Methods and apparatus for anchoring an occluding member

Abstract

Pressure is measured on both sides of an occluding member for determining when pressure forces on the occluding member may cause migration of the occluding member. An alarm indicates when the pressure force on the balloon exceed a predetermined threshold. In another aspect of the invention, a pressure monitor determines when a rate of pressure increase with respect to the fluid volume in the balloon reaches a predetermined threshold when inflating the occluding member. A predetermined amount of fluid is then added to the balloon so that the balloon is not under inflated or over inflated.

1 . A method of anchoring a balloon catheter in a patient, comprising the steps of: 
 positioning the balloon in the patient's body passageway with the balloon in the collapsed shape so that the radially outward extremes contact the body passageway; and advancing the balloon in the patient to a position to be occluded with the balloon in the collapsed shape;    inflating the balloon after the advancing step so that the high friction portion contacts the patient's body passageway for anchoring the balloon in the patient's body passageway.    
     
     
         2 . The method of  claim 1 , wherein: 
 the positioning step is carried out by inserting the balloon into the patient's arterial system; and    the inflating step is carried out with the balloon being positioned in the patient's ascending aorta.    
     
     
         3 . The method of  claim 1 , wherein: 
 the providing step is carried out with the balloon catheter having a first lumen and an opening at the distal end fluidly coupled to the first lumen, the opening being configured for delivery of a fluid into a patient,    
     
     
         4 . The method of  claim 3 , further comprising the step of: 
 introducing cardioplegic fluid into the patient through the first lumen.    
     
     
         5 . The method of  claim 1 , wherein: 
 the providing step is carried out with the balloon catheter having at least three arms extending radially outward from the shaft.    
     
     
         6 . The method of  claim 1 , wherein: 
 the providing step is carried out with the high friction portion having a plurality of ribs.    
     
     
         7 . The method of  claim 1 , wherein: 
 the providing step is carried out with the shaft having a substantially straight portion and a hooked portion connected to the substantially straight portion.    
     
     
         8 . A balloon catheter for occluding a body passageway in a patient, comprising: 
 a shaft; and    a balloon mounted to the shaft, the balloon having an expanded shape and a collapsed shape, the expanded shape being configured to occlude a body passageway in a patient, the balloon including an outer surface having at least two high friction portions and a low friction portion, the low friction portion having a lower coefficient of friction than the high friction portions relative to the patient's body passageway, the balloon having at least three radially extending arms when in the collapsed shape, each of the at least two low friction portions being positioned at radially outward extremes of adjacent radially extending arms, the high friction portion being exposed and being positioned between two of the radially outward extremes of the radially extending arms when the balloon is in the collapsed shape, the high friction portion being everted when the balloon moves from the collapsed shape to the expanded shape.    
     
     
         9 . The balloon catheter of  claim 8 , wherein: 
 the balloon is configured and sized to occlude the patient's ascending aorta.    
     
     
         10 . The balloon catheter of  claim 8 , wherein: 
 the shaft includes a first lumen and an opening at the distal end fluidly coupled to the first lumen, the opening being configured for delivery of a fluid into a patient.    
     
     
         11 . The balloon catheter of  claim 8 , further comprising: 
 a source of cardioplegic fluid fluidly coupled to the first lumen.    
     
     
         12 . The balloon catheter of  claim 8 , wherein: 
 the high friction portion includes a plurality of ribs.    
     
     
         13 . The balloon catheter of  claim 8 , wherein: 
 the shaft has a substantially straight portion and a hooked portion connected to the substantially straight portion.    
     
     
         14 . A method for positioning a balloon in a passageway and occluding the passageway, comprising the steps of: 
 providing a catheter having a shaft and a balloon mounted thereto, the balloon having a collapsed shape and an expanded shape;    inserting the catheter into a body passageway of a patient with the balloon in the collapsed shape;    positioning the catheter in a portion of the body passageway for occluding the portion of the body passageway; inflating the balloon with a fluid;    monitoring a rate of pressure increase in the balloon with respect to a fluid volume in the balloon; and    adding an amount of fluid after the rate of pressure increase in the balloon exceeds a predetermined threshold.    
     
     
         15 . The method of  claim 14 , wherein: 
 the positioning step is carried out by positioning the balloon in the patient's ascending aorta.    
     
