Spin-to-open atherectomy device with electric motor control

• US 10,052,122 B2
• Filed: 01/15/2015
• Issued: 08/21/2018
• Est. Priority Date: 01/17/2014
• Status: Active Grant

• Current Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Inventors: Higgins, Joseph P., Schoenle, Victor L., Grace, Michael J., Cambronne, Matthew D., Kohler, Robert E.
• Primary Examiner(s): Orkin, Alexander
• Application Number:
  US14/597,932
• Publication Number:
  US 20150201956A1
• Time in Patent Office: 1,314 Days
• 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 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/22045 fixed to the catheter; guiding tip
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft
• CPC Class Codes: A61B 2017/320766 eccentric
• CPC Class Codes: A61B 2090/066 for measuring torque
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking

Abstract

A rotational atherectomy system is disclosed, comprising: an elongated, flexible spin-to-open drive shaft having a distal end for insertion into a vasculature of a patient and having a proximal end opposite the distal end remaining outside the vasculature of the patient; a concentric or eccentric abrasive element, preferably a solid crown, attached to the drive shaft proximate the distal end of the drive shaft; an electric motor rotatably coupled to the proximal end of the drive shaft, the electric motor being capable of rotating the drive shaft in a spin-to-open direction; and control electronics for monitoring and controlling the rotation of the electric motor. When an obstruction at the distal end is detected by the applied torque and/or current reaching a predetermined maximum allowed level and with the drive shaft opened to a maximum allowed outer diameter, power to the motor is eliminated.

Claims

1. A spin-to-open rotational atherectomy system, comprising:

an elongated, flexible helically coiled drive shaft having a distal end for insertion into a vasculature of a patient and having a proximal end opposite the distal end remaining outside the vasculature of the patient and having a lumen therethrough, the helical coils of the drive shaft configured to enable the drive shaft to rotate in a spin-to-open direction during high-speed rotation, the drive shaft having a nominal outer diameter and length and a maximum allowed outer diameter limit, wherein when the drive shaft encounters a blockage, the outer diameter increases and the length decreases;

a guidewire adapted to translate and rotate within the lumen of the drive shaft and to allow the drive shaft to translate and rotate over the guidewire;

an abrasive crown attached to the drive shaft proximate the distal end of the drive shaft;

an electric motor rotatably coupled to the proximal end of the drive shaft, the electric motor being capable of rotating the drive shaft in the spin-to-open direction; and

a control unit comprising control electronics adapted to monitoring and controlling the rotation of the electric motor and drive shaft and comprising a maximum limit for torque applied by the electric motor to the drive shaft, a maximum current limit used by the electric motor and a minimum rotational speed limit for the rotating drive shaft, wherein the maximum limits for torque, maximum current and minimum rotational speed are correspondent with the maximum limit for the outer diameter of the drive shaft,

wherein the control electronics eliminate power to the electric motor when the maximum limit of the outer diameter of the drive shaft is reached during a loading event so that no torque or current-induced rotation is transferred from the electric motor to the drive shaft.

2. The rotational atherectomy system of claim 1, wherein the outer diameter of the drive shaft returns to the nominal outer diameter after the power is eliminated to the electric motor.

3. The rotational atherectomy system of claim 1,

wherein the electric motor is contained within a handle;

and

wherein the control electronics are contained in a control unit separate from the handle and electrically tethered to the handle.

4. The rotational atherectomy system of claim 1, wherein the control unit includes internal memory for storing performance specifications.

5. The rotational atherectomy system of claim 1, wherein the control unit includes an external activation control and an external electric motor rotational speed control.

6. The rotational atherectomy system of claim 1, wherein the control unit is simultaneously operable with an electronic heart defibrillator.

7. The rotational atherectomy system of claim 1, wherein the control unit includes a void detector that ensures reliable delivery of saline to the vasculature of the patient.

8. The rotational atherectomy system of claim 1,

wherein the abrasive crown comprises an eccentric solid crown attached to the drive shaft and that has a center of mass that is laterally displaced from a rotational axis of the drive shaft;

and

wherein the eccentric solid crown includes an abrasive exterior surface.