Rotational atherectomy device with distal protection capability and method of use

• US 9,387,006 B2
• Filed: 03/04/2013
• Issued: 07/12/2016
• Est. Priority Date: 05/26/2005
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US13/784,170
• Publication Number:
  US 20130178881A1
• Time in Patent Office: 1,226 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• 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 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320766 eccentric
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A rotational device for removing a stenotic lesion from within a vessel of a patient is disclosed. The device comprises a flexible hollow drive shaft having a distal end insertable into the vessel and an abrasive element located on the drive shaft proximal to the distal end of the drive shaft to abrade a stenotic lesion when the drive shaft rotates. The hollow drive shaft defines a lumen for fluid supplied into the drive shaft to flow in an antegrade direction along the lumen and into the vessel from the drive shaft distal to the abrasive element so that the fluid entering the vessel flows in a retrograde direction over the abrasive element and the drive shaft to entrain debris abraded by the abrasive element for removal of said debris from the patient.

Claims

1. A system for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient, the system comprising:

an elongate sheath defining a sheath lumen therethrough, the sheath being configured to be at least partially disposed within the blood vessel, the sheath including an inflatable element surrounding a distal end portion of the sheath; and

a rotational atherectomy device slidable through the elongate 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 mounted to a distal region of the drive shaft, the abrasive element including an abrasive outer surface;

a first stability element that is fixed to the distal region of the drive shaft and that has a center of mass that is collinear with the longitudinal axis, the first stability element being distally spaced apart from the abrasive element, the first stability element having an outer surface that is less abrasive than the abrasive outer surface of the abrasive element; and

a fluid impermeable membrane surrounding an exterior of the distal region of the drive shaft,

wherein the drive shaft and fluid impermeable membrane extend distally beyond the abrasive element.

2. The system of claim 1 , further comprising a guidewire configured to be slidably withdrawn into the central lumen of the drive shaft.

3. The system of claim 1 , wherein a center of mass of the abrasive element is aligned with the longitudinal axis of the drive shaft.

4. The system of claim 1 , wherein the first stability element is generally round and surrounds the drive shaft.

5. The system of claim 1, wherein the fluid impermeable membrane extends distally beyond the drive shaft.

6. The system of claim 1, wherein the first stability element comprises a solid body surrounding the drive shaft.

7. The system of claim 1, wherein the drive shaft comprises one or more coiled metallic fibers.

8. The system of claim 1, wherein the drive shaft defines an opening of the central lumen at the distal end of the drive shaft.

9. The system of claim 1, wherein the abrasive element is located around the drive shaft.

10. The system of claim 1, wherein the abrasive element is spaced away from a distal end of the drive shaft by a distance of not less than about 3mm.

11. The system of claim 1, wherein the sheath includes a radiopaque marker near the distal end portion of the sheath.

12. The system of claim 1, wherein the sheath defines an inflation lumen extending along a length of the sheath for supplying an inflation medium to the inflatable element.

13. A system for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient, the system comprising:

an elongate sheath defining a sheath lumen therethrough, the sheath being configured to be at least partially disposed within the blood vessel, the sheath including an inflatable element surrounding a distal end portion of the sheath; and

a rotational atherectomy device slidable through the elongate 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 mounted to a distal region of the drive shaft, the abrasive element including an abrasive outer surface;

a first stability element that is fixed to the distal region of the drive shaft and that has a center of mass that is collinear with the longitudinal axis, the first stability element being distally spaced apart from the abrasive element, the first stability element having an outer surface that is less abrasive than the abrasive outer surface of the abrasive element and

a fluid impermeable membrane surrounding an exterior of the distal region of the drive shaft,

wherein the first stability element comprises a solid body surrounding the drive shaft.

14. The system of claim 13, further comprising a guidewire configured to be slidably withdrawn into the central lumen of the drive shaft.

15. The system of claim 13, wherein a center of mass of the abrasive element is aligned with the longitudinal axis of the drive shaft.

16. The system of claim 13, wherein the first stability element is generally round.

17. The system of claim 13, wherein the drive shaft and fluid impermeable membrane extend distally beyond the abrasive element.

18. The system of claim 13, wherein the fluid impermeable membrane extends distally beyond the drive shaft.

19. The system of claim 13, wherein the drive shaft comprises one or more coiled metallic fibers.

20. The system of claim 13, wherein the drive shaft defines an opening of the central lumen at the distal end of the drive shaft.

21. The system of claim 13, wherein the abrasive element is located around the drive shaft.

22. The system of claim 13, wherein the abrasive element is spaced away from a distal end of the drive shaft by a distance of not less than about 3 mm.

23. The system of claim 13, wherein the sheath includes a radiopaque marker near the distal end portion of the sheath.

24. The system of claim 13, wherein the sheath defines an inflation lumen extending along a length of the sheath for supplying an inflation medium to the inflatable element.