Atherectomy Devices and Methods

• US 20170290603A1
• Filed: 04/06/2016
• Published: 10/12/2017
• Est. Priority Date: 04/06/2016
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Piippo Svendsen, Cassandra Ann, Plowe, Charles Anthony, Benjamin, Albert Seiden, Robinson, Paul Joseph, Leingang, Evan
• Granted Patent: US 10,639,062 B2
• Time in Patent Office: Days
• 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 2017/00057 Light
• CPC Class Codes: A61B 2017/00075 Motion
• CPC Class Codes: A61B 2017/00553 using a turbine
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320008 Scrapers
• CPC Class Codes: A61B 2017/320766 eccentric

Abstract

Rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating an abrasive element within the vessel. The abrasive element can be attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly. In particular embodiments, the handle assembly includes a compressed gas driven turbine member that drives rotation of the drive shaft. The turbine member can be rotatably attached to a carriage that is longitudinally translatable in relation to a housing of the handle assembly. The handle assembly can include a latch mechanism that when actuated allows the carriage to translate to a proximal-most position. While the carriage is in the proximal-most position, an open pathway is created so that a guidewire can be slidably passed through the handle assembly and a lumen of the drive shaft.

Claims

1. A rotational atherectomy device comprising:

an elongate flexible drive shaft comprising a torque-transmitting coil, the drive shaft defining a central lumen and a longitudinal axis;

an abrasive element attached to a distal portion of the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis;

a turbine member coupled to a proximal portion of the drive shaft such that rotation of the turbine member rotates the drive shaft about the longitudinal axis; and

an adjustable seal positioned proximally of the turbine member to hinder liquid egress from a proximal end of the central lumen, the adjustable seal having a self-closing portion that is openable to slidably receive a guidewire through the adjustable seal and that is closable to provide a seal of the proximal end of the central lumen.

2. The rotational atherectomy device of claim 1, further comprising a handle assembly in which the turbine member is housed.

3. The rotational atherectomy device of claim 2, further comprising a sheath having a proximal end attached to the handle assembly, the sheath defining a sheath lumen therethrough in which the drive shaft is slidably disposed.

4. The rotational atherectomy device of claim 3, wherein the sheath includes an inflatable member surrounding a distal end portion of the sheath.

5. The rotational atherectomy device of claim 4, wherein the inflatable member defines one or more perfusion openings configured to allow fluid flow between a proximal end of the inflatable member and a distal end of the inflatable member.

6. The rotational atherectomy device of claim 2, further comprising a carriage to which the turbine member is coupled, wherein the carriage is longitudinally translatable in relation to a housing of the handle assembly, and wherein longitudinal translations of the turbine member result in corresponding longitudinal translations of the drive shaft.

7. A rotational atherectomy device comprising:

a handle assembly;

an elongate flexible drive shaft comprising a torque-transmitting coil extending from the handle assembly, the drive shaft defining a central lumen and a longitudinal axis;

an abrasive element attached to the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis;

a turbine member disposed within the handle assembly and coupled to the drive shaft such that rotation of the turbine member drives rotation of the drive shaft about the longitudinal axis; and

a valve coupled to the handle assembly to control rotation of the turbine member between a rotationally stopped state and a rotationally moving state.

8. The rotational atherectomy device of claim 7, further comprising a carriage to which the turbine member is rotatably attached, wherein the carriage is longitudinally translatable in relation to a housing of the handle assembly, wherein the valve is coupled to the carriage.

9. The rotational atherectomy device of claim 8, wherein the valve is spring biased to a closed configuration resulting in the turbine member being in the rotationally stopped state.

10. The rotational atherectomy device of claim 8, wherein the valve is manually actuatable to an open configuration resulting in the turbine member being in the rotationally moving state.

11. The rotational atherectomy device of claim 7, further comprising a sheath having a proximal end attached to the handle assembly, the sheath defining a sheath lumen therethrough in which the drive shaft is slidably disposed.

12. The rotational atherectomy device of claim 11, wherein the sheath includes an inflatable member surrounding a distal end portion of the sheath.

13. The rotational atherectomy device of claim 12, wherein the inflatable member defines one or more perfusion openings configured to allow fluid flow between a proximal end of the inflatable member and a distal end of the inflatable member.

