Method for containing and removing occlusions in the carotid arteries

Abstract

A method for the treatment of a stenosis or an occlusion in a blood vessel is disclosed in which a main catheter is first delivered to a site proximal to the occlusion. The main catheter may include an occlusive device at its distal end. An inner catheter or elongate member (e.g., a guidewire) having an occlusive device at its distal end is delivered to the site of the occlusion, and the occlusive device is activated at a site distal to the occlusion. A therapy catheter is then introduced to treat the occlusion. Next, a catheter is delivered just proximal to the occlusive device, and this catheter is used to aspirate and/or irrigate the area removing particles and debris. The aspiration and irrigation steps are preferably repeated until the particles and debris are removed. Perfusion may be performed by using a perfusion-filter distal of the lesion to be treated or a hypotube which extends beyond the occlusive device attached to the guidewire. The present invention provides for a minimally invasive procedure which can be performed quickly and efficiently, with reduced risks to the patient.

What is claimed is:  
     
         1 . A method for the treatment of an occlusion in a branch of a bifurcated blood vessel having a common portion and two branches, such as the carotid artery, comprising: 
 providing an elongate member having an occlusive device at a distal end portion thereof;    delivering the elongate member through the common portion of the bifurcated vessel and into a branch of the bifurcated vessel, such as the internal carotid artery;    positioning the occlusive device in said branch distal of the occlusion;    sliding a therapy catheter on the elongate member;    occluding said branch only on the distal side of the occlusion by actuating the occlusive device;    treating the occlusion with the therapy catheter;    providing a second catheter having a fluid flow lumen in fluid communication with a fluid flow opening at a distal end portion of the second catheter;    using the occlusive device to occlude said branch of the vessel while: 
 (a) positioning the fluid flow opening of the second catheter in said branch of the vessel at a location between the occlusive device and the treated occlusion;  
 (b) applying fluid pressure to the fluid flow lumen to cause fluid flow along said branch, between (i) an intersection of said branch with the common portion and (ii) said location, whereby fluid flows across the treated occlusion; and  
   deactuating the occlusive device.    
     
     
         2 . The method of    claim 1   , comprising removing the therapy catheter from said branch of the vessel prior to applying the fluid pressure.  
     
     
         3 . The method of    claim 1   , wherein the fluid flow across the treated occlusion flushes emboli in said branch away from the treated occlusion.  
     
     
         4 . The method of    claim 1   , wherein said applying fluid pressure comprises aspirating fluid into the lumen to draw emboli away from the treated occlusion and into the lumen.  
     
     
         5 . The method of    claim 4   , wherein fluid is aspirated at a rate between 0.5 and 5 cc/sec.  
     
     
         6 . The method of    claim 4   , wherein fluid is aspirated at a rate of between 0.5 to 1.1 cc/sec.  
     
     
         7 . The method of    claim 1   , wherein said applying fluid pressure comprises irrigating through the second catheter.  
     
     
         8 . The method of    claim 7   , wherein said method further comprises ejecting sufficient irrigation fluid from the second catheter to transport emboli from the treated occlusion along said branch to the intersection, whereby the emboli are flushed down another branch of the bifurcated vessel.  
     
     
         9 . The method of    claim 8   , wherein the irrigation fluid has a flow rate of between 0.1 and 5 cc/sec.  
     
     
         10 . The method of    claim 8   , wherein the irrigation fluid has a flow rate of between 0.5 and 2 cc/sec.  
     
     
         11 . The method of    claim 1   , wherein the second catheter is an intermediate catheter.  
     
     
         12 . The method of    claim 1   , comprising allowing blood to flow from the common portion of the bifurcated vessel through another branch of the vessel during said using of the occlusive device to occlude said branch.  
     
     
         13 . The method of    claim 1   , comprising applying the fluid pressure to the fluid flow lumen in the form of pulses.  
     
     
         14 . The method of    claim 1   , wherein said providing the elongate member comprises providing a distal elongate member portion that is more flexible than a proximal elongate member portion.  
     
     
         15 . The method of    claim 1   , wherein said applying fluid pressure comprises first aspirating and then irrigating.  
     
