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

• US 8,388,637 B2
• Filed: 01/06/2012
• Issued: 03/05/2013
• Est. Priority Date: 11/23/2006
• Status: Expired due to Fees

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Primary Examiner(s): Houston, Elizabeth
• Application Number:
  US13/344,993
• Publication Number:
  US 20120179179A1
• Time in Patent Office: 424 Days
• Field of Search: 606/159, 606/167, 606/170, 606/180, 606/194, 606/200, 604/19, 604/22
• US Class Current: 606/159
• 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.

Claims

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

a rotatable, flexible drive shaft including a torque transmitting coil and and a fluid transport lumen extending therethrough, the torque transmitting coil and the fluid transport lumen being coaxial along a longitudinal axis;

an eccentric abrasive element mounted on a region of the drive shaft proximal to and spaced away from its distal end, wherein the abrasive element is mounted in a fixed position relative to the drive shaft and has a center of mass offset from the longitudinal axis in a first direction; and

two fluid inflatable counterweights fixed to the drive shaft so as to rotate together with the abrasive element and the drive shaft, each of the two fluid inflatable counterweights being at least partially defined by a flexible, fluid impermeable membrane and having a center of mass offset from the longitudinal axis in a second direction that is opposite from the first direction, the inflatable counterweights comprising;

a distal fluid inflatable counterweight located at a distal end of the drive shaft and spaced away from the abrasive element and,

a proximal fluid inflatable counterweight located on the drive shaft proximal to and spaced away from the abrasive element,

wherein a distal end of the fluid transport lumen of the drive shaft is continuously closed by a fluid impermeable wall that crosses the longitudinal axis such that fluid is prevented from exiting the fluid transport lumen in a longitudinal direction of the longitudinal axis when fluid is moved through the fluid transport lumen.

2. The device of claim 1, wherein the fluid passes from the fluid transport lumen to the proximal and distal fluid inflatable counterweights to inflate the proximal and distal fluid inflatable counterweights when fluid is moved through the fluid transport lumen.

3. The device of claim 2, wherein when fluid is moved through the fluid transport lumen, the fluid passes into the distal fluid inflatable counterweight exits from the distal fluid inflatable counterweight through at least one outflow opening in the distal fluid inflatable counterweight in a direction different from the direction of the longitudinal direction of the longitudinal axis.

4. The device of claim 3, wherein when fluid is moved through the fluid transport lumen, the fluid passes into the proximal fluid inflatable counterweight exits from the proximal fluid inflatable counterweight through at least one outflow opening in the proximal fluid inflatable counterweight in a direction different from the direction of the longitudinal direction of the longitudinal axis.

5. The device of claim 1, wherein the flexible, fluid impermeable membrane of the distal fluid inflatable counterweight is the same continuous structure as the fluid impermeable wall that closes the distal end of the fluid transport lumen.

6. The device of claim 5, wherein the flexible, fluid impermeable membrane of the distal fluid inflatable counterweight is the same continuous structure as the fluid impermeable membrane of the proximal fluid inflatable counterweight.

7. The device of claim 6, wherein the flexible, fluid impermeable membrane of the distal fluid inflatable counterweight is the same continuous structure as the fluid impermeable layer adjacent to the torque transmitting coil.

8. The device of claim 7, wherein the fluid impermeable layer adjacent to the torque transmitting coil extends around an outer circumference of the torque transmitting coil of the drive shaft.

9. The device of claim 1, further comprising an elongate core element advanceable through the fluid transport lumen of the drive shaft to stiffen the drive shaft and thereby assist in the advancement of the drive shaft along a vessel towards a targeted treatment site.

10. The device of claim 9, wherein the elongate core element is removable from the fluid transport lumen after the drive shaft has been advanced to the targeted treatment site.

11. The device of claim 10, further comprising a detachable fluid supply tube that releasably couples with the fluid transport lumen after the elongate core element is removed.

12. The device of claim 1, wherein the fluid impermeable membrane of the distal fluid inflatable counterweight defines a plurality of outflow openings located around a circumference distal fluid inflatable counterweight such that, during rotation of the drive shaft, at least some of said outflow openings are configured to face an inner surface of a treated vessel, so that fluid flow exiting from the outflow openings is configured to form a layer of fluid between the distal fluid inflatable counterweight and a wall of the treated vessel, said layer of fluid being configured to form a fluid bearing between the distal fluid inflatable counterweight and the wall of the treated vessel.

13. The device of claim 12, wherein the fluid impermeable membrane of the proximal fluid inflatable counterweight defines a plurality of outflow openings located around a circumference proximal fluid inflatable counterweight such that, during rotation of the drive shaft, at least some of said outflow openings of the proximal fluid inflatable counterweight are configured to face the inner surface of the treated vessel, so that fluid flow exiting from the outflow openings of the proximal fluid inflatable counterweight is configured to form a layer of fluid between the proximal fluid inflatable counterweight and the wall of the treated vessel.

14. The device of claim 1, wherein the fluid transport lumen of the drive shaft has proximal and distal portions, the proximal portion of the fluid transport lumen having a larger cross-sectional area relative to the cross-sectional area of the distal portion of the fluid transport lumen so that per unit of length hydraulic resistance to fluid flow of the proximal portion of the fluid transport lumen is less than the hydraulic resistance to fluid flow of the distal portion of the fluid transport lumen.

15. The device of claim 1, wherein when fluid is moved through the fluid transport lumen, all the fluid in the distal region of fluid transport lumen exits from the device vessel only through outflow opening in the fluid impermeable membranes of the proximal and distal fluid inflatable counterweights.