Treatment for high pressure bleeding

Abstract

High-pressure bleeding wounds (and other bleeding wounds) may be treated by applying direct pressure directly in the bleeding wound, such as by applying a back pressure in a confined space around and in the wound. Certain substances and articles may be inserted into the wound, and the wound may be enclosed with that substance or article (such as a hemostatic substance, which may be polymeric), by swelling on contact with molecules (such as water molecules in the blood) encountered in the wound, generates the desired pressure to stop or at least reduce the bleeding without the detrimental effects of a tourniquet Clot-inducing substances may be introduced into the wound contemporaneously with direct pressure application directly in the wound. Compressible and non-compressible wounds are treated. Treatment stops bleeding without producing pressure injury or ischemic damage. Medical devices using this technology are provided, including removable, biodegradable, medic-administrable devices.

We claim:  
     
         1 . A method of treating a bleeding wound, comprising applying direct pressure directly in the bleeding wound.  
     
     
         2 . The method of  claim 1 , including applying a back pressure in a confined space around and in the wound.  
     
     
         3 . The method of  claim 1 , including inserting a direct-pressure-applying substance or article into the wound and enclosing the wound with the direct-pressure-applying substance or article therein.  
     
     
         4 . The method of  claim 1 , including inserting a hemostatic substance or article into the wound and enclosing the wound with the hemostatic substance or article therein.  
     
     
         5 . The method of  claim 4 , wherein the hemostatic substance or article includes polymer fibers of diameter about 1 micron or less.  
     
     
         6 . The method of  claim 4 , wherein the hemostatic substance or article swells upon contact with water molecules.  
     
     
         7 . The method of  claim 6 , wherein the water molecules are contained in blood leaving the wound.  
     
     
         8 . The method of  claim 4 , wherein the hemostatic substance or article is lightly crosslinked.  
     
     
         9 . The method of  claim 1 , including placing in the wound an article or substance that absorbs at least 10 times its weight of water.  
     
     
         10 . The method of  claim 4 , wherein the hemostatic substance or article being inserted into the wound is encased in a shell.  
     
     
         11 . The method of  claim 10 , wherein the shell stiffens as the interior hemostatic substance or article swells.  
     
     
         12 . The method of  claim 1 , wherein the bleeding wound is a high-pressure bleeding wound.  
     
     
         13 . The method of  claim 1 , wherein the pressure at which the wound is bleeding is in a range of about 60 to 140 mm Hg.  
     
     
         14 . The method of  claim 4 , wherein the hemostatic substance swells in water.  
     
     
         15 . The method of  claim 4 , wherein the hemostatic substance swells from an initial volume to a  10 -fold volume in one minute in a liquid.  
     
     
         16 . The method of  claim 15 , wherein the liquid is water.  
     
     
         17 . The method of  claim 4 , wherein the hemostatic substance generates at least 60 mm Hg pressure within three minutes of being placed in the bleeding wound.  
     
     
         18 . The method of  claim 4 , wherein the hemostatic substance swells in water and generates at least 60 mm Hg pressure within three minutes of being placed in the bleeding wound.  
     
     
         19 . The method of  claim 1 , including placing at least a polymeric substance in the wound.  
     
     
         20 . The method of  claim 19 , wherein the polymeric substance is a microporous, hydrogel-forming polymer with rapid swelling kinetics.  
     
     
         21 . The method of  claim 19 , wherein the polymeric substance is 
 (a) selected from the group consisting of poly(acrylamide) and hydroxypropyl cellulose; or    (b) a hydrophilic material.    
     
     
         22 . The method of  claim 19 , wherein the polymeric substance is contained within a membrane.  
     
     
         23 . The method of  claim 19 , wherein the membrane is flexible and highly porous.  
     
     
         24 . The method of  claim 1 , including placing directly in the wound a substance that swells at a rate of 100 to 300% volume increase per minute.  
     
     
         25 . The method of  claim 1 , including placing a clot-inducing substance in the wound.  
     
     
         26 . The method of  claim 25 , wherein the clot-inducing substance is 
 (a) selected from the group consisting of thrombin, batroxobin and reptilase; or    (b) a fibrinogen activating enzyme.    
     
     
         27 . The method of  claim 1 , including placing directly in the wound a substance that swells at a rate of 100 to 300% volume increase per minute and a clot-inducing substance.  
     
     
         28 . The method of  claim 1 , wherein the wound is compressible.  
     
     
         29 . The method of  claim 1 , wherein the wound is non-compressible.  
     
     
         30 . The method of  claim 1 , wherein direct pressure application continues until bleeding stops.  
     
     
         31 . The method of  claim 1 , wherein the amount of direct pressure is in the range of about 50 to 90 mm Hg.  
     
     
         32 . The method of  claim 1 , wherein the wound is suffered by a human patient.  
     