     
         16 . The method of    claim 1   , comprising: 
 positioning an outer catheter such that a portion of the outer catheter is in the common portion of the vessel, the outer catheter having a radial extent that permits the therapy catheter and the second catheter to pass through the outer catheter; and    irrigating through the second catheter while simultaneously aspirating through the outer catheter.    
     
     
         17 . The method of    claim 16   , wherein a fluid flow opening of the outer catheter is positioned proximal to the treated lesion.  
     
     
         18 . The method of    claim 1   , wherein the blood vessel is the carotid artery.  
     
     
         19 . The method of    claim 1   , wherein said treating the occlusion comprises balloon angioplasty or deploying a stent.  
     
     
         20 . The method of    claim 1   , wherein said actuating the occlusive device comprises inflating an occlusion balloon.  
     
     
         21 . The method of    claim 20   , wherein the balloon is of a compliant material.  
     
     
         22 . The method of    claim 1   , wherein the elongate member is a tubular metallic guidewire.  
     
     
         23 . A method for the treatment of an occlusion in a branch of a bifurcated blood vessel having a common portion and two branches, such as the carotid artery, comprising: 
 providing an elongate member having an occlusive device at a distal end portion thereof;    delivering the elongate member through the common portion of the bifurcated vessel and into a branch of the bifurcated vessel, such as the internal carotid artery;    positioning the occlusive device in said branch distal of the occlusion;    sliding a therapy catheter on the elongate member;    occluding said branch on the distal side of the occlusion by actuating the occlusive device;    treating the occlusion with the therapy catheter;    removing the therapy catheter from said branch of the vessel;    providing a second catheter having a fluid flow lumen in fluid communication with a fluid flow opening at a distal end portion of the second catheter;    sliding the second catheter on the elongate member after said removal of the therapy catheter;    using the occlusive device to occlude said branch of the vessel while: 
 (a) positioning the fluid flow opening of the second catheter in said branch of the vessel at a location between the occlusive device and the treated occlusion;  
 (b) applying fluid pressure to the fluid flow lumen to cause fluid flow along said branch, between (i) an intersection of said branch with the common portion and (ii) said location, whereby fluid flows across the treated occlusion; and  
   deactuating the occlusive device.    
     
     
         24 . The method of    claim 23   , wherein said applying fluid pressure comprises aspirating fluid into the lumen to draw emboli away from the treated occlusion and into the lumen.  
     
     
         25 . The method of    claim 24   , wherein fluid is aspirated at a rate between 0.5 and 5 cc/sec.  
     
     
         26 . The method of    claim 24   , wherein fluid is aspirated at a rate of between 0.5 to 1.1 cc/sec.  
     
     
         27 . The method of    claim 23   , wherein said applying fluid pressure comprises irrigating through the second catheter.  
     
     
         28 . The method of    claim 27   , wherein said method further comprises ejecting sufficient irrigation fluid from the second catheter to transport emboli from the treated occlusion along said branch to the intersection, whereby the emboli are flushed down another branch of the bifurcated vessel.  
     
     
         29 . The method of    claim 28   , wherein the irrigation fluid has a flow rate of between 0.1 and 5 cc/sec.  
     
     
         30 . The method of    claim 28   , wherein the irrigation fluid has a flow rate of between 0.5 and 2 cc/sec.  
     
     
         31 . The method of    claim 23   , comprising applying the fluid pressure to the fluid flow lumen in the form of pulses.  
     
     
         32 . The method of    claim 23   , further comprising inflating a balloon on an outer catheter within the common portion of the vessel to occlude the common portion.  
     
     
         33 . The method of    claim 23   , wherein the elongate member is a tubular metallic guidewire.  
     
     
         34 . A method for the treatment of an occlusion in a branch of a bifurcated blood vessel having a common portion and two branches, such as the carotid artery, comprising: 
 providing an elongate member having an occlusive device at a distal end portion thereof;    delivering the elongate member through the common portion of the bifurcated vessel and into a branch of the bifurcated vessel, such as the internal carotid artery;    positioning the occlusive device in said branch distal of the occlusion;    sliding a therapy catheter on the elongate member;    occluding said branch only on the distal side of the occlusion by actuating the occlusive device;    treating the occlusion with the therapy catheter;    using the occlusive device to occlude the branch of the vessel while: 
 (a) delivering irrigation fluid to a distal end portion of the therapy catheter through an annulus between the therapy catheter and the elongate member;  
 (b) passing the irrigation fluid out of a fluid flow opening in the distal end portion of the therapy catheter;  
 (c) positioning the fluid flow opening of the therapy catheter in said branch of the vessel at a location near the occlusive device between the occlusive device and the treated occlusion, such that fluid flows across the treated occlusion; and  
   deactuating the occlusive device.    
     
