 5 , wherein when the actuator of the rotational atherectomy handle assembly is adjusted to a location proximal of a threshold position along an upper face of the rotational atherectomy handle assembly, the series of abrasive burrs are in the proximal position and housed within the distal-most end of the sheath.

7. The rotational atherectomy system of claim 6 , wherein when the actuator of the rotational atherectomy handle assembly is adjusted to a location distal of the threshold position along the upper face of the rotational atherectomy handle assembly, the series of abrasive burrs are in the distal position and extend distally from the distal-most end of the sheath.

8. The rotational atherectomy device of claim 5 , wherein contemporaneous with selective activation to drive rotation of the series of abrasive burrs, the torque transmitting coil is selectively translatable distally and proximally along the drive shaft axis.

9. The rotational atherectomy device of claim 8 , further comprising a power button at the rotational atherectomy handle assembly that is selectable to activate the electric motor.

10. The rotational atherectomy device of claim 9 , wherein, responsive to selection of the power button with the series of abrasive burrs in the distal position, the electric motor activates to drive rotation of the series of abrasive burs.

11. The rotational atherectomy system of claim 1 , wherein the distal eccentric abrasive burr has a center of mass offset in a first plane, and the intermediate abrasive eccentric burr has a center of mass offset in a second plane that is radially spaced from the first plane at the radial spacing angle of 20 degrees to 60 degrees.

12. The rotational atherectomy system of claim 11 , wherein the proximal eccentric abrasive burr has a center of mass offset in a third plane that is radially spaced from the second plane at the radial spacing angle of 20 degrees to 60 degrees.

13. The rotational atherectomy system of claim 11 , wherein a combined radial spacing angle for all abrasive eccentric burrs in the series of abrasive burrs is less than 90 degrees.

14. The rotational atherectomy system of claim 1 , wherein each abrasive burr of the series of abrasive burrs is a metallic burr coated with diamond grit.

15. The rotational atherectomy system of claim 1 , wherein the electric motor housed within the rotational atherectomy handle assembly is configured to rotate the torque-transmitting coil so that the series of abrasive burrs orbit in the rotational drive direction about the drive shaft axis.

16. The rotational atherectomy system of claim 15 , wherein the filar wind direction from the distal end to the proximal end of the torque-transmitting coil is opposite from the rotational drive direction urged by the electric motor housed within the rotational atherectomy handle assembly.

17. The rotational atherectomy system of claim 1 , wherein the torque transmitting coil is selectively translatable distally and proximally along the drive shaft axis while the electric motor drives rotation of the series of abrasive burrs.

18. The rotational atherectomy system of claim 17 , further comprising a power button positioned on the actuator of the rotational atherectomy handle assembly and being selectable to activate the electric motor.

19. The rotational atherectomy system of claim 1 , wherein the series of abrasive burrs are metallic components welded to the torque-transmitting coil.

20. The rotational atherectomy system of claim 1 , wherein the series of abrasive eccentric burrs consists of the distal eccentric abrasive burr, an intermediate eccentric abrasive burr, and the proximal eccentric abrasive burr.

Assignees

• Cardio Flow Inc

Inventors

• Mustapha Jihad A
• Petrucci Gary M
• Benjamin Albert Selden
• Welty Ryan D

Classifications

• A61B17/320725

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

• A61B17/3207

  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 title

• A61B2017/320766

  eccentric · CPC title

• A61B2017/320004

  abrasive · CPC title

• A61B17/320758 Primary

  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 title