14. A rotational atherectomy device comprising:

a handle assembly including a housing;

an elongate flexible drive shaft comprising a torque-transmitting coil extending from the housing, the drive shaft defining a central lumen and a longitudinal axis;

an abrasive element attached to the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis;

a turbine member disposed within the housing and coupled to the drive shaft such that rotation of the turbine member rotates the drive shaft about the longitudinal axis;

a carriage to which the turbine member is rotatably attached, wherein the carriage is longitudinally translatable in relation to the housing; and

a latch mechanism coupled to the housing, wherein activation of the latch mechanism allows the carriage to translate to a first position in which the handle assembly positions the drive shaft to receive or withdrawn a guidewire.

15. The rotational atherectomy device of claim 14, wherein when the carriage is located in the first position, an access port defined by the housing is in fluid communication with the central lumen of the drive shaft.

16. The rotational atherectomy device of claim 15, wherein when the carriage is shifted away from the first position, an access port defined by the housing is disconnected from fluid communication with the central lumen of the drive shaft.

17. The rotational atherectomy device of claim 14, wherein the first position is a proximal-most position of the carriage, and when the carriage is located in the proximal-most position and the latch mechanism is deactivated, the carriage is detained in the proximal-most position.

18. The rotational atherectomy device of claim 14, further comprising a valve coupled to the carriage and operable to direct fluid to the turbine member for driving rotation of the turbine member and the drive shaft.

19. A rotational atherectomy system comprising:

a rotational atherectomy device comprising;

a handle assembly including a housing;

an elongate flexible drive shaft comprising a torque-transmitting coil extending from the housing, the drive shaft defining a central lumen and a longitudinal axis;

an abrasive element attached to the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis;

a sheath having a proximal end attached to the housing, the sheath defining a longitudinal sheath lumen therethrough in which the drive shaft is slidably disposed;

a turbine member disposed within the housing and coupled to the drive shaft such that rotation of the turbine member rotates the drive shaft about the longitudinal axis;

an optical sensor configured for detecting rotation of the turbine member; and

a carriage to which the turbine member is rotatably attached, wherein the carriage is longitudinally translatable in relation to the housing; and

a controller operatively connected with the rotational atherectomy device and configured for supplying a pressurized gas for rotating the turbine member, wherein the controller will not supply the pressurized gas unless the optical sensor is in electrical communication with the controller.

20. The rotational atherectomy system of claim 19, wherein the controller will not supply the pressurized gas unless a pressure of a flush fluid supplied to the sheath lumen is above a threshold limit value.

21. A method of performing a rotational atherectomy, the method comprising:

advancing a drive shaft of a rotation atherectomy device along a guide wire so that an eccentric abrasive element of the drive shaft is directed toward a targeted vessel, the drive shaft comprising torque-transmitting coil extending from a handle assembly and being configured to rotate in response to rotation of a turbine member housed within the handle assembly;

withdrawing the guidewire from a proximal end of the central lumen of the drive shaft and through an adjustable seal positioned proximal of the turbine member, the adjustable seal having a self-closing portion that shifts from an open configuration to a closed configuration that provides a seal; and

after withdrawing the guidewire from the drive shaft and through the adjustable seal, rotating the turbine member coupled to the proximal portion of the drive shaft to drive rotation of the drive shaft about a longitudinal axis of the drive shaft.

22. A method of performing a rotational atherectomy on a targeted lesion of a patient, the method comprising:

advancing a drive shaft assembly of a rotation atherectomy device along a guide wire disposed within a vasculature of the patient so that a distal end of the drive shaft assembly is advanced toward the targeted lesion, the drive shaft assembly comprising;

a sheath comprising an elongate tubular member defining a lumen therethrough and an inflatable member disposed about a distal end portion of the tubular member;

a torque-transmitting coil slidably disposed within the lumen and extending distally from a handle assembly, the torque-transmitting coil configured to rotate in response to rotation of a turbine member housed within the handle assembly; and

one or more abrasive elements attached to a distal end portion of the torque-transmitting coil;

inflating the inflatable member while the inflatable member is positioned at the targeted lesion, wherein the inflating results in compression of the targeted lesion; and

rotating the turbine member to drive rotation of the torque-transmitting coil such that the one or more abrasive elements contact the targeted lesion.