     
         35 . The method of    claim 34   , wherein the fluid flow across the treated occlusion flushes emboli in said branch away from the treated occlusion.  
     
     
         36 . The method of    claim 35   , further comprising aspirating through an outer catheter, the outer catheter having a radial extent that permits the therapy catheter to pass through the outer catheter.  
     
     
         37 . The method of    claim 34   , wherein the blood vessel is the carotid artery.  
     
     
         38 . The method of    claim 34   , wherein said treating the occlusion comprises balloon angioplasty or deploying a stent.  
     
     
         39 . The method of    claim 34   , wherein said treating the occlusion comprises breaking up the occlusion, such as atherectomy.  
     
     
         40 . The method of    claim 34   , wherein said actuating the occlusive device comprises inflating an occlusion balloon.  
     
     
         41 . The method of    claim 34   , wherein the elongate member is a tubular metallic guidewire.  
     
     
         42 . A method for the treatment of an occlusion in a branch of bifurcated blood vessel having a common portion and two branches, such as the carotid artery, comprising: 
 providing an elongate member having an occlusive device at a distal end portion thereof;    delivering the elongate member through the common portion of the bifurcated vessel and into a branch of the bifurcated vessel, such as the internal carotid artery;    positioning the occlusive device in said branch distal of the occlusion;    positioning an outer catheter so that a portion of the outer catheter is in the common portion of the vessel;    sliding a therapy catheter within the outer catheter and on the elongate member;    actuating the occlusive device such that it occludes said branch of the vessel;    treating the occlusion with the therapy catheter;    using the occlusive device to occlude the branch of the vessel while: 
 (a) delivering irrigation fluid to a distal end portion of the outer catheter;  
 (b) passing the irrigation fluid out of a fluid flow opening in the distal end portion of the outer catheter;  
 (c) positioning the fluid flow opening of the outer catheter in said branch of the vessel at a location between the occlusive device and the treated occlusion, such that fluid flows across the treated occlusion; and  
   deactuating the occlusive device.    
     
     
         43 . The method of    claim 42   , wherein the fluid flow across the treated occlusion flushes emboli in said branch away from the treated occlusion.  
     
     
         44 . The method of    claim 43   , further comprising: 
 sliding an additional catheter on the elongate member, the additional catheter having a fluid flow opening;    positioning the fluid flow opening of the additional catheter between the occlusion and the occlusive device; and    aspirating through the fluid flow opening of the additional catheter.    
     
     
         45 . The method of    claim 44   , wherein said aspirating is performed before said delivering irrigation fluid.  
     
     
         46 . The method of    claim 43   , wherein the blood vessel is the carotid artery.  
     
     
         47 . The method of    claim 42   , wherein said treating the occlusion comprises breaking up the occlusion, such as atherectomy.  
     
     
         48 . The method of    claim 42   , wherein said treating the occlusion comprises balloon angioplasty.  
     
     
         49 . The method of    claim 42   , wherein said actuating the occlusive device comprises inflating an occlusion balloon.  
     
     
         50 . The method of    claim 42   , wherein the outer catheter is a main catheter.  
     
     
         51 . The method of    claim 42   , wherein the elongate member comprises a tubular metallic guidewire.  
     
     
         52 . A method for treatment of an occlusion in a branch of a bifurcated blood vessel having a common portion and two branches, comprising: 
 positioning an occlusive device distal of the occlusion to occlude said branch of the vessel;    treating the occlusion using a therapy device;    delivering irrigation fluid between the occlusion and the occlusive device such that irrigation fluid flows across the treated occlusion towards an intersection of said branch and the common portion, wherein emboli in said branch are carried to the intersection;    allowing anatomical blood flow in the common portion to carry the emboli through another of the branches.    
     
     
         53 . The method of    claim 52   , additionally comprising using a catheter to aspirate at a location between the occlusion and the occlusive device to draw emboli away from the treated occlusion and into the catheter.  
     
