Methods and apparatus for hemostasis following arterial catheterization

Abstract

A hemostasis device including a resistance heating element for accelerating hemostasis, a blood resistance sensor and a blood resistance indicator, operative to provide an indication of the resistance at the resistance sensor of blood undergoing hemostasis.

1 . A hemostasis device comprising: 
 a resistance heating element for accelerating hemostasis;    a blood resistance sensor; and    a blood resistance indicator, operative to provide an indication of the resistance at said resistance sensor of blood undergoing hemostasis.    
   
   
       2 . A hemostasis device according to  claim 1  and also comprising a power supply connected to said resistance heating element, said resistance sensor and said resistance indicator.  
   
   
       3 . A hemostasis device according to  claim 2  and wherein said power supply is operative to supply a relatively high level current to said resistance heating element.  
   
   
       4 . A hemostasis device according to either of claims  2  and  3  and wherein said power supply is operative to supply a relatively low level current to said resistance sensor.  
   
   
       5 . A method for accelerating hemostasis of an artery of a patient having a puncture after arterial catheterization, the method comprising the steps of: 
 following arterial catheterization, introducing a hemostasis device, such that a forward end of said hemostasis device lies exterior of the artery adjacent said puncture;    accelerating hemostasis by heating tissue in the vicinity of said puncture, thereby shortening the time required for hemostasis; and    following hemostasis, removing said hemostasis device from the patient.    
   
   
       6 . A method according to  claim 5  and also comprising inserting a catheter introducer into said artery prior to said arterial catheterization and wherein following said arterial catheterization, said hemostasis device is introduced through said catheter introducer.  
   
   
       7 . A method according to any of claims  5 - 6  and also comprising measuring the conductivity of blood in the vicinity of said puncture during hemostasis.  
   
   
       8 . A method for monitoring the progress of hemostasis of an artery of a patient having a puncture after arterial catheterization, the method comprising the steps of: 
 following arterial catheterization, introducing a hemostasis device, such that a forward end of said hemostasis device lies exterior of the artery adjacent said puncture;    during hemostasis, measuring the heat conductivity of blood in the vicinity of said puncture, thereby to provide an output indication of the progress of hemostasis; and    following hemostasis, removing said hemostasis device from the patient.    
   
   
       9 . A method according to  claim 8  and also comprising the step of inserting into an artery a catheter introducer prior to arterial catheterization and wherein following said arterial catheterization, said hemostasis device is introduced through said catheter introducer.  
   
   
       10 . A method according to either of  claim 8  or  claim 9  and also comprising inflating a balloon to block said puncture, prior to said hemostasis.  
   
   
       11 . A method according to  claim 10  and also comprising deflating said balloon prior to removing said hemostasis device.  
   
   
       12 . A hemostasis device comprising: 
 a main shaft;    at least one balloon mounted on said main shaft; and    at least one electrode, mounted on said main shaft and being operable to supply an electric current suitable for causing hemostasis.    
   
   
       13 . A hemostasis device according to  claim 12  and wherein said at least one balloon comprises: 
 at least one anchor balloon, disposed at an end of said main shaft; and    at least one peripheral balloon, disposed at a location along said main shaft exterior to a wall of said main shaft.    
   
   
       14 . A hemostasis device according to  claim 13  and wherein said at least one peripheral balloon and a wall of an artery are configured to delimit a region which is subject to hemostasis.  
   
   
       15 . A hemostasis device according to any of claims  12 - 14  and also comprising an electrical power source and a control module.  
   
   
       16 . A hemostasis device according to  claim 15  and wherein said power source is an RF power supply.  
   
   
       17 . A hemostasis device according to  claim 16  and wherein said RF power supply is operative to supply electrical power at RF frequencies within a range of 0.1-10 watts at up to 25 volts.  
   
   
       18 . A hemostasis device according to any of claims  15 - 17  and wherein said control module is operative to measure at least one of electrical current, blood resistance and blood temperature.  
   
   
       19 . A hemostasis device according to any of claims  15 - 18  and wherein said control module is operative to adjust power supplied by said power source based on at least one measurement.  
   
   
       20 . A hemostasis device according to any of claims  12 - 19  and wherein said at least one electrode comprises a pair of electrodes.  
   
   
       21 . A method for producing hemostasis at an artery of a patient having a puncture following arterial catheterization comprising: 
 introducing a hemostasis device comprising at least one electrode into the vicinity of said puncture;    supplying an electric current to said at least one electrode, thereby heating a volume of blood in the vicinity of said puncture, causing hemostasis; and    subsequently removing said hemostasis device from the patient.    
   
   
       22 . A method according to  claim 21  and wherein said introducing comprises introducing via a catheter introducer.  
   
   
       23 . A method according to either of claims  21  and  22  and wherein said introducing also comprises inflating an anchor balloon attached to an end of said hemostasis device.  
   
   
       24 . A method according to any of claims  21 - 23  and wherein said introducing comprises inflating a peripheral balloon.  
   
   
       25 . A method according to  claim 24  and wherein said removing said hemostasis device comprises deflating said peripheral balloon.  
   
