Methods and apparatus for hemostasis following arterial catheterization

Abstract

A hemostasis device including a shaft having a forward end, at least one anchor balloon mounted on the shaft at the forward end and at least one electrical resistance heating element, mounted on the main shaft forward of the at least one anchor element and being operable to enhance hemostasis.

1 . A hemostasis device comprising:
 a shaft having a forward end;   at least one anchor balloon element on said shaft at said forward end; and   at least one electrical resistance heating element, mounted on said shaft forward of said at least one anchor element and being operable to enhance hemostasis.   
   
   
       2 . A hemostasis device according to  claim 1  and wherein said at least one anchor element comprises an anchor balloon. 
   
   
       3 . A hemostasis device according to either of  claims 1  and  2  and wherein said at least one electrical resistance heating element is configured to be suitable for passage through a catheter introducer for introduction thereof to a desired hemostasis location and to be foldable over said forward end of said shaft and said at least one anchor balloon during said passage. 
   
   
       4 . A hemostasis device according to  claim 3  and wherein said electrical resistance heating element is configured to be foldable over said forward end of said shaft in a manner that portions of said electrical resistance heating element generally do not overlap when so folded. 
   
   
       5 . A hemostasis device according to any of the preceding claims and wherein said electrical resistance heating element is configured to define a plurality of leaves. 
   
   
       6 . A hemostasis device according to  claim 5  and wherein said plurality of leaves are arranged generally in a four-leaf clover configuration. 
   
   
       7 . A hemostasis device according to any of the preceding claims and wherein said electrical resistance heating element is resiliently bendable to be foldable over said forward end of said shaft and to extend radially outward from said shaft prior to and following folding thereof. 
   
   
       8 . A hemostasis device according to any of the preceding claims and also comprising at least one peripheral balloon, disposed rearwardly of said at least one anchor balloon along said shaft 
   
   
       9 . A hemostasis device according to  claim 8  and wherein said shaft comprises at least a first lumen and a second lumen, said first lumen being operative to supply fluid to said anchor balloon for inflation thereof and said second lumen being operative to supply fluid to said peripheral balloon for inflation thereof. 
   
   
       10 . A hemostasis device according to any of the preceding claims and wherein said electrical resistance heating element is formed of foil. 
   
   
       11 . A hemostasis device according to either of  claims 8  and  9  and also comprising a first and a second conductor operative to supply electrical power to said electrical resistance heating element, said first conductor extending through said first lumen and said second conductor extending through said second lumen. 
   
   
       12 . A method for accelerating hemostasis of an artery having a puncture after arterial catheterization, the method comprising the steps of:
 following arterial catheterization, introducing through a catheter introducer a hemostasis device including a shaft having a forward end, at least one anchor balloon mounted on said shaft at said forward end and at least one electrical resistance heating element, mounted on said shaft forward of said at least one anchor element, such that a forward end of said hemostasis device lies exterior of the artery adjacent a puncture in a wall of the artery;   accelerating hemostasis in the vicinity of said puncture by operating said electrical resistance heating element, thereby shortening the time required for hemostasis; and   following hemostasis, removing said hemostasis device from the patient.   
   
   
       13 . A method according to  claim 12  and wherein said at least one anchor element comprises an anchor balloon. 
   
   
       14 . A method according to either of  claims 12  and  13  and wherein said introducing said hemostasis device includes passing said hemostasis device through said catheter introducer including folding said at least one electrical resistance heating element over said forward end of said shaft and said at least one anchor balloon. 
   
   
       15 . A method according to  claim 14  and wherein said folding is such that portions of said electrical resistance heating element generally do not overlap when they are folded. 
   
   
       16 . A method according to any of the preceding  claims 12 - 15  and wherein said electrical resistance heating element is configured to define a plurality of leaves, and wherein said folding includes folding of said leaves in a generally non-overlapping arrangement. 
   
   
       17 . A method according to any of the preceding  claims 12 - 16  and wherein during said folding said electrical resistance heating element is resiliently bent and folded over said forward end of said shaft and prior to and following said folding, said electrical resistance heating element extends radially outward from said shaft. 
   
   
       18 . A method according to any of the preceding  claims 12 - 17  and wherein said hemostasis device also includes at least one peripheral balloon, disposed rearwardly of said at least one anchor balloon along said shaft and being arranged for operational interaction with tunica intima, tunica media and tunica adventitia portions of said artery and wherein said accelerating hemostasis comprises:
 allowing a limited volume of blood to collect outside of said artery in a region delimited by the engagement of said at least one peripheral balloon with said artery, following deflation of said anchor balloon; and   employing inflation of said at least one peripheral balloon to apply pressure to said artery to cause said tunica intima, tunica media and tunica adventitia portions on both sides of said puncture to be mutually engaged.   
   
   
       19 . A method according to  claim 18  and wherein said accelerating hemostasis also comprises supplying electrical power to said electrical resistance heating element which stimulates denaturation of proteins in said tunica adventitia portion, thereby causing said tunica adventitia portion to sealingly bridge said tunica media portion at said puncture. 
   
   
       20 . A method according to any of  claims 12 - 19  and wherein said accelerating hemostasis comprises supplying electrical power to said electrical resistance heating element for less than 5 seconds.