Methods and devices for percutaneous and surgical interventions

Abstract

Methods and devices for performing percutaneous and surgical interventions. The devices comprising a tubular portion and retractable mechanism at the distal end of the tubular portion. The retractable mechanism prevents the device from pulling out of an anatomical structure during complex interventions, for example, when switching from an antegrade to a retrograde approach within a blood vessel, enables the use of a single sheath when declotting AV hemodialysis fistulas and can provide occlusion of blood flow during interventions and means of removal of debris or clot from the blood vessel.

1 . A device for use during vascular percutaneous interventions, comprising: 
 a tubular portion, having a proximal end and a distal end, and a lumen extending from the proximal end to the distal end; and    a retractable mechanism near the distal end of the tubular portion, the mechanism providing an increased cross section of the tubular portion when deployed and no increase or substantially no increase in cross section of the tubular portion when retracted;    whereby the tubular portion is introduced into a vessel using either an antegrade or a retrograde approach and whereby the tubular portion can be repositioned within the vessel from an antegrade to a retrograde approach and from a retrograde to an antegrade approach without losing vascular access.    
   
   
       2 . The device of  claim 1 , wherein the device is a vascular sheath.  
   
   
       3 . The device of  claim 1 , wherein the device is a guide catheter.  
   
   
       4 . The device of  claim 1 , further comprising a hemostatic valve near the proximal end of the tubular portion.  
   
   
       5 . The device of  claim 4 , wherein the hemostatic valve is removable.  
   
   
       6 . The device of  claim 1 , further comprising a silicone pinch valve near the proximal end of the tubular portion.  
   
   
       7 . The device of  claim 4 , further comprising a silicone pinch valve positioned between the hemostatic valve and the distal end of the tubular portion.  
   
   
       8 . The device of  claim 1 , wherein the distal end of the tubular portion is beveled or sharpened to assist in puncturing the vessel.  
   
   
       9 . The device of  claim 1 , further comprising a side-arm extending from near the proximal end of the sheath.  
   
   
       10 . The device of  claim 1 , wherein the tubular portion has an outer diameter no greater than 45 mm.  
   
   
       11 . The device of  claim 10 , wherein the tubular portion has an outer diameter ranging from about 1 mm to about 70 mm.  
   
   
       12 . The device of  claim 11 , wherein the tubular portion has an outer diameter ranging from about 1 mm to about 8 mm.  
   
   
       13 . The device of  claim 1 , wherein the tubular portion has a length ranging from about 5 cm to about 135 cm.  
   
   
       14 . The device of  claim 1 , wherein the lumen has a diameter of at least about 1 mm.  
   
   
       15 . The device of  claim 14 , wherein the lumen has a diameter ranging from about 70 mm to about 1 mm.  
   
   
       16 . The device of  claim 15 , wherein the lumen has a diameter ranging from about 1 mm to about 8 mm.  
   
   
       17 . The device of  claim 1 , wherein the retractable mechanism comprises at least one inflatable balloon.  
   
   
       18 . The device of  claim 17 , further comprising at least one balloon inflation port near the proximal end of the tubular portion for inflation of the at least one balloon.  
   
   
       19 . The device of  claim 18 , further comprising at least one inflation channel connecting the at least one balloon to the at least one balloon inflation port.  
   
   
       20 . The device of  claim 19 , wherein the at least one inflation channel is located in the walls of the tubular portion.  
   
   
       21 . The device of  claim 20 , wherein the walls of the tubular portion are hollow and the at least one inflation channel comprises the hollow of the walls of the tubular portion.  
   
   
       22 . The device of  claim 19 , further comprising at least one aperture in the walls of the tubular portion, wherein the at least one aperture connects the at least one inflation channel to the at least one balloon.  
   
   
       23 . The device of  claim 17 , wherein the mechanism comprises a single inflatable balloon and wherein the balloon, when inflated, is circular or oval in shape.  
   
   
       24 . The device of  claim 23 , wherein the balloon, when inflated, has a cross-sectional diameter of no greater than 70 mm.  
   
   
       25 . The device of  claim 24 , wherein the balloon, when inflated, has a cross-sectional diameter ranging from about 2 mm to about 70 mm.  
   
   
       26 . The device of  claim 25 , wherein the balloon, when inflated, has a cross-sectional diameter ranging from about 3 mm to about 20 mm.  
   
   
       27 . The device of  claim 23 , wherein the balloon, when inflated, has a length of no greater than three-quarters the length of the tubular portion.  
   
   
       28 . The device of  claim 23 , wherein the balloon, when inflated, has a length ranging from about 1 mm to about 150 mm.  
   
   
       29 . The device of  claim 17 , wherein the mechanism comprises a plurality inflatable balloons and wherein the balloons, when inflated, form a circular or oval shape.  
   