     
         16 . The method of  claim 14 , wherein: 
 the providing step is carried out with the catheter having a lumen fluidly coupled to the balloon, the catheter also having a pressure sensor and a pressure sensing alarm, the pressure sensing alarm indicating when the rate of pressure increase in the balloon exceeds the predetermined threshold.    
     
     
         17 . The method of  claim 14 , wherein: 
 the adding step is carried out with the amount of fluid being a predetermined volume of fluid.    
     
     
         18 . The method of  claim 14 , wherein: 
 the adding step is carried out by adding the amount of fluid to increase the pressure in the balloon a predetermined amount.    
     
     
         19 . A device for pressurizing a balloon catheter, comprising: 
 a catheter having a shaft and a balloon mounted thereto, the balloon having a collapsed shape and an expanded shape, the collapsed shape being configured for advancement within a patient the catheter having a first lumen fluidly coupled to the balloon for inflating the balloon;    a fluid source coupled to the first lumen for inflating the balloon;    a pressure sensor configured to measure a pressure in an interior of the balloon; and    a pressure monitor coupled to the pressure sensor, the pressure monitor determining when a rate of pressure increase in the balloon with respect to an increase in fluid volume in the balloon exceeds a predetermined threshold.    
     
     
         20 . The device of  claim 19 , further comprising: 
 means for adding a predetermined amount of fluid after the pressure monitor detects the rate of pressure increase exceeds the predetermined threshold.    
     
     
         21 . The device of  claim 19 , further comprising: 
 means for increasing the pressure in the balloon a predetermined amount after the pressure monitor detects the rate of pressure increase exceeds the predetermined threshold.    
     
     
         22 . A method of anchoring an occluding member in a patient, comprising the steps of: 
 inserting a catheter having an occluding member mounted thereto, the occluding member having a collapsed shape and an expanded shape;    positioning the occluding member in a body passageway in the patient; expanding the occluding member to the expanded shape after the positioning step to thereby occlude the body passageway;    monitoring a pressure exerted on the occluding member on a distal side and a proximal side of the occluding member; and    determining a difference between the pressure on the distal and proximal sides of the occluding member.    
     
     
         23 . The method of  claim 22 , further comprising the step of: 
 adjusting a pressure on at least one of the distal and proximal sides of the occluding member.    
     
     
         24 . The method of  claim 22 , wherein: 
 the adjusting step is carried out by adjusting a pressure on the distal side of the occluding member.    
     
     
         25 . The method of  claim 22 , wherein: 
 the inserting step is carried out with the occluding member being a balloon.    
     
     
         26 . The method of  claim 22 , wherein: 
 the inserting step is carried out with the body passageway being an ascending aorta.    
     
     
         27 . A catheter for occluding an ascending aorta in a patient, comprising: 
 a shaft having a distal end and a proximal end;    an occluding member mounted to the shaft, the occluding member having an expanded shape sized to occlude the patient's ascending aorta; a first pressure sensor positioned between the distal end and the occluding member for measuring a pressure on a first side of the occluding member; and    a second pressure sensor positioned between the proximal end and the occluding for measuring a pressure on a second side of the occluding member.    
     
     
         28 . The catheter of  claim 27 , further comprising: 
 a pressure monitor coupled to the first and second pressure sensors, the pressure monitor determining a pressure difference between the first and second pressure sensors.    
     
     
         29 . The catheter of  claim 28 , further comprising: 
 an alarm coupled to the pressure monitor for indicating when a pressure difference sensed by the first and second pressure sensors exceeds a predetermined threshold.    
     
     
         30 . The catheter of  claim 27 , wherein: 
 the occluding member is a balloon; and    the shaft includes a first lumen, a second lumen and an opening at the distal end of the shaft fluidly coupled to the first lumen, the second lumen being fluidly coupled to the balloon for inflating the balloon.    
     
     
         31 . The catheter of  claim 30 , further comprising: 
 means for adjusting the pressure on at least one of the first and second sides of the balloon when a pressure difference sensed by the first and second pressure sensors exceeds a predetermined threshold, the pressure adjusting means reducing the pressure difference to a value below the predetermined threshold.    
     
     
         32 . The catheter of  claim 31 , wherein: 
 the pressure adjusting means is coupled to the first lumen for adjusting a fluid pressure exerted by fluid delivered into the ascending aorta through the first lumen.    
     
