Rotational atherectomy device with fluid inflatable support elements and distal protection capability

• US 8,936,589 B2
• Filed: 02/25/2014
• Issued: 01/20/2015
• Est. Priority Date: 11/23/2006
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US14/189,315
• Publication Number:
  US 20140180318A1
• Time in Patent Office: 329 Days
• Field of Search: 606/159, 606/170, 606/180, 606/194, 606/200, 604/19, 604/22, 604/523
• US Class Current: 604/523
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/22052 eccentric
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22071 Steering
• 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 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208

Abstract

A rotational atherectomy device for abrading a stenotic lesion from a vessel of a patient comprises a flexible drive shaft which extends towards a distal end of the device, a distal fluid inflatable support element located at a distal end of the drive shaft and an abrasive element mounted to the drive shaft proximal to and spaced away from the distal fluid inflatable support element. Both the abrasive element and the distal fluid inflatable support element are rotatable together with the drive shaft and the drive shaft comprises a torque transmitting coil which defines a long lumen of the drive shaft.

Claims

1. A rotational atherectomy device for removing stenotic lesion material from a blood vessel of a patient, the device comprising:

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

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

a proximal stability element that is disposed at the distal region of the drive shaft and that has a center of mass coaxial with the longitudinal axis of the drive shaft, the proximal stability element being proximally spaced apart from the abrasive element by a proximal separation distance;

a distal stability element that is disposed at the distal region of the drive shaft and that has a center of mass coaxial with the longitudinal axis of the drive shaft, the distal stability element being distally spaced apart from the abrasive element by a distal separation distance; and

a fluid impermeable membrane along the drive shaft and surrounding an outer diameter of the torque-transmitting coil from a proximal region of the drive shaft to the distal region of the drive shaft, the fluid impermeable membrane surrounding the outer diameter of the torque-transmitting coil between the proximal stability element to the distal stability element, wherein the central lumen of the drive shaft is configured to provide a fluid impermeable path to the distal region of the drive shaft surrounding an outer diameter of the drive shaft at least from the proximal stability element to the distal stability element,

wherein the proximal separation distance is less than a distance between the abrasive element and a distal end of the rotational atherectomy device.

2. The device of claim 1, wherein the proximal and distal stability elements are fluid-inflatable elements.

3. The device of claim 1, wherein the proximal and distal stability elements are generally round and concentric with the torque-transmitting coil of the drive shaft.

4. The device of claim 1, wherein the proximal and distal stability elements have an exterior surface that is smoother and different from an abrasive exterior surface of the abrasive element.

5. The device of claim 1, wherein an outer diameter of the abrasive element is greater than an outer diameter of each of the proximal and distal stability elements.

6. The device of claim 1, wherein an outer diameter of the abrasive element is less than an outer diameter of each of the proximal and distal stability elements.

7. The device of claim 1, wherein at least one of the proximal and distal stability elements comprises a fluid output port in fluid communication with the central lumen of the drive shaft.

8. 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 defining a central lumen and a longitudinal axis, the drive shaft configured for rotation about the longitudinal axis, the drive shaft configured to be at least partially disposed within the sheath lumen when the system is used for performing the rotational atherectomy;

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

a proximal stability element that is coupled with 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 abrasive element by a proximal separation distance;

a distal stability element that is coupled with 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 abrasive element by a distal separation distance; and

a fluid impermeable membrane along the drive shaft and surrounding an outer diameter of the drive shaft at least between the proximal stability element and the distal stability element,

wherein the proximal separation distance is less than a distance between the abrasive element and a distal end of the rotational atherectomy device.

9. The system of claim 8, wherein the proximal and distal stability elements comprise inflatable stability elements.

10. The system of claim 8, wherein an outer diameter of the abrasive element is less than an outer diameter of each of the proximal and distal stability elements.

11. The system of claim 8, wherein an outer diameter of the abrasive element is greater than an outer diameter of each of the proximal and distal stability elements.

12. 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 into the blood vessel, wherein the rotational atherectomy device comprises;

an elongate flexible drive shaft defining a central lumen and a longitudinal axis, the drive shaft configured for rotation about the longitudinal axis, the drive shaft configured to be at least partially disposed within the sheath lumen when the system is used for performing the rotational atherectomy;

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

a proximal stability element that is coupled with 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 abrasive element by a proximal separation distance;

a distal stability element that is coupled with 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 abrasive element by a distal separation distance; and

a fluid impermeable membrane along the drive shaft and surrounding an outer diameter of the drive shaft at least between the proximal stability element and the distal stability element, wherein the proximal separation distance is less than a distance between the abrasive element and a distal end of the rotational atherectomy device; and

rotating the drive shaft about the longitudinal axis such that the abrasive element contacts the stenotic lesion.

13. The method of claim 12, wherein during said rotation, the 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.

14. The method of claim 12, wherein the delivering the rotational atherectomy device into the blood vessel comprises advancing the drive shaft across the stenotic lesion.

15. The method of claim 12, wherein the rotating causes the abrasive element to remove lesion material particles from the stenotic lesion.

16. The method of claim 15, further comprising:

delivering an elongate drive shaft sheath at least partially into the blood vessel, the drive shaft sheath defining a sheath lumen therethrough, at least a portion of the drive shaft being disposed within the sheath lumen.

17. The method of claim 16, further comprising:

aspirating the lesion material particles into the sheath lumen.