Embolic protection and plaque removal system with closed circuit aspiration and filtering

• US 20070021774A1
• Filed: 07/18/2005
• Published: 01/25/2007
• Est. Priority Date: 07/18/2005
• Status: Active Grant

• Current Assignee: NovoStent Corp.
• Original Assignee: NovoStent Corp.
• Inventors: Hogendijk, Michael
• Granted Patent: US 8,002,725 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Embolic protection and plaque removal apparatus and methods are provided wherein an aspiration device aspirates, filters and reperfuses blood using a closed fluid circuit having a bi-directional working lumen. The plaque removal device includes a plurality of self-expanding cutting elements that form cage that self-centers within the blood vessel to reduce the risk of trauma to the vessel lining.

Claims

1. Apparatus for removing emboli from a vessel during an interventional procedure, the apparatus comprising:

a catheter having a proximal end, a distal end and a lumen, the proximal end in fluid communication with the distal end via the lumen, the distal end configured for intravascular placement in the vessel;

an actuator coupled to the catheter via an inflow path and an outflow path;

a filter disposed in the outflow path; and

a flexible liner disposed within the lumen of the catheter, the liner selectively movable between a first position collapsed against an interior surface of the catheter to permit aspiration from the vessel through the lumen, and a second position wherein the liner expands into the lumen to provide an outflow lumen to reperfuse filtered blood leaving the filter into the vessel.

2. The apparatus of claim 1 further comprising a valve disposed in the inflow path or the outflow path.

3. The apparatus of claim 1 wherein the actuator comprises a syringe.

4. The apparatus of claim 1 further comprising a plaque removal device configured to be slidably advanced through the lumen of the catheter.

5. The apparatus of claim 1 in which the flexible liner is blood impermeable.

6. The apparatus of claim 5 wherein the flexible liner comprises a polymer.

7. The apparatus of claim 1 further comprising an occlusion element disposed adjacent the distal end.

8. The apparatus of claim 1 further comprising:

a shaft having a guide wire lumen;

a plurality of self-expanding cutting elements, the plurality of cutting elements having proximal ends coupled to a proximal hub and distal ends coupled to a distal hub to form a cage,

wherein the cage self-centers when deployed in the vessel.

9. The apparatus of claim 8 wherein the cutting elements comprise a shape memory alloy.

10. The apparatus of claim 8 wherein a central section of each cutting element is disposed substantially parallel to a longitudinal axis of the shaft.

11. Apparatus for removing emboli from a vessel during an interventional procedure, the apparatus comprising:

a catheter having a proximal end, a distal end, a lumen, and a flexible liner disposed within the lumen;

the proximal end in fluid communication with the distal end via the lumen, the flexible liner selectively movable between a first position collapsed against an interior surface of the catheter and a second position wherein the liner expands into the lumen;

an actuator coupled to the catheter via an inflow path and an outflow path;

a filter disposed in the outflow path,

wherein the flexible liner moves between the first position and the second position responsive to movement of the actuator to provide bi-directional flow through the catheter.

12. The apparatus of claim 11 further comprising a valve disposed in the inflow path or the outflow path.

13. The apparatus of claim 11 wherein the actuator comprises a syringe.

14. The apparatus of claim 11 further comprising a plaque removal device configured to be slidably advanced through the lumen of the catheter.

15. The apparatus of claim 11 wherein flexible liner separates blood flowing through the lumen.

16. A method for aspirating and filtering blood from a vessel, the method comprising:

providing apparatus comprising a catheter, an actuator and a filter, the catheter comprising a lumen and a flexible liner that selectively provides bi-directional flow through the lumen;

placing a distal end of the apparatus in a vessel; and

operating the actuator alternately to aspirate blood from the vessel and to filter the blood and reperfuse filtered blood into the vessel.

17. The method of claim 16 wherein the apparatus further comprises an occlusion element, the method further comprising deploying the occlusion element in the vessel to occlude antegrade flow.

18. The method of claim 16 further comprising injecting medicines or anti-clotting agents into the filtered blood prior to reperfusing it into the vessel.

19. The method of claim 16 further comprising:

providing a plaque removal device configured to be advanced through the lumen of the catheter;

operating the plaque removal device to remove plaque from the vessel; and

periodically operating the actuator to aspirate emboli from the vessel generated by operation of the plaque removal device.

20. The method of claim 19 wherein operating the plaque removal device comprises rotating the plaque removal device.