   
       30 . The device of  claim 17 , wherein the mechanism comprises one or more inflatable balloons that, when inflated, form a funnel shape.  
   
   
       31 . (canceled)  
   
   
       32 . The device of  claim 30 , wherein the largest width of the funnel shaped balloon, when inflated, is no greater than 70 mm.  
   
   
       33 . The device of  claim 30 , wherein the largest width of the funnel shaped balloon, when inflated, ranges from about 2 mm to about 60 mm.  
   
   
       34 . The device of  claim 30 , wherein the largest width of the funnel shaped balloon, when inflated, ranges from about 2 mm to about 20 mm.  
   
   
       35 . The device of  claim 17 , wherein the one or more balloons, when inflated, are flush with the distal end of the tubular portion.  
   
   
       36 . The device of  claim 17 , wherein the one or more balloons, when inflated, protrude in front of the distal end of the tubular portion forming a funnel.  
   
   
       37 . The device of  claim 17  wherein the one or more balloons is inflatable to various sizes.  
   
   
       38 . The device of  claim 1 , wherein the retractable mechanism comprises at least one retractable extension.  
   
   
       39 . The device of  claim 38 , wherein the at retractable mechanism comprises two or more arm-like extensions.  
   
   
       40 . The device of  claim 38 , wherein the retractable mechanism comprises one or more extensions forming a funnel-like shape.  
   
   
       41 . The device of  claim 40 , further comprising biodegradable material connecting the extensions together to form the funnel-like shape.  
   
   
       42 . The device of  claim 36 , wherein the retractable mechanism comprises one or more extensions forming a circular shape.  
   
   
       43 . The device of  claim 42 , further comprising biodegradable material connecting the extensions together to form the circular shape.  
   
   
       44 . The device of  claim 38 , wherein the at least one retractable extension is housed within the tubular portion when retracted.  
   
   
       45 . The device of  claim 38 , wherein the at least one retractable extension is folded back against the side surfaces of the tubular portion when retracted.  
   
   
       46 . The device of  claim 38 , wherein the at least one retractable extension is deployable and retractable to various sizes.  
   
   
       47 . A medical device kit, comprising one or more of the devices of  claim 1 .  
   
   
       48 . The kit of  claim 47 , wherein the one or more devices are packaged in sterile condition.  
   
   
       49 . A method for performing a vascular percutaneous intervention comprising utilizing the device of  claim 1 .  
   
   
       50 . A method for performing a vascular percutaneous intervention comprising the steps of: 
 (a) providing a device comprising: 
 a tubular portion, having a proximal end and a distal end, and a lumen extending from the proximal end to the distal end;  
 a retractable mechanism near the distal end of the tubular portion, the mechanism providing an increased cross section of the tubular portion when deployed and substantially no increase in cross section of the tubular portion when retracted;  
   (b) inserting the tubular portion of the device into a blood vessel distal end first with the retractable mechanism retracted;    (c) deploying the retractable mechanism to a size larger than the opening through which the tubular portion entered the blood vessel;    (d) performing the vascular percutaneous intervention;    (e) retracting the retractable mechanism; and    (f) removing the device from the blood vessel.    
   
   
       51 . The method of  claim 50 , wherein the device is inserted using a retrograde approach, wherein the retractable mechanism is deployed to a size larger than the opening through which the tubular portion entered the blood vessel, and wherein the method further comprises the step of, after (d), repositioning the device to an antegrade approach, wherein the deployed retractable mechanism prevents the tubular portion from exiting the blood vessel.  
   
   
       52 . The method of  claim 50 , wherein the retractable mechanism comprises at least one inflatable balloon.  
   
   
       53 . The method of  claim 50 , wherein the retractable mechanism comprises at least one retractable extension.  
   
   
       54 . The method of  claim 50 , wherein the device is in the form of a guide catheter.  
   
   
       55 . A method of repositioning a device within a blood vessel between a retrograde approach and an antegrade approach and vice-versa, comprising utilizing the device  claim 1 .  
   
   
       56 . A method of repositioning a device within a blood vessel between a retrograde approach and an antegrade approach and vice-versa, comprising: 
 (a) providing a device comprising: 
 a tubular portion, having a proximal end and a distal end, and a lumen extending from the proximal end to the distal end;  
 a retractable mechanism near the distal end of the tubular portion, the mechanism providing an increased cross section of the tubular portion when deployed and substantially no increase in cross section of the tubular portion when retracted;  
   (b) inserting the tubular portion of the device into a blood vessel in one direction distal end first with the mechanism retracted;    (c) deploying the mechanism to a size larger than the opening through which the tubular portion entered the blood vessel;    (d) pulling the device back out of the blood vessel, while maintaining vascular access;    (e) pushing the device back into the blood vessel in the opposite direction whereby the deployed mechanism prevents the device from losing vascular assess.    
   
