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Phosphate Fibers is a singular detailed account of the discovery, chemistry, synthesis, properties, manufacture, toxicology, and uses of calcium and sodium calcium polyphosphate fibers. Author Edward J.

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Griffith-the inventor and developer of this …. This book is intended to be the first detailed review of this product. The numerous references …. The idea for this book came from discussions among participants in a symposium on biotechnical applications at the "Pacifichem 89" meeting in Honolulu. It was the majority opinion of this group that a volume dedicated to biotechnical and …. Striking a balance between the scientific and technological aspects of radiation curing, this work includes both a summary of current knowledge as well as many chapters which present the first comprehensive accounts of their subjects.

The traditional use of organic colorants is to impart color to a substrate such as textiles, paper, plastics, and leather. The application of enzymes or whole cells fermentatively active or resting; microbial, plant, or animal to carry out selective transformations of commercial importance is the central theme of industrial biocatalysis. This typically restarts the bleeding and is difficult for treating personnel to accomplish. Despite the potential complications and drawbacks, recent combat such as the Croatian conflict has verified the ability of tourniquets to delay shock in lower extremity arterial injuries.

While fibrin products such as fibrin glue, fibrin sealant and dry fibrin dressing have been developed and shown to be effective in stopping venous bleeding, such fibrin products do have drawbacks. Fibrin products have had a tendency to be washed from the wound during high pressure bleeding, relative high cost.

Some fibrin products put the patient at risk of viral exposure. Virally inactivated fibrin sealant has been developed, and is being used as an adjuvant to multiple types of surgery. Fibrin glue has been shown to be effective in speeding hemostasis along vascular graft suture lines. Fibrin glue has been tested as an adjuvant to surgery in the treatment of complex hepatic injury. Formulations of fibrinogen and thrombin containing dressings, and dry fibrin sealant dressings have been proposed and studied in pig models of vascular injury and grade V liver injury.

Dry fibrin sealant dressing was recently shown to be more effective than standard gauze in decreasing bleeding and maintaining blood pressure in ballistic injury. First, these products are relatively expensive because they are made from human blood requiring a large amount of starting materials and multiple purification processes. Second, although virally inactivated, the fibrinogen contained in the products comes from multiple human donors and cannot be considered totally safe in terms of viral transmission. Third, these products must be held in place until bleeding stops or the material may simply wash out of the wound.

The wash-out problem is especially seen when the bleeding is brisk as with arterial involvement. Thrombin-mediated polymerization of fibrinogen has been the staple of hemostat technology for decades. Indeed, a recent patent dealing with hemostat systems still focuses on this process. Also, treatment of bleeding external wounds also has not progressed much, with conventional treatments not offering much beyond simply covering the wound.

Most conventional dressings do little or nothing to promote hemostatis, prevent infection or relieve pain. Current bandages do little more than cover the wound and absorb fluids. There are emerging products that aid in hemostasis fibrin glue, fibrin sealant, dry fibrin, kitosan, etc. Another difficulty of conventional treatments for bleeding is that the patient loses much of his or her own blood, and transfusion is needed. Blood transfusion suffers from availability problems, purity concerns, etc.

None of the current technologies adequately address the problem of treating high pressure arterial bleeding. A tourniquet alternative that is effective, inexpensive, lacks viral risk, and can be easily administered such as by an army medic would be a medical advance. A solution is still sought to the problem of assuring hemostatis and homeostasis for a penetrating injury such as high-pressure bleeding combat wound until the patient such as a soldier can reach a hospital facility for definitive care. Additionally, better treatment of bleeding external wounds is timely.

Overall, better treatment of hemorrhage by the first responder would save lives, money and limbs, in military and civilian situations. Leakage such as bleeding may be stopped or reduced relatively quickly by pressure equalization comprising enclosing a region around the leak and applying direct-pressure in or around the leak. Notably, bleeding especially high-pressure bleeding from penetrating injuries such as combat wounds may be treated by applying direct pressure within the wound, especially by enclosing an area around the wound and applying direct pressure in that enclosed area.