     
         33 . A method of anchoring an occluding member in an ascending aorta of a patient, comprising the steps of: 
 inserting a catheter into a patient, the catheter including a shaft having an occluding member at a distal end, the occluding member having a collapsed shape and an expanded shape;    positioning the catheter in the patient's ascending aorta;    expanding the occluding member to the expanded shape after the positioning step to thereby occlude the ascending aorta; and    displacing the shaft of the catheter a first amount after the expanding step so that a predetermined portion of the catheter contacts the patient's aortic lumen for anchoring the occluding member in the ascending aorta.    
     
     
         34 . The method of  claim 33 , wherein: 
 the displacing step is carried out by withdrawing an amount of the catheter from the patient so that the predetermined portion of the catheter engages a radially inner portion of the patient's ascending aorta.    
     
     
         35 . The method of  claim 33 , further comprising the step of: 
 displacing the catheter a second amount in a direction opposite to the first amount so that a second predetermined portion of the shaft engages a radially outer wall of the patient's ascending aorta.    
     
     
         36 . The method of  claim 33 , further comprising the step of: 
 inserting the shaft through a delivery cannula, the delivery cannula having a shaft engaging mechanism and a shaft displacing mechanism; the displacing step being performed with the shaft displacing mechanism of the delivery cannula.    
     
     
         37 . A catheter having an expandable member for occluding an ascending aorta in a patient, comprising: 
 a shaft having a longitudinal axis, a distal end, a proximal end, a first lumen and an opening at the distal end in fluid communication with the opening, the opening being configured for delivery of a fluid into the patient's ascending aorta;    an expandable member mounted near the distal end of the shaft, the expandable member having an expanded shape and a collapsed shape, the expanded shape being configured to occlude the patient's ascending aorta; and    a delivery cannula, the shaft being movably coupled to the delivery cannula for movement in a direction parallel to the longitudinal axis in an inward direction and an outward direction;    the shaft having a first portion configured to contact the radially inner wall of the aortic lumen when the shaft is slidably displaced in the outward direction.    
     
     
         38 . The catheter of  claim 37 , further comprising: 
 a shaft displacing mechanism coupled to the delivery cannula, the shaft displacing mechanism being configured to displace the shaft a predetermined amount in the outward direction so that the first portion engages the radially inner wall of the aortic lumen.    
     
     
         39 . The catheter of  claim 37 , wherein: 
 the shaft includes a second portion configured to contact a radially outer wall of the aortic lumen when the shaft is slidably displaced in the inward direction.    
     
     
         40 . The catheter of  claim 39 , wherein: 
 the shaft includes a third portion configured to contact the radially outer wall of the aortic lumen when the shaft is slidably displaced in the inward direction, the second portion being positioned between the first and second portions.    
     
     
         41 . The catheter of  claim 37 , wherein: 
 the delivery cannula includes a lumen for introducing a fluid into the patient.    
     
     
         42 . The catheter of  claim 37 , wherein: 
 the shaft includes a first bend and a second bend, the first portion being positioned between the first and second bends.    
     
     
         43 . A method of anchoring an occluding member in a patient comprising the steps of: 
 inserting a catheter into a patient, the catheter having an occluding member mounted thereto;    positioning the occluding member at a desired location;    expanding the occluding member to occlude the desired location; and clamping a portion of the passageway adjacent the desired location to prevent migration of the occluding member.    
     
     
         44 . The method of  claim 43 , wherein: 
 the inserting step is carried out with the occluding member being a balloon.    
     
     
         45 . The method of  claim 43 , wherein: 
 the clamping step is carried out by clamping the body passageway around the balloon thereby trapping the balloon.    
     
     
         46 . The method of  claim 43 , wherein: 
 the inserting step is carried out with the balloon having an indentation; and    the clamping step is carried out with the clamp being positioned around the indentation.    
     
     
         47 . A method of anchoring an occluding member in a patient's ascending aorta comprising the steps of: 
 inserting an occluding member in the ascending aorta between the coronary ostia and the brachiocephalic artery;    expanding the occluding member in the patient after the inserting step;    positioning an anchor in the brachiocephalic artery, the anchor having a proximal end extending into the aorta, the anchor preventing migration of the occluding member beyond the brachiocephalic artery.    
     
     
         48 . The method of  claim 47 , wherein: 
 the positioning step is carried out with the anchor being a perfusion catheter configured to deliver oxygenated blood to the brachiocephalic artery.    
     
     
         49 . The method of  claim 47 , wherein: 
 the anchor is separate from the catheter.