   
       57 . A method for aspirating blood clots, emboli and other materials from a blood vessel comprising the steps of: 
 (a) providing a device comprising: 
 a tubular portion, having a proximal end and a distal end, and a lumen extending from the proximal end to the distal end;  
 a retractable mechanism near the distal end of the tubular portion, the mechanism providing an increased cross section of the tubular portion when deployed and substantially no increase in cross section of the tubular portion when retracted;  
   (b) inserting the tubular portion of the device into the blood vessel distal end first facing towards the material to be aspirated with the retractable mechanism retracted;    (c) deploying the retractable mechanism to a size that occludes the blood vessel;    (d) removing blood clots, emboli and other materials from the blood vessel;    (e) retracting the retractable mechanism; and    (f) removing the device from the blood vessel.    
   
   
       58 . The method of  claim 57 , wherein the step of (d) removing blood clots, emboli and other materials from the blood vessel comprises aspirating the blood clots, emboli and other materials from the blood vessel through the tubular portion  
   
   
       59 . The method of  claim 57 , wherein the step of (d) removing blood clots, emboli and other materials from the blood vessel comprises pulling the blood clots, emboli and other materials from the blood vessel through the tubular porting using another balloon catheter.  
   
   
       60 . The method of  claim 57 , further comprising the steps of, after (d) removing the blood clot, emboli and other materials from the blood vessel; 
 partially retracting the retractable mechanism to a size smaller than the blood vessel but larger than the opening through which the tubular portion entered the blood vessel;    pulling the device back out of the blood vessel, while maintaining vascular access, whereby the deployed mechanism prevents the device from losing vascular assess;    pushing the device back into the blood vessel in the opposite direction;    deploying the retractable mechanism to a size that occludes the blood vessel; and    aspirating blood clots, emboli and other materials from the opposite direction of the blood vessel.    
   
   
       61 . The method of  claim 49 , wherein the device is a guide catheter.  
   
   
       62 . The method of  claim 49 , wherein the device is a vascular sheath.  
   
   
       63 . A method for performing a vascular percutaneous intervention comprising the steps of: 
 (a) providing a first device comprising: 
 a tubular portion, having a proximal end and a distal end, and a lumen extending from the proximal end to the distal end;  
 a retractable mechanism near the distal end of the tubular portion, the mechanism providing an increased cross section of the tubular portion when deployed and substantially no increase in cross section of the tubular portion when retracted;  
   (b) inserting the tubular portion of the first device into a donor blood vessel distal end first with the retractable mechanism retracted;    (c) deploying the retractable mechanism to a size larger than the opening through which the tubular portion entered the blood vessel;    (d) connecting the first device to a recipient blood vessel; and    (e) transferring materials from the donor blood vessel, through the tubular portion of the first device, and into the recipient blood vessel.    
   
   
       64 . The method of  claim 63  wherein the step of (d) connecting the first device to a recipient blood vessel comprises the step of connecting the first device to a tube and inserting the tube into the recipient blood vessel.  
   
   
       65 . The method of claims  63  wherein the first device further comprises a side arm and the step of (d) connecting the first device to a recipient blood vessel comprises the step of inserting the side arm the recipient vessel.  
   
   
       66 . The method of  claim 63  further comprising the step of providing a second device comprising a tubular portion, having a proximal end and a distal end, and a lumen extending from the proximal end to the distal end and wherein the step of (d) connecting the first device to a recipient blood vessel comprises the step of inserting the second device into recipient vessel and connecting the first device to the second device.  
   
   
       67 . The method of  claim 63 , further comprising the step of interposing a pump between the first device and the recipient blood vessel, wherein the pump assists in aspirating materials from the donor blood vessel and into the recipient blood vessel, or visa-versa.  
   
   
       68 . The method of claim any one of  claim 64  wherein the tube further includes a retractable mechanism, the mechanism providing an increased cross section of the tube when deployed and substantially no increase in cross section of the tube retracted.  
   
   
       69 . The method of  claim 63 , wherein the step of (c) deploying the retractable mechanism to a size larger than the opening through which the tubular portion entered the blood vessel comprises deploying the mechanism to a size that occludes the blood vessel and stops the blood flow through the blood vessel.  
   
   
       70 . The method of  claim 69 , further comprising the steps of: 
 (f) optionally stopping the transfer of materials from the donor blood vessel into the recipient blood vessel; (g) optionally aspirating emboli, debris and other materials out of the recipient blood vessel through the tubular portion;    (h) at least partially retracting the retractable mechanism to re-establish blood flow through the donor blood vessel;    (i) deploying the retractable mechanism to a size larger than the opening through which the tubular portion entered the blood vessel and optionally to a size that stops blood flow through the donor blood vessel; and    (j) reestablishing the transfer of materials from the donor blood vessel into the recipient blood vessel if the transfer has been stopped.    
   
   
       71 . The method of  claim 66 , wherein the first and/or second device is a guide catheter.