Such direct-pressure application advantageously may be by a simple medical device such as a device administrable by a medic. An inventive medical device may be placed directly in the wound, where it stops high pressure bleeding. The acute dressing is both removable for a definitive treatment, and biodegradable if not removed such as because removal is not warranted. The inventive device is simple, easy to apply, much less expensive than other biological products, and does not expose the patient to viral contaminants.

The invention directly addresses the problem of high pressure by simulating the time honored treatment of direct pressure, particularly, pressure directly within the wound. The invention is particularly practical, in that four topics topics 1a, 1c, 1f, 1g of the nine research topics proposed in the hemorrhage control section of the Research on Combat Casualty Care program are addressed.

The inventive medical devices and methods may be used in compressible topic 1f and non-compressible topic 1a bleeding. Medical devices and methods according to the invention are suitable for replacing the tourniquet as the primary field hemostat used by the medic topic 1c. Because medical devices and treatment methods according to the invention are designed to avoid the ischemia associated with tourniquet use, they have no time limit on emergent use topic 1g.

Advantageously, the invention provides acute dressings and other medical devices that may be removed for definitive treatment while also being biodegradable if not removed. In order to accomplish these and other objects of the invention, in a first preferred embodiment, the invention provides a method of treating a fluid leak such as a bleeding wound , comprising inserting into the fluid leak a material swellable on contact with the leaking fluid.

In a second preferred embodiment, the invention provides a method of treating a bleeding wound, comprising applying direct pressure directly in the bleeding wound. Most preferably, direct pressure application continues until bleeding stops. In a third preferred embodiment, the invention provides 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.

Some aspects and features of the invention are now mentioned, without the invention being limited thereto. The inventive methods and devices in an especially preferred embodiment may include applying a back pressure in a confined space around and in the wound. In another especially preferred embodiment, the invention may include inserting a direct-pressure-applying substance or article into the wound and enclosing the wound with the direct-pressure-applying substance or article therein.

In a further especially preferred embodiment, the invention may include inserting a hemostatic substance or article into the wound and enclosing the wound such as by placing a dressing over the wound with the hemostatic substance or article therein.

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  8. Where the invention uses a hemostatic substance or article, in a particularly preferred embodiment, the hemostatic substance or article includes polymer fibers of diameter about 1 micron or less. In another particularly preferred inventive embodiment in which a hemostatic substance or article is used, the hemostatic substance or article swells upon contact with water molecules such as water molecules contained in blood leaving the wound.

    Where a hemostatic substance or article is used, the hemostatic substance or article may be lightly crosslinked. In a particularly preferred embodiment of the invention, a membrane or shell encloses the swellable material, hemostatic substance or article, or the like. Most preferably, the membrane or shell stiffens as the interior hemostatic substance or article or swellable material swells. The invention in a particularly preferred embodiment provides for using such as placing in a wound or disposing in a device a polymeric substance, such as a polymeric substance that is a microporous, hydrogel-forming polymer with rapid swelling kinetics.

    Preferably, the polymeric substance may be poly acrylamide , hydroxypropyl cellulose, or a hydrophilic material. The invention in a particularly preferred embodiment provides for placing a clot-inducing substance such as thrombin, batroxobin, reptilase, a fibrinogen activating enzyme, etc.

    With the invention, a liquid leak such as a bleeding wound, etc. The direct pressure to be applied may be generated by a swellable material, by pneumatic filling of a bladder, singly or in combinations thereof etc. Where a swellable material is used, the swellable material is selected based on the leaking liquid to which it will be exposed, such as blood in a patient, water in a plumbing system, etc. Most preferably, the swellable material absorbs at least 10 times its weight of the leaking liquid, such as, in the case of bleeding, about 10 times its weight of water.

    In a particularly preferred embodiment, the invention provides an exemplary method of treating a bleeding wound, comprising applying direct pressure directly in the bleeding wound, most preferably applying direct pressure in the range of about 50 to 90 mm Hg directly in a high-pressure bleeding wound such as a wound bleeding at about 60 to 90 mm Hg pressure.

    The wounds treatable by the invention include high-pressure bleeding wounds, compressible wounds, non-compressible wounds, external wounds, etc.