     
         33 . The method of  claim 1 , wherein the wound is a battlefield injury.  
     
     
         34 . The method of  claim 1 , wherein the wound is suffered by an animal.  
     
     
         35 . The method of  claim 1 , wherein the bleeding is stopped without producing pressure injury or ischemic damage.  
     
     
         36 . The method of  claim 2 , wherein the direct-pressure-applying substance or article is contained within an elastic hemocompatible shell and also included within the shell is at least one antibiotic and/or analgesic.  
     
     
         37 . The method of  claim 10 , wherein water molecules pass through the shell.  
     
     
         38 . The method of  claim 10 , wherein a clot-promoting substance is included within the shell.  
     
     
         39 . The method of  claim 3 , wherein enclosing the wound comprises placing a dressing over the wound.  
     
     
         40 . A medical device comprising a hemostatic substance placeable directly in a bleeding wound, wherein the wound is a compressible wound or a non-compressible wound.  
     
     
         41 . The device of  claim 40 , wherein the wound is a battlefield injury.  
     
     
         42 . The device of  claim 40 , wherein the bleeding is high pressure bleeding.  
     
     
         43 . The device of  claim 40 , wherein the device stops bleeding at bleeding pressures of up to about 60 to 90 mm Hg.  
     
     
         44 . The device of  claim 40 , wherein the device is removable.  
     
     
         45 . The device of  claim 40 , wherein the device is biodegradable.  
     
     
         46 . The device of  claim 40 , wherein the device when placed in a bleeding wound swells at a rate of about 100 to 300% volume increase per minute.  
     
     
         47 . The device of  claim 40 , wherein the device produces pressure of greater than about 60 mm Hg in a confined space.  
     
     
         48 . The device of  claim 40 , wherein the device is administrable by a medic.  
     
     
         49 . A medical device comprising a back-pressure generator placeable directly in a bleeding wound.  
     
     
         50 . The device of  claim 49 , wherein the back-pressure generator comprises a hemostatic substance or article.  
     
     
         51 . The device of  claim 49 , wherein the back-pressure generator comprises polymer fibers of diameter about 1 micron or less.  
     
     
         52 . The device of  claim 49 , wherein the back-pressure generator swells upon contact with water molecules.  
     
     
         53 . The device of  claim 49 , wherein the back-pressure generator swells upon contact with blood.  
     
     
         54 . The device of  claim 49 , wherein the back-pressure generator comprises a lightly cross-linked material.  
     
     
         55 . The device of  claim 49 , wherein the back-pressure generator absorbs at least 10 times its weight of water.  
     
     
         56 . The device of  claim 49 , including a membrane enclosing an interior hemostatic substance or article.  
     
     
         57 . The device of  claim 56 , wherein the membrane stiffens as the interior hemostatic substance or article swells.  
     
     
         58 . The device of  claim 49 , wherein the back-pressure generator swells from an initial volume to a  10 -fold volume in one minute in a liquid.  
     
     
         59 . The device of  claim 49 , including a polymeric substance.  
     
     
         60 . The device of  claim 49 , including a microporous, hydrogel-forming polymer with rapid swelling kinetics.  
     
     
         61 . The device of  claim 49 , including poly(acrylamide) and/or hydroxypropylcellulose.  
     
     
         62 . The device of  claim 49 , including a flexible, highly porous membrane.  
     
     
         63 . The device of  claim 49 , including a substance that swells at a rate of 100 to 300% volume increase per minute.  
     
     
         64 . The device of  claim 49 , including a clot-inducing substance.  
     
     
         65 . The device of  claim 49 , including thrombin, batroxobin, reptilase, or a fibrinogen activating enzyme.  
     
     
         66 . The device of  claim 49 , including a substance that swells at a rate of 100 to 300% volume increase per minute and a clot-inducing substance.  
     
     
         67 . The device of  claim 49 , wherein the back-pressure generator provides a pressure in the range of about 50 to 90 mm Hg.  
     
     
         68 . The device of  claim 49 , including an elastic hemocompatible shell and at least one antibiotic and/or analgesic within the shell.  
     
     
         69 . The device of  claim 49 , including a bladder within a porous membrane.  
     
     
         70 . The device of  claim 49 , including an impermeable inflatable bladder within a porous membrane.  
     
     
         71 . A method of treating a fluid leak, comprising inserting into the fluid leak a material swellable on contact with the leaking fluid.  
     
     
         72 . The method of  claim 71 , wherein the leaking fluid is a liquid.  
     
     
         73 . The method of  claim 71 , wherein the leaking fluid is blood.  
     
     
         74 . The method of  claim 71 , wherein the leaking fluid is water.  
     
     
         75 . The method of  claim 71 , wherein the leak is a plumbing leak.