     
         54 . The method of    claim 52   , wherein aspiration is performed before irrigation.  
     
     
         55 . The method of    claim 52   , wherein the blood vessel is the carotid artery.  
     
     
         56 . The method of    claim 52   , wherein said treating the occlusion comprises balloon angioplasty.  
     
     
         57 . The method of    claim 52   , wherein said treating the occlusion comprises breaking up the occlusion, such as atherectomy.  
     
     
         58 . The method of    claim 52   , wherein said occluding of said branch comprises inflating an occlusion balloon.  
     
     
         59 . A method for the treatment of an occlusion in a blood vessel, such as the carotid artery, comprising: 
 providing an inner catheter comprising an elongate member having an occlusive device at a distal end portion thereof;    delivering the elongate member through the vessel;    positioning the occlusive device distal of the occlusion;    sliding a therapy catheter on the elongate member;    actuating the occlusive device such that it occludes the vessel;    treating the occlusion with the therapy catheter;    using the occlusive device to occlude the vessel while: 
 (a) delivering irrigation fluid through the elongate member;  
 (b) passing the irrigation fluid out of a fluid flow opening in the occlusive device such that fluid flows across the treated occlusion; and  
   deactuating the occlusive device.    
     
     
         60 . The method of    claim 59   , wherein emboli are flushed away from the treated occlusion.  
     
     
         61 . The method of    claim 60   , wherein the occlusive device comprises a balloon and the fluid flow opening comprises at least one opening in the balloon.  
     
     
         62 . The method of    claim 61   , wherein the at least one opening in the balloon comprises micropores in the balloon material.  
     
     
         63 . The method of    claim 60   , wherein the blood vessel is the carotid artery.  
     
     
         64 . The method of    claim 59   , wherein said treating the occlusion comprises balloon angioplasty.  
     
     
         65 . The method of    claim 59   , wherein said treating the occlusion comprises breaking up the occlusion, such as atherectomy.  
     
     
         66 . The method of    claim 59   , wherein said actuating the occlusive device comprises inflating an occlusion balloon of a compliant material.  
     
     
         67 . The method of    claim 59   , wherein the elongate member is a tubular metallic guidewire.  
     
     
         68 . A method of performing a medical procedure in a blood vessel using an expandable member which seals against walls of the blood vessel in response to application of an expansion force through a range of vessel diameters up to a maximum diameter beyond which sealing will not occur in the vessel, said method comprising: 
 positioning the expandable member in a selected blood vessel distal to an occlusion to be treated at a location where the vessel diameter is at least 20% less than said maximum diameter;    applying an expansion force to cause the expandable member to expand into sealing contact with walls of the selected vessel at said location; and    treating the occlusion while the expandable member is expanded, whereby the expandable member seals against walls of the selected vessel even if the diameter of the selected vessel at said location increases to said maximum diameter as a result of said treatment.    
     
     
         69 . The method of    claim 68   , wherein said expandable member includes a balloon.  
     
     
         70 . The method of    claim 69   , wherein the balloon expands axially as the expansion force is applied to store potential energy for expanding the balloon radially if the diameter of the selected vessel at said location increases.  
     
     
         71 . The method of    claim 68   , in which the blood vessel is the internal carotid artery.  
     
     
         72 . A method of treating an occlusion in a blood vessel, comprising: 
 positioning an expandable member distal to the occlusion to be treated;    performing therapy on the occlusion;    using the expandable member to block migration of emboli created as a result of the therapy, while allowing blood to flow from one side to another side of the expandable member in a proximal to distal direction;    positioning a fluid port of a catheter between the treated occlusion and the expandable member; and    applying suction to the fluid port to aspirate fluid into the catheter while the fluid port is positioned between the treated occlusion and the expandable member.    
     
     
         73 . The method of    claim 72   , comprising injecting irrigation fluid distal to the treated occlusion to create a flow of fluid across the treated occlusion in a distal to proximal direction.  
     
     
         74 . The method of    claim 73   , wherein the catheter comprises an aspiration catheter having an occlusive device near its distal end, said method comprising using the occlusive device to at least substantially block anatomical blood flow through the vessel during said aspiration.  
     
     
         75 . The method of    claim 74   , wherein said injecting comprises advancing a distal opening in an outer catheter to a location adjacent a proximal side of the occlusive device and irrigating through the distal opening of the outer catheter while anatomical blood flow in the vessel is substantially blocked to cause fluid to flow across the treated occlusion in a distal to proximal direction.  
     
