ROTATIONAL ATHERECTOMY SYSTEM WITH ENHANCED DISTAL PROTECTION CAPABILITY AND METHOD OF USE

• US 20110009888A1
• Filed: 11/21/2008
• Published: 01/13/2011
• Est. Priority Date: 11/23/2007
• Status: Active Grant

• Current Assignee: Cardio Flow, Inc
• Original Assignee: Cardio Flow, Inc
• Inventors: Shturman, Leonid
• Granted Patent: US 8,465,510 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• 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 17/3207 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 17/320758 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 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence

Abstract

An atherectomy system for removing a stenotic lesion from within a vessel of a patient is disclosed. The system comprising an atherectomy device for reducing the lesion and a separate elongate drainage catheter for evacuating from the treated vessel embolic particles released into the vessel from the stenotic lesion during its reduction by the atherectomy device during an atherectomy procedure. The atherectomy device and the separate elongate drainage catheter are each configured for introduction into the patent'"'"'s vasculature though separate openings in at least one peripheral artery of the patient.

Claims

1. An atherectomy system for removing a stenotic lesion from within a vessel of a patient, the system comprising an atherectomy device for reducing the lesion and a separate elongate drainage catheter for evacuating from the treated vessel embolic particles released into the vessel from the stenotic lesion during its reduction by the atherectomy device during an atherectomy procedure, the atherectomy device and the separate elongate drainage catheter each being configured for introduction into the patent'"'"'s vasculature though separate openings in at least one peripheral artery of the patient.

2. The atherectomy system according to claim 1, wherein one of the atherectomy device and the drainage catheter comprises an occlusion balloon for temporarily engaging the atherectomy device and the drainage catheter with each other proximal to the stenotic lesion, and for at least restricting flow of fluids towards and away from the treated stenotic lesion.

3. The atherectomy system according to claim 1, wherein the atherectomy device and the drainage catheter are configured for introduction into the patient'"'"'s vasculature through openings located in separate arteries of the patient.

4. The atherectomy system according to claim 1, wherein the atherectomy device comprises a rotational atherectomy device, said rotational atherectomy device comprising an abrasive element mounted to and rotatable together with a flexible drive shaft, the rotatable drive shaft extending through and out of a stationary drive shaft sheath.

5. The atherectomy system according to claim 4, comprising an occlusion balloon mounted to the drainage catheter, the occlusion balloon being inflatable within the vessel proximal to a distal end of the drive shaft sheath, the occlusion balloon being inflatable within the vessel for temporarily engaging the rotational atherectomy device and the drainage catheter with each other proximal to the stenotic lesion, and for at least restricting flow of fluids towards and away from the treated stenotic lesion.

6. The atherectomy system according to claim 5, wherein the drainage catheter includes an occlusion balloon inflation lumen for inflation of the occlusion balloon to a pressure which is sufficient to at least partially restrict the flow of fluids through the vessel towards and away from the treated area, but is insufficient to dilate the vessel.

7. The atherectomy system according to claim 4, comprising an occlusion balloon mounted to the drive shaft sheath of the rotational atherectomy device, the occlusion balloon being inflatable within the vessel proximal to a distal end of the drainage catheter, the occlusion balloon being inflatable within the vessel for temporarily engaging the atherectomy device and the drainage catheter with each other proximal to the stenotic lesion, and for at least restricting flow of fluids towards and away from the treated stenotic lesion.

8. The atherectomy system according to claim 7, wherein the drive shaft sheath includes an occlusion balloon inflation lumen for inflation of the occlusion balloon to a pressure which is sufficient to at least partially restrict the flow of fluids through the vessel towards and away from the treated area, but is insufficient to dilate the vessel.

9. The atherectomy system according to claim 1, wherein the atherectomy device and the separate elongate drainage catheter are configured for introduction into the patient'"'"'s vasculature through openings located in the right and left femoral arteries of the patient.

10. The atherectomy system according to claim 1, wherein the atherectomy device and the separate elongate drainage catheter are configured for introduction into the patient'"'"'s vasculature through openings located in the radial arteries of the patient.

11. The atherectomy system according to claim 1, wherein the atherectomy device and the separate elongate drainage catheter are configured such that one of them may be introduced into the patient'"'"'s vasculature through an opening in the femoral artery and the other may be introduced through an opening in the radial artery of the patient.

12. The atherectomy system according to claim 4, wherein the drive shaft of the rotational atherectomy device comprises at least one torque transmitting coil and at least one fluid impermeable membrane forming a fluid impermeable wall of the lumen of the drive shaft.

13. The atherectomy system according to claim 1, comprising an external inflatable occlusion cuff having proximal and distal ends, the external occlusion cuff being placed around a lower extremity such that its proximal end is located distal to and spaced away from the stenotic lesion located in the ipsilateral iliac, superficial femoral and/or popliteal artery of said extremity, the external inflatable occlusion cuff being inflatable to a pressure which is sufficient to restrict the flow of fluids at least through anterior and posterior tibial arteries of the lower extremity.

14. The atherectomy system according to claim 13, wherein the external inflatable occlusion cuff extends distally along the lower extremity and its distal end is located close to the patient'"'"'s ankle.

15. The atherectomy system according to claim 13, wherein the external inflatable occlusion cuff is in the form of a long sock that extends distally from about the knee area.

16. The atherectomy system according to claim 13, wherein the external inflatable occlusion cuff is configured so that it can be opened and closed around the lower extremity along a longitudinally extending line, said line extending longitudinally distally from the proximal end of the cuff.

17. The atherectomy system according to claim 16, wherein the external inflatable occlusion cuff comprises a zip which allows the external inflatable occlusion cuff to be opened and closed by said zip.

18. A method of using an atherectomy system for removing a stenotic lesion from within a vessel of a patient, the system comprising an atherectomy device and a separate elongate drainage catheter having a drainage lumen for removal of embolic particles produced by the atherectomy device during an atherectomy procedure, the method including the step of introducing the atherectomy device and the separate elongate drainage catheter into the patient'"'"'s vasculature through openings located in separate peripheral arteries of the patient, advancing the separate elongate drainage catheter to a location in which a distal end of the separate drainage catheter is located proximal to a stenotic lesion so that embolic particles produced by the atherectomy device are entrained by retrograde flowing fluid and are aspirated together with the fluid into the drainage lumen of the separate drainage catheter for removal of said embolic particles from the patient'"'"'s body.

19. The method according to claim 18, wherein the atherectomy system comprises an occlusion balloon mounted to a catheter shaft of the drainage catheter for inflatable within the vessel for temporarily engaging the atherectomy device and the drainage catheter with each other proximal to the stenotic lesion, and for at least restricting flow of fluids towards and away from the treated stenotic lesion, the method including the step of inflating the occlusion balloon to at least partially restrict the flow of fluids through the vessel towards and away from the treated area to assist in the aspiration of retrograde flowing fluid and entrained embolic particles into the drainage lumen of the drainage catheter.

20. The method according to claim 19, wherein the stenotic lesion is located within the internal carotid artery and the atherectomy system comprises an occlusion balloon inflatable within the common carotid artery for temporarily engaging the atherectomy device and the drainage catheter with each other proximal to the stenotic lesion, and for at least restricting flow of fluids towards and away from the treated stenotic lesion within the internal carotid artery to assist in the aspiration of the retrograde flowing fluid and embolic particles into the drainage lumen, the method including the step of inflating the occlusion balloon to at least partially restrict the flow of fluids through the common carotid artery towards and away from the treated stenotic lesion within the internal carotid artery to assist in the aspiration of retrograde flowing fluid and entrained embolic particles into the drainage lumen of the drainage catheter.