    Stopping Battlefield Bleeding

    The invention advantageously may be used for treating wounds bleeding in a range of about 60 to mm Hg, or higher, and also may be applied for treating low-pressure bleeding. In the case of high-pressure bleeding wounds, a preferred example of applying direct pressure directly in the bleeding wound is to insert a hemostatic i. By establishing around the wound a confined space, such as the wound covered with an elastic dressing, swelling of a swellable material enclosed therein may be used to produce a back pressure that advantageously stops or at least slows bleeding.

    By provision of such a back pressure within the wound, clot formation may be supported and enhanced, and high pressure arterial bleeding may be stopped or at least slowed, advantageously without compromising collateral blood flow as occurs with a constrictive treatment such as a tourniquet. The application of direct pressure preferably is pressure generated by swelling of at least one swellable material. The amount of pressure applied is in an amount for stopping or at least minimizing bleeding from the wound, preferably such as about 50 to 90 mm Hg pressure most preferably, about 80 mm Hg pressure generated from a swelling substance or article in four minutes or less most preferably about three minutes or less.

    Some polymer structures are shown in Table 2, below. As to the polymer size, preferable to use are polymer fibers of diameter about 10 microns or less, most preferably 1 micron or less. That small-diameter polymer fibers are particularly preferred may be seen by considering that, for a gel fiber, the contraction rate t is equal to a contraction rate constant c times the square of the diameter; this relationship may be used to evaluate particular polymer fibers such as fibers of particular diameters for whether they have rapid swelling kinetics.

    Electrospinning may be used to afford small diameter i. Starting materials suitable for electrospinning or electrospraying include elastomeric materials such as thermoplastic elastomers, such as segmented polyurethanes, ethylene-vinylene acetate EVA copolymer, etc. Biocompatible starting materials such as EVA copolymer are particularly preferred, and biocompatible starting materials that serve as a host for the delivery of a wide variety of small and large therapeutic molecules such as EVA copolymer are most preferred.

    Although theoretically non-biocompatible materials could be used if enclosed in an expandable impermeable membrane such as a syringe port , such a course is not preferred and to be avoided when the staring materials are to be used to formulate a system for wound treatment or other use on or in a patient. As shown in FIG. The starting material solution or melt A is preferably confined in any material formed into a nozzle with various tip bore diameters such as a disposable pipette tip , with a very thin source electrode 97 immersed in it.

    The collector 98 can be a flat plate, wire mesh, rotating metal drum or plate on which the polymer is wound, etc. The solution A to be spun or sprayed can be doped with various substances, such as, in the case of electrospun fibers, doping with various substances that can be released from the electrospun fibers.

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    7. The electrospinning process preferably is continued until a mat accumulates such as an EVA mat of approximate dimensions as desired, such as on the order of mm by mm, or cm by cm by length and width, and micrometers to millimeters for thickness. When a polymer is used as the swellable material, the polymer may be uncrosslinked or crosslinked, preferably crosslinked.

      Crosslinking can be accomplished during polymerization with the use of polyfunctional monomers such as bisacrylamide, or by treatment of the polymer with ionizing radiation e. Where electrospinning is carried out from solution or the melt using un-crosslinked polymers, preferably the polymer is treated with ionizing radiation. The swellable material may be provided for use with a leaking material in a variety of forms, such as a mat of a swelling material, a swelling material contained within a shell or membrane, a swelling material dispensed from a tube or aerosol, etc.

      The form used may be selected based on the characteristics of the leak to be treated, the likely treatment setting, etc. In the case of wound treatment, especially high-pressure wound treatment, the swellable material preferably is contained within a biocompatible, hemocompatible shell or membrane that permits the leaking liquid to pass through the shell or membrane to reach the swellable material.

      The shell or membrane is selected with regard to the leaking material such as blood , the swellable material, and any other treating material such as clotting promoters, antibiotics, analgesics, etc. Elastomeric polymers and hydrophilic, expansile polymers are particularly preferred as shells or membranes as they typically increase in stiffness when stretched due to chain orientation.

      A polymer-filled pouch that expands when exposed to blood can quickly halt bleeding.

      Such stiffening of the shell upon swelling of the interior hemostatic substance or article is desirable for generating back pressure. Preferably the to-be-used membrane is formed as a relatively flat bag, with relatively little unoccupied space around the swellable material. Loose-fitting placement of the swellable material within the membrane is preferred, corresponding to the expansion geometry.