Atherectomy devices and methods

• US 10,639,062 B2
• Filed: 04/06/2016
• Issued: 05/05/2020
• 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
• Primary Examiner(s): Schwiker, Katherine H
• Application Number:
  US15/091,919
• Publication Number:
  US 20170290603A1
• Time in Patent Office: 1,490 Days
• Field of Search: 606159, 606180
• 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;

a combination of multiple ellipsoid eccentric abrasive elements attached to a distal portion of the drive shaft such that a center of mass of each of the multiple ellipsoid eccentric abrasive elements is offset from the longitudinal axis and each of the multiple ellipsoid eccentric abrasive elements is longitudinally spaced apart from one another, wherein the multiple ellipsoid eccentric abrasive elements comprise a distal-most eccentric abrasive element, a proximal-most eccentric abrasive element, and intermediate eccentric abrasive elements, wherein the proximal-most eccentric abrasive element and the distal-most eccentric abrasive element are smaller in maximum diameter than a maximum diameter of each of the intermediate eccentric abrasive elements;

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

an adjustable seal positioned proximally of the rotatable member to hinder liquid egress from a proximal end of the central lumen, the adjustable seal having a self-closing portion selectively adjustable to an open configuration in which the self-closing portion is opened to slidably receive a guidewire through the adjustable seal and to a closed configuration in which the self-closing portion is closed to block the proximal end of the central lumen.

2. The rotational atherectomy device of claim 1, further comprising a handle assembly in which the rotatable 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, further comprising a concentric distal stability element attached to the drive shaft, wherein said combination of multiple ellipsoid eccentric abrasive elements and the concentric distal stability element comprises five ellipsoid eccentric abrasive elements and one concentric distal stability element.

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

a combination of multiple ellipsoid eccentric abrasive elements attached to the drive shaft such that a center of mass of each of the multiple ellipsoid eccentric abrasive elements is offset from the longitudinal axis and each of the multiple ellipsoid eccentric abrasive elements is longitudinally spaced apart from one another, wherein the multiple ellipsoid eccentric abrasive elements comprise a distal-most eccentric abrasive element, a proximal-most eccentric abrasive element, and at least one intermediate eccentric abrasive element, wherein the proximal-most eccentric abrasive element and the distal-most eccentric abrasive element are smaller in maximum diameter than a maximum diameter of the at least one intermediate eccentric abrasive element;

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

a valve mounted in the handle assembly to initiate rotation of the rotatable member from a rotationally stopped state to a rotationally moving state.

8. The rotational atherectomy device of claim 7, further comprising a carriage to which the rotatable 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 rotatable 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 rotatable 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 7, further comprising an inflatable member having 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.

13. 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;

a combination of multiple same-shaped eccentric abrasive elements attached to the drive shaft such that a center of mass of each of the multiple same-shaped eccentric abrasive elements is offset from the longitudinal axis and each of the multiple same-shaped eccentric abrasive elements is longitudinally spaced apart from one another, wherein the multiple same-shaped eccentric abrasive elements comprise a distal-most eccentric abrasive element, a proximal-most eccentric abrasive element, and at least one intermediate eccentric abrasive element, wherein the proximal-most eccentric abrasive element and the distal-most eccentric abrasive element are smaller in maximum diameter than a maximum diameter of the at least one intermediate eccentric abrasive element;

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

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

a latch coupled to the housing, wherein activation of the latch disengages the carriage from a locked position to translate to a first position in which the handle assembly positions the drive shaft to receive or withdraw a guidewire.

14. The rotational atherectomy device of claim 13, 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.

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

16. The rotational atherectomy device of claim 13, 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 is deactivated, the carriage is detained in the proximal-most position.

17. The rotational atherectomy device of claim 13, further comprising a valve coupled to the carriage and operable to direct fluid to the rotatable member for driving rotation of the rotatable member and the drive shaft.

18. 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;

a combination of multiple same-shaped eccentric abrasive elements attached to the drive shaft such that a center of mass of each of the multiple same-shaped eccentric abrasive elements is offset from the longitudinal axis and each of the multiple same-shaped eccentric abrasive elements is longitudinally spaced apart from one another, wherein the multiple same-shaped eccentric abrasive elements comprise a distal-most eccentric abrasive element, a proximal-most eccentric abrasive element, and at least one intermediate eccentric abrasive element, wherein the proximal-most eccentric abrasive element and the distal-most eccentric abrasive element are smaller in maximum diameter than a maximum diameter of the at least one intermediate eccentric abrasive element;

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

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

a carriage to which the rotational 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 rotational member, wherein the controller will not supply the pressurized gas unless the optical sensor is in electrical communication with the controller.

19. The rotational atherectomy system of claim 18, wherein the controller will not supply the pressurized gas unless a detected pressure of a flush fluid supplied to the sheath lumen is above a threshold limit value.