ROTATIONAL ATHERECTOMY DEVICE WITH FLUID INFLATABLE SUPPORT ELEMENTS SUPPORTED BY FLUID BEARINGS

• US 20130296905A1
• Filed: 07/08/2013
• Published: 11/07/2013
• Est. Priority Date: 07/13/2006
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Granted Patent: US 9,333,006 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take 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 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320008 Scrapers
• CPC Class Codes: A61B 2017/320766 eccentric

Abstract

A rotational atherectomy device for removing a stenotic tissue from a vessel of a patient is disclosed. The device comprises a rotatable, flexible, hollow drive shaft having an open distal end. The drive shaft comprising a fluid impermeable wall, an abrasive element mounted to the drive shaft proximal to and spaced away from its distal end, the fluid impermeable wall being formed from a torque transmitting coil and at least one fluid impermeable membrane which define a lumen for the antegrade flow of pressurized fluid through the drive shaft and into a distal fluid inflatable support element to inflate said fluid inflatable support element. The distal fluid inflatable support element is located at the distal end of the drive shaft and has an outer wall comprising an outflow opening.

Claims

1. A method of using a rotational atherectomy device for removing a stenotic lesion from a body vessel, the method comprising:

inserting a rotational atherectomy device into a blood vessel such that an abrasive element of the rotational atherectomy device is positioned proximate to a stenotic lesion, the rotational atherectomy device including;

a rotatable, flexible drive shaft comprising a torque transmitting coil;

at least one fluid impermeable membrane that at least partially defines a fluid delivery lumen extending from a proximal end of the drive shaft toward a distal end portion of the drive shaft;

the abrasive element being mounted to the distal end portion of the drive shaft and comprising an abrasive outer surface that is fixedly positioned relative to the drive shaft; and

proximal and distal fluid inflatable counterweights being positioned on opposite sides of the abrasive element and being in fluid communication with the fluid delivery lumen of the drive shaft;

rotating the drive shaft of the rotational atherectomy device so that the abrasive element, the distal fluid inflatable counterweight, and the proximal fluid inflatable counterweight rotate together with the distal end portion of the drive, wherein the distal fluid inflatable counterweight is positioned distally of a distal end of the abrasive element and spaced axially apart from the abrasive element, wherein the proximal fluid inflatable counterweight is positioned proximally of a proximal end of the abrasive element and spaced axially apart from the abrasive element, and wherein a center of mass of each of the distal fluid inflatable counterweight and the proximal fluid inflatable counterweight is offset from a longitudinal axis of the drive shaft in a first direction while the center of mass of the abrasive element is offset from the longitudinal axis of the drive shaft in a second opposite direction; and

during said rotating, outputting fluid flow through at least one outflow opening of a flexible outer wall of each of the proximal and distal fluid inflatable counterweights.

2. The method of claim 1, further comprising, during said rotating, delivering fluid through the fluid delivery lumen of the drive shaft, into an inflatable space of each of the proximal and distal fluid inflatable counterweights, and out through said at least one outflow opening of each of the proximal and distal fluid inflatable counterweights.

3. The method of claim 2, wherein said delivering the fluid maintains each of the proximal and distal fluid inflatable counterweights in an inflated condition.

4. The method of claim 3, wherein each of the proximal and distal fluid inflatable counterweights is maintained in a deflated condition during said inserting of the rotational atherectomy device.

5. The method of claim 1, wherein the distal fluid inflatable counterweight is fixedly positioned at a distal tip of the drive shaft.

6. The method of claim 1, wherein the inflatable space within the distal fluid inflatable counterweight extends around less that the entire circumference of the drive shaft so that, when the distal fluid inflatable counterweight is inflated with fluid, the center of mass of the distal fluid inflatable counterweight is offset from the longitudinal axis of the drive shaft in said first direction.

7. The method of claim 6, wherein the inflatable space within the proximal fluid inflatable counterweight extends around less that the entire circumference of the drive shaft so that, when the proximal fluid inflatable counterweight is inflated with fluid, the center of mass of the proximal fluid inflatable counterweight is offset from the longitudinal axis of the drive shaft in said first direction.

8. The method of claim 1, wherein the distal fluid inflatable counterweight is spaced axially apart from the abrasive element by a distal separation distance, the proximal fluid inflatable counterweight is spaced axially apart from the abrasive element by a proximal separation distance, wherein the distal separation distance and the proximal separation distance are greater than an overall axial length of the abrasive element.

9. The method of claim 1, wherein the distal fluid inflatable counterweight is spaced axially apart from the abrasive element by a distal separation distance, the proximal fluid inflatable counterweight is spaced axially apart from the abrasive element by a proximal separation distance, wherein the distal separation distance is substantially equal to the proximal separation distance.

10. The method of claim 1, further comprising forming a distal fluid bearing between the outer wall of the distal fluid inflatable counterweight and a wall of the blood vessel during said outputting fluid flow through said at least one outflow opening of the distal fluid inflatable counterweight.

11. The method of claim 10, further comprising forming a proximal fluid bearing between the outer wall of the proximal fluid inflatable counterweight and a wall of the blood vessel during said outputting fluid flow through said at least one outflow opening of the proximal fluid inflatable counterweight.

12. The method of claim 1, wherein the at least one outflow opening through the flexible outer wall of the distal fluid inflatable counterweight is located such that an axis of the at least one outflow opening of the distal fluid inflatable counterweight forms an angle of at least about seventy five (75) degrees with the longitudinal axis of the drive shaft when the distal fluid inflatable counterweight is inflated.

13. The method of claim 12, wherein the at least one outflow opening through the flexible outer wall of the proximal fluid inflatable counterweight is located such that an axis of the at least one outflow opening of the proximal fluid inflatable counterweight forms an angle of at least about seventy five (75) degrees with the longitudinal axis of the drive shaft when the proximal fluid inflatable counterweight is inflated.

14. The method of claim 1, further comprising advancing a guide wire though the blood vessel toward the stenotic lesion, wherein said inserting of the rotational atherectomy device into the blood vessel includes advancing the rotational atherectomy device over the guide wire by slidably receiving the guide wire a distal port of the fluid delivery lumen at a distal-most tip of the drive shaft.