Hemostasis pad and method

Abstract

The present invention relates generally to medical devices for applying hemostatic composition to a puncture or wound site with indwelling tubular element, such as catheter, introducer or tube therein, particularly a hemostatic pad with an opening therethrough in order to allow egress of the indwelling tubular element through the hemostatic pad as the hemostatic pad provide hemostasis at the hemorrhaging site. The device may be applied to, or removed from, the wound site while the tubular element is in place. A method for effecting hemostasis at a puncture wound, includes applying pressure proximal to the puncture wound, and directing a cationic biopolymer of glucosamine application surface of a closure pad against the puncture wound with force sufficient to prevent fluid from exiting the puncture wound. Then the pressure proximal to the puncture wound is removed and the force on the closure pad is maintained for at least a first predetermined time period. The force on the closure pad is removed if hemostasis is verified. The puncture wound may then be dressed over the closure pad, and the dressing and the closure pad removed after a second predetermined time period.

1 . A device for effecting hemostasis at a puncture wound with an indwelling tubular element extending therethrough, said device comprising: 
 a pad having a top surface and a bottom surface, said pad defining an aperture near a central region thereof adapted for passage therethrough of said tubular element, and an elongated cut extending from said aperture to a peripheral point of said pad; and    a hemostatically effective amount of a hemostatic agent on said bottom surface of said pad.    
   
   
       2 . The device of  claim 1 , wherein the hemostatic agent comprises a cationic biopolymer of glucosamine,  
   
   
       3 . The device of  claim 2 , wherein the biopolymer of glucosamine is poly-N-acetylglucosamine.  
   
   
       4 . The device of  claim 2 , wherein the biopolymer of glucosamine is poly-D-glucosamine.  
   
   
       5 . The device of  claim 2 , wherein the biopolymer of glucosamine is an acetate salt of poly-N-acetylglucosamine.  
   
   
       6 . The device of  claim 2 , wherein the biopolymer of glucosamine is an acetate salt of poly-D-glucosamine.  
   
   
       7 . The device of  claim 2 , wherein the biopolymer of glucosamine is poly-N-acetylglucosamine and poly-D-glucosamine.  
   
   
       8 . The device of  claim 2 , wherein the biopolymer of glucosamine is an acetate salt of poly-N-acetylglucosamine and poly-D-glucosamine.  
   
   
       9 . The device of  claim 2 , wherein the biopolymer of glucosamine is an acetate salt of poly-N-acetylglucosamine and an acetate salt of poly-D-glucosamine.  
   
   
       10 . The device of  claim 2 , wherein the biopolymer of glucosamine is poly-N-acetylglucosamine and an acetate salt of poly-D-glucosamine.  
   
   
       11 . The device of  claim 1 , wherein the tubular element is a catheter.  
   
   
       12 . The device of  claim 1 , wherein the tubular element is an introducer.  
   
   
       13 . The device of  claim 1 , wherein the tubular element is a tube.  
   
   
       14 . The device of  claim 1 , wherein said aperture is at an approximate center of said pad.  
   
   
       15 . The device of  claim 1 , wherein said aperture and said cut form a slit.  
   
   
       16 . The device of  claim 15 , wherein said slit is at a bias angle with respect to the central region of the pad.  
   
   
       17 . The device of  claim 16 , wherein said slit is at a bias angle of 45 degrees with respect to the central region of the pad.  
   
   
       18 . The device of  claim 1  further comprising a central non-slip etched area on a top surface of said pad.  
   
   
       19 . The device of  claim 1 , wherein said cut is at a bias angle with respect to the central region of the pad.  
   
   
       20 . The device of  claim 19 , wherein said cut is at a bias angle of 45 degrees with respect to the central region of the pad.  
   
   
       21 . A device for effecting hemostasis at a puncture wound with an indwelling tubular element extending therethrough, said device comprising: 
 a disc having a hemostatic layer attached to a bottom surface of said disc, wherein said disc defines an aperture through said disc, and wherein said aperture is adapted to permit egress of the indwelling tubular element through said disc, and wherein said disc defines a cut extending from said aperture to a peripheral point of said disc.    
   
   
       22 . The device of  claim 21 , wherein the hemostatic layer comprises a cationic biopolymer of glucosamine,  
   
   
       23 . The device of  claim 22 , wherein the biopolymer of glucosamine is poly-N-acetylglucosamine.  
   
