INTEGRATED DISTAL EMBOLIZATION PROTECTION APPARATUS FOR ENDO-LUMINAL DEVICES SUCH AS BALLOON, STENT OR TAVI APPARATUS

التفاصيل البيبلوغرافية
العنوان: INTEGRATED DISTAL EMBOLIZATION PROTECTION APPARATUS FOR ENDO-LUMINAL DEVICES SUCH AS BALLOON, STENT OR TAVI APPARATUS
Document Number: 20120330346
تاريخ النشر: December 27, 2012
Appl. No: 13/332431
Application Filed: December 21, 2011
مستخلص: An endoluminal catheterization device for providing protection against distal embolization of atherosclerotic debris and thrombi emboli resulting from an endoluminal catheterization procedure. The device is adapted to the new TAVI/PAVI methods to prevent the severe risk of brain embolization and stroke. The embolization protection device may also be an integral part of any other intra-luminal treatment or diagnostic device that may induce embolization, such as a balloon, stent, TAVI or atherectomy.
Inventors: FRIMERMAN, Aharon (Tel Aviv, IL)
Claim: 1. An endoluminal catheterization device for providing protection against distal embolization of atherosclerotic debris and thrombi emboli resulting from an endoluminal catheterization procedure, said device comprising: an endoluminal dilatation component mounted on a shaft, said shaft having at least one lumen; a flexible filter integrally mounted on said shaft; and a thin retraction filament extending through said at least one lumen in said shaft and emerging from an opening in said shaft, said retraction filament being attached to said flexible filter for controlling deployment and collapsing of said filter, wherein said flexible filter, when deployed, traps said atherosclerotic debris and thrombi emboli thus allowing blood flow to continue without interference during said endoluminal catheterization procedure.
Claim: 2. The device of claim 1, wherein said dilatation component comprises a self expandable stent.
Claim: 3. The device of claim 1, wherein said dilatation component comprises an angioplasty balloon.
Claim: 4. The device of claim 3 wherein said angioplasty balloon is surrounded by one of an aortic, pulmonic and tri-cuspid valve-carrying stent, and wherein said angioplasty balloon is capable of being inflated to enable deployment of said valve-carrying stent.
Claim: 5. The device of claim 4 wherein said valve-carrying stent surrounds said balloon at its center.
Claim: 6. The device of claim 4 wherein said flexible filter is mounted on said shaft proximal to said dilatation component.
Claim: 7. The device of claim 6, wherein said thin retraction filament emerges from an opening in said shaft proximal to said dilatation component
Claim: 8. The device of claim 7 wherein said valve carrying stent is capable of being advanced retrogradlly to the native valve annulus, for enabling a valve replacement procedure.
Claim: 9. The device of claim 7 wherein said device comprises one of a stationary and pivotable retraction filament reversing point, said reversing point being situated distally to said filter and proximally to said dilatation balloon, for reversing the direction of said retraction filament back to said filter to enable control of its deployment and collapse.
Claim: 10. The device of claim 4 wherein said filter is deployed prior to said inflation of said balloon, for enabling capture of said atherosclerotic debris and thrombi emboli as soon as said valve carrying stent is deployed.
Claim: 11. The device of claim 1, further comprising a safety stopper for ensuring that said deployment of said filter occurs before said balloon inflation, wherein said safety stopper is attached to said retraction filament and is situated at the connection point of said inflation tube with said shaft, thus blocking the entrance of said inflation fluid for inflating said balloon, when said retraction filament is pulled and said filter is not yet deployed.
Claim: 12. The device of claim 1, wherein said flexible filter before deployment is approximately 5 to 8 millimeter in diameter, and the maximal size of said filter when it is deployed is 25 to 35 millimeters in diameter.
Claim: 13. The device of claim 4 wherein said flexible filter is mounted on said shaft distal to said dilatation component.
Claim: 14. The device of claim 13, wherein said thin retraction filament emerges from an opening in said shaft distal to said dilatation component
Claim: 15. The device of claim 13 wherein said valve-carrying stent is capable of being advanced anterogradlly to the native valve annulus, for enabling a valve replacement procedure.
Claim: 16. The device of claim 1 wherein said flexible filter comprises a filter deployment ring encircling a proximal end of said flexible filter for the purpose of controlling deployment and collapsing of said filter, said filter deployment ring comprising a shape memory metal.
Claim: 17. A method for performing an endoluminal catheterization procedure and providing protection against distal embolization resulting in said endoluminal catheterization procedure, said method comprising: inserting an endoluminal catheterization device, comprising an endoluminal dilatation component mounted on a shaft, said shaft having a flexible filter mounted integrally thereon and a thin retraction filament extending through said shaft and emerging from an opening in said shaft, said retraction filament being attached to said flexible filter for controlling its deployment and collapse by releasing and pulling said retraction filament; and expanding said dilatation component, wherein said deployed flexible filter, traps atherosclerotic debris and thrombi emboli that are released from said crushed plaque said expansion of said dilatation component, thus allowing blood flow to continue without interference during said endoluminal catheterization procedure.
Claim: 18. The method of claim 17, wherein said releasing of said retraction filament is achieved by unlocking a locking device which locks said thin retraction filament onto a filament tube through which said retraction filament passes, wherein said retraction filament is attached to said filter, and thus by releasing said retraction filament said filter is also released and allowed to expand by memory.
Claim: 19. The method of claim 17, wherein said controlling of said deployment and collapse of said flexible filter comprises a filter deployment ring encircling a proximal end of said flexible filter, said filter deployment ring comprising a shape memory metal.
Claim: 20. The method of claim 17 wherein said dilatation component comprises an angioplasty balloon surrounded by a valve-carrying stent.
Claim: 21. The method of claim 20 wherein said endoluminal catheterization procedure is advanced retrogradlly, and said thin retraction filament is being emerged from an opening in said shaft proximal to said dilatation component.
Claim: 22. The method of claim 21 wherein said shaft comprises a retraction filament reversing point, said reversing point being situated proximally to said dilatation balloon, for reversing the direction of said retraction filament back to said filter to enable control of its deployment and collapse.
Claim: 23. The method of claim 20 wherein said endoluminal catheterization procedure is advanced anterogradlly and said thin retraction filament is being emerged from an opening in said shaft distal to said dilatation component.
Current U.S. Class: 606/200
Current International Class: 61
رقم الانضمام: edspap.20120330346
قاعدة البيانات: USPTO Patent Applications