   
       26 . A method according to any of claims  21 - 25  and wherein said introducing comprises positioning said at least one electrode in close proximity to a volume of blood.  
   
   
       27 . A method according to any of claims  21 - 26  and wherein said supplying comprises supplying electrical power at RF frequencies.  
   
   
       28 . A method according to  claim 27  and wherein said electrical power comprises electrical power in the range of 0.1-10 watts at up to 25 volts.  
   
   
       29 . A method according to any of claims  21 - 28  and wherein said supplying also comprises adjusting said electric current based on a feedback measurement.  
   
   
       30 . A hemostasis device comprising: 
 a main shaft;    at least one balloon mounted on said main shaft adjacent an end thereof; and    a hemostasis agent supply conduit operative to supply a hemostasis agent at a location at an end of said main shaft beyond said at least one balloon.    
   
   
       31 . A hemostasis device according to  claim 30  and also comprising at least one heating assembly operative to provide heating at said location.  
   
   
       32 . A hemostasis device according to  claim 31  and wherein said at least one heating assembly comprises at least one electrode disposed adjacent said location.  
   
   
       33 . A hemostasis device according to  claim 32  and wherein said at least one electrode is disposed interiorly of said at least one balloon.  
   
   
       34 . A hemostasis device according to  claim 32  and wherein said at least one electrode is disposed exteriorly of said at least one balloon.  
   
   
       35 . A hemostasis device according to any of claims  31 - 33  and wherein said at least one heating assembly comprises an electrical resistive heating element.  
   
   
       36 . A hemostasis device according to  claim 35  and wherein said electrical resistive heating element is disposed within said at least one balloon.  
   
   
       37 . A hemostasis device comprising: 
 a main shaft;    at least one balloon mounted on said main shaft adjacent an end thereof; and    at least one RF electrode located at a location at an end of said main shaft beyond said at least one balloon.    
   
   
       38 . A hemostasis device according to  claim 37  and also comprising a hemostasis agent supply conduit operative to supply a hemostasis agent at a location at an end of said main shaft beyond said at least one balloon.  
   
   
       39 . A hemostasis device according to  claim 37  and wherein said at least one RF electrode is disposed interiorly of said at least one balloon.  
   
   
       40 . A hemostasis device according to  claim 37  and wherein said at least one RF electrode is disposed exteriorly of said at least one balloon.  
   
   
       41 . A hemostasis device comprising: 
 a main shaft;    at least one balloon mounted on said main shaft adjacent an end thereof; and    at least one resistive heating element located at a location at an end of said main shaft beyond said at least one balloon.    
   
   
       42 . A hemostasis device according to  claim 41  and also comprising a hemostasis agent supply conduit operative to supply a hemostasis agent at a location at an end of said main shaft beyond said at least one balloon.  
   
   
       43 . A hemostasis device according to  claim 42  and wherein said at least one resistance heating element is disposed interiorly of said at least one balloon.  
   
   
       44 . A method for producing hemostasis at an artery of a patient having a puncture following arterial catheterization comprising: 
 introducing a hemostasis device including at least one balloon mounted adjacent an end of a shaft to a location in the vicinity of said puncture; and    supplying a hemostasis agent to said location at said end of said shaft beyond said at least one balloon.    
   
   
       45 . A method according to  claim 44  and also comprising providing heating at said location.  
   
   
       46 . A method according to  claim 45  and wherein said providing heating includes locating at least one electrode adjacent said location.  
   
   
       47 . A method according to  claim 46  and wherein said at least one electrode is disposed interiorly of said at least one balloon.  
   
   
       48 . A method according to  claim 46  and wherein said at least one electrode is disposed exteriorly of said at least one balloon.  
   
   
       49 . A method according to any of claims  45 - 48  and wherein said providing heating comprises providing electrical resistive heating.  
   
   
       50 . A method for producing hemostasis at an artery of a patient having a puncture following arterial catheterization comprising: 
 introducing a hemostasis device including at least one balloon mounted adjacent an end of a shaft to a location in the vicinity of said puncture; and    operating at least one RF electrode at said location at said end of said main shaft beyond said at least one balloon.    
   
   
       51 . A method according to  claim 50  and also comprising: 
 supplying a hemostasis agent to said location at said end of said shaft beyond said at least one balloon.    
   
   
       52 . A method according to either of claims  50  and  51  and wherein said at least one RF electrode is disposed interiorly of said at least one balloon.  
   
   
       53 . A method according to either of claims  50  and  51  and wherein said at least one RF electrode is disposed exteriorly of said at least one balloon.  
   
   
       54 . A method for producing hemostasis at an artery of a patient having a puncture following arterial catheterization comprising: 
 introducing a hemostasis device including at least one balloon mounted adjacent an end of a shaft to a location in the vicinity of said puncture; and    operating at least one resistance heating element at said location at an end of said shaft beyond said at least one balloon.    
   
   
       55 . A method according to  claim 54  and also comprising: 
 supplying a hemostasis agent to said location at said end of said shaft beyond said at least one balloon.    
   
   
       56 . A method according to either of claims  54  and  55  and wherein said at least one resistance heating element is disposed interiorly of said at least one balloon.