   
       24 . The device of  claim 22 , wherein the biopolymer of glucosamine is poly-D-glucosamine.  
   
   
       25 . The device of  claim 22 , wherein the biopolymer of glucosamine is an acetate salt of poly-N-acetylglucosamine.  
   
   
       26 . The device of  claim 22 , wherein the biopolymer of glucosamine is an acetate salt of poly-D-glucosamine.  
   
   
       27 . The device of  claim 22 , wherein the biopolymer of glucosamine is poly-N-acetylglucosamine and poly-D-glucosamine.  
   
   
       28 . The device of  claim 22 , wherein the biopolymer of glucosamine is an acetate salt of poly-N-acetylglucosamine and poly-D-glucosamine.  
   
   
       29 . The device of  claim 22 , wherein the biopolymer of glucosamine is an acetate salt of poly-N-acetylglucosamine and an acetate salt of poly-D-glucosamine.  
   
   
       30 . The device of  claim 22 , wherein the biopolymer of glucosamine is poly-N-acetylglucosamine and an acetate salt of poly-D-glucosamine.  
   
   
       31 . The device of  claim 21 , wherein the tubular element is a catheter.  
   
   
       32 . The device of  claim 21 , wherein the tubular element is an introducer.  
   
   
       33 . The device of  claim 21 , wherein the tubular element is a tube.  
   
   
       34 . The device of  claim 21 , wherein said aperture and said cut form a slit extending from an approximately central point to an edge of said disc.  
   
   
       35 . The device of  claim 34 , wherein said slit is at a bias angle with respect to a central region of the disc.  
   
   
       36 . The device of  claim 35 , wherein said slit is at a bias angle of 45 degrees with respect to the central region of the disc.  
   
   
       37 . The device of  claim 21  further comprising a central non-slip etched area on a top surface of said disc.  
   
   
       38 . The device of  claim 21 , wherein said cut is at a bias angle with respect to a central region of the disc.  
   
   
       39 . The device of  claim 38 , wherein said cut is at a bias angle of 45 degrees with respect to the central region of the pad.  
   
   
       40 . A method for effecting hemostasis at a puncture wound with an indwelling tubular element extending therethrough, said method comprising: 
 A) applying pressure proximal to the puncture wound in order to at least partially prevent blood from exiting the puncture wound;    B) providing a closure pad having an application surface bearing a hemostatically effective amount of a hemostatic agent thereon, and wherein said pad defines an aperture therethough to permit egress of said indwelling tubular element through said pad, and includes a cut extending from said aperture to a peripheral point of said pad;    C) directing said pad toward the wound while guiding said cut about said tubular element until said tubular element is resident in said aperture and said application surface is disposed about and to the wound;    D) directing force against said pad sufficient to substantially prevent blood from exiting the puncture wound;    E) removing the pressure proximal to the puncture wound;    F) maintaining the force on said closure pad against the puncture wound for at least a first predetermined time period; and    G) removing the force on said closure pad upon verification of hemostasis.    
   
   
       41 . The method of  claim 40  further comprising the step of: 
 removing said pad while said tubular element remains in place.    
   
   
       42 . The method of  claim 40 , wherein the hemostatic agent comprises a cationic biopolymer of glucosamine,  
   
   
       43 . The method of  claim 42 , wherein the biopolymer of glucosamine is poly-N-acetylglucosamine.  
   
   
       44 . The method of  claim 42 , wherein the biopolymer of glucosamine is poly-D-glucosamine.  
   
   
       45 . The method of  claim 42 , wherein the biopolymer of glucosamine is an acetate salt of poly-N-acetylglucosamine.  
   
   
       46 . The method of  claim 42 , wherein the biopolymer of glucosamine is an acetate salt of poly-D-glucosamine.  
   
   
       47 . The method of  claim 42 , wherein the biopolymer of glucosamine is poly-N-acetylglucosamine and poly-D-glucosamine.  
   
   
       48 . The method of  claim 42 , wherein the biopolymer of glucosamine is an acetate salt of poly-N-acetylglucosamine and poly-D-glucosamine.  
   
   
       49 . The method of  claim 42 , wherein the biopolymer of glucosamine is an acetate salt of poly-N-acetylglucosamine and an acetate salt of poly-D-glucosamine.  
   
   
       50 . The method of  claim 42 , wherein the biopolymer of glucosamine is poly-N-acetylglucosamine and an acetate salt of poly-D-glucosamine.