     
         76 . The method of    claim 73   , wherein the catheter comprises an outer catheter having an occlusive device near its distal end, wherein said method comprises positioning the occlusive device at a location distal to the treated occlusion, wherein said aspiration is performed by aspirating through an opening in the outer catheter that is distal to said location, and wherein said injecting comprises irrigating through an opening in the outer catheter that is proximal to said location to cause a flow of fluid across the treated lesion in a distal to proximal direction.  
     
     
         77 . The method of    claim 72   , wherein the treated occlusion is in a branch of a bifurcated vessel such as the carotid artery.  
     
     
         78 . The method of    claim 77   , comprising injecting irrigation fluid into the branch at a location distal to the treated occlusion and creating a fluid flow across the treated occlusion and to a junction of the branch with a common portion of the bifurcated vessel, whereby the irrigation fluid from said branch is flushed down another branch by anatomical blood flow.  
     
     
         79 . The method of    claim 72   , wherein the aspirated fluid contains emboli.  
     
     
         80 . The method of    claim 72   , wherein the expandable member comprises a filter.  
     
     
         81 . The method of    claim 72   , wherein blood flows through the expandable member.  
     
     
         82 . The method of    claim 72   , wherein said providing fluid flow comprises providing fluid flow from said another side to said one side of the expandable member in a distal to proximal direction during the aspiration of said fluid.  
     
     
         83 . The method of    claim 72   , comprising perfusing blood through a tube which carries blood from one side of the tube to the other.  
     
     
         84 . A method of treating an occlusion in a blood vessel, comprising: 
 positioning an expandable member distal to the occlusion to be treated;    performing therapy on the occlusion;    using the expandable member to block migration of emboli created as a result of the therapy, while allowing blood to flow past the expandable member in a proximal to distal direction;    positioning a fluid port of a catheter between the treated occlusion and the expandable member;    delivering irrigation fluid through the fluid port; and    using the irrigation fluid to provide fluid flow across the treated occlusion in a distal to proximal direction.    
     
     
         85 . The method of    claim 84   , wherein the expandable member comprises an occlusion balloon.  
     
     
         86 . The method of    claim 85   , wherein the catheter comprises an outer catheter.  
     
     
         87 . The method of    claim 86   , comprising perfusing blood through a tube which carries blood from one side of the balloon to the other.  
     
     
         88 . The method of    claim 84   , wherein the treated occlusion is in a branch of a bifurcated vessel such as the carotid artery.  
     
     
         89 . The method of    claim 88   , wherein said delivering comprises delivering irrigation fluid into the branch at a location distal to the treated occlusion and creating a fluid flow across the treated occlusion and to a junction of the branch with a common portion of the bifurcated vessel, whereby the irrigation fluid from said branch is flushed down another branch by anatomical blood flow.  
     
     
         90 . A method of treating an occlusion in a blood vessel, comprising: 
 positioning an expandable member distal to the occlusion to be treated;    using a therapy balloon to perform therapy on the occlusion;    using the expandable member to block migration of emboli created as a result of the therapy, while allowing blood to flow from one side to another side of the expandable member in a proximal to distal direction;    using the therapy balloon to occlude the blood vessel at a location distal to the treated occlusion;    positioning a fluid port of a catheter between the treated occlusion and said location; and    providing fluid flow through the fluid port such that said fluid flows across the treated occlusion.    
     
     
         91 . The method of    claim 90   , comprising injecting irrigation fluid through the fluid port to create a flow of fluid across the treated occlusion in a distal to proximal direction.  
     
     
         92 . The method of    claim 90   , comprising aspirating through the fluid port to create a flow of fluid across the treated occlusion in a proximal to distal direction.  
     
     
         93 . The method of    claim 90   , wherein the treated occlusion is in a branch of a bifurcated vessel such as the carotid artery.  
     
     
         94 . The method of    claim 93   , comprising injecting irrigation fluid into the branch at a location distal to the treated occlusion and creating a fluid flow across the treated occlusion and to a junction of the branch with a common portion of the bifurcated vessel, whereby the irrigation fluid from said branch is flushed down another branch by anatomical blood flow.